NEW YORK, Sept 30 (Reuters) - Endo International Plc said on Tuesday it had reached agreements to settle up to 20,000 legal claims from women who said they were harmed by transvaginal mesh devices, ending nearly all of the U.S. cases against it and its American Medical Systems unit.
Endo, which did not admit liability, said it would increase the amount of money it had set aside to cover vaginal mesh claims from $1.2 billion to approximately $1.6 billion in connection with the latest agreements, according to a regulatory filing from the company.
Previously, in April, Endo announced it reached agreements to settle up to approximately 21,700 additional mesh claims with separate plaintiffs’ law firms. Last year, it settled an undisclosed number of cases for $54.5 million.
Endo President and Chief Executive Officer Rajiv De Silva said in a statement that he was “pleased to resolve substantially all of the remaining U.S. vaginal mesh litigation claims facing our AMS business.”
Endo and its Minnesota-based AMS subsidiary are among several major medical-device manufacturers who have faced a wave of litigation in the last few years over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse. The women suing the companies have accused the companies of selling subpar devices that caused injuries such as chronic pain, incontinence, bleeding and infection.
Endo was the first major mesh defendant to reach a resolution largely ending the litigation against it. C.R. Bard Inc and Johnson & Johnson’s Ethicon Inc unit are facing tens of thousands of lawsuits over similar products, with several trials scheduled for the fall.
Many of those cases have been consolidated before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia, who is overseeing more than 60,000 mesh cases against seven manufacturers.
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.
The FDA announced earlier this year it is considering a proposal to tighten safety standards for mesh used to treat pelvic organ prolapse. (Reporting by Jessica Dye; Editing by Alexia Garamfalvi, Bernard Orr)
Our Standards: The Thomson Reuters Trust Principles.