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Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 1 of 19 PageID 2904



IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHER DISTRICT OF TEXAS

DALLAS DIVISION

CINDY BURTON,

Plaintiff,

v.

WYETH-AYERST LABORATORIES
DIVISION OF AMERICAN HOME
PRODUCTS CORPORATION, ET AL.,

Defendants.

3:99–CV:0305–G

§
§
§
§ CIVIL ACTION NO.
§
§
§
§
§
§

ECF

BRIEF IN SUPPORT OF PLAINTIFF’S RESPONSE TO

DEFENDANT WYETH’S MOTION FOR PARTIAL SUMMARY JUDGMENT

SHELLER, LUDWIG & SHELLER
Steve Sheller
1528 Walnut Street, 3d Floor
Philadelphia, Pennsylvania 19102
Telephone
Facsimile

215.790.7300
215.546.0942

THE MCLARTY FIRM, P.C.
Mary Alice McLarty
Texas Bar No. 13740450
3811 Turtle Creek Blvd., Suite 1400
Dallas, Texas 75219
Telephone
Facsimile

972.974.9883
972.774.9889

THE HOLMAN LAW FIRM, P.C.
David W. Holman
Texas Bar No. 09902500
24 Greenway Plaza, Suite 2000
Houston, Texas 77046
Telephone
Facsimile

713.400.4840
713.400.4841

LAW OFFICE OF RAYMOND VALORI
Raymond Valori
Florida Bar No. 33200
2665 Executive Park Drive, Suite 3
Weston, Florida 33331
Telephone
Facsimile

954.467.6400
954.670.2530

THE LAW OFFICES OF FREEDLAND,
FARMER, RUSSO & SHELLER
Michael Freedland
Florida Bar No. 128988
2665 Executive Park Drive, Suite 3
Weston, Florida 33331
Telephone
Facsimile

954.467.6400
954.670.2530

Attorneys for Plaintiff

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 2 of 19 PageID 2905

TABLE OF CONTENTS

Page

Index of Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

I.

II.

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Standard of Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

III. Argument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

A.

B.

C.

D.

E.

F.

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

The History of the Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Well-settled Epidemiological Evidence Demonstrates That Use of
Fenfluramine And Dexfenfluramine Causes PAH . . . . . . . . . . . . . . . . . . . 7

Cindy Burton Suffers From Pulmonary Hypertension . . . . . . . . . . . . . . . . 9

Cindy Burton’s Pulmonary Hypertension Fits Within The Universally-
Accepted Definition of Pulmonary Arterial Hypertension . . . . . . . . . . . . . 9

Reliable Evidence Shows That Cindy Burton’s PAH Was Caused By
Her Ingestion of Diet Drugs

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Certificate of Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

i

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 3 of 19 PageID 2906

INDEX OF AUTHORITIES

Cases

Allen v. Rapides Parish Sch. Bd.,

204 F.3d 619 (5th Cir. 2000)

Margolis v. Deason, .

464 F.3d 547 (5th Cir. 2006)

Page(s)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Merrell Dow Pharmaceuticals, Inc. v. Havner,

953 S.W.2d 706 (Tex. 1997) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4, 8, 9, 12, 13

Missouri Pac. R.R. v. Navarro,

90 S.W.3d 747 (Tex. App.—San Antonio 2002, no pet.) . . . . . . . . . . . . . . . . . . . 13

Mitusbishi Elec. Indus. Co. v. Zenith Radio Corp.,

475 U.S. 574 (1986) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Piazza’s Seafood World, L.L.C. v. Odom,

448 F.3d 744 (5th Cir. 2006)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Smith v. Wyeth-Ayerst Laboratories Co.,

278 F.Supp. 684 (W.D. N.C. 2003) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Strong v. B.P. Exploration & Production, Inc.,

440 F.3d 665 (5th Cir. 2006)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

ii

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 4 of 19 PageID 2907

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHER DISTRICT OF TEXAS

DALLAS DIVISION

CINDY BURTON,

Plaintiff,

v.

WYETH-AYERST LABORATORIES
DIVISION OF AMERICAN HOME
PRODUCTS CORPORATION, ET AL.,

Defendants.

3:99–CV:0305–G

§
§
§
§ CIVIL ACTION NO.
§
§
§
§
§
§

ECF



BRIEF IN SUPPORT OF PLAINTIFF’S RESPONSE TO

DEFENDANT WYETH’S MOTION FOR PARTIAL SUMMARY JUDGMENT

Plaintiff, Cindy Burton, files this brief in support of her response to Defendant

Wyeth’s Motion for Partial Summary Judgment, and in support of her request that the motion

be denied.

I. Introduction

Wyeth has moved for partial summary judgment on three theories of liability: (1) Ms.

Burton’s claim of “exercise-induced” pulmonary arterial hypertension (PAH); (2) negligence

per se; and (3) conspiracy. As a preliminary matter, Ms. Burton never made a claim for

“exercise-induced” PAH. That is Wyeth’s term. Wyeth uses the term because Ms. Burton’s

PAH was diagnosed after her doctor raised her heart rate with mild exertion or exercise.

Scores of medical authorities defining PAH prove that this is usual and accepted procedure

for diagnosing PAH. The distinction of “exercise-induced” by Wyeth as some other disease

process is flatly wrong and not accepted or recognized by the medical or scientific

Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

1

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 5 of 19 PageID 2908

community. Moreover, there are volumes of scientific studies that demonstrate that Wyeth’s

diet drugs cause PAH—and none of those studies makes the artificial distinction that Wyeth

attempts to make in its motion. Because Wyeth’s motion is without merit in this regard, the

motion for partial summary judgment should be denied.

With regard to negligence per se and civil conspiracy—advanced by Ms. Burton’s

former counsel—Plaintiff Cindy Burton withdraws and abandons those claims.

II. Standard of Review

Under Rule 56, a party is entitled to summary judgment only if it proves that there is

no genuine issue of material fact and that it is entitled to prevail as a matter of law. Strong

v. B.P. Exploration & Production, Inc., 440 F.3d 665, 668 (5th Cir. 2006). This motion, in

effect, argues that the movant “is entitled to judgment as a matter of law.” Margolis v.

Deason, 464 F.3d 547, 550 (5th Cir. 2006) (quoting FED. R. CIV. P. 56(c)). If the movant

meets the initial burden to show that there is no genuine issue of material fact, “the burden

shifts to the nonmoving party to produce evidence or designate specific facts showing the

existence of a genuine issue for trial.” Allen v. Rapides Parish Sch. Bd., 204 F.3d 619, 621

(5th Cir. 2000). In determining whether there is a genuine issue of material fact, all facts

must be evaluated in the light most favorable to the nonmoving party. Mitusbishi Elec.

Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). Summary judgment is

appropriate only if the nonmovant fails to show the existence of a fact issue on at least one

element essential to that party’s case. Piazza’s Seafood World, L.L.C. v. Odom, 448 F.3d 744,

752 (5th Cir. 2006).

Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

2

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 6 of 19 PageID 2909

A.

Introduction

III. Argument

In its motion for partial summary judgment, Wyeth alleges that “exercise-induced”

pulmonary arterial hypertension (“PAH”) is a “different disease” from resting PAH and

1

that, while there might be epidemiological evidence for resting PAH, there is no

epidemiological evidence to support “exercise-induced” PAH. This is a flawed premise.

Pulmonary hypertension is an increase in the blood pressure in the pulmonary artery

(the artery through which the heart pumps blood to the lungs). When secondary causes have

be excluded, PAH or PPH is caused by damage to the pulmonary vascular bed (the small

2

arterioles in the lung through which blood is passes and receives oxygen). As these arterioles

narrow, they are more resistant to blood flow and thereby cause an abnormally high

pulmonary artery pressure.

The method for diagnosing this disease is through a cardiac catheterization. This is

a procedure in which the doctor snakes a catheter into the heart (usually through the leg) and

takes direct measurements of cardiac hemodynamics, including pulmonary artery pressure.

Doctors often measure this pressure while the patient is lying still (at rest) or after raising the

patients heart rate through mild exertion (with exercise).

1

See Wyeth’s Brief in Support of Motion for Partial Summary Judgment, at 30.

2

For the purposes of this motion, Plaintiffs will use the term “pulmonary arterial hypertension,” or
“PAH”, interchangeably with the term “primary pulmonary hypertension,” or “PPH”—as the experts in the
case do. See Deposition of Richard Channick, M.D., April 5, 2005, at 33, attached as Exhibit 9 (“And in my
book that’s the same as saying the patient likely had PAH.”).

Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

3

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 7 of 19 PageID 2910

If a patient has an abnormally elevated pulmonary artery pressure in either case, then

the patient has pulmonary hypertension. Virtually every medical text in the world defines

PAH as abnormal pressure at rest or with exercise. The medical literature never suggests

a diagnosis of PAH with exercise is somehow a different disease process. The simple truth

is that “exercise-induced” PAH (Wyeth’s term) is the same disease as resting PAH.

There is voluminous factual and epidemiological evidence that PAH is caused by

Wyeth’s diet drugs. There is opinion evidence in this case that Cindy Burton’s PAH was

caused by her ingestion of Wyeth’s diet drugs. Wyeth’s attempt to reanalyze the

epidemiological data in an attempt to manufacture an artificial distinction “does not comport

with sound scientific methodology.” See Merrell Dow Pharmaceuticals, Inc. v. Havner, 953

S.W.2d 706, 720 (Tex. 1997).

Because there remain issues of fact as to whether Cindy Burton’s PAH was caused

by her ingestion of Wyeth’s diet drugs, Wyeth’s motion for partial summary judgment should

be denied.

B.

The History of the Problem

Fortunately, much of the basis of this case has already been studied and analyzed by

federal courts. This Court will not be required to re-invent the wheel on a lot of the issues

raised here, because those issues have been previously addressed by Judge Bechtle in the

MDL. See Smith v. Wyeth-Ayerst Laboratories Co., 278 F.Supp. 684, 701 (W.D. N.C. 2003)

(“The Court intends to follow the MDL ruling.”).

To understand the issues raised here, it is helpful to briefly review the history of this

litigation.

Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

4

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 8 of 19 PageID 2911

In 1989, Wyeth, formerly known as American Home Products, acquired A.H.Robins

and began marketing the drug fenfluramine under the name “Pondimin.” See In re: Diet

Drugs, Civil Action No. 99-20593, MDL Docket No. 1203 (E.D. Pa. August 28,

2000)(hereafter “MDL Litigation”), Memorandum and Pretrial Order No. 1415 (hereafter

“MDL Order 1415”), at 6, attached as Exhibit 1. Between 1989 and 1997, Wyeth was

3

responsible for marketing, regulatory compliance, adverse event reporting, safety

surveillance and labeling. Id. In 1992, an article came out that recommended use of

fenfluramine, combined with a drug called phentermine (which was supposed to lessen the

side effects of fenfluramine) for weight loss. Id. This regimen popularly became known as

“Fen-Phen.” Id. This “Fen-Phen” craze took the nation by storm and Wyeth’s sale of its

fenfluramine drugs skyrocketed. Wyeth realized that the diet drugs had the potential to make

hundreds of millions (if not billions) of dollars in profit.

Another related drug, dexfenfluramine, was developed by Servier in France. Id. at 7.

In order to protect its blockbuster profits from Pondimin (which was coming off patent

protection in 1994), Wyeth acquired the rights to market dexfenfluramine, which it did under

the name “Redux” from June 1996 to September 1997. Id. Wyeth’s scheme was to tell

everyone that this drug provided the same anorexic effects as Pondimin, without the need

to add phentermine. Id. In fact, Redux was simply an isomer of Pondimin (the active half of

the same molecule).

3

On January 2, 2007, Wyeth filed six voluminous motions. Because many of the issues raised in
those motions overlap, and for the convenience of the Court, Plaintiff has organized all of the exhibits that
respond to all of the motions into one appendix, entitled Appendix of Exhibits For Plaintiff’s Responses to
Wyeth’s January 2, 2007 Motions (hereafter “Appendix”). All references to Exhibits will be to the exhibits
contained and listed in that Appendix.
Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

5

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 9 of 19 PageID 2912

During this period, Wyeth knew that its drugs could cause serious heart valve damage

and could cause the serious and potentially fatal disease PPH (PAH). Wyeth knew that its

4

label had no warning for the risks of valvular heart disease and a wholly inaccurate

statement regarding PPH. Id. Wyeth studied the effect that a proper label design ( such as a

“black box” warning)—designed to make physicians aware of the danger of PPH—would

have on sales. Wyeth then did everything it could to avoid putting a strong warning on its

5

diet drugs. Wyeth engaged in a campaign to downplay the known risks of the diet drugs,

6

including instructing its sales force to avoid bringing up the PPH risk with physicians and

then to mislead the physicians when it did come up. Wyeth tried to “neutralize” leading

7

experts on PPH when they spoke out about the risks. See Exhibits 6 and 33. Wyeth spent

large amounts of money to have physicians ghost write articles actually authored or edited

4

Despite Wyeth’s knowledge of serious health risks, it failed to change its label or report the
information to the FDA. See Exhibit 1, MDL Order 1415, at 8; see also Generic Expert Report of John
L.Gueriguian, M.D. On Behalf of Plaintiffs (hereafter “Gueriguian Report”), filed in MDL Litigation, April
14, 2000, at 8, attached as Exhibit 2. Wyeth not only knew about serious risks of patients contracting
valvular heart disease, but also it knew about serious risks of developing primary pulmonary hypertension
(PPH). See Exhibit 2, Guerigian Report, at 7. Despite the knowledge (by 1996) that there were over 200
cases of PPH, with at least 64 deaths, Wyeth’s label read, in the “precautions” section, that there were four
cases of PH, but the condition appeared reversible. Id..

5

Wyeth’s own documents show that it knew that “Price and PPH are the key product attributes that
impact physicians’ and managed care’s willingness” to prescribe its diet drugs. See Exhibit 28, Wyeth’s
Internal Correspondence of March 29, 1995. The company knew that “sales potential decreases by as much
an one-half, if there is a PPH warning.” Id; see Exhibit 29, Wyeth’s Internal Correspondence of November
21, 1995 (“a black box for PPH … would be an extremely strong negative”); see also Exhibit 30, Wyeth’s
Internal Correspondence, April 7, 1995.

6

“Every attempt will be made to ensure that no black box warnings, restrictions of use or negative
statements find their way into the redux labeling…. We will make every effort to neutralize these initiatives.”
See Exhibit 31, Wyeth’s Internal Correspondence of November 22, 1995.

7

For example, Wyeth sent a memorandum to its Texas sales force stating “the PPH possibility
should not be brought up unless you are specifically asked a question on it by the physician. When it is
brought up, you should put it in proper perspective by describing the where the information came from and
the controversy surrounding whether or not there is even a direct correlation to anorectics.” See Exhibit 32,
Wyeth Memo, August 8, 1996.
Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

6

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 10 of 19 PageID 2913

by Wyeth’s employees or agents. See Exhibit 18. Finally, Wyeth destroyed adverse event

reports of cardiac side effects of these drugs that it was required to report to the FDA.8

By 1997 Wyeth could no longer conceal the truth about the serious risks of valvular

heart disease. Mayo Clinic researchers observed and reported an association between

fenfluramine and dexfenfluramine and valvular heart disease in March, 1997, and the FDA

requested withdrawal of the drugs from the market. See Exhibit 1, MDL Order 1415, at 8-9.

On September 15, 1997, Wyeth and the FDA announced that there would be no further sales

of the drugs. Id. at 9. The “products were found to be unsafe [and] may not be

compounded.” 21 C.F.R. §216.24.

C. Well-settled Epidemiological Evidence Demonstrates That Use of Fenfluramine

And Dexfenfluramine Causes PAH

It can no longer be doubted that there is sufficient epidemiological evidence to

demonstrate that use of the diet drugs, fenfluramine and dexfenfluramine, can cause PAH.

Judge Bechtle found that “[t]wo well done epidemiological studies establish that the use of

fenfluramine and dexfenfluramine cause PPH.” See Exhibit 1, MDL Order 1415, at 40-41.

8

In fact, Wyeth was cited by the FDA for “overwriting” 14 files of adverse reports of valvular
disease that were required to be reported to the FDA, and “losing” the 14 physical files that contained the
reports from the Mayo Clinic. See Exhibit 3, at 21-25, FDA Citation, September 10, 1997. A Wyeth internal
memorandum indicates that Wyeth’s Drs. Davis and Constantine, two of Wyeth’s officers, ordered the
adverse report files overwritten. See Exhibit 4, Wyeth Memorandum from Mary Frances Moeller, dated
March 12, 1997.
Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

7

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 11 of 19 PageID 2914

Those two studies are the International Primary Pulmonary Hypertension Study (IPPHS) and

9

the Surveillance of North American Pulmonary Hypertension (SNAPH).

10

Id. at 41.

Both studies exceed the requirements for admissible evidence of causation stated in

Merrell Dow Pharmaceuticals, Inc. v. Havner, 953 S.W.2d 706 (Tex. 1997). To establish

causation, Havner requires a doubling of the relative risk factor for those exposed to the

causative agent, a 95% confidence level with a confidence interval that does not include the

number 1.0. Id. at 716-18, 721, 723-24. IPPHS found a 6.3 to 1 relative risk, a 95%

confidence level, at a confidence interval of 3.0 to 13.2. Id. ; see also Affidavit of Harold

Palevsky, M.D., at 3, attached as Exhibit 7. The 6.3 to 1 risk means that diet drug users are

630 times more likely to suffer PPH as non-users. SNAP found a 7.5 to 1 relative risk, a 95%

confidence level, at a confidence interval of 1.7 to 32.4.11

That this causation finding is not doubted is shown in the recent deposition of Wyeth’s

expert, Dr. Steven Koenig. Dr. Koening admitted that he had diagnosed patients with PPH

caused by use of diet drugs:

Q.

So in this over a hundred case that you’ve looked at, have
you ever reached the conclusion that the patient had
pulmonary hypertension caused by diet drugs?

A.

Yeah, I have.

9

The IPPHS study is attached as an exhibit to the Affidavit of Dr. Harold Palevsky. See Exhibit 7,

at Burton Appendix 360.

10

The SNAPH study is also attached as an exhibit to the Affidavit of Dr. Harold Palevsky. See

Exhibit 7, at Burton Appendix 369.

11

Id., at 369.

Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

8

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 12 of 19 PageID 2915

See Deposition of Steven M. Koenig, M.D., December 18, 2006, at 46, 101, attached as

Exhibit 8.

D.

Cindy Burton Suffers From Pulmonary Hypertension

Cindy Burton used fenfluramines (Pondimin and Redux) for approximately a year.

See Exhibit 7, Dr. Palevsky Affidavit, at 5. Following her use of diet drugs, Ms. Burton

contracted pulmonary hypertension. Id. No one disputes this. Wyeth’s expert, Dr. Koenig,

acknowledged that Ms. Burton suffered from pulmonary hypertension, and that it would be

“wrong to state” that she does not. See Exhibit 8, Dr. Koenig Depo., at 101.

E.

Cindy Burton’s Pulmonary Hypertension Fits Within The Universally-Accepted
Definition of Pulmonary Arterial Hypertension

Here is where the rubber meets the road with regard to Wyeth’s motion for partial

summary judgment. In its motion for partial summary judgment, Wyeth attempts to create

an artificial distinction between “exercise-induced” PAH and “resting” PAH, as if they were

different diseases. Wyeth has presented no scientific literature or studies that ever made such

a distinction. Instead, Wyeth is attempting to parse the data in the accepted studies in an

effort to manufacture a distinction that no one in the medical or scientific community

recognizes. Such attempts to reanalyze data have been rejected. See Havner, 953 S.W.2d at

720 (“an expert cannot dissect a study, picking and choosing data, or ‘reanalyze’ the data”

if the process “does not comport with sound scientific methodology.”).

Contrary to Wyeth’s theory in its motion for summary judgment, the medical and

scientific community universally recognizes that PAH diagnosed on “exercise” is just as

much PAH as resting PAH. They are not different diseases. See Exhibit 7, Dr. Palevsky

Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

9

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 13 of 19 PageID 2916

Affidavit, at 3 (“While exercise-associated pulmonary hypertension represents the earliest

phase possible to diagnose pulmonary vascular disease, it in no way implies different

pathogenesis.”).

Cindy Burton’s disease fits within the universally accepted definition of PAH. In the

MDL Litigation, Judge Bechtle explained:

The community of physicians with expertise in diagnosing and treating PPH
have repeatedly reached a consensus concerning the appropriate criteria for
diagnosing and defining the disease. This consensus was expressed at the
World Health Organization meeting in 1973, in a statement of the American
College of Chest Physicians in 1993 and in the Executive Summary of the
World Symposium on Primary Pulmonary Hypertension in 1998. In addition,
this ‘consensus definition’ of PPH has been expressed in every major
epidemiological study concerning the disease that has ever been done.

Exhibit 1, MDL Order 1415, at 39. Dr. Palevsky noted that this same “consensus definition”

is “universally accepted by physicians throughout the world in texts, in peer review journal

articles, and in organization statements. See Exhibit 7, Dr. Palevsky Affidavit, at 2

(attaching texts, peer review journal articles and organization statements that rely on

definition).

Judge Bechtle set out the “consensus definition” of PPH as follows, quoted in relevant

part:

The consensus defining and diagnosing PPH has three elements. The first of
the three criteria necessary to make a diagnosis of primary pulmonary
hypertension is a mean artery pressure > 25 mm Hg at rest or > 30 mm Hg
with exercise as measured at cardiac catheterization.

Exhibit 1, MDL Order 1415, at 39 (emphasis added).

The universality of this definition is shown by the fact that both of Wyeth’s experts,

in their expert reports, state that the “accepted hemodynamic criteria” for a diagnosis of PAH
10

Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 14 of 19 PageID 2917

includes a diagnosis of “30 mm Hg with exercise . . .” See Report of Hunter Clay Champion,

M.D., at ¶9, at 2 (emphasis added), attached as Exhibit 10; Amended Report of Stephen

[sic]

12

Koenig, M.D., at ¶11, at 4, attached as Exhibit 11. Further, Wyeth accepted that

definition as the proper definition of PPH in the Nationwide Class Settlement. See

Nationwide Class Settlement Agreement with American Home Products (As Amended),

dated November 18, 1999, at ¶I(46), at 8, attached as Exhibit 12.

Without dispute, Cindy Burton fits within this “consensus definition” of PPH.

Wyeth’s expert Dr. Koenig reports that “[c]ardiac catheterization is the gold standard for

diagnosing cardiopulmonary diseases such as pulmonary hypertension.” See Exhibit 11,

Koenig report, at ¶25, at 8. In many places in this record, Cindy Burton’s medical reports

concerning her catheterizations are reported, including in the Affidavit of Dr. Palevsky. See

Exhibit 7, at 4. Dr. Palevsky notes that cardiac catheterizations on done in 2002, 2004 and

2006 revealed that Cindy Burton’s mean pulmonary artery pressure exceeded 30 mm Hg with

exercise—in some reports as much as 50 mm Hg—which placed her within the “consensus

definition” of PAH. Id. at 7-8.

Under the approved definition, Cindy Burton’s “exercise diagnosed” PAH is just as

13

much PAH as “resting diagnosed” PAH. It is just as improper to say that there is no evidence

to support “exercise diagnosed” PAH as it would be to say that there was no evidence of

12

The correct name of Wyeth’s expert is “Steven” Koenig.

13

Wyeth does not point to any study or scientific literature that ever referred to someone who is
diagnosed with PAH on exercise as having “exercise-induced” PAH. This artificial construct appears to be
a deliberate misnomer because the exercise does not “induce” the PAH; rather, the exercise is what permits
the physician to diagnose the already existing PAH. Instead of Wyeth’s artificial construct, Dr. Palevsky
uses the term “exercise associated” PAH. See Exhibit 7, at 2-4. It would, perhaps, be more correct, to refer
to her condition as “diet drug-induced” PAH.
Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

11

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 15 of 19 PageID 2918

studies concerning patients who were diagnosed on Thursdays. It is improper to try to

reanalyze the data by carving out subsets. See Havner, 953 S.W.2d at 720.

F.



Reliable Evidence Shows That Cindy Burton’s PAH Was Caused By Her
Ingestion of Diet Drugs

To show that there is reliable evidence of causation, a person must show a peer-

reviewed epidemiological study that meets the accepted criteria for doubling of the risk and

confidence level. See Havner, 953 S.W.2d at 723-24. In this case, two well-respected peer-

reviewed studies—the IPPHS and SNAPH—have found that PPH/PAH is caused by the use

of Wyeth’s diet drugs, in studies that exceed the risk and confidence levels required by

Havner. There is no dispute that Cindy Burton fits within the criteria of that study in terms

of duration and dose.

14

Id. at 720. Those studies “definitely settled the question of a causal

connection between anorectic drugs and PPH.” See Exhibit 7, Dr. Palevsky Affidavit, at 3.

Thus, under Havner, Cindy Burton has presented sufficient epidemiological evidence

to go to the jury on liability.

Wyeth asks this Court to disagree with the conclusion of those studies. Wyeth says

that those studies were done of “resting” PAH, and therefore, the authors of those studies’

conclusions that use of anorexic drugs causes PAH means only that it causes “resting” PAH.

The authors did not say that. They concluded that the use of anorexic drugs causes PAH.

Within the accepted definition, Cindy Burton has PAH caused by her use of diet drugs. Once

again, Wyeth cannot “reanalyze” or “dissect” the study in order to arrive at a different

14

Ms. Burton used Wyeth’s diet drugs for a year. See Exhibit 7, Dr. Palevsky Affidavit, at 4.

Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

12

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 16 of 19 PageID 2919

conclusion than the authors. See Havner, 953 S.W.2d at 720; Missouri Pac. R.R. v. Navarro,

90 S.W.3d 747, 757 (Tex. App.—San Antonio 2002, no pet.).

Wyeth contends that Dr. Channick stated that he could not determine the cause for

Cindy Burton’s “exercise-induced” PAH. That is not so. Dr. Channick, who is one of the

leading specialists in PPH in the world,

15

stated “I believe that she has pulmonary arterial

hypertension associated with her prior ingestion of anorexigen drugs.” See Deposition of

Richard Channick, M.D., November 1, 2006, at 225-26, attached as Exhibit 13. In fact, Dr.

Channick expressly rebutted Wyeth’s contention that “exercise-induced” PAH is not

supported by epidemiological evidence.

Q.

A.

Q.

A.

Q.

You were asked whether there were specific studies that parsed out and
studied only the subset of pulmonary hypertension on exercise cases
versus resting pulmonary hypertension associated with diet drugs. Do
you remember that question?

Yes.

Okay. Would you agree with me that Ms. Burton meets the definition
of someone who has pulmonary hypertension?

Yes.

And would you agree with me that . . . there’s ample epidemiological
evidence to demonstrate that there is an increased risk of contracting
pulmonary hypertension associated with the use of fenfluramines?

A.

That’s correct

Exhibit 13, Channick Depo., at 247-48).

15

See Curriculum Vitae of Richard Neil Channick, M.D., FCCP, attached as Exhibit 14

Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

13

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 17 of 19 PageID 2920

Dr. Harold Palevsky, also recognized throughout the world for his work with

PPH—he has been lecturing, writing and researching PPH since 1984 —concurs. He states:

16

“Based upon the known causes of PAH, the exclusion of other causes and conditions, the

documented use of fenfluramines, the diagnostic studies and observation described in the

medical records and above, Ms. Burton’s exercise associated PAH was, within a reasonable

degree of medical certainty, caused by fenfluramines.” See Exhibit 7, Dr. Palevsky Affidavit,

at 5.

Thus, there is no merit to Wyeth’s contention that there is no reliable evidence that

Cindy Burton’s PAH was caused by her use of Wyeth’s diet drugs. Because Wyeth has

failed to show that it is entitled to judgment as a matter of law on this point, and because fact

issues remain, the motion for partial summary judgment should be denied.

CONCLUSION

For the above reasons, Wyeth’s motion for partial summary judgment should be

denied.

16

See Curriculum Vitae of Harold Ingram Palevsky, M.D., attached as Exhibit 15.
Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

14

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 18 of 19 PageID 2921

Respectfully submitted,

THE HOLMAN LAW FIRM, P.C.

s/ David W. Holman
David W. Holman
Texas Bar No. 09902500
24 Greenway Plaza, Suite 2000
Houston, Texas 77046
Telephone
Facsimile

713.400.4840
713.400.4841

LAW OFFICE OF RAYMOND VALORI

Raymond Valori
Florida Bar No. 33200
2665 Executive Park Drive, Suite 3
Weston, Florida 33331
Telephone
Facsimile

954.467.6400
954.670.2530

THE LAW OFFICES OF FREEDLAND,
FARMER, RUSSO & SHELLER

Michael Freedland
Florida Bar No. 128988
2665 Executive Park Drive, Suite 3
Weston, Florida 33331
Telephone
Facsimile

954.467.6400
954.670.2530

SHELLER, LUDWIG & SHELLER

Steve Sheller
1528 Walnut Street, 3d Floor
Philadelphia, Pennsylvania 19102
Telephone
Facsimile

215.790.7300
215.546.0942

Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

15

Case 3:99-cv-00305-G Document 106 Filed 02/09/07 Page 19 of 19 PageID 2922

THE MCLARTY FIRM, P.C.

Mary Alice McLarty
Texas Bar No. 13740450
3811 Turtle Creek Blvd., Suite 1400
Dallas, Texas 75219
Telephone
Facsimile

972.974.9883
972.774.9889

Attorneys for Plaintiff

CERTIFICATE OF SERVICE

I hereby certify that on February 8, 2007, I electronically submitted the foregoing
document with the clerk of court for the U.S. District Court, Northern District of Texas,
using the electronic case files system of the court. The electronic case files system sent a
“Notice of Electronic Filing” to the following individuals:

Mr. David J. Duke

Mr. Kenneth J. Ferguson

CLARK, THOMAS & WINTERS, P.C.

P. O. Box 1148

Austin, Texas 78767

Telephone 512.472.8800 Facsimile512.474.1129

Counsel for Defendant, Wyeth

Mr. David P. Stone

HARTLINE, DACUS, BARGER, DRYER & KERN

6688 N. Central Expressway, Suite 1000

Dallas, Texas 75206

Telephone 214.346.3705 Facsimile 214.369.2118

Counsel for Defendant, Eckerd Drugs

s/ David W. Holman
David W. Holman

Brief in Support of Plaintiff’s Response to Defendant Wyeth’s Motion for Partial Summary Judgment

16