Endo Health Solutions Inc. said it will pay about $830 million to resolve most lawsuits alleging its vaginal-mesh implants eroded in some women and left them incontinent and in pain.
Endo’s American Medical Systems Inc. unit said in a statement that it’s settling about 20,000 suits over the devices, which include the Perigee, Apogee and Elevate implants. Dublin-based Endo still faces at least 5,000 claims against AMS, including some that have been consolidated for pretrial proceedings in West Virginia, according to court records.
The settlement comes a day after the U.S. Food and Drug Administration said vaginal-mesh inserts should be subject to stricter safety requirements since they amount to high-risk devices. Thousands of women contend the implants cause organ damage and make sex painful.
Endo said in securities filings in February that it was reserving $520 million to deal with vaginal-mesh litigation. The company also has said it has insurance that may cover all or part of the costs of resolving the implant cases. Last year, Endo agreed to pay more than $54 million to resolve an unidentified number of vaginal-mesh suits.
“The settlements, once final, will resolve a substantial majority of the AMS vaginal mesh-related claims,” Endo officials said in Wednesday’s statement.
The FDA had previously ordered Endo, Johnson & Johnson, C.R. Bard Inc. and 31 other vaginal-implant makers to study rates of organ damage and complications linked to the implants after manufacturers faced a wave of suits over the devices.
Doctors inserted more than 70,000 mesh devices in the U.S. in 2010 alone, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs or to treat incontinence, according to court filings.
JNJ pulled four of its lines of vaginal implants off the worldwide market last year in the face of rising numbers of suits.
Under Endo’s settlement, women who contend they were injured by the implants will receive an average of $40,000 per case based on the $800 million settlement.
The settlement is designed to allow women to seek more for their claims if the devices caused severe injuries and forced them to undergo multiple surgeries to have the inserts removed, said Joseph Rice, a South Carolina-based plaintiffs’ attorney who helped negotiate the deal.
Endo still faces vaginal-mesh suits consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia, who is overseeing information exchanges and trials.
The consolidated AMS cases are In re American Medical Systems Inc. Pelvic Repair Systems Products Liability Litigation, 12-md-02325, U.S. District Court, Southern District of West Virginia (Charleston).
Other insert makers, including Bard, Boston Scientific Corp. and Coloplast A/S also are engaging in settlement talks, people familiar with the discussions said in September.
Denmark-based Coloplast agreed in March to pay about $16 million to resolve 400 claims that its inserts harmed women, people familiar with the settlement said. Women in those cases also are receiving an average of $40,000 each, they said.
Vaginal-mesh makers may have more incentive to settle after the FDA’s announcement that regulators are considering tightening safety standards for the devices.
If the inserts are designated high-risk devices, manufacturers would be forced to conduct studies showing their products are safe and effective. Currently, manufacturers get approval based on comparing their mesh to similar products that are already on the market rather than study results.