defense motion - American Tort Reform Association

Transcription

Case 2:12-md-02327 Document 1418 Filed 01/14/15 Page 1 of 4 PageID #: 16792
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
AT CHARLESTON
IN RE ETHICON, INC., PELVIC REPAIR
SYSTEM PRODUCTS LIABILITY
LITIGATION
THIS DOCUMENT RELATES TO ALL
CASES
Master File No. 2:12-MD-02327
MDL 2327
JOSEPH R. GOODWIN
U.S. DISTRICT JUDGE
JOHNSON & JOHNSON’S AND ETHICON’S MOTION TO REVISE CASE
MANAGEMENT PROCEDURES AND FOR DISCOVERY RELATED
TO PLAINTIFF SOLICITATION
During the last several years, the pelvic mesh litigation has continued to aggressively
grow, with nearly one half the cases in this MDL involving only products within the TVT family.
This is a perplexing statistic given the facts that these devices (a) are considered the “gold
standard” for treatment of stress urinary incontinence, (b) have been endorsed by almost every
relevant medical society, and (c) are among the most studied medical devices on the market.
What could account for this incongruity? Johnson & Johnson and Ethicon believe it is, in
part, a direct relationship between the number of filings and the inappropriate, indeed illegal,
solicitation of women by unscrupulous groups and individuals, compounded by ubiquitous
attorney advertising. Numerous women have contacted Johnson & Johnson and Ethicon, upset
about the disclosure of their private medical information and misled into believing Johnson &
Johnson or Ethicon disseminated that information.
Johnson & Johnson and Ethicon feel compelled to inform the Court of these activities,
which include the apparent misuse of women’s private health information protected by HIPAA
(Health Insurance Portability and Accountability Act), and encouraging women to file baseless
lawsuits. These tactics and others detailed in the supporting brief not only threaten the integrity
of the judicial system, but also put women’s health at risk by interfering with the doctor-patient
relationship.
Johnson & Johnson and Ethicon want to rectify this untenable situation so that nonfraudulent cases can be fairly addressed and the illegal solicitation calls stopped. Plaintiffs with
non-fraudulent claims are entitled to their day in court. In order to help effectuate that goal,
Johnson & Johnson and Ethicon proposed mechanisms last year to cull the docket.
The
dramatically different landscape now underscores the need to implement such procedures.
Johnson & Johnson and Ethicon support this motion with the following exhibits:
1. Affidavits (collective exhibit of affidavits).
a.
b.
c.
d.
e.
f.
g.
Affidavit A with attached emails, audio file, and certified transcript of audio file
Affidavit B
Affidavit C
Affidavit D
Affidavit E
Affidavit F
Affidavit G
2. Dickerson and Asbury, “Mesh litigation on the rise, Hellhole report says,” The West
Virginia Record (Dec. 18, 2014).
3. Proposed discovery to MDL plaintiffs.
4. Proposed discovery to MDL counsel.
5. AUGS Final Presidential Blog.
6. Daniel M. Schaffzin, Warning: Lawyer Advertising May Be Hazardous To Your Health!
A Call To Fairly Balance Solicitation Of Clients In Pharmaceutical Litigation, 8
Charleston L. Rev. 319, 330 (Winter 2013-14).
7. BusinessWeek article.
8. A. Liptak, “Competing for Clients, and Paying by the Click,” N.Y. Times (Oct. 15,
2007).
2
9. Brown, Todd, “Specious Claims and Global Settlements,” 42 U. Mem. L.Rev. 559
(Spring 2012).
10. The Silverstein Group, Relentless advertising suggest no end in sight for pelvic mesh
litigation (April 28, 2014).
11. The Silverstein Group, Mass Tort Advertising Report (December 2014).
12. AUGS, Frequently Asked Questions by Providers (March 2014).
13. AUGS, Position Statement on Mesh Midurethral Slings for Stress Urinary Incontinence
(Jan. 3, 2014).
14. The Truth About Vaginal Mesh, health.clevelandclinic.org/ 2013/06/the-truth-aboutvaginal-mesh/.
15. McGovern, Francis, “An Analysis of Mass Torts for Judges,” 73 Tex. L.Rev. 1821
(1995).
Respectfully submitted,
/s/ David B. Thomas
David B. Thomas (W.Va. Bar #3731)
Thomas Combs & Spann PLLC
P.O. Box 3824
Charleston, WV 25338
(304) 414-1807
[email protected]
/s/ Christy D. Jones
Christy D. Jones
Butler Snow LLP
1020 Highland Colony Parkway
Suite 1400
Ridgeland, MS 39157
(601) 985-4523
[email protected]
Counsel for Ethicon, Inc. and Johnson &
Johnson
3
AT CHARLESTON
LITIGATION
MDL 2327
CASES
JOSEPH R. GOODWIN
U.S. DISTRICT JUDGE
CERTIFICATE OF SERVICE
I certify that on January 14, 2015, I electronically filed this document with the clerk of
the court using the CM/ECF system, which will send notification of this filing to CM/ECF
participants registered to receive service in this MDL.
I also certify that on January 14, 2015, a CD containing the audio files which are part of
Exhibit 1, were served upon Plaintiffs’ Liaison Co-Counsel by depositing a true copy thereof in
the regular course of the United States mail, postage prepaid, addressed as follows:
Harry Bell, Esq.
The Bell Law Firm, PLLC
30 Capitol Street
Charleston, WV 25326
Paul T. Farrell, Jr., Esq.
Greene, Ketchum, Bailey, Walker, Farrell & Tweel
419 11th Street
Huntington, WV 25724
Carl N. Frankovitch, Esq.
Frankovitch, Anetakis, Colantonio & Simon
337 Penco Road
Weirton, WV 26062
/s/ David B. Thomas
David B. Thomas (W.Va. Bar #3731)
Case 2:12-md-02327 Document 1418-1 Filed 01/14/15 Page 1 of 48 PageID #: 16796
Exhibit 1
AT CHARLESTON
LITIGATION
CASES
MDL 2327
JOSEPH R. GOODWIN
U.S. DISTRICT JUDGE
Collective audio files, Exhibit 1 to “Johnson & Johnson’s and Ethicon’s Motion to Revise
Case Management Procedures and for Discovery Related to Plaintiffs Solicitation.”
Affidavit A
AFFIDAVIT OF KARI SUTHERLAND, ESQ.
STATE OF MISSISSIPPI
COUNTY OF LAFAYETTTE
KARI SUTHERLAND, first being duly sworn, deposes and states that she is over the age
of 18 years and is a resident of the State of Mississippi and testifies as follows of her own
personal knowledge:
1. I am one of the lawyers for Johnson & Johnson and Ethicon, Inc. in the pelvic mesh
litigation.
2. In early June 20141 received information that a woman named
had left a
message with Johnson & Johnson complaining about phone calls that she had been
receiving concerning pelvic mesh. According to the information conveyed to J&J by Ms.
she never had been implanted with any kind of mesh and thought it was "wrong"
that she was receiving these types of phone calls.
3. I called Ms.
on Monday, June 9,2014, and left her a voicemail.
4. On Tuesday, June 9,1 p
s oke with Ms.
and learned several pieces of information, set
out below. I also emailed her to provide my contact information and a link to my bio.
(Attachment 1, email dated June 10,2014 at 1:47pm).
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
Ms.
is 30 years old and is a nurse.
She never has had mesh implanted.
She resides in
Indiana (Hamilton County).
Her email address is
gmail.com.
She received about 25 phone calls in the month previous to our conversation.
The callers claimed to be from the "U.S. Medical Department"
She advised the callers that she never had undergone amesh implant surgery.
The callers told her she would have to lie in order to get $30,000 - $40,000.
She recorded one of the conversations.
Somehow, the callers knew that she had taken Yaz.
5. I asked Ms.
to send me the recording that she had made. I also asked her to
maintain the original recording. (Attachment 2, email dated June 10, 2014 at 2:06pm).
Page 1 f o2
6. Ms.
responded to me via email and agreed that she would save the recording.
(Attachment 3, email dated June 10, 2014 at 2:23pm).
7. That same day, Ms.
provided me with the recording that she had made of one of the
calls to her concerning pelvic mesh. (Attachment 4, audio file). At my request, she also
subsequently provided the recording to one of my law film's IT specialists.
8. I subsequently had a transcript made of the recording.
transcript).
(Attachment 5, certified
9. Although Ms.
had agreed to execute an affidavit, and had provided additional
information to include in the affidavit, I have not been able to contact her again as of late
June 2014. In one of our last email communications, she indicated that she had an earlier
recording from April 2014 that was consistent with the attached recording. (Attachment
6, email dated June 16,2014 at 5:04pm).
Executed this
day of
2015.
v
KARI SUTHERLAND
COUNTY OF LAFAYETTE
Sworn to nd subsc )ed before me, a N
otary Public in and for the aforesaid State and
County, this
day of
lUidJuA
,2015.
NOTARY PUBLIC
MY COMMI
•%co^
Page 2 of 2
ATTACHMENT 1
From:
Sent:
To:
Subject:
Kari Sutherland <[email protected]>
Tuesday, June 10, 2014 1:47 PM
'
gmail.com'
pelvic mesh litigation [IWOV-ButlerSnow.FID4511479]
Hi
Thanks again so much for speaking with me this afternoon and working with us on hat
t recording.
I really appreciate your help and will definitely be back in touch with you shortly.
My office nformation
i
is below.
My cell phone is
.
And h ere is a link to y bio
m ifyou want to ee
s who you're dealing
with: http://www.butlersnow.com/kari sutheriand.aspx
THANKS,
Kari
Kari L. Sutherland
Butler Snow LLP
Direct: (662) 513-8002
Fax: (662) 513-8001
[email protected]
Butler
•X;
P.O. Box 1138
Oxford, MS 38655-1138
Suite 205
1200 Jefferson Ave.
Oxford, MS 38655
CONFIDENTIALITY NOTE: This e-mail and any attachments may be confidential and protected by legal privilege, if you
are not the intended recipient, be aware that any disclosure, copying, distribution or use of the e-mail or any attachment is
prohibited. If you have received this e-mail in error, please notify us immediately by replying to the sender and deleting
this copy and the reply from your system. Thank you for your cooperation.
CIRCULAR 230 DISCLOSURE; Pursuant to Treasury guidelines, any federal tax advice contained in this communication,
or any attachment, does not constitute a formal tax opinion. Accordingly, any federal tax advice contained in this
communication, or any attachment, is not intended or written to be used, and cannot be used, by you or any other
recipient for the purpose of avoiding penalties that may be asserted by the Internal Revenue Service.
1
ATTACHMENT 2
From:
Sent:
To;
Subject:
Kari Sutherland <[email protected]>
Tuesday, June 10, 2014 2:06 PM
'
gmafl.com'
RE: pelvic mesh litigation [IWOV-ButierSnow.FID4511479]
May imak e another request?
Could you be sure to keep h
t at original recording that you made and not erase/ delete it- even though we now have a
copy and you are sending a copy?
I would appreciate it.
THANKS,
Kari
Kari L. Sutherland
Butler Snow LLP
Direct: (662) 513-8002
Fax: (662) 513-8001
[email protected]
Butler
P.O. Box 1138
Oxford. MS 38655-1138
t: k
N (.') V C
Suite 205
1200 Jefferson Ave.
Oxford, MS 38655
From: Kari Sutherland
Sent: T
uesday, June 10, 2014 i:47 PM
To: '
gm ail.com'
Subject: peivic mesh litigation [IWOV-8utlerSnow.FID4511479]
Hi
t recording,
i reaily appreciate your help and will definitely be back in touch with you shortly.
My office information is below.
My cell phone is
.
And here is a link to my bio ifyou want to ee
s who you're dealing
with: http://www.butiersnow.com/kari sutherland.aspx
THANKS,
Kari
Kari L. Sutherland
Butler Snow LLP
Direct: (662) 513-8002
Fax: (662) 513-8001
[email protected]
B utl ersnow
l
ATTACHMENT 3
From:
Sent:
To:
Subject:
gmail.com
Tuesday, June 10, 2
0 14 2:23 PM
Kari Sutherland
Re: pelvic mesh litigation [IWOV-ButlerSnow.FID4511479]
Kari,
Yes, I' ll definitely keep/save th e video on the iPad. My daughter has a te
n dency to delete thin gs on he
t iPad, but i
stressed the im portance and told her that it's helping other people. (For only 5
yrs he's
oldansold soul, soshe gets it).
Thanks for sending me your bio! Very impressive! I think I definitely gave this info tothe rig ht person for the jo b! I
hope it is very ben eficial to the la wsuit! It's unsettling how some people have no morals or onscious.
c
I'll work on
sending th e vid eo this evening. Let me know ifthe re is anything els e can
I
d o!
Thanks!
Sent from my iPhone
On Jun 1
0 , 2014, at 3:0 6 PM, Kari Sutherland <[email protected]> wrote:
Maymak
I
e another request?
Could you be sure to keep that original recording that you made and not erase/ delete it- even th ough
we now have a co
p y and you are sending a copy?
I would appreciate it.
THANKS,
Kari
Kari L. Sutherland
Butler Snow LLP
Direct: (662) 513-8002
Fax: (662) 513-8001
[email protected]
<image001.gif>
<image002,gif><image003.gif><image004,gi£>
P.O. Box 1138
Oxford, MS 38655-1138
Suite 205
1200 Jefferson Ave.
Oxford, MS 38655
From: Kari Sutherland
Sent: Tuesday, June 10, 2014 1 :47 PM
To: '
@qmail.com'
Subject; pelvic mesh litigation [IWOV-ButlerSnow.FID4511 4793
Hi
t recording.
I really app reciate your help and will definit ely be back in touc h with you shortly.
My office information is belo w.
My cell phone is
.
1
ATTACHMENT 4
PLACEHOLDER FOR AUDIO RECORDING
ATTACHMENT 5
1
AUDIO RECORDING OF
AND A SOLICITOR
2
1
SOLICITOR:
2
are you doing today?
3
:
4
(inaudible) Health Center, how
I’m good.
SOLICITOR:
How are you?
Oh, I’m also fine, thanks for
5
the concern.
6
about
7
don’t worry, you do not have to pay any single
8
penny, a single dollar to anyone.
9
this here again handsome amount of compensation.
10
your
free
medical
compensation
and
you
To receive
Okay.
11
12
actually this call is all
:
So what is this for, what am I
being compensated for?
13
SOLICITOR:
Yeah,
ma’am
actually
we
are
14
helping women who had a surgery in the past and
15
we
16
directly
17
without paying a single penny for that.
18
19
are
helping
from
:
SOLICITOR:
them
the
to
provide
manufacturer
a
of
compensation
the
surgery
Okay?
Okay.
So you told them (inaudible) to
20
believe that you had a medical surgery in your
21
past, am I correct?
22
23
24
25
:
SOLICITOR:
Yes.
Okay.
So with that what kind of
medical surgery you have in your past?
:
But does that make a difference?
3
1
SOLICITOR:
2
:
Sorry?
3
Does that make a difference?
SOLICITOR:
No,
no,
ma’am,
actually,
you
4
know,
5
compensation.
6
receive this 30 up to 40 thousand dollars and
7
then I will go ahead.
8
pursue
9
ahead and help you out?
I
can
this
help
you
for
your
medical
If you are really interested to
medical
10
out
:
So are you interested to
compensation
so
I
go
Well, what -- I guess I’m just
11
wondering what I’m being compensated for.
12
wasn’t any complications.
13
can
SOLICITOR:
There
Ma’am, yeah, we are the -- yeah,
14
because we have the criteria here to receive this
15
medical
16
surgery and for the mesh implant surgery, and I
17
know you never have done this surgery before, but
18
still as a good human being what I can do, I can
19
provide
information
20
surgery
and
21
information only two times on the call, I send to
22
my
23
that’s
24
have to do anything to receive your compensation.
25
Okay?
compensation
counselor
it,
you
and
ma’am,
for
the
about
just
then
apart
bladder
the
have
after
from
sling
bladder
to
to
that
sling
share
my
this
attorney,
you
doesn’t
4
1
2
3
:
But
I’ve
never
had
a
bladder
you
never
sling or mesh surgery.
SOLICITOR:
I
know,
had
4
done this surgery, but if you are interested to
5
receive 30 up to 40 thousand dollars, you just
6
have to tell my compensation officer that I had a
7
bladder
8
complication.
sling
9
10
:
and
after
that
I
had
a
I know, but --
SOLICITOR:
11
12
surgery
:
So I will tell my -That would be lying though.
SOLICITOR:
I do understand, but you have to
13
tell a lie if you want to get the 30 up to 40
14
thousand dollars --
15
16
:
No.
SOLICITOR:
No
one
will
17
thousand dollars like that.
18
lie for that.
19
20
:
:
SOLICITOR:
23
:
25
30,
40
You have to tell a
Can you do this?
No, I will not do that.
22
24
you
Right, but that’s illegal.
SOLICITOR:
21
give
Can you?
That
is
ridiculous,
illegal.
SOLICITOR:
Okay,
bye-bye.
that
is
5
1
2
:
fraud.
3
SOLICITOR:
4
:
5
6
So you are -- I mean this is
Hello?
Yes.
SOLICITOR:
What happened, miss, you don’t
want to lie for the 30 to 40 thousand dollars?
7
:
8
I have morals.
9
so -
10
SOLICITOR:
11
:
No, I don’t want to lie.
I mean
This is fraud, this is illegal,
Ma’am, this is not a scam.
No, it’s a scam because you’re
12
asking me to lie, so if you’re asking me to lie
13
then
14
telling me.
15
is absurd.
16
17
I
don’t
--
who
knows
what
I don’t want any part of this.
SOLICITOR:
:
So I just -What the hell…
18
19
20
21
22
23
24
lies
(WHEREUPON THE AUDIO ENDS)
*************
you’re
This
6
I
CERTIFICATE
2
J
I,
4
a
KELLY SELLERS,
correct
certify that the
transcript
from the
foregoJ-ng
official
5
is
6
electronic sound recordíng of the telephone call
7
on in the above-entitled matter, to the best of
8
my
ability.
9
10
Signed this 6th day of January,
11
t2
13
14
15
t6
t7
18
T9
20
21
22
23
24
25
Wrþ"Å&ee"r-/)
Kelly Sellers, AD/T
544
201-5
ATTACHMENT 6
From:
Sent:
To:
Subject:
gmail.com
Monday, June 16, 20
1 4 5:04 PM
Kari Sutherland
Re: pelvic mesh - dra ft revised affdiavit
Kari,
Sorry it's taken me a ttle
li while to et
g back wit h you! I've been very busy. I'm off of work on Wednesday, so pia
i n on
getting th e affi davit notarized then. (Hopefully this stillgives you plenty of ti
me).
The only de iting I would suggest in the affidavit would be to ad d a little more about me and my career. I thought it
might help th e court see that I'm a credible individual who giv es back to so
ciety through my career.
So, if you want to add a ew
f more deta ils, here they are...
• I'm a gistered
Re
Nurse with a BSN deg ree.
•I've worked for the same health network for 14
years (starting out with an internship in high school)
•I'm a Charge Nurse in ICU .
•
I've wor
ked in (adult) Intensive Care for almost 9 yea
rs.
I'm sure you don't want or eed
n
to add all of that, but thou
I
ght you might want to use some of it.
Also, surprisingly I found the other video that I recorded in April. (I thought my daughter dele ted it). It isn't nea rly as in
depth as the other recording, but it does show consistency, & the
i r attempts to et
g me tofalsify information. If you
want to hear this recording, just let me know! Then you can decide ifyou want to use it. I'm assu ming you probably
will. 1 hope this is even more helpful!
Thanks again!
Sent from my iPhone
On iun 12, 2014, at 0:09
1
AM, KariSutherland <[email protected]> wrote:
Thanks so m
uch for working with us on that recording.
Thomas was able to get th at downloaded and savedl
I've attached a revised draft affidavit for you
r review that deletes th e paragraph with the phone
number.
THANKS,
Kari
Kari L. Sutherland
Butler Snow LLP
Direct: (662) 513-8002
Fax:(662)513-8001
[email protected]
<image001.gif>
<iniage002.gi£><image003.gi£><image004.gif>
l
Supplemental Affidavit of
Kari Sutherland, Esq.
SUPPLEMENTAL AFFIDAVIT OF KARI SUTHERLAND, ESQ.
COUNTY OF LAFAYETTTE
KARI SUTHERLAND, first being duly sworn, deposes and states that she is over the age
of 18 years and is a resident of the State of Mississippi and testifies as follows of her own
personal knowledge:
1. After I executed my affidavit on January 8, 2015,1 received a communication from Ms.
later that afternoon. She indicated that she would execute an affidavit. At the time
COUNTY OF LAFAYETTE
Swornt^rand subscribed before me, a Notary Public in and for the aforesaid State and
County, this y
day of ^JMlUXhdA
, 2015.
NOTARY PUBLIC
MY COMMIT
V\Oec. jo * Pfres /
,*
Page 1 f o1
Affidavit B
AFFIDAVIT OF
STATE OF FLORIDA
COUNTY OF LEON
, first being duiy sworn, deposes and states that she is over the age of
18 years and is a resident of the State of Florida and testifies as follows of her own personal
knowledge:
1. I am 53 years old. I own and operate my own frame shop. I am a resident of
Tallahassee, Florida.
2.
Beginning [date -approximately July 1?] and continuing through today, I have received
numerous calls to my cell phone from callers claiming to be with "American Medical
Services." The callers are trying to get me to sign up for a legal settlement of $30,000$40,000 for bladder sling surgery.
3. Every caller speaks with an Indian accent. All but two of the callers have been men. In
each call, I hear telemarketing noises in the background. It sounds like multiple other
people in the background are also talking on the phone.
4. The callers always provided American-sounding names (such as Jason, Jonathan,
Franklin, etc.) when introducing themselves.
5. Each call starts out with the caller saying they are from American Medical Services. The
caller asks if I ave
h ever had a bladder sling or taken antidepressants. I did have my
gallbladder removed when I was 18 years old, which they apparently knew about from
the beginning since they mentioned it in the first calls. I have since explained to
numerous callers that no, I had my gallbladder removed when I was 18 but I have never
used any of the products they mentioned. The callers emphasize the bladder sling.
6. One of the callers asked me if I had a mother or sister or aunt who had a bladder sling.
7. When I told one caller that I had not used any of the products, he told me not to worry
and that he was going to let her talk to somebody else. He said that other person would
ask me five questions to qualify for the $30-40,000 in settlement money. He said this
other person would give me the answers to these questions.
Page 1 of 3
8. Numerous callers have suggested that I lie to qualify for the money. They frequently say
"wouldn't you like to have $30-40,000." When I tell them I have never had mesh, they
say "that's ok, wouldn't you like $30,000?" I tell them that that would be lying and I am
not entitled to that money. I have had two women call me and both hung up when I said I
was not entitled to the money, while many of the male callers have heard me say that I
am not entitled and stayed on to encourage me to lie.
9. Twice I have been transferred from the initial caller to a second caller who tried to ask
me the same questions. I cut them off and told them if I took that money I would be
stealing, that I am not entitled to it and that to ask me to lie would be wrong. I said this to
other callers as well. When I said this, the callers would frequently hang up on me. One
time I told the caller I would call the police and he hung up on me.
10. The conversation never got far enough that the callers would identify specific attorneys
involved with the settlement.
11.1 was able to call several of the numbers back after receiving the unsolicited calls.
However, I recently attempted to call them back again and the numbers all seem to have
been disconnected.
12.1 have received calls from the following numbers on the following dates and times:
Phone Number
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Page 2 of 3
STATE OF FLORIDA
COUNTY OF LEON
Sworn to and subscribed before me, a Notary Public in and for the aforesaid State and
County, this [% day of /fys
2014.
MY COMMISSION EXPIRES:
si&y.
0''A %
UiSL^J
CHIQUITA MCKNIGHT
MY COMMISSION * FF 070574
EXPIRES: January 17,2018
ThaiMotor/PvbfcUiigew.t£efs
Page 3 of3
Affidavit C
Affidavit D
AFFIDAVIT OF
STATE OF FLORIDA
COUNTY OF MIAMI-DADE
, first being duly sworn, deposes and states that she is over the
age of 18 years and is a er sident of ht e State of Florida and testifies as follows of her own
personal knowledge:
1. I am 52 years old. I am a registered nurse with a master's degree in nursing. I am a
resident of Cutler Bay, Florida.
2. Beginning around January of 2014,1 began receiving unsolicited phone calls to my cell
phone. The callers know my name and tell me that I could receive money from a lawsuit
over vaginal mesh surgery. I have never had vaginal mesh surgery. I have repeatedly
told the callers that I ahve not had the surgery, but they continue to call.
3. When the calls have come in, they frequently do not show a number on caller ID.
Sometimes, they have shown a number that looks foreign.
4. When I eceived
r
the first few calls, I thought it was an accident. I told the callers to take
me off whatever list they had me on. When the calls kept coming, I thought it must be a
scam and started hanging up on the callers.
5. The callers identify themselves as being from different organizations, using names that
suggest they are calling from government agencies. Sometimes they say they are from
the Medical Compensation Department, sometimes the Federal Medical Department.
6. On approximately June 19,2014,1 received one of these calls and asked the caller who
he worked for. He told me he worked for Johnson & Johnson.
7. All of the callers have a thick foreign accent that sounds Indian. The background noises
during the calls make me think they are calling from a call center.
8. The first few calls I received were from a male caller. Then a female caller called me a
several times. Then I began receiving calls from a different male caller.
9. I have asked several times to speak to a supervisor; each time I asked this, my call was
disconnected. The one time I w
as able to speak to a supervisor, the supervisor provided
Page 1 of 2
me with the same English name the initial caller had given me, and when I confronted
him about what an unlikely coincidence it was that he and his employee had the exact
same name, he hung up on me.
10. When the calls first started, I received approximately one phone call a week. Now I
receive approximately one to three calls a month. The calls have come during the day
and late at evening, on weekdays or weekends.
11. On July 16,2014, at 12:13 p.m., I received a similar unsolicited call from a female caller.
My caller ID identified this call as coming from (863) 517-3025.
12. The female caller spoke with an Indian accent. It sounded like she was calling from a
noisy call center. She said she was calling from the Family Health Care Department and
that she was calling about medical compensation.
13. The female caller said that her name was Diana Johnson. I asked her what number I
could call her back at, and she provided (863) 517-3025.
14. The female caller asked me if I or a family member had pelvic mesh, then went through a
list of possible things I or a family member may have had problems with, including
bladder surgery, mesh, Tylenol, steroids, antidepressants, and Risperdal. When I
responded no to all of the above, she said "ok, good bye."
Executed this /
day of
2014.
STATE OF FLORIDA
COUNTY OF MIAMI-DADE
County, this )B day of "DC*-/y
, 2014.
t.
•
KARffT ANN WIIT2
Commission n Y f 19401
Commission Cxpuns
July 08 . 201 7
Page 2 of 2
ARY PUBLIC
Affidavit E
Affidavit F
AFFIDAVIT OF
STATE OF CALIFORNIA
COUNTY OF SAN BERNARDINO
, first being duly sworn, deposes and states that she is over the age of 18
years and is resident
a
of ht e State of California and testifies as follows of her own personal
knowledge:
1. I am 59 years old. I am retired from a civilian law enforcement position and have been a
resident of Rancho Cucamonga, California for approximately 25 years.
2. Beginning around February of 2014,1 began receiving unsolicited phone calls on both
my landline and cellular telephones soliciting my participation in a lcass action lawsuit
related to TVT surgery I ha
d in 2003. The caller asked for me by name and knew I d
ha
undergone the surgery.
3. Each call was from a man with a th
ick accent that sounded Middle Eastern. I am not
certain but I think it was the same man calling each time. He claimed he was calling
from "Medical Healthcare." During other calls, he claimed he was calling from "U.S.
Health Works." Many times, the person calling identified himself as 'Kevin with U.S.
Healthworks."
4. At first I rece
ived a call every few days. The frequency of the calls increased and
sometimes I received two or three calls in a si
ngle day.
5. During the first call, the caller knew my name and knew about my surgeiy. I was very
concerned that someone I did not know had access to my private medical information. I
asked where he got my information. He refused to tell me. From the start of the calls
until June 23, 2014, none of the ca
llers would tell me where they got my medical
information.
6. The caller repeatedly told me I would qualify for a lawsuit if Ineeded an additional
follow-up surgery, had constant pain and discomfort, and my bladder sling did not work.
The caller insisted that I join the class action lawsuit. He said that if I qualified, he would
ralegal to talk b
a out the case. Through several calls, I tol
d the caller
transfer me to a pa
that none of those things were true. In response, he would tell me I didnot qualify and
end the conversation.
Page 1 of 4
7. Approximately one month after I received the first call, I began documenting the time of
the calls and what number appeared on the caller ID.
Date
Time
3/7/2014
3/8/2014
3/8/2014
3/9/2014
3/9/2014
3/11/2014
3/12/2014
3/12/2014
3/13/2014
3/13/2014
3/14/2014
3/21/2014
3/25/2014
3/26/2014
3/26/2014
3/26/2014
3/27/2014
3/28/2014
4/1/2014
4/2/2014
4/2/2014
4/2/2014
4/2/2014
4/3/2014
4/3/2014
4/7/2014
4/18/2014
4/29/2014
5/1/2014
5/2/2014
5/2/2014
6:10 p.m.
10:42 a.m.
1:31p.m.
11:53 a.m.
1:31 p.m.
12:42 p.m.
11:56 a.m.
12:36 p.m.
1:58 p.m.
3:58 p.m.
10:24 a.m.
4:20 p.m.
5:55 p.m.
6:48 a.m.
10:35 a.m.
3:50 p.m.
2:38 p.m.
5:09 p.m.
3:23 p.m.
8:23 a.m.
3:00 p.m.
3:15 p.m.
7:13 p.m.
10:45 a.m.
12:39 p.m.
10:29 a.m.
7:29 a.m.
8:12 a.m.
3:54 p.m.
9:07 a.m.
9:07 a.m.
5/3/2014
5/5/2014
8:00 a.m.
6:45 a.m.
5/7/2014
5/10/2014
5/23/2014
6/3/2014
6/4/2014
2:18 p.m.
11:12 a.m.
11:08 a.m.
11:28 a.m.
1:51 p.m.
Page 2 of 4
Incoming call number on
caller ID
(951) 233-6106
(951)223-6106
(702) 425-5559
(951) 223-6106
(951)223-6106
(305) 507-4567
(626) 985-2357
(727) 493-5888
(786) 522-2805
(951) 223-8842
(202) 666-6110
(305) 507-4567
(909) 184-1544
(562) 453-1414
(562) 453-1414
(561) 345-1818
(201) 214-5452
(909) 117-3122
"Not available"
"International"
"International"
(951) 894-7549
(909) 206-5133
(951)18-5357
(786) 522-9606
(504) 309-6538
(561)345-1818
(561) 345-1818
(909) 154-5625
(909) 206-5139
(909) 206-5139 (immediate
back-to-back calls)
(617)581-1966
"Medical Health, # not
available"
(801)960-2810
(801)960-2810
(786)410-0007
(850) 708-8666
632515455254555
Executed this d\2> day of
JlUli
, 2014.
STATE OF CALIFORNIA
COUNTY OF SAN BERNARDINO
, 2014.
County, this £3 day of OlU V|
i
vmbv
JENNIFER L. H OUGHTON
F
Commission # 2042897 |
Notary P ublic • California z
San B ernardino County |
Page 4 of 4
CALIFORNIA ALL-PURPOSE ACKNOWLEDGMENT
State of California
County of
S(\Y\
0
On
before me, L
. .
Date
.
,
personally appeared
Nams(S) of S igner(s)'
who proved to me on the basis of s atisfactory evidence to
be the personj^ whose namejgf jljkre subscribed to the
within instrument and acknowledged to me that
he/0g$hey executed the samejn his(nep'their authorized
capacity(jes), and that by hi^/ftejv'their signature^ on the
instrument the person^ or the entity upon behalf of
which the person^sf acted, executed the instrument.
JENNIFERL . HOUGHTON
yj
He^e Insert f
Commission # 2042897 Notary P ublic • California |
San Bernardino County
£
1cer tify under PENALTY OF PERJURY under the laws
of the State of California that the foregoing paragraph is
true and correct.
WITNES!
hand and official seal.
Signatur
Place Notary Seal Above
OPTIONAL
Though the information below is not required by law, it may prove valuable to persons relying on the document
and could prevent fraudulent removal and reattachment of this form to another document.
Description of Attached Document
Title or Type of Document:
Document Date:
0*7*
A
f
l
a
t
o
f
' lA)\
Number of Pages:
Signer(s) Other Than Named Above:
Capacity(ies) Claimed by Signer(s)
Signer's Name:
Signer's Name:
• Individual
Corporate Officer — Title(s):
• Individual
•
•
•
•
•
Partner — •Limited • General
Attorney in Fact
Trustee
• Corporate Officer — Title(s):
• Partner — •Limited • General
Top of t humb here
• Attorney in Fact
• Trustee
Guardian or Conservator
• Other:.
• Guardian or Conservator
Signer Is Representing:.
Signer Is Representing:
Top of t humb hers
• Other:
©2007 National Notary Association *9350 De Soto Ave., P.O. Box 2402 • Cha
ts-vorth, CA 91313-2402 «mvw.Nat)ona!Notaryorg Item #5907 Reorder: Call ToO-Free 1-8
00-876-6827
Affidavit G
AFFIDAVIT OF
STATE OF SOUTH CAROLINA
COUNTY OF DARLINGTON
, first being duly sworn, deposes and states that she is over the age of 18
years and is a resident of the State of South Carolina and testifies as of llows of her own personal
knowledge:
1. I have lived in Darlington for approximately 15 years, and lived in the Florence and
Darlington area for approximately 22 years. 1 am
employed as a private caregiver for the
elderly and have previously worked in doctor's office.
2. Beginning approximately in approximately July of 2014 and continuing until
approximately September 1, 2014, I received calls on a daily basis from a man who
identified himself as "Mr. Davis" from the FDA. "Mr. Davis" typically calls between 11
a.m. and 1 p.m.
3. "Mr. Davis" told me that the FDA had a settlement for me for $25,000 from Johnson &
Johnson. "Mr. Davis" said he has been calling women who have had the mesh or the
sling, and said Johnson & Johnson is paying $25,000 to people who have had these
surgeries. He told me he was a mediator between Johnson & Johnson and me. He said
the lawyer he uses is "Albert Lazo."
4. "Mr. Davis" told me that to get the settlement I had to buy a Green Dot Moneypak from
the pharmacy, put $150 on it, and provide him with the number on the back of the card.
He said that once 1 provided him with that information, 1 would receive the settlement
money through Western Union within an hour or so.
5. "Mr. Davis" knew detailed information about surgeries I have had, including detailed
information about a surgery I had last year. I did not provide him with any of that
information and do not know where or how he obtained this information.
6. Almost all of the calls from "Mr. Davis" have come from the phone number (646) 340
8616. One or two calls came from a number that also began (646) 340; I do not have the
rest of he
t number available.
7. "Mr. Davis" speaks with an Indian accent. On one call, I heard someone else talking in
the background; it sounded like that other person was also talking on the phone.
Page 1 f3 o
8. I have called the (646) 340-8616 number and "Mr. Davis" answered the phone and
identified himself as being with the FDA.
9. One time I called the (646) 340-8616 number and another person, who had a lighter
Indian accent than "Mr. Davis," answered the phone and said the accounting office was
closed but would open again in 15 minutes.
10. In approximately August 2014,1 calledAlbert Lazo's office and was told that they do not
have me in their files. I also did a reverse lookup on the phone number (646) 340-8166
and contacted the phone company to let them know that scammers were using the phone
number to try to scam people. I continued to receive daily phone calls from the number
after alerting the phone company.
11. On October 7, 2014, I received a call from the same number from a man identifying
himself as "Eric Miller." This man also spoke with a thick Indian accent. During the
call, I could hear what sounded like another man speaking on a telephone in the
background. "Eric Millers" claimed that he was from New York and was calling from
the FDA on behalf of Johnson & Johnson. He said he was working with Johnson &
Johnson's attorneys. He told me he was working with Albert Lazo law firm. I told him I
thought he was calling from a scam, 1 told hi
m Ithought it was. He asked me to put $150
on a Green Dot Moneypak and said he was not trying to steal that money from me, they
just needed that on the card as a transfer fee. I told him I had talked with Johnson &
Johnson's attorney and knew that he was just a scam.
12.1 asked "Eric Miller" to send me an e-mail to confirm his identity. Shortly thereafter, on
October 7, 2014, I received an e-mail from the e-mail address [email protected]. 1
forwarded a true and accurate copy of the e-mail to an attorney working for Johnson &
Johnson and a true and accurate copy of that e-mail as I forwarded it is attached as
Exhibit A to this Affidavit. Attached to the e-mail was a Microsoft Word document
signed by a 'Teter Williams" and bearing an "FDA" logo. A true and accurate copy of
the substance of that Microsoft Word document is attached as Exhibit B to this Affidavit.
That document was addressed to a
and said that the "company is ready to
pay you 25000$" and lists a "150$" transfer fee that must be paid to receive
compensation.
13. On October 7, 2014,1 called the law offices of Albert Lazo and said I received another
call regarding the mesh lawsuits. The receptionist at the law office said she did not know
what I was talking about and said she documented that I ahd received the solicitation call.
Page 2 of 3
Exhibit A
From:
Sent:
To:
Subject:
Attachments:
Tuesday, October 07, 2014 2:04 PM
Jonathan Skrmetti
Fw: Compensation Approval Letter For B.S.S OR T.V.M
image.png; image.png; approvailetterofB.S.SOrT.V.M.docx
Sent from my LG Mo bile
Original Message
Subject: Compensation Approval Letter For B.S.S OR T.V.M
From: fda gov <[email protected] >
To:
CC:
*Compensation Approval Letter For B.S.S OR T.V.M*
*
*
Approval Number *
Compensation** Amount
*:* *4962SRT*
: 25000$*
This letter is to give you confidential proof of compensation amount of about 25000$, which you are legally
eligible for.
According to your information, you Bladder sling Or Trans vaginal Mesh & suffer from deadly side effect, got
diagnosed in
hospital.
Our company is going to have electronic transaction of compensation amount.
In Order to get your Compensation Amount Call
On 646-340-8616*
#
[image: Inline image 1]
[image: Inline image 2]*
1
Peter Williams
(Manager)
i
Executed this f j /
day of flflJ-nh&iL
, 2014.
STATE OF SOUTH CAROLINA
COUNTY OF DARLINGTON
County, this
I day of /jf'j'/Q/WJ} J , 2014.
/t# //M •
)TARYRTJMIC
NOTARY
PUSmC
Page 3 f3
o
>
Exhibit B
Subject- Approval fetter of Bladder Sling Or Trans Vaginal Mesh Compensation
From: Manager
Peter Williams
To-
4962SBT
Compensation Amount :25008$
This letter is to give you confidential proof of compensation amount of about 25000$, which
you are legally eligible for.
According to your information, you Bladder sling Or Trans vaginal Mesh & suffer from deadly
side effect, got diagnosed in hospital.
Total expense you paid to a doctor is around 3500$ but for side effect that you were suffering
from due to defective mesh or sling which was deadly, company is ready to pay you 25000$.
Our company is going to have electronic transaction of compensation amount.
As you know our company made many expense to fight a case against company in your name
likewise expense of medical records paper work, fee of a lawyer and also transfer chargers for
compensation amount.
in Order toget your Compensation Amount Call On 646-340-8616
Total Expenses:
•
Medical records-200$
•
Lawyer fee-250$
•
Transfer charges-150$
Peter Williams
(Manager)
Exhibit 2
Mesh litigation on the rise, Hellhole report says | West Virginia Record
Page 1 of 2
West Virginia's Legal Journal
Wednesday, December 31, 2014 Last Update: 12/31/14 09:57 am
Home » News »
Email to Friend
Mesh litigation on the rise, Hellhole report says
December 18, 2014 9:22 AM
By CHRIS DICKERSON AND KYLA ASBURY
CHARLESTON – Aside from asbestos claims, mesh litigation has become the largest mass tort and is centered in the U.S. District Court for the Southern
District of West Virginia, according to the latest Judicial Hellholes report released by the American Tort Reform Foundation.
Mesh litigation is also concentrated in Philadelphia, Pa.; Bergen County, N.J.; and Middlesex County, Mass., and is pending in
California, Delaware, Missouri and Texas.
Plaintiffs’ lawyers have filed more than 100,000 product liability claims against mesh manufacturers around the country,
according to the report. More than 60,000 of those claims are pending in the U.S. District Court for the Southern District of
West Virginia before District Judge Joseph R. Goodwin.
In the first ten months of 2014, lawyers spent an estimated $45 million on television advertising regarding mesh litigation,
according to the report.
“Spending on advertising, which was already trending at an astounding $2 million per month for about a year, spiked after one mesh maker announced it
was settling 20,000 lawsuits in late April 2014,” the report states.
The trial bar spent more than $2.5 million on mesh litigation advertising in April, $5.5 million in May, nearly $7.9 million
in June and $8.2 million in July. Spending tapered off in September and October.
Approximately 8,000 television advertisements aired nationwide in May in an attempt to recruit individuals for pelvic mesh
lawsuits, according to the report.
Because of all the mesh litigation and the increase in litigation costs, some manufacturers are halting the sale of their
products and affected women are losing viable treatment options, according to the report.
Goodwin
“The excessive litigation has chilled, if not frozen, medical advancements in this field,” the report states.
No group of medical experts has recommended removing a mesh product from the market or withholding them from
surgeons’ use, according to the report.
” The AUGS and the American College of Ob/Gyn (ACOG) strongly oppose restrictions by state or medical organizations, healthcare systems or insurance
companies that ban currently available surgical options. Instead, they focus on ensuring that doctors appropriately inform their patients of all of the risks
and benefits to the procedures.”
Currently, the Food and Drug Administration is re-evaluating the process it uses to assess pelvic mesh implants and it may reclassify them as a “Class III
device,” which would allow the FDA to require clinical trials that would compare procedures using mesh with those that do not use mesh.
A court-mandated ban on these products could prohibit women from having access to an FDA-accepted option that can
significantly improve their quality of life, according to the report.
There have not been many mesh cases that have gone to trial, considering the amount of cases filed nationwide. In those
few, the outcomes have been inconsistent.
“A few cases have resulted in gigantic awards, while several others have resulted in full defense verdicts,” the report states.
“The key to such results is whether the court conducted a fair trial. As the Judicial Hellholes report has long documented,
Bell
prejudicial court procedures often underlie extraordinary verdicts. That is the case with pelvic mesh litigation.”
In some cases, judges have allowed plaintiffs’ lawyers to introduce inflammatory evidence while precluding defendants
from presenting pertinent information, according to the report. In some cases, judges have even prevented the defendants from telling juries about the
FDA’s process for clearing the devices.
http://wvrecord.com/news/271451-mesh-litigation-on-the-rise-hellhole-report-says
12/31/2014
Mesh litigation on the rise, Hellhole report says | West Virginia Record
Page 2 of 2
“Another prejudicial practice that significantly increases the likelihood of an unwarranted or inflated verdict is the consolidation of multiple cases for trial,”
the report states. “Just as they are in asbestos and pharmaceutical litigation, judges are tempted by plaintiffs’ lawyers to go the consolidation route when
there are thousands of cases on the court docket.”
But consolidation invariably puts court efficiency over the defendants’ due process, according to the report.
The report states that consolidation confusingly mingles evidence by placing the experiences of more than one plaintiff in front of the same jury at the same
time.
“Empirical studies show that multi-plaintiff trials more often result in more and larger plaintiffs’ verdicts than when cases are tried on their individual
merits,” the report states.
Harry F. Bell Jr., a Charleston attorney who is involved on the plaintiffs side of the federal litigation in Charleston, said it’s important to look at the benefits
of an MDL.
“You have to look at MDL litigations as something defendants really like because it provides a great deal of efficiency,” Bell said. “They can manage and
handle claims in such a fashion that it’s far more economical. It’s coordinated. That’s how the whole MDL system works.
“The defendants would prefer to see the cases in federal court in an MDL rather than all of the place.”
Bell also said it’s good for Charleston and West Virginia for MDLs to be assigned here.
“It is a great feather in West Virginia’s cap to have them assigned here,” Bell said. “Many years ago, before the new federal courthouse was built, that was
something Judge (Charles) Haden really wanted to see.
“The MDLs are going to happen somewhere. Why not here? It brings people to the area. The local economy – the hotels, the restaurants, the airport, the
rental car companies – they all appreciate the business.”
As the trial bar looks to squeeze as much profit as possible from mesh litigation, plaintiffs’ lawyers from all over the country are creatively seeking to avoid
federal court jurisdiction, preferring to try their cases before home-state judges or even more plaintiff-friendly courts in other states, according to the report.
“One method plaintiffs’ lawyers use to avoid federal court jurisdiction is to name as a tangential defendant an in-state company that makes a component of
the device in question,” the report states. “This sidesteps the ‘complete diversity’ of citizenship requirement for federal court involvement.”
Some judges have allowed this practice to flourish, according to the report, even as others have recognized these tactics for what they are and dismissed
claims against local defendants that are immune from suit under federal law.
Plaintiffs’ lawyers are also avoiding federal court jurisdiction by filing lawsuits in batches of under 100 plaintiffs.
“This avoids triggering federal jurisdiction as a ‘mass action’ under the Class Action Fairness Act.”
Bell also noted that the mesh litigation awards that have come out of West Virginia have been some of the smallest such awards in the country.
“That goes back to our juries here in West Virginia,” he said. “They’re conservative. They usually end up awarding lower verdicts.”
This entry was posted in Federal Court, News and tagged American Tort Reform Association, Harry F. Bell Jr., Joseph Goodwin, Judicial Hellholes, MDL, mesh litigation. Bookmark the
permalink.
More Stories by Chris Dickerson and Kyla Asbury
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West Virginia Record | West Virginia's Legal Journal
Privacy Policy | Sitemap Copyright © 2014. All rights reserved.
http://wvrecord.com/news/271451-mesh-litigation-on-the-rise-hellhole-report-says
12/31/2014
Exhibit 3
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF WEST VIRGINIA
AT CHARLESTON
IN RE: ETHICON, INC. PELVIC REPAIR
LITIGATION
MDL No. 2327
JOSEPH R. GOODWIN
U.S. DISTRICT JUDGE
This Document Relates to All Cases
DEFENDANTS’ INTERROGATORIES AND
REQUESTS FOR PRODUCTION TO PLAINTIFFS
Defendants Ethicon, Inc. and Johnson & Johnson, pursuant to FED. R. CIV. P. 33 AND 34,
submit these interrogatories and requests for production of documents to Plaintiffs.
In responding to the Interrogatories and Requests for Production of Documents below,
please furnish all information in your possession and the possession of all other persons acting
on your behalf.
Each Interrogatory calls for not only your knowledge, but also all information that is
available to you by reasonable inquiry and due diligence, including inquiry of your agents,
representatives, and attorneys. Each document request calls for documents within your custody
or control, including the custody or control of your agents, representatives, and attorneys.
“Pelvic mesh surgery” means any surgery for the treatment of stress urinary incontinence
or pelvic organ prolapse. It includes, but is not limited to, such terms as “bladder surgery,”
“sling surgery,” “prolapse surgery,” and any other term encompassing pelvic surgery.
An “unsolicited” phone call includes any communication that was not requested, sought,
or specifically invited.
“Advertisement” means all television, print, radio, internet banner ads on non-lawyer
sites, US mail, email, outbound telemarketing, billboard, pamphlet, brochure, DVD and/or CD or
other form of printed, visual, video, audio, electronic or digital communication, advertising or
1
article disseminated by or for plaintiff lawyers or co-counsel firms related to pelvic mesh, stress
urinary incontinence, or pelvic organ prolapse.
“Identify” or “explain” means to provide detailed and specific information about the
subject of the interrogatory, including without limitation: the substance or content of any oral or
written communication, including a complete description of any advertisements; the names of
any person or entities involved; and the date(s) on which any communication, including
advertising, occurred.
ADVERTISEMENT SOLICITATIONS
1.
When did you, or anyone acting on your behalf, first contact a lawyer about your pelvic
mesh surgery?
2.
Had you or anyone else at your house seen a lawyer advertisement about pelvic mesh
before the date you answered in response to Interrogatory No. 1? If so, please identify.
PHONE CALL SOLICITATIONS
3.
Have you or anyone else at your house ever received an unsolicited phone call where
the caller inquired about pelvic mesh surgery? If so, please identify.
PHONE CALLS FOLLOW UP
4.
When did you or anyone else at your house first receive such an unsolicited phone call?
Please identify.
5.
Did the caller encourage you or anyone else at your house to file a lawsuit? If so,
please explain.
6.
Did the caller tell you or anyone else at your house that you or anyone else at your
house was entitled to money? If so, please explain.
7.
Did the caller encourage you (or anyone else at your house) to not be honest in any
respect concerning pelvic mesh? If so, please explain.
8.
Did the caller claim to know medical information about you or anyone else at your
house? If so, please explain.
9.
Did the caller tell you (or anyone else at your house) that he or she was affiliated in any
way with:
2
a. The FDA?
b. Johnson & Johnson?
c. Any lawyer or law firm?
10.
As a result of the unsolicited phone call, did you fill out any sort of questionnaire? If
so, please identify.
11.
As a result of the unsolicited phone call, were you (or anyone else at your house) put
into contact with any lawyer or law firm? If so, please identify.
REQUESTS FOR PRODUCTION
1.
Produce any documents relating in any way to a lawyer advertisement about pelvic mesh
surgery.
2.
Produce any documents relating in any way to an unsolicited phone call concerning
pelvic mesh surgery.
3.
Produce any documents relating in any way to unsolicited written or electronic
communications (other than from your lawyer) concerning pelvic mesh surgery.
4.
Produce any documents referenced in Interrogatory No. 10.
ButlerSnow 24093974v1
3
Exhibit 4
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF WEST VIRGINIA
AT CHARLESTON
IN RE: ETHICON, INC. PELVIC REPAIR
LITIGATION
MDL No. 2327
JOSEPH R. GOODWIN
U.S. DISTRICT JUDGE
This Document Relates to All Cases
DEFENDANTS’ DEPOSITION BY WRITTEN QUESTIONS AND
REQUEST FOR PRODUCTION OF DOCUMENTS
Defendants Ethicon, Inc. and Johnson & Johnson, pursuant to FED. R. CIV. P. 31, 34, and
45, submit this deposition by written questions and requests for production of documents to
MDL counsel of record and request the responses be returned to the Court for en camera review
and a determination as to whether additional investigation is warranted.
“Referral source” means any person or entity from which referrals of potential clients or
plaintiffs were made. This includes, but is not limited to, those persons, groups, entities,
lawyers, law firms or associations that work as call centers, lead generators, intake centers,
retainer management, aggregators, or insurance companies.
“Advertisement” means all television, print, radio, internet banner ads on non-lawyer
sites, US mail, email, outbound telemarketing, billboard, pamphlet, brochure, DVD and/or CD or
other form of printed, visual, video, audio, electronic or digital communication, advertising or
article disseminated by or for plaintiff lawyers or co-counsel firms related to pelvic mesh, stress
urinary incontinence, or pelvic organ prolapse.
“You” includes all lawyers and law firms who have entered an appearance on behalf of
any plaintiff as well as all other lawyers and lawfirms with whom you are associated and who
have a financial interest in any of the MDL cases.
“Identify” or “explain” means to provide detailed and specific information about the
subject of the interrogatory, including without limitation: the substance or content of any oral or
written communication, including a complete description of any advertisements; the names of
1
any person or entities involved; amounts of funding; and the date(s) on which any
communication, including advertising, occurred.
1.
Have you engaged in any direct solicitation of potential plaintiffs in the mesh
litigation? If so, please identify.
2.
Do you have any agreement or other association with any person or entity that has
engaged in any direct solicitation of potential plaintiffs in the mesh litigation? If so,
please identify.
3.
Do you have knowledge of any direct solicitation of potential plaintiffs in the mesh
4.
Have you been associated with any referral source(s) in any manner in the pelvic mesh
5.
Have you funded, directly or indirectly, any advertisements or marketing efforts
concerning the pelvic mesh litigation? If so, please identify.
6.
Do you have any agreement with any third parties related to the funding of the pelvic
mesh litigation? If so, please identify.
REQUESTS FOR PRODUCTION
1.
Produce any documents reflecting the information sought in Deposition Questions
Numbered 1 through 6.
2.
Produce any and all intake records or questionnaires provided to you by a referral source.
ButlerSnow 24094008v1
2
Exhibit 5
AUGS : Blogs : Final Presidential Blog
Page 1 of 1
Final Presidential Blog
By: Charles W. Nager, M.D. on Sep 25, 2014
Dear AUGS members,
It has been my honor to serve as your President this past year. It was a year filled with great progress for AUGS and the subspecialty of Female Pelvic Medicine
and Reconstructive Surgery – launch of the Pelvic Floor Disorders Registry Industry-sponsored sites; continued certification of boarded Female Pelvic Medicine
and Reconstructive Surgeons; first joint meeting between AUGS and IUGA; and a more active role in defining quality outcome measures and guidelines for our
field.
As I step down from this role and Amy Rosenman, MD, steps in as the next AUGS President, my last role is to share with you AUGS’ plans to advocate on behalf
of our patients and ensure their privacy is protected.
Throughout this past year and during the annual meeting in July, AUGS members have expressed their concern for their patients who are being contacted
(usually by phone) by individuals unknown to them asking them personal questions about their gynecologic surgery. Many patients have been appalled that
some person has information about a very intimate personal health matter and details about their vaginal surgery. In many instances they have believed their
physician, the physician’s office, or their local hospital released privacy information about them to some third party. Our investigations have suggested that the
likely source of the release of this information is the insurance company who is either contacting the patient directly by mail or releasing private health information
to a third party subrogation carrier.
As you know, AUGS sent a request for additional information to members on August 27th to understand how prevalent this health privacy violation situation was.
We received 202 responses with 92% indicating that their patients had been contacted by an external source encouraging them to participate in a medical device
lawsuit. The majority (90%) were contacted by phone after their surgery (96%). The caller knew the patient’s name and procedure-specific information. It was less
likely (26%) that they knew the surgeon’s name. Ninety-five percent of you thought AUGS should advocate to protect your patients’ privacy. Ninety-one percent of
you were interested and willing to provide your patients with a fact sheet which provided them with information on how to file a complaint.
During the September Board of Directors Meeting, the Board voted affirmatively to provide providers and patients with a fact sheet that would outline what can be
done to ensure protection of our patients’ privacy, as well as to clarify from where the release of this information is coming. We have developed a downloadable
fact sheet that is included with this message and available on the AUGS Website for providers and the Voices for PFD Website for patients.
I encourage every member to keep an open dialogue with AUGS leadership about concerns you have and/or are hearing concerning violations of patient
information. While AUGS has traditionally been focused on research and education, advocating on behalf of our patients to ensure quality care which includes
patient privacy is an important part of our mission and one which the Board intends to continue to advance.
I want to thank all of you who have contributed to our specialty, our patients, and our society.
Best wishes for you, your loved ones, and your careers.
Sincerely,
Charlie Nager, MD
Released: September 25, 2014, 11:50 am
Keywords:Announcements |
0 Comment(s) — Latest:None
American Urogynecologic Society
2025 M Street NW, Suite 800
Washington, DC 20036
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[email protected]
Support the PFD Research Foundation
http://www.augs.org/p/bl/et/blogaid=209
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in education, research and advocacy.
Contact Us | Privacy Policy | HONcode Accredited
© 2013 American Urogynecologic Society. All rights reserved.
12/31/2014
Exhibit 6
Page 1
Copyright © 2013 Charleston School of Law. All Rights Reserved.
Charleston Law Review
Winter, 2013 - 2014
Charleston Law Review
8 Charleston L. Rev. 319
LENGTH: 17912 words
ARTICLE: WARNING: LAWYER ADVERTISING MAY BE HAZARDOUS TO YOUR HEALTH! A CALL TO
FAIRLY BALANCE SOLICITATION OF CLIENTS IN PHARMACEUTICAL LITIGATION
NAME: Daniel M. Schaffzin*
BIO: * Assistant Professor of Law & Director of Experiential Learning, The University of Memphis Cecil C.
Humphreys School of Law. J.D., 2000, Temple University Beasley School of Law; B.A., 1996, Temple University.
Great thanks go to my wife, Professor Kate Traylor Schaffzin, for her ongoing support of my teaching and scholarship.
Special thanks also go to my fine research assistant, Brandon White, for his many contributions to this article. Lastly, I
offer my genuine thanks to Vinnie Carissimi and my former colleagues in the Health Effects Litigation Group at Pepper
Hamilton LLP. It is a thrill to cite to Vinnie in this article and to express my appreciation for the seeds of inspiration
that he and the Pepper team planted within me many years ago.
LEXISNEXIS SUMMARY:
... Because of this and other risks known to be associated with the drug, the warnings accompanying Pradaxa strongly
advise patients not to stop taking the medication without first talking to medical personnel as doing so might increase
the risk of having a stroke. ... Because of the manner in which lawyers are recruiting clients for mass tort litigation, the
commercial outreach efforts they are undertaking present significant risks of misleading and confusing the already
vulnerable consumers they are attempting to recruit. ... Among 301 patients surveyed, 86% asserted an awareness of
advertisements promoting lawsuits against pharmaceutical companies over a specific drug, and one in five had seen an
advertisement for litigation involving a drug they were taking. ... Shedding further light on the boundaries of
permissible commercial speech when related to professional services, the Court explained: Truthful advertising related
to lawful activities is entitled to the protections of the First Amendment. ... Although the law regulating drug promotion
has never explicitly banned direct advertising to consumers, drug companies historically aimed their promotional efforts
at the physicians who were prescribing their medications. ... In a television commercial, the lawyer should deliver the
disclosures in the form of a major statement that is expressed in language understandable to the reasonable consumer
and presented in a pace, tone, and form (oral or written) consistent with the claims made by the lawyer regarding the
drug at issue.
HIGHLIGHT: COULD THIS HAPPEN TO SOMEONE YOU KNOW? John Jones is a sixty-eight-year-old man
recently diagnosed with atrial fibrillation. n1 To counter the significantly increased risk of stroke associated with this
Page 2
8 Charleston L. Rev. 319, *
condition, n2 John's doctor recently prescribed him the blood-thinning medication Pradaxa. n3 Like other blood
thinners, Pradaxa can cause bleeding. n4 Because of this and other risks known to be associated with the drug, the
warnings accompanying Pradaxa strongly advise patients not to stop taking the medication without first talking to
medical personnel as doing so might increase the risk of having a stroke. n5 During the course of several discussions
about Pradaxa and blood-thinning medications, John's prescribing physician has repeatedly advised John about the
known risks and instructed him not to stop taking Pradaxa before first consulting him.
While watching reruns one weekday morning, John sees a commercial for the law firm Smith & Smith. As the
words "PRADAXA," "FDA," and "WARNING" flash across the screen, a narrator reads the following in an urgent
tone:
Pradaxa users: this is a warning for you. Did you take Pradaxa and experience kidney bleeding, internal bleeding, or a
heart attack? Pradaxa, a blood-thinning drug, was supposed to be a safe anti-coagulant drug. However, reports from the
FDA of Pradaxa side effects are showing a different picture. The FDA has announced new studies that indicate
hundreds of cases of internal bleeding and even death. Originally, Pradaxa studies used by the company to gain FDA
approval suggested only a small increase in the risk of heart attacks with the use of the drug compared to Warfarin. If
you took Pradaxa and suffered from internal bleeding, heart attack, or other complications, then you may be entitled to
financial compensation. So act now as time is limited. Find out if you qualify for compensation. Visit
http://pradaxalawsuit information.com. n6 This website provides information about side effects of Pradaxa and
compensation you may receive. Fill out the online case form now and start your free case evaluation now. Experienced
Pradaxa lawyers will contact you if you qualify for compensation. n7
The commercial included no language advising users of Pradaxa not to stop the medication before consulting a
physician.
John sees this commercial twice during the course of the half-hour television program. Panicked and confused, he
immediately gets on his computer and searches the internet using the phrase "Pradaxa dangerous." n8 Among the first
six search results John views are four links to websites maintained by lawyers or containing advertisements by lawyers
for Pradaxa litigation. n9 Upon surveying several of these websites, John decides that he will stop taking his Pradaxa
prescription and let his doctor know about the decision at his next appointment, scheduled for the next week. n10
TEXT:
[*323]
I. INTRODUCTION
Like John, most Americans need not be anywhere near a doctor's office to face a deluge of information about
pharmaceutical products. A source of significant debate, n11 [*324] pharmaceutical companies spend millions of
dollars a year on direct-to-consumer advertising aimed at promoting drug products and the diseases they are approved to
treat. n12 Just as prevalent, though seemingly less controversial, is a different sort of consumer-targeted advertising
involving the delivery of commercial information about prescription drugs - advertising by law firms seeking clients in
cases alleging the liability of those drug products. n13
While watching television, listening to the radio, and surfing the Internet, the average consumer must make a
conscious effort to avoid the ongoing stream of legal advertisements. A great number of these advertisements caution
and encourage users of prescription drugs to explore possible lawsuits against the companies that make and sell
prescription drugs. n14 Designed to shock the conscience, they employ a common pattern: hurling urgently toned and
prominently positioned sound bites across the media spectrum in a manner that touts the harmful side effects and
Page 3
8 Charleston L. Rev. 319, *324
scientific data undisclosed by profit-hungry drug companies. [*325] The intended effect is to drive the consumer to
contact the advertising lawyer about a potential claim arising from the prescription drug. As exemplified by the
hypothetical case of John Jones, however, the impact of the authoritative - but unqualified - message of the lawyer can
be much more: the consumer, already generally more susceptible by virtue of age or medical condition, loses confidence
in, or simply stops taking, a medication prescribed by his or her physician.
Part II of this article contends that lawyer advertising intended to recruit prescription drug litigants poses a
significant risk to the public's health and should therefore be regulated in a narrowly-tailored manner that protects both
the consumer and the recognized right of attorneys to engage in commercial free speech. Part II fleshes out the asserted
public health risk in three sections. First, in an effort to contextualize the commercial messaging at issue, Part II.A
considers the prevalence of advertising by plaintiffs' lawyers and the inherently self-interested strategies employed by
those lawyers who seek and are ultimately successful in efforts to recruit claimants for pharmaceutical litigation.
Second, Part II.B scrutinizes examples of legal advertising for pharmaceutical claimants across several types of media.
Among other points, the case is made that the content and tone of the messaging communicated by plaintiffs'
pharmaceutical lawyers can frequently render it misleading or confusing when considered from the vantage point of the
consumer. Third, Part II.C details study data and anecdotal evidence demonstrating the adverse impact of legal
advertising for pharmaceutical liability cases on patient compliance and confidence.
In Part III, the article reviews the laws setting existing parameters on permissible legal advertising. Both Supreme
Court jurisprudence impacting legal advertising and pertinent provisions of Model and state ethical rules are considered.
Part IV then prescribes a narrowly tailored solution that honors the substantial governmental interest of protecting the
consumer audience and the recognized commercial speech rights of the attorney advertiser. After a thorough exploration
of federal law and guidance materials governing direct-to-consumer advertising by pharmaceutical companies, it is
proposed that lawyer [*326] advertising for pharmaceutical mass tort claimants should be balanced in a manner akin to
that required of pharmaceutical advertisers. Among other components, lawyers soliciting pharmaceutical litigants
should make a series of clear and prominent disclosures regarding the nature of the commercial speech as advertising;
should refer the consumer to neutral, third-party sources from which more information can be obtained; and should
offer clear instruction to consult with a physician before making any decisions regarding the use of the subject
medication after seeing the advertisement.
II. PREVALENCE OF AND PUBLIC HEALTH RISK ASSOCIATED WITH RECRUTING MASS TORT
PHARMACEUTICAL LITIGANTS
Until the mid-1970s, absolute prohibitions prevented lawyers from advertising their services in any significant form to
the general public. n15 In 1977, however, the Supreme Court struck down a state ban on attorney advertising in Bates v.
State Bar of Arizona, n16 holding that promotion by lawyers was a protected form of commercial free speech. n17 The
more than thirty years since Bates have seen a spectacular increase in attorney advertising across the media spectrum.
n18 Among the most common targets of commercial solicitation by attorneys are tort victims, n19 in particular those
who have been consumers of [*327] prescription medications that have faced the scrutiny of regulators or the scientific
community. n20 Here, it is argued that many of the lawyers searching for plaintiffs willing to sue pharmaceutical
companies use advertising tactics that can both mislead and compromise the well-being of the vulnerable consumers
they are purporting to help.
A. Flood Gates Open: The Prevalence of Attorney Advertising Since Bates and Its Role in the Proliferation of Mass
Tort Pharmaceutical Litigation
Attorneys acted swiftly and decisively on the promotional freedoms sanctioned by Bates and its progeny. n21 In the
decade that followed the Bates decision, one-third of lawyers acknowledged having advertised, with 86% of those
making solicitation through the Yellow Pages and 12% utilizing newspapers. n22 Within fifteen years of the ruling,
attorneys were spending $ 419 million on Yellow Pages advertising, n23 and television advertising by lawyers had
increased from less than $ 100,000 to more than $ 113 million. n24 In 1992 alone, thirteen law firms budgeted more
Page 4
than $ 1 million per year for television promotion. n25
By the year 2000, attorney expenditures on television advertising had increased to approximately $ 236 million.
n26 The start of the twenty-first century also saw lawyers expanding [*328] their promotional strategies to include use
of internet outreach as a supplement to the more traditional forms of television, radio, and print advertising. n27 In
2009, attorneys spent just under $ 500 million on television advertising, approximately $ 102 million on magazine and
newspaper solicitation, and roughly another $ 13 million on radio and internet promotion. n28 A 2012 report issued by
the U.S. Chamber of Commerce's Institute for Legal Reform asserted that trial lawyers are spending more than $ 50
million on Google keyword advertising annually, n29 more than three times the total amount that the 2008 Obama
presidential campaign spent for all online advertising and considerably more than the keyword advertising that Apple
spent on the iPad and iPhone. n30 [*329] In 2010, lawyers spent more than $ 844 million on advertising. n31
While commercial solicitation by lawyers immediately following the Bates decision sought out divorce cases and
estates work, n32 it was not long before personal injury lawyers working on contingency-fee cases became the primary
users of advertising channels. n33 For these practitioners, the freedom to advertise opened the door to the recruitment of
a new category of clients: those who could claim injuries caused by similar exposure to a pharmaceutical product,
medical device, or other product that had been demmed to cause injury. n34 The result was the proliferation of a
refocused brand of mass tort litigation, one that targeted the "dispersed" or "toxic" tort rather than the group claims
arising from a catastrophic accident. n35 By the early 1980s, [*330] mass toxic tort litigation dominated court dockets
n36 and spawned a now well-understood business model that rewards attorneys who can recruit the most claimants in
the most limited period of time. n37
Following the typical paradigm, it is common for lawyers to begin advertising for possible lawsuits within hours of
a report that a marketed drug product has come to be associated with significant consumer injury or negative data. n38
On a rolling basis, the advertising lawyers will evaluate the prospective claims of responding consumers based on
provability of drug exposure, medical records demonstrating related injury, and medical history generally. n39 After
screening out cases deemed to be non-meritorious, the lawyers will then enter contingent-fee [*331] representation
agreements with as many claimants as possible. n40
Once a mass grouping of clients are signed up, the lawyer or firm will likely proceed in one of several ways, all of
which involve an aggregated claims strategy:
. Following what one commentator has called the "wholesaler" approach, the lawyer may hastily move forward
with the filing of a putative class action. n41 Acting swiftly in this regard may create instant publicity that will help to
attract more clients. n42 Being among the first to file a class action may also lead to the lawyer being named lead class
counsel or appointed to a steering committee of plaintiffs' counsel in multi-district litigation situated in or around the
forum where the class action was filed. n43
. Taking a "retailer" approach, the lawyer might alternatively choose to pursue the collected cases individually, but
with an ultimate goal of "bundling" them together for leverage purposes. n44 Here, the strategy will most frequently
involve pre-suit presentation of claims to the potential defendant with the threat of imminent litigation. Proceeding in
this fashion, the lawyer will aim to generate early-term settlement discussions that will commonly join together the
lawyer's stronger claims with those that [*332] might be weaker in terms of causation or damages. n45 If a favorable
settlement is not obtained, the lawyer can then join the claims with a class, if one is certified, or file lawsuits in as many
of the cases as is necessary. n46
. A third, and perhaps most provocative, approach involves the lawyer discontinuing the lawyering role after such
time as the advertising has been placed and the potential claimants have been screened. At that point, the recruiting
lawyer will take the often-significant numbers of claims and refer the same in bulk to lawyers who specialize in mass
tort cases. n47 Usually, the lawyer will make the referral in exchange for some segment of the new lawyer's contingent
fee, if any is recovered, and in reimbursement of other costs expended in pre-referral recruiting and screening of claims.
Page 5
n48 To ensure compliance with ethical obligations, the referring lawyer will often remain involved as the primary client
contact, while the lawyer to whom the cases are referred assumes responsibility for all substantive work. n49
[*333] Regardless of the approach, the immediacy of the advertising and the referral networks tied to this effort
are themselves problematic and raise troubling questions about the potential for harm to the otherwise unassuming
consumer. To wit, in how many cases does the lawyer's drive to be "first to air" with commercials preclude a full and
complete investigation of the negative study data or new warnings giving rise to the purported claims being shopped?
n50 Do the hurried legal advertisers have a plan in place to process the responses they will receive in a manner that will
honor, ethically and otherwise, the prospective clients who are providing those responses? n51 How effectively, if at all,
do the various legal marketing messages communicate to the audience the reality that the sponsoring lawyer will almost
certainly group individual cases together as part of a mass litigation or settlement strategy, or refer those cases to
another law firm that may or may not be sufficiently equipped to handle the cases competently? n52 Is the advertiser a
lawyer, or some other business entity being funded by a lawyer? n53
[*334] Rather than addressing these concerning questions, it has become an expected aspect of mass toxic tort
litigation that plaintiffs' lawyers will pursue aggressive marketing campaigns timed and designed to accumulate - rather
than inform - potential clients. n54 Central to these ads is a theatrical, exaggerated brand of tone and content that further
acts to render the ultimate consumer confused and vulnerable.
B. Dazing and Confusing: How Lawyers Advertise for Mass Tort Pharmaceutical Claims
Today, mass tort lawyers are using every form of media to search for clients. n55 Television campaigns crafted to make
an instantaneous and jolting impact on audience members who see them have long been at the forefront of marketing
efforts undertaken by mass tort lawyers. n56 More recently, the advent of online and social media advertising has
allowed lawyers to increase their reach exponentially and enabled small and less established firms to be more active
participants in mass tort litigation. n57 Because of the manner in which lawyers are [*335] recruiting clients for mass
tort litigation, the commercial outreach efforts they are undertaking present significant risks of misleading and
confusing the already vulnerable consumers they are attempting to recruit.
Perhaps the most recognizable means of recruitment are repetitive television commercials that utilize intimidating
images, harsh phrases, and urgent tones that encourage the viewer to consider potential claims arising from ingestion of
a drug product. n58 Following an all-too-predictable script, the usual commercial presents the plaintiffs' lawyer
speaking authoritatively about new safety information, previously undisclosed by the drug-maker, impacting the
warnings associated with the drug or causing its withdrawal from the market. n59 While the information is delivered,
the name of the drug and the injuries it is being alleged to cause, along with words like "DEATH," "WARNING," and
"DANGER," flash across the screen in bold, enlarged, and colorful fonts. n60 The lawyer, [*336] having delivered the
sound bite that grabs the attention of the viewer, then altruistically invites the viewer to help "you or a loved one who
may have been injured" by seeking out the services of the lawyer's law firm. n61 The viewer is encouraged to call the
law firm immediately because "time may be running out" to preserve the viewer's rights against the drug company. n62
Beyond making use of imperative and sensationalized messaging, plaintiffs' mass tort lawyers also target television
advertising to audiences more likely to be responsive to it. It is well accepted that television advertising soliciting
clients appeals to the unsophisticated and less educated at a disproportionate rate. n63 To further seize on this
vulnerable audience, drug lawyers place their ads to run during the day and late at night, n64 when they are more likely
to reach individuals who are low-income, out of work, infirmed, and elderly. n65 Members of these more [*337]
susceptible target groups are generally not carriers of health and disability insurance or beneficiaries of paid work leave
policies, which makes them more likely to be interested in the timely resolution of claims they perceive as being offered
by the lawyer ads. n66
To expand potential outreach and limit the expense associated with television advertising, lawyers have
increasingly used websites to solicit and screen potential mass tort claimants. n67 Utilizing carefully-planned keyword
Page 6
advertising n68 and strategically-named web addresses (examples include TheActosLawFirm.com, n69
YazLawsuitLawyer.net, n70 and [*338] DangerousDrugs.com n71), lawyers direct the browsing party to legal
advertising sites that purport to offer much more. Commonly, the websites present a dizzying mix of video and other
content offering information about the "side effects" caused by the drug, "warnings" issued or other adverse action taken
by the FDA related to the drug, and changes to the drug's labeling that are characterized as revealing negative data or
drug-related complications previously withheld by the manufacturer. n72 That content is frequently intermingled with
"results" information touting the outcomes obtained by the website sponsors on behalf of other clients. n73 By
providing one-click access to online forms, the sites also invite the viewer to submit contact information necessary to
initiate the screening process. n74 Facebook pages and [*339] Twitter feeds are used by advertising lawyers to drive
viewers to the website. n75
While mass tort lawyers center their commercial messaging to potential clients and subsequent litigation claims
around the allegedly misrepresentative nature of drug company promotional efforts, the marketing tactics they employ
often toe the line between merely sensational and objectively misleading or confusing. In their thirty-second television
spots and website headlines, lawyers authoritatively offer mere pieces of a bigger story, making broad claims about
negative data, serious side effects, and adverse government action, without providing a proper context against which to
weigh those claims. Although they are almost without exception not medically trained, legal advertisers seldom advise
the target consumer to stay on the drug until they are able to talk to a doctor. n76 And rarely, if ever, do they couple
their incomplete warnings with transparent information about the sources supporting their claims or guidance regarding
how to access those sources or disinterested [*340] authorities like the FDA for more information about data,
warnings, or withdrawals. n77
Still, given the prevalence of marketing by mass tort attorneys, today's patients are as (if not more) likely to gather
information about a medication from a legal advertiser as they are from a healthcare professional. n78 Compounding
this reality is the fact that legal advertisers regularly attempt to bury identifying or affiliation information in their
promotional materials, designing materials to masquerade as unbiased news stories n79 or purely informational
resources devoted to patient support. n80 In some cases, the advertising fails to tell the consumer who the lawyer is, if it
is in fact a lawyer, doing the advertising. n81 Similarly, in the cases of lawyers who plan to refer [*341] some or all of
the cases they successfully recruit, the messaging frequently omits any information about the prospect of referral or only
does so in the fine print. n82
Although they are not healthcare professionals, mass tort plaintiffs' lawyers have, through their vast promotional
undertakings, come to be a threatening part of the doctor-patient dialogue. Under the cover of commercial free speech,
these lawyers speak convincingly to consumers about their serious illnesses and the sophisticated medications that have
been prescribed to treat them. n83 The unfortunate result is that the average consumer is left to fend for himself in the
search for a truth that a lawyer is now professing or promising to disclose. n84 Because that "truth" is often delivered
only in part and generally without any disclosure of the inherently self-interested, ulterior business motives of the
lawyer or law firm to gather as many clients as possible, the already vulnerable consumer is potentially being placed at
even greater risk than that being hyped by the legal advertising at issue.
[*342]
C. The Public Health Risk Posed by "Dangerous Drug" Ads: Assessing the Impact on Patient Decision-Making and
Safety
Anecdotal evidence, in the form of both formal survey data and other first-hand reporting from medical professionals,
supports the argument that widespread advertising for pharmaceutical litigation negatively impacts patient attitudes
toward - and compliance with - physician-prescribed medica-tions. n85 In a 2003 poll commissioned by the U.S.
Chamber Institute for Legal Reform, Harris Interactive interviewed people under medical care n86 about their
awareness of product liability litigation involving specific drugs. n87 Among 301 patients surveyed, 86% asserted an
awareness of advertisements promoting lawsuits against pharmaceutical companies over a specific drug, and one in five
Page 7
had seen an advertisement for litigation involving a drug they were taking. n88 Perhaps more notably, nearly nine out of
ten patients responded that they would be "concerned," with another half expressing that they would be "very
concerned," if they "saw an advertisement [*343] regarding litigation over a drug they were taking." n89 Of those
surveyed, 25% responded that seeing an advertisement making claims about a drug they were taking would cause them
to "stop taking the drug immediately." Another 31% answered that they were "not sure" whether they would stop taking
the drug. n90
In 2007, a similar survey funded by pharmaceutical manufacturer Eli Lilly and jointly sponsored by the National
Council for Community Behavioral Healthcare asked 402 psychiatrists for opinions regarding the effect of lawsuit
advertising on the compliance of patients taking antipsychotic medications. n91 Among respondents, nearly all (97%)
reported having patients who had stopped taking or reduced their dosages of antipsychotic medications. n92 Of these
psychiatrists, 52% attributed the reported medication stoppages or dosage reductions to law firm advertisements about
antipsychotic drugs. n93 Additionally, half of the respondents reported that patient caregivers also asked for switches or
stoppages of antipsychotic medications because of concerns generated by law firm advertisements, even if the loved one
taking the medication was responding positively to treatment. n94
[*344] While survey data offer support for the broad premise that histrionic ads for pharmaceutical litigation can
pose risks to patient safety, those risks become more tangible when considering exactly how individual patients are
making medication-related decisions based on those ads alone. In a blog post entitled "Your Medication Can Kill You;
Call Your Lawyer!," Evan Levine, a cardiologist and Clinical Assistant Professor of Medicine at the Montefiore
Medical Center - Albert Einstein College of Medicine, detailed the nearly catastrophic impression that such an ad made
on one of his patients:
I recently had an encounter with a patient who watched, in shock, a television ad portraying this new drug [Pradaxa,] as
problematic and dangerous. He sat in my waiting room anxiously waiting to see me. He was concerned that I had
prescribed a medication, to prevent a stroke, as a result of his irregular rhythm, that could cause him to hemorrhage to
death. "It's all over the TV," he told me. "I saw it on the commercials. Pradaxa is causing people to bleed to death and I
stopped it. I don't think I should be taking a drug that can make you bleed like that. People are suing too."
He had mistakenly placed himself at risk of a stroke by stopping the drug and spent his time and precious money (cost
of a cab and the visit), to come to my office because he was convinced by a very convincing Madison Avenue ad that he
was taking a dangerous drug. n95
Like many patients with atrial fibrillation, Dr. Levine's patient was elderly and thus likely to be more susceptible to a
sensational ad touting the dangers of a medication treating his condition. n96 For this reason, and because the patient
placed himself at increased danger of stroke and other bleeding-related events for the several weeks he was off Pradaxa,
Dr. Levine lamented that "such ads represent a kind of public health risk." n97
In criticizing the legal advertisements at issue, Dr. Levine did not downplay the fact that Pradaxa, like other
blood-thinning drugs used to treat atrial fibrillation, comes with its own set of [*345] significant risks and will cause
some patients to suffer "horrible bleeds." n98 Still, he expressed his medical opinion that Pradaxa is for many patients a
"better" and "safer" medication than its longer-marketed, historically prescribed alternatives: n99
But the free market is about making money, so there are firms out there putting millions into commercials, fishing for
people who had a bleed while taking the drug (even though it is a known risk for any drug that thins the blood). It may
Page 8
be that some of these people do deserve compensation, but what is clearly dangerous is that these ads seem to be
causing some patients to stop taking critical medications! And if you stop Pradaxa, because you were frightened by
some commercial, you will increase your risk of having a stroke.
Many of the ads would scare me, if I did not know the drug to be an important agent to reduce the risk of stroke. n100
Even within the mass tort plaintiffs' bar, debate exists about the appropriateness of and risk for adverse impact posed by
ill-timed and sensationalized drug advertisements. Among the critics, one well-known mass tort lawyer described the
perils of "exuberant advertising" as follows:
But there is another group who may be damaged ... who are not heard from, as they have no constituency: the people
who see these ads. Having spoken extensively with people who respond to these solicitations (including our own), I
know that there is a group who are frightened unnecessarily by the ads, perhaps stopping a drug that is good for them in
their specific situation. There are also those who have false hopes raise that they will get money - but they never hear
from the Website [*346] again. And there are those who have bona fide medical questions that their busy doctor
doesn't have time to answer and are led by the ad to believe that they will get medical advice if they respond. n101
III. EXISTING PARAMETERS OF PERMISSIBLE LEGAL ADVERTISING
For much of American history, broad ethical prohibitions precluded lawyers from engaging in any advertising or other
commercial solicitation of clients. n102 In the mid-1970s, however, the United States Supreme Court began setting
clearer boundaries around the restrictions that may be imposed on commercial free speech. n103 Among its early
rulings in this area, the Court clarified in Bates v. State Bar of Arizona that blanket bans on legal advertising, as a
category of such speech, are unconstitutional. n104 Although the Court extended constitutional shelter to legal
advertising, it did not then pronounce, and has not subsequently deemed, legal advertising to be immune from
regulation. n105 To the contrary, a survey of more recent Supreme Court jurisprudence on the issue of commercial
speech generally, and legal advertising specifically, makes clear that when advertising by lawyers is false, misleading,
or otherwise presents a threat to the public welfare, it may be limited in a manner that does not compromise
constitutional free speech protections. n106
[*347]
A. Overview of Supreme Court Jurisprudence Impacting Legal Advertising
The protections generally afforded to commercial speech extend from the Supreme Court's 1976 decision in Virginia
State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc. n107 In that case, the Court considered the
constitutionality of Virginia's outright ban on the advertising of prescription drug prices. n108 Among its other public
policy implications, the Court noted that preventing disclosure of the banned price information prevented consumers
from "the alleviation of physical pain or the enjoyment of basic necessities" n109 and encroached upon the public's
capacity to make informed choices about economic policy. n110 Striking down the broad advertising prohibition at
issue, the Court held that a state may not "completely suppress the dissemination of concededly truthful information
about entirely lawful activity, fearful of that information's effect upon its disseminators and its recipients." n111 Again,
however, the Court made explicit that the First Amendment does not shield commercial speech if the speech is false or
misleading. n112 Moreover, the Court repeated the well-established doctrine that lawmakers may restrict the time,
place, and manner of commercial speech "provided that they are justified without reference to the content of the
regulated speech, that they serve a significant government[] interest, and that in so doing they leave open ample
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alternative channels for communication of that information." n113
A year later, in Bates v. State Bar of Arizona, the Court established legal advertising as a category of protected free
[*348] speech when it struck down an Arizona state ban on commercial solicitation by lawyers. n114 In Bates, the
Arizona State Bar initiated disciplinary action against two lawyers who had advertised their legal services in a Phoenix
newspaper. n115 Countering the arguments that the advertising ban at issue furthered the state's interests in mitigating a
decrease in professional lawyering quality n116 and limiting consumer costs that would increase if advertising was
permitted, n117 the Court explained that the legal services being advertised by the disciplined attorneys were routine
ones that could be accurately priced before they were performed. n118 The Court further reasoned that permitting legal
advertising would "be in accord with the bar's obligation to "facilitate the process of intelligent selection of lawyers, and
to assist in making legal services fully available.'" n119 The Court also explained that allowing attorney advertising
would have the impact of facilitating consumer choice, potentially lowering the costs of legal services overall. n120
Rather than banning attorney advertising as a means of protecting the public, the Court offered, "the preferred remedy is
more disclosure, rather than less. If the naivete of the public will cause advertising by attorneys to be misleading, then it
is the bar's role to assure that the populace is sufficiently informed as to enable it to place advertising in its proper
perspective." n121
Ultimately, the Bates Court narrowly held that the State Bar "may [not] prevent the publication in a newspaper of []
truthful advertising concerning the availability and terms of routine legal [*349] services." n122 Although it explained
that "complete suppression" of attorney advertising was unconstitutional, the Court highlighted several restrictions on
legal advertising that might be permitted, including false, deceptive, and misleading advertising, n123 advertising
regarding the quality of legal services not susceptible to measurement or verification, n124 and in-person client
solicitation. n125 The Court also called attention to "the special problems of advertising on the electronic broadcast
media [that] will warrant special consideration." n126
Although not a legal advertising case, in Central Hudson Gas & Electric Corp. v. Public Service Commission of
New York, the United State Supreme Court subsequently explained the test it would utilize moving forward in
evaluating commercial speech restrictions. n127 In Central Hudson, the Court weighed the constitutionality of a
state-wide prohibition against advertising by electric utility companies. n128 To assess the ban, the Court announced a
"four-step analysis for commercial speech": (1) the speech must be neither misleading nor related to unlawful activity
such that it falls within the parameters of First Amendment protections; (2) the state must assert a substantial interest to
be advanced by the desired speech restrictions; (3) the desired restrictions must "directly advance" the asserted state
interest; and (4) the asserted interest must not be attainable by a more limited speech restriction than that being
proposed. n129 Applying these criteria, the Court found that, although Central Hudson held a monopoly over the sale of
electrical service, the advertising fell within the category of protected First Amendment speech because Central Hudson
did face competition from companies offering alternatives to its product and the advertising speech at issue was not
otherwise false or [*350] misleading. n130 While the State was able to demonstrate both its substantial interests in
energy conservation and in keeping electricity costs low for consumers, and that the advertising ban at issue would act
to directly advance its conservation-related interest, the Court ultimately concluded that the State could not show that its
conservation policy could not be protected adequately by more limited regulation than the ban. n131
Going to the heart of the test it was articulating, the Central Hudson Court reminded that "the Constitution ...
accords a lesser protection to commercial speech than to other constitutionally guaranteed expression. The protection
available for particular commercial expression turns on the nature both of the expression and of the governmental
interests served by its regulation." n132
In the first attorney advertising case to apply the standard in Central Hudson, the United States Supreme Court in In
re R.M.J. considered a Missouri restriction that permitted attorneys to advertise in newspapers, periodicals, and the
yellow pages information limited to ten identifiable categories. n133 The attorney challenged the Missouri rule after
facing discipline for, among other violations, describing areas of practice in a manner not permitted under the rule. n134
Shedding further light on the boundaries of permissible commercial speech when related to professional services, the
Page 10
Court explained:
Truthful advertising related to lawful activities is entitled to the protections of the First Amendment. But when the
particular content or method of the advertising suggests that it is inherently misleading or when experience has proved
that in fact such advertising is subject to abuse, the States may [*351] impose appropriate restrictions. Misleading
advertising may be prohibited entirely. But the States may not place an absolute prohibition on certain types of
potentially misleading information, e.g., a listing of areas of practice, if the information also may be presented in a way
that is not deceptive. Thus, the Court in Bates suggested that the remedy in the first instance is not necessarily a
prohibition but preferably a requirement of disclaimers or explanation. Although the potential for deception and
confusion is particularly strong in the context of advertising professional services, restrictions upon such advertising
may be no broader than reasonably necessary to prevent the deception. n135
The Court reiterated that when the commercial speech at issue is not misleading, the State can regulate only where it
can articulate a substantial interest in doing so and the restriction is in proportion to the interest being served. n136
Because the attorney's advertisement was not inaccurate or misleading and the state could demonstrate no substantial
interest advanced by the rule at issue, the Court struck down the prohibition as violating the First and Fourteenth
Amendments. n137
In Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, the United States Supreme Court
weighed the challenge of a lawyer who faced sanctions for his use of a newspaper advertisement that included a picture
of the Dalkon Shield contraceptive device and offered the services of the lawyer related to claims that the device was
alleged to have caused serious injuries to some users. n138 In its complaint underlying the proceedings, the Ohio Office
of Disciplinary Counsel asserted [*352] that the Dalkon Shield advertisement violated an Ohio rule that prohibited the
use of illustrations in attorney advertising and required that the information in such advertising be both "dignified" and
limited to a listing of twenty categories. n139 Again using the Central Hudson test, the Court first determined that
information conveyed through the illustration of the IUD device was neither false nor misleading. n140 The Court then
explained that the State's asserted substantial interest in ensuring that lawyers maintain dignity in their communications
with the public was not sufficient "to justify the abridgment of their First Amendment rights." n141 Ultimately
condemning the broad prohibition supporting it, the Court held that the lawyer's use of an accurate illustration of the
IUD device could not support his reprimand. n142 The Court again emphasized that "because disclosure requirements
trench much more narrowly on an advertiser's interests than do flat prohibitions on speech, "warnings or disclaimers
might be appropriately required ... in order to dissipate the possibility of consumer confusion or deception.'" n143
The Court most recently addressed legal advertising as commercial speech in Florida Bar v. Went for It, Inc. n144
At issue in Went for It was a rule that prohibited lawyers from sending targeted, direct-mail communications to victims
and their relatives within thirty days of an accident or disaster or otherwise accepting referrals received through a
violation of the rule. n145 Upholding the rule, the Court explained that the speech [*353] at issue was neither false nor
misleading but found that the State had properly asserted a "substantial interest both in protecting injured Floridians
from invasive conduct by lawyers and in preventing the erosion of confidence in the profession that such repeated
invasions have engendered." n146 Importantly, the Court placed great weight on the results of a two-year study from
which a 106-page report was generated "containing data - both statistical and anecdotal - supporting" the State's asserted
substantial interest in preventing an erosion of public confidence in lawyers. n147 The Court also deemed the thirty-day
restriction at issue, unlike an outright prohibition of interminable length, to be sufficiently "narrow both in scope and in
duration." n148
B. Model and State Rules of Professional Conduct
Within the framework set forth by the Supreme Court, the ABA Model Rules of Professional Conduct permit lawyers
to advertise. n149 Model Rule 7.2(a) states that "subject to the requirements of Rule 7.1 and 7.3, a lawyer may advertise
Page 11
services through written, recorded or electronic communication, including public media." n150 Rule 7.1 specified that
"[a] lawyer shall not make a false or misleading communication about the lawyer or the lawyer's services," and clarifies
that "[a] communication is false or misleading if it contains a material misrepresentation of fact or law, or omits a fact
necessary to make the statement considered as a whole not materially misleading." n151 With limited exception, Rule
7.3(a) restricts legal advertising "by in-person, live telephone or real-time electronic contact solicit ... when a significant
motive for the lawyer's doing so is the lawyer's pecuniary gain ... ." n152 Generally, Rule [*354] 7.3(c) further requires
an attorney to include the language "Advertising Material" on all packaging of print advertising and at the beginning
and ending of any recorded or electronic communication. n153
Consistent with the Model Rules, every state has adopted ethical rules governing attorney advertising. n154 While
all state rules generally prohibit attorneys from advertising in a manner that is false and misleading, a number of states
now require attorney advertising to include explicit disclaimers and other disclosures designed to protect the consumer.
In Alabama, for example, lawyer advertising must state that "no representation is made that the quality of the legal
services to be performed is greater than the quality of legal services performed by other [*355] lawyers." n155
Likewise, in Missouri, lawyers must accompany advertising with a statement that "the choice of a lawyer is an
important decision and should not be based solely upon advertisements." n156 In other states, rules require that
advertising make clear the geographic location of the office that will provide the advertised services n157 or the
identification of any attorney not affiliated with the advertising firm who has paid for any portion of the advertising
costs. n158 In an effort to ensure compliance with and the intended impact of advertising disclosure requirements,
[*356] many states have incorporated into ethical rules language requiring that all mandated disclosures be displayed
with a prominence at least equivalent to the information about the legal services being advertised. n159
IV. A PRESCRIPTION FOR CHANGE: REQUIRING FAIR BALANCE IN LAWYER ADVERTISING FOR
PHARMACEUTICAL CASES AND CLIENTS
Like advertising for pharmaceutical litigation, promotion by pharmaceutical companies is pervasive. n160 Throughout
the 1990s [*357] and into the first decade of the 21st century, expenditures in pharmaceutical advertising rose
exponentially, increasing from $ 11.4 billion in 1996 to $ 29.9 billion in 2005 to $ 32 billion in 2008. n161 While patent
expiration for certain major drugs appears to have curbed promotional spending in recent years, n162 pharmaceutical
companies still spent more than $ 27 billion to promote their products in 2012. n163
Perhaps the most significant adjustment in pharmaceutical company promotion over the last several decades has
been the shift in focus to direct-to-consumer marketing efforts (DTC). n164 Until the late 1990s, pharmaceutical
companies used DTC advertising in relatively limited ways, relying almost exclusively on print advertisements in
magazines and newspapers. n165 After the FDA issued draft guidelines in 1997 addressing permissible broadcast DTC
advertising, spending on DTC promotion skyrocketed to $ 1.2 billion in 1998, representing a more than three-fold rise
from DTC expenditures just three years before. n166 [*358] In the decade that followed, pharmaceutical company
outlays on promotion to consumers via television and radio commercials, print advertising, and online messaging
continued to swell, exceeding $ 5 billion in both 2006 and 2007 and remaining steady ever since. n167
The prevalence of consumer-directed promotion of pharmaceuticals has sparked an intense debate focused on the
impact that pharmaceutical DTC advertising can and should be permitted to have on American public health and the
doctor-patient relationship. n168 Like proponents of lawyer advertising for mass tort cases, advocates for DTC
promotion tout the positive impact that the spread of information can have on patient education and empowerment, the
relationship between patients and healthcare providers, and patient compliance with and access to medicines. n169
Opponents counter, arguing that pharmaceutical advertising to patients overemphasizes drug benefits, pushes new drugs
before complete safety information is known, encourages inappropriate prescribing and overutilization, increases patient
costs, and ultimately harms the healthcare [*359] provider-patient relationship. n170 While the same commercial free
speech standards protect both DTC advertising by pharmaceutical companies and lawyer solicitation for pharmaceutical
cases, n171 pharmaceutical companies face far greater scrutiny in the form of streamlined regulations requiring
balanced disclosure of risk information in all promotional messaging to a consumer audience. n172 With many of the
Page 12
considerations supporting regulation of DTC advertising, it is time for the implementation of similar restrictions as a
means of mitigating the public health risk posed by direct solicitation of clients in pharmaceutical litigation. n173
A. Federal Regulation of Direct-to-Consumer Promotion by Pharmaceutical Companies
The Federal Food, Drug, and Cosmetic Act (FDCA), enacted in 1938, authorizes the Food and Drug Administration
(FDA) to regulate the advertising of prescription drug products. n174 Section 502(n) of the FDCA, as clarified by the
FDA's implementing regulations, n175 mandates that a prescription drug advertisement must include the established
name of the prescription, the brand name (if any), the formula showing quantitatively each ingredient, and a "true
statement of ... information in brief [*360] summary relating to side effects, contraindications, and effectiveness" of
the product being advertised. n176 In addition to meeting this "brief summary" requirement, the FDCA and FDA
regulations articulate that prescription drug advertisements must not be false and misleading, n177 must not omit
material facts, including information "about the consequences" that can result from the promoted use, n178 and must
present information about the risks and benefits of the drug in a fair and balanced way. n179 The "fair balance"
requirement is met when the drug promotion presents the product's safety risk information in a manner comparable to
the scope, depth, and detail of the information about its effectiveness. n180
Although the law regulating drug promotion has never explicitly banned direct advertising to consumers, drug
companies historically aimed their promotional efforts at the physicians who were prescribing their medications. n181
In 1983, however, a small group of companies began campaigns that included more aggressive marketing to consumers.
n182 In [*361] response to concerns about the appropriateness of marketing to an audience beyond medical providers,
the FDA requested a voluntary moratorium to allow for the agency to consider the boundaries of permissible DTC
advertising. n183 The moratorium concluded in 1985 upon the FDA's placement of a notice in the Federal Register. The
notice confirmed the agency's regulatory jurisdiction over DTC promotion and clarified that the same "fair balance" and
"brief summary" requirements that governed marketing to healthcare providers applied to direct marketing to
consumers. n184
1. Requirements for Risk Disclosure in Print DTC Advertising
To satisfy the brief summary requirement, drug manufacturers using print advertisements in promotion to consumers
historically included the entire section of the approved professional labeling, which included side-effect and warning
information for the drug product. n185 Over time, however, the FDA became more sensitive to the consumer's ability to
understand information that was both voluminous and technical in the full labeling accompanying the print ads. n186 As
a result, the [*362] FDA issued draft guidance in 2004, entitled Brief Summary: Disclosing Risk Information in
Consumer-Direct Print Advertisements, in which the agency clarified three alternative approaches by which
pharmaceutical advertisers can satisfy the brief summary requirements for DTC print ads. n187 Each alternative
requires the drug manufacturer to provide in its print advertisement information on the most serious and most common
risks associated with the product. n188 The first option permits the print advertisement to be accompanied by
FDA-approved patient labeling. n189 Alternatively, the manufacturer can include the approved portion of the patient
labeling including the product risk information. n190 Under the third option, a manufacturer can include in the print
advertisement a "highlights" section with the approved product (physician-intended) labeling rewritten in language
understandable to consumers. n191
[*363]
2. Requirements for Risk Disclosure in Broadcast DTC Advertising
In 1997, the FDA issued a Draft Guidance for Industry: Consumer-Directed Broadcast Advertisements. n192 The draft,
which became final in August 1999, instructs that DTC broadcast promotion for a pharmaceutical product must include
a "thorough major statement" communicating details about the product's most important risks "in consumer-friendly
language." n193 The broadcast advertisement must "not [be] false or misleading in any respect," and, among other
Page 13
means of ensuring truth and clarify, must communicate "that the advertised product is available only by prescription and
that only a prescribing healthcare professional can decide whether the product is appropriate" for the patient. n194
Information about the product's effectiveness and information about the product's safety must be presented in a balanced
fashion. n195 The advertisement must also communicate information about the product's approved uses and limitations
on its use in language understandable to the reasonable consumer. n196
In addition to information that must be explicitly included in the broadcast advertisement, the Guidance specified
that ad sponsors "are also required to present a brief summary or, alternatively, may make "adequate provision ... for
dissemination of the approved or permitted package labeling in connection with the broadcast presentation.'" n197 To
satisfy this "adequate provision" requirement, broadcast advertisers must include reference in the commercial to four
different sources through which the consumer can access complete labeling information for the drug product being
promoted: a toll-free [*364] telephone number, a website address, a concurrently running print advertisement in a
widely-circulated publication, and referral to a physician, pharmacist, or other healthcare provider. n198
3. FDA Guidance Regarding Presentation of Risk Information Generally
More recently, in its 2009 Draft Guidance for Industry, Presenting Risk Information in Prescription Drug and Medical
Device Promotion, the FDA offered detailed insight into its expectations regarding the adequate disclosure of product
risk information in advertisements for drug products. n199 Addressing promotion generally, the Draft Guidance offered
"recommendations" on how to comply with FDA regulations requiring truthful and balanced information about product
safety and efficacy. n200 The agency made clear that while its guidance documents are not legally binding, they
together reflect its current position on how the content and format of a promotional piece contribute to the clear and
accurate communication about product risk. n201
Articulating a broad concern about conveying information in a manner that minimizes product risk, n202 the
agency explained [*365] that its assessment of risk information will focus on the "net impression ... communicated by
all elements of the piece as a whole... . A promotional communication that conveys a deceptive net impression of the
product could be misleading, even if specific individual claims or presentations are not misleading." n203 Notably, the
FDA confirmed that it makes use of a "reasonable consumer standard," similar to that previously adopted by the Federal
Trade Commission, in evaluating promotional materials. n204 Pursuant to this standard, the FDA examines advertising
from the perspective of a reasonable consumer or particular group of consumers acting reasonably in the circumstances.
n205 Moreover, the agency clarified, multiple interpretations of or reactions to a claim are possible if they are all
reasonable, and a violation will be found if any one reasonable interpretation violates regulations because it is false or
misleading. n206
In the Draft Guidance, the FDA elaborated upon and offered examples of several factors - categorized as "general
considerations," "considerations of content," and "considerations of format" - the agency considers in its assessment of
risk information presented in drug and device advertising. n207 Among the general characteristics the FDA considers in
evaluating adequate balance of safety and benefit information are: (1) use of appropriate language for the target
audience; n208 (2) appropriate use of signals (e.g., headlines, change of announcer); n209 [*366] (3) appropriate
framing of risk information (e.g., severity, specificity); n210 and (4) hierarchy of risk information (i.e., most important
risk information should come first). n211
Beyond these general considerations, the Draft Guidance noted the manner in which the FDA considers the
quantity, materiality, and comprehensiveness of the risk information contained in the piece. n212 Regarding quantity,
the FDA will assess the "comparability" of risk and benefit information in a promotional piece by looking to: (1) the
number of statements about benefits and risk; (2) the completeness and depth of detail about benefits and risks; (3) the
amount of time or space devoted to benefits and risks; and (4) the use of components that enhance or distract from the
presentation of risk or benefit information. n213 In assessing materiality, the Guidance clarified that the FDA may
consider a promotional piece that excludes material information about a product's risks to be misleading, even if the
piece dedicates similar space or time to other risk and benefit presentations. n214 To evaluate comprehensiveness, the
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FDA [*367] assesses both the quality and quantity of the risk information in the advertisement at issue. n215
Specifically, the agency will look from the standpoint of the consumer as to whether the piece incorporates the most
relevant risks, including all of the most serious risks. n216
The Draft Guidance also made clear the significance of formatting in the FDA's determination of whether
promotional materials are false and misleading. n217 Importantly, the FDA explained "format" to include "the shape,
size, and general layout of all portions of a print promotional piece, as well as the general plan of organization,
arrangement, and theme in non-print promotional pieces such as videos and broadcast ads." n218 In reviewing print
advertising, the FDA looks to whether risk information is included in the same parts of the piece as the benefit
information. Placement of risk information is problematic if it compromises reader perceptions of the relative
importance or utility of the information. n219 The FDA's evaluation of print promotion will also assess whether there
are substantial differences in font size between risk and benefit information, and, regardless of the font used to display
benefit information, whether the presentation of risk information is in a font that is difficult to read because of size or
style. n220 Although the Draft Guidance recognized the difference in formatting print and non-print advertising, the
FDA noted that in both the contrast between text and background should not highlight benefits more than risk
information. n221 Specifying non-print advertising, the FDA explained that text that is superimposed on other images
or visual components, such as graphics, should be reasonably visible [*368] and should appear on the screen long
enough to be read and understood. n222 Further, visuals used in non-print promotions should not distract from
statements of product risk, and, to this same end, any audio used should be consistent in pace, volume, and articulation
for both risk and benefit information. n223
B. A "Fair & Balanced" Approach to Lawyer Advertising for Pharmaceutical Cases and Claims
In the mad dash for pharmaceutical claimants, many mass tort lawyers have shown a penchant for resorting to any
means necessary to advertise their services. n224 Even presuming for purposes of this analysis that the more
questionable advertisements toe but do not cross the line of providing false and misleading information, the ads
unquestionably and very intentionally bombard a highly-susceptible audience with information that is at best out of
context. Left in a panic, with more questions than answers, the reasonable audience member cannot be faulted for
reacting abruptly with a decision to stop or alter compliance with a medication that may be keeping her alive. Because
of the advertisement, that reasonable audience member may also now have broader doubts about the discretion of her
doctor, who decided to prescribe a "dangerous" medication to her in the first place.
Standing alone, the growing body of anecdotal evidence showing the adverse patient impact caused by advertising
for pharmaceutical litigation gives rise to a substantial governmental interest necessary to enhance existing restrictions
[*369] on such advertising. n225 The need to address the generalized public contempt for lawyer advertising of this
variety provides an additional substantial interest supporting enhanced regulations. n226 Regarding the latter
justification, the United States Supreme Court has recognized that "the interest of the States in regulating lawyers is
especially great since lawyers are essential to the primary governmental function of administering justice, and have
historically been "officers of the courts.'" n227
Taken together, federal law governing direct-to-consumer advertising by pharmaceutical companies and the FDA
regulations and guidance materials informing it provide a framework for the regulation of mass tort legal advertising to
consumers. At the heart of the requirements governing pharmaceutical DTC advertising is the expectation that
promotional messaging will be fairly balanced in its reporting of the drug product's risk-benefit profile. n228 Whether a
particular promotional piece - be it on television, online, or in print - is fair and balanced takes into account numerous
variables, including the substantive content, the relative prominence and positioning of information about efficacy and
safety, and what information might not be included in the piece. n229
[*370] Patterned accordingly, state ethical codes should require all legal advertising for mass tort pharmaceutical
cases to include the following disclosures:
Page 15
. Along the lines of the following, the advertisement should strongly encourage audience members to consult a
healthcare professional with any questions or concerns about the drug product at issue: "You Should Not Stop Taking
[Drug Product] Without Consulting Your Doctor. If You Have Questions About Your or a Loved One's Use of [Drug
Product], Those Questions Should Be Directed to A Doctor."
. If the advertisement includes information about negative data from a study involving the drug, recent changes to
the drug's label, or adverse governmental action related to the drug (e.g., a Department of Justice investigation of a
manufacturer's improper promotion), then the advertisement must offer clear and prominent reference to the source of
the information and direction to the audience about where to go for independent verification and more information. For
example: "For More Information About the Recent Change to [Drug Product's] Label, Go to www.FDA.gov."
. If the advertising attorney or firm contemplates the referral of any solicited claims, then the advertisement should
make the audience clearly aware of that possibility: "Your Case May Be Referred to Another Lawyer or Law Firm,
Who May Perform Legal Services On Your Behalf. If Your Case Is Referred, You Will Be Contacted and Information
About the Referral, Including Information About the Referral Attorney, Will Be Provided to You."
In a television commercial, the lawyer should deliver the disclosures in the form of a major statement that is
expressed in language understandable to the reasonable consumer and presented in a pace, tone, and form (oral or
written) consistent [*371] with the claims made by the lawyer regarding the drug at issue. n230 In print or online
advertising, the lawyer should include the disclosures as part of a brief summary placed with a prominence and
formatted in a style consistent with the drug-related claims. Regardless of the advertising medium, the lawyer should
make explicitly clear, by way of an oral disclosure if in a TV commercial and a prominently displayed proviso if in print
or on a website, that the material being viewed is "ATTORNEY ADVERTISING."
Short of an outright ban, which would almost certainly run afoul of the First Amendment, requiring more fairly
balanced legal advertising by way of the above-described disclosures presents a narrowly-tailored means of affording
both continued commercial speech protections to legal advertisers and enhanced consumer protections to the inherently
more vulnerable audience members on the receiving end of that speech. Where mandating the disclosures will also
likely have the effect of restoring some public trust in the legal profession, they appear to be well-positioned to
withstand any constitutional scrutiny that might come their way under Central Hudson.
V. CONCLUSION
In his lament against the overzealous commercial messaging utilized by some plaintiffs' mass tort lawyers, cardiologist
Evan Levine concluded with the following suggestion:
Perhaps the good lawyers out there should counter this commercial with their own:
If you or your loved one stopped taking Pradaxa, because of a commercial on TV, which inappropriately judged
Pradaxa as a drug that is likely to harm someone, and then suffered a devastating stroke because of this, then call the
law offices of XXX at 1 800 [... .] You may be entitled to compensation from [*372] the law firm who irresponsibly
convinced your loved one to stop taking their medication. n231
Although tongue-in-cheek, Dr. Levine's proposal speaks to the substantial government interests driving the need to
regulate attorney advertising for pharmaceutical mass tort claims more rigorously. It also contemplates the narrowly
tailored manner in which to carry out that regulation.
Page 16
Every day, thousands of people see, read, and hear lawyer advertisements seeking clients who have taken
"dangerous" or "defective" drugs. In order to protect the public, those advertisements must be fairly balanced so as to
remind the consumer that no decisions about use of a medication should be made without first consulting a healthcare
professional. If requiring advertising for pharmaceutical claims to be fairly balanced will save even one life, then the
restrictions suggested in this article should be implemented immediately.
Legal Topics:
For related research and practice materials, see the following legal topics:
Computer & Internet LawTrade Secret ProtectionFormer Employer's CustomersEnvironmental LawLitigation &
Administrative ProceedingsToxic TortsLegal EthicsLegal Services MarketingAdvertising
FOOTNOTES:
n1. "Atrial fibrillation is an irregular and often rapid heart rate that commonly causes poor blood flow to the
body. During atrial fibrillation, the heart's two upper chambers (the atria) beat chaotically and irregularly - out of
coordination with the two lower chambers (the ventricles) ... . Atrial fibrillation symptoms include heart
palpitations, shortness of breath[,] and weakness." Atrial Fibrillation, Mayo Clinic (Feb. 8, 2013),
http://www.mayoclinic.com/health/atrial-fibrillation/DS00291. "Atrialfibrillation is increasingly prevalent
among older adults." Margaret Fang et al., Atrial Fibrillation in the Elderly, 120 Am. J. Med. 481, 481 (2007),
available at http://www.ncbi.nlm.nih.gov/pubmed/17524745. Moreover, atrial fibrillation "causes approximately
24% of strokes in patients aged 80 to 89 years." Id.
n2. Gina Shaw, AFib Treatment: Preventing Clots and Controlling Heart Rate and Rhythm, WebMD (June
21, 2013), http://www.webmd.com/heart/atrial-fibrillation-stroke-11/a-fib-treatments (stating that patients with
atrial fibrillation "have a five times greater risk of suffering a stroke than someone without [the condition]").
n3. Pradaxa, marketed by Boehringer Ingelheim, "is a prescription blood-thinning medicine used to reduce
the risk of stroke and blood clots in people with atrial fibrillation [(AFib)] not caused by a heart valve problem."
Pradaxa, https://www.pradaxa.com (last visited Nov. 10, 2013). According to the American Heart Association,
Medications are often prescribed [to patients with atrial fibrillation] to prevent and treat blood clots[,] which can
lead to a stroke. Additional drugs may be prescribed to control heart rate and rhythm in the [atrial fibrillation]
patient. These medications may also be used in conjunction with other treatments. The heart rhythm can be more
difficult to control. The longer [a patient has] untreated [atrial fibrillation], the less likely it is that normal
rhythm can be reestablished.
Medication options may include blood thinners, rate controllers, and rhythm controllers.
Atrial Fibrillation Medications, Am. Heart Ass'n,
Page 17
http://www.heart.org/HEARTORG/Conditions/Arrhythmia/AboutArrhythmia/Atrial-Fibrillation-Medications_UCM_423781_Art
(last updated Feb. 21, 2013).
n4. Pradaxa's package insert and warnings to consumers make clear that "Pradaxa can cause bleeding[,]
which can be serious and sometimes lead to death." Pradaxa, https://www.pradaxa.com (last visited Nov. 10,
2013). According to the National Blood Clot Alliance, "Blood[-]thinning medications do save lives[] because
they can treat or prevent dangerous blood clots. But, they also pose one possible and very serious side effect:
Bleeding. Since blood thinners slow the clotting of blood, unwanted and sometimes dangerous bleeding can
occur with the use of these medications." Living Your Best Life While Taking Blood Thinners, Nat'l Blood Clot
Alliance, http://www.stoptheclot.org/documents/Nuisance%20Bleeding%20Flye r.NBCA.pdf (last visited Nov.
10, 2013). See also infra note 98.
n5. Pradaxa, supra note 3 (stating, in bold print, not to stop taking Pradaxa without first consulting the
prescribing physician).
n6. While both the law firm and website address in this hypothetical are fictional, the website
"www.pradaxalawsuitinfo.com" does exist as a promotional mechanism owned by the law firm of O'Hanlon,
McCollom & Demerath, the self-proclaimed "Pradaxa Injury Lawyers." See About the Pradaxa Lawsuit,
O'Hanlon, McCollom & Demerath, http://pradaxa lawsuitinfo.com (last visited Nov. 10, 2013).
n7. See Don't File a Pradaxa Lawsuit Until You Read This, Pradaxa Lawsuit,
http://www.pradaxalawsuitsettlements.com (last visited Nov. 10, 2013) (warning Pradaxa patients via YouTube
video using virtually identical language).
n8. See Google, http://www.google.com/#q=pradaxa+dangerous (last visited Nov. 10, 2013) (using
Google's search engine, the author conducted a web search using the phrase "Pradaxa dangerous").
n9. See, e.g., What is Pradaxa, Doyle Raizner L.L.P., http://www.pradaxalitigation.com (last visited Nov.
10, 2013) (inviting reader, on behalf of Houston, Texas-based law firm Doyle Raizner LLP, to view sections
regarding "why Pradaxa is a dangerous drug": "Pradaxa Timeline"; "Potential Claim?"; "Pradaxa Information";
"Why is Pradaxa a Dangerous Drug?"; "Pradaxa Adverse Effects"; and "Why Choose Doyle Raizner?").
n10. See Evan Levine, Your Medication Can Kill You; Call Your Lawyer!, Leftist Rev. (May 19, 2012),
Page 18
http://www.leftistreview.com/2012/05/19/your-medication-can-kill-you-call-your-lawyer/evanlevine/ (noting
patient who, after watching a television advertisement portraying Pradaxa as problematic and dangerous, was
concerned that the author of the article, his doctor, had prescribed a medication that could cause the patient to
hemorrhage to death); see also infra notes 95-100 and accompanying text.
n11. See U.S. Gov't. Accountability Office, GAO-07-54, Prescription Drugs: Improvements needed in
FDA's Oversight of Direct-to-Consumer Advertising 8 (2006) (noting that "the practice of advertising
prescription drugs to consumers has been controversial"). The United States is one of the two countries in the
world (the other being New Zealand) to permit direct-to-consumer advertising by pharmaceutical companies. Id.
Numerous articles have focused on the regulation of direct-to-consumer advertising and the long-standing
debate surrounding its appropriateness. See, e.g., Julie M. Donohue et al., A Decade of Direct-to-Consumer
Advertising of Prescription Drugs, 357 New. Eng. J. Med. 673, 674 (2007), available at
http://www.nejm.org/doi/full/10.1056/NEJMsa070502 ("[The article] examines recent trends in the
[pharmaceutical] industry's use of direct-to-consumer advertising ... , assesses the timing of advertising
campaigns relative to the introduction of drugs in order to shed light on safety issues, and examines trends in the
FDA's regulation of drug advertising during the past decade."); Timothy McIntire, Note, Legal and Quality of
Patient Care Issues Arising from Direct-to-Consumer Pharmaceutical Sales, 33 U. Mem. L. Rev. 105, 106 (2002)
(exploring "the courts' unique role in health care quality, specifically as it relates to legal issues surrounding
direct-to-consumer pharmaceutical advertising"); Francis B. Palumbo & C. Daniel Mullins, The Development of
Direct-to-Consumer Prescription Drug Advertising Regulation, 57 Food & Drug L.J. 423, 424 (2002)
(observing the "government agencies responsible for overseeing drug advertising, and presenting the history of
drug advertising laws, regulations, and policies as these items relate specifically to [direct-to-consumer]
advertising"); Victor E. Schwartz et al., Marketing Pharmaceutical Products in the Twenty-First Century: An
Analysis of the Continued Viability of Traditional Principles in the Age of Direct-to-Consumer Advertising, 32
Harv. J.L. & Pub. Pol'y 333, 336 (2009) (examining "rules of law that establish the legal landscape for warnings
and advertising in the pharmaceutical context... . [and] concluding that, irrespective of the rise of
[direct-to-consumer] advertising, traditional principles of law fully retain their viability in the
post-[direct-to-consumer] world both as a matter of jurisprudence and sound public policy").
n12. See infra notes 160-67 and accompanying text. See also Levine, supra note 10 (commenting that the
average citizen living in the United States "has surely been exposed to thousands of television and internet ads
by big pharmaceutical companies promoting products that do everything from thinning blood to improving
erections... . Those ads can make millions more for Big Pharma[,] since the result is often patients demanding
the most expensive [brand-name] drugs.")
n13. Levine, supra note 10 ("Adding a counterpoint to the drug ads, and even more confusion for
consumers, law firms troll the same airwaves for potential claimants in lawsuits against those same
pharmaceutical companies. It is a strange phenomenon indeed and I see the results play out in my practice
sometimes.").
Page 19
n14. See Michael J. Miller, Pharmaceutical Direct-to-Consumer Advertising Regulations, For the Defense
(DRI, Chicago, IL), Oct. 2011, at 12, 12-13, available at http://www.dritoday.org/ftd/2011-10f.pdf (citing Press
Release, Kantar Media, Kantar Media Reports U.S. Advertising Expenditures Declined 12.3 Percent in 2009,
(Mar. 17, 2010, 8:00 AM), available at http://www.
businesswire.com/news/home/20100317005458/en/Kantar-Media-Reports-U.S.-Advertising-Expenditures-Declined)).
n15. See Ralph H. Brock, This Court Took a Wrong Turn with Bates: Why the Supreme Court Should
Revisit Lawyer Advertising, 7 First Amend. L. Rev. 145, 149-50 (2009) (quoting Valentine v. Chrestensen, 316
U.S. 52 (1942)) (noting the Supreme Court's historical adherence to "the broad rule articulated in Valentine v.
Chrestensen ... that while the First Amendment guards against government restriction of speech in most
contexts, "the Constitution imposes no such restraint on government as respects purely commercial
advertising.'").
n16. 433 U.S. 350 (1977).
n17. Id. at 383.
n18. Michael P. Stone & Thomas J. Miceli, Optimal Attorney Advertising, 32 Int'l Rev. L. & Econ. 329,
329 (2012).
n19. Nora Freeman Engstrom, Legal Access and Attorney Advertising, 19 Am. U. J. Gender Soc. Pol'y & L.
1083, 1089 (2011) ("In the decades following the Bates decision, advertisements for legal services - and
particularly personal injury legal services, which now make up the bulk of television advertising - have
proliferated.").
n20. See Michael Freedman, New Techniques in Ambulance Chasing, Forbes (Nov. 12, 2001, 12:00 AM),
http://www.forbes.com/forbes/2001/1112/ 056.html (overviewing "the surge" in lawyer advertising soliciting
potential plaintiffs for "deep-pocket attacks on big corporations, especially pharmaceutical companies").
n21. For a more in-depth discussion of the cases that followed Bates and further elaborated upon the
boundaries of attorney advertising, see infra Section III.A.
Page 20
n22. Peyton Paxson, Have You Been Injured? The Current State of Personal Injury Lawyers' Advertising,
36.2 J. Popular Culture 191, 191 (2002).
n23. Id.
n24. Stone & Miceli, supra note 18, at 331 (citing Bob D. Cutler, Chris Moberg, & Kurt Schimmel,
Attorney Advertising: The Link Between Ad Cues and Consumer Search Criteria, 19 J. Prof'l Servs. Mktg., no.
1, 1999, at 1).
n25. Id.
n26. Id. (citing data provided by Kantar-TNS).
n27. Id.
n28. Id.
n29. See New Media Strategies, U.S. Chamber Inst. for Legal Reform, The Plaintiffs' Bar Goes Digital: An
Analysis of the Digital Marketing Efforts of Plaintiffs' Attorneys & Litigation Firms 5 (2012), available at
http://www.instituteforlegalreform.com/sites/default/files/The& uscore;Plaintiffs_Bar_Goes_Digital_
2012_0.pdf [hereinafter Plaintiffs' Bar Goes Digital]. By its own account, the Institute for Legal Reform ("ILR")
"is a national campaign, representing the nation's business community, with the critical mission of making
America's legal system simpler, fairer and faster for everyone. Founded by the U.S. Chamber of Commerce in
1998 to address the country's litigation explosion, ILR is the only national legal reform advocate to approach
reform comprehensively by not only working to change the laws, but also changing the legal climate." See
About IRL, U.S. Chamber Inst. for Legal Reform, http://www.legalreformnow.com/about-ilr/ (last visited Nov.
10, 2013). Among its other stated aims, the ILR works to "neutralize plaintiff trial lawyers' excessive influence
over the legal and political systems"; "create and maintain public support for legal reform, including building
alliances with groups and organizations to advance the legal reform agenda"; "enact common sense reforms to
ensure fairness in liability suits"; and "ensure damage awards are fair and equitable, eliminate frivolous lawsuits,
and enforce legal ethics rules." Id.
Page 21
n30. Plaintiffs' Bar Goes Digital, supra note 29, at 5; see also Alison Frankel, Plaintiffs' Lawyer Spend
Millions in Online Ads. Should We Care?, Reuters (Mar. 1, 2012),
http://blogs.reuters.com/alison-frankel/2012/03/01/
plaintiffs-lawyers-spend-millions-in-online-ads-should-we-care/; Brian Quigley, Trial Lawyers Stepping Up
Online Advertising Spending, U.S. Chamber Inst. for Legal Reform (Feb. 26, 2012),
http://www.instituteforlegalreform.com/blog/
commentary/trial-lawyers-stepping-up-online-advertising-spending (noting Institute for Legal Reform press
release concerning study and observing that "the study also shows that lawyers are using the burgeoning world
of social media, including Twitter, Facebook, and YouTube to find new clients. Per the study, "the litigation
industry uses social communities to increase the reach of their own web content and online presence in an effort
to encourage potential clients to share their personal contact information.'").
n31. See Kantar Media, U.S. Chamber Inst. for Legal Reform, Lawyers Mass Tort Solicitation Advertising
2 (2011), available at http://www.yumpu
.com/en/document/view/9024025/lawyers-mass-tort-solicitation-advertising-institute-for-legal- reform.
n32. Freedman, supra note 20.
n33. See Engstrom, supra note 19, at 1089 ("In the decades following the Bates decision, advertisements for
legal services - and particularly personal injury legal services, which now make up the bulk of television
attorney advertising - have proliferated."); id. at 1090 n.33 (quoting Am. Bar Ass'n Comm'n on Advertising,
Lawyer Advertising at the Crossroads: Professional Policy Considerations 130 (1995) [hereinafter ABA
Comm'n on Advertising] ("Most television advertisements have been for personal injury or other contingency
fee-based services.")); Paxson, supra note 22, at 192 (noting that "the leading specialization among advertisers is
personal injury law, its practitioners representing victims of automobile accidents, medical malpractice, and "slip
and fall' injuries; a calamity for the prospective client provides a business opportunity for the legal
professional").
n34. This type of case is distinguished from a "mass accident" tort case, in which the potential plaintiffs
have common claims of liability but potentially different measures of damages. See Task Force on Contingent
Fees of the Am. Bar Ass'n Tort Trial & Ins. Prac. Section, Contingent Fees in Mass Tort Litigation, 42 Tort Trial
& Ins. Prac. L.J. 105, 107 (2006) [hereinafter ABA Task Force on Contingency Fees]. By contrast, "in a
dispersed mass tort, the issue of causation will have some common questions, such as whether the particular
product involved has particular defects or causes particular types of injuries. There are also, however, issues that
are different for each claimant." Id.
n35. Id. at 106 (quoting Manual for Complex Litigation (Fourth) 343-44 (2004)) (citations omitted).
Page 22
"Mass torts litigation "emerges when an event or series of related events injure a large number of people or
damage their property.' A mass tort is defined by both the nature and number of claims; the claims must arise out
of an identifiable event or product, affecting a very large number of people and causing a large number of
lawsuits asserting personal injury or property damage to be filed."
The Manual goes on to distinguish between mass torts that revolve around a single event, such as a hotel fire or
other mass accident, and more "dispersed' mass torts involving the ingestion of a particular drug or the use of a
particular product.
Id.; see also Deborah R. Hensler, Has the Fat Lady Sung? The Future of Mass Toxic Torts, 26 Rev. Litig. 883,
890 (2007) (highlighting the differences between catastrophic and toxic mass torts litigations).
n36. See Karen A. Geduldig, Note, Casey at the Bat: Judicial Treatment of Mass Tort Litigation, 29 Hofstra
L. Rev. 309, 310 (2000) (footnote omitted) (noting that "by 1990, [mass tort claims] encompassed seventy-five
percent of all new federal product liability filings"); Hensler, supra note 35, at 894 (noting that annual federal
product liability filings increased 270% from 1976 to 1986, much of that growth attributable to mass tort claims
in litigation focused on injuries alleged to have been caused by asbestos, the Dalkon Shield intra-uterine
contraceptive device, and the anti-nausea drug Bendectin).
n37. See Mark Herrmann, From Saccharin to Breast Implants: Mass Torts, Then and Now, 26 Litig., Fall
1999, at 50, 51.
n38. See Paul D. Rheingold, Excess in Mass Tort Litigation, 7 Mealey's Emerging Drug and Devices Rep.,
no. 18, Sept. 19, 2002, at 37 (reporting that within a day of the July 2002 announcement that the Prempro
hormone replacement therapy trials were being halted as a result of side effects, there were lawyer websites
seeking Prempro cases and, "by Labor Day 2002, there were at least 38 sites, trolling for Prempro cases").
n39. ABA Task Force on Contingency Fees, supra note 34, at 108.
n40. Id. ("The claimants who appear to have viable cases will be signed up to contingent fee contracts that
specify that the lawyer will receive a percentage, often 33 percent or 40 percent, of any recovery the client
receives net of expenses. Hundreds or thousands of such clients might be signed up in this initial stage of the
mass tort.").
Page 23
n41. See Rheingold, supra note 38, at 38 (noting that within days of the report of the terminated Prempro
study in 2002, "a number of class actions were filed, all attendant with the type of publicity that comes from
alerting the press to the commencement of a class suit").
n42. Id.
n43. See Herrmann, supra note 37, at 51.
n44. Id. (detailing the "different but equally hasty response" from "the retailers" who instead choose to file
individual cases); ABA Task Force on Contingency Fees, supra note 34, at 108-09 (describing the strategy of
"bundling" cases for settlement purposes).
n45. ABA Task Force on Contingency Fees, supra note 34, at 108-09.
n46. See Herrmann, supra note 37, at 51.
n47. ABA Task Force on Contingency Fees, supra note 34, at 108; Nathan Koppel, Referrals Get Rough
Around the Edges; Referral Fees Are Big Business for the Highest Bidder, But What About the Client?, Tex.
Law., Mar. 29, 1999, at 1 ("The idea behind a freewheeling, free-market referral system is to channel cases,
usually complex plaintiffs' cases, from the hands of lawyers too inexperienced or otherwise ill-equipped to
handle them into the right hands ... That still happens, of course. But lawyers in the middle of the increasingly
rough-and-tumble referral market say a new model has arisen. Many lawyers now use mass advertising to
dredge in and sign up clients just to refer them out en masse - even shopping them to the highest bidder.").
n48. ABA Task Force on Contingency Fees, supra note 34, at 108; Freedman, supra note 20 (noting one
such referral arrangement in which the recruiting firm paid to run the advertising, screen callers, and then refer
potential plaintiffs to the other firm for "actual prosecution" of the cases).
Page 24
n49. Howard M. Erichson, Beyond the Class Action: Lawyer Loyalty and Client Autonomy in Non-Class
Collective Representation, 2003 U. Chi. Legal F. 519, 536 (2003).
n50. Rheingold, supra note 38, at 37. (decrying the next-day lawyer advertising that followed the halting of
the Prempro hormone replacement therapy trials: "It would be interesting to get some straight answers from the
advertisers - lawyers and businesspeople - what their plans were. Did they do a sound, albeit rapid, analysis of
what the prospects were for suit? Did they analyze the manufacturer's warnings as to whether they were
adequate or not?").
n51. Id. ("One would also like to know what these advertisers intend to do with the many responses they
received. Have they undertaken to get full information about the experiences of the women responding? How
did they deal with the anguished question from responders about whether they should stay on [Prempro]? Did
the women feel that there was some chance of making a financial recovery based upon the language in the
Website or other ads?").
n52. Erichson, supra note 49, at 537 (quoting Interview with Alex H. MacDonald, Esq. (Apr. 26, 2002))
("According to one lawyer who has represented a number of plaintiffs in the diet drugs mass tort litigation:
"There are lawyers in diet pills ... who as a function of advertising and the really pernicious referral systems that
exist among and between these people who advertise on television and funnel literally thousands of cases to
some guy because the guy will split the fees 50/50, a referral fee that's totally unbelievable and of questionable
ethics - they will send cases to people who never saw a document, have never in their lives tried a case to jury
verdict, [and] were simply made powerful because they had a thousand cases.'") (alteration in orginal).
n53. Rheingold, supra note 38, at 37 ("A major contribution to the advertising problem is who facilitates the
advertising. It was questionable enough when lawyers became merchants and had no intention of handling
themselves (and had no ability to do so in any case). It is worse when non-lawyers promote the advertising.
There are dozens of companies out there that - for a very sizeable fee - will design your ads and run them for
you. They will sell you a territory (your zip code or region or they will get you national prominence by paying to
come up high on a search engine).").
n54. Erichson, supra note 49, at 537; see also Herrmann, supra note 37, at 51 - 52 ("But regardless of
whether the plaintiffs' lawyer is a wholesaler or a retailer, speed is of the essence. Class action complaints must
be filed, or an inventory of clients gathered, promptly on the heels of [the event giving rise to the prospective
mass toxic tort litigation].")
Page 25
n55. Rheingold, supra note 38, at 38 ("A manufacturer can be sure today that if it recalls a product or puts
out a new warning that there will be ads the next day seeking victims who used its product. And it is not just the
Net, it is TV and newspaper ads.").
n56. See Simon Dumenco, Ambulance Chasers Offer Lessons in Digital Marketing: Marketing Do's and
Don'ts - Especially Don'ts! - from a Surprising Source, Adver. Age (Feb. 29, 2012),
http://adage.com/print/232934 ("If you've ever been anywhere near daytime or late-night TV, you already know
that personal-injury lawyers are big TV-marketing spenders.").
n57. Erichson, supra note 49, at 535 ("For lawyers hoping to attract a sufficient number of similar clients to
achieve the critical mass needed for mass representation, earlier forms of lawyer advertising would have been
inefficient and prohibitively expensive. Internet advertising, especially web-based consortium advertising
services that attract potential clients with particular types of injuries or claims and connect those potential clients
with lawyers in their homes states, enables small and less established firms to seek entry into mass litigation
practice.") (footnote omitted).
n58. Freedman, supra note 20 (noting that the "ads use scare phrases like "FDA Investigation,' and feature
hospital patients hooked to IV units").
n59. See, e.g., Law Firm of Elk & Elk, Mirena IUD Users Having Medical Problems, YouTube (Nov. 14,
2012), http://www.youtube.com/watch?v=Eizn3z STeqA (warning that "Women with a Mirena IUD are having
medical problems," including "perforating the uterine wall" and "the IUD migrating to the abdomen, requiring
surgery, causing sepsis, and other complications"; the commercial also loosely describes an FDA Warning Letter
to Bayer, the IUD manufacturer, cautioning about "false or misleading presentations regarding Mirena"); Craig
Swapp & Associates, Avandia Diabetes Drug Side Effects Lawyer, YouTube (Nov. 10, 2010),
http://www.youtube.com/watch?v=HACY WLY_bSc (warning diabetics who "have been treated with the
popular diabetes drug Avandia, you should be aware that the FDA has issued a warning on the possible
increased risk of heart attack or other heart ailments. Avandia is the subject of a federal Senate investigation.").
n60. See, e.g., Charles E. Boyk Law Offices, LLC, Yaz Warning Commercial Launched by Ohio Yaz Injury
Lawyer, YouTube (Mar. 12, 2009), http://www.youtube.com/watch?v=qskyilp5Q_8 (warning women who have
taken or are currently taking Yazmin, Yaz, or Ocella birth control, as the word "Warning!!" flashes across the
screen in large, red, bold font).
n61. See, e.g., Law Offices of Robert J. Fenstersheib & Associates, P.A., Dialysis Attorney: GranuFlo
Page 26
Lawyer, YouTube (Feb. 28, 2013), http://www.youtube.com/watch?v=0WdkLLC1_9Q (seeking plaintiffs for
litigation focused on Granuflo and Naturalyte hemiodialysis treatment; commercial includes no speaking, but
rather sharp beeping sounds of hospital machine accompanying the flashing words, "If you or a loved one has
undergone hemodialysis treatment and suffered from a heart attack, We Want to Help" and "Go to
GranufloLawSuitHelp.com" on the screen).
n62. See, e.g., The U.S. Drug Watchdog Now Warns Time May be Running Out to Get Women Yaz or
Yasmin Birth Control Pill Users Identified if they Suffered a Heart Attack[,] Stroke[,] or a Embolism, PR Web
(May 14, 2012), http://www.prweb.com/releases/2012/5/prweb9500724.htm (warning that time is running out to
file a lawsuit); Kay Van Wey, Yaz Lawyers Warn: Time is Running Out to File a Yaz Side Effects Lawsuit, Van
Wey Law, http://www.
vanweylaw.com/practice_areas/female-yaz-lawyers-can-file-a-yaz-side-effects-lawsuit-for-you.cfm (last visited
Nov. 22, 2013) (same).
n63. Nora Freeman Engstrom, Run-of-the-Mill Justice, 22 Geo. J. Legal Ethics 1485, 1524 (2009)
[hereinafter Run-of-the-Mill Justice] (citing ABA Comm'n on Advertising, supra note 33, at 97).
n64. Kantar Media, supra note 31, at 15 (stating, as part of an analysis summary, that "advertising is geared
toward Daytime TV viewers - a significant portion of whom are elderly and/or retired.").
n65. Freedman, supra note 20 (reporting on one mass tort lawyer's knowledge that "ads running during the
day attract the poor, the disabled, the unemployed and others who may not know where or how to look for a
lawyer. Real-life judge shows like Judge Mills Lane and Judge Judy are jackpots. Talk shows like Montel
Williams are effective, too. Jerry Springer's audience was a fertile source of clients until, strangely enough,
producers toned down the scratching and hair-pulling. And never run ads on Fridays or during Christmas week.
The audience isn't in a litigious mood, he says.").
n66. Run-of-the-Mill Justice, supra note 63, at 1524.
n67. See First-of-Its-Kind Study Finds Plaintiffs' Lawyers' Online Marketing Tactics Among Most
Sophisticated, Expensive, U.S. Chamber of Commerce (Feb. 29, 2012),
http://www.uschamber.com/press/releases/2012/february/first-its-kind-study-finds-plaintiffs'-lawyers'-onlinemarketing-tactic ("The study details how many plaintiffs' firms create and dispatch a wide variety of websites
and use social media tools such as Twitter and Facebook to create a complex web of information presented in a
broad variety of ways, all designed to attract and vet potential clients for lawsuits.").
Page 27
n68. See id. Google offers the following explanation of keyword advertising on its network:
Keywords are words or phrases you choose to match your ads with corresponding user search terms and relevant
web content on the Google Network. Selecting high quality, relevant keywords for your advertising campaign
can help you reach the customers you want, when you want.
Imagine you're craving a hamburger. You head to a restaurant, and see that the items on the menu are "Food"
and "Meat in between bread." Even if this restaurant served the best burger in town, you might leave without
ordering anything. They'd lose your business - simply because the words they used weren't the same words you
had in mind.
To get your ads to appear when people search for your product or service, the keywords you choose need to
match the words or phrases that people use, or should be related to the content of the websites your customers
visit.
How Keywords Work, Google, https://support.google.com/adwords/answer/ 1704371?hl=en (last visited Nov.
10, 2013).
n69. Actos Bladder Cancer Lawsuit Information, Jackson Allen & Williams, LLP,
http://www.theactoslawfirm.com (last visited Nov. 10, 2013) (advertising legal services under the guise of
providing "Actos Bladder Cancer Lawsuit Information" and "Information and help for victims of Actos").
n70. Yaz Lawsuit: A Patient Advocacy Group, McEwen Law Firm, Ltd. & Crumley Roberts, Attorneys at
Law, http://www.yazlawsuitlawyer.net/ (last visited Nov. 10, 2013) (providing at the top of the webpage the
phrase "Yaz Lawsuit: A Patient Advocacy Group," which appears next to the logos for McEwen Law Firm, Ltd.,
and Crumley Roberts, Attorneys at Law, the two apparent sponsors of the site).
n71. Jacoby & Meyers, LLP, http://www.dangerousdrugs.com (last visited Nov. 10, 2013) (soliciting
claimants in cases involving antidepressants; anti-seizure drugs; arthritis drugs; birth control drugs; cough, cold,
and flu medications; diabetes drugs; heart, cholesterol, and hypertension medications; painkillers; sleeping pills;
statins; weight loss drugs; and dietary supplements; website video offers lawyers who "can provide you with
aggressive representation that will give you the greatest chance of a favorable settlement outcome").
Page 28
n72. See supra notes 58-62, 68-71 and accompanying text.
n73. See, e.g., Proven Results, Kershaw, Cutter, & Ratinoff, LLP,
http://www.kcrlegal.com/proven-results.aspx (last visited Nov. 10, 2013) (providing a list of multi-million dollar
lawsuit settlements the law firm obtained); Yaz Lawsuit, supra note 70 (providing a "results" category on
website's homepage, wherein viewers may observe statistics about how much money the law firms supporting
the websites have gleaned as a result of Yaz litigation).
n74. See, e.g., Drug Injury Case Evaluation Forms, Law Offices of Thomas J. Lamb, P.A.,
http://www.druginjurylaw.com/Evaluation-menu.html (last visited Nov. 10, 2013) (providing a list of drug
injury case evaluation forms applicable to numerous pharmaceutical drugs awaiting potential litigation by the
sponsor); Morgan & Morgan, http://www.forthepeople.com/?gclid=CPnfls T8uboCFcxaMgodPnwAKQ (last
visited Nov. 10, 2013) (providing, on website's homepage, a form for a "FREE, Immediate, Case Evaluation," as
well as a 24/7 live chat feature and 24/7 toll-free phone number).
n75. See, e.g., Girard Gibbs LLP, Actos Lawyers, Twitter, https://twitter.com/ActosLawyers (last visited
Nov. 10, 2013) (Twitter account tied to Girard Gibbs law firm; twitter profile touts that Gibbs firm is a "national
litigation firm committed to protecting the rights of individuals who suffered injuries after taking the diabetes
drug Actos"); Jacoby & Meyers, LLP, Dangerous Drugs, Facebook,
https://www.facebook.com/pages/Dangerous-Drugs/370769239670713 (last visited Nov. 10, 2013) (Jacoby &
Meyers's Facebook page containing links throughout to content on the firm's DangerousDrugs.com website);
Jacoby & Meyers, LLP, Twitter, http://twitter.com/DrugsDangerous (last visited Nov. 10, 2013) (Jacoby &
Meyers's Twitter feed); Twitter, http://twitter.com/PradaxaLawsuit (last visited Nov. 10, 2013) (Twitter account
tied to legal website filepradaxalawsuit.com).
n76. See, e.g., Edward M. Bernstein & Associates, Zocor Lawsuit - Zocor Lawyer: Ed Bernstein, YouTube
(June 13, 2011), http://www.youtube.com/ watch?v=RupSJt7k2JU (advising viewer, "If you have taken the
cholesterol drug Zocor or the generic equivalent and have been diagnosed with Rhabdomyolysis, Myopathy, or
Kidney Failure, you may be entitled to compensation ... ."; in tiny, white print, the words "Never stop taking any
medication before asking your doctor" flash instantaneously onto screen but are drowned out by the words
"Zocor Alert: You May be Entitled to Compensation" in large, red font); Gerard Gibbs, Actos Bladder Cancer
Injury Lawsuit, YouTube (Oct. 24, 2011), http://www.youtube.com/watch?v=PXSGBjrOw6I (seeking claims
against Actos, a drug indicated to treat Type II diabetes; advertisement warns of Actos link to bladder cancer but
contains no warning that viewer should not stop taking medication without first consulting doctor).
n77. Although most legal advertisements offer no source or reference information, those that do tend to bury
the presentation of that information. An example is a commercial by Norris Injury Lawyers soliciting users of
Chantix, a medication indicated to assist patients with smoking cessation. See Norris Injury Lawyers, Chantix
Page 29
Lawsuits, YouTube (Mar. 11, 2010), http://www.youtube.com/watch?v=VUcz9tu_nLQ. In the one-minute ad,
the voiceover describes FDA reports about patients taking Chantix who have experienced suicidal thoughts,
aggressive behavior, and serious emotional changes. Id. While the phrases "Chantix Suicide Dangers," "suicidal
thoughts," "aggressive behavior," and "serious emotional changes" remain on the screen in large,
color-contrasted fonts, source data, noting retrieval from the FDA.gov website, appears on the screen in tiny font
for only seconds. Id.
n78. See supra note 8 and accompanying text.
n79. See, e.g., Felicia L. Stern, Pradaxa Lawsuits Being Investigated by Bernstein Liebhard, LLP, as Next
Conference in Federal Pradaxa Litigation Set for January 10th, PR Web (Dec. 29, 2012),
http://www.prweb.com/releases/Pradaxa-Lawsuit/Pradaxa-Bleeding/prweb10278400.htm (article on file with
author; originally appeared in S.F. Chron.). Crafted as a press release, the author retrieved this piece during a
search for new stories about Pradaxa-related litigation. The headline and story body gave the impression that a
third-party is reporting on lawsuits, newly-filed by the Bernstein Liebhard, LLP law firm, on behalf of patients
who experienced severe side effects such as bleeding as a result of ingesting Pradaxa. Id.
n80. See, e.g., Climaco, Wilcox, Peca, Tarantino & Garofoli Co., L.P.A., Ohio Class Action and Mass Tort
Alerts, Ohio Consumer Alert, http://www. ohioconsumeralert.com (last visited Nov. 10, 2013) (purporting to
offer "class action and mass tort alerts" to Ohio consumers).
n81. A case in point is the website www.ZyprexaSideEffectsLawyer.com. On its main page, the site offers
content about "Zyprexa Side Effects," the FDA's issuance of "limited Zyprexa warning information," and
"Zyprexa and Diabetes Link." Zyprexa Side Effects, Zyprexa Side Effects Lawyer,
http://www.zyprexasideeffectslawyer.com (last visited Nov. 10, 2013). Although the page alludes to information
about "lawyers and attorneys" and offers the reader the opportunity to "learn about your legal rights," no
individual lawyers or law firms are named anywhere on the site. Moreover, although Zyprexa is still a marketed
product, the website appears to be outdated, evidenced by the August 6, 2008 article as the headlining source on
the website. Id.
n82. Glen Lerner, Glen Lerner Dangerous Drug Pradaxa Wrongful Death Lawyer Attorney, YouTube (Mar.
9, 2012), http://www.youtube.com/watch?v=EyerBMDfTbM (disclosing in small print, for a fleeting second at
commercial's conclusion, that "some work may be performed by, or referred to, other attorneys").
n83. Over the last 15 years, significant mass tort litigations have focused on patients taking drugs indicated
Page 30
to treat significant illnesses, including type II diabetes (Avandia, Actos, Januvia, Byetta); severe mental
illnesses, such as schizophrenia and bipolar disorder (Zyprexa, Seroquel, Risperdal); stroke prevention
(Pradaxa); and pain (Vioxx, Celebrex), among others.
n84. See, e.g., The Carlson Law Firm & Komie & Morrow, LLP, Help for Pradaxa Patients,
http://pradaxadruglawyer.com (last visited Nov. 10, 2013) (identifying The Carlson Law Firm and Komie &
Morrow LLP as sponsors and containing banner headlines offering "Help for Pradaxa Patients" and "Help for
Pradaxa Bleeding Injury").
n85. Steven Garber, Inst. for Civil Justice, Economic Effects of Product Liability and Other Litigation
Involving the Safety and Effectiveness of Pharmaceuticals 80-81 (2013), available at
http://www.rand.org/pubs/monographs/MG1259.html (overviewing survey data addressing the impact of
litigation on consumer compliance with prescribed therapies); Levine, supra note 10 ("Adding a counterpoint to
the drug ads, and even more confusion for consumers, law firms troll the same airwaves for potential claimants
in lawsuits against those same pharmaceutical companies. It is a strange phenomenon indeed and I see the
results play out in my practice sometimes.").
n86. The interviewees were selected from lists of patients with at least one of eight diagnosed medical
conditions: high cholesterol, hypertension, arthritis, depression, obesity, diabetes, heart disease, or stomach
ulcers. Harris Interactive, U.S. Chamber Inst. for Legal Reform, Pharmaceutical Liability Study: Report on
Findings 54 (2003), available at http://www.us chamber.com/sites/default/files/press/rx_pharmaceuti
cal_liability_study_report.pdf. See also supra note 29.
n87. Id. at 3 (identifying as two primary research objectives the "measure[ment of] patient awareness of
advertisements for product liability litigation, and what actions they might take as a result of seeing such an
advertisement" and the "investigat[ion of] patient concern toward the effect of product liability litigation on new
product development and availability").
n88. Id. at 39-40.
n89. Id. at 41.
n90. Id. at 42; see also Judyth Pendell, AEI-Brookings Joint Center for Regulatory Studies, The Adverse
Page 31
Side Effects of Pharmaceutical Litigation 13 (2003), available at http://regulation2point0.org/wp-content/
uploads/downloads/2010/04/phpgM.pdf ("Using a Harris poll of doctors, pharmacists, and patients to inquire
about the impact of liability on pharmaceutical prescribing, warning, and compliance adds force to the existing
evidence that the tort liability system creates over[-]deterrent effects... . Patients may learn of litigation
involving the drug and not begin the medication or stop taking medication they are currently on ... .").
Corroborating the patient responses, about two in five physicians and pharmacists surveyed reported cases of
patients who stopped taking properly prescribed medication upon becoming aware of litigation surrounding the
medication. Id. at 9; Harris Interactive, supra note 86, at 26, 33.
n91. New Survey Shows Product Liability Litigation May Jeopardize Treatment Outcomes for People with
Severe Mental Illnesses, Eli Lilly & Co. (June 13, 2007),
https://investor.lilly.com/releasedetail.cfm?releaseid=248836.
n92. Id.; see also Garber, supra note 85, at 81.
n93. Eli Lilly & Co., supra note 91; see also Garber, supra note 85, at 81.
n94. Eli Lilly & Co., supra note 91.
n95. Levine, supra note 10.
n96. Id.
n97. Id.
n98. Id. ("The fact is that Pradaxa does reduce the blood from clotting (some might say it does thin the
blood) and like any blood thinner, whether it is Coumadin, or even Aspirin, or Pradaxa, it can increase the risk
of bleeding. This is something that will happen anytime you take any blood thinner. Fall down and bang yourself
while taking Coumadin or Pradaxa and you will bleed more than if you weren't taking it.").
Page 32
n99. Id. Dr. Levine noted that he had, after spending "an entire visit to educate him, again, about the risks
and benefits of Pradaxa compared to Coumadin," restarted Pradaxa therapy for the patient who had stopped the
drug after watching the Pradaxa litigation ad. Id.
n100. Id.
n101. Rheingold, supra note 38, at 38.
n102. See 3 James B. Astrachan et al., The Law of Advertising § 46.02[1] (2013) (providing a detailed
historical background of the jurisprudence and debate surrounding the prohibitions on legal advertising until the
Bates case).
n103. See Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748, 770 (1976)
(overturning state prohibition against advertisement of prescription drug prices as unconstitutional).
n104. Bates v. State Bar of Ariz., 433 U.S. 350 (1977) (overturning as unconstitutional an Arizona ban on
attorney advertising).
n105. See generally Brock, supra note 15, at 151-61 (surveying Supreme Court decisions dealing with
lawyer advertising).
n106. For a concise overview of the Supreme Court cases impacting legal advertising, and an outline of
other areas of law implicated by attorney advertising for mass tort pharmaceutical cases, see Vincent V.
Carissimi, Lawyer Advertising in Pharmaceutical Litigation, Address to the Pennsylvania Bar Institute (Feb. 1,
2006), in Pharmaceutical Litigation 39, 39-46 (2006).
n107. 425 U.S. 748 (1976). For a more recent discussion of Virginia State Board of Pharmacy and its
progeny, see Nat Stern & Mark Joseph Stern, Advancing an Adaptive Standard of Strict Scrutiny for
Content-Based Commercial Speech Regulation, 47 U. Rich. L. Rev. 1171 (2013).
Page 33
n108. Va. State Bd. of Pharmacy, 425 U.S. at 749-50.
n109. Id. at 764.
n110. Id. at 765 & n.19; see also Stern & Stern, supra note 107, at 1173.
n111. Va. State Bd. of Pharmacy, 425 U.S. at 773.
n112. Id. at 771 (citing Gertz v. Robert Welch, Inc., 418 U.S. 323, 340 (1974); Konigsberg v. State Bar, 366
U.S. 36, 49 & n.10 (1961)).
n113. Id.
n114. Bates v. State Bar of Arizona, 433 U.S. 350, 384 (1977).
n115. Id. at 354-56.
n116. Id. at 368.
n117. Id. at 377.
n118. See id. at 372.
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n119. Id. at 376-77 (quoting Model Code of Prof'l Responsibility EC 2-1 (1976)).
n120. Id. at 377 ("Although it is true that the effect of advertising on the price of services has not been
demonstrated, there is revealing evidence with regard to products; where consumers have the benefit of price
advertising, retail prices often are dramatically lower than they would be without advertising. It is entirely
possible that advertising will serve to reduce, not advance, the cost of legal services to the consumer.") (footnote
omitted).
n121. Id. at 374-75.
n122. Id. at 384.
n123. Id. at 383.
n124. Id. at 383-84.
n125. Id. at 384.
n126. Id.
n127. 447 U.S. 557 (1980).
n128. Id. at 558-59.
n129. Id. at 564, 566.
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n130. Id. at 566-68.
n131. Id. at 570-71.
n132. Id. at 562-63 (citing Ohralik v. Ohio State Bar Ass'n, 436 U.S. 447, 455-56 (1978)).
n133. In re R.M.J., 455 U.S. 191, 194 (1982). The permitted advertising could include only the lawyer's
name, address and telephone number, areas of practice, date and place of birth, schools attended, foreign
language ability, office hours, fee for an initial consultation, availability of a schedule of fees, credit
arrangements, and the fixed fee for "routine' legal services. Id.
n134. Id. at 196-97.
n135. Id. at 203 (citing Bates v. State Bar of Ariz., 433 U.S. 350, 375 (1977)) (citation omitted).
n136. Id.
n137. Id. at 206-07.
n138. 471 U.S. 626, 630-31 (1985). The advertisement specified that the IUD device was "alleged to have
caused serious pelvic infections resulting in hospitalizations, tubal damage, infertility, and hysterectomies. It is
also alleged to have caused unplanned pregnancies ending in abortions, miscarriages, septic abortions, tubal or
ectopic pregnancies, and full-term deliveries." Id. at 631. It also noted that the attorney was currently handling
lawsuits involving the device, that readers should "not assume it is too late to take legal action," that cases would
be handled on a contingent fee basis, and that no fees would be owed by clients if the case resulted in no
recovery. Id.
Page 36
n139. Id. at 632.
n140. Id. at 639-40. Here, the Court noted that "the advertisement's information and advice concerning the
Dalkon Shield ... were entirely accurate" in that the advertisement did not promise successful lawsuits, did not
suggest that the advertising lawyer had special expertise other than his work on other litigation involving the
product, "reported the indisputable fact that the Dalkon Shield had spawned an impressive number of lawsuits,"
and advised readers that the attorney was willing to represent other women asserting similar claims. Id.
n141. Id. at 648.
n142. Id. at 655-56.
n143. Id. at 651 (quoting In re R.M.J., 455 U.S. 191, 201 (1982)).
n144. 515 U.S. 618 (1995).
n145. Id. at 620, 621; see also Brock, supra note 15, at 163.
n146. Id. at 635.
n147. Id. at 626-28.
n148. Id. at 629, 635. Among "the anecdotal record mustered by the Bar," the Court pointed to newspaper
editorial pages criticizing Florida lawyers using targeted, direct mail after accidents, as well as scathing excerpts
from complaints of direct-mail recipients. Id. at 627-28.
Page 37
n149. See Model Rules of Prof'l Conduct R. 7.1-7.3.
n150. Id. at R. 7.2(a).
n151. Id. at R. 7.1.
n152. Id. at R. 7.3(a).
n153. Id. at R. 7.3(c).
n154. See Ala. Rules of Prof'l Conduct R. 7.1-7.6; Alaska Rules of Prof'l Conduct R. 7.1-7.5; Ariz. Rules of
Prof'l Conduct R. 7.1-7.5; Ark. Rules of Prof'l Conduct R. 7.1-7.5; Cal. Rules of Prof'l Conduct R. 1-400; Colo.
Rules of Prof'l Conduct R. 7.1-7.6; Conn. Rules of Prof'l Conduct R. 7.1-7.5; Del. Rules of Prof'l Conduct R.
7.1-7.6; Fla. Rules of Prof'l Conduct R. 4-7.1-4-7.11; Ga. Rules of Prof'l Conduct R. 7.1-7.5; Haw. Rules of
Prof'l Conduct R. 7.1-7.5; Idaho Rules of Prof'l Conduct R. 7.1-7.6; Ill. Rules of Prof'l Conduct R. 7.1-7.6; Ind.
Rules of Prof'l Conduct R. 7.1-7.5; Iowa Rules of Prof'l Conduct R. 32:7.1-32:7.8; Kan. Rules of Prof'l Conduct
R. 7.1-7.5; Ky. Rules of Prof'l Conduct S. Ct. R. 3.130(7.01)-3.130(7.60); La. Rules of Prof'l Conduct R.
7.1-7.10; Me. Rules of Prof'l Conduct R. 7.1-7.6; Md. Rules of Prof'l Conduct R. 7.1-7.5; Mass. Rules of Prof'l
Conduct R. 7.1-7.5; Mich. Rules of Prof'l Conduct R. 7.1-7.5; Minn. Rules of Prof'l Conduct R. 7.1-7.5; Miss.
Rules of Prof'l Conduct R. 7.1-7.7; Mo. Rules of Prof'l Conduct R. 4-7.1-4-7.6; Mont. Rules of Prof'l Conduct R.
7.1-7.5; Neb. Rules of Prof'l Conduct R. 3-507.1-3-507.5; Nev. Rules of Prof'l Conduct R. 7.1-7.6; N.H. Rules
of Prof'l Conduct R. 7.1-7.5; N.J. Rules of Prof'l Conduct R. 7.1-7.5; N.M. Rules of Prof'l Conduct R.
16-701-16-705; N.Y. Rules of Prof'l Conduct R. 7.1-7.5; N.C. Rules of Prof'l Conduct R. 7.1-7.5; N.D. Rules of
Prof'l Conduct R. 7.1-7.5; Ohio Rules of Prof'l Conduct R. 7.1-7.6; Okla. Rules of Prof'l Conduct R. 7.1-7.5; Or.
Rules of Prof'l Conduct R. 7.1-7.5; Pa. Rules of Prof'l Conduct R. 7.1-7.7; R.I. Rules of Prof'l Conduct R.
7.1-7.5; S.C. Rules of Prof'l Conduct R. 7.1-7.5; S.D. Rules of Prof'l Conduct R. 7.1-7.5; Tenn. Rules of Prof'l
Conduct R. 7.1-7.6; Tex. Rules of Prof'l Conduct R. 7.01-7.07; Utah Rules of Prof'l Conduct R. 7.1-7.5; Vt.
Rules of Prof'l Conduct R. 7.1-7.5; Va. Rules of Prof'l Conduct R. 7.1-7.5; Wash. Rules of Prof'l Conduct R.
7.1-7.6; W. Va. Rules of Prof'l Conduct R. 7.1-7.5; Wis. Rules of Prof'l Conduct R. 7.1-7.6; Wyo. Rules of Prof'l
Conduct R. 7.1-7.4.
n155. Ala. Rules of Prof'l Conduct R. 7.2(e); see also Colo. Rules of Prof'l Conduct R.7.1 (a)(2) (stating
that, "A communication is false or misleading if it compares the lawyer's services with other lawyers' services,
unless the comparison can be factually substantiated."); Ky. Rules of Prof'l Conduct S. Ct. R. 3.130(7.15)(1)(c)
(stating that, "A communication is false, deceptive or misleading if it compares the lawyer's services with other
Page 38
lawyers' services, unless the comparison can be factually substantiated."); Tenn. Rules of Prof'l Conduct R.
7.1(c) (stating that, "A communication is false or misleading if it compares the lawyer's services or fees with
other lawyers' services or fees, unless the comparison can be factually substantiated.").
n156. Mo. Rules of Prof'l Conduct R. 4-7.2(f); see also Fla. Rules of Prof'l Conduct R. 4-7.3(b) ("Except as
otherwise provided in this subdivision, all advertisements other than lawyer referral service advertisements shall
contain the following disclosure: "The hiring of a lawyer is an important decision that should not be based solely
upon advertisements. Before you decide, ask us to send you free written information about our qualifications and
experience.'").
n157. See, e.g., Ark. Rules of Prof'l Conduct R. 7.2(d) ("Any communication made pursuant to this Rule
shall ... disclose the geographic location or offices of the attorney or the firm in which the lawyer or lawyers
who actually perform the services advertised principally practice law."); Pa. Rules of Prof'l Conduct R. 7.2(i)
("All advertisements and written communications shall disclose the geographic location, by city or town, of the
office in which the lawyer or lawyers who will actually perform the services advertised principally practice law.
If the office location is outside the city or town, the county in which the office is located must be disclosed.").
n158. Fla. Rules of Prof'l Conduct R. 4-7.2(c)(7) ("No lawyer shall, directly or indirectly, pay all or a part of
the cost of an advertisement by a lawyer not in the same firm."); Pa. Rules of Prof'l Conduct R. 7.2(j) ("A lawyer
shall not, directly or indirectly (whether through an advertising cooperative or otherwise), pay all or any part of
the costs of an advertisement by a lawyer not in the same firm or by any for-profit entity other than the lawyer's
firm, unless the advertisement discloses the name and principal office address of each lawyer or law firm
involved in paying for the advertisement and, if any lawyer or law firm will receive referrals from the
advertisement, the circumstances under which referrals will be made and the basis and criteria on which the
referral system operates.").
n159. See, e.g., Fla. Rules of Prof'l Conduct R. 4-7.12(c) ("Any words or statements required by this
subchapter to appear in an advertisement must appear in the same language in which the advertisement appears.
If more than [one] language is used in an advertisement, any words or statements required by this subchapter
must appear in each language used in the advertisement."); Ky. Rules of Prof'l Conduct S. Ct. R. 3.130(7.25)
("All advertisements must include the words "THIS IS AN ADVERTISEMENT,' unless excepted by SCR
3.130(7.09). In recorded telephone, electronic, video, or digital communications, other than television, the
speaker must first state "THE FOLLOWING IS AN ADVERTISEMENT' and must further state at the end of
the communication "THIS MESSAGE HAS BEEN AN ADVERTISEMENT.' All television communication,
video recording or digital recording must prominently display the words "THIS IS AN ADVERTISEMENT' on
the screen for as long as the lawyer's or firm's name appears on the screen. If a television communication video
recording, or digital recording is longer than 60 seconds, the words "THIS IS AN ADVERTISEMENT' must be
displayed throughout the entire communication. The words "THIS IS AN ADVERTISEMENT' must be
prominently displayed on every page of any advertisement in writing, and displayed without scrolling on the
first screen of every page of a website."); Mo. Rules of Prof'l Conduct R. 4-7.2(f) (""Conspicuous' means that
Page 39
the required disclosure must be of such size, color, contrast, location, duration, cadence, or audibility that an
ordinary person can readily notice, read, hear, or understand it."); N.Y. Rules of Prof'l Conduct R. 7.1(f) ("Every
advertisement other than those appearing in a radio, television or billboard advertisement, in a directory,
newspaper, magazine or other periodical (and any web sites related thereto), or made in person pursuant to Rule
7.3(a)(1), shall be labeled "Attorney Advertising' on the first page, or on the home page in the case of a web site.
If the communication is in the form of a self-mailing brochure or postcard, the words "Attorney Advertising'
shall appear therein. In the case of electronic mail, the subject line shall contain the notation "ATTORNEY
ADVERTISING.'").
n160. See Palumbo & Mullins, supra note 11, at 423 ("Direct-to-consumer (DTC) prescription drug
advertising is now well known to practically all American households. One needs only to watch virtually any
commercial television program or to browse through any consumer-directed magazine to view advertisements
for a variety of prescription drugs."). In 2007, it was reported that in one year the average American watches
sixteen hours of pharmaceutical advertisements. See Lia Mulligan, You Can't Say That on Television:
Constitutional Analysis of a Direct-to Consumer Pharmaceutical Advertising Ban, 37 Am. J.L. & Med. 444, 444
(2011) (citing Dominick L. Frosch et al., Creating Demand for Prescription Drugs: A Content Analysis of
Television Direct-to-Consumer Advertising, 5 Annals Fam. Med. 6, 6 (2007)); see also Congressional Budget
Office, Promotional Spending for Prescription Drugs 1 (2009), available at
http://www.cbo.gov/sites/default/files/cbofiles/ ftpdocs/105xx/doc10522/12-02-drugpromo_brief.pdf
(overviewing recent trends and the effects of pharmaceutical promotion).
n161. Dhaval M. Dave, Effects of Pharmaceutical Promotion: A Review and Assessment 3 (Nat'l Bureau of
Econ. Research, Working Paper No. 18830, 2013), available at http://www.nber.org/papers/w18830.
n162. Id.
n163. Id.
n164. See C. Lee Ventola, Direct-to-Consumer Pharmaceutical Advertising: Therapeutic or Toxic, 36
Pharmacy & Therapeutics 669, 669, 670 (2011), available at
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/pdf/ ptj3610669.pdf (highlighting the rapid growth of
DTC advertising over the last several decades and that such promotion "is now the most prominent type of
health communication that the public encounters").
n165. Congressional Budget Office, supra note 160, at 2.
Page 40
n166. Ventola, supra note 164, at 670. While many commentators point to the 1997 issuance of the FDA
draft guidance as the trigger for the explosive growth in DTC advertising, Ventola notes that "there is evidence
that this trend began much earlier. For example, in 1980, total spending on DTCPA was $ 12 million; in 1990, it
was $ 47 million; and in 1995, it was $ 340 million, representing a nearly 3,000% increase in expenditures
during a 15-year period before broadcast ad regulations had even been relaxed." Id. (footnotes omitted).
n167. Id.; see also Congressional Budget Office, supra note 160, at 3 (providing graphic chart). While DTC
spending in 2008 decreased for the first time in well over a decade as a result of a nationwide financial crisis and
subsequent economic downturn, the $ 4.8 billion spent on DTC promotion still represented nearly a quarter of
pharmaceutical manufacturers' expenditures for all promotional activities. Congressional Budget Office, supra
note 160, at 3; Ventola, supra note 164, at 670.
n168. See Jeremy A. Greene & David Herzberg, Hidden in Plain Sight: Marketing Prescription Drugs to
Consumers in the Twentieth Century, 100 Am. J. Public Health 793, 793 (2010) available at
http://www.ncbi.nlm.nih.gov/pmc/ articles/PMC2853635/pdf/793.pdf ("Considerable controversy persists,
however, about the impact of DTC advertising on American public health and the doctor-patient relationship.
Whereas some argue that advertising has indeed democratized access to important new medications, others
decry the coarsening of medical discourse, the diminution of physicians' authority, and the risks of
overprescription and inappropriate prescription by the manipulation of consumer awareness and consequent
pressure on prescribers.") (footnotes omitted).
n169. Ventola, supra note 164, at 672-73 (discussing in some detail the arguments in support of DTC drug
ads).
n170. Id. at 673-82.
n171. See supra Sections III.A & B.
n172. See infra Section IV.A.
Page 41
n173. See Miller, supra note 14, at 13 ("Many of the same concerns activating regulation of DTC
advertising apply with equal force to lawyer advertising."). Along very similar lines to what is posited in this
article, Miller asserts that lawyer advertising should be regulated to require "warnings" to potential clients about
the "risks" of pursuing contingent fee claims. Id. "Specifically, lawyer advertisements should include a warning
that not all claimants will prevail and that significant or easily obtained results - which are frequently touted by
lawyer advertisements - are not necessarily typical. Now is the time for a renewed effort to examine and better
monitor lawyer advertising to ensure that it is not false or misleading and that it adequately warns consumers of
the actual risks and benefits associated with legal services." Id.
n174. 21 U.S.C. §§301-399f (2006); see generally Palumbo & Mullins, supra note 11, at 424-31 (providing
an overview of the historical and legislative evolution of prescription drug advertising).
n175. See 21 C.F.R. § 202.1(e)(1) (2011).
n176. 21 U.S.C. § 352(n), (3) (2006).
n177. See U.S. Food & Drug Admin., Guidance for Industry: Presenting Risk Information in Prescription
Drug and Medical Device Promotion, at 3 n.10 (Draft May 2009) [hereinafter Presenting Risk Information]
(citing 21 U.S.C. § 352(n), (q)(1); 21 C.F.R. § 202.1(e)(5)(i)), available at http://www.fda.
gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation /Guidances/UCM155480.pdf ("Prescription
drugs and restricted devices are misbranded if their advertising is false or misleading in any particular [way].").
n178. Id. (citing 21 U.S.C. § 352(n); 21 C.F.R.§§1.21, 202.1(e)(5)(iii)).
n179. Id. (citing 21 C.F.R. § 202.1(e)(5)(ii)).
n180. 21 C.F.R. § 202.1(e)(5)(ii) (2011). Regarding the fair balance doctrine, the regulations specify that
drug manufacturers must "present a fair balance between information relating to side effects and
contraindications and information relating to effectiveness of the drug in that the information relating to
effectiveness is presented in greater scope, depth, or detail than is required by section 502(n) of the act and this
information is not fairly balanced by a presentation of a summary of true information relating to side effects and
contraindications of the drug ... ." Id.
Page 42
n181. See Palumbo & Mullins, supra note 11, at 424.
n182. See Amy Shaw, Direct-to-Consumer Advertising (DTC) of Pharmaceuticals, CSA ProQuest
Discovery Guides, 1, 4 (Mar. 2008) (quoting Julie M. Donahue et al., A Decade of Direct-to-Consumer
Advertising of Prescription Drugs, 357 New Eng. J. Med. 673-81 (2007)), available at
http://www.csa.com/discoveryguides/direct/review.pdf (describing "the first DTC television advertisement" by
Boots Pharmaceuticals and a DTC marketing effort by Merck and Dohme, both in the early 1980s, as "two
drug-marketing campaigns [that] "broke with tradition and pursued a marketing strategy that depended on
consumers' taking a more active role in prescribing decisions'").
n183. Direct-to-Consumer Advertising: Hearing Before the Subcomm. on Consumer Affairs, Foreign
Commerce, & Tourism of the S. Comm. on Commerce, Sci., & Transp., 107th Cong. 6 (2001) (statement of
Nancy M. Ostrove, Deputy Director, Division of Drug Marketing, Advertising, and Communications of FDA),
available at http://www.fda.gov/NewsEvents/testi mony/ucm115206.htm (noting that among the steps taken
during the moratorium to assess the impact of DTC advertising, the FDA conducted research and sponsored a
series of public meetings, and the University of Illinois and Stanford Research Institute jointly sponsored a
symposium to evaluate DTC advertising "from a broad research and policy perspective").
n184. Direct-to-Consumer Advertising of Prescription Drugs; Withdrawal of Moratorium, 50 Fed. Reg.
36677, 36678 (Sept. 9, 1985) (concluding that "current regulations governing prescription drug advertising
provide sufficient safeguards to protect consumers"); see also Ventola, supra note 162, at 670.
n185. See Donna U. Vogt, Cong. Research Serv., RL32853, Direct-to-Consumer Advertising of
Prescription Drugs 18 (2005), available at http://www.law.umaryland.edu/marshall/crsreports/crsdocume
nts/RL3285303252005.pdf.
n186. Id.
n187. U.S. Food & Drug Admin., Guidance for Industry: Brief Summary: Disclosing Risk Information in
Consumer-Directed Print Advertisements at 3-6 (Draft Jan. 2004) [hereinafter FDA Brief Summary], available
at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM069984.pdf.
Page 43
n188. Id. at 6; see also Vogt, supra note 185, at 18 (noting that each approach would still require the
disclosure of "all contraindications; all warnings; the major precautions, including any that describe serious
adverse drug experiences or steps to be taken to avoid such experiences; and the three to five most common
nonserious adverse reactions most likely to affect the patient's quality of life or compliance with drug therapy").
n189. FDA Brief Summary, supra note 187, at 4. According to the FDA website's description of "Patient
Labeling," "for some prescription medicines, FDA approves special patient materials to instruct patients about
the safe use of the product. These materials may be given to patients by their health care provider or pharmacist,
and are considered part of FDA-regulated product labeling." Patient Labeling and Risk Communication, FDA,
http://www.fda.gov/ AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/C DER/ucm169617.htm
(last visited Nov. 10, 2013).
n190. FDA Brief Summary, supra note 187, at 5.
n191. Id. at 5-6.
n192. U.S. Food & Drug Admin., Guidance for Industry: Consumer-Directed Broadcast Advertisements
(1999) [hereinafter Consumer-Directed Broadcast Advertising], available at
http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM070065.pdf.
n193. Id. at 2.
n194. Id.
n195. Id.
n196. Id.
Page 44
n197. Id. at 1. (alteration in original) (quoting 21 C.F.R. § 202.1(e)(1)).
n198. Id. at 2-3.
n199. See Presenting Risk Information, supra note 177.
n200. Id.
n201. Id. at 2 ("FDA's guidance documents, including this draft guidance, do not establish legally
enforceable responsibilities. Instead, guidelines describe FDA's current thinking on a topic and should be viewed
only as recommendations, unless specific regulatory or statutory requirements are cited.").
n202. Id. at 3. The Guidance noted that "omission or minimization of risk information is the most frequent
violation of the regulations cited in advertising and promotion enforcement letters sent to sponsors ... ." Id. In
further support of this concern, the Guidance pointed to research indicating, among other points, that "60 percent
of patients believe ads directed at them do not provide enough information about risks, 60 percent of physicians
believe that patients have little or no understanding from these ads about what the possible risks and negative
effects of the products are, and 72 percent of physicians believe that patients have little or no understanding
from these ads about who should not use the product." Id. (citing Kathryn J. Aikin, John L. Swasy, & Amie C.
Braman, Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs Summary of FDA Survey Research Results 4-5, 7-8 (Nov. 19, 2004), available at
http://www.fda.gov/downloads/ Drugs/ScienceResearch/ResearchAreas/DrugMarketingAdvertisin
gandCommunicationsResearch/UCM152890.pdf).
n203. Presenting Risk Information, supra note 177, at 4.
n204. Id. at 5 (citing Federal Trade Commission, FTC Policy Statement on Deception, (Oct. 14. 1983),
appended to FTC v. Cliffdale Assocs., Inc., et al., 103 F.T.C. 110, 170 (1984) [hereinafter FTC Policy Statement
on Deception]).
Page 45
n205. Id. at 6.
n206. Id.
n207. Id. at 6-20.
n208. Id. at 7. Here, the FDA elaborated that appropriate DTC language is that which presents "both benefit
and risk information in clear, understandable, and non-technical language for consumer audiences." Id.
n209. Id. at 7-8. Quoting the FTC Policy Statement on Deception, the Draft Guidance explained that
""accurate information ... may not remedy a false headline [or signal] because reasonable consumers may only
glance at the headline' and skip the remainder of the text." Id. (alteration in original) (quoting FTC Policy
Statement on Deception at 182).
n210. Id. at 8-9. The Draft Guidance defined "framing" as "how a particular piece of information is stated or
conveyed, such as by emphasizing either the positive or negative aspects of the information or by presenting the
information in vague versus specific terms." Id. at 8. To preempt the possibility that framing risk information
differently might alter the manner in which audience members might respond to that information, the Draft
Guidance clarified that "risk information should be presented in the same terms or with the same degree of
specificity as benefit information." Id. at 9.
n211. Id. at 9-10.
n212. Id. at 10-14.
n213. Id. at 11. Citing to social science research, the Draft Guidance elaborated that "the quantity of
information presented can affect the net impression of the piece. The amount of information presented is one
component that, together with choice of words, color, graphics, voiceover, and other aspects of the piece, can
affect cognitive load, the mental effort required to understand the various components of information in the
piece." Id. at 10-11.
Page 46
n214. Id. at 11. The Draft Guidance defined "material facts" as "those that would influence reasonable
consumers ... about a product." Id. at 12. Among the factors that FDA will use to determine if a fact is material is
the promotional piece's target audience and the nature of the benefit claims it is making. Id. at 12-13.
n215. Id. at 14.
n216. Id. at 11-14.
n217. Id. at 14-20.
n218. Id. at 14-15. In speaking generally to formatting, the Draft Guidance explains that "manufacturers
should note that any [of the] formatting factors could make a piece false or misleading and that each factor could
interact with others to increase this problem or to create a false or misleading impression when there might not
be one if a factor were considered in isolation." Id. at 15.
n219. Id. at 15-16.
n220. Id. at 16-17.
n221. Id. at 17-18.
n222. Id. at 18-19.
n223. Id. at 19-20.
Page 47
n224. See Krysten Crawford, New Worry for Vioxx Victims - Scams, Cnn Money (Dec. 1, 2004, 6:28 PM),
http://money.cnn.com/2004/12/01/news/ fortune500/vioxx_ads/ ("Lawyers have used pop-up ads, spam,
customized Web sites and paid ad searches to find Vioxx users... . So Vioxx lawyers are being aggressive, but
does that mean they're crossing the line? Tort reform advocates think so. "You can't tell me that some of these
lawyers aren't motivated purely by greed,' said Gretchen Schaefer, a spokeswoman for the American Tort
Reform Association. She claims lawyers are promising huge rewards to Vioxx users, even those who aren't
injured, so they can file more lawsuits.").
n225. Regarding the demonstration of a substantial governmental interest, the United States Supreme Court
has said that the second prong of the Central Hudson test does not require "empirical data come ... accompanied
by a surfeit of background information... . We have permitted litigants to justify speech restrictions by reference
to studies and anecdotes pertaining to different locales altogether, or even, in a case applying strict scrutiny, to
justify restrictions based solely on history, consensus, and "simple common sense.'" Lorillard Tobacco Co. v.
Reilly, 533 U.S. 525, 555 (2001) (alteration in original) (quoting Florida Bar v. Went for It, Inc., 515 U.S. 618,
628 (1995)).
n226. See Miller, supra note 14, at 80 (offering survey data in support of the point that "the public concern
and disdain for lawyer advertising coupled with the high price of litigation creates a substantial government
interest to do more to regulate overzealous and potentially misleading lawyer advertising").
n227. Ohralik v. Ohio State Bar Ass'n, 436 U.S. 447, 460 (1978) (quoting Goldfarb v. Va. State Bar, 421
U.S. 773, 792 (1975)); see also Brock, supra note 15, at 156 (noting that "in a lawyer advertising case, the
[substantial government interest] prong of the Central Hudson test is easily met").
n228. See supra notes 178-79 and accompanying text.
n229. See Presenting Risk Information, supra note 177, at 21 ("It is important to re-emphasize that, in
addition, to specific risk-related claims, FDA also considers the net impression conveyed by all elements of a
piece. For this reason, manufacturers should focus not just on individual claims or presentations, but on
messages conveyed by the promotional piece as a whole.").
n230. See Miller, supra note 14, at 80 ("With a television ad, for instance, a lawyer could deliver the
disclosure orally. When an attorney discusses the risks orally during the ad, the lawyer would voice the
disclosure as equally emphatically or prominently as voicing the other claims.").
Page 48
n231. Levine, supra note 10.
Exhibit 7
Mass Tort Lawsuit Lead Generator Jesse Levine Has Victims for Sale - Businessweek
Page 1 of 3
Bloomberg Businessweek
Politics & Policy
http://www.businessweek.com/articles/2013-12-12/mass-tort-lawsuit-lead-generator-jesse-levine-has-victims-for-sale
Need Victims for Your Mass Lawsuit? Call Jesse Levine
By Paul M. BarrettDecember 12, 2013
On April 22, 2011, a Missouri resident named Linda Burke received a phone call from a woman who identified herself as “Sarah.” Burke didn’t know Sarah, but that didn’t
stop the caller from asking some exceptionally personal questions. Had anyone in the Burke household died after taking a diabetes drug called Avandia? Sarah “refused to
tell me who she worked for, [her] address, or phone number, and hung up,” Burke said later, according to state court records. At the time, Avandia’s manufacturer,
GlaxoSmithKline (GSK), was besieged by lawsuits linking Avandia to an increased risk of heart attack. Burke and scores of other Missouri residents wanted no part of the
Avandia litigation, court records show. “Getting an avalanche of calls,” a consumer named Walter Lechtreck complained to the state’s attorney general. “They’re soliciting
about a lawsuit against this pharmaceutical company about Avandia. I’m getting this almost daily. Twice already today.”
After investigating, Missouri Attorney General Chris Koster discovered that a company called Internet Technology Partnerships was behind the solicitations. ITP has ties to
a network of websites including MedRecallNews, ServicesToLawyers, and Pearl-Shucker.com, among others. These companies do law firm marketing and identify clients
for mass-injury lawsuits against pharmaceutical manufacturers. They’re all operated by Jesse Levine of Norristown, Pa.
Levine is not an attorney. His line of work is known as lead generation: Lawyers pay him for the names of alleged victims. He has rivals with names such as All Your
Leads Needs, Tort Law Group, Your Lead Caller, Guaranteed Performance, and MassTortROI (return on investment). They provide the pipeline that connects claimants to
lawyers—or vice versa. The sites are the hidden plumbers of the mass-tort industry, a web of plaintiffs’ attorneys, paid expert witnesses, and accountants who annually
pursue billions of dollars’ worth of lawsuits against companies that make drugs, chemicals, cars, and other products.
Levine prefers a different metaphor for what he does. The “pearls” produced by his trademarked Pearl-Shucker Lead Qualification System are medical patients whose woes
bring large settlements. The system “was developed over the last 10 years and began with a white paper I published in 2002, introducing this landmark process for legal
marketing and data mining,” Levine explains on one of his websites. “Since then, we’ve built a system for developing thousands of qualified case leads and have become
the ‘in-house’ marketing department for law firms of all sizes around the country.”
Levine employs 13 people full time in the Philadelphia suburbs and supplements them with $4-an-hour contractors in the Philippines. His workers sometimes gather names
and personal data that consumers provide to Levine websites. On other occasions, the telemarketers use lists Levine purchases from consumer survey firms that identify
people who’ve purchased certain categories of drugs. Levine’s employees call the prospects, find out if they’ve suffered side effects, and ask whether they’d like to sue the
pharmaceutical manufacturer. There’s no charge upfront. If a consumer says yes and she’s saved her medical paperwork, Levine will sell her name to a plaintiffs’ lawyer.
Leads go for $500 to $2,000 apiece, depending on how thoroughly they’re vetted and the likelihood that the manufacturer in question will ultimately consent to a
substantial settlement. BP’s (BP) agreement last year to pay out what’s now estimated at more than $9 billion to businesses harmed by the 2010 Gulf of Mexico oil spill is
one example of a big settlement that has grown even bigger by the addition of claimants vacuumed up by lead generators.
In theory, these little-known businesses channel legitimate injury victims to upstanding lawyers. State bar rules prohibit lawyers from sharing their client fees with
nonlawyers, but generally it’s not illegal to purchase names of potential clients, according to Stephen Gillers, a professor at New York University School of Law
specializing in professional ethics. “I suppose the concern, as with any business or financial transaction,” he adds, “is that you should know who you’re doing business
with.”
Levine, who advertises himself online as “the Ambassador of consumer advocacy,” has had a long and colorful career as a financial consultant and marketer and comes to
lead generation with troubling baggage. He served two short stints in federal prison on financial fraud convictions. Perhaps his brushes with the legal system inform his
current dedication to righting perceived wrongs. In an Oct. 7 press release on PR Newswire, he described himself as having “worked diligently to ensure that victims of
medical negligence gain maximum compensation for their suffering.”
The business of procuring clients for personal injury lawyers isn’t new. The pejorative term “ambulance chaser” describes not only an attorney who hands out business
cards at accident scenes or emergency rooms but also a nonattorney recruiter. In some places, ambulance chasers are referred to as “case runners.” Traditionally, these
shadowy characters have operated on a small scale, taking $50 or $100 for a promising referral. Earlier this year the Texas Court of Criminal Appeals affirmed the
conviction of a legendary Corpus Christi case runner named Mauricio Celis. Prosecutors alleged Celis collected millions of dollars from plaintiffs’ lawyers from 2004
through 2007. While Celis had close ties with South Texas tort firms, it turned out his own claim to being an attorney was false and led to a criminal sentence of 10 years’
probation.
Plaintiffs’ attorneys value access to large batches of potential clients because the ability to mount hundreds or even thousands of claims provides leverage in settlement
negotiations with a corporate defendant. LexisNexis, a unit of the large British data provider Reed Elsevier (RUK), promises plaintiffs’ lawyers that within 48 hours it will
“fill your new business pipeline with pre-qualified legal leads.” Other companies implicitly concede that some of their prospects may be more reliable than others.
Exclusive Attorney Leads, for instance, charges $695 for the name of a woman who has taken a contraceptive called Yaz and subsequently suffered blood clots, a
complication that can be a side effect of the Bayer (BAYN:GR) product. That’s the price listed online if the Yaz lead has been cleared by an “American” screener. The
name of a similar patient who has been cleared by an “off shore” screener costs only $500, according to Exclusive’s website. Phone messages seeking comment from
Exclusive were not returned. Without conceding wrongdoing, Bayer has so far settled about 1,900 contraceptive cases for a total of more than $400 million.
For several years, Glaxo felt the pressure of mass litigation concerning Avandia. In 2012 the company agreed to pay $3 billion to settle federal and state government claims
that it illegally marketed the diabetes drug and others. In Missouri, Attorney General Koster formally alleged that Levine’s telephone fishing for Avandia plaintiffs violated
the state’s Do Not Call list and failed “to disclose to consumers that the purpose of the call was to solicit the sale of legal services.” Levine denied wrongdoing but agreed to
pay a settlement of $35,000 and to follow the law. In an e-mail, he says he settled only “because legal fees would have exceeded the amount of the settlement (seems
sometimes there is no ‘winning’; you pay, win or lose).”
Several prominent injury lawyers interviewed for this article acknowledged the surge in lead generating, but said they personally don’t do business with Levine or his
rivals. “I don’t know who’s behind the curtain, that’s what concerns me,” says Tor Hoerman, the founder of TorHoerman Law in Chicago. He concedes, though, that within
the firm’s large pools of clients, it may represent individuals originally procured by lead generators, sold to other plaintiffs’ firms, and then referred to TorHoerman Law.
Some cross-referencing of Levine’s marketing materials with public court records reveals that in at least one case involving Actos, a diabetes drug, Hoerman is representing
a lead identified by Levine. Hoerman serves as a lead counsel in a consolidated case in state court in Cook County, Ill., involving thousands of claims against Takeda
Pharmaceutical (4502:JP), which makes Actos, a medication that allegedly increases the risk of bladder cancer. Takeda has denied wrongdoing. One of Hoerman’s clients
in that litigation is Edward McCusker of Jacksonville, Fla. McCusker’s profile matches that of an “Edward” featured on Levine’s website as a sample Actos lead. “Edward
was taking Actos from 2005-2008 as treatment for type II diabetes,” the site states. “While taking Actos he was diagnosed with bladder cancer in 2006. … [T]he cancer
recurred several times.”
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Hoerman says the Branch Law Firm in Albuquerque referred McCusker to him as a client. “I don’t ask whether referring law firms use [lead generators],” he says. Turner
Branch of the Branch Law Firm didn’t respond to a detailed e-mail seeking comment or a follow-up phone call. “I’ve made the assumption that they [referring law firms]
have checked out the ethics of these arrangements,” Hoerman adds. “I guess I need to know more about it.” When informed of Levine’s history, Hoerman says, “Oh, s---.
Yeah, I’ve got to look into this.”
During the pre-Internet phase of his career, Levine operated Physicians Finance Group in Philadelphia. He assured clients that for a fee he would help them secure loans.
“He got clients by advertising in the Wall Street Journal, through word-of-mouth, and a network of brokers throughout the country,” a federal prosecutor named Linda Dale
Hoffa told the Philadelphia Inquirer in 1989. Unfortunately, Levine didn’t get his clients the $130 million in loans he promised.
“Not one transaction was completed, and not one advanced fee was returned,” Hoffa said. Levine took more than $1 million, spending some of it on his family, on himself,
and for office redecoration, according to the government. These activities led to convictions in Philadelphia and Chicago and Levine’s two visits to the federal prison in
Allenwood, Pa., one from 1989 to 1990 and the other from 1994 to 1995. In April 1994, the sentencing judge in Chicago described the punishment as “highly lenient.”
Now in his mid-70s, Levine is of average height, slim, and sinewy. He has short-cropped silver hair, dresses nattily in dark tones, and wears mirrored aviator-style
sunglasses. He’s outgoing and, former colleagues attest, nonconfrontational. “An office manager who worked for Levine in 1984 and 1985 said in court papers that she
occasionally fielded telephone calls from irate clients and that Levine had instructed her to tell the clients he was not available,” the Inquirer reported in February 1989. “If
a client showed up, he left the office and returned after the client left.”
I met Levine for two conversations at eateries at the hectic 30th Street Amtrak train station in Philadelphia. He expressed regret about his past crimes and said he had feared
they’d come back to haunt him: “This is my nightmare for 25 years.” He added, “I paid my debt to society, and I think now I’m helping people.”
One of the ways Levine cultivates lawyers is by attending and sponsoring plaintiffs’ litigation seminars. Pearl-Shucker.com was advertised as a “featured sponsor” of the
Pradaxa Litigation Conference at the Fontainebleau Miami Beach hotel in November 2012. Manufactured by Boehringer Ingelheim, Pradaxa blood-thinning medication has
been targeted by more than 1,300 claims linking it to dangerous bleeding. (Boehringer has denied wrongdoing.) The Miami Beach gathering was co-chaired by Hoerman
and included lectures such as “State of the Pradaxa Litigation: Multi-District Litigation Formation, Case Management Orders, Common Benefit Fees, and Foreign
Defendants,” which was delivered by Mikal Watts of Watts Guerra in San Antonio. Watts is one of the best-known mass-tort lawyers in the country.
Illustration by Tim Lahan
Ryan Thompson, one of Watts’s law partners and another presenter at the Pradaxa conference, says Watts Guerra takes referrals from other law firms but doesn’t directly
employ Levine or other lead generators. Asked whether Watts Guerra’s stable of thousands of clients might include “pearl-shucked” leads, Thompson says, “It’s certainly
possible.” He calls lead generators “leeches on our industry” and says the prospective clients they identify often don’t pan out. Still, he expects lead generators to
proliferate, “because there’s money to be made.”
Thompson acknowledges, more broadly, that questions about how mass-tort lawyers gather clients will continue. His partner Watts has run into controversy from his
representation of thousands of claimants seeking money from BP as a result of the April 2010 Gulf oil spill. In February federal agents raided two Watts Guerra offices in
San Antonio and served search warrants for files related to BP cases. “The investigation concerns the origin of the BP claims,” says Michael McCrum, Watts’s criminal
defense lawyer. McCrum says Watts did nothing wrong and that, as far as he knows, federal investigators are not focusing on outside lead-generation firms. Federal
authorities declined to comment.
That’s not to say lead generators have failed to notice the multibillion-dollar BP litigation, which is being supervised by a federal judge in New Orleans. With characteristic
verve, Levine has set up bpclaims.info, a website with a physical address on West Main Street in Norristown, Pa.
“The most common misconception” of the BP settlement agreement, Levine says in a statement quoted on the BP Claims site, is that businesses have to be located on the
coast to qualify. “Any business in Alabama, Louisiana, Florida, Texas, and Mississippi that suffered a loss of revenue between May and December 2010 could be leaving
settlement money on the table,” he adds. “It’s nothing short of a moral imperative to make sure every business in the five states takes advantage of the court-ordered
settlement and collects every penny in the fund. Given the severe financial, natural, and emotional toll exacted on American shores by this foreign company, it’s almost a
patriotic duty.”
Barrett is an assistant managing editor and senior writer at Bloomberg Businessweek. His new book, Law of the Jungle, tells the story of the Chevron oil pollution case in
Ecuador.
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Exhibit 8
Competing for Clients, and Paying by the Click - New York Times
Page 1 of 3
October 15, 2007
SIDEBAR
Competing for Clients, and Paying by the Click
By ADAM LIPTAK
You can do cool things with Google, like take the pulse of the legal profession.
Google is, of course, more than a search engine. It also sells advertising, including the shaded “sponsored
links” that run next to the real search results. It auctions off those ads to advertisers, who agree to pay a
given amount each time someone clicks on their link.
“Christmas recipes,” for instance, was going for 54 cents per click the other day. “Britney Spears” cost 36
cents, and “Britney Spears nude” only 21 cents.
But “Oakland personal injury lawyer” cost $58.03. “Asbestos attorney” cost $51.68. And “mesothelioma
attorney Texas” — mesothelioma is a kind of cancer caused by inhaling asbestos — cost $65.21.
A Web site called CyberWyre, at www.cwire.org, posts a regularly updated list of the most expensive search
terms. “The four leading industries are definitely law, medicine, finance and travel,” said Sam Elhag, who
writes for the site. On a recent visit, lawyers and lung cancer dominated the top 10.
Ted Frank, the director of the Legal Center for the Public Interest at the American Enterprise Institute, said
the fact that some personal injury lawyers were willing to pay $60 a click was telling, particularly given that
relatively few of those clicks would bring in actual business.
“These lawyers don’t really litigate cases — they settle cases,” Mr. Frank said. “And they need a big
inventory of cases. The only job of the attorney is to come up with the clients.”
“There is nothing wrong with what Google is doing,” he added. “There is nothing wrong with advertising for
clients. It’s just fascinating that clients are worth so much.”
And there is no client more lucrative than one with mesothelioma. That word has hovered near the top of
the CyberWyre list since 2003, Mr. Elhag said.
William G. Childs, an assistant professor at Western New England College School of Law, explained why, as
he put it, “mesothelioma is clearly the highest-dollar value.”
“It doesn’t happen except through asbestos, with vanishingly small exceptions,” Professor Childs said. “The
vast majority of cases settle and settle rather easily. And they’re not hard to work up.”
The market for Google search terms says something, then, about the market for plaintiffs’ lawyers. For
reasons that baffle economists, personal injury lawyers all charge roughly the same amount for their
services, typically a third to 40 percent of any recovery.
http://www.nytimes.com/2007/10/15/us/15bar.html?_r=2&adxnnl=1&pagewanted=print...
12/31/2014
Page 2 of 3
“What explains this puzzle?” asked Alex Tabarrok, who teaches economics at George Mason University. “No
one knows.” It may be, he said, that offering to work for less might be thought to signal that you are a bad
lawyer.
In any event, Mr. Frank said, the high prices on Google are a direct consequence of this economic anomaly.
“Instead of competing on price,” he said of plaintiffs’ lawyers, “they compete on Google.”
Google advertising has the benefit of being narrowly focused, said Walter Olson, a senior fellow at the
Manhattan Institute, a conservative research group. “I assume relatively few people searching for
‘mesothelioma’ are doing it out of idle curiosity,” Mr. Olson said.
But some of them are looking for medical information, and they are often disappointed. “If you are
searching for information on mesothelioma,” Mr. Olson said, “you will have to dodge dozens and dozens of
lawyer advertisements.”
The top sponsored link that came up yesterday with a search for “mesothelioma,” for instance, was for a site
that promised information “about mesothelioma’s causes, symptoms and types of treatment.” It urged
readers to contact a toll-free number for more information. In the fine print at the bottom, the site revealed
that it was sponsored by a Texas law firm.
For what it’s worth, what little medical information appeared on the site seemed sound and disinterested.
That is not always the case, Mr. Olson said. “In areas like cerebral palsy,” he said, lawyers’ Web sites “will
steer you into highly tendentious information.”
Personal injury lawyers are not the only ones who advertise on Google. “Tax lawyer” cost $34.32 the other
day, “bankruptcy lawyer” $8.46 and “patent lawyer” $5.08.
“Pro bono lawyer” — the kind who handles cases without a fee — went for $2.89. (The top advertiser was a
referral service for criminal defense lawyers. And no, they were not volunteering to handle cases pro bono.)
Susan Crawford, a visiting professor at the University of Michigan Law School, said lawyers’ enormous
enthusiasm for Internet advertising meant the medium might have reached middle age. “Lawyers are
usually the slowest to adopt any form of new technology,” she said.
Professor Childs, who has written about advertising by lawyers on Google on his TortsProf blog,
lawprofessors.typepad.com/tortsprof, said he sometimes typed in Web site addresses rather than clicking
on sponsored links when doing his research.
“It feels a little weird to cost them 50 bucks to satisfy my curiosity,” he said.
That had not occurred to me. In working on this column, I looked at a bunch of lawyers’ Web sites, at a
cumulative cost to them of, oh, $1,000. Sorry.
Online: An archive of Adam Liptak’s articles and columns: nytimes.com/adamliptak.
Copyright 2007The New York Times Company
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Exhibit 9
Page 1
Copyright (c) 2012 University of Memphis Law Review
University of Memphis Law Review
Spring, 2012
University of Memphis Law Review
42 U. Mem. L. Rev. 559
LENGTH: 25033 words
ARTICLE: Specious Claims and Global Settlements
NAME: S. Todd Brown*
BIO: * Associate Professor of Law and Director of the Center for the Study of Business Transactions, University at
Buffalo Law School.
LEXISNEXIS SUMMARY:
... Predictable settlement evidentiary targets generate opportunities and incentives for repeat players to develop and
present intrinsically bad mass tort claims as good. ... Although there may never be another mass tort that possesses all
of the factors that have complicated asbestos personal injury litigation-including the long latency period between
exposure and manifestation of an injury, unique association with a horrific disease, sheer volume of potential victims,
shocking misconduct by key defendants and defendant elasticity-it nonetheless provides a useful study of the impact of
judicial management and settlement expectations on private behavior. ... In a 2010 study, the RAND Institute for Civil
Justice reported that 86% of the claims paid by asbestos trusts in 2007 and 2008 were nonmalignant claims, which have
largely been discredited elsewhere and subjected to considerable legislative and judicial restrictions. ... Although many
of the courts overseeing asbestos litigation routinely limited discovery into individual claims, Judge Jack approved
increasingly aggressive inquiries into the screening practices that generated the claims before her. ... As in the litigation
screenings in the asbestos and silica litigations, fen-phen doctors who generated large volumes of qualifying claims
could earn millions of dollars within a few months. ... For example, although early oversubscription in the fen-phen
global settlement might be explained by reference to the fact that compensation for unaudited claims was paid before
the audited claims were reviewed, thus allowing repeat players to obtain large recoveries before their entire claim pools
might be subjected to audit, several objectively specious claims were submitted after the court ordered audits of every
claim submitted, criminal investigations were announced, and civil suits against some of those involved were initiated.
... In asbestos bankruptcies, where a select group of plaintiffs' firms largely dictate the terms of any trust distribution
procedures and claim processors must rely upon repeat business from these same firms, evidentiary targets will vary
little and tend to be far easier to satisfy than in the tort system and less likely to change unexpectedly than private
inventory settlements. ... In mandatory settlements, for example, incurring any costs beyond those required to satisfy
the effective settlement criteria may not yield any additional benefits. ... If the manner of selecting claims is
predictable, those submitting claims may alter filing patterns to reduce the chances that their claims, or those within
their inventories that may not withstand scrutiny, will be audited. ... If the claims submitted are homogenous, random
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sampling of an entire claim pool is the most straightforward and ostensibly fair method of both identifying offending
claims and spreading the risk of audit equally among those advancing claims.
TEXT:
[*560]
I. INTRODUCTION
Few problems are more disruptive to the efficient negotiation and operation of comprehensive mass tort
settlements than oversubscription, which, at times, appears to be fueled primarily by specious claims. In settlements
with opt-out rights, a flood of claims can generate a market for lemons, with the weakest claims submitted to the
settlement and the strongest opting out and seeking recovery at trial or in private settlement. In binding settlements,
oversubscription may result in a common problem, requiring dramatic reductions in payment that effectively transfer
recoveries from those with intrinsically strong claims to those with weak claims.
Why are some comprehensive mass tort settlements overrun by specious claims? At first glance, the question
suggests relatively straightforward answers: greed, the unethical schemes of a few plaintiffs that are "bad apples," and
the inability or unwillingness of courts and defendants to challenge them. Thus, payment of specious claims is merely
another cost of settlement, n1 and the "bad [*561] apples" who submit them clearly recognize that it will cost
settlement administrators more to uncover than it will to simply pay the claims.
Without rejecting the bad apple explanation entirely, the available evidence suggests that specious claims within
some mass torts are more complex than this explanation suggests. Specious filings have overwhelmed not only those
settlements where advancing frivolous claims is rational, but also those where private self-interest should, in theory,
discourage them. n2 In these cases, the vast majority of questionable claims were recruited, developed, and advanced by
groups of repeat players following a streamlined and compartmentalized model of litigation. And, as in other group
settings with comparable patterns of collective misconduct, n3 the fact that many participants are strikingly ordinary
and otherwise ethical, law-abiding actors indicates that the bad apple rationale is, at best, incomplete. n4
In order to address this question in greater detail, Part II of this Article provides a descriptive account of the
entrepreneurial [*562] claim markets n5 that generated specious claims in three high profile mass tort litigation
contexts: asbestos litigation, silica litigation, and fen-phen litigation. Although frivolous claims appear in a wide variety
of litigation and claim resolution settings, these cases were selected due to the volume of specious claims advanced and
the availability of claim development and filing information that is not commonly accessible in mass tort litigation and
settlement. The discussion not only identifies the specific practices that generated large volumes of dubious claims, but
also places them in the context of the litigation and settlement environments in which they arose.
With the benefit of this experience, Part III identifies some distinguishing characteristics of the specious claim
markets discussed in the case studies. Although commonly viewed by commentators as an adverse selection problem in
which claim quality and value are fixed-but hidden-types, n6 this discussion evaluates the extent to which
comprehensive "going forward" settlements n7 [*563] may encourage practices that resemble claim manufacturing
rather than fact development and yield circumstances in which rational ignorance prevails both at the group and
individual level among repeat players. Even to the extent that some participants may have opportunities or obligations
to identify and prevent specious claim development practices, compartmentalization of responsibility and cognitive
justifications that tend to neutralize comparable concerns in other settings work in much the same way in
entrepreneurial mass tort claim development. This presents not only problems for ethical enforcement, but also suggests
that merely escalating the risk of discovery and severity of individual sanctions may not be as effective as conventional
wisdom suggests.
With this basic framework in mind, Part IV evaluates the potential for future specious claim markets in modern
aggregate litigation and advances proposals for controlling these markets in collective settlements. This Part
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demonstrates that settlements susceptible to targeted development require more sophisticated provisions that address the
opportunity, incentive, and neutralization patterns that fuel specious claim markets. Specifically, this Part emphasizes
the need to ensure that deterrence messages reach the appropriate individuals and sub-groups, identify and target group
incentives to advance specious claims, and manage their opportunities to do so. Although others have suggested the use
of statistical methods to frame mass tort settlement values, this Part explains that these methods may be more valuable
in controlling oversubscription and specious claim filings against claim resolution facilities post-settlement and outlines
how these methods may be effectively employed in this context. To that end, this discussion provides a general
framework for settlement criteria, proposes an adaptive audit approach to monitoring claims in going forward collective
settlements, and suggests a more active role for courts in settlement planning.
II. Three Studies in Specious Claim Markets
The three cases analyzed below-regarding asbestos litigation, silica litigation, and fen-phen litigation-present
distinct sce [*564] narios in which an overwhelming mass of specious claims flooded courts or comprehensive
settlements. Although there may never be another mass tort that possesses all of the factors that have complicated
asbestos personal injury litigation-including the long latency period between exposure and manifestation of an injury,
unique association with a horrific disease, sheer volume of potential victims, shocking misconduct by key defendants
and defendant elasticity-it nonetheless provides a useful study of the impact of judicial management and settlement
expectations on private behavior. Likewise, the silica litigation provides a helpful point of comparison to asbestos
litigation even though the specious claim market there never gained an effective foothold. The fen-phen case is perhaps
most interesting because it challenges our expectations concerning the propensity for specious claims to arise where
discovery seems likely and sanctions are potentially severe.
A. Specious Claim Markets in Asbestos Litigation and Settlement
Asbestos litigation has been aptly characterized as both the "mother of all mass torts" and the "mother of
invention" due to the special problems it posed for courts. n8 Its history has been marked by a series of judicial
experiments, both in substantive and procedural law, across individual states and in federal courts. This history also
makes asbestos litigation an ideal starting point for this discussion.
1. The Historical Litigation and Settlement Environment in Asbestos Litigation
To appreciate the manner in which asbestos litigation evolved, it is helpful to understand the problems it created
for courts. The long latency period between exposure to airborne asbestos fibers and the onset of asbestos-related
disease made identifying the sources of the plaintiffs' asbestos exposure difficult. n9 [*565] Though many who are
exposed to asbestos and develop markers suggesting physiological damage from this exposure may not become
impaired until years later, they might be barred from pursuing litigation if they wait until this impairment occurs. n10 In
the interim, potential claimants would be forced to bear the financial burden of regular medical screening and the
personal costs of living in the shadow of potentially developing debilitating or even terminal asbestos-related diseases.
Some courts sought to reduce the barriers to recovery, enable plaintiffs to preserve their rights, and shift costs from
those exposed to asbestos to those responsible for the exposure through a variety of changes that have been
characterized as "special asbestos law." n11 These modifications include recognizing physiological changes as
compensable harms even where the plaintiff has no discernible impairment, relaxing evidentiary burdens to account for
the long latency period of asbestos disease, and embracing plain [*566] tiff-friendly adjustments to the calculation of
damages. n12 As a result, many claims that would not be compensable in typical personal injury cases-e.g., those
lacking sufficient evidence to establish specific causation-could now go before a jury and be compensable. n13
Beyond the expansion of substantive law, the prevalence of "shotgun complaints" and relaxed venue and joinder
rules in some jurisdictions generated amorphous consolidations of vague and indistinguishable claims. Plaintiffs with no
connection to the forum state or only speculative, tangential ties to the forum were nonetheless allowed to join in cases
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with in-state plaintiffs. n14 These complaints often provided notice of the basic facts of the plaintiffs' respective cases in
name only. n15 [*567]
As a practical matter, consolidation, liberal pleading, and limited discovery n16 have had a substantial impact on
pre-trial dispositive motions. It is simply not possible to establish that no reasonable jury could find for a specific
plaintiff when the foundations of her claim are so vague and sweeping that they could be fairly read to assert any
number of potential allegations. n17 Thus, even if the ability to survive summary judgment or a motion to dismiss might
serve as a reasonable baseline for settlement purposes in theory, the number of claims that could do so under this
framework could be far greater than expected in traditional tort litigation.
Faced with the administrative burden of managing this litigation, some courts became adept at encouraging the
parties to settle. n18 In Madison County, Illinois, for example, defendants fre [*568] quently complained that the
asbestos court implemented "a system that made a fair trial almost impossible" by, among other things: rejecting
requests for more definitive statements or discovery defendants needed to prepare for trial effectively, limiting the
defense case for trivial discovery oversights, and forcing defendants to prepare for multiple trials on the same day while
allowing the plaintiff to choose which one would proceed when that day arrived. n19 Less extreme but comparable
examples of settlement pressure have been noted in other states. n20 Regardless of the degree to which defendants'
characterizations fairly capture the reality of the procedures employed, they reflect a common perception that the deck
was stacked against non-settling defendants.
Within these jurisdictions, claims that survived early dispositive motions were most often settled, either
individually or as [*569] part of inventory settlements. n21 In inventory settlements, firms generally conditioned the
settlement of their strongest claims on the concurrent settlement of some or all of the other claims they represented. n22
Even claims that had not yet been subjected to discovery or, for that matter, placed on an active trial docket, could be
settled and paid. n23 Although some of these inventory settlements may have conditioned payment on the production of
nominal supporting evidence n24 -usually no more than sufficient to survive summary judgment-this was not always the
case.
Under the circumstances, it is not surprising that both plaintiffs and defendants preferred private administration
schemes for settling asbestos claims. For several years, most asbestos claims were filed in "plaintiff friendly"
jurisdictions n25 where mass settlement was a given, n26 and administrative approaches allowed both sides to avoid
some of the expense of litigation. Thus, some defendants agreed to forward-looking inventory settlement arrangements
with specific firms, n27 while others adopted larger comprehensive settlement administration plans involving multiple
firms n28 [*570] and other defendants. n29 These settlements typically provided fixed grids and criteria similar to that
used by the Manville Personal Injury Settlement Trust. n30 As a result, using a claim's prospects for surviving summary
judgment as the nominal standard for compensation was transformed from a common practice into a fixed settlement
target.
The problem with these private arrangements, however, was that they failed to provide lasting peace and, in fact,
tended to encourage firms to recruit more claims and submit them for payment. n31 In short, it became apparent that
any settlement that failed to resolve existing and future claims could generate more new claims than it resolved. n32
In the mid-1990s, the leading candidate for resolving all current and future mass tort claims appeared to be a class
action suit under Rule 23 of the Federal Rules of Civil Procedure. n33 Under the proposed comprehensive class action
settlements in Amchem Products, Inc. v. Windsor n34 and Ortiz v. Fibreboard Corp., n35 the settlement proponents
settled inventory claims and [*571] attempted to limit future asbestos claimants' recoveries to a proposed distribution
procedure that paid claims according to fixed categories upon the submission of sufficient evidence to satisfy the
applicable criteria. n36 This approach promised the efficiency of the administrative model of private settlement plans
and was intended to afford defendants lasting peace from future claims. n37
After the Supreme Court effectively foreclosed class action certification for asbestos claims in Amchem and Ortiz,
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thus dooming the class action settlement approach, n38 litigants pursued the same basic settlement approach under
Section 524(g) of the Bankruptcy Code. n39 In this system, the lawyers who control the largest asbestos claim
inventories also control critical appointments in the bankruptcy case, n40 enjoy little resistance from most
defendant-debtors and others in designing the terms of the resulting trusts, n41 and hold leadership positions in the
trusts once they are established. n42 Not surprisingly, these terms and the manner in which the trusts operate largely
reflect the interests of the firms that establish them. n43 Thus, much like asbestos litigation and settlement practice
[*572] in state court, compensation from asbestos bankruptcy trusts is available at a standard that provides a rough
approximation of whether the claims could survive summary judgment. n44 The result has been a system that neither
resembles the traditional adversary process nor compensates for the policing functions of adversary litigation that have
been stripped away. n45
2. Claim Recruiting and Development
To meet the demand for rising asbestos claims, enterprising lawyers drew inspiration from medical screening and
monitoring programs. n46 Historically, these programs were used to evaluate at-risk populations for signs of disease,
with the goal of identifying and treating these diseases early. n47 These firms often enlisted un [*573] ions and other
organizations to nominally sponsor screenings of current and former workers in high-risk industries, n48 and they could
easily present these screenings as a public service. n49 Moreover, the lawyers' presence could be seen as
complementing this service; ensuring that victims would obtain the medical benefits of the screening, while providing
ready access to lawyers who could help them preserve and pursue their legal rights. n50 [*574]
Over time, litigation screenings elevated claim-manufacturing efficiency over medical accuracy. Untrained
employees assumed responsibility for taking medical histories, n51 which were often incomplete and inaccurate. n52
Similarly, some screening companies intentionally performed tests incorrectly to increase the likelihood of generating
signs of impairment. n53 Many screening doctors did not see their work in this area as "medical work"; n54 they
assumed their role was not to provide medical care, but to assist the lawyers in developing a colorable case for each
prospective plaintiff.
As a result, firms that used litigation screening companies could generate claim volumes that far exceeded those
achievable through traditional medical screenings. In a 2004 study, for exam [*575] ple, researchers found that an
objective medical screening identified potential asbestos injuries in only 4.5% of the x-rays examined, while litigation
screenings had produced ostensible diagnoses of asbestos personal injuries in an astounding 95.9% of cases from the
same x-ray pool. n55 This recruiting system was remarkably skilled at maximizing the size of the lawyers' respective
inventories because the enterprise could focus on building a mass of claims that satisfied a low nominal compensation
standard with little care for whether or not those claims represented actual injuries recognized under applicable tort law.
n56
3. The Impact of Specious Claims on Asbestos Settlements and Recoveries
A telling point of general reference for the impact of asbestos claim inflation generally is the Manville Personal
Injury Settlement Trust. Prior to its bankruptcy in 1982, the Johns-Manville Corporation ("Manville") was the lead
defendant in thousands of suits across the country because numerous asbestos personal injury victims could be linked to
Manville products. n57 For much the same reason, a substantial number of asbestos claimants have since pursued
claims against the Manville Trust. n58
Overwhelming claim volumes, including tens of thousands of claims that were generated through dubious
litigation screenings, have dramatically curtailed payments from the Manville Trust to claimants for most of its
existence. Although Manville's [*576] Disclosure Statement for its Chapter 11 Plan estimated that the trust would
receive between 83,000 and 100,000 claims throughout its lifetime, 100,000 claims were filed within the first year
alone. n59 In fact, more than 190,000 claimants were seeking compensation from the fund by January 1992. n60 The
trust ultimately obtained authority to revise its payment scheme, the heart of which was the dramatic reduction of
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payments to new claimants. n61 Still, by 2005, the trust had received over 690,000 claims-excluding withdrawn
claims-and was paying 5% of the scheduled value to settling claimholders. n62
The Manville example unfortunately reflects the common reality across asbestos bankruptcy trusts. n63 In a 2010
study, the RAND Institute for Civil Justice reported that 86% of the claims paid by asbestos trusts in 2007 and 2008
were nonmalignant claims, n64 which have largely been discredited elsewhere and subjected to considerable legislative
and judicial restrictions. n65 Given the volume of claims, "most trusts do not have sufficient funds to pay every claim in
full and, thus, administrators set a payment percentage that is used to determine the actual payment a claimant will be
offered." n66 Specifically, the median payment percentage of the trusts studied was 25% and fell as low as 1.1%. n67
[*577]
Notwithstanding this persistent pattern, courts continue to confirm asbestos bankruptcy plans that encourage
oversubscription. In 2009, for example, Judge Gerber of the United States Bankruptcy Court for the Southern District of
New York approved the 524(g) plan in the T H Agriculture & Nutrition ("T.H.A.N.") bankruptcy case based, in part, on
representations that all current and future asbestos claimants would be paid in full. n68 Although only 14,024 claims
were pending prior to the bankruptcy n69 and a mere 12,486 were qualified under the claim review process as of the
effective date, 93,331 claimholders were allowed to vote on the plan. n70 By the time the T.H.A.N. trust began
accepting post-petition claim filings in April 2011, the trust had already paid out nearly $ 400 million to claimants and
raised its projected total liability from $ 900 million to roughly $ 2.5 billion, requiring the trust to reduce its payment
percentage to 30% going forward. n71
The transformation of T.H.A.N. from a peripheral defendant, to targeted defendant, and, ultimately, to the source
of yet an [*578] other asbestos trust plagued by oversubscription, is remarkable. During its first three decades as a
peripheral asbestos defendant, T.H.A.N. paid approximately $ 2 million total to asbestos plaintiffs in the tort system.
n72 Less than five years after it became a targeted defendant in 2003, T.H.A.N. was in bankruptcy. Moreover, a mere
eight years after its defendant profile changed, T.H.A.N.'s aggregate liability had grown more than 1250-fold in
connection with its global settlement. n73
Of course, oversubscription has had substantial consequences for otherwise viable companies and plaintiffs with
intrinsically strong claims alike. In asbestos, specious claims have historically overwhelmed courts n74 and diverted
compensation from strong claims to weak claims and the lawyers that bring them. n75 And though many defendants
would have faced substantial liability for intrinsically strong asbestos claims alone, this surge of specious [*579]
claims forced dozens into bankruptcy n76 and transformed asbestos litigation into an "endless search for a solvent
bystander." n77
B. Silica Personal Injury: A Failed Specious Claim Market
While asbestos mass tort litigation has experienced multiple peaks and valleys in its forty-year history, silica
personal injury filings did not reach epic proportions until the early 2000s. n78 Given the ready comparisons between
asbestosis and silicosis litigation, plaintiff-oriented litigation conferences and defense-side journals alike touted silica
litigation as the "next asbestos." n79 Indeed, the Wall Street Journal reported that silica mass tort litigation appeared
poised to rival asbestos litigation, both in terms of size and character. n80 [*580]
Notwithstanding its promising start, silica personal injury litigation as a mass tort was "essentially over" by the end
of 2005. n81 In 2003, more than 10,000 of these claims were consolidated in Multidistrict Litigation 1553 ("the Silica
MDL"), which was overseen by Judge Janis Jack in the United States District Court for the Southern District of Texas.
n82 In 2005, following extensive discovery and a Daubert hearing, Judge Jack issued an opinion n83 that exposed
numerous flaws in the litigation screening practices-largely borrowed from asbestos litigation practice n84 -that
generated the vast majority of the underlying claims.
Although many of the courts overseeing asbestos litigation routinely limited discovery into individual claims,
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Judge Jack approved increasingly aggressive inquiries into the screening practices that generated the claims before her.
As in other multidistrict litigation, n85 the court required the submission of plaintiff fact sheets that included relevant
medical and diagnostic information, including the identity of the doctor diagnosing the plaintiff with a silica-related
disease and copies of supporting documentation. n86 Moreover, notwithstanding plaintiffs' efforts to quash subpoenas
directed to the diagnosing doctors due to their designation as consulting experts, the defendants were able to depose Dr.
George Martindale. n87 Following some troubling revelations at this deposition, the court "proposed Daubert
hearings/Court depositions for all of the remaining diagnosing doctors, as well as the screening companies (such as
N&M) that hired most of them." n88 [*581]
The court's inquiry revealed a number of disturbing practices that mirrored those found in asbestos litigation.
Among other things, those who took medical histories and performed complicated pulmonary function tests had no
medical training, n89 doctors performed rushed examinations-if any physical exams occurred at all-and "simply
ignored" differential diagnosis, n90 and screening companies "shopped" individual x-rays to different doctors until
receiving a positive diagnosis. n91 One doctor even left pre-signed ILO forms n92 with the screening company. n93
Moreover, some law firms only paid the screening companies for positive diagnoses, n94 giving the screening
companies and the doctors they employed a strong financial incentive to generate a high positive reading yield.
In sum, this inquiry revealed a practice that effectively ensured that the doctors and others involved could avoid
accountability. Specifically, screening companies divided responsibility for several critical steps in the medical review
process, n95 so nobody "assumed overall responsibility and oversight for the entire process." n96 Indeed, most of the
silica screening doctors justified their involvement by marginalizing their own roles. They argued that most of the work
was done by others, n97 that they were misled into believing they were merely verifying previous diagnoses, n98 that
they were not really diagnosing anyone with anything or otherwise [*582] practicing medicine, n99 and that the
misleading language in the reports they signed was merely legalese prepared by lawyers or screening company officials.
n100
As a result of these practices, the rate of positive diagnoses was shockingly high. One of the screening companies,
for example, "found 400 times more silicosis cases than the Mayo Clinic (which sees 250,000 patients a year) treated
during the same period." n101 Moreover, although a dual diagnosis of asbestosis and silicosis is the medical equivalent
of hitting a hole-in-one, the vast majority of the plaintiffs advancing silicosis claims in the Silica MDL had been
involved in asbestos litigation and had submitted nominal diagnoses of asbestosis in support of their claims for payment
from asbestos settlements. n102 On the stand, one of the doctors who rendered conflicting diagnoses for the same
plaintiff in the Silica MDL and asbestos litigation said he "didn't know" if he could explain the discrepancy between the
two diagnoses and subsequently asked for counsel, terminating his testimony. n103 As Judge Jack surmised:
These diagnoses were about litigation rather than health care. And yet this statement, while true, overestimates the
motives of the people who engineered them. The word "litigation" implies (or should imply) the search for truth and the
quest for justice. But it is apparent that truth and justice had very little to do with these diagnoses-otherwise more effort
would have been devoted to ensuring they were accurate. Instead, these diagnoses were driven by neither health nor
justice: they were manufactured for money. n104
Following the opinion, few of the silica claims were pursued in state court. In Texas, for example, of the
approximately 5839 silica cases technically on the docket, only fifty-four plain [*583] tiffs attempted to satisfy the
medical reporting law passed in 2005, and only twenty-two were active as of September 2010. n105
C. The Fen-Phen Settlement Specious Claim Market
Fen-Phen was a wildly popular anti-obesity treatment in the 1990s. The FDA requested its withdrawal in
September 1997, after reports suggested a connection between use of the treatment and valvular heart disease and
pulmonary hypertension, primarily in women. n106 The subsequent flood of personal injury claims against American
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Home Products, the distributor of the drugs suspected in causing these injuries, ultimately led to the Nationwide Class
Action Settlement Agreement. n107 At the time, this settlement was considered an impressive achievement; it appeared
to overcome the legitimacy concerns that doomed Amchem and Ortiz, n108 and its claim qualification criteria appeared
to limit the potential for over-claiming. This section highlights the conditions of the settlement and how,
notwithstanding its strict parameters, a clear specious claim market arose and flooded the settlement with claims.
1. The Nationwide Class Action Settlement Agreement
Much like asbestos trusts and other comprehensive settlements, the Nationwide Class Action Settlement
Agreement required claimants to submit medical evidence, including a physician's report, demonstrating a qualifying
medical injury. n109 The [*584] assessment form submitted by board-certified cardiologists or cardiothoracic
surgeons to classify claims required use of a specified formula in support of the doctor's determination that the claimed
valvular leakage was mild, moderate, or severe. n110 In addition, the form required information concerning the
claimant's medical history. n111
To verify the quality of the claim pool, the settlement agreement established a detailed audit process. Unlike most
asbestos settlements and trusts, audits of 15% of the claims filed were mandatory rather than discretionary or
conditioned on the consent of plaintiffs' counsel. n112 The settlement also provided for severe, albeit discretionary,
penalties in the event the court concluded that there was no medical basis for an audited claim. n113 These penalties
included audits of other claims involving the same attorneys or physicians, payment of certain costs and fees, and
potential referral for criminal prosecution. n114
2. Oversubscription and Specious Claims
Although the fen-phen settlement was carefully structured to screen out weak claims, it was not infallible. Given
the structure of the settlement, a claimant with a disqualifying history might otherwise qualify if the doctor omitted that
history from the Green Form. Moreover, if the doctor exaggerated the measurements of a claimant's valvular leakage,
the claimant might qualify for a substantially higher payment classification under the matrix established in the
settlement than she was otherwise entitled. Thus, [*585] plaintiffs could readily advance claims that appeared to
satisfy the settlement criteria where, in fact, their claims had little or no intrinsic merit.
Several plaintiffs' lawyers and screening service providers recruited dozens of doctors to review large volumes of
echocardiograms, many of which had actually been taken by technologists in hotel rooms and other sites around the
country. n115 As in the litigation screenings in the asbestos and silica litigations, fen-phen doctors who generated large
volumes of qualifying claims could earn millions of dollars within a few months. n116
The manner in which these "echocardiogram mills" operated generated objectively specious claims. Among other
things, some technologists systematically over-read and over-measured the echocardiograms to show that the patients
had positive readings when they did not or qualified higher leakage requirements than the tests actually reflected. n117
Nonetheless, some of the doctors either signed off on the technologists' readings without any review or delegated their
review obligations to other parties. n118 One doctor allegedly spent between sixteen seconds and no more than seven
minutes per diagnosis and intentionally manipulated the equipment to capture misleading images to generate ostensible
diagnoses. n119 In at least one case, the U.S. Attorney's office alleged that the measurements reported on the form
"were not consistent with the measurements of hearts of human beings." n120
Notwithstanding the potential for audit, the settlement was besieged with far more nominally qualifying claims
than statisti [*586] cally possible, leading the court to order an audit of the entire claim pool. n121 Early audit reports
revealed that roughly 12.5% of the claims submitted were legitimate under the settlement criteria and that "high
percentages of unfounded medical diagnoses correlated with particular physicians and particular plaintiffs' law firms."
n122 In sum, the overwhelming majority of the claims were intrinsically weak but nominally qualifying due to
manipulation of the evidence. Although the Nationwide Class Action Settlement was initially projected to largely
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resolve the fen-phen litigation at a cost of $ 3.75 billion, n123 American Home Products Corporation and its successors
n124 have paid roughly $ 21 billion to settle the suits to date. n125
III. Specious Claim Opportunities, Incentives, and Justifications
Speciousness is in the eye of the beholder. A claim advanced by a plaintiff who was never exposed to a defendant's
product and lacks a verifiable injury is likely to be viewed as specious by most observers, while one with a lengthy
history of exposure and extensive medical documentation of a resulting injury will be viewed as non-specious. Beyond
these clear categories, however, whether a claim is specious or not tends to be murky. Are claims specious if they are
unlikely to succeed at trial, or are they specious only if they are unlikely to get to a jury? Should we treat claims as
specious merely because they are of unknown veracity, or should we accept the defendant's settlement in spite of this
lack [*587] of knowledge as evidence that the claims are non-specious? In global settlement, should we consider
claims specious because, contrary to the apparent assumptions of the settlement agreement, the manner in which they
are developed reduces the likelihood that traditional plaintiff self-selection and attorney gate-keeping will occur, or
should we limit this term to those cases in which supporting information is actively manufactured to create a knowingly
deceptive perspective of claim merit?
If we accept that claim merit and value are fixed and known, we can distinguish specious and non-specious claims
solely on merit. For example, if we characterize claims as having one of two fixed types, frivolous claims with zero
value and non-frivolous claims with a value of D, it is possible to outline a basic framework for determining who should
submit claims to a settlement grid. Plaintiffs with frivolous claims know their type and that they will face less scrutiny
in a streamlined settlement, so they should be expected to subscribe to the settlement. Likewise, those holding
non-frivolous claims should also submit claims for payment where they expect to receive compensation that exceeds D.
Conversely, non-frivolous types with expected damages in excess of D should either seek to opt out (if possible) or find
their claims undervalued in a binding settlement. In either case, adverse selection has negative consequences for either
high-value non-frivolous claim holders-who are forced to accept a lower value than D in a binding settlement-or for
defendants-who lose the peace they sought through settlement as increasing numbers of stronger claims opt out. In sum,
this basic adverse selection framework promises to explain both why specious claims are filed and paid and how their
presence undermines the objectives of global settlement.
Such a simplified framework, however, omits the largest pool of claims: those that are neither clearly frivolous nor
clearly meritorious. Even if claims are intrinsically fixed types, the evidentiary support for claims in litigation and
settlement tends to be malleable and subject to competing interpretations. Thus, if merit is based on satisfaction of the
adopted standard, those who knowingly advance frivolous claims can do so because they are able to manufacture
sufficient evidentiary support to satisfy the established criteria. If we limit "merit" under this standard to intrinsic merit,
this malleability can yield sufficient internal uncertainty so that repeat players may submit frivolous claims they believe
to be non-frivolous or, at least, do not have sufficient reasons to view as [*588] objectively frivolous. n126 In short,
distinguishing specious and non-specious claims solely on the basis of known information about their merits is unlikely
to capture the universe of claims we commonly view as specious.
Some claims are developed specifically in a manner that is intended to manufacture the appearance of merit
without regard for whether the claims do, in fact, have merit. At least some of these manufactured claims may have
intrinsic merit, but we are unable to distinguish them from manufactured claims that do not. In light of the ability of
plaintiffs and their counsel to control how they develop claims and the degree to which development shortcuts reduce
the capacity of streamlined settlement administration systems to distinguish good and bad claims, this Part treats all
such manufactured claims as specious regardless of their unknown intrinsic merit. In these cases, the onus should be on
the plaintiffs to devise more reliable mechanisms for producing support that is reliable.
Similarly, even claim development practices that may produce reliable evidentiary support under most
circumstances may become unreliable when critical stages are outsourced to unreliable parties. Although some courts
have concluded that lawyers are entitled to accept the work of medical and other legal professionals at face value for
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ethical purposes, it may be just as difficult, if not impossible, to distinguish the good and bad claims that are generated
as it is in the intentional claim manufacturing scenario. Here, too, this Part treats these claims as specious not because it
speaks to their intrinsic merit but because the claims are ultimately presented as something they are not: premised upon
reliable evidentiary support. As a whole, then, this Part focuses not only on claims that are specious inasmuch as the
evidence known to the [*589] plaintiffs should preclude their submission, but also those claims that are based on
development practices that, by design or manipulation by key participants, will generate evidence that frames bad
claims as good.
Although some may take issue with this approach in light of the fact that it characterizes some innocent plaintiffs'
intrinsically meritorious claims as specious, this is not a normative judgment as much as it is an assessment of the range
of practices that plague global settlement. Given the critical role that repeat players have in collective litigation and
settlement, n127 targeting their incentive framework with respect to unreliable practices and outsourcing should
encourage self-selection and gate-keeping against advancing frivolous claims more effectively than merely targeting
those individuals advancing claims that they know to be frivolous. n128 Indeed, the case studies demonstrate that the
orthodox focus on the latter is unlikely to succeed across cases. For example, although early oversubscription in the
fen-phen global settlement might be explained by reference to the fact that compensation for unaudited [*590] claims
was paid before the audited claims were reviewed, n129 thus allowing repeat players to obtain large recoveries before
their entire claim pools might be subjected to audit, several objectively specious claims were submitted after the court
ordered audits of every claim submitted, n130 criminal investigations were announced, n131 and civil suits against
some of those involved were initiated. n132
In addition, although the basic adverse selection framework may reflect the risk-reward assessment when there is
one decision maker controlling the process from beginning to end, mass tort claims are mostly recruited and developed
by discrete sub-groups, with individuals playing specific roles and performing routine, yet critical tasks in a larger
group effort. This division of functions across sub-groups and individuals further limits the knowledge attributable to
any one participant, thereby increasing the likelihood that participants will perceive objectively specious claims as
sufficiently colorable to warrant submission in settlement. n133 Moreover, organizational dynamic research suggests
that group socialization and institutional memory encourages the escalation and justification of dubious practices even
where participants are otherwise ethical and upstanding citizens. n134
In sum, the origins for oversubscription are more complex and nuanced than those reflected in the basic adverse
selection [*591] model. To account for these considerations, this Part incorporates claim uncertainty and
organizational dynamics into a broader framework for analyzing and predicting oversubscription potential in global
settlement. Specifically, this Part outlines how collective settlement alters claim recruiting and development
opportunities, generates distinct incentives to pursue these opportunities, and reinforces common justifications for
advancing specious claims.
A. Development Opportunities in Collective Settlement
Although most tort cases settle, these settlements tend to be framed by the parties' respective expected outcomes if
a given case went to trial. n135 Predicting trial outcomes is far from a perfect science. For example, assume a case in
which the plaintiff has strong objective evidence of exposure to a defective product and injury, but her evidence
supporting a causal connection between the two hinges upon the credibility of a medical expert. One jury might not find
the expert credible, while another might find the testimony compelling. A third jury could also discount the quality of
the exposure evidence or injury even if the defense raised only a perfunctory challenge to it. This uncertainty carries the
potential for under- or over-compensation at trial, with both sides adopting rough acceptable settlement ranges given
their respective understandings of the risks given the available evidence and applicable law.
Collective settlements can reduce this uncertainty dramatically by supplanting tort law with a negotiated grid for
compensation. In these cases, objective exposure and injury criteria replace the costly individualized assessment of
exposure to a dangerous product or an accident plus injury, and the causal connection between the two, in a typical tort
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claim. Thus, claims that might have substantially different values in tort litigation may nonetheless be pooled in the
same injury or exposure categories for the purposes of settlement. The manner in which this pooling is framed can, in
turn, alter recruiting and development opportunities for plaintiffs' firms. [*592]
1. Predictability and Fixed Targets
In each of the markets reviewed, plaintiffs expected that their claims were compensable upon satisfaction of a
predictable lower evidentiary standard than typically required at trial. This predictability is apparent in two distinct
ways. First, the recurring pattern of obtaining "inventory" or "block" asbestos settlements for claims that survived early
dispositive motions effectively reduced the nominal standard for asbestos claims to whether they had sufficient support
to survive a motion to dismiss. n136 Again, plaintiffs could recruit and target claim development toward a fixed
standard, but predictability may have been the product of substantial changes in substantive law and procedure, high
defendant elasticity, and the presence of repeat players on both sides, n137 rather than any specific fixed settlement
plan. As the judge overseeing asbestos litigation in New York City from 1987 to 2008 noted, this elasticity meant that
the risk of non-recovery "all but disappeared" by the early 1990s. n138
Second, each of the comprehensive settlements qualified claims for payment upon satisfaction of clear,
"check-the-box" [*593] criteria that were far more predictable and less difficult to satisfy than might be expected in
tort. n139 Unlike traditional one-to-one case settlements, which tend to be agreed upon after the defendant has evaluated
the specific facts of the claim, comprehensive settlements provided ample opportunity for firms to recruit new clients
and develop their claims to the fixed nominal standard. In asbestos bankruptcies, where a select group of plaintiffs'
firms largely dictate the terms of any trust distribution procedures n140 and claim processors must rely upon repeat
business from these same firms, n141 evidentiary targets will vary little and tend to be far easier to satisfy than in the
tort system and less likely to change unexpectedly than private inventory settlements.
Finally, although the plaintiffs in the Silica MDL could not rely on a similar track record in state silica personal
injury litigation, many at the time saw the litigation as following the same track-including a substantial potential for
high defendant elasticity n142 -and the litigation may have succeeded but for a "fortuitous combination of factors" that
brought the unreliability of these screening practices front and center in the MDL. n143
2. Targeted Development and Claim Manufacturing
The ability to focus recruiting and development to a specific evidentiary target expands the claim pool to those that
would [*594] stand little chance of success at trial. n144 For example, where a work history is sufficient evidence of a
causal link under the criteria, the absence of credible evidence that the plaintiff was exposed long enough to cause the
alleged injury under applicable tort law is no longer relevant to the recruiting decision. Likewise, although the
persuasive value of the evidence supporting a specific client's heart valve or lung abnormalities may be limited at trial,
that concern should not deter firms from accepting the case when it can be submitted for payment under a fixed standard
that accepts the evidence as sufficient.
Beyond evidentiary gaps, targeted development generates opportunities for dubious evidentiary development
practices. For example, a firm may have reservations about advancing a claim for which plaintiff-friendly doctors
repeatedly fail to find evidence of physiological changes sufficient to warrant compensation in litigation, but it may
continue shopping those x-rays to other doctors until they find one who is willing to make that representation when it
only takes one such report to obtain compensation from an existing settlement. n145 At the extreme, fixed targets
suggest an opportunity to manufacture claims by creating evidence that bears little resemblance to reality.
Conceptually, the targeted development pattern will sound familiar to students of the collapse of the subprime
mortgage market and the subsequent economic crisis. Once demand exceeded the available supply of high-grade
mortgages, brokers and financial institutions identified gaps in credit rating assumptions that allowed them to obtain,
package, and sell high-risk loans as low [*595] risk investment vehicles. n146 For example, credit score averaging
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may have been intended to provide a rough measure of the creditworthiness of individual borrowers across a mortgage
pool, but aggressive issuers soon realized they could satisfy the criteria by pooling mortgages that were likely to go into
default with those supported by borrowers with artificially high credit scores. n147
3. Distinguishing True Positives and Positive Potential
To appreciate the degree to which this shift may alter claim opportunities, consider the following thought
experiment involving a product used by one million people. In the absence of exposure, statistical evidence suggests
that roughly 7% (70,000) of the population would contract lung cancer in their lifetimes. According to scientific studies,
however, approximately 7.7% (77,000) of those exposed to the product will contract lung cancer. Thus, the number of
true positives due to exposure to the product will be 7000. Assume that the damages suffered by all lung cancer victims
in the exposure pool have a range of $ 200,000 to $ 20,000,000, with a mean of $ 1,500,000 and a median of $
1,000,000.
If each case is litigated separately, we may expect considerable variability in verdicts. Only one in eleven lung
cancer diagnoses among those exposed to the product may be attributable to product exposure, and different juries may
reach dramatically different results in roughly comparable cases. Thus, the range of cases in which liability is found
may be far higher or lower than the statistical evidence suggests. Moreover, verdict amounts could be substantially
higher or lower in any given case than expected across the plaintiff pool due to differences in plaintiffs' education, age,
and other factors influencing damages. In the aggregate, however, we may expect that some true positives will not be
compensated in litigation while those that are not true positives will be compensated, including some that may involve
substantial damages. [*596]
To address the large volume of litigation in this hypothetical, current plaintiffs and the defendant agree to establish
a comprehensive grid settlement that breaks claims into distinct pools and allocates roughly equivalent compensation to
individual claims within each pool. In this settlement, the defendant agrees to pay an amount equal to the average
cancer damages figure ($ 1,500,000) spread across the number of true positives (7000), or $ 10,500,000,000.
In the settlement, defining the evidentiary criteria for exposure, injury, and a causal connection between the two
will be critical. If the settlement focuses exclusively on the first two elements, the absence of any need to advance a
causal link will increase the potential number of qualifying claims under the settlement by compensating all users who
ultimately contract lung cancer (77,000), rather than the much smaller number of true positives (7000). Thus, the
per-claim compensation must be reduced to a level that reflects the actual likelihood of causation-one in eleven-or $
136,363.64. This amount, of course, is a small fraction (.68%) of the highest damage claims ($ 20,000,000) and only
68% of even the lowest value damage claims ($ 200,000). At this level, the settlement is likely to suffer from
considerable challenges prior to approval and, if possible, encourage substantial opt-outs by high value claims. Thus, if
plaintiffs are unwilling to accept the substantial discount and defendants are unwilling or unable to increase the pool of
funds dedicated to the settlement, the parties must narrow the compensation criteria toward the true positive or litigation
positive pool.
Now assume that the scientific literature suggests the addition of two criteria: 1) exposure to the product for at least
one year; and 2) compensation only to those with a specified form of lung cancer. This should limit the pool of
qualifying claims to no more than 10,000 claimants without excluding any true positives. This substantial reduction in
the potential claimant pool should, in theory, increase the potential compensation to each qualifying claimant
dramatically ($ 1,050,000 per claim) without requiring additional settlement funding. Moreover, if we assume less than
100% subscription from qualifying claimants, the per-claim compensation for individual claims may be significantly
higher. In sum, the aggregate payment should be sufficient for deterrence purposes, and the individual compensation
levels should be sufficient to encourage substantial buy-in from the true positive pool. [*597]
Both components, however, have limits. First, the one-year exposure condition may be difficult, if not impossible,
to verify in the real world. In the absence of contemporaneous, objective records demonstrating exposure, plaintiffs with
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qualifying injuries may nonetheless present claims based on claimed exposure periods that far exceed reality. On the
other hand, requiring objective proof that may not be available-for example, shopping receipts or labels from products
purchased years earlier-as a condition of qualification may preclude settlement approval.
Second, limiting compensation to a subset of cancer claims necessarily involves the inclusion of expert reports,
which will serve a limiting function only to the extent that these claims are objectively distinguishable from others and
that the settlement incorporates sufficient monitoring mechanisms to test the veracity of the reports submitted. As
demonstrated in all three of the case studies above, some doctors have a propensity to over-read medical records and
tests in favor of satisfying fixed criteria, particularly where their opinions are highly subjective. Even when provided
with objectively verifiable standards, the fen-phen case study suggests that at least some doctors may manipulate the
data or equipment in a manner that superficially satisfies the fixed criteria. n148
As a result, the practical potential volume of claims that may be shaped and advanced as qualifying may exceed
settlement projections dramatically. This is true in spite of the parties' efforts to limit compensation, using largely
objective criteria, to a pool that is only modestly larger than the pool of true positives. The question at this point is not
whether the plaintiffs have incentives to do so or intend to do so fraudulently. Rather, the point of this thought
experiment is merely to frame the potential opportunity to advance bad claims as good in aggregate settlement, even
where the settlement terms appear to limit this potential. Of course, once the number of apparently compensable claims
exceeds projections, this opportunity and the incentive to continue filing may become limited as courts reduce
compensation or adopt more aggressive monitoring. In a case with extremely high true positive projections, however,
large volumes of intrinsically weak claims may be compensated over an extended period of time without discovery.
[*598]
B. Strategic and Targeted Development Incentives
If we view predictable evidentiary targets and permissive monitoring and enforcement systems as generating the
opportunity to advance specious claims, the financial incentive to exploit this opportunity is obvious: those who
advance weak claims stand to earn additional returns at little risk. Without discounting this argument as far as it goes,
the direct economic advantage of advancing bad claims does not necessarily suggest that those responsible do so with
knowledge of the specious nature of the claims. Indeed, if we accept the assertions of several doctors and lawyers
involved in the case studies as true, ignorance of the most disturbing practices in those cases appears rampant. This is
not to suggest that these self-serving assertions are true, but it does raise an interesting question as to whether the mass
settlement approach encourages a systemic pattern of rational ignorance. To that end, this section focuses not only on
the direct economic incentives to advance specious claims, but also the manner in which the process promotes rational
ignorance in claim development.
1. Direct Economic Incentives
For all of their potential efficiencies, mass torts do not strip away all of the potentially substantial costs associated
with establishing the merit of individual claims. Some costs may be shared by similar claims within a mass tort,
including the costs of investigating the defendants' conduct, scientific evidence establishing a link between a product or
event and certain types of injuries, and the transaction costs of litigating these and other issues. Other costs, however,
are unique to each claim, including developing the factual or medical support for an alleged injury and the plaintiff's
exposure to the defendant's product, or other causal link to the defendant's conduct. Discussions of the efficiencies of
mass tort litigation focus on common expenses because cost-spreading is at the heart of the economies of scale that are
promised by aggregation, but individual claim expenses can be substantial. n149 [*599]
Against this backdrop, economic incentives to adopt targeted development are twofold: they allow firms to
generate additional claims that are compensable under the nominal criteria for compensation and avoid costs they would
otherwise incur in preparing a case for trial. Thus, firms may increase the pool of claims across which common costs
may be spread, thereby reducing the per-claim cost of development. At the same time, by avoiding certain
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claim-specific costs ordinarily associated with litigation, firms may further reduce their up-front expenses.
The ability to target development to predictable criteria is significant because it may be far more efficient to
increase the yield of claims within a pool of potential plaintiffs than it is to identify new prospective plaintiffs.
Competition for new clients in many cases is intense and expensive, particularly after a comprehensive settlement is
established. n150 This competition may not only limit the pool of potential plaintiffs available to any one firm but also
increase the potential that plaintiffs with specious but superficially compensable claims under the predictable or fixed
evidentiary standard will find representation with a competing firm.
2. Rational Ignorance and Development
The opportunity and potential cost savings associated with targeted development comes at the expense of
potentially valuable information about the respective strengths and weaknesses of individual claims. The question, then,
is whether collective settlement generates an environment in which the cost of developing this information is greater
than the reasonably expected benefits of doing so. In short, does collective settlement promote rational ignorance?
In traditional litigation, aggressive fact development not only improves the evidentiary support required for any
possible trial but also the firm's information advantage concerning the in [*600] trinsic merits of individual claims.
Lawyers abhor nasty surprises in litigation, particularly those that they or their clients could or should have been aware
of in advance. Positive and negative information can serve a valuable function in guiding litigation and settlement
strategy as the case proceeds by allowing firms to periodically reassess the value of a case and determine acceptable exit
strategies and settlement ranges as information improves. n151 Thus, a firm that develops cases only to the bare
minimum required to survive summary judgment may dramatically weaken prospects for recovery by grossly over- or
under-valuing their potential merits. n152
In aggregate litigation and settlement, however, ignorance with respect to these facts may be rational, depending
on the nature of certain claims, the settlement structure, and the firm's general business model. In mandatory
settlements, for example, incurring any costs beyond those required to satisfy the effective settlement criteria may not
yield any additional benefits. Even where low value claims might be financially viable under a more reliable evidentiary
development process, targeting recruiting and development to the evidentiary target alone may improve claim yield and
aggregate recoveries to a level that more than offsets the nominal risk of doing so. In some circumstances, the expected
per-claim recoveries may be so low that even the usual process of distinguishing good and bad claims in anticipation of
potential litigation may be too expensive or yield too few claims for spreading common costs to a level that renders
them positive net value claims. Likewise, as in traditional litigation, we may expect some firms to adopt a "settlement
mill" approach even where it may be possible to generate greater returns by a more nuanced or tiered development
strategy. n153
If we assume the firm is attempting to maximize its investment, targeted investment should occur only where a
more traditional case development approach will not be expected to yield [*601] higher recoveries. Thus, the option to
obtain recovery from a fixed global settlement should not encourage uniform targeted development where those holding
strong claims can opt out and obtain significantly higher recoveries in the tort system.
Even the investment-maximizing firm, however, may adopt distinct development tracks for claims within the same
case. Thus, the case evaluation process may put some claims on a litigation development track and preserve less
promising claims in the firm's inventory but place them on a targeted development track. At different points in
pre-settlement litigation or case-specific development, once promising claims may appear less promising and shift to a
less thorough development approach going forward. Thus, a firm may limit its development costs by tiered development
strategies without sacrificing its ability to advance the strongest claims at trial or its potential to leverage a larger
volume of less developed, but potentially compensable, inventory claims.
To illustrate, assume a lawyer in the early 1990s has been screening out asbestos claims that he believes to be weak
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and developing the cases he accepts as he would any other case. These costs include obtaining follow-up medical
reports, developing documentary records supporting each client's work history, and interviewing potential witnesses
who can support his clients' claims. He discovers that other plaintiffs file lower value claims that can survive motions to
dismiss and obtain settlement without these additional costs. If he decides to forego these additional steps for any of his
low value claims, he can save considerable time and expense to both his own and his clients' benefit. n154 He can also
add claims to his inventory that his competitors are otherwise accruing. To the extent that some defendants refuse to
settle or demand this additional evidence as a condition of settlement, he has the option of developing this additional
evidence, dismissing these defendants and settling with the remaining defendants, or using the leverage from his
stronger claims that are trial ready to obtain an inventory settlement covering all of his claims. [*602]
C. Targeted Development and Manufactured Claim Practices
Predictability of compensation alters the playing field because it transforms the potential adverse selection problem
in collective settlement into an opportunity to strategically tailor recruiting and development to the superficial
satisfaction of the effective qualification criteria. The advocate's role of presenting claims in the light most favorable to
the client tracks common practice in traditional civil litigation, n155 but the threat of adversarial testing of this
one-sided evidence may be perceived as limited or non-existent for at least some of the firm's inventory. Claims
presented with all of the zeal contemplated by the adversary process may run roughshod over settlement regimes that
lack the capacity or will to challenge them. Also, systems that create opportunities to obtain recovery without
meaningful claim review generate incentives for firms to take a relaxed approach to screening the claims that they bring.
n156
Although firms can afford to be indifferent to intrinsic claim quality under the circumstances, opportunity and
incentive alone do not make corruption of the recruiting and development process inevitable. Each of the case studies in
Part II of this Article demonstrate how multiple participants worked together to generate specious claims in large
volumes, but they also involved many more professionals who continued to approach recruiting and development
without cutting corners or advancing volumes of claims that were impossible to build without the services of those
[*603] who did so. n157 Even within those plaintiff groups that advanced specious claims, the case studies do not
clearly establish how many of the actual participants were aware of the corrupt practices involved, and those who were
directly involved in the most questionable conduct arguably neutralized the corrupt nature of their actions.
The patterns and practices outlined in the case studies in Part II tend to track common themes found in research
concerning other forms of group conduct that breaks from societal norms: opportunity, incentive, and justification. n158
In oversubscription resulting from dubious claim filings, predictable evidentiary targets create the opportunity, and
targeted development promises considerable financial benefits. The distinguishing factor among those who embraced
increasingly dubious recruiting and development practices is the degree to which sub-group rationalizations were
sufficient to neutralize individual or firm concerns about their propriety.
1. The Targeted Development Spiral
At first glance, predictability is significant only inasmuch as it allows firms to avoid unnecessary costs. The ability
to avoid claim-specific inquiries and costs that are not required to create a qualifying evidentiary record under the
collective settlement is part of the presumptive value of collective settlements inasmuch as they replace expensive
evidentiary support with less expensive alternatives. For example, as seen in the fen-phen global settlement, collective
settlements may only require verified forms that include fill-in-the-blank responses in lieu of the expensive medical
expert reports-and associated battles over those reports-that might be expected at trial. [*604]
The danger in targeted development is that the most efficient mechanisms for generating the required evidence
may also be among the least reliable measures of merit. For example, although it may be possible to employ traditional
medical screenings to identify potential victims and subsequently develop their claims in a manner that is consistent
with accepted medical practice, this approach is far more time-consuming and would yield far fewer clients than
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litigation screenings.
With competition among doctors and screening companies focused on yield rather than quality, this disconnect
suggests that the quality of diagnoses generated in the market for screening services will reach the lowest predictably
compensable level over time. Any screening company that generated 5% positive diagnosis yields during the heyday of
asbestos screening, for example, would quickly be out of business where other firms provided equally compensable
diagnoses for 50 to 90% of the individuals they screened. n159
Targeted development can be particularly problematic where the volume of potential low or negative expected
value claims is high. In these cases, the financial incentives to maximize volume and control costs encourage the use of
doctors or service providers who generate the highest yields through the most financially expedient means possible. The
result, as demonstrated in asbestos and silica litigation, is a virtual avalanche of newly generated claims that satisfy the
evidentiary target but leave it virtually impossible for anyone-courts, defendants, or even the law firms advancing
them-to distinguish the good claims on merit. The low sunk costs per claim may make it more rational to simply jettison
any claims that are challenged n160 than to press forward with litigation, even if some of those claims might have merit.
[*605]
As demonstrated by the asbestos and fen-phen case studies, systemic problems arise when these mechanisms
expand the pool of compensable claims far beyond expectations. The key here is that it was not only possible to target
real or perceived criteria but that doing so generated a volume of claims that could not be managed efficiently without
(a) reducing payments to a level that denied legitimate claim holders their rightful share of any recovery, (b) demanding
additional funding, thus denying defendants the peace they bargained for, or (c) embracing costly and time-consuming
verification procedures that might offset much, if not all, of the transaction cost avoidance benefits expected from
settlement.
2. Neutralizing Normative Concerns
Group corruption research suggests that one possible distinction between the different subgroups in these cases is
the degree to which those who advanced specious claims embraced various neutralizing justifications and procedures
for their specious claims. This research has long demonstrated that groups and subgroups "can develop norms that are
far removed from generally accepted societal norms." n161
Specifically, although other justifications appear to be present, the neutralizing justifications prevalent in the case
studies fall into two rough categories: denial of wrongfulness and denial of responsibility. n162 In this context, denial of
wrongfulness refers to those justifications that deny the illegality, immorality, harmful nature, or victim of the conduct.
Denial of responsibility captures those justifications that deflect personal responsibility for any particular conduct,
including the belief that they were bound to take specific actions due to their role or the common rationalization that
"everybody does it." n163 These justifications tend to have a cumula [*606] tive effect or work in concert to neutralize
potential concerns about the participant's role. n164
a. Denial of Wrongfulness
As Professors Aguilera and Vadera note, "individuals who use rationalization justifications tend to argue that their
behaviors are not criminal as laws and regulations codifying their behaviors as illegal may not exist, may be dated or
not enforced, or their applicability may be questionable." n165 Commentators and courts acknowledged asbestos
screenings and their perceived shortcomings for years before the Silica MDL. Yet, courts and defendants continued to
allow the claims to proceed and settle, often without meaningful challenge. Similarly, the pattern of lax ethical
enforcement against those who submitted dubious asbestos claims-and, subsequently, silica claims n166 -reinforced the
perspective that mass torts were different. n167 In sum, the resulting claims could be perceived as non-frivolous
because any claim that can be reasonably presented as warranting settlement is, by definition, a non-frivolous claim.
n168
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Even participants who suspected that some of the claims were weak or frivolous could easily reason that the
defendants "deserved their fate" due to their own illegal or unethical conduct. n169 Asbestos, silica, and fen-phen
litigation all involved products that were responsible for the premature deaths and life-altering injuries of thousands of
victims, and the companies involved were easy targets for vilification. Indeed, after claim patterns are criticized or even
entire cases are debunked as scientifically implausible, the [*607] presumption that the companies nevertheless "got
what they deserved" may continue unabated.
b. Denial of Responsibility
In retrospect, it seems clear that judicial and academic perceptions of accepted practice in the mass torts discussed
were not in line with the offending lawyers' and doctors' understandings. Lawyers do not simply switch hats from
zealous advocates to diligent gatekeepers once a settlement is available, and few of the lawyers' actions in these cases
conclusively demonstrate more than a willingness to take the information at their disposal at face value. At the same
time, with a few notable exceptions, most of the doctors involved operated under a common, n170 but mistaken, view
of their role in the process as "hired guns," rather than objective medical analysts.
Even if these perceptions of accepted practice were mistaken, they have been reinforced by a long history of
accepting similar conduct in litigation. Doctors and other experts have been widely characterized as "hired guns" for
one side or the other for as long as any of us alive today have been involved in civil litigation practice. n171 The
practices that Judge Jack condemned in the Silica MDL were occasionally recognized, albeit rarely punished, during
[*608] the fifteen years prior to her decision. n172 To be clear, this is not to say that all of these activities were ethical
or even legal; it is merely recognition that the perception of what constitutes an accepted practice by lawyers tends to be
shaped more by recognized patterns than by unspoken expectations and rules that are rarely enforced.
Denial of responsibility can be problematic in these cases because the specialization and division of responsibility
that generate considerable efficiencies in mass tort litigation also yield a potential compartmentalization problem. n173
Compartmentalization of responsibility enables participants to rationalize and avoid consideration of broader issues
with the process. n174 Even if participants [*609] harbor suspicions, stepping beyond their respective roles to examine
the process diminishes the efficiency gained by the division of labor and may be viewed as bad form-an implicit
suggestion that one's colleagues or superiors are unprofessional, unethical, incompetent, or worse-within the system.
n175 Moreover, subgroups and individuals frequently believe that it is not in their best interests to ask questions or
otherwise overstep their roles, particularly where they are fungible players in the process. n176
Compartmentalization presents significant problems for managing specious claims through ethical controls.
Regardless of whether the systemic ignorance is inadvertent or by design, it may afford those involved a level of
protection against liability and reinforce the perception that outside criticism is overblown. n177 Outside observers and
others involved in the process may never know whether a participant is an ostrich-one who buried her head in the
sand-or a fox-"a grand schemer who fully intended to follow the path of wrongdoing, and who contrived his ignorance
only as a liability-screening precaution, like a good getaway car." n178 Put differently, even if courts and disciplinary
authorities diligently pursue those that intentionally advance specious claims, they may be less comfortable doing so
with respect to those who may be [*610] viewed as simply being zealous advocates, and the inability to clearly
distinguish the two may provide cover for the foxes.
Against this backdrop, it should come as no surprise that compartmentalization has been an effective barrier to
sanctions in the cases discussed. Although there may be compelling reasons to conclude that some of the attorneys
involved in the Silica MDL intentionally manufactured specious claims, n179 the compartmentalization of
responsibility has served as an effective "getaway car" to date. n180 Likewise, notwithstanding concerns about the high
correlation between specious fen-phen claims and certain law firms, n181 the only criminal and civil litigation claims
filed to date focus on the doctors and others whose actions are difficult to explain as anything other than intentional
fraud or misrepresentation. n182 [*611]
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IV. Managing Oversubscription in Aggregate Litigation and Settlement
Framing specious claim filings as merely the product of opportunistic plaintiffs or lawyers provides some bright
lines and suggests relatively easy solutions. If we assume that claims are objectively fixed types, the incentive structure
for advancing specious claims may be altered by enforcing ethical rules and otherwise penalizing those who advance
them. At the same time, controlling the opportunity to advance dubious claims through largely objective evidentiary
criteria and aggressive audit mechanisms may be viewed as sufficient to deter the rise of specious claim markets that
threaten the stability of a settlement.
The foregoing analysis reinforces the view that targeting opportunities and incentives to advance dubious claims
are important components of controlling oversubscription, but it also reveals their limits. Modern ethical and procedural
rules tend to focus on bad apples who are either aware or should be aware of their misconduct, but this focus leaves
substantial gaps in coverage. Likewise, the best opportunity-limiting controls employed to date have been plagued by
practices that exploited blind spots that go undiscovered for months or years when verification mechanisms are static.
In short, an effective post-settlement verification system must not only account for intentional frivolous filings but
also client recruiting and development practices that shield lead firms from knowing that any given claim is frivolous.
This requires a more aggressive mechanism for identifying gaps between ex ante settlement claim expectations and the
manner in which the qualification criteria are satisfied in practice, as well as the degree to which specific repeat players
appear to advance colorable but manufactured evidentiary support. Against this backdrop, this Part evaluates modern
aggregate litigation practice and proposes basic mechanisms for discouraging the emergence of specious claim markets
through collective settlement design. [*612]
A. Pre-Settlement Opportunism in Modern Practice
Tort reform and judicial recognition of the need to rein in certain practices have altered the mass tort landscape in
recent years. Key state court decisions have established more restrictive joinder n183 and pleading n184 requirements.
Moreover, many states have passed laws that require plaintiffs to demonstrate actual impairment in order to initiate
certain types of suits, n185 and several courts have adopted inactive dockets for claims advanced by asymptomatic
asbestos plaintiffs. n186 In addition, some well-publicized decisions have scaled back the substantive aspects of
"special asbestos law." n187 As a result, filing rates in some of the former hotbeds of asbestos litigation have
plummeted. n188 Like [*613] wise, the Class Action Fairness Act n189 has effectively addressed concerns about the
certification of nationwide class actions in state courts, n190 and the pleading standards announced by the Supreme
Court in Bell Atlantic Corp. v. Twombly n191 and Ashcroft v. Iqbal n192 impose limits that should effectively limit
shotgun-style complaints in federal court. n193
Moreover, individual judges continue to refine the process of managing aggregate litigation, including the use of
staggered claim-specific discovery devices that generate far more information about not only the specific allegations
underlying individual claims, but also the nature of the evidence supporting those allegations. In many mass tort cases,
plaintiffs are required to file plaintiff fact sheets ("PFS") or comparable documentation that specifies basic information
for each individual claim under pre-trial case management orders. n194 The required information will often include
basic client identification information, information [*614] about the nature of the alleged injuries, the date of onset of
the injuries, the identity of the person making the initial diagnosis, the products used or exposed to, and other relevant
personal, work, or medical information. n195 A claimant's failure to submit this information by the deadline may result
in dismissal of her claim or financial sanctions. n196
PFS requirements are a significant improvement over informal aggregation and bankruptcy practices that have
effectively taken the mere presence of claims as proof that pre-litigation case [*615] investigations have taken place,
but they may not reveal sufficient information to distinguish good and bad claims. PFS forms vary considerably from
one case to the next, and they are not, of course, a substitute for traditional discovery. In most cases, they provide only
limited opportunities for evaluating the relative merits of individual claims or their supporting evidence. n197
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Similarly, more courts have embraced the use of Lone Pine n198 orders or comparable orders to mandate
disclosure of key evidentiary support for individual claims. n199 Most often, these orders seek proof of specific
causation; for example, expert medical reports demonstrating a causal relationship between a defendant's product and
the plaintiff's injury. n200 The orders routinely afford plaintiffs a limited time frame to file the required information or
reports and establish procedures for dismissing claims for which this information is not provided. n201 Although courts
may issue [*616] Lone Pine orders at any stage of the proceedings, they typically avoid doing so where existing case
management orders fill the same role or the disclosures sought by defendants are perceived as premature. n202
Moreover, Lone Pine orders may be issued shortly before or after a comprehensive settlement is reached, n203 and then
be limited to non-settling claims, leading some firms that are the target of these orders to complain that they are punitive
or designed to strong-arm plaintiffs into "lowball" settlements. n204
The emphasis on pretrial consolidation in multi-district litigation increases the potential for comprehensive
settlement in that forum, and the manner in which these cases are litigated may place a greater emphasis on
distinguishing claims based on merit. Collectively, the practices discussed suggest that diligent defendants may
effectively control the asbestos and silica development model-targeting only an anticipated nominal standard without
preserving a cost-effective means of distinguishing good and bad [*617] claims internally-by demanding higher
evidentiary standards in any firm-specific or global settlement and seeking orders requiring Lone Pine submissions from
those who attempt to hold out. Plaintiffs' firms that continue to marginalize development in this way or otherwise fail to
verify the reliability of their experts' conclusions thus run the risk that their costs will be inflated rather than reduced,
their cases dismissed, or both.
These changes reflect a larger shift in courts' and defendants' attention to rooting out specious claims that should
encourage firms to avoid marginal claim development strategies prior to global settlement. By improving opportunities
to gauge the quality of a firm's claims, these practices strengthen the value of individual merit in building repeat players'
reputation in settlement negotiations. n205 Claim-specific inquiry options allow defense counsel, who also tend to be
repeat players, to observe and distinguish the firms that advance primarily strong claims from others, and firms that
effectively distinguish good and bad claims and develop them accordingly are better positioned to absorb the costs of
advancing this information. n206 Thus, firms known as effective gatekeepers should enjoy an advantage in negotiating
individual or inventory settlement terms, and firms with equally poor reputations may find future settlement values
discounted, if settlement is forthcoming at all.
B. Settlement Terms and Administration
Continued use of fixed qualification criteria and limiting options for inquiry into the evidentiary support for claims
submitted to a global settlement remain imperfect but frequently necessary realities of any system designed to resolve a
large volume of claims effectively. Moreover, these settlements still occur before detailed claim-specific investigation,
even when the available evidence suggests that the underlying claims are questionable. n207 [*618] Standing alone,
these facts suggest that future collective settlements will continue to have unanticipated blind spots that may be
exploited, particularly given the substantial degree of creativity and flexibility of mass tort practice.
Notwithstanding its shortcomings, the fen-phen global settlement provides some evidence of the utility of
controlling for evidentiary malleability. In its favor, the settlement was not content to rely on the mere fact that medical
evidence was attested to by a doctor but provided objectively verifiable criteria to guide the doctor's assessment. n208
Once the audit began, this objective component was helpful not only in distinguishing good and bad claims, but also in
distinguishing some would-be foxes from ostriches. The former has helped mitigate the damage of specious claim
filings, while the latter has supported civil and criminal actions against the doctors responsible for generating large
numbers of these claims.
One significant flaw in the fen-phen settlement is that the deterrence message did not reach its intended target: the
doctors responsible for generating dubious medical reports. Neither the medical assessment form, nor the other
documents provided to the doctors, suggests that the settlement is any different from any other proceeding in which the
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doctor may be involved, and nowhere on these forms is it suggested that the claims will be subjected to a mandatory
audit. Indeed, precisely because it is viewed as a settlement form, doctors may have reasonably believed that their work
would be subjected to less scrutiny. To that end, the view that these doctors simply rolled the dice in manipulating the
objective data overlooks the fact that the doctors who continued to sub [*619] mit specious claims failed to appreciate
the risks they were taking in doing so.
Targeting the message to specific participants in collective settlement may not fully deter specious claim filings,
but it should discourage ostriches from burying their heads in the sand and force foxes to take steps that objectively
reveal their intent to engage in misconduct. In the fen-phen case, this would require little more than an
acknowledgement from the medical professional that she understands that other medical professionals will review all
submissions to ensure compliance with the objective criteria. In other settings, comparable acknowledgement of the
likelihood of audit and potential sanctions for misleading or fraudulent submissions-beyond boilerplate language
concerning the submissions being submitted on penalty of perjury-should serve the same purpose.
C. Audit Design and Flexibility
Audits are often viewed as being in conflict with the goal of streamlining administration and reducing transaction
costs, and plaintiffs and settlement administrators frequently oppose settlement terms or motions seeking claim
information that may impose significant costs. n209 Conversely, the absence of any mechanism to ensure that the
claims submitted are, in fact, compliant with the terms and intent of the settlement invites rampant filing of specious or
frivolous claims. Thus, an effective audit system must strike a balance between controlling costs and deterring and
disallowing payment of specious claims.
There is no one-size-fits-all model for collective settlement design. The specific terms and structure of any
particular settlement must take into account the nature of the claims, settlement objectives of the parties, and the
likelihood that the terms will not obtain sufficient support from plaintiffs to be approved. Thus, procedures that impose
greater risks or costs upon those submitting claims should generally demand higher claim payments or other
concessions.
To that end, although this section consolidates a variety of research relevant to audit patterns and identifies the
strengths and weaknesses of the different proposals, it does not attempt to frame a uniform model of global settlement.
Nonetheless, this discussion [*620] suggests, at a minimum, that audits should be mandatory, include pool selection
tied to repeat player claim pools rather than just claim type, provide for variable degrees of claim inquiry, and
incorporate a range of sanctions and holdback options. Audits with substantial future claim submissions should
incorporate provisions that allow administrators to adapt sampling and audit methods to address changes in filing
patterns and discoveries quickly. Although others have suggested the use of comparable sampling mechanisms to aid in
determining a defendant's aggregate liability prior to settlement, n210 this discussion highlights their potential benefits
in discovering and deterring opportunistic claim development leading to oversubscription.
1. Mandatory Audit Pools
Audit terms tend to be negotiated prior to the establishment of a global settlement and largely reflect the parties'
respective interests in the broader settlement. Thus, where defendants are concerned about the prospects that
oversubscription will overwhelm the settlement, and thereby undermine the settlement, audit provisions tend to be
mandatory and authorize detailed inquiry into the intrinsic merit of the claims reviewed. Conversely, when defendants
are reasonably assured of peace notwithstanding any oversubscription, audit standards tend to be left to the discretion of
the trust or the lawyers submitting claims to the claim facility. For example, as previously noted, the fen-phen global
settlement initially contemplated a mandatory audit of one out of every twenty claims before the court required audits of
every claim submitted. n211 By contrast, few of the existing asbestos settlement trusts have mandatory audit provisions,
and most of the largest trusts require the consent of plaintiff-controlled trust advisory committees n212 before claim
audits can occur. n213 [*621]
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To provide an effective deterrent against specious filings, audits must present a credible threat of discovery. The
absence of mandatory audits provide at least a partial explanation for the substantial oversubscription to asbestos trusts
and the fact that the practices that flooded those settlements went largely unchallenged for several years prior to the
Silica MDL. Indeed, in virtually every other context in which audits are employed to deter undesirable conduct,
mandatory audits of at least some portion of the conduct to be monitored are the norm. Moreover, given that specious
claim markets are driven by repeat players, the mandatory audit of a fraction of the total claims filed will both limit
audit costs and provide a reasonable deterrent if coupled with other provisions designed to sanction those found to
submit frivolous claims.
2. Random and Stratified Sampling
A common method of balancing the need to monitor the veracity of claims submitted against the costs associated
with doing so is to limit audits to a portion of the claim pool. If the manner of [*622] selecting claims is predictable,
those submitting claims may alter filing patterns to reduce the chances that their claims, or those within their inventories
that may not withstand scrutiny, will be audited. To that end, any audit plan must be random and sufficiently spread
across the relevant pool to maximize the ratio between limiting cost, on the one hand, and deterring and disallowing
specious claim submissions on the other.
If the claims submitted are homogenous, random sampling of an entire claim pool is the most straightforward and
ostensibly fair method of both identifying offending claims and spreading the risk of audit equally among those
advancing claims. When the population is diverse, however, a random sample of the entire pool may not sufficiently
investigate some sub-pools and excessively audit claims within others, so stratified sampling n214 may be preferable.
This ensures that relatively proportionate samples within the sub-pool are represented and evaluated, which may
improve the potential to discover discrepancies common to the sub-pool and spread the risk and costs of audit evenly
among roughly comparable claims. If stratified sampling is appropriate, the critical question is identifying the
appropriate subpopulations such that the selected samples reflect sufficiently homogenous sub-pools of the claims filed.
In stratified sampling, defining audit sub-pools according to not only claim type but also by professional should
improve both deterrence and disallowance of specious claims. Even if claims within specific classes are comparable
types, the manner in which the claims are developed and advanced by different claimants can vary wildly across the
sub-pool. On the other hand, repeat players tend to follow identifiable patterns when developing and advancing claims,
n215 yielding easily defined sub-pools that are largely homogenous and providing a basis for testing the veracity of
their submissions in the aggregate by testing a small but representative sample. [*623]
3. Audit Detail and Inquiry Levels
Balancing the costs and inquiry value of an audit not only takes place with respect to determining the sample size
but also the degree to which individual claims selected for audit will be investigated. Thus, audits may vary from
requiring modest additional information to searching investigations of the intrinsic merit of individual claims and the
manner in which the claims were developed. The appropriate degree of inquiry should thus be guided, at least in part,
by the potential malleability of supporting evidence and factors suggesting that the claims advanced may not be reliable.
As patterns are revealed over the life of the settlement, administrators may modify their audit patterns to account
for discernable distinctions in filing patterns within certain exposure or injury types and geographic regions. These
distinctions, whether they are inconsistent with actual filing patterns in other regions or categories or pre-settlement
projections with respect to the relevant sub-pools, may warrant enhanced scrutiny within a portion of the claim pool
long before oversubscription becomes obvious in the aggregate.
In addition, because key professionals tend to be repeat players not only within but also across mass tort cases, a
repeat player's broader reputation for veracity in claim submissions is relevant to the degree to which their claims
should be investigated. Tailoring audit severity to account for a known past offenders' propensity for employing dubious
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practices not only enhances the potential to identify comparably unreliable practices early on but, over time and across
cases, should discourage firms from taking shortcuts or employing experts who do. This will effectively place the
burden of ensuring veracity on the parties best suited to do so: the repeat players who control claim development.
4. Sanctions and Repeat Players
Deterrence requires a credible threat of not only discovery but also sanction. Thus, in order to deter effectively, the
costs associated with discovery of a pattern of specious filings may need to be far greater than mere rejection of the
offending claims. Otherwise, repeat players may simply view rejection of frivolous claims as a no-risk proposition.
After all, if they do not submit frivolous [*624] claims, they will certainly not obtain recovery for them. If they do,
however, there is at least some chance that the claims will be paid. Thus, if the potential aggregate returns on the
frivolous claims that slip through exceed the aggregate costs of submitting them, it is economically rational to advance
the entire inventory of such claims.
The fact that lawyers and other professionals tend to be repeat players involved with multiple claims within a case
provides substantial opportunities for employing meaningful sanctions. For example, the imposition of mandatory
audits across all past and future submissions by specific offending law firms should encourage firms to take greater care
in selecting and overseeing those responsible for generating claims. Moreover, similar provisions concerning claims
supported by evidence generated by repeat offender doctors and screening companies may discourage firms from
employing their services. In either case, the certain delays associated with mandatory audits alone will effectively
reduce the financial returns of firms that advance unreliable claims and rely upon unreliable experts and should
encourage greater care in claim and service provider selection.
5. Deferred and Suspended Compensation
A settlement plan that audits only a small fraction of the pool and pays other claims as they are processed raises the
specter that claimants will dump large volumes of specious claims on the settlement up front. Those that are selected for
audit may not be paid, but others may be paid before the settlement administrators identify any issues and adapt their
procedures for more effectively screening weak claims. And once claims are paid, unwarranted payments tend to be
difficult to recover.
In the aggregate, settlements may establish a mandatory suspended payment trigger if the number of claims
submitted exceed the projected true positive estimates over a given timeframe. Thus, if the settlement projects X
submissions during the initial claim submission period, this trigger would be automatic if the aggregate filings exceed X
or some percentage above X. This could be applied to the entire settlement pool, discrete sub-pools within the
settlement, or both. In the absence of deferred payment until the close of the submission period and suspended payment
upon satisfaction of a trigger, the settlement administrator may be [*625] contractually obligated to pay claims, even
after the data suggest that the settlement is oversubscribed. By expressly authorizing or requiring deferred payment until
the window for submitting claims closes and suspension of payments if they exceed the relevant threshold, this
provision would close any gap that might otherwise arise if administrators are required to seek supplemental authority
before suspending payment.
In addition, suspending payment of submissions by a particular doctor or firm once they exceed a specific
threshold or otherwise qualify for full inventory audits may discourage rampant oversubscription. Under this approach,
payment of claims advanced by repeat players who submit more than a fixed number of claims or diagnoses in a
submission period may be deferred until any random audits for the claim pool are completed. Thus, those who exceed
the threshold by filing numerous dubious claims risk delayed payment, especially if those claims are subjected to a full
mandatory audit, which should encourage those who submit large numbers of claims to avoid claims that are likely to
fail the audit.
Although deferred or suspended payment may also delay payment for those submitting good claims as well, such
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an approach could be tailored in a number of ways. The approach could streamline these audits, limit the holdback to a
portion of the claims-for example, an amount no greater than a portion of the attorney's contingency fee-allow a
staggered payment schedule to reduce the effect without undermining the deterrence value of the audit, or incorporate a
bonding option for repeat players in which they obtain a bond to satisfy any settlement recovery demands for previously
compensated specious claims. Repeat players who develop a reputation for filing specious claims across mass tort
settlements may be priced out of the bonding option or otherwise suffer enterprise-level sanctions which, in turn, will
reduce the degree to which ignorance of claim quality, either real or asserted, is rational. In sum, an up-front deferred
payment or bonded submission system may improve the timing of compensation for the substantial majority of good
and well-developed claims submitted by avoiding the need for more draconian measures down the road.
Whatever the form, audits and other monitoring schemes that limit opportunities to exploit collective settlements
are a necessary cost that will yield the greatest benefit if they effectively discourage specious claim recruiting and
submissions. Although [*626] many modern settlements include these measures, some-particularly asbestos
bankruptcy trusts-fall far short of presenting a credible threat of discovery and sanction. And notwithstanding the fact
that even well designed audits have failed to deter specious claim markets in all cases, their absence invites targeted
development with little care for whether the claims have intrinsic merit.
6. Adaptable Sampling and Flexibility
Given the adaptability of claim recruiting and development markets, audit procedures that are fixed by settlement
terms at the outset lend themselves to obsolescence once the settlement begins processing claims. If we assume that
audits are merely reviewing claims that were developed pre-settlement, this potential may not be a significant problem.
Where claim development can adapt in response to sampling or other audit rules, however, administrators may not be
equipped to identify or react to these adaptations in a timely manner, particularly where the settlement may be read to
require court approval before making any such changes. To that end, initial settlement design should not only
incorporate learning about claims and practices derived pre-settlement but also mechanisms to continue this learning
and adaptation during the life of the settlement.
D. The Judicial Role in Aggregate Settlement Administration
Judges play a critical role in establishing the legitimacy of an aggregate settlement. To bind class members, for
example, Rule 23(e)(2) specifically requires a judicial finding that the settlement is "fair, reasonable, and adequate"
following a fairness hearing. n216 Likewise, section 524(g) of the Bankruptcy Code conditions the entry of a channeling
injunction-the centerpiece of an asbestos reorganization plan-on the court's finding that "the trust will operate through
mechanisms . . . that provide reasonable assurance that the trust will value, and be in a financial position to pay, present
claims and future demands that involve similar claims in substantially the same manner." n217 Even in the absence of
an express rule or statutory requirement, judicial approval is desirable [*627] as a means of demonstrating that a
settlement is the product of a fair and open process.
Nonetheless, hearings concerning the approval of global settlements tend to marginalize consideration of the
practical elements of settlement administration generally and the likelihood that the settlement will be overrun by
dubious claims specifically. This is not surprising inasmuch as potential objectors are frequently unhappy plaintiffs,
who are concerned with their own compensation rather than the long-term risk of settlement depletion. Defendants have
presumably negotiated monitoring terms as part of the larger settlement discussions, but the risk of oversubscription
may be of little concern when the defendants' costs are fixed. Likewise, the plaintiffs' firms that support the settlement
have little interest in creating more hoops for themselves or their referral firms to jump through. Finally, as seen in
dozens of asbestos bankruptcies since the adoption of section 524(g), legal representatives for future claimants focus
primarily on maximizing assets obtained from defendants and insurers rather than insisting upon strict monitoring of the
claims submitted by the lawyers who effectively control their appointments. n218
This failure is particularly problematic in global settlements where absent tort victims' recoveries will be limited to
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a fixed fund. Current plaintiffs and their counsel have no interest in embracing provisions that may delay or preclude
their own recoveries, and defendants have no incentive to insist upon verification mechanisms when their own liability
is fixed. Thus, even if the parties before the court agree that the settlement is "fair, reasonable, and adequate," a
settlement plan that lacks sufficient verification mechanisms to deter rampant oversubscription will not be so for
claimants who must proceed against an increasingly depleted settlement fund over time. In these situations, adequacy is
not a snapshot as of the settlement; it is a question of whether the settlement plan as a whole is fair, reasonable, and
adequate throughout its operation. [*628]
V. Conclusion
Specious claim markets arise not only because some bad apples find it profitable to exploit gaps in settlement
design but also because the focus on these bad apples overlooks group dynamics that weaken informal checks on
specious claim submissions in traditional litigation. Predictable settlement evidentiary targets generate opportunities and
incentives for repeat players to develop and present intrinsically bad mass tort claims as good. If we assume that bad
apples are primarily responsible for these claims, limiting the opportunities to exploit settlement terms and elevating the
sanctions associated with doing so should be sufficient to deter specious filings. This assumption, however, is
inconsistent with what we know about similarly corrupt practices in virtually every other institutional or group context,
and the absence of self-knowledge-that is, that the actor realizes that the action or practice is corrupt-limits the potential
impact of common opportunity- and incentive-based controls alone.
Notwithstanding these limitations, understanding the potential issues in collective settlement also suggests more
adaptable and targeted solutions. These include not only framing criteria to account for potential malleability and
manipulation but also an adaptive monitoring system that targets the relevant groups, sub-groups, and individuals
responsible for advancing claims. Specifically, sampling methods should focus not only on global claim patterns, but
also the patterns employed by specific repeat players, incorporate mechanisms for refinement to identify and account for
new techniques and strategies for generating claims, and afford settlement administrators with the tools necessary to
avoid or recover payments on account of specious claims. At the same time, settlement forms and communications may
be improved by ensuring that deterrence and compliance messages are effectively communicated to the appropriate
sub-groups and individuals.
Legal Topics:
For related research and practice materials, see the following legal topics:
Environmental LawHazardous Wastes & Toxic SubstancesAsbestosGeneral OverviewEnvironmental LawLitigation &
Administrative ProceedingsGeneral OverviewTortsProcedureSettlementsMultipartiesPartial Settlements
FOOTNOTES:
n1 See, e.g., Ian Ayres, Optimal Pooling in Claim Resolution Facilities, 53 LAW & CONTEMP. PROBS.
159, 160 (1990), available at http://digitalcommons.law.yale.edu/fsspapers/1541 ("The adverse selection of
frivolous claimants represents an important transaction cost of claims facilities that non-frivolous claimants must
bear.").
n2 See infra Part II.C.
n3 See JAMES WILLIAM COLEMAN, THE CRIMINAL ELITE: UNDERSTANDING
WHITE-COLLAR CRIME 178 (4th Ed. 1998) ("Almost all of the studies have agreed on one point:
White-collar offenders are psychologically 'normal' . . . ."); Blake E. Ashforth & Vikas Anand, The
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42 U. Mem. L. Rev. 559, *628
Normalization of Corruption in Organizations, 25 RES. ORGANIZATIONAL BEHAV. 1, 5 (2003) (proposing
a model that offers an explanation why "otherwise morally upright individuals . . . routinely engage in corruption
without experiencing conflict"); Stelios C. Zyglidopoulos et al., Rationalization, Overcompensation and the
Escalation of Corruption in Organizations, 84 J. BUS. ETHICS. 65, 65 (2009) ("While voracious ambition and
greed certainly played a role in the corporate corruption noted, most of the perpetrators were otherwise law
abiding and respectful citizens.").
n4 See Zyglidopoulos et al., supra note 3, at 65 (noting that, given the large number of otherwise law
abiding citizens involved in corporate scandals, "the bad individual theory of corruption (enacted by evil
characters) falls somewhat flat, indicating that self-deception and rationalization played a major role in
justifying the practices"). See generally Niki A. Den Nieuwenboer & Muel Kaptein, Spiraling Down into
Corruption: A Dynamic Analysis of the Social Identity Processes that Cause Corruption in Organizations to
Grow, 83 J. BUS. ETH. 133 (2008) (discussing the process by which group corruption evolves notwithstanding
low base rate for corruption in organizations).
n5 As used in this Article, the term "claim markets" refers to the markets for mass tort client recruiting and
claim development services. Participants in these markets include law firms that primarily, if not exclusively,
recruit new clients and refer them to larger firms for litigation and settlement, medical screening companies and
doctors who generate the medical reports required to advance the claims, and outside litigation support
organizations that assist lawyers in managing client information and preparing claim submissions. The term
"specious claim markets" similarly refers to those claim markets in which the methods used to recruit and
develop claims generate superficially plausible, but ultimately unreliable or intentionally misleading, evidentiary
support.
n6 See, e.g., RICHARD A. NAGAREDA, MASS TORTS IN A WORLD OF SETTLEMENT 145 (2007)
(discussing the classic adverse selection problem in settlement design); Francis E. McGovern, Resolving Mature
Mass Tort Litigation, 69 B.U. L. REV. 659, 688 (1989) ("Unlike most torts where not every individual harmed
seeks legal redress, mature mass torts generate an overabundance of plaintiffs through widespread publicity,
including a substantial number of false positive claims.").
n7 Although we often envision settlements as covering claims that have already been advanced, some of the
largest global settlements are established to process and pay both existing claims and any new claims that may
arise going forward. These "going forward" settlements may have a limited window for accepting new claims,
but others-including substantially all asbestos bankruptcy trusts-are designed to accept newly filed claims years
or even decades after they are established. These settlements tend to establish a compensation grid, which
categorizes current and future claims submitted by a range of factors-i.e., type and severity of injury, level of
exposure to a harmful product or event, et cetera-and assigns settlement values to each category.
n8 See Alex J. Grant, Note, When Does the Clock Start Ticking?: Applying the Statute of Limitations in
Asbestos Property Damage Actions, 80 CORNELL L. REV. 695, 696 (1995).
n9 See Peter H. Schuck, Some Reflections on the Future of Mass Torts, 12 CONN. INS. L.J. 505, 506
(2006) ("The unusually long latency periods associated with asbestos-related illnesses both multiplied the
number of such claimants and increased the difficulty of product (and hence defendant) identification,
necessitating some evidentiary innovations in order to facilitate the claims.").
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n10 See In re Asbestos Cases, 586 N.E.2d 521, 523 (Ill. App. Ct. 1991) (noting many plaintiffs with little or
no disability or impairment had filed asbestos lawsuits because they feared being barred by statute of
limitations); Richard L. Marcus, They Can't Do That, Can They? Tort Reform via Rule 23, 80 CORNELL L.
REV. 858, 871 n.72 (1995) ("In the current tort system, an individual who has been exposed to asbestos and who
exhibits even minor x-ray changes must generally file suit promptly or face the bar of the statute of limitations."
(alteration in original) (quoting Memorandum in Support of the Joint Motion of the Settling Parties for Approval
of Notice to the Class at 50, Carlough v. Amchem Prods., Inc., 158 F.R.D. 314 (E.D. Pa. 1993) (No.
93-CV-0215))).
n11 See Lester Brickman, Disparities Between Asbestosis and Silicosis Claims Generated by Litigation
Screenings and Clinical Studies, 29 CARDOZO L. REV. 513, 515-518 (2007) [hereinafter Brickman,
Disparities]; Lester Brickman, On the Applicability of the Silica MDL Proceeding to Asbestos Litigation, 12
CONN. INS. L.J. 289, 292 (2006) [hereinafter Brickman, Silica MDL]; Lester Brickman, On the Theory Class's
Theories of Asbestos Litigation: The Disconnect Between Scholarship and Reality, 31 PEPP. L. REV. 33, 54-59
(2003) [hereinafter Brickman, Disconnect]; Lester Brickman, The Asbestos Litigation Crisis: Is There a Need
for an Administrative Alternative?, 13 CARDOZO L. REV. 1819, 1840-52 (1992); Victor E. Schwartz &
Rochelle M. Tedesco, The Law of Unintended Consequences in Asbestos Litigation: How Efforts to Streamline
the Litigation Have Fueled More Claims, 71 MISS. L.J. 531, 536 (2001).
n12 See Brickman, Disconnect, supra note 11, at 56-58; see also James A. Henderson, Jr. & Aaron D.
Twerski, Asbestos Litigation Gone Mad: Exposure-Based Recovery for Increased Risk, Mental Distress, and
Medical Monitoring, 53 S.C. L. REV. 815, 817-18 (2002) (noting the "radical departures from longstanding
norms of tort law" allowing pre-injury claims to obtain recovery).
n13 See Deborah R. Hensler & Mark A. Peterson, Understanding Mass Personal Injury Litigation: A
Socio-Legal Analysis, 59 BROOK. L. REV. 961, 1046 (1993) (noting substantial, yet highly subjective, damages
have been awarded based on estimates of future medical expenses and plaintiffs' concern about their fate).
n14 See JENNIFER L. BIGGS ET AL., AM. ACAD. OF ACTUARIES, OVERVIEW OF ASBESTOS
ISSUES AND TRENDS 15-16 (2007) available at http://www.actuary.org/pdf/casualty/asbestosaug07.pdf
(noting broad discretion plaintiffs have enjoyed in filin in the forum of their choice).
n15 See generally Joe E. Basenberg & S. Leanna Bankester, Notice Pleading in the Mass Tort Arena: What
Is Sufficient Notice?, 68 ALA. LAW. 74, 74-76 (2007) (describing the use in mass tort actions of "shotgun
complaints" that often evidence a lack of factual and legal inquiry by plaintiffs). As one court noted, quoting an
attorney from a prominent plaintiffs' firm:
It has been their practice over the many years of this consolidated litigation in New York Supreme Court,
which has involved thousands of asbestos personal injury suits, to file a Standard Asbestos Complaint against a
general list of numerous (currently approximately 100) defendants, which have been identified as making,
selling, using, incorporating, installing, or providing premises with asbestos or asbestos products. The causes of
action in the complaint are stated generally and jointly against all the defendants: "During the course of
[plaintiff's] employment, plaintiff was exposed to the defendants' asbestos and asbestos containing materials to
which exposure directly and proximately caused him to develop an asbestos related disease."
Arseneault v. Congoleum Corp., No. 01 Civ. 10657 (LMM), 2002 WL 472256, at *1 (S.D.N.Y. Mar. 26,
2002) (alterations in original). This approach to pleading has been acknowledged in other forms of aggregate
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42 U. Mem. L. Rev. 559, *628
litigation as well. See Canadian Nat'l/Ill. Cent. R.R. Co. v. Smith, 926 So. 2d 839, 840-41 (Miss. 2006)
(discussing FELA case asserting exposure to wide range of toxic substances); 3 M Co. v. Glass, 917 So. 2d 90,
91 (Miss. 2005) (discussing similar issue in state court silica litigation).
n16 See Cimino v. Raymark Indus., Inc., 751 F. Supp. 649 (E.D. Tex. 1990) (consolidating over two
thousand claims in class action asbestos litigation), aff'd in part, vacated in part, 151 F.3d 297 (5th Cir. 1998);
Brent M. Rosenthal, Toxic Torts and Mass Torts, 55 SMU L. REV. 1375, 1385-86 (2002) (discussing disputes
over individual claim discovery in Texas courts); Schwartz & Tedesco, supra note 11, at 536 (discussing the
expediting of asbestos mass tort claims by way of consolidation and shortened discovery procedures).
n17 After more than a decade of implicit endorsement of these practices in Mississippi, for example, the
state supreme court observed that the plaintiffs "don't appear to know when they were exposed, where they were
exposed, by whom they were exposed, or even if they were exposed." Harold's Auto Parts, Inc. v. Mangialardi,
889 So. 2d 493, 495 (Miss. 2004) (characterizing pleading practices in the state as "a perversion of the judicial
system unknown prior to the filing of mass-tort cases"). Prior to Mangialardi, these vagaries effectively
increased the costs of litigation for defendants and likewise made it difficult, if not impossible, to effectively
distinguish cases on their respective merits.
n18 See Castano v. Am. Tobacco Co., 84 F.3d 734, 746 (5th Cir. 1996) (referring to forced settlement
approaches as "judicial blackmail"); JOHN H. BEISNER & JESSICA D. MILLER, LITIGATE THE TORTS,
NOT THE MASS: A MODEST PROPOSAL FOR REFORMING HOW MASS TORTS ARE ADJUDICATED
7 (2009) (discussing judicial approaches designed to force settlement in mass tort cases); Brickman, Silica
MDL, supra note 11, at 308 ("These aggregations effectively forced defendants to adopt mass settlement
strategies even though many of the claimants had suffered no actual asbestos-related injury or could not show
that any asbestos related disease was substantially caused by exposure to a defendant's products."); Keith N.
Hylton, Asbestos and Mass Torts with Fraudulent Victims, 37 SW. U. L. REV. 575, 587 (2008) ("In addition to
simply boosting the total damage award, the addition of a fraudulent claim also enhances the likelihood of
settlement. If the defendant faces the risk of an enormous judgment representing the claims of thousands of
plaintiffs, it will feel great pressure to settle in order to avoid a bankrupting damages judgment. Including
fraudulent claims therefore not only enhances the aggregate award, it enhances the probability of a settlement."
(footnote omitted)); Schwartz & Tedesco, supra note 11, at 544 (arguing that mass consolidation "does not
promote efficiency; it merely forces defendants to settle").
n19 See Patrick M. Hanlon & Anne Smetak, Asbestos Changes, 62 N.Y.U. ANN. SURV. AM. L. 525, 554-55
(2007) (summarizing criticisms of the Madison County, Illinois, asbestos case management).
n20 See, e.g., Mark A. Behrens, Some Proposals for Courts Interested in Helping Sick Claimants and
Solving Serious Problems in Asbestos Litigation, 54 BAYLOR L. REV. 331, 350-51 (2002) (noting "draconian"
pressure placed on defendants in a Mississippi case and consolidation issues in West Virginia); Hanlon &
Smetak, supra note 19, at 549-52, 574 n.193 (discussing Mississippi and Michigan). Michelle J. White, Asbestos
Litigation: Procedural Innovations and Forum Shopping, 35 J. LEGAL STUD. 365 (2006) (discussing forum
shopping and favorable venues for asbestos plaintiffs in various states).
n21 Inventory settlements generate obvious agency problems, but these issues are beyond the scope of this
Article. For a discussion of these issues, see Howard M. Erichson, Beyond the Class Action: Lawyer Loyalty
and Client Autonomy in Non-Class Collective Representation, 2003 U. CHI. LEGAL F. 519, 569-75 (2003).
Page 28
42 U. Mem. L. Rev. 559, *628
n22 See NAGAREDA, supra note 6, at 25 (discussing grouping of weak claims with strong claims in block
settlements).
n23 See, e.g., Ill. Cent. R.R. Co. v. Byrd, 44 So. 3d 943, 947-49 (Miss. 2010) (discussing inventory
settlement plan).
n24 See id. at 944-45 (noting low conditions for settlement documentation in agreement between firm and
defendant).
n25 For a discussion of the impact of forum shopping in asbestos litigation, see White, supra note 20, at 365
(acknowledging plaintiffs' ability to forum shop in asbestos litigation and discussing the impact on trial
outcomes between 1987 and 2003).
n26 See, e.g., Lester Brickman, Ethical Issues in Asbestos Litigation, 33 HOFSTRA L. REV. 833, 840
(2005) (noting that asbestos claims had little or no risk of going unpaid and thus arguing that the contingency
fees lawyers were charging were "unreasonable").
n27 See id. (arguing inventory settlements with going forward provisions effectively removed risk of
non-recovery).
n28 A notable example is the Owens Corning National Settlement Program ("NSP"). See NAGAREDA,
supra note 6, at 108-13 (discussing the operation of the NSP).
n29 Two notable examples of multi-plaintiff and multi-defendant arrangements are the Wellington
Agreement and the settlement system administered by the Center for Claims Resolution. See Richard L. Marcus,
Reassessing the Magnetic Pull of Megacases on Procedure, 51 DEPAUL L. REV. 457, 481 & n.116 (2001).
n30 The Manville Personal Injury Settlement Trust was established under Johns-Manville Corporation's
Chapter 11 Plan of Reorganization to process and pay qualifying asbestos claims against the company. Frank J.
Macchiarola, The Manville Personal Injury Settlement Trust: Lessons for the Future, 17 CARDOZO L. REV.
583, 583 (1996). The trust currently divides compensable injuries into eight categories-mesothelioma, two
categories of lung cancer, "other" cancer, three categories of asbestosis (ranked according to severity) and
"other" asbestos disease-and assigns a base settlement value to each category. See CLAIMS RESOLUTION
MGMT. CORP., 2002 TRUST DISTRIBUTION PROCESS 1,
http://www.claimsres.com/documents/MT/TDP02.pdf. Claimants must also provide basic information
concerning their work histories and exposure to qualify for settlement. Id. at 13.
n31 See Marcus, supra note 29, at 481-82.
n32 NAGAREDA, supra note 6, at 111.
n33 See Francis E. McGovern, The Defensive Use of Federal Class Actions in Mass Torts, 39 ARIZ. L.
REV. 595, 606 (1997) (noting that class actions were the "preferred procedural device" at the time).
Page 29
42 U. Mem. L. Rev. 559, *628
n34 521 U.S. 591 (1997).
n35 527 U.S. 815 (1999).
n37 See id. at 79.
n38 See id. at 159-60 (noting that the "modern class action is an institution ill-suited for . . . a redistributive
program").
n39 See id. at 21-22 (discussing use of bankruptcy to fashion mass tort resolution across different mass
torts); see also Georgene Vairo, Mass Torts Bankruptcies: The Who, the Why and the How, 78 AM. BANKR.
L.J. 93, 128 (2004) ("Given the failure of the Amchem and Ortiz class action settlements and the failure of
Congress to act on a general level, bankruptcy may well be the only option available to defendants seeking
peace in an intractable litigation.").
n40 See generally S. Todd Brown, Section 524(g) Without Compromise: Voting Rights and the Asbestos
Bankruptcy Paradox, 2008 COLUM. BUS. L. REV. 841, 861-62 (discussing strategic and competitive dominance
of the small number of firms controlling the largest inventories in asbestos bankruptcies).
n41 See id. at 860-62; see also William P. Shelley et al., The Need for Transparency Between the Tort
System and Section 524(g) Asbestos Trusts, 17 NORTON J. BANKR. L. & PRAC. 257, 261 (2008) ("The
dynamics of the bankruptcy process tend to lead to trust agreements . . . that are largely written by counsel for
the asbestos claimants themselves.").
n42 See Brown, supra note 40, at 862-63.
n43 See id. at 893-94 (outlining issues with the oversight of asbestos bankruptcy plans and settlement
administration); see also Yair Listokin & Kenneth Ayotte, Protecting Future Claimants in Mass Tort
Bankruptcies, 98 NW. U. L. REV. 1435, 1481 (2004) (discussing obstacles to ensuring fairness in mass tort
bankruptcies); Linda S. Mullenix, Commentary, Back to the Futures: Privatizing Future Claims Resolution, 148
U. PA. L. REV. 1919, 1926 (2000) (noting limits of information provided to courts approving mass tort
settlements).
n44 See Charles E. Bates et al., The Naming Game, MEALEY'S LITIG. REP.: ASBESTOS, Sept. 2, 2009,
at 1, 7, available at http://www.bateswhite.com/media/pnc/9/media.229.pdf (noting the higher propensity to file
claims against trusts because, among other reasons, their standards "are typically less strict than the burden of
proof in the Tort System"); see generally Shelley et al., supra note 41.
n45 See NAGAREDA, supra note 6, at 150 ("The problem of overclaiming inheres in any move from a tort
system predicated on individualized proof toward a streamlined administrative regime. Efficient application of a
compensation grid necessarily involves cutting corners by comparison to the detailed proof that might be
Page 30
42 U. Mem. L. Rev. 559, *628
demanded in tort litigation."); Deborah R. Hensler, Revisiting the Monster: New Myths and Realities of Class
Action and Other Large Scale Litigation, 11 DUKE J. COMP. & INT'L L. 179, 188 (2001) ("Thousands of
lesser-value claims may be resolved en masse according to negotiated schedules of damages that pay little
attention to individual claim differences and involve little adversarial litigation.").
n46 See Lester Brickman, The Use of Litigation Screenings in Mass Torts: A Formula for Fraud?, 61 SMU
L. REV. 1221, 1226-27 (2008) [hereinafter Brickman, Litigation Screenings] (discussing the creation of asbestos
litigation screening practices).
n47 See Brickman, Disconnect, supra note 11, at 63; David Maron & Walker W. (Bill) Jones, Taming an
Elephant: A Closer Look at Mass Tort Screening and the Impact of Mississippi Tort Reforms, 26 MISS. C. L.
REV. 253, 264 (2006). For example, following the terrorist attacks of September 11, 2001, a variety of screening
programs were established to test and track the physical and mental injuries suffered by first responders and
other high-risk populations. See generally John Howard, The World Trade Center Disaster: Health Effects and
Compensation Mechanisms, 16 J.L. & POL'Y 69 (2007).
n48 See Brickman, Disconnect, supra note 11, at 76 (noting the role of unions in mass screenings); Charles
Silver & Lynn A. Baker, Mass Lawsuits and the Aggregate Settlement Rule, 32 WAKE FOREST L. REV. 733,
741 (1997) ("Unions, churches, homeowners and renters associations, and other voluntary membership groups
are also potential sources of clients.").
n49 The late Fred Baron's remarks at the National Press Club in 2002 provide a vivid example of how this
"public service" argument has been used to deflect criticism of litigation screenings:
Myth 1: Plaintiffs' lawyers notoriously go out with x-ray vans, find people who work in factories, and
develop large numbers of clients. Quite honestly, I am offended when somebody criticizes me for providing free
medical services to a person who is working in a factory and who has been exposed to asbestos. . . . Hundreds
and hundreds of people who have developed cancer have first learned that they had cancer, hopefully early
enough to save their life, as a result of x-ray screenings that were provided either by their union or by plaintiff's
counsel. I am offended when people tell me that, "it's terrible that you are giving free medical treatment to
working people who end up filing suits." I do not buy that argument. When a victim is diagnosed with a disease
and somebody is legally responsible under state law, there should be no barrier to that individual filing a suit to
reclaim their rights.
Fred Baron, Address at the Nat'l Press Club (June 18, 2002), in CIV. JUST. F., Apr. 2003, at 11, 12,
available at http://heartland.org/sites/all/modules/custom/heartlandmigration/files/pdfs/12337.pdf; see also
Roger C. Cramton, Lawyer Ethics on the Lunar Landscape of Asbestos Litigation, 31 PEPP. L. REV. 175,
182-83 (2003) ("Even though the medical benefits of screening are dubious and the quality of the testing
provided is subject to question . . ., Baron's argument has a large popular appeal. A grievance body that
examines and possibly punished the recruitment methods would be subject to much public criticism and
hostility."(footnote omitted)).
n50 See Joseph F. Rice & Nancy Worth Davis, Judicial Innovation in Asbestos Mass Tort Litigation, 33
TORT & INS. L.J. 127, 140 n.74 (1997) (noting that while screenings may be perceived as a public service, they
serve as a "double-edged sword" for plaintiffs' attorneys who must make prompt filings upon discovery of signs
of exposure to avoid tolling of statutes of limitation).
Page 31
42 U. Mem. L. Rev. 559, *628
n51 See Brickman, Disconnect, supra note 11, at 67 ("While the recording of patient information such as
medications, age, race, medical history, and exposure history are crucial to prevent errors in interpretation, the
persons hired by screening enterprises to gather that information typically lack any qualifications for the taking
of exposure and medical histories and usually receive no training."(footnote omitted) (internal quotation marks
omitted)).
n52 See id. at 80 (discussing manipulation of medical histories).
n53 See id. at 67-68 ("Screening enterprises administer pulmonary function tests in a manner that generates
far higher numbers of lung-impaired persons than would be the case if the standards established by the
American Thoracic Society were observed."); id. at 90 ("Both the X-ray equipment used and the process of
administering the X-rays leave much to be desired. However, the resultant poor quality of X-rays may actually
improve B-readers' ability, if not propensity, to misread the X-ray." (footnote omitted)).
n54 See ABA COMM'N. ON ASBESTOS LITIG., REPORT TO THE HOUSE OF DELEGATES
RECOMMENDATION 8 (2003),
http://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-015/020103-Exhibit12.pdf ("The x-rays are generally
read by doctors who are not on site and who may not even be licensed to practice medicine in the state where the
x-rays are taken or have malpractice insurance for these activities. According to these doctors, no doctor/patient
relationship is formed with the screened workers and no medical diagnoses are provided. Rather, the doctor
purports only to be acting as a litigation consultant and only to be looking for x-ray evidence that is 'consistent
with' asbestos-related disease."). At least one doctor has successfully defended a medical malpractice complaint
based on his screening activities by insisting that he was not involved in a doctor-patient relationship with those
he screened. Adams v. Harron, No. 97-2547, 1999 WL 710326, at *2 (4th Cir. Sept. 13, 1999) (per curiam).
n55 See Joseph N. Gitlin et al., Comparison of "B" Readers' Interpretations of Chest Radiographs for
Asbestos Related Changes, 11 ACAD. RADIOLOGY 843, 855 (2004).
n56 One plaintiffs' lawyer acknowledged this fact, explaining, "The sole purpose for . . . asbestos screening
programs is in anticipation of future litigation against. sic asbestos manufacturers" and the process is "geared
toward collecting evidence for future asbestos litigation." Brief of Appellants at 19, In re Asbestos Prods. Liab.
Litig., Nos. 98-1166, 98-1165, 1998 WL 34085715 (3d Cir. 1998).
n57 See Brown, supra note 40, at 846-47.
n58 Recent Developments in Assessing Future Asbestos Claims Under the FAIR Act: Hearing on S. 852
Before the S. Comm. on the Judiciary, 109th Cong. 190-92 (2005) [hereinafter Lederer Testimony] (testimony
of Mark E. Lederer, Chief Financial Officer, Manville Personal Injury Settlement Trust),
http://www.access.gpo.gov/congress/senate/pdf/109hrg/25947.pdf.
n59 Id. at 198.
n60 See MANVILLE PERSONAL INJURY SETTLEMENT TRUST: HISTORY,
http://www.mantrust.org/history.htm (last visited May 5, 2012).
Page 32
42 U. Mem. L. Rev. 559, *628
n61 See id.
n62 See Lederer Testimony, supra note 58, at 193.
n63 See Mauger v. A.W. Chesterton, Inc., No. 2154, No. 1631, 2007 Phila. Ct. Com. Pl. LEXIS 193, at *25
(Phila. Ct. Com. Pl. June 25, 2007) (discussing other trusts that have received several hundred thousand claims).
n64 LLOYD DIXON ET AL., RAND INST. FOR CIV. JUST., ASBESTOS BANKRUPTCY TRUSTS:
AN OVERVIEW OF TRUST STRUCTURE AND ACTIVITY WITH DETAILED REPORTS ON THE
LARGEST TRUSTS xiv (2010) [hereinafter RAND 2010 REPORT], available at
http://www.rand.org/content/dam/rand/pubs/technicalreports/2010/RANDTR872.pdf. The nonmalignant
designation, however, may be over-inclusive given the limits of the data available to RAND. Id. at xiii-xiv.
n65 See Mark A. Behrens, Asbestos Litigation Screening Challenges: An Update, 26 T.M. COOLEY L.
REV. 721, 755 (2009). See infra Part IV.A for a more detailed discussion.
n66 RAND 2010 REPORT, supra note 64, at xv.
n67 Id.
n68 In re T H Agric. & Nutrition, L.L.C., No. 08-14692 (REG), 2009 WL 7193573 (Bankr. S.D.N.Y. May
28, 2009); see also Declaration of Francine F. Rabinovitz in Support of Confirmation of the First Amended
Prepackaged Plan of Reorganization of T H Agriculture & Nutrition, L.L.C. Under Chapter 11 of the
Bankruptcy Code at P 35, In re T H Agric. & Nutrition, L.L.C., No. 08-14692 (REG), 2009 WL 6679826 (Bankr.
S.D.N.Y. May 15, 2009) ("The anticipated Asbestos PI Trust funding will allow the Asbestos PI Trust to pay
100% of the value of each Asbestos PI Claim for the life of the Asbestos PI Trust."); Kirk T. Hartley et al.,
Commentary, Pre-packaged Plan of Inequity: The Financial Abuse of Future Claimants in the T H Agriculture &
Nutrition 524(g) Asbestos Bankruptcy, MEALEY'S ASBESTOS BANKR. REP., Nov. 2011, at 1, 3-4, available
at http://www.bateswhite.com/media/pnc/2/media.492.pdf.
n69 Disclosure Statement with Respect to a Prepackaged Plan of Reorganization of T H Agriculture &
Nutrition, L.L.C. Under Chapter 11 of the Bankruptcy Code at 4, In re T H Agric. & Nutrition, L.L.C., No. 1:08
BK14692, 2008 WL 7947215 (Bankr. S.D.N.Y. Oct. 10, 2008) [hereinafter THAN Disclosure Statement].
n70 Declaration of James Sean McGuire Certifying Tabulation of Ballots Regarding Vote on Debtor's
Prepackaged Plan of Reorganization at 6, In re T H Agric. & Nutrition, LLC, No. 08-14692 (REG), 2009 WL
7193573 (Bank. S.D.N.Y. Nov. 24, 2008).
n71 Notice Regarding Commencement of Claim Filing on April 1, 2011, THAN Asbestos Personal Injury
Trust (Mar. 14, 2011), http://www.thanasbestostrust.com/Files/20110321THANCommencementNotice.PDF.
n72 THAN Disclosure Statement, supra note 69, at 4.
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42 U. Mem. L. Rev. 559, *628
n73 Id. at 4-5.
n74 Brown, supra note 40, at 890-91 (discussing how specious claim filings overwhelm efficiencies in
asbestos bankruptcies); see also Frederick T. Smith, Commentary, Class Actions' Uncertain Future: Lessons
from Ortiz v. Fibreboard, reprinted in ANDREWS TOXIC CHEMICALS LITIG. REP., Nov. 15, 1999, at 1,
10-11 ("In some parts of the country, mass tort claims have threatened to overwhelm the civil justice system,
accounting for more than one-quarter of the entire civil caseload in certain courts.").
n75 See Asbestos Litigation: Hearing Before S. Comm. on the Judiciary, 107th Cong. 8-9 (2002), available
at http://www.gpo.gov/fdsys/pkg/CHRG-107shrg88289/pdf/CHRG-107shrg88289.pdf (noting how unimpaired
asbestos claims diminish recoveries for the sick); Brickman, Litigation Screenings, supra note 46, at 1228 ("I
estimate that lawyers have spent at least $ 500 million, and perhaps as much as $ 1 billion, to conduct litigation
screenings that have generated over 1,000,000 claimants, most of whose claims are specious, and contingency
fees well in excess of thirteen billion dollars." (footnote omitted)); Matthew Bergman & Jackson Schmidt,
Editorial, Change Rules on Asbestos Lawsuits, SEATTLE POST-INTELLIGENCER, May 30, 2002, at B7
(noting that "the genuinely sick and dying are often deprived of adequate compensation as more and more funds
are diverted into settlements of the non-impaired claims"); Quenna Sook Kim, Asbestos Trust Says Assets Are
Reduced as the Medically Unimpaired File Claims, WALL ST. J., Dec. 14, 2001, at B6 (noting that "a
'disproportionate amount of Trust settlement dollars have gone to the least injured claimants-many with no
discernible asbestos-related physical impairment whatsoever'").
n76 See Charles Bates & Charlie Mullin, Commentary, The Bankruptcy Wave of 2000-Companies Sunk By
an Ocean of Recruited Asbestos Claims, MEALEY'S LITIG. REP.: ASBESTOS, Jan. 24, 2007, at 39, 39,
available at www.bateswhite.com/media/pnc/6/media.286.pdf ("Mass recruited claims caused the bankruptcy
wave of asbestos defendants that began in 2000 and eventually resulted in the bankruptcy of more than 40
companies."). The authors conclude that "the cost to defendants, their insurers, and seriously injured asbestos
claimants from the mass recruiting of over 600,000 unimpaired asbestos claimants may eventually total $ 50
billion." Id. at 44.
n77 'Medical Monitoring and Asbestos Litigation'-A Discussion with Richard Scruggs and Victor Schwartz,
MEALEY'S LITIG. REP.: ASBESTOS, Mar. 1, 2002, at 1, 5, available at
http://www.shb.com/attorneys/SchwartzVictor/MedicalMonitoringandAsbestosLitigation2002.pdf (recounting
the experiences of former asbestos plaintiffs' lawyer Dickie Scruggs).
n78 See STEPHEN J. CARROLL ET AL., RAND INST. FOR CIV. JUST., THE ABUSE OF MEDICAL
DIAGNOSTIC PRACTICES IN MASS LITIGATION: THE CASE OF SILICA ix (2009) [hereinafter RAND
SILICA REPORT], http://www.rand.org/pubs/technicalreports/2009/RANDTR774.pdf.
n79 See Martha Sharp, Silica: The Next Asbestos?, 3 ENFORCE: INS. POL'Y ENFORCEMENT J., no. 3,
2004 at 5, 6, available at http://www.docstoc.com/docs/34386057/The-Next-Asbestos (noting sharp rise in silica
litigation claims and suggesting that each claim would be worth "six figures"). Aside from the similarities in the
resulting injuries-asbestosis and silicosis are both incurable lung diseases with long latency periods-many
Americans have been exposed to silica dust at home and in the workplace. See id.; see also RAND SILICA
REPORT, supra note 78, at 37 (discussing wide range of industries with workplace exposure to silica dust).
n80 Susan Warren, Silicosis Suits Rise Like Dust: Lawyers in Asbestos Cases Target Many of the Same
Page 34
42 U. Mem. L. Rev. 559, *628
Companies, WALL ST. J., Sept. 4, 2003, at B5.
n81 RAND SILICA REPORT, supra note 78, at ix.
n82 Id. at 3-4.
n83 In re Silica Prods. Liab. Litig., 398 F. Supp. 2d 563, 567 (S.D. Tex. 2005).
n84 See Brickman, Disparities, supra note 11, at 577-78.
n85 See discussion infra Part III.A.
n86 In re Silica Prods. Liab. Litig., 398 F. Supp. 2d at 576.
n87 Id. at 579-81. Although plaintiffs' counsel represented that Martindale was a consulting expert in their
motion to quash his deposition, "Dr. Martindale testified that he was not Plaintiffs' expert and had specifically
refused Plaintiffs' lawyers' requests to serve as their expert." Id. at 581. More significantly, Dr. Martindale
testified that he had not intended to diagnose anyone with silicosis and withdrew the ostensible "diagnoses"
bearing his signature for 3617 plaintiffs in the litigation. Id. at 581-84.
n88 Id. at 584.
n89 Id. at 598-99.
n90 Id. at 600, 629.
n91 See id. at 601.
n92 An ILO form is frequently used to document findings of lung abnormalities and will often be sufficient
medical documentation to establish such findings in asbestos settlements.
n93 In re Silica Prods. Liab. Litig., 398 F. Supp. 2d at 600-01.
n94 See id. at 601.
n95 Id. at 633 ("In many cases, a different person performed each of the following steps: taking the
occupational history, performing the physical exam, reading the x-ray, analyzing the pulmonary function tests,
taking the medical history, and finally, making a diagnosis. The people performing the steps were so
compartmentalized that often they did not know the others' identities, let alone whether they were qualified and
were performing their assigned tasks correctly.").
Page 35
42 U. Mem. L. Rev. 559, *628
n96 Id.
n97 Id. at 583-84, 605-06, 609-11, 617, 619, 639 n.121.
n98 Id. at 582.
n99 See id. at 584, 603-04, 618-19, 634-35, 640.
n100 Id. at 583, 604, 617.
n101 Id. at 603.
n102 Id.
n103 Id. at 607.
n104 Id. at 635.
n105 HON. JOSEPH HALBACH, JR., CAUSE NO. 2004-70000 STATEWIDE SILICA MDL, 333D
DISTRICT COURT OF HARRIS COUNTY,TEXAS, TEXAS CIVIL PRACTICE & REMEDIES CODE
SECTION 90.010(k) REPORT (Sept. 1, 2010), http://www.justex.net/JustexDocuments/24/Section 90.010(k)
Report.pdf.
n106 David J. Morrow, Fen-Phen Maker to Pay Billions in Settlement of Diet-Injury Cases, N.Y. TIMES,
Oct. 8, 1999, at A1, available at
http://www.nytimes.com/1999/10/08/business/fen-phen-maker-to-pay-billions-in-settlement-of-diet-injury-cases.html?pagewante
n107 Nationwide Class Action Settlement Agreement with American Home Products Corp. (As Amended),
MDL No. 1203, Civ. No. 99-20593 (E.D. Pa. Nov. 18, 1999), [hereinafter Diet Drugs 1999 Settlement],
http://www.settlementdietdrugs.com/pdfs/AmendedSettlement%20Agreement%20.pdf.
n108 NAGAREDA, supra note 6, at 136-43.
n109 See Diet Drugs 1999 Settlement, supra note 107, at § VI.C.
n110 See Appendix to GREEN FORM, Settlement Matrix Compensation Benefits Guide for Physicians,
Attorneys and Class Members (on file with author).
n111 Id.
Page 36
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n112 See Diet Drugs 1999 Settlement, supra note 107, at § VI.E.1 (providing for audit of 15% of the claim
pool). All other nominally qualifying claims were to be paid without audit, but payments for the audited claims
were withheld pending the results of the audit. Id. at § VI.E.2; see Brown v. Am. Home Prods. Corp. (In re Diet
Drugs Prods. Liab. Litig.), MDL No. 1203, Civ. No. 99-20593, 2002 U.S. Dist. LEXIS 23595, at *12 (E.D. Pa.
Nov. 26, 2002) ("As of now, 85% of the claims must be paid without any real check on their legitimacy.").
n113 Diet Drugs 1999 Settlement, supra note 107, at § VI.E.8.
n114 Id.
n115 See Brickman, Litigation Screenings, supra note 46, at 1259-60 (discussing recruiting and screening
practices).
n116 See Indictment at 11-12, United States v. Tai, No. 2:10-cr-00769-JS (E.D. Pa. Nov. 30, 2010)
[hereinafter Tai Indictment] (outlining more than $ 2 million in billings for mass produced diagnoses);
Complaint at 10-11, AHP Settlement Trust v. Crouse, No. 03-5252 (E.D. Pa. Sept. 19, 2003) [hereinafter Crouse
Complaint], http://www.settlementdietdrugs.com/pdfs/ComplaintAgainstLindaCrouse091803.pdf (noting over $
3.2 million earned in eleven months).
n117 See Tai Indictment, supra note 116, at 9.
n118 See id.
n119 See Crouse Complaint, supra note 116, at 10-11 (noting that one doctor earned more than $ 3.2 million
in eleven months from just two of the roughly twenty-five law firms using her services).
n120 Tai Indictment, supra note 116, at 10.
n121 See In re Diet Drugs Prods. Liab. Litig., 553 F. Supp. 2d 442, 476 (E.D. Pa. 2008) ("Numerous
attorneys, some with nefarious intentions, operated echocardiogram mills to develop a vast inventory of
claimants . . . . This flood of claims was unexpected and out of step with the learned projections based on
epidemiologic and demographic evidence.").
n123 Morrow, supra note 106.
n124 American Home Products Corporation, subsequently known as Wyeth, was acquired by Pfizer Inc. on
October 15, 2009. Wyeth Transaction, PFIZER,
http://www.pfizer.com/investors/shareholderservices/wyethtransaction.jsp (last visited May 6, 2012).
n125 Alex Berenson, Analysts See Merck Victory in Vioxx Settlement, N.Y. TIMES, Nov. 10, 2007, at A1,
Page 37
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available at http://www.nytimes.com/2007/11/10/business/10merck.html?pagewanted=all.
n126 See, e.g., George Loewenstein et al., Self-Serving Assessments of Fairness and Pretrial Bargaining, 22
J. LEGAL STUD. 135, 138-39 (1993) ("Plaintiffs are likely to systematically overestimate the value of their
claims, and defendants are likely to underestimate the value of claims brought against them."); Deborah L.
Rhode, Moral Counseling, 75 FORDHAM L. REV. 1317, 1325 (2006) ("Even with the best of intentions,
attorneys, like any decision makers, are subject to cognitive biases, peer pressures, and information barriers that
compromise counseling responsibilities."); Jean R. Sternlight & Jennifer Robbennolt, Good Lawyers Should Be
Good Psychologists: Insights for Interviewing and Counseling Clients, 23 OHIO ST. J. ON DISP. RESOL. 437,
543 (2008) (noting clients report facts as they cognitively perceive them).
n127 There is general agreement that plaintiffs' lawyers are the driving force behind mass tort claim
recruiting and filing patterns. See Brickman, Litigation Screenings, supra note 46, at 1232-33 (criticizing the
entrepreneurial model of asbestos litigation and its role in expanding the volume of asbestos claims); Richard A.
Nagareda, Autonomy, Peace, and Put Options in the Mass Tort Class Action, 115 HARV. L. REV. 747, 808
(2002) (noting the "driving force" in selecting certain cases is entrepreneurship); Richard A. Nagareda, In the
Aftermath of the Mass Tort Class Action, 85 GEO. L.J. 295, 319 (1996) (analyzing the role of entrepreneurial
mass tort attorneys in mass tort filing patterns); David Rosenberg, Response, Mandatory-Litigation Class
Action: The Only Option for Mass Tort Cases, 115 HARV. L. REV. 831, 848-49 (2002) (analyzing claim
investment considerations in mass tort); Jack B. Weinstein, Ethical Dilemmas in Mass Tort Litigation, 88 NW.
U. L. REV. 469, 480 (1994) ("The speed with which the number of breast implant cases exploded on the scene is
attributable in part to a well-organized plaintiffs' bar, which now has the capital, organizational skills, and
advertising techniques to seek clientele.").
n128 Cf. McGovern, supra note 33, at 606 (noting the impact of timing on potential returns and the manner
in which it may influence client recruiting). For example, even before the Silica MDL, asymptomatic asbestos
client recruiting dropped significantly due to the growth of deferred dockets, tort reform, and restrictions on
consolidation. See TOWERS WATSON, A SYNTHESIS OF ASBESTOS DISCLOSURES FROM FORM
10-KS: INSIGHTS 1 (2010),
http://www.towerswatson.com/assets/pdf/1492/AsbestosDisclosuresInsights4-15-10.pdf.
n129 NAGAREDA, supra note 6, at 241-42.
n130 See, e.g., Tai Indictment, supra note 116, at 7-12 (detailing criminal action against doctor involved in
fen-phen specious claims diagnoses after full audits were ordered).
n131 See, e.g., Jeremy Hudson, Woman Sentenced in Fen-Phen Scam, THE CLARION-LEDGER, Dec. 22,
2004, at 1B (recounting how a sixty-three year-old woman was sentenced to ten months in prison for taking $
250,000 in a fake settlement); Robert Lenzner & Michael Maiello, The $ 22 Billion Gold Rush, FORBES (Apr.
10, 2006), http://www.forbes.com/forbes/2006/0410/086.html (questioning how much of $ 22 billion in
settlement payments went to individuals with specious claims).
n132 See Reed Abelson & Jonathan D. Glater, Tough Questions Are Raised on Fen-Phen Compensation,
N.Y. TIMES, Oct. 7, 2003, at C1 (discussing RICO case against fen-phen echo-mill doctor).
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42 U. Mem. L. Rev. 559, *628
n133 See Ashforth & Anand, supra note 3, at 12 ("Specialization not only fosters a diffusion of
responsibility, it makes it difficult for any individual to comprehend (and easy to deny) the 'big picture.'").
n134 See supra notes 3-4 and accompanying text.
n135 See, e.g., LLOYD DIXON & GEOFFREY MCGOVERN, ASBESTOS BANKRUPTCY TRUSTS
AND TORT COMPENSATION 8-9 (2011), available at
http://www.rand.org/content/dam/rand/pubs/monographs/2011/RANDMG1104.pdf.
n136 As a group of prominent plaintiffs' firms argued in the W.R. Grace bankruptcy, the only relevant
question was whether the claimant could produce some form of evidence in support of her claim, not whether
the evidence was questionable. Response to and Opposition to Debtor's Motion to Compel Asbestos Personal
Injury Claimants Represented by Edward O. Moody, P.A., Foster & Sear L.L.P., Motley Rice LLC, and
Williams Bailey Law Firm, LLP to Respond to the W.R. Grace Asbestos Personal Injury Questionnaire and
Motley Rice LLC's Joinder in the Responses of Various Law Firms Representing Asbestos Personal Injury
Claimants in Opposition to Debtor's Motion Compel, In re W.R. Grace & Co., No. 01-01139355 (Bankr. D. Del.
2006). Similarly, the court in the Armstrong bankruptcy rejected an estimation analysis that assumed plaintiffs
in the tort system must identify a debtor's product to be compensated because it was not "the reality in asbestos
litigation," where limits on product identification records would "preclude summary judgment on this issue." In
re Armstrong World Indus., Inc., 348 B.R. 111, 130 (D. Del. 2006).
n137 Repeat players in litigation tend to adopt recognized settlement patterns. Moreover, RAND reports
that some defense attorneys actively encouraged plaintiffs to file additional suits against their clients, apparently
as a means of generating fees during the inevitable march toward settlement. RAND SILICA REPORT, supra
note 78, at xiv.
n138 See Hon. Helen E. Freedman, Selected Ethical Issues in Asbestos Litigation, 37 SW. U. L. REV. 511,
525 (2008).
n139 See supra notes 44-45 and accompanying text.
n140 See generally Brown, supra note 40 (discussing strategic and competitive dominance of the small
number of firms controlling the largest inventories in asbestos bankruptcies).
n141 See id. at 843.
n142 In fact, the plaintiffs in that case adopted an aggressive, high-dollar settlement approach premised on
the assumption that the defendants would follow the asbestos litigation settlement model. See Roger Parloff,
Diagnosing for Dollars, FORTUNE (June 13, 2005),
http://money.cnn.com/magazines/fortune/fortunearchive/2005/06/13/8262537/index.htm ("In April 2004 the
plaintiffs' lead counsel presented the defendants with a letter demanding $ 1 billion to settle the cases. He
suggested that the price was a bargain, because 'litigating the Silica MDL will collectively cost the defendants
more than $ 1,500,000,000' in pretrial expenses alone.").
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n143 RAND SILICA REPORT, supra note 78, at 27.
n144 Although some may find this expansion beyond colorable litigation claims problematic standing
alone, this normative view is not without controversy. The focus of this Article is not, however, to determine the
appropriate evidentiary standard for collective settlement but to identify the manner in which the standard
selected may be distorted beyond one or more of the settlement proponents' expectations.
n145 See David Egilman, Letter to the Editor, Asbestos Screenings, 42 AM. J. INDUS. MED. 163 (2002),
available at http://www.egilman.com/Documents/publications/screenings.pdf ("I was amazed to discover, that in
some of the screenings, the worker's X-ray had been 'shopped around' to as many as six radiologists until a
slightly positive reading was reported by the last one of them.").
n146 See, e.g., FIN. CRISIS INQUIRY COMM'N, FINANCIAL CRISIS INQUIRY REPORT xviii-xxii
(2011), available at http://www.gpo.gov/fdsys/pkg/GPO-FCIC/pdf/GPO-FCIC.pdf.
n147 Although others have discussed this pattern in more technical terms, an excellent layman's account
may be found in Michael Lewis, THE BIG SHORT: INSIDE THE DOOMSDAY MACHINE (2010).
n148 See supra Part II.C.
n149 To illustrate, one firm noted that the cost of producing case-specific expert medical reports was
"unduly burdensome and time-consuming." Memorandum of Law in Support of Plaintiffs' Motion for Extension
of Time to Comply with Pretrial Order No. 29 Requiring Case-Specific Expert Reports for Only the Plaintiffs
Represented by Weitz & Luxenberg, P.C., or Alternatively to Amend Order to Certify for Interlocutory Appeal
Under 28 U.S.C. § 1292(b), at 7, In re Bextra & Celebrex Marketing Sales Practices & Prod. Liab. Litig., MDL
No. 1699, No. M:05-CV-01699-CRB (N.D. Cal. Aug. 29, 2008) [hereinafter Weitz & Luxenberg
Memorandum].
n150 See, e.g., John C. Coffee, Jr., Class Wars: The Dilemma of the Mass Tort Class Action, 95 COLUM.
L. REV. 1343, 1374 (1995).
n151 See Joseph A. Grundfest & Peter H. Huang, The Unexpected Value of Litigation: A Real Options
Perspective, 58 STAN. L. REV. 1267, 1279 (2006).
n152 See id.
n153 See generally Nora Freeman Engstrom, Run-of-the-Mill Justice, 22 GEO. J. LEGAL ETHICS 1485
(2009) (discussing settlement mills in traditional litigation).
n154 This assumes that the financial expenses may be deducted from the clients' recovery in addition to the
lawyer's fee.
n155 See, e.g., T. Leigh Anenson, Absolute Immunity from Civil Liability: Lessons for Litigation Lawyers,
Page 40
42 U. Mem. L. Rev. 559, *628
31 PEPP. L. REV. 915, 923 (2004) (discussing attorneys' "freedom to err" on the side of their clients in the
adversary system); Gerald Walpin, America's Adversarial and Jury Systems: More Likely to Do Justice, 26
HARV. J.L. & PUB. POL'Y 175, 177 (2003) ("Zealous, faithful advocacy means the obligation to search out all
favorable evidence, to seek, neutralize or destroy all unfavorable evidence, and to press the most favorable
interpretation of the law for his client.").
n156 Cf. Janet Cooper Alexander, Do the Merits Matter? A Study of Settlements in Securities Class
Actions, 43 STAN. L. REV. 497, 547-48 (1991) ("Having established a system in which all cases that survive a
motion to dismiss are settled for a certain percentage of the stakes, plaintiffs' attorneys have less incentive to
screen cases carefully. Thus, the existence of a 'going rate' encourages the filing of more, and weaker, suits than
attorneys would bring under the conventional economic model.").
n157 Indeed, some high-profile plaintiffs' lawyers and doctors actively lobbied against some of the practices
discussed in this Article. See Asbestos Litigation: Hearing Before S. Comm. on the Judiciary, supra note 75, at
24-26 (prepared statement of Steven Kazan) (criticizing recruiting practices of entrepreneurial mass tort firms);
Egilman, supra note 145, at 163.
n158 See generally Ruth V. Aguilera & Abhijeet K. Vadera, The Dark Side of Authority: Antecedents,
Mechanisms, and Outcomes of Organizational Corruption, 77 J. BUS. ETH. 431 (2008) (drawing upon the
Opportunity-Motivation-Justification model of crime to explain corporate corruption).
n159 See Brickman, Disparities, supra note 11, at 526-30 (noting screening doctor positive yields of
50-90%).
n160 Given this cost consideration, it may not be surprising that so many silica and asbestos claimants
accepted dismissal rather than attempting to build sufficient evidentiary support to satisfy the higher standards
adopted in some states and courts following the Silica MDL. See Aricka Flowers, Judge Robreno: Cleaning Up
Clogged Asbestos MDL, SOUTHEAST TEXAS RECORD (Aug. 5, 2009, 11:56 AM),
http://www.setexasrecord.com/news/220412-judge-robreno-cleaning-up-clogged-asbestos-mdl (noting dismissal
of thousands of asbestos claims); supra note 105 and accompanying text.
n161 See Nieuwenboer & Kaptein, supra note 4, at 137.
n162 This framework collapses elements of those advanced by Aguilera & Vadera, supra note 158, at
431-37, and Ashforth & Anand, supra note 3, at 16-22.
n163 See Aguilera & Vadera, supra note 158, at 436; Ashforth & Anand, supra note 3, at 18.
n164 See Zyglidopoulos et al., supra note 3, at 70.
n165 See Aguilera & Vadera, supra note 158, at 436.
n166 See Ashforth & Anand, supra note 3, at 18 (discussing the influence of "slippage between behavior
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and rules" in enforcement on perceptions of legality and propriety).
n167 See generally Carrie Menkel-Meadow, Ethics and the Settlements of Mass Torts: When the Rules
Meet the Road, 80 CORNELL L. REV. 1159 (1995) (discussing ambiguities of ethical issues in mass tort
litigation).
n168 See Choctaw, Inc. v. Campbell-Cherry-Harrison-Davis & Dove, 965 So. 2d 1041, 1045-47 (Miss.
2007) (agreeing with firm's assertion that claims that targeted settlement criteria were historically paid and,
accordingly, not "frivolous" by definition).
n169 See Ashforth & Anand, supra note 3, at 18-20.
n170 Michael A. Silverstein, Letter to the Editor, WALL ST. J., Dec. 13, 2005, at A13 (defending
organization's decision to honor screening doctor criticized by Judge Jack in the Silica MDL because he was
merely acting as an expert witness in that case).
n171 See generally David E. Bernstein, Keeping Junk Science out of Asbestos Litigation, 31 PEPP. L. REV.
11, 13 (2003) (arguing that "hired gun" physicians misdiagnose lung abnormalities and misidentify causation in
asbestos litigation); Lee Mickus, Discovery of Work Product Disclosed to a Testifying Expert Under the 1993
Amendments to the Federal Rules of Civil Procedure, 27 CREIGHTON L. REV. 773, 792 n.85 (1994) ("An
expert witness eager to please his employer may sometimes form his opinion solely on the basis of incomplete
information disclosed to him by counsel."); Joseph Sanders, The Bendectin Litigation: A Case Study in the Life
Cycle of Mass Torts, 43 HASTINGS L.J. 301, 348-86 (1992) (discussing use of expert testimony on both sides in
Bendectin litigation); Jeffrey J. Parker, Note, Contingent Expert Witness Fees: Access and Legitimacy, 64 S.
CAL. L. REV. 1363 (1991) (discussing hired gun experts and expert bias).
n172 For example, one court noted significant concerns with comparable practices in 1990. See Raymark
Indus., Inc. v. Stemple, No. 88-1014- K, 1990 U.S. Dist. LEXIS 6710, at *6 (D. Kan. May 30, 1990) ("For all
purposes, Raymark and this court reasonably assumed, given the defendant attorneys' professional
responsibilities and Rule 11 compliance, that they would only submit claims of at least some merit, but surely
would not recklessly acquiesce in the filing of a constant, steady flow of faulty claims. As this opinion will
demonstrate, such is apparently the case. As stated at the time of hearing on the motions, this claim process
appears to be a 'professional farce!' The process makes a mockery of the practices of law and medicine! Indeed,
if this court were now to acquiesce in any of them it would make a 'laughingstock' of the court!").
n173 See In re Silica Prods. Liab. Litig., 398 F. Supp. 2d 563, 633 (S.D. Tex. 2005) (noting how the
compartmentalization of screening duties allowed one silica screening doctor to "reconcile his acquiescence in
false diagnosing language"). The court continued:
Repeatedly, the diagnosing doctors testified as to their blind (and, as it happens, unfounded) faith that other
physicians had taken the necessary steps to legitimize their diagnoses. By dividing the diagnosing process
among multiple people, most of whom had no medical training and none of whom had full knowledge of the
entire process, no one was able to take full responsibility over the accuracy of the process. This is assembly line
diagnosing. And it is an ingenious method of grossly inflating the number of positive diagnoses.
Id. at 633-34.
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n174 Donald Palmer, Extending the Process Model of Collective Corruption, 28 RES.
ORGANIZATIONAL BEHAV. 107, 115 (2008) (noting that division of labor and requiring participants to
focus on their specific tasks "substitute for more time consuming mindful and rational cost benefit or normative
analysis that might lead organizational participants to eschew wrongful courses of action").
n175 See id. ("The division of labor also diffuses responsibility, such that participants in one part of an
organization sometimes do not feel obligated to (in fact, might even be forbidden from) point(ing) out the
wrongful character of the behavior of employees in another part of the organization.").
n176 See Ashforth & Anand, supra note 3, at 25-34 (discussing socialization of corruption across groups).
n177 See DAVID LUBAN, LEGAL ETHICS AND HUMAN DIGNITY 220 (2007) (discussing "willful"
ignorance and its potential for liability avoidance); Stephen Fraidin & Laura B. Mutterperl, Advice for Lawyers:
Navigating the New Realm of Federal Regulation of Legal Ethics, 72 U. CIN. L. REV. 609, 638 (2003)
("Attorneys might avoid knowledge of certain information because they believe that ignorance permits them
better to defend the client or to circumvent ethical obligations."); Robert Rubinson, Attorney Fact-Finding,
Ethical Decision-Making and the Methodology of Law, 45 ST. LOUIS L.J. 1185, 1204 (2001) ("Since every
ethical rule requires a factual predicate and lawyers themselves determine whether such a factual predicate
exists, attorneys can control the process of ethical decision-making through fact-finding. This deceptively simple
point-rarely acknowledged in ethics discourse-demonstrates the extraordinary impact of fact-finding on ethical
decision-making.").
n178 See LUBAN, supra note 177, at 220-21.
n179 As Judge Jack concluded:
The record does not reveal who originally devised this scheme, but it is clear that the lawyers, doctors and
screening companies were all willing participants. And if the lawyers turned a blind eye to the mechanics of the
scheme, each lawyer had to know that Mississippi was not experiencing the worst outbreak of silicosis in
recorded history. Each lawyer had to know that he or she was filing at least some claims that falsely alleged
silicosis. The fact that some claims are likely legitimate, and the fact that the lawyers could not precisely identify
which claims were false, cannot absolve them of responsibility for these mass misdiagnoses which they have
dumped into the judicial system.
In re Silica Prods. Liab. Litig., 398 F. Supp. 2d 563, 635-36 (S.D. Tex. 2005).
n180 Id. at 679 (noting that sanctions ordered in that case were "substantially less than the total amount of
damages" caused by the specious filings); see also RAND SILICA REPORT, supra note 78, at 18 ("In the end,
only one of the plaintiffs' firms involved in the silica litigation ended up paying a penalty for their practices
during the silica litigation. And the sanction levied against that firm was small."); David J. Kahne, Curbing the
Abuser, Not the Abuse: A Call for Greater Professional Accountability and Stricter Ethical Guidelines for Class
Action Lawyers, 19 GEO. J. LEGAL ETHICS 741, 741 (2006) ("However, while Judge Jack's proclamation and
the new legislation have sought to eliminate frivolous claims and compensate those truly harmed, nothing has
been done to penalize the clearly unethical conduct prevalent amongst lawyers in mass tort adjudication.").
n181 See NAGAREDA, supra note 6, at 145.
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n182 See, e.g., Tai Indictment, supra note 116 (criminal action against doctor involve in fen-phen specious
claim diagnoses); Crouse Complaint, supra note 116 (RICO action against doctor filed by fen-phen settlement
trust); see also Mark A. Behrens & Cary Silverman, Now Open for Business: The Transformation of
Mississippi's Legal Climate, 24 MISS. C. L. REV. 393, 400-01 (2005) (discussing prosecution of those involved
in fabricating evidence submitted to separate fen-phen settlement plans).
n183 See, e.g., Brickman, Litigation Screenings, supra note 46, at 1291 (discussing Mississippi's approach);
Victor E. Schwartz et al., West Virginia as a Judicial Hellhole: Why Businesses Fear Litigating in State Courts,
111 W. VA. L. REV. 757, 768 (2009) (comparing Mississippi's reforms to those of West Virginia).
n184 See, e.g., Maron & Jones, supra note 47, at 280-81; Basenberg & Bankester, supra note 15, at 74
(discussing change to "shotgun-style complaint" practice in Mississippi).
n185 See Mark A. Behrens & Phil Goldberg, The Asbestos Litigation Crisis: The Tide Appears to Be
Turning, 12 CONN. INS. L.J. 477, 492 (2006) (noting that Ohio, Georgia, Texas, Florida, Kansas, and South
Carolina have adopted medical criteria laws).
n186 See id. at 489-91 ("Inactive dockets were first adopted in the late 1980s and early 1990s in
jurisdictions that were experiencing large numbers of filings by the unimpaired-Massachusetts (September
1986), Chicago (March 1991), and Baltimore City (December 1992). Since 2002, the list of jurisdictions with
inactive asbestos dockets has grown to include Cleveland, Ohio (March 2006); Minnesota (coordinated
litigation) (June 2005); St. Clair County, Illinois (February 2005); Portsmouth, Virginia (August 2004); Madison
County, Illinois (January 2004); Syracuse, New York (January 2003); New York City (December 2002); and
Seattle, Washington (December 2002)." (footnote omitted)).
n187 For example, Texas embraced a more restrictive exposure standard for asbestos personal injury suits in
2007. See Borg-Warner Corp. v. Flores, 232 S.W.3d 765, 773 (Tex. 2007).
n188 See, e.g., Bates & Mullin, supra note 76, at 40-42 (discussing Mississippi and Texas and concluding
that "less than 10 percent, and more likely less than five percent of the historical non-malignant claims would
have been filed if the current tort environment had prevailed over the last two decades").
n189 Class Action Fairness Act of 2005, Pub. L. No. 109-2, 119 Stat. 4 (codified at 28 U.S.C. § § 1453,
1711-15 (2006 & Supp. IV 2010)).
n190 See, e.g., John C. Coffee, Jr., New World of Class Actions: CAFA, Exxon, and Open Issues, N.Y.
L.J., July 21, 2005, at 25.
n191 550 U.S. 544 (2007).
n192 556 U.S. 662 (2009).
n193 Recent Supreme Court opinions have been interpreted to require far more than the boilerplate
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allegations that dominated mass tort pleadings previously. See, e.g., Limestone Dev. Corp. v. Vill. of Lemont,
Illinois, 520 F.3d 797, 802-03 (7th Cir. 2008) ("Twombly teaches that a defendant should not be forced to
undergo costly discovery unless the complaint contains enough detail, factual or argumentative, to indicate that
the plaintiff has a substantial case."); David Marcus, The Past, Present, and Future of Trans-Substantivity in
Federal Civil Procedure, 59 DEPAUL L. REV. 371, 415-26 (2010).
n194 A typical PFS process was outlined by the Ninth Circuit:
CMO 19 ordered plaintiffs to complete a Plaintiff's Fact Sheet in all respects and serve it within 45 days
after transmission of the blank PFS. For cases where no PFS was returned, Defendants' Liaison Counsel were to
send a letter warning that the case was subject to dismissal, after which the plaintiff would have an additional 15
days to comply. If a PFS were received on time but was not completed in all respects, a deficiency letter was to
be sent allowing an additional 15 days to serve a completed PFS and warning that the case was subject to
dismissal if one were not received.
In re Phenylpropanolamine (PPA) Prods. Liab. Litig., 460 F.3d 1217, 1225 (9th Cir. 2006).
n195 For example, Administrative Order No. 12 in the Asbestos MDL requires "a report identifying each
plaintiff by full name, date of birth, last four digits of plaintiffs sic SSN, and a statement indicating the status of
the plaintiff in the case before the Court." Amended Administrative Order No. 12A at 1, In re Asbestos Prods.
Liab. Litig. (No. VI), No. MDL 875 (E.D. Pa. Aug. 27, 2009),
http://www.paed.uscourts.gov/documents/MDL/MDL875/adord12.pdf. It also requires the identification of
"each and every prior or pending court or administrative action" brought on account of the alleged injuries. Id. In
addition, plaintiffs must "submit to the court a copy of the medical diagnosing report or opinion upon which the
plaintiff now relies for prosecution of the claims as if to withstand a dispositive motion," and the objective and
subjective data that support them "shall be identified and descriptively set out within the report or opinion." Id.
at 2.
n196 See, e.g., In re Guidant Corp. Implantable Defibrillators Prods. Liab. Litig., 496 F.3d 863, 867 (8th
Cir. 2007) (upholding dismissal based on failure to submit compliant PFS by the deadline); In re
Phenylpropanolamine, 460 F.3d at 1234, 1237-38, 1240 (same); Bacher v. Actavis Totowa, LLC, No. 2:09CV-00665, 2009 U.S. Dist. LEXIS 119305 (S.D. W. Va. Dec. 18, 2009) (sanctioning counsel for failing to
comply with PFS order); Case Management Order No. 1, In re Oral Sodium Phosphate Solution-Based Prods.
Liab. Litig., No. 1:09-SP-80000 (N.D. Ohio Nov. 24, 2009), http://www.ohnd.uscourts.gov/assets/Clerks
OfficeandCourtRecords/MDL/2066/CMO1.pdf (establishing procedures for compliance with PFS requirement,
including provision for dismissing claims for noncompliance); In re Prempro Prods. Liab. Litig., No. 4:03CV-1507-WRW, 2009 U.S. Dist. LEXIS 18773 (E.D. Ark. Feb. 27, 2009) (order noting potential sanctions,
including attorneys fees, and dismissal of cases with prejudice if PFS deadline was not met); In re Fosamax
Prods. Liab. Litig., MDL No. 1789, No. 1:08- CV-04901, 2009 U.S. Dist. LEXIS 59690 (S.D.N.Y. Jan. 12, 2009)
(dismissing claim with prejudice for failing to submit PFS by deadline); In re Bextra & Celebrex Mktg., Sales
Practices & Prods. Liab. Litig., MDL No. 1699, No. 05- CV-01699 CRB, 2007 U.S. Dist. LEXIS 7807 (N.D. Cal.
Jan. 12, 2007) (same); In re Rezulin Prods. Liab. Litig., 223 F.R.D.109, 118 (S.D.N.Y. 2004) (same), vacated in
part MDL No. 1348, No. 03 Civ. 1756, 2004 WL 1700618 (S.D.N.Y. Jul. 27, 2004).
n197 See BEISNER & MILLER, supra note 18, at 17 ("Fact sheets help provide an early, bird's eye view of
the nature of the litigation, but they do not provide all of the information necessary to evaluate the merits of
plaintiffs' claims. Some claimants provide false or incomplete answers, reasoning that among thousands of
pending cases, their answers will never be scrutinized. Other claimants may simply decline to devote the time
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and effort needed to completely answer the questions.").
n198 So-called "Lone Pine Orders" take their name from a case management order entered in a New Jersey
state court order that required submission of basic information about individual claims. Lore v. Lone Pine
Corp., No. L-33606-85, 1986 WL 637507 (N.J. Super. Ct. Law Div. Nov. 18, 1986).
n199 See James P. Muehlberger & Boyd S. Hoekel, An Overview of Lone Pine Orders in Toxic Tort
Litigation, 71 DEF. COUNS. J. 366, 370-73 (2004) (identifying and discussing use of Lone Pine orders in
different state and federal courts). Courts may also adopt comparable orders requiring expedited discovery from
defendants. See, e.g., Abbatiello v. Monsanto Co., 569 F. Supp. 2d 351, 354 (S.D.N.Y. 2008) (discussing the
application of Lone Pine orders).
n200 See generally Muehlberger & Hoekel, supra note 199, at 366-67.
n201 See In re Vioxx Prods. Liab. Litig., 388 Fed. App'x. 391, 397-98 (5th Cir. 2010) (finding trial judge
did not abuse discretion by dismissing claims that did not satisfy medical report requirement in pre-trial order);
Acuna v. Brown & Root Inc., 200 F.3d 335, 340 (5th Cir. 2000) (affirming dismissal of claims). But see
McManaway v. KBR, Inc., 265 F.R.D. 384, 388-89 (S.D. Ind. 2009) (approving Lone Pine order without
procedure for automatic dismissal but noting potential defense cost assessments to plaintiffs if claims were
subsequently dismissed on summary judgment). Courts have been willing to extend time frames where justified,
but these extensions are increasingly limited and are frequently referenced in support of orders dismissing
non-compliant claims with prejudice.
n202 See In re Digitek Prod. Liab. Litig., 264 F.R.D. 249, 258-59 (S.D. W. Va. 2010) (rejecting request for
Lone Pine order due to relatively early stage in the case and the "number of measures" adopted to advance the
litigation previously); In re Vioxx Prods. Liab. Litig., 557 F. Supp. 2d 741, 744 (E.D. La. 2008) ("In crafting a
Lone Pine order, a court should strive to strike a balance between efficiency and equity. Lone Pine orders may
not be appropriate in every case and, even when appropriate, they may not be suitable at every stage of the
litigation. For example, in the present case, a Lone Pine order may not have been appropriate at an earlier stage
before any discovery had taken place since little was known about the structure, nature and effect of Vioxx by
anyone other than perhaps the manufacturer of the drug."); Morgan v. Ford Motor Co., No. 06-1080 (JAP), 2007
U.S. Dist. LEXIS 36515, at *42-43 (D.N.J. May 17, 2007) (rejecting motion for Lone Pine style order that
"would require over 700 Plaintiffs to produce affidavits from qualified environmental experts and licensed
physicians, while Defendants were required to produce no discovery" and requiring plaintiffs to "submit a Rule
26(a)(1) simple statement including the 'nature and extent of injuries suffered,' their treating physicians, and
medical authorizations").
n203 See Pretrial Orders Nos. 29, 30, and 31, In re Bextra and Celebrex Mktg. Sales Practices and Prod.
Liab. Litig., MDL. No. 1699, No. M:05-cv-01699 (N.D. Cal. 2008). For a similar approach, see Pretrial Order
No. 121, In re Avandia Mktg., Sales Practices and Prods. Liab. Litig., No. 2007- MD-1871, 2010 WL 4720335
(E.D. Pa. Nov. 15, 2010).
n204 See Weitz & Luxenberg Memorandum, supra note 149, at 7.
n205 See, e.g., Robert H. Mnookin, Negotiation, Settlement and the Contingent Fee, 47 DEPAUL L. REV.
Page 46
42 U. Mem. L. Rev. 559, *628
363, 365 (1998) ("Concerns about reputation operate to constrain opportunism, at least somewhat.").
n206 See, e.g., Brian L. Connelly, et al., Signaling Theory: A Review and Assessment, 37 J. MGMT. 39,
41-45 (2011) (discussing signaling theory and its various applications).
n207 For example, in the four years during which the World Trade Center litigation was pending, fewer
than sixty of the roughly nine thousand claims had been investigated through the adversary process to a
significant degree, and the first public signs of potentially specious claim filings in that case came from an
independent Associated Press investigation into a limited subset of claims. See David B. Caruso, Credibility in
Question for Some 9/11 Health Damage Suits, BOSTON.COM (Feb. 8, 2010),
http://articles.boston.com/2010-02-08/news/293264301ground-zero-workers-trials. A comprehensive settlement
was reached shortly after this report and before the planned bellwether trials were to begin. See Mireya Navarro,
Deal Is Reached on Health Costs of 9/11 Workers, N.Y. TIMES, Mar. 12, 2010, at A1 ("The first 12 cases were
scheduled to come to trial on May 16 in Manhattan, and those trials will now not take place.").
n208 See supra Part II.C.1.
n209 See, e.g., DIXON & MCGOVERN, supra note 135, at 25-26.
n210 See Alexandra D. Lahav, Rough Justice, (Sept. 23, 2010) (unpublished manuscript), available at
http://papers.ssrn.com/sol3/papers.cfm?abstractid?=1562677.
n211 See supra Part II.C.
n212 Trust advisory committees play a significant role in setting policy and overseeing the operation of
asbestos bankruptcy trusts. See RAND 2010 REPORT, supra note 64, at xvi ("Trustees are required to obtain the
consent of the trust advisory committee (TAC) (representing current claimants) and the future claimants'
representative (FCR) (representing future claimants) before major actions by the trust can be taken (such as
revising trust distribution procedures, or TDPs)."). As one prominent attorney recently noted, "The selection of
the trustees and members of the trust advisory committees (TACs) that oversee the operation of the trusts is
heavily influenced, if not controlled outright, by counsel for the asbestos claimants." See Shelley et al., supra
note 41, at 261. Not surprisingly, lawyers from these same firms dominate trust advisory committee positions,
particularly at the largest trusts. See RAND 2010 REPORT, supra note 64, at 14 & App. B.
n213 At least twenty-one trusts (AC&S, Armstrong, ASARCO, AWI, Babcock & Wilcox, Burns and Roe,
C.E. Thurston & Sons, Combustion Engineering, DII, Federal-Mogul, G-I Holdings, H.K. Porter, J.T Thorpe,
Kaiser Aluminum, Leslie Controls, Owens-Corning, Plibricio, Porter-Hayden, Shook and Fletcher, THAN,
USG, and Western Asbestos), which include the largest trusts established since 2000, require consent from the
trust advisory committee. For example, section 5.8 of the USG Trust Distribution Procedures provides, in
relevant part, "The PI Trust, with the consent of the TAC and the Futures Representative, may develop methods
for auditing the reliability of medical evidence." QUIGLEY CO. INC., UNITED STATES GYPSUM:
ASBESTOS PERSONAL INJURY TRUST DISTRIBUTION PROCEDURES 42,
http://www.quigleyreorg.com/ch11pdfs/1451-1500/1488Exa.pdf. At least eight others (A-Best, A&I, API,
ARTRA, Keene, Manville, Raytech, and UNR) authorize, but do not require, claim audits.
Page 47
42 U. Mem. L. Rev. 559, *628
n214 Under stratified sampling, claims are broken into discrete strata, within which claims are subjected to
random audits.
n215 See Brown, supra note 40, at 921 (discussing identifiable common filing practices across cases among
repeat players).
n216 FED. R. CIV. P. 23(e)(2).
n217 11 U.S.C. § 524(g)(2)(B)(ii)(V) (2006).
n218 Brown, supra note 40, at 190.
Exhibit 10
Blog Archives - The Silverstein Group
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Relentless advertising suggests no
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advertising by attorneys and law
firms in 211 media markets and on
11 national broadcast networks and
more than 80 national cable
With over $2 million spent on
nearly 7,000 ads, March marked
the 11th consecutive month that
pelvic (transvaginal) mesh
products were among the top
three products targeted in
plaintiffs' attorney television
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networks.
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The continued prominence of this advertising indicates
that the manufacturers of pelvic mesh products -- although already facing
thousands of claims nationwide -- should not expect a reprieve from
further litigation any time soon.
As indicated by the map below showing advertising activity over the past
6 months, pelvic mesh attorney ads are broadcast in nearly every local
media market in the country.
Over 50,000 pelvic mesh ads have been broadcast over the past
year. The great majority of advertising spending was devoted to ads aired
on national cable and broadcast networks. Just five law firms accounted
for over two-thirds of all ad spending.
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Exhibit 11
Airbag ads debut, Benicar advertising triples - December 2014 Mass Tort Ad Report
Page 1 of 6
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REPORT HIGHLIGHTS
Xarelto remains top drug or
Benicar ad spend triples
device despite drop in ads
Mass tort ads targeting the
Xarelto was once again the top
blood pressure drug Benicar
drug featured in mass tort TV
more than tripled in November
ads and should remain a
primary target after the recent
following an FDA warning
that the drug causes
decision to consolidate nearly
severe gastrointestinal
two dozen suits in federal court.
problems and the filing of a
number of lawsuits.
http://us7.campaign-archive2.com/?u=35ed1e6f2b2f1244337e3f989&id=42294bf5fa
12/31/2014
Page 2 of 6
Pelvic mesh ads up after
plaintiffs’ victories
Following a number of plaintiffs'
victories at trial, advertising
spending on mass tort ads
targeting pelvic mesh products
increased by 27% in
November.
Are potential jurors biased by attorney ads?
Determine potential juror bias with
comprehensive analyses of attorney
advertising around the trial venue.
DRUGS & MEDICAL DEVICES
TOP MOVERS
Drugs and medical devices with the greatest change in the estimated amount spent compared with the
previous month.
Biggest Increase
Pelvic Mesh +27%
November: $3.8M
October: $3M
Top 3 Increases
1. Pelvic Mesh +$830K
2. Hip Implants +480K
3. Benicar +154K
12/31/2014
Page 3 of 6
Biggest Decrease
Xarelto -26%
November: $5.3M
October: $7.2M
Top 3 Decreases
1. Xarelto -$1.9M
2. Risperdal-Risperidone -$480K
3. Testosterone -$270K
TOP DRUGS & MEDICAL DEVICES FEATURED IN
MASS TORT ADS
1. XARELTO: $5.3M
2. PELVIC MESH: $3.8M
3. HIP IMPLANTS: $1.4M
4. POWER MORCELLATORS: $1.4M
5. TESTOSTERONE: $680K
6. OTHER: $2M
Know before the lawsuits are filed.
Detect and monitor litigation threats with
regular reports on mass tort TV ads targeting
particular drugs and devices.
12/31/2014
Page 4 of 6
Law firms launch airbag defect ad campaigns
amidst auto recalls
In the wake of national recalls of vehicles with
Takata airbags, plaintiffs’ law firms have begun an
aggressive advertising campaign seeking
potential victims.
Over $340,000 was spent by law firms in
November to air nearly 1,100 ads focused on the
airbag issue.
Read full article
AIRBAG RECALL MASS TORT ADS: EST. SPENDING
BY MEDIA MARKET, NOVEMBER 2014.
12/31/2014
Page 5 of 6
Top Markets:
Key:
$147K
National Broadcast*
1. Richmond
$1 - $10,000
2. San Francisco
$10,001 - $20,000
3. New Orleans
4. Baton Rouge
5. Shreveport
$20,001 - $30,000
$12K
$30,001 - $40,000
National Cable**
$40,001+
* Includes national broadcast networks such as CBS, ABC, and Fox.
** Includes national cable channels such as ESPN, CNN, and Fox News.
TOP MASS TORT ADVERTISERS, NOVEMBER 2014.
Top Sponsor Spending
PULASKI & MIDDLEMAN ATTORNEYS: $2.3M
GOLDWATER LAW FIRM: $1.6M
PARILMAN & ASSOCIATES ATTORNEYS: $1.5M
RELION GROUP: $837K
AVRAM BLAIR & ASSOCIATES: $807K
VIDEOS
Airbag Recall Mass Tort Ads
Watch Video At Mass Tort
Benicar Mass Tort Ad
Watch Video
Ad Watch Blog
12/31/2014
Page 6 of 6
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The Silverstein Group, using data provided by Kantar
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12/31/2014
Exhibit 12
Frequently Asked Questions by Providers
Mid-urethral Slings for Stress Urinary Incontinence
Mid-urethral Slings were first performed in Europe in the early 1990s. The FDA approved the first mid-urethral sling (MUS) for use in the
United States in 1998. Since that time over 3 million mid-urethral slings have been sold world-wide. Full length mid-urethral slings are
considered safe and effective by the US Food and Drug Administration (FDA).
In 2008, the FDA issued a public health notification on complications associated with transvaginal mesh. In 2011, the FDA updated its
statement and noted that complications associated with transvaginal mesh used to repair prolapse are not rare and that it was
continuing to evaluate mesh use for MUS. In 2013, the FDA further updated its position noting that “the safety and effectiveness of
multi-incision slings is well established in clinical trials that followed patients up to one year.”
After the FDA issued its initial statements, additional information appeared in the media, including some lawyer advertisements related
to transvaginal mesh. Because mesh is used in both procedures (transvaginal mesh for prolapse and MUS for stress urinary
incontinence) there may be some questions about the use of mesh.
The purpose of this Frequently Asked Questions document is to provide factual information for healthcare providers who are involved in
the care of women considering such treatment.
Does the evidence indicate that mid-urethral slings are effective for the treatment of SUI?
A broad evidence base including high quality scientific papers in medical journals in the US and the world supports
the use of mid-urethral slings as a treatment for SUI [1]. There are greater than 2000 publications in the scientific
literature describing mid-urethral slings in the treatment of SUI. These studies include the highest level of scientific
evidence in the peer reviewed scientific literature [1]. The MUS has been studied in virtually all types of patients, with
and without comorbidities, and all types of SUI. Numerous randomized, controlled trials comparing types of midurethral slings, as well as comparing MUS to other established SUI procedures, have consistently demonstrated its
clinical effectiveness [1-4] and patient satisfaction [4]. Among historical SUI procedures, the MUS has been studied
as long in follow-up after implantation as any other procedure and has demonstrated superior safety and efficacy. This
includes a recent 17 year follow-up study. [5]. No other surgical treatment for SUI before or since has been subject to
such extensive investigation.
Does the evidence indicate that mid-urethral slings are safe in the treatment of SUI?
The MUS is the most studied anti-incontinence procedure in medical history. Furthermore, it is likely that more
individuals have undergone this surgical procedure for the treatment of SUI than any other. The difficulties and
complications associated with mid-urethral slings are similar in character to that seen with non-mesh procedures
(bladder outlet obstruction, urinary tract injury, dyspareunia, pain, etc.) with the exception of vaginal mesh exposure
and mesh perforations into the urinary tract.
What is the material used for mid-urethral slings and have studies shown the material to be safe?
Currently available mid-urethral slings are composed of macroporous, knitted, monofilament polypropylene,
sometimes known as “Type I” meshes. As a suture material, polypropylene is widely used, durable and employed in a
broad range of sizes and applications. Polypropylene material has been used in most surgical specialties (including
general surgery, cardiovascular surgery, transplant surgery, ophthalmology, otolaryngology, gynecology, and urology)
for over five decades, in millions of patients in the US and the world. As the knitted form, polypropylene mesh is the
consensus material as a graft augmentation layer for hernia repairs in a number of areas in the human body and has
significantly and favorably impacted the field of hernia surgery. [6, 7] As an implant for the surgical treatment of SUI,
macroporous, monofilament polypropylene has demonstrated long-term durability, safety, and efficacy for up to 17
years [5].
Are all mid-urethral slings currently available in the US made of the same type of material?
Yes. Although the manufacturing, packaging, size and specific implantation techniques vary between procedures and
are proprietary, all midurethral slings available in the US are made of polypropylene knitted into a macroporous mesh.
Does the MUS mesh made of polypropylene degrade over time?
Polypropylene is a stable and well-accepted biomaterial with a history of over five decades of use in mesh implants. In
recent years, concerns regarding implanted polypropylene degradation have been raised as a result of very high-
magnification images that show portions of some explanted synthetic meshes with “cracked” surfaces.[8] These
surface changes were further hypothesized to lead to adverse clinical outcomes, though this is not supported by the
extensive peer-reviewed literature related to polypropylene mesh repairs. Prospective studies have followed patients
with implanted mid-urethral slings for 17 years and show excellent durability and safety of the procedure. [5]
Is there scientific evidence that the mesh used in polypropylene mid-urethral slings causes cancer in humans?
Tumors related to the implantation of surgical grade polypropylene for mid-urethral slings in humans have never been
reported. There is no compelling evidence supporting human malignant transformation related to polypropylene
despite the millions of individuals implanted with various forms of this material spanning well over a half century
world-wide. The possibility that biomaterial prosthetic devices could cause tumors or promote tumor growth has been
the focus of extensive research by both clinicians and biomaterial researchers. [9, 10]. It is known that tumor
formation related to biomaterials in animals is largely dependent on the physical, not the chemical configuration of the
implant, with smooth large surface areas (discs and thin sheets) being potentially carcinogenic, and irregular disrupted
surfaces (e.g. those that contain pores as in meshes) lacking carcinogenicity [10, 11].
Has there been an FDA recall of mid-urethral slings or the mesh material?
None of the FDA communications regarding mesh used in pelvic reconstructive surgery were related to a recall nor
did they suggest that the material or implantation of mid-urethral slings were dangerous, or should be stopped.
Has the FDA warned against surgical placement of mid-urethral slings?
The mid-urethral sling was not the subject of the 2011 FDA Safety Communication, “Urogynecologic Surgical Mesh:
Update on the Safety and Effectiveness of Vaginal Placement for Pelvic Organ Prolapse.”[12] In this document, it
was explicitly stated: “The FDA continues to evaluate the effects of using surgical mesh for the treatment of SUI and
will report about that usage at a later date.” In 2013, the FDA website stated clearly that: “The safety and
effectiveness of multi-incision slings is well-established in clinical trials that followed patients for up to one-year.” [13].
The FDA has specifically exempted full-length mid-urethral slings from the need for additional mandated research.
What is a 522 study and does it involve mid-urethral slings?
A 522 study refers to a specific section of the FDA regulatory framework wherein a commercial entity is required to
perform additional post-marketing research following its regulatory approval by the FDA. Once 522 studies are
mandated, they are subject to FDA oversight. Completion and review of these studies by the FDA is a requirement
for continuing the sales and marketing of such products by the commercial entity under FDA scrutiny. 522 studies
have been mandated for certain mesh products including some single incision slings (“mini-slings”). Currently
available multi-incision mid-urethral slings are not subject to 522 studies.
The information above is intended to provide patients and physicians with general information, and is not intended to
substitute for the treating physician's clinical judgment. The treating physician should make all treatment decisions based
upon his or her independent judgment and the patient's individual clinical presentation.
Our Organizations
The American Urogynecologic Society (AUGS), founded in 1979, is a non-profit organization representing more than 1,700 members
including practicing physicians, nurse practitioners, physical therapists, nurses and health care professionals, as well as researchers
from many disciplines, all dedicated to treating female pelvic floor disorders (pelvic organ prolapse and urinary incontinence). AUGS
promotes the highest quality patient care through excellence in education, research and advocacy.
SUFU, the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction, is a non-profit organization dedicated to
improving the art and science of Urology through basic and applied clinical research in urodynamics and neurourology, voiding function
and dysfunction, female urology and pelvic floor dysfunction, and to disseminate and teach these concepts. It is the oldest professional
organization dedicated to this field consisting of interested physicians, basic scientists, and other health care professionals, and has
grown to over 500 members.
This FAQ statement was drafted by an AUGS/SUFU MUS task force composed of Charles Nager, Paul Tulikangas, and Dennis Miller
from AUGS and Eric Rovner and Howard Goldman from SUFU. This FAQ statement was approved by both the AUGS Board of
Directors and the SUFU Board of Directors.
Disclosures: Dr. Nager is a principal investigator in the NICHD/NIH Pelvic Floor Disorders Network which is conducting an FDA
recommended randomized trial involving transvaginal mesh for prolapse and the NICHD/NIH through a public/private cooperative
arrangement has received partial financial support from Boston Scientific Corporation for this study. Dr Miller receives consulting fees
and royalties from Boston Scientific for prolapse mesh. Drs. Tulikangas, Rovner, and Goldman have no disclosures.
AUGS-SUFU FAQs by Providers on Mid-urethral Slings for SUI
-2-
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Ogah, J., J.D. Cody, and L. Rogerson, Minimally invasive synthetic suburethral sling operations for
stress urinary incontinence in women. Cochrane Database Syst Rev, 2009(4): p. CD006375.
Novara, G., et al., Updated systematic review and meta-analysis of the comparative data on
colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female
stress urinary incontinence. Eur Urol, 2010. 58(2): p. 218-38.
Ward, K. and P. Hilton, Prospective multicentre randomised trial of tension-free vaginal tape and
colposuspension as primary treatment for stress incontinence. BMJ, 2002. 325(7355): p. 67.
Richter, H.E., et al., Retropubic versus transobturator midurethral slings for stress incontinence. N
Engl J Med, 2010. 362(22): p. 2066-76.
Nilsson, C.G., et al., Seventeen years' follow-up of the tension-free vaginal tape procedure for female
stress urinary incontinence. Int Urogynecol J, 2013. 24(8): p. 1265-9.
Cobb, W.S., K.W. Kercher, and B.T. Heniford, The argument for lightweight polypropylene mesh in
hernia repair. Surg Innov, 2005. 12(1): p. 63-9.
Scott, N.W., et al., Open mesh versus non-mesh for repair of femoral and inguinal hernia. Cochrane
Database Syst Rev, 2002(4): p. CD002197.
Clave, A., et al., Polypropylene as a reinforcement in pelvic surgery is not inert: comparative analysis
of 100 explants. Int Urogynecol J, 2010. 21(3): p. 261-70.
McGregor, D.B., et al., Evaluation of the carcinogenic risks to humans associated with surgical
implants and other foreign bodies - a report of an IARC Monographs Programme Meeting.
International Agency for Research on Cancer. Eur J Cancer, 2000. 36(3): p. 307-13.
Ratner, B.D., et al., eds. Biomaterials Science: An Introduction to Materials in Medicine - 3rd Edition.
2013, Academic Press: Waltham, MA.
Oppenheimer, B.S., et al., The latent period in carcinogenesis by plastics in rats and its relation to the
presarcomatous stage. Cancer, 1958. 11(1): p. 204-13.
FDA, Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Vaginal Placement for
Pelvic Organ Prolapse. 2011:
http://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/UCM262760.pdf.
FDA, Considerations about Surgical Mesh for SUI
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroG
ynSurgicalMesh/ucm345219.htm). . 2013.
AUGS-SUFU FAQs by Providers on Mid-urethral Slings for SUI
-3-
Exhibit 13
Position Statement on Mesh Midurethral Slings for
Stress Urinary Incontinence
The polypropylene mesh midurethral sling is the recognized
worldwide standard of care for the surgical treatment of
stress urinary incontinence. The procedure is safe, effective, and
has improved the quality of life for millions of women.
Introduction
The purpose of this position statement by the American Urogynecologic Society (AUGS) and the
Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) is to support
the use of the midurethral sling in the surgical management of stress urinary incontinence, the type of
urine leakage generally associated with coughing, laughing and sneezing.
Developed in the early 1990’s, midurethral slings (MUS) treat stress urinary incontinence (SUI) in a
minimally invasive, generally outpatient procedure. This technique utilizes a small mesh strip
composed of monofilament polypropylene placed through the vagina under the mid-urethra exiting
from 2 small sites in either the suprapubic or groin areas.
SUI is a highly prevalent condition of involuntary urine leakage resulting from faulty closure of the
urethra typically associated with coughing, sneezing or exertion. SUI is often a debilitating and
bothersome condition that can substantially reduce a woman’s quality of life. Although non-surgical
treatments such as pelvic floor exercises and behavioral modification are helpful in alleviating
symptoms in some women [1], many proceed with surgery which is a more effective treatment [2].
In July 2011, the U.S. Food and Drug Administration (FDA) released a white paper [3] and safety
communication [4] on the safety and effectiveness of transvaginal placement of surgical mesh
specifically for pelvic organ prolapse. In addition, lawyers have publicly advertised their services,
targeting women with transvaginal mesh placed for both pelvic organ prolapse and stress urinary
incontinence (SUI), and the media has reported on the pelvic organ prolapse mesh litigation. We are
concerned that the multimedia attention has resulted in confusion, fear, and an unbalanced negative
perception regarding the midurethral sling as a treatment for SUI. This negative perception of the
MUS is not shared by the medical community and the overwhelming majority of women who have
been satisfied with their MUS. Furthermore, the FDA website states that: “The safety and
effectiveness of multi-incision slings is well-established in clinical trials that followed patients for up to
one-year.”[5].
Justification for the Position Statement
1. Polypropylene material is safe and effective as a surgical implant.
Polypropylene material has been used in most surgical specialties (including general surgery,
cardiovascular surgery, transplant surgery, ophthalmology, otolaryngology, gynecology, and
urology) for over five decades, in millions of patients in the US and the world (personal
communication with manufacturers of polypropylene suture and mesh). As an isolated thread,
polypropylene is a widely used and durable suture material employed in a broad range of sizes
and applications. As a knitted material, polypropylene mesh is the consensus graft material for
augmenting hernia repairs in a number of areas in the human body and has significantly and
favorably impacted the field of hernia surgery. [6, 7] As a knitted implant for the surgical treatment
of SUI, macroporous, monofilament, light weight polypropylene has demonstrated long term
durability, safety, and efficacy up to 17 years [8].
2. The monofilament polypropylene mesh MUS is the most extensively studied antiincontinence procedure in history.
A broad evidence base including high quality scientific papers in medical journals in the US and
the world supports the use of the MUS as a treatment for SUI [9]. There are greater than 2000
publications in the scientific literature describing the MUS in the treatment of SUI. These studies
include the highest level of scientific evidence in the peer reviewed scientific literature [9]. The
MUS has been studied in virtually all types of patients, with and without comorbidities, and all
types of SUI. Multiple randomized, controlled trials comparing types of MUS procedures, as well
as comparing the MUS to other established non-mesh SUI procedures, have consistently
demonstrated its clinical effectiveness [9-12] and patient satisfaction [12]. Among historical SUI
procedures, the MUS has been studied as long in follow-up after implantation as any other
procedure and has demonstrated superior safety and efficacy [8]. No other surgical treatment for
SUI before or since has been subject to such extensive investigation.
3. Polypropylene mesh midurethral slings are the standard of care for the surgical treatment
of SUI and represent a great advance in the treatment of this condition for our patients.
Since the publication of numerous level one randomized comparative trials, the MUS has become
the most common surgical procedure for the treatment of SUI in the US and the developed world.
This procedure has essentially replaced open and transvaginal suspension surgeries for
uncomplicated SUI. There have been over 100 surgical procedures developed for the
management of SUI and there is now adequate evidence that the MUS is associated with less
pain, shorter hospitalization, faster return to usual activities, and reduced costs as compared to
historic options that have been used to treat SUI over the past century. Full-length midurethral
slings, both retropubic and transobturator, have been extensively studied, are safe and effective
relative to other treatment options and remain the leading treatment option and current gold
standard for stress incontinence surgery [13]. Over 3 million MUS have been placed worldwide
and a recent survey indicates that these procedures are used by > 99% of AUGS members [14].
4. The FDA has clearly stated that the polypropylene MUS is safe and effective in the
treatment of SUI.
The midurethral sling was not the subject of the 2011 FDA Safety Communication,
“Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Vaginal Placement for
Pelvic Organ Prolapse.”[3]. In this document, it was explicitly stated: “The FDA continues to
evaluate the effects of using surgical mesh for the treatment of SUI and will report about that
usage at a later date.” In 2013, the FDA website stated clearly that: “The safety and effectiveness
of multi-incision slings is well-established in clinical trials that followed patients for up to one-year.”
[5].
AUGS-SUFU Position Statement on Mesh Midurethral Slings for SUI
-2-
Conclusion
The polypropylene midurethral sling has helped millions of women with SUI regain control of their
lives by undergoing a simple outpatient procedure that allows them to return to daily life very quickly.
With its acknowledged safety and efficacy it has created an environment for a much larger number of
women to have access to treatment. In the past, concerns over failure and invasiveness of surgery
caused a substantial percent of incontinent women to live without treatment. One of the unintended
consequences of this polypropylene mesh controversy has been to keep women from receiving any
treatment for SUI. This procedure is probably the most important advancement in the treatment of
stress urinary incontinence in the last 50 years and has the full support of our organizations which are
dedicated to improving the lives of women with urinary incontinence.
Our Organizations
The American Urogynecologic Society (AUGS), founded in 1979, is the premier non-profit
organization representing more than 1,700 members including practicing physicians, nurse
practitioners, physical therapists, nurses and health care professionals, as well as researchers from
many disciplines, all dedicated to treating female pelvic floor disorders (pelvic organ prolapse and
urinary incontinence). As the leader in Female Pelvic Medicine and Reconstructive Surgery, AUGS
promotes the highest quality patient care through excellence in education, research and advocacy.
SUFU, the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction, is
a non-profit organization dedicated to improving the art and science of Urology through basic and
applied clinical research in urodynamics and neurourology, voiding function and dysfunction, female
urology and pelvic floor dysfunction, and to disseminate and teach these concepts. It is the oldest
professional organization dedicated to this field consisting of interested physicians, basic scientists,
and other health care professionals, and has grown to over 500 members.
Midurethral Sling Task Force
This position statement was drafted by members Charles Nager, Paul Tulikangas, and Dennis Miller
from AUGS and Eric Rovner and Howard Goldman from SUFU.
Approved by the AUGS Board of Directors and the SUFU Board of Directors January 3, 2014.
-3-
References
1.
Imamura, M., et al., Systematic review and economic modelling of the effectiveness and costeffectiveness of non-surgical treatments for women with stress urinary incontinence. Health
Technol Assess, 2010. 14(40): p. 1-188, iii-iv.
2.
Labrie, J., et al., Surgery versus physiotherapy for stress urinary incontinence. N Engl J Med,
2013. 369(12): p. 1124-33.
3.
FDA, Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Vaginal
Placement for Pelvic Organ Prolapse. 2011:
http://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/UCM262760.pdf.
4.
FDA, FDA Safety Communication: UPDATE on Serious Complications Associated with
Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. 2011.
5.
FDA, Considerations about Surgical Mesh for SUI
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/U
roGynSurgicalMesh/ucm345219.htm). . 2013.
6.
Cobb, W.S., K.W. Kercher, and B.T. Heniford, The argument for lightweight polypropylene
mesh in hernia repair. Surg Innov, 2005. 12(1): p. 63-9.
7.
Scott, N.W., et al., Open mesh versus non-mesh for repair of femoral and inguinal hernia.
Cochrane Database Syst Rev, 2002(4): p. CD002197.
8.
Nilsson, C.G., et al., Seventeen years' follow-up of the tension-free vaginal tape procedure for
female stress urinary incontinence. Int Urogynecol J, 2013. 24(8): p. 1265-9.
9.
Ogah, J., J.D. Cody, and L. Rogerson, Minimally invasive synthetic suburethral sling
operations for stress urinary incontinence in women. Cochrane Database Syst Rev, 2009(4):
p. CD006375.
10.
Novara, G., et al., Updated systematic review and meta-analysis of the comparative data on
colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of
female stress urinary incontinence. Eur Urol, 2010. 58(2): p. 218-38.
11.
Ward, K. and P. Hilton, Prospective multicentre randomised trial of tension-free vaginal tape
and colposuspension as primary treatment for stress incontinence. BMJ, 2002. 325(7355): p.
67.
12.
Richter, H.E., et al., Retropubic versus transobturator midurethral slings for stress
incontinence. N Engl J Med, 2010. 362(22): p. 2066-76.
13.
Cox, A., S. Herschorn, and L. Lee, Surgical management of female SUI: is there a gold
standard? Nat Rev Urol, 2013. 10(2): p. 78-89.
14.
Clemons, J.L., et al., Impact of the 2011 FDA transvaginal mesh safety update on AUGS
members' use of synthetic mesh and biologic grafts in pelvic reconstructive surgery. Female
Pelvic Med Reconstr Surg, 2013. 19(4): p. 191-8.
-4-
Exhibit 14
The Truth About Vaginal Mesh — Health Hub from Cleveland Clinic
Page 1 of 3
Current URL: http://health.clevelandclinic.org/2013/06/the-truth-about-vaginal-mesh/
The Truth About Vaginal Mesh
The story behind sensational headlines
By Women's Health Team | 6/17/13 11:17 a.m.
Sensational news coverage and ads by law firms have spread fear among
women about vaginal mesh, a medical device used to treat pelvic organ prolapse (POP) [LINK:
http://my.clevelandclinic.org/ob_gyn/womens_health/urogynecology_pelvic_floor_disorders/pelvi
c_organ_prolapse.aspx]
, which occurs when weakened pelvic muscles allow these organs to drop from
their normal position.
With so much negative information out there, what are the facts about vaginal mesh?
“Women need to know that they can’t believe everything they hear on the news,” says gynecologist
Marie Paraiso, MD [LINK: http://my.clevelandclinic.org/staff_directory/staff_display.aspx?
doctorid=1835] , Head, Section of Urogynecology and Reconstructive Pelvic Surgery. “Early meshes
were not well designed for acceptance into the body, but not all mesh is bad.”
For women who have had vaginal mesh inserted, Dr. Paraiso advises watching for the most common
complications. If your doctor is recommending vaginal mesh, be sure he or she is highly skilled for the
procedure and that other alternatives have been ruled out.
How vaginal mesh works
Vaginal mesh has been used since about 2005 to treat POP, and is very similar to the mesh products
that have been used to treat hernias for many years.
“It’s placed in the space between the vagina and bladder or rectum and attached to the ligaments in the
pelvis,” says Dr. Paraiso. “It spans the area where the prolapse is taking place and gives the vagina the
support it once had.”
The way these early vaginal meshes were designed, along with the inexperience of many physicians
using them, led the Food and Drug Administration to issue a statement in 2008 [LINK:
http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976
.htm]
warning of serious complications from these devices, she says. A second warning followed in
2011.
What are the complications?
Most complications from vaginal mesh occur in the first three to six months following the procedure,
says Dr. Paraiso.
http://health.clevelandclinic.org/2013/06/the-truth-about-vaginal-mesh/
12/31/2014
Page 2 of 3
If you’ve received a vaginal mesh procedure, watch for:
•
•
•
•
Pain during intercourse
Other types of chronic pain
Fever or vaginal discharge that’s bloody or malodorous
A recurrence of the prolapse
What are the alternatives?
Every woman who receives a recommendation for vaginal mesh should ask about alternative methods
of treatment. Dr. Paraiso and her colleagues use vaginal mesh rarely, and only in select cases where it’s
needed.
Most frequently, she can use a woman’s own tissues to create additional support for the pelvic organs.
“There are surgeons with very good experience who are well-prepared for pelvic floor surgery,” says Dr.
Paraiso. “Ask your doctor what type of training and experience they have in treating POP, and ask what
your alternatives are.”
More information
Incontinence and Prolapse Treatment Guide [LINK:
http://www.clevelandclinic.org/lp/pelvic_organ_prolapse_incontinence/index.html?
utm_campaign=prolapseguide-url&utm_medium=offline&utm_source=redirect]
We welcome your comments. However, we cannot provide a medical opinion without an in-person
consultation. To learn about Cleveland Clinic services available to you, please fill out our WebMail form.
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12/31/2014
Page 3 of 3
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12/31/2014
Exhibit 15

defense motion - American Tort Reform Association

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