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Case 3:99-cv-00305-G Document 103 Filed 02/09/07 Page 1 of 13 PageID 2857

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



PLAINTIFF’S BRIEF IN SUPPORT OF RESPONSE
TO DEFENDANT WYETH’S MOTION TO LIMIT

THE TESTIMONY OF PLAINTIFF’S GENERIC EXPERTS

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 103 Filed 02/09/07 Page 2 of 13 PageID 2858

TABLE OF CONTENTS

Page

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

I. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

II. Plaintiff Will Not Call This Generic Expert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

III. Argument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

A.

B.

C.

D.

E.

F.

These Matters Have Already Been Ruled Upon By The MDL Judge
And There Is No Reason To Revisit Them . . . . . . . . . . . . . . . . . . . . . . . . . 2

Dr. Avorn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Drs. Barst and Rich . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Dr. Bloor

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Dr. Gueriguian . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Dr. Hayes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

G.

Dr. Sears

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Certificate of Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Plaintiff’s Brief in Support of Response To Defendant Wyeth’s
Motion to Limit The Testimony of Plaintiff’s Generic Experts

i

Case 3:99-cv-00305-G Document 103 Filed 02/09/07 Page 3 of 13 PageID 2859

INDEX OF AUTHORITIES

Cases

Page(s)

Daubert v. Merrell Dow Pharmaceuticals, Inc.,

509 U.S. 579 (1993) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

First Nat. Bank of Louisville v. Lustig,

96 F.3d 1554 (5th Cir. 1996)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Smith v. Wyeth-Ayerst Laboratories Co.,

278 F.Supp. 684 (W.D. N.C. 2003) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2, 5

Plaintiff’s Brief in Support of Response To Defendant Wyeth’s
Motion to Limit The Testimony of Plaintiff’s Generic Experts

ii

Case 3:99-cv-00305-G Document 103 Filed 02/09/07 Page 4 of 13 PageID 2860

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



PLAINTIFF’S BRIEF IN SUPPORT OF RESPONSE
TO DEFENDANT WYETH’S MOTION TO LIMIT

THE TESTIMONY OF PLAINTIFF’S GENERIC EXPERTS

Plaintiff, Cindy Burton, files this brief in support of her response to Wyeth’s motion

on generic experts, as follows:

I. Introduction

Wyeth’s motion, for the most part, goes through the MDL orders and recites what the

MDL court held on Daubert rulings with regard to the Generic Experts. Plaintiff intends to

follow all Daubert rulings of the MDL court. Thus, Wyeth’s motion is unnecessary and

should be denied.

II. Plaintiff Will Not Call This Generic Expert

Plaintiff will not call Dr. Oury as an expert witness.

Plaintiff’s Brief in Support of Response To Defendant Wyeth’s
Motion to Limit The Testimony of Plaintiff’s Generic Experts

1

Case 3:99-cv-00305-G Document 103 Filed 02/09/07 Page 5 of 13 PageID 2861

III. Argument

A.

These Matters Have Already Been Ruled Upon By The MDL Judge And There
Is No Reason To Revisit Them

The MDL court expended a great deal of time and resources “disposing of Daubert

issues applicable to the vast majority of cases within this MDL No. 1203.” See In re: Diet

Drugs, Civil Action No. 99-20593, MDL Docket No. 1203 (E.D. Pa. February 1, 2001),

Memorandum and Pretrial Order No. 1685, at 2, attached as Exhibit 5. These Daubert

1

rulings were to have “final and uniform value” in the vast majority of cases. Id. at 5.

Plaintiff intends to rely on the Daubert rulings of the MDL court, just as other courts

have done. 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.”). Thus, Wyeth’s motion is

unnecessary. However, in this response, Plaintiff will address Wyeth’s arguments and

identify what the MDL court held.

B.

Dr. Avorn

Wyeth asks that this Court exclude Dr. Avorn’s testimony: (1) regarding the thoughts

and expectations of physicians; (2) “reaction” to documents discussing the approval process

for Redux; (3) speculation concerning the processing of adverse drug event reports; and (4)

recounting of various documents or testimony.

Plaintiff will not call Dr. Avorn to testify on what doctors expect or FDA regulations.

1

References are to Exhibits in the Appendix of Exhibits for Plaintiff’s Responses to Wyeth’s

January 2, 2007 Motions. The Appendix contains all the evidence to respond to all the motions.

Plaintiff’s Brief in Support of Response To Defendant Wyeth’s
Motion to Limit The Testimony of Plaintiff’s Generic Experts

2

Case 3:99-cv-00305-G Document 103 Filed 02/09/07 Page 6 of 13 PageID 2862

However, the MDL court held that Dr. Avorn is “fully qualified within [his] discipline

[ ] and that [he] can testify concerning the risks and benefits of the diet drugs in issue.” See

In re: Diet Drugs, Civil Action No. 99-20593, MDL Docket No. 1203 (E.D. Pa. June 20,

2000), Memorandum and Pretrial Order No. 1332, at 9, attached as Exhibit 22. Further, the

parties agreed that Dr. Avorn “can provide the medical and scientific testimony as it relates

to PPH.” Id.

The MDL court also held that while Dr. Avorn was not qualified to testify about FDA

regulation, Dr. Avorn is “fully qualified to opine on the medical facts and science regarding

the risks and benefits of the diet drugs in question and to compare that knowledge with what

was provided in the text of labeling and warnings in the diet drugs in question. In other

words, [Dr.] Avorn [is] fully qualified to render an opinion as to the label’s completeness,

accuracy and – it follows from that – the extent to which the inaccuracies or omissions could

either deprive a reader or mislead a reader of what the risks and benefits of the diet drugs in

issue are or were at the time the labeling was published.” Id. The MDL court held that it

could not exclude Dr. Avorn’s opinions “comparing the facts in evidence with the status of

the content shown in the labeling of the diet drugs.” Id.

With regard to documents, the MDL court held as follows: “Whether a particular

document can be introduced through a witness as a basis for his expert opinion will, of

course, be left to the trial judge in the transferor court.” Id. at 7; see also First Nat. Bank of

Louisville v. Lustig, 96 F.3d 1554, 1576 (5th Cir. 1996) (expert may rely on hearsay evidence

in forming an opinion). The MDL court further held that if the document is admitted in

Plaintiff’s Brief in Support of Response To Defendant Wyeth’s
Motion to Limit The Testimony of Plaintiff’s Generic Experts

3

Case 3:99-cv-00305-G Document 103 Filed 02/09/07 Page 7 of 13 PageID 2863

evidence, it can be read or paraphrased to a witness but, on the other hand, if it is

inadmissible, irrelevant or prejudicial, “it will not get into evidence and the witness will not

be called upon to speak about it.” See Exhibit 22, at 7. Because the MDL court could not

predict whether the documents would be admissible at trial, the MDL court denied Wyeth’s

motion to exclude all testimony about documents. Id.

C.

Drs. Barst and Rich

Wyeth argues that Drs. Barst and Rich should not be permitted to testify concerning:

(1) FDA regulatory matters; (2) the efficacy of Pondimin and Redux for treating obesity; and

(3) concerning Aminorex.

Plaintiffs will not ask Dr. Barst or Rich to testify about FDA regulatory matters,

except “to the extent that Dr. Rich testifies as to regulatory matters and occurrences of which

he has firsthand personal knowledge, such as his participation in FDA advisory committee

hearings . . .” See Exhibit 5, MDL Order 1685, at 55 n.22. The MDL court held that Drs.

2

Barst and Rich were fully competent, however, to testify as to the Wyeth label’s “accuracy

and the extent to which an inaccuracy or omission could either deprive or mislead a reader

as to the risks of these diet drugs at the time the labeling was published.” Id. at 56. Further,

Drs. Barst and Rich can testify about the “origins, symptoms, treatment and other aspects of

PH and PPH, including causation of these diseases by diet drugs.” Id. at 54.

2

Dr. Rich has been designated as a fact witness by the Plaintiff.

Plaintiff’s Brief in Support of Response To Defendant Wyeth’s
Motion to Limit The Testimony of Plaintiff’s Generic Experts

4

Case 3:99-cv-00305-G Document 103 Filed 02/09/07 Page 8 of 13 PageID 2864

Plaintiffs will not ask Drs. Barst or Rich to testify as to the efficacy of Pondimin or

Redux for treating obesity (the MDL court held that Dr. Sears, the creator of the Zone Diet,

was fully competent to speak to that issue).

With regard to testimony regarding the Aminorex experience in the 1960s, the MDL

court held that such evidence “may support evidence of notice to the pharmaceutical

community . . .” See Exhibit 22, MDL Order 1332, at 9. Without hearing this evidence in

context, the court cannot rule on its admissibility. See Smith v. Wyeth-Ayerst Laboratories

Co., 278 F.Supp.2d 684, 704 (W.D. N.C. 2003) (admitting Aminorex evidence for notice,

historical data).

D.

Dr. Bloor

Wyeth contends that Dr. Bloor’s testimony was excluded in the MDL court so it

should be excluded here. Wyeth is partially correct. Dr. Bloor’s testimony concerning rat

slides was inadmissible because it could not be tested, and his testimony on causation was

excluded. See Exhibit 5, MDL Order 1685, at 39-43. However, the MDL court held that Dr.

Bloor could testify that with regard to whether a study “warranted further investigation with

regard to the potential of fenfluramines to cause cardiac fibrosis.” Id. at 44.

E.

Dr. Gueriguian

Wyeth contends Dr. Gueriguian cannot testify about: (1) the prescribing practices of

other physicians; (2) his personal opinions about corporate conduct; and (3) pathology

testimony based on unreliable methodology. Wyeth contends that such testimony was

excluded by the MDL. Again, Wyeth is partially correct.

Plaintiff’s Brief in Support of Response To Defendant Wyeth’s
Motion to Limit The Testimony of Plaintiff’s Generic Experts

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Case 3:99-cv-00305-G Document 103 Filed 02/09/07 Page 9 of 13 PageID 2865

Plaintiff does not intend to call Dr. Gueriguian to testify about the prescribing

practices of other physicians. And, Plaintiff does not intend to ask for Dr. Gueriguian’s

testimony based on Dr. Bloor’s unreliable testimony or Dr. Gueriguian’s testimony

concerning Wyeth’s corporate intent.

However, Dr. Gueriguian was the Medical Director at the FDA during the relevant

time period. Plaintiff intends to call him to testify—and the MDL court ruled he

could—about how information should be communicated to the FDA, what information

should be reflected on labels as mandated by applicable regulations, and what reasonable

FDA officials would do with adverse event information. Id. at 51-54.

F.

Dr. Hayes

Dr. Hayes is the former commissioner of the FDA. Although he was not addressed

by the MDL court , Wyeth seeks to exclude his testimony as to: (1) Wyeth’s motives and

3

intent; (2) recitation of contents of various documents; and (3) use of “non-regulatory

meaning of certain terminology in a regulatory context.”

Plaintiff does not intend to call Dr. Hayes to testify concerning the corporate intent

of Wyeth. With regard to documents, as the MDL court observed, if the documents are

admitted or admissible, Dr. Hayes can read from them. See Exhibit 22, MDL Order 1332, at

7. That can only be determined at trial.

With regard to “non-regulatory terminology,” it appears that Wyeth is attempting to

argue that Dr. Hayes uses the term “medically serious” incorrectly. It appears that Wyeth is

3

The MDL court denied a motion to exclude Dr. Hayes. See Exhibit 5, MDL Order 1685, at 33 n.9.

Plaintiff’s Brief in Support of Response To Defendant Wyeth’s
Motion to Limit The Testimony of Plaintiff’s Generic Experts

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Case 3:99-cv-00305-G Document 103 Filed 02/09/07 Page 10 of 13 PageID 2866

arguing that this Court should exclude such evidence because it is unreliable or that it may

tend to confuse jurors under FED. R. EVID. 403. Obviously, such a challenge should be made

at trial when the court has the opportunity to understand the alleged error in context. More

4

properly, the matter appears one for cross-examination. See Daubert v. Merrell Dow

Pharmaceuticals, Inc., 509 U.S. 579, 596 (1993).

G.

Dr. Sears

Finally, Wyeth seeks to exclude the testimony of Dr. Barry Sears on: (1) FDA efficacy

requirements; or (2) Wyeth’s marketing or disclosure obligations. Plaintiff does not intend

to call Dr. Sears to testify about the FDA requirements or about Wyeth’s marketing or

disclosure obligations. However, as the MDL court held, Dr. Barry Sears, the creator of the

Zone Diet, is fully qualified under Daubert to testify “about the effectiveness of Pondimin

and Redux in treating obesity.” See Exhibit 5, MDL Order 1685, at 64.

CONCLUSION

Plaintiff, Cindy Burton, intends to follow the MDL’s Daubert rulings to the letter.

For that reason, Wyeth’s motion is unnecessary and should be denied.

4

For example, Wyeth’s motion asserts, without evidence other than citations to the Code of Federal
Regulation, that Dr. Hayes, the former Commissioner of the FDA is using the term “medically serious”
incorrectly, that is, not as it is used in the cited statutes. In the full context of the question answered in the
definition, Dr. Hayes was asked, without objection, if there were adverse event reports that he considered
medically serious. See Wyeth Motion, at App. 7, pp. 89-91. What he considers medically serious may be
different than what the statute calls “serious.” Without further elaboration, this Court could not decide how
to rule.

Plaintiff’s Brief in Support of Response To Defendant Wyeth’s
Motion to Limit The Testimony of Plaintiff’s Generic Experts

7

Case 3:99-cv-00305-G Document 103 Filed 02/09/07 Page 11 of 13 PageID 2867

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

Plaintiff’s Brief in Support of Response To Defendant Wyeth’s
Motion to Limit The Testimony of Plaintiff’s Generic Experts

8

Case 3:99-cv-00305-G Document 103 Filed 02/09/07 Page 12 of 13 PageID 2868

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

Plaintiff’s Brief in Support of Response To Defendant Wyeth’s
Motion to Limit The Testimony of Plaintiff’s Generic Experts

9

Case 3:99-cv-00305-G Document 103 Filed 02/09/07 Page 13 of 13 PageID 2869

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

Plaintiff’s Brief in Support of Response To Defendant Wyeth’s
Motion to Limit The Testimony of Plaintiff’s Generic Experts

10