March 14, 2016 — U.S. District Judge Cathy Seibel has blocked testimony from four plaintiffs’ experts in lawsuits alleging that Bayer’s Mirena IUD causes uterine perforations.
In a nearly 150-page Opinion & Order (PDF), Judge Seibel blocked all testimony from Roger C. Young, John Jarrell, Susan Wray and Richard Strassberg. She denied a request to block testimony from seven of Bayer’s experts.
The experts were disqualified for a variety of reasons, but most notable was Dr. Young, who argued that Mirena is capable of perforating the uterus based on a speculative comparison between the female uterus and pig hearts.
He said he had “felt a lot of uteruses that had been taken out at the time of hysterectomy, and it feels remarkably like the pig hearts that my grandmother used to buy when I was a kid.” Dr. Young later corrected himself to say it was actually chicken hearts and he had no basis for comparing uterine tissue to pig hearts.
According to Law360, the decision is a major blow for plaintiffs, whose cases depend on expert testimony and scientific support for their claims. Bayer is accused of failing to warn that Mirena can perforate the uterus spontaneously. Instead, Bayer only warned about perforations during the insertion procedure.
Hundreds of women have experienced perforations months or even years after insertion. Because doctors were not aware of the risk, some women were misdiagnosed and left in chronic pain. The only way to remove Mirena after it has perforated the uterus and migrated into the abdomen is with surgery.
As of mid-February, about 1,255 lawsuits involving Mirena were pending under Judge Seibel in a Multi-District Litigation (MDL No. 2434) in New York. The first trials were expected to begin on April 25, but it seems likely that plaintiffs will ask for time to get new experts.