(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
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
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
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
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
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