arthritis drugs

Transcription

arthritis drugs

LitigationWatch:
ARTHRITIS DRUGS
SEPTEMBER 2005
TRACKING EMERGING LITIGATION INVOLVING DRUGS USED TO TREAT ARTHRITIS
7
9
12
15
16
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VIOXX
VIOXX
VIOXX
CELEBREX
BEXTRA
REMICADE
Merck Moves to
Exclude Causation
Testimony in New
Jersey Vioxx Case
Multidistrict Panel
Grants Motion to
Create State Vioxx
MDL
Federal Judge
Refuses to Remand,
Then Refuses to
Stay Vioxx Action
Northern District of
California to Get
Celebrex, Bextra
MDL
Pfizer Wants
Michigan Law
Applied to
Pennsylvania
Bextra Case
Defendants
Designate Experts
in Remicade
Wrongful Death
Case
After $253.4
Million Verdict,
Merck Says
It May Settle
Some Suits
WHITEHOUSE STATION, N.J. — Just days after saying it would continue to
fight each Vioxx personal injury claim despite being hit with a more than $250
million verdict, the drug’s manufacturer said it may consider settling some of the
most serious cases.
According to a company spokesman, Merck will consider settling suits brought by
people who took Vioxx for at least 18 months and who had few other risk factors
for heart disease. The Aug. 25 announcement came just days after Merck said it
would not be settling any of the claims, despite a state court jury’s decision to award
$253.4 million to the widow of a Texas man who died after taking Vioxx for about
two months.
Merck said it would be appealing the
verdict on numerous grounds. Based on
the facts presented in that case — the
first in the nation to go to trial — there
would not have been a settlement offer
from Merck if it applied the recently
announced requirements for considering
resolution of Vioxx claims.
Meanwhile, Merck is gearing up to try a
case in New Jersey state court, where trial
will begin Sept. 12 in Humeston v. Merck
Inc. The plaintiff, Frederick "Mike"
Humeston alleges that he suffered a nonfatal heart attack after taking Vioxx intermittently for two months. Merck contends that Humeston suffered a myocardial infarction as a result of several risk
factors for heart disease, including high
cholesterol, anxiety and obesity.
www.harrismartin.com
After Humeston, trial is slated to get
underway in another state court
pulmonary embolism case in Texas.
And, on Nov. 28, the first federal case is
scheduled for trial in the U.S. District
Court for the Eastern District of
Louisiana, where the Vioxx MDL is
overseen by Judge Eldon E. Fallon.
However, there is speculation that trial
may be postponed due to the effects of
Hurricane Katrina, which forced staff in
the Eastern District of Louisiana to move
operations to Houston.
For more information about the
recent Vioxx verdict and upcoming
trials, please see Courtroom News
on Page 7 and the Interview with
plaintiff ’s trial counsel, Mark Lanier,
on Page 4.
HARRISMARTIN’S LITIGATION WATCH: ARTHRITIS DRUGS – SEPTEMBER 2005
Table of Contents
ON THE COVER
After 253.4 Million Verdict, Merck Says It May Settle Some Suits
1
INTERVIEW
Mark Lanier, Lead Plaintiff’s Trial Counsel in Ernst, Discusses the Verdict and Its Impact
4
RESEARCH WATCH
Summaries of Recent Arthritis Drugs-Related Studies Published in the Medical Literature
6
COURTROOM NEWS
Jury Awards $253.4 Million to Plaintiff in First-Ever Vioxx Trial
7
Ernst v. Merck & Co. Inc., et al., No. 19961*BH02 (Texas Dist. Ct., Brazoria Cty.).
Merck Moves to Exclude Causation Testimony in New Jersey Vioxx Case
7
Humeston v. Merck & Co. Inc., No. ATL-L-2272-03 (N.J. Super. Ct., Atlantic Cty.).
Merck Moves to Exclude Business Ethicist’s Testimony in Vioxx Suit
8
Merck Wants Opinions of ‘Expert with a Cause’ Excluded Entirely from Vioxx Trial
8
Multidistrict Panel Grants Motion to Create State Vioxx MDL
9
In Re: Vioxx Litigation, No. 05-0436 (Texas Sup. Ct.).
Merck Opposes Plaintiffs’ Motion for Protective Order Related to Employee Depos
10
In re: Vioxx Products Liability Litigation, MDL Docket No. 1657 (E.D. La.).
Committees Identify Stroke Case for Early Trial; No Date Set
10
Hofmann v. Merck & Co. Inc., et al., No. 05-4103 (E.D. Pa.).
Federal Judge Says Texas Vioxx Medicaid Lawsuit Belongs in State Court
11
The State of Texas v. Merck & Co. Inc., No. 05-606 (W.D. Texas).
Federal Judge Refuses to Remand,Then Refuses to Stay Vioxx Action
12
Waitt v. Merck & Co. Inc., et al., No. 05-0759 (W.D. Wash.).
Judge Says Distributor May be Held Liable in Vioxx Injury Case
12
Martin v. Merck & Co. Inc., No. 05-750 (E.D. Calif.).
Plaintiffs’ Case Against Merck Remanded After Judge Severs Vioxx Claim
13
Edsall v. Merck & Co. Inc., No. 05-2244 (N.D. Calif.).
Judge Rejects Merck’s Fraudulent Joinder, Improper Misjoinder Arguments
14
Anderson v. Merck & Co. Inc., No. 05-4036 (C.D. Calif.).
Northern District of California to Get Celebrex, Bextra MDL
15
In re Bextra and Celebrex Marketing, Sales Practices and Products Liability Litigation, Docket No. 1699 (JPML).
Pfizer to California Court: Celebrex is No Vioxx
15
Anderson v. Merck & Co. Inc., et al., No. BC331454 (Calif. Super. Ct., Los Angeles Cty.).
Pfizer Wants Michigan Law Applied to Pennsylvania Bextra Case
16
Henderson v. Merck & Co. Inc., et al., No. 04-5987 (E.D. Pa.).
Defendants Designate Experts in Remicade Wrongful Death Case
17
Huff v. Centocor Inc., et al., No. 04-1279 (D. S.C.).
Iowa Plaintiff Blames Remicade for Brain Damage
17
Jennifer Rae Zach, et al. v. Centocor Inc., et al., No. LACV066002 (Iowa Dist. Ct., Johnson Cty.).
Georgia Plaintiff Alleges Enbrel Caused Development of Multiple Sclerosis
18
Baggett v. Amgen Inc., et al., No. 4-05-cv-82 (M.D. Ga., Columbus Div.).
LITIGATION WATCH: ARTHRITIS DRUGS
3
ALL DOCUMENTS AVAILABLE FREE TO SUBSCRIBERS AT WWW.HARRISMARTIN.COM
A HarrisMartin Interview with W. Mark Lanier
Lead plaintiffs’ counsel in Ernst discusses the trial
And life after the landmark verdict
On Aug. 19, a jury awarded $253.4 million to the widow of Robert Ernst, a
Texas man who died after taking the
now withdrawn arthritis drug, Vioxx.
Ernst’s case was the first to proceed to
trial since plaintiffs around the country
began filing cases against Merck nearly
three years ago.
W. Mark Lanier, Esq.
Lead plaintiff ’s trial counsel was W.
Mark Lanier, a Houston attorney who
until then was best known for several
high-profile asbestos verdicts. Lanier is
the founder of The Lanier Law Firm
and is widely recognized as one of the
top trial lawyers in the country.
Lanier spoke with HarrisMartin
Publishing recently about the landmark
verdict and the potential impact on the
future of Vioxx litigation.
HarrisMartin: Were you at all surprised
by either the outcome of this case or
the total damages awarded?
Lanier: Let’s just say I was cautiously
optimistic. Our jury paid great attention to the trial, and I am a believer in
the jury system. I had confidence they
would do what was right.
Three years ago, when the first Vioxx
cases were being filed, would you have
ever imagined that one day a jury
would return a verdict of $253 million
in favor of one of your clients?
Nope. I had no idea how damaging the
documents were for Merck. I had no
idea how much Merck knew compared
to what Merck was telling people.
There is a report now that Merck will
consider settling some cases if they
involve plaintiffs who took Vioxx
4
longer than 18 months and who have
no pre-existing cardiovascular conditions. But, if that’s true, a case like
Ernst wouldn’t be one of the ones settled, correct? Why do you think they
changed their opinion then about settling cases where before they stated
emphatically they would fight each
one?
Ernst will not be settled under the new
“proposal.” Merck needs to get responsible and address all cases of Vioxx damage, not merely those with 18 month
exposure. Clearly the verdict changed
the settlement posture somewhat.
Where would this case have been without Merck’s decision to withdraw
Vioxx? In other words, what impact did
that decision have on the movement of
the case and the verdict?
Withdrawing the drug might have
helped Merck as much as it hurt Merck.
Merck was allowed to argue that it took
a responsible course of action the
moment it had concern over the drug’s
adverse effects. We were allowed to
argue that the drug must be dangerous
or Merck would have continued sales.
Merck has indicated it will appeal the
verdict on grounds that Dr. Araneta
should have been precluded from testifying. What is it that made her testimony so important, and without her
live testimony, might this case have
turned out differently?
Dr. Araneta said nothing that other
experts did not also say. While I do not
believe it was error to allow her testimony — remember, Merck designated her
as a witness and Merck told the jury
what Dr. Araneta believed in opening
statements. Any alleged error is harmless
because Dr. Araneta’s testimony was
cumulative of others’ testimony.
Was there any one witness who you
believe was the most compelling?
Alan Nies, the Merck head scientist on
Vioxx, and Alise Reicin, the Merck
“defender of the Vioxx franchise.”
Although they were both Merck witnesses, they were most compelling for us.
They showed the callous disregard
Merck had for science and for victims.
There has been a lot of talk about this
verdict in legal circles, on web blogs,
on talk shows and news magazines, and
I’ve heard a lot of people say this is a
verdict that was more about emotion
than it was about Merck and its legal
duty to warn. What’s your response to
that?
Anyone whose says that is either a
Merck spinster, or someone who knows
nothing about the trial and the evidence. Merck killed thousands upon
thousands of people for profit — and
knew it the whole time. That would
not be tolerated by most any jury anywhere.
You’ve been involved in a lot of verdicts
and settlements on behalf of clients.
Where does this one rank?
Although this is not my largest, it is
probably my most satisfying. The cause
is incredibly just. And we have a chance
to make a difference in America and
save lives.
The causation issues in this trial were
somewhat complex. In a nutshell, how
is it that you were able to show the
jury that Vioxx caused Mr. Ernst’s
death when Merck had argued that he
died from arrhythmia, a condition the
manufacturer has stated is not caused
by Vioxx?
“Merck needs to get responsible
and address all cases of Vioxx damage,
not merely those
with 18 month exposure.”
I used the Merck Manual along with
basic medical textbooks. They showed
that you need a 90 percent blockage to
have the arrhythmia Mr. Ernst died
from. Mr. Ernst had a maximum 75
percent blockage with atherosclerosis.
Either something so stressed Mr. Ernst
in his sleep that he needed more oxygen
than he could get, or there was a clot.
The only stress Merck witnesses offered
were bad dreams or sleep apnea. The
jury went with the textbooks and the
clot.
What are the implications of this finding — that it’s possible an arrhythmia
could be caused by ingestion of Vioxx
— for the future of Vioxx litigation?
You will still need a prothrombotic
event (blood clot). There are many
arrhythmias that are not caused by heart
attacks.
How significant were the jury instructions regarding causation in this case?
Was it important that the jury was
instructed to answer whether Vioxx was
a cause, rather than the cause of Mr.
Ernst’s death? And, is it likely that
other jurors around the country will be
instructed similarly?
It is very important. The law doesn’t say
that Vioxx must be the only cause.
There can always be more than one
proximate or producing cause.
I recently read a report which stated
that Merck stands a better chance at
winning the upcoming trial because of
where it is being held — in New Jersey.
They list as the reasons: a more affluent and/or sympathetic jury; favorability regarding home-state status; and
examples in the first trial from which
to learn. Can you comment on why
this may or may not be the case?
The jury is a toss up. If lawyers on both
sides do their job in voir dire, the jury is
not one where bias or sympathy should
play a part. I plan on trying cases in
New Jersey, and I plan on winning.
Merck has a benefit having been
through a trial, but the plaintiff ’s team
has my transcript as a road map.
Tell me a little bit about what life has
been like at the Lanier Law Firm since
this verdict. Any different?
More e-mails! We have had significant
more media attention, but ultimately we
just get back to work.
The Guerra case, which is set for trial
in Hidalgo County after Humeston in
New Jersey, is also yours. Will you be
trying this, and can you tell me a little
about the facts surrounding this case?
My plan is to try it. Guerra died of a
pulmonary embolism. I look forward to
kicking my game against Merck up a
couple of notches.
5
Journal
Watch
A Comparison of Reported
Gastrointestinal and
Thromboembolic Events Between
Rofecoxib and Celecoxib Using
Observational Data
Journal: Drug Safety 2005;28(9):803-16
Authors: R. Kasliwal, D. Layton, S.
Harris, L. Wilton, S.A. Shakir
Summary: A study comparing the incidence of gastrointestinal events and
thromboembolic events reported for
15,286 and 17,458 patients prescribed
Vioxx or Celebrex, respectively.
Incidence rates of the first event during
treatment within each thromboembolic
and gastrointestinal group were calculated during the 270 days after the patient
started receiving either drug. The results
indicated that for the GI event groups,
the adjusted relative risks for Vioxx compared to Celebrex were 1.21 for symptomatic upper GI events and 1.60 for complicated conditions. For the thromboembolic event groups, the relative risks were
1.04 for cardiovascular events, 1.43 for
cerebrovascular events and 0.36 for
peripheral venous events. The data led
researchers to conclude that for the three
thromboembolic event groups, there is
no evidence of a statistically significant
difference between Vioxx and Celebrex
when adjusting for identified risk factors.
The researchers cautioned, however, that
they had information on only a limited
number of confounding variables for
thromboembolic events.
Web Site:
http://www.adisonline.info/drs/default.asp
Arthritis Drugs In the Medical
Literature This Month
Risk of Retinal Vein Occlusions in
Patients Treated with Rofecoxib
(Vioxx)
Journal: Ophthalmologia 2005 JulAug;219(4):243-7
Authors: C.H. Meyer, J.C. Schmidt,
E.B. Rodrigues, S. Mennel
Summary: The report focuses on three
patients each who suffered sudden
decrease in vision following treatment
with Vioxx. One, a 78-year-old who was
taking 50mg developed sudden decrease
of vision in her right eye; another 68year-old female developed a branch retinal vein occlusion with flame-shaped
hemorrhages one day after taking 25mg
of Vioxx; and a third 47-year-old male
who took Vioxx for one week developed
decreased and clouded vision and was
later diagnosed with central retinal vein
occlusion. The reports led the authors to
suggest that under certain conditions
patients with predisposed thrombosis
may be at risk for both cardiovascular
and ocular thrombotic events when taking COX-2 inhibitors.
Web Site: n/a
COX-2 Inhibitors and Arterial
Hypertension: An Analysis of
Spontaneous Case Reports in the
Pharmacovigilance Database
Journal: European Journal of Clinical
Pharmacology 2005 Aug 24 [Epub]
6
Authors: G. Durrieu, P. Olivier, J.L.
Montastruc
Summary: This study was designed to
evaluate the main characteristics of case
reports of arterial hypertension related to
COX-2 inhibitor use in real-life practice.
The researchers identified 34 cases of
arterial hypertension that occurred
between April 2000 and November 2003
and were related to coxibs. Most cases of
arterial hypertension occurred during the
first 15 days of treatment and were more
frequent among Vioxx users than
Celebrex users. The researchers concluded that coxibs are associated with a risk
of arterial hypertension in real-life practice and that the adverse drug reactions
that formed the basis for the study are of
special epidemiological importance due
to the risks of arterial hypertension and
the widespread use of coxibs.
Web Site:
www.springerlink.com/link.asp?id=100413
Vioxx
Texas Jury Awards $253.4
Million to Plaintiff in FirstEver Vioxx Trial
ANGLETON, Texas — The family of a
Texas man who suffered a fatal heart
attack after taking Vioxx has been awarded $253.4 million in the first-ever trial
involving the withdrawn arthritis drug.
Ernst v. Merck & Co. Inc., et al., No.
19961*BH02 (Texas Dist. Ct., Brazoria
Cty.).
The Aug. 19 verdict reached by the
Brazoria County 23rd District Court jury
included $229 million in punitive damages, sources said. The five-week trial was
overseen by Judge Ben Hardin.
Plaintiff Carol Ernst claimed that her
husband Robert died in 2001 as a result
of taking Vioxx for eight months.
Merck argued during trial that Ernst suffered an arrhythmia that ultimately
caused his death and that his heart condition was most likely resulted from
clogged arteries, not Vioxx. The manufacturer maintained that there exist no
studies linking Vioxx ingestion and
arrhythmia.
Testifying for the plaintiffs were Dr.
David Egilman, warnings and causation,
Brown University, Providence, R.I.; Dr.
Isaac Wiener, cardiology; Dr. Benedict
Lucchesi, cardiology and pharmacology,
University of Michigan; and Dr. Kenneth
McCoin, economist, Houston.
Merck called Dr. Thomas Wheeler,
pathology, Louisville, Ky.; Dr. Craig
Pratt, cardiology, Houston; and Dr.
Maria Araneta, coroner.
Counsel for Merck were David C.
Kiernan of Williams & Connolly in
Washington, D.C.; Gerry Lowry of
Fulbright & Jaworski in Houston; and
Joe Piorkowski Jr. of Joseph D..
Piorkowski Jr. in Washington, D.C.
Ernst was represented by W. Mark
Lanier, Kenneth S. Soh, Dara G. Hegar,
Richard D. Meadow, Philip Sonar and
Maura Kolb of the Lanier Law Firm in
Houston; Benedict Morelli of Morelli
Ratner in New York; Lisa Blue of Baron
& Budd in Dallas; and Randy Moore of
the Moore Law Firm in Lake Jackson,
Texas.
Vioxx
Merck Moves to Exclude
Causation Testimony in New
Jersey Vioxx Case
ATLANTIC CITY, N.J. — Merck &
Co. has moved to exclude evidence
offered by experts testifying on behalf of
a plaintiff in New Jersey, arguing that the
causation testimony isn’t sound and that
the plaintiff had a history of poor health
that led to the heart attack he now
blames on Vioxx. Humeston v. Merck &
Co. Inc., No. ATL-L-2272-03 (N.J.
Super. Ct., Atlantic Cty.).
Merck filed the motion Aug. 8 in the
Atlantic County Superior Court, where
Merck and plaintiff William Humeston
are preparing for a trial expected to begin
next month. Humeston and several
experts hired to testify on his behalf contend that the plaintiff suffered a nonfatal
heart attack caused by his ingestion of
the withdrawn arthritis drug.
Humeston, a 60-year-old Vietnam
Veteran who suffered a wartime shrapnel
injury to his knee, claims he took Vioxx
regularly, then intermittently, for two
months before suffering a heart attack on
Sept. 18, 2001.
Merck says, however, that Humeston’s
contention that Vioxx caused his heart
attack overlooks the fact that he suffered
from a number of ailments, any one or
combination of which could have caused
his injury.
According to the defendant, Humeston
suffered from anxiety, high cholesterol
and was clinically obese — all risk factors
for myocardial infarctions such as the one
he suffered.
“Most infarctions occur in persons with
at least one risk factor, and any one or all
of the factors present in Mr. Humeston’s
case are sufficient to cause heart disease
or heart attacks,” Merck argues. “Thus,
Mr. Humeston’s use of Vioxx must be
considered against this backdrop of significant preexisting medical conditions
— conditions which caused him to be at
a higher risk of MI than the general population.”
Merck says Humeston’s experts have
opined that his minimal and intermittent
use of Vioxx was the “but for” cause of
the plaintiff ’s thrombus and resulting
heart attack. But, they argue that those
same experts cannot specifically state
within the required degree of medical or
scientific probability that Humeston’s
heart attack was caused by Vioxx.
“Although plaintiffs’ experts purport to
rule out Mr. Humeston’s risk factors,
they do not and cannot answer how and
why they did so — and certainly not to
the requisite degree of medical probability required under New Jersey law.
Merck says that the plaintiffs have also
failed to identify a reliable scientific
methodology for determining that
Humeston’s heart attack was caused by
Vioxx, as opposed to his multiple preexisting conditions.
“Because even their own experts have to
accept the basic science of how a heart
attack happens and how it happened in
7
Mr. Humeston, they are left with little
more than guilt by temporal association
— that is, he had it while on Vioxx so
Vioxx must have caused it,” Merck says.
“This is not the kind of rigorous and
well-supported scientific reasoning
demanded by New Jersey law.”
Merck is represented by Diane P. Sullivan
of Dechert in Princeton, N.J., and
Wilfred P. Coronato of Hughes, Hubbard
& Reed in Jersey City, N.J.
Document Is Included
See Page 19 or
Call (800) 496-4319
Motion Ref# ART-0509-01
Vioxx
Merck Moves to Exclude
Business Ethicist’s Testimony
In Vioxx Suit
ATLANTIC CITY, N.J. — A business
ethics professor whose opinion about
Merck’s conduct in the years leading up
to its decision to pull Vioxx from the
market should not be heard by jurors in
the nation’s second Vioxx trial, attorneys
for the company argue in a brief filed
recently. Humeston v. Merck & Co. Inc.,
No. ATL-L-2272-03 (N.J. Super. Ct.,
Atlantic Cty.).
Merck says in its Aug. 8 brief that the
opinion of Professor W. Michael
Hoffman Ph.D. regarding Merck’s business ethics is “not even conceivably relevant” to the case in which he has been
designated to testify and that the Atlantic
County Superior Court jury slated to
hear the trial should not be permitted to
weigh the testimony because it fails to
meet admissibility standards.
“Professor Hoffman’s opinions as to
Merck’s supposed business ethics have no
8
bearing on any element of plaintiffs’
claims and therefore do not tend to prove
or disprove any fact that is of consequence to the determination of plaintiffs’
action,” Merck alleges.
Hoffman’s expert report indicates that he
will testify as to whether Merck’s actions
with respect to Vioxx were ethical.
Specifically, he has indicated that based
on the application of the principles of
business ethics, Merck “willfully placed
profits over patients, putting thousands
of lives at risk, thereby violating its own
stated values and acting unethically.”
Merck, however, argues that the relevant
issue is not whether the manufacturer
lived up to Hoffman’s concept of an ethical corporation, but whether the company met its legal obligations to plaintiffs.
The brief also notes that Hoffman himself has conceded that his opinions about
Merck’s communications with doctors
and its customers does not extend
beyond ethical obligations.
“Professor Hoffman does not contend
that a company living up to its supposed
‘ethical’ duties necessarily complies with
the law,” Merck argues, adding that for
this reason, Hoffman’s testimony has
been excluded by courts on four separate
occasions. “This disconnect between
ethics and the law renders Professor
Hoffman’s opinions about the former categorically irrelevant as to the latter.”
Merck also contends that Hoffman’s
opinions are not based on methodologies
that would survive any reliability test
under New Jersey law. Instead, Hoffman
acquired his knowledge of Merck’s corporate state of mind from reading newspaper articles and documents posted on the
FDA web site, according to the brief.
Those same documents can be examined
and readily understood by the jury,
which would then be able to reach its
own conclusion about what Merck knew
and intended regarding risks allegedly
associated with Vioxx, the brief says.
In addition to arguing that Hoffman
should be precluded from testifying that
Merck’s conduct regarding Vioxx was
unethical, the drug maker says that any
testimony regarding the alleged inadequacy of Merck’s warning label should also
be excluded.
“Although disclaiming any expertise in
medicine, epidemiology, the development
or marketing of prescription drugs, the
prescription drug industry, or the design
of warnings for drug products, Professor
Hoffman opines that Merck was ethically
deficient in issuing warnings regarding
Vioxx’s cardiovascular effects after the
VIGOR study, and in particular,
Professor Hoffman opines that Merck
should have listed ‘the issues with regard
to VIGOR … in the warning part of the
label, and not in the precautions part of
the label,’” Merck asserts. “Any such testimony regarding Merck’s duties with
respect to product labeling and warnings
should be excluded.”
of Dechert in Princeton, N.J.; and
Wilfred P. Coronato of Hughes Hubbard
Document Is Available
Search www.harrismartin.com or
Call (800) 496-4319
Vioxx
Merck Wants Opinions of
‘Expert with a Cause’
Excluded Entirely from Trial
ATLANTIC CITY, N.J. — Merck has
moved to exclude all testimony expected
to be presented by plaintiff ’s expert Dr.
David Egilman in a Vioxx case slated to
go to trial in New Jersey on Sept. 12.
Humeston v. Merck & Co. Inc., No. ATLL-2272-03 (N.J. Super. Ct., Atlantic
Cty.).
In a motion filed Aug. 8 in Atlantic
County Superior Court, Merck accuses
plaintiff Frederick Humeston of proffering Dr. Egilman as a one-stop shop for
expert testimony, including opinions
regarding Merck’s legal duty to patients
who took Vioxx and the suppression of
certain research data showing that the
drug caused an increased risk of cardiovascular side effects.
However, the defendant claims that
Egilman’s testimony is inadmissible under
the New Jersey Rules of Evidence.
Merck says that Egilman’s opinions in the
instant case are consistent with prior
statements he has made in other cases
that collectively demonstrate he has
become much more an advocate for a
cause than an expert prepared to testify
on matters derived from careful, accepted, peer-reviewed methodological analysis.
“Overall, Dr. Egilman’s testimony and
report is not the product of reliable,
objective scientific analysis designed to
aid the trier of fact, but a hostile partisan
attack designed to further Dr. Egilman’s
personal agenda,” the motion says.
“Collectively, Dr. Egilman’s intemperate
statements in both public and litigation
settings, his history of campaigns against
‘corporate misdeeds,’ and his comportment in prior litigation combine to render Dr. Egilman unfit to ‘assist the trier
of fact’ as required by Rule 702.”
According to Merck, plaintiffs have indicated that Egilman will testify on behalf
of Humeston, who alleges he suffered a
heart attack as a result of ingesting Vioxx.
Merck says that the expert is expected to
testify that Merck breached its ethical or
legal obligation concerning Vioxx in that
the manufacturer failed to adequately
warn the public about dangers it knew
were associated with the arthritis drug.
Merck contends, however, that jurors
shouldn’t be allowed to hear such “personal and subjective” testimony, especially from Egilman, who it says is not qualified in the areas of labeling, marketing or
testing of prescription drugs. Similarly,
Egilman has not provided any research or
methodology establishing that his opinions are reliable, or that they are relevant,
Merck says, noting that Humeston has
already testified that he never saw any
advertising for Vioxx and had never
heard of the drug before it was prescribed
to him by his physician.
Merck further argues that expert testimony regarding the defendant’s alleged violation of legal standards concerning its
duty to warn consumers is inadmissible
because it is the court’s responsibility to
instruct jurors on the requirements of the
relevant law. And, it is the jurors who
then must apply that law to the facts and
evidence before it, Merck adds.
Similarly, the motion says Egilman’s frequent remarks indicating that Merck has
failed to comply with certain discovery
obligations by withholding from plaintiffs’ counsel and the FDA certain information regarding its evaluation of Vioxx
usurps the roles of lawyer as advocate and
the court as arbiter in this case.
Therefore, his opinions regarding Merck’s
alleged refusal to produce certain documents related to the testing and marketing of Vioxx are inadmissible, the motion
asserts.
“Dr. Egilman is not a lawyer, he is not
counsel for plaintiffs, and he certainly is
not the judge in this case,” Merck argues.
“He therefore lacks the ‘knowledge, skill,
expertise, training, or education’ to tell
the jury whether Merck has complied
with its discovery obligation. And even if
he were so qualified, discovery is not the
province of an expert witness.”
Finally, the manufacturer urges the court
to preclude Egilman from testifying generally about corporate conduct and
malfeasance, issues that Merck says the
witness has taken up in furtherance of a
“hostile partisan attack designed to further” his own agenda.
“Given his open and manifest ideological bias, Dr. Egilman should be disqualified from testifying altogether,” the
motion says.
of Dechert in Princeton, N.J., and
Wilfred P. Coronato of Hughes Hubbard
Call (800) 496-4319
Vioxx
Multidistrict Panel Grants
Motion to Create Texas
State Vioxx MDL
AUSTIN, Texas — A Multidistrict
Litigation Panel in Texas has granted a
motion by Merck & Co. to transfer
approximately 50 Vioxx cases to a single,
state court district judge. In Re: Vioxx
Litigation, No. 05-0436 (Texas Sup. Ct.).
The Supreme Court’s MDL panel granted the motion Aug. 25, more than two
months after the drug manufacturer filed
a Rule 13 motion to consolidate and
transfer the claims.
In its petition, Merck argued that the
cases all shared common issues of fact
related to the company’s development,
state of knowledge, and pre-and postapproval testing of Vioxx. The June 6
petition also noted that nearly all of the
parties involved in the cases had informally endorsed the proposal to create a
state court MDL for Texas Vioxx cases.
9
Merck’s motion also suggested that the
parties were in agreement that the cases
should be transferred to the Harris
County District Court and that they be
assigned to Judge Randy Wilson of the
157th District Court or Judge Tracy
Christopher of the 295th District Court.
The Multidistrict Litigation Panel stated
in its order that it would issue a second
finding at a later date naming the judge
to whom the cases will be transferred.
In the event that a pretrial judge or litigant concludes that additional judges are
needed in the future, the panel will entertain requests to transfer cases to additional judges, the order says.
The order also notes that if the cases that
are ready for trial are not remanded to
the trial court, the panel will consider
complaints from litigation about the
delay and decide whether to grant relief.
Call (800) 496-4319
Order Ref# ART-0509-18
Vioxx
Merck Opposes Plaintiffs’
Motion for Protective Order
Related to Employee Depos
NEW ORLEANS — Merck has filed an
opposition to a motion plaintiffs filed in
the MDL for a protective order preventing the cross-noticing of Merck employee
depositions in the New Jersey coordinated litigation. In re: Vioxx Products
Liability Litigation, MDL Docket No.
1657 (E.D. La.).
The opposition, filed Aug. 16 in the U.S.
District Court for the Eastern District of
Louisiana, states that the plaintiffs’ deci10
sion to seek the protective order directly
contradicts discussions between the parties that occurred during a May status
conference.
Merck also claims that the motion is at
odds with the MDL court’s discovery
orders, specifically Pretrial Order No. 9,
which is designed to promote coordination between state and federal proceedings.
“As both state and federal courts have
recognized, coordinating federal and state
discovery benefits all parties and the
Court by reducing the waste that frequently results from overlapping litigation,” the opposition says.
According to Merck, plaintiffs liaison
counsel agreed to the cross-noticing of
Merck employee depositions during a
May 23 status conference, but now indicate that they were issued without any
prior consultation or discussion between
liaison counsel.
Merck argues that if each deposition were
to be taken separately, it would result in a
waste of resources to the detriment of the
defendant and the plaintiffs.
“This is the type of litigation that calls
out for such discovery coordination
because of the sheer volume of cases in
both state and federal court, and because
plaintiffs in these cases are interested in
virtually the same discovery,” Merck contends.
The defendant also notes that the MDL
plaintiffs’ motion is “particularly odd”
because they are seeking protection from
their own depositions claiming that they
didn’t know about them.
Merck says the plaintiffs contend they
didn’t participate in any discussions
regarding the dates and locations of the
depositions and were only given two
weeks’ notice that they had been crossnoticed.
“However, since Lead Counsel in this
proceeding also serve as lead counsel in
New Jersey, they are the ones who
noticed the New Jersey depositions in the
first place,” Merck asserts. “The fact that
the same counsel are noticing, taking and
seeking protective orders from the same
depositions makes plaintiffs’ effort to circumvent PTO-9 all the more inexcusable.”
The opposition was filed by Phillip A.
Wittmann, Anthony M. DiLeo, Dorothy
H. Wimberly and Carmelite M. Bertaut
of Stone Pigman Walther Wittmann in
New Orleans.
Call (800) 496-4319
Opposition Ref# ART-0509-12
Vioxx
Committees Identify Stroke
Case for Early Trial; No
Trial Date Set
NEW ORLEANS — The MDL plaintiff
and defense steering committees have
reportedly agreed on a stroke case that
could be the second federal Vioxx case to
go to trial. Hofmann v. Merck & Co. Inc.,
et al., No. 05-4103 (E.D. Pa.).
According to a joint status report filed in
the U.S. District Court for the Eastern
District of Louisiana, the two groups
have chosen Hofmann v. Merck & Co.
Inc., a case filed in the Eastern District of
Pennsylvania, as the first stroke case for
early trial. The report says, however, that
the Plaintiffs Steering Committee has
objected to Hofmann being set for trial at
this time.
“The parties continue to meet and confer
to discuss what type of case should be the
second case tried in the MDL and a trial
plan for that case,” the report says.
The announcement comes less than one
month after the committees selected a
heart attack case, Plunkett v. Merck & Co.
Inc., as the first of several thousand federal Vioxx cases now pending in the
Eastern District of Louisiana to be tried.
Plunkett was filed by Evelyn Irvin
Plunkett on behalf of her husband,
Richard, who died of a heart attack in
2001 after taking Vioxx for one month.
Richard Irvin Jr., who managed a wholesale seafood business in Florida, was 53
years old when he died.
Plunkett’s lawsuit was initially filed in
Palm Beach County Circuit Court in
Florida. On Aug. 23, the case was directly filed in the Eastern District of
Louisiana and will be tried beginning
Nov. 28 before Judge Eldon E. Fallon,
who is presiding over MDL 1657.
The Hofmann case, which has not yet
been transferred to MDL 1657, was filed
on behalf of Klaus Hofmann, who took
Vioxx in the days leading up to a stroke
he suffered on Sept. 25, 2000. In addition to suing Merck, Hofmann has also
named numerous Merck researchers as
defendants in the lawsuit.
Hofmann is represented by Thomas R.
Kline, Shanin Specter, Lee B. Balefsky
and Michelle L. Tiger of Kline & Specter
in Philadelphia.
Plunkett is represented by Andy
Birchfield Jr., James Paul Sizemore and
Jere L. Beasley of Beasley, Allen, Crow,
Methvin, Portis & Miles in Montgomery,
Ala.
Documents Are Available
Call (800) 496-4319
Joint Report Ref# ART-0509-09
Hofmann Complaint
Ref# ART-0509-10
Plunkett Complaint Ref# ART-0509-11
Vioxx
Federal Judge Says Texas
Vioxx Medicaid Lawsuit
Belongs in State Court
AUSTIN, Texas — A lawsuit filed by the
State of Texas, seeking reimbursement of
money it paid to include Vioxx in the
state’s Medicaid program, has been
returned to state court after Merck
removed the suit. The State of Texas v.
Merck & Co. Inc., No. 05-606 (W.D.
Texas).
Judge Lee Yeakel of the U.S. District
Court for the Western District of Texas
remanded the case to the Travis County
District Court, rejecting claims by Merck
that the state’s allegations were premised
on alleged violations of federal regulation
and that the State of Texas could not be
considered a party for jurisdiction purposes.
The state sued Merck earlier this year,
alleging that it relied on misrepresentations the manufacturer made regarding
Vioxx when it opted to place the arthritis
drug on Texas’s Medicaid formulary. The
state alleges that Merck concealed or
failed to disclose information about the
cardiovascular dangers associated with
Vioxx and is seeking restitution for the
value of all payments made for Vioxx
prescriptions under the program, plus
additional civil penalties.
Merck removed the case, maintaining
that federal question jurisdiction exists
because Texas’s claims are premised on
allegations that Merck violated regulations set forth and enforced by the FDA
under the authority of the federal Food,
Drug & Cosmetic Act. Merck further
argued that Texas’s petition raises important federal questions related to the country’s Medicaid program and that the
diversity exists because the real plaintiff
in the action is the Texas Health and
Human Services Commission, and not
Texas.
However, Judge Yeakel held that Merck
failed in its attempt to prove the existence of diversity jurisdiction based on
the identity of the named plaintiff being
the state’s Health and Human Services
Commission. Judge Yeakel stated that it
is well-settled that a state is not a citizen
for the purposes of diversity jurisdiction,
and where a state is a party, there can be
no federal jurisdiction.
Similarly, Merck failed to carry its burden
of proving that federal question jurisdiction exists, the judge stated.
“Generally, a suit arises under federal law
if there appears on the face of the complaint some substantial, disputed question of federal law,” Judge Yeakel wrote.
“Here, based on Texas’s state-court petition, Texas clearly has asserted against
Merck only Texas state-law claims under
a Texas statute.”
Additionally, the court noted, the plaintiffs’ petition clearly indicates that the
Medicaid program at issue in the complaint is Texas’s, rather than the federal
Medicaid program.
The State of Texas is represented by
Margaret M. Moore, Mark B. Tobey,
Edward D. Burbach and Patrick J.
O’Connell of the Texas Attorney
General’s Office in Austin, Texas; and
Michael T. Gallagher of Gallagher, Lewis
& Downey in Houston.
Merck is represented by Richard L.
Josephson and Travis J. Sales of Baker
Botts in Houston; and Kevin M. Sadler
of Baker Botts in Austin, Texas.
11
Call (800) 496-4319
Opinion Ref# ART-0509-17
Vioxx
Federal Judge Refuses to
Remand, Then Refuses to Stay
Vioxx Action
SEATTLE — A federal judge recently
refused to stay a Vioxx class action, but
only after ruling that the plaintiffs failed
to show that the case had been wrongly
removed by Merck under the recently
enacted Class Action Fairness Act. Waitt
v. Merck & Co. Inc., et al., No. 05-0759
(W.D. Wash.).
U.S. Judge Robert S. Lasnik of the U.S.
District Court for the Western District of
Washington held July 27 that under the
CAFA, it is the plaintiffs’ burden to
prove that the class action would not be
subject to damage and class member
restrictions imposed by the new law.
Judge Lasnik said the question of
whether it is the plaintiffs’ burden to
show that removal based on the CAFA
was improper is an issue of first impression in federal jurisprudence.
The underlying complaint was filed in
King County Superior Court by Robert
Waitt who is seeking economic damages
from Merck for its alleged failure to
reimburse him the cost of his unused
Vioxx prescription. Waitt also maintains
that Merck refused to return the unused
portion after the company failed to reimburse him.
Merck removed the case to the Western
District and moved to stay the matter
pending a ruling on whether it would be
12
transferred to MDL 1657. Waitt filed a
cross-motion to remand, which Merck
opposed on the ground that such
motions should be considered by the
MDL court.
According to Judge Lasnik, resolution of
the issues raised by Waitt’s motion to
remand turned upon the recently enacted
CAFA, specifically upon whether it places
the burden of proof for the propriety of
removal upon the plaintiff or defendant.
Each party argued it was the responsibility of the other to show that removal was
proper or improper.
Judge Lasnik concluded it was Merck’s
reading of the statute in that it was
Congress’ intent for the CAFA to impose
upon plaintiffs the burden of demonstrating that removal from state court was
improvident.
Waitt’s lone attempt to discharge the burden was to argue that he made a prima
facie showing that his damages would not
meet the $5 million amount-in-controversy requirement imposed by the CAFA
for cases to remain in state court, the
judge said. However, the plaintiff ’s
response failed to include any of the economic damages suffered by the nationwide class he purportedly represents,
Judge Lasnik noted.
“In short, plaintiff has not met his burden; it follows that remand to state court
is inappropriate,” the opinion said.
Similarly inappropriate, Judge Lasnik
ruled, would be deciding that the case
should be stayed based on Merck’s argument that it involves facts similar to
those in cases consolidated in MDL
1657. The judge found that because the
instant matter does not involve allegations of personal injury or claims that
Merck failed to warn of increased health
risks associated with Vioxx, it does not
involve questions similar to cases that are
consolidated in the Eastern District of
Louisiana.
Waitt is represented by Richard Lawrence
Martens of Martens-Ragen in Seattle.
Merck is represented by Douglas A.
Hofmann and Jeffrey Royal Johnson of
Williams, Kastner & Gibbs in Seattle.
NNC Group is represented by Andrew
C. Gauen of Merrick, Hofstedt &
Lindsey in Seattle.
Call (800) 496-4319
Vioxx
Judge Says Distributor May be
Held Liable in Vioxx Case
SACRAMENTO, Calif. — A California
judge has rejected an argument by Merck
& Co. Inc. that a defendant distributor
cannot be held liable for allegedly failing
to warn a Vioxx user of cardiovascular
risks associated with the drug. Martin v.
Merck & Co. Inc., No. 05-750 (E.D.
Calif.).
Judge Lawrence K. Karlton of the U.S.
California said in a remand order entered
Aug. 15 that California courts have never
addressed the issue of whether distributors can be sued for injuries caused by
pharmaceuticals. However, Judge
Karlton stated that the general rule is
that strict liability for failure to provide
adequate warnings runs to distributors as
well as manufacturers, and may also
extend to retailers in California.
“Because California courts have not
specifically addressed the issue, at the
very least, it is an unsettled question of
law,” Judge Karlton wrote. “Therefore,
Merck cannot meet its heavy burden so
as to defeat plaintiff ’s motion to
remand.”
The distributor, McKesson Corp., was
named along with Merck in a lawsuit
filed in state Superior Court by John
Martin, who claims he was injured as a
result of ingesting Vioxx.
Merck removed the lawsuit to federal
court, arguing that McKesson had been
fraudulently joined. According to the
defendant, Martin cannot maintain a
viable claim against McKesson for his
alleged injuries because California law
does not impose a duty to warn on distributors. Martin moved to remand, and
in further support of its removal, Merck
argued that it is good public policy to
apply to distributors the same exemption
from liability in pharmaceutical liability
cases as pharmacists are entitled to under
California law.
Judge Karlton, however, said the parallel
argument fails because California’s public
policy justification for exempting pharmacists from liability in similar circumstances is that pharmacists provide services.
“McKesson, unlike pharmacists, does not
provide the public with an analogous
service. More importantly however, by
relying primarily on public policy arguments, Merck effectively concedes that
such a cause of action is not presently
precluded under California law,” the
judge wrote. “Therefore, Merck fails to
meet its heavy burden to show to ‘a near
certainty’ that McKesson’s joinder was
fraudulent.”
Judge Karlton also rejected Merck’s argument that Martin’s claims cannot stand
because the learned intermediary applies
to absolve distributors such as McKesson
of any potential liability. The judge
noted first that the learned intermediary
doctrine is a defense that courts don’t
usually consider in determining fraudulent joinder. Second, Judge Karlton
commented that where a plaintiff —
such as Martin — alleges that the dangers of the drug were scientifically know-
able to the manufacturer, but that the
doctor wasn’t warned of such dangers, liability may still extend to the manufacturer.
though the plaintiff ’s original complaint
didn’t name Merck as a defendant. Edsall
v. Merck & Co. Inc., No. 05-2244 (N.D.
Calif.).
In the alternative, Merck had argued that
Martin’s motion to remand should be
denied because his general allegations
against both defendants should not be a
substitute for properly pleaded claims
specifically asserted against McKesson.
Merck said Martin’s failure to distinguish
factual allegations against McKesson
amounts to an admission of fraudulent
joinder.
In an Aug. 4 Memorandum and Order,
Judge Marilyn Hall Patel of the U.S.
District Court for the Northern District
of California ruled that because complete
diversity did not exist at the time Merck
was joined to the complaint, and because
severance of the Vioxx-related claims was
not initiated by the plaintiff, the federal
court lacks jurisdiction over the Vioxx
claims.
After reviewing Martin’s pleading and the
factual record established in the case,
Judge Karlton opined that Martin properly alleged viable state law causes of
action against McKesson and, therefore,
remand was warranted.
Plaintiff Mylene Edsall sued several
defendants in Contra Costa Superior
Court for injuries she sustained while
receiving hyperbaric oxygen therapy at a
Walnut Creek, Calif., hospital. When
Edsall filed her complaint, Merck was
not specifically identified as a defendant;
however, it was later revealed in a third
amended complaint that Edsall ingested
Vioxx prior to Merck’s decision to withdraw the drug and was seeking damages
as a result.
Martin is represented by C. Jean Cain,
Clayeo C. Arnold and Clifford Lee
Carter of the Law Office of Clayeo C.
Arnold in Sacramento, Calif.
Merck is represented by Susan B. Altman
of Reed Smith in San Francisco.
Call (800) 496-4319
Vioxx
Plaintiffs’ Case Against Merck
Remanded After Judge Severs
Vioxx Claim
SAN FRANCISCO — The severed
Vioxx-related claims of a woman who
sued Merck after allegedly suffering an
injury in a hyperbaric oxygen chamber
have been remanded to state court even
After learning of the consolidated Vioxx
proceedings in Los Angeles County,
Merck’s co-defendants moved to sever the
claims against them from those asserted
against Merck. A state Superior Court
judge granted the motion and Merck
subsequently removed the action to the
Northern District of California, asserting
jurisdiction on the basis of diversity of
citizenship.
In June, Edsall moved to remand, arguing that there was not complete diversity
at the time Merck was joined as a defendant in the state court action. Edsall also
sought attorneys’ fees associated with the
motion to remand. Merck followed with
its own motion, asking the federal judge
to stay the matter pending a decision by
the Judicial Panel on Multidistrict
Litigation on whether the case would be
transferred to the Vioxx MDL.
13
Judge Patel noted that while the interest
of judicial economy frequently warrants a
stay under circumstances presented by
Edsall’s case, there are some instances
where a motion to remand will raise
questions of fact or law that wouldn’t
otherwise arise in the MDL proceedings.
“In particular, where case-specific issues
of fact or law are raised by a motion to
remand and a defendant has clearly failed
to meet the substantive and procedural
requirements for removing a state court
action, ‘the court should promptly complete its consideration and remand the
case to state court,’” the judge wrote.
Judge Patel said that a cursory examination of Merck’s removal notice revealed
that complete diversity did not exist at
the time Merck’s status as a “Doe” defendant was revealed in the third amended
complaint. Additionally, the state court
order severing Edsall’s claims against
Merck and removing all non-diverse
defendants from the instant action was
issued in response to a motion filed by
Merck’s co-defendants and, therefore, has
no bearing on the issue of jurisdiction,
Judge Patel concluded.
“It is well-established that a change in the
nature of the claims or in the identity of
the parties that occurs after a plaintiff ’s
initial complaint has been filed in state
court will not give rise to removal jurisdiction unless that change came about as
a result of some ‘voluntary’ action taken
by the plaintiff,” the judge said. “As
there is nothing in Merck’s notice of
removal to suggest that plaintiffs did anything to bring about the severance of
their claims against Merck from their
claims against Merck’s co-defendants, the
state court’s order severing those claims
cannot serve as a basis for removing
plaintiffs’ state court action to this
court.”
Judge Patel further refused to award
attorneys’ fees to plaintiffs’ counsel, citing
their “apparent indifference to the out-
14
come of the proceedings.” According to
the judge, Edsall failed to file an opposition to Merck’s motion to stay or to submit a timely reply brief in support of her
motion to remand.
Edsall is represented by Geoffrey Becker
of Lafayette, Calif.
Merck is represented by Kevin Michael
Hara of Reed Smith Crosby Heafey in
Oakland, Calif.; Michael K. Brown and
Thomas J. Yoo of Reed Smith in Los
Angeles; and Steven J. Boranian of Reed
Smith in San Francisco.
Call (800) 496-4319
Memorandum Order
Ref# ART-0509-04
Vioxx
Judge Rejects Merck’s
Fraudulent Joinder, Improper
Misjoinder Arguments
its burden of demonstrating that distributor McKesson Corp. could be found
liable for the plaintiffs’ alleged injuries.
Similarly, Judge Walter held that there
was no misjoinder of plaintiffs because
the case did not include various groups of
plaintiffs suing separate groups of defendants, a prerequisite for a finding of misjoinder under federal law.
The plaintiffs had sued McKesson and
Merck for allegedly causing their Vioxxrelated injuries. Merck removed the case
alleging fraudulent joinder of McKesson
and fraudulent misjoinder of the plaintiffs. The manufacturer had urged the
court in the event that it found no fraudulent joinder of McKesson to sever the
plaintiffs over whom the court has jurisdiction based on complete diversity of
citizenship.
Judge Walter found that the plaintiffs
alleged in their complaint that McKesson
distributed and sold Vioxx and purported
to warn or inform users regarding the
risks associated with the drug, yet concealed information with regard to the
actual dangers “so as to maximize sales
and profits at the expense of the health
and safety of the public.”
LOS ANGELES — A federal judge has
rejected a claim by Merck & Co. Inc.
that several plaintiffs in a California
Vioxx suit were improperly misjoined to
the complaint and that the plaintiffs similarly fraudulently joined a distributor
defendant for the purpose of keeping the
case in state court. Anderson v. Merck &
Co. Inc., No. 05-4036 (C.D. Calif.).
“These allegations clearly connect
Defendant McKesson to Plaintiffs’
alleged injuries,” the judge wrote.
“Although the majority of Plaintiffs’ allegations are stated against all ‘Defendants,’
including McKesson, under the liberal
pleading requirements, such general allegations against all ‘Defendants’ are sufficient to charge Defendant McKesson
with the alleged wrongful conduct.”
In a motion remanding the case to the
Los Angeles County Superior Court,
Judge John F. Walter of the U.S. District
Court for the Central District of
California held that the complaint —
which was filed by plaintiffs from
California, New Jersey and New York —
included allegations sufficient to satisfy
Judge Walter further held that the causes
of action asserted against McKesson are
viable under California law, contrary to
arguments asserted by Merck, which
according to the judge failed to cite any
California case holding that a distributor
cannot be held liable for failure to warn.
Plaintiffs are represented by Brian S.
Kabateck, Richard Kellner and Frank
Eric Marchetti of Kabateck Brown
Kellner in Los Angeles; and Shawn
Khorrami and Patricia L. Mitchell of the
Law Offices of Shawn Khorrami in Van
Nuys, Calif.
Merck is represented by Steven J.
Boranian, Thomas J. Yoo, Michael K.
Brown and Gary Yunchian Chen of Reed
Smith in San Francisco.
Call (800) 496-4319
Celebrex, Bextra
Northern District of California
To Get Celebrex, Bextra MDL
WASHINGTON, D.C. — The Judicial
Panel on Multidistrict Litigation (JPML)
has entered an order transferring nearly
31 cases alleging injuries caused by
Bextra and Celebrex to a single federal
judge in California, HarrisMartin
Publishing is reporting. In re Bextra and
Celebrex Marketing, Sales Practices and
Products Liability Litigation, MDL
Docket No. 1699 (JPML).
According to an order released by the
JPML just minutes ago, one docket
involving personal injury and sales and
marketing claims related to the arthritis
drugs will be overseen by Judge Charles
R. Breyer of the U.S. District Court for
the Northern District of California.
Numerous plaintiffs moved to create
Celebrex and Bextra MDLs after the
FDA requested that Pfizer remove Bextra
from the market due to potentially fatal
side effects, and that the manufacturer
include stricter warnings on Celebrex’s
labeling to indicate the risk of cardiovascular injury. In all, four prospective
dockets were created for products liability
and marketing and sales practices claims,
or a combination of both.
Initially, the moving plaintiffs had
requested that the consolidated docket be
established in the U.S. District Court for
the Eastern District of Louisiana, where
the Vioxx MDL is currently situated.
Others requested that the cases be transferred to federal district courts in
California, Delaware, Florida, New Jersey
and Texas.
Pfizer, which manufacturers Celebrex and
Bextra, opposed centralization of all
products liability actions, but supported
consolidation of the marketing/sales practices cases, urging the judicial panel to
transfer the cases to the U.S. District
Court for the Southern District of New
York.
Opponents had also urged the panel to
separate the dockets because of unique
questions of fact related to each drug or
the type of claims asserted.
According to the JPML order, however,
the actions in all four multidistrict dockets involve common questions of fact and
centralization of the claims as one multidistrict proceeding in the Northern
District of California will serve the convenience of the parties.
The JPML also noted that no suggested
location stood out as the geographic focal
point for the litigation.
“Thus we have searched for a transferee
judge with the time and experience to
steer this complex litigation on a prudent
course,” the order said. “By centralizing
this litigation in the Northern District of
California before Judge Charles R.
Breyer, we are assigning this litigation to
a jurist experienced in complex multidistrict litigation and sitting in a district
with the capacity to handle this litigation.”
Call (800) 496-4319
Celebrex
Pfizer to California Court:
Celebrex is No Vioxx
LOS ANGELES — Pfizer Inc. has filed a
brief in California, asking the judge overseeing the coordination of Vioxx cases
there to sever any claims that also allege
injury caused by ingestion of Celebrex.
Anderson v. Merck & Co. Inc., et al., No.
BC331454 (Calif. Super. Ct., Los
Angeles Cty.).
The Objection to Coordination of
Claims, which Pfizer filed Aug. 29 in Los
Angeles Superior Court, says that allowing the Celebrex claims to proceed in the
coordinated Vioxx proceedings would
only perpetuate the filing of more cases.
“The perception created by a coordination proceeding for products liability
actions that included Celebrex likely
would attract new unmeritorious filings,”
the brief says. “Plaintiffs’ counsel who
have chosen not to file cases at this time
would be tempted to submit cases to a
coordinated proceeding in hopes of piggybacking on existing counsel’s cases.”
Pfizer has been named in a number of
California state court cases where plaintiffs contend they were injured after taking Vioxx and Celebrex. Those cases
have been transferred to Los Angeles, and
consolidated under JCCP 4247, a multidistrict state court coordinated proceeding.
15
However, Pfizer asserts that the Celebrex
claims should be severed from those
involving Vioxx because, among other
things, Celebrex remains on the market
and has been declared by the FDA to be
a safe and effective drug.
Document Is Included
See Page 32 or
Call (800) 496-4319
“Unlike most other products liability
cases previously granted coordination status, Celebrex® is still on the market,”
the objection states. “The FDA has
never required or event requested its
withdrawal from the market. And, no
court or jury in the country has held that
Celebrex® is defective in any regard
(including with regard to its warnings),
or that Pfizer was negligent in any respect
relating to Celebrex®.”
Bextra
According to the objection, plaintiffs’
claims concerning Celebrex do not
involve questions of fact or law common
to those asserted against Vioxx manufacturer Merck & Co. Similarly, the coordinated Vioxx proceedings have been ongoing for years and Pfizer has not had an
opportunity to participate in any of the
discovery activity to date.
“In the absence of common discovery
issues, there would be no value to coordinating the Celebrex® claims in JCCP
4247,” Pfizer contends. “The inclusion
of Pfizer within JCCP 4247 at this point
would require wholesale adjustment to
the Court’s plan for the management of
these coordinated proceedings.”
Pfizer also notes that judges in the federal
Vioxx MDL and the coordinated state
court Vioxx proceedings in New Jersey
have entered orders severing Celebrex
claims and remanding them to their originating courts.
Pfizer is represented by Michael C.
Zellers, Mollie F. Benedict and Peter E.
Schnaitman of Tucker, Ellis & West in
Los Angeles; and Charles Q. Socha, K.
Michele Anderson and Su-Lyn Combs of
Socha, Perczak, Setter & Anderson in
Denver.
16
Pfizer Wants Michigan Law
Applied to Pennsylvania
Bextra Case
PHILADELPHIA — Several defendants
have filed a motion for judgment on the
pleadings in a case filed in Pennsylvania
by a Michigan woman who claims she
suffered blood clots after taking Bextra
and Vioxx. Henderson v. Merck & Co.
Inc., et al., No. 04-5987 (E.D. Pa.).
In a motion filed July 21, the defendants,
led by Pfizer Inc., maintain that the case
has no connection to the Eastern District
of Pennsylvania and should be dismissed
under Michigan law. Michigan has a
statute prohibiting civil lawsuits against
pharmaceutical manufacturers for products that received FDA approval.
Pfizer argues that even if the U.S.
Pennsylvania applies its own state’s law to
the complaint, the majority of plaintiff
Mary Henderson’s claim would nevertheless be precluded by statutes prohibiting
recovery from strict products liability and
punitive damages.
“It is well-settled under Pennsylvania law
… that prescription drugs have been
removed from the realm of Pennsylvania’s
strict liability scheme,” Pfizer contends.
Henderson, a resident of Michigan, sued
Pfizer and several other defendants,
claiming she suffered a series of blood
clots and a heart attack in March 2003
after taking Bextra. Henderson then
switched to Vioxx and again suffered
dangerous blood clots in 2004, he complaint alleges. The lawsuit was eventually
transferred to the Vioxx MDL; however,
all of the non-Vioxx claims were simultaneously severed and remanded to the
Eastern District of Pennsylvania.
Pfizer now argues that Pennsylvania’s
choice of law analysis should dictate that
the laws of Michigan be applied to the
case because only that state’s governmental interests would be impaired if the
forum state’s laws were applied. Because
Michigan prohibits its citizens from
recovering against a drug manufacturer in
tort, the Eastern District would be directly contradicting Michigan’s interest by
allowing the case to move forward in
Pennsylvania, Pfizer says.
On the other hand, the manufacturer
notes, Pennsylvania has no interest in
whether foreign citizens such as
Henderson may recover against foreign
corporations. Regardless, Pennsylvania
law wouldn’t provide Henderson the remedy she seeks either because Pennsylvania
courts have held that the
Commonwealth’s strict liability law doesn’t apply to prescription drugs.
Henderson’s other claims for breach of
warranty, fraud and punitive damages
would similarly fail under Pennsylvania
law because they weren’t pled with sufficient particularity, Pfizer argues.
Henderson, however, contends in an
Aug. 5 Opposition that the case should
not be governed by Michigan law because
it concerns defendants with significant
ties to New York, Delaware, New Jersey
and Pennsylvania.
“Pfizer places great emphasis on the fact
that the plaintiff was a resident of
Michigan, but this completely ignores the
fact that Merck is a Pennsylvania entity,
Pfizer is a Delaware entity with a principal place of business in New York, and
Pharmacia Corporation, Pharmacia &
Upjohn, and G.D. Searle are Delaware
corporations with principal places of
business in New Jersey,” Henderson
argues. “Thus, many states have interests
in this action, and all of these states
(except for Michigan) would find that a
drug manufacturer can be held liable for
injuries caused by its product regardless
of whether there was FDA approval.”
She further contends that Michigan law
would not completely protect the defendants from liability because exceptions to
the immunity statute allow for recovery
where it is shown that the manufacturer
committed fraud to achieve FDA
approval for its product. Pfizer disputes
that claim arguing not only that it denies
any such allegations of fraud, but that
Michigan courts have struck down the
exceptions based on federal preemption
arguments.
As for Pfizer’s argument that the claims
would be similarly dismissed under
Pennsylvania law, Henderson maintains
that the defendants would be subject to
strict liability because the danger complained of was avoidable.
“Where a class of drugs has established,
as a matter of reasonable medical certainty, what the risk of a known side effect is,
and another ‘me-too’ drug is introduced
to the marketplace which substantially
elevates that risk, it cannot be said that
those drugs were ‘unavoidably unsafe.’
With respect to Bextra and Vioxx, the
limitation set forth [by Pennsylvania law]
should not apply,” Henderson’s opposition states.
Henderson also argues that there is sufficient evidence, at this stage in the proceedings, to sustain her causes of action
for fraud, breach of warranty and punitive damages.
Henderson is represented by Scott D.
Levensten and James McHugh of The
Beasley Firm in Philadelphia.
Pfizer is represented by Raymond
Williams and Stephanie Fogel of Piper
Rudnick Gray Cary in Philadelphia.
Documents Are Included
See Pages 36 and 48 or
Call (800) 496-4319
Motion for Judgment
Ref# ART-0509-07
Remicade
Defendants Designate Experts
In Remicade Death Case
COLUMBIA, S.C. — Defendant
Centocor has designated experts in a
wrongful death suit filed by a South
Carolina man whose wife died after being
treated with Remicade. Huff v. Centocor
Inc., et al., No. 04-1279 (D. S.C.).
The Aug. 4 designation filed in the U.S.
District Court for the District of South
Carolina includes three experts who have
been designated to testify at trial.
Centocor has also indicated that it
reserves the right to elicit testimony from
three additional experts, all of them company officials.
Centocor, Johnson & Johnson and
Ortho-McNeil Pharmaceutical Inc. were
all named in a complaint filed in March
2004 by Marcus Huff. Huff alleges that
his wife Elaine was prescribed one infusion of Remicade and subsequently died
after developing mycobacterium avium
complex (MAC) and tuberculosis.
Huff claims the defendants failed to adequately warn physicians and consumers
of Remicade’s association with the risk of
tuberculosis and other infections.
Experts identified by Centocor are Mark
H. DeLegge, M.D., FACG, CNSP of the
Medical University of South Carolina’s
Division of Gastroenerology and
Hepatology in Charleston, S.C.; Grace
McCall Auten, M.D., of Piedmont
Infectious Disease Consultants in
Hickory, N.C.; and Barbara G.
Matthews, M.D., MPH, of BioDirect
Inc. in Silver Spring, Md.
Centocor also indicated that it reserves
the right to elicit testimony from its Vice
President of Medical Affairs, Thomas F.
Schaible; Vice President of Sales &
Marketing, Scott Habig; and Stella S.
Jones, Ph.D., the company’s Vice
President of Regulatory Affairs.
Huff is represented by Fred Thompson of
Motley Rice in Mt. Pleasant, S.C.
J. Drayton Hastie III of Parker Poe
Adams & Bernstein in Columbia, S.C.
are counsel for Centocor, Johnson &
Johnson and Ortho-McNeil. David N.
Allen and John E. Grupp of Parker Poe
Adams & Berstein in Charlotte, N.C.;
and John D. Winter of Patterson Belknap
Webb & Tyler in New York are counsel
for the defendants.
Documents are Available
Call (800) 496-4319 or
Search www.harrismartin.com
Designation Ref# ART-0509-16
Remicade
Iowa Plaintiff Blames
Remicade for Brain Damage
IOWA CITY, Iowa — The mother of
Crohn’s Disease patient has sued the
manufacturer of Remicade, alleging the
biologic therapy was defective and caused
her daughter to suffer severe brain damage. Jennifer Rae Zach, et al. v. Centocor
Inc., et al., No. LACV066002 (Iowa Dist.
Ct., Johnson Cty.).
17
LITIGATION WATCH: ARTHRITIS DRUGS – ONLINE AT WWW.HARRISMARTIN.COM
On July 8, Marjorie Carson-Zach, as
mother and conservator of Jennifer Rae
Zach, filed a lawsuit in the Iowa District
Court for Johnson County against
Centocor Inc., which manufactures and
markets Remicade, and Johnson &
Johnson Inc., which owns Centocor.
Carson-Zach’s allegations include strict
product liability, breach of express and
implied warranties, failure to warn, negligence, misrepresentation, loss of consortium and negligent infliction of emotional distress.
Jennifer Rae Zach was diagnosed with
Crohn’s Disease in July 2002 and was
administered Remicade for treatment of
the disease from approximately July 2002
through April 2004 at the University of
Iowa Hospitals and Clinics.
Centocor designed, manufactured, marketed and sold Remicade for use by
patients with Crohn’s Disease, ankylosing
spondylitis and rheumatoid arthritis.
Carson-Zach asserts that her daughter —
her Crohn’s Disease aside — was in good
health and succeeding as a university student prior to beginning the Remicade
treatment. In July 2003, however, Zach
began to experience “psychological problems,” Carson-Zach says.
According to the complaint, for the
remainder of 2003 and in subsequent
years, Zach sustained severe damage to
her brain, nervous system and body,
resulting in permanent brain damage and
the need for 24-hour care.
In June 2004, Zach was diagnosed with
demyelination of the brain secondary to
Remicade, the lawsuit says. On or about
Aug. 11, 2004, after the University of
Iowa Hospitals and Clinics filed a report
of Zach’s diagnosis with the FDA,
Centocor updated its warning label for
Remicade and cooperated with the filing
of a relevant FDA warning, the complaint alleges.
18
Carson-Zach claims the allegedly defective condition of Remicade was “unreasonably dangerous to users or consumers,
including [Zach], when used in a reasonably foreseeable manner.”
Furthermore, Carson-Zach asserts that
the conduct of the defendants was willful, wanton and in reckless disregard of
the health, safety and rights of plaintiffs,
thereby entitling plaintiffs to punitive
damages in addition to other damages
and costs.
Counsel for the plaintiffs are James L
Pray, Brian P. Rickert and Rebecca A.
Brommel of Brown, Winick, Graves,
Gross, Baskerville and Schoenebaum in
Des Moines, Iowa.
Document is Available
Call (800) 496-4319 or
Complaint Ref# ART-0509-21
Enbrel
Georgia Plaintiff Says Enbrel
Caused Multiple Sclerosis
COLUMBUS, Ga. — A Georgia resident has filed a personal injury and product liability lawsuit involving the product
Enbrel, alleging the drug caused his
development of multiple sclerosis.
Baggett v. Amgen Inc., et al., No. 4-05-cv82 (M.D. Ga., Columbus Div.).
On June 22, David William Baggett filed
suit in the State Court of Muscogee
County (Ga.), claiming that because of
the acts and/or omissions of the defendants, which resulted in Baggett’s use of
Enbrel, he sustained permanent injuries,
including but not limited to multiple
sclerosis. Defendants Amgen Inc.,
Immunex Corp. and Immunex
Manufacturing Corp. removed the case
on July 28 to the U.S. District Court for
the Middle District of Georgia.
Baggett is seeking a trial court judgment
against each of the defendants jointly and
severally for all alleged damages and
injuries. His allegations include strict liability, negligent and intentional misrepresentation, defective design and failure to
warn.
Baggett alleges that the defendants have
marketed or co-marketed Enbrel without
adequately warning of the dangers associated with its use and by overstating the
utility and safety of Enbrel as compared
to those dangers.
Baggett asserts that he was prescribed
self-administered injections of Enbrel
beginning on June 23, 2003, allegedly
without any knowledge of the serious
side effects that Enbrel could cause.
Following his prescription and alleged
proper administration of Enbrel, Baggett
says he began to suffer physical illness
and injury that have caused and will continue to cause pain and suffering, emotional distress, reduction in ability to
enjoy life, as well as economic losses in
earning capacity and medical expenses.
Baggett is represented by Richard A.
Childs in Columbus, Ga.
Counsel for Amgen Inc., Immunex Corp.
and Immunex Manufacturing Corp. are
Jerry A. Buchanan and Benjamin A.
Land of Buchanan & Land in Columbus,
Ga.; Michael L. Kidney of Hogan &
Hartson in Washington, D.C.; and Mark
D. Gately of Hogan & Hartson in
Baltimore. Counsel for Wyeth, Wyeth
Pharmaceuticals Inc. and all purported
Wyeth defendants are Stephen Brooks of
Nelson Mullins Riley & Scarborough in
Atlanta and Michael W. Hogue of Nelson
Mullins Riley & Scarborough in
Columbia, S.C.
Documents are Available
Call (800) 496-4319 or
Complaint Ref# ART-0509-19
Removal Notice Ref# ART-0509-20
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Register Now for HarrisMartin’s
BENZENE LITIGATION CONFERENCE
“Effective Handling of Benzene Cases: The Pros Speak”
Under the direction of conference co-chairs Raphael Metzger and Lawrence Riff, HarrisMartin Publishing has developed an
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2:30 p.m. – 2:45 p.m. Refreshment Break
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2:45 p.m. – 4:00 p.m.
Settling a Benzene Case: The Ethical Minefield
• Representation of Joint Clients
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• Confidentiality Agreements
• Discharging the Duty of Candor during Mediation
Judge Victoria G. Chaney, Los Angeles Superior Court
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Moderator: Diane Karpman, Karpman & Associates,
Los Angeles, CA
8:15 a.m. – 8:30 a.m.
Welcome by Co-Chairs
Plaintiff Co-Chair:
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Defense Co-Chair:
Lawrence P. Riff, Steptoe & Johnson LLP, Los Angeles, CA
8:30 a.m. – 10:00 a.m.
Pure and "Trace" Benzene Cases: The Fundamentals
• In What Settings Do the Cases Arise?
• Who are the Potential Defendants and Potential
Plaintiffs?
• Joint Defense Issues
• How Do the Cases Really Play Out in Court?
Plaintiff Speakers:
Dean Hartley, Hartley & O'Brien, Wheeling, WV
Raphael Metzger, Metzger Law Group, Long Beach, CA
J. Keith Hyde, Provost Umphrey, Beaumont, TX
Defense Speakers:
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Houston, TX
Robert Scott, Abrams, Scott & Bickley, Houston, TX
Lawrence P. Riff, Steptoe & Johnson LLP, Los Angeles, CA
4:00 p.m. – 5:00 p.m.
Primer on Diseases of Blood
• Structure and Function of the Blood Forming Organs
• Hematotoxicity of Benzene
• Genotoxicity of Benzene
• Carcinogenicity of Benzene
Greg Sarna, M.D., FACP (Medical Oncology), Cedar Sinai
Medical Center, Los Angeles, CA
5:00 p.m. – 6:30 p.m.
Networking Cocktail Reception
Day 2, Friday, September 30, 2005
10:00 a.m. – 10:15 a.m. Refreshment Break
7:30 a.m. – 8:30 a.m.
Continental Breakfast
10:15 a.m. – 11:15 a.m.
Benzene Exposure Assessment
• Theories, Data Gaps and Solutions
Herschel Hobson, Ph.D., J.D., Herschel L. Hobson Law,
Beaumont, TX
Dennis Paustenbach, Ph.D., CIH, DABT, ChemRisk, San
Francisco, CA
8:30 a.m. – 9:30 a.m.
The Toxicology and Epidemiology of Benzene
• Cancer Effects
• Non-Cancer Effects
David Pyatt, Ph.D., Summitt Toxicology, Lafayette, CO
Myron A. Mehlman, Ph.D., Mt. Sinai School of Medicine,
New York, NY
11:15 a.m. – 12:00 noon
The Law: Proving Up and Defending Against Liability
• The Legal Theories
• The Legal Defenses
• The Law of Causation
• Expert Opinion Admissibility
• Motion Practice
Denyse Clancy, Baron & Budd, Dallas, TX
Frederick J. Ufkes, Kirkpatrick Lockhart Nicholson Graham
LLP, Los Angeles, CA
9:30 a.m. – 10:30 a.m.
Successful Trial Themes in the Plaintiff and Defense Cases
• Picking the Right Jury
• Identifying the Moral and Emotional Hot Buttons
Angela Abel, DecisionQuest, Atlanta, GA
Tom Girardi, Girardi & Keese, Los Angeles, CA
Robert Scott, Abrams, Scott & Bickley, Houston, TX
12:00 noon – 1:30 p.m. Luncheon
10:45 a.m. – 12:00 noon
Medical Causation: The Synthesis of General
and Specific Causation
Nachman Brautbar, MD, USC, Los Angeles, CA
Joseph Fedoruk, MD, DABT, CIH, Exponent, Irvine, TX
1:30 p.m. – 2:30 p.m.
Managing the Benzene Docket:
The In-House Perspective
Theodore P. Ray, ExxonMobil Corporation, Irving, TX
J. Thomas Deal, Chevron U.S.A. Inc., San Ramon, CA
Richard B. (Burt) Ballanfant, Shell Oil Co., Houston, TX
10:30 a.m. – 10:45 a.m.
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