Okuda v. Wyeth, Case No. 1:04-cv-80 DN

• Decision Date: 24 July 2012
• Docket Number: Case No. 1:04-cv-80 DN
• Parties: TOSHIKO OKUDA, Plaintiff, v. WYETH, et al., Defendants.
• Court: U.S. District Court — District of Utah

TOSHIKO OKUDA, Plaintiff,

v.WYETH, et al., Defendants.

Case No. 1:04-cv-80 DN

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF UTAH, CENTRAL DIVISION

Dated July 24, 2012.

ORDER ON DEFDENDANTS'

MOTIONS IN LIMINE

District Judge David Nuffer

After careful review of the memoranda and other materials submitted by the parties, the Court rules on Defendants' motions in limine as follows:

IT IS HEREBY ORDERED that Defendants' motion in limine no. 1 (docket no. 178) to exclude argument regarding punitive damages is GRANTED. Under Utah Code Ann. §78B-8-203:

(1) Punitive damages may not be awarded if a drug causing the claimant's harm:

(a) received premarket approval or licensure by the Federal Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Section 301 et seq. or the Public Health Service Act, 42 U.S.C. Section 201 et seq. . . .

The requirements of this statute are disjunctive, so that subparagraph (1)(b), applicable to over-the-counter medications, is not applicable.¹ The statute makes no exception to its application based on the relative time of use and approval or based on off-label use or concurrent use with other approved drugs. The issue of preemption does not arise because Plaintiff has produced no evidence that Defendants withheld or misrepresented information Defendants were required to submit to the FDA. In light of this ruling, Plaintiff shall not characterize Defendants' actions asmalicious or reprehensible or argue (or imply) that the jury should punish Defendants by an award of damages.

IT IS FURTHER ORDERED that Defendants' motion in limine no. 2 (docket no. 233) to exclude evidence and argument regarding the number of women whose breast cancers were purportedly caused by hormone therapy is DENIED. This evidence is relevant to the issue of general causation, as well as the need for further testing, the adequacy of the warnings given, and the risk/benefit analysis. Weaknesses in the studies giving rise to these numbers may be established on cross-examination or by Defendants' experts.

IT IS FURTHER ORDERED that Defendants' motion in limine no. 3 (docket no. 235) to exclude marketing evidence on which neither Plaintiff nor her physicians relied is GRANTED. Plaintiff has thus far failed to present evidence that she or her physicians relied on specific marketing materials. They are not admissible as circumstantial evidence of the source of any belief of Plaintiff or her physicians in off-label benefits, because that connection is too speculative and the marketing evidence will confuse the jury and needlessly consume time.

IT IS FURTHER ORDERED that Defendants' motion in limine no. 4 (docket no. 237) to exclude evidence of medical articles purportedly "ghostwritten" by professional writers acting on Wyeth's behalf is GRANTED. Plaintiff has not produced sufficient evidence that she or her prescribing physicians relied on any ghostwritten article in taking or prescribing the HRT drugs at issue or that the information in the articles is false. The fact that Wyeth was engaging in a fairly common, but little known practice, with a pejorative name would distract the jury and needlessly consume time. Plaintiff relies on the articles to show that Defendants were actively engaged in a campaign to overemphasize the benefits and downplay the breast cancer risks.However, the overpromotion theory only comes into play if the warnings given were adequate and the prescribing physicians disregarded the warnings in reliance on the promotional materials.

IT IS FURTHER ORDERED that Defendants' motion in limine no. 5 (docket no. 239) to exclude causality assessments made by clinical investigators when medical study participants report an adverse medical event in the course of the study is GRANTED IN PART AND DENIED IN PART. The causality assessments are relevant to the issue of Defendants' knowledge of the association between their HRT drugs and breast cancer. To that extent, the motion is denied. However, the evidence is not admissible to rebut the contention by Defendants' experts that it is not scientifically possible to determine the cause of breast cancer with respect to a particular patient. Similarly, the evidence may not be used to argue that Wyeth's causality assessments are similar to, or otherwise demonstrate support for, the causation analysis offered by Plaintiff's experts. The causality assessments are clearly not a scientifically reliable means to determine the cause of cancer and will not be admitted for this purpose. For this same reason, the results of any such causality assessment will not be admitted. Accordingly, except as outlined above, the motion is granted.

IT IS FURTHER ORDERED that Defendants' motion in limine no. 6 (docket no. 241) to exclude warnings and labeling changes that post-date Plaintiff's use of hormone therapy medications is DENIED. These labels may be used to establish proximate cause on the issue of the adequacy of the warnings: that adequate study would have resulted in stronger warnings and such warnings would have changed the plaintiff's physicians' prescribing practices. Plaintiff intends to establish that her physicians would have and actually did alter their prescription practices in the face of these warnings. The new warnings and labels are not subsequent remedial measures under Fed. R. Evid. 407 because they were required by the FDA.

IT IS FURTHER ORDERED that Defendants' motion in limine no. 7 (docket no. 243) to exclude any evidence or testimony regarding testing that could have been done to further investigate the potential link between Defendants' hormone therapy ("HT") medications and breast cancer risk is DENIED. This order is consistent with the order entered July 6, 2012 (docket no. 231). Also consistent with that order, opinion evidence purporting to set or identify an objective standard for testing that Defendants should have performed will not be permitted. A curative instruction may be appropriate to clarify the lack of an objective standard for testing.

IT IS FURTHER ORDERED that Defendants' motion in limine no. 8 (docket no. 245) to exclude at trial evidence and argument regarding Defendants' sales representatives' who did not call on or influence Plaintiff's prescribers during the relevant time period, i.e., when Plaintiff was taking Defendants' estrogen and progestin (E+P) drugs, is GRANTED.

IT IS FURTHER ORDERED that Defendants' motion in limine no. 9 (docket no. 247) to exclude evidence of the relationship between Premarin and endometrial cancer is GRANTED IN PART AND DENIED IN PART. While it may be that, as Plaintiff claims, "[h]ormones cause hormone-receptor positive cancers by promoting the growth of existing hormone-dependent abnormalities into full-blown, clinical cancer,"² evidence of the relationship between Premarin and endometrial cancer has the potential for confusion and prejudice. The court is alerted to this issue, and shall ensure that Plaintiff limits presentation of and emphasis on such evidence. Plaintiff may not argue that because Premarin was linked to endometrial cancer, then E&P HT causes breast cancer, or that Defendants' response to the endometrial cancer issue in 1975 means they must have been aware of and hiding the breast cancer risk of E&P HT. Evidence of the 1975 conflict between the FDA and Wyeth over the marketing response to the Premarin-endometrial cancer link appears to violate Rule...