Opinion ID: 1381810
Heading Depth: 1
Heading Rank: 3

Heading: Denial of Wyeth's and Upjohn's Motions for Judgment as a Matter of Law on Proximate Causation

Text: The district court denied Wyeth's and Upjohn's motion for judgment as a matter of law based on their claim that Scroggin did not prove that their failure to warn of the risk of breast cancer proximately caused her breast cancer. We review the denial of their motions de novo, viewing the evidence in the light most favorable to the prevailing party and making all reasonable inferences in favor of the jury's verdict. Boerner, 394 F.3d at 598. Judgment as a matter of law is only appropriate when no reasonable jury could have found for the nonmoving party. Mattis v. Carlon Elec. Prods., 295 F.3d 856, 860 (8th Cir.2002). Ordinarily proximate cause is a question of fact, except where the evidence is such that reasonable minds cannot differ. Ashley County, 552 F.3d at 667 (citing Wilson v. Evans, 284 Ark. 101, 679 S.W.2d 205, 206 (1984)). Wyeth and Upjohn argue that the evidence was not sufficient to show that an adequate warning would have prevented Scroggin's breast cancer. The parties disagree about who had the burden to show what effect an adequate warning would have had. Specifically, they argue about the application of the heeding presumption  the presumption that a person would have heeded an adequate warning if given  and whether it applies to pharmaceutical cases. Notably, neither party asked Dr. Kuperman if he would have prescribed the medication to Scroggin if there had been an adequate warning. Scroggin argues that the heeding presumption is a rebuttable presumption, shifting the burden to Wyeth and Upjohn to show that an adequate warning would not have prevented Scroggin's injuries. Although Arkansas law generally applies the heeding presumption in this manner, see Smith v. Rogers Group, Inc., 348 Ark. 241, 72 S.W.3d 450, 458 (2002), Arkansas has yet to consider the presumption in a pharmaceutical case. Wyeth argues that the presumption should only imply that the physician would have considered it, but that the burden remains on the plaintiff to show that an adequate warning would have altered the physician's decision to prescribe the product and the plaintiff's decision to take it. [15] The Tenth Circuit noted in a pharmaceutical case that [t]he vast majority of jurisdictions hold that where a warning is inadequate, the plaintiff is entitled to a rebuttable presumption that an adequate warning would have been heeded if one had been given. Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 855 (10th Cir. 2003). Given the current application of the heeding presumption in Arkansas and the majority view, we conclude that Arkansas likely would require Wyeth and Upjohn to rebut the presumption even in a case involving pharmaceutical products. Moreover, Wyeth and Upjohn rely on Eck v. Parke, Davis & Co., 256 F.3d 1013, 1019 (10th Cir.2001) (relying on Oklahoma law), which required the drug manufacturer defendants to rebut the presumption by showing that the additional information would not have changed the prescribing physician's course of treatment. Wyeth and Upjohn failed to establish that Dr. Kuperman would have prescribed the hormone replacement therapy despite an adequate warning. Although conflicting, the evidence on proximate causation was sufficient to allow the jury to find that a failure to warn was the proximate cause of Scroggin's injuries. Dr. Kuperman testified that he still prescribes estrogen plus progestin to menopausal women and that the initially reported results of the WHI study indicated a slight relationship. On the other hand, his prescription practices for these drugs have changed since the WHI study. Since 2002, Dr. Kuperman has written fewer prescriptions for hormone replacement therapy drugs. Moreover, he tries to keep the prescription duration to below five years, as the breast cancer risk increases with use. Dr. Naftalis testified that Scroggin would not have developed breast cancer if she had taken the therapy for five years rather than eleven. Accordingly, the jury could reasonably conclude that had Wyeth and Upjohn adequately warned of the breast cancer risk, Scroggin would have been among Dr. Kuperman's patients who do not take hormone replacement therapy drugs or among those who take them for a shorter period of time. Dr. Kuperman also testified that he would respect a patient's wishes and not prescribe hormone replacement therapy if she was concerned about the risk of breast cancer. Thus, the jury could have concluded that Scroggin would have chosen not to take the drugs if the warnings had been adequate. Although Wyeth and Upjohn focus on Scroggin's acknowledgment that she would have accepted a small risk and that she did not know that estrogen plus progestin use causes breast cancer, the jury was not so limited. The jury heard Scroggin explain her understanding of risk as anything that could possibly happen, even if highly unlikely, and how the equivocal language in the pre-WHI labels reassured her that the risk was small. The current labels do not simply identify the 1.24 relative risk reported from the WHI study, but also include a boxed warning, with straightforward language, and devote substantial attention to the risk of breast cancer. Scroggin testified that she would not have taken hormone replacement therapy if she had known of the risk as it was currently understood.
Scroggin's argument during the punitive damages phase of the trial was two fold: (1) Wyeth and Upjohn were aware that estrogen plus progestin could cause breast cancer but had consciously disregarded the risk, and (2) Wyeth downplayed the risk, campaigning against its acceptance within the scientific community, the FDA, and the general population. In support of her argument, Scroggin presented Dr. Parisian as an expert witness on FDA regulations and Wyeth's and Upjohn's lack of compliance therewith. The district court ordered Dr. Parisian to base her opinion on her observations over the years and her understanding of the regulations referenced in her expert report, her deposition, and the supplemental briefs. During Dr. Parisian's testimony, the district court expressed frustration that she was not linking her testimony to FDA regulations. Because Dr. Parisian's testimony consisted mostly of her reading documents, and not expert analysis, the district court concluded that most of Dr. Parisian's punitive damages testimony should have been excluded. Thus, although it had denied Wyeth's and Upjohn's motions to strike during the trial, the district court granted their post-trial motions and struck much of Dr. Parisian's testimony and related exhibits. Without that evidence, the district court determined that Scroggin failed to present clear and convincing evidence warranting punitive damages and granted Wyeth's and Upjohn's motions for judgment as a matter of law. The district court ruled that if it had not granted those motions, it would have granted a new trial on punitive damages.
Scroggin argues that the district court erred in striking Dr. Parisian's testimony. We review a district court's decision to exclude expert testimony for an abuse of discretion. Larson, 414 F.3d at 940. Federal Rule of Evidence 702 permits expert testimony to assist the jury in understanding technical or scientific evidence. As an initial matter, we disagree with Scroggin's contention that Wyeth and Upjohn did not preserve their objection to Dr. Parisian's testimony. The district court stated that the defendants submitted motions to exclude, lodged numerous objections during the punitive damages stage, and requested, both orally and in writing, that Dr. Parisian's punitive damages testimony be stricken or excluded. That Wyeth and Upjohn did not object during Dr. Parisian's testimony until the court expressed its own concerns did not waive their objection, for as the court noted, their specific points had been made and were well-known to [the court] and [Scroggin's] counsel. Dr. Parisian's testimony began with a brief overview of some federal regulations, followed by discussion of specific exhibits, largely devoid of regulatory analysis. The record reflects that often Dr. Parisian simply read the contents of exhibits, thus undermining the asserted basis for expert testimony. At a sidebar conference during the testimony, the district court instructed Scroggin's counsel to relate the testimony to FDA guidelines; nevertheless, the testimony continued in the same manner. Accordingly, we cannot say that the district court abused its discretion in striking Dr. Parisian's testimony.
Scroggin asserts that even without the excluded testimony and related exhibits, the evidence was sufficient to support the jury's award of punitive damages. We review de novo a court's grant of judgment as a matter of law. Carter, 456 F.3d at 846. Judgment as a matter of law is only warranted where the evidence at trial is wholly insufficient to support a jury finding. Id. Arkansas law allows for punitive damages when a defendant knew or ought to have known ... that his or her conduct would naturally and probably result in injury or damage and that he or she continued the conduct with malice or in reckless disregard of the consequences from which malice may be inferred. Ark. Code. Ann. § 16-55-206. [M]alice is not necessarily personal hate; it is, rather, an intent and disposition to do a wrongful act greatly injurious to another. Yeakley v. Doss, 370 Ark. 122, 257 S.W.3d 895, 899 (2007) (citing Fegans v. Norris, 351 Ark. 200, 89 S.W.3d 919 (2002)). A claim for punitive damages is properly submitted to the jury under Arkansas law where the claim is supported by substantial evidence. Morris v. Union Pac. R.R., 373 F.3d 896, 903 (8th Cir.2004) (internal quotations omitted) (citing D'Arbonne Constr. Co. v. Foster, 354 Ark. 304, 123 S.W.3d 894, 898 (2003)).
We affirm the district court's grant of judgment as a matter of law to Upjohn. Most of the evidence presented during the punitive damages phase concerned Wyeth, and the evidence related to Upjohn focused on its efforts to market Provera as the other half of estrogen replacement therapy. These advertisements violated federal regulations, but there is no dispute that prescribing progestin along with estrogen had become the standard of care in hormone replacement therapy. Scroggin also contends that a jury could infer malice because Upjohn failed to conduct an in-house study of the breast cancer risk after the Degge Group found that further study was needed. Upjohn, however, did not conceal or restrict the dissemination of the information. It allowed the Degge Group to publish its findings, thus informing the scientific community of the current state of the science. On this record, then, there was not substantial evidence showing that Upjohn acted with such a conscious indifference to the consequences that malice may be inferred. D'Arbonne Constr. Co., 123 S.W.3d at 898.
We adopt the district court's alternative holding as to Wyeth and remand for a new trial on punitive damages. Scroggin presented sufficient evidence to submit the question of punitive damages to the jury, even without Dr. Parisian's testimony. Moreover, many of the stricken exhibits had been admitted prior to Dr. Parisian's testimony and without any requirement that they be presented in relation to Dr. Parisian's knowledge of FDA regulations. Accordingly, the jury could have considered those exhibits and drawn its own conclusions. In ruling on the post-verdict motions, the district court set forth a detailed analysis of the evidence, explaining that each piece failed to present clear and convincing evidence of reckless indifference. We conclude that this individualized treatment of the evidence may inadvertently have obscured the full scope of Wyeth's conduct that the evidence collectively portrayed. Although Wyeth's failure to organize one study to allow for adequate evaluation of the breast cancer risk, or its attempts to undermine the results of one adverse publication, may not reflect reckless disregard, a consistent pattern of such conduct might do so. A jury could find that although each study added to the evidence suggesting a risk of breast cancer, Wyeth nevertheless continued to engage in a practice of both inaction and mitigation. The district court noted that the evidence showed that Wyeth attempted to convey that there was no definitive link between estrogen plus progestin hormone replacement therapy and breast cancer. But Scroggin's claim also rested on the theory that Wyeth deliberately avoided studying hormone replacement therapy's effect on breast cancer. Moreover, a jury could reasonably construe Wyeth's documents as repeated efforts over many years to undermine information and studies that attempted to show a breast cancer link. A jury reasonably could find that these efforts allowed Wyeth to promote the false understanding that hormone replacement therapy was not linked to breast cancer and then to promote reliance on this understanding. Viewed as a whole, then, the evidence presented could allow a jury to find or infer that Wyeth was guilty of malicious conduct within the meaning of Arkansas law. There is also merit to Scroggin's assertion that the district court characterized certain evidence in Wyeth's favor. In entertaining a motion for judgment as a matter of law, the court must draw all reasonable inferences in favor of the nonmoving party, and it may not make credibility determinations or weigh the evidence. Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150, 120 S.Ct. 2097, 147 L.Ed.2d 105 (2000). The law requires the district court to disregard all evidence favorable to the moving party that the jury is not required to believe. Id. at 151, 120 S.Ct. 2097. The court, however, credited Justin Victoria's characterization of Wyeth's response to the 1976 Hoover study, thus ignoring Wyeth's efforts to refute and mitigate the results of the study. Likewise, the documents suggesting that Wyeth had a policy of refusing drug samples for breast cancer studies are not as clear as Wyeth would have the jury believe. These documents, and many of the stricken documents, were Wyeth's internal documents and thus not capable of being rebutted or characterized by Scroggin's witnesses. The jury could have concluded that the documents spoke for themselves and rejected Wyeth's self-interested explanation. Cf. Wilcox v. State Farm Mut. Auto. Ins. Co., 253 F.3d 1069, 1070-71 (8th Cir.2001) (noting that it would not be obvious error to credit employer's affidavit detailing employee's performance deficiencies when employee was given a clear opportunity to contradict the affidavit). For these reasons, we conclude that there was sufficient evidence upon which a jury could conclude that Wyeth acted with reckless disregard to the risk of injury, even without Dr. Parisian's testimony. The admission and the jury's consideration of Dr. Parisian's testimony, however, amounted to prejudicial error, and thus the appropriate remedy is a new trial. Because a new trial may be had on punitive damages alone without injustice to the parties, we adopt the district court's alternative judgment granting a new trial to Wyeth on the punitive damages claim. See England v. Gulf & W. Mfg. Co., 728 F.2d 1026, 1029 (8th Cir. 1984) (citing Gasoline Prods. Co. v. Champlin Ref. Co., 283 U.S. 494, 500, 51 S.Ct. 513, 75 L.Ed. 1188 (1931)). We have considered Wyeth's and Upjohn's assertion that a new trial on the liability phase is required due to district court errors and conclude that none of the alleged errors affected Wyeth's or Upjohn's substantial rights.