Drug & Device News

New York Appeals Court Upholds Dismissal of Mirena MDL

The U.S. Court of Appeals for the Second Circuit has upheld the summary judgment dismissal of the multidistrict lawsuit (MDL) against the maker of the intrauterine birth control device Mirena after finding that none of the experts proffered by the nearly 1,300 plaintiffs were reliable. Mirena MDL v. Bayer Healthcare Pharmaceuticals Inc., 2017 U.S. App. LEXIS 20875 (2nd Cir. 10/24/17).

Plaintiffs all claimed they were injured by the implantable intrauterine birth control device marketed by Bayer under the name Mirena. All parties agreed that it was possible for a user's uterus to be injured during the insertion of the device, but the plaintiffs claimed that their injuries did not occur at insertion but later on, because the device migrated and perforated their uteri.

The plaintiffs presented three expert witnesses to back up their claims that the device migrated after insertion, but the U.S. District Court for the Southern District of New York found all three unreliable. Specifically, District Court Judge Cathy Siebel found that none of the experts had done any research on the question of Mirena device migration prior to being hired by the plaintiffs, and all assumed that the women's explanation of the cause of their injuries was valid. According to Judge Siebel, the plaintiffs' experts accepted this explanation, then “worked backwards to hypothesize a mechanism by which it might occur.”

The Second Circuit panel, made up of Judges John Walker Jr., Jose Cabranes and Reena Raggi, affirmed after finding that the expert testimony offered did not meet the test for admissibility found in Daubert v. Merrell Dow Pharmaceuticals. One of the criteria in Daubert — that the expert's theory is one that had been accepted by the relevant scientific community — seemed particularly troubling to the appeals court, as it was shown that the obstetrics and gynecological community has not accepted that the “secondary perforation” the plaintiffs claimed is something that actually occurs. On this point, the court concluded that “[n]ot only do the experts fail to identify any authorities that directly support the existence of secondary perforation, but what scientific authority there is casts doubt on the phenomenon's existence.”