A federal judge this week ruled that five women who claim they were harmed by Essure sterilization coils can go ahead with their lawsuit against coil-maker Bayer Healthcare.
Bayer, which is facing a barrage of lawsuits across the country, had asked that the case be dismissed because the U.S. Food and Drug Administration in 2002 gave premarketing approval to Essure, a status that shields devices from product liability litigation in state courts.
While U.S. District Judge John R. Padova in Philadelphia rejected most of the women's claims against Bayer, he concluded that two were reasonable and should not be dismissed: that the company used misleading advertising and that it failed to warn about Essure's risks.
"He's allowing the two claims to proceed, so we're moving forward with discovery," said the plaintiffs' lead attorney, Marcus Susen of Fort Lauderdale, Fla., referring to the process of obtaining pretrial evidence.
In a statement, Bayer said it was pleased that Padova significantly narrowed the case. "Two prior courts considering similar claims dismissed those suits entirely," the statement said. "As FDA itself has stated recently, 'Essure remains an appropriate option for the majority of women seeking a permanent form of birth control.' Bayer stands by the positive benefit-risk profile of Essure."
Last month, the FDA responded to petitions to take Essure off the market by requiring a prominent "black box" label warning and better information for patients. The agency also directed Bayer to conduct a new study to assess complication and failure rates with the tiny metal coils, which are implanted in the fallopian tubes to scar the tubes shut and thus prevent pregnancy.
The procedure is advertised as a simple and less invasive alternative to tubal surgery, which involves cutting, burning, or clipping the fallopian tubes. The FDA has received more than 5,000 complaints of adverse events, including organ perforation, pelvic pain, unintended pregnancies, and abnormal bleeding. About 28,000 dissatisfied women have joined the Facebook group Essure Problems.
One of them, Amanda Rusmisell of Charlotte, N.C. - who had a hysterectomy to treat Essure side effects - praised Padova's ruling.
"I feel these cases will bring to light the issues we have found with Essure and the entire [regulatory] process," she said. "We have been failed by the medical industry and the FDA. We are working all avenues to make changes, including Congress."
In Congress, 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.
The five cases consolidated in U.S. District Court in Philadelphia are being closely watched nationally because they are the farthest along in the litigation process and could help other plaintiffs to shape legal strategies, said Fort Lauderdale lawyer Holly Ennis, who is representing about 200 Essure users across the country.
The consolidated cases 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 a hysterectomy.
While Padova dismissed 10 of the plaintiffs' 12 claims, he gave them the option of amending their legal arguments to try to restore five, including that Bayer's manufacturing and physician training were negligent.