Torkie-Tork v. Wyeth

Filing 319

ORDERED that defendant's motions in limine are resolved as follows: a. Defendant's Motion in Limine No. 1 [Doc. No. 124] concerning "marketing and promotional material" is DEFERRED. b. Defendant' s Motion in Limine No. 2 [Doc. No. 139] concerning the relationship between Premarin and endometrial cancer is GRANTED IN PART and DENIED IN PART. c. Defendant's Motion in Limine No. 3 [Doc. No. 127] regarding causality ass essments is GRANTED IN PART and DENIED IN PART . d. Defendant's Motion in Limine No. 4 [Doc No. 131] concerning "excess breast cancers" allegedly caused by Prempro is GRANTED. e. Defendant's Motion in Lim ine No. 5 [Doc. No. 133] concerning changes in the Prempro label after the Women's Health Initiative ("WHI") study is DENIED. f. Defendant's Motion in Limine No. 6 [Doc. No. 135] concerning the use of IMS data i s DENIED as moot, given the parties' stipulation [Doc. No. 213] that plaintiff will not present evidence or argument relating to the IMS data for plaintiff's prescribing physicians. g. Defendant's Motion in Limine No. 7 [Doc. No. 137] concerning the defendant's "ghostwriting" Prempro articles is DENIED. h. Defendant's Motion in Limine No. 8 [Doc. No. 142] concerning the profit margin on Prempro is DENIED. i. Defendant' s Motion in Limine No. 9 [Doc. No. 147] concerning reference to Pfizer is GRANTED j. Defendant's Motion in Limine No. 10 [Doc. No. 150] concerning reference to the absence of defendant's corporate representative at tria l is GRANTED IN PART and DENIED IN PART, insofar as plaintiff may not comment the presence or absence of defendant's corporate representative unless the corporate representative is absent for the entirety of the trial. k. Defendant' s Motion in Limine No. 11 [Doc. No. 152] concerning Wyeth's net worth, profits, employee salaries, and other financial information is GRANTED IN PART and DENIED IN PART, insofar as plaintiff may introduce evidence concerning defend ant's net worth and profits may be probative on the question of punitive damages, and its probative value is not sustantially outweighted by the danger of unfair prejudice under Rule 403, Fed.R.Evid. l. Defendant's Motion in Limine No. 12 [Doc. No. 154] concerning defendant's alleged failure to test Prempro is DENIED.It is further ORDERED that plaintiff's previously-deferred motions in limine are resolved as follows: a. Plaintiff's previously-deferr ed Motion in Limine No. 10 [Doc. No. 160] concerning causality assessments in the HERS study is DENIED. b. Plaintiff's previously-deferred Motion in Limine No. 11 [Doc. No. 122], concerning the number of women who use and b enefit from hormone therapy is GRANTED, in light of the granting of defendant's Motion in Limine #4 supra, which excluded reference to "excess breast cancers" caused by Prempro. c. Plaintiff's previously-deferred Motion in Limine No. 12 [Doc. No. 140] is DENIED as moot. (See order for details) Signed by District Judge T. S. Ellis, III on 11/12/2010. (nmcc)

Torkie-Tork v. Wyeth

Doc. 319

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF VIRGINIA
Alexandria Division

GEORGIA TORKIE-TORK,
Plaintiff,
v.

No. l:04cv94S

WYETH,
Defendant. ORDER

'Hie matter is before the Court on the parties' motions in limine.
For good cause,

It is hereby ORDERED that defendant's motions in limine are resolved as follows; a. Defendant's Motion in Limine No. I (Doc. No. 124) concerning "marketing and promotional material1" is DEFERRED. The category of marketing and promotional material is too broad and vague, and it is appropriate to consider this objection in the context of specific evidentiary submissions and deposition designations. b. Defendant's Motion in Limine No. 2 (Doc. No. 139) concerning the

relationship between Premarin and endometrial cancer is GRANTED IN
PART and DENIED IN PART. The motion is denied insofar as the

relationship between Premarin and endometrial cancer is probative (i) as background for the development of E+P therapy, and (ii) as evidence of causation by promotion of cancer. Evidence and argument on these
matters will be allowed, but because extensive testimony and evidence

Dockets.Justia.com

concerning Premarin and endometrial cancer is unnecessary and may lead

to jury confusion, it is appropriate to allow defendant to renew this

objection should circumstances warrant. The motion is granted insofar as the connection between endometrial cancer and Premarin may not be used
to suggest notice to Wyeth of cancer risks associated with Prempro, because the two drugs and the two corresponding forms of cancer are

distinct. Allowing such argument would lead to substantial jury confusion
and is therefore barred by Rule 403, Fed. R. Evid.
c. Defendant's Motion in Limine No. 3 (Doc. No. 127) regarding causality
assessments is GRANTED IN PART and DENIED IN PART. The

motion is denied insofar as causality assessments are probative of
defendant's level of knowledge as to the risks of breast cancer for those taking Prempro inasmuch as defendant might have considered such information when deciding whether to conduct additional, more thorough tests of Prempro's risks. As a general matter, such evidence is relevant and its probative value is not substantially outweighed by its prejudicial effect under Rule 403, Fed. R. Evid. At trial, defendant may renew this objection as to specific pieces of evidence, should circumstances warrant.

The motion is granted insofar as plaintiff may not argue that Wyeth's
causality assessments are similar to or otherwise demonstrate support for
the causation analysis offered by plaintiffs experts. Wyeth's causality

assessments are not admissible to demonstrate the existence of a process for determining general or specific causation because Wyeth's causality

assessments are required by the FDA and do not meet the reliability or

sufficiency prongs of Rule 702, Fed. R. Evid., and Daubert v. Merrell
Dow Pharmaceuticals, 509 U.S. 579 (1993). Plaintiffs own causation

theories, on the other hand, must pass muster under both Rule 702 and
Daubert.

d.

Defendant's Motion in Limine No. 4 (Doc. No. 131) concerning "excess
breast cancers" allegedly caused by Prempro is GRANTED. The

probative value of such evidence is substantially outweighed by its
prejudicial effect. See Rule 403, Fed. R. Evid.

e.

Defendant's Motion in Limine No. 5 (Doc. No. 133) concerning changes
in the Prempro label after the Women's Health Initiative ("WHI") study is DENIED. Evidence of changes in the Prempro label after the WHI study
is probative and not unfairly prejudicial in light of defendant's intention to argue that the continued approval and prescription of Prempro supports a
conclusion that the drug is, and was at the time plaintiff took the drug, reasonably safe.

f.

Defendant's Motion in Limine No. 6 (Doc. No. 135) concerning the use of
IMS data is DENIED as moot, given the parties' stipulation (Doc. No. 213) that plaintiff will not present evidence or argument relating to the IMS data for plaintiffs prescribing physicians.

g.

Defendant's Motion in Limine No. 7 (Doc. No. 137) concerning the

defendant's "ghostwriting" Prempro articles is DENIED. Such evidence
is probative of (i) defendant's failure to warn the medical community of

the risks of taking Prempro; (ii) defendant's disregard for such risks, as

that disregard may bear on the appropriateness of punitive damages; and
(iii) the information relied upon by plaintiffs doctors when prescribing Prempro. This testimony is relevant to the extent Wyeth relies on ghostwritten studies in arguing that its warnings were adequate in light of

then-existing scientific understanding of Prempro's breast cancer risks, or
alternatively, the material is relevant to the extent plaintiffs doctors relied

on ghostwritten materials in deciding whether to prescribe Prempro to
plaintiff.

h.

Defendant's Motion in Limine No. 8 (Doc. No. 142) concerning the profit
margin on Prempro is DENIED. Evidence of the profit margin on

Prempro is probative of (i) defendant's motive to conceal the risks of the

drug, and (ii) defendant's ability to fund additional studies of such risks.
It should be noted that defendant has stipulated it had sufficient funds to conduct a study on the scale of the WHI study, and in light of this

stipulation, extensive evidence and testimony concerning the profit margin
on Prempro may not be necessary. Accordingly, defendant is granted leave

to object to such evidence as cumulative should circumstances warrant.

i.

Defendant's Motion in Limine No. 9 (Doc. No. 147) concerning reference
to Pfizer is GRANTED. Plaintiff may not reference in trial (i) Pfizer,
Inc.'s acquisition of Wyeth, (ii) Pfizer's products, or (iii) purported

conduct of Pfizer insofar as the conduct is not attributable directly to
Wyeth. Pfizer had no role in the manufacturing of Prempro, and its

acquisition of Wyeth was structured so as to prevent Pfizer from acquiring

the assets and liabilities of Wyeth. Based on this structure, therefore,
while Wyeth's profits may be relevant to punitive damages, Pfizer's
profits are not. Plaintiff has also argued that witnesses' relationship with

Pfizer may relate to bias; such evidence has minimal probative value that

is substantially outweighed by the danger of unfair prejudice in the form of jury confusion. Accordingly, any reference to Pfizer is barred by Rules
401 and 403, Fed. R. Evid.

j.

Defendant's Motion in Limine No. 10 (Doc. No. 150) concerning reference to the absence of defendant's corporate representative at trial is
GRANTED IN PART and DENIED IN PART, insofar as plaintiff may
not comment the presence or absence of defendant's corporate

representative unless the corporate representative is absent for the entirety

of the trial. Mention of the corporate representative's presence has
virtually no probative value, and in any event, to the extent such an

observation has any probative value, that value is substantially outweighed by the danger of unfair prejudice. See Rule 403, Fed. R. Evid. Only if

defendant's corporate representative is absent for the entirety of the trial
may the unfair prejudice be sufficiently minimized to render it appropriate
for plaintiff to comment on such absence.

k.

Defendant's Motion in Limine No. 11 (Doc. No. 152) concerning Wyeth's
net worth, profits, employee salaries, and other financial information is

GRANTED IN PART and DENIED IN PART, insofar as plaintiff may

introduce evidence concerning defendant's net worth and profits, but

plaintiff may not introduce evidence of defendant's budget allocation or compensation for plaintiffs employees. Evidence of net worth and profits

may be probative on the question of punitive damages, and its probative value is not substantially outweighed by the danger of unfair prejudice under Rule 403, Fed. R. Evid. On the other hand, evidence concerning

defendant's budget allocation and individual employees' compensation,
while minimally probative, must be excluded because its probative value
is substantially outweighed by the danger of unfair prejudice. Id. 1. Defendant's Motion in Limine No. 12 (Doc. No. 154) concerning defendant's alleged failure to test Prempro is DENIED. Evidence that defendant failed to test Prempro is relevant to plaintiffs failure to warn
claim inasmuch as the failure to test may, under certain circumstances,

reflect a negligent or reckless disregard for whether the risks of Prempro
were properly understood and thus properly conveyed to the public.

It is further ORDERED that plaintiffs previously-deferred motions in limine are
resolved as follows:

a.

Plaintiffs previously-deferred Motion in Limine No. 10 (Doc. No. 160)
concerning causality assessments in the HERS study is DENIED. Defendant seeks to reference causality assessments from the HERS trial as an illustration of the flaws in causality assessments generally. Given that defendant's motion in limine #3 to exclude all causality assessments was

denied in part, supra, such that evidence of causality assessments will be

admitted for the limited purpose of establishing so-called "red flags" for
potential Prempro dangers, it is appropriate to allow defendant to discuss

causality assessments from the HERS study as well. This evidence is
probative insofar as defendant seeks to limit the weight that the jury

should give evidence from causality assessments in general. b. Plaintiffs previously-deferred Motion in Limine No. 11 (Doc. No. 122),
concerning the number of women who use and benefit from hormone
therapy, is GRANTED, in light of the granting of defendant's Motion in Limine #4 supra, which excluded reference to "excess breast cancers" caused by Prempro. The probative value of such evidence is substantially outweighed by its prejudicial effect. See Rule 403, Fed. R. Evid.
c. Plaintiffs previously-deferred Motion in Limine No. 12 (Doc. No. 140) is
DENIED as moot, given the motion is contingent on the granting of

defendant's Motion in Limine No. 5, which was denied supra.

The Clerk is directed to send a copy of this Order to all counsel of record.

Alexandria, Virginia
November 15, 2010

T. S. Ellis, III

United States District Judge