(Adds background on litigation, FDA action)
By Jessica Dye
April 30 Endo International Plc said Wednesday it has agreed to pay $830 million to resolve legal claims from women who say they were injured by transvaginal mesh devices.
The company said in a statement that the agreement will cover what it called a substantial majority of the mesh litigation brought against its American Medical Systems subsidiary. Endo did not admit liability or fault.
Endo and its AMS unit are among several major medical-device manufacturers that have been hit with tens of thousands of lawsuits over the mesh devices, which are used to treat pelvic organ prolapse and stress urinary incontinence.
As of Feb. 20, Endo and AMS together faced approximately 22,000 lawsuits over the devices, according to Endo's most recent annual filing with the U.S. Securities and Exchange Commission. Endo agreed last year to pay $54.5 million to settle an undisclosed number of mesh cases.
Cases against other defendants, including C.R. Bard Inc and Johnson & Johnson's Ethicon unit, are pending.
Women implanted with the devices have alleged in lawsuits across the U.S. that they suffered pain during sex, bleeding and other complications.
The Endo agreement in principle is still subject to several conditions, including confirmation of medical records for plaintiffs, the company said. Endo said it had previously set aside $520 million to cover all legal claims arising from the mesh devices.
Endo said it will incur a pretax, noncash charge of $625 million in the first quarter to help cover the costs of the settlement, according to the statement.
A lawyer representing some of the plaintiffs, Joe Rice of Motley Rice, said the settlement would be implemented over the next year. In a statement, he called it a result of "adversarial but respectful and professional negotiation on the part of all the parties."
In 2008, the U.S. Food and Drug Administration notified transvaginal mesh manufacturers about reports of potential complications stemming from the devices. In 2012, the agency ordered AMS and other manufacturers to conduct post-market safety studies and monitor the rate at which adverse events were reported.
On Tuesday, the FDA said it was considering proposals to tighten safety standards for mesh used to treat pelvic organ prolapse. If finalized, the proposals would require manufacturers to submit data proving the devices' safety and effectiveness before allowing them onto the market.
(Reporting by Jessica Dye; Editing by Bernard Orr and Prudence Crowther)