On July 28, 2016, Judge Cathy Seibel of the Southern District of New York granted summary judgment in favor of Bayer Healthcare Pharmaceuticals, Inc., thereby dismissing lawsuits pending against Bayer in a multidistrict litigation (MDL) proceeding alleging that Mirena, the company’s intrauterine device (IUD), perforated, embedded in or migrated from the plaintiffs’ uteruses. In re Mirena IUD Prods. Liab. Litig., 2016 U.S. Dist. LEXIS 99221 (S.D.N.Y. July 28, 2016). Judge Cathy Seibel deemed fatal the plaintiffs’ failure to provide admissible expert testimony in establishing the “general causation” element of their various products liability claims, concluding that a lay juror could not reasonably accept that the IUD caused the alleged injury without the aid of an expert’s explanation. The judge also rejected an argument by the plaintiffs that Bayer’s own admissions could supplant expert testimony.
Bayer acknowledged that the procedure to insert the IUD can result in perforation (or a tear) in the uterine wall, but the plaintiffs’ consolidated complaints focused on “secondary perforation,” which they allege occurs when the IUD spontaneously migrates through the uterus after, rather than during, insertion. Bayer’s negligence in designing and implementing Mirena, the plaintiffs insist, subjected them to the health hazards wrought by secondary perforation. Bayer disputes that Mirena causes secondary perforation, touting widespread doubt in the scientific community regarding whether the phenomenon can even occur.
In an earlier ruling, the court excluded all of plaintiffs’ experts who opined on general causation, discerning that nearly every Daubert factor weighed against their admission. See In re Mirena IUD Prods. Liab. Litig., 2016 U.S. Dist. LEXIS 29752, at **58–155 (S.D.N.Y. Mar. 8, 2016). Without the benefit of expert testimony on causation plaintiffs had to argue that a lay juror would not require an expert’s explanation to understand how the presence of an IUD can result in secondary perforation. In other words, to avoid summary judgment, the plaintiffs had to convince Judge Seibel that the normal, uninformed person could accept a premise that had been questioned or outright rejected by most scientists in the field.
Unsurprisingly, Judge Seibel was not persuaded. Citing extensive precedent affirming the need for plaintiffs to provide expert testimony to help answer complex causation questions, she held that the absence of expert support doomed the Mirena plaintiffs. “That one’s bone might break if crushed in a car crash is within the ordinary experience of a lay person,” Seibel wrote. “That a medical device might spontaneously burrow into or burst through the wall of an anatomical cavity is not.”
The plaintiffs also contended that statements by Bayer or Bayer employees acknowledging the possibility of secondary perforation were admissible hearsay as statements against Bayer’s own interest under Federal Rule of Evidence 801(d)(2) and sufficed to prove general causation. Although Judge Seibel found that “no court has held that admissions can substitute for required expert testimony,” she refused to reject the possibility of a statement against interest supplanting an expert’s explanation in establishing causation. Still, the statements highlighted by the plaintiffs—including Bayer’s label warnings and employee statements suggesting that perforation could occur “after” insertion—were far too nebulous to afford the argument any credibility in this case. Resolving the statements’ ambiguity, Judge Seibel recognized, necessitated the expert testimony the plaintiffs could not provide.
Given how severely the facts were slanted against the plaintiffs in this case, the outcome merits a measured response. Still, by reinforcing the vital importance of expert testimony in a complex mass tort battle, it could encourage more defendants to resist the temptation to settle when confident that the science is on their side. That Judge Seibel cited cases from jurisdictions across the nation in support of her holding serves as a good reminder that judges prefer their jurors engaged in straightforward fact-finding rather than in solving complex causation questions.
Keywords: mass tort litigation, expert testimony, statements against interest, multidistrict litigation, Mirena, jurors