March 14, 2016 — A federal judge overseeing more than 1,250 lawsuits involving Mirena has blocked all testimony from four plaintiffs’ experts, dealing a major blow to women with uterine perforations.
In a 141-page Opinion & Order (PDF) issued on March 9, U.S. District Judge Cathy Seibel allowed testimony from all seven of Bayer’s experts, but blocked testimony from four plaintiffs’ experts — Roger C. Young, John Jarrell, Susan Wray and Richard Strassberg.
One notable disqualification was Dr. Young, who unsuccessfully argued that Mirena can cause uterine perforations based on a speculative comparison between the human uterus and pig hearts.
Judge Seibel said Dr. Young had no basis for comparing uterine tissue to pig hearts, except that 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.” He later corrected himself to say it was actually chicken hearts.
According to Law360, the decisions is bad for plaintiffs because their claims rely on scientific evidence and expert testimony. With the first “bellwether” trial set for April 25, plaintiffs may ask for a delay so they can find new experts. The cases are currently centralized in a federal Multi-District Litigation (MDL No. 2434) in New York.
Bayer is accused of failing to warn that Mirena can perforate the uterus spontaneously. The label only warns about perforations during insertion, despite hundreds of women who were injured months or even years after the insertion procedure.
The problem with a lack of warnings is that doctors may be unaware of the risk. Some women were misdiagnosed and left in chronic pain for months before undergoing additional medical procedures. In many cases, surgery is necessary to remove Mirena after it migrates into the abdomen.