Endo International announced yesterday that it would pay $830 million to resolve legal claims from women who say they were injured by the company’s transvaginal mesh implant devices.
According to Endo’s statement, the agreement covers most of the litigation brought against Endo subsidiary, American Medical Systems. Endo did not admit liability or fault, Reuters reports. Tens of thousands of lawsuits have been filed against medical device makers over the mesh implants used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI); Endo and American Medical face about 22,000 such lawsuits. In 2013 Endo agreed to pay $54.5 million to settle an undisclosed number of cases.
The new settlement comes one day after the U.S. Food and Drug Administration (FDA) announced its proposal to reclassify vaginal-mesh devices into Class III, the high-risk device category. This action is in response to thousands of reports from women who contend the implants cause injuries and complications including organ damage, infections, urinary problems, and painful intercourse. Last year, Endo agreed to pay more than $54 million to resolve an unidentified number of vaginal-mesh suits, according to Bloomberg Businessweek.
In 2012, the FDA ordered Endo, Johnson & Johnson, C.R. Bard and 31 other transvaginal mesh implant makers to study rates of organ damage and complications linked to the implants, according to Businessweek. If transvaginal mesh devices are reclassified as high-risk devices, manufacturers would be required to conduct studies showing their products are safe and effective. Under the current classification, manufacturers can seek expedited 510(k) approval if the device is substantially similar to one already on the market.
Businessweek calculates that under the settlement terms, women injured by the implants will receive an average of $40,000 per case. Endo still faces transvaginal-mesh suits in multidistrict litigations before U.S. District Judge Joseph Goodwin in Charleston, West Virginia.