Court Dismisses 1,225 Cases in IUD Multidistrict Litigation

U.S. District Court, Southern District of New York

A New York federal court granted summary judgment to Shook clients Bayer HealthCare Pharmaceuticals Inc., Bayer Pharma AG and Bayer Oy, dismissing 1,225 cases and ending multidistrict litigation alleging injuries from the use of Bayer's intrauterine contraceptive system Mirena®.

The court first determined that the plaintiffs' proposed experts were unqualified to give expert testimony on whether the Mirena could cause injuries after insertion. Following that ruling, the plaintiffs argued that expert testimony was unneeded, basing their argument of causation on company employee statements; the court disagreed, finding the remaining medical questions too intricate for a jury and noting that allowing such an argument could discourage companies from conducting candid product-safety reviews.

"Because Mirena is a medical device and the theory of secondary perforation is a concept requiring a nuanced understanding of IUDs and uterine anatomy, the Court has no serious doubt that all jurisdictions would treat this issue as one requiring expert testimony to prove causation," the court held.

"In summary, no court has held that admissions can substitute for required expert testimony, and this Court will not be the first," the opinion states. "Such a ruling would disregard the purpose of the requirement for expert testimony, leaving jurors to speculate, and would chill free and frank discussion by manufacturers of drugs or devices." The court further noted that "even if such statements could ever suffice, they would have to be much less ambiguous than the ones Plaintiffs offer here."

Following the decision, two Law360 stories covered the ruling and the lack of reliable expert testimony. Law360 also later recognized the decision as one of the most significant product liability rulings of 2016.

In re Mirena IUD Prods. Liab. Litig., MDL No. 2434 (S.D.N.Y. 2016).