Torkie-Tork v. Wyeth

Filing 372

MEMORANDUM OPINION. Signed by District Judge T. S. Ellis, III on 12/15/2010. (tche)

Torkie-Tork v. Wyeth

Doc. 372

IN T H E U N I T E D S T A T E S D I S T R I C T C O U R T FOR THE EASTERN DISTRICT OF VIRGINIA Alexandria Division

L DEC I 5 2010

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y

GEORGIA TORKIE-TORK, Plaintiff,
v.

)

C L E R K , U . S . DISTRICT COURT ALEXANDRIA. VIRGINIA

No. l:04cv94S

WYETH,
Defendant.

MEMORANDUM OPINION

In this removed diversity products liability matter, plaintiff claims defendant's
hormone therapy product, Prempro, caused or aggravated her breast cancer. Because

numerous suits of this nature were filed in many jurisdictions, the Judicial Panel on Multidistrict Litigation convened multidistrict litigation ("MDL") proceedings in the
E a s t e r n D i s t r i c t o f A r k a n s a s , a n d t h i s m a t t e r w a s t r a n s f e r r e d to t h a t d i s t r i c t f o r

participation in the MDL proceedings, including general discovery. See Torkie-Tork v. Wyeth, No. 1:04cv945 (E.D. Va. Nov. 1, 2004) (Conditional Transfer Order). At the
conclusion o f MDL proceedings, the matter was returned to this district for all further

proceedings, including case-specific discovery, summary judgment, and if necessary, a
trial. See Torkie-Tork v. Wyeth, MDL No. 1507 (E.D. Ark. Apr. 8,2010) (Conditional

Remand Order). After disposition of various summary judgment motions,1 two claims

1At the summary judgment stage, plaintiff conceded that under Virginia law, summary
judgment was appropriate for Wyeth on the claims for strict liability for failure to warn, strict liability for design defect, negligent misrepresentation, and breach of express
warranty. See Torkie-Tork v. Wyeth, No. 1;04cv945, -- F. Supp. 2d --, 2010 U.S. Dist. LEXIS 106819 (E.D. Va. Oct. 4, 2010) (Memorandum Opinion) CWyeth T). Wyeth also

sought, and was granted, summary judgment on plaintiffs fraud claims. See id. (granting
Wyeth summary judgment on the claim for fraudulent misrepresentation, but not for the claims of fraudulent concealment and negligent design defect); Torkie-Tork v. Wyeth, No. 1:04cv945, -- F. Supp. 2d --,2010 U.S. Dist. LEXIS 117592 (E.D. Va. Nov. 4, 2010)

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remained for trial: (i) the claim that Wyeth negligently failed to provide an adequate

warning of the breast cancer risks associated with Prempro, and (ii) the claim that Wyeth
negligently designed Prempro with respect to the risk o f breast cancer.
Among the myriad motions filed prior to trial was W y e t h ' s motion in limine to exclude any evidence concerning Wyeth?s "failfure] to t e s t . . . Prempro.*' Def. Mot. in Limine No. 12. This motion was denied; although plaintiff apparently was not asserting a

separate claim for negligent failure to conduct additional studies o f Prempro, it was
unclear prior to trial whether evidence relevant to this issue might also be relevant to
p l a i n t i f f ' s n e g l i g e n t failure to w a r n claim. Yet in the c o u r s e o f t h e trial, it b e c a m e

increasingly clear that plaintiffs counsel was eliciting testimony and presenting
documents for the purpose o f establishing and suggesting to the j u r y that Wyeth had

negligently failed to conduct studies o f Prempro, in addition to those required by the FDA, to assess more accurately any link between Prempro and breast cancer. Indeed, it
became clear at this point in the trial that plaintiff intended to argue to the j u r y that

Wyeth had a duty to conduct additional studies and that the failure to do so was part o f
the negligent failure to warn claim. For its part, Wyeth consistently argued that under

Virginia law, a manufacturer had no duty to conduct studies or tests in these
circumstances. Given the conflicting legal positions, the potential for jury confusion was

manifest. Accordingly, to avoid jury confusion, it became necessary to resolve the
question whether, under Virginia law, Wyeth has a duty to conduct additional tests or
studies. This question was briefed and argued, and a bench ruling issued making clear
that Virginia law, in the circumstances at bar, imposes no duty on a manufacturer to

(Memorandum Opinion) ("Wyeth //") (granting Wyeth summaryjudgment on the remaining portion of the fraud claim, namely fraudulent concealment).

conduct additional studies or tests o f its products. The jury was instructed accordingly, and this Memorandum Opinion elucidates this ruling.
I.

Plaintiff Georgia Torkie-Tork is a citizen o f Virginia, Defendant Wyeth is a

Delaware corporation with its principal place of business in New Jersey, During times
relevant to this litigation, Wyeth was one o f the world's largest pharmaceutical

companies3 and the maker of Prempro, a hormone replacement therapy drug approved by
the Food and Drug Administration ("FDA") for treatment of menopausal symptoms.
Prempro is a combination hormone therapy drug consisting primarily of the hormones
estrogen and progestin ("E+P").

Beginning in or about 1996, plaintiff began experiencing severe menopausal
symptoms. To address these symptoms, plaintiff obtained and filled prescriptions for

Prempro from three physicians at various times, although the evidence is in dispute as to
when she first began taking Prempro and the length of time for which she took it.

Although not pertinent to the question addressed here, it is worth briefly noting developments in the case since the issuance of the bench ruling addressed here. Following completion of plaintiffs case in chief, Wyeth was granted judgment as a matter of law on plaintiffs design defect claim pursuant to Rule 50(a), Fed. R. Civ. P. See Torkie-Tork v. Wyeth, No. 1:04cv945 (E.D. Va. Nov. 30,2010) (Order). A ruling on

Wyeth's motion for judgment as a matter of law on plaintiffs punitive damages claim
was initially deferred but ultimately granted at the conclusion of Wyeth's case in chief.

See Torkie-Tork v. Wyeth, No. 1:04cv945 (E.D. Va. Dec. 2, 2010) (Order). Additionally,
at the conclusion of Wyeth's case in chief, plaintiff won judgment as a matter of law on Wyeth's claim for contributory negligence. Id. Jury deliberations commenced on December 2, 2010, and the following day, the jury returned a unanimous verdict in favor of Wyeth, ruling that plaintiff had not proven, by the greater weight of the evidence, "that

the warnings Wyeth provided to her prescribing doctor(s) were inadequate." See TorkieTork v. Wyeth, No. I:04cv945 (E.D. Va, Dec. 3,2010) (Jury Verdict). Given this finding, the jury neither reached nor decided questions of proximate causation or damages.

3Pfizer Inc. purchased Wyeth at some point since the filing ofthis action.

Plaintiffclaimed she began taking the drug sometime in 1998, but the pharmacy records produced show prescriptions only as early as May 1999. In any event, the parties agree that she ceased using Prempro in June 2002. Thus, plaintiff contends she took Prempro continuously for four years, whereas Wyeth points out that pharmacy records show only

about two and a half years of use.4
Plaintiffcontends that three doctors prescribed her Prempro at various times. Only two of the asserted prescribing doctors testified at trial and neither specifically
recalled prescribing Prempro to plaintiff. One of these doctors, William Hurwitz,

employed plaintiffas a receptionist. During the pertinent period, Hurwitz specialized,

not in gynecology, but in pain management medicine.5 He also testified that it was his

general practice to read and to rely on the warning labels for any drug before prescribing
it to a patient, and that had he prescribed Prempro for plaintiff, which he does not

specifically remember doing, he would first have read Prempro's warning label.
Plaintiffs second testifying physician, Dr. Joel Schulman, is an internal medicine
practitioner specializing in pulmonary medicine. Schulman testified that he served as

plaintiffs internist and did not recall prescribing Prempro for plaintiff. Although he testified that it was possible he renewed an existing Prempro prescription for plaintiff, Schulman characterized that scenario as "highly unlikely," adding that it was his ''general rule . . . not to prescribe [Prempro] initially" because he preferred for patients to rely on

Plaintiff contends that many of her pharmacy records were destroyed in the ordinary course of business by the pharmacies and thus do not reflect her full prescription history. Hurwitz lost his license to practice medicine based on events that culminated in felony
convictions for unlawful distribution and dispensing of controlled substances, Tr,
1 1 / 1 8 / 1 0 P M , at 2 1 9 : 1 6 - 2 2 0 : 1 2 .

a gynecologist to determine whether hormone therapy is prudent in the patient's
particular circumstances. Tr. 11/18/10 AM, at 61:17-25,73:4-11. The warning label for Prempro contained several statements regarding breast cancer, including the following:
The majority o f s t u d i e s . . . have not shown [a breast cancer] association in women who have e v e r used estrogen replacement therapy. The effect o f added progestins on the risk o f breast cancer is unknown, although a moderately increased risk in taking combination estrogen/progestin therapy has been reported. Other studies have not shown this relationship.

See Wyeth /, 2010 U.S. Dist. LEXIS 106819 at *3-7 (discussing the Prempro label).6 The
parties' experts differed sharply on whether the Prempro warning label accurately and

adequately disclosed the breast cancer risks associated with taking Prempro.1
The use o f Prempro proved effective for the treatment of plaintiff s symptoms,
and she continued using the drug until June 2002, at which time an abnormality was

noted on her mammogram.8 At the direction of Dr. Ronald Orleans, plaintiffs
gynecologist, she immediately discontinued her use of Prempro, and a follow-up

6 In fact, at the time plaintiff was prescribed Prempro, the words "breast cancer" appeared
in the Prempro entry of the Physician's Desk Reference at least 16 times. Wyeth I, in resolving summary judgment on p l a i n t i f f s fraud claims, addressed the accuracy o f the Prempro warning label, concluding that no statement in the warning label was false in light o f the existing science. 2010 U.S. Dist, LEXIS 106819 at * 18-32. In particular, a statistical analysis o f the relevant universe o f scientific studies identified by both parties--with appropriate consideration o f the studies' confidence intervals-- confirmed that the Prempro label was not false in stating that the "majority o f studies . . . have not shown [a breast cancer] association" for ever-use o f estrogen replacement
therapy. Id a t * 19-25.
A 1999 c o m p r e s s i o n m a m m o g r a m revealed a s p o t in p l a i n t i f f s left breast in t h e e x a c t

place where, in 2002, cancer was detected. Although the spot was not determined to be cancerous in 1999, plaintiff was advised to have annual mammograms thereafter. She

did not thereafter undergo all annual mammograms prior to 2002, missing "one or two"
mammograms because she claimed it was difficult fitting them into her work schedule.
Tr. 1 1 / 2 3 / 1 0 P M , at 2 8 2 : 6 - 1 0 ; Tr. 1 1 / 2 4 / 1 0 , at 6 7 : 1 7 - 6 8 : 2 0 .

sonogram and needle biopsy were performed. Based on the results o f these procedures, plaintiff was diagnosed with hormone receptor positive breast cancer on June 18, 2002, Thereafter on June 2 7 , 2 0 0 2 , she underwent a partial mastectomy to remove the cancerous tissue. A pathology report signed on July 3, 2002 confirmed that the cancer

was hormone receptor positive, meaning that the cancer was o f a type that can be fueled

by hormones such as those contained in Prempro. A surgical procedure on July 24, 2002
confirmed that the June 27, 2002 mastectomy had removed all cancerous tissue. The
cancer has not recurred.

After plaintiffceased taking Prempro, the Women's Health Initiative ("WHI")

released results from a large-scale clinical trial of hormone therapy drugs indicating a

1.24 relative risk of breast cancer for those taking Prempro.9 After publication of the
WHI results, sales o f Prempro dropped dramatically. The trial record reflects that

Prempro continues to be sold, although with a new warning label. Wyeth's consistent
contention has been that prior to the WHI study's release, scientific studies had been

inconclusive regarding Prempro's breast cancer risk. At trial, plaintiff has contended that
instead o f allowing the b r e a s t c a n c e r association to remain inconclusive until the WHI

study was completed, Wyeth should have conducted further studies of Prempro on its own to ascertain the nature of the risk and to warn doctors accordingly.10

9A relative risk of 1.24 means that, in general, women who take combination hormone
therapy drugs like Prempro are 1.24 times as likely to be diagnosed with breast cancer as women who did not take such a drug. For example, if the general risk of breast cancer in

a population is, as plaintiffs expert witness testified, 30 out of 1,000--meaning that without anyone taking Prempro, one would expect 30 women out o f every 1,000 to develop breast cancer--then the introduction of Prempro would increase the risk to
approximately 37 out o f 1,000, Tr. 11 /23/10 PM, at 190:23-191:1.

It is worth noting that for purposes of winning FDA approval for Prempro, Wyeth conducted certain required studies. The FDA, in approving Prempro and its warning

II.

Analysis properly begins with the Supreme Court o f Virginia's clearly-expressed view that products liability actions may take one o f three forms. In this respect, the Supreme Court o f Virginia noted specifically in Morgen Industries, Inc. v. Vaughan, 252 Va, 60, 65 (1996), that a product may be " u n r e a s o n a b l y ] dangerous" for the purposes of

a products liability action " i f it is [i] defective in assembly or manufacture, [ii] unreasonably dangerous in design, or [iii] unaccompanied by adequate warnings
concerning its hazardous properties." Id. at 65. At least one court has concluded that

because there are only three recognized, independent bases for products liability actions
in Virginia, a separate failure to test claim cannot stand. See Sykes v. Bayer Pharms.
Corp., 548 F. Supp. 2d 208, 215 (E.D. Va. 2008) (denying a failure to test claim,

reasoning that because Virginia courts recognize only three types of products liability
claims, "|b]y implication, any other type of product-liability claim cannot succeed.").
But this point does not alone suffice to dispose o f the question whether under

Virginia law Wyeth had a duty to conduct additional studies of Prempro beyond those
required by the FDA such that its failure to do so amounted to a negligent failure to warn.
label in 1994, concluded that the drug was safe and effective for its intended use based on

then-existing scientific studies. The jury was properly instructed that this finding by the
FDA was not conclusive as to whether this warning was adequate. See Tr. 12/2/10, at 202:14-203:1; see also Wyeth v. Levine, -- U.S. --, 129 S. Ct. 1187,1204 (2009); Hill v.

SearleLabs, 884 F.2d 1064, 1068 (8th Cir. 1989)), Additionally, Wyeth also participated
in post-FDA-approval studies. Specifically, Wyeth (i) supported the Women's Health

Initiative by providing Prempro to all participants free o f charge, and (ii) provided financial support for the Nurses' Health Study, a long-term, ongoing questionnaire-based
study o f women's health that collected data on, among other associations, the link between hormone replacement therapy and breast cancer. Nevertheless, solely for the purpose of resolving the present issue, this Memorandum Opinion proceeds on the assumption that plaintiff could, if permitted, adduce evidence that Wyeth had the

resources to conduct further tests of Prempro to reveal the breast cancer risks with greater
precision.

This question is resolved by the Supreme Court's further teaching in Owens-Corning
Fibergtas Corp v. Watson, 243 Va. 128 (1992). There, the Supreme Court o f Virginia made unmistakably clear that a manufacturer's duty to warn o f a product's dangers

imposes no underlying duty to conduct additional studies or tests because a failure to
warn claim rests on a reason to know standard rather than the broader should have known

standard. Id. at 134-36. As Justice Hassell put it, speaking for a unanimous court,

"[t]here is a significant legal difference between the phrases reason to know and should
know"; the latter f o r m u l a t i o n m a y r e q u i r e a m a n u f a c t u r e r to c o n d u c t a d d i t i o n a l s t u d i e s

while the former does not. Id, at 135.

Justice Hassell went on to make unmistakably

clear that in a products liability action, including one for failure to warn, "the appropriate standard in Virginia is whether a manufacturer has a reason to know, not whether the manufacturer should know," o f a product's dangerous properties. Id. at 136 (citing
Featherall v. Firestone, 219 Va. 9 4 9 , 962 (1979)). In reaching t h i s result, the Supreme

Court o f Virginia struck a proper balance between the costs to manufacturers o f additional studies and tests--costs which are subsequently passed onto consumers, often in the form o f delays in releasing the product--and the benefits o f bringing the drug to market expeditiously based on existing knowledge o f the product's dangers.

1' The distinction between the two standards is clearly seen in other jurisdictions. For
example, California recognizes both a strict liability failure to warn claim and a negligent failure to warn claim, with the critical distinction being that the negligence claim focuses on "what a reasonably prudent manufacturer would have known and warned about," while the strict liability claim centers on w h a t dangers were " k n o w n or knowable" in light o f then-existing science. Cartin v. Superior Court, 920 P.2d 1347, 1351 (Cal, 1996), While California and Virginia apparently employ the same knowledge standard in a negligent failure to warn claim, Virginia recognizes no strict liability claim for failure to warn. See Harris v. T.I., Inc., 243 Va. 63, 71 (1992) (noting that strict liability is not recognized in Virginia).

Plaintiff seeks to avoid the plain meaning o f the Owens-Corning opinion by arguing that the c o u r t ' s pronouncements are mere dicta. This argument is unpersuasive. To be sure, the Owens-Corning teaching was issued in an odd procedural context. The

trial record in Owens-Corning indicated that the trial court instructed the jury to apply a
should ha ve known standard, and because neither party objected, the instruction b e c a m e

the "became the law o f [the] case." Id. at 136. Nonetheless, notwithstanding the
a f f i r m a n c e , the S u p r e m e C o u r t m a d e c l e a r t h a t t h e i n s t r u c t i o n was in e r r o r and that a
correct instruction should have been based on the reason to know standard. Nor was

Owens-Corning the first Supreme Court decision to reach this conclusion; in the Featherall case, the Supreme Court o f Virginia adopted the Restatement (Second) of
T o r t s § 388 ( 1 9 6 5 ) a n d its r e a s o n to k n o w s t a n d a r d . See F e a t h e r a l l , 2 1 9 Va. at 9 6 2 .

Moreoever, the Supreme Court has relied on Owens-Coming's discussion o f the reason
to know standard in various subsequent decisions. See, e.g., Jones v. Ford Motor Co.,

263 Va. 237, 253 (2002) (applying the reason to know standard in a negligent failure to
warn c a s e i n v o l v i n g u n i n t e n d e d a c c e l e r a t i o n in F o r d v e h i c l e s ) .
In s u m , t h e r e c a n b e n o s e r i o u s d o u b t t h a t t h e r e a s o n to k n o w s t a n d a r d , as

elucidated in the Owens-Coming opinion, applies here. Indeed, in the context o f pharmaceutical drugs, as here, imposition o f the reason to know standard is particularly sensible given the FDA already requires testing o f any drug as a qualification for

approval. Accordingly, evidence and testimony is not admissible for the purpose o f
establishing that Wyeth could have or should conducted additional tests o f Prempro, and counsel must not be permitted to advance arguments in this regard. The only dangers for which Wyeth had a duty to warn adequately are those dangers which Wyeth knew or had

reason to know existed based onthe science available at the time the product left Wyeth's
hands. Owens-Corning, 243 Va. at 134-36.; see also Morgan Indus., 252 Va. at 65

(discussing the elements of a failure to warn claim); see also n.7 supra.

The Clerk is directed to send a copy of this Memorandum Opinion to all counsel
ofrecord.

Alexandria, Virginia December 15,2010
T . S . E l l i s , HI

United States district Judge

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