Federal judge weighing Essure lawsuits
Thousands of women around the country who claim harm from Essure sterilization coils hope a federal judge in Philadelphia will allow five lawsuits to proceed against manufacturer Bayer Healthcare despite the device's protected status.
Thousands of women around the country who claim harm from Essure sterilization coils hope a federal judge in Philadelphia will allow five lawsuits to proceed against manufacturer Bayer Healthcare despite the device's protected status.
But at a hearing on Monday, U.S. District Judge John R. Padova sounded unimpressed with some of the legal arguments submitted by lawyers for the five women. Padova directed lead attorney Marcus Susen of Fort Lauderdale, Fla., to resubmit part of the case with more specifics by Friday.
"In 23 years, I can't remember a case where I had to start by asking plaintiffs what the count [charge] is all about," Padova said.
The U.S. Food and Drug Administration is reevaluating the safety and effectiveness of Essure - tiny metal coils implanted in the fallopian tubes to scar them shut - in response to more than 5,000 adverse events reported since the device was approved in 2002. Complaints include organ perforation, pelvic pain, unintended pregnancies, and abnormal bleeding.
But the U.S. Supreme Court ruled in 2008 that under federal law, medical devices that receive premarket approval from the FDA are shielded from product liability litigation in state courts.
The five cases consolidated in U.S. District Court in Philadelphia began with a lawsuit filed in 2014 in Philadelphia Common Pleas Court by Heather Walsh of Bonita Springs, Fla. She said her coils migrated to her uterus, requiring hospitalizations and an eventual hysterectomy.
The consolidated litigation claims that Bayer invalidated Essure's premarket approval through negligence and deception. Among other things, the suit alleges that Bayer inadequately trained physicians, did not report known hazards to the FDA, and used misleading advertising.
Bayer, headquartered in Germany with offices in Pittsburgh and Whippany, N.J., has denied the allegations. The company says Essure is an important option for women who want a permanent form of birth control without conventional tubal ligation surgery.
Padova said he was "provisionally" rejecting one of the plaintiffs' legal arguments: that failure to comply with various federal requirements automatically invalidates a premarket approval. "We were unable to find any cases that support plaintiffs' theory of self-invalidation," he said.
He repeatedly asked how Bayer's alleged misdeeds were directly linked to the individual plaintiffs' injuries.
Susen responded that if the women had been told about the hazards, they never would have opted for Essure.
More than 23,000 women have joined a Facebook page called Essure Problems to demand that the device be taken off the market. In Congress, U.S. Rep. Mike Fitzpatrick, a Bucks County Republican, has introduced the "E-Free Act," which would require the FDA to revoke its premarket approval of Essure.
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