Endo International Plc agreed to pay more than $400 million to resolve lawsuits alleging its vaginal- mesh implants eroded in some women and left them in pain, people familiar with the settlement said.
Endo, which rose almost two percent today, said it settled “substantially all” the remaining U.S. suits against its American Medical Systems Holdings unit over the Perigee, Apogee and Elevate mesh implants, Chief Executive Officer Rajiv De Silva said yesterday in a statement. De Silva said the company was adding $400 million to its $1.2 billion liability reserve for the devices, designed to support pelvic muscles and treat incontinence.
The deal resolves more than 10,000 suits for an average of about $48,000 apiece, according to two people familiar with the settlement who didn’t want to be identified because they weren’t authorized to speak publicly about the accord.
Endo officials agreed this year to pay about $830 million to settle an additional 20,000 suits over the implants, which have been blamed for organ damage in women. That accord came a day after the U.S. Food and Drug Administration said vaginal- mesh inserts should be subject to stricter safety requirements because they are high-risk devices.
Blaine Davis, an spokesman for Dublin-based Endo, didn’t immediately return a call yesterday seeking comment on the value of the vaginal-mesh settlement.
“We believe these settlements will allow the AMS business to continue its return to growth and enhance focus on operations and profitability,” De Silva said in in the statement.
In Endo’s first set of vaginal mesh settlements, the company paid $54.4 million to resolve an undisclosed number of suits over the devices in June 2013. The company has now agreed to pay almost $1.3 billion to resolve suits over the implants.
The FDA 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 devices after manufacturers faced a wave of lawsuits.
Doctors inserted more than 70,000 mesh devices in the U.S. in 2010, 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.
J&J, the world’s biggest maker of health-care products, has pulled four lines of vaginal implants off the global market.
Endo still faces about 5,000 suits over the mesh implants, the people familiar with yesterday’s settlement said.
Some of those cases have been consolidated in Charleston, West Virginia, before U.S. District Judge Joseph Goodwin, who is overseeing information exchanges and trials.
Other insert makers, including Natick, Massachusetts-based Boston Scientific Corp., Bard, based in Murray Hill, New Jersey, and Coloplast A/S also were engaging in settlement talks, people familiar with the discussions said earlier this year.
Coloplast, based in Humlebaek, Denmark, agreed in March to pay about $16 million to resolve 400 claims that its inserts harmed women, people familiar with that settlement said. Women in those cases are receiving an average of $40,000 each, they said.
Endo hasn’t faced a trial over its devices. The company is scheduled for its first trial early next year in Texas state court on claims that it defectively designed the vaginal-mesh implants, according to court filings.
Last month, a Texas jury ordered Boston Scientific to pay $73 million in damages to a woman who argued her defectively designed implant left her in constant pain.
Endo rose $1.02 to $69.36 at 9:31 a.m. in Nasdaq trading. The stock fell 16 cents to $68.18 at 9:39 a.m.
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).