Mirena MDL v. Bayer HealthCare Pharmaceuticals Inc.
Docket: 16-2890-cv(L); 16-3012-cv(CON)
Court: Court of Appeals for the Second Circuit; October 24, 2017; Federal Appellate Court
Plaintiffs-appellants, women injured by the IUD Mirena, appeal the District Court's July 29, 2016 judgment, which followed the exclusion of their expert witnesses on general causation in a March 8, 2016 order and the granting of summary judgment to Bayer Pharmaceuticals on July 28, 2016, concluding the multi-district litigation (MDL). The plaintiffs, who alleged various claims against Bayer, including negligence and failure to warn, argue that the court improperly excluded their evidence regarding secondary perforation, which occurs post-insertion. The core issue of the appeal is whether Mirena can cause injuries through secondary perforation, a fact Bayer did not warn about. The plaintiffs presented three types of evidence to establish general causation: statements from Bayer employees indicating potential for secondary perforation, a 2014 label change for Mirena, and expert testimony. The District Court, however, ruled the expert testimony unreliable and not helpful, noting that it was based on the disputed assumption of secondary perforation and failed to meet Daubert standards. Bayer subsequently moved for summary judgment, asserting that without expert witnesses, the plaintiffs could not establish causation. The District Court agreed, emphasizing the necessity of expert testimony in such complex medical cases, and granted summary judgment to Bayer, effectively ending the MDL.
The District Court ruled that the admissions made by the parties were too ambiguous to replace expert testimony, leading to a judgment entered on July 29, 2016, which is now under appeal. The standard of review for the admission or exclusion of expert testimony is highly deferential, adhering to an "abuse of discretion" standard. The appellate court will only reverse a district court's decision if there is a manifest error, applicable to both reliability determinations and ultimate conclusions.
The appellate court reviews summary judgment de novo, favoring the losing party in interpreting evidence and resolving ambiguities. Summary judgment is affirmed only when no genuine dispute exists regarding any material fact, entitling the movant to judgment as a matter of law.
The District Court's decision to exclude three Plaintiffs' expert witnesses on general causation—Dr. Young, Dr. Jarrell, and Dr. Wray—was upheld. Under the Daubert standard, which outlines factors for evaluating expert testimony, the court identified key issues with the Plaintiffs’ experts:
1. The theories presented were not widely accepted in the obstetrics and gynecology community, and the available scientific authority questioned the existence of secondary perforation.
2. The experts lacked pre-litigation expertise on secondary perforation, developing their theories solely for this case. Dr. Young had no prior knowledge of Mirena or uterine perforation, Dr. Jarrell had no experience with IUDs or hormonal contraception, and Dr. Wray was unfamiliar with the concept of secondary perforation prior to this litigation.
The experts involved in the case lacked direct literature support for the concept of secondary perforation and based their hypotheses on an assumption of its existence, which was the central dispute. Plaintiffs likened this situation to the Kumho Tire case, where the mechanism of a tire blowout was questioned, but in this instance, the existence of secondary perforation itself is contested. Consequently, the experts failed to address the core question adequately. The District Court appropriately excluded the Plaintiffs’ expert testimony based on these grounds.
Following this, the District Court granted summary judgment in favor of Defendant Bayer. It established that state law dictates the necessary evidence for proving general causation in medical malpractice claims, which typically requires expert testimony when the causal relationship is beyond lay knowledge. The court found that all states generally require expert evidence for causation, a conclusion supported by various legal precedents. Plaintiffs argued that party admissions could sometimes replace expert testimony but failed to demonstrate that any such admissions were sufficient for establishing general causation. Specifically, they presented excerpts from Bayer employee emails that purported to admit the possibility of secondary perforation; however, these emails merely reported adverse event occurrences without endorsement and were deemed anecdotal and of limited evidential value. Thus, the District Court concluded that no reasonable juror could find general causation based on the Plaintiffs’ evidence.
Plaintiffs argued that a sentence from a 2008 Bayer PowerPoint presentation indicated general causation for secondary perforation, stating that "Migration into the abdomen (spontaneous perforation unrelated to insertion) can occur." However, the court noted the lack of context for the presentation and found that the statement did not provide sufficient evidence for the jury regarding the causes of secondary perforation, thus requiring expert testimony. Additionally, Dr. Costales, Bayer's Global Medical Expert, testified in 2013 that while a perforation could occur unrelated to insertion, this acknowledgment did not demonstrate that causation was more likely than not. The Plaintiffs also cited a 2014 label change for Mirena, which stated that perforation could occur most often during insertion but might not be detected until later. The court characterized this label's wording as ambiguous and not a valid substitute for expert testimony. Ultimately, the District Court's decision to grant summary judgment in favor of the Defendant was affirmed, with the court finding the Plaintiffs' arguments unmeritorious.
