Drug & Device News

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.”