pretrial statement

Transcription

pretrial statement

Case 2:12-cv-05201 Document 320 Filed 08/04/14 Page 1 of 25 PageID #: 13901
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF WEST VIRGINIA
AT CHARLESTON
IN RE: ETHICON, INC. PELVIC REPAIR
SYSTEM PRODUCTS LIABILITY
LITIGATION
Master File No. 2:12-MD-02327
MDL No. 2327
JOSEPH R. GOODWIN
U.S. DISTRICT JUDGE
THIS DOCUMENT RELATES TO:
Jo Beth Huskey, et al. v.
Johnson & Johnson, et al.
Case No.: 2:12-cv-05201
[PROPOSED]
JOINT PRETRIAL ORDER
In accordance with Local Rule of Civil Procedure 16.7(b) and Rules 16 and 26 of the
Federal Rules of Civil Procedure, and pursuant to Pretrial Order No. 127, Plaintiff Jo Huskey
(“Plaintiff”) and Defendants Ethicon, Inc. and Johnson & Johnson (“Ethicon”), by their
undersigned counsel, hereby respectfully submit the following [Proposed] Joint Pretrial Order for
the Court’s consideration:
I.
PRETRIAL DISCLOSURES REQUIRED BY FEDERAL RULE OF CIVIL
PROCEDURE 26(A)(3) AND OBJECTIONS THERETO
A.
Witnesses each party expects to present and may call if the need arises
1.
Names of witnesses Plaintiff expects to present at trial:
The final list of witnesses that Plaintiffs will present at trial is dependent on several
factors, including but not limited to any further pre-trial rulings by the court; Plaintiffs’ ability to
present certain witnesses whom they do not control for live testimony; and the Court’s time
limitations:
i.
ii.
iii.
iv.
Jo Huskey
Allan Huskey
Dr. Bruce Rosenzweig
Dr. Jerry Blaivas
v.
vi.
vii.
2.
Dr. Erin Carey
Scott Guelcher, Ph.D.
David Epperly
Names of witnesses Plaintiff may call if the need arises at trial:
i.
ii.
iii.
iv.
v.
vi.
3.
Gretchen Dean PT
Nancy Davidson
Dr. John Steege
Russell Dunn, Ph.D.
Abhay Pandit, Ph.D.
Any witness called by the Defendant
Ethicon’s objections, if any, to Plaintiff’s witness list:
Ethicon objects to any witness listed by Plaintiff testifying to that which is beyond what
is set forth in their report and insofar as said witness’s testimony has been excluded by the
Court’s rulings on Ethicon’s motions to exclude or in limine motions. In addition, Ethicon
objects to Plaintiff calling any fact witness or treating physician not previously identified or
made available for deposition.
4.
Names of witnesses Ethicon expects to present at trial:
The final list of witnesses that Ethicon will present at trial is dependent on several factors,
including (a) the witnesses that Plaintiff presents during her case-in-chief, (b) the Court’s rulings
on motions, and (c) the trial schedule and availability of Ethicon’s witnesses. Ethicon also
reserves the right to call any witness listed by Plaintiff. Subject to those considerations, Ethicon
presently expects to call the following witnesses at trial:
i.
ii.
iii.
iv.
v.
Daniel Sexton, M.D.
Christina Pramudji, M.D.
Plaintiff’s treating physicians:
a.
Gretchen Byrkit, M.D.
b.
Colleen Fitzgerald, M.D.
c.
James Harms, M.D.
d.
Elizabeth Mueller, M.D.
e.
Dele Ogunleye, M.D.
f.
Derin Rominger, M.D.
g.
Kenneth Schoenig, M.D.
h.
Bryan Yocks, M.D.
Plaintiff’s coworkers and friends:
a.
Bryan Jasker
b.
Ruth Teel
c.
Terry Ward
Ethicon employees:
a.
Piet Hinoul, M.D.
b.
Axel Arnaud, M.D.
5.
Names of witnesses Ethicon may call if the need arises at trial:
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
ix.
x.
xi.
xii.
xiii.
xiv.
xv.
xvi.
xvii.
xviii.
xix.
xx.
xxi.
xxii.
xxiii.
xxiv.
xxv.
xxvi.
xxvii.
xxviii.
xxix.
xxx.
xxxi.
xxxii.
xxxiii.
xxxiv.
xxxv.
xxxvi.
xxxvii.
xxxviii.
xxxix.
xl.
xli.
xlii.
xliii.
xliv.
Laura Angelini
Thomas Barbolt, Ph.D., DABT
Thomas A. Barocci, Ph.D.
Boris Batke
Catherine Beath
Dan Burkley
Peter Cecchini
Meng Chen, M.D.
Judi Gauld
James Hart, M.D.
Matthew Henderson
Kimberly Hunsicker
Joerg Holste
Michelle Irvin
Richard Isenberg, M.D.
Harry Johnson, M.D.
Gregory Jones
Scott Jones
Gene Kammerer
Brian Kanerviko
Aaron Kirkemo, M.D
Dan Lamont
Reynaldo Librojo
Susan Lin
Bryan Lisa
Brian Luscombe
Brett Marshall
Codi Marshall
Clint Marshall
Jim Mittenthal
Charles Nager, M.D.
Sean O’Bryan
Charlotte Owens, M.D.
Jennifer Paine
Paul Parisi
David Robinson, M.D.
Mark Schneider
Daniel Smith
Shelby Thames, Ph.D.
Timothy Ulatowski, M.S
David Weber, M.D., M.P.H.
Martin Weisberg, M.D.
Mark Yale
Wenxin Zheng, M.D.
xlv.
6.
Any other treating physician or health care provider identified in
the medical records for plaintiff Jo Huskey.
Plaintiff’s objections, if any, to Ethicon’s witness list:
Pursuant to Pretrial Order #127, Plaintiffs will serve their objections to Ethicon’s witness
list by August 14, 2014. Plaintiffs object to any witness listed by Ethicon testifying to that which
is beyond what is set forth in their report and insofar as said witness’s testimony has been
excluded by the Court’s rulings on Ethicon’s motions to exclude or in limine motions. In
addition, Plaintiffs object to Ethicon calling any fact witness or treating physician not previously
identified or made available for deposition. Finally, Plaintiffs object to testimony from
physicians who treated Mrs. Huskey for conditions not relevant to her TVT-O and resulting
pelvic pain, or conditions that Ethicon’s experts have been precluded from testifying about at
trial.
B.
Designation of witnesses whose testimony is expected to be presented by
means of deposition (whether videotaped or otherwise)
1.
Plaintiff
As with live testimony, the Plaintiffs’ final list for presentation by deposition will depend
on several factors, including but not limited to any further pre-trial rulings by the court, including
clarifications of rulings already made; Plaintiffs’ ability to present certain witnesses whom they
do not control for live testimony; and the Court’s time limitations:
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
ix.
x.
xi.
xii.
xiii.
xiv.
xv.
xvi.
xvii.
xviii.
xix.
xx.
2.
Dr. Gretchen Byrkit
Dr. Sohail Siddique
Gretchen Dean PT
Nancy Davidson
Dr. Derin Rominger
Michelle Irvin
Bryan Jasker
LauraAngelini
Thomas Barbolt, Ph.D., DABT
Dr. Meng Chen
Dr. James Hart
Brigette Helhammer
Dr. Piet Hinoul
Joerg Holste, DVM, Ph. D.
Dr. Richard Isenberg
Dr. Aaron Kirkemo
Dr. Bernd Klosterhalfen
Dr. David Robinson
Daniel Smith
Dr. Martin Weisberg
Ethicon
The final list of witnesses that Ethicon will present at trial via deposition is dependent on
several factors, including (a) the witnesses that Plaintiff present during her case-in-chief, whether
live or by deposition, (b) the Court’s rulings on motions, (c) the Court’s rulings on deposition
designations, and (d) the trial schedule and availability of Ethicon’s witnesses. Ethicon reserves
the right to designate deposition testimony for any witness presented at trial by the Plaintiff or
whose deposition is played by the Plaintiff. Ethicon also reserves the right to call via deposition
any witness listed by Plaintiff. Subject to those considerations, Ethicon may call the following
witnesses at trial via deposition:
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
ix.
x.
xi.
xii.
xiii.
xiv.
xv.
xvi.
xvii.
xviii.
xix.
xlvi.
xlvii.
xlviii.
C.
Peter Cecchini
Jim Hart, M.D.
Kim Hunsicker
Richard Isenberg, M.D.
Gene Kammerer
Aaron Kirkemo, M.D.
Dan Lamont
James Mittenthal
Charles Nager, M.D.
Sean O’Bryan
Charlotte Owens
Gretchen Byrkit, M.D.
Colleen Fitzgerald M.D.
James Harms, M.D.
Bryan Jasker
Elizabeth Mueller, M.D.
Dele Ogunleye, M.D.
Derin Rominger, M.D.
Kenneth Schoenig, M.D.
Ruth Teel
Terry Ward
Bryan Yocks, M.D.
Exhibits each party expects to offer, may offer if the need arises, and
objections thereto
1.
Plaintiff expects to offer or utilize the exhibits and/or documents identified
in the accompanying Attachment A.
2.
Ethicon’s objections to Plaintiff’s exhibit list will be provided on August
18, 2014, as provided in PTO #122.
3.
Ethicon expects to offer or utilize the exhibits and/or documents identified
in the accompanying Attachment B. This list does not include medical
literature or similar documents and materials that Ethicon may use with
the appropriate witnesses such as learned treatises.
II.
Ethicon may offer if the need arises the exhibits and/or documents
identified in the accompanying Attachment C. This list includes medical
literature and similar documents and materials that Ethicon may use with
the appropriate witnesses such as learned treatises.
5.
Plaintiffs’ objections to Ethicon’s exhibit list will be provided on August
18, 2014, as provided in PTO #122.
CONTESTED ISSUES OF LAW REQUIRING A RULING BEFORE TRIAL
A.
B.
III.
4.
By Plaintiff
1.
Any motions in limine or other evidentiary pretrial motions not yet filed.
2.
Plaintiffs’ Motion to Permit Live Trial Testimony Via Contemporaneous
Transmission
By Ethicon
1.
Defendants’ Omnibus Motions in Limine (Huskey Doc. 282)
2.
Defendants’ Motion to Exclude Evidence of Spoliation (Huskey Doc. 274)
3.
Defendants’ Motion to Limit Testimony of Erin Teeter Carey (Huskey
Doc. 275)
4.
Defendants’ Motion to Exclude Testimony by Scott Guelcher, Ph.D. in
Reliance on Documents Identified in his Supplemental Reliance List
Served August 1, 2014 and to Preclude Testimony other than Those
Opinions Contained in Dr. Guelcher’s Expert Report Served February 21,
2014 (Huskey Doc. 314)
5.
Defendants’ Motion to Exclude Testimony by Bruce Rosenzweig, M.D.,
on Matters Contained in his Fourth Supplemental Expert Report Served
July 31, 2014 and Accompanying Reliance List (Huskey Doc. 316)
6.
Defendants’ Motion to Deem Requests for Admissions Admitted, or
Alternatively, to Compel (MDL Doc. 1017)
7.
Defendants’ Motion to Exclude Certain Opinions of Jerry G. Blaivas,
M.D.
STATEMENT OF ESSENTIAL ELEMENTS THAT PLAINTIFF MUST
ESTABLISH FOR EACH CLAIM AND THE DAMAGES OR RELIEF SOUGHT,
ACCOMPANIED BY SUPPORTING LEGAL AUTHORITIES
A.
By Plaintiff
For this case, Plaintiffs have not disputed that Illinois law applies to liability issues and
New Jersey law applies to punitive damages issues. An explanation of the elements of each of
Plaintiffs’ claims, under the applicable state’s law, follows.
Claim I: Negligence
“A product liability action asserting a claim based on negligence, such as negligent
design, is based upon fundamental concepts of common law negligence…As in any negligence
action, a plaintiff must establish the existence of a duty, a breach of that duty, an injury that was
proximately caused by that breach, and damages.” Jablonski v. Ford Motor Co., 955 N.E.2d
1138, 1153 (Ill. 2011); Calles v. Scripto-Tokai Corp., 224 Ill. 2d 247, 270 (2007); Heastie v.
Roberts, 226 Ill. 2d 515, 556, (2007)). In Illinois, a manufacturer has a non-delegable duty to
design reasonably safe products. Calles, 224 Ill. 2d at 264. Additionally, a manufacturer of a
prescription medical device has a duty to warn prescribing physicians or other health
professionals who may prescribe the device of the product’s known dangerous propensities. See
Hansen v. Baxter Health Corp., 198 Ill. 2d 420, 430-32 (2002).
Strict Liability Counts:
To recover under strict liability in Illinois, a “plaintiff must prove that the injury or
damage resulted from the condition of the product, that the condition was an unreasonably
dangerous one, and that the condition existed at the time the product left the manufacturer’s
control.” Coney v. J.L.G. Industries, Inc., 97 Ill. 2d 104, 111 (1983); Woodill v. Parke Davis &
Co., 79 Ill. 2d 26, 31 (1980).
Claim II: Strict Liability – Failure To Warn
Under Illinois law, a product can perform as intended yet subject its seller to strict
liability if the seller fails to warn of a danger known to the seller but unanticipated by the
consumer. See, e.g., Solis v. BASF Corp., 979 N.E.2d 419 (Ill.App.Ct. 1st Dist. 2012). A
product is in a defective and unreasonably dangerous condition precisely because of the absence
of an adequate warning. Miller v. Rinker Boat Co., 815 N.E.2d 1219, 1240 (Ill.App.Ct. 4th Dist.
1986). To prove a product defect claim based on a defendant’s failure to warn, a plaintiff must
show ”that the defendant knew or should have known, in the exercise of ordinary care, that the
product was unreasonably dangerous and defendant failed to warn of its dangerous
propensity.” Solis v. BASF Corp., 979 N.E.2d 419, 443 (Ill.App.Ct. 1st Dist. 2012) (quoting Blue
v. Environmental Engineering, Inc., 215 Ill. 2d 78, 96, 828 N.E.2d 1128, 293 Ill. Dec. 630
(2005). Even if a manufacturer provides general information about risks in using a product,
Illinois law requires the manufacturer to warn of more specific failures or complications where
the manufacturer has more knowledge than members of the medical community (e.g.,
physicians). Moreover, “[d]octors who have not been sufficiently warned of the harmful effects
of a [device] cannot be considered ‘learned intermediaries’ and the adequacy of warnings is a
question of fact, not law, for the jury to determine….” Hansen v. Baxter Health Corp., 198 Ill. 2d
420, 432 (2002).
Claim III: Strict Liability – Design Defect
Illinois recognizes two tests for design defect claims. A plaintiff may establish a design
defect through either the “consumer expectation test” or the “risk-utility test.” Under the
consumer expectation test, a plaintiff may present “‘evidence that the product failed to perform
as safely as an ordinary consumer would expect when used in an intended or reasonably
foreseeable manner.’” Mikolajczyk v. Ford Motor Co., 231 Ill. 2d 516, 526 (2008) (citing
Lamkin v. Towner, 138 Ill. 2d 510, 529 (1990)). Alternatively, a plaintiff may prevail on a
design defect claim under the risk-utility test by proving “the product’s design proximately
caused his injury and the defendant fail[ed] to prove that on balance the benefits of the
challenged design outweigh[ed] the risk of danger inherent in such designs.” Id.
Claim IV: Punitive Damages
Under New Jersey law, punitive damages are determined by statute. The provisions of
N.J.S.A. § 2A:15-5.12 state in pertinent part as follows:
a. Punitive damages may be awarded to the plaintiff only if the plaintiff proves,
by clear and convincing evidence, that the harm suffered was the result of the
defendant’s acts or omissions, and such acts or omissions were actuated by actual
malice or accompanied by a wanton and willful disregard of persons who
foreseeably might be harmed by those acts or omissions. This burden of proof
may not be satisfied by proof of any degree of negligence including gross
negligence.
b. In determining whether punitive damages are to be awarded, the trier of fact
shall consider all relevant evidence, including but not limited to, the following:
(1) The likelihood, at the relevant time, that serious harm would arise from the
defendant’s conduct;
(2) The defendant’s awareness or reckless disregard of the likelihood that the
serious harm at issue would arise from the defendant’s conduct;
(3) The conduct of the defendant upon learning that its initial conduct would
likely cause harm; and
(4) The duration of the conduct or any concealment of it by the defendant.
Count V: Loss of Consortium
Loss of consortium encompasses loss of support and loss of society, which includes
companionship and sexual intercourse. Brown v. Metzger, 104 Ill. 2d 30, 34 (1984). Consortium
includes loss of a spouse’s companionship, happiness and society; it also includes material
services, elements of companionship, felicity and sexual intercourse, “all welded into a
conceptualistic unity.” Ford-Sholebo v. U.S., 980 F. Supp. 2d 917, 1002 (N.D. Ill. 2013) (citing
Dini v. Naiditch, 20 Ill. 2d 406 (1960)). “Although both loss of consortium and loss of society
are incapable of being measured with precision and particularity, a trier of fact must nevertheless
place a monetary value on these items.” Ford-Sholebo, 980 F. Supp. 2d at 1002.
B.
By Ethicon
Plaintiff brings the following claims:
1.
Failure to warn
2.
Design defect
3.
Negligence
4.
Punitive damages
5.
Loss of consortium
Failure to Warn
1.
To establish a claim for failure to warn, the Plaintiff must prove (1) that
there was a duty to warn, (2) that the defendant knew or should have
known that the product could cause the injury in question, (3) that the
warning was inadequate, and (4) that the inadequate warning was the
proximate cause of the plaintiff’s injuries. See Giles v. Wyeth, Inc., 500
F. Supp. 2d 1063, 1065 (S.D. Ill. 2007).
2.
Under the learned intermediary doctrine, the manufacturer’s duty to
warn is not to the patient, but to the prescribing physician. Id.
3.
“[T]here is no duty to warn of a risk that is already known by those to be
warned.” Proctor v. Davis, 682 N.E.2d 1203, 1211 (Ill. App. Ct. 1997);
see also Hansen v. Baxter Healthcare Corp., 764 N.E.2d 35, 42 (Ill.
2002) (“[A] prescription medical device manufacturer need not provide
a warning of risks already known to the medical community.”).
4.
Thus, “[n]o duty to warn arises where the risk of harm is apparent to the
foreseeable user, regardless of any superior knowledge on the part of the
manufacturer.” Sollami v. Eaton, 201 Ill. 2d 1, 772 N.E.2d 215, 221, 265
Ill. Dec. 177 (Ill. 2002).
5.
Under Illinois law, proximate cause is the cause “that, in the natural or
ordinary course of events, produced the plaintiff’s injury.” Richter v.
Village of Oak Brook, 958 N.E.2d 700, 709 (Ill. App. 2001) (citing Ill.
Pattern Jury Instructions Civil 15.01).
Design Defect
1.
To establish a claim for design defect, Plaintiff must prove: (1) a
condition of the product that results from design; (2) the condition made
the product unreasonably dangerous; (3) the condition existed at the time
the product left the defendant’s control; (4) the plaintiff suffered an
injury; and (5) the injury was proximately caused by the
condition. Salerno v. Innovative Surveillance Technology, Inc., 932
N.E.2d 101, 108 (Ill. App. Ct. 2010).
2.
To establish that the product is unreasonably dangerous, the plaintiff
may rely on either the consumer-expectation test or the risk-utility test,
or both. Huskey v. Ethicon, Inc., 2014 U.S. Dist. LEXIS 64789, 3-6
(S.D. W. Va. May 12, 2014) (citing Mikolajczyk v. Ford Motor Co., 231
Ill. 2d 516, 901 N.E.2d 329, 336 (Ill. 2008)).
3.
Under the consumer-expectation test, “the plaintiff may introduce
‘evidence that the product failed to perform as safely as an ordinary
consumer would expect when used in an intended or reasonably
foreseeable manner.’” Mikolajczyk, 901 N.E.2d at 336, 901 N.E.2d at
336 (quoting Lamkin v. Towner, 138 Ill. 2d 510, 563 N.E.2d 449, 457,
150 Ill. Dec. 562 (Ill. 1990)). In a case such as this where the learned
intermediary doctrine applies, the relevant consumer is the learned
intermediary, not the patient or the average layperson.
4.
Under the risk-utility test, the jury analyzes a range of factors, including:





the product’s utility to the user and to the public as a whole;
the likelihood that the product will cause injury and the probable
seriousness of the injury;
the product’s compliance with “design standards in the industry,
design guidelines provided by an authoritative voluntary
organization, or design criteria set by legislation or governmental
regulation”;
the instructions and warnings accompanying the product; and
the availability and feasibility of alternative designs at the time the
product at issue was manufactured.
Sosnowski v. Wright Med. Tech., Inc., 2012 U.S. Dist. LEXIS 41303 (N.D.
Ill. Mar. 27, 2012) (citing Mikolajczyk, 901 N.E.2d at 335, 352; Calles v.
Scripto-Tokai Corp., 864 N.E.2d 249, 260 (Ill. 2007)).
5.
Illinois has adopted comment k to the Restatement (Second) of Torts §
402A, which provides, in pertinent part, as follows:
there are some products which, in the present state of human
knowledge, are quite incapable of being made safe for their
intended and ordinary use. . . . Such a product, properly prepared,
and accompanied by proper directions and warning, is not
defective, nor is it unreasonably dangerous.
Restatement (Second) of Torts, § 402A, comment k at 353-54 (1965); see
also Lawson v. GD Searle & Co., 356 N.E.2d 779 (Ill. 1976); Glassman v.
Wyeth Labs., Inc., 238 Ill. App. 3d 533, 606 N.E.2d 338, 342, 179 Ill. Dec.
506 (Ill. App. Ct. 1992).
Negligence
In order to establish a cause of action for negligence under Illinois law, the
plaintiff must demonstrate: (1) a duty owed by the defendant to the
plaintiff; (2) breach of that duty; and (3) injury proximately caused by the
breach. Jones v. Chicago HMO Ltd. of Illinois, 191 Ill.2d 278, 294 (Ill.
2000) (negligence).
Punitive Damages
As this Court is aware, Ethicon’s position is that the New Jersey Products
Liability Acts bars punitive damages in this case. Because the Court has rejected
this position, Ethicon suggests that, while preserving its objection, in order to
establish a claim for punitive damages, Plaintiff must prove the following by
clear and convincing evidence to recover punitive damages under New Jersey
law:
i.
The harm suffered was the result of the defendant’s acts or
omissions; and
ii.
Such acts or omissions were actuated by actual malice or
accompanied by a wanton and willful disregard of persons who
foreseeably might be harmed by those acts or omissions.
N.J. Stat. 2A:15-5.12-4(a).
Loss of Consortium
1.
A loss of consortium claim “encompasses two basic elements of [the
marital] relationship: loss of support and loss of society, which includes
companionship and sexual intercourse.” Ford-Sholebo v. United States,
980 F. Supp. 2d 917, 1002 (N.D. Ill. 2013) (internal quotation marks and
citations omitted).
2.
A claim for loss of consortium is only actionable if the primary plaintiff
has shown both liability and damages. See Bergman v. U.S. Silica, 2006
U.S. Dist. LEXIS 76500 (S.D. Ill. Oct. 17, 2006)
Damages
1.
Compensatory Damages
Plaintiff may recover the following compensatory damages under Illinois law.
These damages must be proven with reasonable probability.
i.
Reasonable expenses for necessary medical care, treatment, and
services received by Plaintiff, sustained in the past and those that
are reasonably certain to be sustained in the future;
ii.
The value of earnings lost and the present value of the earnings
reasonably certain to be lost in the future.
iii.
Physical pain and suffering, emotional distress, sustained in the
past and that is reasonably certain to be sustained in the future; and
See Ill. PJC 30.04.01, 30.05, 30.05.01, 30.06, 30.07, 30.08
2.
Consortium Damages
Plaintiff may recover the following damages for his loss of consortium claim:
(i)
Loss of support provided by Ms. Huskey. Ford-Sholebo v. United
States, 980 F. Supp. 2d 917, 1002 (N.D. Ill. 2013) (internal
quotation marks and citations omitted).
(ii)
Loss of society, including loss of companionship and sexual
intercourse. See id.
Punitive damages are not allowed on a loss of consortium claim. Hammond v.
North Am. Asbestos Corp., 97 Ill.2d 195, 454 N.E.2d 210, 73 Ill.Dec. 350 (1983).
3.
Punitive Damages
If and only if the Court determines that punitive damages may be considered,
factors that the jury may consider when deciding on an amount of punitive
damages include:
i.
Likelihood, at the relevant time, that serious harm would arise
from the defendant’s conduct;
ii.
The defendant’s awareness or reckless disregard of the likelihood
that the serious harm at issue would arise from the defendant’s
conduct;
iii.
The conduct of the defendant upon learning that its initial conduct
would likely cause harm;
iv.
The duration of the conduct or any concealment of it by the
defendant;
v.
Profitability of the misconduct to the defendant;
vi.
When the misconduct terminated; and
vii.
The financial condition of Ethicon at the time of the wrongdoing
up through the time of judgment, meaning its ability to pay.
See Tarr v. Ciasull’s Auto Mall, 943 A.2d 866 (N.J. 2008); N.J. Stat. Section
2A:15-5.12(b))(1)-(4) and (c)(2)-(4); Herman v. Sunshine Chem. Specialties, 133
N.J. 329, 345 (1993).
Any punitive damages should be measured by product sales in the pertinent
geographical area, and any award of punitive damages must bear a reasonable
relationship to the award of compensatory damages. See State Farm v. Campbell,
538 U.S. 408, 422 (2003); BMW of N. Am. v. Gore, 517 U.S. 559, 580-81 (1996).
IV.
STATEMENT OF ESSENTIAL ELEMENTS THAT ETHICON MUST
ESTABLISH IN SUPPORT OF ANY MERITORIOUS DEFENSES,
ACCOMPANIED BY SUPPORTING LEGAL AUTHORITIES
A.
By Ethicon
1.
B.
By Plaintiff
1.
V.
As noted above, to preserve the issue for appeal, Ethicon will continue to
raise the defenses of immunity from punitive damages and preemption of
claims regarding the composition of the mesh, which the Court has
rejected at the summary judgment stage. Huskey v. Ethicon, 2014 U.S.
Dist. LEXIS 92315 (S.D. W. Va. July 8, 2014).
Ethicon seeks to “preserve for appeal” its assertions relating to immunity
from punitive damages and preemption of claims regarding the
composition of the mesh. Plaintiffs refer the Court to its rulings on these
issues during the summary judgment stage (Huskey v. Ethicon, 2014 U.S.
Dist. LEXIS 92315 (S.D.W.Va. July 8, 2014), and incorporate by
reference the arguments presented in opposition to Ethicon’s prior
motions.
BRIEF SUMMARY OF MATERIAL FACTS AND THEORIES OF LIABILITY
OR DEFENSE
A.
Plaintiff’s Summary of Material Facts and Theories
In the 1990s, Ethicon, Inc., a division of Johnson & Johnson, began developing a mesh
product that was designed to treat stress urinary incontinence. In 1997, Ethicon submitted its
510(k) application to the FDA for the first of these products, called “Tension Free Vaginal Tape
(‘TVT’).” The device was a huge success financially. After enjoying 5 years of financial success
with this product, Ethicon was beginning to face competition from other medical device
companies. It was at this time, in 2002, that Ethicon developed their second product to treat
stress urinary incontinence, called “TVT-O.” In 2002, some French scientists developed a new
procedure to treat stress urinary incontinence. This procedure used a new and different surgical
approach than previous treatments for stress urinary incontinence—an approach which was
thought to be safer than previous surgeries. This approach was known as the “transobturator”
approach, because the surgeon would implant the device through an area of the pelvic floor
called the Obturator Membrane. Ethicon’s competitors were beginning to develop their own
transobturator products at this time. Ethicon was concerned about losing market share to these
competitors, and therefore Ethicon decided to develop their TVT-O product and get it on the
market as quickly as possible.
However, the TVT-O product (and its placement) also presented serious safety risks. The
mesh is made of polypropylene, with other additives, plus tools to aid with implantation. The
mesh will “rope and curl” and deform with very little tension. According to Ethicon’s own
internal documents, the mesh is a heavyweight mesh with small pores and a large surface area.
When the mesh is implanted, it causes a foreign body reaction that lead to inflammation and
scarring around the mesh fibers. Consultants for Ethicon, including Dr. Bernd Klosterhalfen,
warned that he use of heavyweight, small-pore mesh increased the foreign body response,
causing danger to the patient. But Ethicon has continued to use that mesh in the TVT-O product.
Other alternatives were available (and more were being developed), and relevant meaningful
information was not shared with physicians and, ultimately, Mrs. Huskey.
There are other complications associated with the TVT-O product. There are substantial
amounts of bacteria in the vaginal region, and placing a polypropylene mesh in that area can lead
to infection. The polypropylene material in the TVT-O product is also subject to shrinkage,
degradation, and other undesirable characteristics that lead to conditions such as chronic pelvic
pain, erosions, and urinary and sexual dysfunction.
After the TVT-O device was launched onto the market, Ethicon engaged in a substantial
TVT-O marketing campaign. Ethicon provided material to physicians espousing extremely low
complication rates, and extremely high efficacy rates associated with the TVT-O product.
Ethicon brochures for the TVT-O device all include the following statements: recovery is quick;
patients should be back to a regular or normal routine after the procedure; this is a one-time
treatment that is “minimally invasive;” “few patients experience complications;” and there
should be very little discomfort after the procedure. Ethicon brochures for the TVT-O device
also noted that the device was “used to treat over 1 million women worldwide.” However, this
figure includes the sale of several different TVT devices and is not specific to the TVT-O device.
Ethicon also included the statement “trusted in over 1 million patients” in TVT-O brochures.
However, this statement falsely represents that there have been over 1 million patients satisfied
with the TVT product and no such data exists. The Ethicon brochures omit details of several
risks and potential complications, including: pelvic pain, dyspareunia (pain with sexual
intercourse), severity of complications, permanency of complications, and the risk that the mesh
cannot be removed in the event of complications. Additionally, the data Ethicon relied on for
many of these claims came from studies by investigators with an interest in the outcome of the
studies.
To exacerbate the problem, Ethicon did not inform physicians or patients about the
numerous safety issues associated with the TVT-O product. The Instructions for Use for the
TVT-O product failed to warn about specific complications, such as roping and curling of the
mesh; degradation of the mesh, resulting in injuries; or problems associated with using smallpore, heavy-weight mesh. Also, while Ethicon warned generally of the risk of infection, it failed
to distinguish between a surgical infection and a mesh infection. In additional to excluding
specific complications, the TVT-O IFUs also failed to include the permanency and severity of
complications associated with the use of the TVT-O device. The TVT-O IFU notes only that the
body’s “transitory” response to the mesh may lead to erosion, exposure, or inflammation, despite
Ethicon having knowledge that these complications can be ongoing and chronic. Finally, Ethicon
knew that the polypropylene used in the TVT-O had been found to be cytotoxic, but it failed to
inform physicians of these risks.
Additionally, Ethicon continued to sell the TVT-O device despite knowing that by 2010,
it had a product, the Abbrevo, that had less mesh and less foreign body. Therefore, according to
Ethicon, the Abbrevo had the potential to cause, among other things, less chronic and persistent
pain. Ethicon also failed to inform all physicians and their patients about the Abbrevo or that it
had a product that used less mesh and could possibly reduce problems related to the mesh. As a
result, Ms. Huskey was never made aware of the Abbrevo.
The mesh used in the TVT-O product is the “old construction” hernia mesh developed by
Ethicon in 1974. Ethicon continued to use this heavyweight, small pore mesh even after Ethicon
had access to safer mesh. By the early 2000s, Ethicon had access to lighter weight, larger pore
meshes that were much safer for patients, yet for marketing and business reasons Ethicon
continued selling the old construction mesh in the TVT-O. One patient who received the “old
construction” TVT-O mesh was Jo Huskey.
Mrs. Huskey is a 54-year-old resident of Maroa, Illinois, where she lives with her
husband of seven years. Her home of Maroa, Illinois is a small town of fewer than 2,000
residents in central Illinois. Mrs. Huskey lives in a rural home, where she enjoys taking care of
her two dogs. She is no longer physically active, despite a former highly active lifestyle, and has
had to give up her job as a physical therapy assistant, due in part to the pain and complications
caused by the TVT-O product.
In 2011, Mrs. Huskey was first diagnosed with stress urinary incontinence. Dr. Gretchen
Byrkit implanted Ethicon’s TVT-O mesh product—the heavyweight, small-pore mesh—into
Mrs. Huskey in February of 2011. Unfortunately, the surgery did not solve Mrs. Huskey’s
problems. In March of 2011, Mrs. Huskey was suffering from painful and severe complications
(pelvic pain and dyspareunia) and presented to Dr. Byrkit with exposed mesh on her right side.
Dr. Byrkit attempted to surgically repair the mesh exposure; however, Mrs. Huskey subsequently
experienced another erosion. When Mrs. Huskey suffered that second mesh erosion, she
attempted to live with the pain, but ultimately could not do so. At that time, Dr. Byrkit referred
Mrs. Huskey to Dr. Sohail Siddique.
In November 2011, Dr. Siddique performed surgery to remove Mrs. Huskey’s TVT-O
mesh. Dr. Siddique saw so much eroded and edematous tissue during the procedure, that he
thought his only option was to remove the entire mesh. Dr. Siddique, therefore, cut into Mrs.
Huskey’s vaginal wall and up into her groin where the mesh was infected and partially
incorporated. Unfortunately, a portion of the mesh had retracted behind Mrs. Huskey’s pubic
bone and was unable to be removed. Since then, Mrs. Huskey continues to suffer from severe
and chronic pelvic pain. All of this impacts her mentally and physically. She suffers from
dyspareunia that will last for days after sex (if she is able to have intercourse at all) as well as
depression. She is extremely physically debilitated and can no longer work—leading to large
economic losses.
In this case, Plaintiffs will ask the jury to hold Ethicon responsible for selling the TVT-O
and marketing it as a safe product when Ethicon knew or should have known that the TVT-O
was unreasonably dangerous. Ethicon was also negligent in failing to ensure the safety of the
TVT-O before subjecting thousands of women, including Mrs. Huskey, to significant risk.
Finally, Ethicon failed to adequately warn Mrs. Huskey and her treating physician of the risks
and complications of the TVT-O and its procedure.
Plaintiffs will ask the jury to compensate Mrs. Huskey for her injuries, which have
impacted her daily life in many significant ways. They will also ask the jury to punish Ethicon
for its corporate conduct in misleading Mrs. Huskey. Ethicon marketed the TVT-O product as
safe and effective, and convinced physicians of the same, even though Ethicon knew that the
mesh could lead to potentially severe complications. Therefore, Ethicon should be punished to
deter it, and possibly others, from bringing medical devices to market without adequately
ensuring their safety, and without adequately warning physicians and their patients about the
device’s hazards.
B.
Ethicon’s Summary of Material Facts and Theories
i.
Summary of Facts
Plaintiff Jo Huskey claims injuries from TVT-O including mesh erosion, pelvic
pain, dyspareunia (pain with sex), infection, scarring, loss of sleep and depression.
Ethicon manufactures and markets the TVT-O device, which is a mesh tape called a
“sling,” placed under the urethra to address stress urinary incontinence.
The PROLENE* Polypropylene Mesh tape in the TVT-O device, which is the
only part left in the body, is constructed of knitted filaments of extruded polypropylene
strands identical in composition to that used in PROLENE polypropylene non-absorbable
surgical suture. The FDA approved Prolene polypropylene as safe and effective as a
drug, and it was eventually categorized as a Class III medical device. Devices such as
TVT-O are Class II devices which FDA recognizes as having reasonable assurances of
safety and efficacy.
Mrs. Huskey, who resides in Illinois, began complaining to her healthcare
providers about urinary incontinence in 2008. Her records document complaints in
March 2008. In June 2008, Mrs. Huskey expressed concern to one of her healthcare
providers about frequent urinary urgency and an incident of leakage at work. She tried
pelvic floor exercises without success. In October 2009, Mrs. Huskey again complained
to her doctor of urinary incontinence. She told her doctor that she had this condition for
“many years.” It was not until 2010, however, that Mrs. Huskey sought a surgical
solution for her urinary incontinence.
Before surgery to manage stress urinary incontinence, Mrs. Huskey had a history
of two vaginal deliveries, one of which involved the use of forceps and led to tearing in
the pelvic area. She had worked as a physical therapy assistant and had injured her back
and sacroiliac joint on multiple occasions from lifting patients. Indeed, even after two
back surgeries, Mrs. Huskey continued to experience low back pain from lifting patients
in 2009 and afterwards.
Mrs. Huskey’s medical records document a long history of severe and chronic
abdominal pain; low back pain which radiated into her right buttock, thigh, calf and foot;
pelvic pain; pain with sex; vaginal infections; degenerative joint disease; herniated disc at
L5-S1; episodes of “unrelenting” epigastric pain; gastroesophageal reflux disease
(described as a 10 out of 10 on the pain scale); gastric ulcers secondary to her
nonsteroidal anti-inflammatory drugs; chronic constipation; irritable bowel syndrome;
diverticulitis, hypothyroidism; insomnia; depression; and symptoms of menopause.
Mrs. Huskey had her first office visit with Dr. Gretchen Byrkit, a board certified
gynecologist, on January 27, 2011. She was 51 years old and complained of menopausal
symptoms, painful urination, urinary frequency, depression, left lower quadrant pelvic
pressure mainly after intercourse, and “constant” vaginal irritation. She experienced
urine leakage when she laughed, coughed, sneezed, and performed other activities. Mrs.
Huskey had tried years of conservative management of her stress urinary incontinence,
which had not worked for her. She wanted other options.
Dr. Byrkit recommended TVT-O surgery to treat Mrs. Huskey’s stress urinary
incontinence. Dr. Byrkit knew and documented the risks of TVT-O in her records.
These risks included hemorrhage, infection, damage to internal organs, including the
bowel, bladder, blood vessels, and ureters, death, mesh erosion, or that mesh could be
seen through the skin of the vagina, that there were some patients who were not helped
by the procedure and that they would need to have further work-up and treatment,
bladder perforation, damage to the urethra, risk of overcorrection, which could result in
need to self-catheterize to eliminate urine; need for further surgery; scarring; need to
remove the device, and pain, whether there was mesh erosion or not. Dr. Byrkit
understood that the potential risks and complications could range from mild to severe and
from temporary to permanent, and that passage of the trocars through the tissues in the
groin area could cause pain. Dr. Byrkit has never used TVT-Abbrevo.
During the procedure on February 23, 2011, Dr. Byrkit noted that the mesh had
“buttonholed” through the vaginal mucosa, which is a known complication. Dr. Byrkit
reinserted the product without complication. Mrs. Huskey had temporary groin pain after
the implant, another known complication. Within ten days of implant, Mrs. Huskey
experienced heavy vaginal bleeding after engaging in vacuuming, grocery shopping, and
washing the dog. She had also started a new job as a physical therapy assistant.
Bleeding is another known complication. At the first post-op visit on March 9, 2009, Dr.
Byrkit palpated mesh on the right side. Dr. Byrkit observed a small mesh exposure on
subsequent post-op visits. Mesh exposure and erosions are known complications. On
June 29, 2011, Dr. Byrkit sewed the vaginal mucosa over the exposed mesh. Mrs.
Huskey continued to have mesh exposure. Dr. Byrkit referred Mrs. Huskey to Dr. Sohail
Siddique, a urogynecologist. On November 18, 2011, Dr. Siddique removed the mesh.
He found that there was no evidence of mesh, sutures or foreign body in the urethra.
Mrs. Huskey has not had mesh exposure or erosion since Dr. Siddique’s surgery.
While Mrs. Huskey’s mesh exposure was on the right side, Mrs. Huskey reports
pelvic pain on her left side. She continues to have low back pain, degenerative joint
disease, and sacroiliac joint pain.
Mrs. Huskey claims that she can no longer work at her job as a physical therapist
assistant. None of her doctors have advised her not to continue in that position, and the
Social Security Administration has denied her claim for disability benefits.
ii.
Theories and Defenses
Plaintiff contends that Ethicon failed to warn of the risks of the TVT-O and that
the TVT-O was defectively designed. For the following reasons, Ethicon denies these
allegations in their entirety and denies liability to Plaintiff under any theory of recovery.
Ethicon further denies that TVT-O, or any action or inaction on Ethicon’s part, caused or
contributed to Ms. Huskey’s alleged damages.
Failure to Warn
Plaintiff cannot establish a claim for failure to warn under Illinois law.
First, each one of the complications Plaintiff alleges in this case were warned of
or known by Dr. Byrkit and the medical community. Under the learned intermediary
doctrine, the duty to warn runs not to the Plaintiff, but to the implanting physician, and
there is no duty to warn of risks that are known within the medical community.
In addition, Plaintiff cannot show that any purported failure to warn was the cause
of her injuries. Specifically, the IFU was not material to Dr. Byrkit’s decision to
prescribe the TVT-O for Ms. Huskey. Though Dr. Byrkit testified that she uses the same
implantation procedure described in the IFU, that is not tantamount to her relying on the
IFU in connection with Ms. Huskey’s treatment. Further, Plaintiff cannot establish that
an allegedly adequate warning would have changed Dr. Byrkit’s decision to implant the
TVT-O. Plaintiff claims that Dr. Byrkit would not have used the device had she known it
was not appropriate for active, exercising women. This supposed contraindication does
not exist, as neither medical evidence nor expert testimony establishes that the device is
not appropriate for use in active, exercising women. Finally, she cannot establish that
each of her alleged injuries was the result of the TVT-O.
Design Defect
Plaintiff cannot show that the TVT-O was defectively designed. It has been and
remains the “gold standard” for treatment of stress urinary incontinence, and has been
deemed safe and effective by regulators and practitioners alike. It has been successfully
used to treat stress urinary incontinence in many women, its benefits outweigh its risks,
and it has performed as expected. Further, Plaintiffs cannot show a safer alternative
design or that any alleged design defect was the cause of Ms. Huskey’s injuries.
Negligence
Plaintiff’s claim for negligence is based on the same series of facts and duties as
her claims for failure to warn and design defect. Thus, it fails for the same reasons
Plaintiff’s strict liability claims fail.
Loss of Consortium
Mr. Huskey’s claim for loss of consortium is dependent on the success of at least
one of Ms. Huskey’s claims. Because Ms. Huskey’s claims are without merit, the loss of
consortium claim also fails.
Punitive Damages
Punitive damages are not appropriate in this case. Ethicon at all times acted in
good faith based on FDA’s approval of PROLENE, FDA’s classification of surgical
mesh based on its safety and effectiveness, FDA’s clearance of TVT-O, FDA’s review
and determination that TVT-O and similar products are safe and effective, and reasonable
scientific evidence. Ethicon has complied with government regulations. There is no
malice or wanton or willful misconduct shown.
VI.
SINGLE LISTING OF CONTESTED ISSUES OF FACT AND ISSUES OF LAW,
TOGETHER WITH CASE AND STATUTORY CITATIONS
A.
By Plaintiff
Issues of fact:

Whether Ethicon breached the applicable standard of care for medical device
manufacturers.

Whether the TVT-O product had a design defect that made it unreasonably
dangerous.

Whether Ethicon failed to warn of the risks of the TVT-O product.

Whether Ethicon’s actions or inactions caused damage to Jo Huskey.

Whether Ethicon’s actions or inactions cased damage to Allan Huskey.

A calculation of the value of the Huskey’s damages, including economic and noneconomic damages.

Whether Ethicon engaged in either actual malice or willful or wanton conduct that
foreseeably led to harm by Jo and Allan Huskey; and

If “yes” to the above, what amount should Ethicon have to pay in punitive
damages?
Issues of law:
For case citations to the applicable law, please see Section III above:

Whether Ethicon should be held liable for negligence because its conduct in the
testing, design, sale and/or marketing of the TVT-O device fell below the
applicable standard of care, thereby causing harm to Mrs. Huskey.

Whether Ethicon should be held negligent and/or strictly liable because of its
conduct in the failure to warn of the risks of the TVT-O device.

Whether Ethicon should be held strictly liable for defective design because its
product was unreasonably dangerous and caused harm to Mrs. Huskey.

If liability is established based on any of the grounds stated above, whether
Ethicon should also be held liable to Mr. Huskey for loss of consortium, based on
loss of society, comfort, companionship, sexual relations, and other aspects of the
marital relationship

If liability is established based on any of the grounds stated above, whether
Ethicon should also be held liable for punitive damages, given that it had
knowledge of substantial risks associated with the TVT-O, and yet it continued to
sell the product, and it did not warn physicians or patients about many of the risks
B.
By Ethicon
Ethicon reserves the right to identify different/ additional issues of fact or law in
response to Plaintiff’s case at trial.
The following issues of fact:
i.
Whether Plaintiff has proven by a preponderance of the evidence that she
sustained harm as a result of the TVT-O device.
ii.
Whether Plaintiff has proven by a preponderance of the evidence that Dr.
Byrkit was not adequately warned of the risks of the device.
iii.
Whether Plaintiff has proven by a preponderance of the evidence that a
different warning would have altered Dr. Byrkit’s prescription decision.
iv.
Whether Dr. Byrkit knew the risks associated with TVT-O.
v.
Whether Plaintiff has proven by a preponderance of the evidence that the
TVT-O device was designed in a defective manner at the time it left
Ethicon’s control.
vi.
Whether Plaintiff has proven by a preponderance of the evidence that, as a
result of the alleged design defect, her TVT-O device failed to function as
expected by surgeons prescribing and implanting the device.
vii.
risks of the TVT-O outweigh its benefits.
viii.
alleged defective condition or failure to warn rendered the TVT-O device
unreasonably dangerous in the view of surgeons trained in the treatment of
stress urinary incontinence.
ix.
alleged defective and unreasonably dangerous condition of the TVT-O
device was a producing cause of her alleged damages.
x,
Whether Plaintiff has proven a safer alternative design for TVT-O existed
at the time she received her implant.
xi.
Whether a surgery involving an autologous fascial sling qualifies as a
safer alternative design for TVT-O.
xii.
Whether Ethicon reasonably relied upon pre-clinical, clinical, and other
studies and experience, including regulatory experience, with Prolene
polypropylene sutures and mesh in developing and selling TVT-O.
xiii.
Whether Ethicon have acted with actual malice or accompanied by a
wanton and willful disregard of persons who foreseeably might be
harmed. N.J. Stat. 2A:15-5.12-4(a).
The following issues of law:
i.
Whether the failure to warn of the risks of the TVT-O was a producing
cause of Plaintiff’s alleged injuries.
VII.
ii.
Whether a defective design of TVT-O was a producing cause of Plaintiff’s
alleged injuries.
iii.
Whether Plaintiff’s design claims that arise out of the composition of
Prolene polypropylene are preempted.
iv.
Whether Comment k bars Plaintiff’s design defect claims.
v.
Whether Ethicon is immune from punitive damages under the New Jersey
Products Liability Act (NJPLA).
vi.
Whether Plaintiff has proven by clear and convincing evidence that they
are entitled to punitive damages.
STIPULATIONS
A.
The parties stipulate to the authenticity of exchanged medical records (while
reserving all other objections).
B.
The parties stipulate to the authenticity of any document authored by an Ethicon
employee that was produced by Ethicon in this litigation and bears an Ethicon
Bates number.
C.
The parties stipulate that they will not refer to Plaintiff’s fee agreement and/or
who is responsible for expenses incurred in connection with the litigation.
D.
The parties stipulate that they will not suggest that a recovery from this action
may or may not be subject to federal income tax or any other tax.
E.
The parties stipulate that they will not suggest that other women have had their
mesh removed due to, or for the purpose of furthering, litigation.
F.
Unless evidence is uncovered and presented that it occurred in Ms. Huskey’s case,
the parties stipulate that they will not refer to testimony or evidence regarding
“funding companies” who may be working with physicians and/or attorneys
regarding mesh removal surgeries.
G.
The parties stipulate that they will not directly or indirectly attack the American
Court System, plaintiffs’ attorneys, defense attorneys, or recent tort reform
campaigns, and that they will not refer to a purported “litigation crisis,” “lawsuit
crisis,” “lawsuit abuse,” “litigious society,” or similar terms or phrases.
H.
The parties stipulate that they will not suggest that a verdict for Plaintiff will
adversely impact medical device companies’ incentive and/or ability to develop
new devices.
I.
The parties stipulate that they will not suggest that damage awards may drive up
the price of products, make products less readily available, put manufacturers out
of business, or cause jobs to be lost.
J.
The parties stipulate that they will not refer to the effect of litigation on the cost of
purchasing or maintaining insurance.
K.
The parties stipulate that they will not comment or make any suggestion about the
existence of the PSC, the fact that there is a group of lawyers representing injured
women who are cooperating to prosecute these cases, or the size of Ethicon’s
defense team.
L.
The parties stipulate that they will not offer any evidence, comment, or inference
concerning other pending civil actions alleging injury from pelvic repair products,
including the number of pending cases. If Plaintiffs believe Defendants have
opened the door to such evidence, counsel will address the matter with the Court
and defense counsel prior to offering such evidence.
M.
The parties stipulate that they will not use deposition video clips in their opening
statements.
N.
The parties stipulate that they will not use the video featuring Dr. Todd Heniford
entitled, “The Benefits of Lightweight Meshes in Ventral Hernia Repair.” If
Plaintiffs believe Defendants have opened the door to such evidence, counsel will
address the matter with the Court and defense counsel prior to offering such
evidence.
O.
The parties stipulate that they will not refer to the recall of the Protegen device.
P.
The parties stipulate that they will not refer to MSDS sheets from other suppliers
or any MSDSs that suggest polypropylene causes cancer.
Q.
The parties stipulate that they will not refer to the 483 action that preceded the
hiring of Meng Chen as postmarket surveillance director.
R.
The parties stipulate that they will not refer to the following:
a.
Criminal guilty pleas and fines, such as that relating to the drugs Topamax
or Risperdal;
b.
State attorney general actions, such as an Oregon attorney general action
relating to the over-the-counter drug Motrin and the multiple attorney
general actions relating to the drug Risperdal;
c.
Consent decrees with the U.S. Department of Justice or FDA, such as that
regarding various McNeil manufacturing plants;
d.
Settlements or fines with the U.S. Department of Justice or Securities and
Exchange Commission, such as any settlement related to the drug
Risperdal, the entity Omnicare, Inc., and overseas activities, including any
reserves set aside for settlement payments; and
e.
Any investigations or proceedings by any political bodies or enforcement
agencies, such as investigation relating to the drug Doribax or the
congressional investigation into over-the-counter McNeil drugs.
S.
The parties anticipate that they will reach an agreed stipulation concerning the net
worth of Ethicon and Johnson and Johnson.
T.
The parties anticipate that that they will reach an agreed stipulation concerning
the total sales of TVT-O in the State of Illinois and/or the United States.
U.
Stipulation Regarding Corporate Structure and Related Issues (PTO 63, MDL
Doc. 756).
V.
The parties will discuss whether they can reach any evidentiary stipulations that
would aid the advancement of trial.
VIII. SUGGESTIONS FOR THE AVOIDANCE OF UNNECESSARY PROOF AND
CUMULATIVE EVIDENCE
A.
Joint Suggestions
None at this time.
B.
By Plaintiff
Plaintiffs are aware of this Court’s prior statements regarding avoiding duplication and
promoting efficiency at trial. Plaintiffs will continue to meet and confer with defense counsel to
reach those goals and will provide the Court with an update regarding any agreements or
outstanding issues at or before the pretrial hearing.
C.
By Ethicon
PTO # 127 provides that after July 31, 2014, no additional testimony may be designated
absent leave of the Court. On August 14, 2014, the parties will have a hearing with Judge Eifert
to determine unresolved objections to designations. In the interest of efficiency, Ethicon also
suggests that the parties be required to provide counsel opposite with the actual video testimony
they intend to play at trial (not just the names of witnesses) no less than 48 hours prior to that
testimony being played. Absent exceptional circumstances, the parties should be barred from
using video clips not provided at least 48 hours in advance, or different clips than those provided
at least 48 hours in advance.
Because of the vast numbers of documents that have been produced by Defendants and
the thousands that have been identified as exhibits in depositions, and because the parties do not
yet have rulings from the court on the various dispositive and evidentiary motions, Defendants’
exhibit lists are exhaustive. Defendants anticipate that Plaintiff’s list will be equally
lengthy. Accordingly, Defendants suggest that the Court require each party to identify no more
than 50 exhibits that they reasonably, in good faith, anticipate to use at trial recognizing that
circumstances may arise that require the use of other exhibits on the list, but that should be an
exception that could not be anticipated.
IX.
SUGGESTIONS CONCERNING ANY NEED FOR ADOPTING SPECIAL
PROCEDURES FOR MANAGING DIFFICULT OR PROTRACTED ASPECTS
OF THE TRIAL THAT MAY INVOLVE COMPLEX ISSUES, MULTIPLE
PARTIES, DIFFICULT LEGAL QUESTIONS, OR UNUSUAL PROOF
PROBLEMS
The parties anticipate that they will agree on notification by the party presenting evidence
of the identity and timing of upcoming witnesses.
X.
LIST OF SPECIAL VOIR DIRE QUESTIONS
Plaintiffs request that the Court utilize the special voir dire questions set forth on the
accompanying Attachment D.
XI.
STATEMENT OF REALISTIC ESTIMATE OF TRIAL DAYS REQUIRED
This Court has not yet given guidance as to how much time will be permitted for trial, but
the parties are aware of the Court’s limitation of nine trial days (exclusive of jury deliberation) in
prior trials, with the trial days divided equally between the parties.
XII.
COURTROOM TECHNOLOGY REQUESTS
The parties have arranged for the appropriate courtroom technology and have timely
advised the Court’s technology staff as to same.
XIII. ANY OTHER MATTERS RELEVANT FOR PRETRIAL DISCUSSION OR
DISPOSITION, INCLUDING THOSE SET FORTH IN FEDERAL RULE OF
CIVIL PROCEDURE 16
A.
By Plaintiff
Plaintiffs request that any court ruling as to restriction of the Plaintiffs’ presentation of
evidence equally apply to Defendants’ presentation of evidence.
B.
By Ethicon
None at this time.
ButlerSnow 22179235v1
Case 2:12-cv-05201 Document 320-1 Filed 08/04/14 Page 1 of 242 PageID #: 13926
ATTACHMENT A
Plaintiff's Exhibit list for Jo Beth Huskey, et al. v. Ethicon Inc., et al.
Case No.: 2:12-cv-05201
Plaintiffs reserve the right to further supplement this exhibit list as may be warranted during the course of trial.
In identifying documents, Plaintiffs do not admit that all or part of any documents are admissible at trial, or may be used in any way.
Plaintiffs reserve all rights to object to the use of all or any part of any document listed herein.
EX #
1
2
3
4
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
5
6
7
8
9
10
11
12
13
EXHIBIT DESCRIPTION
Abbrevo Product Exemplar
Prolift Product Exemplar
Prolift +M Product Exemplar
TVT-O Laser Cut product Exemplar
TVT-O Mechanically cut product
exemplar
11/19/13 E-Mail from Benjamin
Watson to Andrew Faes
6/27/13 E-Mail from Ben Watson to
Andrew Faes
Prolene Suture Product Exemplar
11/5/13 letter from Benjamin M.
Watson to Thomas P. Cartmell
TVT Mechanically Cut Product
Exemplar
12/18/13 letter from Benjamin M.
Watson to Andrew Faes
Ultrapro Product Exemplar
Gynemesh PS Product Exemplar
24
25
All Issue reports for entire TVT
product line from 1998 to the present
AMS IFU for the Sparc System
8/29/13 E-mail from Ben Watson to
Andrew Faes
Bard 2008 IFU for Align
Bard 2008 IFU for Align TO
8/11/13 Email from Ben Watson to
Andrew Faes
11/15/13 E-Mail from Benjamin
Watson to Bryan Aylstock
TVT- Secur Product Exemplar
26
27
28
9/6/13 E-Mail from Kelly Crawford
to Cheryll Calderon and several others
TVT-Exact Product Exemplar
2011 AMS Monarc IFU
14
15
16
17
18
19
20
21
22
23
PAGE 1 OF 241
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
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36
37
38
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40
41
42
43
44
45
46
47
48
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50
ADVAMED 00001669
DEPO.ETH.MESH.000003
67
ETH-00262
ETH-00289
ETH-00295
ETH-01748
ETH-02358
ETH-02794
ETH-03531
ETH-03877
ETH-07152
ETH-10187
ETH-18761
ETH-18879
ETH-18963
ETH-47351
ETH-47376
ADVAMED 00001670
68
ETH-00265
ETH-00294
ETH-00300
ETH-01814
ETH-02367
ETH-02799
ETH-03567
ETH-03886
ETH-07158
ETH-10202
ETH-18763
ETH-18879
ETH-18963
ETH-47355
ETH-47379
51
52
53
54
55
56
57
58
59
60
61
62
63
64
ETH-47802
ETH-49659
ETH-67877
ETH-83454
ETH-83788
ETH.MESH 00748451
ETH.MESH.00000272
ETH.MESH.PM.000049
ETH.MESH.00002157
ETH.MESH.00006636
ETH.MESH.00006796
ETH.MESH.00007091
ETH.MESH.00008043
ETH.MESH.00011316
ETH-47808
ETH-49660
ETH-67882
ETH-83455
ETH-83788
ETH.MESH 00748803
ETH.MESH.00000272
ETH.MESH.PM.000049
ETH.MESH.00002171
ETH.MESH.00006636
ETH.MESH.00006796
ETH.MESH.00007092
ETH.MESH.00008112
ETH.MESH.00011318
65
ETH.MESH.00017239
ETH.MESH.00017248
66
ETH.MESH.00017369
ETH.MESH.00017372
29
34
PAGE 2 OF 241
EXHIBIT DESCRIPTION
TVT Laser Cut Product Exemplar
Email from Secunda 10/17/08
Lab book
Gynemesh PS Brochure
Prolift Brochure
Prolift brochure
Letter from Paine 2/22/08
TVM Journal Article
TVM Article
Everett Memo 2/28/05
Minutes 12/12/02
Prolift CER
Prolift Brochure
Email from Brown 1/18/05
Prolift improvement
Prolift training
2008 PHN response
2008 PHN
2006 Journal of Surgical Research
article
Mesh testing
Prolift IFU
Email from Ciarocca 6/14/06
Porosity measurement
Mesh 510k
Macroporous email
TVT Tension Free Training Film
Brochure
Interim explant report
Stand and deliver presentation
Email from Jennifer Haby
POP training
FDA PHN
Trocar-Guided Transvaginal Mesh
Repair of
Pelvic Organ Prolapse
The impact of pelvic organ prolapse
on sexual function in women
with urinary incontinence
Case No.: 2:12-cv-05201
EX #
67
68
69
70
71
72
73
74
75
76
77
78
79
IDENTIFIER NO. BEG.
ETH.MESH.00019863
ETH.MESH.00019925
ETH.MESH.00029963
ETH.MESH.00030096
ETH.MESH.00030098
ETH.MESH.00030099
ETH.MESH.00030372
ETH.MESH.00031538
ETH.MESH.00033325
ETH.MESH.00033877
ETH.MESH.00066957
ETH.MESH.00066960
ETH.MESH.00066963
IDENTIFIER NO. END
ETH.MESH.00019924
ETH.MESH.00020019
ETH.MESH.00029966
ETH.MESH.00030098
ETH.MESH.00030098
ETH.MESH.00030102
ETH.MESH.00030373
ETH.MESH.00031538
ETH.MESH.00033325
ETH.MESH.00033879
ETH.MESH.00066957
ETH.MESH.00066960
ETH.MESH.00066964
80
81
82
83
84
85
86
87
88
89
90
91
92
ETH.MESH.00067354
ETH.MESH.00067902
ETH.MESH.00070187
ETH.MESH.00071794
ETH.MESH.00078537
ETH.MESH.00080128
ETH.MESH.00080795
ETH.MESH.00081133
ETH.MESH.00081180
ETH.MESH.00083765
ETH.MESH.00086463
ETH.MESH.00093575
ETH.MESH.00128358
ETH.MESH.00067354
ETH.MESH.00067904
ETH.MESH.00070211
ETH.MESH.00071794
ETH.MESH.00078539
ETH.MESH.00080128
ETH.MESH.00080924
ETH.MESH.00081139
ETH.MESH.00081180
ETH.MESH.00083770
ETH.MESH.00086465
ETH.MESH.00093588
ETH.MESH.00128360
93
94
95
96
97
98
99
ETH.MESH.00130934
ETH.MESH.00131058
ETH.MESH.00132906
ETH.MESH.00132987
ETH.MESH.00133231
ETH.MESH.00133744
ETH.MESH.00134029
ETH.MESH.00130941
ETH.MESH.00131095
ETH.MESH.00132907
ETH.MESH.00132989
ETH.MESH.00133232
ETH.MESH.00133745
ETH.MESH.00134031
EXHIBIT DESCRIPTION
TVT O 510k
Letter to Hojnoski
Email from Brian Luscombe
TVT Training policy
Training policy
Email from Abely 5/22/03
email from Luscombe 7/7/03
PE PPT
Ethicon Presentation
TVT Complication data
10/17/08 Email from Prutzman
10/14/08 Voice mail from Mahar
FDA Notification
e-mail from Eric Globerman 12-152008
1/27/05 Email from Brennan
Risk Plan
TVT IFU Email
Lightning 510k email
10/14/08 Email from Lisa
Protocol Number: 300-07-006
Prolift+M IFU
Mesh data table
8/24/07 Letter from FDA
Prosima related email
SOP Copy Review
5/11/04 Email from Carino
7/30/98 Marketing Research Study
TVT
TVT Professional Education
Lift Training Restrictions
Cadaver labs
11/25/05 Email from Weisberg
TVT Promotion
TVT Complaint email
101
102
103
104
105
ETH.MESH.00134498
ETH.MESH.00134795
ETH.MESH.00139845
ETH.MESH.00142266
ETH.MESH.00143133
ETH.MESH.00134499
ETH.MESH.00134795
ETH.MESH.00139867
ETH.MESH.00142267
ETH.MESH.00143135
Email from Dr. Dennis Miller 1/15/06
TVT World Registry PPT
Code of Ethics
Copy approval
Objections & Handling Statements
PAGE 3 OF 241
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
106
107
108
109
110
111
ETH.MESH.00143697
ETH.MESH.00143700
ETH.MESH.00143758
ETH.MESH.00144268
ETH.MESH.00144270
ETH.MESH.00144304
ETH.MESH.00143699
ETH.MESH.00143702
ETH.MESH.00143759
ETH.MESH.00144269
ETH.MESH.00144278
ETH.MESH.00144331
112
113
114
115
116
117
ETH.MESH.00145084
ETH.MESH.00145555
ETH.MESH.00147904
ETH.MESH.00148352
ETH.MESH.00148354
ETH.MESH.00148811
ETH.MESH.00145088
ETH.MESH.00145555
ETH.MESH.00147904
ETH.MESH.00148352
ETH.MESH.00148354
ETH.MESH.00148813
118
119
ETH.MESH.00155508
ETH.MESH.00155598
ETH.MESH.00155516
ETH.MESH.00155600
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
ETH.MESH.00156682
ETH.MESH.00156906
ETH.MESH.00156909
ETH.MESH.00158629
ETH.MESH.00159473
ETH.MESH.00160131
ETH.MESH.00160612
ETH.MESH.00160615
ETH.MESH.00160638
ETH.MESH.00160822
ETH.MESH.00161129
ETH.MESH.00161131
ETH.MESH.00161444
ETH.MESH.00161512
ETH.MESH.00161953
ETH.MESH.00161969
ETH.MESH.00156750
ETH.MESH.00156908
ETH.MESH.00156938
ETH.MESH.00158636
ETH.MESH.00159473
ETH.MESH.00160138
ETH.MESH.00160625
ETH.MESH.00160623
ETH.MESH.00160639
ETH.MESH.00160825
ETH.MESH.00161130
ETH.MESH.00161132
ETH.MESH.00161445
ETH.MESH.00161513
ETH.MESH.00161954
ETH.MESH.00161984
136
ETH.MESH.00162420
ETH.MESH.00162425
PAGE 4 OF 241
EXHIBIT DESCRIPTION
Memo from To to Copy Review
Team 9/2/00
Copy approval
Copy Review- TVT Brochure 2002
TVT copy review
TVT Brochure
Sales force update
Ulmsten, et al. A Multicenter Study
of Tension-Free Vaginal Tape (TVT)
for Surgical Treatment of Stress
Urinary Incontinence
TVT complaint table
TVT complaint table
Copy Review Submission Form
Copy Review Submission Form
TVT Ad
Retropubic Compared With
Transobturator
Tape Placement in Treatment of
Urinary
Incontinence
2004 press release
Memo: Copy review submission
compliance
TVT Copy Review
Professional Education Program
Ulmsten 1999
Copy review memo
Ward Article 2003
TVT Brochure Review for Reprint
TVT Brochure
Memo from J.L. Toth 6/9/00
copy approval
copy approval
product pointer
Detail sheet
TVT Brochure
TVT O Brochure
TVT Brochure
Gynecare TVT and Thermachoice
Physician Mailers
Case No.: 2:12-cv-05201
EX #
137
138
139
140
IDENTIFIER NO. BEG.
ETH.MESH.00162420
ETH.MESH.00163558
ETH.MESH.00163623
ETH.MESH.00163644
IDENTIFIER NO. END
ETH.MESH.00162425
ETH.MESH.00163574
ETH.MESH.00163623
ETH.MESH.00163659
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
ETH.MESH.00164023
ETH.MESH.00164643
ETH.MESH.00166617
ETH.MESH.00167104
ETH.MESH.00167119
ETH.MESH.00167310
ETH.MESH.00169748
ETH.MESH.00199408
ETH.MESH.00203456
ETH.MESH.00206974
ETH.MESH.00209295
ETH.MESH.00211510
ETH.MESH.00220335
ETH.MESH.00223428
ETH.MESH.00235558
ETH.MESH.00236722
ETH.MESH.00236796
ETH.MESH.00259269
ETH.MESH.00260591
ETH.MESH.00262015
ETH.MESH.00271641
ETH.MESH.00279582
ETH.MESH.00164027
ETH.MESH.00164648
ETH.MESH.00166632
ETH.MESH.00167110
ETH.MESH.00167119
ETH.MESH.00167352
ETH.MESH.00169751
ETH.MESH.00199413
ETH.MESH.00203456
ETH.MESH.00206981
ETH.MESH.00209299
ETH.MESH.00211515
ETH.MESH.00220336
ETH.MESH.00223431
ETH.MESH.00235570
ETH.MESH.00236749
ETH.MESH.00236796
ETH.MESH.00259274
ETH.MESH.00260592
ETH.MESH.00262016
ETH.MESH.00271641
ETH.MESH.00279588
163
ETH.MESH.00280338
ETH.MESH.00280350
164
165
166
167
168
169
170
171
ETH.MESH.00294195
ETH.MESH.00301367
ETH.MESH.00301741
ETH.MESH.00302105
ETH.MESH.00302390
ETH.MESH.00310152
ETH.MESH.00311805
ETH.MESH.00311832
ETH.MESH.00294203
ETH.MESH.00301369
ETH.MESH.00301742
ETH.MESH.00302106
ETH.MESH.00302392
ETH.MESH.00310153
ETH.MESH.00311810
ETH.MESH.00311832
PAGE 5 OF 241
EXHIBIT DESCRIPTION
TVT brochure
Patient Brochure
TVT O copy review
Patient Brochure
FDA Notification About Use of
Surgical Mesh
TVT Family of Products Brochure
TVT Brochure
Clinical Expert Report 2006
2006 Product Pointer
TVT Value Dossier
TVT brochure
Design validation strategy
3/30/99 Email from Carol Gillick
TVTO-PA 510k
Email from Hinoul 9/22/09
TVT IFU
biocompatibility memo
Email from Raimo Sump
Professional Education Presentation
Sales spreadsheet
Design input strategy
TVT O Development email
e-mail from Dan Smith 02-19-2004
Nick Franco PPT
Protegen in the news
Conceptual advances in the surgical
management
of genital prolapse
Tensile properties of five commonly
used mid-urethral slings relative to
the TVT
Email from Nicola Seller
11/21/05 Email from Lamont
TVT LCM Memo
2/23/06 Memo from Dan Lamont
Product Quality Issue 12/10/07
Emails regarding complication rates
IIS Process
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
ETH.MESH.00316780
ETH.MESH.00318775
ETH.MESH.00319128
ETH.MESH.00319364
ETH.MESH.00321804
ETH.MESH.00325674
ETH.MESH.00329112
ETH.MESH.00329259
ETH.MESH.00331800
ETH.MESH.00335479
ETH.MESH.00339053
ETH.MESH.00339053
ETH.MESH.00339083
ETH.MESH.00339437
ETH.MESH.00340990
ETH.MESH.00345289
ETH.MESH.00345312
ETH.MESH.00345328
ETH.MESH.00348626
ETH.MESH.00350879
ETH.MESH.00351439
ETH.MESH.00353748
ETH.MESH.00316783
ETH.MESH.00318778
ETH.MESH.00319129
ETH.MESH.00319365
ETH.MESH.00321805
ETH.MESH.00325675
ETH.MESH.00329113
ETH.MESH.00329260
ETH.MESH.00331836
ETH.MESH.00335484
ETH.MESH.00339057
ETH.MESH.00339053
ETH.MESH.00339084
ETH.MESH.00339442
ETH.MESH.00340999
ETH.MESH.00345291
ETH.MESH.00345327
ETH.MESH.00345329
ETH.MESH.00348663
ETH.MESH.00350881
ETH.MESH.00351441
ETH.MESH.00353748
194
ETH.MESH.00355003
ETH.MESH.00355007
195
196
197
198
ETH.MESH.00363605
ETH.MESH.00371496
ETH.MESH.00371547
ETH.MESH.00372341
ETH.MESH.00363625
ETH.MESH.00371594
ETH.MESH.00371594
ETH.MESH.00372357
199
200
201
ETH.MESH.00373310
ETH.MESH.00387386
ETH.MESH.00394544
ETH.MESH.00373388
ETH.MESH.00387391
ETH.MESH.00394553
202
203
ETH.MESH.00396836
ETH.MESH.00397674
ETH.MESH.00396836
ETH.MESH.00397674
PAGE 6 OF 241
EXHIBIT DESCRIPTION
TVT Literature Search Review
Summary
Draft FDA response 2008
Sales Do's and Dont's
8/5/05 Email from Hojnoski
Definition Major Invasive Surgeries
12/5/07 Email from Pelkey
10/13/08 Email from Paine
1/19/07 Email from Yale
CAP Audit
Organization chart
Marketing Piece
TVT brochure
TVT brochure email
TVT Brochure
Global regulatory strategy
Copy Review of TVT complications
TVT brochure
Approval of brochure
Clinical Expert Report 5/28/10
FDA PHN 2008
3/23/10 Email from Dan Smith
Product spreadsheet
Nilsson et. al. Eleven years
prospective follow-up of the tensionfree vaginal tape procedure for
treatment of stress urinary
incontinence
Company Procedure for Design
Changes to Existing
Products
TVT 510(k)
Performance Data
TVM response letter
TVT Presentation with complaint data
Target Sheet
LCM Regulatory strategy
Review of Surgical Techniques
Presentation
TVT Professional Education
Case No.: 2:12-cv-05201
EX #
204
205
206
207
208
209
210
IDENTIFIER NO. BEG.
ETH.MESH.00400954
ETH.MESH.00406656
ETH.MESH.00409657
ETH.MESH.00409665
ETH.MESH.00409670
ETH.MESH.00409674
ETH.MESH.00409674
IDENTIFIER NO. END
ETH.MESH.00400956
ETH.MESH.00407950
ETH.MESH.00409658
ETH.MESH.00409665
ETH.MESH.00409670
ETH,MESH.00409675
ETH.MESH.00409675
211
212
213
214
215
216
217
218
219
220
221
222
223
224
ETH.MESH.00420577
ETH.MESH.00432936
ETH.MESH.00439996
ETH.MESH.00440005
ETH.MESH.00442080
ETH.MESH.00461576
ETH.MESH.00467706
ETH.MESH.00477387
ETH.MESH.00480823
ETH.MESH.00519476
ETH.MESH.00523348
ETH.MESH.00524059
ETH.MESH.00525441
ETH.MESH.00526028
ETH.MESH.00420577
ETH.MESH.00432936
ETH.MESH.00439998
ETH.MESH.00440007
ETH.MESH.00442081
ETH.MESH.00461576
ETH.MESH.00467709
ETH.MESH.00477387
ETH.MESH.00480823
ETH.MESH.00519481
ETH.MESH.00523354
ETH.MESH.00524060
ETH.MESH.00525466
ETH.MESH.00526031
225
ETH.MESH.00526473
ETH.MESH.00526474
226
ETH.MESH.00527044
ETH.MESH.00527046
227
228
229
230
231
232
233
ETH.MESH.00528570
ETH.MESH.00528636
ETH.MESH.00529512
ETH.MESH.00533250
ETH.MESH.00533283
ETH.MESH.00539862
ETH.MESH.00540951
ETH.MESH.00528573
ETH.MESH.00528641
ETH.MESH.00529512
ETH.MESH.00533256
ETH.MESH.00533286
ETH.MESH.00539898
ETH.MESH.00540983
EXHIBIT DESCRIPTION
Ulmsten letter
Letters re TVT World
Alex C Wang Study
e-mail from Kelly Thain 12-19-2002
Email from Rick Isenberg
6/7/02 Email from Isenberg
Faculty Development and
Management Presentation
1/5/05 Email from Angelini
TVT complaints
Prolift training
ACOG 2007 email
2007 Professional Education Plan
Kaiser Pelvic Floor
Wang Article 2004
email from Bogardus 10/9/06
Southern Region Meeting 2006
Email from Allison London Brown
5/6/05 Email from Allison London
Brown
RE:JJHCS# for Docs trained on
August 25
Professional education
communication issues
Product Quality Plan
Letter to Vince Lucente
TVT World-wide Registry 2009
TVT World report
TVT Registry
WH&U TVT & POP
234
235
236
237
238
239
ETH.MESH.00541379
ETH.MESH.00548524
ETH.MESH.00562421
ETH.MESH.00569297
ETH.MESH.00581000
ETH.MESH.00581590
ETH.MESH.00541380
ETH.MESH.00548525
ETH.MESH.00562421
ETH.MESH.00569298
ETH.MESH.00581003
ETH.MESH.00581612
11-18-2003 memo Mesh Fraying TVT
Professional education strategy
2010 Strategy Alignment
email from Chaves 3/10/09
05/10/10 Email from Hinoul
Patient marketing
PAGE 7 OF 241
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
EXHIBIT DESCRIPTION
240
241
ETH.MESH.00584291
ETH.MESH.00584488
ETH.MESH.00584292
ETH.MESH.00584494
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
ETH.MESH.00584527
ETH.MESH.00584561
ETH.MESH.00584846
ETH.MESH.00585802
ETH.MESH.00585842
ETH.MESH.00585906
ETH.MESH.00585937
ETH.MESH.00591127
ETH.MESH.00592915
ETH.MESH.00593165
ETH.MESH.00595406
ETH.MESH.00597472
ETH.MESH.00632022
ETH.MESH.00632511
ETH.MESH.00637636
ETH.MESH.00637748
ETH.MESH.00643046
ETH.MESH.00656164
ETH.MESH.00658058
ETH.MESH.00658177
ETH.MESH.00658421
ETH.MESH.00658453
ETH.MESH.00584527
ETH.MESH.00584561
ETH.MESH.00584847
ETH.MESH.00585802
ETH.MESH.00585843
ETH.MESH.00585909
ETH.MESH.00585939
ETH.MESH.00591128
ETH.MESH.00592916
ETH.MESH.00593165
ETH.MESH.00595407
ETH.MESH.00597477
ETH.MESH.00632026
ETH.MESH.00632511
ETH.MESH.00637636
ETH.MESH.00637749
ETH.MESH.00643085
ETH.MESH.00656165
ETH.MESH.00658065
ETH.MESH.00658198
ETH.MESH.00658429
ETH.MESH.00658458
264
265
266
ETH.MESH.00658806
ETH.MESH.00659678
ETH.MESH.00679489
ETH.MESH.00658810
ETH.MESH.00659690
ETH.MESH.00679490
267
268
269
270
271
272
273
274
275
ETH.MESH.00680025
ETH.MESH.00687819
ETH.MESH.00692880
ETH.MESH.00692884
ETH.MESH.00704053
ETH.MESH.00719198
ETH.MESH.00722339
ETH.MESH.00742724
ETH.MESH.00744073
ETH.MESH.00680030
ETH.MESH.00687822
ETH.MESH.00692881
ETH.MESH.00692885
ETH.MESH.00704054
ETH.MESH.00719209
ETH.MESH.00722349
ETH.MESH.00742724
ETH.MESH.00744081
2/15/06 Email from Jacqueline Flatow
6/6/06 Email from Herve Fournier
Laser-Cut Mesh v. Mechanical-Cut
Mesh PPT
Kammerer on erosions
Mesh for TVM
5/9/06 Email from Kammerer
Email from Kammerer 1/20/2006
Next Generation mesh email
Email from Hinoul 4/8/2009
9/14/09 Email from Savidge, S
Mesh Technical Report
Email from Kirkemo 1/4/2010
Email from Tincello, 1/4/2011
TVT Complaint issues
PPT TVT Abbrevo
TVT complaint data
TVT Professional education history
TVT Value Dossier
Concern over Journal Article
Seven Years Brochure
Surgeon's Resource Monograph
TVT Brochure
TVT Family of Products Brochure
International Urogynecology Journal
2001
2004 Journal of Gyn & Ob article
Sales training meeting
Study of the biomechanical properties
of synthetic mesh
implanted in vivo
12/19/05 Email from Mahar
TVT complication data
1/16/06 Email from Amin
Complications under-reported article
Anti-mesh email
510k history
Project Lightning Update
Marketing Presentation
PAGE 8 OF 241
Case No.: 2:12-cv-05201
EX #
276
277
278
279
280
281
282
283
IDENTIFIER NO. BEG.
ETH.MESH.00746146
ETH.MESH.00748213
ETH.MESH.00748310
ETH.MESH.00750766
ETH.MESH.00751159
ETH.MESH.00756100
ETH.MESH.00756887
ETH.MESH.00756984
IDENTIFIER NO. END
ETH.MESH.00746149
ETH.MESH.00748278
ETH.MESH.00748450
ETH.MESH.00750769
ETH.MESH.00751159
ETH.MESH.00756102
ETH.MESH.00756888
ETH.MESH.00756984
284
285
286
287
288
289
290
ETH.MESH.00764215
ETH.MESH.00764400
ETH.MESH.00766347
ETH.MESH.00772228
ETH.MESH.00772231
ETH.MESH.00776368
ETH.MESH.00803652
ETH.MESH.00764216
ETH.MESH.00764400
ETH.MESH.00766349
ETH.MESH.00772229
ETH.MESH.00772232
ETH.MESH.00776391
ETH.MESH.00803652
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
ETH.MESH.00803680
ETH.MESH.00805453
ETH.MESH.00806647
ETH.MESH.00810056
ETH.MESH.00815310
ETH.MESH.00823660
ETH.MESH.00824100
ETH.MESH.00832555
ETH.MESH.00832562
ETH.MESH.00832937
ETH.MESH.00838428
ETH.MESH.00840056
ETH.MESH.00844331
ETH.MESH.00844341
ETH.MESH.00845911
ETH.MESH.00846411
ETH.MESH.00846523
ETH.MESH.00847536
ETH.MESH.00803680
ETH.MESH.00805456
ETH.MESH.00806647
ETH.MESH.00810057
ETH.MESH.00815313
ETH.MESH.00823660
ETH.MESH.00824100
ETH.MESH.00832556
ETH.MESH.00832564
ETH.MESH.00832939
ETH.MESH.00838428
ETH.MESH.00840056
ETH.MESH.00844335
ETH.MESH.00844344
ETH.MESH.00845912
ETH.MESH.00846417
ETH.MESH.00846523
ETH.MESH.00847536
309
ETH.MESH.00857821
ETH.MESH.00857922
310
ETH.MESH.00857891
ETH.MESH.00857893
PAGE 9 OF 241
EXHIBIT DESCRIPTION
Peggy Norton Article
TVT IFU revision
Modified TVT Blue System
Interim report
EWHU Incontinence Board Meeting
Arrowhead Campaign 2003
TVT complication data figures
10/28/05 Email from Robinson
Email from Jacqueline RussoJankewicz
10/22/08 Email from de los Reyes
Ogilvy Public Relations Worldwide
TVT brochure email
TVT brochure email
ACOG Event
Are all Meshes created equal
presentation
TVT training form
Professional Education update
TVT for different types of patients
Risk Benefit Analysis
EWH&U Clinical Development PPT
Meeting Minutes 4/12/07
Thunder meeting
modified TVT O
Characteristics Synthetic Materials
TVT-S PPT
TVT complication data
TVT O IFU issues
Gynecare TVT Obturator System
Sales Training
Launch Meeting
"Top Ten Reason To
Pursue….Gynecare TVT
Obturator System"
Case No.: 2:12-cv-05201
EX #
311
IDENTIFIER NO. BEG.
ETH.MESH.00858080
IDENTIFIER NO. END
ETH.MESH.00858081
312
ETH.MESH.00858092
ETH.MESH.00858093
313
ETH.MESH.00858094
ETH.MESH.00858095
314
315
316
317
318
319
320
321
322
ETH.MESH.00858096
ETH.MESH.00858175
ETH.MESH.00858252
ETH.MESH.00858891
ETH.MESH.00860142
ETH.MESH.00862727
ETH.MESH.00863391
ETH.MESH.00863405
ETH.MESH.00864122
ETH.MESH.00858097
ETH.MESH.00858177
ETH.MESH.00858253
ETH.MESH.00858891
ETH.MESH.00860144
ETH.MESH.00862728
ETH.MESH.00863393
ETH.MESH.00863407
ETH.MESH.00864123
323
324
325
326
327
328
329
330
331
ETH.MESH.00864131
ETH.MESH.00864138
ETH.MESH.00864490
ETH.MESH.00864493
ETH.MESH.00864497
ETH.MESH.00864503
ETH.MESH.00864503
ETH.MESH.00865069
ETH.MESH.00865322
ETH.MESH.00864133
ETH.MESH.00864139
ETH.MESH.00864492
ETH.MESH.00864496
ETH.MESH.00864500
ETH.MESH.00864507
ETH.MESH.00864507
ETH.MESH.00865072
ETH.MESH.00865323
332
333
334
335
336
337
338
339
340
341
342
343
344
ETH.MESH.00865384
ETH.MESH.00869908
ETH.MESH.00870466
ETH.MESH.00874032
ETH.MESH.00875544
ETH.MESH.00875647
ETH.MESH.00875776
ETH.MESH.00906445
ETH.MESH.00922443
ETH.MESH.00983775
ETH.MESH.00993760
ETH.MESH.00994917
ETH.MESH.00995283
ETH.MESH.00865392
ETH.MESH.00869909
ETH.MESH.00870476
ETH.MESH.00874035
ETH.MESH.00875546
ETH.MESH.00875649
ETH.MESH.00875776
ETH.MESH.00906445
ETH.MESH.00922446
ETH.MESH.00983792
ETH.MESH.00993769
ETH.MESH.00994918
ETH.MESH.00995285
345
ETH.MESH.00995286
ETH.MESH.00995353
PAGE 10 OF 241
EXHIBIT DESCRIPTION
TVT O Development memo
Gynecare R&D Monthly Update June
Gynecare R&D Monthly Update March
Gynecare R&D Monthly Update May
Mulberry Weekly Meeting Minutes
Memo from Allison London Brown
Marketing overview
Email from Smith 6/1/09
Email from Dan Smith 2/27/04
TVT O complaint email
TVT modifications and marketing
Email from Brian Luscombe re Aug
11 program
Dennis Miller's comments
TVT O complaint
TVT O complaint
TVT O IFU issues
IFU Credo issue
TVT O IFU tips
3/2/04 Email from Charlotte Owens
Protecting TVT in professional
education
Thunder meeting note
Mesh Meeting Minutes
Hold Notice
11/16/05 Email from Carol Brennan
510k mesh data
Bidirectional elasticity statement
SOP Copy Review
Email from Lauren Felsenfeld
Email from Barbara McCabe
Email from Lauren Felsenfeld
Female Urinary Incontinence A
Primary Care Perspective
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
346
347
ETH.MESH.00995508
ETH.MESH.00995691
ETH.MESH.00995512
ETH.MESH.00995692
EXHIBIT DESCRIPTION
In Stress Urinary Incontinence
Rigorous Data. Reproducible Results
PCP Tri-Fold Invitation
SUI: More Widespread Than
Commonly Thought, More Treatable
Than Many Patients Believe
Email from Dharini Amin
Ethicon, Inc. Complaint Reporting
Statement
Ulmsten 1996
Nilsson 2004
Clinical Study Agreement for IIS
Clinical Expert Report TVT SECUR
TVT SECUR Presentation
9/9/10 Email from Darlene Kyle
Memo: Mesh Fraying For TVT
Devices
TVT Steps Guide
2007 Worldwide ComplaintReporting Statement
2001 Marketing plans
348
349
ETH.MESH.00995694
ETH.MESH.00995830
ETH.MESH.00995695
ETH.MESH.00995831
350
351
352
353
354
355
356
ETH.MESH.00995835
ETH.MESH.00998130
ETH.MESH.00999764
ETH.MESH.01028045
ETH.MESH.01037447
ETH.MESH.01042853
ETH.MESH.01068905
ETH.MESH.00995836
ETH.MESH.00998135
ETH.MESH.00999767
ETH.MESH.01028086
ETH.MESH.01037455
ETH.MESH.01042892
ETH.MESH.01068906
357
358
ETH.MESH.01126906
ETH.MESH.01128676
ETH.MESH.01126907
ETH.MESH.01128676
359
360
ETH.MESH.01128704
ETH.MESH.01137269
ETH.MESH.01128704
ETH.MESH.01137293
361
362
363
364
365
366
ETH.MESH.01137270
ETH.MESH.01137272
ETH.MESH.01159961
ETH.MESH.01160507
ETH.MESH.01186068
ETH.MESH.01192300
ETH.MESH.01137293
ETH.MESH.01137293
ETH.MESH.01159962
ETH.MESH.01160518
ETH.MESH.01186072
ETH.MESH.01192308
367
368
ETH.MESH.01192895
ETH.MESH.01203207
ETH.MESH.01192901
ETH.MESH.01203260
e-mail from Lisa Kwiatek 07-07-2000
2001 Marketing Plan
Letter to Ciarrocca 6/6/01
CPC Monthly report
Make Data and Safety Your Choice
Hinoul 2005
Transvaginal mesh repair of anterior
and posterior vaginal
wall prolapse: a clinical and
ultrasonographic study
Labeling FDA Guidance
369
370
371
ETH.MESH.01203957
ETH.MESH.01217285
ETH.MESH.01217673
ETH.MESH.01203957
ETH.MESH.01217288
ETH.MESH.01217673
Future of surgical meshes presentation
Focus group
TVT-Next
PAGE 11 OF 241
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
372
373
374
375
376
ETH.MESH.01217925
ETH.MESH.01218019
ETH.MESH.01218446
ETH.MESH.01219629
ETH.MESH.01219984
ETH.MESH.01217959
ETH.MESH.01218019
ETH.MESH.01218449
ETH.MESH.01219630
ETH.MESH.01219994
377
378
379
380
381
382
383
384
385
386
387
ETH.MESH.01220135
ETH.MESH.01220661
ETH.MESH.01220693
ETH.MESH.01220710
ETH.MESH.01220871
ETH.MESH.01221024
ETH.MESH.01221055
ETH.MESH.01222075
ETH.MESH.01222617
ETH.MESH.01223035
ETH.MESH.01228079
ETH.MESH.01220145
ETH.MESH.01220663
ETH.MESH.01220697
ETH.MESH.01220711
ETH.MESH.01220872
ETH.MESH.01221025
ETH.MESH.01221058
ETH.MESH.01222079
ETH.MESH.01222654
ETH.MESH.01223038
ETH.MESH.01228084
388
389
390
391
ETH.MESH.01236139
ETH.MESH.01238048
ETH.MESH.01238454
ETH.MESH.01239065
ETH.MESH.01236139
ETH.MESH.01238051
ETH.MESH.01238456
ETH.MESH.01239066
392
393
394
395
396
397
398
399
ETH.MESH.01243954
ETH.MESH.01252509
ETH.MESH.01259495
ETH.MESH.01262553
ETH.MESH.01264260
ETH.MESH.01264497
ETH.MESH.01265223
ETH.MESH.01268264
ETH.MESH.01243954
ETH.MESH.01252512
ETH.MESH.01259509
ETH.MESH.01262556
ETH.MESH.01264260
ETH.MESH.01264498
ETH.MESH.01265239
ETH.MESH.01268277
400
401
402
403
404
ETH.MESH.01271090
ETH.MESH.01310061
ETH.MESH.01310476
ETH.MESH.01310482
ETH.MESH.01316727
ETH.MESH.01271099
ETH.MESH.01310065
ETH.MESH.01310481
ETH.MESH.01310482
ETH.MESH.01316765
PAGE 12 OF 241
EXHIBIT DESCRIPTION
AN EXPLORATORY 91-DAY
TISSUE REACTION STUDY OF
POLYPROPYLENE-BASED
SURGICAL MESH IN RATS (PSE
ACC. NO. 00-0035)
Design FMEA TVT LCM Project
Test report
5/9/06 Email from Flatow
Design verification report
e-mail from Herve Fournier 06-292006
TVT O development
email from Kammerer 9/24/03
Mesh data
Kammerer - closed to innovation
Pariente article
Memo: Elongation 2006
Pull out strength study
Marszalek 2007
Nilsson podcast
Worldwide Complaint Reporting
Statement
e-mail from Piet Hinoul 04-16-2009
Email from Robinson 7/16/09
Worldwide Complaint-Reporting
Statement
Prolift M CER
Prolift M Presentation
Pore size discussion
Risk Management Report
Risk Management Report
Scandinavian Journal of Urology and
Nephrology 1995
TVT LCM Risk Report
TVT LCM Risk Report
TVT AFMEA
TVT Factbook
Case No.: 2:12-cv-05201
EX #
405
406
407
408
409
410
411
IDENTIFIER NO. BEG.
ETH.MESH.01317508
ETH.MESH.01317510
ETH.MESH.01317515
ETH.MESH.01405166
ETH.MESH.01405167
ETH.MESH.01409412
ETH.MESH.01419741
IDENTIFIER NO. END
ETH.MESH.01317613
ETH.MESH.01317514
ETH.MESH.01317524
ETH.MESH.01405166
ETH.MESH.01405167
ETH.MESH.01409412
ETH.MESH.01419741
412
ETH.MESH.01424029
ETH.MESH.01424035
413
414
415
416
417
418
419
420
421
422
423
424
425
ETH.MESH.01424246
ETH.MESH.01673341
ETH.MESH.01706065
ETH.MESH.01716847
ETH.MESH.01746858
ETH.MESH.01760853
ETH.MESH.01782867
ETH.MESH.01784823
ETH.MESH.01785259
ETH.MESH.01805958
ETH.MESH.01805985
ETH.MESH.01808729
ETH.MESH.01809078
ETH.MESH.01424290
ETH.MESH.01673341
ETH.MESH.01706065
ETH.MESH.01716848
ETH.MESH.01746861
ETH.MESH.01760861
ETH.MESH.01782867
ETH.MESH.01784828
ETH.MESH.01785260
ETH.MESH.01805958
ETH.MESH.01805985
ETH.MESH.01808741
ETH.MESH.01809079
426
ETH.MESH.01809080
ETH.MESH.01809081
427
428
429
430
431
432
433
434
435
436
437
438
439
440
ETH.MESH.01809082
ETH.MESH.01811758
ETH.MESH.01811770
ETH.MESH.01813975
ETH.MESH.01814371
ETH.MESH.01814384
ETH.MESH.01815505
ETH.MESH.01815567
ETH.MESH.01815607
ETH.MESH.01816990
ETH.MESH.01819505
ETH.MESH.01819526
ETH.MESH.01822361
ETH.MESH.01856586
ETH.MESH.01809083
ETH.MESH.01811758
ETH.MESH.01811772
ETH.MESH.01813978
ETH.MESH.01814372
ETH.MESH.01814400
ETH.MESH.01815513
ETH.MESH.01815568
ETH.MESH.01815607
ETH.MESH.01816990
ETH.MESH.01819506
ETH.MESH.01819570
ETH.MESH.01822363
ETH.MESH.01856586
PAGE 13 OF 241
EXHIBIT DESCRIPTION
TVT Factbook
DDSA
TVT Risk Doc
Thunder presentation
2007 Thunder PPT
Design transfer checklist
TVT Exact AFMEA
The Argument for Lightweight
Polypropylene
Mesh in Hernia Repair
Test for local effects after
implantation
TVT Brochure PPT
Grier presentation
ACOG 2007 email
TVT registry
Ultrapro CER
Factors Related to mesh Shrinkage
Clinical Expert Rpt. Laser Cut Mesh
Mesh degradation email
TVT-S PPT
The Mesh Story
Test report
Email from Parisi 12/17/04
Comparison of Laser-Cut and
Machine-Cut Mesh
Memo: VOC on new Laser Cut TVT
Mesh
LCM business case
12/10/04 Email from Steve Bell
11/02/04 Email from Patty Lancos
Design Control
Design control
TVT O IFU issues
6/19/03 Email from Any Godwin
6/24/03 Email from Godwin
Mesh development Timeline
Thunder meeting minutes
POP literature review
Monthly complaint review PPT
Case No.: 2:12-cv-05201
EX #
441
442
443
444
445
446
447
IDENTIFIER NO. BEG.
ETH.MESH.01945854
ETH.MESH.01949009
ETH.MESH.01949198
ETH.MESH.01950408
ETH.MESH.01961610
ETH.MESH.01988643
ETH.MESH.01992234
IDENTIFIER NO. END
ETH.MESH.01945854
ETH.MESH.01949013
ETH.MESH.01949200
ETH.MESH.01950451
ETH.MESH.01961611
ETH.MESH.01988644
ETH.MESH.01992237
448
449
ETH.MESH.02010834
ETH.MESH.02011199
ETH.MESH.02010855
ETH.MESH.02011201
450
451
452
453
454
455
ETH.MESH.02017152
ETH.MESH.02017169
ETH.MESH.02026591
ETH.MESH.02053629
ETH.MESH.02058110
ETH.MESH.02059212
ETH.MESH.02017158
ETH.MESH.02017190
ETH.MESH.02026595
ETH.MESH.02053632
ETH.MESH.02058112
ETH.MESH.02059241
456
457
458
459
460
461
462
463
ETH.MESH.02089392
ETH.MESH.02091873
ETH.MESH.02095523
ETH.MESH.02101709
ETH.MESH.02105223
ETH.MESH.02106156
ETH.MESH.02122903
ETH.MESH.02134271
ETH.MESH.02089399
ETH.MESH.02091873
ETH.MESH.02095525
ETH.MESH.02101719
ETH.MESH.02105223
ETH.MESH.02106156
ETH.MESH.02122907
ETH.MESH.02134273
464
465
466
ETH.MESH.02148431
ETH.MESH.02157878
ETH.MESH.02170708
ETH.MESH.02148460
ETH.MESH.02157880
ETH.MESH.02170709
467
468
469
470
471
472
473
474
475
476
ETH.MESH.02180737
ETH.MESH.02180826
ETH.MESH.02180828
ETH.MESH.02180833
ETH.MESH.02183533
ETH.MESH.02183537
ETH.MESH.02184435
ETH.MESH.02185004
ETH.MESH.02185584
ETH.MESH.02189932
ETH.MESH.02180737
ETH.MESH.02180827
ETH.MESH.02180830
ETH.MESH.02180833
ETH.MESH.02183536
ETH.MESH.02183537
ETH.MESH.02184436
ETH.MESH.02185004
ETH.MESH.02185605
ETH.MESH.02189935
PAGE 14 OF 241
EXHIBIT DESCRIPTION
Email from Yale 3/30/06
Document Preservation Notice 2006
Complaint spreadsheet
Meeting report
Mesh description email
Test method validation
Biomechnical consideration for
Pelvic floor mesh design
Mesh test results
Ethicon Expert Meeting: Meshes for
Pelvic Floor Repair
Mesh literature review
Material Safety Data Sheet
Gynemesh PS paper
TVT Blue memo
Prolift surgical technique
Scientific Advisory Panel on Pelvic
Floor Repair
Chronic Toxicity
Complication data analysis
Consulting Agreement - Nilsson
WW Marketing Team Update PPT
Email from Jason Hernandez
5/26/09 Email from Carolyn Brennan
Cytotoxicity Draft
4/22/09 Email from Holste with
literature
Klosterhalfen report
Lucente email
Email from Ronnie Toddywala re
Project Mulberry
11/12/04 Email from Menneret
Sibylle memo 11/10/04
10/18/04 Dr. Eberhard letter
Pore size email
Meshes spreadsheet
Email from Osman, R 4/3/09
email from Flint 4/27/10
biomechanics of pelvic floor mesh
FDA lightning
Case No.: 2:12-cv-05201
EX #
477
478
479
480
481
482
483
IDENTIFIER NO. BEG.
ETH.MESH.02195783
ETH.MESH.02195798
ETH.MESH.02207388
ETH.MESH.02212596
ETH.MESH.02212840
ETH.MESH.02218268
ETH.MESH.02218436
IDENTIFIER NO. END
ETH.MESH.02195797
ETH.MESH.02195799
ETH.MESH.02207389
ETH.MESH.02212596
ETH.MESH.02212842
ETH.MESH.02218268
ETH.MESH.02218439
484
485
486
487
488
489
ETH.MESH.02219202
ETH.MESH.02222437
ETH.MESH.02227221
ETH.MESH.02227224
ETH.MESH.02227368
ETH.MESH.02232854
ETH.MESH.02219210
ETH.MESH.02222656
ETH.MESH.02227222
ETH.MESH.02227224
ETH.MESH.02227368
ETH.MESH.02232874
490
491
492
493
494
496
497
498
499
500
ETH.MESH.02232930
ETH.MESH.02233126
ETH.MESH.02236180
ETH.MESH.02236580
ETH.MESH.02237103
ETH.MESH.02237665
ETH.MESH.02248778
ETH.MESH.02249594
ETH.MESH.02249638
ETH.MESH.02249640
ETH.MESH.02232936
ETH.MESH.02233187
ETH.MESH.02236187
ETH.MESH.02236580
ETH.MESH.02237104
ETH.MESH.02237665
ETH.MESH.02248778
ETH.MESH.02249594
ETH.MESH.02249665
ETH.MESH.02249642
501
502
504
505
506
507
508
ETH.MESH.02249668
ETH.MESH.02250914
ETH.MESH.02253078
ETH.MESH.02254357
ETH.MESH.02268613
ETH.MESH.02268618
ETH.MESH.02270823
ETH.MESH.02249688
ETH.MESH.02250945
ETH.MESH.02253079
ETH.MESH.02254360
ETH.MESH.02268614
ETH.MESH.02268621
ETH.MESH.02270825
EXHIBIT DESCRIPTION
Prolift+M design matrix
Lightning mesh strength
Prolift M launch
Mesh testing
Mesh comparison chart
TOPA alignment presentation
TVTO-PA test
Material Specification for TVT
Prolene
TVT Design History
Klosterhalfen report
Thunder MGPP Decision
Mesh timeline
Prolift Use Discussion
2002 Journal of Surgical Research
article
Prolift Presentation
TVT Brochure
TVT brochure
TVT Family of Products PPT
Foreign TVT brochure
Mechanical vs. Machine cut Mesh
Risk Management PPT
5/9/02 Email from Pollard
Audit
Medical Device Auditing &
Consulting Inc.
CAPAs
Email from Christiana Bielinski
Prolift trial
email from Burkley 2/3/03
email from Dion 2/21/03
Mesh user needs
509
510
511
512
513
514
515
ETH.MESH.02271018
ETH.MESH.02286052
ETH.MESH.02310653
ETH.MESH.02316434
ETH.MESH.02319312
ETH.MESH.02319408
ETH.MESH.02324740
ETH.MESH.02271018
ETH.MESH.02286053
ETH.MESH.02310657
ETH.MESH.02316436
ETH.MESH.02319315
ETH.MESH.02319409
ETH.MESH.02324740
3/25/05 Email from Charlotte Owens
IFU prolift
Email from Pompilio 10/21/08
ACOG 2007 email
TVT-Base (LCM) Risk Analysis
Sales school
PAGE 15 OF 241
Case No.: 2:12-cv-05201
EX #
516
518
519
521
522
523
524
525
525
526
527
529
530
531
532
533
534
535
536
537
538
539
540
541
542
543
544
545
546
547
548
549
550
551
552
553
554
555
556
557
558
IDENTIFIER NO. BEG.
ETH.MESH.02340306
ETH.MESH.02340402
ETH.MESH.02340471
ETH.MESH.02340504
ETH.MESH.02340568
ETH.MESH.02340902
ETH.MESH.02340974
ETH.MESH.02341954
ETH.MESH.02588182
ETH.MESH.02347206
ETH.MESH.02347208
ETH.MESH.02588977
ETH.MESH.02589032
ETH.MESH.02590865
ETH.MESH.02599329
ETH.MESH.02614726
ETH.MESH.02619504
ETH.MESH.02619601
ETH.MESH.02620914
ETH.MESH.02620964
ETH.MESH.02621143
ETH.MESH.02621661
ETH.MESH.02621670
ETH.MESH.02621931
ETH.MESH.02621936
ETH.MESH.02621966
ETH.MESH.02622081
ETH.MESH.02622276
ETH.MESH.02622374
ETH.MESH.02622456
ETH.MESH.02622581
ETH.MESH.02622612
ETH.MESH.02622627
ETH.MESH.02622686
ETH.MESH.02622755
ETH.MESH.02622778
ETH.MESH.02622954
ETH.MESH.02623159
ETH.MESH.02623164
ETH.MESH.02623268
ETH.MESH.02623282
IDENTIFIER NO. END
ETH.MESH.02340369
ETH.MESH.02340470
ETH.MESH.02340503
ETH.MESH.02340567
ETH.MESH.02340755
ETH.MESH.02340973
ETH.MESH.02341046
ETH.MESH.02342093
ETH.MESH.02588182
ETH.MESH.02347207
ETH.MESH.02347209
ETH.MESH.02588978
ETH.MESH.02589079
ETH.MESH.02590865
ETH.MESH.02599330
ETH.MESH.02614733
ETH.MESH.02619511
ETH.MESH.02619616
ETH.MESH.02620917
ETH.MESH.02620968
ETH.MESH.02621146
ETH.MESH.02621664
ETH.MESH.02621674
ETH.MESH.02621935
ETH.MESH.02621941
ETH.MESH.02621970
ETH.MESH.02622084
ETH.MESH.02622279
ETH.MESH.02622377
ETH.MESH.02622953
ETH.MESH.02622585
ETH.MESH.02622616
ETH.MESH.02622631
ETH.MESH.02622690
ETH.MESH.02622759
ETH.MESH.02622782
ETH.MESH.02623742
ETH.MESH.02623163
ETH.MESH.02623168
ETH.MESH.02623272
ETH.MESH.02623286
PAGE 16 OF 241
EXHIBIT DESCRIPTION
TVT IFU
TVT FU
TVT IFU
TVT IFU
TVT SECUR IFU
IFU TVT O
TVT-O IFU
IFU Prolift M
Thunder mesh presentation
TVT PCP Patient Story Flashcard
PCP Tri-Fold Invitation
Meeting minutes 12/14/01
5/18/11 PPT Mesh Erosion
Thunder Technical Review
Cytoxcicity Assessment
TVT Brochure
TVT Brochure
Issue Report TVT Retropubic
TVT issue report
TVT issue report
Issue Report 2001
Issue Report
Issue Report 2001
Issue Report 2001
Issue Report 2001
Issue Report 2001
Issue Report 2001
Issue Report 2002
Issue Report 2002
Issue Report 2002
Issue Report 2002
Issue Report 2002
Issue Report 2002
Issue Report 2002
Issue Report 2002
Issue Report 2002
Issue Report 2002
Issue Report 2002
Issue Report 2002
Case No.: 2:12-cv-05201
EX #
559
560
561
562
563
564
565
566
IDENTIFIER NO. BEG.
ETH.MESH.02625032
ETH.MESH.02626378
ETH.MESH.02627331
ETH.MESH.02627418
ETH.MESH.02627466
ETH.MESH.02628698
ETH.MESH.02629333
ETH.MESH.02630134
IDENTIFIER NO. END
ETH.MESH.02625037
ETH.MESH.02627330
ETH.MESH.02628697
ETH.MESH.02627421
ETH.MESH.02627471
ETH.MESH.02630133
ETH.MESH.02629342
ETH.MESH.02632004
567
ETH.MESH.02842658
ETH.MESH.02842659
568
569
570
571
572
573
574
575
576
577
578
579
580
ETH.MESH.02877814
ETH.MESH.02992136
ETH.MESH.02995494
ETH.MESH.03021946
ETH.MESH.03031629
ETH.MESH.03032928
ETH.MESH.03032974
ETH.MESH.03086214
ETH.MESH.03131261
ETH.MESH.03146492
ETH.MESH.03160750
ETH.MESH.03165090
ETH.MESH.03208548
ETH.MESH.02881493
ETH.MESH.02992137
ETH.MESH.02995494
ETH.MESH.03021946
ETH.MESH.03031631
ETH.MESH.03032928
ETH.MESH.03032975
ETH.MESH.03086219
ETH.MESH.03131265
ETH.MESH.03146516
ETH.MESH.03160752
ETH.MESH.03165091
ETH.MESH.03208549
581
582
583
ETH.MESH.03208738
ETH.MESH.03259439
ETH.MESH.03358217
ETH.MESH.03208739
ETH.MESH.03259440
ETH.MESH.03358224
584
585
587
588
589
590
591
592
593
594
595
596
ETH.MESH.03361364
ETH.MESH.03427878
ETH.MESH.03456681
ETH.MESH.03458123
ETH.MESH.03459088
ETH.MESH.03460640
ETH.MESH.03472794
ETH.MESH.03475340
ETH.MESH.03482828
ETH.MESH.03531443
ETH.MESH.03535750
ETH.MESH.03571983
ETH.MESH.03361367
ETH.MESH.03427946
ETH.MESH.03456696
ETH.MESH.03458138
ETH.MESH.03459104
ETH.MESH.03460640
ETH.MESH.03472794
ETH.MESH.03475354
ETH.MESH.03482828
ETH.MESH.03531448
ETH.MESH.03535750
ETH.MESH.03571983
PAGE 17 OF 241
EXHIBIT DESCRIPTION
Issue Report 2002
Issue Report 2004
Issue Report 2005-2007
Issue Report
TVT-WORLD Meeting Minutes
6/15/10
TVT-World-Wide Observational
Registry for Long-Term Data
Draft TVT Paper
Evidence to Support Innovation
T-Pro PPT
Maher paper
FDA review
FDA presentation 2011
Prosima email
2006 Urogynecol Journal article
Email from Holste 2/16/11
TVM business story
FDA 522 response
2/25/09 Email from Hernandez
World Registry PPT
4/24/09 Email from Judi Gauld
The perils of commercially driven
surgical innovation
TVT IFU
SOP Copy Review
TVT Brochure
TVT Brochure
TVT brochure
2008 FDA PHN
SOP Copy Review
5/11/01 Letter from Ethicon
5/7/08 Email from Carolyn Brennan
10/12/05 TVT, Blue Mesh
Physician Segment Study
Case No.: 2:12-cv-05201
EX #
597
598
IDENTIFIER NO. BEG.
ETH.MESH.03573964
ETH.MESH.03574660
IDENTIFIER NO. END
ETH.MESH.03573981
ETH.MESH.03574660
599
600
601
602
603
604
605
606
607
608
609
610
611
612
614
615
616
617
618
ETH.MESH.03606055
ETH.MESH.03624321
ETH.MESH.03642757
ETH.MESH.03643186
ETH.MESH.03643767
ETH.MESH.03644287
ETH.MESH.03652924
ETH.MESH.03653779
ETH.MESH.03654151
ETH.MESH.03656697
ETH.MESH.03656727
ETH.MESH.03657426
ETH.MESH.03658927
ETH.MESH.03665469
ETH.MESH.03665531
ETH.MESH.03667696
ETH.MESH.03699547
ETH.MESH.03713701
ETH.MESH.03714031
ETH.MESH.03606059
ETH.MESH.03624322
ETH.MESH.03642805
ETH.MESH.03643186
ETH.MESH.03643769
ETH.MESH.03644287
ETH.MESH.03652955
ETH.MESH.03653780
ETH.MESH.03654151
ETH.MESH.03656699
ETH.MESH.03656731
ETH.MESH.03657427
ETH.MESH.03659180
ETH.MESH.03665487
ETH.MESH.03665532
ETH.MESH.03667704
ETH.MESH.03699547
ETH.MESH.03713703
ETH.MESH.03714034
619
620
621
622
ETH.MESH.03715571
ETH.MESH.03715978
ETH.MESH.03716625
ETH.MESH.03719177
ETH.MESH.03715574
ETH.MESH.03715980
ETH.MESH.03716626
ETH.MESH.03719195
623
624
625
626
627
ETH.MESH.03722384
ETH.MESH.03731339
ETH.MESH.03735432
ETH.MESH.03736578
ETH.MESH.03736932
ETH.MESH.03722386
ETH.MESH.03731340
ETH.MESH.03735433
ETH.MESH.03736578
ETH.MESH.03736932
628
629
630
631
632
633
634
ETH.MESH.03737259
ETH.MESH.03738466
ETH.MESH.03738468
ETH.MESH.03738513
ETH.MESH.03738517
ETH.MESH.03738826
ETH.MESH.03742571
ETH.MESH.03737280
ETH.MESH.03738467
ETH.MESH.03738470
ETH.MESH.03738514
ETH.MESH.03738519
ETH.MESH.03738827
ETH.MESH.03742597
PAGE 18 OF 241
EXHIBIT DESCRIPTION
TVT sales figures
Letter from Berger 2/25/05
Primary Care Physician Education
Programs
2004 Kaminski memo
Prolapse development
Brand Equity PPT
Quality issues email
Physician Segment Study
Audit Corrective Plan
FDA PHN 2008
Lin on PMS
Email from Hino 7/30/09
Email from Takahito 7/30/09
Email from Takase 2/12/10
TVTO-PA 510k
2008 PHN Response
6/22/09 Email from Lisa
SOP for Reg Affairs on Advertising
Vendor list
Evaluation of TVT Complaints
Email from Martin Weisberg RE:
leVal
email from Weisberg 8/1/01
Focus on Mesh exposure
e-mail from Paul DeCosta 9-17-2009
Tape position at rest
email from Isenberg 6/7/02
8/28/00 Memo from Weisberg
11/1/00 Complaint
Medical Affairs Staff Meeting
February 13, 2009
Mesh dyspareunia
Procedure Risk Management
Case No.: 2:12-cv-05201
EX #
635
636
IDENTIFIER NO. BEG.
ETH.MESH.03742864
ETH.MESH.03752671
IDENTIFIER NO. END
ETH.MESH.03742891
ETH.MESH.03752672
637
ETH.MESH.03753245
ETH.MESH.03753245
638
639
ETH.MESH.03753682
ETH.MESH.03801838
ETH.MESH.03753682
ETH.MESH.03801846
640
641
642
643
644
645
ETH.MESH.03803462
ETH.MESH.03843518
ETH.MESH.03878853
ETH.MESH.03904451
ETH.MESH.03905472
ETH.MESH.03905619
ETH.MESH.03803465
ETH.MESH.03843519
ETH.MESH.03878881
ETH.MESH.03904480
ETH.MESH.03905477
ETH.MESH.03905621
646
647
648
649
650
651
652
653
654
655
656
657
658
659
ETH.MESH.03907327
ETH.MESH.03907468
ETH.MESH.03907853
ETH.MESH.03908707
ETH.MESH.03909708
ETH.MESH.03909721
ETH.MESH.03910175
ETH.MESH.03910183
ETH.MESH.03910418
ETH.MESH.03910799
ETH.MESH.03911107
ETH.MESH.03911390
ETH.MESH.03911712
ETH.MESH.03915380
ETH.MESH.03907330
ETH.MESH.03907469
ETH.MESH.03907854
ETH.MESH.03908708
ETH.MESH.03909713
ETH.MESH.03909733
ETH.MESH.03910177
ETH.MESH.03910193
ETH.MESH.03910421
ETH.MESH.03910800
ETH.MESH.03911109
ETH.MESH.03911394
ETH.MESH.03911715
ETH.MESH.03915380
EXHIBIT DESCRIPTION
SOP for aFMEA dFMEA
TVT 510k
Biomechanical considerations
presentation
TVT Abbrevo Launch Planning Stage
Gate 2010
TVT Inserting Techniques
Email from Laura Angelini re
Transient Leg Pain
with Mulberry
Complaint Handling
Reg strategy
Meshes in floor repair
Email from Martin Weisberg
Trans-obturator TVT Procedure INOut
2nd Generation TVT
6/6/03 Email from Le Treguilly
email from Evans 4/27/05
Arnaud email
New Products Development
10/15/02 Email from Arnaud
Email from Arnaud 11/26/02
7/21/04 Email from Araud
TVT Complaint email
Email from Arnaud 2/13/01
660
661
662
663
664
665
666
ETH.MESH.03917309
ETH.MESH.03917375
ETH.MESH.03918801
ETH.MESH.03922950
ETH.MESH.03922966
ETH.MESH.03924557
ETH.MESH.03926030
ETH.MESH.03917312
ETH.MESH.03917378
ETH.MESH.03918803
ETH.MESH.03922951
ETH.MESH.03922967
ETH.MESH.03924586
ETH.MESH.03926031
11/28/99 Email from Rodrigo Bianchi
email from Weisberg 11/26/02
9/10/03 Email from Wanendeya
email from Robinson 1/16/07
email from 1/10/07
Meshes in Pelvic Floor Repair
high level f/u's from today meeting
ETH.MESH.03930123
Seven-Year Follow-up of the TensionFree Vaginal Tape Procedure
667
ETH.MESH.03930120
PAGE 19 OF 241
Case No.: 2:12-cv-05201
EX #
668
669
670
671
672
IDENTIFIER NO. BEG.
ETH.MESH.03932909
ETH.MESH.03932912
ETH.MESH.03934030
ETH.MESH.03938897
ETH.MESH.03949361
IDENTIFIER NO. END
ETH.MESH.03932911
ETH.MESH.03932914
ETH.MESH.03934032
ETH.MESH.03938898
ETH.MESH.03949365
673
674
ETH.MESH.03964822
ETH.MESH.03966039
ETH.MESH.03964828
ETH.MESH.03966040
675
676
677
678
679
680
681
682
683
684
685
686
687
688
689
690
691
ETH.MESH.03983705
ETH.MESH.04015102
ETH.MESH.04036976
ETH.MESH.04037600
ETH.MESH.04038031
ETH.MESH.04038180
ETH.MESH.04044797
ETH.MESH.04048515
ETH.MESH.04048515
ETH.MESH.04054691
ETH.MESH.04066979
ETH.MESH.04081189
ETH.MESH.04081189
ETH.MESH.04081189
ETH.MESH.04081301
ETH.MESH.04082973
ETH.MESH.04088711
ETH.MESH.03983705
ETH.MESH.04015104
ETH.MESH.04036981
ETH.MESH.04037600
ETH,MESH.04038066
ETH.MESH.04038181
ETH.MESH.04044800
ETH.MESH.04048520
ETH.MESH.04048520
ETH.MESH.04054691
ETH.MESH.04066980
ETH.MESH.04081190
ETH.MESH.04081190
ETH.MESH.04081190
ETH.MESH.04081302
ETH.MESH.04082974
ETH.MESH.04088712
EXHIBIT DESCRIPTION
History of TVT-O
History of TVT
2008 FDA PHN
2/20/06 Email from Buchon
Data test sheet
Partners, Sales, Usage & Business
Need Assessment
Fast Break Promotion
TVT Key Selling Points Verses
Competitors
Email from Batke 3/1/12
2005 Batke report
Boris Batke PPT
Focus on Mesh
email from Jamiolkowski 2/29/12
TVT Update
Nilsson interview
KOL Interview: Carl G. Nilsson
History of SECUR
email from Fujihara 8/4/09
Complication reports
Meeting agenda
Meeting agenda
Work in progress weekly
Possible Complications
Medical Assessment
692
693
694
695
696
ETH.MESH.04090122
ETH.MESH.04092868
ETH.MESH.04093117
ETH.MESH.04093125
ETH.MESH.04093838
ETH.MESH.04090122
ETH.MESH.04092869
ETH.MESH.04093118
ETH.MESH.04093125
ETH.MESH.04093838
e-mail from Meng Chen 10-12-2007
Meng Chen e-mail 12-19-2008
Email from Meng Chen 1/29/09
TVT IFU email
697
698
699
ETH.MESH.04094396
ETH.MESH.04094863
ETH.MESH.04096555
ETH.MESH.04094396
ETH.MESH.04094864
ETH.MESH.04096555
Patient Deaths (01-2006 to 02-2008)
e-mail from Bryan Lisa 01-29-2009
Quarterly MDR review
700
701
ETH.MESH.04097335
ETH.MESH.04097659
ETH.MESH.04097336
ETH.MESH.04097663
Medical Assessment #10100054041
4/24/09 Email from Divilio
PAGE 20 OF 241
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
702
703
704
705
ETH.MESH.04120970
ETH.MESH.04121755
ETH.MESH.04122262
ETH.MESH.04123297
ETH.MESH.04120976
ETH.MESH.04121756
ETH.MESH.04122264
ETH.MESH.04123299
706
707
ETH.MESH.04123300
ETH.MESH.04127133
ETH.MESH.04123320
ETH.MESH.04127134
708
709
710
711
712
713
714
715
716
717
718
719
720
721
722
723
724
725
ETH.MESH.04193990
ETH.MESH.04205632
ETH.MESH.04316544
ETH.MESH.04385229
ETH.MESH.04447134
ETH.MESH.04500235
ETH.MESH.04540382
ETH.MESH.04548236
ETH.MESH.04549731
ETH.MESH.04551757
ETH.MESH.04566349
ETH.MESH.04579677
ETH.MESH.04611734
ETH.MESH.04932707
ETH.MESH.04932710
ETH.MESH.04937874
ETH.MESH.04938061
ETH.MESH.04939027
ETH.MESH.04193993
ETH.MESH.04205636
ETH.MESH.04316562
ETH.MESH.04385245
ETH.MESH.04447142
ETH.MESH.04500458
ETH.MESH.04540382
ETH.MESH.04548242
ETH.MESH.04549731
ETH.MESH.04551795
ETH.MESH.04566351
ETH.MESH.04579677
ETH.MESH.04611734
ETH.MESH.04932709
ETH.MESH.04932711
ETH.MESH.04937876
ETH.MESH.04938066
ETH.MESH.04939035
726
727
728
729
ETH.MESH.04939544
ETH.MESH.04940233
ETH.MESH.04941016
ETH.MESH.04945496
ETH.MESH.04939567
ETH.MESH.04940233
ETH.MESH.04941016
ETH.MESH.04945496
730
731
732
733
ETH.MESH.04947217
ETH.MESH.04985249
ETH.MESH.04985249
ETH.MESH.05120364
ETH.MESH.04947219
ETH.MESH.04985252
ETH.MESH.04985252
ETH.MESH.05120365
PAGE 21 OF 241
EXHIBIT DESCRIPTION
Complication and Reoperation Rates
After
Apical Vaginal Prolapse Surgical
Repair
Prolift trial and communications
TVT O IFU
e-mail from James Hart 2010
Trocar-guided mesh repair of vaginal
prolapse using partially-absorbable
mesh; one year outcomes
email from Maree 1/9/08
Major Executive Committee Actions
1999
Strategic Plan Challenge
Design Controls
Secur CER
Corporate Product characterization
TVT registry
Ethicon Process Overview
CDMA Meeting
FDA 522
TVM Risk Doc
FDA meeting 2011
Henderson on Lucente
Gary Pruden PPT 6/6/06
email from Hinoul 3/5/12
IVS email
TVT-S Plan
11-25-2002 Memo Ultrasonic Slitting
of Prolene mesh for TVT
Gynemesh efficacy memo
Lightweight Mesh developments
4/18/05 email to Holste
e-mail from Edward Dormier 12-1406
8/23/05 Email from Paula Evans
email from Evans 8/23/05
TVT backlash
Case No.: 2:12-cv-05201
EX #
734
735
736
737
738
739
740
741
742
743
IDENTIFIER NO. BEG.
ETH.MESH.05127423
ETH.MESH.05131462
ETH.MESH.05135901
ETH.MESH.05163323
ETH.MESH.05164815
ETH.MESH.05181555
ETH.MESH.05183409
ETH.MESH.05217097
ETH.MESH.05220458
ETH.MESH.05222673
IDENTIFIER NO. END
ETH.MESH.05127430
ETH.MESH.05131463
ETH.MESH.05135903
ETH.MESH.05163325
ETH.MESH.05164820
ETH.MESH.05181558
ETH.MESH.05183410
ETH.MESH.05217144
ETH.MESH.05220464
ETH.MESH.05222701
745
746
748
749
ETH.MESH.05224752
ETH.MESH.05225354
ETH.MESH.05236223
ETH.MESH.05237034
ETH.MESH.05224761
ETH.MESH.05225385
ETH.MESH.05236255
ETH.MESH.05237037
750
751
752
753
754
755
ETH.MESH.05237872
ETH.MESH.05245392
ETH.MESH.05246116
ETH.MESH.05315240
ETH.MESH.05315601
ETH.MESH.05316775
ETH.MESH.05237872
ETH.MESH.05245399
ETH.MESH.05246122
ETH.MESH.05315295
ETH.MESH.05316097
ETH.MESH.05316812
756
757
758
759
760
761
762
763
764
765
766
767
768
769
770
771
772
773
ETH.MESH.05336977
ETH.MESH.05336981
ETH.MESH.05342338
ETH.MESH.05347751
ETH.MESH.05347755
ETH.MESH.05367673
ETH.MESH.05432198
ETH.MESH.05443059
ETH.MESH.05443077
ETH.MESH.05443495
ETH.MESH.05446127
ETH.MESH.05447475
ETH.MESH.05453719
ETH.MESH.05454207
ETH.MESH.05456117
ETH.MESH.05457602
ETH.MESH.05466605
ETH.MESH.05479411
ETH.MESH.05336980
ETH.MESH.05336981
ETH.MESH.05342340
ETH.MESH.05347754
ETH.MESH.05347769
ETH.MESH.05367679
ETH.MESH.05432224
ETH.MESH.05443064
ETH.MESH.05443085
ETH.MESH.05443495
ETH.MESH.05446139
ETH.MESH.05447476
ETH.MESH.05453727
ETH.MESH.05454214
ETH.MESH.05456118
ETH.MESH.05457609
ETH.MESH.05466612
ETH.MESH.05479411
PAGE 22 OF 241
EXHIBIT DESCRIPTION
1/20/10 Email from Holste
Email from Scott Jones 2/1/2011
Email from Urquhart 5/20/10
TVT sales figures
TVT Publication strategy
TVT EPI email
Email from Linton 12/11/08
K962530 Modified Prolene mesh
TVT records
TVT IFU
Email Compliance Information
Update 10/30/08
TVT IFU
TVT Patent Portfolio
Trezwik mesh paper
Mesh Properties How Important Are
They
Email from D. Smith 1/3/06
GLP Archives 6/99
Prolene study report
PSE ACCESSION NO. 02-0579
Professional education cost
containment
EWHU Presentation
Lucente consultant trip
COI policy
COI policy on clincials
Scion material spec
SOP for aFMEA dFMEA
Testing protocol
Mesh test method
Meshes spreadsheet
3/13/06 Email from Holste
How inert is PP
Prolene Study
Cadaver lab photos
Email from McDivitt 8/16/04
Ultrapro Mesh line
Meeting minutes 2/23/07
Research & Development PPT
Case No.: 2:12-cv-05201
EX #
774
775
IDENTIFIER NO. BEG.
ETH.MESH.05479501
ETH.MESH.05479535
IDENTIFIER NO. END
ETH.MESH.05479502
ETH.MESH.05479535
EXHIBIT DESCRIPTION
Batke CV
Mesh chart
776
777
778
779
780
781
782
783
784
785
786
787
788
ETH.MESH.05479535
ETH.MESH.05479717
ETH.MESH.05483362
ETH.MESH.05483836
ETH.MESH.05489861
ETH.MESH.05493965
ETH.MESH.05494064
ETH.MESH.05495419
ETH.MESH.05500891
ETH.MESH.05505944
ETH.MESH.05514963
ETH.MESH.05529274
ETH.MESH.05529653
ETH.MESH.05479535
ETH.MESH.05479717
ETH.MESH.05483362
ETH.MESH.05483836
ETH.MESH.05489867
ETH.MESH.05493999
ETH.MESH.05494066
ETH.MESH.05495422
ETH.MESH.05500901
ETH.MESH.05505945
ETH.MESH.05514963
ETH.MESH.05529275
ETH.MESH.05529653
789
ETH.MESH.05534009
ETH.MESH.05534009
Microporous, Medium, Macroporous
Batke PPT
10/2/03 ULTRAPRO Mesh PPT
Test report
Contract
Meshes in Pelvic Floor Repair
6/1/03 Email from Hellhammer
Mesh scientific statement
TVT-S material spec
Risk assessment
Excel Spreadsheet
2000 Irby memo
email from Hoepffner 11/30/2000
Risk Management Report TVT
SECUR System
790
791
792
793
794
795
796
797
798
799
800
801
802
803
804
805
806
807
808
809
810
811
ETH.MESH.05536032
ETH.MESH.05548122
ETH.MESH.05549189
ETH.MESH.05549696
ETH.MESH.05560961
ETH.MESH.05567793
ETH.MESH.05570260
ETH.MESH.05572912
ETH.MESH.05585033
ETH.MESH.05588123
ETH.MESH.05611588
ETH.MESH.05641096
ETH.MESH.05642489
ETH.MESH.05644163
ETH.MESH.05718101
ETH.MESH.05718952
ETH.MESH.05722820
ETH.MESH.05740424
ETH.MESH.05768705
ETH.MESH.05793739
ETH.MESH.05794787
ETH.MESH.05794926
ETH.MESH.05536032
ETH.MESH.05548123
ETH.MESH.05549191
ETH.MESH.05549700
ETH.MESH.05560963
ETH.MESH.05567794
ETH.MESH.05570261
ETH.MESH.05572913
ETH.MESH.05585053
ETH.MESH.05588126
ETH.MESH.05611588
ETH.MESH.05641098
ETH.MESH.05642491
ETH.MESH.05644171
ETH.MESH.05718108
ETH.MESH.05718952
ETH.MESH.05722822
ETH.MESH.05740428
ETH.MESH.05768712
ETH.MESH.05793740
ETH.MESH.05794788
ETH.MESH.05794930
Year to Date TVT Complaint Review
cadaver lab email
Email from Komarnycky 4/29/05
Cecchini re FDA DVD
2011 FDA email
Professional education memo
Ultrapro PPT
email from Wohler 7/9/07
Complaint Summary
11/17/99 meeting minutes
Email from Sumeray 4/23/01
Surgeon's Feedback
Klinge presentation
Mesh Chart
9/9/09 Email from Peter Meier
TVT training
TVT Compensation plan
TVT O Development Memo
Seven Year Data Report
TVT Brochure
PAGE 23 OF 241
Case No.: 2:12-cv-05201
EX #
812
813
814
815
816
IDENTIFIER NO. BEG.
ETH.MESH.05795106
ETH.MESH.05795299
ETH.MESH.05795318
ETH.MESH.05795322
ETH.MESH.05795421
IDENTIFIER NO. END
ETH.MESH.05795106
ETH.MESH.05795300
ETH.MESH.05795319
ETH.MESH.05795324
ETH.MESH.05795508
817
818
819
ETH.MESH.05795664
ETH.MESH.05815791
ETH.MESH.05823421
ETH.MESH.05795669
ETH.MESH.05815802
ETH.MESH.05823426
820
821
822
823
824
825
826
827
828
829
ETH.MESH.05845592
ETH.MESH.05889974
ETH.MESH.05916450
ETH.MESH.05918082
ETH.MESH.05918776
ETH.MESH.05920530
ETH.MESH.05920616
ETH.MESH.05920618
ETH.MESH.05960623
ETH.MESH.05972834
ETH.MESH.05845599
ETH.MESH.05889974
ETH.MESH.05916450
ETH.MESH.05918116
ETH.MESH.05918776
ETH.MESH.05920532
ETH.MESH.05920617
ETH.MESH.05920628
ETH.MESH.05960623
ETH.MESH.05972866
830
831
832
833
ETH.MESH.05992137
ETH.MESH.05997866
ETH.MESH.06001408
ETH.MESH.06003151
ETH.MESH.05992138
ETH.MESH.05997867
ETH.MESH.06001408
ETH.MESH.06003196
834
835
836
837
838
839
840
841
842
843
ETH.MESH.06005207
ETH.MESH.06006730
ETH.MESH.06022108
ETH.MESH.06034548
ETH.MESH.06034753
ETH.MESH.06051144
ETH.MESH.06087471
ETH.MESH.06087513
ETH.MESH.06136033
ETH.MESH.06164409
ETH.MESH.06005210
ETH.MESH.06006737
ETH.MESH.06022109
ETH.MESH.06034555
ETH.MESH.06034753
ETH.MESH.06051146
ETH.MESH.06087472
ETH.MESH.06087514
ETH.MESH.06136043
ETH.MESH.06164410
PAGE 24 OF 241
EXHIBIT DESCRIPTION
Ethicon training
Professional education budget cuts
TVT Training Course
TVT Training Strategy
Ulmsten, et. al. An Ambulatory
Surgical Procedure Under Local
Anesthesia for Treatment of Stress
TVT Brochure
HPG value adds
Mary, et al., Comparison of the In
Vivo Behavior or Polyvinylidene
Fluoride and Polypropylene Sutures
used in Vascular Surgery
email from Hoepffner 12/20/99
Boris Batke PPT
Secant PPT
5/4/04 Email from Jill Schiaparelli
Mesh literature list
7/20/07 Email from Chomiak
Email from Koehler, P 2/12/08
TVT Complaint analysis
Asset Purchase Agreement
Converting during Professional
Education email
LCM Project
email from Kammerer 10/1/07
The perils of commercially driven
surgical innovation
Strengthen EBM 2009
Risk Assessment Review 07/09
SOP Copy Review
Customer Complaint memo
email from Maree 11/10/07
TVT Brochure
TVT Brochure
Mesh specs
email from Smith 1/16/04
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
844
845
846
847
848
849
ETH.MESH.06214296
ETH.MESH.06260647
ETH.MESH.06261965
ETH.MESH.06372356
ETH.MESH.06403724
ETH.MESH.06661874
ETH.MESH.06214300
ETH.MESH.06260671
ETH.MESH.06261967
ETH.MESH.06372363
ETH.MESH.06403740
ETH.MESH.06661979
850
851
852
ETH.MESH.06695438
ETH.MESH.06696367
ETH.MESH.06696593
ETH.MESH.06695442
ETH.MESH.06696379
ETH.MESH.06696593
853
854
855
856
857
ETH.MESH.06705963
ETH.MESH.06773418
ETH.MESH.06773520
ETH.MESH.06773538
ETH.MESH.06828689
ETH.MESH.06705976
ETH.MESH.06773425
ETH.MESH.06773524
ETH.MESH.06773542
ETH.MESH.06828690
858
ETH.MESH.06828907
ETH.MESH.06828909
859
ETH.MESH.06851860
ETH.MESH.06852464
861
862
ETH.MESH.06852118
ETH.MESH.06857406
ETH.MESH.06852129
ETH.MESH.06857406
863
864
865
866
ETH.MESH.06858146
ETH.MESH.06858314
ETH.MESH.06859904
ETH.MESH.06861426
ETH.MESH.06858147
ETH.MESH.06858318
ETH.MESH.06859904
ETH.MESH.06861429
867
868
869
ETH.MESH.06861946
ETH.MESH.06867612
ETH.MESH.06868377
ETH.MESH.06861946
ETH.MESH.06867612
ETH.MESH.06868382
870
871
872
873
874
875
ETH.MESH.06873447
ETH.MESH.06881079
ETH.MESH.06881589
ETH.MESH.06884516
ETH.MESH.06884726
ETH.MESH.06884728
ETH.MESH.06873458
ETH.MESH.06881080
ETH.MESH.06881591
ETH.MESH.06884517
ETH.MESH.06884727
ETH.MESH.06884732
PAGE 25 OF 241
EXHIBIT DESCRIPTION
Product Specification Gynecare
Prolift +M
R&D Guide
Email from Karl 8/26/11
Global Harms List Document
Study SO04/2-2-1
TVT design file
04-17-2006 memo From Gene
Kammerer
Seppa Email: Perf Eval
LCM FMEA
Value Proposition Report Project
TVTx
PMS Annual Summary
10/22/12 Email form Eley
7/4/12 Email from Eley
Prolift training
3/24/05 Email from Kimberly
Hunsicker
TVT CE Mark Technical File 08-272008
Review of Biocompatibility Data
2000
TVT Bridge
Email from Dan Smith re TVT-O
resin Jan
31th
Test Mesh Thickness
TVT Insights
TVT Secur complaint
Product Data and Technical
Information
Matrix material
Mesh shrink
Due Diligence Growth Opportunity
Outline
TVT complaints
email from Burns 6/22/04
TVT O Complaint
TVT O Complaint
Ongoing TVT-O Action Items
Case No.: 2:12-cv-05201
EX #
876
877
IDENTIFIER NO. BEG.
ETH.MESH.06892171
ETH.MESH.06893952
IDENTIFIER NO. END
ETH.MESH.06892172
ETH.MESH.06893952
878
879
880
881
882
883
884
885
886
887
ETH.MESH.06894461
ETH.MESH.06910622
ETH.MESH.06917699
ETH.MESH.05918776
ETH.MESH.06921060
ETH.MESH.06923868
ETH.MESH.06927231
ETH.MESH.07181044
ETH.MESH.07181045
ETH.MESH.07190442
ETH.MESH.06894467
ETH.MESH.06910625
ETH.MESH.06917704
ETH.MESH.05918776
ETH.MESH.06921077
ETH.MESH.06923871
ETH.MESH.06927235
ETH.MESH.07181044
ETH.MESH.07181045
ETH.MESH.07190446
888
889
890
891
ETH.MESH.07192012
ETH.MESH.07192033
ETH.MESH.07192242
ETH.MESH.07192412
ETH.MESH.07192014
ETH.MESH.07192041
ETH.MESH.07192242
ETH.MESH.07192414
892
893
894
895
896
897
898
899
900
901
902
903
904
905
906
ETH.MESH.07192872
ETH.MESH.07192929
ETH.MESH.07194129
ETH.MESH.07197998
ETH.MESH.07198250
ETH.MESH.07198825
ETH.MESH.07200224
ETH.MESH.07200381
ETH.MESH.07200382
ETH.MESH.07205369
ETH.MESH.07212397
ETH.MESH.07226377
ETH.MESH.07226404
ETH.MESH.07226579
ETH.MESH.07236287
ETH.MESH.07192877
ETH.MESH.07192929
ETH.MESH.07194129
ETH.MESH.07197998
ETH.MESH.07198250
ETH.MESH.07198828
ETH.MESH.07200244
ETH.MESH.07200381
ETH.MESH.07200382
ETH.MESH.07205370
ETH.MESH.07212398
ETH.MESH.07226379
ETH.MESH.07226405
ETH.MESH.07226582
ETH.MESH.07236288
907
908
ETH.MESH.07236294
ETH.MESH.07250424
ETH.MESH.07236297
ETH.MESH.07250425
909
910
ETH.MESH.07250485
ETH.MESH.07252746
ETH.MESH.07250541
ETH.MESH.07252750
PAGE 26 OF 241
EXHIBIT DESCRIPTION
Ultra Pro mesh PP
Impact of Polymer Pore Size on the
Interface Scar Formation
in a Rat Model
Restoring the Joys of life
TOPA CRS
TVT PP may behave like Marlex
TVT Brochure
TOPA project
3/10/10 Email from Kirkemo
1/28/09 Email from Urquhart
AE report
4/12/04 memo to Josh Samon
Erosion investigation surgeon
interview
Erosion investigation
Erosions investigation
PA Consulting Group
Normal lntraabdominal Pressure in
Healthy Adults
Vailhe transfer notice
Forces on pelvic floor
email from Vailhe 3/31/11
Biomechanics on the pelvic floor
POP exposures
POP exposures
email from Savidge 3/12/12
Burkley memo 1/26/12
Email from Vellucci 3/1/12
3/7/12 Email from Jamiolkowski
Clinical Expert Report
4/1/11 Email from Kanerviko
Hinoul Email Workshop Vaginal
Tapes
FDA Inspection 2005
3/14/05 Response to Inspectional
Observations FDA-483 issued
Audit
Case No.: 2:12-cv-05201
EX #
911
912
913
IDENTIFIER NO. BEG.
ETH.MESH.07270482
ETH.MESH.07277675
ETH.MESH.07278193
IDENTIFIER NO. END
ETH.MESH.07270484
ETH.MESH.07277696
ETH.MESH.07278223
EXHIBIT DESCRIPTION
Complications Chart
Franchise Work Instructions
PMS Summary PPT
914
915
916
917
918
ETH.MESH.07281437
ETH.MESH.07284816
ETH.MESH.07316869
ETH.MESH.07386591
ETH.MESH.07387254
ETH.MESH.07281458
ETH.MESH.07284819
ETH.MESH.07316869
ETH.MESH.07386592
ETH.MESH.07387257
919
920
921
922
923
ETH.MESH.07424335
ETH.MESH.07424660
ETH.MESH.07424692
ETH.MESH.07455424
ETH.MESH.07456394
ETH.MESH.07424336
ETH.MESH.07424661
ETH.MESH.07424693
ETH.MESH.07455425
ETH.MESH.07456394
924
925
926
927
928
929
930
931
932
933
934
935
ETH.MESH.07464959
ETH.MESH.07469275
ETH.MESH.07474296
ETH.MESH.07506192
ETH.MESH.07724068
ETH.MESH.07726805
ETH.MESH.07805664
ETH.MESH.07876572
ETH.MESH.07876820
ETH.MESH.07876870
ETH.MESH.07876890
ETH.MESH.07876905
ETH.MESH.07464974
ETH.MESH.07469281
ETH.MESH.07474407
ETH.MESH.07506201
ETH.MESH.07724080
ETH.MESH.07726817
ETH.MESH.07805664
ETH.MESH.07876819
ETH.MESH.07876925
ETH.MESH.07876888
ETH.MESH.07876903
ETH.MESH.07876924
936
937
938
939
940
941
942
943
944
945
946
947
ETH.MESH.07913934
ETH.MESH.07931874
ETH.MESH.07937824
ETH.MESH.07946455
ETH.MESH.07983955
ETH.MESH.08003173
ETH.MESH.08003181
ETH.MESH.08003197
ETH.MESH.08003215
ETH.MESH.08003231
ETH.MESH.08003247
ETH.MESH.08003263
ETH.MESH.07913986
ETH.MESH.07931886
ETH.MESH.07937825
ETH.MESH.07946468
ETH.MESH.07983972
ETH.MESH.08003180
ETH.MESH.08003196
ETH.MESH.08003212
ETH.MESH.08003230
ETH.MESH.08003246
ETH.MESH.08003262
ETH.MESH.08003278
Establishment Inspection Report 2005
Legacy PMS Plan
TVT Presentation
KOL Strategy
8/3/00 Email from Lisa Gardner
7/16/99 Memo- Medical Report: TVT
Adverse Events
Letter to TVT Preceptors 5/21/99
TVT Blue study
TVTO-PA 510k
TVT EPI email
biocompatibility and toxicity testing
memo
Barbolt memo 11/2/01
AAMI standards
Prolene study report
Independent MD&D Sector Audit
handwritten notes
Science Behind LW Mesh
TVT Secure 510(k)
510K TVT-S
Lab report 19285 05
Lab report 19281 05
Lab report 19283 05
Clinical Evaluation Report Prolene
Polypropylene Suture
Performance review
Email from Amy Vie 10/22/08
HCC Guide on Kickbacks
Procedure for Approval of Ads
TVT Brochure
TVT Brochure
TVT brochure
TVT Brochure
TVT Brochure
TVT Brochure
TVT Brochure
PAGE 27 OF 241
Case No.: 2:12-cv-05201
EX #
948
949
950
951
952
IDENTIFIER NO. BEG.
ETH.MESH.08003279
ETH.MESH.08003295
ETH.MESH.08003303
ETH.MESH.08148403
ETH.MESH.08156958
IDENTIFIER NO. END
ETH.MESH.08003294
ETH.MESH.08003302
ETH.MESH.08003318
ETH.MESH.08148403
ETH.MESH.08156958
953
ETH.MESH.08163743
ETH.MESH.08163750
954
955
956
957
958
959
960
961
962
963
964
965
966
967
968
ETH.MESH.08164248
ETH.MESH.08164278
ETH.MESH.08164608
ETH.MESH.08165497
ETH.MESH.08167415
ETH.MESH.08167452
ETH.MESH.08167647
ETH.MESH.08167853
ETH.MESH.08168000
ETH.MESH.08168728
ETH.MESH.08168861
ETH.MESH.08218336
ETH.MESH.08299913
ETH.MESH.08307644
ETH.MESH.08315779
ETH.MESH.08164256
ETH.MESH.08164286
ETH.MESH.08164609
ETH.MESH.08165499
ETH.MESH.08167417
ETH.MESH.08167453
ETH.MESH.08167650
ETH.MESH.08167854
ETH.MESH.08168001
ETH.MESH.08168733
ETH.MESH.08168861
ETH.MESH.08218350
ETH.MESH.08299917
ETH.MESH.08307645
ETH.MESH.08315810
969
970
971
972
973
974
975
976
977
978
979
980
981
982
983
984
ETH.MESH.08334244
ETH.MESH.08345895
ETH.MESH.08381779
ETH.MESH.08382650
ETH.MESH.08385338
ETH.MESH.08438961
ETH.MESH.08450919
ETH.MESH.08471322
ETH.MESH.08471342
ETH.MESH.08471362
ETH.MESH.08471370
ETH.MESH.08472792
ETH.MESH.08472822
ETH.MESH.08473003
ETH.MESH.08474542
ETH.MESH.08474547
ETH.MESH.08334245
ETH.MESH.08345895
ETH.MESH.08381779
ETH.MESH.08382651
ETH.MESH.08385342
ETH.MESH.08438985
ETH.MESH.08450103
ETH.MESH.08471327
ETH.MESH.08471354
ETH.MESH.08471369
ETH.MESH.08471375
ETH.MESH.08472792
ETH.MESH.08472823
ETH.MESH.08473005
ETH.MESH.08474546
ETH.MESH.08474554
PAGE 28 OF 241
EXHIBIT DESCRIPTION
TVT Brochure
TVT Brochure
TVT Brochure
translation of German article
TVT Users forum
2004 Performance and Development
Plan
Company Procedure on US
Regulatory Affairs Review of
Promotion and Advertising Material
SOP for Reg Affairs on Advertising
G Jones resume
TVT Meeting Minutes 1999
Prolapse mesh explants
Email from Angelini 10/3/00
7/27/00 Email from Angelini
3/3/00 Email from Hoepffner
TVT IFU email
Spychaj report
mesh shrinkage presentation
Barbolt memo 10/1/97
Nilsson 2013
RCT data
Clinical Expert Report Prolift +M
e-mail from Gene Kammerer 08-262006 and attachment
Email from Kevin Mahar
Paul Parisi hire notice
2011 EW Priorities
Nuvance
Risk Management
Parisi Performance Review
Hart Career Profile
05 Hart Performance Review
Special Assignment Memo
Kevin Mahar award application
Kevin Mahar nomination
Smith performance review
Case No.: 2:12-cv-05201
EX #
985
986
987
988
989
990
IDENTIFIER NO. BEG.
ETH.MESH.08474555
ETH.MESH.08474562
ETH.MESH.08474570
ETH.MESH.08476210
ETH.MESH.08476210
ETH.MESH.08476285
IDENTIFIER NO. END
ETH.MESH.08474561
ETH.MESH.08474569
ETH.MESH.08474577
ETH.MESH.08476342
ETH.MESH.08476342
ETH.MESH.08476287
991
992
993
994
995
996
997
998
999
1000
1001
1002
1003
1004
1005
1006
1007
1008
1009
1010
1011
1012
1013
1014
1015
1016
ETH.MESH.08476335
ETH.MESH.08477464
ETH.MESH.08505071
ETH.MESH.08505229
ETH.MESH.08505286
ETH.MESH.08505291
ETH.MESH.08515453
ETH.MESH.08516130
ETH.MESH.08516133
ETH.MESH.08579092
ETH.MESH.08581412
ETH.MESH.08583253
ETH.MESH.08691844
ETH.MESH.08692182
ETH.MESH.08692184
ETH.MESH.08692186
ETH.MESH.08692193
ETH.MESH.08692237
ETH.MESH.08692278
ETH.MESH.08692297
ETH.MESH.08692305
ETH.MESH.08692312
ETH.MESH.08692318
ETH.MESH.08692660
ETH.MESH.08692670
ETH.MESH.08692673
ETH.MESH.08476342
ETH.MESH.08477481
ETH.MESH.08505071
ETH.MESH.08505229
ETH.MESH.08505288
ETH.MESH.08505291
ETH. MESH.08515497
ETH.MESH.08516131
ETH.MESH.08516134
ETH.MESH.08579093
ETH.MESH.08581413
ETH.MESH.08583257
ETH.MESH.08691874
ETH.MESH.08692183
ETH.MESH.08692185
ETH.MESH.08692188
ETH.MESH.08692197
ETH.MESH.08692237
ETH.MESH.08692279
ETH.MESH.08692304
ETH.MESH.08692311
ETH.MESH.08692317
ETH.MESH.08692324
ETH.MESH.08692667
ETH.MESH.08692672
ETH.MESH.08692696
1017
ETH.MESH.08695896
ETH.MESH.08695896
1018
1019
1020
1021
1022
ETH.MESH.08696050
ETH.MESH.08696084
ETH.MESH.08793207
ETH.MESH.08793648
ETH.MESH.08798099
ETH.MESH.08696055
ETH.MESH.08696134
ETH.MESH.08793210
ETH.MESH.08793648
ETH.MESH.08798110
PAGE 29 OF 241
EXHIBIT DESCRIPTION
Dan Smith Employee review
TVT 510K
TVT 510k
Patient contact material
Clinical Report- Scandinavian
Multicenter Study
Development Process
Cecchini (ETHUS)
Cecchini on IFU
Regulatory strategy
Cecchini on IFU
510k PP mesh
Cecchini re DVD to FDA
Cecchini re DVD to FDA
POP exposures
Falconer 1996
Career Profile
Bart Pattyson job offer
Bart Pattyson resume
Bart Pattyson Agreement
Bart Pattyson job application
Bart Pattyson hire notice
Bart Pattyson warning
Bart Pattyson review
Contract
2004 Cancellation Agreement
Consulting Agreement 1999
3/28/02 Letter from Howard
Zauberman
1997 Consulting and Technology
Agreement
License and Supply Agreement
11/11/02 Email from Carino
Study Justification
2002-2003 US Marketing Plan
Case No.: 2:12-cv-05201
EX #
1023
1024
1025
1026
1027
1028
1029
1030
1031
1032
IDENTIFIER NO. BEG.
ETH.MESH.09264884
ETH.MESH.09264945
ETH.MESH.09266657
ETH.MESH.09275875
ETH.MESH.09279097
ETH.MESH.09306898
ETH.MESH.09320517
ETH.MESH.09479067
ETH.MESH.09557798
ETH.MESH.09557819
IDENTIFIER NO. END
ETH.MESH.09264885
ETH.MESH.09264946
ETH.MESH.09266658
ETH.MESH.09275876
ETH.MESH.09279105
ETH.MESH.09306910
ETH.MESH.09320518
ETH.MESH.09479068
ETH.MESH.09557818
ETH.MESH.09557819
1033
1034
1035
1036
1037
1038
1039
1040
1041
1042
1043
1044
1045
ETH.MESH.09557820
ETH.MESH.09625725
ETH.MESH.09625974
ETH.MESH.09629446
ETH.MESH.09630638
ETH.MESH.09634052
ETH.MESH.09634299
ETH.MESH.09634662
ETH.MESH.09645766
ETH.MESH.09651393
ETH.MESH.09651966
ETH.MESH.09652185
ETH.MESH.09653077
ETH.MESH.09557856
ETH.MESH.09625973
ETH.MESH.09626241
ETH.MESH.09629458
ETH.MESH.09630739
ETH.MESH.09634104
ETH.MESH.09634318
ETH.MESH.09634688
ETH.MESH.09645766
ETH.MESH.09651401
ETH.MESH.09651966
ETH.MESH.09652185
ETH.MESH.09653079
1046
1047
1048
1049
1050
1051
1052
1053
1054
1055
1056
1057
1058
ETH.MESH.09654601
ETH.MESH.09655947
ETH.MESH.09656632
ETH.MESH.09656790
ETH.MESH.09656792
ETH.MESH.09671612
ETH.MESH.09671620
ETH.MESH.09744840
ETH.MESH.09744848
ETH.MESH.09744858
ETH.MESH.09744866
ETH.MESH.09744870
ETH.MESH.09746615
ETH.MESH.09654601
ETH.MESH.09655947
ETH.MESH.09656632
ETH.MESH.09656791
ETH.MESH.09656792
ETH.MESH.09671620
ETH.MESH.09671620
ETH.MESH.09744845
ETH.MESH.09744855
ETH.MESH.09744863
ETH.MESH.09744867
ETH.MESH.09744871
ETH.MESH.09746617
EXHIBIT DESCRIPTION
Meeting Minutes 11/11/98
1998 Prolene Re-Design
Email from Ellington 6/23/98
Old construction mesh
Mesh improvement project
Marketing plan
FDA meeting 2011
Photos
Mesh explant pictures
Lab notebook
Seven Year Data for Ten Year
Prolene Study
NDA No. 16-394
IND #1688
NDA #13-374
NDA #16-374, S-002, S-003
PMA number N16374
N16374/S34 Received 10-13-1998
N16374 Received 10-15-1990
when the implant worries the body
POP invention disclosure
Ultrapro PPT
Biomechanics of mesh
Trzewik meeting
Uniaxial test- theoretical
considerations
Definition of stress shielding
Prolift biomechanics presentation
LCM mesh qualities
LCM Mesh qualities
Trzewik presentation
Weights and Charts
TVT brochure
TVT Brochure
TVT Brochure
TVT Patient Brochure
Contract
1059
ETH.MESH.09746948
ETH.MESH.09746998
License and Supply Agreement 1997
PAGE 30 OF 241
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
EXHIBIT DESCRIPTION
1060
1061
1062
ETH.MESH.09747177
ETH.MESH.09747632
ETH.MESH.09747728
ETH.MESH.09747177
ETH.MESH.09747643
ETH.MESH.09747728
1063
ETH.MESH.09747994
ETH.MESH.09748017
1064
1065
1066
ETH.MESH.09748308
ETH.MESH.09748634
ETH.MESH.09748790
ETH.MESH.09748385
ETH.MESH.09748635
ETH.MESH.09748791
1067
1068
1069
1070
ETH.MESH.09888187
ETH.MESH.09982887
ETH.MESH.10040025
ETH.MESH.10040062
ETH.MESH.09888223
ETH.MESH.09982888
ETH.MESH.10040059
ETH.MESH.10040164
1071
1072
1073
1074
1075
ETH.MESH.10150515
ETH.MESH.10183005
ETH.MESH.10216874
ETH.MESH.10281860
ETH.MESH.10489347
ETH.MESH.10150849
ETH.MESH.10183061
ETH.MESH.10216875
ETH.MESH.10281874
ETH.MESH.10489358
3/21/03 Letter to Ulmsten from Helms
Ulmsten Device PPT
Email from Carl Linsky
TVT Acquisition Analysis and
Recommendation
Project TOMEL Due Diligence
Summary
4/23/01 Letter to Donald Ostergard
Ulmsten 2001
SEVEN YEAR DATA FOR TEN
YEAR PROLENE STUDY: ERF 85219
TVTO-PAC meeting
Surgical mesh study
K97408 09-28-2012
Clinical Evaluation Report TVT
Family of Products
Marketing plan
AUGS lecture
MUS Update
TVTO-PA memo
1076
1077
1078
ETH.MESH.10575391
ETH.MESH.10575607
ETH.MESH.10575626
ETH.MESH.10575453
ETH.MESH.10575613
ETH.MESH.10575630
1079
1080
1081
ETH.MESH.10575759
ETH.MESH.10591538
ETH.MESH.10632664
ETH.MESH.10575764
ETH.MESH.10591567
ETH.MESH.10632670
THE DEGRADATION AND
BIOCOMPATIBILITY OF SUTURE
MATERIALS
Rabbit study
Suture study
Long-Term Comparative Study of
Nonabsorbable Sutures
TVT IFU status 9/97
Email from Taggart, D 10/29/09
1082
1083
ETH.MESH.10632681
ETH.MESH.10633517
ETH.MESH.10632683
ETH.MESH.10633591
e-mail to Ryan Heniford 05-04-2010
TVT mesh specs rev. 10
PAGE 31 OF 241
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
1084
1085
ETH.MESH.10645237
ETH.MESH.10683482
ETH.MESH.10645242
ETH.MESH.10683816
1086
ETH.MESH.111336474
ETH.MESH.11336487
1087
1088
ETH.MESH.11336034
ETH.MESH.PM.000004
ETH.MESH.11336070
ETH.MESH.PM.000004
1089
ETH.MESH.PM.000010
ETH.MESH.PM.000010
1090
1091
ETH.MESH.PM.000011
ETHMESH00030025
ETH.MESH.PM.000011
ETHMESH00030026
1092
1093
ETHMESH00144252
ETHMESH00155619
ETHMESH00144252
ETHMESH00155627
1094
1095
1096
1097
1098
1099
1100
1101
ETHMESH00158082
ETHMESH00158559
ETHMESH00159634
ETHMESH00159636
ETHMESH00162841
ETHMESH00163582
ETHMESH00175569
ETHMESH00211038
ETHMESH00158082
ETHMESH00158590
ETHMESH00159635
ETHMESH00159719
ETHMESH00162856
ETHMESH00163597
ETHMESH00175569
ETHMESH00211041
1102
1103
ETHMESH00223634
ETHMESH00223640
ETHMESH00223634
ETHMESH00223640
PAGE 32 OF 241
EXHIBIT DESCRIPTION
PROLENE* (POLYPROPYLENE)
SUTURES:
SURFACE ADDITIVE STUDY TISSUE
RESPONSE, RATS - PILOT
STUDY:
FINAL REPORT
TVT CER
TEN YEAR IN VIVO SUTURE
STUDY
SCANNING ELECTRON
MICROSCOPY
FIVE YEAR REPORT
SEVEN YEAR DATA FOR TEN
YEAR PROLENE TM STUDY: ERF
85-219
TVT procedure video 2002-036
ETHICON/GYNECARE
"V.LUCENTE, MD - TVT
w/ANTERIOR COLP." VIDEO
CLIPS FOR WEB SITE OR DATE
5/14/01
Dr. Axel Arnaud- Meshes for
Incontinence and Pelvic Floor Repair
Video
Letter to James Meeuwesen, MD
Gynecare TVT Statement Regarding
Complications
Tips for Scheduling Your
Appointment(s)
Professional Education Program
Copy Review Form
Gynecare TVT Slides
Accurate HCP Report
Mini TVT-O Team Meeting
Design & Development Plan - TVT
RR
Excel Design Requirements Matrix
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
1104
ETHMESH00223800
ETHMESH00223800
1105
ETHMESH00223801
ETHMESH00223801
1106
ETHMESH00301977
ETHMESH00301977
1107
1108
ETHMESH00311802
ETHMESH00340836
ETHMESH00311804
ETHMESH00340838
1109
ETHMESH00340839
ETHMESH00340839
1110
1111
1112
ETHMESH00353635
ETHMESH00354724
ETHMESH00354725
ETHMESH00353674
ETHMESH00354724
ETHMESH00354725
1113
1114
1115
ETHMESH00371496
ETHMESH00400957
ETHMESH00524444
ETHMESH00371594
ETHMESH00400978
ETHMESH00524445
1116
1117
ETHMESH00524907
ETHMESH00525322
ETHMESH00524907
ETHMESH00525400
1118
ETHMESH00533025
ETHMESH00533026
1119
ETHMESH00534496
ETHMESH00534497
1120
ETHMESH00589494
ETHMESH00589494
1121
1122
ETHMESH00607406
ETHMESH00659429
ETHMESH00607410
ETHMESH00659430
1123
ETHMESH00700348
ETHMESH00700350
1124
ETHMESH00748275
ETHMESH00748275
1125
ETHMESH00766975
ETHMESH00766976
1126
ETHMESH00862206
ETHMESH00862209
PAGE 33 OF 241
EXHIBIT DESCRIPTION
TVT Exact Design Verification
Design Review Data
eDesign History File #747 - TVT
Exact Design Verification Report
DFMEA Rev A TVT Laser Cut Mesh
Email from David Robinson re TVT
data
Clinical Expert Report by Isenberg
TVT Instructions for Use Revision Design Verification Memo
Clinical Evaluation Report - TVT
Accessory Abdominal Guide
Excel - Pain Scores
Excel - Pain Scores
Letter from FDA to Gregory R. Jones
Surgeon's Resource Monograph
7 Year Data by Martin Weisberg
Presentation - TVT Bonnie Blair
Campaign
IIS Study Monthly Update July/August 2009
Declaration of the End of the Registry
FMEA-0000536 Rev 1 - Application
FMEA TVT Classic
Email from Aaron Kirkemo re Scion
PA commercial recommendation
Product Pointer: SECUR
Email from Harel Gadot re Laser Cut
Mesh Positioning
Excel - Application FMEA TVT
Calssic
TVT and Thermachoice Patient
Advertising
Corporate Product Characterization Product Performance Evaluation
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
1127
ETHMESH00862227
ETHMESH00862235
1128
ETHMESH00862284
ETHMESH00862289
1129
ETHMESH00863924
ETHMESH00863934
1130
ETHMESH00995657
ETHMESH00995657
1131
ETHMESH01066916
ETHMESH01066932
1132
ETHMESH01068862
ETHMESH01068862
1133
ETHMESH01212090
ETHMESH01212099
1134
ETHMESH01212090
ETHMESH01212094
1135
ETHMESH01218594
ETHMESH01218596
1136
ETHMESH01247379
ETHMESH01247379
1137
ETHMESH01250926
ETHMESH01250926
1138
ETHMESH01250962
ETHMESH01250962
1139
HMESH_ETH_00019554
HMESH_ETH_00019581
1140
1141
HMESH_ETH_00379723
Klosterhalfen-14
HMESH_ETH_00379723
Klosterhalfen-14
1142
1143
1144
K-1
K-10
K-11
K-1
K-10
K-11
1145
1146
K-21
K-22
K-21
K-22
1147
K-23
K-23
PAGE 34 OF 241
EXHIBIT DESCRIPTION
Validation Protocol for Knitting,
Scouring and Heat-Setting 6-mil Old
Construction Blue Prolene Mesh
Material Specification for TVT
Prolene Mesh Roll Stock
Clinical Expert Report - "inside out"
transobturator approach
Presentation - Female Urinary
Incontinence A Primary Care
Perspective
Risk Management Report (Legacy)
for TVT and TVT-O
Excel - Applications FMEA for TVT
Exact
Risk Management Report for TVT
Abbrevo
Risk Management Report for TVT
Laser Cut Mesh (LCM)
Email from Allison London Brown re
TVT U Completion Report Version 3
Exact
Classic
Classic
NDA Prolene Polypropylene Braided
Suture
Discussions with patent department
Klosterhalfen correspondence
J&J Settles Anti-Kickback
Allegations News
Margolis: Getting the Mesh Out
Margolis CV
AUGS FPMRS Subspecialty
Certification
Henry Ford VUI training
ABOG 2012 Guide to Learning on
FPMRS
Case No.: 2:12-cv-05201
EX #
1148
1149
1150
1151
IDENTIFIER NO. BEG.
K-24
K-27
K-29
K-30
IDENTIFIER NO. END
K-24
K-27
K-29
K-30
EXHIBIT DESCRIPTION
MDL Member List of Cases
Marianne Kaminski resume
Protegen recall letter
TVT 510k Summary
1152
K-35
K-35
1153
K-38
K-38
1154
1155
K-44
K-51
K-44
K-51
1156
K-52
K-52
1157
1158
1159
1160
1161
1162
1163
1164
1165
1166
1167
1168
1169
1170
1171
1172
1173
1174
1175
1176
1177
1178
1179
K-7
K-9
Klinge01
Klinge02
Klinge03
Klinge04
Klinge05
Klinge06
Klinge07
Klinge08
Klinge09
Klinge10
Klinge11
Klinge13
Klinge14
Klinge15
Klinge16
Klinge17
Klinge18
Klinge19
Klinge20
Klinge22
Klinge23
K-7
K-9
Klinge01
Klinge02
Klinge03
Klinge04
Klinge05
Klinge06
Klinge07
Klinge08
Klinge09
Klinge10
Klinge11
Klinge13
Klinge14
Klinge15
Klinge16
Klinge17
Klinge18
Klinge19
Klinge20
Klinge22
Klinge23
TVT Mesh pore photographs up close
Presentation and Management of
Major Complications
of Midurethral Slings: Are
Complications Under-reported?
Suffering in Silence: David and
Teresa Sawyer
Shlomo Raz resume
Mesh Sling in an Era of Uncertainty:
Lessons Learned and the
Way Forward
Bladder Perforation During TensionFree
Vaginal Tape Procedures
Doctors Speak Out Against TVT
PAGE 35 OF 241
Case No.: 2:12-cv-05201
EX #
1180
1181
1182
1183
1184
1185
IDENTIFIER NO. BEG.
Klinge24
Klinge25
Klinge32
KLOS0026
KLOS0105
KLOS0175
IDENTIFIER NO. END
Klinge24
Klinge25
Klinge32
KLOS0063
KLOS0138
KLOS0222
1186
1187
1188
1189
1190
KLOS0322
Klosterhalfen-01
Klosterhalfen-02
Klosterhalfen-03
Klosterhalfen-04
KLOS0359
Klosterhalfen-01
Klosterhalfen-02
Klosterhalfen-03
Klosterhalfen-04
1191
Klosterhalfen-05
Klosterhalfen-05
1192
Klosterhalfen-06
Klosterhalfen-06
1193
1194
1195
1196
1197
Klosterhalfen-15
Klosterhalfen-16
Klosterhalfen-17
Klosterhalfen-18
Klosterhalfen-19
Klosterhalfen-15
Klosterhalfen-16
Klosterhalfen-17
Klosterhalfen-18
Klosterhalfen-19
1199
Klosterhalfen-21
Klosterhalfen-21
1200
1201
1202
1203
Klosterhalfen-22
Klosterhalfen-23
Klosterhalfen-25
Muehl-01
Klosterhalfen-22
Klosterhalfen-23
Klosterhalfen-25
Muehl-01
1204
Muehl-02
Muehl-02
1205
Muehl-03
Muehl-03
PAGE 36 OF 241
EXHIBIT DESCRIPTION
Biological Response to mesh
History and Morphometry of Mesh
Optimierung der Biokompatibilitat
Memoire Submitted for the Degree of
Master 2 Surgical Sciences
Klosterhalfen resume
Letter 11-6-13 on Klosterhalfen
Consultant agreement
Consultant form
Klosterhalfen correspondence and
reports
Klosterhalfen correspondence and
reports
German correspondence on mesh
Klosterhalfen
2003 Surgeon listing
29 participants questionnaire
29 participants questionnaire
Klosterhalfen expert report
Polypropylene as a reinforcement in
pelvic surgery
is not inert: comparative analysis of
100 explants
Modified classification of surgical
meshes for hernia repair based
on the analyses of 1,000 explanted
meshes
Klosterhalfen letter with report
Biological Response to Mesh
Expert Report of Thomas Muehl
New Obiective Measurement to
Characterize
the Porosity of Textile Implants
Elongation of textile pelvic floor
implants under load is related to
complete loss of effective porosity,
thereby favoring incorporation
in scar plates
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
1206
1207
1208
1209
1210
1211
1212
Muehl-04
Muehl-05
Muehl-06
Muehl-07
Muehl-08
P-1442
PUBLICALLY
AVAILABLE
Muehl-04
Muehl-05
Muehl-06
Muehl-07
Muehl-08
P-1442
PUBLICALLY
AVAILABLE
1213
PUBLICALLY
AVAILABLE
PUBLICALLY
AVAILABLE
1214
1215
1216
1217
1218
1219
1220
1221
1222
1223
1224
1225
PUBLICALLY
AVAILABLE
T-0268
T-0533
T-0535
T-0544
T-0548
T-0561
T-0572
T-0578
T-0735
T-0751
T-0752
PUBLICALLY
AVAILABLE
T-0268
T-0533
T-0535
T-0544
T-0548
T-0561
T-0572
T-0578
T-0735
T-0751
T-0752
1226
1227
1228
T-0755
T-0764
T-0765
T-0755
T-0764
T-0765
1229
1230
1231
T-0772
T-1021
T-1022
T-0772
T-1021
T-1022
1232
1233
T-103
T-1097
T-103
T-1097
PAGE 37 OF 241
EXHIBIT DESCRIPTION
Klinge article - Auswah der
Herniennetze nach
der „ effektiven Porositat" warum
das Gewicht weniger wichtig ist
Muehl study report
Figure 1 on pore size
Figure 5 on pore size
Close up pic of mesh
Chevron MSDS
ISO 14971 2000; First Edition 20012-15
Transcript of Obstetrics and
Gynecology Medical Devices Panel 98-2011
Transcript of Obstetrics and
Gynecology Medical Devices Panel 99-2011
Burkley CV
Jennifer Paine Deposition Notice
Jennifer Paine resume
2008 PHN
2006 Executive Summary
Regulatory Organization chart
Jenn Paine Resume
Evidence Clinical Selling PP
Bart Pattyson resume
KOL Strategy
China Sales
Professional Education Chart
Professional Education Chart
Evolution of TVT Family presentation
Matt Henderson Resume
Matt Henderson resume
IFU Index and Production Bates
Range Chart
Chris Vailhe resume
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
1234
1235
1236
1237
1238
T-1124
T-116
T-1192
T-1193
T-12
T-1124
T-116
T-1192
T-1193
T-12
1239
1240
1241
1242
1243
T-1201
T-1212
T-1213
T-1214
T-1215
T-1201
T-1212
T-1213
T-1214
T-1215
1244
1245
1246
1247
T-1222
T-1223
T-1233
T-1240
T-1222
T-1223
T-1233
T-1240
1248
T-1242
T-1242
1249
1250
1251
1252
1253
1254
1255
1256
T-1243
T-1244
T-1245
T-1246
T-1263
T-1264
T-1279
T-1296
T-1243
T-1244
T-1245
T-1246
T-1263
T-1264
T-1279
T-1296
1257
T-1297
T-1297
1258
T-1303
T-1303
1259
T-131
T-131
PAGE 38 OF 241
EXHIBIT DESCRIPTION
Anterior Colporrhaphy versus
Transvaginal
Mesh for Pelvic-Organ Prolapse
Code of Conduct
Meshes/Devices
Mesh Development Timeline
TVT regulatory notes
Klosterhalfen et al. The lightweight
and large porous mesh concept for
hernia repair
Shah abstract 1144
2006 Hernia journal article
2009 Intl Urogyn Journal article
2006 Intl Urogyn Journal article
Schumpelick et. al. Hernia Repair
Sequelae
2006 AJOG article
Boris Batke PPT
Research & Development PPT
DVD- Benefits of Lightweight
Meshes featuring B. Todd Heniford
M.D.
The benefits of lightweight meshes in
Ventral Hernia Repair in Ventral
Hernia Repair" Video
Flexible implant
English Translation Flexible Implant
J Urology Abstract 1772
Death Risk
Permanent Pain
TVT IFU
James Hart CV
Mutator activity induced by
microRNA-155 (miR-155)
links inflammation and cancer
Birolini et. al. Mesh cancer: long
term mesh infection leading to
squamous-cell carcinoma of the
abdominal wall
FDA Public Health Notification
10/20/08
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
1260
1261
1262
1263
1264
1265
T-1313
T-1326
T-1330
T-1331
T-1332
T-158
T-1313
T-1326
T-1330
T-1331
T-1332
T-158
1266
1267
1268
1269
1270
1271
1272
1273
1274
1275
1276
1277
T-159
T-16
T-163
T-17
T-173
T-178
T-179
T-180
T-20
T-2004
T-2063
T-2065
T-159
T-16
T-163
T-17
T-173
T-178
T-179
T-180
T-20
T-2004
T-2063
T-2065
1278
1279
T-2072
T-2074
T-2072
T-2074
1280
1281
1282
1283
T-2114
T-2138
T-2158
T-2169
T-2114
T-2138
T-2158
T-2169
1284
T-219
T-219
1285
1286
1287
1288
1289
1290
1291
T-220
T-2241
T-2245
T-2248
T-2249
T-2262
T-2263
T-220
T-2241
T-2245
T-2248
T-2249
T-2262
T-2263
PAGE 39 OF 241
EXHIBIT DESCRIPTION
Mesh Platform Review November
2010 Powerpoint
Phillips Sumika MSDS Marlex
TVT certificate
TVT O certificate
TVT O certificate
15 U.S.C section 53
TVT brochure Breaking the Ice about
SUI
blue book memo
TVT Brochure
2008 TVT family Brochure
SOP Copy Review Rev. 2
SOP Copy Review Rev. 7
Brochure Spreadsheet
Copy Review email
2012 PMS PowerPoint
6/18/13 Letter from Christy Jones
St. Hilaire Resume
ACOG 2007 Practice Bulletin
Update on Technology: Vessel
Sealing Devices
TVT Brochure
Kwon et al. Inflammatory
Myofibroblastic Tumor of the
Urinary Tract Following TVT
Dan Smith Resume
TVT patient Brochure 2013
TVT weight
Operating Procedure for dFMEA
Rev. 5
Operating Procedure for dFMEA
Rev. 14
Barbolt 30b6 notice
28 day rat study
Barbolt 30b6 notice
Barbolt 30b6 notice and studies
Barbolt deposition notice
7 Year Dog Study
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
1292
T-277
T-277
1293
1294
1295
1296
1297
1298
1298
1299
1300
1301
1302
T-287
T-302
T-3049
T-3050
T-3134
Klosterhalfen-20
T-3138
T-3231
T-3253
T-3268
T-3271
T-287
T-302
T-3049
T-3050
T-3134
Klosterhalfen-20
T-3138
T-3231
T-3253
T-3268
T-3271
1303
1304
1305
1306
T-3278
T-3336
T-3339
T-3346
T-3278
T-3336
T-3339
T-3346
1307
1308
1309
T-3347
T-335
T-3352
T-3347
T-335
T-3352
1310
1311
1312
1313
1314
T-3355
T-3371
T-3442
T-3446
T-3482
T-3355
T-3371
T-3442
T-3446
T-3482
1315
1316
1317
1318
1319
T-3483
T-3485
T-3486
T-3490
T-3491
T-3483
T-3485
T-3486
T-3490
T-3491
PAGE 40 OF 241
EXHIBIT DESCRIPTION
Clave et. al., Polypropylene as a
reinforcement in pelvic surgery is not
inert: comparative analysis of 100
explants
Costello et.al, Characterization of
Heavyweight and Lightweight
Polypropylene Prosthetic Mesh
Explants from a Single Patient
NY Times article
Lin Performance Review 2006
Lin Performance Review 2007
J & J Credo
Klosterhalfen letter
G Jones resume
Trzewik CV
T-Pro Thunder Presentation
Nilsson Seventeen years' follow-up
Paul Parisi Resume
2007 WW Sales Operations Overview
Isenberg CV
R&D Administration
What Are The Risks?
2012 risks identified in Isenberg
depo; What Are The Risks?
510(k) Summary 01/28/98
What are the Risks?
T-3355.What are risks; What Are The
Risks?
BJU Intl. (2002) 90, 764-76
Aaron Kirkemo CV 2013
Deciding when to Submit a 510(k)
The Cochrane Collaboration
Retropubic versus Transobturator
Midurethral Slings for Stress
Incontinence
AUGS statement
AUGS statement
AUA statement
AUA statement
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
1320
T-3492
T-3492
1321
1322
T-3494
T-3507
T-3494
T-3507
1323
T-3525
T-3525
1324
T-3526
T-3526
1325
T-3530
T-3530
1326
T-3532
T-3532
1327
1328
1329
1330
1331
1332
1333
1334
T-3533
T-3534
T-3535
T-3537
T-3549
T-3550
T-3557
T-356
T-3533
T-3534
T-3535
T-3537
T-3549
T-3550
T-3557
T-356
1335
T-3561
T-3561
1336
T-3562
T-3562
PAGE 41 OF 241
EXHIBIT DESCRIPTION
Novel Surgical Technique for the
Treatment of Female Stress
Urinary Incontinence: Transobturator
Vaginal Tape Inside-Out
Prospective multicentre randomised
trial of tension-free
vaginal tape and colposuspension as
primary treatment
for stress incontinence
Cadaver lab evaluations
Long-term efficacy of Burch
colposuspension: a 14-year follow-up
study
Burch colposuspension: a 10-20 year
follow up
Tension-free Vaginal Tape for the
Treatment of Urodynamic Stress
Incontinence: Efficacy and Adverse
Effects at 10-Year Follow-Up
Tension-free vaginal tape procedure
without preoperative
urodynamic examination: Long-term
outcome
Long-term follow-up of the
retropubic tension-free vaginal
tape procedure
ICS Fact Sheet
FDA website on SUI
Margolis: Getting the mesh out
Protegen recall
Mesh pics
TVT sales
Kobashi 1999
Bladder Perforation During TensionFree
Vaginal Tape Procedures
Presentation and Management of
Major Complications
of Midurethral Slings: Are
Complications Under-reported?
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
1337
1338
T-3570
T-3571
T-3570
T-3571
1339
1340
1341
1342
T-3572
T-3573
T-3574
T-3575
T-3572
T-3573
T-3574
T-3575
1343
1344
1345
T-373
T-4
T-4000
T-373
T-4
T-4000
1346
1347
T-4013
T-4016
T-4013
T-4016
1348
1349
T-5
T-528
T-5
T-528
1350
1351
1352
T-529
T-530
T-6
T-529
T-530
T-6
1353
1354
T-7
T-717
T-7
T-717
1355
1356
T-8
T-827
T-8
T-827
1357
T-837
T-837
1358
T-838
T-838
1359
1360
T-9
T1262
T-9
T1262
PAGE 42 OF 241
EXHIBIT DESCRIPTION
Suffering in Silence: David and
Teresa Sawyer
9.8.11 FDA Panel
Laparoscopic Burch colposuspension
for stress urinary incontinence:
When, how, and why?
HCC Training
OIG J&J CIA
AUGS MUS statement
Hazell et al., Under-Reporting of
Adverse Drug Reactions
Organization chart
Heniford DVD
email from Wohler 7/9/07 and
translation certification
Vaginal implants PPT
Procedure of establishment
registration and device listing
Patent 6,932,759 Kammerer et al.
Eurpoean Patent Spec. 1 399 088 B1
U.S. Patent 7,112,210 B2
Operating Procedure for 510k
Procedure on Notification Decision
Process
LIGHTning
Franchise Document for creating a
regulatory strategy
TOPA & SCION PPT
Hilton et al. Postural perineal pain
associated with perforation of the
lower urinary tract due to insertion of
a tension-free vaginal tape
Wyczolkowski et al., Reoperation
after complicated tension-free tape
procedures
Procedure Quality System Regulatory
Impact in ADAPTIV
TVT Benefits
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
EXHIBIT DESCRIPTION
1951
1952
ETH.MESH.00855158
ETH.MESH.01785259
ETH.MESH.00855159
ETH.MESH.01785260
1953
1954
ETH.MESH.02157879
ETH.MESH.01752532
ETH.MESH.02157880
ETH.MESH.01752535
1955
ETH.MESH.05337217
ETH.MESH.05337218
1956
ETH.MESH.05882021
ETH.MESH.05882044
1962
1963
T-3177
ETH.MESH.09747038
T-3177
ETH.MESH.09747111
1964
1965
1966
T-3183
ETH.MESH.09747337
T-3192
T-3183
ETH.MESH.09747369
T-3192
1967
1968
1969
1970
1971
1972
ETH.MESH.09747505
ETH.MESH.09747493
ETH.MESH.10150870
ETH.MESH.10150872
T-3204
ETH.MESH.08562491
ETH.MESH.09747537
ETH.MESH.09747495
ETH.MESH.10150870
ETH.MESH.1015087219
T-3204
ETH.MESH.08562495
1973
1974
1975
1976
1977
T-271
T-726
T-1228
T-307
T-675
T-271
T-726
T-1228
T-307
T-675
1978
ETH.MESH.03905059
ETH.MESH.03905072
e-mail from Peter Meier 12-14-2007
e-mail from Piet Hinoul 01-17-2010
Intermediate Report- Prolapse Mesh
Explants 6-2009
Mesh design argumentation issues
e-mail from Dennis Miller 07-062011
New polymer for intra-abdominal
meshes- PVDF co-polymer
Seven Year Dog Study exhibit 153
pages
Seven Year Dog study exhibit 12
pages
Evaluation of POP explants 12/2012
Spreadsheet of mesh explants
TVT Animation Video
Notice to take oral deposition through
designated witnesses
03-05-1997 Medscand Agreement
Payments to Medscand by J&J Per
license and supply agreement
Asset purchase agreement
Payments to Medscand
Professor Ulmsten Consulting
Agreement
Cancellation Agreement
Ulmsten payments spreadsheet
Nilsson payments spreadsheet
Payments to Ulmsten as consultant
Career Development profile
Our Ethical Code for the Conduct of
Research and development
Image of TVT-retropubic
Meshes/Devices
Material Safety Data Sheet
Piet Hinoul CV
Clinical Expert Report Gynecare
TVT Secur System
1957
1958
1959
1960
1961
PAGE 43 OF 241
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
1979
1980
T-3516
P-1295
T-3516
P-1295
1981
1982
ETH.MESH.05445953
ETH.MESH.02587926
ETH.MESH.05445969
ETH.MESH.02587926
1983
1984
ETH.MESH.09747684
T-1364
ETH.MESH.09747684
T-1364
1985
1986
1987
1988
ETH.MESH.01219542
T-1384
T-2167
T-311
ETH.MESH.01219548
T-1384
T-2167
T-311
1989
1990
T-3137
ETH.MESH.04945231
T-3137
ETH.MESH.04945239
1993
1994
1995
ETH.MESH.03662811
ETH.MESH.03658577
ETH.MESH.03662811
ETH.MESH.03658577
2000
2001
2002
P-0001
P-0002
P-0001
P-0002
2003
P-0003
P-0003
2004
ETH.MESH.12831359
ETH.MESH.12831359
2005
ETH.MESH.12831360
ETH.MESH.12831360
1996
1997
1998
1999
PAGE 44 OF 241
EXHIBIT DESCRIPTION
Scandinavian Multicenter Study of
the Tension Free Vaginal Tape
Procedure Clinical Report
Holste CV
e-mail and attachment from Shnoda
Pullen 10-11-2006
when the implant worries the body
Project name: Tension Free Vaginal
Tape
Mesh image
Project TVT laser cut mesh design
history file
History of Secur
Holste deposition excerpt
Weisberg CV
Chevron Phillips Materials Safety
Data Sheet
e-mail from Joerg Holste 4-14-2005
Pelvic Mesh Floor Forum Montag 17
September 2007
Factors related to mesh shrinkage
Biocompatibility of Ultrapro
What has to be considered for
alloplastic selection of nets and slings
at the pelvic floor
Experimental investigations with
alloplastic materials:
Wissenchaftliche Grundlagen
Kondos & Kondos Video
Advertisement
January 14, 2014 letter from
Benjamin Watson to Andrew Faes
Biocompatibility of Meshes
Biological response to Mesh
R&D perspective the journey from
Prolift to Prolift +M
09/30/87 IR Microscopy of Explanted
Prolene received from Prof. R.
Guidoin
2/3/00 Hellhammer meeting re
Uppsala
Case No.: 2:12-cv-05201
EX #
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
IDENTIFIER NO. BEG.
ETH.MESH.12831361
ETH.MESH.12831362
ETH.MESH.12831363
ETH.MESH.12831365
ETH.MESH.12831366
ETH.MESH.12831367
ETH.MESH.12831368
ETH.MESH.12831369
ETH.MESH.12831370
ETH.MESH.12831371
ETH.MESH.12831372
ETH.MESH.12831373
ETH.MESH.12831374
ETH.MESH.12831375
ETH.MESH.12831377
ETH.MESH.12831378
ETH.MESH.12831380
ETH.MESH.12831381
ETH.MESH.12831382
ETH.MESH.12831383
IDENTIFIER NO. END
ETH.MESH.12831361
ETH.MESH.12831362
ETH.MESH.12831364
ETH.MESH.12831365
ETH.MESH.12831366
ETH.MESH.12831367
ETH.MESH.12831368
ETH.MESH.12831369
ETH.MESH.12831370
ETH.MESH.12831371
ETH.MESH.12831372
ETH.MESH.12831373
ETH.MESH.12831374
ETH.MESH.12831376
ETH.MESH.12831377
ETH.MESH.12831379
ETH.MESH.12831380
ETH.MESH.12831381
ETH.MESH.12831382
ETH.MESH.12831383
2026
ETH.MESH.12831391
ETH.MESH.12831404
2027
ETH.MESH.12831405
ETH.MESH.12831406
2028
ETH.MESH.12831407
ETH.MESH.12831408
2030
HMESH_ETH_00083293
HMESH_ETH_00083296
2031
2032
ETH.MESH.05478745
ETH.MESH.05478745
2033
ETH.MESH.04945136
ETH.MESH.04945144
2034
ETH.MESH.02184130
ETH.MESH.02184138
2035
T-3599
T-3599
EXHIBIT DESCRIPTION
2/19/86 Dog Study Notes
3/14/86 Dan Burkley Notes
7/14/86 Dog Study notes
6/11/90 Dog study notes
6/24/99 Dog Study notes part II
9/30/87 IR Microscopy of explanted
Prolene
6/15/82 Crack Depth in Explnated
Prolene Polypropylene Sutures
11/12/87 Explants Study Meeting
Minutes 1/8/87
06/14/10 Klinge email re Dubai 2010
classification of mesh
Email from Boris Batke re Glossary
of Meshes
Email from Klinge re Glossary for
meshes
Ultrapro Plug presentation
Poerngrosse Email attaching Muehl
Article
Email from Martin Chomiak re
Nachtrag re; artikel
TVT Retropubic Mechanical Cut,
U.S. Sales
2036
T-3600
T-3600
TVT Blue mesh, laser cut: 810041BL
2029
PAGE 45 OF 241
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
2037
2038
T-3601
T-3602
T-3601
T-3602
2039
2040
2041
2043
2044
2045
2047
T-3603
T-3604
T-3605
T-3607
T-3608
T-3609
ETH.MESH.00655898
T-3603
T-3604
T-3605
T-3607
T-3608
T-3609
ETH.MESH.00655917
ETH.MESH.00863998
ETH.MESH.00863998
2048
2049
2050
2052
2053
2054
PAGE 46 OF 241
EXHIBIT DESCRIPTION
Gynecare Sales 1997-2013 TVT-0 &
TVT Classic, OUS
TVT-R Sales
TVT-0 mechanical cut: 810081,
810081E5
TVT-0 laser cut mesh: 810081L
TVT -O Sales
TVT Sales documents
W. Virginia Sales Data
J&J Profit & Loss Statement
Beta Targeting spreadsheet
Aigmueller et. al. Ten year follow-up
after the tension free vaginal
procedure
Aigmueller et. al. Reasons for
dissatisfaction ten years after TVT
procedure
April 2003 AUA Voc Interviews
Complications that I have seen in my
clinical practice caused by synthetic
mesh slings, authored by Michael
Margolis
Rapoport, D., Fenster, H., Wright, J.,
Reported complications of tensionfree vaginal tape procedures: A
review, BC Medical Journal, Vol. 49,
No. 9, Nov. 2007
Anger, J., Litwin, M, Wang, Q.,
Pashos, C., Rodriguez, L.,
Complications of Sling Surgery
Among Female Medicare
Beneficiaries, Obstetrics &
Gynecology, Vol. 109, No. 3, Mar.
2007
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
2055
2056
2057
2058
2059
2060
2061
2062
PAGE 47 OF 241
EXHIBIT DESCRIPTION
Mazouni, C., Karsenty, G., Bretelle,
F., Bladou, F., Gamerre, M. and
Serment, G. (2004), Urinary
complications and sexual function
after the tension-free vaginal tape
procedure. Acta Obstetricia et
Gynecologica Scandinavica, 83: 955961. doi: 10.lllllj.00016349.2004.00524.x
TeLinde's Operative Gynecology 10th
edition, 2011, Chapter 37 Stress
3. BJOG. 2008 Jan;115(2):219-25;
discussion 225. Randomised trial of
laparoscopic Burch colposuspension
versus tension-free vaginal tape: longterm follow up
Demirkesen, O., Does Vaginal AntiIncontinence Surgery Affect Sexual
Satsifaction? A Comparison of TVT
and Burch-Colposuspension,
Neurology, Vol. 34(2): 214-219,
Mar.-Apr. 2008
2. Int Urogynecol J. 2013 Nov 29.
[Epub ahead of print] Comparison of
polypropylene mesh and porcinederived, cross-linked urinary bladder
matrix materials implanted in the
rabbit vagina and abdomen
Glatt, A., The Prevalence of
Dyspareunia, Obstetrics &
Gynecology, Vol. 75, No. 3, Part 1,
Mar. 1990
Hurd, W., Conflicts of Interest and
Medical Publishing, Obstetrics &
Gynecology, Vol. 122, No. 3, Sept.
2013
Visco, A., The Impossible Voyage,
Female Pelvic Medicine &
Reconstructive Surgery, Vol. 20, No.
1, Jan./Feb. 2014
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
2078
ETH.MESH.02253333
ETH.MESH.02253415
2079
ETH.MESH.02588301
ETH.MESH.02588303
2080
DEF HOLSTE 3
DEF HOLSTE 3
2081
ETH.MESH.02319001
ETH.MESH.02319001
2082
DEF HOLSTE 5
DEF HOLSTE 5
2083
2084
ETH.MESH.02614776
Holste 1304
ETH.MESH.02614799
Holste 1304
2095
ETH.MESH.01186613
ETH.MESH.01186613
2063
2065
2096
2097
2098
ETH.MESH.02626960
ETH.MESH.02626965
2099
2100
ETH.MESH.09656790
ETH.MESH.02652145
ETH.MESH.09656795
ETH.MESH.02652152
2106
2107
ETH.MESH.03906527
ETH.MESH.03906527
PAGE 48 OF 241
EXHIBIT DESCRIPTION
Powerpoint by Mark D. Walters, MD
entitled Surgery for Stress Urinary
Incontinence: Does One Sling Fit
All?
Manodoro, S., Graft-related
complications and biaxial
tensiametry following experimental
vaginal implantation of flat mesh of
variable dimensions
Surgical Mesh Treatment of Women
with Pelvic Organ prolapse and
Stress Urinary Incontinence
Institut und Praxisgemeinschaft Fur
Pathologie
Final Report, PSE Accession No. 000035
Tissue Reaction and Integration of
Polypropylene-Based Surgical Mesh
in Rats
Biology of polypropylene/polyglactin
910 grafts
24 Week Intramuscular
Tissue/Absorption Study in Rats
Results Prolift
From presentation to publication:
ensuring quality in the reporting of
urogynaecology research
IUGA 2009 Italy Sponsorship Invoice
Steege, et al, Evaluation and
treatment of Dyspareunia
TVT Issue Report
e-mail from Juergen Trzewik 4-132010 and attachments
TVT Issue Report
Urogynecology and Reconstructive
Pelvic Surgery Third Edition; Mark
D. Walters, MD
Graft or no Graft?
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
2108
T-3531
T-3531
2109
T-3532
T-3532
2110
T-3533
T-3533
2111
ETH.MESH.10182464
ETH.MESH.10182468
2112
ETH.MESH.00396502
ETH.MESH.00396549
2113
2114
2115
ETH.MESH.10368729
ETH.MESH.1368737
2116
ETH.MESH.08476335
ETH.MESH.08476342
2117
2118
2119
2120
2121
ETH.MESH.04533500
ETH.MESH.04533502
2125
2126
ETH.MESH.05337225
ETH.MESH.05339015
ETH.MESH.05337228
ETH.MESH.05339017
2127
ETH.MESH.05337267
ETH.MESH.05337267
2122
2123
2124
PAGE 49 OF 241
EXHIBIT DESCRIPTION
Olsson, et al., Long-term efficacy of
the tension-free vaginal tape
procedure for the treatment of urinary
incontinence
Heinonen, et al., Tension-free vaginal
tape procedure without preoperative
outcome
Svenningsen et al., Long term followup of the retopubic tension free
vaginal tape procedure
Product Division Strategic Plans
1999-2005
Global Congress of Minimally
Invasive Gynecology
AUA Guidelines for the surgical
management of female stress urinary
incontinence
Update of AUA guideline
AUA News October, 2013
Scandinavian Multicenter Study
Clinical report
Augs position statement miduretheral
slings
Augs conflict of interest policy
AUGS- about Augs
Sunbeam sues the A.M.A.
Professional medical organizations
and commercial conflicts of interest:
Ethical Issues
AUGS membership: Join AUGS
AUGS corporate support- corporate
members
e-mail from Brian Luscombe 07-062011
e-mail from Paul Parisi 06-27-2011
e-mail from Dennis Miller, MD 0627-2011
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
2128
13001
13002
13003
13004
13005
13006
ETH.MESH.04005863
ETH.MESH.00222779
ETH.MESH.00222464
ETH.MESH.00259047
ETH.MESH.00340835
ETH.MESH.02265802
ETH.MESH.02265803
ETH.MESH.04006038
ETH.MESH.00223267
ETH.MESH.00222778
ETH.MESH.00259513
ETH.MESH.00340835
ETH.MESH.02265802
ETH.MESH.02265809
13007
ETH.MESH.03671138
ETH.MESH.03671138
13008
13009
13010
13011
ETH.MESH.03456775
ETH.MESH.00166287
ETH.MESH.01218099
ETH.MESH.02620354
ETH.MESH.03456779
ETH.MESH.00166292
ETH.MESH.01218103
ETH.MESH.02621558
13012
13013
13014
ETH.MESH.02621559
ETH.MESH.02623743
ETH.MESH.02625055
ETH.MESH.02622455
ETH.MESH.02625054
ETH.MESH.02626377
13015
ETH.MESH.00371572
ETH.MESH.00371573
13016
ETH.MESH.00371587
ETH.MESH.00371594
13017
ETH.MESH.00371496
ETH.MESH.00371497
13018
ETH.MESH.00764323
ETH.MESH.00764325
PAGE 50 OF 241
EXHIBIT DESCRIPTION
Theoretical and experimental
evaluation of implant materials used
in pelvic organ prolapse repair
DH1019 TVT-O
DH1019 TVT-O
DH1019 TVT-O
TVT Classic
TVT Classic
TVT Classic
MS455-012; Revision 18
Material Specification for Pelletized
Unpigmented Polypropylene Resin
(Type F040-S Undyed)
Product Pointer for TVT Tension-free
Vaginal Tape Patient Education
Brochure
TVT-S The Support is Here
TVT Laser Cut Mesh Rev. 1
TVT Classic 1999-2000
Issue Report TVT Retropubic 2001
Open Date Between 01-Jan-2001 and
31-Dec-2001
TVT Classic 2002
TVT Classic 2003
Alex C. Wang, Tension-Free Vaginal
Tape (TVT) for Urinary Stress
Incontinence - A Preliminary Report
M. Eriksson (Medscand),
Scandinavian Multicenter Study of
the Tension Free Vaginal Tape
Procedure Clinical Report
Letter from FDA granting 510(k)
clearance for TVT
5-Year Press Release
Long-term Data Proves Safety and
Efficacy of GYNECARE TVT
Tension-free Support for Treating
Draft 2: For Immediate Release
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
13019
ETH.MESH.03483690
ETH.MESH.03483696
13020
ETH.MESH.00409659
ETH.MESH.00409663
13021
ETH.MESH.00015598
ETH.MESH.00015607
13022
ETH.MESH.00160813
ETH.MESH.00160821
13023
ETH.MESH.05793690
ETH.MESH.05793693
13024
ETH.MESH.04985249
ETH.MESH.04985252
13025
ETH.MESH.04122262
ETH.MESH.04122264
13026
ETH.MESH.00585823
ETH.MESH.00585832
13027
ETH.MESH.01784428
ETH.MESH.01784435
13028
ETH.MESH.05475773
ETH.MESH.05475822
13029
ETH.MESH.01218361
ETH.MESH.01218367
13030
ETH.MESH.03913651
ETH.MESH.03913655
13031
ETH.MESH.06861473
ETH.MESH.06861473
PAGE 51 OF 241
EXHIBIT DESCRIPTION
Yale email chain originating
06/07/20020re Wang's rejections
Customer Initiated Research Grant
Request (Wang)
Cosson, et al, Mechanical properties
of synthetic implants used in the
repair of prolapse and urinary
incontinence in women: which is the
ideal material? Int Urogynecol J
(2003) 14: 169-178
Only Gynecare TVT Has Long-term
Results You Can See
GYNECARE TVT Introduction to
cross train the Uterine Health reps on
TVT
Evans email chain re TVT Laser Cut
Value Proposition and Forecast
Hart, James, MD email chain
originating 02/28/2006 re TVT-O
Training
Kammerer, Gene Email to Volpe,
Clifford Subject: GY:
***URGENT*** French
STANDARD ON TVT & MESHES
(COMMENTS REQUIRED)
Robinson, D, email chain originating
12/15/2006 re TVT-S Cookbooks
Boris Batke, Ethicon R&D,
Presentation: The (clinical) argument
of lightweight mesh in abdominal
surgery
State of Knowledge in "mesh
shrinkage"--What we know)
CDMA Europe Meeting Urinary
Incontinence Platform
Meeting Minutes
GYNECARE TVT SECUR
Competitive Product Update 2007 by
Dan Smith
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
13032
ETH.MESH.04126728
ETH.MESH.04126730
13033
ETH.MESH.00311792
ETH.MESH.00311794
13034
ETH.MESH.03459211
ETH.MESH.03459213
13035
13036
ETH.MESH.07937826
ETH.MESH.04050265
ETH.MESH.07937828
ETH.MESH.04050267
13037
13038
13039
ETH.MESH.06239100
ETH.MESH.00211259
ETH.MESH.03334244
ETH.MESH.06239108
ETH.MESH.00211260
ETH.MESH.03335261
13040
ETH.MESH.00349508
ETH.MESH.00349512
13041
ETH.MESH.06927248
ETH.MESH.06927249
13042
ETH.MESH.07455220
ETH.MESH.07455221
13043
13044
ETH.MESH.05125293
ETH.MESH.10633520
ETH.MESH.05125297
ETH.MESH.10633528
PAGE 52 OF 241
EXHIBIT DESCRIPTION
Gynecare TVT Secur system -Postmarket Surveillance Review
Meeting
Aran Maree Email chain originating
11/08/2007 re Australia update and
telephone call with Prof Frazer
FOR IMMEDIATE RELEASE: New
Study Offers More Than a Decade Of
Evidence For Minimally-Invasive
Surgery To Treat Female
Incontinence"
Nilsson 11 year press release
FDA Public Health Notification:
Serious Complications Associated
with Transvaginal Placement of
Surgical Mesh in Repair of POP and
SUI
Letter re: Deleval
Bobertz, E email chain originating
July 9, 2009 re Resin information
request -- Neuchatel discussion of
resin and syringes
Emails re TVT-Exact IFU
Run on eg log.txt
TVT Ad - Make Data and Safety
Your Choice
Smith, D email Subject Information
regarding Scion
Response to MHRA inquiry
regarding inertness of polypropylene
mesh
Email from Piet Hinoul to Axel
Arnaud with attached article: L.
Lewis Wall, MD, The perils of
commercially driven surgical
innovation, American Journal of
Obstetrics & Gynecology, March
2009
Revision History of MS-0000108
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
13045
13046
13047
13048
ETH.MESH.00524059
ETH.MESH.03905968
ETH.MESH.09748842
ETH.MESH.09748848
ETH.MESH.00524149
ETH.MESH.03905975
ETH.MESH.09748846
ETH.MESH.09748853
13049
ETH.MESH.00584811
ETH.MESH.00584813
13050
ETH.MESH.06696589
ETH.MESH.06696592
13051
ETH.MESH.00330760
ETH.MESH.00330764
13052
ETH.MESH.00302181
ETH.MESH.00302185
13053
ETH.MESH.00303084
ETH.MESH.00303085
13054
ETH.MESH.03574916
ETH.MESH.03574919
13056
ETH.MESH.03575061
ETH.MESH.03575061
13057
ETH.MESH.00864101
ETH.MESH.00864102
13058
13059
ETH.MESH.00858110
ETH.MESH.02180759
ETH.MESH.00858111
ETH.MESH.02180761
13061
ETH.MESH.01814740
ETH.MESH.01814741
13062
13062
ETH.MESH.00261818
ETH.MESH.00349122
ETH.MESH.00261818
ETH.MESH.00349122
13063
ETH.MESH.00865147
ETH.MESH.00865147
13064
ETH.MESH.00260739
ETH.MESH.00260744
PAGE 53 OF 241
EXHIBIT DESCRIPTION
Issue Report TVT Retropubic 2001
Open Date Between 01-Jan-2001 and
31-Dec-2001
Gynecare Pro-lift Ad
Consultancy Agreement - Falconer
Consultancy Agreement - Razapour
Emails from Gene Kammerer re
Ultrasonic slitting of prolene mesh
for TVT
Minute: Tactile appraisal of TVT
LCM & LCM-MC both vs MCM
Email chain from Cindy Crosby re
MHRA request - TVT blue pigment
risk assessment
Email from Daniel Lamont to
Jacqueline Flatow fwd TVT LCM design inputs
Emails between Daniel Lamont and
Carolyn Brennan re Complaint
Summaries
Emails between Charlotte Owens and
Carol Holloway re Medical Review
file #30005136
Email from Charlotte Owens to Carin
Rassier re Complaint 30005255
Emails between Dan Smith and
Vincent Lucente re TOVT
development
April 10, 2003 meeting minutes from
Project Leader Dan Smith
Memo from Jean de Leval, MD
Email from Dan Smith to Katrin
Elbert re IFU changes
Email from Katrin Elbert re TVT-O
IFU changes
TVT Secur dFMEA Rev #1
Email from Axel Arnaud re Mulberry
IFU
Email chain from Brian Luscombe re
Mulberry Final DRAFT #1
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
13065
ETH.MESH.03918552
ETH.MESH.03918553
13066
ETH.MESH.00864413
ETH.MESH.00864413
13067
13068
ETH.MESH.06881576
ETH.MESH.02340829
ETH.MESH.06881580
ETH.MESH.02340901
13069
ETH.MESH.00866317
ETH.MESH.00866318
13069
ETH.MESH.04099233
ETH.MESH.04099234
13070
13071
ETH.MESH.00211263
ETH.MESH.02342102
ETH.MESH.00211265
ETH.MESH.02342102
13072
ETH.MESH.10632650
ETH.MESH.10632653
13073
13074
ETH.MESH.00864085
ETH.MESH.06880021
ETH.MESH.00864087
ETH.MESH.06880023
13075
13076
ETH.MESH.00640394
ETH.MESH.05119622
ETH.MESH.00640395
ETH.MESH.5119631
13077
ETH.MESH.06884249
ETH.MESH.6884250
13078
13079
ETH.MESH.08167644
ETH.MESH.06852120
ETH.MESH.08167645
ETH.MESH.06852123
13080
13081
13082
13083
13084
13085
ETH.MESH.02019485
ETH.MESH.03965159
ETH.MESH.04049320
ETH.MESH.08376560
ETH.MESH.06880472
ETH.MESH.03918253
ETH.MESH.02019485
ETH.MESH.03965195
ETH.MESH.04049320
ETH.MESH.08376564
ETH.MESH.06880478
ETH.MESH.03918264
EXHIBIT DESCRIPTION
Emails between Brian Luscombe,
Axel Arnaud and Janice Burns re De
Leval Publication
Email from David Robinson MD to
Dan Smith regarding deLeval’s
Babcock technique
Email Kevin Mahar to Janice Burns
re “TVTO”
TVT-O IFU
Emails between Janice Burns and
Katrin Elbert re mulberry IFU
Email from Melissa Day to Meng
Chen and others re #10100078150
Email chain from Susan Lin re TVT
EXACT IFU Proof Read 9/14/09
Prolene
Email from John Young to Aaron
Kirkemo re IFU
Email Brian Luscombe to Dan Smith
and Janice Burns, et al. re Design
Validation
Emails re Design Validation
Sales Representative Quick
Reference Sheet
TVT Commonly Asked Questions
Emails re Ulmsten opinion on
Mulberry
Email from Hellhammer re Cardozo
Trial
Cytotoxicty Risk Assessment
Email from Zaddem re obt muscle
thickness values
The Science of "What's Left Behind"
TVTO Data 2006 & 2007
TVT Obturator System reference
doi:10.1016/j.eururo.2003.09.003
Licensing Agreement
13086
13087
13088
ETH.MESH.03934952
ETH.MESH.03715869
ETH.MESH.00209965
ETH.MESH.03934967
ETH.MESH.03715876
ETH.MESH.00209968
TVTO April 30, 2003 Meeting Report
Emails re Mulberry Final DRAFT #1
Emails re TVTO mini IFU rewrite
PAGE 54 OF 241
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
13089
ETH.MESH.01279975
ETH.MESH.01279976
13090
ETH.MESH.07383730
ETH.MESH.07383731
13091
ETH.MESH.00074499
ETH.MESH.00074499
13092
ETH.MESH.11353422
ETH.MESH.11353439
13093
13094
ETH.MESH.05447481
ETH.MESH.00004755
ETH.MESH.05447482
ETH.MESH.00004755
13095
13096
ETH.MESH.06040171
ETH.MESH.09158424
ETH.MESH.06040173
ETH.MESH.09158430
13097
ETH.MESH.00303944
ETH.MESH.00303945
13098
13099
13100
ETH.MESH.00328895
ETH.MESH.03916716
ETH-50330
ETH.MESH.00328901
ETH.MESH.03916727
ETH-50330
13101
13102
13103
ETH.MESH.00304013
ETH.MESH.09004550
ETH.MESH.00746209
ETH.MESH.00304014
ETH.MESH.09004555
ETH.MESH.00746209
13104
ETH.MESH.00746210
ETH.MESH.00746212
13105
ETH.MESH.00526484
ETH.MESH.00526487
13106
ETH.MESH.00746204
ETH.MESH.00746208
13107
ETH.MESH.03274663
ETH.MESH.03274670
13108
ETH.MESH.10372553
ETH.MESH.10372564
13109
ETH.MESH.02106803
ETH.MESH.02106803
PAGE 55 OF 241
EXHIBIT DESCRIPTION
Harel Gadot email with attached
diagram
Robert Zipfel email chain re Ultrapro
mesh information -- identical mesh to
PROLIFT+M
Gynecare Pro-Lift+M Pelvic Floor
Repair System Training Presentation
Risk Assessment Summary for
Products in the Gynecare TVT Secure
System
Thomas Barbolt email chain re How
inert is polypropylene?
Printout from 1998 Guidoin Explant
Kevin Mahar email chain re Laser
Cut Mesh Positioning
ARTISYN Advisory Board notes
Daniel Lamont email chain re
Gynemesh issue
David Robinson email chain re
Quality issue with a batch of
gynemesh
Notes
Slide: Selecting the Right Mesh
Daniel Lamont email chain re Post
Launch Reviews
Elongation test data
LCM Product Pointer
Surgeon Evaluation Questions for
Laser Cut Mesh
Price St. Hilaire email chain re Laser
Cut Mesh - Launch Strategy EMEA
Jason Hernandez email chain re TVT
LCM Early EU Feedback
Marie-Ange Damotte email chain re
TVT Laser Cut First Human Use surgeon preference questionnaire
Sungyoon Rha email re First Human
Use - Surgeon preference
Questionnaire
Physician Post-Operative
Questionnaire
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
13110
ETH.MESH.00998347
ETH.MESH.00998348
13111
ETH.MESH.10372554
ETH.MESH.10372564
13112
ETH.MESH.10302268
ETH.MESH.10302279
13113
13114
13115
ETH.MESH.11445930
ETH.MESH.02229061
ETH.MESH.09170211
ETH.MESH.11445931
ETH.MESH.02229061
ETH.MESH.09170213
13116
ETH.MESH.00590896
ETH.MESH.00590897
13117
ETH.MESH.01202101
ETH.MESH.01202103
13118
ETH.MESH.10237693
ETH.MESH.10237695
13119
ETH.MESH.01795909
ETH.MESH.01795929
13120
13121
13122
ETH.MESH.09161482
ETH.MESH.11434367
ETH.MESH.11434264
ETH.MESH.09161484
ETH.MESH.11434379
ETH.MESH.11434272
13123
ETH.MESH.02201463
ETH.MESH.02201467
13124
13125
13126
ETH.MESH.08170224
ETH.MESH.03918352
N/A
ETH.MESH.08170232
ETH.MESH.03918352
N/A
13127
N/A
N/A
PAGE 56 OF 241
EXHIBIT DESCRIPTION
Harel Gadot email re Laser Cut Mesh
- Launch Strategy EMEA
An Evaluation of the application of
the GYNECARE TVT Obturator
System Tension-free Support for
Incontinence with Laser Cut Mesh
Protocol
An Evaluation of the application of
the GYNECARE TVT Obturator
System Tension-free Support for
Incontinence with Laser Cut Mesh
Protocol 300-05-xxx Amendment 1
Ona Bernal email chain re Week 1:
TVT Abbrevo Eval
Abbrevo marketing video
Abbrevo marketing video - script
Piet Hinoul email re EJOGRB-084159R1 - Minor Revision
Aaron Kirkemo email re My revised
writeup of the DeLaval and
Waltregny visit
Greg Prine email chain re New
Gynecare TVT Abbrevo sales
literature and DVD now available
Clinical Expert Report Gynecare
TVT Abbrevo
Christine Destefano email re
Approved TVTAA-474-10-10_12
Gynecare TVT Abbrevo Clinical
Data Review Flashcard
Abbrevo Launch Selling Guide
Abbrevo Physician Brochure
Marianne Kaminski email chain re
ICS/Paris-Gala Invitee List
Kevin Frost email chain re SGS
Fellowes Symposium
Marketing Plan TVT-O
Excerpt from TVT 510(k)
Tension Free Vaginal Tape (TVT)
System 510(k) Notification - FOIA
copy ?
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
13128
13129
ETH.MESH.07730291
ETH.MESH.02169504
ETH.MESH.07730295
ETH.MESH.02169511
13130
13131
13132
ETH.MESH.06003173
N/A
PM.000003.m4v
ETH.MESH.06003180
N/A
PM.000003.m4v
13133
N/A
N/A
13135
N/A
N/A
13136
N/A
N/A
13137
N/A
N/A
13138
13139
N/A
N/A
N/A
N/A
13140
N/A
N/A
13141
N/A
N/A
13142
13143
N/A
N/A
N/A
N/A
13144
N/A
N/A
13145
N/A
N/A
PAGE 57 OF 241
EXHIBIT DESCRIPTION
Lapinskas, I, email chain originating
01/27/2012 re Discussion of 3.5 mil
Prolene production
TVT 20021016
TVT - Freedom From Stress Urinary
Incontinence
Patient Brochure Index (8/26/2013)
Training Videos
General Program Memorandum
#G91-1 from Director, Office of
Device Evaluation
Medical Device Reporting for
Manufacturers by Department of
Health and Human Services, Public
Health Services, FDA
FDA Science and Mission at Risk –
Report from Subcommittee on
Science and Technology
Rule 26 Expert Report of Christina
Pramudji, MD
Slide of LW LPR mesh used in pelvic
floor
Degradation slides
Draft - AUGS-SUFU Position
Statement on Mesh Midurethral
Slings for Stress Urinary
Incontinence (MIL00268)
AUGS/SUFU MUS Task Force
Agenda (MIL00282)
Summary of 63 TVT-O RCTs Batiste Defense Trial Exhibit
D23501.1
Study Slides - various testimony
Trial Testimony of Melvyn Anhalt,
MD in Linda Batiste Trial
Trial Testimony of Piet Hinoul in
Linda Batiste Trial
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
13146
N/A
N/A
13147
N/A
N/A
13148
N/A
N/A
13149
N/A
N/A
13150
ETH.MESH.0988068
13151
ETH.MESH.12729337
13152
14000
14001
ETH.MESH.07690752
ETH.MESH.01147116
ETH.MESH.01538120
PAGE 58 OF 241
EXHIBIT DESCRIPTION
Ethicon Website: Uterine & Pelvic
Surgery - Gynecare TVT Retropubic
System Tension-Free Support for
Incontinence 03/24/2014
10:11:49 PM
http://www.ethicon.com/healthcareprofessionals/products/uterinepelvic/incontinence-slings/gynecaretvt-retropubic-system-tension-freesupport-incontinence#!science-andtechnology
Ethicon Website: Uterine & Pelvic
Surgery
Gynecare TVT Retropubic System
Tension-Free Support for
Incontinence 03/24/2014
10:11:49 PM
http://www.ethicon.com/healthcareprofessionals/products/uterinepelvic/incontinence-slings/gynecaretvt-retropubic-system-tension-freesupport-incontinence#!science-andtechnology
Katherine Seppa Memo to Raimo
Sump & Allison London-Brown re
Performance Evaluation of TVT U
PROLENE Mesh: Mechanical Cut
versus Laser Cut. Study (LIMS# BE2005-1920) Version 3 5/5/2005
FDA Device Labeling Guidance
#G91-1 (blue book memo)
5/30/1985 Protocol for 10 year in
vivo study for Prolene Sutures in
Dogs.
Five Year Data for Ten Year
PROLENE Study
PROLENE Study
Bates produced documents
Case No.: 2:12-cv-05201
EX #
14002
14003
14004
14005
14006
14007
IDENTIFIER NO. BEG.
ETH.MESH.02293673
ETH.MESH.06928076
ETH.MESH.09960437
ETH.MESH.13681529
ETH.MESH.1370033
ETH.MESH.13739540
IDENTIFIER NO. END
ETH.MESH.02293677
ETH.MESH.06928077
ETH.MESH.09960439
ETH.MESH.13681532
ETH.MESH.1370037
14024
ETH.MESH.13371347
ETH.MESH.13771356
14025
ETH.MESH.13371330
ETH.MESH.13371337
14026
ETH.MESH.13371338
ETH.MESH.13771346
14027
ETH.MESH.13371322
ETH.MESH.13771322
14028
ETH.MESH.13371326
14029
ETH.MESH.13371319
ETH.MESH.13771321
14031
ETH.MESH.00592915
ETH.MESH.00592916
14032
ETH.MESH.08581412
ETH.MESH.08581413
14033
ETH.MESH.01252509
ETH.MESH.01252512
14021
14022
14023
PAGE 59 OF 241
EXHIBIT DESCRIPTION
Minimally Invasive Synthetic
Suburethral Sling Operations for
Stress Urinary Incontinence in
Women (Review); The Cochrane
Collaboration. Wiley Publishers
2010, Issue 1
Minimally Invasive Synthetic
Suburethral Sling Operations for
Stress Urinary Incontinence in
Women (Review); The Cochrane
Collaboration. Wiley Publishers
2009, Issue 4
Evaluation and Management of
compliactions from synthetic mesh
after pelvic reconstructive surgery.
AJOG February 2014
Litigation Hold Notice Dated July 26,
2005
Litigation Hold Notice Dated October
13, 2004
Litigation Hold Notice Dated October
19, 2004
Litigation Hold Notice Dated
December 10, 2003
Litigation Hold Notice Dated
December 17, 2003
Litigation Hold Notice Dated May
16, 2001
e-mail from Sandy Savidge
September 14, 2009
e-mail from Alyson Wess February 7,
2010
e-mail from Aaron Kirkemo May 14,
2010
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
14034
ETH.MESH.05134613
ETH.MESH.05134614
14035
ETH.MESH.05337225
ETH.MESH.05337228
14036
14037
ETH.MESH.05339015
ETH.MESH.03753682
ETH.MESH.05339017
ETH.MESH.03753682
14038
14039
ETH.MESH.01239065
ETH.MESH.008581095
ETH.MESH.01239066
ETH.MESH.08581104
14040
ETH.MESH.00846523
ETH.MESH.00846523
14041
ETH.MESH.00640394
ETH.MESH.00640395
14042
ETH.MESH.03715571
ETH.MESH.03715574
14043
14045
ETH.MESH.00865147
ETH.MESH.00161131
ETH.MESH.00865147
ETH.MESH.00161132
14046
ETH.MESH.03918552
ETH.MESH.03918553
14047
ETH.MESH.00864413
ETH.MESH.00864413
14048
ETH.MESH.04099233
ETH.MESH.04099234
14049
14050
ETH.MESH.00211263
ETH.MESH.02342102
ETH.MESH.00211265
ETH.MESH.02342102
14051
ETH.MESH.10632650
ETH.MESH.10632653
14052
ETH.MESH.00864085
ETH.MESH..00864087
14053
ETH.MESH.04050265
ETH.MESH.04050267
14054
ETH.MESH.05795299
ETH.MESH.05795300
14055
ETH.MESH.05119622
ETH.MESH.05119631
14056
ETH.MESH.06884249
ETH.MESH.06884250
PAGE 60 OF 241
EXHIBIT DESCRIPTION
e-mail from Colin Urquhart June 22,
2009
e-mail from Brian Luscombe July 6,
2011
e-mail from Paul Parisi June 27, 2011
Abbrevo launch planning stage gate
e-mail from David Robinson July 16,
2009
EWHU Invitiation council
e-mail from David Robinson
February 28, 2006
Sales Representative quick reference
sheet
e-mail from Matin Weisberg
November 11, 2003
e-mail from Axel Arnaud July 17,
2003
product pointer April 17, 2001
e-mail from Brian Luscombe May 15,
2003
e-mail from David Robinson May 21,
2004
e-mail from Melissa Day September
24, 2008
e-mail from Susan Lin October 21,
2009
Prolene IFU
e-mail from John Young October 26,
2009
2003
meeting with Professor deLeval
January 23, 2009
e-mail from Marianne Kaminski
August 27, 2004
TVT commonly asked questions and
objections
2003
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
14057
14058
ETH.MESH.08167644
ETH.MESH.00163582
ETH.MESH.08167645
ETH.MESH.00163597
14059
ETH.MESH.00211259
ETH.MESH.00211260
14060
14061
14062
ETH.MESH.11434302
ETH.MESH.07464959
ETH.MESH.00002157
ETH.MESH.11434309
ETH.MESH.07464974
ETH.MESH.00002172
14065
ETH.MESH.10489347
ETH.MESH.10489358
14068
14069
ETH.MESH.05445953
ETH.MESH.03753245
ETH.MESH.05445969
ETH.MESH.03753245
14070
ETH.MESH.02184130
ETH.MESH.012184138
14071
14072
14073
14078
ETH.MESH.04945136
ETH.MESH.00259431
ETH.MESH.06880021
ETH.MESH.05145790
ETH.MESH.04945144
ETH.MESH.00259434
ETH.MESH.06880023
ETH.MESH.05145792
14079
14080
ETH.MESH.04061755
ETH.MESH.11434367
ETH.MESH.04061766
ETH.MESH.11434379
14081
ETH.MESH.07455220
ETH.MESH.07455221
14082
ETH.MESH.01737143
ETH.MESH.01737148
14083
14084
14085
14086
14087
ETH.MESH.00584811
ETH.MESH.02654027
ETH.MESH.02653319
ETH.MESH.02653001
ETH.MESH.00346227
ETH.MESH.00584813
ETH.MESH.02654034
ETH.MESH.02653323
ETH.MESH.02653005
ETH.MESH.00346227
14088
14089
14090
ETH.MESH.11445930
ETH.MESH.02229061
ETH.MESH.00160822
ETH.MESH.11445931
ETH.MESH.02229061
ETH.MESH.00160825
14091
ETH.MESH.00147034
ETH.MESH.00147036
PAGE 61 OF 241
EXHIBIT DESCRIPTION
e-mail from Brigitte Hellhammer
November 11, 1999
Patient Brochure
e-mail from Sandy Savidge October
19, 2009
TVT Obturator System Selling Guide
2010
memo to P. Cecchini May 26, 2000
Stop Coping Start living
TVTO-PA Evidence generation
strategy
e-mail from James Ward October 11,
2006
Biomechanics (pelvic forces)
e-mail from Martin Chomiak May 29,
2008 and attachment
e-mail from Joerg Holste October 7,
2010 and attachment
Use Related Hazard Worksheet
Email re: Design Validation
Gynecare TVT google text ads
Original vs. Vodified inside out
transobturator procedure
Briefing documents
Response from C. Huntington 03-062012
Tension Free Tapes and Pelvic Nerve
Neuropathy
e-mail from Gene Kammerer April
19, 2004
TVT-O Issue report
TVT-O Issue report
TVT-O Issue report
e-mail from Bryan Lisa 01-04-2009
e-mail from Ona Bernal May 16, 2011
Opening Video
Copy review submission form
New Gynecare Device Introduces
Unique "Inside-Out" obturator
approach to treat stress incontinence
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
14092
ETH.MESH.03458104
ETH.MESH.03458104
14093
ETH.MESH.02994957
ETH.MESH.0265582802655834
ETH.MESH.02653165
ETH.MESH.02994962
14097
ETH.MESH.03913357
ETH.MESH.03913359
14098
ETH.MESH.11336181
ETH.MESH.11336183
14099
14100
ETH.MESH.01809082
ETH.MESH.09656795
ETH.MESH.01809083
ETH.MESH.09656795
14101
14102
ETH.MESH.02899547
ETH.MESH.09888187
ETH.MESH.02899547
ETH.MESH.09888223
14103
14105
ADVAMED 00000953
ETH.MESH.04941016
ADVAMED 00000960
ETH.MESH.04941016
14106
ETH.MESH.05337225
ETH.MESH.05337228
14107
ETH.MESH.05337267
ETH.MESH.05337268
14111
ETH.MESH.11336474
ETH.MESH.11336487
14112
ETH.MESH.09888187
ETH.MESH.09888223
14114
ETH.MESH.05845592
ETH.MESH.05845599
14094
14095
ETH.MESH.02655834
ETH.MESH.02653170
14096
PAGE 62 OF 241
EXHIBIT DESCRIPTION
Product Pointer: TVT Obturator
System
Clinical and quality of life outcomes
in women treated by the TVT-O
procedure
Issue report TVT-O
Issue report TVT-O
Teo et. al. Randomised trial of TVT
and TVT-O for the treatment of
urodynamic stress incontinence in
women
e-mail from Axel Arnaud May 31,
2007
Interim report on the physical testing
of PROLENE, PVDF, ETHILON &
NOVAVIL
Memo: VOC on new Laser Cut TVT
Mesh
Mesh pic
Investigator Initiated Study Research
Grant Request
7 year dog study
Ogah, et al. Minimally Invasive
Synthetic Suburetheral Sling
Operations: A Short Version
Cochrane review
Lightweight Mesh Developments
2011
e-mail from Dennis Miller 06-272011
Ten Year in Vivo Suture Study/Five
Year Report -August 10, 1990
Prolene Study-Oct. 15, 1992
Comparision of the In Vivo
Behaviour of Polyvinylidene Flouride
and Polypropylene Sutures Used in
Vascular Surgery; ASAIO Journal
1998, Celine Mary
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
14115
ETH.MESH. 04088291
ETH.MESH.04088300
ETH.MESH.12831391
ETH.MESH.12831404
14116
14126
14127
14128
14130
EXHIBIT DESCRIPTION
pelvic surgery is not inert:
comparartive analysis of 100
explants; Arnaud Clave
Materials characterizations and
historical analysis of explanted
polypropylene, PTFE, and PET
hernia meshes from an individual
patient; A.J. Wood,
Synthesis, Characterization and
Swelling Characteristics of Graft
Copolymerized Isotactic
Polypropylene Film; Sehgal
Resistance of Polyproplylene to
Chemicals
IR Microscopy of explanted ProleneSept. 30, 1987
Abbott Mesh Complications 2014
14144
Current Procedural Terminology 2014
2006 - Collinet - ICS
2007 - Latthe - BJOG
2007 - Tamussino - AJOG
2008 - Collinet - Int Urogynecol J
2008 - Feng - Int Urogynecol J
2008-Waltregny, Gaspar, Reul,
Hamida, Bonnet and de LevalUrology
2010 - Dyrkorn - Int Urogynecol J
2011 - Laurikainen - Neuro Urodyn
(ICS Abstract)
2012 - Abdel-Fattah - Eur Urol
2012 - Cheng - Eur J Obstet Gynecol
Reprod Biol
14145
2013 - Athanasiou - Int Urogynecol J
14146
Clinical and quality-of-life outcomes
in women
treated by the TVTO procedure; Lim
14134
14135
14136
14137
14138
14139
14140
14141
14142
14143
ETH.MESH.02994957
ETH.MESH.02994962
PAGE 63 OF 241
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
14160
ETH.MESH.08633904
14161
ETH.MESH.08633904
ETH.MESH.0083655800836560
14162
ETH.MESH.04044618
ETH.MESH.04044622
14163
14164
ETH.MESH.10182464
ETH.MESH.09306898
ETH.MESH.10182464
ETH.MESH.09306910
ETH.MESH.00836560
14165
14166
14167
14168
14169
14170
14171
14172
14173
14174
14175
ETH.MESH.01186613
ETH.MESH.01805514
ETH.MESH.PM.000144
ETH.MESH.03906527
ETH.MESH.01186613
ETH.MESH.01805514
ETH.MESH.PM.000144
ETH.MESH.03906527
ETH.MESH.04050379
ETH.MESH.08315476
ETH.MESH.04050379
ETH.MESH.08315483
14176
14177
14178
14179
ETH.MESH.01203957
ETH.MESH.02623743
ETH.MESH.02626472
ETH.MESH.01203997
ETH.MESH.02623747
ETH.MESH.0262478
14189
ETH.MESH.09952168
ETH.MESH.09952169
14193
ETH.MESH.00368550
ETH.MESH.00368560
14188
PAGE 64 OF 241
EXHIBIT DESCRIPTION
TVT Abbrevo objections and
frequenlty asked questions
e-mail from David Robinson
February 21, 2008
Falconer, et. al. Influence of
Different Sling Materials on
Connective Tissue Metabolism in
Stress Urinary Incontinent Women
Product division strategic plans 19992005
2002 US Marketing plan
Aigmueller, et. Al. Ten-year followup after the tension-free vaginal tape
procedure
Aigmueller, et al. Reasons for
dissatisfaction ten years after TVT
procedure
IUGA 2009 Italy sponsorship invoice
AUGS Conflict oF Interest Policy
From presentation to publication:
ensuring quality in the reporting of
Urogynaecology Research
April 12th Board up-date
TVT-O procedure video
Graft or no Graft
PelvicHealthSolutions.com
TVT versus TVT-O RCT
Ward et al 5 year follow up
The future of surgical meshes: the
industry's perspective
Issue report TVT retropubic
Isssue report TVT retropubic
UCLAhealth.org
National Vital Statistics Report-US
Lifetables 2009
Email from March 31, 2009 re: MiniTVTO
Master Consulting Agreement
3/1/2007
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
14194
ETH.MESH.08792936
ETH.MESH.08792938
14198
14199
ETH.MESH.10525612
14200
14202
ETH.MESH.00857704
ETH.MESH.00857705
14203
14204
ETH.MESH.01215019
ETH.MESH.01215024
EXHIBIT DESCRIPTION
Email re: Recommendations for NonSales and Marketing Glamour Award
Trip
Urologic Clinics of North America:
Controversies in Female Pelvic
Reconstruction; August 2012;
Volume 39; Number 3
2011 All Agreements and Amounts
Urologynecology and Reconstructive
Pelvic Surgery: Third Edition;
Walters; Elsevier
e-mail from Peter Meier Februay 2009
Tseng et.al. Randomized comparison
of arc vs. TVT
www.Ethicon.com
14205
ETH.MESH.12910023
ETH.MESH.12910026
14206
ETH.MESH.12910030
ETH.MESH.12910032
14207
ETH.MESH.12910111
ETH.MESH.12910113
14208
ETH.MESH.08113329
ETH.MESH.08113329
14210
14211
14212
14213
14214
ETH.MESH.02342152
ETH.MESH.02341658
ETH.MESH.02341954
ETH.MESH.02342153
ETH.MESH.02341664
ETH.MESH.02341959
14216
ETH.MESH.07383730
ETH.MESH.0738731
e-mail from Martin Weisberg to Piet
Hinoul 06-21-2013
Hinoul 06-21-2013
Hinoul 06-25-2013
e-mail from Jennifer Haby to Piet
Hinoul November 12, 2012
Bekelman, et al. Scope and Impact of
Financial Conflicts of Interest in
Biomedical Research
McLennan et. Al. The Influence of
Industry sponsorship on the
acceptance of abstracts and their
publication
Seeding Trial
Prolene IFU
Prolift IFU
Prolift +M IFU
e-mail from Robert Zipfel February
25, 2009
14217
ETH.MESH.08113329
ETH.MESH.08113330
e-mail from Jennifer Hamby
November 12, 2012 and attachement
14209
PAGE 65 OF 241
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
14218
ETH.MESH.05337217
ETH.MESH.05337220
14219
14220
ETH.MESH.04005863
ETH.MESH.01752532
ETH.MESH.04006038
ETH.MESH.01752535
14250
ETH.MESH.02239427
ETH.MESH.02239435
14251
ETH.MESH.00074499
14252
14253
14254
14255
14256
14257
14258
ETH.MESH.05106179
ETH.MESH.02631406
ETH.MESH.02625722
ETH.MESH.02626097
ETH.MESH.02652145
ETH.MESH.02620681
ETH.MESH.02625246
ETH.MESH.05106186
ETH.MESH.02631414
ETH.MESH.02625725
ETH.MESH.02626101
ETH.MESH.02652152
ETH.MESH.02620685
ETH.MESH.02625249
14259
ETH.MESH.00303084
ETH.MESH.00303085
14271
ETH.MESH.00590896
ETH.MESH.00590897
14272
ETH.MESH.10525611
ETH.MESH.10525612
14273
ETH.MESH.12861293
ETH.MESH.12861295
14274
14275
ETH.MESH.09748797
ETH.MESH.02218436
ETH.MESH.09748801
ETH.MESH.02218439
14276
14277
14278
ETH.MESH.09982887
ETH.MESH.PM.00004
ETH.MESH,00261818
ETH.MESH.09982888
ETH.MESH.PM.00004
ETH.MESH.00261818
14279
ETH.MESH.01202101
ETH.MESH.01202103
14280
ETH.MESH.01279975
ETH.MESH.01279976
PAGE 66 OF 241
EXHIBIT DESCRIPTION
e-mail from Dennis Miller July 06,
2011
Theoretical and Experimental
Evaluation of Implant Materials Used
in Pelvic Organ Prolapse Repair
Mesh design augmentation issues
Evidence Generation Strategy for
mini TVT-O
Gynecare Prolift +M Pelvic Floor
Repair System Traning Presentation
Trocar-guided mesh repair of vaginal
prolapse using partially absorbable
mesh: 1 year outcomes
Issue report TVT
Issue report TVT
Issue report TVT
Issue report TVT
Issue report TVT
Issue report TVT
e-mail from Dan Lamont 02-20-2007
e-mail from Piet Hinoul March 11,
2009
e-mail from Christopher Teasdale
October 26, 2011 and attachment
e-mail from Lucy Peterson 09-172013 and attachments
Falconer, et. al. Influence of
Different Sling Materials on
Stress Urinary Incontinent Women
TVTOPAC Cadaver Lab report
e-mail from Marc Feinberg April 10,
2011
TVT training video 2002-036
e-mail from Katrin Elbert 1-11-2005
e-mail from Aaron Kirkemo 1-7-2009
e-mail and attachment from Harel
Gadot
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
14281
14282
14283
14284
14285
14286
14287
14288
14289
14290
14291
14292
14293
14294
ETH.MESH.00856011
ETH.MESH.00856013
ETH.MESH.08696132
ETH.MESH.00198312
ETH.MESH.00865064
ETH.MESH.01198483
ETH.MESH.01318832
ETH.MESH.08696132
ETH.MESH.00198313
ETH.MESH.00865065
ETH.MESH.01198486
ETH.MESH.01318838
14295
14296
14297
14298
14299
14300
14301
14302
14303
14304
14305
14306
14308
14308
14309
14310
14311
14312
14313
14314
14315
14316
14317
14318
14319
ETH.MESH.01809300
ETH.MESH.01811342
ETH.MESH.05213926
ETH.MESH.06875939
ETH.MESH.07219684
ETH.MESH.09491316
ETH.MESH.09495508
ETH.MESH.09746793
ETH.MESH.09981210
ETH.MESH.09981230
ETH.MESH.09981234
ETH.MESH.00748020
ETH.MESH.03574946
ETH.MESH.07478619
ETH.MESH.07203213
ETH.MESH.08334245
ETH.MESH.03499528
ETH.MESH.03589219
ETH.MESH.03738479
ETH.MESH.00595116
ETH.MESH.08219093
ETH.MESH.00540707
ETH.MESH.03928235
ETH.MESH.02235375
ETH.MESH.06886064
ETH.MESH.01809305
ETH.MESH.01811342
ETH.MESH.05213951
ETH.MESH.06875941
ETH.MESH.07219723
ETH.MESH.09491317
ETH.MESH.09495510
ETH.MESH.09746795
ETH.MESH.09981212
ETH.MESH.09981232
ETH.MESH.09981237
ETH.MESH.00748020
ETH.MESH.03574949
ETH.MESH.07478633
ETH.MESH.07203214
ETH.MESH.08334254
ETH.MESH.03499529
ETH.MESH.03589220
ETH.MESH.03738480
ETH.MESH.00595118
ETH.MESH.08219094
ETH.MESH.00540707
ETH.MESH.03928235
ETH.MESH.02235387
ETH.MESH.06886072
PAGE 67 OF 241
EXHIBIT DESCRIPTION
Public Health Notification with
revisions
1997 Marlex PP MSDS
2001 Marlex PP MSDS
2003 Marlex PP MSDS
2004 Marlex PP MSDS
2007 Marlex PP MSDS
2008 Marlex PP MSDS
2011 Marlex PP MSDS
2004 Ciba IRGANOX 1076 MSDS
Medscand agreement
TVOT Dan Smith memo
2003 Axel Arnaud email
IUGA poster
TVT-O validation strategy
Protocol for Mullberry development
lab
TVT-O development email
Data printout
Mulberry COGS
Clinical expert report
TVT-O IFU memo
TVT-O IFU email
Mulberry memo
TVT-O design history email
TVT-O risk assessment
Letter to Dr. Peck
Sterilization validation
DHF changes
LCM project
2005 sling complaint
2004 sling complaint
2003 TVT mesh complaint
2009 email re dyspareunia
Complaint form
TVT-O complaint
Axel Arnaud memo
TVT Abbrevo memo
TVT-O IFU
Case No.: 2:12-cv-05201
EX #
14320
14321
14322
14323
14324
14325
14326
14327
14328
14329
14330
14331
14332
14333
14334
14335
14336
14337
14338
14339
14340
14341
14342
14344
14345
14346
14347
14348
IDENTIFIER NO. BEG.
ETH.MESH.05134282
ETH.MESH.08865069
ETH.MESH.07638149
ETH.MESH.07638180
ETH.MESH.07638289
ETH.MESH.05342590
ETH.MESH.09143435
ETH.MESH.10651893
ETH.MESH.04982729
ETH.MESH.08614712
ETH.MESH.08073794
ETH.MESH.08307690
ETH.MESH.08073801
ETH.MESH.09293114
ETH.MESH.04982735
ETH.MESH.04982748
ETH.MESH.01613291
ETH.MESH.02652710
ETH.MESH.02658063
ETH.MESH.02657205
ETH.MESH.02655451
ETH.MESH.02655902
ETH.MESH.02656482
ETH.MESH.01819528
ETH.MESH.0353750
ETH.MESH.01218361
ETH.MESH.00008072
ETH.MESH.00237968
IDENTIFIER NO. END
ETH.MESH.05134282
ETH.MESH.08865072
ETH.MESH.07638149
ETH.MESH.07638180
ETH.MESH.07638289
ETH.MESH.05342592
ETH.MESH.09143436
ETH.MESH.10651915
ETH.MESH.04982734
ETH.MESH.08614714
ETH.MESH.08073795
ETH.MESH.08037692
ETH.MESH.08073803
ETH.MESH.09293114
ETH.MESH.04982743
ETH.MESH.04982752
ETH.MESH.01613292
ETH.MESH.02652984
ETH.MESH.02658254
ETH.MESH.02658062
ETH.MESH.02655901
ETH.MESH.02656481
ETH.MESH.02657204
ETH.MESH.01819528
ETH.MESH.0353750
ETH.MESH.01218361
ETH.MESH.00008072
ETH.MESH.00237968
14349
14352
14353
14354
14355
14356
14357
14358
14359
14360
14361
14362
ETH.MESH.02232937
ETH.MESH.00080842
ETH.MESH.01405170
ETH-00255
ETH-65881
ETH.MESH.02053630
ETH.MESH.05479718
ETH.MESH.05585066
ETH.MESH.05479410
ETH.MESH.00528626
ETH.MESH.06403725
ETH.MESH.05316755
ETH.MESH.02232937
ETH.MESH.00080842
ETH.MESH.01405170
ETH-00255
ETH-65881
ETH.MESH.02053630
ETH.MESH.05479718
ETH.MESH.05585066
ETH.MESH.05479410
ETH.MESH.00528626
ETH.MESH.06403725
ETH.MESH.05316755
PAGE 68 OF 241
EXHIBIT DESCRIPTION
2009 TVT-O changes email
Sales figures
Professional education material
AUGS email
AUGS email
Bonus rating worksheet
AUGS email
AUGS statement
AUGS position statement email
2013 AUGS funding email
AUGS statement
Sales rep memo
AUGS guidelines
2012 credentialing email
Complaint reporting memo
TVT Issue Report
TVT Issue Report
TVT Issue Report
TVT Issue Report
TVT Issue Report
TVT Issue Report
Literature review
Ethicon regulatory tracking
Factors influencing shrinkage
Pelvic floor repair memo
Ethicon sales spreadsheet
The lighweight and large porous
mesh concept
clinical study report
Thunder PPT
Gynemesh PS Brochure
TVT specs
Gynemesh PS white paper
Boris Batke PPT
Ultrapro sizing
Lightweight Mesh PPT
design validation report
TVT-S revision history
soft Prolene mesh material
Case No.: 2:12-cv-05201
EX #
14363
14364
14365
14366
14368
14369
14370
14371
14372
IDENTIFIER NO. BEG.
ETH.MESH.02588170
ETH.MESH.03658980
ETH.MESH.00584491
ETH.MESH.05225380
ETH.MESH.06692673
ETH.MESH.02126222
ETH.MESH.02310501
ETH.MESH.02310498
ETH.MESH.00544657
IDENTIFIER NO. END
ETH.MESH.02588170
ETH.MESH.03658980
ETH.MESH.00584491
ETH.MESH.05225380
ETH.MESH.06692673
ETH.MESH.02126222
ETH.MESH.02310501
ETH.MESH.02310498
ETH.MESH.00544657
EXHIBIT DESCRIPTION
Thunder biomesh
TVT-O PA materials
New standards for MUS
TVT insert
TVT Issue Report
Nilsson interview
Matrix mesh material
Matrix avatar material
Mesh lab results
14373
14374
HMESH_ETH_00129489
ETH.MESH.10644647
HMESH_ETH_00129489
ETH.MESH.10644647
2012 email re porosity
2004 busines plan
14375
HMESH_ETH_00108021
HMESH_ETH_00108021
2006 tiMesh email
14376
14377
HMESH_ETH_00110207
HMESH_ETH_00110207
2009 shrinkage email
LAB BOOK 3217
72
63
48
28
72
63
48
28
ETH.MESH.11336184
ETH.MESH.11336071
ETH.MESH.11336165
ETH.MESH.05243697
ETH.MESH.00302411
ETH.MESH.06592114
ETH.MESH.07249428
ETH.MESH.07249429
ETH.MESH.00770754
ETH.MESH.00221997
ETH.MESH.01317769
ETH.MESH.11336184
ETH.MESH.11336071
ETH.MESH.11336165
ETH.MESH.05243697
ETH.MESH.00302411
ETH.MESH.06592114
ETH.MESH.07249428
ETH.MESH.07249429
ETH.MESH.00770754
ETH.MESH.00222463
ETH.MESH.01318358
14378
14379
14380
14381
14382
14383
14384
14385
14386
14387
14388
14389
14390
14391
14393
14394
14395
14396
14397
14397
PAGE 69 OF 241
2007 pore size email
Anatomy of MUS
Stability assessment
Performance qualification protocol
Lab Notebook 3984
Lab Notebook 3707
Lab Notebook 3156
Lab Notebook 3773
Lab Notebook 3870
1985 suture study report
Beagle degradation study
1990 dog suture study
Mesh overview german powerpoint
DFMEA LCM
Professional education video
Gynecare monthly status report
TVT-O overview memo
TVT-O testing and design verification
Case No.: 2:12-cv-05201
EX #
14400
14402
14403
14404
14405
14406
14407
14409
14410
14411
14412
IDENTIFIER NO. BEG.
ETH.MESH.01318359
ETH.MESH.01318832
ETH.MESH.02604409
ETH.MESH.05837856
ETH.MESH.06592114
ETH.MESH.07249428
ETH.MESH.07249429
ETH.MESH.02340759
ETH.MESH.00585823
ETH.MESH.02621559
ETH.MESH.06398827
IDENTIFIER NO. END
ETH.MESH.01318831
ETH.MESH.01319499
ETH.MESH.02604415
ETH.MESH.05837859
ETH.MESH.06592114
ETH.MESH.07249428
ETH.MESH.07249429
ETH.MESH .02340828
ETH.MESH.00585823
ETH.MESH.02621559
ETH.MESH.06398932
14413
ETH.MESH.04383723
ETH.MESH.04383737
14414
ETH.MESH.02134274
ETH.MESH.02134279
14415
14416
ETH.MESH.03910156
ETH.MESH.03918067
ETH.MESH.03910159
ETH.MESH.03918068
14417
ETH.MESH.01808311
ETH.MESH.01808318
14418
ETH.MESH.02268619
ETH.MESH.02268621
14419
14420
ETH.MESH.03801834
ETH.MESH.00864113
ETH.MESH.03801835
ETH.MESH.00864114
14421
14422
14424
ETH.MESH.00862602
ETH.MESH.00863631
ETH.MESH.00347001
ETH.MESH.00862602
ETH.MESH.00863631
ETH.MESH.00347007
14425
ETH.MESH.00862982
ETH.MESH.00862982
14426
ETH.MESH.02134312
ETH.MESH.02134314
14427
ETH.MESH.10039201
ETH.MESH.10039266
14428
ETH.MESH.01754389
ETH.MESH.01754416
14429
14430
ETH.MESH.00584714
ETH.MESH.00863703
ETH.MESH.00584714
ETH.MESH.00863709
PAGE 70 OF 241
EXHIBIT DESCRIPTION
TVT-O validation document
TVT-O validation strategy
Mulberry protocol
Plastic Needle memo
TVT-O IFU
2006 Kammerer email on particle loss
TVT Issue Report
PROLENE Technical File
Memo from Barbolt re:
biocompatibility Risk Assessment for
PROLENE
Product Safety Profile for PROLENE
Mesh.
Memo from Axel Arnaud re:
Transobturator TVT
10/18/2002 email re: Gynemesh
1/22/2003 Trip Report from Ethicon
trip to Liege, Belgium
Letter from John Karl to Dan Burkley
4/10/2003 Memo by Dan Smith re:
TVT-O project status and risks
7/29/2003 Email thread re: Article
8/22/2003 TVT-O “Project
Mulberry” Slides
TVT-O Post Launch Info PPT
10/2/2003 Article by Jean de Leval
10/28/2003 Memo to Design History
File, Project Mulberry
Biocompatibility Risk Assessment
for the Gynecare TVT Obturator
TVT-O 510(k) Application and
Clearance
12/16/2003 TVT-O Clinical Expert
Report (CER).
2/19/2004 email thread re: Prolene
Mesh
Email from Dan Smith re: TVT-O
Case No.: 2:12-cv-05201
EX #
14431
IDENTIFIER NO. BEG.
ETH.MESH.00918015
IDENTIFIER NO. END
ETH.MESH.00918019
14432
ETH.MESH.05094838
ETH.MESH.05094901
14433
14434
ETH.MESH.00570955
ETH.MESH.05564746
ETH.MESH.00570956
ETH.MESH.05564747
14435
ETH.MESH.05224295
ETH.MESH.05224391
14436
ETH.MESH.00589602
ETH.MESH.00589607
14437
ETH.MESH.05701011
ETH.MESH.05701058
14438
ETH.MESH.07226481
ETH.MESH.07226482
EXHIBIT DESCRIPTION
MSDS for Sunoco C4001
General Surgery USA: Market
Performance vs. BP
Intermediate Report—Prolapse Mesh
Explants.
2/17/2010 Holste email
TVT Abbrevo 510(k) Clearance and
Application
Article by Teo, R. et al. “Randomized
Trial of Tension-Free Vaginal Tape
and Tension-Free Vaginal TapeObturator for Urodynamic Stress
Incontinence in Women.”
PA Consulting Presentation:
“Investigating Mesh Erosion in
Pelvic Floor Repair.”
Ethicon response to email from Clare
Huntington.
14439
14440
14441
14442
ETH.MESH.10282657
ETH.MESH.09908346
ETH.MESH.1318359
ETH.MESH.01319500
ETH.MESH.10282661
ETH.MESH.09908660
14443
ETH.MESH.00107688
ETH.MESH.00107688
14444
ETH.MESH.02596794
ETH.MESH.02596794
14445
ETH.MESH.02234752
ETH.MESH.02234759
14446
ETH.MESH.10224489
ETH.MESH.10224490
Nilsson, C.G., et al. Seventeen Years’
Follow-up of the Tension-free
Vaginal Tape Procedure for Female
Stress Urinary Incontinence .
TVT-O Design History Book 3 of 7
11/9-11/2010 AAGL Meeting PPT
Presentation
11/24/2010 TVT Abbrevo PPT
Presentation.
2011 Article titled “An Anatomic
Comparison of the Original Versus a
Modified Inside-Out Transobturator
Procedure.”
8/6/2011 email re: 6 Weeks into
Abbrevo Launch.
14447
14448
ETH.MESH.08335798
ETH.MESH.05107016
ETH.MESH.08335799
ETH.MESH.05107017
8/26/2011 email thread re: Minislings vs. Standard Midurethral Slings
2/3/2012 email thread
ETH.MESH.01320123
PAGE 71 OF 241
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EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
14449
ETH.MESH.05109369
ETH.MESH05109398
14450
ETH.MESH.00354725
ETH.MESH.00354725
14451
14452
ETH.MESH.00632655
ETH.MESH.03454297
ETH.MESH.00632655
ETH.MESH.03455078
14453
ETH.MESH.04058175
ETH.MESH.04058209
14454
ETH.MESH.07903520
ETH.MESH.07903520
14455
ETH.MESH.09294125
ETH.MESH.09294125
PAGE 72 OF 241
EXHIBIT DESCRIPTION
Spreadsheet of Ethicon product
positioning for various products
Excel Spreadsheet of Pain associated
with TVT-O
PPT Slides “TVT Abbrevo U.S.
Launch Overview.”
Federal Register
5/26-27 PPT Presentation titled “The
Evolution of Slings for SUI.”
Ethicon PPT Presentation titled
“Scion PA Commercial Strategy.”
5/18/2010 Gynecare TVT Abbrevo
Launch Planning Stage Gate PLT
PPT Presentation.
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2010 Mar;149(1):106-11. doi:
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20006
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Laïlla Vicens JM, ContasureNeedleless compared with
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Zacharakis D, Skampardonis N,
Lourantou D, Antsaklis A., Seven
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Bekelman JE, et al, Scope and Impact
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Cholhan, J.J., Hutchings, T.B., &
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Hubka P, Nanka O, Martan A, Svabik
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Valpas A, Kivelä A, Penttinen J,
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21891
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21892
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EXHIBIT DESCRIPTION
Vincent Latouzey, Jean Philippe
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21894
21895
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21896
21898
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21901
Walter JE. SOGC Technical Update
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21902
Waltregny D, Gaspar Y, Reul O,
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TVT-O for the treatment of female
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Urology,53:401-10,21-Aug-07
21903
Wang AC and Chen MC.
Comparison of tension-free vaginal
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21904
Wang F, Song Y and Huang H.
Prospective randomized trial of TVT
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21905
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21906
EXHIBIT DESCRIPTION
Wang W, Zhu L and Lang J.
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Wang, A.C., et al A histologic and
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21907
Wang, Y., Zhang, P. Plastic
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21908
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21909
Ward KL and Hilton P (on behalf of
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Prospective multicenter randomized
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BMJ,325:1-7,13-Jul-02
21910
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IDENTIFIER NO. END
EXHIBIT DESCRIPTION
Ward KL and Hilton P. Tension-free
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21911
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Whiteside JL and Walters MD.
Anatomy of the obturator region:
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Wilbrand Woebcken, International
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21912
21913
21914
21915
21916
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IDENTIFIER NO. BEG.
IDENTIFIER NO. END
21917
EXHIBIT DESCRIPTION
William S. Cobb, Alfredo M.
Carbonell, Corey L. Kalbaugh, Yonge
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Risk of Open Placement of
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American Surgeon , 75 (2009) 762768.
William S. Cobb, Justin M. Burns,
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21918
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21919
21920
Williams D.F. "Biomedical
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21920
Withagen MI, Milani AL, den Boon
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Trocar-guided mesh compared with
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21922
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IDENTIFIER NO. END
21923
21924
21925
EXHIBIT DESCRIPTION
Withagen MI, Vierhout ME, Milani
AL; Does trocar-guided tension-free
vaginal mesh (Prolift) repair provoke
prolapse of the unaffected
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Wolfgang Schartl, Light Scattering
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Wood, et al. Materials
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Wu JM, Kawasaki A, Hundley AF,
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Predicting the number of women
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American Journal of Obstetrics &
Gynecology,205:230.e1-5 ,02-Apr-11
21926
Company News; Sunoco Agrees to
Buy Mitsubishi's Aristech Chemical
Johnson & Johnson Unit to Halt
Urinary Implants
Wyczolkowski, M., Klima W.,
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Complicated Tension-Free Vaginal
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Wyn Brown, Light Scattering:
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21927
21928
21929
21930
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IDENTIFIER NO. END
21931
21932
EXHIBIT DESCRIPTION
X. Colin and J. Verdu, Strategy for
studying thermal oxidation of organic
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Science and Technology , 65 (2005)
411-419.
Xiao Xun Zhang et al. (2011),
Advanced Materials Research, 239242, 2809
Yoram Abramov, Antonio R. Webb,
Jay-James R. Miller, Adeeb
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characterization of vaginal versus
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the rabbit, American Journal of
Obstetrics and Gynecology , 194
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21933
Yu-Chang Tyan, Jiunn-Der Liao,
Ruth Klauser, Ie-Der Wu, ChihChiang Weng, Assessment and
characterization of degradation effect
for the varied degrees of ultra-violet
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polypropylene non-woven fabric
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21934
Yuri W. Novitsky and Michael J.
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Basic Science and Clinical Concepts,
Plastic and Reconstructive Surgery ,
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21935
Yutaka Tokiwa, Buenaventurada P.
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Int J Mol Sci. 2009
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21936
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IDENTIFIER NO. END
EXHIBIT DESCRIPTION
Zheng H, Si Z, Kasperk R, Bhardwaj
RS, Schumpelick V, Klinge U,
Klosterhalfen B. Recurrent inguinal
hernia: disease of the collagen
matrix? World J Surg. 2002
Apr;26(4):401-8. Epub 2002 Jan 2.
21937
Zhu L, Lang J, Hai N, and Wong F.
Comparing vaginal tape and
transobturator tape for the treatment
of mild and moderate stress
incontinence International Journal of
Gynecology & Obstetrics (2007) 99,
14-17
Zullo MA, Plotti F, Calcagno M,
Marullo E, Palaia I, Bellati F, Basile
S, Muzii L, Angioli R, and Panici PB.
One-year follow-up of tension-free
vaginal tape (TVT) and transobturator suburethral tape from inside
to outside (TVT-O) for surgical
incontinence: a prospective
randomised trial. European
Urology,51:1376-82,07-Nov-06
Skaff Junior, M., Fares, N., Leite, K.,
Goncalves, A. Changing Mesh
Material would change the
Inflammatory Response? Differences
between Polypropylene (Gynemesh)
and Polyvinylidene Flouride
(Dynamesh)
October 2007 Powerpoint titled
“Concept of complex regional pain
syndrome in the groin and strategies
for treatment”
St. Moritz meeting 01/14/2003
Powerpoint titled “PVDF: a new
alternative?”
21938
21939
21940
21941
21942
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EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
EXHIBIT DESCRIPTION
Powerpoint titled “Concept of
complex regional pain syndrome in
the groin, and strategies for treatment”
21943
St. Moritz meeting 01/14/2003
Powerpoint titled “PVDF: a new
alternative?”
21944
37th Congress of the ESSR
05/25/2002 Powerpoint titled
“Pathophysiological concept for mesh
repair”
Powerpoint titled “Complications of
open incisional hernia repair (IHR)
Powerpoint titled “Long-term
inertness of meshes”
Powerpoint titled “Aktuelle
hernientherapie”
04/11/07 email from Pavel Luks to
Dr. Klinge re “Czech surgical
congress, June”
02/03/08 email from Petra Koehler to
Drs. Klinge, Klosterhalfen and
Schumpelick re Definition of
Lightweight Concept
21945
21946
21947
21948
21949
21950
PAGE 200 OF 241
Case No.: 2:12-cv-05201
EX #
30060
30085
30214
30215
30216
30217
30218
30219
30220
30221
30222
30223
30224
30225
30226
30227
30228
30229
30230
30231
30232
30233
30234
30235
30236
30237
30238
30239
30240
30241
30242
30243
30244
30245
30246
30247
30248
30249
30250
30251
30252
IDENTIFIER NO. BEG.
T-60
T-85
T-214
T-215
T-216
T-217
T-218
T-219
T-220
T-221
T-222
T-223
T-224
T-225
T-226
T-227
T-228
T-229
T-230
T-231
T-232
T-233
T-234
T-235
T-236
T-237
T-238
T-239
T-240
T-241
T-242
T-243
T-244
T-245
T-246
T-247
T-248
T-249
T-250
T-251
T-252
IDENTIFIER NO. END
T-60
T-85
T-214
T-215
T-216
T-217
T-218
T-219
T-220
T-221
T-222
T-223
T-224
T-225
T-226
T-227
T-228
T-229
T-230
T-231
T-232
T-233
T-234
T-235
T-236
T-237
T-238
T-239
T-240
T-241
T-242
T-243
T-244
T-245
T-246
T-247
T-248
T-249
T-250
T-251
T-252
PAGE 201 OF 241
EXHIBIT DESCRIPTION
T-60
T-85
Smith Exhibit T-214
Smith Exhibit T-215
Smith Exhibit T-216
Smith Exhibit T-217
Smith Exhibit T-218
Smith Exhibit T-219
Smith Exhibit T-220
Smith Exhibit T-221
Smith Exhibit T-222
Smith Exhibit T-223
Smith Exhibit T-224
Smith Exhibit T-225
Smith Exhibit T-226
Smith Exhibit T-227
Smith Exhibit T-228
Smith Exhibit T-229
Smith Exhibit T-230
Smith Exhibit T-231
Smith Exhibit T-232
Smith Exhibit T-233
Smith Exhibit T-234
Smith Exhibit T-235
Smith Exhibit T-236
Smith Exhibit T-237
Smith Exhibit T-238
Smith Exhibit T-239
Smith Exhibit T-240
Smith Exhibit T-241
Smith Exhibit T-242
Smith Exhibit T-243
Smith Exhibit T-244
Smith Exhibit T-245
Smith Exhibit T-246
Smith Exhibit T-247
Smith Exhibit T-248
Smith Exhibit T-249
Smith Exhibit T-250
Smith Exhibit T-251
Smith Exhibit T-252
Case No.: 2:12-cv-05201
EX #
30253
30254
30255
30256
30257
30258
30259
30260
30261
30262
30263
30264
30265
30266
30267
30311
30312
30313
30314
30315
30316
30317
30318
30319
30320
30321
30322
30323
30324
30325
30326
30327
30328
30329
30330
30331
30332
30333
30334
30335
30336
IDENTIFIER NO. BEG.
T-253
T-254
T-255
T-256
T-257
T-258
T-259
T-260
T-261
T-262
T-263
T-264
T-265
T-266
T-267
T-311
T-312
T-313
T-314
T-315
T-316
T-317
T-318
T-319
T-320
T-321
T-322
T-323
T-324
T-325
T-326
T-327
T-328
T-329
T-330
T-331
T-332
T-333
T-334
T-335
T-336
IDENTIFIER NO. END
T-253
T-254
T-255
T-256
T-257
T-258
T-259
T-260
T-261
T-262
T-263
T-264
T-265
T-266
T-267
T-311
T-312
T-313
T-314
T-315
T-316
T-317
T-318
T-319
T-320
T-321
T-322
T-323
T-324
T-325
T-326
T-327
T-328
T-329
T-330
T-331
T-332
T-333
T-334
T-335
T-336
PAGE 202 OF 241
EXHIBIT DESCRIPTION
Smith Exhibit T-253
Smith Exhibit T-254
Smith Exhibit T-255
Smith Exhibit T-256
Smith Exhibit T-257
Smith Exhibit T-258
Smith Exhibit T-259
Smith Exhibit T-260
Smith Exhibit T-261
Smith Exhibit T-262
Smith Exhibit T-263
Smith Exhibit T-264
Smith Exhibit T-265
Smith Exhibit T-266
Smith Exhibit T-267
Weisberg Exhibit T-311
Case No.: 2:12-cv-05201
EX #
30337
30338
30339
30340
30341
30342
30343
30344
30345
30346
30347
30348
30349
30350
30351
30352
30353
30354
30355
30356
30357
30358
30359
30360
30361
30362
30363
30364
30365
30366
30367
30368
30369
30370
30371
30372
30373
30374
30375
30376
30377
IDENTIFIER NO. BEG.
T-337
T-338
T-339
T-340
T-341
T-342
T-343
T-344
T-345
T-346
T-347
T-348
T-349
T-350
T-351
T-352
T-353
T-354
T-355
T-356
T-357
T-358
T-359
T-360
T-361
T-362
T-363
T-364
T-365
T-366
T-367
T-368
T-369
T-370
T-371
T-372
T-373
T-374
T-375
T-376
T-377
IDENTIFIER NO. END
T-337
T-338
T-339
T-340
T-341
T-342
T-343
T-344
T-345
T-346
T-347
T-348
T-349
T-350
T-351
T-352
T-353
T-354
T-355
T-356
T-357
T-358
T-359
T-360
T-361
T-362
T-363
T-364
T-365
T-366
T-367
T-368
T-369
T-370
T-371
T-372
T-373
T-374
T-375
T-376
T-377
PAGE 203 OF 241
EXHIBIT DESCRIPTION
Case No.: 2:12-cv-05201
EX #
30378
30379
30380
30381
30382
30383
30384
30385
30386
30387
30388
30389
30390
30391
30392
30393
30394
30395
30396
30397
30398
30399
30400
30401
30402
30403
30404
30405
30406
30407
30408
30409
30410
30411
30412
30413
30414
30415
30416
30417
30418
IDENTIFIER NO. BEG.
T-378
T-379
T-380
T-381
T-382
T-383
T-384
T-385
T-386
T-387
T-388
T-389
T-390
T-391
T-392
T-393
T-394
T-395
T-396
T-397
T-398
T-399
T-400
T-401
T-402
T-403
T-404
T-405
T-406
T-407
T-408
T-409
T-410
T-411
T-412
T-413
T-414
T-415
T-416
T-417
T-418
IDENTIFIER NO. END
T-378
T-379
T-380
T-381
T-382
T-383
T-384
T-385
T-386
T-387
T-388
T-389
T-390
T-391
T-392
T-393
T-394
T-395
T-396
T-397
T-398
T-399
T-400
T-401
T-402
T-403
T-404
T-405
T-406
T-407
T-408
T-409
T-410
T-411
T-412
T-413
T-414
T-415
T-416
T-417
T-418
PAGE 204 OF 241
EXHIBIT DESCRIPTION
Smith Exhibit T-406
Smith Exhibit T-407
Smith Exhibit T-408
Smith Exhibit T-409
Smith Exhibit T-410
Smith Exhibit T-411
Smith Exhibit T-412
Smith Exhibit T-413
Smith Exhibit T-414
Smith Exhibit T-415
Smith Exhibit T-416
Smith Exhibit T-417
Smith Exhibit T-418
Case No.: 2:12-cv-05201
EX #
30419
30420
30421
30422
30423
30424
30425
30426
30427
30428
30429
30430
30431
30432
30433
30434
30435
30436
30437
30438
30439
30440
30441
30442
30443
30444
30445
30446
30447
30448
30449
30450
30451
30452
30453
30454
30455
30456
30457
30458
30459
IDENTIFIER NO. BEG.
T-419
T-420
T-421
T-422
T-423
T-424
T-425
T-426
T-427
T-428
T-429
T-430
T-431
T-432
T-433
T-434
T-435
T-436
T-437
T-438
T-439
T-440
T-441
T-442
T-443
T-444
T-445
T-446
T-447
T-448
T-449
T-450
T-451
T-452
T-453
T-454
T-455
T-456
T-457
T-458
T-459
IDENTIFIER NO. END
T-419
T-420
T-421
T-422
T-423
T-424
T-425
T-426
T-427
T-428
T-429
T-430
T-431
T-432
T-433
T-434
T-435
T-436
T-437
T-438
T-439
T-440
T-441
T-442
T-443
T-444
T-445
T-446
T-447
T-448
T-449
T-450
T-451
T-452
T-453
T-454
T-455
T-456
T-457
T-458
T-459
PAGE 205 OF 241
EXHIBIT DESCRIPTION
Smith Exhibit T-419
Smith Exhibit T-420
Smith Exhibit T-421
Smith Exhibit T-422
Smith Exhibit T-423
Smith Exhibit T-424
Smith Exhibit T-425
Smith Exhibit T-426
Smith Exhibit T-427
Smith Exhibit T-428
Smith Exhibit T-429
Smith Exhibit T-430
Smith Exhibit T-431
Smith Exhibit T-432
Smith Exhibit T-433
Smith Exhibit T-434
Smith Exhibit T-435
Smith Exhibit T-436
Smith Exhibit T-437
Smith Exhibit T-438
Smith Exhibit T-439
Smith Exhibit T-440
Smith Exhibit T-441
Smith Exhibit T-442
Smith Exhibit T-443
Smith Exhibit T-444
Smith Exhibit T-445
Smith Exhibit T-446
Smith Exhibit T-447
Smith Exhibit T-448
Smith Exhibit T-449
Smith Exhibit T-450
Smith Exhibit T-451
Smith Exhibit T-452
Smith Exhibit T-453
Smith Exhibit T-454
Smith Exhibit T-455
Smith Exhibit T-456
Smith Exhibit T-457
Smith Exhibit T-458
Smith Exhibit T-459
Case No.: 2:12-cv-05201
EX #
30460
30461
30462
30463
30464
30465
30466
30467
30468
30469
30470
30494
30499
30531
30674
30675
30676
30677
30678
30679
30680
30681
30682
30683
30684
30685
30686
30687
30688
30689
30690
30691
30692
30693
30694
30695
30696
30697
30698
30699
30700
IDENTIFIER NO. BEG.
T-460
T-461
T-462
T-463
T-464
T-465
T-466
T-467
T-468
T-469
T-470
T-494
T-499
T-531
T-674
T-675
T-676
T-677
T-678
T-679
T-680
T-681
T-682
T-683
T-684
T-685
T-686
T-687
T-688
T-689
T-690
T-691
T-692
T-693
T-694
T-695
T-696
T-697
T-698
T-699
T-700
IDENTIFIER NO. END
T-460
T-461
T-462
T-463
T-464
T-465
T-466
T-467
T-468
T-469
T-470
T-494
T-499
T-531
T-674
T-675
T-676
T-677
T-678
T-679
T-680
T-681
T-682
T-683
T-684
T-685
T-686
T-687
T-688
T-689
T-690
T-691
T-692
T-693
T-694
T-695
T-696
T-697
T-698
T-699
T-700
PAGE 206 OF 241
EXHIBIT DESCRIPTION
Smith Exhibit T-460
Smith Exhibit T-461
Smith Exhibit T-462
Smith Exhibit T-463
Smith Exhibit T-464
Smith Exhibit T-465
Smith Exhibit T-466
Smith Exhibit T-467
Smith Exhibit T-468
Smith Exhibit T-469
Smith Exhibit T-470
O'Bryan Exhibit T-494
O'Bryan Exhibit T-499
T-531
Hinoul Exhibit T-674
Case No.: 2:12-cv-05201
EX #
30701
30702
30703
30704
30705
30706
30707
30708
30709
30710
30711
30712
30713
30713
30714
30715
30716
30717
30718
30719
30720
30721
30722
30723
30724
30725
30726
30727
30728
30729
30730
30731
30732
30733
30858
30879
30880
30922
30923
30924
30925
IDENTIFIER NO. BEG.
T-701
T-702
T-703
T-704
T-705
T-706
T-707
T-708
T-709
T-710
T-711
T-712
T-713
T-713
T-714
T-715
T-716
T-717
T-718
T-719
T-720
T-721
T-722
T-723
T-724
T-725
T-726
T-727
T-728
T-729
T-730
T-731
T-732
T-733
T-0858
T-879
T-0880
T-922
T-923
T-924
T-925
IDENTIFIER NO. END
T-701
T-702
T-703
T-704
T-705
T-706
T-707
T-708
T-709
T-710
T-711
T-712
T-713
T-713
T-714
T-715
T-716
T-717
T-718
T-719
T-720
T-721
T-722
T-723
T-724
T-725
T-726
T-727
T-728
T-729
T-730
T-731
T-732
T-733
T-0858
T-879
T-0880
T-922
T-923
T-924
T-925
PAGE 207 OF 241
EXHIBIT DESCRIPTION
Arnaud Exhibit T-0858
T-879
Robinson Exhibit T-922
Case No.: 2:12-cv-05201
EX #
30926
30927
30928
30929
30930
30931
30932
30933
30934
30935
30936
30937
30938
30939
30940
30941
30942
30943
30944
30945
30946
30947
30948
30949
30950
30951
30952
30953
30954
30955
30956
30957
30958
30959
30960
30961
30962
30963
30964
30965
30966
IDENTIFIER NO. BEG.
T-926
T-927
T-928
T-929
T-930
T-931
T-932
T-933
T-934
T-935
T-936
T-937
T-938
T-939
T-940
T-941
T-942
T-943
T-944
T-945
T-946
T-947
T-948
T-949
T-950
T-951
T-952
T-953
T-954
T-955
T-956
T-957
T-958
T-959
T-960
T-961
T-962
T-963
T-964
T-965
T-966
IDENTIFIER NO. END
T-926
T-927
T-928
T-929
T-930
T-931
T-932
T-933
T-934
T-935
T-936
T-937
T-938
T-939
T-940
T-941
T-942
T-943
T-944
T-945
T-946
T-947
T-948
T-949
T-950
T-951
T-952
T-953
T-954
T-955
T-956
T-957
T-958
T-959
T-960
T-961
T-962
T-963
T-964
T-965
T-966
PAGE 208 OF 241
EXHIBIT DESCRIPTION
Case No.: 2:12-cv-05201
EX #
30967
30968
30969
30970
30971
30972
30973
30974
30975
30976
30977
30978
30979
30980
30981
30982
30983
30984
30985
30986
30987
30988
30989
31192
31193
31194
31195
31196
31197
31198
31199
31200
31201
31202
31203
31204
31205
31206
31207
31208
31209
IDENTIFIER NO. BEG.
T-967
T-968
T-969
T-970
T-971
T-972
T-973
T-974
T-975
T-976
T-977
T-978
T-979
T-980
T-981
T-982
T-983
T-984
T-985
T-986
T-987
T-988
T-989
T-1192
T-1193
T-1194
T-1195
T-1196
T-1197
T-1198
T-1199
T-1200
T-1201
T-1202
T-1203
T-1204
T-1205
T-1206
T-1207
T-1208
T-1209
IDENTIFIER NO. END
T-967
T-968
T-969
T-970
T-971
T-972
T-973
T-974
T-975
T-976
T-977
T-978
T-979
T-980
T-981
T-982
T-983
T-984
T-985
T-986
T-987
T-988
T-989
T-1192
T-1193
T-1194
T-1195
T-1196
T-1197
T-1198
T-1199
T-1200
T-1201
T-1202
T-1203
T-1204
T-1205
T-1206
T-1207
T-1208
T-1209
PAGE 209 OF 241
EXHIBIT DESCRIPTION
Holste Exhibit T-1192
Case No.: 2:12-cv-05201
EX #
31210
31211
31212
31213
31214
31215
31216
31217
31218
31219
31220
31221
31222
31223
31224
31225
31227
31228
31229
31230
31231
31232
31233
31238
31240
31249
31250
31251
31252
31253
31254
31255
31256
31257
31258
31259
31260
31261
31262
31263
31264
IDENTIFIER NO. BEG.
T-1210
T-1211
T-1212
T-1213
T-1214
T-1215
T-1216
T-1217
T-1218
T-1219
T-1220
T-1221
T-1222
T-1223
T-1224
T-1225
T-1227
T-1228
T-1229
T-1230
T-1231
T-1232
T-1233
T-1238
T-1240
T-1249
T-1250
T-1251
T-1252
T-1253
T-1254
T-1255
T-1256
T-1257
T-1258
T-1259
T-1260
T-1261
T-1262
T-1263
T-1264
IDENTIFIER NO. END
T-1210
T-1211
T-1212
T-1213
T-1214
T-1215
T-1216
T-1217
T-1218
T-1219
T-1220
T-1221
T-1222
T-1223
T-1224
T-1225
T-1227
T-1228
T-1229
T-1230
T-1231
T-1232
T-1233
T-1238
T-1240
T-1249
T-1250
T-1251
T-1252
T-1253
T-1254
T-1255
T-1256
T-1257
T-1258
T-1259
T-1260
T-1261
T-1262
T-1263
T-1264
PAGE 210 OF 241
EXHIBIT DESCRIPTION
T-1227
T-1228
T-1229
T-1230
T-1231
T-1232
T-1233
T-1238
T-1240
T-1249
Case No.: 2:12-cv-05201
EX #
31265
31266
31267
31268
31269
31270
31271
31272
31273
31274
31275
31276
31277
31278
31279
31280
31281
31282
31283
31284
31285
31286
31287
31288
31289
31290
31291
31292
31293
31294
31295
31296
31297
31298
31299
31300
31301
31302
31303
31304
31305
IDENTIFIER NO. BEG.
T-1265
T-1266
T-1267
T-1268
T-1269
T-1270
T-1271
T-1272
T-1273
T-1274
T-1275
T-1276
T-1277
T-1278
T-1279
T-1280
T-1281
T-1282
T-1283
T-1284
T-1285
T-1286
T-1287
T-1288
T-1289
T-1290
T-1291
T-1292
T-1293
T-1294
T-1295
T-1296
T-1297
T-1298
T-1299
T-1300
T-1301
T-1302
T-1303
T-1304
T-1305
IDENTIFIER NO. END
T-1265
T-1266
T-1267
T-1268
T-1269
T-1270
T-1271
T-1272
T-1273
T-1274
T-1275
T-1276
T-1277
T-1278
T-1279
T-1280
T-1281
T-1282
T-1283
T-1284
T-1285
T-1286
T-1287
T-1288
T-1289
T-1290
T-1291
T-1292
T-1293
T-1294
T-1295
T-1296
T-1297
T-1298
T-1299
T-1300
T-1301
T-1302
T-1303
T-1304
T-1305
PAGE 211 OF 241
EXHIBIT DESCRIPTION
Hart Exhibit T-1296
Hart Exhibit T-1297
Hart Exhibit T-1298
Hart Exhibit T-1299
Hart Exhibit T-1300
Hart Exhibit T-1301
Hart Exhibit T-1302
Hart Exhibit T-1303
Hart Exhibit T-1304
Hart Exhibit T-1305
Case No.: 2:12-cv-05201
EX #
31306
31307
31308
31309
31310
31311
31312
31313
31314
31315
31316
31317
31318
31319
31320
31321
31322
31323
31324
31325
31326
31327
31328
31329
31330
31331
31332
31333
31334
31335
31336
31337
31338
31339
32105
32106
32107
32108
32109
32110
32111
IDENTIFIER NO. BEG.
T-1306
T-1307
T-1308
T-1309
T-1310
T-1311
T-1312
T-1313
T-1314
T-1315
T-1316
T-1317
T-1318
T-1319
T-1320
T-1321
T-1322
T-1323
T-1324
T-1325
T-1326
T-1327
T-1328
T-1329
T-1330
T-1331
T-1332
T-1333
T-1334
T-1335
T-1336
T-1337
T-1338
T-1339
T-2105
T-2106
T-2107
T-2108
T-2109
T-2110
T-2111
IDENTIFIER NO. END
T-1306
T-1307
T-1308
T-1309
T-1310
T-1311
T-1312
T-1313
T-1314
T-1315
T-1316
T-1317
T-1318
T-1319
T-1320
T-1321
T-1322
T-1323
T-1324
T-1325
T-1326
T-1327
T-1328
T-1329
T-1330
T-1331
T-1332
T-1333
T-1334
T-1335
T-1336
T-1337
T-1338
T-1339
T-2105
T-2106
T-2107
T-2108
T-2109
T-2110
T-2111
PAGE 212 OF 241
EXHIBIT DESCRIPTION
Hart Exhibit T-1306
Hart Exhibit T-1307
Hart Exhibit T-1308
Hart Exhibit T-1309
Hart Exhibit T-1310
Hart Exhibit T-1311
Hart Exhibit T-1312
Hart Exhibit T-1313
Hart Exhibit T-1314
Hart Exhibit T-1315
Hart Exhibit T-1316
Hart Exhibit T-1317
Hart Exhibit T-1318
Hart Exhibit T-1319
Hart Exhibit T-1320
Hart Exhibit T-1321
Hart Exhibit T-1322
Hart Exhibit T-1323
Hart Exhibit T-1324
Hart Exhibit T-1325
Hart Exhibit T-1326
Hart Exhibit T-1327
Hart Exhibit T-1328
Hart Exhibit T-1329
Hart Exhibit T-1330
Hart Exhibit T-1331
Hart Exhibit T-1332
Hart Exhibit T-1333
Hart Exhibit T-1334
Hart Exhibit T-1335
Hart Exhibit T-1336
Hart Exhibit T-1337
Hart Exhibit T-1338
Hart Exhibit T-1339
Barbolt Exhibit T-2105
Case No.: 2:12-cv-05201
EX #
32112
32113
32114
32115
32116
32117
32118
32119
32120
32121
32122
32123
32124
32125
32126
32127
32128
32129
32130
32131
32132
32133
32134
32135
32136
32137
32138
32139
32140
32141
32142
32143
32144
32145
32146
32147
32148
32149
32150
32151
32152
IDENTIFIER NO. BEG.
T-2112
T-2113
T-2114
T-2115
T-2116
T-2117
T-2118
T-2119
T-2120
T-2121
T-2122
T-2123
T-2124
T-2125
T-2126
T-2127
T-2128
T-2129
T-2130
T-2131
T-2132
T-2133
T-2134
T-2135
T-2136
T-2137
T-2138
T-2139
T-2140
T-2141
T-2142
T-2143
T-2144
T-2145
T-2146
T-2147
T-2148
T-2149
T-2150
T-2151
T-2152
IDENTIFIER NO. END
T-2112
T-2113
T-2114
T-2115
T-2116
T-2117
T-2118
T-2119
T-2120
T-2121
T-2122
T-2123
T-2124
T-2125
T-2126
T-2127
T-2128
T-2129
T-2130
T-2131
T-2132
T-2133
T-2134
T-2135
T-2136
T-2137
T-2138
T-2139
T-2140
T-2141
T-2142
T-2143
T-2144
T-2145
T-2146
T-2147
T-2148
T-2149
T-2150
T-2151
T-2152
PAGE 213 OF 241
EXHIBIT DESCRIPTION
Smith Exhibit T-2138
Case No.: 2:12-cv-05201
EX #
32153
32154
32155
32156
32157
32158
32159
32159
32160
32160
32161
32162
32163
32164
32165
32166
32167
32168
32169
32170
32171
32172
32173
32174
32175
32176
32177
32178
32179
32180
32181
32182
32183
32184
32185
32186
32240
32241
32242
32243
32244
IDENTIFIER NO. BEG.
T-2153
T-2154
T-2155
T-2156
T-2157
T-2158
T-2159
T-2159
T-2160
T-2160
T-2161
T-2162
T-2163
T-2164
T-2165
T-2166
T-2167
T-2168
T-2169
T-2170
T-2171
T-2172
T-2173
T-2174
T-2175
T-2176
T-2177
T-2178
T-2179
T-2180
T-2181
T-2182
T-2183
T-2184
T-2185
T-2186
T-2240
T-2241
T-2242
T-2243
T-2244
IDENTIFIER NO. END
T-2153
T-2154
T-2155
T-2156
T-2157
T-2158
T-2159
T-2159
T-2160
T-2160
T-2161
T-2162
T-2163
T-2164
T-2165
T-2166
T-2167
T-2168
T-2169
T-2170
T-2171
T-2172
T-2173
T-2174
T-2175
T-2176
T-2177
T-2178
T-2179
T-2180
T-2181
T-2182
T-2183
T-2184
T-2185
T-2186
T-2240
T-2241
T-2242
T-2243
T-2244
PAGE 214 OF 241
EXHIBIT DESCRIPTION
Case No.: 2:12-cv-05201
EX #
32245
32246
32247
32248
32249
32250
32251
32252
32253
32254
32255
32256
32257
32258
32259
32260
32261
32262
32263
32264
32265
33115
33116
33117
33118
33119
33120
33121
33122
33123
33124
33125
33126
33127
33128
33129
33130
33131
33132
33133
33134
IDENTIFIER NO. BEG.
T-2245
T-2246
T-2247
T-2248
T-2249
T-2250
T-2251
T-2252
T-2253
T-2254
T-2255
T-2256
T-2257
T-2258
T-2259
T-2260
T-2261
T-2262
T-2263
T-2264
T-2265
T-3115
T-3116
T-3117
T-3118
T-3119
T-3120
T-3121
T-3122
T-3123
T-3124
T-3125
T-3126
T-3127
T-3128
T-3129
T-3130
T-3131
T-3132
T-3133
T-3134
IDENTIFIER NO. END
T-2245
T-2246
T-2247
T-2248
T-2249
T-2250
T-2251
T-2252
T-2253
T-2254
T-2255
T-2256
T-2257
T-2258
T-2259
T-2260
T-2261
T-2262
T-2263
T-2264
T-2265
T-3115
T-3116
T-3117
T-3118
T-3119
T-3120
T-3121
T-3122
T-3123
T-3124
T-3125
T-3126
T-3127
T-3128
T-3129
T-3130
T-3131
T-3132
T-3133
T-3134
PAGE 215 OF 241
EXHIBIT DESCRIPTION
Case No.: 2:12-cv-05201
EX #
33135
33136
33137
33142
33161
33162
33163
33163
33175
33177
33178
33179
33180
33181
33182
33183
33184
33185
33186
33187
33188
33189
33190
33191
33192
33193
33194
33195
33196
33197
33198
33199
33200
33201
33202
33203
33204
33205
33206
33207
33208
IDENTIFIER NO. BEG.
T-3135
T-3136
T-3137
T-3142
T-3161
T-3162
T-3163
T-3163
T-3175
T-3177
T-3178
T-3179
T-3180
T-3181
T-3182
T-3183
T-3184
T-3185
T-3186
T-3187
T-3188
T-3189
T-3190
T-3191
T-3192
T-3193
T-3194
T-3195
T-3196
T-3197
T-3198
T-3199
T-3200
T-3201
T-3202
T-3203
T-3204
T-3205
T-3206
T-3207
T-3208
IDENTIFIER NO. END
T-3135
T-3136
T-3137
T-3142
T-3161
T-3162
T-3163
T-3163
T-3175
T-3177
T-3178
T-3179
T-3180
T-3181
T-3182
T-3183
T-3184
T-3185
T-3186
T-3187
T-3188
T-3189
T-3190
T-3191
T-3192
T-3193
T-3194
T-3195
T-3196
T-3197
T-3198
T-3199
T-3200
T-3201
T-3202
T-3203
T-3204
T-3205
T-3206
T-3207
T-3208
PAGE 216 OF 241
EXHIBIT DESCRIPTION
Jones Exhibit T-3142
T-3161
T-3162
T-3163
T-3163
T-3175
Angelini Exhibit T-3177
Case No.: 2:12-cv-05201
EX #
33209
33210
33211
33212
33213
33214
33215
33216
33217
33218
33219
33220
33221
33222
33223
33224
33225
33226
33227
33228
33229
33230
33258
33319
33320
33321
33322
33323
33324
33325
33326
33327
33328
33329
33330
33331
33332
33333
33334
33335
33336
IDENTIFIER NO. BEG.
T-3209
T-3210
T-3211
T-3212
T-3213
T-3214
T-3215
T-3216
T-3217
T-3218
T-3219
T-3220
T-3221
T-3222
T-3223
T-3224
T-3225
T-3226
T-3227
T-3228
T-3229
T-3230
T-3258
T-3319
T-3320
T-3321
T-3322
T-3323
T-3324
T-3325
T-3326
T-3327
T-3328
T-3329
T-3330
T-3331
T-3332
T-3333
T-3334
T-3335
T-3336
IDENTIFIER NO. END
T-3209
T-3210
T-3211
T-3212
T-3213
T-3214
T-3215
T-3216
T-3217
T-3218
T-3219
T-3220
T-3221
T-3222
T-3223
T-3224
T-3225
T-3226
T-3227
T-3228
T-3229
T-3230
T-3258
T-3319
T-3320
T-3321
T-3322
T-3323
T-3324
T-3325
T-3326
T-3327
T-3328
T-3329
T-3330
T-3331
T-3332
T-3333
T-3334
T-3335
T-3336
PAGE 217 OF 241
EXHIBIT DESCRIPTION
Chen Exhibit T-3319
Chen Exhibit T-3320
Chen Exhibit T-3321
Chen Exhibit T-3322
Chen Exhibit T-3323
Chen Exhibit T-3324
Chen Exhibit T-3325
Chen Exhibit T-3326
Chen Exhibit T-3327
Chen Exhibit T-3328
Chen Exhibit T-3329
Chen Exhibit T-3330
Chen Exhibit T-3331
Chen Exhibit T-3332
Chen Exhibit T-3333
Chen Exhibit T-3334
Chen Exhibit T-3335
Isenberg Exhibit T-3336
Case No.: 2:12-cv-05201
EX #
33337
33338
33339
33340
33341
33342
33343
33344
33345
33346
33347
33348
33349
33350
33351
33352
33353
33354
33355
33356
33357
33358
33359
33360
33361
33362
33363
33364
33365
33366
33367
33368
33369
33370
33371
33372
33373
33374
33375
33376
33377
IDENTIFIER NO. BEG.
T-3337
T-3338
T-3339
T-3340
T-3341
T-3342
T-3343
T-3344
T-3345
T-3346
T-3347
T-3348
T-3349
T-3350
T-3351
T-3352
T-3353
T-3354
T-3355
T-3356
T-3357
T-3358
T-3359
T-3360
T-3361
T-3362
T-3363
T-3364
T-3365
T-3366
T-3367
T-3368
T-3369
T-3370
T-3371
T-3372
T-3373
T-3374
T-3375
T-3376
T-3377
IDENTIFIER NO. END
T-3337
T-3338
T-3339
T-3340
T-3341
T-3342
T-3343
T-3344
T-3345
T-3346
T-3347
T-3348
T-3349
T-3350
T-3351
T-3352
T-3353
T-3354
T-3355
T-3356
T-3357
T-3358
T-3359
T-3360
T-3361
T-3362
T-3363
T-3364
T-3365
T-3366
T-3367
T-3368
T-3369
T-3370
T-3371
T-3372
T-3373
T-3374
T-3375
T-3376
T-3377
PAGE 218 OF 241
EXHIBIT DESCRIPTION
Case No.: 2:12-cv-05201
EX #
33378
33379
33380
33381
33382
33383
33384
33385
33386
33387
33388
33389
33390
33391
33392
33393
33394
33395
33396
33419
33420
33421
33422
33423
33424
33442
33443
33444
33445
33446
33447
33448
33449
33450
33451
33452
33453
33454
33455
33456
33457
IDENTIFIER NO. BEG.
T-3378
T-3379
T-3380
T-3381
T-3382
T-3383
T-3384
T-3385
T-3386
T-3387
T-3388
T-3389
T-3390
T-3391
T-3392
T-3393
T-3394
T-3395
T-3396
T-3419
T-3420
T-3421
T-3422
T-3423
T-3424
T-3442
T-3443
T-3444
T-3445
T-3446
T-3447
T-3448
T-3449
T-3450
T-3451
T-3452
T-3453
T-3454
T-3455
T-3456
T-3457
IDENTIFIER NO. END
T-3378
T-3379
T-3380
T-3381
T-3382
T-3383
T-3384
T-3385
T-3386
T-3387
T-3388
T-3389
T-3390
T-3391
T-3392
T-3393
T-3394
T-3395
T-3396
T-3419
T-3420
T-3421
T-3422
T-3423
T-3424
T-3442
T-3443
T-3444
T-3445
T-3446
T-3447
T-3448
T-3449
T-3450
T-3451
T-3452
T-3453
T-3454
T-3455
T-3456
T-3457
PAGE 219 OF 241
EXHIBIT DESCRIPTION
Kirkemo Exhibit T-3442
Case No.: 2:12-cv-05201
EX #
33458
33459
33460
33461
33462
33463
33464
33465
33466
33467
33468
33469
33470
33471
33472
33473
33474
33475
33476
33477
33478
33479
33480
33481
33482
33483
33484
33485
33486
33487
33488
33489
33490
33491
33492
33493
33494
33495
33496
33497
33498
IDENTIFIER NO. BEG.
T-3458
T-3459
T-3460
T-3461
T-3462
T-3463
T-3464
T-3465
T-3466
T-3467
T-3468
T-3469
T-3470
T-3471
T-3472
T-3473
T-3474
T-3475
T-3476
T-3477
T-3478
T-3479
T-3480
T-3481
T-3482
T-3483
T-3484
T-3485
T-3486
T-3487
T-3488
T-3489
T-3490
T-3491
T-3492
T-3493
T-3494
T-3495
T-3496
T-3497
T-3498
IDENTIFIER NO. END
T-3458
T-3459
T-3460
T-3461
T-3462
T-3463
T-3464
T-3465
T-3466
T-3467
T-3468
T-3469
T-3470
T-3471
T-3472
T-3473
T-3474
T-3475
T-3476
T-3477
T-3478
T-3479
T-3480
T-3481
T-3482
T-3483
T-3484
T-3485
T-3486
T-3487
T-3488
T-3489
T-3490
T-3491
T-3492
T-3493
T-3494
T-3495
T-3496
T-3497
T-3498
PAGE 220 OF 241
EXHIBIT DESCRIPTION
Case No.: 2:12-cv-05201
EX #
33499
33500
33501
33502
33503
33504
33505
33506
33507
33508
33509
33510
33511
33512
33513
33514
33515
33516
33517
33518
33519
33520
33521
33522
33523
33524
33525
33526
33527
33528
33529
33530
33531
33532
33533
33534
33535
33536
33576
33577
33578
IDENTIFIER NO. BEG.
T-3499
T-3500
T-3501
T-3502
T-3503
T-3504
T-3505
T-3506
T-3507
T-3508
T-3509
T-3510
T-3511
T-3512
T-3513
T-3514
T-3515
T-3516
T-3517
T-3518
T-3519
T-3520
T-3521
T-3522
T-3523
T-3524
T-3525
T-3526
T-3527
T-3528
T-3529
T-3530
T-3531
T-3532
T-3533
T-3534
T-3535
T-3536
T-3576
T-3577
T-3578
IDENTIFIER NO. END
T-3499
T-3500
T-3501
T-3502
T-3503
T-3504
T-3505
T-3506
T-3507
T-3508
T-3509
T-3510
T-3511
T-3512
T-3513
T-3514
T-3515
T-3516
T-3517
T-3518
T-3519
T-3520
T-3521
T-3522
T-3523
T-3524
T-3525
T-3526
T-3527
T-3528
T-3529
T-3530
T-3531
T-3532
T-3533
T-3534
T-3535
T-3536
T-3576
T-3577
T-3578
PAGE 221 OF 241
EXHIBIT DESCRIPTION
Case No.: 2:12-cv-05201
EX #
33579
33580
33581
33582
33583
33584
33585
33586
33587
33588
33589
33590
33591
33592
33593
33594
33595
33596
33597
33598
34000
34001
34002
34003
34004
34005
34006
34007
34008
34009
34010
34011
34012
34013
34014
34015
34016
34017
34018
31340A
31341A
IDENTIFIER NO. BEG.
T-3579
T-3580
T-3581
T-3582
T-3583
T-3584
T-3585
T-3586
T-3587
T-3588
T-3589
T-3590
T-3591
T-3592
T-3593
T-3594
T-3595
T-3596
T-3597
T-3598
T-4000
T-4001
T-4002
T-4003
T-4004
T-4005
T-4006
T-4007
T-4008
T-4009
T-4010
T-4011
T-4012
T-4013
T-4014
T-4015
T-4016
T-4017
T-4018
T-1340A
T-1341A
IDENTIFIER NO. END
T-3579
T-3580
T-3581
T-3582
T-3583
T-3584
T-3585
T-3586
T-3587
T-3588
T-3589
T-3590
T-3591
T-3592
T-3593
T-3594
T-3595
T-3596
T-3597
T-3598
T-4000
T-4001
T-4002
T-4003
T-4004
T-4005
T-4006
T-4007
T-4008
T-4009
T-4010
T-4011
T-4012
T-4013
T-4014
T-4015
T-4016
T-4017
T-4018
T-1340A
T-1341A
PAGE 222 OF 241
EXHIBIT DESCRIPTION
Hellhammer Exhibit T-4000
Hart Exhibit T-1340A
Case No.: 2:12-cv-05201
EX #
31342A
31343A
31344A
31345A
31346A
31347A
31348A
31349A
31350A
33371A
IDENTIFIER NO. BEG.
T-1342A
T-1343A
T-1344A
T-1345A
T-1346A
T-1347A
T-1348A
T-1349A
T-1350A
T-3371A
IDENTIFIER NO. END
T-1342A
T-1343A
T-1344A
T-1345A
T-1346A
T-1347A
T-1348A
T-1349A
T-1350A
T-3371A
PAGE 223 OF 241
EXHIBIT DESCRIPTION
Isenberg Exhibit T-3371A
Case No.: 2:12-cv-05201
EX #
40001
40002
40003
40004
40005
40006
40007
40060
40061
40243
40334
40450
40596
40603
40617
40694
40695
40696
40697
40698
40699
40700
40701
40702
40773
40818
40865
40878
41029
41141
41142
41143
41144
41145
41146
41147
41148
41149
41150
41151
41152
IDENTIFIER NO. BEG.
P-0001
P-0002
P-0003
P-0004
P-0005
P-0006
P-0007
P-0060
P-0061
P-243
P-0334
P-0450
Plaintiff's 596
Plaintiff's 603
Plaintiff's 617
Plaintiff's 694
Plaintiff's 695
Plaintiff's 696
Plaintiff's 697
Plaintiff's 698
Plaintiff's 699
Plaintiff's 700
Plaintiff's 701
Plaintiff's 702
P-0773
Plaintiffs-818
Plaintiffs-865
P-0878
Plaintiff's 1029
1141
1142
1143
1144
1145
1146
1147
1148
1149
1150
1151
1152
IDENTIFIER NO. END
P-0001
P-0002
P-0003
P-0004
P-0005
P-0006
P-0007
P-0060
P-0061
P-243
P-0334
P-0450
Plaintiff's 596
Plaintiff's 603
Plaintiff's 617
Plaintiff's 694
Plaintiff's 695
Plaintiff's 696
Plaintiff's 697
Plaintiff's 698
Plaintiff's 699
Plaintiff's 700
Plaintiff's 701
Plaintiff's 702
P-0773
Plaintiffs-818
Plaintiffs-865
P-0878
Plaintiff's 1029
1141
1142
1143
1144
1145
1146
1147
1148
1149
1150
1151
1152
PAGE 224 OF 241
EXHIBIT DESCRIPTION
Klosterhalfen Exhibit P-0001
P-243
Plaintiff's 596
Plaintiff's 603
Plaintiff's 617
Kirkemo Exhibit Plaintiff's -694
Plaintiffs-818
Plaintiffs-865
Plaintiff's 1029
Barbolt Exhibit 1141
Case No.: 2:12-cv-05201
EX #
41153
41154
41155
41156
41157
41158
41159
41160
41161
41162
41163
41164
41165
41181
41182
41183
41184
41185
41185
41186
41187
41188
41271
41295
41296
41297
41298
41299
41300
41301
41302
41303
41304
41305
41306
41307
41308
41309
41310
41458
41659
IDENTIFIER NO. BEG.
1153
1154
1155
1156
1157
1158
1159
1160
1161
1162
1163
1164
1165
Plaintiff's 1181
Plaintiff's 1182
Plaintiff's 1183
Plaintiff's 1184
Plaintiff's 1185
Plaintiff's 1185
Plaintiff's 1186
Plaintiff's 1187
Plaintiff's 1188
Plaintiff's 1271
Plaintiff's 1295
Plaintiff's 1296
Plaintiff's 1297
Plaintiff's 1298
Plaintiff's 1299
Plaintiff's 1300
Plaintiff's 1301
Plaintiff's 1302
Plaintiff's 1303
Plaintiff's 1304
Plaintiff's 1305
Plaintiff's 1306
Plaintiff's 1307
Plaintiff's 1308
Plaintiff's 1309
Plaintiff's 1310
P-1458
P-1659
IDENTIFIER NO. END
1153
1154
1155
1156
1157
1158
1159
1160
1161
1162
1163
1164
1165
Plaintiff's 1181
Plaintiff's 1182
Plaintiff's 1183
Plaintiff's 1184
Plaintiff's 1185
Plaintiff's 1185
Plaintiff's 1186
Plaintiff's 1187
Plaintiff's 1188
Plaintiff's 1271
Plaintiff's 1295
Plaintiff's 1296
Plaintiff's 1297
Plaintiff's 1298
Plaintiff's 1299
Plaintiff's 1300
Plaintiff's 1301
Plaintiff's 1302
Plaintiff's 1303
Plaintiff's 1304
Plaintiff's 1305
Plaintiff's 1306
Plaintiff's 1307
Plaintiff's 1308
Plaintiff's 1309
Plaintiff's 1310
P-1458
P-1659
PAGE 225 OF 241
EXHIBIT DESCRIPTION
Plaintiff's 1181
Plaintiff's 1182
Plaintiff's 1183
Plaintiff's 1184
Plaintiff's 1185
Plaintiff's 1185
Plaintiff's 1186
Plaintiff's 1187
Plaintiff's 1188
Plaintiff's 1271
Holste Plaintiff's Exhibit 1295
Case No.: 2:12-cv-05201
EX #
41662
41826
41944
41951
41952
41953
41954
41958
41959
41960
41944-A
49000
49001
49002
49003
49004
49005
IDENTIFIER NO. BEG.
P-1662
Plaintiff's 1826
P-1944
P-1951
P-1952
P-1953
P-1954
P-1958
P-1959
P-1960
P-1944A
Defense -1
Defense -2
Defense -3
Defense -4
Defense -5
Defense -6
IDENTIFIER NO. END
P-1662
Plaintiff's 1826
P-1944
P-1951
P-1952
P-1953
P-1954
P-1958
P-1959
P-1960
P-1944A
Defense -1
Defense -2
Defense -3
Defense -4
Defense -5
Defense -6
PAGE 226 OF 241
EXHIBIT DESCRIPTION
Plaintiff's 1826
Klosterhalfen Exhibit P-1944A
Holste
Holste
Holste
Holste
Holste
Holste
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
90001
90002
EXHIBIT DESCRIPTION
Expert report of Jerry G. Blaivas,
M.D., including all supplements,
exhibits, and appendices
Expert report of Abhay Prandit, PhD.,
including all supplements, exhibits,
and appendices
Expert report of Bruce A. Rosezweig,
Expert report of John F. Steege,
Expert report of Erin Carey, M.D.,
and appendices
Expert report of Russell F. Dunn,
PhD., , including all supplements,
Expert report of Scott A. Guelcher,
Ph.D., including all supplements,
Expert report of David Epperly,
and appendices
90003
90004
90005
90006
90007
90008
Expert report of Bernd Klosterhalfen,
and appendices
Medical Records of Jo Beth Huskey
Billing Records of Jo Beth Huskey
Jo Huskey Photograph
Allan Hukey Photograph
Jo Huskey White Dog Photograph
Jo Huskey Brown Dog Photograph
Jo & Allan Huskey pyramids
photograph
Jo Huskey foothills photograph
Jo Huskey canyon photograph
Jo Huskey Wedding photographs
Jo Huskey recreation photographs
90009
92001
92002
90012
90013
90014
90015
90016
90017
90018
90019
90020
PAGE 227 OF 241
Case No.: 2:12-cv-05201
EX #
90021
90022
90023
91001
91002
91003
91004
91005
91006
91007
91008
91009
91010
91011
91012
91013
91014
91015
91016
91017
91018
91019
91020
91021
91022
91023
91024
91025
91026
91027
91028
91029
91030
91031
91032
91033
91034
91035
91036
91037
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
Huskey01
Huskey02
Huskey03
Huskey04
Huskey05
Huskey06
Huskey07
Huskey08
Huskey09
Huskey10
Huskey11
Huskey12
Huskey13
Huskey14
Huskey15
Huskey16
Huskey17
Huskey18
Huskey19
Huskey20
Huskey21
Huskey22
Huskey23
Huskey24
Huskey25
Huskey01
Fitzgerald01
Fitzgerald02
Fitzgerald03
Fitzgerald04
Fitzgerald05
Fitzgerald06
Fitzgerald07
Fitzgerald08
Fitzgerald09
Fitzgerald10
Fitzgerald11
Huskey01
Huskey02
Huskey03
Huskey04
Huskey05
Huskey06
Huskey07
Huskey08
Huskey09
Huskey10
Huskey11
Huskey12
Huskey13
Huskey14
Huskey15
Huskey16
Huskey17
Huskey18
Huskey19
Huskey20
Huskey21
Huskey22
Huskey23
Huskey24
Huskey25
Huskey01
Fitzgerald01
Fitzgerald02
Fitzgerald03
Fitzgerald04
Fitzgerald05
Fitzgerald06
Fitzgerald07
Fitzgerald08
Fitzgerald09
Fitzgerald10
Fitzgerald11
PAGE 228 OF 241
EXHIBIT DESCRIPTION
Jo Huskey marine photographs
Jo & Allan Huskey waterfall
photograph
Jo & Allan Huskey photograph
Jo Huskey Exhibit 01
Allan Wayne Huskey Exhibit 01
Dr. Colleen Fizgerald Exhibit 01
Case No.: 2:12-cv-05201
EX #
91038
91039
91040
91041
91051
91052
91053
91054
91055
91056
91057
91058
91059
91060
91061
91062
91063
91064
91065
91066
91067
91068
91069
91070
91071
91072
91073
91074
91075
91076
91077
91078
91079
91080
91081
91082
91083
91084
91085
91086
91087
IDENTIFIER NO. BEG.
Fitzgerald12
Mueller01
Mueller02
Mueller03
Mueller04
Mueller05
Mueller06
Schoenig01
Schoenig02
Yocks01
Yocks02
Yocks03
Yocks04
Teel01
Teel02
Teel03
Teel04
Teel05
Teel06
Teel07
Byrkit01
Byrkit02
Byrkit03
Byrkit04
Byrkit05
Byrkit06
Byrkit07
Byrkit08
Byrkit09
Byrkit10
Byrkit11
Byrkit12
Byrkit13
Byrkit14
Byrkit15
Byrkit16
Byrkit17
Byrkit18
Byrkit19
Byrkit20
Byrkit21
IDENTIFIER NO. END
Fitzgerald12
Mueller01
Mueller02
Mueller03
Mueller04
Mueller05
Mueller06
Schoenig01
Schoenig02
Yocks01
Yocks02
Yocks03
Yocks04
Teel01
Teel02
Teel03
Teel04
Teel05
Teel06
Teel07
Byrkit01
Byrkit02
Byrkit03
Byrkit04
Byrkit05
Byrkit06
Byrkit07
Byrkit08
Byrkit09
Byrkit10
Byrkit11
Byrkit12
Byrkit13
Byrkit14
Byrkit15
Byrkit16
Byrkit17
Byrkit18
Byrkit19
Byrkit20
Byrkit21
PAGE 229 OF 241
EXHIBIT DESCRIPTION
Dr. Nancy Mueller Exhibit 01
Dr. Kenneth Schoenig 01
Dr. Kenneth Schoenig 02
Dr. Brian Yocks 01
Dr. Brian Yocks 02
Dr. Brian Yocks 03
Dr. Brian Yocks 04
Ruth Teel 01
Ruth Teel 02
Ruth Teel 03
Ruth Teel 04
Ruth Teel 05
Ruth Teel 06
Ruth Teel 07
Dr. Gretchen Byrkit 01
Case No.: 2:12-cv-05201
EX #
91088
91089
91090
91091
91092
91093
91094
91095
91096
91099
91100
91101
91102
91103
91104
91105
91106
91107
91108
91109
91110
91111
91112
91113
91114
91115
91116
91117
91118
91119
91120
91121
91122
91123
91124
91125
91126
91127
91128
91129
91130
IDENTIFIER NO. BEG.
Byrkit22
Byrkit23
Byrkit24
Byrkit25
Byrkit26
Byrkit27
Brykit28
Byrkit29
Byrkit30
Byrkit31
Siddique01
Siddique02
Siddique03
Siddique04
Dean01
Dean02
Dean03
Dean04
Dean05
Dean06
Dean07
Dean08
Dean09
Dean10
Ogunleye01
Ogunleye02
Ogunleye03
Ogunleye04
Ogunleye05
Ogunleye06
Ogunleye07
Ogunleye08
Davidson01
Davidson02
Davidson03
Ward01
Ward02
Ward03
Ward04
Ward05
Ward06
IDENTIFIER NO. END
Byrkit22
Byrkit23
Byrkit24
Byrkit25
Byrkit26
Byrkit27
Brykit28
Byrkit29
Byrkit30
Byrkit31
Siddique01
Siddique02
Siddique03
Siddique04
Dean01
Dean02
Dean03
Dean04
Dean05
Dean06
Dean07
Dean08
Dean09
Dean10
Ogunleye01
Ogunleye02
Ogunleye03
Ogunleye04
Ogunleye05
Ogunleye06
Ogunleye07
Ogunleye08
Davidson01
Davidson02
Davidson03
Ward01
Ward02
Ward03
Ward04
Ward05
Ward06
PAGE 230 OF 241
EXHIBIT DESCRIPTION
Dr. Sohail Siddique 01
Gretchen Dean 01
Gretchen Dean 02
Gretchen Dean 03
Gretchen Dean 04
Gretchen Dean 05
Gretchen Dean 06
Gretchen Dean 07
Gretchen Dean 08
Gretchen Dean 09
Gretchen Dean 10
Dr. Bamidele Ogunleye 01
Nancy Davidson 01
Nancy Davidson 02
Nancy Davidson 03
Dr. Terry Ward 01
Dr. Terry Ward 02
Dr. Terry Ward 03
Dr. Terry Ward 04
Dr. Terry Ward 05
Dr. Terry Ward 06
Case No.: 2:12-cv-05201
EX #
91131
91132
91133
91134
91135
91136
91137
91138
91139
91140
91141
91142
91143
91144
91145
91146
91147
91148
91149
91150
91151
91152
91153
91154
91155
91156
91157
91158
91159
91160
91161
91162
91163
91164
91165
91166
91167
91168
91169
91170
91171
IDENTIFIER NO. BEG.
Harms01
Harms02
Harms03
Harms04
Harms05
Rominger01
Rominger02
Rominger03
Rominger04
Rominger05
Irvin01
Irvin02
Irvin03
Irvin04
Irvin05
Irvin06
Irvin07
Irvin08
Irvin09
Irvin10
Irvin11
Irvin12
Irvin13
Irvin14
Irvin15
Irvin16
Irvin17
Irvin18
Irvin19
Irvin20
Irvin21
Irvin22
Irvin23
Irvin24
Irvin25
Irvin26
Irvin27
Irvin28
Irvin29
Jakser01
Jakser02
IDENTIFIER NO. END
Harms01
Harms02
Harms03
Harms04
Harms05
Rominger01
Rominger02
Rominger03
Rominger04
Rominger05
Irvin01
Irvin02
Irvin03
Irvin04
Irvin05
Irvin06
Irvin07
Irvin08
Irvin09
Irvin10
Irvin11
Irvin12
Irvin13
Irvin14
Irvin15
Irvin16
Irvin17
Irvin18
Irvin19
Irvin20
Irvin21
Irvin22
Irvin23
Irvin24
Irvin25
Irvin26
Irvin27
Irvin28
Irvin29
Jakser01
Jakser02
PAGE 231 OF 241
EXHIBIT DESCRIPTION
Dr. James Harms 01
Dr. James Harms 02
Dr. James Harms 03
Dr. James Harms 04
Dr. James Harms 05
Dr. Derin Rominger 01
Michelle Irvin 01
Michelle Irvin 02
Michelle Irvin 03
Michelle Irvin 04
Michelle Irvin 05
Michelle Irvin 06
Michelle Irvin 07
Michelle Irvin 08
Michelle Irvin 09
Michelle Irvin 10
Michelle Irvin 11
Michelle Irvin 12
Michelle Irvin 13
Michelle Irvin 14
Michelle Irvin 15
Michelle Irvin 16
Michelle Irvin 17
Michelle Irvin 18
Michelle Irvin 19
Michelle Irvin 20
Michelle Irvin 21
Michelle Irvin 22
Michelle Irvin 23
Michelle Irvin 24
Michelle Irvin 25
Michelle Irvin 26
Michelle Irvin 27
Michelle Irvin 28
Michelle Irvin 29
Bryan Jasker 01
Bryan Jasker 02
Case No.: 2:12-cv-05201
EX #
91172
91173
IDENTIFIER NO. BEG.
Jasker03
Jakser04
IDENTIFIER NO. END
Jasker03
Jakser04
91174
Zheng01
Zheng01
91175
Zheng02
Zheng02
91176
Zheng03
Zheng03
91177
Zheng04
Zheng04
91178
Zheng05
Zheng05
91179
Zheng06
Zheng06
91180
Zheng07
Zheng07
91181
Zheng08
Zheng08
91182
Zheng09
Zheng09
91183
Zheng10
Zheng10
91184
Zheng11
Zheng11
91185
Zheng12
Zheng12
91186
Zheng13
Zheng13
91187
Zheng14
Zheng14
91188
Zheng15
Zheng15
91189
Zheng16
Zheng16
91190
Zheng17
Zheng17
91191
Zheng18
Zheng18
91192
Zheng19
Zheng19
PAGE 232 OF 241
EXHIBIT DESCRIPTION
Bryan Jasker 01
Bryan Jasker 01
Wenxin Zheng Deposition
04/03/2014 Exhibit 01
04/03/2014 Exhibit 02
04/03/2014 Exhibit 03
04/03/2014 Exhibit 04
04/03/2014 Exhibit 05
04/03/2014 Exhibit 06
04/03/2014 Exhibit 07
04/03/2014 Exhibit 08
04/03/2014 Exhibit 09
04/03/2014 Exhibit 10
04/03/2014 Exhibit 11
04/03/2014 Exhibit 12
04/03/2014 Exhibit 13
04/03/2014 Exhibit 14
04/03/2014 Exhibit 15
04/03/2014 Exhibit 16
04/03/2014 Exhibit 17
04/03/2014 Exhibit 18
04/03/2014 Exhibit 19
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
91193
Zheng20
Zheng20
91194
Zheng21
Zheng21
91195
Zheng22
Zheng22
91196
Zheng23
Zheng23
91197
Zheng24
Zheng24
91198
Zheng25
Zheng25
91199
Zheng26
Zheng26
91200
Zheng27
Zheng27
91201
Zheng28
Zheng28
91902
Zheng29
Zheng29
91203
Zheng30
Zheng30
91204
Zheng31
Zheng31
91205
Zheng32
Zheng32
91206
Zheng33
Zheng33
91207
Zheng34
Zheng34
91208
Zheng35
Zheng35
91209
Zheng36
Zheng36
91210
Zheng37
Zheng37
91211
Zheng01
Zheng01
91212
Zheng02
Zheng02
PAGE 233 OF 241
EXHIBIT DESCRIPTION
04/03/2014 Exhibit 20
04/03/2014 Exhibit 21
04/03/2014 Exhibit 22
04/03/2014 Exhibit 23
04/03/2014 Exhibit 24
04/03/2014 Exhibit 24
04/03/2014 Exhibit 26
04/03/2014 Exhibit 27
04/03/2014 Exhibit 28
04/03/2014 Exhibit 29
04/03/2014 Exhibit 30
04/03/2014 Exhibit 31
04/03/2014 Exhibit 32
04/03/2014 Exhibit 33
04/03/2014 Exhibit 34
04/03/2014 Exhibit 35
04/03/2014 Exhibit 36
04/03/2014 Exhibit 37
12/03/2013 Exhibit 01
12/03/2013 Exhibit 02
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
91213
Zheng03
Zheng03
91214
Zheng04
Zheng04
91215
Zheng05
Zheng05
91216
Zheng06
Zheng06
91217
Sexton01
Sexton01
91218
Sexton02
Sexton02
91219
Sexton03
Sexton03
91220
Sexton04
Sexton04
91221
Sexton05
Sexton05
91222
Sexton06
Sexton06
91223
Sexton07
Sexton07
91224
Sexton08
Sexton08
91225
Sexton09
Sexton09
91226
Sexton10
Sexton10
91227
Sexton11
Sexton11
91228
Sexton12
Sexton12
91229
Sexton13
Sexton13
91230
Sexton14
Sexton14
91231
Sexton15
Sexton15
91232
Sexton16
Sexton16
PAGE 234 OF 241
EXHIBIT DESCRIPTION
12/03/2013 Exhibit 03
12/03/2013 Exhibit 04
12/03/2013 Exhibit 05
12/03/2013 Exhibit 06
Daniel Sexton Deposition 4/4/2014
Exhibit 01
Exhibit 02
Exhibit 03
Exhibit 04
Exhibit 05
Exhibit 06
Exhibit 07
Exhibit 08
Exhibit 09
Exhibit 10
Exhibit 11
Exhibit 12
Exhibit 13
Exhibit 14
Exhibit 15
Exhibit 16
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
91233
Sexton17
Sexton17
91234
Sexton18
Sexton18
91235
Sexton19
Sexton19
91236
Sexton20
Sexton20
91237
Sexton01
Sexton01
91238
Sexton02
Sexton02
91239
Sexton03
Sexton03
91240
Sexton04
Sexton04
91241
Sexton05
Sexton05
91242
Sexton01
Sexton01
91243
Sexton02
Sexton02
91244
Sexton03
Sexton03
91245
Sexton04
Sexton04
91246
Sexton05
Sexton05
91247
Sexton06
Sexton06
91248
Sexton07
Sexton07
91249
Sexton08
Sexton08
91250
Sexton09
Sexton09
91251
Sexton10
Sexton10
91252
Ong01
Ong01
PAGE 235 OF 241
EXHIBIT DESCRIPTION
Exhibit 17
Exhibit 18
Exhibit 19
Exhibit 20
Exhibit 01
Exhibit 02
Exhibit 03
Exhibit 04
Exhibit 05
Exhibit 01
Exhibit 02
Exhibit 03
Exhibit 04
Exhibit 05
Exhibit 06
Exhibit 07
Exhibit 08
Exhibit 09
Exhibit 10
Kevin Ong Deposition 04/25/2014
Exhibit 01
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
91253
Ong02
Ong02
91254
Ong03
Ong03
91255
Ong04
Ong04
91256
Ong05
Ong05
91257
Ong06
Ong06
91258
Ong07
Ong07
91259
Ong08
Ong08
91260
Ong09
Ong09
91261
Ong10
Ong10
91262
Ong11
Ong11
91263
Ong12
Ong12
91264
Ong13
Ong13
91265
Ong14
Ong14
91266
Ong01
Ong01
91267
Ong02
Ong02
91268
Ong03
Ong03
91269
Ong04
Ong04
91270
Ong05
Ong05
91271
Ong06
Ong06
91272
Ong07
Ong07
PAGE 236 OF 241
EXHIBIT DESCRIPTION
Exhibit 02
Exhibit 03
Exhibit 04
Exhibit 05
Exhibit 06
Exhibit 07
Exhibit 08
Exhibit 09
Exhibit 10
Exhibit 11
Exhibit 12
Exhibit 13
Exhibit 14
Exhibit 01
Exhibit 02
Exhibit 03
Exhibit 04
Exhibit 05
Exhibit 06
Exhibit 07
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
91273
Ong08
Ong08
91274
Ong09
Ong09
91275
Ong10
Ong10
91276
Ong11
Ong11
91277
Ong12
Ong12
91278
Ong13
Ong13
91279
Ong14
Ong14
91280
Ong15
Ong15
91281
Ong16
Ong16
91282
Thames01
Thames01
91283
Thames02
Thames02
91284
Thames03
Thames03
91285
Thames04
Thames04
91286
Thames05
Thames05
91287
Thames06
Thames06
91288
Thames07
Thames07
91289
Thames08
Thames08
91290
Thames09
Thames09
91291
Thames10
Thames10
91292
Thames01
Thames01
PAGE 237 OF 241
EXHIBIT DESCRIPTION
Exhibit 08
Exhibit 09
Exhibit 10
Exhibit 11
Exhibit 12
Exhibit 13
Exhibit 14
Exhibit 15
Exhibit 16
Shelby Thames Deposition
04/21/2014 Exhibit 01
04/21/2014 Exhibit 02
04/21/2014 Exhibit 03
04/21/2014 Exhibit 04
04/21/2014 Exhibit 05
04/21/2014 Exhibit 06
04/21/2014 Exhibit 07
04/21/2014 Exhibit 08
04/21/2014 Exhibit 09
04/21/2014 Exhibit 10
01/21/2014 Exhibit 01
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
91293
Thames02
Thames02
91294
Thames03
Thames03
91295
Thames04
Thames04
91296
Thames05
Thames05
91297
Thames06
Thames06
91298
Thames07
Thames07
91299
Thames08
Thames08
91300
Thames09
Thames09
91301
Thames10
Thames10
91302
Thames11
Thames11
91303
Thames12
Thames12
91304
Thames13
Thames13
91305
Thames14
Thames14
91306
Thames15
Thames15
91307
Thames16
Thames16
91308
Thames17
Thames17
91309
Thames18
Thames18
91310
Pramudji01
Pramudji01
91311
Pramudji02
Pramudji02
91312
Pramudji03
Pramudji03
PAGE 238 OF 241
EXHIBIT DESCRIPTION
01/21/2014 Exhibit 02
01/21/2014 Exhibit 03
01/21/2014 Exhibit 04
01/21/2014 Exhibit 05
01/21/2014 Exhibit 06
01/21/2014 Exhibit 07
01/21/2014 Exhibit 08
01/21/2014 Exhibit 09
01/21/2014 Exhibit 10
01/21/2014 Exhibit 11
01/21/2014 Exhibit 12
01/21/2014 Exhibit 13
01/21/2014 Exhibit 14
01/21/2014 Exhibit 15
01/21/2014 Exhibit 16
01/21/2014 Exhibit 17
01/21/2014 Exhibit 18
Christina Pramudji Deposition
04/11/2014 Exhibit 01
04/11/2014 Exhibit 02
04/11/2014 Exhibit 03
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
91313
Pramudji04
Pramudji04
91314
Pramudji05
Pramudji05
91315
Pramudji06
Pramudji06
91316
Pramudji07
Pramudji07
91317
Pramudji08
Pramudji08
91318
Pramudji09
Pramudji09
91319
Pramudji10
Pramudji10
91320
Pramudji01
Pramudji01
91321
Pramudji02
Pramudji02
91322
Pramudji03
Pramudji03
91323
Pramudji04
Pramudji04
91324
Pramudji05
Pramudji05
91325
Pramudji06
Pramudji06
91326
Pramudji07
Pramudji07
91327
Pramudji08
Pramudji08
91328
Weber01
Weber01
91329
Weber02
Weber02
91330
Weber03
Weber03
91331
Weber04
Weber04
91332
Weber05
Weber05
PAGE 239 OF 241
EXHIBIT DESCRIPTION
04/11/2014 Exhibit 04
04/11/2014 Exhibit 05
04/11/2014 Exhibit 06
04/11/2014 Exhibit 07
04/11/2014 Exhibit 08
04/11/2014 Exhibit 09
04/11/2014 Exhibit 10
01/10/2014 Exhibit 01
01/10/2014 Exhibit 02
01/10/2014 Exhibit 03
01/10/2014 Exhibit 04
01/10/2014 Exhibit 05
01/10/2014 Exhibit 06
01/10/2014 Exhibit 07
01/10/2014 Exhibit 08
David Weber Deposition 04/24/2014
Exhibit 01
Exhibit 02
Exhibit 03
Exhibit 04
Exhibit 05
Case No.: 2:12-cv-05201
EX #
IDENTIFIER NO. BEG.
IDENTIFIER NO. END
91333
Weber06
Weber06
91334
Weber07
Weber07
91335
Weber08
Weber08
91336
Weber09
Weber09
91337
Weber10
Weber10
91338
Weber01
Weber01
91339
Weber02
Weber02
91340
Weber03
Weber03
91341
Weber04
Weber04
91342
Sirls01
Sirls01
91343
Srils02
Srils02
91344
Srils03
Srils03
91345
91346
91347
91348
91349
91350
91351
91352
91353
91354
91355
91356
91357
91358
91359
91360
Sirls04
Johnson01
Johnson02
Johnson03
Johnson04
Johnson05
Elser01
Elser02
Elser03
Elser04
Elser05
Elser06
Elser6A
Elser07
Elser08
Elser09
Sirls04
Johnson01
Johnson02
Johnson03
Johnson04
Johnson05
Elser01
Elser02
Elser03
Elser04
Elser05
Elser06
Elser6A
Elser07
Elser08
Elser09
PAGE 240 OF 241
EXHIBIT DESCRIPTION
Exhibit 06
Exhibit 07
Exhibit 08
Exhibit 09
Exhibit 10
Exhibit 01
Exhibit 02
Exhibit 03
Exhibit 04
Larry Sirls Deposition 12/14/2012
Exhibit 01
Exhibit 02
Exhibit 03
Exhibit 04
Harry Johnson Deposition Exhibit 01
Denise Elser Deposition Exhibit 01
Denise Elser Deposition Exhibit 6A
Case No.: 2:12-cv-05201
EX #
91361
91362
91363
IDENTIFIER NO. BEG.
Elser10
Elser11
Elser12
IDENTIFIER NO. END
Elser10
Elser11
Elser12
PAGE 241 OF 241
EXHIBIT DESCRIPTION
ATTACHMENT B
Case 2:12-cv-05201 Document
320-2 Filed 08/04/14 Page 2 of 24 PageID #: 14169
Defendants' Condensed Case-Specific Exhbit List
In re: Ethicon, Inc. Pelvic Repair Systems Products Liability Litigation, Master File No. 2:12-CV-05201 (MDL 2327) (Jo Huskey)
Defendants reserve the right to further supplement this exhibit list as may be warranted during the course of trial.
In identifying documents, Defendants do not admit that all or part of any documents are admissible at trial, or may be used in any way.
Defendants reserve all rights to object to the use of all or any part of any document listed herein.
Exhibit
DX10001
DX10002
DX10003
DX10004
DX10005
DX10006
DX10007
DX10008
DX10010
Bates Range (if applicable)
HUSKEYJ-AEBHA-MDR00001-00007
HUSKEYJ-APT-EMP00001-00061
HUSKEYJ-AWH-MDR00001-00013
HUSKEYJ-ABMC-MDR00001-00124
HUSKEYJ-ABMC-BIL00001-00012
HUSKEYJ-ABMC-PAT00001-00002
HUSKEYJ-AUSH-INS00001-00229
HUSKEYJ-CARLE-MDR00001-00750
HUSKEYJ-CARLE-BIL00001-00033
HUSKEYJ-CARCL-MDR00001-00042
HUSKEYJ-CJVWC-MDR00001-00116
HUSKEYJ-CHRIC-MDR00001-00033
Date
Description
A&E Behavioral HC
Accelerated Physical Therapy
Advanced Women’s Healthcare
Advocate BroMenn Medical Center
Aetna
Carle
Carle Clinic
Carol Jo Veecchie Women’s and Children’s Center
Christie Clinic
Page 1 of 11
Offered
Admitted
Exhibit
DX10012
DX10013
DX10014
DX10016
DX10017
DX10018
DX10019
DX10020
DX10021
DX10023
HUSKEYJ-DECMH-MDR00001-00221
HUSKEYJ-DECMH-BIL00001-00013
HUSKEYJ-DECMH-PAT00001-00002
HUSKEYJ-DNA-MDR00001-00016
HUSKEYJ-DDC-MDR00001-00057
HUSKEYJ-IPSSI-MDR00001-00011
HUSKEYJ_IPSSI_MDR00018 -00046
HUSKEYJ-IMSA-MDR00001-00026
HUSKEYJ-KIMC-MDR00001-00132
HUSKEYJ-KIMC-BIL00001-00025
HUSKEYJ-LUMC-MDR00001-00007
HUSKEYJ-LUMC-BIL00001-00001
HUSKEYJ-LUMC-PAT00001-00001
HUSKEYJ-LOUMC-MDR00001-00005
HUSKEYJ-MLLCN-MDR00001-00001
HUSKEYJ_MILPC_MDR00001-00009
HUSKEYJ-LOSBO-MDR00001-00010
Date
Description
Decatur Memorial Hospital
Decatur Neurosurgery Associated
Digestive Disease Consultants
Institute for Plastic Surgery at SIU
Internal Medicine Subspecialty Associates
Kirby Medical Center
Loyola University Medical center
McLean County Neurology
Millennium Pain Center
Osborne, Larry, D.M.D.
Page 2 of 11
Offered
Admitted
Exhibit
DX10024
DX10025
DX10026
DX10027
DX10028
DX10029
DX10030
DX10031
DX10032
DX10033
DX10034
DX10035
DX10036
HUSKEYJ-OSFMG-MDR00001-00004
HUSKEYJ-OSJMC-MDR00001-00003
HUSKEYJ-OSJMC-BIL00001-00001
HUSKEYJ-OSJMC-PAT00001-00001
HUSKEYJ-PERSC-INS00001-00003
HUSKEYJ-PRAC-MDR00001-00004
HUSKEYJ-WHRAI-MDR00001-00003
HUSKEYJ-SSID-MDR00001-00166
HUSKEYJ_SCI_MDR00001-00060
HUSKEYJ-SIUMH-MDR00001-00082
HUSKEYJ-SOSA-SSA00001-00001
HUSKEYJ-SCD-MDR00001-00263
HUSKEYJ-SJOHH-MDR00107-00116
HUSKEYJ-SJOHH-BIL00001-00004
HUSKEYJ-SJOHH-PAT00001-00001
HUSKEYJ-SMARH-MDR00001-00278
HUSKEYJ-SMARH-BIL00001-00045
HUSKEYJ-SMARH-EMP00001-00069
HUSKEYJ-SMARH-EMP00001-00080(rebates)
Date
Description
OSF Medical Group
OSF St. Joseph Medical Center
Personal Care
Prairie Cardiovascular
Raino, William H., M.D.
Siddique, Sohail A., M.D.
Simmons Cancer Institute at SUI
SIU School of Medicine and Healthcare Department of Obstetrics &
Gynecology
SSA
Springfield Memorial Hospital Medical Center
St. John’s Hospital
St. Mary’s Hospital
St. Mary’s Hospital Employment Records
Page 3 of 11
Offered
Admitted
Exhibit
DX10037
DX10038
DX10039
DX10040
DX10041
DX10042
DX10043
DX10044
DX10045
DX10046
DX10047
DX10048
DX10049
DX10050
DX10051
DX10052
DX10053
DX10054
DX10055
DX10056
DX10057
DX10058
DX10059
DX10060
DX10061
DX10062
DX10063
DX10064
DX10065
DX10066
DX10067
DX10068
DX10069
DX10070
DX10071
Date
Description
HUSKEYJ-WMS-BIL00001-00005
HUSKEYJ-WALGC-BIL00001-00051
HUSKEYJ-TAWAR-MDR00001-00047
HUSKEYJ-WHCSD-MDR00001-00068
HUSKEYJ-BYOCK-MDR00001-00135
HUSKEYJ-MEMMC-BIL00001-00004
HUSKEYJ-MEMMC-MDR0001-00821
HUSKEYJ-CARPG-MDR00001-00408
HUSKEYJ-SUPP-BIL00001-00001
HUSKEYJ_PSR_00658 - HUSKEYJ_PSR_01976
HUSKEYJ_LERCC_LEG00001 HUSKEYJ_LERCC_LEG00822
ETH.MESH.02340902 - ETH.MESH.02340908
HUSKEYJ_DECMH_MDR00038
Wal-Mart
Walgreen
Ward, Terry A., D.C.
Women’s Health Care Specialists of Decatur
Yorks, Brian C., M.D.
Memorial Medical Center
Carle Physician Group
SuperValu Pharmacy
The Hartford Insurance Company
HSUKEYJ_TAXDOCS_0001 - HUSKEYJ_TAXDOCS_0079
9/6/2012
3/15/2014
1997
1997
1997
1997
1998
1998
1998
1998
1998
1998
1999
1999
1999
1999
1999
2000
Jo Huskey Divorce File
TVT-O IFU
TVT-O Implant Sticker
Plaintiff Fact Sheet
Plaintiff Profile Form
Plaintiff Journal
Plaintiff Tax documents
Complaint
Plaintiffs' Response to Ethicon, Inc. and Johnson & Johnson's First Setof
Interrogatories
Naproxen 500 mg
Synthroid
Tylenol - OTC
Axid
Axid
Synthroid
Propulsid
Lorabid
Bentyl
Claritin
Augmentin
Doxycycline
Zyban
Antivert
Allegra
Vioxx
Page 4 of 11
Offered
Admitted
Exhibit
DX10072
DX10073
DX10074
DX10075
DX10076
DX10077
DX10078
DX10079
DX10080
DX10081
DX10082
DX10083
DX10084
DX10085
DX10086
DX10087
DX10088
DX10089
DX10090
DX10091
DX10092
DX10093
DX10094
DX10095
DX10096
DX10097
DX10098
DX10099
DX10100
DX10101
DX10102
DX10103
DX10104
DX10105
DX10106
DX10107
DX10108
DX10109
DX10110
DX10111
DX10112
DX10113
DX10114
DX10115
DX10116
DX10117
Date
Description
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2001
2001
2001
2001
2001
2001
2001
2002
2002
2002
2002
2002
2002
2002
2002
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2006
2006
2006
2006
2006
2007
Pred
Bentyl
Zantac
Ultram
Oxycontin
Valium
Vistaril
Robaxin
Proventil
Paxil
Keflex
Z-pak
Ambien
Sudafed
Levoxyl
Ceftin
Albuterol
Diflucan
Zantac
Benadryl
Amoxicillin
Protonix
Levoxyl
Celebrex
Bextra
Skelaxin
Doxycycline
Ibuprofen
Anthrotrec
Lortab
Protonix
Levoxyl
Vicodin
Nexium
Biaxin XL
Pred
Naproxen
Bentyl
Zithromax
Advair
Levoxyl
Protonix
Reglan
Midrin
Percocet
Melatonin
Page 5 of 11
Offered
Admitted
Exhibit
DX10118
DX10119
DX10120
DX10121
DX10122
DX10123
DX10124
DX10125
DX10126
DX10127
DX10128
DX10129
DX10130
DX10131
DX10132
DX10133
DX10134
DX10135
DX10136
DX10137
DX10138
DX10139
DX10140
DX10141
DX10142
DX10143
DX10144
DX10145
DX10146
DX10147
DX10148
DX10149
DX10150
DX10151
DX10152
DX10153
DX10154
DX10155
DX10156
DX10157
DX10158
DX10159
DX10160
DX10161
DX10162
DX10163
Date
Description
2007
2007
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
Naproxen
Amoxicillin
AZO standard - OTC
Amoxicillin
Cipro
Xifaxan
Vagifem
Diflucan [fluconazole]
Azithromycin
Nexium
Estrace vaginal cream
Levothyroxine
Syntrhroid [levothyroxine]
Cytomel [liothyronine]
Zyrtec
Soma
Protonix [Pantoprazole]
Proair inhaler
Nexium
Proventil inhaler
SMZ/TMP [Bactrim]
Synthroid
Pyridium [Phenazopyridine]
Cleocin 2% cream [clindamycin vaginal cream]
Naproxen
Effexor [venlafaxine]
Mobic
Penicillin K
Premarin vaginal cream
Azithromycin
Effexor
Prozac [fluoxetine]
Zyrtec-D [cetirizine]
Bactrim DS
Synthroid
Azithromycin
Zegerid
Melatonin
Ambien [Zolpidem]
Ibuprofen
Page 6 of 11
Offered
Admitted
Exhibit
DX10164
DX10165
DX10166
DX10167
DX10168
DX10169
DX10170
DX10171
DX10172
DX10173
DX10174
DX10175
DX10176
DX10177
DX10178
DX10179
DX10180
DX10181
DX10182
DX10183
DX10184
DX10185
DX10186
DX10187
DX10188
DX10189
DX10190
DX10191
DX10192
DX10193
DX10194
DX10195
DX10196
DX10197
DX10198
DX10199
DX10200
DX10201
DX10202
DX10203
DX10204
DX10205
DX10206
DX10207
DX10208
DX10209
Date
Description
2011
2011
2011
2011
2011
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
Fluticasone
Hydrocodone/APAP
Pencillin K
Metoclopramide [Reglan]
Acetaminophen w/codeine #3 [Tylenol #]
Prozac
Vicodin
Dicyclomine
Aleve
Benadryl
Synthroid
Cymbalta
Tramadol [nucynta]
Nitro-bid 2% vaginal ointment
Omeprazole [Prilosec]
Carafate [Sucralfate]
Amoxicillin
Zantac [ranitidine]
Protonnix [Pantoprazole]
Meclizine [nivert]
Hydrocodone
Amitriptyline
Zyrtec-D
Pred
Amitriptyline
Cymbalta
Synthroid
Zyrtec D
Tramadol
Gabapentin
Vaginal valium
Naproxen
Ponstel
Nortriptyline
Azithromycin
K Clavulanate
Acetaminophen w/ codeine #3 [Tylenol #3]
Ondansetron [Zofran]
Trazodone [Desyrel]
Alprazolam [Xanax]
Doxycycline
Page 7 of 11
Offered
Admitted
Exhibit
DX10210
DX10211
DX10212
DX10213
DX10214
DX10215
DX10216
DX10217
DX10218
DX10219
DX10220
DX10221
DX10222
DX10223
DX10224
DX10225
DX10226
DX10231
DX10232
HUSKEYJ_EMAILS_0001 - HUSKEYJ_EMAILS_0092
HUSKEY_HARTFORD_SUBPOENA_00199 HUSKEY_HARTFORD_SUBPOENA_00200
DX10264
Depo Ex. 4 to Jo Huskey deposition - SSA Internet Application Summary
ETH.MESH.08033628 - ETH.MESH.08033629
DX10268
DX10269
DX10270
ETH.MESH.03472794
DX10271
ETH.MESH.07949530 - ETH.MESH.07949536
DX10272
DX10273
Dilaudid
Tramadol ER
Synthroid
Fluticasone
Nortriptyline
Amoxicillin
Hydrocodone/APAP
Tizanidine
Nitrostat
Cephalexin
Amoxicillin K Clavulanate
Proair inhaler
Depo Ex. 1 to Gretchen L. Byrkit, M.D. deposition - TVT Patient Brochure
"Stop Coping, Start Living"
Depo Ex. 2 to Gretchen L. Byrkit, M.D. deposition - CV
5/22/2011 Various email strings between Jo Huskey and others
Depo Ex. 2 to Gretchen Dean deposition - CV
Depo Ex. 10 to Gretchen Dean deposition - Subjective and Objective
Findings - Therapy for Jo Beth Marshall
Depo Ex. 4 to Colleen M. Fitzgerald, M.D. deposition - CV
Depo Ex. 10 to Colleen M. Fitzgerald, M.D. deposition - Attending
4/6/2013 Physician's Statement of Continued Disability
7/22/2008 Depo Ex. 2 to James J. Harms, M.D. deposition - CV
2/23/2011 Depo Ex. 3 to Jo Huskey deposition - Byrkit notes - initial surgery date
DX10265
DX10266
DX10267
Description
2014
2014
2014
2014
2014
2014
2014
2014
2014
2014
2014
2014
2014
2014
2014
DX10233
DX10261
DX10262
DX10263
Date
ETH.MESH.08041899 - ETH.MESH.08041900
Depo Ex. 5 to Jo Huskey deposition - Jesus Calling by Sarah Young
Depo Ex. 2 to Michelle M. Irvin deposition - CV
Depo Ex. 3 to Michelle M. Irvin deposition - Redacted CV (first page only)
Depo Ex. 4 to Michelle M. Irvin deposition - FDA website "Information on
Surgical Mesh for POP and SUI"
Depo Ex. 5 to Michelle M. Irvin deposition - Memo to EWHU Team re
10/00/2008 FDA Public Health Notification
Depo Ex. 6 to Michelle M. Irvin deposition - General Incontinence
Depo Ex. 8 to Michelle M. Irvin deposition - Defendants' Fact Sheet
Depo Ex. 9 to Michelle M. Irvin deposition - Email from Irvin to Irvin re:
10/14/2010 10/14 Post Call Notes
Page 8 of 11
Offered
Admitted
Exhibit
Date
Description
DX10274
ETH.MESH.07975392
DX10275
ETH.MESH.07954016 - ETH.MESH.07954017
3/17/2009
DX10276
ETH.MESH.07949421 - ETH.MESH.07949422
1/5/2012
DX10277
ETH.MESH.07949444 - ETH.MESH.07949446
8/8/2011
DX10279
ETH.MESH.07949397
3/12/2012
DX10280
ETH.MESH.07949452 - ETH.MESH.07949453
9/13/2011
DX10282
ETH.MESH.08039431 - ETH.MESH.08039639
DX10283
ETH.MESH.00658058 - ETH.MESH.00658065
DX10284
ETH.MESH.00161953 - ETH.MESH.00161954
DX10285
ETH.MESH.00169748 - ETH.MESH.00169751
DX10286
ETH.MESH.00658430 - ETH.MESH.00658431
DX10287
ETH.MESH.08033400 - ETH.MESH.08033467
DX10288
ETH.MESH.07954580 - ETH.MESH.07954586
2/18/2011
DX10291
DX10295
ETH.MESH.08041927 - ETH.MESH.08041928
12/7/2010
DX10296
DX10297
DX10298
DX10299
DX10300
HUSKEYJ-EMAILS_0059
DX10301
DX10302
DX10303
Deppo Ex. 21 to Michelle M. Irvin deposition - pages from TVT-O IFU
Depo Ex. 22 to Michelle M. Irvin deposition - TVT and TVT-O sales
materials
Depo Ex. 23 to Michelle M. Irvin deposition - TVT Family of Products
sales materials
2/8/2013
5/13/1999
DX10304
DX10305
DX10335
DX10336
DX10337
DX10338
DX10339
HUSKEY_HARTFORD_SUBPOENA_00414HUSKEY_HARTFORD_SUBPOENA_00416
Depo Ex. 10 to Michelle M. Irvin deposition - TVT-O v. Monarc study
design
Depo Ex. 11 to Michelle M. Irvin deposition from Irvin to Talbott re +M
Mondays
Depo Ex. 12 to Michelle M. Irvin deposition - email from Taylor to Pagel,
etal. Re : FDA Mesh Correspondence on 1/3/12
Depo Ex. 13 to Michelle M. Irvin deposition - email from Tan to Parker, et
al. re: Your Signature on FDA Submission
Depo Ex. 15 to Michelle M. Irvin deposition - email from Irvin to Irvin re:
Product Complaint
Depo Ex. 16 to Michelle M. Irvin deposition - email from Irvin to Maker,
et al. re This Evenings FDA Call re: Internal Use Only
Depo Ex. 18 to Michelle M. Irvin deposition - Gynecare TVT Family of
Products
Depo Ex. 20 to Michelle M. Irvin deposition - Only Gynecare TVT Has
Long-term Results You Can See…brochure
12/1/2012
Depo Ex. 24 to Michelle M. Irvin deposition - TVT Professional Education
Depo Ex. 25 to Michelle M. Irvin deposition - email from Kelly to Byerly,
et al re GMD Help
12/6 Post Call Notes
Depo Ex. 4 to Elizabeth Mueller deposition - CV
Depo Ex. 6 to Dele Ogunleye deposition - email from Huskey to Davidson
re: Hey Chick
Depo Ex. 8 to Dele Ogunleye deposition - CV
Depo Ex. 2 to Derin S. Rominger, M.D. deposition - CV
Depo Ex. 1 to Kenneth R. Schoenig, M.D. deposition - CV
Depo Ex. 2 to Ruth E. Teel, M.A. deposition - CV
Depo Ex. 7 to Ruth E. Teel, M.A. deposition - Global Assessment of
Functioning (GAF) Scale
Depo Ex. 1 to Dr. Terry A. Ward deposition - CV
Depo Ex. 3 to Dr. Terry A. Ward deposition - Office Notes
Depo Ex. 6 to Dr. Terry A. Ward deposition - New Patient Information
Form
Depo Ex. 3 to Dr. Brian Yocks deposition - Fax from Yocks attaching
Attending Physician's Statement of Functionality
Thomas Barocci CV
All materials reviewed by Thomas Barocci
Dan Schultz CV
All materials reviewed by Dan Schultz
Timothy Ulatowski CV
Page 9 of 11
Offered
Admitted
Exhibit
DX10340
DX10341
DX10342
DX10343
DX10344
DX10345
DX10346
DX10347
DX10348
DX10349
DX10350
DX10351
DX10352
DX10353
DX10354
DX10355
DX10356
DX10357
DX10358
DX10359
DX10360
DX10361
DX10362
DX10363
DX10364
DX10365
DX10366
DX10367
DX10368
DX10369
DX10370
DX10371
DX10372
DX10373
DX10374
DX10375
DX10376
DX10377
Description
All materials reviewed by Timothy Ulatowski
Wenxin Zheng CV
All materials reviewed by Wenxin Zheng
David Weber CV
All materials reviewed by David Weber
Daniel Sexton CV
All materials reviewed by Daniel Sexton
Michael Greenberg CV
All materials reviewed by Michael Greenberg
Kevin Ong CV
All materials reviewedby Kevin Ong
Shelby Thames CV
All materials reviewed by Shelby Thames
Larry Sirls CV
All materials reviewed by Larry Sirls
Christina Pramudji CV
All materials reviewed by Christina Pramudji
Harry Johnson CV
All materials reviewed by Harry Johnson
Denise Elser CV
All materials reviewed by Denise Elser
Elizabeth Kavaler CV
All materials reviewed by Elizabeth Kavaler
Piet Hinoul CV
Deposition exhibits of Michael Greenberg
Deposition exhibits of Harry Johnson
Deposition exhibits of Kevin Ong
Deposition exhibits of Christina Pramudji
Deposition exhibits of Daniel Sexton
Deposition exhibits of Wenxin Zheng
Depo Ex. 1 to Kenneth R. Schoenig,M.D.deposition - CV
HUSKEYJ_EMAILS_0091 HUSKEYJ_EMAILS_0127
DX10378
DX10379
DX10380
DX10381
DX10382
Date
Huskey E-mails
Updated Plaintiff Fact Sheet
Updated Plaintiff Profile Form
Depo Ex. 12 to Jo Huskey Deposition - Photograph
Depo Ex. 14 to Jo Huskey Deposition - Facebook Page
Depo Ex. 15 to Jo Huskey Deposition - Facebook Page Exceprt (Attorney
at Law Like)
Depo Ex. 16 to Jo Huskey Deposition - E-mails
Depo Ex. 24 to Jo Huskey Deposition - Psychological Evaluation
Huskey's Illinois Workers' Compensation Claim
Page 10 of 11
Offered
Admitted
Exhibit
Date
Description
DX10383
Depo Ex. 4 to Jo Huskey Deposition - Social Security Disability Claim
DX10384
DX10385
DX10386
DX10387
DX10388
DX10389
DX10390
Patient Brochure sent to Jo Huskey from Dr. Byrkit in July 2011
Grpahics to be used at trial
TVT-O Exemplar
Photogrpah of TVT-O
Deposition exhibits of Elizabeth Kavaler
Deposition exhibits of Shelby Thames
Deposition exhibits of David Weber
Page 11 of 11
Offered
Admitted
Defendants' Master Condensed Exhibit List
Exhibit
Date
Description
DX20001
ETH.MESH.02340902 to
ETH.MESH.02340973
05/12/2010 TVT-O Instructions for Use. 5/12/2010 to Present Day
DX20002
DX20003
DX20004
ETH.MESH.09625817
ETH.MESH.09625816
ETH.MESH.09629448
ETH.MESH.09625737
ETH.MESH.09629858
ETH.MESH.09629720
ETH.MESH.09629714
ETH.MESH.09630340
ETH.MESH.09630232
ETH.MESH.09630739
ETH.MESH.09630681
ETH.MESH. 09630683
ETH.MESH.09630678
ETH.MESH.09630649
ETH.MESH.09630648
ETH.MESH.09630647
ETH.MESH. 09630640
ETH.MESH. 09630742
ETH.MESH.09630982
ETH.MESH. 09630944
ETH.MESH.09631140
ETH.MESH. 09630985
ETH.MESH.09631453
01/17/1966 Prolene NDA Submission Letter
01/19/1966 FDA Receipt Letter for Prolene NDA
DX20005
DX20006
DX20007
DX20008
DX20009
DX20010
DX20011
DX20012
DX20013
DX20014
DX20015
DX20016
DX20017
DX20018
DX20019
DX20020
DX20021
DX20022
DX20023
DX20024
03/14/1969 FDA Labeling Approval for Prolene
04/16/1969 FDA Approval Letter: NDA #16-374
10/30/1969 NDA Supplement S-001
05/08/1970 FDA Approval Letter: NDA #16-374/S-001
06/29/1970 FDA amended Approval Letter: NDA #16-374/S-001
10/28/1971 NDA Supplement S-002 (amend)
04/26/1973 FDA Letter to Ethicon
05/03/1973 NDA Supplement S-005 (letter agreeing to changes)
05/25/1973 NDA Supplement S-005 (final labeling)
07/10/1974 NDA Supplement S-007 (annual report)
Page 1 of 12
Offered
Admitted
Exhibit
DX20025
DX20026
DX20027
DX20028
DX20029
DX20030
DX20031
DX20032
DX20033
DX20034
DX20035
DX20036
DX20037
DX20038
DX20039
DX20040
DX20041
DX20042
DX20043
DX20044
DX20045
DX20046
ETH.MESH.09631401
ETH.MESH.09631389
ETH.MESH.09631467 to ETH.MESH.
09631500
ETH.MESH.09631325
ETH.MESH.09631463
ETH.MESH.09631244
ETH.MESH.09631174
ETH.MESH.09631941
ETH.MESH.09631713
ETH.MESH.09632266
ETH.MESH.09632311
ETH.MESH.09632328
ETH.MESH.09632315
ETH.MESH.09632350
ETH.MESH.09632618
ETH.MESH.09632646
ETH.MESH.09632671
ETH.MESH.09632757
ETH.MESH.09632847
ETH.MESH.09632331
ETH.MESH.09632858
ETH.MESH.09632606
Date
Description
02/26/1975 NDA Supplement S-009 (original)
05/22/1975 NDA Supplement S-009 (1st amend)
08/08/1975 NDA Supplement S-009 (2nd amend)
11/22/1977 NDA Supplement S-013 (orig.)
09/19/1978 NDA Supplement S-012 (1st amend.)
09/19/1978 NDA Supplement S-013 (amend.)
Page 2 of 12
Offered
Admitted
Exhibit
DX20047
DX20048
DX20049
DX20050
DX20051
DX20052
DX20053
DX20054
DX20055
DX20056
DX20057
DX20058
DX20059
DX20060
DX20061
DX20062
DX20063
DX20064
DX20065
DX20066
DX20067
DX20068
DX20069
ETH.MESH.09632774
ETH.MESH.09632957
ETH.MESH.09632976
ETH.MESH.09632896
ETH.MESH.09632959
ETH.MESH.09633000
ETH.MESH.09632673
ETH.MESH.09632870
ETH.MESH.09632861
ETH.MESH.09632899
ETH.MESH.09632978
ETH.MESH.09633023
ETH.MESH.09633062
ETH.MESH.09633241
ETH.MESH.09633026
ETH.MESH.09633004
ETH.MESH.09633211
ETH.MESH.09633366to
ETH.MESH.09633381
ETH.MESH.09633362
ETH.MESH.09633436
ETH.MESH.09633769
ETH.MESH.09633426
ETH.MESH.09633903
Date
Description
08/14/1979 NDA Supplement S-012 (2nd amend.)
12/28/1979
01/04/1980
02/15/1980
04/23/1980
04/23/1980
05/02/1980
NDA Supplement S-020
FDA Approval Letter: NDA #16-374/S-017
NDA Supplement S-012 (3rd amend.)
09/19/1980 NDA Supplement S-1 [1980]
10/14/1980 NDA Supplement S-2 [1980]
02/24/1983 NDA Supplement S26
02/29/1984 NDA Supplement S28 (orig.)
03/12/1984 FDA Approval Letter: NDA #16-374/S27
09/13/1984 NDA Supplement S28 (amend.)
Page 3 of 12
Offered
Admitted
Exhibit
DX20070
DX20071
DX20072
DX20073
DX20074
DX20075
DX20076
DX20077
DX20078
DX20079
DX20080
DX20081
DX20082
DX20083
DX20084
DX20085
DX20086
DX20087
DX20089
ETH.MESH.09633446
ETH.MESH.09634018
ETH.MESH.09634005
ETH.MESH.09634048
ETH.MESH.09634023
ETH.MESH.09634132
ETH.MESH.09634106
ETH.MESH.09634206
ETH.MESH.09634187
ETH.MESH.09634318
ETH.MESH.09634303
ETH.MESH.09634369
ETH.MESH.09634356
ETH.MESH.09634688
ETH.MESH.09634663
ETH.MESH.05217100
ETH.MESH.08476213
ETH.MESH.10039079
ETH.MESH.10040065
Date
Description
07/05/1990 FDA Order, July 5, 1990
10/12/1990 FDA Letter, October 12, 1990
08/09/1996 FDA Clearance Letter, Modified PROLENE
01/28/1998 FDA Clearance Letter, TVT
10/26/2001 FDA Clearance Letter, TVT-Blue
09/28/2012 FDA Updated Clearance Letter – TVT
Page 4 of 12
Offered
Admitted
Exhibit
DX20090
DX20091
DX20092
DX20093
DX20094
DX20095
DX20097
ETH.MESH.10039074
ETH.MESH.10039204
ETH.MESH.09634318
ETH.MESH.05217111
ETH.MESH.08476245
ETH.MESH.10039093
ETH.MESH.09634081
DX20098
No Bates No.
Date
Description
09/28/2012 FDA Updated Clearance Letter – TVT-Blue
09/28/2012 FDA Updated Clearance Letter – TVT-Obturator
00/00/1988 Package Insert Changes for NDA #16-374/S34
00/00/1996 Section I of Modified PROLENE 510(k)
00/00/1997 Section I of TVT 510(k)
00/00/2001 Section I of TVT-Blue 510(k)
04/16/1985-04/15/1986 Section 6 of Annual Report 1985-1986
FDA 24-Hour Summary, Obstetrics & Gynecology Devices Panel,
09/08-09/2011 September 8-9, 2011
DX20099
No Bates No.
DX20100
DX20101
DX20102
DX20103
DX20104
No Bates No.
ETH.MESH.09634703
No Bates No.
ETH.MESH.09625729
ETH.MESH.09626241
DX20105
No Bates No.
DX20106
No Bates No.
FDA Executive Summary, "Surgical Mesh for Treatment of Women with
pelvic Organ Prolapse and Stress Urinary Incontinence, Obstetrics &
09/08-09/2011 Gynecology Devices Advisory Committee Meeting, Sept. 8-9, 2011
FDA website; Medical Devices - Implants and Prosthetics; Considerations
about Surgical Mesh for SUI.
(http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/Impla
03/27/2013 ntsandProsthetics/UroGynSurgicalMesh/ucm345219.htm)
Date Unknown Prolene IND/NDA
Chart of Supplemental NDAs
Government Submissions Log Sheet
IND 1688
FDA Public Health Notice: Serious Complications Associated with
Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ
10/20/2008 Prolapse and Stress Urinary Incontinence
FDA Safety Communication: UPDATE on Serious Complications
Associated with Transvaginal Placement of Surgical Mesh for Pelvic
07/13/2011 Organ Prolapse
Page 5 of 12
Offered
Admitted
Exhibit
Date
Description
DX20107
No Bates No.
DX20108
DX20110
No Bates No.
No Bates No.
FDA Guidance on Use of International Standard ISO-10993, “Biological
evaluation of medical devices Part 1: Evaluation and Testing” issued
04/23/2013 4/23/2013.
FDA Letter to Henning re: Reclassification of Nonabsorbable
07/05/2013 Polypropylene Surgical Suture
00/00/2011 2011 Advisory Committee materials on SUI - FDA Presentation SUI
DX20111
No Bates No.
00/00/2011 2011 Advisory Committee materials on SUI - Presentation AdvaMed – SUI
DX20112
No Bates No.
DX23486
No Bates Number
DX23487
No Bates Number
00/00/2011 2011 Advisory Committee materials on SUI - SUI Briefing Book
FDA Obstetrics & Gynecology Devices Advisory Committee Meeting,
09/08/2011 Sept. 8, 2011 Transcript
FDA Obstetrics & Gynecology Devices Advisory Committee Meeting,
09/09/2011 Sept. 9, 2011 Transcript
DX23504
DX23505
DX23506
DX23507
DX23508
DX23509
DX23510
DX23546
DX23547
DX23548
ETH.MESH.00222463
ETH.MESH.01318358
ETH.MESH.00222778
ETH.MESH.01318831
ETH.MESH.00223267
ETH.MESH.01319499
ETH.MESH.01320123
ETH.MESH.07206065
ETH.MESH.03981384
ETH.MESH.02340567
Gynecare TVT-O Project Overview Memo, Flowchart, DHCC, Final
Drawings, Regulatory, Design
Gynecare TVT-Obturator Testing Development, Process Development,
Design Verification
Gynecare TVT-O Biocompatibility Testing, Stability Testing, Packaging
Assessment-Qualification
Gynecare TVT-Obturator Sterilization Validation
Gynecare TVT-Obturator Design Validation, Clinical Assessment, Design
Reviews, Process Reviews, Design Transfer, Meeting
Gynecare TVT-Obturator Helical Passers + Winged Guide - Process
Validation Strategy and Process Documentation
Gynecare TVT-O Mediline (Plastic Tube and Mesh Attachment) - Process
Validation Strategy and Process Documentation
Clinical Evaluation Report for Gynecare TVT Obturator System Tension08/06/2010 free Support for Incontinence
J&J Law Department Document Preservation Notice - February 18, 2011
02/18/2011
TVT IFU
Page 6 of 12
Offered
Admitted
Exhibit
DX23550
DX23552
Description
TOMUS Satisfaction Study for Wai Patient Satisfaction After Midurethral
Sling Surgery for Stress Urinary Incontinence (D31549)
DX23549
DX23551
Date
ETH.MESH.09922578
Advanced Urogynecology of Michigan PC: Pelvic Organ Prolapse/Urinary
Incontinence Sexual Function Questionnaire (PISQ-12) (D31669)
R&D Memorandum on PA Mesh Assessments for TVTO-PA from Katrin
12/12/2012 Elbert
ETH.MESH.00573895
ETH.MESH.00525421
01/22/2010 SCION PA/SUI Treatment Unmet Needs Exploratory Research PowerPoint
Gynecare TVT Obturator System: Anatomic path associated with the
"inside-out" obturator approach
Gynecare TVT Obturator System: Anatomic path associated with the
"inside-out" obturator approach (Color Native Copy of
ETH.MESH.00525402 to ETH.MESH.00525421)
ETH.MESH.05217144
ETH.MESH.08476342
ETH.MESH.07877006
510(k) Notification and clearance letter for Modified Prolene*,
06/25/1996 Nonabsorbable Synthetic Mesh, 510(k) K962530; for hernia repair
01/28/1998 Tension Free Vaginal Tape (TVT) System 510(k) Notification Cleared:
January 28, 1998, K974098
12/08/2003 Document entitled "Modified Gynecare TVT Obturator System Special
510(k),"
DX20203
No Bates No.
National Institute for Clinical Excellence (NICE) – Final Appraisal
Determination – Tension-free vaginal tape (Gynecare TVT) for stress
01/17/2003 incontinence.
DX20204
DX20205
DX20206
No Bates No.
ETH.MESH.08158397
No Bates No.
DX20207
No Bates No.
DX20208
DX20209
No Bates No.
No Bates No.
DX23553
DX23554
DX20124
DX20128
DX23375
07/13/2011 AUGS website – Mesh Information for Patients with Pelvic Floor Disorders
AUGS Position Statement on the Restriction of Surgical Options for Pelvic
03/26/2013 Floor Disorders
11/13/2013 AUGS: FPMRS Subspecialty Certification
2011 AUA Position Statement on the Use of Vaginal Mesh for the Surgical
00/00/2011 Treatment of Stress Urinary
AUGS Position Statement on Restriction of Surgical Options for Pelvic
00/00/2013 Floor Disorders
02/00/2012 AUA 2012 Position Statement on use of mesh
Page 7 of 12
Offered
Admitted
Exhibit
Date
Description
AUGS launched informed consent information on their website
http://www.augs.org/p/bl/et/blogid=6&blogaid=43 and
02/00/2012 www.augs.org/informedconsent
DX20210
No Bates No.
DX20211
DX20212
No Bates No.
No Bates No.
DX20213
No Bates No.
DX20214
No Bates No.
DX20215
No Bates No.
DX20216
DX20217
DX20218
No Bates No.
No Bates No.
No Bates No.
03/00/2013 2013 March - AUGS Position Statement on Restrictions of Surgical Options
09/00/2013 NICE: September 2013 statement
AUA Position Statement on the Use of Vaginal Mesh for the Surgical
11/00/2011 Treatment of Stress Urinary Incontinence
11/00/2011 Treatment of Stress Urinary Incontinence (November 2011)
ACOG Committee Opinion. Innovative Practice: Ethical Guideliens.
12/00/2006 Obstetrics & Gynecology, 2006;108(6):1589-1595
EAU Guidelines on Surgical Treatment of Urinary Incontinence, Eur.
Date Unknown Urology 62 (2012) 1118-1129
Date Unknown NICE Guideline 1.10.3, n.11
1/3/2014 AUGS Position Statement on Midurethral Slings for SUI
DX20219
DX20220
DX20221
No Bates No.
No Bates No.
No Bates No.
British Association of Urological Surgeons - Synthetic Vaginal Tapes for
No date Stress Incontinence (Procedure-Specific Information for Patients)
07/00/2013 ICS Fact Sheets - A Background to Urinary and Faecal Incontinence
00/00/2011 IUGA - Stress Urinary Incontinence (A Guide for Women)
DX20222
DX20223
DX20224
DX22013
No Bates No.
No Bates number
No Bates number
No Bates No.
09/09/2010 FDA Perspective on Surgical Mesh for Stress Urinary Incontinence (SUI)
00/00/2013 2013 AUA SUI Patient Guide
00/00/2011 Stress Urinary Incontinence Monograph by AUA Foundation
ADCOM submission on SUI mesh. Submission to FDA for the 9/8/2011
Ad Com meeting by the TVM working group for stress urinary
08/30/2011 incontinence
DX22017
DX22020
No Bates No.
No Bates number
AdCom SUI Briefing Book (8.30.2011) Docket Submission to the
September 8 and 9, 2011 Obstetrics and Gynecology Devices Panel of the
Medical Devices Advisory Committee: Safety and Effectiveness of
09/09/2011 Surgical Mesh for the Treatment of Stress Urinary Incontinence.
09/09/2011 Obstetrics and Gynecology Medical Devices Panel Transcript Excerpt,
September 9, 2011, 11 pages
Page 8 of 12
Offered
Admitted
Exhibit
Date
Description
Guideline for the Surgical Management of Female Stress Urinary
00/00/2012 Incontinence (2012 update to the 2009 Guideline)
DX23538
DX23540
Guideline for the Surgical Management of Female Stress Urinary
00/00/2012 Incontinence (2012 update to the 2009 Guideline) (Condensed Version)
AUGS - SUFU Frequently Asked Questions by Patients; Mid-urethral
03/12/2014 Slings for Stress Urinary Incontinence
AUGS - SUFU Frequently Asked Questions by Patients; Mid-urethral
03/12/2014 Slings for Stress Urinary Incontinence
DX23541
AUGS and SUFU Release FAQ documents for Patients and Providers on
03/12/2014 Mesh Midurethral Slings for SUI; By: Charles W. Nager, M.D.
DX23585
AUGS Committee Opinion regarding Evaluation of Uncomplicated Stress
06/00/2014 Urinary Incontinence in Women Before Surgical Treatment
DX23586
IUGA Position Statement on Mid-Urethral Slings for Stress Urinary
07/00/2014 Incontinence
DX23587
RANZCOG & UGSA Supports the Use of Mid-Urethral Slings in the
03/24/2014 Surgical Management of Female Stress Urinary Incontinence
DX23591
DX23539
DX20603
DX20604
DX20605
DX20606
DX20607
DX20608
DX23501
DX23502
DX23503
DX21688
Summary of Pre-Clinical Studies
Summary of Long-Term Studies
Summary of "Gold Stanard" Studies
Summary of TVT RCTs
Summary of Industry Guideline Statements
Summary of TVT Clinical Studies from 1998-2000
Summary of 63 TVT-O RCTs
Summary of TVT Long-term Studies Prior to Launch of TVT-O
Summary of TVT-O Long-term Studies
ETH.MESH.08003294
Ethicon Copy Review Submission form: GYNECARE TVT Family of
12/10/2008 Products Patient Brochure
Page 9 of 12
Offered
Admitted
Exhibit
DX23542
DX23588
DX20747
DX23293
DX20658
Description
ETH.MESH.08003318
ETH.MESH.08003302
TVT, TVT-O & TVT Secur Patient Brochure (Copy Approved:
01/26/2011 01/26/2011)
TVT, TVT-O, TVT Secur, TVT Exact and TVT-Abbrevo Patient Brochure
00/00/2011 (Copy Approved: 2011)
ETH.MESH.03932914
ETH.MESH.03932911
07/12/2000 Axel Arnaud - The history of TVT.
ETH.MESH.08156958
PowerPoint presentation entitled "GYNECARE TVT Tension-free Support
for Incontinence, Advanced Users Forum for the Experienced Clinician"
09/24/2002 Prof. Ed. Slide Deck (2002-310)
07/19/1996 Ethicon Corporate Product Characterization Product Safety Profile
DX20557
DX20639
Date
ETH.MESH.04447142
ETH.MESH.08218350
ETH.MESH.08218336
1/16/2007 Axel Arnaud "History of TVT-O" document
10/01/1997 Document from R&D Ethicon Germany "Literature Review on
Biocompatibility of Prolene Sutures and Implants"
10/01/1997 Ethicon memo to from Thomas A. Barbol to G. Robertson regarding
Biocompatibility Risk Assessment for PROLENE* Polypropylene Mesh
DX20659
DX20702
ETH.MESH.5315295
ETH.MESH.05316812
06/16/1999 Ethicon document dated 6/16/1999 "GLP Archives PSE Acc No. 97-0197"
ETH.MESH.00526474
ETH.MESH.00133232
05/06/2005 E-mail from Allison London Brown to Nancy Leclair, Dharini Amin, et al.
regarding Laser cut Mesh; cc: Kevin Mahar, et al.
11/25/2005 E-mail chain, top one from Martin Weisberg to Dharini Amin, Patricia
Hojnoski, Carolyn Brennan, et al. regarding Change Request: Updated
TVT and TVT-O Complication Rates 11-5-05; cc: Price St. Hilaire and
Kevin Mahar
11/29/2005 E-mail chain, top one from Dan Smith to Patricia Hojnoski and Martin
Weisberg regarding Updated TVT and TVT-O complication rates 11-1505; cc: Gary Borkes, Raimo Sump, and Naomi Sinclair
01/16/2006 E-mail chain, top one from Dharini Amin to David Robinson, Kevin
Mahar, and Price St. Hilaire regarding: Gynecare TVT Latest Complication
Data
03/05/2003 Ethicon document "REPORT. PSE Accession N. 02-0579, Project No
48010, "Histological Evaluation and Comparison of Mechanical Pull Out
Strength of Prolene Mesh and Prolene Soft mesh in a Rabbit Model"
DX20928
DX21231
DX21286
ETH.MESH.03714034
DX21287
ETH.MESH.00692885
DX21310
Page 10 of 12
Offered
Admitted
Exhibit
ETH.MESH.00477387
Date
Description
7/14/2006 PowerPoint presentation entitled "2007 Professional Education Plan,
ETHICON, ETHICON Products, ETHICON Women's Health and Urology,
Johnson and Johnson Wound Management," July 14, 2006,
DX21409
DX21410
DX21629
DX22093
DX22105
ETH.MESH.00311810
ETH.MESH.00164648
ETH.MESH.06773542
ETH.MESH.06772949
ETH.MESH.07277696
DX22108
DX22109
DX22163
DX22372
ETH.MESH.06774030
ETH.MESH.02134273
ETH.MESH.03738470
ETH.MESH.01218019
07/20/2006 E-mail chain, regarding TVT data McNelis, Linda
09/25/2008 TVT sales piece
07/04/2012 E-mail string, top one from Marjorie Eley to Daniel Lamont regardint TVT
MDV? - 10100156899
08/08/2012 PowerPoint, "PMS Staff Meeting, Dan Lamont,"
09/07/2012 Work Instruction, Quality System, Franchise Work Instructions for
Summary and Individual Medical Device Reporting PR551-006, Rev: 31,
Released: 07 Sep 2012, CO: 100047158
Franchise Procedure for Post Market Surveillance (PMS), Document Name
09/25/2012 (#): PR-0000385, Revision: 4
Draft memo from Thomas Barbolt to M. Rippy re: Mechanisms of
00/00/1998 Cytotoxicity for TVT Polypropylene Mesh
09/05/2003 - 09/06/2003 E-mail string, top one from Martin Weisberg to Marianne Kaminski
regarding TVT Response for Peggy Norton, M.D.
No Date Document entitled "Design FMEA TVT LCM Project"
DX22966
DX23010
DX23025
DX23052
DX23124
DX23149
DX23215
DX23227
ETH.MESH.06772879
ETH.MESH.08334245
ETH.MESH.03544696
ETH.MESH.00316783
No Bates number
ETH.MESH.05316097
No Bates number
No Date Franchise Procedure for Post Market Surveillance, Document Name (#):
PR-0000385, Revision: 5
No Date LCM Project, Photograph Comparing Laser Cut Mesh v. Mechanical Cut
Mesh
No Date Packet of organizational charts, 19 pages
No Date TVT Literature Search Review Summary - Deviation from normal
complaint process
Part 803 - Medical Device Reporting, 17 pages
04/10/2000 Protocol, PSE ACCESSION NO.00-0035 An Exploratory 91-Day Tissue
Reaction Study of Soft Prolene Mesh (3.5 mil Construction) and Vypro II
Mesh in Rats (PSE ACC. NO.00-0035)
No Date Deposition Subject Matter
Page 11 of 12
Offered
Admitted
Exhibit
DX23408
ETH.MESH.00302392
DX23419
ETH.MESH.06924643
Date
Description
02/23/2006 Memo from Dan Lamont to DHF0000176 regarding TVT-Base & TVT-O
Complaint Review for Laser Cut Mesh (LCM) Risk Analysis
09/01/2010 Memorandum from J. Javier Briceno and Aaron Kirkemo to DHF0000978 TOPA regarding Preliminary Risk Analysis for TVT-O PA
No Date Gynecare TVT SECUR System Professional Education Program
Opportunities, Consider -- Proper Targeting, Course Effectiveness, & Costs
DX23498
ETH.MESH.05795106
ETH.MESH.02189935
09/07/2007 E-mail chain from Vincenza Zaddem to Dr. Dieter Engel; cc: Christophe
Mauge, Clifford Volpe regarding Info needed for FDA - Lightning
ETH.MESH.01822363
10/18/2006 E-mail string, top one from Dan Smith to Harel Gadot, Marcia Snyman, et
al. regarding TVT SECUR; cc: Clifford Volpe, et al.
DX23499
DX23500
DX23201
DX23202
DX22433
ETH.MESH.08307645
ETH.MESH.10179216
Piet Hinoul's CV
Email attaching spreadsheet of RCT Data until 11/2012 on TVT-O and
04/05/2013 TVT
Date Unknown CER TVT Family of Products
DX20630
ETH.MESH.00371573
DX23282
DX20889
DX20905
ETH.MESH.00409663
ETH.MESH.00409669
ETH.MESH.00409665
DX20916
DX23291
DX23292
DX23295
DX23296
ETH.MESH.05453727
No Bates Number
No Bates Number
ETH.MESH.01219994
Tension-Free Vaginal Tape Procedure for USI – A Preliminary Report. By
08/07/1987 Alex Wang. This study was included in the TVT 510k submission
Reynaldo Librojo's CV
TVT Customer Initiated Research Grant Request submitted by Alex Wang
10/08/2002
E-mail string from Alex Wang to Mark Sumeray in regards to Alex Wang's
11/15/2002 proposal
E-mail string from Marty Chomiak to Amy Godwin, et al in regards to Dr.
12/19/2002 Wang's Study Agreement
10/15/1992 Seven Year Data for Ten Year Prolene Study: ERF 85-219
Boston Scientific Xenform Product Page
AUA Guideline for the Surgical Management of Female Stress Urinary
00/00/2009 Incontinence: Update (2009)
Completion Report for the Design Verification of TVT Laser Cut Mesh
03/20/2006 (CPC-2006-0014)
Page 12 of 12
Offered
Admitted
ATTACHMENT C
Case 2:12-cv-05201 Document Defendants'
320-3 Case-Specific
Filed 08/04/14
Page 2 of 318 PageID #: 14193
Exhibit List
Exhibit
DX10001
DX10002
DX10003
DX10004
DX10005
DX10006
DX10007
DX10008
DX10009
DX10010
DX10011
HUSKEYJ-ABMC-BIL00001-00012
HUSKEYJ-ABMC-PAT00001-00002
HUSKEYJ-AUSH-INS00001-00229
Date
Description
A&E Behavioral HC
Accelerated Physical Therapy
Advanced Women’s Healthcare
Advocate BroMenn Medical Center
Aetna
Carle
Carle Clinic
Carol Jo Veecchie Women’s and Children’s Center
There is no exhibit DX10009.
Christie Clinic
Page 1 of 12
Offered
Admitted
320-3 Case-Specific
Filed 08/04/14
Exhibit List
Exhibit
DX10012
DX10013
DX10014
DX10015
DX10016
DX10017
DX10018
DX10019
DX10020
DX10021
DX10022
DX10023
HUSKEYJ_IPSSI_MDR00018 -00046
HUSKEYJ-KIMC-BIL00001-00025
HUSKEYJ-LUMC-PAT00001-00001
HUSKEYJ-LOUMC-MDR00001-00005
HUSKEYJ-MLLCN-MDR00001-00001
HUSKEYJ-MFPC-MDR00001-00001
Date
Description
Decatur Memorial Hospital
Decatur Neurosurgery Associated
Digestive Disease Consultants
Institute for Plastic Surgery at SIU
Internal Medicine Subspecialty Associates
Kirby Medical Center
Loyola University Medical center
McLean County Neurology
Millennium Pain Center
Osborne, Larry, D.M.D.
Page 2 of 12
Offered
Admitted
320-3 Case-Specific
Filed 08/04/14
Exhibit List
Exhibit
DX10024
DX10025
DX10026
DX10027
DX10028
DX10029
DX10030
DX10031
DX10032
DX10033
DX10034
DX10035
DX10036
HUSKEYJ-OSJMC-MDR00001-00003
HUSKEYJ-OSJMC-BIL00001-00001
HUSKEYJ-OSJMC-PAT00001-00001
HUSKEYJ-PERSC-INS00001-00003
HUSKEYJ-PRAC-MDR00001-00004
HUSKEYJ-SSID-MDR00001-00166
HUSKEYJ-SCD-MDR00001-00263
HUSKEYJ-SJOHH-BIL00001-00004
HUSKEYJ-SJOHH-PAT00001-00001
HUSKEYJ-SMARH-BIL00001-00045
HUSKEYJ-SMARH-EMP00001-00069
HUSKEYJ-SMARH-EMP00001-00080(rebates)
Date
Description
OSF Medical Group
OSF St. Joseph Medical Center
Personal Care
Prairie Cardiovascular
Raino, William H., M.D.
Siddique, Sohail A., M.D.
Simmons Cancer Institute at SUI
SIU School of Medicine and Healthcare Department of Obstetrics &
Gynecology
SSA
Springfield Memorial Hospital Medical Center
St. John’s Hospital
St. Mary’s Hospital
St. Mary’s Hospital Employment Records
Page 3 of 12
Offered
Admitted
320-3 Case-Specific
Filed 08/04/14
Exhibit List
Exhibit
DX10037
DX10038
DX10039
DX10040
DX10041
DX10042
DX10043
DX10044
DX10045
DX10046
DX10047
DX10048
DX10049
DX10050
DX10051
DX10052
DX10053
DX10054
DX10055
DX10056
DX10057
DX10058
DX10059
DX10060
DX10061
DX10062
DX10063
DX10064
DX10065
DX10066
DX10067
DX10068
DX10069
DX10070
DX10071
Date
Description
HUSKEYJ-WHCSD-MDR00001-00068
HUSKEYJ-MEMMC-BIL00001-00004
HUSKEYJ-MEMMC-MDR0001-00821
HUSKEYJ-CARPG-MDR00001-00408
HUSKEYJ-SUPP-BIL00001-00001
HUSKEYJ_LERCC_LEG00001 HUSKEYJ_LERCC_LEG00822
ETH.MESH.02340902 - ETH.MESH.02340908
HUSKEYJ_DECMH_MDR00038
Wal-Mart
Walgreen
Ward, Terry A., D.C.
Women’s Health Care Specialists of Decatur
Yorks, Brian C., M.D.
Carle Physician Group
SuperValu Pharmacy
The Hartford Insurance Company
HSUKEYJ_TAXDOCS_0001 - HUSKEYJ_TAXDOCS_0079
9/6/2012
3/15/2014
1997
1997
1997
1997
1998
1998
1998
1998
1998
1998
1999
1999
1999
1999
1999
2000
Jo Huskey Divorce File
TVT-O IFU
TVT-O Implant Sticker
Plaintiff Fact Sheet
Plaintiff Profile Form
Plaintiff Journal
Plaintiff Tax documents
Complaint
Plaintiffs' Response to Ethicon, Inc. and Johnson & Johnson's First Setof
Interrogatories
Naproxen 500 mg
Synthroid
Tylenol - OTC
Axid
Axid
Synthroid
Propulsid
Lorabid
Bentyl
Claritin
Augmentin
Doxycycline
Zyban
Antivert
Allegra
Vioxx
Page 4 of 12
Offered
Admitted
320-3 Case-Specific
Filed 08/04/14
Exhibit List
Exhibit
DX10072
DX10073
DX10074
DX10075
DX10076
DX10077
DX10078
DX10079
DX10080
DX10081
DX10082
DX10083
DX10084
DX10085
DX10086
DX10087
DX10088
DX10089
DX10090
DX10091
DX10092
DX10093
DX10094
DX10095
DX10096
DX10097
DX10098
DX10099
DX10100
DX10101
DX10102
DX10103
DX10104
DX10105
DX10106
DX10107
DX10108
DX10109
DX10110
DX10111
DX10112
DX10113
DX10114
DX10115
DX10116
DX10117
Date
Description
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2001
2001
2001
2001
2001
2001
2001
2002
2002
2002
2002
2002
2002
2002
2002
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2006
2006
2006
2006
2006
2007
Pred
Bentyl
Zantac
Ultram
Oxycontin
Valium
Vistaril
Robaxin
Proventil
Paxil
Keflex
Z-pak
Ambien
Sudafed
Levoxyl
Ceftin
Albuterol
Diflucan
Zantac
Benadryl
Amoxicillin
Protonix
Levoxyl
Celebrex
Bextra
Skelaxin
Doxycycline
Ibuprofen
Anthrotrec
Lortab
Protonix
Levoxyl
Vicodin
Nexium
Biaxin XL
Pred
Naproxen
Bentyl
Zithromax
Advair
Levoxyl
Protonix
Reglan
Midrin
Percocet
Melatonin
Page 5 of 12
Offered
Admitted
320-3 Case-Specific
Filed 08/04/14
Exhibit List
Exhibit
DX10118
DX10119
DX10120
DX10121
DX10122
DX10123
DX10124
DX10125
DX10126
DX10127
DX10128
DX10129
DX10130
DX10131
DX10132
DX10133
DX10134
DX10135
DX10136
DX10137
DX10138
DX10139
DX10140
DX10141
DX10142
DX10143
DX10144
DX10145
DX10146
DX10147
DX10148
DX10149
DX10150
DX10151
DX10152
DX10153
DX10154
DX10155
DX10156
DX10157
DX10158
DX10159
DX10160
DX10161
DX10162
DX10163
Date
Description
2007
2007
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
Naproxen
Amoxicillin
AZO standard - OTC
Amoxicillin
Cipro
Xifaxan
Vagifem
Azithromycin
Nexium
Levothyroxine
Syntrhroid [levothyroxine]
Cytomel [liothyronine]
Zyrtec
Soma
Proair inhaler
Nexium
Proventil inhaler
SMZ/TMP [Bactrim]
Synthroid
Pyridium [Phenazopyridine]
Cleocin 2% cream [clindamycin vaginal cream]
Naproxen
Effexor [venlafaxine]
Mobic
Penicillin K
Azithromycin
Effexor
Prozac [fluoxetine]
Zyrtec-D [cetirizine]
Bactrim DS
Synthroid
Azithromycin
Zegerid
Melatonin
Ambien [Zolpidem]
Ibuprofen
Page 6 of 12
Offered
Admitted
320-3 Case-Specific
Filed 08/04/14
Exhibit List
Exhibit
DX10164
DX10165
DX10166
DX10167
DX10168
DX10169
DX10170
DX10171
DX10172
DX10173
DX10174
DX10175
DX10176
DX10177
DX10178
DX10179
DX10180
DX10181
DX10182
DX10183
DX10184
DX10185
DX10186
DX10187
DX10188
DX10189
DX10190
DX10191
DX10192
DX10193
DX10194
DX10195
DX10196
DX10197
DX10198
DX10199
DX10200
DX10201
DX10202
DX10203
DX10204
DX10205
DX10206
DX10207
DX10208
DX10209
Date
Description
2011
2011
2011
2011
2011
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
Fluticasone
Hydrocodone/APAP
Pencillin K
Acetaminophen w/codeine #3 [Tylenol #]
Prozac
Vicodin
Dicyclomine
Aleve
Benadryl
Synthroid
Cymbalta
Tramadol [nucynta]
Nitro-bid 2% vaginal ointment
Omeprazole [Prilosec]
Amoxicillin
Zantac [ranitidine]
Protonnix [Pantoprazole]
Meclizine [nivert]
Hydrocodone
Amitriptyline
Zyrtec-D
Pred
Amitriptyline
Cymbalta
Synthroid
Zyrtec D
Tramadol
Gabapentin
Vaginal valium
Naproxen
Ponstel
Nortriptyline
Azithromycin
K Clavulanate
Acetaminophen w/ codeine #3 [Tylenol #3]
Trazodone [Desyrel]
Alprazolam [Xanax]
Doxycycline
Page 7 of 12
Offered
Admitted
320-3 Case-Specific
Filed 08/04/14
Exhibit List
Exhibit
DX10210
DX10211
DX10212
DX10213
DX10214
DX10215
DX10216
DX10217
DX10218
DX10219
DX10220
DX10221
DX10222
DX10223
DX10224
DX10225
DX10226
DX10227
DX10228
DX10229
DX10230
DX10231
DX10232
DX10233
DX10234
DX10235
DX10236
DX10237
DX10238
DX10239
DX10240
DX10241
DX10242
DX10243
DX10244
DX10245
DX10246
DX10247
DX10248
DX10249
DX10250
DX10251
DX10252
DX10253
Date
Description
2014
2014
2014
2014
2014
2014
2014
2014
2014
2014
2014
2014
2014
2014
2014
HUSKEYJ_EMAILS_0001 - HUSKEYJ_EMAILS_0092
Dilaudid
Tramadol ER
Synthroid
Fluticasone
Nortriptyline
Amoxicillin
Hydrocodone/APAP
Tizanidine
Nitrostat
Cephalexin
Amoxicillin K Clavulanate
Proair inhaler
Depo Ex. 1 to Gretchen L. Byrkit, M.D. deposition - TVT Patient
Brochure "Stop Coping, Start Living"
Depo Ex. 2 to Gretchen L. Byrkit, M.D. deposition - CV
5/22/2011 Various email strings between Jo Huskey and others
Depo Ex. 2 to Gretchen Dean deposition - CV
Depo Ex. 10 to Gretchen Dean deposition - Subjective and Objective
Findings - Therapy for Jo Beth Marshall
Page 8 of 12
Offered
Admitted
Case 2:12-cv-05201 Document 320-3
Filed 08/04/14 Page 10 of 318 PageID #: 14201
Defendants' Case-Specific Exhibit List
Exhibit
DX10254
DX10255
DX10256
DX10257
DX10258
DX10259
DX10260
DX10261
DX10262
DX10263
HUSKEY_HARTFORD_SUBPOENA_00199 HUSKEY_HARTFORD_SUBPOENA_00200
DX10264
DX10265
DX10266
DX10267
Date
Description
Depo Ex. 4 to Colleen M. Fitzgerald, M.D. deposition - CV
Depo Ex. 10 to Colleen M. Fitzgerald, M.D. deposition - Attending
4/6/2013 Physician's Statement of Continued Disability
7/22/2008 Depo Ex. 2 to James J. Harms, M.D. deposition - CV
2/23/2011 Depo Ex. 3 to Jo Huskey deposition - Byrkit notes - initial surgery date
DX10270
DX10271
DX10272
ETH.MESH.03472794
ETH.MESH.07949530 - ETH.MESH.07949536
10/00/2008
DX10273
ETH.MESH.08041899 - ETH.MESH.08041900
10/14/2010
DX10274
ETH.MESH.07975392
DX10275
ETH.MESH.07954016 - ETH.MESH.07954017
3/17/2009
DX10276
ETH.MESH.07949421 - ETH.MESH.07949422
1/5/2012
DX10277
DX10278
ETH.MESH.07949444 - ETH.MESH.07949446
8/8/2011
DX10279
ETH.MESH.07949397
3/12/2012
DX10280
DX10281
ETH.MESH.07949452 - ETH.MESH.07949453
9/13/2011
DX10282
ETH.MESH.08039431 - ETH.MESH.08039639
DX10283
ETH.MESH.00658058 - ETH.MESH.00658065
Depo Ex. 4 to Jo Huskey deposition - SSA Internet Application Summary
Depo Ex. 5 to Jo Huskey deposition - Jesus Calling by Sarah Young
Depo Ex. 2 to Michelle M. Irvin deposition - CV
Depo Ex. 3 to Michelle M. Irvin deposition - Redacted CV (first page
only)
Depo Ex. 4 to Michelle M. Irvin deposition - FDA website "Information
on Surgical Mesh for POP and SUI"
Depo Ex. 5 to Michelle M. Irvin deposition - Memo to EWHU Team re
FDA Public Health Notification
Depo Ex. 6 to Michelle M. Irvin deposition - General Incontinence
Depo Ex. 8 to Michelle M. Irvin deposition - Defendants' Fact Sheet
Depo Ex. 9 to Michelle M. Irvin deposition - Email from Irvin to Irvin re:
Depo Ex. 10 to Michelle M. Irvin deposition - TVT-O v. Monarc study
design
Depo Ex. 11 to Michelle M. Irvin deposition from Irvin to Talbott re +M
Mondays
Depo Ex. 12 to Michelle M. Irvin deposition - email from Taylor to Pagel,
etal. Re : FDA Mesh Correspondence on 1/3/12
Depo Ex. 13 to Michelle M. Irvin deposition - email from Tan to Parker,
et al. re: Your Signature on FDA Submission
Product Complaint
Depo Ex. 16 to Michelle M. Irvin deposition - email from Irvin to Maker,
et al. re This Evenings FDA Call re: Internal Use Only
Depo Ex. 18 to Michelle M. Irvin deposition - Gynecare TVT Family of
Products
Depo Ex. 20 to Michelle M. Irvin deposition - Only Gynecare TVT Has
Long-term Results You Can See…brochure
DX10284
ETH.MESH.00161953 - ETH.MESH.00161954
Deppo Ex. 21 to Michelle M. Irvin deposition - pages from TVT-O IFU
ETH.MESH.08033628 - ETH.MESH.08033629
DX10268
DX10269
Page 9 of 12
Offered
Admitted
Exhibit
Date
Description
DX10285
ETH.MESH.00169748 - ETH.MESH.00169751
DX10286
ETH.MESH.00658430 - ETH.MESH.00658431
DX10287
ETH.MESH.08033400 - ETH.MESH.08033467
DX10288
DX10289
DX10290
ETH.MESH.07954580 - ETH.MESH.07954586
2/18/2011
DX10291
DX10292
DX10293
DX10294
DX10295
ETH.MESH.08041927 - ETH.MESH.08041928
12/7/2010
DX10296
DX10297
DX10298
DX10299
DX10300
HUSKEYJ-EMAILS_0059
DX10301
DX10302
DX10303
2/8/2013
5/13/1999
DX10304
DX10305
DX10306
DX10307
DX10308
DX10309
DX10310
DX10311
DX10312
DX10313
DX10314
DX10315
DX10316
DX10317
DX10318
HUSKEY_HARTFORD_SUBPOENA_00414HUSKEY_HARTFORD_SUBPOENA_00416
12/1/2012
Depo Ex. 22 to Michelle M. Irvin deposition - TVT and TVT-O sales
materials
Depo Ex. 23 to Michelle M. Irvin deposition - TVT Family of Products
sales materials
Depo Ex. 24 to Michelle M. Irvin deposition - TVT Professional
Education
Depo Ex. 25 to Michelle M. Irvin deposition - email from Kelly to
Byerly, et al re GMD Help
Depo Ex. 4 to Elizabeth Mueller deposition - CV
Depo Ex. 6 to Dele Ogunleye deposition - email from Huskey to
Davidson re: Hey Chick
Depo Ex. 8 to Dele Ogunleye deposition - CV
Depo Ex. 1 to Kenneth R. Schoenig, M.D. deposition - CV
Depo Ex. 2 to Ruth E. Teel, M.A. deposition - CV
Depo Ex. 7 to Ruth E. Teel, M.A. deposition - Global Assessment of
Functioning (GAF) Scale
Depo Ex. 1 to Dr. Terry A. Ward deposition - CV
Depo Ex. 3 to Dr. Terry A. Ward deposition - Office Notes
Depo Ex. 6 to Dr. Terry A. Ward deposition - New Patient Information
Form
Depo Ex. 3 to Dr. Brian Yocks deposition - Fax from Yocks attaching
Attending Physician's Statement of Functionality
Jerry G. Blaivas, M.D. FACS CV
All materials reviewed by Jerry G. Blaivas, M.D. FACS and Deposition
Exhibits
Vladimir Iakovlev CV
All materials reviewed by Vladimir Iakovlev and Deposition Exhibits
Abhay Pandit, Ph.D. CV
All materials reviewed by Abhay Pandit Ph.D. and Deposition Exhibits
Bruce A. Rosenzweig, M.D. CV
All materials reviewed by Bruce A. Rosenzweig, M.D. and Deposition
Exhibits
John F. Steege CV
All materials reviewed by John F. Steege and Deposition exhibits
Erin Teeter Carey, M.D. MSCR CV
All materials reviewed by Erin Teeter Carey, M.D. and Deposition
Exhibits
Page 10 of 12
Offered
Admitted
Exhibit
DX10319
DX10320
DX10321
DX10322
DX10323
DX10324
DX10325
DX10326
DX10327
DX10328
DX10329
DX10330
DX10331
DX10332
DX10333
DX10334
DX10335
DX10336
DX10337
DX10338
DX10339
DX10340
DX10341
DX10342
DX10343
DX10344
DX10345
DX10346
DX10347
DX10348
DX10349
DX10350
DX10351
DX10352
DX10353
DX10354
DX10355
DX10356
DX10357
DX10358
DX10359
DX10360
DX10361
Date
Description
Howard C. Jordi, Ph.D. CV
All materials reviewed by Howard C. Jordi, Ph.D.
Aditya Kulkarni CV
All materials reviewed by Aditya Kulkarni
Uwe Klinge CV
All materials reviewed by Uwe Klinge
Thomas Muehl CV
All materials reviewed by Thomas Muehl
Russell F. Dunn, Ph.D., P.E. CV
All materials reviewed by Russell F. Dunn, Ph.D., P.E. and Deposition
Exhibits
Scott A. Guelcher, Ph.D. CV
All materials reviewed by Scott A. Guelcher, Ph.D. and Deposition
Exhibits
David W. Epperly MBA, CPA, ABV, CCF, CVA CV
All materials reviewed by David W. Epperly MBA, CPA, ABV, CCF,
CVA and Deposition Exhibits
Bernd Klosterhafen CV
All materials reviewed by Bernd Klosterhafen
Thomas Barocci CV
All materials reviewed by Thomas Barocci
Dan Schultz CV
All materials reviewed by Dan Schultz
Timothy Ulatowski CV
All materials reviewed by Timothy Ulatowski
Wenxin Zheng CV
All materials reviewed by Wenxin Zheng
David Weber CV
All materials reviewed by David Weber
Daniel Sexton CV
All materials reviewed by Daniel Sexton
Michael Greenberg CV
All materials reviewed by Michael Greenberg
Kevin Ong CV
All materials reviewedby Kevin Ong
Shelby Thames CV
All materials reviewed by Shelby Thames
Larry Sirls CV
All materials reviewed by Larry Sirls
Christina Pramudji CV
All materials reviewed by Christina Pramudji
Harry Johnson CV
All materials reviewed by Harry Johnson
Denise Elser CV
All materials reviewed by Denise Elser
Elizabeth Kavaler CV
Page 11 of 12
Offered
Admitted
Exhibit
DX10362
DX10363
DX10364
DX10365
DX10366
DX10367
DX10368
DX10369
DX10370
DX10371
DX10372
DX10373
DX10374
DX10375
DX10376
DX10377
Description
All materials reviewed by Elizabeth Kavaler
Piet Hinoul CV
Deposition exhibits of Michael Greenberg
Deposition exhibits of Harry Johnson
Deposition exhibits of Kevin Ong
Deposition exhibits of Christina Pramudji
Deposition exhibits of Daniel Sexton
Deposition exhibits of Wenxin Zheng
Depo Ex. 1 to Kenneth R. Schoenig,M.D.deposition - CV
DX10378
DX10379
DX10380
DX10381
DX10382
Date
Huskey E-mails
Updated Plaintiff Fact Sheet
Updated Plaintiff Profile Form
Depo Ex. 14 to Jo Huskey Deposition - Facebook Page
Depo Ex. 15 to Jo Huskey Deposition - Facebook Page Exceprt (Attorney
at Law Like)
Depo Ex. 24 to Jo Huskey Deposition - Psychological Evaluation
Huskey's Illinois Workers' Compensation Claim
DX10383
Depo Ex. 4 to Jo Huskey Deposition - Social Security Disability Claim
DX10384
DX10385
DX10386
DX10387
DX10388
DX10389
DX10390
Patient Brochure sent to Jo Huskey from Dr. Byrkit in July 2011
Grpahics to be used at trial
TVT-O Exemplar
Photogrpah of TVT-O
Deposition exhibits of Elizabeth Kavaler
Deposition exhibits of Shelby Thames
Deposition exhibits of David Weber
Page 12 of 12
Offered
Admitted
Defendants' Master Exhibit List
Exhibit
Date
Description
DX20001
ETH.MESH.02340973
05/12/2010 TVT-O Instructions for Use. 5/12/2010 to Present Day
DX20002
DX20003
DX20004
ETH.MESH.09625817
ETH.MESH.09625816
ETH.MESH.09629448
ETH.MESH.09625737
ETH.MESH.09629858
ETH.MESH.09629720
ETH.MESH.09629714
ETH.MESH.09630340
ETH.MESH.09630232
ETH.MESH.09630739
ETH.MESH.09630681
ETH.MESH.09630683
ETH.MESH.09630678
ETH.MESH.09630649
ETH.MESH.09630648
ETH.MESH.09630647
ETH.MESH. 09630640
ETH.MESH. 09630742
ETH.MESH.09630982
ETH.MESH. 09630944
ETH.MESH.09631140
ETH.MESH. 09630985
ETH.MESH.09631453
ETH.MESH.09631401
ETH.MESH.09631389
01/17/1966 Prolene NDA Submission Letter
01/19/1966 FDA Receipt Letter for Prolene NDA
DX20005
DX20006
DX20007
DX20008
DX20009
DX20010
DX20011
DX20012
DX20013
DX20014
DX20015
DX20016
DX20017
DX20018
DX20019
DX20020
DX20021
DX20022
DX20023
DX20024
DX20025
DX20026
03/14/1969 FDA Labeling Approval for Prolene
04/16/1969 FDA Approval Letter: NDA #16-374
06/29/1970 FDA amended Approval Letter: NDA #16-374/S-001
10/28/1971 NDA Supplement S-002 (amend)
04/26/1973 FDA Letter to Ethicon
05/03/1973 NDA Supplement S-005 (letter agreeing to changes)
05/25/1973 NDA Supplement S-005 (final labeling)
Page 1 of 191
Offered
Admitted
Exhibit
DX20027
DX20028
DX20029
DX20030
DX20031
DX20032
DX20033
DX20034
DX20035
DX20036
DX20037
DX20038
DX20039
DX20040
DX20041
DX20042
DX20043
DX20044
DX20045
DX20046
DX20047
DX20048
DX20049
09631500
ETH.MESH.09631325
ETH.MESH.09631463
ETH.MESH.09631244
ETH.MESH.09631174
ETH.MESH.09631941
ETH.MESH.09631713
ETH.MESH.09632266
ETH.MESH.09632311
ETH.MESH.09632328
ETH.MESH.09632315
ETH.MESH.09632350
ETH.MESH.09632618
ETH.MESH.09632646
ETH.MESH.09632671
ETH.MESH.09632757
ETH.MESH.09632847
ETH.MESH.09632331
ETH.MESH.09632858
ETH.MESH.09632606
ETH.MESH.09632774
ETH.MESH.09632957
ETH.MESH.09632976
Date
Description
05/22/1975 NDA Supplement S-009 (1st amend)
08/08/1975 NDA Supplement S-009 (2nd amend)
09/19/1978 NDA Supplement S-012 (1st amend.)
Page 2 of 191
Offered
Admitted
Exhibit
DX20050
DX20051
DX20052
DX20053
DX20054
DX20055
DX20056
DX20057
DX20058
DX20059
DX20060
DX20061
DX20062
DX20063
DX20064
DX20065
DX20066
DX20067
DX20068
DX20069
DX20070
DX20071
DX20072
DX20073
ETH.MESH.09632896
ETH.MESH.09632959
ETH.MESH.09633000
ETH.MESH.09632673
ETH.MESH.09632870
ETH.MESH.09632861
ETH.MESH.09632899
ETH.MESH.09632978
ETH.MESH.09633023
ETH.MESH.09633062
ETH.MESH.09633241
ETH.MESH.09633026
ETH.MESH.09633004
ETH.MESH.09633211
ETH.MESH.09633366to
ETH.MESH.09633381
ETH.MESH.09633362
ETH.MESH.09633436
ETH.MESH.09633769
ETH.MESH.09633426
ETH.MESH.09633903
ETH.MESH.09633446
ETH.MESH.09634018
ETH.MESH.09634005
ETH.MESH.09634048
Date
Description
08/14/1979 NDA Supplement S-012 (2nd amend.)
12/28/1979
01/04/1980
02/15/1980
04/23/1980
04/23/1980
05/02/1980
NDA Supplement S-020
NDA Supplement S-012 (3rd amend.)
09/19/1980 NDA Supplement S-1 [1980]
10/14/1980 NDA Supplement S-2 [1980]
02/29/1984 NDA Supplement S28 (orig.)
09/13/1984 NDA Supplement S28 (amend.)
Page 3 of 191
Offered
Admitted
Exhibit
DX20074
DX20075
DX20076
DX20077
DX20078
DX20079
DX20080
DX20081
DX20082
DX20083
DX20084
DX20085
DX20086
DX20087
DX20088
DX20089
DX20090
DX20091
DX20092
DX20093
DX20094
ETH.MESH.09634023
ETH.MESH.09634132
ETH.MESH.09634106
ETH.MESH.09634206
ETH.MESH.09634187
ETH.MESH.09634318
ETH.MESH.09634303
ETH.MESH.09634369
ETH.MESH.09634356
ETH.MESH.09634688
ETH.MESH.09634663
ETH.MESH.05217100
ETH.MESH.08476213
ETH.MESH.10039079
ETH.MESH.07876931
ETH.MESH.10040065
ETH.MESH.10039074
ETH.MESH.10039204
ETH.MESH.09634318
ETH.MESH.05217111
ETH.MESH.08476245
Date
Description
07/05/1990 FDA Order, July 5, 1990
10/12/1990 FDA Letter, October 12, 1990
08/09/1996 FDA Clearance Letter, Modified PROLENE
01/28/1998 FDA Clearance Letter, TVT
10/26/2001 FDA Clearance Letter, TVT-Blue
12/08/2003 FDA Clearance Letter, TVT-Obturator
09/28/2012 FDA Updated Clearance Letter – TVT
09/28/2012 FDA Updated Clearance Letter – TVT-Blue
09/28/2012 FDA Updated Clearance Letter – TVT-Obturator
00/00/1988 Package Insert Changes for NDA #16-374/S34
00/00/1996 Section I of Modified PROLENE 510(k)
00/00/1997 Section I of TVT 510(k)
Page 4 of 191
Offered
Admitted
Exhibit
DX20095
DX20096
DX20097
ETH.MESH.10039093
ETH.MESH.07876945
ETH.MESH.09634081
DX20098
No Bates No.
Date
Description
00/00/2001 Section I of TVT-Blue 510(k)
00/00/2003 Section I of TVT-Obturator 510(k)
04/16/1985-04/15/1986 Section 6 of Annual Report 1985-1986
FDA 24-Hour Summary, Obstetrics & Gynecology Devices Panel,
09/08-09/2011 September 8-9, 2011
DX20099
No Bates No.
DX20100
DX20101
DX20102
DX20103
DX20104
No Bates No.
ETH.MESH.09634703
No Bates No.
ETH.MESH.09625729
ETH.MESH.09626241
FDA Executive Summary, "Surgical Mesh for Treatment of Women with
pelvic Organ Prolapse and Stress Urinary Incontinence, Obstetrics &
09/08-09/2011 Gynecology Devices Advisory Committee Meeting, Sept. 8-9, 2011
FDA website; Medical Devices - Implants and Prosthetics; Considerations
about Surgical Mesh for SUI.
(http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/Impl
Date Unknown antsandProsthetics/UroGynSurgicalMesh/ucm345219.htm)
Date Unknown Prolene IND/NDA
Chart of Supplemental NDAs
Government Submissions Log Sheet
IND 1688
FDA Public Health Notice: Serious Complications Associated with
Prolapse and Stress Urinary Incontinence
FDA Safety Communication: UPDATE on Serious Complications
Associated with Transvaginal Placement of Surgical Mesh for Pelvic
Organ Prolapse
FDA Guidance on Use of International Standard ISO-10993, “Biological
evaluation of medical devices Part 1: Evaluation and Testing” issued
4/23/2013.
FDA Letter to Henning re: Reclassification of Nonabsorbable
Polypropylene Surgical Suture
2011 Advisory Committee materials on SUI - FDA Presentation SUI
DX20105
No Bates No.
10/20/2008
DX20106
No Bates No.
07/13/2011
DX20107
No Bates No.
04/23/2013
DX20108
DX20109
DX20110
No Bates No.
No Bates No.
07/05/2013
00/00/2011
00/00/2011
DX20111
DX20112
No Bates No.
No Bates No.
00/00/2011 2011 Advisory Committee materials on SUI - Presentation AdvaMed – SUI
00/00/2011 2011 Advisory Committee materials on SUI - SUI Briefing Book
Page 5 of 191
Offered
Admitted
Exhibit
Date
Description
DX20113
DX20114
DX20115
ETH.MESH.00086288
ETH-00807 to ETH-00808
ETH-01816 to ETH-01819
Date Unknown FDA clearance letter for Gynecare Prosima
Date Unknown FDA Clearance letter for Gynemesh soft mesh for pelvic floor repair
Date Unknown FDA Clearance letter for Prolene soft mesh
DX20116
DX20117
DX20118
DX20119
DX20120
No Bates No.
No Bates No.
No Bates No.
No Bates No.
No Bates No.
Date Unknown
Date Unknown
Date Unknown
Date Unknown
Date Unknown
DX20121
No Bates No.
DX20122
No Bates No.
FDA Staff Manual Guides, Volume II - Delegations Of Authority
Date Unknown Regulatory - "Determination of Classification of Devices"; SMG 1410.406.
FDA website; Medical Devices - Implants and Prosthetics; FDA's Role
Date Unknown and Activities.
DX20123
No Bates No.
American Urogynecologic Society; Letter to Members from Tony Visco,
MD, AUGS President; "AUGS Position Statement on the Restriction of
03/26/2013 Surgical Options for Pelvic Floor Disorders"; March 26, 2013.
DX20124
ETH.MESH.05217144
DX20125
ETH to 02240 to 02242
DX20126
No Bates No.
ETH.MESH.08515497
ETH.MESH.08476342
DX20127
DX20128
DX20129
DX20130
DX20131
DX20132
DX20133
No Bates No.
ETH.MESH.08476213
No Bates No.
No Bates number
No Bates No.
FDA Letter re: N16374 (Prolene, Polypropylene Nonabsorbable Suture).
FDA Medical Devices Device Labeling
FDA Product Classification Database; Product Code FTL.
FDA Product Classification Database; Product Code FTM.
FDA Product Classification Database; Product Code OTN.
510(k) Notification and clearance letter for Modified Prolene*,
06/25/1996 Nonabsorbable Synthetic Mesh, 510(k) K962530; for hernia repair
FDA notification and clearance letter for Prolene, Nonabsorbable
08/09/1996 Synthetic Mesh, 510(k) K962530, for hernia repair
09/10/1997 510(k) Notification for Polypropylene Mesh Hernia Device (K972412)
09/18/1997 510(k) Notification for Prolene Polypropylene Mesh Hernia Device
Nonabsorbable Synthetic Surgical Mesh
January 28, 1998, K974098
510(k) Submission; "Gynecare Tension Free Vaginal Tape System";
01/28/1998 Physical Description; January 28, 1998.
01/28/1998 FDA clearance letter for TVT (K974098)
01/28/1998 K974098 (Prolene) 1998 FDA 510(k) FDA 510(k) Submission
January 28, 1998, K974098, 133 pages
02/23/1999 K984220 (Prolene) 2/23/1999 FDA 510(k) Submission
Page 6 of 191
Offered
Admitted
Exhibit
DX20134
ETH.MESH.01316765
DX20135
No Bates No.
DX20136
ETH-01646 to ETH-01715
DX20137
DX20138
ETH-01646 to ETH-01818
No Bates No.
DX20139
ETH.MESH.00748450
DX20140
DX20141
DX20142
ETH-00797 to ETH-00927
No Bates No.
No Bates No.
DX20143
ETH.MESH.07876987
ETH.MESH.03658926
ETH.MESH.00020230
DX20144
DX20145
DX20146
ETH.MESH.00078537
DX20147
DX20148
DX20149
DX20150
ETH.MESH.00906445
No Bates No.
No Bates No.
No Bates No.
DX20151
No Bates No.
DX20152
No Bates No.
DX20153
No Bates No.
DX20154
No Bates No.
Date
Description
Letter from Cecchini to Linsky re: Regulatory Strategy for Modifications 03/04/1999 Tension Free Vaginal Tape (TVT) System (Original 510(k) #K974098)
Regulatory Strategy for Modifications – Tension Free Vaginal Tape (TVT)
03/04/1999 System (Original 510(k) #K974098)
510(k) notification and clearance for Modified Prolene* Soft
04/06/2000 Polypropylene Mesh (K001122)
DHS Approval of Prolene Soft (Polypropylene) Mesh w/510(K)
05/23/2000 Notification
05/23/2000 K001122 (Prolene Soft) 5/23/2000 FDA 510(k) Submission
GYNECARE Tension-Free Vaginal Tape (TVT) Blue System – 510(k)
notification and clearance letter (K012628) from (FDA’s FOIA Electronic
10/26/2001 Reading Room)
510(k) Notification and clearance for Gynemesh Prolene* Soft
11/06/2001 Polypropylene Synthetic Surgical Mesh for Pelvic Floor Repair (K013718)
01/08/2002 K013718 (Prolene Soft) 1/8/2002 FDA 510(k) Submission
09/17/2003 K031925 (Proceed mesh) 9/17/2003 FDA 510(k) Submission
Declaration of Conformity with Design Controls: The New 510(k)
11/10/2003 Paradigm
510(k) submission - FDA notification and clearance, K042603 - Prolene
11/18/2004 Fastener System
11/28/2005 Document entitled "Section 5, 510(k) Summary"
03/07/2007 Email from Joerg Holste re: Lightning 510(k) requirements
Email from Vincenza Zaddem to Bryan Lisa re: 510(k) mesh data with
01/18/2008 strength
09/05/2008 K082216 (Ethicon Mesh) 9/5/2008 FDA 510(k) Submission
04/09/2010 K093932 (Ethicon Physiomesh) 4/9/2010 FDA 510(k) Submission
01/13/2011 510(k) Overview, Heather Rosencrans
IOM Report: Medical Devices and the Public’s Health, the FDA 510(k)
07/29/2011 Clearance Process at 35 Years
Written Statement of Ralph F. Hall, Professor of Practice, University of
11/15/2011 Minnesota Law School. A defense of 510(k) process with facts and graphs
Letter to FDA from five Congressman questioning FDA’s 510(k)
12/16/2011 clearance process, and draft Final Response to FDA
Draft response to letter to FDA from five Congressman questioning FDA’s
01/23/2012 510(k) clearance process
Page 7 of 191
Offered
Admitted
Exhibit
Date
Description
K113205 (ARTISYN Y SHAPED mesh) 6/12/2012 FDA 510(k)
06/12/2012 Submission
DX20156
No Bates No.
ETH.MESH.10040065
DX20157
No Bates No.
DX20158
No Bates No.
DX20159
No Bates No.
DX20160
No Bates No.
DX20161
DX20162
DX20163
DX20164
No Bates No.
ETH-01815 to ETH-01893
ETH-02245 to ETH-02273
No Bates No.
DX20165
No Bates No.
ETH.MESH.00748450
510(k) Notification for Polypropylene Mesh Hernia Device (K972412)
510(k) notification for Prolene soft mesh
510(k) notification for Prolene, hernia repair
510(k) Summary of Safety and Effectiveness K071512
Summary of Safety and Effectiveness, Tension Free Vaginal Tape (TVT)
Date Unknown System, FDA 510(k) Notification Database. K974098
No Date Modified TVT Blue System (Tension Free Vaginal Tape) and Accessory
TVT0AA Abdominal Guides and Couplers 510(k) submission
DX20167
ETH.MESH.08505288
No Date Regulatory Strategy for Modifications Tension Free Vaginal Tape (TVT)
System (Orig. 510(k) k974098)
DX20168
DX20169
DX20170
DX20171
DX20172
DX20173
DX20174
DX20175
No Bates No.
No Bates No.
No Bates No.
No Bates No.
No Bates No.
No Bates No.
No Bates No.
No Bates No.
DX20176
No Bates No.
DX20177
No Bates No.
DX20155
09/28/2012 TVT – FDA clearance letter attaching 510(k) notification (K974098).
Ethicon (1997). Summary of Safety and Effectiveness, Tension Free
Vaginal Tape (TVT) System, FDA 510(k) Notification Database.
00/00/1997 K974098.
ODE Annual Report 2008. Special 510(k)s are meant for changes to
00/00/2008 marketed devices.
Institute of Medicine; Report: Medical Devices and the Public's Health 07/00/2011 The 510(k) Clearance Process at 35 Years;" July 2011.
510(k) Summary; "Gynecare Modified Prolene polypropylene mesh non
08/00/1996 absorbable synthetic surgical mesh"; August 1996.
Date Unknown
Date Unknown
Date Unknown
Date Unknown
DX20166
21 CFR 321
21 USC §201
21 USC §321
21 USC §351
21 USC §352
21 USC §360
21 USC §374
Code of Federal Regulations, Title 21 - Food and Drugs
Code of Federal Regulations; Title 21 - Food and Drugs; Chapter 9 Federal Food, Drug and Cosmetic Act; Subchapter V - Drugs and Devices;
Date Unknown Part A - Drugs and Devices; Section 201.
Code of Federal Regulations; Title 21 - Food and Drugs; Chapter 9 Federal Food, Drug and Cosmetic Act; Subchapter II - Definitions; Part
Date Unknown 321.
Date Unknown
Date Unknown
Date Unknown
Date Unknown
Date Unknown
Date Unknown
Date Unknown
Date Unknown
Page 8 of 191
Offered
Admitted
Exhibit
Date
Description
Code of Federal Regulations; Title 21 - Food and Drugs; Chapter 9 Federal Food, Drug and Cosmetic Act; Subchapter V - Drugs and Devices;
Date Unknown Part A - Drugs and Devices; Section 515.
DX20178
No Bates No.
DX20179
No Bates No.
DX20180
No Bates No.
Code of Federal Regulations; Title 21 - Food and Drugs; Chapter I - Food
Date Unknown and Drug Administration Department of Health and Human Services
and Drug Administration Department of Health and Human Services;
Subchapter A - General; Part 10 - Administrative Practices and
Procedures; Subpart B - General Administrative Procedures; Section 10.75
Date Unknown - Internal agency review of decisions.
No Bates No.
Subchapter H - Medical Devices; Part 807 - Establishment Registration
Date Unknown and Device Listing for Manufacturers and Initial Importers of Devices.
No Bates No.
and Device Listing for Manufacturers and Initial Importers of Devices;
Date Unknown Section 807.81 - When a premarket notification submission is required.
No Bates No.
Subpart E - Premarket Notification Procedures; Section 807.87(e) Date Unknown Information required in a premarket notification submission.
DX20181
DX20182
DX20183
DX20184
No Bates No.
DX20185
No Bates No.
Subpart E - Premarket Notification Procedures; Section 807.87(k) Date Unknown Information required in a premarket notification submission.
Subchapter H - Medical Devices; Part 807.92(a)(3) - Content and format
Date Unknown of a 510(k) summary.
Page 9 of 191
Offered
Admitted
Exhibit
Date
Description
Subchapter H - Medical Devices; Part 860 - Medical Device Classification
Procedures.
Subchapter H - Medical Devices; Part 860.136 - Medical Device
Classification Procedures.
Procedures; Subpart A - General; Section 860.7(g)(3) - Determination of
safety and effectiveness.
Procedures; Subpart A - General; Section 860.7(g)(3) - Determination of
safety and effectiveness.
Subchapter H - Medical Devices; Part 860.3 - Definitions
Subchapter H - Medical Devices; Part 860.7 - Determination of safety and
effectiveness.
Subchapter H - Medical Devices; Part 862-892 –for example Clinical
Chemistry and Clinical Toxicology Devices; Section 862.9 - Limitations of
exemptions from section 510(k) of the Federal Food, Drug and Cosmetic
Act.
Subchapter H - Medical Devices; Part 866 - Immunology and
Microbiology Devices.
DX20186
No Bates No.
Date Unknown
DX20187
No Bates No.
Date Unknown
DX20188
No Bates No.
Date Unknown
DX20189
No Bates No.
Date Unknown
DX20190
No Bates No.
Date Unknown
DX20191
No Bates No.
Date Unknown
DX20192
No Bates No.
Date Unknown
DX20193
No Bates No.
Date Unknown
No Bates No.
Subchapter H - Medical Devices; Part 878 - General and Plastic Surgery
Date Unknown Devices; Subpart E - Surgical Devices; Section 878.3300 - Surgical Mesh.
DX20194
Page 10 of 191
Offered
Admitted
Exhibit
DX20195
No Bates No.
DX20196
DX20197
DX20198
DX20199
No Bates No.
No Bates No.
No Bates No.
No Bates No.
Date
Description
Subchapter H - Medical Devices; Part 878 - General and Plastic Surgery
Devices; Subpart E - Surgical Devices; Section 878.5010 - Nonabsorbable
Date Unknown polypropylene surgical suture.
05/31/1991
11/14/1991
06/03/2003
06/06/2003
56 FR 24684 – (May 31, 1991) – Reclassification of PP sutures
56 FR 57960 – (Nov. 14, 1991)
68 FR 32983 – (June 3, 2003)
FR Vol. 68, Number 106 (Tuesday, June 6, 2003)
No Bates number
No Date Code of Ethics for Regulatory Professionals (Black and White / Color)
DX20200
DX20201
No Bates number
No Date Code of Ethics for Regulatory Professionals, 14 pages
DX20202
No Bates No.
Declaration of Reynaldo Librojo (Affidavit)
DX20203
No Bates No.
01/17/2003
DX20204
07/13/2011
DX20205
DX20206
No Bates No.
ETH.MESH.08158397
No Bates No.
03/26/2013
11/13/2013
DX20207
No Bates No.
00/00/2011
DX20208
DX20209
No Bates No.
No Bates No.
00/00/2013
02/00/2012
DX20210
No Bates No.
02/00/2012
DX20211
DX20212
No Bates No.
No Bates No.
03/00/2013
09/00/2013
DX20213
No Bates No.
11/00/2011
DX20214
No Bates No.
11/00/2011
National Institute for Clinical Excellence (NICE) – Final Appraisal
Determination – Tension-free vaginal tape (Gynecare TVT) for stress
incontinence.
AUGS website – Mesh Information for Patients with Pelvic Floor
Disorders
AUGS Position Statement on the Restriction of Surgical Options for
Pelvic Floor Disorders
AUGS: FPMRS Subspecialty Certification
2011 AUA Position Statement on the Use of Vaginal Mesh for the
Surgical Treatment of Stress Urinary
AUGS Position Statement on Restriction of Surgical Options for Pelvic
Floor Disorders
AUA 2012 Position Statement on use of mesh
AUGS launched informed consent information on their website
http://www.augs.org/p/bl/et/blogid=6&blogaid=43 and
www.augs.org/informedconsent
2013 March - AUGS Position Statement on Restrictions of Surgical
Options
NICE: September 2013 statement
Treatment of Stress Urinary Incontinence
Treatment of Stress Urinary Incontinence (November 2011)
Page 11 of 191
Offered
Admitted
Exhibit
Date
Description
ACOG Committee Opinion. Innovative Practice: Ethical Guideliens.
12/00/2006 Obstetrics & Gynecology, 2006;108(6):1589-1595
EAU Guidelines on Surgical Treatment of Urinary Incontinence, Eur.
Date Unknown Urology 62 (2012) 1118-1129
Date Unknown NICE Guideline 1.10.3, n.11
1/3/2014 AUGS Position Statement on Midurethral Slings for SUI
British Association of Urological Surgeons - Synthetic Vaginal Tapes for
No date Stress Incontinence (Procedure-Specific Information for Patients)
07/00/2013 ICS Fact Sheets - A Background to Urinary and Faecal Incontinence
00/00/2011 IUGA - Stress Urinary Incontinence (A Guide for Women)
DX20215
No Bates No.
DX20216
DX20217
DX20218
No Bates No.
No Bates No.
No Bates No.
DX20219
DX20220
DX20221
No Bates No.
No Bates No.
No Bates No.
DX20222
DX20223
DX20224
No Bates No.
No Bates number
No Bates number
09/09/2010 FDA Perspective on Surgical Mesh for Stress Urinary Incontinence (SUI)
00/00/2013 2013 AUA SUI Patient Guide
00/00/2011 Stress Urinary Incontinence Monograph by AUA Foundation
ETH.MESH.01316765
05/14/2001 Design History: DH0263-DH0278, 1 book 1999, DH0268: TVT (Tension
Free Vaginal Tape) 5mm Version
ETH-03558
ETH.MESH.01317514
02/28/2002 DDSA Appendix VI "Form" describing hazards
04/25/2002 Device Design Safety Assessment (DDSA) Re-evaluation for TVT,
DX20225
DX20226
DX20227
DX20228
DX20229
DX20230
DX20231
DX20232
DX20233
DX20234
DX20235
DX20236
ETH.MESH.02058855
ETH.MESH.10618414
ETH.MESH.10618415
ETH.MESH.10618425
ETH.MESH.10984130
ETH.MESH.01317529
ETH.MESH.10985341
ETH.MESH.10618456
ETH.MESH.10618383
00/00/2004 2004 Clinical DDSA
aFMEA-0000536, 1 APP
aFMEA-0000536, REV HIST
aFMEA-0000536, Version 1
CO-0029547 (referenced in FMEA-0000536)
DDSA Re-Evaluation for TVT and Related Documents, Including
Preventia Rev 8
Design, Development and Validation Plan for TVT-L, Version A
Design, Development and Validation Plan for TVT-L, Version B
dFMEA-0000242, 1 APP
Page 12 of 191
Offered
Admitted
Exhibit
DX20237
DX20238
DX20239
DX20240
DX20241
DX20242
DX20243
DX20244
DX20245
DX20246
DX20247
DX20248
DX20249
DX20250
DX20251
DX20252
DX20253
DX20254
DX20255
DX20256
ETH.MESH.10618384
ETH.MESH.10618380
ETH.MESH.10984175
ETH.MESH.10984186
ETH.MESH.10984196
ETH.MESH.10984218
ETH.MESH.10984227
ETH.MESH.10984232
ETH.MESH.10984240
ETH.MESH.10984261
ETH.MESH.10984272
ETH.MESH.10984278
ETH.MESH.10984291
ETH.MESH.10984299
ETH.MESH.10984308
ETH.MESH.10984326
ETH.MESH.10984331
ETH.MESH.10984334
ETH.MESH.10984335
ETH.MESH.10984340
Date
Description
dFMEA-0000242, REV HIST
dFMEA-0000242, Version 1
Documents Referenced in FMEA-0000242
Page 13 of 191
Offered
Admitted
Exhibit
DX20257
DX20258
DX20259
DX20260
DX20261
DX20262
DX20263
DX20264
DX20265
DX20266
DX20267
DX20268
DX20269
DX20270
DX20271
DX20272
DX20273
DX20274
DX20275
DX20276
ETH.MESH.10984341
ETH.MESH.10984347
ETH.MESH.10984354
ETH.MESH.10984357
ETH.MESH.10984359
ETH.MESH.10984367
ETH.MESH.10983682
ETH.MESH.10983727
ETH.MESH.10983690
ETH.MESH.10983698
ETH.MESH.10983707
ETH.MESH.10983716
ETH.MESH.10983010
ETH.MESH.10983011
ETH.MESH.10983012
ETH.MESH.10983013
ETH.MESH.10983014
ETH.MESH.10983015
ETH.MESH.10983016
ETH.MESH.10983017
Date
Description
Documents Referenced in RMR-0000017
EMSP030 (Neuchatel Procedure for pFMEAs), Approvers and Dates
EMSP030 (Neuchatel Procedure for pFMEAs), Version 5
EMSP030 (Neuchatel Procedure for pFMEAs), Version A
EMSP030 (Neuchatel Procedure for pFMEAs), Version B
EMSP030 (Neuchatel Procedure for pFMEAs), Version C
EMSP030 (Neuchatel Procedure for pFMEAs), Version D
FM-0000465 aFMEA Form, Version 1
FM-0000466 dFMEA Form, Version 1
Page 14 of 191
Offered
Admitted
Exhibit
DX20277
DX20278
DX20279
DX20280
DX20281
DX20282
DX20283
DX20284
DX20285
DX20286
DX20287
DX20288
DX20289
DX20290
DX20291
DX20292
DX20293
DX20294
DX20295
DX20296
ETH.MESH.10983018
ETH.MESH.10983019
ETH.MESH.10983020
ETH.MESH.10983021
ETH.MESH.10983022
ETH.MESH.10983728
ETH.MESH.10983023
ETH.MESH.10983024
ETH.MESH.10983729
ETH.MESH.10983730
ETH.MESH.10983732
ETH.MESH.10983283
ETH.MESH.10983307
ETH.MESH.10983329
ETH.MESH.10983361
ETH.MESH.10983395
ETH.MESH.10983429
ETH.MESH.10983465
ETH.MESH.10983499
ETH.MESH.10983535
Date
Description
Form - EDOC0112, Approvers and Dates
Form FM-0000467, Version 1
Form FM-0000467, Version 2
Form, EDOC0112, Version A
Form, EDOC0112, Version B
Form, EDOC0112, Version C
German Risk Management Procedures, QSV 04-01, Version 10
Page 15 of 191
Offered
Admitted
Exhibit
DX20297
DX20298
DX20299
DX20300
DX20301
DX20302
DX20303
DX20304
DX20305
DX20306
DX20307
DX20308
DX20309
DX20310
DX20311
DX20312
DX20313
DX20314
DX20315
DX20316
ETH.MESH.10983575
ETH.MESH.10983141
ETH.MESH.10983611
ETH.MESH.10983647
ETH.MESH.10983681
ETH.MESH.10983159
ETH.MESH.10983178
ETH.MESH.10983197
ETH.MESH.10983217
ETH.MESH.10983237
ETH.MESH.10983259
ETH.MESH.10618502
ETH.MESH.10618507
ETH.MESH.10618537
ETH.MESH.10618550
ETH.MESH.10618538
ETH.MESH.10618540
ETH.MESH.10618547
ETH.MESH.10618510
ETH.MESH.10618511
Date
Description
OP650-010 (DDSA), Version 1
OP650-010 (DDSA), Version 1 APP
OP650-010 (DDSA), Version 2 APX I
OP650-010 (DDSA), Version 2 APX II
OP650-010 (DDSA), Version 2 APX III
OP650-010 (DDSA), Version 2 APX IV
OP650-010 (DDSA), Version 2 APX IX
Page 16 of 191
Offered
Admitted
Exhibit
DX20317
DX20318
DX20319
DX20320
DX20321
DX20322
DX20323
DX20324
DX20325
DX20326
DX20327
DX20328
DX20329
DX20330
DX20331
DX20332
DX20333
DX20334
DX20335
DX20336
ETH.MESH.10618512
ETH.MESH.10618514
ETH.MESH.10618516
ETH.MESH.10618517
ETH.MESH.10618577
ETH.MESH.10618594
ETH.MESH.10618578
ETH.MESH.10618580
ETH.MESH.10618587
ETH.MESH.10618590
ETH.MESH.10618551
ETH.MESH.10618552
ETH.MESH.10618554
ETH.MESH.10618556
ETH.MESH.10618557
ETH.MESH.10618635
ETH.MESH.10618644
ETH.MESH.10618636
ETH.MESH.10618639
ETH.MESH.10618601
Date
Description
OP650-010 (DDSA), Version 2 APX V
OP650-010 (DDSA), Version 2 APX VI
OP650-010 (DDSA), Version 2 APX VII
OP650-010 (DDSA), Version 2 APX VIII
Page 17 of 191
Offered
Admitted
Exhibit
DX20337
DX20338
DX20339
DX20340
DX20341
DX20342
DX20343
DX20344
DX20345
DX20346
DX20347
DX20348
DX20349
DX20350
DX20351
DX20352
DX20353
DX20354
DX20355
DX20356
ETH.MESH.10618606
ETH.MESH.10618607
ETH.MESH.10618610
ETH.MESH.10618611
ETH.MESH.10618613
ETH.MESH.10618615
ETH.MESH.10618304
ETH.MESH.10618321
ETH.MESH.10618305
ETH.MESH.10618308
ETH.MESH.10618315
ETH.MESH.10618319
ETH.MESH.10618276
ETH.MESH.10618279
ETH.MESH.10618280
ETH.MESH.10618282
ETH.MESH.10618284
ETH.MESH.10618363
ETH.MESH.10618372
ETH.MESH.10618373
Date
Description
Page 18 of 191
Offered
Admitted
Exhibit
DX20357
DX20358
DX20359
DX20360
DX20361
DX20362
DX20363
DX20364
DX20365
DX20366
DX20367
DX20368
DX20369
DX20370
DX20371
DX20372
DX20373
DX20374
DX20375
DX20376
ETH.MESH.10618324
ETH.MESH.10618331
ETH.MESH.10618335
ETH.MESH.10618336
ETH.MESH.10618339
ETH.MESH.10618340
ETH.MESH.10618365
ETH.MESH.10618342
ETH.MESH.10618343
ETH.MESH.10618688
ETH.MESH.10618692
ETH.MESH.10618693
ETH.MESH.10618647
ETH.MESH.10618654
ETH.MESH.10618658
ETH.MESH.10618659
ETH.MESH.10618662
ETH.MESH.10618663
ETH.MESH.10618668
ETH.MESH.10618665
Date
Description
OP650-010 (DDSA), Version 6 APX X
Page 19 of 191
Offered
Admitted
Exhibit
DX20377
DX20378
DX20379
DX20380
DX20381
DX20382
DX20383
DX20384
DX20385
DX20386
DX20387
DX20388
DX20389
DX20390
DX20391
DX20392
DX20393
DX20394
DX20395
DX20396
ETH.MESH.10618666
ETH.MESH.10618700
ETH.MESH.10618705
ETH.MESH.10619306
ETH.MESH.10619102
ETH.MESH.10618892
ETH.MESH.10618930
ETH.MESH.10618968
ETH.MESH.10619003
ETH.MESH.10619038
ETH.MESH.10619074
ETH.MESH.10619125
ETH.MESH.10619148
ETH.MESH.10619169
ETH.MESH.10619195
ETH.MESH.10619077
ETH.MESH.10619223
ETH.MESH.10619251
ETH.MESH.10619290
ETH.MESH.10618853
Date
Description
OP650-010 (DDSA), Version 7 APX X
OP650-010 (DDSA), Version REV HIST
OP650-010 (DDSA), Version REV HIST
OP650-011 OP for dFMEA (& a FMEA after v6), REV HIST
OP650-011 OP for dFMEA (& a FMEA after v6), Version 1
OP650-011 OP for dFMEA (& a FMEA after v6), Version 5 APP
Page 20 of 191
Offered
Admitted
Exhibit
DX20397
DX20398
DX20399
DX20400
DX20401
DX20402
DX20403
DX20404
DX20405
DX20406
DX20407
DX20408
DX20409
DX20410
DX20411
DX20412
DX20413
DX20414
DX20415
DX20416
ETH.MESH.10618931
ETH.MESH.10618932
ETH.MESH.10983025
ETH.MESH.10983070
ETH.MESH.10983030
ETH.MESH.10983055
ETH.MESH.10983035
ETH.MESH.10983060
ETH.MESH.10983071
ETH.MESH.10983040
ETH.MESH.10983045
ETH.MESH.10983050
ETH.MESH.10983072
ETH.MESH.10983115
ETH.MESH.10983124
ETH.MESH.10983133
ETH.MESH.10983076
ETH.MESH.10983080
ETH.MESH.10983084
ETH.MESH.10983087
Date
Description
OP650-011 OP for dFMEA (& a FMEA after v6), Version APX VI
OP650-011 OP for dFMEA (& a FMEA after v6), Version APX VII
pFMEA100177, Approvers and Dates
pFMEA100177, Version 3
pFMEA100177, Version A
pFMEA100177, Version A
pFMEA100177, Version B
pFMEA100177, Version B
pFMEA100177, Version B TVT Standard
pFMEA100177, Version C
pFMEA100177, Version D
pFMEA100177, Version E
pFMEA-100178, Approvers and Dates
pFMEA-100178, Version 10
pFMEA-100178, Version A
pFMEA-100178, Version B
pFMEA-100178, Version B
pFMEA-100178, Version D
Page 21 of 191
Offered
Admitted
Exhibit
DX20417
DX20418
DX20419
DX20420
DX20421
DX20422
DX20423
DX20424
DX20425
DX20426
DX20427
DX20428
DX20429
DX20430
DX20431
DX20432
DX20433
DX20434
DX20435
DX20436
ETH.MESH.10983091
ETH.MESH.10983095
ETH.MESH.10983099
ETH.MESH.10983103
ETH.MESH.10983107
ETH.MESH.10619944
ETH.MESH.10619961
ETH.MESH.10619648
ETH.MESH.10982977
ETH.MESH.10619416
ETH.MESH.10982995
ETH.MESH.10619441
ETH.MESH.10982999
ETH.MESH.10619467
ETH.MESH.10983001
ETH.MESH.10619700
ETH.MESH.10619917
ETH.MESH.10619501
ETH.MESH.10983002
ETH.MESH.10619527
Date
Description
pFMEA-100178, Version E
pFMEA-100178, Version F
pFMEA-100178, Version G
pFMEA-100178, Version H
pFMEA-100178, Version J
PR602-003, REV HIST
PR602-003, REV HIST
PR602-003, Version 1
PR602-003, Version 1 APP
Page 22 of 191
Offered
Admitted
Exhibit
DX20437
DX20438
DX20439
DX20440
DX20441
DX20442
DX20443
DX20444
DX20445
DX20446
DX20447
DX20448
DX20449
DX20450
DX20451
DX20452
DX20453
DX20454
DX20455
DX20456
ETH.MESH.10983004
ETH.MESH.10619726
ETH.MESH.10619915
ETH.MESH.10619751
ETH.MESH.10619913
ETH.MESH.10619553
ETH.MESH.10983007
ETH.MESH.10619579
ETH.MESH.10983009
ETH.MESH.10619854
ETH.MESH.10982981
ETH.MESH.10619778
ETH.MESH.10619910
ETH.MESH.10619806
ETH.MESH.10619907
ETH.MESH.10619835
ETH.MESH.10619901
ETH.MESH.10619855to
ETH.MESH.10619872
ETH.MESH.10982986
ETH.MESH.10619890
Date
Description
Page 23 of 191
Offered
Admitted
Exhibit
DX20457
DX20458
DX20459
DX20460
DX20461
DX20462
DX20463
DX20464
DX20465
DX20466
DX20467
DX20468
DX20469
DX20470
DX20471
DX20472
DX20473
DX20474
DX20475
DX20476
ETH.MESH.10982989
ETH.MESH.10619604
ETH.MESH.10619964
ETH.MESH.10619319
ETH.MESH.10619333
ETH.MESH.10619629
ETH.MESH.10619922
ETH.MESH.10619675
ETH.MESH.10619921
ETH.MESH.10619361
ETH.MESH.10982991
ETH.MESH.10619389
ETH.MESH.10982993
ETH.MESH.07295622
ETH.MESH.10983745
ETH.MESH.10983936
ETH.MESH.10983968
ETH.MESH.10984000
ETH.MESH.10984032
ETH.MESH.10983757
Date
Description
PR602-003, Version 5 APX I-III
PR602-003, Version 5 APX IV-X
Preventia Rev 5
QSV 04-02, Version 1
Page 24 of 191
Offered
Admitted
Exhibit
DX20477
DX20478
DX20479
DX20480
DX20481
DX20482
DX20483
DX20484
DX20485
DX20486
DX20487
DX20488
DX20489
DX20490
DX20491
DX20492
DX20493
DX20494
DX20495
DX20496
ETH.MESH.10983769
ETH.MESH.10983783
ETH.MESH.10983797
ETH.MESH.10983811
ETH.MESH.10983824
ETH.MESH.10983844
ETH.MESH.10983852
ETH.MESH.10983878
ETH.MESH.10983906
ETH.MESH.10984138
ETH.MESH.10986953
ETH.MESH.10618730
ETH.MESH.10618725
ETH.MESH.10618715
ETH.MESH.10618756
ETH.MESH.10618735
ETH.MESH.10618752
ETH.MESH.10618740
ETH.MESH.10618750
ETH.MESH.10618746
Date
Description
Reference Document in RMR-0000044
Risk Assessment for the TVT Disposable Kit, Version 2
RMP-0000001, Version 1
RMR-0000017, REV HISTO
RMR-0000017, Version 1
RMR-0000017, Version 1 APP
Page 25 of 191
Offered
Admitted
Exhibit
DX20497
DX20498
DX20499
DX20500
DX20501
DX20502
DX20503
DX20504
DX20505
DX20506
DX20507
DX20508
DX20509
DX20510
DX20511
DX20512
DX20513
DX20514
DX20515
DX20516
ETH.MESH.10618748
ETH.MESH.10618814
ETH.MESH.10618792
ETH.MESH.10618811
ETH.MESH.10618806
ETH.MESH.10618808
ETH.MESH.10984033
ETH.MESH.10984120
ETH.MESH.10984129
ETH.MESH.10984042
ETH.MESH.10984048
ETH.MESH.10984054
ETH.MESH.10984060
ETH.MESH.10984069
ETH.MESH.10984078
ETH.MESH.10984089
ETH.MESH.10984096
ETH.MESH.10984104
ETH.MESH.10984112
ETH.MESH.10985423
Date
Description
RMR-0000044, REV HIST
SCP-EPG50, Approvers and Dates
SCP-EPG50, Version 10
SCP-EPG50, Version 11
SCP-EPG50, Version A
SCP-EPG50, Version A
SCP-EPG50, Version B
SCP-EPG50, Version C
SCP-EPG50, Version D
SCP-EPG50, Version E
SCP-EPG50, Version F
SCP-EPG50, Version G
SCP-EPG50, Version H
SCP-EPG50, Version J
TVT Blue Mesh German Tech File Risk Assessment Documents,
Including Preventia Rev 7
Page 26 of 191
Offered
Admitted
Exhibit
DX20517
DX20518
DX20519
DX20520
DX20521
DX20522
DX20523
DX20524
DX20525
DX20526
DX20527
DX20528
DX20529
DX20530
DX20531
DX20532
DX20533
DX20534
DX20535
ETH.MESH.10987148
ETH.MESH.10984443
ETH.MESH.10986985
ETH.MESH.10618444
ETH.MESH.10618412
ETH.MESH.10986808
ETH.MESH.00156908
ETH.MESH.05795621
ETH.MESH.00156955
ETH.MESH.00156952
00156856
ETH.MESH.05795599
ETH.MESH.00158590
ETH.MESH.00159411
ETH.MESH.00144211
ETH.MESH.05795508
ETH.MESH.00159433
ETH.MESH.05795536
ETH.MESH.00144565
Date
Description
TVT DDSA
TVT German Tech File Risk Assessment Documents, Including Preventia
Rev 7
TVT Reusable Introducer Risk Assessment, Version 1
TVT-AA CE Mark DDSA
TVT-AA DDSA and Related Risk Assessment Documents, Version 2
TVT-AA DDSA and Related Risk Assessment Documents, Version 2
12/02/1998 TVT Professional Education Program - Incontinence Surgery, Slides with
Notes for Preceptor - Slide Deck - Copy Approval (1998-220)
TVT Professional Education Program - Incontinence Surgery, Slides with
12/15/1998 Notes for Preceptor - Slide Deck - (1998-220)
TVT Professional Education Program - Incontinence Surgery, Slides with
12/15/1998 Notes for Preceptor - Slide Deck - Copy Approval (1998-220)
12/15/1998 TVT Professional Education Program Slide Deck (1998-219)
TVT Tension-free Vaginal Tape Prof. Ed. Slide Deck - Copy Approval
12/15/1998 (1998-218)
12/15/1998 TVT Tension-free Vaginal Tape Prof. Ed. Slide Deck (1998-218)
08/14/2000 Gynecare TVT Professional Education Program
Dr. Lucente TVT Tension-free Support for Incontinence Video for E-Prof
05/21/2001 Ed Web Site Slide Deck - Copy Approval (2001-200)
Dr. Lucente TVT Tension-free Support for Incontinence Video for E-Prof
05/21/2001 Ed Web Site Slide Deck (2001-200)
Gynecare TVT Tension-Free Support for Incontinence Professional
06/20/2001 Education Slides
TVT Tension-free Support for Incontinence Prof. Ed. Binder and
06/20/2001 Accompanying Slides - Slide Deck - Copy Approval (2001-227)
TVT Tension-free Support for Incontinence Prof. Ed. Binder and
06/20/2001 Accompanying Slides - Slide Deck (2001-227)
GYNECARE TVT Tension-free Support for Incontinence e-Prof Ed
10/01/2001 Module Slide Deck - Copy Approval (2001-423)
Page 27 of 191
Offered
Admitted
Exhibit
DX20536
ETH.MESH.00160094
DX20537
ETH.MESH.PM.000008
DX20538
ETH.MESH.08107354
DX20539
DX20540
DX20541
DX20542
DX20543
DX20544
DX20545
DX20546
DX20547
DX20548
DX20549
DX20550
DX20551
DX20552
DX20553
ETH.MESH.00144723
ETH.MESH.00147319
ETH.MESH.00155903
ETH.MESH.00155906
ETH.MESH.05958527
ETH.MESH.PM.000004
ETH.MESH.00142624
ETH.MESH.00155975
ETH.MESH.01805965
ETH.MESH.00155906
ETH.MESH.0598527 to
ETH.MESH.05958530
ETH.MESH.00147325
ETH.MESH.PM.000003
00158084
DX20554
ETH.MESH.00397674
ETH.MESH.00158067
DX20555
ETH.MESH.05321899
DX20556
ETH.MESH.05321900
ETH.MESH.08156958
DX20557
Date
Description
10/01/2001 Module Slide Deck - Copy Approval (2001-423)
10/01/2001 Module Slide Deck (2001-423)
Additional Slides for TVT Tension-Free Support for Incontinence
10/23/2001 Professional Education Binder - Slide Deck (2001-469)
Additional Slides for TVT Tension-Free Support for Incontinence
Professional Education Binder - Slide Deck Copy Approval (2001-469)
TVT Procedure Video - Copy Approval (2002-036)
TVT Procedure Video (2002-036)
TVT Mesh Properties and Positioning - Slide Deck - Copy Approval
01/31/2002 (2002-071)
TVT Mesh Properties and Positioning - Slide Deck - Copy Approval
01/31/2002 (2002-071)
01/31/2002 TVT Mesh Properties and Positioning - Slide Deck (2002-071)
10/23/2001
01/23/2002
01/23/2002
01/23/2002
01/23/2002
01/23/2002
02/20/2002 TVT In-Service Video - Prof. Ed. Slide Deck - Copy Approval (2002-096)
02/20/2002 TVT In-Service Video - Prof. Ed. Slide Deck - Copy Approval (2002-096)
02/20/2002 TVT In-Service Video - Prof. Ed. Slide Deck (2002-096)
02/20/2002 TVT In-Service Video - Prof. Ed. Slide Deck (2002-096)
Minimizing and Managing Complications: TVT - Prof. Ed. Slide Deck 05/10/2002 Copy Approval (2002-275)
Minimizing and Managing Complications: TVT - Prof. Ed. Slide Deck
05/10/2002 (2002-275)
TVT Tension-Free Support for Incontinence with Abdominal Guides Case
06/20/2002 Video - Prof. Ed. Slide Deck - Copy Approval (2002-353)
06/20/2002 Video - Prof. Ed. Slide Deck (2002-353)
PowerPoint presentation entitled "GYNECARE TVT Tension-free Support
for Incontinence, Advanced Users Forum for the Experienced Clinician"
09/24/2002 Prof. Ed. Slide Deck (2002-310)
Page 28 of 191
Offered
Admitted
Exhibit
DX20558
DX20559
DX20560
ETH.MESH.00143785
ETH.MESH.00159886
DX20566
ETH.MESH.PM.000011
ETH.MESH.03620413
ETH.MESH.00373388
ETH.MESH.00131095
ETH.MESH.03620415
ETH.MESH.03624322
ETH.MESH.00166555
DX20567
ETH.MESH.00147904
DX20568
ETH.MESH.00145555
DX20569
DX20572
ETH.MESH.00541391
ETH.MESH.05958869
ETH.MESH.04046302
ETH.MESH.01130568
DX20573
ETH.MESH.00148893
DX20574
ETH.MESH.00148901
DX20575
ETH.MESH.00148908
ETH.MESH.01130564
ETH.MESH.00167685
ETH.MESH.00369995
DX20561
DX20562
DX20563
DX20564
DX20565
DX20570
DX20571
DX20576
DX20577
DX20578
Date
Description
TVT Advanced Users Forum - Prof. Ed. Slide Deck - Copy Approval
09/24/2002 (2002-310)
TVT- Dr. Axel Arnaud - Meshes for Incontinence and Pelvic Floor Repair
TVT- Dr. Axel Arnaud - Meshes for Incontinence and Pelvic Floor Repair
11/20/2002 Video - Prof. Ed. Slide Deck (2002-680)
Gynecare TVT Tension-Free Support for Incontinence - Prof. Ed. Slide
10/16/2003 Deck - Copy Approval (2003-712)
10/16/2003 Deck (2003-712)
10/16/2003 Deck (2003-712) - Slide handouts
10/16/2003 Deck (2003-712) - Updated Slides
Document entitled "Professional Education for GYNECARE TVT
09/23/2004 Physician Training," September 2004
11/04/2004 Deck - Copy Approval (2004-873)
11/04/2004 Deck (2004-873)
Gynecare TVT Updated Statement of Complications December 2004 01/19/2005 Prof. Ed. Slide Deck (2005-1060)
Gynecare TVT Updated Statement of Complications December 2004 01/19/2005 Prof. Ed. Slide Deck (2005-1060)
TVT and TVT-O Update - Prof. Ed. Slide Deck - Copy Approval (200502/03/2005 1117)
02/03/2005 TVT and TVT-O Update - Prof. Ed. Slide Deck (2005-1117)
Complication Statement Updates - Prof. Ed. Slide Deck - (2008-113, 200802/05/2008 114, 2008-116)
Complication Statement Updates - Prof. Ed. Slide Deck - Copy Approval
02/05/2008 (2008-113, 2008-114, 2008-116)
02/05/2008 (2008-113, 2008-114, 2008-116)
02/05/2008 (2008-113, 2008-114, 2008-116)
02/05/2008 (2008-113, 2008-114, 2008-116)
04/30/2008 Combined TVT Prof Ed Slide Deck - Copy Approval (2008-570)
04/30/2008 Combined TVT Prof Ed Slide Deck (2008-570)
Page 29 of 191
Offered
Admitted
Exhibit
DX20579
DX20580
DX20581
ETH.MESH.02124769
ETH.MESH.03751819
DX20582
ETH.MESH.05779953
ETH.MESH.06087212
DX20583
ETH.MESH.06090245
DX20584
ETH.MESH.03958008
No Bates number
DX20585
DX20586
DX20587
DX20588
DX20589
DX20590
No Bates number
No Bates No.
ETH.MESH.00159719
ETH.MESH.10281860
No Bates No.
ETH.MESH.00156938
Date
Description
The Science of What's Left Behind - Prof. Ed. Slide Deck - Copy Approval
04/20/2009 (2009-473)
04/20/2009 The Science of What's Left Behind - Prof. Ed. Slide Deck (2009-473)
TVT Retropubic Patient DVD Components: cover, sleeve, interface - Prof.
03/03/2011 Ed. Slide Deck - Copy Approval (TVTR-098-11-2/13)
TVT Retropubic Patient DVD Components: cover, sleeve, interface - Prof.
03/03/2011 Ed. Slide Deck (TVTR-098-11-2/13)
TVT Female Urinary Incontinence PCE - Prof. Ed. Slide Deck - Copy
04/11/2011 Approval (TVT-162-11-4/13)
TVT Female Urinary Incontinence PCE - Prof. Ed. Slide Deck (TVT-16204/11/2011 11-4/13)
06/04/2013 TVT/SUI Professional Education Index and Production Bates Range
Chart, 4 pages
06/04/2013 TVT/SUI Professional Education Index and Production Chart
TVT/SUI Professional Education Original and Updated Indexes and
Production Bates Ranges; Exhibits T-764 and T-764 to B. Pattyson
06/04/2013 deposition
00/00/2001 2001 Gynecare TVT Professional Education Enhancements
TVT Market Update - Clinical Expertise TVT Prof Ed Slide Deck (TVT00/00/2013 413-13)
Date Unknown TVT-R Prof Ed Slide Deck
No Date TVT/SUI Professional Education Program
DX20591
DX20592
DX20593
DX20594
DX20595
DX20596
DX20597
DX20598
DX20599
DX20600
DX20601
DX20602
DX20603
DX20604
ETH.MESH.PM.000006
ETH.MESH.PM.000009
ETH.MESH.PM.000057
ETH.MESH.PM.000068
ETH.MESH.PM.000088
ETH.MESH.PM.000089
ETH.MESH.PM.000090
ETH.MESH.PM.000134
ETH.MESH.PM.000151
ETH.MESH.PM.000154
ETH.MESH.PM.000012
Date Unknown
Date Unknown
Date Unknown
Date Unknown
Date Unknown
Date Unknown
Date Unknown
Date Unknown
Date Unknown
Date Unknown
Date Unknown
Anatomy Videos
Anatomy Videos
Anatomy Videos
Anatomy Videos
Anatomy Videos
Anatomy Videos
Anatomy Videos
Anatomy Videos
Anatomy Videos
Anatomy Videos
Tension-Free Vaginal Tape A Procedure Video
Summary of Pre-Clinical Studies
Summary of Long-Term Studies
Page 30 of 191
Offered
Admitted
Exhibit
DX20605
DX20606
DX20607
DX20608
Date
Description
Summary of "Gold Standard" Studies
Summary of TVT RCTs
Summary of Industry Guideline Statements
Summary of TVT Clinical Studies from 1998-2000
ETH.MESH.06003212
2005 16-page copy of document entitled "Stress Urinary Incontinence in
Women"
ETH.MESH.05768712
2005 8-page copy of document entitled "2005 Variable Compensation Plan
Sales Representative"
ETH.MESH.07931939
No Bates number
2005 Document entitled "2005 Performance and Development Plan Summary
for Patricia Hojnoski"
Document entitled "Ethicon WW Regulatory Affairs 2005 Business Plan 2005
WW Regulatory"
2006 8-page copy of document entitled "2006 Johnson Medal Nomination"
DX20609
DX20610
DX20611
DX20612
ETH.MESH.05457609
DX20613
DX20614
DX20615
ETH.MESH.00169751
ETH.MESH.00525466
ETH.MESH.06021657
2006 Advertisement entitled "In Stress Urinary Incontinence, Consistent Results.
Reliable Outcomes"
2006 Ethicon Women's Health & Urology Southern Region Meeting 2006
2008 Document entitled "2008 CME Conference & Exhibition Overview"
ETH.MESH.00658458
2008 Marketing piece titled "The Gynecare TVT Family of Products, 3
SUI Solutions, Delivering Data, Safety & Choice"
No Bates number
ETH.MESH.06006737
2009 Document entitled "Levels of Evidence" by William Cavanagh
2009 Goals and Objectives - Piet Hinoul - 2009
ETH.MESH.06260671
2010 R&D CO-OP Welcome Guide Spring 2010
DX20616
DX20617
DX20618
DX20619
DX20620
DX20621
ETH.MESH.10281874
DX20622
No Bates No.
DX20623
No Bates number
2013 PowerPoint presentation entitled "Tension-free Midurethral Sling: Market
Update"
Ethicon: Polypropylene monofilament suture summary of biological data
10/14/1965 dated October 14, 1965.
E-mail string Price St. Hilaire regarding Bidirectional Elasticity Statement;
01/01/1970 cc: Bryan Lisa, Janice Burns, et al.
Page 31 of 191
Offered
Admitted
Exhibit
No Bates number
DX20624
DX20625
No Bates No.
DX20626
No Bates No.
DX20627
No Bates No.
DX20628
No Bates No.
DX20629
No Bates No.
DX20630
ETH.MESH.00371573
DX20631
No Bates No.
Date
Description
E-mail string, top one to St. Hilaire Price regarding Bidirectional Elasticity
Statement; cc: Jonathan Meek
Technical Report ERF ACCESSION No. 74-275 re: Pyrogenicity of 10-0
10/08/1974 Prolene Polypropylene Suture in “Microsurgery” Package
01/01/1970
04/28/1982 Ethicon: memos regarding vascular symposium. Atlantic City 4/28/1982.
Ethicon Memo. Subject: Additional Explanation of Ethiflex Failure
10/15/1982 Probability Memo of 10/15/1982.
Ethicon Memo dated October 19, 1982 re: Additional explanation of
10/19/1982 Ethiflex failure probability Memo of 10/18/1982.
Ethicon Memo, February 16, 1984. Subject: Force to "Straighten" Size 5/0
02/16/1984 Prolene Prolypropylene Suture.
ETH.MESH.09557819
ETH.MESH.09557820
No Bates number
Tension-Free Vaginal Tape Procedure for USI – A Preliminary Report. By
08/07/1987 Alex Wang. This study was included in the TVT 510k submission
Letter from O’Donnell to FDA re N16374 (PROLENE, Polypropylene
10/15/1990 Nonabsorbable Suture)
General Program Memorandum #G91-1 from Director, Office of Device
03/08/1991 Evaluation
U.S. Food and Drug Administration Medical Device Labeling Guidance
03/08/1991
#G91-1 (blue book memo), 10 pages
10/01/1992 Handwritten notes from 7 year dog study
10/25/1992 Large Documents from 7 year dog study
Sep-1993 "Human Factors Principles for Medical Device Labeling"
No Bates No.
12/11/1995 FR Notice, Vol. 60, No. 237, (12/11/95), comment 11
07/19/1996 Corporate Product Characterization - Product Safety Profile (Prolene)
07/19/1996 Ethicon Corporate Product Characterization Product Safety Profile
DX20643
ETH.MESH.04447134
ETH.MESH.04447142
ETH.MESH.08696055
ETH.MESH.08696134
ETH.MESH.09747038
ETH.MESH.08696134
DX20644
DX20645
No Bates No.
No Bates number
DX20632
No Bates number
DX20633
DX20634
DX20635
DX20636
DX20637
DX20638
DX20639
DX20640
DX20641
DX20642
Consulting & Technology Agreement between Johnson & Johnson
02/13/1997 International and Professor Ulf Ivar Ulmsten
02/13/1997 License and Supply Agreement
02/13/1997 License and Supply Agreement
License and Supply Agreement between J&J International and Medscand
02/13/1997 re: Ulmsten’s device
Medical Device Reporting for Manufacturers by Department of Health and
03/01/1997 Human Services, Public Health Services, FDA
Mar-1997 Medical Device Reporting for Manufacturers, 50 pages
Page 32 of 191
Offered
Admitted
Exhibit
DX20647
ETH.MESH.09747111
ETH.MESH.01317613
DX20648
ETH.MESH.08476320
DX20649
ETH.MESH.07510207
DX20646
DX20650
DX20651
ETH.MESH.00349237
ETH.MESH.02614733
ETH.MESH.09747728
DX20652
DX20653
ETH.MESH.09747728
ETH.MESH.09747643
Date
Description
03/05/1997 Memo from Mark Dumenil to George Bortwick, et al. regarding
Medscand Agreement
03/20/1997 Medscand Medical Validation Fact Book – Heat Sealer HSE-3
07/03/1997 First page of TVT for Urinary Stress Incontinence - A Preliminary Report
Cytotoxicity Assessment of Ulmsten Sling – Prolene polypropylene Mesh
using the ISO Elution Method. Report, PSE Accession No. 97-0128,
07/29/1997 Project No. 16672
Memo from Thomas Barbolt to C. Linsky re: Cytotoxicity Risk
Assessment for the TVT (Ulmsten) Device. Attached to the memo is a
08/08/1997 Summary of Cytotoxicity Testing
08/28/1997 Report, PSE ACCESSION NO. 97-0174. PROJECT NO, 16672
09/11/1997 E-mail from Cary Linsky to Henry Esparza regarding TVT (Ulmsten) 510k Submission
Linsky email re TVT (Ulmsten) - 510 sumission -- "The primary reason
09/11/1997 for delaying the 510k submission …
09/16/1997 Slides entitled "Tension Free Vaginal Tape (TVT) Ulmsten Device," PAC
Meeting Review
DX20654
DX20655
DX20656
ETH.MESH.09747756
ETH.MESH.05315244
ETH.MESH.08218350
DX20657
DX20658
ETH.MESH.08218350
ETH.MESH.08218336
Tension Free Vaginal Tape (TVT) - Ulmsten Device - PAC Meeting
09/16/1997 Review
2nd page of A 28-Day intramuscular Tissue Reaction Study in Rats of
09/26/1997 Polypropylene Mesh from the TVT (Ulmsten) Device
10/01/1997 1-page copy of memo from Thomas A. Barbolt, Ph.D. to G. Robertson
regarding Biocompatibility Risk Assessment for PROLENE*
Polypropylene Mesh
10/01/1997 Document from R&D Ethicon Germany "Literature Review on
Biocompatibility of Prolene Sutures and Implants"
10/01/1997 Ethicon memo to from Thomas A. Barbol to G. Robertson regarding
Biocompatibility Risk Assessment for PROLENE* Polypropylene Mesh
DX20659
DX20660
DX20661
DX20662
ETH.MESH.08218337
ETH.MESH.00371571
ETH.MESH.00371503
10/01/1997 Literature Review on Biocompatibility of Prolene Sutures and Implants
10/28/1997 Cytotoxicity Summaries submitted with TVT 510k application
10/29/1997 Confidentiality of Information
Page 33 of 191
Offered
Admitted
Exhibit
DX20663
DX20664
DX20665
DX20666
DX20667
DX20668
ETH.MESH.00371580
ETH.MESH.00371522
ETH.MESH.00371542
ETH.MESH.00371551
ETH.MESH.09847718
ETH.MESH.09804803
ETH.MESH.09747732
DX20669
DX20670
DX20671
DX20672
ETH.MESH.00371546
ETH.MESH.03658577
No Bates No.
No Bates number
DX20673
DX20674
No Bates number
DX20675
DX20676
DX20677
No Bates number
No Bates number
No Bates number
DX20678
DX20679
DX20680
ETH.MESH.08476342
ETH.MESH.05315265
ETH.MESH.09747701
Date
Description
Female Stress Urinary Incontinence Clinical Guidelines Panel Summary
Report on Surgical Management of Female Stress Urinary Incontinence.
Printed in The Journal of Urology in September 1997. This report was
10/29/1997 included in the TVT 510k application
10/29/1997 Labeling documents submitted with initial 510k application
Section 3 of the TVT 510k submission – Comparison of the new device to
10/29/1997 predicate device
10/29/1997 Section 5 of the TVT 510k submission – Performance Data
11/04/1997 Chart entitled "Project:Ulmsten Device,
11/24/1997 PR551-006 Revision History - In effect 11.24.1997
12/02/1997 E-mail from Cary Linsky to Robin Ciardiello, Peter Checchini, et al.
regarding TVT Update
Section 4 of the TVT 510k submission – Patient-Contacting material
12/29/1997 identification
01/11/1998 Biocompatibility of Ultrapro
Food and Drug Administration - Ethicon correspondence; FAX from Keith
Foy to Gregory T. Jones regarding requested labeling changes in K974098
01/14/1998 submission; January 14, 1998.
01/28/1998 2-page copy of letter from Celia M. Witten to Gregory R. Jones regarding
K974098 Tension Free Vaginal Tape (TVT) System Regulatory Class: II
Product Code: FTL; plus attachments
01/28/1998 501(k) Summary of Safety and Effectiveness for TVT
01/28/1998 Document entitled "Section Summary of Safety and Effectiveness," with
attachment
01/28/1998 Excerpt, Section 7, Summary of Safety and Effectiveness, 5 pages
01/28/1998 Section 7, Summary of Safety and Effectiveness, 5 pages
Tension Free Vaginal Tape (TVT) System 501(k) Notification, 121 pages
01/28/1998
01/28/1998 Tension Free Vaginal Tape (TVT) System 510(k) Notification
Final Report, PSE Accession No. 97-0197, Project no. 16672 – A 28 Day
IntraMuscular Tissue Reaction Study in Rats of Polypropylene Mesh from
01/30/1998 the TVT (Ulmsten) Device. Sponsor: Ethicon
02/02/1998 Document entitled "Project Name: Tension Free Vaginal Tape (Ulmsten
Device),"
DX20681
Page 34 of 191
Offered
Admitted
Exhibit
DX20682
ETH.MESH.04447163
ETH.MESH.09747684
Date
Description
Ethicon LTD Clinical Research and
Development, TVT for GSI Surgery Investigator Brochure, A Prospective
Randomized Comparative Trial of a Tension-Free Vaginal Tape (TVT)
Vs. Burch Culposuspension for ‘Primary’ Genuine Stress Incontinence CT03/17/1998 TVT-001-97
06/01/1998 Document entitled "Project Name: Tension Free Vaginal Tape (Ulmsten
Device)," Project Description: Development of the TVT for use in Female
Stress Incontinence for the US Market (4Q, 98)
DX20683
ETH.MESH.08692237
DX20684
DX20685
ETH.MESH.00130941
ETH.MESH.09264946
06/02/1998 Letter with redactionfrom Laurie Myers to Pattyson Bartholomew
regarding congratulations on the beginning of an exciting career with
Ethicon, Inc. and Johnson & Johnson
06/23/1998 Email from Larry Ellington re Prolene Mesh for TVT
07/30/1998 Document entitled "The following is a summary of key points extracted
from the U.S. Marketing Research Study on TVT. Please share with your
team" cc: Richard Grineau
Summary of key points extracted from the US Marketing Research Study
07/30/1998 on TVT
08/17/1998 Document from Bob Rousseau to Karen Lessig regarding Prolene Mesh
Re-Design Project
ETH.MESH.09264885
11/11/1998 Document from R. Rousseau to Project Team regarding Meeting Minutes
of Project Planning Meeting
No Bates number
11/15/1998 New York Times article entitled "Death in Surgery Reveals Troubled
Practice and Lax Hospital," by Jennifer Steinhauer
TVT-2 Changes; Rational for approving customer requested changes to
11/19/1998 the present TVT Device
ETH.MESH.09266657
ETH.MESH.00130941
DX20686
DX20687
DX20688
DX20689
DX20690
DX20691
ETH.MESH.07295656
DX20692
No Bates No.
03/02/1999
DX20693
ETH.MESH.05443513
03/04/1999
ETH.MESH.00203456
03/26/1999
03/30/1999
DX20694
DX20695
Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance.
Guidance for the Preparation of a Premarket Notification Application for
a Surgical Mesh. 03.02.1999 FDA Guidance
Development and Validation of op601-015: Operating Procedure for
Optical Evaluation to Determine Porosity of Mesh Samples Using the
Nikon Steromicroscope and ImagePro Plus Image Analysis System
Version 1
Letter from Boston Scientific to FDA re: Request for Remedial Action
Exemption per E1996001
E-mail chain top one from Caroll Gillick to Irene Leslie, Peter Cecchini, et
al. regarding TVT insert; cc: Sewart Taylor, et al.
Page 35 of 191
Offered
Admitted
Exhibit
ETH.MESH.09748017
Date
Description
04/19/1999 TVT Acquisition Analysis & Recommendation
DX20696
ETH.MESH.05611588
DX20697
ETH.MESH.02620914
ETH.MESH.02620917
May-1999 Document entitled "Complaint Summary: TVT Serious Injuries (SI) and
Deaths 5/99 to Date," 10 pages
05/1999 Issue Report TVT Retropubic 1999-2000 Open Date Between 01-Jan-1999
and 31-Dec-2000
DX20698
DX20699
DX20700
DX20701
DX20702
DX20703
ETH.MESH.07425661
05/21/1999 Letter to TVT Preceptors: DRAFT 5-21-1999
ETH.MESH.02342102
ETH.MESH.09747794
ETH.MESH.5315295
ETH.MESH.03662715
ETH.MESH.07424336
05/29/1999 Prolene Mesh IFU. Dates of use: 5/29/1999 to 7/3/2011
06/01/1999 PowerPoint presentation entitled "TVT Acquisition, Review with Mr.
Lenehan June 1, 1999"
06/16/1999 Ethicon document dated 6/16/1999 "GLP Archives PSE Acc No. 97-0197"
DX20704
ETH.MESH.08165499
Products and Technologies for Incontinence and Pelvic Floor Defects –
07/03/1999 Focus on Biological Materials
07/16/1999 Document entitled "Note to File" regarding Medical Report: TVT Adverse
Events; cc: Alessandro Rosetti, Berkley Pollard, John Paulson, and Sylvia
Gummer
07/28/1999 Document entitled "Meeting Minutes: TVT Development-Team-Meeting"
DX20705
DX20706
DX20707
DX20708
DX20709
DX20710
DX20711
DX20712
ETH.MESH.00946315
ETH.MESH.09264584
ETH.MESH.00145496
ETH.MESH.00141445
ETH.MESH.05972866
ETH.MESH.09747369
ETH.MESH.08692696
08/17/1999 Policy on Conduct in the Operating and Procedure Room
Ethicon Memo re: Design History File for the Prolene Mesh Improvement
08/18/1999 Project, Executive Summary
Draft Dear Doctor letter from Barbara Schwartz notifying local doctors
10/08/1999 that Ethicon is about to start an advertising campaign for TVT
11/02/1999 TVT Detail Sheet (TVT001R)
11/15/1999 Asset Purchase Agreement
11/15/1999 Asset Purchase Agreement between J&J and Mescand
Consulting Agreement between J&J and Ulmsten
11/15/1999
Page 36 of 191
Offered
Admitted
Exhibit
DX20713
DX20714
DX20715
DX20716
DX20717
ETH.MESH.08167645
ETH.MESH.06692673
ETH.MESH.09263411
ETH.MESH.05641098
ETH.MESH.03617312
ETH.MESH.03917312
Date
Description
11/15/1999 Emails Re: AW: Cordozo Trial, some redacted material
11/15/1999 Ulmsten & Ethicon Consulting Agreement
Ethicon Memo re: Prolene Mesh – European Conversion to 5-mil
11/16/1999 Construction – Meeting Minutes of 11/16/1999
11/17/1999 TVT Star PD 99/20 meeting notes
Emails between Richard Isenberg, Jochen Hoepffner, Axel Arnaud and
11/25/1999 Allesandro Rossetti re TVT event Dangerous Procedure/Death
11/28/1999 E-mail chain, top one from Rodrigo Bianchi to Alessandro Rossetti, Axel
Arnaud, et al. regarding TVT event; cc: Laura Angelini, et al.
DX20718
DX20719
DX20720
DX20721
DX20722
DX20723
DX20724
DX20725
DX20726
DX20727
DX20728
DX20729
DX20730
DX20731
ETH.MESH.02216613
ETH-12350 to ETH-12351
ETH.MESH.06694813
ETH.MESH.0160411 to
ETH.MESH.0160418
ETH.MESH.01316896
ETH.MESH.03917333
ETH.MESH.08167854
ETH.MESH.00160666
ETH.MESH.07424693
ETH.MESH.05529275
ETH.MESH.09275945
ETH.MESH.06852129
Memo from Thomas Barbolt to R. Rousseau dated re: Biocompatibility
12/02/1999 Risk Assessment for Soft Prolene Mesh
Revised memo to R. Rousseau re: Biocompatibility Risk Assessment for
12/02/1999 Soft Prolene Mesh
12/15/1999 Emails Re: TVT Blue – feedback from Carl Gustaff Nilsson
12/28/1999 Corporate Product Characterization, Monthly Highlights, December 1999
02/09/2000 Statement of Janet Heinrich
02/15/2000 February 15, 2000 U.S. Regulatory Strategy – TVT Pigmented Blue
02/16/2000 Email traffic re: AW: Vibrating Needleholder for TVT
03/03/2000 E-mail chain, top one from Dr. Hans-Jochen Hoepffner to Hans-Jochen
Hoepffner regarding Article on complications
04/03/2000 Email from Lorie Gawreluk re: TVT: Copy Review
04/05/2000 Email string re: TVT Blue - Feasibility Study: Suspended activities
Letter from Will Irby (Product Director) to sales, representatives Failure to
Disclose Adverse, Risks/Complications, Dangerous Procedure/Tensioning
04/17/2000 Professional Education/Training
Email from Robert Rousseau to Anthony Lopez re: Mesh Thickness
05/04/2000 Testing
05/26/2000 Biocompatibility Review
Page 37 of 191
Offered
Admitted
Exhibit
ETH.MESH.0746495 to
ETH.MESH.0749741
ETH.MESH.05494066
ETH.MESH.03924557
ETH.MESH.05493999
06/06/2000 "Meshes in Pelvic Floor Repair" By Brigitte Hellhammer
6/6/2000 32-page copy of document entitled "Meshes in Pelvic Floor Repair:
Findngs from literature review and conversations/interviews with surgeons"
ETH.MESH.03904451
ETH.MESH.03924586
ETH.MESH.00160639
06/06/2000 Meshes in Pelvic Floor Repair
Meshes in Pelvic Floor Repair - Findings from literature review and
6/6/2000 conversations/interviews with surgeons (Brigitte Hellhammer)
06/09/2000 Memo from J.L. Toth to Copy Review Team regarding "A Multicenter
Study of Tension-Free Vaginal Tape (TVT) for Surgical Treatment of
Stress Urinary Incontinence" Article (TVT005) - REVIEW FOR REPRINT
ETH.MESH.00160625
06/09/2000 Memo from J.L. Toth to Copy Review Team regarding GYNEARE TVT
Tension-free Support for Incontinence Patient Education Brochure
(TVT016) - REVIEW FOR REPRINT
Memo to the Copy Review Team from J.L. Toth re: GYNECARE TVT
Tension-free Support for IncontInence Patient Education Brochure
06/09/2000 (TVT016)
Benefit – Side Effect Analysis for TVT Device by Richard A. Isenberg,
06/15/2000 M.D. (6/15/2000)
6/15/2000 Clinical Expert Report for TVT written by Rich Isenberg
ETH.MESH.00349227
ETH.MESH.06852129
DX20734
DX20735
DX20736
DX20737
DX20738
DX20739
Description
05/26/2000 Ethicon central file memo dated 5/26/2000 to Peter Cecchini from Thomas
Barbolt regarding Review of Biocompatbility Data on the Tension Free
Vaginal Tape (TVT) System for Compliance to FDA G-95/ISO
10993/EN30993
Memo from Richard Hutchinson to P. Cecchini re: Review of
Biocompatibility Data on the Tension Free Vaginal Tape (TVT) System
05/26/2000 for Compliance to FDA G-95/ISO 10993/EN 30993
5/26/2000 Memo from Richard W. Hutchinson to P. Cecchini Regarding Review of
Biocompatibility Data on the Tension Free Vaginal Tape (TVT) System
for Compliance to FDA G-95/ISO 10993/EN 30993
06/01/2000 E-mail chain, top one from Dr. Brigitte Hellhammer to Dr. Juergen
Hoefer regarding WG: TVT Instructions for use; with attachments
DX20732
DX20733
Date
DX20740
DX20741
DX20742
DX20743
ETH.MESH.00160623
ETH.MESH.00824007
ETH.MESH.07226582
DX20744
No Bates number
06/26/2000 Document entitled "What are the Risks?" copy approved 6/26/2000; 1 page
ETH.MESH.01137293
07/07/2000 Email string re: 2001 Gynecare Marketing Plans - Confidential
DX20745
DX20746
Page 38 of 191
Offered
Admitted
Exhibit
DX20747
ETH.MESH.03932914
ETH.MESH.01317524
Date
Description
07/12/2000 Axel Arnaud - The history of TVT.
07/12/2000 Preventia TVT-2
DX20748
DX20749
DX20750
ETH.MESH.01317524
No Bates No.
ETH.MESH.08167650
PREVENTIA TVT-2 Risk Analysis Procedure/Tensioning
07/12/2000 Frayed mesh/particle loss
Document regarding U.S. Patent No. 6,090,116 dated 7/18/00, list M.
D’Aversa and R. Dougherty as the inventors for this product which is a
07/18/2000 knitted surgical mesh comprised of knitted yarn
07/27/2000 E-mail chain with redactions, top one from Laura Angelini to Dr. Brigitte
Hellhammer regarding Pelvic Floor Repair; cc: Hans-Jochen Hoepffner
DX20751
DX20752
No Bates No.
ETH.MESH.07387254
ETH.MESH.07387257
DX20753
ETH.MESH.08793648
DX20754
ETH.MESH.03909713
Email from Robert Rousseau to Robert Tannhauser et al. re: US
07/31/2000 6,090116. 7/31/2000
08/03/2000 E-mail from Lisa Gardner to Laura Angelini, Edward Badger, Ellen Blum,
Mike Breznak, et al. regarding August Status Report - Gynecare
Marketing; cc: Rosanne Pickell and Lisa Jannone
08/18/2000 Placeholder/ with chart enitled "Study Justification: Gynecare Clinical
Research Program 2001"
08/21/2000 6-page copy of e-mail chain from Axel Arnaud to Hans-Joehen Hoepffher
regarding Pelvic floor repair Procedural Strategy; cc: Richard Isenberg
DX20755
ETH.MESH.08793646
ETH.MESH.08793647
ETH.MESH.09746617
ETH.MESH.00377236
08/21/2000 E-mail from Richard Isenberg to Mike Breznak regarding WOW Business
Plan --2001, Clinical Research; cc: Barbara Schwartz, Zenobia Walji,
Ettore, Carino, et al.
Emails between Axel Arnaud and Jochen Hoepffner re pelvic floor repair
08/21/2000 procedural strategy
Memo from Martin Weisberg to Rick Isenberg re Discussion with
08/28/2000 [REDACTED], Failure to Disclose Adverse Risks/Complications
08/28/2000 Memo from Marty Weisberg to Rick Isenberg regarding Discussion with
Redacted; cc: Michael Amerman
09/06/2000 Letter from Howard Zauberman to Carl Nilsson Regarding Surgeon Panel
Agreement
09/06/2000 Memorandum from Madeline J. Santora, R.N. to File#02- Yitzhak Berger,
M.D. regarding File Review of Protocol #98-88018-A-CA
ETH.MESH.00108423
ETH.MESH.00345805
09/20/2000 Product Recall / Market Withdrawal / Field Correction Update Report
09/22/2000 Email from Lisa Bryan re Peclin
DX20756
DX20757
DX20758
ETH.MESH.03909713
ETH.MESH.03736578
ETH.MESH.03736578
DX20759
DX20760
DX20761
DX20762
DX20763
Page 39 of 191
Offered
Admitted
Exhibit
DX20764
DX20765
ETH.MESH.00143702
ETH.MESH.00143699
ETH.MESH.00143699
Date
Description
Memo from J.L. Toth to Copy Review Team re "A Multicenter Study of
Tension-Free Vaginal Tape (TVT) for Surgical Treatment of Stress
09/22/2000 Urinary Incontinence Article (TVT005) - REVIEW FOR REPRINT
Memo from J.L. Toth to Copy Review Team re "A three-year follow up of
tension free vaginal tape for surgical treatment of female stress urinary
09/22/2000 incontinence" Article (TVT015) - REVIEW FOR REPRINT
09/22/2000 Memo from J.L. Toth to Copy Review Team regarding "A three-year
follow up of tension free vaginal tape for surgical treatment of female
stress urinary incontinence" Article (TVT015 - REVIEW FOR REPRINT
DX20766
ETH.MESH.04044800
Oct-2000 TVT Update Success & Complications (Causes and Recommendations)
ETH.MESH.08167453
10/03/2000 E-mail chain, top one from Laura Angelini to Zenobia Walji regarding R:
Prof. Klutke - Confidential
DX20767
DX20768
DX20769
ETH.MESH.05529653
Memo from Martin Weisberg to Rick Isenberg re Complaint Failure to
11/01/2000 Disclose Adverse Risks/Complications
11/01/2000 Memo from Marty Weisberg to Rick Isenberg regarding Complaint, with
redactions
New York Times article entitled "Company News; Sunoco Agrees to Buy
11/10/2000
Mitsubishi's Aristech Chemical"
11/30/2000 1-page copy of e-mail dated 11/30/2000 from Hans-Jochen Hoepffner to
Rebecca Levine regarding Problem Statements for TVT Brainstorming
Meeting
11/30/2000 Copy Approval Forms to Copy Review Team from J.L. Toth regarding
TVT Resource Monograph
Emails between Rebecca E. Levine, Ph.D. (Sr. Engineer, R&D) and
Jochen Hoepffner re Problem Statements from TVT Brainstorming
11/30/2000 Meeting
ETH.MESH.05958248
ETH.MESH.00658198
ETH.MESH.00310066
Memo to copy Review Team from J.L. Toth re: TVT Resource
Monograph. The attached “Surgeon’s Resource Monograph” presented the
11/30/2000 results from a June 2000 Summit Meeting involving a 17-surgeon panel
Surgeon’s Resource Monograph: Expert opinions on the use of
11/30/2000 GYNECARE TVT Tension-Free Support for Incontinence
Quality Review Board: Medscand TVT. Ref: Quality Review Board #
12/04/2000 QB00-019
ETH.MESH.03736932
ETH.MESH.03736932
DX20770
No Bates number
DX20771
ETH.MESH.05529653
DX20772
ETH.MESH.05958248
DX20773
DX20774
DX20775
DX20776
DX20777
Page 40 of 191
Offered
Admitted
Exhibit
DX20778
DX20779
DX20780
Date
ETH.MESH.02613708
No Bates number
No Bates No.
ETH.MESH.00159719
12/13/2000
12/15/2000
01/06/2001
01/12/2001
DX20781
DX20782
ETH.MESH.01992236
01/16/2001
DX20783
ETH.MESH.01160507
01/16/2001
DX20784
ETH.MESH.01425113
02/12/2001
DX20785
Description
Completion Report Design Verification for Soft PROLENE Mesh/Mesh
Curling
International Standard ISO 14971, 40 pages
66 FR 3523, 3525 (Jan. 6, 2001)
Document from J.L. Toth to Copy Review Team regarding GYNECARE
TVT Tension-free Support for Incontinence Professional Education
Enhancments
"Form for Test Method Applicability/Suitability"
Email from Edward Dormier including the December 2000 Corporate
Product Characterization
Ethicon “Final Report, PSE Accession No. 00-0035, An Exploratory 91Day Tissue Reaction Study of Polypropylene-Based Surgical Mesh in Rats
(PSE ACC. No. 00-0035)
Axel Arnaud email re Dr. Lucente/TVT Procedure
Improvements/Prevention of Overstretching
Issue Report TVT Retropubic 2001, Open Date Between 01-Jan-2001 and
31-DEC-2001
ETH.MESH.03915380
ETH.MESH.02621674
02/13/2001
02/21/2001
ETH.MESH.02609925
No Bates number
ETH.MESH.00376674
Memo to Prolene Soft Mesh Team re: Prolene Soft Mesh Validation
03/05/2001 Completion Report for Pre and Intra-Operative Usage from Mark Mooney
04/04/2001 MedWatch Medical Device Reporting Code Instructions, 5 pages
04/06/2001 E-mail from Kimberly Hunsicker to [email protected]
regarding ATTN: DR. BERGER; cc: Alma Colt
ETH.MESH.00161132
No Bates number
Product Pointer: Gynecare TVT Tension-free Support for Incontinence: A
04/11/2001 Synthetic Sling with Erosion Rates No Higher than Autologous Slings
04/19/2001 Guidance on Medical Device Patient Labeling; Final Guidance for Industry
And FDA Reviewers
04/19/2001 Guidance on Medical Device Patient Labeling; Final Guidance for Industry
and FDA Reviewers, Document issued on April 19, 2001, 53 pages
DX20786
DX20787
DX20788
DX20789
DX20790
DX20791
ETH.MESH.01203260
DX20792
ETH.MESH.05642491
DX20793
DX20794
ETH.MESH.05642489
ETH.MESH.09748635
04/23/2001 3-page copy of E-mail from Mark Sumeray to Greg Jones and Richard
Isenberg; cc: Joel S. Lippman and Dr. Brigitte Hellhammer regarding
Vypro Pelvic Floor Repair PD 00/3
Email from Mark Sumeray to Greg Jones et al re Vypro Pelvic Floor
04/23/2001 Repair PD 00/3
04/23/2001 Letter from Ulf to Donald Ostergard regarding meeting in Cannes
DX20795
Page 41 of 191
Offered
Admitted
Exhibit
Date
Description
ETH.MESH.01317613
Gynecare TVT Tension-free Support for Incontinence Statement
05/01/2001 Regarding Complications
PowerPoint: Tissue Reaction and Integration of Polypropylene-Based
Surgical Mesh in Rats. By Ethicon R&D (R.W. Hutchinson, T.A. Barbolt,
05/04/2001 and W.G. Lieuallen)
05/11/2001 Letter from Linda Gephart to recipient redacted regarding TVT*Device
Reference: 30001175
05/14/2001 Design History: DH0263-DH0278, 1 book 1999, DH0268: TVT (Tension
Free Vaginal Tape) Factbook
ETH.MESH.00412035
ETH.MESH.00412028
ETH.MESH.02621935
Clinical Study Agreement for Investigator Initiated Studies -#28 - 20005/15/2001 029 CSA
Clinical Study Agreement for Investigator Initiated Studies -#28 - IIS20005/15/2001 028 CSA
05/22/2001 Issue Report TVT Retropubic 2001, Open Date Between 01-Jan-2001 and
31-DEC-2001
ETH.MESH.02621941
31-DEC-2001
DX20796
ETH.MESH.00144252
DX20797
ETH.MESH.02319001
ETH.MESH.03482828
DX20798
DX20799
DX20800
DX20801
DX20802
DX20803
DX20804
DX20805
DX20806
DX20807
ETH.MESH.05494066
ETH.MESH.02058112
ETH.MESH.02621970
ETH.MESH.01159961
ETH.MESH.03905477
06/01/2001 Hellhammer email to Dr. Hoefer
06/01/2001 Project TVT-L
31-DEC-2001
06/06/2001 Biocompatibility Risk Assessment for the TVT-L Device
06/06/2001 E-mail chain, top one from Martin Weisberg to Rita Mcintyre regarding
TVT recommendation from Dr. Alex Wang
DX20808
DX20809
DX20810
DX20811
DX20812
ETH.MESH.03905477
ETH.MESH.01159962
ETH.MESH.00349225
ETH.MESH.08797004
06/06/2001 Email string re: TVT recommendation from Dr. Alex Wang
06/06/2001 Letter from Thomas A. Barbolt to S. Ciarrocca regarding Biocompatibility
Risk Assessment for the TVT-L Device
Memo from Thomas Barbolt to S. Ciarrocca re: Biocompatibility Risk
06/06/2001 Assessment for the TVT-L Device
E-mail from Cheryl Bogardus to Susan McGee regarding Sales results in
06/15/2001
TVT DTC pilot areas; cc: Zenobia Walji
Page 42 of 191
Offered
Admitted
Exhibit
ETH.MESH.00144269
Date
Description
ETH.MESH.08798010
06/15/2001 Two Memos to Copy Review team regarding GYNECARE TVT Tensionfree Support for Incontinence Patient Brochure (Resubmission of materials
per FDA requirements)
06/18/2001 "2002 - 2003 US Marketing Plan for GYNECARE TVT Tension-free
Support for Incontinence"
ETH.MESH.08798110
06/18/2001 2002-2003 US Marketing Plan for TVT
DX20813
DX20814
DX20815
DX20816
DX20817
ETH.MESH.00159473
ETH.MESH.02089399
ETH.MESH.08168001
DX20818
ETH.MESH.02622084
06/20/2001 Gynecare TVT Tension-free Support for Incontinence Mesh Sales Aid
06/22/2001 Scientific Advisory Panel on Pelvic Floor Repair Preliminary Minutes
06/27/2001 E-mail with attachment from Dr. Brigitte Hellhammer to
[email protected] regarding Draft of Revised TVT Instructions
for Use
07/2001 Issue Report TVT Retropubic 2001, Open Date Between 01-Jan-2001 and
31-DEC-2001
DX20819
DX20820
DX20821
ETH.MESH.00144331
ETH.MESH.00764325
00582991
ETH.MESH.02622616
07/03/2001 Presentation: TVT Sales Force Update @ Divisional Meeting
Ethicon Final Report, PSE Accession No. 00-0035 An Exploratory 91-day
Tissue Reaction Study of Polypropylene-Based Surgical Mesh in Rats
07/11/2001 (PSE Acc. No. 00-0035) dated 7.11.01
07/19/2001 Copy Approval Forms to Copy Review Team from J.L. Toth regarding
GYNECARE TVT Tension-Free Support for Incontinence Surgeon's
Resource Monograph - RESUBMISSION
5-Year Press Release, Long-term Data Proves Safety and Efficacy of
GYNECARE TVT Tension-free Support for Treating Stress Urinary
08/02/2001 Incontinence Draft 2: For Immediate Release
Modified TVT Blue and TVT –AA (Abdominal Approach) for Stress
08/06/2001 Urinary Incontinence (K012628)
08/08/2001 Issue Report TVT Retropubic 2002 (Jan-May), Open Date Between 01Jan-2002 and 31-May-2002
No Bates No.
ETH.MESH.02622279
E-mail from James McDivitt to Thomas Barbolt dated 8/16/2001 re:
08/16/2001 Autoclaving Prolene
31-DEC-2001
ETH.MESH.00165429
09/27/2001 Email from Lorie Gawreluk re: COPY REVIEW: TVT Presentations
ETH.MESH.03354675
ETH.MESH.00161389
DX20822
DX20823
DX20824
DX20825
DX20826
DX20827
DX20828
Page 43 of 191
Offered
Admitted
Exhibit
DX20829
Date
Description
ETH.MESH.09306910
ETH.MESH.03909733
09/28/2001 2002 US Marketing Plan for TVT
10/2001 13-page copy of document entitled "New Products Development Gynecare
Products"
ETH.MESH.01217288
ETH.MESH.07469281
ETH.MESH.02622377
10/12/2001 "Summary of Findings and Next Steps from 10.12.01 TVT DTC Focus
Groups"
11/02/2001 Letter from Thomas A. Barbolt to K. Lessig regarding Biocompatibility
Risk Assessment for TVT-AA Revised
31-DEC-2001
ETH.MESH.00220877
ETH.MESH.00339442
ETH.MESH.02622631
Ethicon December 2, 2001 Memo to Maggie D’Aversa from David Stoloff
re: Gynemesh Prolene Soft Mesh – Preclinical Functionality Testing
12/02/2001 Strategy
Surgeon's Brochure: "Five Years of Proven Performance" Surgeon
12/06/2001 Brochure
01/2002 Issue Report TVT Retropubic 2002 (Jan-May), Open Date Between 2001Jan-2002 and 31-May-2002
DX20830
DX20831
DX20832
DX20833
DX20834
DX20835
DX20836
DX20837
ETH.MESH.00031325
ETH.MESH.00029966
DX20838
DX20839
DX20840
ETH.MESH.00142610
ETH.MESH.03909829
ETH.MESH.02625037
Letter to Gregory Jones from Celia M. Witten with FDA dated 1.8.02
regarding K013718 Trade name Gynemesh Prolene Soft Nonabsorbable
01/08/2002 Synthetic Surgical Mesh for Pelvic Floor Repair
01/16/2002 E-mail from Brian Luscombe to DL-ETHUSSO SLS GYNECARE DMs,
et al. regarding ALERT!!!!Professional Ads for GYNECARE TVT!!; cc:
DL-ETHUSSO SLS GYNECARE
Email from Teresa Kyle to Brian Luscombe re: GC-334 TVT Procedure
01/23/2002 Video – Revised
01/29/2002 E-mail with attachment, re: Confidential/ Project TVM
01/30/2002 Issue Report TVT Retropubic 2002 (Jun), Open Date Between 01-Jun2002 and 30-Jun-2002
DX20841
DX20842
DX20843
DX20844
DX20845
ETH.MESH.00156181
ETH.MESH.00397327
ETH.MESH.00823997
ETH.MESH.03909812
Basics of Incontinence - Dr. Jill Peters-Gee - Slide Deck - Copy Approval
01/31/2002 (2002-010)
01/31/2002 Basics of Incontinence - Dr. Jill Peters-Gee - Slide Deck (2002-010)
01/31/2002 Clinical Assessment of the Device TVT Disposable Kit
02/07/2002 E-mail string, top one dated 2/07/02, Re: TR: TVM
Page 44 of 191
Offered
Admitted
Exhibit
DX20846
DX20847
DX20848
DX20849
Date
Description
ETH.MESH.00199408
ETH.MESH.02622585
02/08/2002 Gynemesh PS Design Validation Strategy
ETH.MESH.02249668
ETH.MESH.00005609
ETH.MESH.03738510
02/19/2002 Audit Report by MDACI
E-mail from Luscombe cc-ing Walji Forwarding updated Statement of
02/20/2002 Complications for GYNECARE TVT
03/2002 "Ask MA" Newsletter, Volume 2, Issue 1
DX20850
DX20851
DX20852
ETH.MESH.00001140
ETH.MESH.00411560
ETH.MESH.03738514
03/02/2002 “Ask MA” Newsletter
IUPUI and Clarian/Methodist Hospital Informed Consent Statement IRB#
03/04/2002 02-018
03/06/2002 E-mail chain, top one from Martin Weisberg to Richard Isenberg
regarding Urethral Erosion
ETH.MESH.03738519
ETH.MESH.00005682
ETH.MESH.02622690
03/06/2002 E-mail from Martin Weisberg to Richard Isenberg, Cheryl Bogardus, and
Lee Ann Berger regarding Urethral Erosion
03/13/2002 E-mail string from Beth Zipp to Scott Jones, Kara Davidson, et al.
regarding TVT Slides on Complications
ETH.MESH.08695896
03/28/2002 Letter from Howard Zauberman to Mr. Jan Johansson regarding 2001
sales performance of GYNECARE Worldwide Division of Ethicon, Inc.
ETH.MESH.08797110
04/05/2002 E-mail from Rosanne Pickell to DL-GP WW Management Board
regarding GYNECARE TVT PR Campaign; cc: Lorie Gawreluk
ETH.MESH.02622782
ETH.MESH.01808741
ETH.MESH.08793553
ETH.MESH.00156980
04/25/2002 Corporate Product Characterization Product Performance Evaluation
Group Test Report for PROLENE Mesh
04/25/2002 E-mail from Ettore Carino to Kimberly Mullarkey regarding DTC Review
DX20853
DX20854
DX20855
DX20856
DX20857
DX20858
DX20859
DX20860
DX20861
DX20862
04/26/2002 E-mail from Cheryl Bogardus to Janet Toth regarding Copy Review
submissions- approval; cc: Brian Luscombe
Page 45 of 191
Offered
Admitted
Exhibit
ETH.MESH.03907469
DX20863
ETH.MESH.07425073
DX20864
ETH.MESH.07425115
DX20865
DX20866
ETH.MESH.00411413
ETH.MESH.02249642
DX20867
DX20868
ETH.MESH.02216611
ETH.MESH.00409675
DX20869
ETH.MESH.03735433
Date
Description
“Second Generation TVT” strategy document written by A. Arnaud,
05/01/2002 Product Defect, Dangerous Procedure/Tensioning
05/03/2002 1-page copy of E-mail from Ethicon Interactive Communications to All
Ethicon regarding DOCUMENT RETENTION ANNUAL PURGE, with
attachments
05/03/2002 E-mail to DL-ETHUSSO All Ethicon from Ethicon Interactive
Communications, with attachments, regarding Document Retention
Annual Purge
05/07/2002 Research Subject Information and Consent Form, Version May 7, 2002
05/09/2002 E-mail chain, top one from Berkley Pollard to Rita Mcintyre, Mark Yale,
et al. regarding Ethicon Inc. Audit Report; cc: Catherine Beath, Evan
Sakellos, et al.
Final Report, PSE Accession No. 01-0321, Project No. 48010 by Lesley G.
Hough. A 28-Day Tissue Reaction Study of Prolene Polypropylene Mesh
and AutoClaved Prolene Polypropylene Mesh Implanted Intramuscularly
05/23/2002 and Subcutaneously in Rats
06/07/2002 E-mail chain, top one from Richard Isenberg to Greg Jones, Cheryl
Bogardus, et al. regarding Dr. Alex Wang, Taiwan - Reports of "Tape
Rejection" with TVT
06/07/2002 E-mail chain, top one from Richard Isenberg to Richard Hu, Kay Koh, et
al. regarding Friday June 7 Conference Call; cc: Greg Jones
DX20870
DX20871
DX20872
DX20873
ETH.MESH.03735433
ETH.MESH.03483696
ETH.MESH.03713703
ETH.MESH.02183537
Emails between Rick Isenberg and Dr. Alex Wang
06/07/2002 Product Defect; Failure to Disclose Adverse Risks/Complications
ETH.MESH.00875543
06/10/2002 Yale email chain originating 06/07/20020re Wang's rejections
06/23/2002 Document entitled "Evaluation of TVT Complaints Prepared by Martin
Weisberg, M.D."
07/03/2002 Burkley, D.F. Porosity Measurement of Various Meshes (produced in
native format)
07/26/2002 E-mail from Ethicon Interactive Communication to DL-ETHUSSO All
Ethicon regarding 7/22/02 Important Document Preservation Notice
ETH.MESH.02623163
08/14/2002 Issue Report TVT Retropubic 2002 (Jul-Dec), Open Date Between 01-Jul2002 and 31-Dec-2002
DX20874
DX20875
DX20876
Page 46 of 191
Offered
Admitted
Exhibit
Date
Description
ETH.MESH.02623168
ETH.MESH.02249642
ETH.MESH.02623272
08/30/2002 Complaint Vigilance Audit Report with Summary - Ethicon, Inc.
09/04/2002 Issue Report TVT Retropubic 2002 (Jul-Dec), Open Date Between 01-Jul2002 and 31-Dec-2002,
ETH.MESH.02623286
ETH.MESH.00030025
ETH.MESH.00409658
ETH.MESH.00409658
09/27/2002 Letter to Dr. James Meeuwesen of Pueblo, CO from Scott Jones (sales rep)
Rejection of Polypropylene Tape After The Tension-Free Vaginal Tape
10/04/2002 (TVT) Procedure, A. Wang, MD
10/04/2002 Rejection of Polypropylene Tape After the Tension-Free Vaginal Tape
(TVT) Procedure, Alex C. Wang, M.D.
ETH.MESH.03910210
10/04/2002 Report: Visit to Pr Jean de Leval (Arnaud & DeLacroix)
DX20877
DX20878
DX20879
DX20880
DX20881
DX20882
DX20883
DX20884
DX20885
No Bates No.
ETH.MESH.03910206
10/04/2002
10/08/2002
ETH.MESH.03910207
10/08/2002
ETH.MESH.00349681
ETH.MESH.00409663
10/08/2002
10/08/2002
ETH-18415
ETH.MESH.03910193
Memo to Hospital Materials Managers & or Directors from Gynecare
10/10/2002 Worldwide Ethicon dated 10.10.02 regarding Gynecare Gynemesh*PS
10/13/2002 E-mail chain, top one from Axel Arnaud to Martin Weisberg regarding
Soft Prolene
DX20886
DX20887
DX20888
DX20889
DX20890
The Least Burdensome Provisions of the FDA Modernization Act of 1997:
Concept and Principles; Final Guidance for FDA and Industry (dated
10/4/2002)
E-mail from Axel Arnaud to Laura Angelini regarding TVT/Pr de Leveal
(Liege, BELGIUM); cc: Bruno De Lacroix
E-mail from Axel Arnaud to Laura Angelini regarding TVT/Pr de Leveal
(Liege, BELGIUM); cc: Bruno De Lacroix
Regulatory Strategy-United States
TVT Customer Initiated Research Grant Request submitted by Alex Wang
DX20891
Page 47 of 191
Offered
Admitted
Exhibit
Date
Description
ETH.MESH.00143759
10/16/2002 Copy Review Submission Form
No Bates number
10/16/2002 Document entitled "What are the Risks?" copy approved 10/16/2002; 1
page
DX20892
DX20893
DX20894
No Bates number
No Bates number
10/16/2002 Document entitled "What are the Risks?" with handwritten changes, copy
approved 10/16/2002; 1 page
10/16/2002 Document entitled "What are the Risks?" with handwritten changes, copy
DX20895
DX20896
DX20897
ETH.MESH.00143759
DX20898
DX20899
ETH-18669 to 18673
ETH.MESH.02619918
No Bates No.
DX20900
ETH.MESH.02134042
DX20901
ETH.MESH.08793210
DX20902
Ethicon Copy Review Submission form: “TVT Patient Brochure Reprint.”
10/16/2002 Submitted by Robin Osman
Accomplishments & Projects of Paul J. Parisi, September 2001 – October
10/22/2002 2002
10/22/2002 Thomas J. Paul, Inc. document with product entitled TVT Abdominal
Guide Announcement Letter
10/26/2002 PL 107-250 (October 26, 2002)
Final Report, PSE Accession No. 24 02-0079. 14-Day Adhesion
Prevention Study of Interceed Fabric, PDS or POE VI-Based Films on
Prolene-Soft, Pronova, or Vypro Mesh, and Competitive products in the
10/28/2002 Rabbit Sidewall Model with Peritoneal Defects
ETH.MESH.00005660
ETH.MESH.08793210
Emails between Martin Weisberg and Mark Sumeray (VP Clinical Trials)
re Dr. Wang's proposal to perform histological and immunohistochemical
10/31/2002 study on biopsies taken from women with tape erosion
Email to DL-ETHUSSO SLS Gynecare Reps and Others from B.
Luscombe re: All Sling Materials Can Cause Erosion – Urology Times
11/07/2002 Article
11/11/2002 E-mail chain top, one from Ettore Carinoo to Mark Sumeray regarding Dr.
Wang's Proposal
04035368
ETH.MESH.00409669
ETH.MESH.04939567
E-mail chain, top one dated 11 Nov. 2002, with attachment re: Porosity of
11/11/2002 meshes
E-mail string from Alex Wang to Mark Sumeray in regards to Alex
11/15/2002 Wang's proposal
Memo from Gene Kammerer to Brian Luscombe, et al in regards to
11/25/2002 Ultrasonic Slitting of PROLENE Mesh for TVT
DX20903
DX20904
DX20905
DX20906
Page 48 of 191
Offered
Admitted
Exhibit
Date
Description
ETH.MESH.03910421
11/26/2002 E-mail chain, top one from Axel Arnaud to Dr. Reinhard Juraschek, et al.
regardign Mini TVT- mesh adjustment; cc: Susanne Landgrebe
ETH.MESH.03917378
ETH.MESH.02622759
Weisberg email chain originating 11/22/2002 re Mini TVT mesh
adjustment - "... overtension is not possible and that tension free placement
11/26/2002 of the tape is not critical..."
12/2002 Issue Report TVT Retropubic 2002 (Jan-May), Open Date Between 01Jan-2002 and 31-May-2002
DX20907
DX20908
DX20909
ETH.MESH.00409670
DX20910
DX20911
ETH.MESH.00409670
ETH.MESH.00279588
DX20912
DX20913
DX20914
DX20915
ETH.MESH.03918331
ETH.MESH.03801822
ETH.MESH.03918333
ETH.MESH.00409665
DX20916
DX20917
DX20918
DX20919
DX20920
ETH.MESH.01815664
ETH-03883
ETH.MESH.00766976
ETH.MESH.02268614
ETH.MESH.06873458
DX20921
ETH.MESH.08627147
DX20922
DX20923
DX20924
ETH.MESH.02268621
ETH.MESH.07226586
DX20925
ETH.MESH.01222617
12/03/2002 E-mail chain, top one from Martin Weisberg to Mark Sumeray regarding
Prolene rejection
12/03/2002 Weisberg email chain originating 11/15/2002 re Prolene rejection
12/04/2002 E-mail string, top one from Cheryl Bogardus to Jacqueline RussoJankewicazdated 12/4/2002 regarding Boston Scientific - A history Lesson
on ProteGen Sling
Email from Nina Wanendeya to Martin Weisberg and Axel Arnaud re:
12/05/2002 Mulberry
Email from Nina Wanendeya to Martin Weisberg, Amy Godwin, and Axel
12/05/2002 Arnaud re: Mulberry clinical & regulatory meeting
12/05/2002 Email from Wanendeya re: Mulberry
E-mail string from Marty Chomiak to Amy Godwin, et al in regards to Dr.
12/19/2002 Wang's Study Agreement
Project Mulberry Preliminary Clinical Diligence Report. By Jessica Shen,
01/06/2003 Marty Weisberg, and Amy Godwin
01/23/2003 "Prolene Resin Manufacturing Specifications" by John Karl
DTC Focus Group Summary - Gynecare TVT and Thermachoice Patient
01/27/2003 Advertising
E-mail chain; top one from Daniel Burkley to Dorothy Dion, et al.
02/03/2003 regarding Athos: Analytical Testing; cc: Scott Ciarrocca, et al
02/14/2003
Due Diligence Growth Opportunity Outline: Next generation TVT
02/14/2003 E-mail string from Jacqueline Russo-Jankewicz to Lynn Hall, Kimberly
Mullarkey, et al. regarding Stressful Secrets Viral Email
02/21/2003 E-mail string, top one from Dorothy Dion to Scott Ciarrocca regarding
ATHOS: PROLENE Additives and Exposure
02/24/2003 Clinical Strategy for TVT-D Revision #1
Histological Evaluation and Comparison of Mechanical Pull Out Strength
02/28/2003 of Prolene Mesh and Prolene Soft Mesh in A Rabbit Model
Page 49 of 191
Offered
Admitted
Exhibit
Date
Description
ETH.MESH.01222654
02/28/2003 Protocol, PSE Accession No. 02-0579, Project No 48010
ETH.MESH.00858095
03/04/2003 Gynecare R&D Monthly Update - March
ETH.MESH.05316812
03/05/2003 Ethicon document "REPORT. PSE Accession N. 02-0579, Project No
48010, "Histological Evaluation and Comparison of Mechanical Pull Out
Strength of Prolene Mesh and Prolene Soft mesh in a Rabbit Model"
ETH.MESH.02134271
03/05/2003
DX20926
DX20927
DX20928
DX20929
DX20930
ETH-11280 to ETH-11316
ETH.MESH.01218449
DX20931
DX20932
DX20933
DX20934
DX20935
DX20936
DX20937
DX20938
DX20939
DX20940
DX20941
ETH.MESH.04205636
ETH.MESH.09747177
ETH.MESH.00863946
ETH.MESH.03919404
ETH.MESH.06886411
ETH.MESH.02249716
ETH.MESH.07393307
ETH.MESH.00865217
ETH.MESH.00858081
ETH.MESH.03926031
Mechanisms of Cytotoxicity for TVT Polypropylene Mesh (DRAFT)
Report, PSE Accession No. 02-0579, Project No. 48010 by Nicole Cirelli.
Histological Evaluation and Comparison of Mechanical Pull Out Strength
of Prolene Mesh and Prolene Soft Mesh in a Rabbit Model
03/05/2003
03/19/2003 Corporate Product Characterization for the Product Performance
Evaluation Group Final Test Report for PROLENE Mesh at Secant
Medical, PTO2-0746, Version 1
03/20/2003 "Strategic Plan Challenge, March 20, 2003"
03/21/2003 Letter from M.E. Helms to Professor Ulf Ulmsten regarding follow up to
your inquiry regarding a potential payment for the clinical trial work
03/25/2003 March 25, 2003 Email from Cheryl Bogardus re: Mulberry Project
03/26/2003 Email from Axel Arnaud re Mulberry
03/26/2003 Email from Axel Arnaud to Martin Weisberg re: Mulberry
03/27/2003 Final Report: Corporate Compliance Complaint Investigation
03/31/2003 E-mail with attachments from Tiffany Peterson to to Cheryl Bogardus,
Cary Braun, et al. regarding March Month End Report
Email from Martin Weisberg to Mary Amore and Amy Godwin re: Project
04/08/2003 Mulberry
04/09/2003 Meeting Notes from Dan Smith re: high level f/u’s from today’s meeting
04/14/2003 Minutes from Team Meeting by Dan Smith
Page 50 of 191
Offered
Admitted
Exhibit
ETH.MESH.00865072
DX20942
DX20943
DX20944
DX20945
ETH.MESH.008650672
ETH.MESH.03918497
ETH.MESH.06879330
ETH.MESH.05920532
Date
Description
04/16/2003 E-mail from Dan Smith to Brian Luscombe, et al. regarding Draft report
translated by "Babel fish" http://babelfish.altavista.com/tr; cc: Jean de
Leval, et al.
04/16/2003 Email from Dan Smith to group re: Draft report translated by "Babel fish"
Email from Martin Weisberg to Axel Arnaud re: Mulberry/Clinical Data
04/16/2003 Pr de Leval/Safety
04/16/2003 Email traffic re: Mulberry Naming
04/17/2003 1-page copy of e-mail from Boris Batke to Jill Schiaparelli, Paul
Campbell, et al. regarding Literature list Lightweight Meshes
DX20946
DX20947
DX20948
DX20949
DX20950
DX20951
ETH.MESH.01813076
ETH.MESH.01813074
ETH.MESH.03801846
ETH.MESH.02183536
ETH.MESH.00864039
ETH.MESH.00756102
Expenses Incurred by Professeur Jean de Leval from February 2003
04/17/2003 through 5 April 2003
Email from Suzanne Dufau to Dan Smith re: Pr. De Leval – Mulburry
04/18/2003 project
04/20/2003 Email from Martin Weisberg to Group re: mulberry clinical opinion.
04/22/2003 E-mail chain, top one dated 22 April 2003 re: Pore Size request
04/27/2003 E-mail string from Brian Luscombe to Dan Smith regarding Opportunities
May-2003 Document entitled "Arrowhead Campaign"
DX20952
ETH.MESH.03612846
DX20953
ETH.MESH.03934930
DX20954
DX20955
DX20956
ETH.MESH.03918548
ETH.MESH.03918553
ETH.MESH.00030098
DX20957
DX20958
ETH.MESH.00030098
05/01/2003 E-mail string from Brian Luscombe to DL-ETHUSSO SLS GYNECARE
DMs regarding Sales Leads from Prof. Jounal Advertising; cc: Teresa
Kyle, et al.
05/03/2003 E-mail chain, top one from Frederic C. Daoud to Axel Arnaud regarding
APPEL URGENT de Leval
05/07/2003 E-mail thread, top one from Jean de Leval to JBURNS@ ethgb.jnj.com
regarding Urgent Message; cc: Axel Arnaud, et al.
05/08/2003 Email from Janice Burns to group re: De Leval Publication
05/13/2003 Letter from Anthony Powell and Marianne Kaminski to Gynecare
Continence Health Sales Team
Memo from Anthony Powell (VP, Sales) and Marianne Kaminski (Dir. of
PE and Relations) to Gynecare Continence Health Sales Team re
05/13/2003 GYNECARE TVT Physician Training Policy
Page 51 of 191
Offered
Admitted
Exhibit
DX20959
DX20960
ETH.MESH.07393700
ETH.MESH.02614324
ETH.MESH.00875546
Date
Description
Memo to Gynecare Continence Health Sales Team re: Gynecare TVT
05/13/2003 Physician Training Policy
Corporate Product Characterization – Product Performance Evaluation
05/22/2003 Group – Revised Final Test Report
05/22/2003 E-mail from Ethicon Interactive Communications to DL-ETHUSSO All
Ethicon, et al regarding Gynecare Document Hold Preservation Notice
DX20961
DX20962
DX20963
DX20964
DX20965
DX20966
DX20967
DX20968
ETH.MESH.00030098
ETH.MESH.00030102
ETH.MESH.03910890
ETH.MESH.00858097
ETH.MESH.02222656
ETH.MESH.00863842
ETH.MESH.00862728
ETH.MESH.00862728
05/22/2003 Email string re: Gynecare TVT Physician Training Policy
05/22/2003 Email string re: TVT letter to editor
05/25/2003 Email from Axel Arnaud re Follow up Mulberry
05/28/2003 GYNECARE R&D MONTHLY UPDATE – MAY
05/29/2003 DHF 25 1-323 - CE Mark of TVT - AA Kit.pdf
05/29/2003 Matrix of ongoing clinical studies
Email from Dan Smith to Janice Burns et al. re: My notes from the
06/02/2003 Thursday evening presentation 5/22/03 and Friday’s surgery
06/02/2003 E-mail from Dan Smith to Janice Burns, et al. regarding My notes from
the Thursday evening presentation 5/22/03 and Friday's surgery
DX20969
DX20970
DX20971
DX20972
DX20973
ETH.MESH.00862753
06/02/2003 Emails re: Mulberry Clinical Decision
Summary and history of reclassification process. Medical devices;
Designation of Special Control for Eight Surgical Suture Devices, Final
Rule. Linda S. Kahan, Deputy Director, Center for Devices and
Radiological Health. (Please see 1990 letters re: FDA Reclass on PP
06/03/2003 Sutures, (07.05.1990 and 10.12/1990) 21 CFR 878.5010
06/04/2003 E-mail chain, top one from Janice Burns to Dan Smith, et al. regarding
IFU Key points
No Bates No.
ETH.MESH.06879417
ETH.MESH.07693238
ETH.MESH.03907854
06/04/2003 Email from Axel Araud to Dan Smith re: Mulberry Clinical Decision
06/06/2003 E-mail chain, top one from Laure Le Treguilly to Sascha Blessin regarding
TVT - Serious complication; cc: Michael Harm, et al.
ETH.MESH.03907854
Emails between Sascha Blessin (Sr. Marketing Mng., Gynecare
Europe/Germany) and Laure Le Treguilly (Gynecare Marketing Mng.) re
06/06/2003 TVT - Serious complication, Dangerous Procedure/Death
DX20974
DX20975
Page 52 of 191
Offered
Admitted
Exhibit
DX20976
DX20977
DX20978
DX20979
DX20980
ETH.MESH.00858177
ETH.MESH.00261584
ETH.MESH.00569426
ETH.MESH.00764216
ETH.MESH.01811295
ETH.MESH.00865487
DX20983
Description
06/06/2003 Mulberry Weekly Meeting Minutes. By Dan Smith
06/09/2003 Email from Sean O'Bryan re Mulberry stage gate action item closed
06/10/2003 ABC 2 News Interview
06/11/2003 E-mail from from Jacqueline Russo-Jankewicz to Brian Luscombe,
Zenobia Walji regarding Stressful Secrets press release crosses wire
ETH.MESH.00312306
ETH.MESH.01815613
06/16/2003 Email from Meg Helms to Dan Smith re: Discussion 11th June 2003
06/16/2003 E-mail thread with redactions, top one from Axel Arnaud to Meg E.
Helms regarding Discussion 11th June 2003; cc: Nina Wanendeya and
Janice Burns
Final Report, PSE Accession No. 00-0035. AN EXPLORATORY 91DAY TISSUE REACTION STUDY OF POLYPROPYLENE-BASED
06/16/2003 SURGICAL MESH IN RATS
Correspondence re: Response to Request for Information regarding
MedWatch No. 3900420000-2003-0001, from Mark Yale to Suzanne
06/17/2003 Malli, FDA/CDRH Medical Device Reporting
06/17/2003 E-mail chain, top one from Dan Smith to Dirk Van Brochoven, et al.
regarding FW: Discussion 11th June 2003
ETH.MESH.01814372
06/20/2003 E-mail chain, top one from Katrin Elbert to Dan Smith regarding Design
Control
DX20981
DX20982
Date
ETH.MESH.02200993
DX20984
DX20985
ETH.MESH.06879446
DX20986
DX20987
DX20988
DX20989
ETH.MESH.01815607
ETH.MESH.00260443
ETH.MESH.02180737
ETH.MESH.00764258
DX20990
DX20991
DX20992
ETH.MESH.00261539
ETH.MESH.00569441
06/23/2003
E-mail from Dan Smith to Janice Burns, Sean O'Bryan, et al. regarding
IFU; cc: Axel Arnaud, et al.
06/24/2003 Email b/w Amy Godwin and Axel Arnaud re: Mulberry Clinical Study 3
06/24/2003 E-mail chain, top one from Sean O'Bryan to Dan Smith regarding IFU
Email from Ronnie Toddywala regarding Project Mulberry [HOT
06/24/2003 DOCUMENT]
06/24/2003 E-mail string with attachment from Jacqueline Russo-Jankewicz regarding
Dr. Donnica and Stressful Secrets Media Results
06/26/2003 E-mail chain, top one from Martin Weisberg to Janice Burns, et al.
regarding IFU Update; cc: Brian Luscombe, et al.
06/30/2003 HealthNewsDigest.com article entitled "Summer Can be Stressful for
Women with SUI"
Page 53 of 191
Offered
Admitted
Exhibit
ETH.MESH.05585053
DX20993
DX20994
DX20995
Date
Description
06/30/2003
PowerPoint by Boris Batke: Ultrapro – Project Edelweiss
ETH.MESH.01813112
ETH.MESH.01815723
ETH.MESH.00030373
ETH.MESH.03715980
07/01/2003 Email from Dan Smith to Meg Helms re: Mulberry Clinical Study 3
07/03/2003 E-mail chain, top one from Suzanne Dufau to Dan Smith regarding TR:
Honoraires 2 trimestre Pr. De LEVAL; cc: Jean Francois Blanc
07/07/2003 E-mail from Brian Luscombe to DL-ETHUSSO SLS GYNECARE REPS,
et al. regarding "Urethral erosion may occur with any sling material
Article (TVT063)
07/09/2003 E-mail chain, top one from Martin Weisberg to Terry Courtney regarding
TVT question
ETH.MESH.00261558
07/10/2003 E-mail chain, top one from Martin Weisberg to Janice Burns, et al.
regarding IFU Update
ETH.MESH.00198393
ETH.MESH.0688509 to
ETH.MESH.0688510
ETH.MESH.00865352
ETH.MESH.03911161
ETH.MESH.01813202
ETH.MESH.03928542
07/10/2003 E-mail chain, top one from Sean O'Bryan to Janice Burns, Donna Taggart,
et al. regarding IFU Update; cc: Sean O'Bryan
07/10/2003 E-mail thread, top one from Martin Weisberg to Janice Burns, et al.
regarding Publication EAU; cc: Dan Smith
DX20996
DX20997
DX20998
DX20999
DX21000
DX21001
DX21002
DX21003
07/14/2003 July 14-15, 2003 Emails re: PROJECT MULBERRY
07/15/2003 Email from Axel Arnoud to Michael Harm re: Ralf Tunn
07/15/2003 Email from Dan Smith to group re: Mulberry – mesh color
07/17/2003 E-mail chain, top one from Axel Arnaud to Amy Godwin regarding
Suggestions for a reply to the competent authority; cc: Martin Weisberg
DX21004
DX21005
DX21006
DX21007
DX21008
ETH.MESH.03365251
ETH.MESH.00261563
07/23/2003 Email traffic re: ifu
ETH.MESH.00262123
ETH.MESH.00864102
“Novel surgical technique for the treatment of female stress urinary
07/24/2003 incontinence: Transobturator Vaginal Tape Inside-Out.” By Jean de Leval
E-mail chain, top one from Dan Smith to [email protected] regarding
07/24/2003 TOVT development; cc: Paul Parisis and Brian Luscombe
07/23/2003 Email fromWeisberg re: IFU update
Page 54 of 191
Offered
Admitted
Exhibit
DX21009
ETH.MESH.00944183
ETH.MESH.00030140
DX21010
DX21011
DX21012
DX21013
ETH.MESH.00864123
ETH.MESH.03803465
ETH.MESH.001220663
ETH.MESH.03918752
DX21014
DX21015
DX21016
DX21017
DX21018
DX21019
DX21020
DX21021
DX21022
DX21023
DX21024
ETH.MESH.01220663
ETH.MESH.00198428
ETH.MESH.00864133
ETH.MESH.06887044
ETH.MESH.01220693
ETH.MESH.08001453
ETH.MESH.00222284
ETH.MESH.00260527
ETH.MESH.00260475
ETH.MESH.02281705
ETH.MESH.03738467
Date
Description
Secrecy Agreements (unexecuted) between Gynecare and Drs. Samuel
Atkinson, Gerald Frankel, James Presthus, Dennis Miller, and mark
07/24/2003 Mokrzycki
07/30/2003 E-mail from Brian Luscombe to DL-ETHUSSO SLS GYNECARE REPS,
et al. regarding NEW!!! "Value Added" Selling Tools for GYNECARE
TVT; cc: Martin Chomiak
08/06/2003 Email string from Dan Smith to Brian Luscombe and others re: Article
Email traffic beginning with an email from Laura Angelini to Steve Bell et
08/08/2003 al. re: Transient Leg Pain with MULBERRY
E-mail chain, top one dated 14 Aug 2003 from Kammerer to Toddywala
08/14/2003 Re August 11 Program
E-mail chain, top one from Amy Godwin to Jean [email protected]
08/14/2003
regarding TVT Blue; cc: Axel Arnaud, et al.
08/14/2003 E-mail string, top one from Gene Kammerer to Ronnie Toddywala
regarding Aug 11 program
08/14/2003 Text Approval Form #2003-059
E-mail chain, top one from Brian Luscombe to Mosaddeq Hossain, et al.
08/15/2003 regarding Aug 11 program; cc: Dan Smith, et al
08/18/2003 E-mail thread, top one from Jean De Leval to Jean De Leval; cc: Amy
Godwin, Axel Arnaud, et al. regarding TVT Blue
08/18/2003 Emails re Dr. Alex Wang's complaints re frayed and uneven mesh
08/26/2003 Emails from Greg Jones and Philip Newlands re: Clinical Evaluation
Quality Assurance Strategy – Project Mulberry. Signed by R. Wiggins,
08/26/2003 QA Manager, on 8/26/2003
08/27/2003 Text Approval Form #2003-059 Rev 1
08/28/2003 E-mail chain, top one from Martin Weisberg to Sean O'Bryan, Greg Jones,
et al. regarding New Illustrations; cc: Jean de Leval, et al.
09/02/2003 General Procedure, Title: FMEA, Spec #EPG05
09/06/2003 E-mail chain, top one Martin Weisberg to Peggy Norton regarding TVT
DX21025
DX21026
DX21027
ETH.MESH.03738467
ETH.MESH.00865850
Emails between Martin Weisberg and Dr. Peggy Norton re TVT
09/06/2003 Underreporting of complications Professional Education/Training
09/07/2003 September 7-24, 2003 Emails re: JEB Audit Finding Summary – Draft
Page 55 of 191
Offered
Admitted
Exhibit
Date
Description
ETH.MESH.00862868
09/08/2003 E-mail thread, top one from Janice Burns to David Waltregny, Dan Smith,
et al. regarding Revision of manuscript submitted to European Urology
ETH.MESH.03932905
09/11/2003 E-mail chain, top one from Axel Arnaud to Regis Gauderon regarding
Demande info- historique TVT
DX21028
DX21029
DX21030
DX21031
DX21032
DX21033
ETH.MESH.00865392
ETH.MESH.02270201
ETH.MESH.02287969
ETH.MESH.00222104
ETH.MESH.00198486
DX21034
DX21035
DX21036
DX21037
DX21038
ETH.MESH.00261609
ETH.MESH.00222326
ETH.MESH.01028086
ETH.MESH.05483362
ETH.MESH.05483362
DX21039
DX21040
DX21041
DX21042
DX21043
DX21044
ETH.MESH.00261682
ETH.MESH.01220710
ETH.MESH.00402070
ETH.MESH.00261617
ETH.MESH.06887117
ETH.MESH.06885495
DX21045
DX21046
ETH.MESH.00222223
09/12/2003 Email string re: 2004 TVT Volumes + mulberry
Clinical Expert Report for Obturator and Posterior Guides (author: M.
09/16/2003 Weisberg)
Corporate Product Characterization Product Performance Evaluation /
09/19/2003 Test Report for Project Edelweiss (UltraPro)
Summary of MULBERRY Lab Feeback from US physicians—INTERIM
09/19/2003 report as of September 19th 2003
09/24/2003 E-mail chain, top one from Sean O'Bryan to Donna Taggart, Janice Burns,
et al. regarding Additional questions on the GYNECARE TVT insert; cc:
[email protected]
09/29/2003 Emails re: Mulberry sheath issue update
Approvals Manufacturing and Process Validation Strategy. Signed by
10/01/2003 Dan Smith and Robert Hendershoot
Oct-2003 Clinical Study Agreement for Investigator Initiated Studies
10/02/2003 "ULTRAPRO Mesh Pricing Committee Presentation"
10/02/2003 Document Produced in native formate/ PowerPoint presentation entitled
"ULTRAPRO Mesh Pricing Committee Presentation"
10/02/2003 Email from Dan Smith re: Mulberry sheath issue update
Email from Gene Kammerer to Georgina NG re: Technical data on
10/14/2003 competitve meshes from Europe
10/15/2003 Informed Consent for Participation in Research Activities
10/16/2003 Email from Alan Bossenger re: John Sheets Update
“Novel SurgicalTechnique for theTreatment of Female Stress Urinary
Incontinence:TransobturatorVaginalTape Inside-Out.” By Jean de Leval.
10/17/2003 European Urology
10/17/2003 Email from Amy Godwin to Janice Burns, Dan Smith, et al. rearding
Study #3 extension; cc: Martin Weisberg, et al.
10/23/2003 Design Input Strategy – Project Mulberry, signed by Dan Smith
Page 56 of 191
Offered
Admitted
Exhibit
DX21047
DX21048
DX21049
ETH.MESH.00259274
ETH.MESH.00865317
ETH.MESH.00524445
ETH.MESH.03715645
Date
Description
10/23/2003 Design Input Strategy Project Mulberry by Dan Smith and Janice Burns
10/23/2003 Email from Weisberg re: EJU Publication
Letter from Martin Weisberg (Director, Medical Affairs, Gynecare) - 7
Year Data Indicates Strong Continued Safety and Effectiveness For
10/25/2003 GYNECARE TVT Tension-free Support for Incontinence
10/28/2003 E-mail chain, top one from Martin Weisberg to Janice Burns regarding
EJU Publication
DX21050
DX21051
DX21052
ETH.MESH.05123917
ETH.MESH.05236255
ETH.MESH.07938633
DX21053
DX21054
ETH.MESH.00541380
ETH.MESH.01126907;
ETH.MESH.00541380
10/30/2003 Document entitled "GYNECARE TVT Public Relations Activities 2003"
10/30/2003 Presentation: TVT Patent Portfolio by Andrea Slater-Tomko
11/07/2003 PowerPoint presentation entitled "GYNECARE TVT Tension-free Support
for Incontinence, Sales Update, November 7, 2003"
11/18/2003 Memo from Martin Weisberg to File re: Mesh Fraying for TVT Devices
11/18/2003 Memo from Marty Weisberg to File regarding Mesh Fraying for TVT
Devices; cc: Mosaddeq Hossain, et al.
DX21055
DX21056
DX21057
DX21058
DX21059
DX21060
DX21061
DX21062
DX21063
DX21064
ETH.MESH.03715574
ETH.MESH.03715574
ETH.MESH.00865627
ETH. MESH.00865625 to
ETH.MESH.00865627
ETH.MESH.02270951
ETH.MESH.00863924
ETH.MESH.00222899 to 00222909
ETH.MESH.00259644
ETH.MESH.02180669
11/26/2003 E-mail chain from Martin Weisberg to Barbara L. McCabe regarding
LeVal
11/26/2003 E-mail chain, top one from Martin Weisberg to Barbara L. McCabe
regarding leVal
11/26/2003 E-mail from David Waltregny to Axel Arnaud, et al. regarding e-mail
written on behalf of Professor de Leval; cc: Jean Leval
11/26/2003 E-mail with no subject from David Waltregyn to Burns, Axel Arnaud and
Dan Smith; cc: Jean de Leval;
12/3/2003 E-mail string from Zenobia Walji to Scott Ciarrocca regarding Is
there a good time when we can speak tomorrow if possible or so
metime this week?
12/16/2003 Clinical Expert Report
12/16/2003 Clinical Expert Report signed by Dr. Martin Weisberg
12/16/2003 Clinical Expert Report. Signed by Martin Weisberg
12/16/2003 Email from Wanendeya re: Gift for Jean DeLeval
Page 57 of 191
Offered
Admitted
Exhibit
DX21065
DX21066
ETH.MESH.01318848
ETH.MESH.03715161
ETH.MESH.06164410
Date
Description
12/18/2003 Potential Failure, Mode, and Effects Analysis (Process FMEA)
01/12/2004 Email traffic re: TVT vs SPARC study
01/16/2004 E-mail chain, top one from Dan Smith to Susan Meltzer, et al. regarding
FW: Dedication; cc: Fernando Jaramillo, et al.
DX21067
DX21068
DX21069
DX21070
DX21071
DX21072
ETH.MESH.05793693
No Bates number
GYNECARE TVT Introduction to cross train the Uterine Health reps on
01/29/2004 TVT
Feb-2004 PowerPoint, "2004 Strategic Alignment Regulatory Affaris & Quality
Assurance, Catherine V. Beath, Worldwide Vice President, RA/QA,
February 2004," 30 pages
02/17/2004 Email from Janice Burns to Group re: EJU de Leval Publication
ETH.MESH.00865633
ETH.MESH.00900458
ETH.MESH.02270825
ETH.MESH.00863393
02/24/2004 E-mail chain, top one dated 24 Feb 2004 re: mesh implants – user needs
E-mail chain re: Mesh Implants – User Needs - Zaddem to Scott
02/26/2004 Ciarrocca, Josh Samon and Liz Vailhe
02/27/2004 E-mail chain, top one from Dan Smith to Janice Burns regarding
Important: 2 TVT Complaints concerning allegedly brittle mesh
ETH.MESH.06881079
ETH.MESH.06881080
ETH.MESH.00863392
ETH.MESH.00865323
Email from Dan Smith re Important: 2 TVT Complaints concerning
02/27/2004 allegedly brittle mesh
02/27/2004 E-mail string, top one from Dan Smith to Janice Burns regarding
Important 2 TVT Complaints concerning allegedly brittle mesh
Emails between Dan Smith and Janice Burns re: Important: 2 TVT
02/27/2004 Complaints concerning allegedly brittle mesh
03/02/2004 E-mail chain, top one from Charlotte Owens to Dan Smith regarding
Reminder on BLUE mesh
DX21073
DX21074
DX21075
DX21076
DX21077
DX21078
DX21079
DX21080
DX21081
DX21082
DX21083
ETH.MESH.00865323
ETH.MESH.08003196
ETH.MESH.00776577
ETH.MESH.00776576
No Bates No.
ETH.MESH.00776577
Email from Steve Bell (Director Marketing Europe) to Sales & Marketing
03/02/2004 Team re Reminder on Blue Mesh - frayed mesh/particle loss
Ethicon Copy Review Submission form: GYNECARE TVT Patient
03/03/2004 Brochure. Submitted by Robin Osman
03/12/2004 Email from G. Maroney to Dr. Donnica re: TVT info to Oprah
03/12/2004 E-mail from Gina Maroney to [email protected] regarding TVT info to
Oprah
03/12/2004 Gynecare TVT Competitive Overview Brand Positioning Matrix
03/12/2004 Letter to Oprah from G. Maroney enclosed with Exhibit T-3037
Page 58 of 191
Offered
Admitted
Exhibit
DX21084
ETH.MESH.03910638
ETH.MESH.05793740
Date
Description
03/17/2004 E-mail chain, top one dated 17 March 2004, re: critical Q&A
03/24/2004 2-page copy of project plan for Advance TVT Sales
DX21085
DX21086
ETH.MESH.01988643
DX21087
ETH.MESH.01424246
ETH.MESH.02180761
ETH.MESH.00637637
03/25/2004 Email from Vincenza Zaddem to Scott Ciarrocca re: disclosure questions
Holste, J; Test report No.: B0086/02, Histopathological
03/25/2004 report/Immunohistochemical report
Summary of Confidential Meeting held on 22 March 2004 and preprared
03/29/2004 by Professor Jean de Leval, MD, University of Liege
04/06/2004 E-mail from Paul Parisi to [email protected] regarding Updated slides on
TVT; cc: Mickey Karram
ETH.MESH.01993602
ETH.MESH.07190446
Ethicon Memo re: Risk Assessment for Laser Cutting of D’Art Gynemesh
04/07/2004 PS Implants
04/07/2004 Interoffice Memorandum from Josh Samson to Michael Pelekis regarding
Risk Assessments for Laser Cutting of D'Art Gynemesh*PS Implants
DX21088
DX21089
DX21090
DX21091
DX21092
DX21093
DX21094
DX21095
DX21096
ETH-3882 to ETH-3888
ETH.MESH.00128386
ETH.MESH.00658065
ETH.MESH.02614520
ETH.MESH.00862208
ETH.MESH.05918776
DX21097
ETH.MESH.00128360
Memo from Pelekis to Samon re: Risk Assessment for Laser Cutting of
04/07/2004 D'ART Gynemesh PS
Incontinence Planning Briefing Discussion, April 9th, 2004/prepared by
04/09/2004 Zenobia Walji
Surgeon Brochure “Only GYNECARE TVT has long-term Results you
04/14/2004 can see… and believe”
Corporate Product Characterization – Product Performance Evaluation–
04/27/2004 Study Report. LIMS Project #: BE-2004-916
04/27/2004 LIMS Project #: BE-2004-916 - Secant from Cornelia 2004 Validation
05/04/2004 E-mail from Jill Schiaparelli to Karen Zaderej, Daniel Brostoff, et al.
regarding Marlex Epxerience
05/11/2004 E-mail string from Ettore Carino to Kimberly Mullarkey, Lissette,
Caro-Rosado, et al. regarding Revenue acceleration approaches
DX21098
DX21099
DX21100
DX21101
ETH.MESH.00637749
ETH.MESH.08002850
ETH.MESH.03577122
05/21/2004 Email string re: TVT PE History
06/02/2004 E-mail chain, top one from Martin Weisberg to Charlotte Owens
regarding Dr. Disciullo; bbc: Joel S. Lippman
06/16/2004 E-mail from Charlotte Owens to Thomas White regarding Complaint
300046633
Page 59 of 191
Offered
Admitted
Exhibit
DX21102
DX21103
ETH.MESH.00639186
ETH.MESH.00639191
ETH.MESH.03910800
Date
Description
E-mail from Kevin Mahar discussing next steps for mesh; question
07/14/2004 whether synthetics are better than non-synthetics
07/17/2004 E-mail from M. Kaminski re: D’Art Professional Education Strategy
07/21/2004 E-mail chain, top one from Axel Arnaud to Janice Burns regarding TVT
Erosion?
DX21104
DX21105
DX21106
ETH.MESH.03910800
ETH.MESH.00915105
ETH.MESH.03490356
ETH.MESH.05456118
07/21/2004 Email from Axel Arnaud re TVT Erosions?
E-mail chain, top one dated 30 Jul 2004 re: Prolene material: pull strength
07/30/2004 improvement
08/12/2004 Letter from Lee Ann Berger to Hiroko Hoshino regarding 830041 - 5mm
TVT device Reference # 30004455 Affiliate # GC20040002
James McDivitt email chain re Autoclaving PROLENE -- Prolene resin
08/16/2004 has cytotoxic components
No Bates No.
ETH.MESH.06884517
08/16/2004 McDivitt, James e-mail re: Autoclaving PROLENE dated Aug 16, 2004.
08/18/2004 E-mail from Kevin Mahar to Paul DeCosta, et al. regarding Dr. Jensen
Follow Up; cc: Lisa Pitts, et al.
ETH.MESH.06869753
08/18/2004 Human Cadaver Wetlab Report/Results DRAFT, Document (#): SO 04/2
HCW 3, Datum: August 18, 2004
DX21107
DX21108
DX21109
DX21110
DX21111
DX21112
DX21113
DX21114
DX21115
ETH.MESH.05795300
ETH.MESH.05222701
ETH.MESH.04192739
ETH.MESH.03793298
ETH.MESH.05456925
10/06/2004 Regulatory Strategy (dated 10/06/2004)
10/07/2004 E-mail from Dan Smith to Richard Hutchinson, et al. regarding TVTx Next Generation TVT "Project INITIATION"
ETH.MESH.05456924
10/07/2004 Email from Dan Smith to TVTx - Next Generation TVT "Project Initiation"
ETH.MESH.00031560
ETH.MESH.08692672
PowerPoint, "Gynecare Professional Relations and Professional Education,
10/07/2004 'Educating Customers Worldwide to improve the lives of women,'"
Cancellation Agreement between Ethicon, Inc., Contape S.A., and the
10/18/2004 estate of Professor Ulf Ivar Ulmsten
08/27/2004 Email string re: 2004 Budget - PE August adjustments
Oct-2004 Gynecare TVT Tension-Free Vaginal Tape Instructions
10/05/2004 Letter dated 5 Oct. 2004 re: Notification of Opinion
DX21116
DX21117
DX21118
DX21119
Page 60 of 191
Offered
Admitted
Exhibit
DX21120
ETH.MESH.09747495
DX21121
ETH.MESH.02180833
DX21122
No Bates No.
ETH.MESH.05537701
DX21123
DX21124
No Bates No.
ETH.MESH.05548123
Date
Description
10/18/2004 Cancellation Agreement with Ulmsten
Translated letter of Dr. J. Eberhard to Emilie (Bus. Unit Manager,
10/18/2004 Gynecare Switzerland), re: TVT Tape KEY DOCUMENT
Tsui, K., et al. Complications of synthetic graft materials used in
Suburethral sling procedures. Int Urogynecol J. 2005;16:165-167.
10/19/2004 Published online 10/19/2004
10/27/2004 E-mail chain top one from Artibani Walter to Peter Meier regarding
Results of TVTx preclinical trial; cc: Janice Burns and Dan Smith
MSDS Total Petrochemicals USA Polypropylene Copolymer Sheet,
10/29/2004 Validation date: October 29, 2004
11/01/2004 E-mail chain top one from Dan Smith to Karran Mickey regarding Update
from Oct 27 cadaver lab; cc: Laura Angelini
DX21125
DX21126
ETH. MESH.01813975 to
ETH. MESH.01813978
ETH.MESH.05960623
DX21127
DX21128
ETH.MESH.06705976
ETH.MESH.02180830
11/02/2004 E-mail string top one from Patty Lancos to Manuel Castro and Dan Smith
regarding FDA Prep
11/03/2004 E-mail chain, top one from Eltore Carino to Marianne Kaminski and Janet
Toth regarding Express lane CR; cc: Paul Parisi, et al.
11/09/2004 Draft Gynecare Value Proposition Report Project TVTx
11/10/2004 Fax from Sibylle Basso to David Menneret, 3 pages, enclosing letter from
Dr. Eberhard re TVT Blue
DX21129
DX21130
DX21131
ETH.MESH.06661979
ETH.MESH.02225871
ETH.MESH.02180827
11/10/2004 Target Sheet, DH0269: TVT (TENSION FREE VAGINAL TAPE)
FACTBOOK
Document titled “Textile Analysis of Heavyweight, Midweight and
Lightweight Polypropylene Mesh in a porcine ventral hernia model”.
11/11/2004 Presented on 11/11/2004 – 11/13/2004
11/12/2004 E-mail chain, top one from Daivd Menneret to Eric Gauthier regarding
TR: Mesh Fraying: Dr. EBERHARD letter; cc: Sybille Basso, et al.
ETH.MESH.01814252
11/12/2004 E-mail chain, top one from Mark Yale to David Menneret and Linda
Vendome regarding Mesh Fraying; cc: Sybille Basso, et al.
ETH.MESH.02180827
ETH.MESH.01814252
Email from David Menneret to Dan Smith and others re Mesh Fraying:
11/12/2004 DR. EBERHARD letter
DX21132
DX21133
DX21134
DX21135
11/12/2004 E-mail string re: Mesh Fraying
Page 61 of 191
Offered
Admitted
Exhibit
Date
Description
ETH.MESH.00632026
11/16/2004 E-mail chain with redactions, top one from Steve Bell to Kevin Mahar
regarding TVT REPORT
ETH.MESH.00411717
ETH.MESH.00632029
Clinical Study Agreement for Investigator Initiated Studies - 300-04-014
11/18/2004
11/18/2004 E-mail chain, top one from Aixa Colon to Kevin Mahar and Janice Burns
regarding TVTx launch costs for financial model;cc: Dan Smith
ETH.MESH.00259042
ETH.MESH.00259042
11/22/2004 2004 Strategy Tree Project Definition
11/22/2004 2004 Strategy Tree Project Definition
ETH.MESH.01811758
11/29/2004 E-mail from Paul Parisi to Ettore Carino, Kevin Mahar, et al. regarding
TVT Laser cut mesh business case (for meeting this afternoon)
ETH.MESH.00155600
ETH.MESH.03573981
ETH.MESH.00656170
ETH.MESH.07898871
7 year Data Press Release, New Study Shows Minimally-Invasive Surgery
11/30/2004 for Female Incontinence Offers Good Long-Term Cure Rates
DX21136
DX21137
DX21138
DX21139
DX21140
DX21141
DX21142
DX21143
DX21144
ETH.MESH.00142468
Development Contract - TVT-Next (TVTx), email string re: final attempt,
Article - Functional and Anatomical Outcome of Anterior and Posterior
11/30/2004 Vaginal Prolapse Repair with Prolene Mesh
12/01/2004 2-page copy of E-mail from Linda Nichols to Linda Ansell, Geraldine
Canfield, et al. regarding FW: TVTx Charter document for 12/06 GAT
meeting, plus attachments
12/2/2004 2-page copy of document dated 12/02/2004 entitled"GYNECARE Copy
Review Submission Form"
DX21145
DX21146
ETH.MESH.08003212
ETH.MESH.01811772
12/08/2004 Brochure Reprint. Submitted by Robin Osman
12/10/2004 E-mail string from Steve Bell to Dan Smith, Kevin Mahar, et al.
regarding VOC on Laser cut mesh
DX21147
DX21148
ETH.MESH.01811772
DX21149
ETH.MESH.09908704
Emails between Steve Bell, Kevin Mahar and Dan Smith re VOC on Laser
12/10/2004 cut mesh - underreporting of complications
Ethicon Memo from Leibowitz, December 14, 2004, re: Comparison of
Laser-Cut and Machine-Cut TVT Mesh to Meshes from Competitive
12/14/2004 Devices (BE-2004-1641)
DX21150
ETH.MESH.05567008
Letter from Donald Voeller at FDA to Francisco Aponte, Plant Manager at
Ethicon LLC, enclosing copy of the Establishment Inspection Report (EIR)
12/14/2004 for the inspection conducted at Ethicon, LLC in May 2004
Page 62 of 191
Offered
Admitted
Exhibit
DX21151
ETH.MESH.01809081
ETH.MESH.01809081
DX21152
DX21153
DX21154
DX21155
DX21156
ETH.MESH.03358822
ETH.MESH.00411731
ETH.MESH.01809078
ETH.MESH.06878439
ETH.MESH.05245399
DX21157
DX21158
DX21159
DX21160
ETH.MESH.05245392
ETH.MESH.00067662
ETH.MESH.00440005
ETH.MESH.00440007
DX21161
Date
Description
Memo from Becky Leibowitz to Dan Smith re: Comparison of Laser-Cut
and Machine-Cut TVT Mesh to Meshes from Competitive Devices (BE12/14/2004 2004-1641).
12/14/2004 Memo from Becky Leibowitz to Paul Parisi and Dan Smith
regarding Comparison of Laser-Cut and Machine-Cut TVT Mesh
from Competitive Devices (BE-2004-1641); cc: Mark Storch,
RDCF
12/15/2004 E-mail string. Dr. Dennis Miller to Barbara Schwartz
Clinical Study Agreement for Investigator Initiated Studies
12/17/2004
12/17/2004 E-mail string re: Important Laser Cut Mesh Update
Memo: VOC on new Laser Cut TVT Mesh. From Allison London-Brown
12/17/2004 to P. Parisi and K. Mahar
12/21/2004 8-page copy of E-mail from Dr. Joerg Holste to Steve Bell and Peter
Meier regarding TVT-Next generation Questions; cc: Dan Smith and
Mark L. Storch
Email from Joerg Holste to Steve Bell et al. re TVT - Next Generation
12/21/2004 Questions
01/03/2005 Preceptor Recommendation Form – Dr. Omar Sarmini
Angelini email chain re Important Laser cue mesh Update ...roping and
sheath issues with tension ... didn't want to change produce because would
01/05/2005 not allow them to reply on the Ulmsten 7 year data.
01/05/2005 E-mail string from Laura Angelini to Ronnie Toddywala, Dan
Smith, et al. regarding Important Laser cut mesh Update; cc: Kevin
Mahar, et al.
ETH.MESH.00439999
ETH.MESH.04036981
01/05/2005 E-mail string, top one from Dan Smith to Laura Angelini, et al. regarding
Important Laser cut mesh Update; cc: Kevin Mahar
01/13/2005 6-page copy of document entitled "Report Analysis of Competitors
meshes: Dynamesh, Dynamesh Light, Dynamesh IPOM"
01/18/2005 Document entitled "2004 Performance and Development Plan Summary
for Patricia Hojnoski"
DX21165
ETH.MESH.07931886
ETH.MESH.00442826
DX21166
ETH-18761
DX21162
DX21163
DX21164
01/18/2005 Email from Allison London-Brown to Steve Bell re: TVT Laser Mesh info
Email from Kelly Brown to Gene Kammerer re: Proposal for work with
01/18/2005 CBAT
Page 63 of 191
Offered
Admitted
Exhibit
DX21167
ETH.MESH.00145548
DX21168
DX21169
ETH.MESH.00442129
ETH.MESH.02248778
DX21170
ETH.MESH.004427970
ETH.MESH.00067904
Date
Description
Gynecare TVT Updated Statement of Complications December 2004 01/19/2005 Prof. Ed. Slide Deck - Copy Approval (2005-1060)
PowerPoint Mechanical vs. “Machine”-cut Mesh, January 19, 2005
01/19/2005 Prepared by: Allison London Brown & Gene Kammerer
1/19/2005 PowerPoint Presentation, "Mechanical vs. Machine-cut Mesh"
PowerPoint slide re Improve Efficiency – Know Your Target: The
01/24/2005 Physician – The Scientist: Rational – The Healer: Emotional
01/27/2005 E-mail string from Carolyn Brennan to Paul Parisi regarding TVT
procedures; cc: Carolyn Brennan
DX21171
DX21172
ETH.MESH.00411706
ETH.MESH.00223431
DX21173
DX21174
DX21175
DX21176
DX21177
DX21178
DX21179
No Bates No.
ETH.MESH.00524907
ETH.MESH.00162419
ETH.MESH.00162425
ETH.MESH.01037545
ETH-18459
ETH.MESH.00656170
ETH.MESH.00656165
DX21180
ETH.MESH.02627421
DX21181
DX21182
DX21183
No Bates No.
No Bates No.
ETH.MESH.02627471
1/28/2005
01/31/2005 E-mail from Raimo Sump to Steve Bell, et al. regarding TVTx Minutes /
Agenda - Team Meeting: January 25th 2005 / February 1st 2005; cc: Aixa
Colon, et al.
"TVT Bonnie Blair Campaign, Professional Advertising Initiatives,
02/01/2005 February 1, 2005"
02/01/2005 Presentation: TVT Bonnie Blair Campaign
02/02/2005 Gynecare Copy Review Submission Form
Gynecare TVT and ThermaChoice Mailers for Physicians with redactions
02/02/2005
02/08/2005 Final Report: Ethicon Study No. SO04/2-2-1 "A 3 month pre-clinical trial
to assess the fixation force of a new TVT (TVTx) in the sheep model"
02/16/2005 Dear Doctor Letter from Paul Parisi dated February 16, 2005
02/16/2005 E-mail chain from Julie Hocknell to DL-ETHITPR Gynecare Marketing,
et al regarding attached article from Jan. issue of the British Journal of
Obs & Gynae
E-maih chain, top one from Cheryl Bogardus to Allison London Brown
rearding final attempt; cc: Kevin Mahar
02/18/2005 Issue Report TVT Retropubic 2005-2007
02/22/2005 MSDS for Alcoa Kama Polypropylene Sheet 2/22/2005.
Lamont, D (Gynecare) Memo re: TVT laser cut mesh (LCM) risk analysis
02/24/2005 summary dated 2/24/2005.
02/25/2005 Issue Report TVT Retropubic 2005-2007
DX21184
Page 64 of 191
Offered
Admitted
Exhibit
ETH.MESH.03574660
DX21185
DX21186
DX21187
DX21188
DX21189
DX21190
DX21191
DX21192
ETH.MESH.00067904
ETH.MESH.01037530
ETH.MESH.03574919
ETH-07247 to ETH-07303
ETH.MESH.02283782
ETH.MESH.03574965
ETH.MESH.0228368485
ETH.MESH.06828690
Date
Description
02/25/2005 Letter with redactions from Lee Ann Berger regarding TVT Device
Reference # 30005117
02/27/2005 Email traffic re: TVT procedures
A 3 month pre-clinical trial to assess the fixation force of a new TVT
02/28/2005 (TVTx) in the sheep model - Ethicon's Final Report
03/01/2005 E-mail from Charlotte Owens to Carol Holloway regarding Medical
Review file #30005136
03/02/2005 Approvals and Summary Memo for Version A of the Application FMEA
03/03/2005 e-mail from Dr. Charlotte Owens
03/04/2005 E-mail chain with redactions, top one from Thomas White to Carin
Rassier regarding Call from call center
03/04/2005 e-mail from S. Ciarrocca re Product Release Authorization
03/08/2005 E-mail chain, top one from Allison London Brown to Paul Parisi
regarding Certificates for Prolift training;; cc: Kevin Mahar and Erika Lane
DX21193
DX21194
DX21195
DX21196
ETH.MESH.06828690
ETH.MESH.00411684
ETH.MESH.03499529
ETH.MESH.05549191
DX21197
DX21198
DX21199
ETH.MESH.05505944
ETH.MESH.07510349
ETH.MESH.03577583
DX21200
DX21201
ETH.MESH.00753180
ETH.MESH.06828909
03/08/2005 Email string re: Certificates for Prolift Training
3/10/2005
03/10/2005 Letter from Lee-Ann Berger to Ms. Jocelyne Wallingford regarding
Unknown TVT Reference # 30005146 Affiliate # 15662
03/11/2005 3-page copy of E-mail from Dr. Joerg Holste to Sandy Savidge, Raimo
Sump, et al. regarding Infection risk implantation TVT U; cc: Thomas
Barbolt, et al.
03/11/2005 Clinical Infection Risk Assessment for Gynecare TVT Universal (TVT U)
03/11/2005 Email traffic re: Infection risk implantation TVT U
03/15/2005 E-mail from Charlotte Owens to Carin Rassier re review of report for
complaint 30005201
03/23/2005 Regulatory Strategy dated March 23, 2005
03/24/2005 E-mail chain, top one from Kimberly Hunsicker to Laura Angelini
regarding ICS Submission; cc: Kevin Mahar, et al.
DX21202
ETH.MESH.02271018
DX21203
03/25/2005
E-mail string from Charlotte Owens to Scott Ciarrocca regarding
Hematoma
Page 65 of 191
Offered
Admitted
Exhibit
DX21204
ETH.MESH.06859835
No Bates number
DX21205
ETH.MESH.03575061
DX21206
DX21207
ETH.MESH.00189091
ETH.MESH.02661378
DX21208
ETH.MESH.03575072
DX21209
ETH.MESH.05795324
Date
Description
03/31/2005 Email re: Laser Cut TVT
Material Safety Data Sheet for C4001 Polypropylene Homopolymer, 6
04/01/2005
pages
04/05/2005 E-mail from Charlotte Owens to Carin Rassier regarding Medical Review
file #30005136
04/05/2005 Minutes from Design Change Review
Research Funding Agreement (MEDICAL DEVICES AND FINANCIAL
SUPPORT) - Study: The relationship of URP to outcomes following
urinary incontinence surgery; Study Product: MiniTorr & TVT
4/7/2005
04/12/2005 E-mail chain, top one from Carolyn to Carin Rassier regarding Complaint
30005270
04/13/2005 3-page copy of E-mail chain, top one from Marianne Kaminski to
Marianne Kaminski, et al. regarding Q1 PE results; cc: Susie Chilcoat
DX21210
DX21211
DX21212
DX21213
DX21214
DX21215
DX21216
ETH.MESH.00994918
ETH.MESH.05795324
ETH.MESH.00658429
No Bates No.
ETH.MESH.00918019
ETH.MESH.04945496
ETH.MESH.03575083
04/13/2005 E-mail from Barbara L. McCabe to Dharini Amin and Kristen Tonnessen
regarding Sheath Sales Tool; cc: Kevin Mahar
04/13/2005 Email string re: Q1 PE results - REVISED
04/13/2005 Education Brochure. Submitted by Robin Osman
MSDS C4001 Polypropylene Homopolymer, Published online April 13,
04/13/2005 2005
MSDS C4001 Polypropylene Homopolymer, Published online April 13,
04/13/2005 2005 Sunoco, Inc. (R&M)
ETH.MESH.03908708
04/18/2005 Email from Klosterhalfen to Holste re Ultrapro vs. Prolene Soft Mesh
04/21/2005 E-mail from Charlotte Owens to Carin Rassier regarding Complaint
30005285
30005297
04/27/2005 E-mail from Paula Evans to DL-ETHITPR Gynecare Marketing, et al.
regarding FW: PROLENE vs polypropylene; cc: Barbara L. McCabe
ETH.MESH.05549700
Komamycky, P email chain originating04/28/2005 re Bio compatibility
04/29/2005 samples -- Discussion involving issues with Supplier, resin changes
DX21217
ETH.MESH.03575101
DX21218
DX21219
DX21220
Page 66 of 191
Offered
Admitted
Exhibit
DX21222
DX21223
ETH.MESH.00995834
ETH.MESH.00995831
No Bates No.
DX21224
ETH.MESH.02614624
DX21225
ETH.MESH.00307227
DX21221
DX21226
ETH.MESH.03713784
ETH.MESH.06696379
DX21227
DX21228
DX21229
ETH.MESH.08486474
ETH.MESH.06696379
ETH.MESH.00526473
DX21230
DX21231
DX21232
DX21233
ETH.MESH.00526474
ETH.MESH.00029282
ETH.MESH.00032754
ETH.MESH.03575054
DX21234
ETH.MESH.03575123
DX21235
DX21236
DX21237
ETH.MESH.00875776
ETH.MESH.03575123
Date
Description
05/02/2005 For Internal Use - Do Not Distribute to Customers Field Communication
05/03/2005 E-mail Thread re Complication Data for TVT and TVTO
05/04/2005 Spreadsheet
Test report from Katherine Seppa to Raimo Sump and Allison LondonBrown re: Performance Evaluation of TVT U PROLENE Mesh:
05/04/2005 Mechanical Cut versus laser cut. Study (LIMS# BE-2004-1920) Version 2
Ethicon Memo from Seppa, May 5, 2005, re: Performance Evaluation of
TVT U Prolene Mesh: Machine Cut verses Laser Cut. Study (LIMS# BE05/05/2005 2005-1920) Version 3
Ethicon Memo re: Performance Evaluation of TVT U PROLENE Mesh:
05/05/2005 Mechanical Cut versus Laser Cut. Study (LIMS# BE-2005-1920) Version 3
05/05/2005 Memo from Katherine Seppa to Raimo Sump and Allison LondonBrown regarding Performance Evaluation of TVT U PROLENE
Mesh: Mechanical Cut versus Laser Cut Study (LIMS# BE-20051920) Version 3
05/05/2005 Regulatory Strategy dated May 5, 2005
Test report from Katherine Seppa to Raimo Sump and Allison LondonBrown re: Performance Evaluation of TVT U PROLENE Mesh:
05/05/2005 Mechanical Cut versus laser cut. Study (LIMS# BE-2005-1920) Version 3
05/06/2005 E-mail from Allison London Brown to Nancy Leclair, Dharini
Amin, et al. regarding Laser cut Mesh; cc: Kevin Mahar, et al
05/06/2005 E-mail from Allison London Brown to Nancy Leclair, Dharini Amin, et al.
regarding Laser cut Mesh; cc: Kevin Mahar, et al.
05/09/2005 E-mail dated 09 May 2005
Gynecare memo to Amy Smalling from Tom Lech re: Field Visit April 2605/10/2005 27, 2005
05/15/2005 E-mail chain, top one from Carolyn Brennan to Carin Rassier regarding
Complaint 30005258; cc: Carolyn Brennan
05/18/2005 E-mail from Charlotte Owens to Carin Rassier regardign Complaint
30005318
05/18/2005 E-mail string re: Gynemesh GPSL complaint
05/18/2005 E-mail to Rassier from Owens re: Complaint
Page 67 of 191
Offered
Admitted
Exhibit
DX21238
DX21239
ETH.MESH.03911618
ETH.MESH.02627471
ETH.MESH.03575189
DX21240
DX21241
DX21242
DX21243
ETH.MESH.00524436
ETH.MESH.06403725
ETH.MESH.03923934
ETH.MESH.00160212
Date
Description
05/25/2005 E-mail chain, top one dated 25 May 2005, re: mesh adoption
05/25/2005 TVT Retropubic Issue Report No. 30005181
30005352
06/01/2005 E-mail Thread, 6/1/2005 Subject, FYI
Final Report: Ethicon Study No. SOD4/2-2-1: A 3
month pre-clinical trial to assess the fixation force of a new TVT (TVTx)
06/02/2005 in the sheep model
06/09/2005 Press Interview Frankfurt June 9, 2005
06/22/2005 GYNECARE Copy Review Submission Form
DX21244
DX21245
DX21246
DX21247
DX21248
ETH.MESH.01208507
ETH.MESH.06707499
ETH.MESH.03575300
ETH.MESH.00528573
ETH.MESH.00126933
Impact of tension-free vaginal tape on sexual function: results of a
prospective study. Int Urogynecol J (2005) 17: 54-59. [HOT
06/27/2005 Regulatory Strategy dated June 27, 2005
06/30/2005 E-mail chain, top one from Charlotte Owens to Carol Holloway regarding
Complaint 30005423
07/08/2005 Email string re: GYNEMESH & Cutting for Particular procedure
07/12/2005 E-mail chain, top one from Robert Zipfel to Kevin Mahar regarding
GYNEMESH & Cutting for Particular procedure
DX21249
DX21250
DX21251
ETH.MESH.03911629
ETH.MESH.00528641
ETH.MESH.02101719
07/14/2005 E-mail chain, top one dated 14 July 2005, re: Greetings from Gynecare
07/25/2005 Product Quality Plan for Gynecare Gynemesh XL, 6 pages
08/2005 Consulting Agreement Requisition Form
DX21252
No Bates number
Aug-2005 PowerPoint, "ETHICON Quality & Compliance August, 2005," 17 pages
DX21253
ETH.MESH.00319365
08/15/2005 E-mail Thread from Patricia Hojnoski to Mark Yale and Sergio Gadaleta;
cc: Carolyn Brennan and Mark L. Storch regarding FDA additional
information request - follow-up to UFR no. 230097 0000-2005-0001
DX21254
Page 68 of 191
Offered
Admitted
Exhibit
ETH.MESH.00525573
DX21255
ETH.MESH.04985252
Date
Description
08/16/2005 E-mail from Allison London Brown to Kevin Mahar, Dharini
Amin, et al. regarding TVT Laser Cut Mesh; cc: Bob Roda
08/23/2005 E-mail string, top one from Paual Evans to Sungyoon Rha
regarding TVT Laser Cut Value Proposition and Forecast
DX21256
DX21257
ETH.MESH.004985249
ETH.MESH.00749517
Evans email chain re TVT Laser Cut Value Proposition and Forecast 08/23/2005 TVT Classic roping/sheath issues - failure to warn
8/23/2005 Final Report, PSE Accession Number 05-0395, PROJECT Number
67379, Electronic Design Histor File Number: EDHF0000120
DX21258
ETH.MESH.00749541
DX21259
DX21260
DX21261
DX21262
No Bates number
ETH.MESH.00525400
ETH.MESH.07281922
ETH.MESH.00161947
8/23/2005 Final Report, PSE Accession Number 05-0396, PROJECT Number
67379, Electronic Design History File Number: EDHF0000120
08/23/2005 United States Patent No. US 6,932, 759 B2
08/24/2005 Gynecare TVT Professional Education slides
08/29/2005 Establishment Inspection Report, including related forms and CAPAs
08/31/2005 Gynecare Copy Review Submission Form
DX21263
DX21264
DX21265
DX21266
DX21267
DX21268
ETH.MESH.02095172
ETH.MESH.00032867
ETH.MESH.07281437
ETH.MESH.03905619
ETH.MESH.00993769
ETH.MESH.03905691
09/06/2005 E-mail chain, top one from Kimberly Hunsicker to Jessica X. Shen, et
al.regarding ICS - Event Summary
E-mail of 06 Sep 2005 from Charles Riedley (DM) to Scott Jones
attaching 8/11/05 memo (field visit letter) to sales rep Jared Davis from
Tom Lech (RM), congratulating Davis on what he has accomplished in the
Oklahoma territory in 4 months and discussing the doctors in OK that they
09/06/2005 want to convert into customers
09/08/2005 Establishment Inspection Report
09/15/2005 Email from Martin Weisberg re clinical expert report
10/03/2005 E-mail Thread, 10/3/2005 Subject, Journal of Urology - Incontinence
10/04/2005 Document entitled "Response to FDA's letter dated 10/04/2005"
DX21269
DX21270
DX21271
ETH.MESH.00330775
ETH.MESH.03535750
10/05/2005 Ethicon response to FDA’s 483 observation
Gynecare letter from Carol Holloway to Mr. Herve Fournier regarding
10/12/2005
810041B TVT Device, Blue Mesh
Page 69 of 191
Offered
Admitted
Exhibit
DX21272
DX21273
DX21274
ETH.MESH.0353750
ETH.MESH.01221058
ETH.MESH.06268141
ETH.MESH.00133745
Date
Description
10/12/2005 Letter from Carol Holloway to Herve Fournier re: TVT Device, Blue Mesh
Pariente J-L; An independent biomechanical evaluation of commercially
10/12/2005 available suburethral slings. Issues in Women’s Health
Potential Failure Mode and Effects Analysis (Process FMEA). Process
10/13/2005 Function: Resin, Molding, Packaging, and Inspection issues.
10/15/2005 E-mail chain, top one from Kevin Mahar to Price St. Hilaire and Linwood
Staub regarding TVT Promotion; cc: Dharini Amin, et al.
DX21275
DX21276
DX21277
DX21278
ETH.MESH.00684888
ETH.MESH.00683204
E-mail chain, top one from K. Mahar to D. Armin and others, dated
10/17/2005 10/17/05, re: TVT 2005 spending
10/29/2005 Email traffic re: Prefyx Prepubic Sling Device
ETH.MESH.00311848
ETH.MESH.00327896
Presentation: Investigator Initiated Study Process by Kimberly Hunsicker,
10/31/2005 MSN, CRNP (Regional Manager, Clinical Operations) - Inadequate testing
11/07/2005 7-page copy of E-mail from Lisa Kaiser to Mark Yale and Wanda PatireSinger regarding FW: TVT Records; cc: Mary Ann O'Donnell
ETH.MESH.05220464
ETH.MESH.00323802
00875649
ETH.MESH.00875649
11/07/2005 E-mail chain, top one from Wanda Patire-Singer to Lisa Kaiser, et al.
regarding TVT Records; cc: Mary Ann O'Donnell
DX21279
DX21280
DX21281
DX21282
DX21283
DX21284
DX21285
ETH.MESH.03905351
ETH.MESH.00301742
ETH.MESH.00133232
DX21286
ETH.MESH.03714034
DX21287
11/15/2005 ETHICON, INC. Complaint Reporting Statement for TVT and TVT-O
Email from Carolyn Brennan (Project Manager, Worldwide Customer
11/16/2005 Quality) re Updated TVT and TVT-O Complication Rates 11-15-05
11/16/2005 E-mail from Carolyn Brennan to Naomi Sinclair, Gary Borkes, Patricia
Hojnoski, Martin Weisberg, Dharini Amin regarding Updated TVT and
TVT-O Compliction Rates 11-15-05; cc: Mark Yale and Carolyn Brennan;
with attachments
11/18/2005 Emails re: Updated TVT and TVT-O Complication Rates 11-15-05
11/21/2005 E-mail chain, top one from Daniel Lamont to Jacqueline Flatow regarding
Great News for TVT Laser Cut Mesh
11/25/2005 E-mail chain, top one from Martin Weisberg to Dharini Amin, Patricia
Hojnoski, Carolyn Brennan, et al. regarding Change Request: Updated
TVT and TVT-O Complication Rates 11-5-05; cc: Price St. Hilaire and
Kevin Mahar
11/29/2005 E-mail chain, top one from Dan Smith to Patricia Hojnoski and Martin
Weisberg regarding Updated TVT and TVT-O complication rates 11-1505; cc: Gary Borkes, Raimo Sump, and Naomi Sinclair
Page 70 of 191
Offered
Admitted
Exhibit
DX21288
ETH.MESH.00018861
ETH.MESH.03005723
ETH.MESH.01433325
ETH.MESH.01217223
ETH.MESH 00033877 to
ETH.MESH.0033879
PowerPoint, "ETHICON Women's Health & Urology Marianne Kaminski,
12/12/2005 Bob Roda, Franchise Strategic Planning Meeting, December 12-13, 2005,”
12/13/2005 E-mails top one from Dharini Amin to DL-ETHUSSO SLS GYNECARE
REPS re: GYNECARE TVT Complication Data, with attachments
ETH.MESH.00132989
DX21290
DX21292
Description
PowerPoint: GYNECARE TVT Tension-free Support for Incontinence –
12/05/2005 Professional Education Slides
12/07/2005 E-mail chain, top one from David W. Wilson to Alison Shankly, et al.
regarding Help for NON-UK MEDICAL AFFAIRS COMPLAINTS; cc:
Barbara Walker, et al.
12/12/2005 E-mail chain, top one from Giselle Bonet to David Robinson, Vincent
Lucente, et al. regarding Mesh dinner and Cadaver Lab; cc: Eric
Dastmalchain,et al.
Email from Ethicon Scientific Info Svcs re: GYNECARE LITERATURE
12/12/2005 ALERT – December 12, 2005
DX21289
DX21291
Date
DX21293
DX21294
DX21295
DX21296
DX21297
Ethicon response to FDA 483 observations issued 9/8/2005 –
implementation update. Relates to the 483 FDA observation on MDR
12/15/2005 reportable events
12/19/2005 Email from Kevin Mahar re Lazer cut mesh
ETH.MESH.00319672
ETH.MESH.00687819
ETH.MESH.00687822
12/19/2005 E-mail string from Kevin Mahar to Price St. Hilaire, Traci Gorky,
et al. regarding Laser cut mesh
ETH.MESH.00995657
ETH.MESH.00845912
12/21/2005 E-mail from David Robinson to Martin Weisberg and Michael
Connaughton regarding 10100015704 question
12/20/2005 Presentation: SUI, A Primary Care Perspective
DX21298
ETH.MESH.00148395
ETH.MESH.00148394
ETH.MESH.00148354
GYNECARE Copy Review Submission Form for the submission, “Bonnie
12/21/2005 Blair ‘Breaking the ice about SUI’ campaign video message.”
ETH.MESH.00585910
ETH.MESH.05246122
01/02/2006 Email of TVT
01/03/2006 7-page copy of e-mail from Dan Smith to Allison London Brown, Meng
Deng, et al. regarding Results of TVTx preclinical trial; cc: Andrew
Beveridge, et al.
DX21299
DX21300
DX21301
DX21302
DX21303
Page 71 of 191
Offered
Admitted
Exhibit
DX21304
ETH.MESH.00995690
DX21305
ETH.MESH.00330763
DX21306
DX21307
ETH.MESH.00692823
ETH.MESH.00692880 and
ETH.MESH.00692883
ETH.MESH.00134499
Date
Description
01/04/2006 E-mail Thread, Subject, Bonnie Blair Approval Of PCP Kit and Invite
Email Katy Hopkins (MHRA) to David Wilsonre: Adverse Incidnet report
01/12/2006 – TVT erosions (change to dying process)
E-mail from D. Amin to Preceptors, dated 1/13/06, regarding Gynecare
TVT latest Complication Data, with attachment contatining latest
01/13/2006 complication data for TVT and TVT Obturator systems
01/13/2006 E-mail from Dharini Amin to Preceptors regarding GYNECARE TVT
Latest Complication Data with attachment
01/15/2006 Email chain, top one from Dr. Dennis Miller to Dharini Amin Re:
Gynecare TVT Latest Complication Data; cc: Price St. Hilaire and Lucente
DX21308
DX21309
ETH.MESH.00134499
ETH.MESH.00692885
01/15/2006
01/16/2006
DX21310
DX21311
DX21312
ETH.MESH.00846417
ETH.MESH.00995285
ETH.MESH.08470987
01/17/2006
01/18/2006
E-mail from Dr. D. Miller responding to D. Amin’s responding to her email (Exh. 378) that sent Preceptors the latest Complication Data for TVT
and TVT Obturator systems
E-mail chain, top one from Dharini Amin to David Robinson, Kevin
Mahar, and Price St. Hilaire regarding: Gynecare TVT Latest
Complication Data
E-mail string, top one from David Robinson to Dharini Amin regarding
GYNECARE TVT Latest Complication Data
E-mail thread Subject, Revised PPT Presentation
01/20/2006 2005 Performance and Development Plan Summary for Cindy Crosby
DX21313
DX21315
DX21316
ETH.MESH.00585909
ETH.MESH.01218596
ETH.MESH.00850666
DX21317
ETH.MESH.00330761
01/20/2006 E-mail chain, top one from Gene Kammerer to Sungyoon Rha, et al.
regarding TVT - TVT-O Specifications; cc: Jacqueline Flatow
London Brown email chain originating 01/20/2006 re TVT U Completion
01/20/2006 Report Version 3 - laser cut mesh products
01/24/2006 E-mail string re: TVM Discussions
Email from Scott Ciarrocca re: MHRA request – TVT erosions (change to
01/27/2006 dying process)
DX21318
No Bates No.
ETH.MESH.03911715
01/31/2006 Arnaud, Axel e-mail re: TVT - TVT-O Specifications dated Jan 31, 2006
01/31/2006 E-mail chain, top one from Axel Arnaud to Gene Kammerer regarding
TVT - TVT-O Specifications
DX21314
DX21319
Page 72 of 191
Offered
Admitted
Exhibit
DX21320
ETH.MESH.03911715
DX21321
ETH.MESH.00394544
DX21322
ETH.MESH.04939001
ETH.MESH.00337678
ETH.MESH.00142630
DX21323
Date
Description
01/31/2006 Email from Axel Arnaud re TVT - TVT-O Specifications
Memo to Sunny Rha re: Global Regulatory Strategy - Gynecare TVT 02/01/2006 Laser Cutting Project
Biocompatibility Risk Assessment for laser-cut implant of GYNECARE
02/03/2006 TVT. Memo from Dr. Joerg Holste to Jacqueline Flatow
E-mail chain, top one dated February 3, 2006/ Subject: “A message from
02/03/2006 Sheri McCoy” with attached New R&D Structure Chart
02/2006 Copy Review Submission Form
DX21324
ETH.MESH.00847536
DX21325
DX21326
DX21327
ETH.MESH.00847536
ETH.MESH.01320367
ETH.MESH.00847264
02/06/2006 E-mail string from David Robinson to Carolyn Brennan and
Dharini Amin regarding TVT Complications
02/06/2006 Email traffic re: TVT complications
02/06/2006 Ethicon Corporate Product Characterization Plan, TVT – Laser Cut Mesh
02/07/2006 E-mail from David Robinson to Giselle Bonet regarding Abstract I
referenced regarding painful intercourse and mesh repairs
DX21328
DX21329
DX21330
DX21331
DX21332
DX21333
DX21334
DX21335
DX21336
DX21337
DX21338
ETH.MESH.00874032
ETH.MESH.00874035
ETH.MESH.03649005
ETH.MESH.00585937
ETH.MESH.00584292
ETH.MESH.00584292
ETH.MESH.03938897
ETH.MESH.00223784
ETH.MESH.00153996
ETH.MESH.02319315
Email from Mark Yale to Cindy Crosby et al. Re: MHRA Request - TVT
02/08/2006 (change to dying process)
02/08/2006 E-mail string from Mark Yale to Cindy Crosby and Sergio Gadaleta
regarding MHRA request - TVT (change to dying process)
02/10/2006 Design Validation Report dated February 10, 2006
02/13/2006 Email from Gene Kammerer to Quentin Manley et al re: TVM Discussions
02/15/2006 E-mail string, top one from Jacqueline Flatow to Sungyoon Rha regarding
Dver Protocol for particle loss; cc: Gene Kammerer, et al.
Email traffic b/w Jacqueline Flatow and Sungyoon Rha re: DVer protocol
02/15/2006 for particle loss
02/20/2006 Email from Xavier Buchon re Pr Cosson
Risk Management Report, TVT Laser Cut Mesh (LCM). Document
02/21/2006 Number RMR-0000017, Rev. 3
E-mail string re: Abstract referenced regarding painful intercourse and
02/22/2006 mesh repairs
Memo from Dan Lamont to DHF0000176 in regards to TVT-Bse & TVTO Complaint Review for Laser Cut Mesh (LCM) Risk Analysis
2/23/2006
Page 73 of 191
Offered
Admitted
Exhibit
DX21339
DX21340
DX21341
DX21342
DX21343
ETH.MESH.01784782
ETH.MESH.00302392
ETH.MESH.00302106
ETH.MESH.01945376
ETH.MESH.03358914
ETH.MESH.00846523
DX21344
DX21345
ETH.MESH.00134031
ETH.MESH.06196417
DX21346
DX21347
DX21348
ETH.MESH.06696419
ETH.MESH.00154101
ETH.MESH.01222079
DX21349
DX21350
DX21351
ETH.MESH.01784828
ETH.MESH.01761327
ETH.MESH.01784828
Date
Description
Memo from Dan Lamont to DHF0000176 re: TVT-Base & TVT-O
02/23/2006 Complaint Review for Laser Cut Mesh (LCM) Risk Analysis
02/23/2006 TVT-Base & TVT-) Review for Laser Cut (LCM) Risk Analysis
02/24/2006 Memo from Dan Lamont to DHF0000176 regarding TVT Laser Cut Mesh
(LCM) Risk Analysis Summary
02/27/2006 Design Validation Report dated February 27, 2006
02/28/2006 E-mail dated 28 Feb 2006, re: large animal models for pelvic floor repair
02/28/2006 E-mail with highlights from David Robinson to Dharini Amin, Price St.
Hilaire regarding tvt o training; cc: Dr. James Hart
03/01/2006 E-mail chain, top one from Kevin Mahar to David Robinson regarding:
Urgent Request: Revised TVT Complication data 2-9-06
03/03/2006 E-mail chain, top one from Jose Luis Rosado to Jose Luis Rosado,
Carolyn, Brennan, et al. regarding Clinical Studies; cc: Kimberly
Hunsicker
Performance Evaluation of TVT PROLENE Blue Mesh: Elongation
Properties of Mechanical Cut versus Laser Cut. Sent from Jacquelnie
03/03/2006 Flatow to Sunny Rha and Gene Kammerer
E-mail chain, top one dated March 6, 2006/ Subject: “TVT Product
03/06/2006 Complaint from Dr. Redacted”.
03/06/2006 Memo from Gene W. Kammerer to Dr. Weisberg and Dr. David
Robinson regarding Elongation Characteristics of Laser Cut
Prolene Mesh for TVT
03/07/2006 Clinical Expert Report by David Robinson and Martin Weisberg
03/07/2006 Clinical Expert Report, Laser Cut Mesh
03/07/2006 Clinical Expert Report, laster-cut mesh for Gynecare TVT, etc.
DX21352
ETH.MESH.08470703
03/08/2006 2005 Performance and Development Plan Summary for Catherine Beath
ETH.MESH.00750769
03/09/2006 Interim Report PSE ACCESSION NO. 05-0070: Amendment 15 TEST
AND CONTROL ARTICLE MATERIAL CHARACTERIZATION
PROGRAM
DX21353
DX21354
Page 74 of 191
Offered
Admitted
Exhibit
DX21355
ETH.MESH.00838428
ETH.MESH.05446139
DX21356
DX21357
DX21358
DX21359
ETH.MESH.05446139
ETH.MESH.04095026
ETH.MESH.04095025
ETH.MESH.07250541
DX21360
DX21361
DX21362
DX21363
DX21364
DX21365
DX21366
DX21367
DX21368
DX21369
DX21370
DX21371
DX21372
DX21373
ETH.MESH.00753163
ETH.MESH.07972878
ETH.MESH.01219984
ETH.MESH.00169742
ETH.MESH.00169730
ETH.MESH.00700350
ETH.MESH.01945854
ETH.MESH.01769881
ETH.MESH.00528656
ETH.MESH.06695442
ETH.MESH.00167104
ETH.MESH.01782116
ETH.MESH.01949013
Date
Description
"Characteristics of Synthetic Materials Used in Prolapse and Incontinence
03/13/2006 Surgery" powerpoint presentation By A. Arnaud & D. Robinson
03/13/2006 2-page copy of E-mail with attachments from Dr. Joerge Holste to Dr.
Dieter Engel, et al. regarding Mesh and Tissue Contraction in Animal; cc:
Boris Batke, et al.
E-mail chain with attachment 3/13/2006, re: AW: Mesh and Tissue
03/13/2006 Contraction in Animal
Ethicon response to FDA 483 observations issued 9/8/2005 – Final
03/14/2006 Response
03/14/2006 Ethicon’s Final Status Update re: FDA 483 observation
03/14/2006 Letter from Catherine V. Beath to Ray Abrahams regarding Response to
Inspectional Observations FDA-483 issued 09/08/2005 - Final Update; cc:
Kinh Quoc and Cindy L. Crosby
03/14/2006 Regulatory Strategy dated March 14, 2006
03/21/2006 "Dear Doctor"
03/22/2006 Completion Report for the Design Verification of TVT Laser Cut Mesh
03/22/2006 GYNECARE Copy Review Submission Form,
03/30/2006 Gadot email re Laser Cut Mesh Positioning (Redacted)
03/30/2006 Yale emtl re TVT laser cut equivalency - safety of laser cut unknown
04/02/2006 Dear Team Letter
E-mail from Bonet to Amin, dated 4/14/06, with attachment regarding
targeting criteria concerning who 1st and 2nd year target customers would
04/14/2006 be
Memo from Gene Kammerer to David Robinson and Sunny Rha in
regards to Justification for Utilizing the Elasticity Test as the Elongation
4/17/2006 Requirements on TVT Laser Cut Mesh
04/18/2006 Martin Weisberg Clinical Expert Report Laser Cut Mesh
E-mail dated 4/27/06 to Carolyn Brennan from David Robinson, re: TVT
04/27/2006 and Prolift Report
04/27/2006 J&J Law Department Document Preservation Notice
Page 75 of 191
Offered
Admitted
Exhibit
ETH.MESH.03358224
Date
Description
05/01/2006 E-mail string, top one from Gene Kammerer to Herve Fournier regarding
French STANDARD ON TVT & Meshes (COMMENTS REQUIRED)
DX21374
DX21375
DX21376
DX21377
DX21378
DX21379
ETH.MESH.01219630
Kammerer, G e-mail re: French Standard on TVT and Meshes (Comments
05/01/2006 Required) dated May 1, 2006.
E-mail chain, top one dated 03 May 2006 from Kevin Mahar to Allison
London Brown forwarding email from Ophelie Berthier inquiring about
05/03/2006 the changes.
Email from Gene Kammerer to Christophe Vailhe re: [2006-00013] – GT1
05/03/2006 etudes cliniques Vendredi 5 Mai AFNOR 10h
05/04/2006 E-mail from Gene Kammerer to Herve Fournier and Axel Arnaud
regarding New Standards for Urethral Slings; cc: Rebecca Leibowitz
Email from Gary Borkes forwarding April 26, 2006 Email from Carolyn
05/05/2006 Brennan re: Alignment of TVT Categories
05/09/2006 E-mail from Gene Kammerer to Jacqueline Flatow regarding Particle loss
on TVT
05/09/2006 E-mail string top one from Jacqueline Flatow to Gene Kammerer
regarding Particle loss on TVT; cc: Rebecca Leibowitz
No Bates No.
ETH.MESH.01782055
05/09/2006 Flatow, Jacqueline e-mail re: Particle loss on TVT dated May 9, 2006.
Email from Josheph Steele to Giselle Bonet re: What is POP Q? – A little
05/10/2006 something your POP experts are going to love…
ETH.MESH.0554680
ETH.MESH.00333248
05/18/2006 Email from Risa Cantimbuhan re Design Transfer checklist discussion
05/27/2006 All Active CAPA'S with readactions
No Bates No.
ETH.MESH.00134125
ETH.MESH.01221054
ETH.MESH.01221025
ETH.MESH.02135851
ETH.MESH.00585802
DX21380
DX21381
DX21382
DX21383
DX21384
DX21385
DX21386
ETH.MESH.01194149
DX21387
ETH.MESH.03526693
ETH.MESH.08164257
DX21388
DX21389
ETH.MESH.00870476
ETH.MESH.05495400
Ethicon, Summary of Biocompatabiligy Testing for the Sheath Material
05/31/2006 for TVT Products [HOT DOCUMENT]
Ethicon, Summary of Biocompatabiligy Testing for the Sheath Material
05/31/2006 for TVT Products [HOT DOCUMENT]
PowerPoint, "Promotion and Advertising of Medical Devices, John
Jun-2006
Paulson, Ph.D., RAC June, 2006," 36 pages
06/02/2006 Document entitled "Ethicon Expert Meeting, Meshes for Pelvic Floor
Repair"
06/02/2006 Minutes, Ethicon Expert Meeting Meshes for Pelvic Floor Repair
DX21390
DX21391
ETH.MESH.01592134
06/05/2006 Design Validation Report dated June 5, 2006
Page 76 of 191
Offered
Admitted
Exhibit
DX21392
ETH.MESH.01409422
ETH.MESH.02900615
Date
Description
06/06/2006 Design Transfer Checklist, Document Name (#): FM-0000121, Version: 3
06/06/2006 E-mail chain, top one from David Robinson to Judith Gauld, Jenny
Mitchell, et al. regarding Candidature; cc: Graeme Scott
DX21393
ETH.MESH.00584494
DX21394
ETH.MESH.04611734
DX21395
06/06/2006 E-mail string top one from Herve Fournier to Gene Kammerer and
Rebecca Leibowitz regarding New Standards for Urethral Slings (First
UNOFFICIAL draft in French of AFNOR WG 1 and WG 2]
**URGENT**; cc: Axel Arnaud and Xavier Buchon
06/06/2006 Navtive Format Sheet / PowerPoint entitled "Executive Summary,
Medical, Regulatory and Quality Systems Diagnostic"
ETH.MESH.03171094
06/09/2006 E-mail string from Anna Gray to David Robinson, Allison London
Brown, et al. regarding Meeting
ETH.MESH.00585843
06/12/2006 E-mail chain, top one from Gene Kammerer to Sungyoon Rha regarding
TVT LCM - Particle loss (reimbursement submission)
Email from Gene Kammerer re TVT LCM - particle loss (reimbursement
06/12/2006 submission)
06/14/2006 E-mail chain, top one re: Mesh Microns
Company Procedure for US Regulatory Affairs Review of Promotion and
06/15/2006 Advertising Materials for Medical Devices
DX21401
ETH.MESH.00585844
ETH-83454 to ETH-83455
ETH.MESH.08164256
ETH.MESH.01431618
DX21402
ETH.MESH.00167119
DX21403
ETH.MESH.00585823
ETH.MESH.01220145
ETH.MESH.09671612
ETH.MESH.00033399
DX21396
DX21397
DX21398
DX21399
DX21400
DX21404
DX21405
DX21406
DX21407
DX21408
ETH.MESH.08003230
ETH.MESH.09671614
06/15/2006 E-mail chain, top one dated 15 Jun 2006 re: Mesh Microns
Product Pointer: Gynecare TVT Tension-free Support for Incontinence -06/26/2006 available in laser cut mesh
Kammerer, Gene Email to Volpe, Clifford Subject: GY:
***URGENT*** French STANDARD ON TVT & MESHES
06/27/2006 (COMMENTS REQUIRED)
E-mail chain from Herve Fournier to Gener Kammerer, et al in regards to
6/29/2006 "New Standards for Urethral Slings"
07/01/2006 Email from Juergen Trzewik to Peter Meier re Netzdiskussion
07/07/2006 E-mail dated 07 Jul 2006 from Renee Casey to multiple recipients
Ethicon Copy Review Submission form: GYNECARE TVT Tension-free
07/12/2006 Support for Incontinence Patient Brochure. Submitted by Robin Osman
07/14/2006 E-mail from Juergen Trzewik to Peter Meier regarding Netzdiskussion
Page 77 of 191
Offered
Admitted
Exhibit
ETH.MESH.00477387
Date
Description
7/14/2006 PowerPoint presentation entitled "2007 Professional Education Plan,
ETHICON, ETHICON Products, ETHICON Women's Health and
Urology, Johnson and Johnson Wound Management," July 14, 2006,
DX21409
DX21410
DX21411
DX21412
DX21413
DX21414
DX21415
DX21416
ETH.MESH.00311810
ETH.MESH.00704054
ETH.MESH.05454207
ETH.MESH.05454214
ETH.MESH.03274601
ETH.MESH.02091873
No Bates No.
No Bates number
07/20/2006 E-mail chain, regarding TVT data McNelis, Linda
08/01/2006 Article "Complications from sling surgery under-reported"
08/01/2006 Email from Juergen Trzewik to Peter Meier re fotos cadevar lab
08/01/2006 E-mail with attachments from Jurgen Trzewik to [email protected]
regarding fotos cadevar lab
08/03/2006
08/03/2006
08/08/2006
08/09/2006
Email string re: Publication
Holste & Barbolt signed ISO 10993 testing documents
Holste, J Chronic Toxicity signed 8/8/06.
PowerPoint presentation entitled "WW Sales Operations Overview 2007
Business Plan,"
DX21417
DX21418
ETH.MESH.00748031
ETH.MESH.08334244
DX21419
ETH.MESH.08334245
DX21420
DX21421
ETH.MESH.06001408
ETH.MESH.00584527
DX21422
DX21423
DX21424
ETH.MESH.03274905
ETH.MESH.03265595
ETH.MESH.04499742
Design Requirements Matrix – “Laser Cut TVT Design Verification
08/10/2006 activities have been completed and met all the requirements.”
08/28/2006 E-mail from Gene Kammerer to Jacqueline Flatow regarding Photographs
of LCM vs MCM
E-mail from Gene Kammerer to Sunny Rha and others attachign a
PowerPoint file with some photos of the LCM vs MCM after elongation
8/28/2006 @ 50%
LCM project Photographs Comparing Laser Cut Mesh vs Mechanical Cut
08/28/2006 Mesh
Placehold/PowerPoint, "Second half photo presentation" re: Degradation
08/29/2006
08/30/2006 Email string re: looks good. Time for any more small edit??
09/03/2006 Meeting Minutes 9/03/06
09/12/2006 56-page copy of document entitled "Confidential Interim Statistical Report"
DX21425
DX21426
DX21427
ETH.MESH.06893565
No Bates number
09/25/2006 E-mail string, top one from Harel Gadot to David Robinson, Dan Smith,
et al. regarding from Aviram Suchard-Gynecare Israel
09/26/2006 United States Patent No. US 6,932, 759 B2
Page 78 of 191
Offered
Admitted
Exhibit
DX21428
DX21429
DX21430
DX21431
DX21432
DX21433
DX21434
DX21435
DX21436
DX21437
DX21438
DX21439
DX21440
DX21441
DX21442
DX21443
DX21444
DX21445
DX21446
DX21447
ETH.MESH.08003246
ETH.MESH.00874289
ETH.MESH.00874288
ETH.MESH.03173069
ETH.MESH.09651966
Date
Description
09/27/2006 Brochure. Submitted by Robin Osman
E-mail chain, top one dated 04 Oct 2006 from Jessica Shen to Judi Gauld
10/04/2006 and others re TVT registry
10/04/2006 E-mail from Mark Yale to Jessica Shen and Allison London Brown
regarding TVT registry
10/04/2006 Email string re: TVT registry
10/06/2006 Lighning PowerPoint presentation by Peter Meier
Emails between Cheryl Bogardus (EWHU) and Dharini Amin (Product
Director, Continence Health) re TVT 10 year anniversary/10 year data
10/09/2006 from Nilsson
10/11/2006 E-mail chain dated 10/11/2006, re: Preclinical Contraction Model
Proposed Common Disclaimers, ETHICON Copy Review, Draft: October
10/16/2006 16, 2006 – Nancy M. Leclair
Smith, Dan email chain re TVT Secur - TVT-Classic roping/sheath issues 10/18/2006 failure to warn
ETH.MESH.00524060
ETH.MESH.05445953
ETH.MESH.00157023
ETH.MESH.01822636
ETH.MESH.03258249
ETH.MESH.03915832
ETH.MESH.03491457
ETH.MESH.00849017
11/14/2006 Memo to File #10100026461, November 14, 2006
11/15/2006 E-mail chain, top one from David Robinson to Judith Gauld and Jessican
X. Shen regardign Pelvic Floor/Mesh Strategy
No Bates number
No Bates No.
ETH.MESH.02992137
11/20/2006 5-page copy of document entitled "Material Safety Data Sheet"
11/20/2006 Sunoco Material Safety Data Sheet for C4001 Polypropylene
11/22/2006 Lightning Clinical Strategy
ETH.MESH.03921612
ETH.MESH.01041417
ETH.MESH.07186624
ETH.MESH.02195798
ETH.MESH.04204343
11/30/2006 Email from Ralf Felix Gotter re The more procedures the more problems
11/30/2006 TVT Worldwide Observational Registry for Long-Term Data, Protocol
300-06-006
TVT-World-Wide Observational Registry for Long-Term Data - Protocol
11/30/2006 300-06-006
12/01/2006 Email from Axel Arnuad re Strength
Dec-2006 WOMENS HEALTH - Monthly Report
10/22/2006 Email string re: Registry Conf. Call Today
11/10/2006 E-mail chain, top one dated 10 Nov. 2006, re: TR: 2007 Priorities for PFR
DX21448
DX21449
ETH.MESH.04947219
E-mail string from Gene Kammerer to Edward Dormier in regards to TVT
12/6/2006 Support
Page 79 of 191
Offered
Admitted
Exhibit
DX21450
DX21451
DX21452
DX21453
Description
ETH.MESH.08168733
12/12/2006 6-page copy of document dated 12/12/2006 entitled "State of the
knowledge in 'mesh shrinkage' - What do we know?"
ETH.MESH.08168728
ETH.MESH.00411754
ETH.MESH.03460640
ETH.MESH.08345895
ETH.MESH.00703285
ETH.MESH.00744081
12/12/2006 State of the knowledge of "mesh shrinkage" - What do we know?
Research Funding Agreement (Drug/Medical Device and Financial
12/14/2006 Support - United States)
12/18/2006 Patient advertisement for TVT
12/22/2006 E-mail from K. Mahar to C. Bogardus regarding Contact at Lifescan who
ran the BB King campaing
PowerPoint presentation titled “GYNECARE TVT* Family of Products"
01/01/2007 by D. Amin
Jan-2007 PowerPoint, "Building Your Business Through Patient Marketing January
2007"
ETH.MESH.00161513
ETH.MESH.03912639
ETH.MESH.03912639
01/02/2007 TVT sales piece (TVTS004)
01/08/2007 Email from Axel Arnaud re TVT Cookbooks
01/08/2007 E-mail from Axel Arnaud to Harel Gadot regarding TVT Cookbooks
DX21454
DX21455
Date
DX21456
DX21457
DX21458
DX21459
ETH.MESH.04204342
DX21460
DX21461
DX21462
DX21463
DX21464
DX21465
DX21466
DX21467
DX21468
ETH.MESH.04204341
ETH.MESH.003922967
ETH.MESH.03922966
ETH.MESH.04601632
ETH.MESH.06868382
ETH.MESH.06868377
ETH.MESH.03912707
ETH.MESH.05768712
01/09/2007 E-mail chain, top one from Harel Gadot to Bob Roda, Cheryl Bogardus, et
al. regarding FW: Report from Austria; cc: Andrew Beveridge and Bruno
Delacroix
01/09/2007 Email from Harel Gadot re report from Austria
01/10/2007 E-mail chain, top one from David Robinson to Harel Gadot, Bob Roda, et
al. regarding Report from Austria; cc: Andrew Beveridge and Bruno
Delacroix
01/10/2007 Email from David Robinson re Report from Austria
01/12/2007 E-mail from Pickell to McCoy, re: Confidential Approval Needed
01/16/2007 E-mail chain, top one from Dr. Reinhard Juraschek to Dan Smith
regarding WG: shrinkage review
01/16/2007 Email from Reinhard Juraschek re shrinkage review
E-mail chain, top one dated 17 Jan. 2007, re: Meeting Minutes/ December
01/17/2007 7
01/25/2007 2005 Sales Rep Compensation Plan
Page 80 of 191
Offered
Admitted
Exhibit
Description
ETH.MESH.00729821
02/05/2007 E-mail from Dharini Amin to Scott Serels, Salil Khandwala et al.
regarding Summit Meeting - TVT Breakout Session - Moderator
Script
ETH.MESH.00722349
02/06/2007 E-mail chain, top one from Price St. Hilaire to Vince Lucente regarding
FYI; cc: Kevin Mahar
ETH.MESH.04599877
ETH.MESH.05466612
02/12/2007 2/12/07 E-mail Chain, re: Dr. Riachi
02/23/2007 8-page copy of document entitled "Ethicon Expert Meeting, Meshes for
Pelvic Floor Repair"
ETH.MESH.02017158
Ethicon Expert Meeting Meshes for Pelvic Floor Repair, Friday, February
02/23/2007 23rd, 2007
PowerPoint, "Factors related to mesh shrinkage, What do we know? A
review of literature and internal studies," dated 2/23/2007, K. Spychaj, 43
02/23/2007 pages – color
DX21469
DX21470
DX21471
Date
DX21472
DX21473
DX21474
DX21475
ETH.MESH.01782867
ETH.MESH.02097309
ETH.MESH.00311813
DX21476
DX21477
ETH.MESH.01000323
ETH.MESH.03922619
02/23/2007 Spychaj, K. Factors related to mesh shrinkage
03/07/2007 E-mail string from David Robinson to Dan Smith, Axel Arnaud, et
al. regarding DRAFT of the latest "cookbook" after my trip to
Germany; cc: Ralf Felix Gotter
Email from Dan Smith re DRAFT of the latest "cookbook" after my trip to
03/09/2007 Germany
03/14/2007 E-mail from David Robinson to Axel Arnaud regarding Conf call
tomorrow; cc: Judith Gauld, with attachments re 5-week results
DX21478
DX21479
DX21480
ETH.MESH.01193867
ETH.MESH.00460911
ETH.MESH.00533091
03/14/2007 Sub-Urethral Slings, Dhinager Subramanian, HE&R – EMEA
ETH.MESH.00539898
03/16/2007 E-mail chain, top one dated 16 Mar 2007 re: Mesh comparative data
03/19/2007 Letter from David Robinson to Dr. Peter Rosenblatt regarding the
ETHICON Investigator Initiated Study Grant Review
03/20/2007 1-page copy e-mail from Renee Selman to Mark Yale regarding Conflict
with Town hall
03/20/2007 TVT-World-Wide Observational Registry for Long-Term Data, TVTWORLD, Protocol 300-06-006
ETH.MESH.03161019
03/21/2007 E-mail chain, top one dated 21 March 2007 re: meeting
DX21481
ETH.MESH.00328977
DX21482
DX21483
DX21484
Page 81 of 191
Offered
Admitted
Exhibit
ETH.MESH.04206265
DX21485
DX21486
DX21487
DX21488
DX21489
DX21490
DX21491
ETH.MESH.00593165
ETH.MESH.00460793
ETH.MESH.00329003
ETH.MESH.01218361
ETH.MESH.00742724
ETH.MESH.00832556
ETH.MESH.00410545
DX21492
ETH.MESH.02319409
DX21493
ETH.MESH.00069114
DX21494
DX21495
DX21496
DX21497
DX21498
01404750
ETH.MESH.01761403
ETH.MESH.06055067
ETH.MESH.00525175
ETH.MESH.00163623
DX21499
DX21500
ETH.MESH.03913655
ETH.MESH.03913615
Date
Description
03/26/2007 E-mail from Harel Gadot to Olga Smolugova regarding Sheri McCoy visit
to Russia; cc: Cheryl Bogardus, et al.
03/28/2007 Vailhe Technical report
E-mail chain, top one from D. Amin to A. Meek with “cc” to J. Hovsepian
04/02/2007 and P. Parisi, dated 4/2/07, regarding TVT NTM draft outline
04/03/2007 EWH&U Board Meeting – Agenda and Minutes
"State of the knowledge in 'mesh shrinkage' - What do know" by Kerstin
04/05/2007 Spychaj
04/12/2007 Ethicon Women's Heath & Urology: Project Lightning Update
04/12/2007 Thunder Meeting Minutes
04/17/2007 E-mail from Jennifer Paine to Carmen Goble regarding Declined"
Updated: 2 Investigator Initiated Study reviews from Dr. ARB Smith &
Dr. Michael Woods (with Marketing)
04/17/2007 E-mail with attachment from David Robinson to Cyrus Guidry regarding
Shrinkage
04/30/2007 E-mail from Robert De Fillippo to David Robinson regarding Dinner w
Dr. Mikrzycki & Dr. Hatangadi
05/08/2007 Monthly Complaint Review Meeting (May 8, 2007)
Email traffic re: RECENT AAVIS MESH USERS FORUM / TVT
05/10/2007 REIMBURSEMENT UPDATE (Australia)
Email traffic re: RECENT AAVIS MESH USERS FORUM / TVT
05/10/2007 REIMBURSEMENT UPDATE (Australia)
05/14/2007 E-mail string with attachment from Jason Hernandez to Dharini Amin
regarding Bonnie Article from 06 in Curves Gym Magazine
Document entitled "ETHICON Women's Health & Urology Submission
05/29/2007
Form"
06/01/2007 CDMA Europe Meeting Urinary Incontinence Platform - Meeting Minutes
06/01/2007 Meeting minutes CDMA Europe Meeting, Urinary Incontinence
Platfrom
DX21501
DX21502
ETH.MESH.00843767
DX21503
ETH.MESH.01405170
06/12/2007 Emails re: Copy Review Schedule 6/13
"Exploratory Program 'Thunder'" Powerpoint presentation By: Clifford
06/18/2007 Volpe and Peter Meier
Page 82 of 191
Offered
Admitted
Exhibit
DX21505
ETH.MESH.00622076
ETH.MESH.01777036
DX21506
ETH.MESH.02092891
DX21507
ETH.MESH.00294195
DX21504
DX21508
ETH.MESH.05588126
DX21509
DX21510
ETH.MESH.05588123
ETH.MESH.05920617
Date
Description
06/19/2007 Ethicon Women’s Health and Urology Business Review, June 19, 2007
E-mail chain, top one dated 20 Jun 2007 Re: Drafted Standard for SUI
06/20/2007 slings and POP/AFNOR/France
Preclinical Investigational Study of Swine Models to Evaluate Mesh
Contraction and Tissue Integration over a 13 week period. Note, plaintiffs
have used this to suggest that Gynemesh PS/Prolene Soft has the most
06/21/2007 contraction.
Tensile Properties of Five Commonly Used Mid-Urethral Slings relative to
06/22/2007 TVT
Email from Dieter Engel to John Gillespie et al. re How inert is
07/06/2007 polypropylene?
07/09/2007 4-page copy of E-mail from Dr. Stephen Wohlert to Dr. Brigitte
Hellhammer and Dr. Dieter Engel regarding How Inert is Polypropylene?
CC: Boris Batke, et al.
Email from Stephen Wolhert to Brigitte Hellhammer et al. re Costello
07/09/2007 Article
07/20/2007 2-page copy of e-mail from Martin Chomiak to Boris Batke, Gillian
Jamieson, et al. regarding Defining light weight mesh
DX21511
DX21512
ETH.MESH.00311804
DX21513
No Bates No.
DX21514
DX21515
DX21516
DX21517
ETH.MESH.07465383
ETH.MESH.04089693
ETH.MESH.01405166
ETH.MESH.01819505
No Bates number
Emails between Paula Welland (UK Country Director), Paula Evans, and
07/20/2007 David Robinson re TVT data - underreporting of complications
PowerPoint authored by Bart Pattyson and Christopher O’Hara, “China
07/20/2007 Sales Recertification July 20-22, Shanghai, China”
Compilation of citations for various studies pertaining to: PROLENE
Biocompatibility; PROLENE Cytotoxicity; PROLENE Toxicity;
07/23/2007 PROLENE Sensitization; PROLENE Carcinogenicity
07/26/2007 E-mail chain, top one dated 26 July 2007 re: CIRs
"Exploratory Program 'Thunder' A Material designed for Pelvic Floor"
07/31/2007 Powerpoint presentation By: Clifford Volpe and Peter Meier
Aug-2007 Organizational Chart entitled "ETHICON QA/RA Orgnization," 1 page
DX21518
ETH.MESH.09479225
DX21519
DX21520
DX21521
ETH.MESH.00869908
ETH.MESH.01280905
08/13/2007 Document entitled "Orientation Page" concerning records retention
requirements
Harel Gadot PowerPoint, “Incontinence Platform WW Marketing Team
08/19/2007 Update August 19th”
Page 83 of 191
Offered
Admitted
Exhibit
DX21522
DX21523
DX21524
ETH.MESH.01264510
ETH.MESH.00000272
ETH.MESH.00844344
ETH.MESH.00844335
DX21525
DX21526
ETH.MESH.021989933
DX21527
ETH.MESH.00922443
DX21528
No Bates No.
ETH.MESH.02249382
Date
Description
E-mail chain, top one dated 23 Aug. 2007 re: macro porous – lower limit
08/23/2007 of pore size
Email from Vincenza Zaddem to David Robinson re: macroporous - lower
08/23/2007 limit of pore size
08/31/2007 E-mail string top one from David Robinson to Thomas Barbolt regarding
Asking TVT Complication? - Fraying
08/31/2007 E-mail string top one from David Robinson to Yukie Yamano and Joseph
Megan regarding Asking TVT Complication? - Fraying; cc: Dharini Amin
and Price St. Hilaire
Email From Christoph Walther to Vincenza Zaddem re: "Info needed for
09/10/2007 FDA"
Email from Vincenza Zaddem to Price St. Hilaire et al. regarding
09/12/2007 bidirectional elasticity statement
Letter from Tim Ulatowski to Dr. Markus Fieber re: establishment
inspection report (EIR) for the inspection conducted by the FDA at the
09/12/2007 Ethicon GmbH facility
09/12/2007 PowerPoint, "Worldwide Quality and Regulatory 2008 Business Plan"
DX21529
DX21530
DX21531
DX21532
ETH.MESH.00895869
ETH.MESH.00647347
ETH.MESH.03922261
ETH.MESH.06372363
09/23/2007 E-mail chain, top one dated 23 Sep 2007 re: Mesh Fold Study
09/24/2007 Emails re: I2R
Email from Andrew Beveridge toTed Foltyn and Christophe Mauge re:
10/03/2007 AMS Mini Arc
10/05/2007 Global Harms List Document for Review & Comment by Medical Affairs
Personnel
DX21533
ETH.MESH.04090122
DX21534
DX21535
DX21536
DX21537
DX21538
DX21539
ETH.MESH.00653368
ETH.MESH.00647416
ETH.MESH.01948902
No Bates number
No Bates number
10/12/2007 E-mail from Meng Chen to Carolyn Brennan regarding TVTs and bladder
perforation; cc: Joseph Scavona
10/22/2007 10/22/07 Pipeline Leadership Team Meeting Minutes
10/25/2007 E-mail chain top one from Dr. Chuan Teng Khoo to David Robinson
(unredacted)
Organizational Chart, Salaried Headcount ETHICON Quality &
10/31/2007 Regulatory Affairs October 31, 2007
10/31/2007 Salaried Headcount, ETHICON Quality & Regulatory Affairs
11/2007 Document entitled "FDA Science and Mission at Risk, Report of the
Subcommittee on Science and Technology"
Page 84 of 191
Offered
Admitted
Exhibit
Date
Description
ETH.MESH.04126889
11/06/2007 E-mail chain, top one from Aran Maree to Michelle Wagner regarding
TVT complaint telecon 5 November
No Bates number
11/09/2007 PowerPoint, "Evidence Clinical Selling Gynecare Recertification Cairo 9th
Nov 2007, Nadine Jamous, Health Economics and Outcomes Manager
J&J, Medical Middle East"
ETH.MESH.00311794
ETH.MESH.02212596
Aran Maree Email chain originating 11/08/2007 re Australia update and
11/12/2007 telephone call with Prof Frazer - "the IFU is fundamentally misleading ..."
11/14/2007 PowerPoint, "Mesh Testing, Elizabeth Vailhe, 22 pages
Executive Summary: Preliminary Results of Peri-operative and 3-Month
Outcomes from a World-wide Observational Registry of Tension-free
Vaginal Tapes in Women with Stress Urinary Incontinence [HOT
12/01/2007 7-page copy of document entitled "Sponsored Research Contract, The
Curators of of the University of Missouri"
12/05/2007 Email chain between Catherine Beath, Ramy Mahmoud, Mark Yale,
David Robinson, et al. re: agenda
Document entitled "Regulatory Affairs Benchmarking Discussion-Ethicon,
12/12/2007
Inc."
Meeting Report between Marian Devonec and Dr. Axel Arnaud re: “A
lifting thread and technique for percutaneous modeling of soft tissues” and
12/19/2007 its application to the surgical treatment of SUI
DX21540
DX21541
DX21542
DX21543
DX21544
DX21545
DX21546
DX21547
DX21548
DX21549
DX21550
ETH.MESH.00520256
ETH.MESH.05489867
ETH.MESH.00325675
DEPUY013010196 to
DEPUY013010198
ETH.MESH.00832562
ETH.MESH.01774813
ETH.MESH.02588180
ETH.MESH.05208710
12/21/2007 Slide from Trzewik presentation
Jan-2008 E-mail string with redacted first page, top one from Aran Maree to
Christianan Bielinski regarding TGA Meeting; cc: Mark Yale
DX21551
ETH.MESH.00874631
01/09/2008 E-mail chain, top one from Christiana Bielinski to Mark Yale regarding
TGA Meeting
DX21552
DX21553
DX21554
DX21555
ETH.MESH.04127134
ETH.MESH.00836056
ETH.MESH.00786494
01/09/2008 Law, Jan email chain re TGA Meeting
01/11/2008 E-mail chain, top one dated 11 Jan 2008 re: pregnancy and UI
E-mail chain, top one dated January 15, 2008, with redactions re:
01/15/2008 Headlines for Your Review
Page 85 of 191
Offered
Admitted
Exhibit
DX21556
DX21557
DX21558
DX21559
DX21560
DX21561
DX21562
DX21563
ETH.MESH.00081289
Date
Description
Memo to Jennifer Paine, et al from Renee Selman dated 1.16.08 regarding
01/16/2008 Project Lightning Status
01/18/2008 Ethicon memo to from Ken Tompkins to ETHICON Global Management
Board regarding GMB Meeting Minutes for January 17, 2008
ETH.MESH.03717475
ETH.MESH.07088827
No Bates number
ETH.MESH.0029667
01/30/2008 Email re: NICE IP Review – single incision slings
01/31/2008 Printout of IIS Studies from 2007-2008
Feb-2008 Slide Deck KOL Strategy February 2008
ETH-83788
ETH-00291
ETH.MESH.08692667
ETH.MESH.05920628
02/05/2008 Ethicon Corporate Product Characterization anayslis by Dan Burkley
02/05/2008 GPS for Pelvic Floor Repair
Master Consulting Agreement between Ethicon (signed by Price St.
02/08/2008 Hilaire) and Carl Nilsson
02/12/2008 4-page copy of e-mail with attachments from Petra Koehler to Gillian
Jamieson and Boris Batke regarding WG: Dr. Schumpelick
ETH.MESH.05920628
ETH.MESH.04096632
ETH.MESH.07383028
Email correspondence between Petra Koehler and others re: Dr.
02/12/2008 Schumpelick
02/20/2008 E-mail dated 20 Feb. 2008 re: WHU MDR Presentation Update
02/21/2008
PowerPoint, “Regulatory is Exciting?”
DX21564
DX21565
DX21566
DX21567
DX21568
ETH.MESH.10339337
Executive Summary - Preliminary Results of Peri-Operative and 3-month
Outcomes from a World-Wide Observational Registry of Tension-Free
02/22/2008 Vaginal Tapes in Women with Stress Urinary Incontinence
DX21569
ETH.MESH.01193971
Executive Summary—Preliminary Results of Peri-Operative and 3-Month
outcomes from a World-Wide Observational Registry of Tension-free
02/26/2008 Vaginal Tapes in Women with Stress Urinary Incontinence
ETH.MESH.03731339
ETH.MESH.00810057
ETH.MESH.02590865
ETH.MESH.01279976
02/27/2008 Email from Dan Smith to Matter Henderson, et al. re: tape position at rest
02/27/2008 E-mail from Kyung Yu to Andrew Meek, Jim Gatewood, et al. regarding
Prof Ed Discussion; cc: Brad Kerl
02/28/2008 "Thunder: Technical Review" powerpoint presentation
03/03/2008 2-page copy of E-mail from Harel Gadot to Ted Foltyn, et al. re: Next Step
in SUI Sling
ETH.MESH.08474542
03/04/2008 2007 Performance and Development Plan Summary for Daniel Smith
DX21570
DX21571
DX21572
DX21573
DX21574
Page 86 of 191
Offered
Admitted
Exhibit
DX21575
DX21576
DX21577
ETH.MESH.00162643
ETH.MESH.01139410
ETH.MESH.07220440
Date
Description
03/05/2008 Sales Representative Quick Reference Sheet
E-mail chain, top one dated 06 Mar 2008 from Et Carino to Walji –
03/06/2008 attaches presentation
Human Factors Design Verification; Design 30 (b) (6) Topic I (TVT
03/10/2008 Project Names), 1 page
03/10/2008 Letter from Craig Swanson to Catherine Beath regarding eclosing a copy
of establishment inspection report
DX21578
DX21579
DX21580
ETH.MESH.00907010
ETH.MESH.00163557
ETH.MESH.03162639;
ETH.MESH.00855163
03/14/2008 E-mail chain, top one dated 14 Mar 2008 re: Mesh properties
03/20/2008 2-page copy of e-mail dated 03/20/2008 from Judith Galud to David
Robinson regarding Business Overview Agenda - please do not forward,
plus attachments
DX21581
DX21582
DX21583
DX21584
DX21585
ETH.MESH.03162639
ETH.MESH.02317390
ETH.MESH.01760854
ETH.MESH.02170708
ETH.MESH.00006636
03/20/2008 Email string re: Business Overview Agenda - please do not forward
03/20/2008
03/26/2008
03/26/2008
04/2008
DX21586
ETH.MESH.06867612
DX21587
DX21588
DX21589
ETH.MESH.00874657
ETH.MESH.06152378
ETH.MESH.02227222
DX21590
ETH.MESH.00318889
Apr-2008
Email traffic re: Project SCION Update & Next Steps
David Robinson, Gynemesh PS Clinical Expert Report
Email from David Robinson to Dr. Vincent Lucente re: UP
B. Klosterhalfen, Institute of Pathology Duren Hospital Germany, Interim
report mesh explants pelvic floor repair
PowerPoint, "MATRIX Material," 19 pages
04/02/2008 Email from Catherine Beath re: TVT
04/05/2008 E-mail string from Judith Gauld to David Robin regarding Request
04/08/2008 E-mail from Dr. Joerg Holste to Peter Mier, Juergen Trzewik, et al.
regarding Interim Report Mesh Implants Pelvic floor Prof. Klosterhalfen;
cc: Tracy Boyle, et al.
04/17/2008 E-mail chain, top one from Mark Yale to Jennifer M. Paine regarding
Medical Devices Vigilance System
DX21591
Page 87 of 191
Offered
Admitted
Exhibit
DX21592
DX21593
Date
Description
ETH.MESH.08692183
04/18/2008 Letter with redaction from Theresa Dunn to Bartholomew regarding
confirmation of offer to take on your new role with Ethicon, Inc. as a
Professional Education Director, Worldwide
ETH.MESH.00065646
ETH.MESH.00165490
E-mail from J. Harrison to P. St. Hilaire, S. Jones and “cc” to L. Hall,
dated 4/23/2008, regarding “’09 NTS by Minor” with attachment that
04/23/2008 contains the current assumptions for NTS by minor for the ’09 BP
4/28/2008 2-page copy of document entitled "Ethicon Women's Health & Urology
Submission Form"
DX21594
ETH.MESH.00365662
DX21595
DX21596
DX21597
DX21598
DX21599
DX21600
DX21601
DX21602
DX21603
DX21604
ETH.MESH.08385342
05/01/2008
ETH.MESH.08385338
05/01/2008
05/02/2008
ETH.MESH.06379485
ETH.MESH.02227224
ETH.MESH.00345290
ETH.MESH.00345291
ETH.MESH.03752672
ETH.MESH.02211912
ETH.MESH.00333248
ETH.MESH.01128676
DX21605
DX21606
DX21607
DX21608
04/28/2008
ETH.MESH.07088878
ETH.MESH.02184138
ETH.MESH.00333195
05/09/2008
05/16/2008
Document entitled "Label Content Approval," LCA Reference No. 0512007 Rev 2
Technical Memo from James Ward and Tim Muench to Patrice Napoda
and Petra Kohler regarding Technical memo project NUVANCE Risk
Assessment of Implant Cross Over
Technical Memo Project Nuvance
E-mail from Sheri Dodd to Mark L. Storch, Dr. James Hart, et al.
regarding NICE Summary: How does it work and what are the
implications for the US
"MGPP Thunder Decision Meeting" powerpoint presentation
Email from Price St. Hilaire to Krystina Laguna re: Copy Review TVT
Complications
05/16/2008 Email string re: Copy Review TVT Complications
05/23/2008 E-mail string, top one from Susan Lin to Jennifer M. Paine and Scott
Ciarrocca regarding question
LNE Test Report re: Mechanical Characterization of Suburethral Tapes
05/27/2008 and of Pelvic Floor Repair Meshes
05/27/2008 Spreadsheet, All Active CAPA's, May 27, 2008, with redactions
05/28/2008 E-mail from Jason Hernandez to Ji Hee Yeo, Julie, Hocknell, et al.
regarding New TVT SECUR, TVT-O and TVT (including AA) Procedural
Step Guide
05/28/2008 Email re: NICE IP – Single Incision Sub Urethral Slings
05/29/2008 E-mail chain with attachment, dated 5/29/2008, re: Nachtrag: der Artikel
06/03/2008 Corporate CAPA Review Board (CCRB) - May 27, 2008 Meeting Minutes
Page 88 of 191
Offered
Admitted
Exhibit
DX21609
DX21610
DX21611
ETH.MESH.04094761
ETH.MESH.09479026
ETH.MESH.09479256
ETH.MESH.05224710
DX21612
DX21613
ETH.MESH.04048520
ETH.MESH.04048520
Date
Description
E-mail chain, top one dated 4 June 2008, re: TVT-WORLD Registry –
06/04/2008 Adverse Event 10100071469
06/10/2008 Ethicon-Secant Development Contract 6.10.2008
06/10/2008 Ethicon-Secant Development Contract 6.10.2008
06/16/2008 4-page copy of E-mail from Mark Yale to Wanda Patire-Singer and Linda
McNelis regarding Company Procedure for the Management of Litigation
Support PR-000023: Annual Review and Training Needed; cc: Karen
Gabbett, Ana Neve, et al.
KOL Interview: Carl G. Nilsson w/meeting attendees and summary of
06/18/2008 meeting
06/18/2008 KOL interview: Carl G. Nilsson, Interview: 06.18.08 (10-4pm)
DX21614
DX21615
ETH.MESH.00318715
ETH.MESH.00331836
07/09/2008
07/22/2008
DX21616
DX21617
DX21618
DX21619
ETH.MESH.03459104
ETH.MESH.00167352
DX21622
ETH.MESH.03021946
ETH.MESH.06851864
ETH.MESH.06851860
ETH.MESH.00057413
DX21623
ETH.MESH.00057416
DX21624
ETH.MESH.03459212
DX21620
DX21621
08/13/2008
08/15/2008
Email chain re: URGENT Request relating to coding for various meshes,
Prolift and TVT products, and manufacturing locations, top email from
Mark Yale to group, original email from Christine Bielinski to Leslie
Young and Patrice Napoda
E-mail string, top one from Karl Reese to Jennifer M. Paine regarding
Corrective Action Plan - Ethicon Audit June 2-3, 2008; cc: Elizabeth
Goral, et al.
Ethicon Copy Review Submission form: Update Patient Brochure on
www.whatshappeningdownthere.com/SUI
Gynecare TVT Tension-Free Support for Incontinence - Value Dossier US HE&R
08/25/2008 T-Pro (Thunder) Pipeline Leadership Team (PLT) PowerPoint Presentation
08/27/2008 CE Mark Technical File for Gynecare TVT Mesh Device, Gynecare TVT
Kit (TVT-D), and Gynecare TVT-AA
08/27/2008 Gynecare TVT AA - CE Mark Technical File
E-mail chain, top one dated 28 Aug 2008 re: Copy Review Exception
08/28/2008 Needed
Talking Points on Pelvic Floor Repair Mesh, internal document re: recent
08/28/2008 changes with FDA concerning same
FOR IMMEDIATE RELEASE: New Study Offers More Than a Decade
Of Evidence For Minimally-Invasive Surgery To Treat Female
09/05/2008 Incontinence", Nilsson 11 year press release
Page 89 of 191
Offered
Admitted
Exhibit
DX21625
DX21626
No Bates No.
ETH.MESH.00147509
ETH.MESH.04099156
DX21627
DX21628
DX21629
DX21630
DX21631
DX21632
DX21633
DX21634
DX21635
DX21636
ETH.MESH.06121292
ETH.MESH.00164648
ETH.MESH.00332884
ETH.MESH.00332853
ETH.MESH.01746859
ETH.MESH.05181558
ETH.MESH.00332850
ETH.MESH.00852296
ETH.MESH.03193640
ETH.MESH.03983643
DX21637
ETH.MESH.00329113
DX21638
DX21639
ETH.MESH.06201216
ETH.MESH.00329113
Date
Description
Bako, A., et al. Review of Synthetic Mesh-Related Complications in
09/09/2008 Pelvic Floor Reconstructive Surgery. Int Urogynecol J 2009;20:103-111
09/16/2008 Document stamped approved on September 16, 2008, Marketing Services
09/18/2008 E-mail string, top one from Carolyn Brennan to Meng Chen regarding
Terms related to pelvic mesh exposure and the most recent review on
commercial pelvic floor repair systems
09/19/2008 E-mail string from Bart Pattyson to Ji Hee Yeo regarding Thanks very
much!
09/25/2008 TVT sales piece
09/29/2008 Spreadsheet, All Active 56 CAPA's
BSI Nonconformities, FDA 483, and FDA Management Discussion Point
10/01/2008 Active CAPA's
Email re: TVT World registry. NB that this email was sent months before
10/01/2008 the Adverse Events Report
10/01/2008 E-mail string, top one from Susan Lin to Lauren Taveroni regarding EPI
& Fairl Balance Status?
10/03/2008 Worldwide CAPA Monthly September 2008 – Confidential
October 5-7, 2008 Emails re: Randomized, Controlled Trials Needed for
10/05/2008 Incontinence Devices
10/07/2008 Email string re: TVT World Registry
10/10/2008 E-mail from Scott Finley to Greg Pine regarding Key Customer
Engagement
10/13/2008 E-mail chain, top one from Jennifer Paine to Catherine Beath, Sergio
Gadaleta, et al. regarding FDA Public Health Notice on Surgical Mesh for
POP and SUI -URGENT
Email from Jennifer Paine to Catherine Beath and others re: Quality Board
10/13/2008 on Mesh Advisory
10/13/2008 E-mail string from Jennifer Paine to Jacqueline Russo-Jankewicz, et al. re:
FDA Public health Notice on Surgical Mesh for POP and SUI - URGENT.
E-mail Thread from Jennifer M. Paine to Catherine Beath, Sergio
Gadaleta, and Mark Yale regarding FDA Public Health Notice on Surgical
Mesh for POP and SUI - URGENT
DX21640
Page 90 of 191
Offered
Admitted
Exhibit
Date
Description
ETH.MESH.00080128
10/14/2008 E-mail Thread from Bryan Lisa to Julia A. Marders; cc: Jennifer Paine
regarding Ethicon comments on FDA Public Health Notification
ETH.MESH.05826034
10/14/2008 Voice mail from Kevin Mahar to ETHICON Women's Health & Urology
U.S. Sales & Marketing
10/14/2008 Voice mail from Kevin Mahar to Ethicon Women's Health & Urology
U.S. Sales & Marketing Organization
10/15/2008 Draft Dear Physician Letter from Ethicon Medical Affairs
10/15/2008 E-mail from Jacqueline Russo-Jankewicz to Jennifer M. Paine, et al.
regarding FDA notification/Current drafts; with attachments; cc: Kevin
Mahar, et al.
10/16-10/17/08 E-mail Chain, re: Confidential, Potential FDA Notification
10/16/2008 Plan
E-mail dated 16 Oct. 2008, with attachment re: Confidential-Potential
10/16/2008 FDA Notification Plan
10/17/2008 Document entitled "Draft for review, 10/17/08, FDA Notification About
Use of Surgical Mesh to Treat Pelvic Organ Prolapse and Stress Urinary
Incontinence Email to EWHU Organization from Renee Selman"
DX21641
DX21642
ETH.MESH.00066960
DX21643
DX21644
ETH.MESH.00066817
ETH-47351 to ETH-47355
DX21645
DX21646
DX21647
ETH.MESH.04606783
ETH.MESH.02065133
ETH.MESH.05826033
DX21648
ETH.MESH.00066957
DX21649
ETH.MESH.00066957
10/17/2008 E-mail from Devon Prutzman to Renee Selman, et al. re FDA Notification
documents.
10/17/2008 E-mail from Devon Prutzman to Renee Selman, Kevin Mahar, et al.
regarding Confidential: FDA Notification documents; cc: David Robinson
DX21650
ADVAMED 00001669 to ADVAMED
00001670
10/17/2008 E-mail Thread from Jeffrey Secunda to Art Butcher and Donna Gardner;
cc: Nancy Jackson and Tara Federici regarding FW: PHN on Serious
Complications Associated with Transvaginal Placement of Surgical Mesh
DX21651
DX21652
DX21653
DX21654
DX21655
ETH.MESH.00852657
ETH.MESH.05826028
ETH.MESH.07049552
ETH.MESH.03665487
AdvaMed letter to FDA re: Public Health Notification on Transvaginal
Placement of Surgical mesh in Repair of Pelvic Organ Prolapse and Stress
10/19/2008 Urinary Incontinence
10/20/2008
Document entitled "FDA Public Health Notification: Serious
Complications Associated with Transvaginal Placement of Surgical Mesh
in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence"
10/20/2008 Email between Colin Urquhart, Peter Jones and others
Email chain regarding FDA Public Health Notification; TVT patient
10/20/2008 brochure attached.
Page 91 of 191
Offered
Admitted
Exhibit
No Bates number
DX21656
No Bates number
DX21657
No Bates number
DX21658
DX21659
ETH.MESH.02629342
ETH.MESH.00164025
DX21660
DX21661
DX21662
DX21663
ETH.MESH.04038686
ETH.MESH.02122840
ETH.MESH.02310657
ETH-47376 to ETH-47379
ETH-47376 to ETH-47380
ETH.MESH.02310657
Date
Description
10/20/2008 FDA Public Health Notification: Serious Complications Associated with
Prolapse and Stress Urinary Incontinence , 1 page
Prolapse and Stress Urinary Incontinence , 3 pages
Prolapse and Stress Urinary Incontinence
10/20/2008 Issue Report, TVT Retropubic 2008-2009 Open Date Between 01-Jan2008 and 31-DEC 2009
10/21/2008 "FINAL - 10/21/08, FDA Notification About Use of Surgical Mesh to
Treat Pelvic Organ Prolapse and Stress Urinary Incontinence Standby for
Media/Analyst Inquiries"
Email from Barbara Montresor to Ethicon Global Management Board re:
10/21/2008 Background Information: FDA Notice re: Use of Mesh
Email from Harel Gadot to “Regional Leaders” re: INfomration about
10/21/2008 FDA notification on use of mesh in pelvic surgery
Email from Renee Selman (WW President, Ethicon WH&U) to EWHU
Team re Information about FDA notification on use of mesh in pelvic
10/21/2008 surgery
10/21/2008 E-mail from Sandy Pompilio to Nicholas Antoun, et al. regarding
Infromation about FDA notification on use of mesh in pelvic surgery; with
attachment
DX21664
DX21665
ETH.MESH.00080164
ETH.MESH.00350881
10/21/2008 Email from Scott Jones to Jonathan Meek and others re: FDA notification
10/21/2008 FDA Notification About Use of Surgical Mesh to Treat Pelvic Organ
Prolapse and Stress Urinary Incontinence Standby for Media/Analyst
Inquiries
ETH.MESH.00164025;
ETH.MESH.05603820
10/21/2008 Final -- 10/21/2008 FDA Notification About Use of Surgical Mesh to
Treat Pelvic Organ Prolapse and Stress Urinary Incontinence Standby for
Media/Analyst Inquiries
ETH.MESH.00095870
Scott Jones e-mail re: information about FDA notification on use of mesh
10/21/2008 in pelvic surgery
DX21666
DX21667
DX21668
Page 92 of 191
Offered
Admitted
Exhibit
DX21669
DX21670
DX21671
DX21672
DX21673
DX21674
DX21675
ETH.MESH.00164027
ETH.MESH.07049554
ETH.MESH.07937825
ETH.MESH.00291935
ETH.MESH.07104841
ETH.MESH.03934032
ETH.MESH.00590065
ETH.MESH.05224761
DX21676
DX21677
DX21678
DX21679
DX21680
DX21681
DX21682
DX21683
DX21684
DX21685
DX21686
ETH.MESH.05224761
ETH.MESH.01203957
ETH.MESH.00008072
ETH.MESH.00320602
ETH.MESH.02249593
ETH.MESH.00856006
ETH.MESH.05220093
No Bates No.
ETH.MESH.00133731
ETH.MESH.00858891
Date
10/21/2008
Description
Standby statement in response to the FDA’s October 2008 PHN. FDA
Notification About Use of Surgical Mesh to Treat Pelvic Organ Prolapse
and Stress Urinary Incontinence Standby for Media/Analyst Inquiries
10/22/2008 Email string re: TVT-World AE Coding
Emails Re: Information about FDA notification on use of mesh in pelvic
10/22/2008 surgery
PHC Barbara Levy MD and Vincent Lucente, MD - Dear Friends and
Colleagues letter enclosing Public Health Notification from FDA relating
to procedures using surgical mesh for the repair of pelvic organ prolapse
10/22/2008 and stress urinary continence
Email from Julie Bird to Marketing re: IMPORTANT – Information
10/23/2008 regarding FDA Publication on the use of Mesh
Email string re: Information about FDA notification on use of mesh in
10/23/2008 pelvic surgery (Partially Redacted)
10/23/2008 Piet Hinoul e-mail re: 2008 FDA PHN
10/30/2008 10-page copy of E-mail from Compliance Information Update to Aarin
Beckerle, et al. regarding PLEASE NOTE: NEW Procedures for
Managing Litigation Holds; cc: Lisa Demarest and Mark Yale
10/30/2008 E-mail from Compliance Informatin Update to Aarin Beckerle, Michael
Abrejera, et al. regarding PLEASE NOTE: NEW Procedures for
Managing Litigation Holds effective November 6, 2008; cc: Lisa
Demarest, et al.
11/14/2008 The Future of Surgical Meshes PowerPoint
11/18/2008 Ethicon PFR online training course
E-mail chain, top one dated 25 Nov. 2008, re: FDA Mesh Safety Notice
11/25/2008 Could Have Long-Term Impact
E-mail from Mark Yale to Mark Yale, Catherine Beath, et al. regarding
11/25/2008 Post Mark Surveillance Steering Committee Kick-Off
11/25/2008 E-mail from Secunda re: FDA PHN of Surgical mesh
Letter from FDA enclosing an establishment inspection report (EIR) from
12/01/2008 an inspection of Ethicon SARL
12/04/2008 MSDS for Marlex ® Polypropylene (All grades) dated 12/4/2008.
12/08/2008 Document entitled "Surgical Mesh to Treat Stress Urinary Incontinence
and Pelvic Organ Prolapse"
Document re: Goals, Benefits and Strategy for TVT R versus TVTO and
12/08/2008 TVTS
Page 93 of 191
Offered
Admitted
Exhibit
DX21687
DX21688
DX21689
DX21690
DX21691
ETH.MESH.01673341
ETH.MESH.08003294
ETH.MESH.05183410
ETH.MESH.00067363
ETH.MESH.02227368
ETH.MESH.00772229
Date
Description
Presentation: "Stop Coping. Start Living. Treatment Options for Urinary
12/09/2008 Incontinence."
12/11/2008
12/15/2008
12/15/2008
12/17/2008
Linda Linton email chain re TVT 11 Year E-blast Results (1st Round)
Email attaching Vincent Lucente Webinar Transcript
Meshes/Devices Chart
E-mail chain, top one from Robin Osman to Joy M. de Los Reyes
regarding 2008 Budget Spend; cc: Alyson Wess, et al.
DX21692
DX21693
ETH.MESH.00772232
ETH.MESH.00772232
12/17/2008 Email from Robin Osman re Updated Fair Balance for TVT Brochure
12/17/2008 E-maill chain, top one from Robin Osman to Susan Lin regarding Updated
Fair Balance for TVT Brochure
DX21694
DX21695
DX21696
DX21697
DX21698
DX21699
DX21700
DX21701
ETH.MESH.00772229
ETH.MESH.00772226
ETH.MESH.00772220
ETH.MESH.00339084
ETH.MESH.04092869
ETH.MESH.00872521
No Bates No.
ETH.MESH.01202103
DX21702
DX21703
DX21704
DX21705
ETH.MESH.01238051
ETH.MESH.09656632
ETH.MESH.09656632
Osman email chain . . . Unfortunately we can't print the new brochure. . .
12/17/2008 Regulatory rejected my Copy Review submission . . .
Email from Robin Osman re: TVT Patient Brochure Fair Balance – Needs
12/18/2008 Approval!
Email from Robin Osman re: TVT Patient Brochure Fair Balance/EPI
12/18/2008 Changes
12/18/2008 E-mail thread from Bryan Lisa to Susan Lin regarding FW: TVT Patient
Brochure Fair Balance/EPI Changes
12/19/2008 E-mail from Meng Chen to Segio Gadaleta and Mark Yale regarding
#10100080654 and TVT IFUs
12/22/2008 E-mail from David Robinson re: mesh complications
Phillips Sumika Polypropylene Company Material Safety Data Sheet
12/24/2008 Marlex Polypropylene (All Grades) Revision No. 5.03
01/07/2009 E-mail chain, top one from Aaron Kirkemo to Piet Hinoul, Harel Gadot, et
al. regarding My revised writeup of the DeLeval and Waltregny visit; cc:
Axel Arnaud
01/07/2009 Email Traffic re: My revised writeup of the DeLeval and Waltregny visit
01/08/2009 Biomechanical consideration presentation
Placeholder/PowerPoint entitled "Biomechanical considerations"
01/08/2009
Page 94 of 191
Offered
Admitted
Exhibit
DX21706
ETH.MESH.02252224
ETH.MESH.04879993
Date
Description
Letter from FDA to Marinelba Rosado, General Manager Ethicol LLC San
Lorenzo Puerto Rico plant concerning FDA inspections of the plant
8/11/2008 – 9/5/2008. Inspections showed deviations from the CAPA
system. Concerns Prolene and mesh products, as well as other sutures,
01/09/2009 and products manufactured at the plant
01/12/2009 E-mail chain, top one from Gary Pruden to Christi Shaw-Sarubbi
regarding Networking
DX21707
DX21708
DX21709
ETH.MESH.00602477
ETH.MESH.00345329
ETH.MESH.06034753
DX21710
ETH.MESH.01238051
E-mail dated 1/14/09 to David Robinson, et al., from Judi Gauld, plus
01/14/2009 attachments, re: Minutes and Agenda
01/14/2009 E-mail string, top one from Susan Lin to Susan Kleczkowski and Aaron
Kirkemo re: Revised TVT CR #2008-1359
How to Handle a Customer Complaint
01/14/2009
01/15/2009 E-mail chain, top one from Piet Hinoul to Stale Kvitle regarding TR:
Comments on MiniMe to Julie and Zeb
DX21711
DX21712
DX21713
DX21714
ETH.MESH.02107485
ETH.MESH.02122904
ETH.MESH.02122907
ETH.MESH.03208549
Meeting with Prof deLeval and Prof Waltregny regarding several
01/23/2009 questions [HOT DOCUMENT]
Email from Joseph Scavona (Worldwide Quality) re TVT Complications
Statement 2008 with attached draft slide of Complaint Reporting
Statement with most significant reported TVT complications through
01/26/2009 December 2008
Email from Joseph Scavona to Hillary Perkins re: TVT Complications
01/26/2009 Statement 2008
01/28/2009 E-mail chain, top one from Piet Hinoul to Colin Urquhart regarding TVT
WORLD AE Report; cc: Judi Gauld
DX21715
DX21716
DX21717
DX21718
DX21719
DX21720
ETH.MESH.07181044
ETH.MESH.07181044
ETH.MESH.07181043
No Bates No.
ETH.MESH.00071794
Email from Colin Urquhart (Clinical Project Manager) to Piet Hinoul re
01/28/2009 TVT World AE Report
01/28/2009 E-mail from Colin Urquhart to Piet Hinoul regarding TVT WORLD AE
Report, with attachment, 17 pages
01/28/2009 Email string re: TVT World AE Report
01/28/2009 Hinoul, Piet e-mail re: TVT WORLD AE Report dated Jan 28, 2009.
01/29/2009 E-mail chain from Meng Chen to Bryan Lisa regarding TVT IFU
ETH.MESH.04094864
Page 95 of 191
Offered
Admitted
Exhibit
ETH.MESH.04093125
DX21721
DX21722
ETH.MESH.04093125
DX21723
ETH.MESH.00071794
ETH.MESH.04094864
ETH.MESH.04093118
ETH.MESH.9479249 to
ETH.MESH.9479251
DX21724
DX21725
DX21726
DX21727
DX21728
DX21729
DX21730
ETH.MESH.00007092
ETH.MESH.00007092
ETH.MESH.00590820
ETH.MESH.03280601
ETH.MESH.03208739
DX21731
ETH.MESH.05205733
Date
Description
01/29/2009 E-mail chain, top one from Meng Chen to Bryan Lisa regarding TVT IFUs
on tape extrusion, exposure and erosion
Email from Meng Chen re TVT IFUs on tape extrusion, exposure and
01/29/2009 erosion
E-mail re: TVT IFUs on tape extrusion, exposure and erosion, from Meng
01/29/2009 Chen to Bryan Lisa
01/29/2009 E-mail string, top one from Bryan Lisa to Meng Chen regarding TVT
IFUs on tape extrusion, exposure and erosion
01/29/2009 Emails Re: TVT IFUs on tape extrusion, exposure and erosion
Email from Rousseau to Majercak re: welding ends of braided wire of
02/04/2009 guide catheters
Email from Jennifer Haby to Melissa Chaves re: CR Approved 2009-98.
02/06/2009 The Ethicon Worldwide Complaint Reporting Statement was attached to it
02/06/2009 E-mail from Jennifer Haby to Melissa Chaves, Scott Jones, et al.
regarding CR Approved 2009-98; cc: Cathy Guiney
02/07/2009 E-mail string
02/07/2009 E-mail string re: Bernard the writer
02/25/2009 Email from Jason Hernandez (Worldwide Product Director, Incontinence)
re Quick Response Needed to Finalize TVT WORLD Recommendation
for Board Meeting on Monday Mar 2nd with attached presentation: TVT
WORLD Registry - Maximizing the investment - SBT (Strategic Business
Team) Feb 2009
02/26/2009 E-mail chain, top one from Renee Selman to Kevin Mahar and Lesley
Fornio regarding Catching-Up
DX21732
ETH.MESH.00134795
DX21733
ETH.MESH.02106140
02/27/2009 1-page copy of E-mail from Jason Hernandez to Nicholas Antoun, Nuno
Barboza, et al. regarding TVT WORLD Board meeting presentation; cc:
Harel Gadot, plus attachments
02/27/2009 E-mail chain, top one from Jason Hernandez to Lesley Fronio and Paul
Sung regarding Regional Input to Finalize TVT WORLD
Recommendation for Board Meeting on Monday Mar 2nd; cc: Harel Gadot
DX21734
DX21735
DX21736
ETH.MESH.00134794
ETH.MESH.02106140
02/27/2009 E-mail from Jason Hernandez to Nicholas Antoun, Nuno Barboza
regarding TVT WORLD Board meeting presentation; cc: Harel Gadot, et
al.
Email string re: Regional Input to Finalize TVT World Recommendation
02/27/2009 for Board meeting on Monday Mar 2nd
Page 96 of 191
Offered
Admitted
Exhibit
ETH.MESH.02106156
DX21737
DX21738
DX21739
DX21740
DX21741
DX21742
DX21743
ETH.MESH.00134795
ETH.MESH.03966040
ETH.MESH.08474547
ETH.MESH.00353200
ETH.MESH.00339057
ETH.MESH.00006796
ETH.MESH.01262556
Date
Description
03/02/2009 E-mail thread from Jason Hernandez to Harel Gadot regarding Ensuring
Internal Team Maintains TVT World Decision Confidential to Allow
Formal Notification
03/02/2009 Slide deck, TVT World Registry Maximizing the investment
03/06/2009 E-mail string, top one from Scott Finley to Melissa Chaves regarding Fast
Break Update
03/10/2009 Email Bryan Lisa to Melissa Chaves re: CR Pieces
Physician brochure/sales aid, Make DATA and SAFETY Your Choice
03/11/2009 Sales aid with Nilsson 11 year data
E-mail dated 12 March 2009 with attachment re: CR Approved 2009-308
03/12/2009 NTM PFR Pres. 1 of 2
03/18/2009 E-mail chain, top one from David Robinson to Dr. James Hart, Piet
Hinoul, et al. regarding Invitation to speak to IUGA workshop
DX21744
DX21745
ETH.MESH.03209119
ETH.MESH.00406656
DX21746
DX21747
DX21748
DX21749
DX21750
DX21751
DX21752
DX21753
DX21754
DX21755
DX21756
ETH.MESH.01186072
ETH.MESH.06767603
ETH.MESH.01238294
ETH.MESH.00948634
ETH.MESH.01238316
ETH.MESH.02184436
ETH.MESH.00591028
ETH.MESH.00591128
ETH.MESH.05122250
ETH.MESH.09032795
03/19/2009 Email string re: TVT World - Next steps following board meeting
03/20/2009 Letter from Patricia Beach to Oscar Aguirre regarding TVT World
Registry
03/23/2009 GYNECARE TVT advertisement: “Make Data and Safety Your Choice.”
03/24/2009 E-mail string from Thomas L. Divilio to Meng Chen regarding
10100092375
Email from Piet Hinoul to Axel Arnaud regarding meeting [HOT
03/27/2009 Health Care Compliance Ethicon, Inc. Frequently Asked Questions
03/31/2009 E-mail from Piet Hinoul re: smoking and erosion - :”We knew didn’t we!”
04/03/2009 E-mail chain, top one from Osman Rathore to Meng Deng, et al. regarding
FW: Analytical characterization - Optimization Structure
04/07/2009 Email from Piet Hinoul to Aaron Kirkemo re: Tvt Sheath
04/08/2009 Emails between Piet Hinoul and Aaron Kirkemo re registry for all!
04/14/2009 PowerPoint, What’s Going on Out There BP Kickoff Meeting
04/16/2009 Email from Paragian to Hackman re: TVT Test Results
Page 97 of 191
Offered
Admitted
Exhibit
DX21757
ETH.MESH.07090181
ETH.MESH.00432936
DX21758
ETH.MESH.02148460
DX21759
DX21760
DX21761
DX21762
DX21763
ETH.MESH.02138455
ETH.MESH.02148431
ETH.MESH.00591234
ETH.MESH.00591212
ETH.MESH.03259440
Date
Description
04/20/2009 Email string re: AUGS Draft TVT World Abstract
04/21/2009 Placeholder/PowerPoint presentation entitled "Professional Education
Continuum of Education" Lissette Caro Rosado
04/22/2009 2-page copy of e-mail plus attachment from Dr. Joerg Holste to Jonathan
Meek and Peter Meier regarding Question on Monocryl absorption; cc:
Lynn Hall, et al.
E-mail chain, top one dated 22 April 2009 re: TVT Mesh Pore Size
04/22/2009 Measurement
Email from Dr. Joerg Holste to Jonathan Meet, et al. re: Question on
04/22/2009 Monocryl absorption
04/22/2009 Emails from Piet Hinoul RE: Meeting Minutes Prof deLeval 20/04/09
04/22/2009 Emails from Piet Hinoul RE: Meeting Minutes Prof deLeval 20/04/09
04/24/2009 E-mail string, top one from Judi Gauld to Colin Urquhart regarding green
journal
DX21764
DX21765
DX21766
DX21767
ETH.MESH.03259440
ETH.MESH.00327179
ETH.MESH.00533256
ETH.MESH.00533256
04/24/2009 Gauld email chain re Green Journal
04/28/2009 Emails from Carlos Lugo-Ponce RE: not for human use
TVT-World-Wide Observational Registry for Long-Term Data Protocol
04/28/2009 300-06-006 Protocol Amendment 2
04/28/2009 TVT-WORLD-Wide Observational Registry for Long-Term Data, TVTWORLD, Protocol: 300-06-006, Protocol Amendment 2: 28 April 2009,
Summary of Changes: 11-21,
DX21768
DX21769
DX21770
DX21771
ETH.MESH.00095928
No Bates number
ETH.MESH.05342340
ETH.MESH.04120969
DX21772
ETH.MESH.00679490
DX21773
John Wood e-mail to Scott Jones re: patient safety alert AL09-20;
04/29/2009 Transvaginal Placement of Surgical Mesh
May-2009 PowerPoint, "Ethicon 2009 Strategic Plan, May 2009," 25 pages
05/02/2009 E-mail string from Ignatius Ferreira to Bart Pattyson regarding Intl
Preceptor opportunity - S. Africa
05/11/2009 E-mail string, top one from Piet Hinoul to Liza Ovington and Thomas
Divilio regarding Dindo reference and mesh use in the pelvic floor; David
Robinson
05/14/2009 E-mail from Kevin Mahar to Sandra Humbles, Tom Eagan, et al.
regarding Global Sales Training Team Minute Meetings from 5/12/09; cc:
Jennifer Warren
Page 98 of 191
Offered
Admitted
Exhibit
DX21774
DX21775
Date
Description
ETH.MESH.03843519
No Bates number
ETH.MESH.02249526
05/14/2009 E-maill string, top one from Dr. James Hart to Piet Hinoul, David
Robinson, et al. regarding Follow up on dealing with complaints 1
05/18/2009 ETHICON Regulatory Compliance Council Meeting, 1 page
05/20/2009 E-mail chain, top one from Christiana Bielinski to Catherine Beath
regarding ERCC Meeting May 18
ETH.MESH.00509656
ETH.MESH.00815313
ETH.MESH.02250945
05/21/2009 Professional Education Application - GYNECARE TVT Platform
05/22/2009 E-mail string, top one from Julie Bird to Melissa Chaves, et al. regarding
Continence Health Global Strategic Team; cc: Zeb Viana
05/26/2009 All Active CAPA'S
DX21776
DX21777
DX21778
DX21779
ETH.MESH.02122904
05/26/2009 E-mail chain, plus attachment, top one from Carolyn Brennan to Jason
Hernandez regarding TVT Complications Statement 2008; cc: Joseph
Scavona, et al.
ETH.MESH.02122905
05/26/2009 E-mail string with attachment, top one from Carolyn Brennan to
Jason Hernandez regarding TVT Complications Statement 2008;
cc: Joseph Scavona
DX21780
DX21781
DX21782
ETH.MESH.00873913
05/26/2009 Emails re: Communication PQI09-028
DX21783
ETH.MESH.08003262
05/29/2009 Support for Incontinence Patient Brochure (Not including TVT Secur)
ETH.MESH.08003278
ETH.MESH.00873918
No Bates number
ETH.MESH.06022096
DX21787
05/29/2009 Support for Incontinence Patient Brochure (Not including TVT Secur)
Emails re: Communication to Customers TVT Case Sweden – Draft
06/01/2009 090601
06/2009 GAO Report, 6/09
06/02/2009 Health Canada Letter from Roland Rotter to Leslie Martinez regarding
Request for Additional Information under Section 39 of the Medical
Device Regulations
DX21788
ETH.MESH.00001634
Spreadsheets Comparing Uphold, Pinnacle and Elevate Features, Benefits
and Response – Sales Training Tool Developed by Scott Jones – provides
sales reps with information about competitor products and “responses”
06/03/2009 about competitor products for when the reps are out in the field
DX21789
No Bates No.
06/19/2009 Sunoco Material Safety Data Sheet. Product Name: C4001 Polypropylene
DX21784
DX21785
DX21786
Page 99 of 191
Offered
Admitted
Exhibit
DX21790
DX21791
DX21792
DX21793
DX21794
DX21795
DX21796
DX21797
ETH.MESH.00873938
ETH.MESH.00082303
ETH.MESH.00139867
ETH.MESH.00319129
ETH.MESH.02011199
ETH.MESH.02250793
ETH.MESH.03665532
ETH.MESH.06239108
ETH.MESH.03656731
DX21798
DX21799
DX21800
DX21801
DX21802
ETH.MESH.06022109
ETH.MESH.03656699
ETH.MESH.04066979
ETH.MESH.09655947
ETH.MESH.09655947
DX21803
ETH-49659 to ETH-49660
Date
Description
Email from Nils Hamvik re: TVT Product Complaint – Summary Meeting
06/23/2009 Ystad 2009-0617
Email from Karl Reese at BSI discussing audit findings from 2009 BSI
audit. Discussing 6 minor NCRs and 1 major NCR. Most of these all deal
06/25/2009 with documentation
AdvaMed (Advanced Medical Technology Association) Code of Ethics on
07/01/2009 Interactions with Health Care Professionals
07/08/2009 DM/Sales Rep Do's and Don’t's
Email from Peter Meier to Jonathan Meek, Piet Hinoul et al. re TPO_TPP
07/13/2009 and the comparison of PVDF to PP
07/15/2009 Email from Christiana Bielinski re: FDA Inquiry on Prolene Mesh
07/22/2009 E-mail Thread from Bryan Lisa to Patrice Napoda and John Paulson
regarding TVT Japanese Package Insert
Bobertz, E email chain originating July 9, 2009 re Resin information
07/28/2009 request -- Neuchatel discussion of resin and syringes
07/30/2009 E-mail Thread from Takahito Hino to Patrice Napoda; cc: Ryuichi
Urakawa, John Paulson, Bryan Lisa, Tomohiro Nagaoka regarding
URGENT: TVT Japanese Package Insert
07/30/2009 Memo from Neal Brunner to Pat Napoda regarding Risk Assessment
review of Proposed changes to TVT Japanese Package Insert
Takahito, Hino email chain originating July 21, 2009 re TVT Japanese
07/30/2009 Package Insert - PMDA wants more wanings added
08/04/2009 Email re Dynamesh in Brazil
08/05/2009 Email from Juergen Trzewik re def. Stress Shielding
08/05/2009 E-mail from Juergen Trzewik to Sandy Savidge, Dr. Joerg Holste, et al.
regarding def. stress shielding
08/10/2009 E-mail string, top one with attachment from Aaron Kirkemo to Harel
Gadot, et al. regarding RAB - T-Pro redfinition?? CC: Peter Meier et al.
DX21804
DX21805
ETH.MESH.01751094
ETH.MESH.05722822
DX21806
DX21807
DX21808
ETH.MESH.02157878
ETH.MESH.02157880
ETH.MESH.00002327
09/07/2009 Project: Safety review – TVT and TVT-O procedures. By David Robinson
09/09/2009 E-mail from Peter Meier to Jonathan Meek, Clifford Volpe, et al.
regarding attached translation of interim expert report on histology of 172
human pelvic floor mesh explants; cc: Dr. Joerg Holste, et al.
09/09/2009 E-mail from Peter Meier to Jonathan Meek, et al regarding interim expert
report on histology of pelvic floor mesh explants from Prof. Klosterhalfen
09/15/2009 Ethicon Women's Health & Urology organizational charts 9/15/09
Page 100 of 191
Offered
Admitted
Exhibit
DX21809
DX21810
DX21811
DX21812
DX21813
DX21814
DX21815
DX21816
DX21817
DX21818
DX21819
DX21820
DX21821
DX21822
DX21823
DX21824
ETH.MESH.00533266
ETH.MESH.03232948
ETH.MESH.03352819
ETH.MESH.05740428
ETH.MESH.06921077
ETH.MESH.06921060
ETH.MESH.00619737
ETH.MESH.01208522
ETH.MESH.01262291
ETH.MESH.06124140
ETH.MESH.03026533
ETH.MESH.00540983
ETH.MESH.09038695
ETH.MESH.03367232
ETH.MESH.03334244
ETH.MESH.00595328
No Bates number
DX21825
ETH.MESH.03643186
DX21826
DX21827
ETH.MESH.05440655
Date
Description
Communication Plan to close TVT World Registry - Confidential and not
to be disclosed externally - by Jason Hernandez, Worldwide Product
09/29/2009 Director, Continence Health
10/06/2009 Email string re: TVT World authorship
10/09/2009 E-mail chain, top one dated 09 Oct. 2009 re: Lucente 3 Year Data
Email to Lissette Caro-Rosado from Robert Zipfel re: AAGL additional
10/28/2009 supplies
11/10/2009 E-mail chain top one from Joseph Lanza to Stephanie Grupe regarding
Preread for Web Conference; cc: Dan Smith, et al.
11/10/2009 Email from Joseph Lanza re Preread for Web Conference
E-mail re: Quick Question from Erika Lane, Sales Training, from Paul
11/11/2009 Sung (Ethicon) to Erika Lane and Lena Tai (Ethicon)
TVT and TVT-O for surgical treatment of primary stress urinary
incontinence: prospective randomized trial. Int Urogynecol J (2009).
11/12/2009 [HOT DOCUMENT]
11/20/2009 E-mail string re: the fat lady has sung – here is Halina’s talk
11/23/2009 E-mail string from Jiahui Zhao to Bart Pattyson regarding certificate
E-mail chain, top one dated 24 Nov. 2009 re: Action Required:
11/24/2009 Faculty/KOL Contracting for 2010
11/30/2009 WH&U TVT & POP MDR Guidance Most Commonly Reported Patient
Events
Email from Dr. L. Thomas Divilio re: IFU Mesh fixation Updates for
12/03/2009 UPP/UHS/PVP
12/14/2009 5-page copy of e-mail from Zeb Vina to Ulrika Kohler, Piet Hinoul, et al.
regarding Danish case;; cc: Kristina Grafstorm
12/22/2009 Run on eg log.txt
12/24/2009 E-mail string re: response
PowerPoint "Ethicon Women's Health and Urology Brand Equity Study
Jan-2010
Final Report January, 2010," 65 pages
Jan-2010 PowerPoint "Ethicon Women's Health and Urology Brand Equity Study
Final Report January, 2010," 66 pages
01/05/2010
E-mail dated 1/05/2010 re: Ethicon R&D Seminar series
Page 101 of 191
Offered
Admitted
Exhibit
DX21834
ETH.MESH.02597972
ETH.MESH.00595463
ETH.MESH.00340999
ETH.METH.00806647
ETH.MESH.09653079
ETH.MESH.09653077
ETH.MESH.09479053
DX21835
ETH.MESH.01785259
DX21836
ETH.MESH.00748275
ETH.MESH.05127430
DX21828
DX21829
DX21830
DX21831
DX21832
DX21833
Date
Description
01/05/2010 Email traffic re: IFU
01/07/2010 Email from Bryan Lisa re: Scion pathways
01/08/2010 Global Regulatory Strategy for TVT IFU (RMC P15506/E) Update (Part
II, RA0001-2010, Rev. 0)
01/08/2010 Slide Deck EWHU Continuum of Education "The Journey"
01/13/2010 E-mail with attachments regarding Ethicon R&D Seminar Series,
Organizer Michael Steffensen
01/13/2010 Ethicon R&D Seminar Series meeting minutes
01/14/2010 Ethicon-Secant Supply Agreement 1.14.2010
Email from Dr. Piet Hinoul to Dr. David Robinson, et al. Re: +M
01/17/2010 relaxation
Application FMEA for TVT Classic – Revision History for aFMEA, folder
01/19/2010 # SUBOTH0003571 (eDHF 0000834)
01/20/2010 2-page copy of e-mail from Dr. Joerg Holste to Petra Koehler and Axel
Arnaud regarding Tissue reaction ULTRAPRO
DX21837
DX21838
DX21839
DX21840
DX21841
DX21842
DX21843
DX21844
DX21845
DX21846
DX21847
DX21848
DX21849
ETH.MESH.05127423
ETH.MESH.00549779
ETH.MESH.00335589
ETH.MESH.08474555
ETH.MESH.01208482
ETH.MESH.03657427
ETH.MESH.05443495
ETH.MESH.02184949
ETH.MESH.00340839
ETH.MESH.08014327
ETH.MESH.00335189
ETH.MESH.00351701
Email from Joerg Holste to Petra Koehler and Axel Arnaud re Tissue
01/20/2010 reaction ULTRAPRO
E-mail chain, top one dated 21 Jan. 2010 re: Sales Training not included
01/21/2010 in Dr. Lucente’s 2010 contract?
01/21/2010 Ethicon LLC Organization Chart
Email from Piet Hinoul to Axel Arnaud regarding TR: Dyspareunia after
02/10/2010 midurethral slings [HOT DOCUMENT]
02/12/2010 E-mail Thread from Shizuka Takase to Bryan Lisa; cc: Darlene Jane Kyle,
Krystina Laguna, Patrice Napoda et al. regarding RE: Health Canada
Notification for surgical mesh in repair of POP and SUI
02/17/2010 Burkley, D.F. Porosity Measurements of Prolene Meshes
E-mail chain, top one dated 17 Feb. 2010 re: Interesting article on PP in
02/17/2010 vivo degradation
Gynecare TVT Device Instructions for Use Revision Design Verification
02/17/2010 Memo signed by Kirkemo, Robinson and Hinoul
02/24/2010 E-mail string from Jonathan Fernandez to Carol Padgett regarding Dr.
Alvina Driscoll
02/25/2010 Neuchatel Operations Organizational Chart February, 25 2010
02/26/2010 February 26-March 16, 2010 Emails re: first draft equivalence ABBREVO
Page 102 of 191
Offered
Admitted
Exhibit
DX21850
DX21851
DX21852
DX21853
DX21854
DX21855
DX21856
DX21857
DX21858
DX21859
DX21860
ETH.MESH.00658431
ETH.MESH.00596832
ETH.MESH.00607410
ETH.MESH.06927235
ETH.MESH.00127528
ETH.MESH.06927235
ETH.MESH.01201383
ETH.MESH.06927249
ETH.MESH.00585723
ETH.MESH.00364754
ETH.MESH.06767587
ETH.MESH.06767603
DX21861
ETH.MESH.00351441
Date
Description
Physician brochure/sales aid, Make DATA and SAFETY Your Choice
02/26/2010 Sales aid with Nilsson 11 year data TVT sales piece (TVTS-029-10-2/12)
Emails re: URGENT – 101000092524 (Complaint #5006302 – DIR
03/04/2010 20818)
03/09/2010 Emails re Scion PA commercial recommendation
03/10/2010 E-mail from Aaron Kirkemo to Ramy Mahmoud, David Robinson, et al.
regarding Scion PA commerical recommendation; cc: Paul Decosta
03/10/2010 Greg Prine e-mail and Brian Langen e-mail re: TVT Conversion
Kirkemo, A email chain originating 03/09/2010 re Scion PA commercial
03/10/2010 recommendation - describing faults of obturator and mini slings
03/19/2010 Emails re: EBM Sub-team meetings for EWHU
Smith, D email Subject Information regarding Scion " ... What could
03/19/2010 increase speed to market ..."
03/23/2010 E-mail chain dated 23 March 2010, re: Tissue engineering contacts
03/23/2010 Email from Dan Smith re: Input to the one-pager to BR
03/23/2010 E-mail from Dan Smith to Aaron Kirkemo regarding information
regarding Scion
03/23/2010 E-mail from Edward Dormier to Aaron Kirkemo, Ramy Mahmoud, et al.
regarding Meeting with Bridget - Transformation nature of Scion delivery
System
03/23/2010 E-mail string, top one from Dan Smith to Edward Dormier, Paul DeCosta,
et al. regarding Input to the one-pager to BR; cc: David Robinson, et al.
DX21862
DX21863
DX21864
DX21865
DX21866
ETH.MESH.00364743
ETH.MESH.04566610
ETH.MESH.05567792
ETH.MESH.09656791
03/23/2010 Emails re: Input to the one-pager to BR
03/31/2010 Dear Colleagues letter from the Evidence Based Medicine Team
04/09/2010 Emails re: ETHICON SECURESTRAP – GOOD NEWS!
04/13/2010 E-mail string top one from Juergen Trzewik to Stale Kvitle regarding
Peter, I am trying to call your cell but not coming though can you call me
back
Page 103 of 191
Offered
Admitted
Exhibit
DX21867
DX21868
ETH.MESH.02619511
ETH.MESH.04600270
ETH.MESH.02185004
DX21869
DX21870
DX21871
ETH.MESH.04123299
ETH.MESH.00533094
ETH.MESH.02601785
DX21872
DX21873
Date
Description
04/20/2010 E-mail to Hinoul and Kirkemo from Robinson re: Marketing engagements
Document entitled “Johnson & Johnson, 2010, Questions & Answers,
04/22/2010 Annual Shareholders Meeting, April 22, 2010”
E-mail chain, top one from James Flint to Elizabeth Vailhe regarding
04/27/2010
Surface Area
04/28/2010 E-mail string,top one from Dr. James Hart to David Robinson, et al.
regarding Manuscript of Internal review; cc: Piet Hinoul
May-2010 Document entitled "IIS Study Monthly Update: May 2010"
05/03/2010 E-mail from Piet Hinoul to Judi Gauld, David Robinson, et al. regarding
Article on role of evidence in introducing innovative techniques in
urogyaecology
ETH.MESH.00352065
ETH.MESH.00581003
Pre-clinical Perforance Evaluation and Initial Implant Fixation Force
05/07/2010 Study of TVT Abbrevo
05/10/2010 E-mail chain from Piet Hinoul to Dhinagar Subramanian, et al. regarding
Updated: Kick-off Call Sub-urethral Slings Outcomes Study
ETH.MESH.03654151
E-mail string top one from Susan Lin to Bryan Lisa regarding TVT tech
files - Post-Market Surv
E-mail chain, top one dated 4 June 2010 re: TVT Post Op Complication
06/04/2010 Closing Memo
06/16/2010 E-mail string, top one from Dr. James Hart to Axel Arnaud, Charman
Barham, et al. regarding Investigator-Initiated Studies Policy
DX21874
DX21875
DX21876
DX21877
DX21878
DX21879
05/21/2010
ETH.MESH.01067064
ETH.MESH.05347754
ETH.MESH.00335251
06/18/2010 Ethicon Finance Division Organizational Charts, June 18, 2010
ETH.MESH.02239873
ETH.MESH.00824100
06/30/2010 Process Failure Modes and Effect Analysis (pFMEA) – TVT Assembly
Jul-2010 PowerPoint, "EWH&U Clinical Development Update July 2010"
ETH.MESH.01201364
ETH.MESH.00534496
07/12/2010 E-mail thread from Patricia Beach to Judi Gauld, David Robinson, et al.
regarding TVM Manuscript for AUGS
07/14/2010 Declaration of the End of the Registry
Preclinical Efficacy Assessment for ETHICON GYNECARE
07/16/2010 GYNEMESH M
Placeholder/PowerPoint, "TOPA & SCION PA Alignment, August 2010,"
Aug-2010
DX21880
DX21881
DX21882
DX21883
ETH.MESH.04940233
ETH.MESH.02218268
DX21884
DX21885
ETH.MESH.00353635
Clinical Evaluation Report - Gynecare TVT Tension-Free Vaginal Tape /
08/02/2010 Tension-Free Vaginal Tape Accessory Abdominal Guide
Page 104 of 191
Offered
Admitted
Exhibit
DX21886
ETH.MESH.04384165
ETH.MESH.01795873
Date
Description
Clinical Evaluation Report: Gynecare TVT* Tension-free Vaginal
08/02/2010 Tape/Tension-free Vaginal Tape Accessory Abdominal Guide
08/02/2010 Document, "Clinical Evaluation Report Gynecare TVT," etc.
DX21887
ETH.MESH.02599330
08/02/2010 E-mail chain, top one from Piet Hinoul to David Robinson no subject
DX21888
DX21889
DX21890
DX21891
ETH.MESH.02599330
No Bates number
ETH.MESH.04502251
ETH.MESH.00529512
DX21892
ETH.MESH.05997867
Email regarding the value of a 5 year study
TOPA & SCION PA Alignment
Full bladder standing cough test
Letter from Patt Beach to Vincent Lucente regarding IIS Publication and
AE Reporting
08/18/2010 E-mail chain with redaction, top one from Piet Hinoul to David Robinson
regarding TR: E-mail string response
08/02/2010
08/04/2010
08/06/2010
08/12/2010
DX21893
DX21894
DX21895
DX21896
DX21897
DX21898
DX21899
DX21900
ETH.MESH.01745572
ETH.MESH.00751159
ETH.MESH.01310482
ETH.MESH.00869999
ETH.MESH.03258872
ETH.MESH.02252005
DX21904
ETH.MESH.00149178
ETH.MESH.04945144
ETH.MESH.00579340
ETH.MESH.01035602
ETH.MESH.02252038
DX21905
ETH.MESH.03521804
DX21901
DX21902
DX21903
July 1, 2008 – August 24, 2010 emails re: Product Complaint CC100700508/24/2010 Taiwain
09/02/2010 PowerPoint Slide - EWHU Incontinence - EWHU Board Meeting
09/09/2010 Application History for FMEA -0000536
Clinical Evaluation Report Mesh Erosions by Peter A. Meier, MD,
09/13/2010 Principal Scientist, Johnson & Johnson Medical GmBH
09/27/2010 Email string re: Aes from TVT-W
10/01/2010 Email from Laura Vellucci to Catherine Beath re: “Need Info”
Memo dated October 6, 2010 to all field sales associates from Mary
Garzillo, manager of privacy & health care compliance, re: Business
10/06/2010 Associate Agreement (BAA) Customer Response letter
10/07/2010 E-mail with attachment dated 07 Oct 2010, re: Poerngrosse
E-mail Corresp. Re: An Anatomic comparison of the original versus a
10/08/2010 modified inside-out transobturator procedure- Hinoul
10/13/2010 Appendix 1 Clinical Site Monitoring Visit Report
10/18/2010 Emails re: Save Ethicon Aurangabad
E-mail chain, top one dated 20 Oct 2010 re: WG New Complaint
10/20/2010 10100129770
Page 105 of 191
Offered
Admitted
Exhibit
Date
Description
ETH.MESH.05567794
10/20/2010 E-mail string, top one from Catherine Beath to Neelu Medhekar regarding
Telephone Call for FDA (Dr. David Krause) - Surgical Mesh
ETH.MESH.00584561
ETH.MESH.07192033
ETH.MESH.04120903
10/21/2010 E-mail from Gene Kammerer to Christophe Vailhe regarding Mesh
Erosion
Letter from Bruce Rosenberg to the Department of Justice; FDA, dated
10/25/2010 October 25, 2010, Re: Injuries/Deaths
10/27/2010 E-mail string, top one from Catherine Beath to Gary Pruden regarding
Pelvic Floor Mesh
E-mail chain, top one dated 01 Nov 2010, and attachment, re: WG: mesh
11/01/2010 erosions report
11/01/2010 Letter from Ian Rhodes to Michael Richter regarding Investigation into
mesh erosion in pelvic floor repair
Letter to Michael Richter from PA Consulting re "Investigation into mesh
11/01/2010 erosion in pelvic floor repair"
Nov-2010 PowerPoint presentation entitled "Mesh Platform Review"
ETH.MESH.00856582
ETH.MESH.02252209
ETH.MESH.08516134
ETH.MESH.00748278
E-mail string re: neo clinical trial. Piet Hinoul: “Each individual study
11/03/2010 does not contribute to the success of those products
E-mail string from November 8 to November 16, 2010 with C. Beath re
11/08/2010 Puerto Rico inspection
11/09/2010 E-mail string, top one from David Krause to Peter Cecchini regarding
Ethicon DVD
11/9/2010 TVT Classic IFU Revision Project Design Requirements Waiver Rationale
Memo
ETH.MESH.08516132
11/10/2010 E-mail string, top one from Neeul Medheckar to Nancy Leclair and Peter
Cecchini regarding Ethicon Mesh DVD-FDA Request Follow Up
ETH.MESH.00341011
ETH.MESH.02252228
ETH.MESH.05136678
Ethicon Memo, 11/11/2010, re: Global Regulatory Strategy for TVT IFU
11/11/2010 (RMC P15506/E) Update (Part II, RA0001-2010, Rev. 1)
Email L. Vellucci to Colin Pollard (FDA) re: L. Vellucci – Response to
11/12/2010 your voice mail
11/12/2010 E-mail string from Aaron Kirkemo to Lennox Hoyte, et al regarding
Invitation: Workshop on problems in multi-scale material modeling and
image-based geometries related to biomedical and other data; cc: Clifford
Volpe, et al.
11/14/2010 E-mail chain, top one from Piet Hinoul to Jean de Leval, Pierre Bonnet, et
al. regarding TR: International Urogynecology Journal - Decision on
Manuscript ID IUJ-09-10-0414
DX21906
DX21907
DX21908
DX21909
DX21910
DX21911
DX21912
No Bates No.
ETH.MESH.02254360
ETH.MESH.00870098
ETH.MESH.07192041
DX21913
DX21914
DX21915
DX21916
DX21917
DX21918
DX21919
DX21920
DX21921
ETH.MESH.00579514
DX21922
Page 106 of 191
Offered
Admitted
Exhibit
DX21923
DX21924
DX21925
DX21926
DX21927
DX21928
DX21929
DX21930
11/19/2010 E-mail string from Lissette Caro-Rosado to Ronald Harton and Marti
Heckman, et al. regarding KOL Usage
November 19, 2010 e-mail from Ronald Horton discussing payments to
11/19/2010 KOLs (doctors/ preceptors) and noting totals for the highest paid
12/01/2010 ISS Update Meeting
No Bates No.
ETH.MESH.02588978
ETH.MESH.08382652
ETH.MESH.05916450
12/03/2010 E-mail string re: thermachoice. Aaron Kirkemo (mention of Brian Flynn)
12/14/2010 ERM team meeting Minutes
DX21931
DX21932
No Bates No.
DX21933
DX21934
ETH.MESH.07192412
ETH.MESH.04540382
ETH.MESH.07192014
DX21936
DX21937
DX21938
DX21939
DX21940
DX21941
Description
ETH.MESH.07386592
ETH.MESH.00028556
ETH.MESH.01027991
ETH.MESH.08474562
ETH.MESH.07192414
DX21935
Date
ETH.MESH.07192012
ETH.MESH.00336374
ETH.MESH.05131463
ETH.MESH.00371551
ETH.MESH.00371542
No Bates No.
ETH.MESH.05570260 and
ETH.MESH.05570261
01/10/2011 E-mail with attachment from Dave Bourdeau to Paul Parisi regarding
EWH&U Summary of Priorities Jan 2011.xlsx
Placeholder/PowerPoint entitled "Chronic Pain Prevention/future 01/16/2011 Bioengineer's point of view"
01/18/2011 Document entitled "PA Consulting Group, Mesh Erosion Interview Pathology, Minutes of Meeting"
01/18/2011 First Amendment to Secant-Ethicon Supply Agreement dated 1/18/2011.
PA Consulting Group - Mesh Erosion Interview - Pathology
01/18/2011 (Klosterhalfen)
01/18/2011 PowerPoint - Ethicon Process Overview SSI/PMS/Escalation
01/20/2011 Document entitled "PA Consulting Group, Mesh Erosion Interview Surgeon, Minutes of Meeting"
PA Consulting Group - Mesh Erosion Interview - Surgeon (Rhona
01/20/2011 Kearney)
01/31/2011 Worldwide Records and Information Management Policy. 61 pages
02/01/2011 2-page copy of E-mail to List from Scott Jones to Shari Hendrickson,
Kevin Forst, et al. regarding Fire Code Violation - basement storage area
urgent clean out required
02/01/2011 TVT System - Clinical testing of new device - References
02/01/2011 TVT System - Comparison of the New Device to Predicate Device
Braskem Material Safety Data Sheet. Product Name: C4001
02/08/2011 Polypropylene
02/08/2011 E-mail chain, top one from Paul Parisi to Alyson Wess, Nancy Leclair, et
al. regarding FDA request; cc: Kenneth Pagel
DX21942
Page 107 of 191
Offered
Admitted
Exhibit
DX21943
Date
Description
ETH.MESH.07197998
ETH.MESH.07197998
02/09/2011
02/09/2011
DX21945
ETH.MESH.00855643
02/15/2011
DX21946
DX21947
ETH.MESH.02010834
ETH.MESH.02185584
ETH.MESH.02185605
ETH.MESH.03146492
ETH.MESH.01264498
ETH.MESH.07192242
ETH.MESH.07192242
02/16/2011
02/16/2011
02/16/2011
DX21944
DX21948
DX21949
DX21950
DX21951
02/16/2011
02/17/2011
02/17/2011
02/17/2011
DX21952
DX21953
DX21954
DX21955
ETH.MESH.05826236
ETH.MESH.03031631
No Bates No.
ETH.MESH.03643769
2/17/2011
Email from Christophe Vailhe to Michael Richter et
al. Re: You have been selected - Forces on the pelvic floor - challenge to
determine
E-mail from Christophe Vailhe to Michael Richter, Noah Papas, et al.
regarding You have been selected - Forces on the pelvic floor - challenge
to determine; cc: Clifford Volpe
Email from David Robinson to Judi Gauld regarding FW: SECURITY
IUGA abstract
"Biomechanical consideration for Pelvic floor mesh design" by Juergen
Trzewik and Christoph Vailhe
Biomechanical consideration for Pelvic Floor mesh design
Document entitled "Biomechanical consideration for Pelvic floor mesh
design"
Email from Joerg Holste to Judi Gauld et al. re Prosima +M clin stra
E-mail dated February 17, 2011 Subject “mesh pore size – tissue
compliance and contraction”
Email from Peter Meier to Julie Bird et al., Re Sales reps in UK
E-mail from Peter Meier to Julie Bird regarding sales reps in UK; cc:
Berman Gregory
E-mail string from Brian Luscombe to Francois Barbe regarding Dr. Stone
02/23/2011 E-mail string from Gary Pruden to Piet Hinoul, Bridget Ross, et al.
regarding My MosalQ - Ethicon Subscription Alerts - Maher Paper
Johnson & Johnson Form 10-K (Annual Report) Filed 02/25/11 for the
02/25/2011 Period Ending 01/02/11, 117 pages
02/28/2011 3-page copy of E-mail chain, top one from Adrian Roji to Matt Henderson
regarding KP Update
DX21956
DX21957
Presentation: ETHICON Polypropylene Mesh Technology by Boris Batke,
03/01/2011 Associate Director R&D
DX21958
ETH.MESH.05479717
ETH.MESH.05823426
DX21959
DX21960
No Bates No.
ETH.MESH.04152869
03/08/2011 Email to Brian Luscombe from Scott Finley re: HPG Value Adds
Guidance for Industry and Food and Drug Administration Staff. Clinical
Investigations of Devices Indicated for the Treatment of Urinary
Incontinence. The draft of this document was issued on September 19,
03/08/2011 2008
03/11/2011 Email between Colin Urquhart and Elaine Adie
DX21961
ETH.MESH.05163325
Email from Alyson Wess (Group Marketing Director, EWH&U Global
03/14/2011 Strategic Marketing) re Incontinence PMT: 3/3 Meeting Notes
Page 108 of 191
Offered
Admitted
Exhibit
DX21962
DX21963
DX21964
ETH.MESH.00304383
ETH.MESH.04556937
ETH.MESH.02185605
ETH.MESH.02252642
Date
Description
03/21/2011 E-mail chain, top one from Daniel Lamont to Carolyn Brennan and
Melissa Day regarding Technical File Request from IGZ
Email from Laura Vellucci re: Summary of 3/24/2011 telephone
03/24/2011 conversation with Colin Pollard
03/25/2011 E-mail dated 25 Mar 2011, attachment re: Forces on the pelvic forces
03/30/2011 E-mail chain, top one from Kristie Gauntt to Catherine Beath regarding
Pelvic Floor Mesh
DX21965
ETH.MESH.07198250
DX21966
ETH.MESH.07236297
E-mail chain, top one from Christophe Vailhe to Joe Robinson regarding
Thanks & Pictures; cc: Gregory Berman
03/31/2011 E-mail chain, top one from Piet Hinoul to Susanne Ludgate, Chris
Chapple, et al. regarding RE: Workshop on Vaginal Tapes
03/31/2011
DX21967
DX21968
ETH.MESH.07236297
ETH.MESH.07236288
DX21969
DX21970
DX21971
DX21972
DX21973
DX21974
DX21975
ETH.MESH.03604096
ETH.MESH.09656790
ETH.MESH.09320518
ETH.MESH.04566351
ETH.MESH.02217344
No Bates No.
ETH.MESH.03032974
DX21976
DX21977
DX21978
DX21979
DX21980
ETH.MESH.00589828
ETH.MESH.05982133
ETH.MESH.07456394
ETH.MESH.04925014
Letter by Piet Hinoul, Medical Affairs Director, re Workshop on Vaginal
03/31/2011 Tapes
04/01/2011 E-mail chain, top one from Brian Kanerviko to Laura Vellucci, Sarah
McManus, et al. regarding FW: Workshop on Vaginal Tapes; cc: Nicola
Selley, et al.
04/07/2011 Document titled “10. Product Verification and Validation; Animal Studies”
04/13/2011 Email from Juergen Trzewik to Stale Kvitle et al re laser cutting
04/14/2011 Meeting Scheduling regarding FDA Dry Run on Surgical Mesh for SUI
and PFR
04/15/2011 E-mail string,top one from Brain Kanerviko to Sharon M. Andrews
regarding Ethicon Attendees for April 21 Surgical Mesh Meeting
04/21/2011 Email from Brian Kanerviko to group re: FDA EWHU Mesh Meeting
PowerPoint entitled “FDA and Ethicon PFR and SUI Dialogue, April 21,
04/21/2011 2011,” 57 pages
04/26/2011 E-mail with attachment from Brian Kanerviko to Sandy Savidge, Piet
Hinoul, et al. regarding Final FDA presentation
E-mail dated 4/29/11 to Lissette Caro-Rosado, et al., from Laura Vellucci,
04/29/2011 plus attachment, re: FDA request for additional information
5/3/2011 PowerPoint - FDA and Ethicon PFR and SUI Dialogue
05/06/2011 E-mail from Susan Lin to Brian Kanerviko regarding EPI
05/06/2011 Email from Brian Kanerviko re: Notes from FDA download
Page 109 of 191
Offered
Admitted
Exhibit
ETH.MESH.04121756
DX21981
DX21982
DX21983
DX21984
ETH.MESH.07192872
ETH.MESH.07192877
ETH.MESH.07192929
ETH.MESH.02589079
Date
Description
05/12/2011 E-mail string, top one from Dr. James Hart to Judi Gauld; cc: Piet Hinoul
regarding a Message from Bridget Ross: A Landmark Study in the New
England Jounal of Medicine
Email from Piet Hinoul to Pann Hermansson and Christophe Vailhe Re
05/18/2011 Forces in the pelvic floor
05/18/2011 E-mail string from Piet Hinoul to Paan Hermansson and Christophe
Vailhe regarding FW: Forces in the pelvic floor
May 18, 2011 PA Consulting Report_ Investigating Mesh Erosion in
05/18/2011 Pelvic Floor Repair and PowerPoint presentation
05/18/2011 PowerPoint, "Investigating Mesh Erosion in Pelvic Floor Repair,"
DX21985
DX21986
ETH.MESH.02589079
ETH.MESH.05164820
05/18/2011 REPORT - Investigating Mesh Erosion in Pelvic Floor Repair
05/25/2011 E-mail chain, top one from Aaron Kirkemo to Jennifer Paradise regarding
FPMRS Newsletter to Customers (Draft)
DX21987
DX21988
No Bates No.
DX21989
ETH.MESH.08136486
DX21990
ETH.MESH.04557644
ETH.MESH.02323272
ETH.MESH.04932709
ETH.MESH.04932711
ETH.MESH.05336980
ETH.MESH.08476568
DX21991
DX21992
DX21993
DX21994
DX21995
DX21996
DX21997
ETH.MESH.05718101
ETH.MESH.05718108
Excerpt of 6/6/11 letter sent to plaintiffs’ counsel by defense counsel that
06/06/2011 lists Ethicon sales divisions and territories
PowerPoint: GYNECARE TVT* Tension Free Support for Incontinence –
06/06/2011 Advanced Users Forum for the Experienced Clinician
PowerPoint, “EWHU Board Meeting Update: Recent FDA Feedback on
06/13/2011 Regulatory Requirements for PRF Mesh Products,” 9 pages
06/14/2011 E-mail string re: FDA PFR Surgical Mesh Update
06/14/2011 E-mail string, top one from Dr. James Hart to Jessica X. Shen regarding
FDA PFR Surgical Mesh Update
06/14/2011 E-mail string, top one from Dr. James Hart to Jessica X. Shen regarding
FDA PFR Surgical Mesh Update
06/14/2011 E-mail string, top one from Jennifer Paradise to Paul Parisi regarding Cost
Containment
Email from Nicola Selley forwarding email from L. Vellucci re: FDA
06/16/2011 PFR Surgical Mesh Update
Email fron Konrad Schmitt to Boris Batke et al. re Classification of
06/21/2011 Meshes - UPDATE
06/21/2011 E-mail string with attachments from Konrad Schmit to Boris Batke, Lars
Fuchte, et al. regarding Classification of Meshes - UPDATE; cc: Colin
Morgan, Paul Juelicher, et al.
Page 110 of 191
Offered
Admitted
Exhibit
Date
Description
ETH.MESH.07192929
06/22/2011 PowerPoint entitled "Investigating Mesh Erosion in Pelvic Floor Repair"
No Bates No.
ETH.MESH.02253043
ETH.MESH.02253079
Report of the Special Committee of the Board of Directors of Johnson &
06/27/2011 Johnson
Email from Jeffrey Secunda at AdvaMed re: FDA request for Mesh sales
06/29/2011 data
07/14/2011 E-mail chain, top one from Christiana Bielinski to Catherine Beath
regarding FDA Health Notificiation
DX21998
DX21999
DX22000
DX22001
DX22002
DX22003
02253079
No Bates No.
ETH.MESH.04945245
DX22004
DX22005
DX22006
DX22007
ETH.MESH.07198825
ETH.MESH.07198828
ETH.MESH.04056609
07/14/2011 Email from Catherine Beath re: FDA Health Notification
07/18/2011 Response ltr to FDA
07/21/2011 3-page copy of E-mail from Boris Batke to DL-MEDDENO R&D Europe,
et al. regarding WG: Updated Preservation Notice - Ethicon, Inc.; cc:
Konrad Schmitt, et al.
Email from Christophe Vailhe to Ian Rhodes at PA Consulting re Mesh
07/21/2011 erosion report attached
07/21/2011 E-mail string, from Christophe Vailhe to Ian Rhodes regarding Mesh
erosion report attached
ETH.MESH.00301369
ETH.MESH.00301369
07/29/2011 Email from Piet Hinoul to Julie Bird re: Query from Simon Jackson
Email from Vijay K. Madikondia (Manager, Internal Assessment) re BSI
Technical File Audit – July 28-29, 2011 - Mesh-related complications not
07/29/2011 seen in traditional repairs
08/02/2011 E-mail chain, top one from Nicola Selley to Vijay Madikonda regarding
BSI Technical File Audit - July 28-29, 2011
ETH.MESH.04056609
08/02/2011 E-mail from Julie Bird to Kristan Alliston regarding FW: Query from
Simon Jackson
DX22012
No Bates No.
ETH.MESH.06261967
DX22013
No Bates No.
Citizen Petition to FDA on Mesh, filed by "Public Citizen" - a consumer
advocacy group. Asking FDA to ban the marketing of all non-absorbable
mesh, order it recalled, require any mesh in future to be classified as Class
08/25/2011 III
08/26/2011 E-mail chain, top one from John Kar to Bob Washington, et al. regarding
Braskem… A Little History
ADCOM submission on SUI mesh. Submission to FDA for the 9/8/2011
Ad Com meeting by the TVM working group for stress urinary
08/30/2011 incontinence
DX22008
DX22009
DX22010
DX22011
Page 111 of 191
Offered
Admitted
Exhibit
DX22015
ETH.MESH.07237718
ETH.MESH.08563578
DX22016
No Bates No.
DX22014
Date
Docket Submission to the September 8 and 9, 2011 Obstetrics and
Gynecology Devices Panel of the Medical Devices Advisory Committee:
SAFETY AND EFFECTIVENESS OF SURGICAL MESH FOR THE
08/30/2011 TREATMENT STRESS URINARY INCONTINENCE
Email thread, top one from Brian Kanerviko to Laura Moen-Ftacek
08/30/2011 regarding comments on SUI
Email from Bridget Ross to Alex Gorsky, Mike Mahoney and Gary
09/06/2011 Pruden re: Background: FDA Panel Pelvic Floor Mesh
DX22017
No Bates No.
09/09/2011
DX22018
No Bates No.
ETH.MESH.02289613
No Bates number
09/09/2011
DX22019
Description
09/09/2011
09/09/2011
AdCom SUI Briefing Book (8.30.2011) Docket Submission to the
September 8 and 9, 2011 Obstetrics and Gynecology Devices Panel of the
Medical Devices Advisory Committee: Safety and Effectiveness of
Surgical Mesh for the Treatment of Stress Urinary Incontinence.
Docket Submission to the September 8 and 9, 2011 Obstetrics and
Gynecology Devices Panel of the Medical Devices Advisory Committee:
SAFETY AND EFFECTIVENESS OF SURGICAL MESH FOR THE
TREATMENT STRESS URINARY INCONTINENCE, issued September
9, 2011
Email from Bridget Ross to Alex Gorsky, Mike Mahoney and Gary
Pruden re: FDA Mesh Panel – Day 1
Obstetrics and Gynecology Medical Devices Panel Transcript Excerpt,
September 9, 2011, 11 pages
DX22020
DX22021
No Bates No.
DX22022
ETH.MESH.05572800
ETH.MESH.03642805
E-mail from Matthew Johnson dated September 22, 2011, to Adrian Roji,
2 pages, asking Adrian to forward to US field the 9/22/11 “dear surgeon”
09/22/2011 letter re the 9/8-9/2011 FDA committee panel meetings
Email from Jeffrey Secunda to Ginger Glaser, Rob Miragliuolo, Scott
10/06/2011 Robirds, and Brian Kanerviko regarding Surgical Mesh – Notes
10/14/2011 47-page copy of document entitled "Pelvic Organ Prolapse Condition
Business Team Meeting"
DX22023
DX22024
DX22025
ETH.MESH.03719195
ETH.MESH.03642805
No Bates number
10/14/2011 Document entitled "Polypropylene Mesh for Pelvic Floor Repair (PFR),
Focus on Mesh Exposure, Road to Improvement,"
10/14/2011 E-mail from Lissette Caro-Rosado to Tom Affeld, et al. with attachments
regarding PFR Extended CLT Meeting
10/17/2011 Phillips Sumika Material Safety Data Sheet for Marlex HGX-030-01
Polypropylene,
DX22026
Page 112 of 191
Offered
Admitted
Exhibit
DX22027
ETH.MESH.03360840
DX22028
ETH.MESH.00948684
ETH.MESH.05819961
Date
Description
Email from Brian Kanerviko to Laura Vellucci regarding Neo Clinical for
10/25/2011 510k
E-mail re: DA MKTG from Nadine Rupeiks (Ethicon Sales Learning &
10/27/2011 Development) to Christopher Yarashas (Ethicon) copy to Erika Lane
10/28/2011 E-mail string from Kevin Frost to Mary Byerly regarding PHS_Treatment
for Pelvic Organ Prolapse_5.docx; cc: Brian Luscombe
DX22029
DX22030
DX22031
DX22032
DX22033
DX22034
DX22035
No Bates No.
ETH.MESH.05827611
No Bates No.
ETH.MESH.01809083
04543030
DX22036
ETH.MESH.08579092
ETH.MESH.08579093
DX22037
No Bates No.
DX22038
DX22039
ETH.MESH.01217925
ETH.MESH.07200244
DX22040
DX22041
DX22042
ETH.MESH.07200224
ETH.MESH.08474570
No Bates No.
DX22043
No Bates No.
ETH.MESH.04927141
DX22044
Letter to Margaret Hamburg, M.D., FDA, from Congressional Medical
Technology Caucus and other members of Congress expressing concern
11/03/2011 about regulatory issues facing the medical device industry
11/04/2011 E-mail with attachment from Kevin Frost to Scott Jones regarding
Marketing Mastery & Teaching Institutions
11/16/2011 Dwyer, PL, et al. The Mesh Debate. Int Urogynecol J 2012;23(1):1-2
12/10/2011 London Memo to Parisi and Mahar re VOC on new laser Cut TVT Mesh
E-mail from C. Beath to N. Selley and B. Kanerviko, dated 1/3/12,
01/03/2012 forwarding e-mail that has 522 Order for Surgical Mesh attached
Email From Christophe Vailhe to Clifford Volpe et al. Re Mesh Exposure 01/09/2012 Ethicon Position - Short List
01/09/2012 E-mail from Christophe Vailhe to Clifford Volpe, Aaron Kirkemo, et al.
regarding Mesh Exposure - Ethicon Position - Short List
Emailwire.com – Study Shows Women with Vaginal Mesh Implants have
01/11/2012 a Higher Rate of Re-operation
An exploratory 91-Day Tissue Reaction Study of
01/16/2012 Polypropylene Based Surgical Mesh in Parts (PSE ACC. NO. 00-0035)
01/16/2012 E-mail from Christophe to [email protected] regarding
Biomechanics of the pelvic floor; cc: Susanne Landgrebe
Email from Christophe Vailhe to Juergon Trzewik re Biomechanics of the
01/16/2012 pelvic floor
01/20/2012 Dem Letter
Letter from 112th US Congress House of Representatives to Hon. Fred
01/20/2012 Upton, Hon. J. Pitts, Hon. C. Stearns, dated 01/20/2012
01/24/2012 Emails re: Pelvic Floor / Sling Reportable Malfunctions
Page 113 of 191
Offered
Admitted
Exhibit
DX22045
DX22046
DX22047
DX22048
DX22049
ETH.MESH.04927119
ETH.MESH.04038055
ETH.MESH.07200381
ETH.MESH.07200381
ETH.MESH.07200382
ETH.MESH.07200382
Date
Description
Email from Nicola Selley re: SUFU 2012 Annual Meeting – Invitation to
01/26/2012 Participate
01/29/2012 E-mail from Susanne Landgrebe to Boris Batke, Michael Richter, et al.
regarding WH&U Position Paper: Erosion
Email from Christophe Vailhe to Clifford Volpe Re Exposure Position
02/01/2012 Norderstedt 2012.pptx
02/01/2012 E-mail from Christophe Vailhe to Clifford Volpe, Aaron Kirkemo, et al.
regarding Exposure Position Norderstedt 2012.pptx
02/02/2012 "Mesh Exposure Ethicon Position" Powerpoint presentation
02/02/2012 PowerPoint entitled "Mesh Exposure Ethicon Position"
DX22050
DX22051
DX22052
DX22053
DX22054
DX22055
DX22056
ETH.MESH.07278223
ETH.MESH.07730295
No Bates No.
No Bates No.
ETH.MESH.01948907
ETH.MESH.05918116
ETH.MESH.04038181
02/17/2012 PowerPoint,"PMS Summary Information"
Lapinskas, I, email chain originating 01/27/2012 re Discussion of 3.5 mil
Prolene production
Organizational Chart, 1 page
Organizational Charts, 8 pages
PowerPoint, "Research & Development,” 26 pages
Solving the Device Design Puzzle – Biomedical Engineered Medical
02/27/2012 Textiles from Secant Medical
02/29/2012 E-mail chain, top one from Dennis Jamiolkowski to Laura Vellucci, et al.
regarding RE: Your Professional Opinion; cc: Boris Batke, et al.
02/24/2012
02/27/2012
02/27/2012
02/27/2012
DX22057
ETH.MESH.07226379
DX22058
ETH.MESH.04015104
DX22059
DX22060
DX22061
ETH.MESH.04548236
ETH.MESH.04548242
ETH.MESH.04937876
03/01/2012 E-mail chain, top one from Laura Vellucci to Dennis Jamiolkowski, et al.
regarding FW: Polypropylene Mesh; cc: Aaron Kirkemo and Laura
Vellucci
03/01/2012
Emails between Boris Batke and Casey Mayes re: AGES Pelvic Floor
Conference –Gala Dinner Invitation
03/05/2012 CDMA Meeting Minutes -2012
03/05/2012 Document entitled "CDMA Meeting Minutes - 2012"
03/05/2012 E-mail chain, top one from Piet Hinoul to Laura Vellucci regarding
Polypropylene mesh; cc: Sandy Savidge
DX22062
DX22063
No Bates No.
ETH.MESH.07212398
2011 Survey of FDA Scientists Essay Excerpts – updated 03/06/2012,
03/06/2012 Union of Concerned Scientists
03/06/2012 Response to e-mail from C. Huntington 26 January 2012 (15:38) with
attached publication
DX22064
Page 114 of 191
Offered
Admitted
Exhibit
Date
Description
ETH.MESH.07226405
03/07/2012 E-mail chain top one from Dennis Jamiolkowski to Laura Vellucci, et al.
regarding Infromation on PROLENE Suture and PROLENE Mesh
DX22066
No Bates No.
Voices of Scientists at the FDA – 2011 Survey of Scientists at the FDA,
03/07/2012 Union of Concerned Scientists, Survey Methodology
DX22067
ETH.MESH.05440648
ETH.MESH.05440649
DX22065
DX22068
DX22069
ETH.MESH.07205370
ETH.MESH.07205370
03/09/2012 Response to MHRA Inquiry regarding inertness of polypropylene mesh
E-mail dated 3/12/2012, with attachment re: CLAVE publication –
03/12/2012 Ethicon response
Email from Sandra Savidge, Dan Burkely and Dennis Jamiolkowski re
Response to email from Clare Huntington 26 January 2012 regarding
publication by Clave et al., Polpropylene as a reinforcement in pelvic
surgery is not inert: comparative analysis of 100 explants, Int. Urogynecol
03/12/2012 J (2010 21:261-270)
03/12/2012 Memo from Sandra Savidge, et al. to Laura Vellucci regarding Response
to email from Clare Huntington 26 January 2012
DX22070
DX22071
ETH.MESH.07724080
No Bates number
DX22072
DX22073
No Bates No.
DX22074
No Bates No.
DX22075
DX22076
No Bates No.
ETH.MESH.03949361
DX22077
DX22078
No Bates No.
No Bates number
DX22079
DX22080
ETH.MESH.07246719
ETH.MESH.05600923
Independent MD&D Sector Audit by QualityHub, Inc. Pore size, Fibrotic
03/14/2012 bridging/scar plate/ contraction/ shrinkage Chronic inflammatory response
03/26/2012 Procedure, Quality System, Regulatory Impact Assessment Process in the
ADAPTIV System, PR-0011368 Rev: 1, Released: 26 Mar 2012, CO:
100020470, 10 pages
Medical Design blog article. Lawmakers, AdvaMed urge swift passage of
03/29/2012 FDA user fee reauthorization
Statements of Jeffrey Shuren, M.D., J.D. and Janet Woodcock, M.D.
before the Committee on Health, Education, Labor and Pensions, United
03/29/2012 States Senate
The Hill – Healthwatch article. GOP senators decry report of medical
03/29/2012 device approval times
03/30/2012 Dyed Prolene Batch Review
04/13/2012 MSDS Alcoa Kama Polypropylene Sheet, Published online April 13, 2012
04/19/2012 Material Safety Data Sheet, Ethylene Oxide, 8 pages
Study Report dated May 8, 2012: A systematic review of patient-years of
experience in prospective randomized controlled trials (RCTs) in
05/08/2012 incontinence.
E-mail chain, top one dated 30 May 2012, Re: Regulatory Background on
05/30/2012 Gynecare
Page 115 of 191
Offered
Admitted
Exhibit
DX22081
DX22082
ETH.MESH.05479410
ETH.MESH.05585066
DX22083
ETH.MESH.04037600
DX22084
ETH.MESH.03753245
ETH.MESH.08692279
ETH.MESH.06592242
DX22085
Date
Description
"The (clinical) argument of lightweight mesh in abdominal surgery"
06/03/2012 presentation by Boris Batke
06/03/2012 "Ultrapro" PowerPoint presentation by Boris Batke
Melbourne AGES 2012 Presentation by Boris Batke (Associate Director
06/03/2012 R&D): Innovations in Mesh Development)
Placeholder, Document produced in native format, Biomechanics (Pelvic
06/03/2012 Forces)
06/06/2012 Memorandum from Dave Bourdeau to Bart Pattyson regarding Verbal
Warning - Request for Confidential Information
06/07/2012 E-mail chain, top one from Christian Falconer to Laura Angelini regarding
Time Flies
DX22086
DX22087
ETH.MESH.04579677
DX22088
No Bates No.
DX22089
DX22090
ETH.MESH.07246042
ETH.MESH.04551795
DX22091
No Bates No.
DX22092
No Bates No.
ETH.MESH.06773542
ETH.MESH.04927259
ETH.MESH.04927337
ETH.MESH.04927761
DX22093
DX22094
DX22095
DX22096
DX22097
DX22098
DX22099
No Bates No.
ETH.MESH.04927307
ETH.MESH.7223581
E-mail chain, top one dated 6/10/2012 re: Dr. Lucente/Mesh from
06/10/2012 Henderson to T. Schmid re de-emphasizing Lucente
Bloomberg article, “J&J Sold Vaginal Mesh Implant After Sales Halt
06/26/2012 Ordered”
Email from L. Vellucci to M. Sakurai and others re: RA info for
06/27/2012 Prolift/Gynemesh PS in Japan
06/28/2012 E-mail with attachment from Piet Hinoul to Jeffrey Hammond, Dr. James
Hart, et al. regarding Benefit risk profile TVM
154-page copy of document dated 6/30/12 entitled “Worldwide Policies on
06/30/2012 Information Asset Protection”
9-Page copy of document dated 6/30/12 entitled “Restoration of Files,”
06/30/2012 plus attachments
07/04/2012 E-mail string, top one from Marjorie Eley to Daniel Lamont regardint
TVT MDV? - 10100156899
07/04/2012 Emails re: CSD Meeting
07/10/2012 Email from Peter Schroeer re: ABHI Meeting
07/11/2012 Emails from Catherine Beath re: ABHI Meeting
Letter from Jorge Serrano to Kelsey Schaefer, dated July 13, 2012 re:
Synthetic Surgical Mesh Complaint – Waiver of Confidentiality and a
document entitled “Authorization to Disclose Health information,” signed
07/13/2012 by Jorge Serrano on July 12, 2012
07/16/2012 Emails re: Meeting on July 18th – Room 305
07/18/2012 PowerPoint presentation entitled "Medicines and Healthcare products
Regulatory Agency, July 18, 2012, Ethicon, Inc."
Page 116 of 191
Offered
Admitted
Exhibit
DX22100
DX22101
DX22102
Date
Description
No Bates number
07/19/2012 2-page copy of document entitled "English Translation," plus attachments
ETH.MESH.07691122
ETH.MESH.04948624
ETH.MESH.05125297
07/19/2012 PowerPoint, "Postmarket Surveillance Initiative (PSI)
Email from Keith Pelatowski at AMS re: Followup from Committee on
07/20/2012 the Safety of devices Meeting Yesterday – Use of Mesh
07/26/2012 E-mail from Piet Hinoul to Axel Arnaud no subject with article entitled
"The perils of commercially driven sugical innovation"
DX22103
DX22104
DX22105
DX22106
DX22107
ETH.MESH.05125297
ETH.MESH.06772949
No Bates No.
ETH.MESH.05721910
ETH.MESH.07277696
07/26/2012
08/08/2012
08/10/2012
09/07/2012
09/07/2012
DX22108
DX22109
DX22110
DX22111
DX22112
DX22113
DX22114
ETH.MESH.06774030
ETH.MESH.08484246
ETH.MESH.02212593
ETH.MESH.06773130
No Bates No.
ETH.MESH.08479644
ETH.MESH.06773522
09/25/2012
Email from Piet Hinoul to Axel Arnaud with attached article: L. Lewis
Wall, MD, The perils of commercially driven surgical innovation,
American Journal of Obstetrics & Gynecology, March 2009
PowerPoint, "PMS Staff Meeting, Dan Lamont,"
Global Harmonization Task Force (GHTF) Guidance on AERs during
Clinical Trials
PR551-006 Rev 31 Franchise Procedure for Summary and Individual
Medical Device Reporting with Revision History and Appendices
Work Instruction, Quality System, Franchise Work Instructions for
Summary and Individual Medical Device Reporting PR551-006, Rev: 31,
Released: 07 Sep 2012, CO: 100047158
Franchise Procedure for Post Market Surveillance (PMS), Document
Name (#): PR-0000385, Revision: 4
09/26/2012 Work Instructions for Handling Product Complaints, Rev. 44
Slide entitled “Importance of Mesh Construction and Properties to the
10/01/2012 Tissue Repair Patient,” 2 pages
Franchise Procedure for Post Market Surveillance (PMS)
10/02/2012
10/08/2012 PubMed search results, printed 10/08/2012
10/17/2012 EWHU CPC
10/22/2012 E-mail string, top one from Marjorie Eley to Carolyn Brennan regarding
TVT Closure Reports to MHRA; cc: Jayne Morgan and Daniel Lamont
DX22115
DX22116
ETH.MESH.06104617
DX22117
No Bates No.
10/31/2012 certified copy of FOIA request
Department of Health Press Release regarding “Better guidance and
11/22/2012 support for NHS surgeons on vaginal tape and mesh implants.”
Page 117 of 191
Offered
Admitted
Exhibit
DX22118
No Bates No.
DX22119
DX22120
DX22121
No Bates No.
No Bates number
ETH.MESH.09319608
DX22122
No Bates number
DX22123
No Bates number
No Bates number
DX22124
No Bates number
Date
Description
E-mail from Sarah Sant (Ethicon Business Unit Leader – UK & Ireland)
regarding the press release “Better guidance and support for NHS
surgeons on vaginal tape and mesh implants” published on the
11/22/2012 Department of Health’s website
York Health Economics Consortium Medicines and Healthcare Products
11/22/2012 Regulatory Agency Final Report
11/28/2012 PowerPoint presentation entitled "EWHU CPC 11/28/2012"
12/03/2012 PR-000385 Revision History - Revision 5 - Released 12/3/12
12/10/2012 Document entitled "What are the Risks?" With handwritten changes, copy
12/10/2012 Document entitled "What are the Risks?"copy approved 12/10/2012; 1 page
12/28/2012 Procedure, Quality System, Procedure for Establishment Registration and
Medical Device Listing, 100083526
03/11/2013 Document entitled "Guidance Documents" print dated 3/11/13; 10 pages
DX22125
DX22126
No Bates No.
No Bates number
03/26/2013
03/28/2013
No Bates number
03/29/2013
No Bates number
04/02/2013
ETH.MESH.08615571
No Bates No.
04/08/2013
DX22127
DX22128
DX22129
DX22130
DX22131
DX22132
DX22133
DX22134
DX22135
No Bates No.
ETH.MESH.08562562
No Bates No.
No Bates number
04/08/2013
04/15/2013
04/30/2013
Website Statement re: AUGS Position Statement on the Restriction of
Surgical Options for Pelvic Floor Disorders (Anthony G. Gisco, M.D.,
AUGS President)
6-page copy of document entitled "Notice to Take Video Deposition of
Matt Henderson"
4-page copy of letter from Benjamin M. Watson to Thomas P. Cartmell
regarding In re: Ethicon, Inc. Pelvic Repair System Products Liability
Litigation, MDL No. 2327
2-page copy of letter from Christy D. Jones to Bryan Aylstock, Esq.
regarding In re: Ethicon In.c. Pelvic Repair System, Products Liability
Litigation, MDL No.2327
E-mail string from Brian Luscombe to Scott Jones regarding SGS
Questions; cc: George Callen
TRC First Amended Ethicon LLC Specific 30 B 6 dated 4-8-13
Exhibits for the Dan Smith Depo (Patents) (Dr. Validation) (Dr. Cadaver
Labs)
Career Development Profile
05/05/2013 Patient Satisfaction After Midurethral Sling
05/06/2013 2-page copy of document entitled "Infections/Inflammation of the
Genitourinary Tract: Kidney & Bladder (I)"
Page 118 of 191
Offered
Admitted
Exhibit
DX22136
DX22137
Date
Description
MITTENTHAL-0121 to
MITTENTHAL-0151
05/06/2013 39-page copy of document, entitled "Ethicon_Sales_KipDewitt_NEW.txt"
No Bates number
No Bates number
MITTENTHAL-0109 to
MITTENTHAL-0119
05/08/2013 Revision History of Procedure OP650-011, 16 pages
05/09/2013 2-page copy of letter from Benjamin M. Watson to Bryan Aylstock In re:
Ethicon, Inc. Pelvic Repair System, Products Litigation MDL No.2327,
with attachments
05/10/2013 11-page copy of document entitled "Applications Discussed in Ethicon
Factfinding
MITTENTHAL-0120
05/10/2013 1-page copy of document entitled " 3rd Parties Mentioned
MITTENTHAL-0102 to
MITTENTHAL-0108
to DEPO.ETH.MESH.00000073
05/10/2013 7-page copy of document entitled "IT-Related Contact Names in Relation
to Pelvic Mesh Due Diligence
06/03/2013 Spreadsheet, Pelvic Mesh Litigation: DHF and eDHF Collection and
Production
DX22138
DX22139
DX22140
DX22141
DX22142
DX22143
No Bates No.
No Bates number
Johnson & Johnson Profit and Loss Statement 2012 & 2011 - 001220Ethicon USA – M17917-Women’s Health & Urology – Report Name:
06/11/2013 BRDMFN028
06/18/2013 1-page copy of letter from Christy D. Jones to Bryan Aylstock regarding
update on the issue raised concerning Renee Selman's custodial file
DX22144
DX22145
DX22146
DX22147
MITTENTHAL-1155 to
MITTENTHAL-1274
No Bates No.
ETH.MESH.10150849
ETH.MESH.00373048
DX22148
DX22149
DX22150
DX22151
DX22152
DX22153
DX22154
No Bates No.
No Bates No.
No Bates number
ETH.MESH.05795436
ETH.MESH.09671620
No Bates No.
7/15/2013 Group of documents
Hinoul P. Clinical Evaluation Report: GYNECARE TVT* Family of
07/16/2013 Products. Revision 4. 2013 Jul 19
07/19/2013 Clinical Evaluation Report Gynecare TVT Family of Products
Placeholder/PowerPoint presentation entitled "Patient Selection Criteria &
07/29/2013 Clinical Data"
07/31/2013
08/29/2013
09/10/2013
09/17/2013
09/25/2013
10/17/2013
TVT Issue/MedWatch Reports produced by LeClair Ryan as of 7.31.13
Notice for mesh products – Scion TOPA etc, (776) 30(b)(6)
1-page copy of document entitled "Certification," plust attachments
TVT Courses and Wales – Dan Smith Measurements
Spreadsheets re: weight, thickness and porosity of various meshes
Article "Doctors Speak Out Against TVT" from TVTNO.org
Page 119 of 191
Offered
Admitted
Exhibit
DX22155
DX22156
No Bates No.
No Bates No.
ETH.MESH.01217690
Date
Description
Johnson & Johnson Profit and Loss Statement 2012 & 2011 - 001220Ethicon USA – M17917-Women’s Health & Urology – Report Name:
10/23/2013 BRDMFN028
11/17/2013 VUI Training Program Design from Henry Ford Hospital
6-Dec Development Contract TVT-NEXT (TVTx)
DX22157
DX22158
DX22159
DX22160
DX22161
DX22167
No Bates No.
No Bates No.
No Bates No.
No Bates No.
ETH.MESH.00140861
ETH.MESH.02134273
ETH.MESH.10183005
ETH.MESH.09264884
No Bates No.
ETH.MESH.02621558
DX22168
DX22169
No Bates No.
ETH.MESH.05644163
DX22170
No Bates No.
ETH.MESH.07226590
DX22162
DX22163
DX22164
DX22165
DX22166
DX22171
DX22172
DX22173
ETH.MESH.00581612
DX22174
ETH.MESH.03719177
DX22175
DX22176
ETH.MESH.02017169
No Bates No.
00/00/1926-00/00/2011
00/00/1965
00/00/1983
00/00/1990
Ibbotson SBBI Stocks, Bonds, Bills and Inflation 1926-2011 – Handout
Ethicon 1965
Ethicon: Incidence of surgery by specialty and procedure. 2Q 1983.
SMDA, The Safe Medical Devices act of 1990 (P.L. 101-629)
00/00/1997 Gynecare TVT Case Report Form
Draft memo from Thomas Barbolt to M. Rippy re: Mechanisms of
00/00/1998 Cytotoxicity for TVT Polypropylene Mesh
00/00/1998 Gynecare European marketing plan
00/00/1998 Long term goals
00/00/1999 Ethicon 1999
00/00/1999 Issue Reports - TVT Classic 1999-2000
Letter to Laura Angelini from Professor Ulmsten around the time of the
00/00/1999 1999 Asset Purchase Agreement. (This has not yet been produced.)
00/00/1999 Pelvic Floor Repair – Surgeon’s Feedback on Mesh Concept
Diana, Massimo, et al. Treatment of vaginal vault prolapse with
abdominal sacral colpopexy using prolene mesh. Am J Surg.
00/00/2000 2000;179:126-128
00/00/2000 TVT Clinical Expert Report (2000)
00/00/2000-00/00/2007 Ethicon Monthly Complaint Assessments
00/00/2001 Gynecare 2001 - Patient Marketing - Where We've Been
Hellhammer T-4002 Chris Vailhe report “Polypropylene Mesh for Pelvic
00/00/2001 Floor Repair (PFR) – Focus on Mesh Exposure – Road to Improvement
Hellhammer, B., Meshes in Pelvic Floor Repair – Findings from literature
00/00/2001 review and interviews with surgeons.
00/00/2001-00/00/2002 Erosion Extrusion Issue Reports 2001-2002
Page 120 of 191
Offered
Admitted
Exhibit
DX22177
DX22178
DX22179
DX22180
DX22181
DX22182
DX22183
DX22184
DX22185
DX22186
DX22187
DX22188
DX22189
DX22190
DX22191
DX22192
DX22193
DX22194
ETH.MESH.00340838
ETH.MESH.02625054
ETH.MESH.01271281
ETH.MESH.02053630
ETH.MESH.02626377
ETH.MESH.00032889
ETH.MESH.03924740
ETH.MESH.00160821
ETH.MESH.00164270
ETH.MESH.00858253
ETH.MESH.00803710
ETH.MESH.08163743
ETH.MESH.01192308
DX22195
ETH.MESH.00034720
No Bates No.
No Bates No.
ETH.MESH.00528626
ETH.MESH.00609367
ETH.MESH.02628697
DX22196
ETH.MESH.05457602
DX22197
DX22198
ETH.MESH.00002740
Date
Description
00/00/2002 CER Update for TVT 06/15/2000
00/00/2002 TVT Classic 2002
00/00/2003 GYNECARE TVT information: “Lasting freedom for your SUI patients.”
00/00/2003 Gynemesh PS "White Paper"
00/00/2003 TVT Classic 2003
"2005 Business Plan" Report which appears to be a report from a sales
00/00/2004 planning tool, A Plus, that was used by Ethicon for a short period of time
00/00/2004 Ethicon Wound Closure Manual, 2004
GYNECARE TVT advertisement: “Only GYNECARE TVT Has Long00/00/2004 term Results You Can See…and Believe.”
GYNECARE TVT advertisement: “Why do more surgeons choose
00/00/2004 GYNECARE TVT?”
Memo from Allison London Brown to Dan Smith in regards to
00/00/2004 Mechanical Cut vs. Laser Cut Mesh Rationale
00/00/2004 PowerPoint, “Are all meshes created equal?”
00/00/2004 Scott Finley 2004 Performance Review
“Review of Surgical Technique to Insert Implants in Urogynecology” by P.
00/00/2005 Hinoul
A 3 month pre-clinical trial to assess the fixation force of a new TVT
00/00/2005 (TVTx) in the sheep model - Published article
00/00/2005 Ethicon USA Trial Balance 2005
00/00/2005 JNJ Annual Report for 2005 - Publicly available
00/00/2005 Product Quality Plan for Gyecare Gynemesh XL
00/00/2005 Spreadsheet titled “Planning Grid” - Approx. 2005
00/00/2005-00/00/2007 TVT Classic 2005-2007
00/00/2006 2006 Johnson Medal Nomination: Ultrapro Lightweight mesh product line
Article Presentation and Management of Major Complications of
00/00/2006 Midurethral Slings: Are Complications Under-reported?
Chart of 16 studies 1996-2006 on success rates and complications seen in
00/00/2006 use of synthetic meshes and biologic meshes
Page 121 of 191
Offered
Admitted
Exhibit
DX22199
DX22200
DX22201
ETH.MESH.00584491
ETH-00255
No Bates No.
DX22202
DX22203
ETH.MESH.00033491
No Bates No.
DX22204
ETH.MESH.00033325
ETH.MESH.00514921
DX22205
DX22206
DX22207
Date
Description
00/00/2006 Email re AFNOR standards
00/00/2006 Ethicon Marketing Brochure
Gynecare Local Patient Marketing Guidance 2006 Patient Education
00/00/2006 Events
Professional Education PowerPoint presentation titled "The Science of
00/00/2006 Augmented Extracorporeal Reconstructive Pelvic Surgery"
13 Week PSM study on Contracture and Integration in Swine Models
00/00/2007 (2007)
2007 Co-op Advertising Program Guidance (Gynecare TVT and Prolift) –
00/00/2007 redacted
ETH.MESH.00033513
No Bates No.
ETH.MESH.03925203
00/00/2007 Ethicon Wound Closure Manual, 2007
DX22209
DX22210
DX22211
ETH.MESH.00140725
No Bates No.
No Bates No.
GYNECARE TVT® System Tension-free Support for Incontinence
Minimally Invasive Sling Quick Reference - geared for sales
representativesor for Ethicon’s corporate account directors; identifies 4
00/00/2007 different TVT products and the physicians that are appropriate for each one
00/00/2007 ISO 14971:2007
DX22212
ETH.MESH.06861946
00/00/2007 PE GF 4750 - Purell PP technical data info
DX22213
ETH-18694 to ETH-18721
00/00/2007 PowerPoint, Ethicon Women’s Health & Urology Professional Education
DX22214
DX22215
ETH.MESH.00019846
ETH.MESH.05478745
Professional Relations 2007 Budget, Key Initiatives, Health Strategies,
00/00/2007 TVT Professional Education Spreadsheet including Women Treated Totals
00/00/2008 "Ultrapro Plug" PowerPoint presentation by Boris Batke
ANSI/AAMI/ISO 10993-7:2008, EO residual ISO testing, American
National Standard, Biological evaluation of medical devices--Part 7:
00/00/2008 Ethylene oxide, sterilization residuals
Millennium Research Group Report: US Markets for Soft Tissue Repair
00/00/2008 2008.
DX22208
DX22216
DX22217
DX22218
DX22219
ETH.MESH.07474407
No Bates No.
No Bates No.
00276231
Page 122 of 191
Offered
Admitted
Exhibit
DX22220
DX22221
DX22222
DX22223
DX22224
DX22225
DX22226
DX22227
DX22228
DX22229
DX22230
DX22231
ETH.MESH.00001823
ETH-18722 to ETH-18731
ETH.MESH.07181045
ETH.MESH.02630133
ETH.MESH.0176065
ETH.MESH.03209119
ETH.MESH.00621976
No Bates No.
DX22234
ETH.MESH.00562144
No Bates No.
ETH.MESH.00008702
ETH.MESH.00296727
ETH.MESH.01264260
ETH.MESH.00336978
DX22235
ETH.MESH.00001419
DX22232
DX22233
DX22236
DX22237
No Bates No.
ETH.MESH.00803678
Date
Description
PowerPoint entitled "Project Brief PFR Prof Ed Advisory"; Project
Sponsor Scott Jones; Product Director, Pelvic Floor Repair – Advisory
Boards Were Conducted to Obtain Doctor Feedback – Purpose Was to
Stay in Touch with Ethicon Customers as Per Scott Jones
00/00/2008
00/00/2008 PowerPoint, 2008 Pelvic Floor Business Plan, Price St. Hilaire
00/00/2008-00/00/2009 Procedure Information Spreadsheet
00/00/2008-00/00/2009 TVT Classic 2008-2009
00/00/2009 Accurate HCP Report (inclusive of all contracts with end dates in 2009)
00/00/2009 Communication Plan to Close TVT World Registry
Draft 2009 U.S. Field Sales Execution Plan by K. Mahar titled
00/00/2009 “Redefining Execution”
00/00/2009 Grants, Sponsorships, and Other Support chart
00/00/2009 HE&R 2009 Resource Planning – R&D
00/00/2009 Medical Operations Organization Organizational Chart
00/00/2009 2009.
00/00/2009 Piet Hinoul Presentation
00/00/2009 Post Market Surveillance Organization (Chart w/ other slides)
PowerPoint entitled "Material Science Considerations,” by Howard B.
Goldman, MD" [urologist at Cleveland Clinic] delivered by Dr. Goldman
during a webinar to surgeons who were looking to understand more about
00/00/2009 the mesh material
PowerPoint entitled "Competitive Steal Share Strategy Pelvic Floor Repair
US Plan," 7 pages, presented by Scott Jones to VP of Sales & Marketing
re need to provide assurance to drs who are intimidated about using mesh;
eliminate concerns about erosions; drive good patient outcomes through
prof ed and evidence-based medicine. Introduces and details the “Pelvic
00/00/2009 Floor Guarantee Strategy” which was NOT adopted
00/00/2009 PowerPoint, “EWH&U Professional Education” by Lissette Caro Rosado
Page 123 of 191
Offered
Admitted
Exhibit
DX22238
DX22239
DX22240
DX22241
DX22242
DX22243
DX22244
DX22245
DX22246
DX22247
DX22248
DX22249
DX22250
DX22251
ETH.MESH.00608748
No Bates No.
No Bates No.
00276826
ETH.MESH.02236785
ETH.MESH.00831400
ETH.MESH.0122104
ETH.MESH.02632004
No Bates No.
ETH.MESH.03743387
Date
00/00/2010
Description
2010 Goals & Objects Professional Education Operations
00/00/2010 2010.
00/00/2010 Physician patient follow-up form letter
00/00/2010 TVT Clinical Expert Report (2010)
00/00/2010-00/00/2012 Spreadsheets - Revenue?!?
00/00/2010-00/00/2012 TVT Classic 2010-2012
Franchise Procedure for Product Complaint Management, Revision
00/00/2011 History for PR-0000118
http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics00/00/2011 Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx
DX22252
DX22253
No Bates No.
No Bates No.
ETH.MESH.02232140
ETH.MESH.00396836
DX22254
DX22255
DX22256
No Bates No.
No Bates No.
No Bates No.
00/00/2011 Stress Urinary Incontinence Patient Counseling Guide
00/00/2012 "Review of Surgical Techniques using Mesh" by David Robinson
American Urogynecologic Society, Position Statement on Restriction of
00/00/2012 Surgical Options for Pelvic Floor Disorders (2012)
DX22257
DX22258
No Bates No.
No Bates No.
04005370
No Bates No.
No Bates No.
00/00/2012 Guide to Learning in Female Pelvic Medicine and Reconstructive Surgery
00/00/2012 JNJ Annual Report for 2012 – Publicly available
00/00/2012 2012.
00/00/2012 Retropubic Patient Preparation (Video)
00/00/2013 Summary History Related to GyneMesh, Final
DX22259
DX22260
DX22261
Page 124 of 191
Offered
Admitted
Exhibit
DX22263
ETH.MESH.01966785
ETH.MESH.00140980
DX22264
No Bates No.
DX22265
ETH.MESH.00335477
ETH.MESH.00335496
ETH.MESH.00335605
ETH.MESH.03644287
ETH.MESH.09479021
ETH.MESH.02621664
DX22262
DX22266
DX22267
DX22268
DX22269
Date
Description
The Use of Meshes in Urogynecology: An Update by A. Arnaud, M.D.,
01/00/2006 Ethicon Medical Affairs
01/00/2007 Building Your Business Through Patient Marketing. Ethicon – 10 slides
E360 website for physicians cane online – exact date unknown, but early
01/00/2009 2009
Organizational Chart titled "Gary Pruden's Direct Reports"/ (People who
01/00/2009 report directly to Pruden as of 1/2009)
01/00/2009 Women's Health & Urology Organizational Charts
Johnson & Johnson Wound Management, A Division of ETHICON, INC.,
01/00/2010 Organizational Charts, January, 2010
01/00/2010 PowerPoint Slide - Segmentation Validation Study Final Results
01/00/2011 First Amendment to Secant-Ethicon Supply Agreement, Jan. 2011
01/01/2001 - 12/31/2001 Issue Report TVT Retropubic 2001, Open Date Between 01-Jan-2001 and
31-DEC-2001
DX22270
DX22271
DX22272
DX22273
DX22274
DX22275
DX22276
ETH.MESH.02622276
ETH.MESH.04127140
ETH.MESH.03916619
ETH.MESH.03922928
ETH.MESH.05598252
ETH.MESH.00584168
ETH.MESH.01808318
Issue Report TVT Retropubic 2001 Open Date Between 01-Jan-2001 and
01/01/2001-12/31/2001 31-Dec-2001
01/08-09/2008 Email traffic re: TGA Meeting
01/11-12/2007 Email traffic re: Feedback please on TVT Family value presentation
01/13-24/2007 Email traffic re: OR agenda Tunn
Email thread, top one from Brian Kanerviko to Jessica Shen, Judi Gauld,
01/17-20/2012 and Piet Hinoul regarding Sample Size Starting point
01/18-19/2006 Email thread regarding TVT Mesh Pore Size
01/22/2003 - 01/31/2003 Trip Report, Michael Tracey
DX22277
DX22278
DX22279
ETH.MESH.03911108
ETH.MESH.04094396
DX22280
ETH.MESH.1813075 to
ETH.MESH.1813076
01/9/2003 - 02/20/2003 E-mail string, top one from Axel Arnaud to Elisabeth Angleitner
regarding TVT Complications; cc: Ingrid Schauer
01-2006 / 02-2008 Document entitled "Patient Deaths"
Frais pour Le Projet Mulberry, Pro. Jean de Leval, Periode Fevrier 2003 –
5 Avril 2003 (Fees for Project Mulberry, Pro. Jean de Leval, February
02/00/2003-04/05/2003 2003 – 5 April 2003)
Page 125 of 191
Offered
Admitted
Exhibit
DX22281
DX22282
DX22283
DX22284
ETH.MESH.04651950
ETH.MESH.00475758
ETH.MESH.09479251
ETH.MESH.00335413
DX22285
DX22286
DX22287
DX22288
DX22289
DX22290
DX22291
DX22292
DX22293
Date
Description
2/06 E-mail Chain, re: Important FDA Somerville Inspection Concluded
02/00/2006 Day 7
An Update on the Use of Mesh in Pelvic Reconstructive Surgery by A.
Arnaud M.D., Salt Lake City, February 2006 Incontinence & Pelvic Floor
02/00/2006 Summit.
02/00/2009 Ethicon 2.2009 Email re Welding ends of braided wire of guide catheters
02/00/2009 Global Supply Chain Organizational Charts
02/00/2009 TVT World Registry, Maximizing the Investment, PowerPoint presentation
No Bates No.
ETH.MESH.03915279
ETH.MESH.01429443
ETH.MESH.05567111
ETH.MESH.05573256
ETH.MESH.02056874
ETH.MESH.00156164
ETH.MESH.00330760
ETH.MESH.07724080
GAO Report to Congressional Requesters – Medical Devices – FDA Has
02/00/2012 Met Most Performance Goals but Device Reviews Are Taking Longer
02/01-03/2010 Email traffic re: TVT
02/04/2005 - 02/06/2005 Agenda GYNECARE 2005 Incontinence & Pelvic Floor Summit,"
Partnering to Transform Women's Health"
02/08-09/2011 Emails re: FDA request
02/08-09/2011 Emails re: FDA request
Emails re: Health Canada Notification for surgical mesh in repair of POP
02/09-10/2010 and SUI
02/12/2002 - 02/13/2002 "Gyencare TVT: Welcome Presentation for Launch Meeting"
Emails between Cary Brennan and Cindy Crosby re: MHRA request –
02/21-23/2006 TVT blue pigment risk assessment
02/28/2012 - 02/29/2012 Johnson & Johnson Independent MD&D Sector Audit Confidential Report
DX22294
DX22295
DX22296
DX22297
DX22298
DX22299
No Bates No.
ETH.MESH.01424035
ETH.MESH.05566002
ETH.MESH.00608728
ETH.MESH.00335519
Department of Health & Human Services document for Medical Device
03/00/1997 Reporting for Manufacturers
Cobb, WS, et al. “The Argument for Lightweight Polypropylene Mesh in
03/00/2005 Hernia Repair”. Surgical Innovation. 2005;12(1):T1-T7
Women's Health & Urology Division, Profit & Loss Statements YTD from
03/00/2005-12/00/2011 March 2005 through December 2011.
2009 PDM Goals for Erika Lane Sales Training Planning Manager March
03/00/2009 2009
03/00/2009 Ethicon Organization Global Management Board Organization
Page 126 of 191
Offered
Admitted
Exhibit
DX22300
No Bates No.
DX22301
DX22302
ETH.MESH.05479718
No Bates No.
No Bates number
DX22303
DX22310
DX22311
ETH.MESH.01749241
DX22312
ETH.MESH.06867612
ETH.MESH.00139306
DX22305
DX22306
DX22307
DX22308
DX22309
DX22313
DX22314
DX22315
DX22316
DX22317
DX22318
Description
Stand & Deliver Health Care Compliance Update March 2009 Elaine
03/00/2009 Kling
03/00/2011 "Ethicon Polypropylene Mesh Technology" Powerpoint by Boris Batke
03/00/2011 Instructor Copy of Exam, EP US HSR PSS Inguinal Exam
03/00/2011 PowerPoint, “Ethicon Polypropylene Mesh Technology,” by Boris Batke
ETH.MESH.01949200
ETH.MESH.03934879
ETH.MESH.00318889
ETH.MESH.00328820
ETH.MESH.02323290
ETH.MESH.00222094
ETH.MESH.00033462
DX22304
Date
ETH.MESH.00139309
ETH.MESH.02105961
No Bates number
ETH.MESH.00260592
ETH.MESH.02254670
ETH.MESH.03964828
03/01/2006-03/02/2006 E-mail string re: Gyne mesh patient complaint
03/04-25/2003 Email traffic re: Mulberry
03/07/2008-04/17/2008 E-mail string re: Medical Devices Vigilance System
Emails from Axel Arnaud RE: Revised “Procedural Pearls” Images [HOT
03/24-27/2007 DOCUMENT]
03/31/2011-04/01/2011 Emails from Brian Kanerviko re: FDA meeting date to discuss mesh
PowerPoint: Project Mulberry, Athos, and Hybrid Mesh. April
04/00/2003 2003—Individual Depth Interviews
M.D. News, Dallas/Fort Worth Edition, April 2006, re: article titled
04/00/2006 "Minimally Invasive Treatment for SUI and Pelvic Organ Prolapse"
Interim report mesh explants pelvic floor repair. Prof. B. Flosterhalfen,
04/00/2008 Institute of Pathology Duren Hospital, Germany
Section of Ethicon Powerpoint showing Weights "Matrix Material"
04/00/2008 PowerPoint Presentation
04/00/2009 Company Procedure for Records Retention Schedule
ETHICON, INC. ADMINISTRATIVE RETENTION SCHEDULE
04/00/2009 Approved April, 2009, PR-0000018, Appendix 1 Revision #10
Email from Harel Gadot RE: TVT WORLD Registry One-Pager Being
04/02-03/2008 Created [HOT DOCUMENT]
04/07/2006 - 11/22/2010 Risks disclosed in TVT Classic label
04/13-14/2003 Email from Dan Smith re: Mulberry update
04/21-25/2011 Emails re: FDA EWHU Mesh Meeting
04/24/2009 - 05/06/2009 E-mail string, top one from Dharini Amin to Scott Miller and Scott Finley
regarding PARTNERS Sales, Usage, & Business Need Assessment
DX22319
Page 127 of 191
Offered
Admitted
Exhibit
DX22320
DX22321
DX22322
DX22323
DX22324
DX22325
DX22326
DX22327
DX22328
DX22329
DX22330
DX22331
DX22332
DX22333
DX22334
DX22335
DX22336
DX22337
DX22338
DX22339
DX22340
ETH.MESH.00327176
ETH.MESH.02620917
ETH.MESH.00335580
ETH.MESH.00609366
ETH.MESH.02056849
ETH.MESH.00222102
ETH.MESH.00524748
ETH.MESH.02056852
ETH.MESH.03918583
ETH.MESH.00400978
ETH.MESH.01819528
ETH.MESH.06879401
ETH.MESH.06003180
ETH.MESH.00862757
ETH.MESH.01813082
ETH.MESH.04543224
ETH.MESH.04543291
ETH.MESH.00260440
ETH.MESH.03456779
ETH.MESH.01137293
ETH.MESH.04096555
Date
Description
Emails from Carlos Lugo-Ponce RE: URGENT Compaint on TVT Classic
04/28-29/2009 – preliminary Report
TVT Retropubic Issue Report
05/00/1999
05/00/2009 Ethicon, LLC Operations San Lorenzo, PR Organizational Charts
05/00/2011 Phase 1 Worksheet: The Broader J&J Healthcare Environment
05/17-24/2010 Emails re: Incontinence Tapes
05/22-23/2003 Mulberry Workshop
05/25/2005-06/01/2005 Email re: TVT Meeting with Agency
05/25-28/2010 Email from Krystina Laguna re: Incontinence Tapes
Email traffic re: AUA Report – VOC on ATHOS, MULBERRY, and
05/27/2003-06/03/2003 HYBRID MESH
06/00/2000 TVT Surgeons Resource Monograph
06/00/2009 WW Customer Complaints – received from Carey Brennan
06/02-03/2003 Email traffic re: Mulberry Clinical Decision
06/06/2007-10/1/2007 E-mail string re: Minimally invasive dissection tools
06/06-09/2003 Emails re: “double edged sword” and “article”
06/06-11/2003 Email traffic re: Article
Emails re: MHRA request for information – STRICTLY
06/15/2012-07/06/2012 CONFIDENTIAL PRIVILEGED INFORMATION
06/21-27/2012 Emails re: DoH Meeting Information
06/23-24/2003 Email from D. Smith to J. Burns, S. O’Bryan, G. Borkes, et al. re: IFU
New Literature Release for incontinence - Freedom From SUI
06/30/1999-07/13/1999 w/handwritten notes
Document entitled "Incontinence/Pelvic Floor Management GYNECARE
TVT Tension-free Support for Incontinence, 2001 Marketing Plan," July
07/00/2001 2001
07/00/2007 Powerpoint slide - Quarterly MDR Review
Page 128 of 191
Offered
Admitted
Exhibit
ETH.MESH.07946468
DX22341
DX22342
DX22343
DX22344
DX22345
DX22346
ETH.MESH.09479016
No Bates No.
No Bates No.
ETH.MESH.03928542
ETH.MESH.04193993
Date
Description
ADM Module 2: Complaince, Introduction to HCC: Key Takeaways &
Contacts
07/00/2009
07/00/2011 J&J 7.2011 Email re Secant Supply Agreement
Principles on Conduct of Clinical Trials: Communication of Clinical Trial
07/00/2011 Results by PhRMA
07/00/2013 Clemons – Impact of 2011 FDA Safety Update 2013
07/00/2013 Dutch Health Care Inspectorate Report—J&J Medical/Smit
07/16-17/2003 Email traffic re: Suggestions for a reply to the competent authority
07/20/1999 - 09/15/1999 Major Executive Committee Actions, with redactions
DX22347
DX22348
DX22349
DX22350
DX22351
DX22352
DX22353
DX22354
DX22355
DX22356
DX22357
DX22358
DX22359
ETH.MESH.04193993
ETH.MESH.07270484
No Bates No.
ETH.MESH.03364665
ETH.MESH.06946134
ETH.MESH.00864139
ETH.MESH.03911391
No Bates No.
ETH.MESH.00533026
ETH.MESH.00260750
ETH.MESH.00319458
ETH.MESH.00527046
07/20/1999-09/15/1999 Major Executive Committee Actions, 07/20/1999-09/15/1999
07/2010 - 07/2012 Spreadsheet, Products: TVT
07/21/2009-07/30/2009 Emails Re: URGENT: TVT Japanese Package Insert
07/23-29/2003 Email traffic re: ifu
E-mail string re: SAE PROSIMA PROTOCOL 300-06-005, SITE 11 MR
07/25/2007-08/07/2007 Sayer, Subject Number 11010
07/29/2003 - 07/30/2003 E-mail string, top one from Mosaddeq Hossain to Dan Smith regarding
Dennis Miller's Comments
07/29/2003-08/14/2003 Email traffic re: Transient leg Pain with MULBERRY
U.S. General Accounting Office; Report to the Chairman, Subcommittee
on Health and the Environment, Committee on Energy and Commerce,
House of Representatives; Medical Devices: "FDA's 510(k) Operations
08/00/1988 Could Be Improved"; August 1988.
08/00/2009 HS Study Monthly Update Project Manager Patricia Beach
08/07-15/2003 Email traffic re: Mulberry Final DRAFT #1
Email re: FDA Additional Information Request – Follow-up to UFR No.
230097 0000-2005-0001, top email from Diane Dwyer (FDA) to Mark
08/12-15/2005 Yale
08/21/2006 - 08/24/2006 E-mail string, top one from Matt Henderson to Joseph Steele and Dharini
Amin regarding JJHCS# for Docs trained on August 25th
Page 129 of 191
Offered
Admitted
Exhibit
DX22364
ETH.MESH.03911346
ETH.MESH.00574137
ETH.MESH.07250425
ETH.MESH.07281458
ETH.MESH.09497079
DX22365
No Bates No.
DX22366
ETH.MESH.03571983
DX22367
DX22368
DX22369
ETH.MESH.00519070
ETH.MESH.00519071
ETH.MESH.00519072
DX22360
DX22361
DX22362
DX22363
DX22370
DX22371
DX22372
DX22373
DX22374
No Bates No.
ETH.MESH.01813132
ETH.MESH.03738470
ETH.MESH.02253415
DX22375
No Bates No.
ETH.MESH.04929974
DX22376
ETH.MESH.00209579
Date
Description
08/25/2003-09/08/2003 Email traffic re: tvt complication
Emails from David Waltregny Re: Partially degradable tape [HOT
08/28-29/2010 DOCUMENT]
08/29/2005 -09/08/2005 Form FDA - 483
08/29/2005-09/08/2005 Establishment Inspection Report (EIR)
Email traffic among Patricia Hojnoski, Martin Weisberg, and Naomi
08/30/2005-09/15/2005 Sinclair re: Clinical expert report
In 2000, there was a recall of six lots of TVT implicating 5440 units,
which occurred following complaints of "needle pulloff" during the
surgical procedure itself, which could cause complications. Ethicon
notified the FDA in September 2000 and implemented new assembly
procedures that would avoid the problem. Most of the recalled lots had an
09/00/2000 expiration date of 2005
PowerPoint Slide - Physician Segmentation Study for Gynecare TVT 09/00/2004 Final Presentation
Ethicon, An Evaluation of the GYNECARE Family of TVT Systems
(Tension-free Support for Incontinence) For The Treatment of Stress
09/00/2006 Urinary Incontinence [HOT DOCUMENT]
09/00/2006 Protocol Number: 300-06-006 [HOT DOCUMENT]
09/00/2006 Protocol Number: 300-06-006 [HOT DOCUMENT]
Rechberger, TR, et al. Risk of Tape Rejection in Urogynecological
09/00/2006 Surgeries. Int Urogynecol J 2006;17(Suppl. 2):S302
09/01-04/2003 Email traffic re: Mulberry/de Leval fees and expenses
09/05/2003 - 09/06/2003 E-mail string, top one from Martin Weisberg to Marianne Kaminski
regarding TVT Response for Peggy Norton, M.D.
09/08/2011 - 09/09/2011 Surgical Mesh for Treatment of Women with Pelvic Organ Prolapse and
Stress Urinary Incontinence FDA Executive Summary, Obstetrics &
Gynecology Devices Advisory Committeee Meeting, September 8-9, 2011
09/08-09/2011 24-hr Summary of Ob/Gyn Devices Panel
OBSTETRICS & GYNECOLOGY DEVICES PANEL. Summary of the
09/08-09/2011 hearings/presentations
Email traffic among John Young, Susan Lin, Donna Taggart, Aaron
Kirkemo, and David Robinson re: Susan Lin’s desire for us to modify the
warning and precautions statement on use of device on patients using
09/14/2006-10/21/2009 anticoagulants
Page 130 of 191
Offered
Admitted
In identifying documents, Defendants do not admit that all or part of any documents are admissible at t

pretrial statement

Transcription

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