Endo’s American Medical Systems Inc. unit reported that it’s settling about 20,000 law suit product liability injury claims over the medical devices, which include the Perigee, Apogee and Elevate implants. Endo, a medical device company based in Ireland, is still exposed to at least 5,000 injury claims against AMS, including some that have been consolidated for pretrial proceedings in West Virginia.
FDA Strict Safety Requirements for Mesh
The settlement announcement comes hot on the heels of the U.S. Food and Drug Administration announcement that vaginal-mesh inserts should be subject to stricter safety requirements since they are high-risk devices. Endo said it has insurance that may cover all or part of the costs of resolving the implant cases. Last year, Endo agreed to pay more than $54 million to resolve an unidentified number of vaginal-mesh suits.
The FDA had ordered Endo, Johnson & Johnson, C.R. Bard Inc. and 31 other vaginal-implant companies to study rates of organ damage and complications linked to the implants after manufacturers were sued over the devices.
Doctors inserted more than 70,000 mesh devices in the U.S. in 2010 alone, to strengthen pelvic muscles that failed to support internal organs or to treat incontinence. JNJ halted of its lines of vaginal implant devices last year after facing a barrage of law suits.
Details: $40,000 Settlement Case Average
Endo’s settlement, offers women who claim that they were injured by the implants an average of $40,000 per case based on the $800 million settlement. The settlement allows women to seek more for their damages if the devices caused devastating injuries and forced them to undergo multiple surgeries to have the mesh removed.
Mesh Manufacturers Under Pressure to Settle
Endo still faces vaginal-mesh suits consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia. Bard, Boston Scientific Corp. and Coloplast A/S also are involved in settlement talks.
Coloplast announced in March, that it would pay about $16 million to settle 400 injury claims that its mesh inserts damaged women. Women in those Coloplast cases also are receiving an average of $40,000 each.
Other vaginal-mesh manufacturers may settle after the FDA’s announcement that regulators are tightening safety standards for the devices. If the inserts are designated high-risk devices, manufacturers would be forced to conduct studies showing their products are safe and effective.
Now manufacturers get approval based on comparing their mesh to similar products that are already on the market rather than study results. This is the so called 510(k) approval method, an extremely controversial FDA approval process. According to some experts, this approval process has led to this debacle involving mesh injuries, damages in metal on metal hips and other complex medical devices. This is because the process allows for a short cut which the manufacturers exploited in their rush to garner market share in their production of “me too” devices.
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).