Endo International PLC announced last month that it has reached agreements to end “virtually all known” mesh product liability claims in the U.S. and that it expects to pay out $775 million to cover the costs of those as well as all known international claims. Dublin-based Endo, in a statement, said that under the agreements it is slated to end the known U.S. claims at “reasonable values” and will make installment payments starting in the fourth quarter of this year and continue making payments until the end of 2019. The company said it intends to set aside $775 million to cover about 22,000 mesh implant claims in the U.S., in addition to all known international mesh product liability claims and other mesh-related matters.
Endo said that it wasn’t aware of any claims that won’t be covered by the $775 million. However, the company says it can’t predict the number of any future claims or the resolution of any unresolved claims. Endo CEO Paul Campanelli, in a statement, said:
We believe it is a very important milestone for Endo to have reached agreements to resolve virtually all known U.S. mesh product liability claims. While it remains possible that additional claims will be filed, we believe today’s announcement will assist most mesh claimants to move forward with their lives and will permit Endo to move forward with an even greater focus on executing against our core strategic priorities.
In March 2016, Endo said it was winding down its Astora Women’s Health unit, formerly AMS Women’s Health, to reduce the potential for product liability claims related to future mesh implants. Endo’s subsidiary had been hit by suits alleging health complications allegedly caused by a number of vaginal mesh devices. In April 2014, Endo said that it had reached settlements with several of the remaining Plaintiffs suing American Medical Systems Inc. over allegedly harmful vaginal mesh products, resolving “substantially all” of the claims in the case without admitting any liability or fault. The 2014 settlement announcement came just five months after the company announced it would pay $830 million to settle “a substantial majority” of the lawsuits related to AMS’ vaginal mesh devices.
The day before, the U.S. Food and Drug Administration (FDA) issued two proposed orders that would reclassify surgical mesh for transvaginal repair of pelvic organ prolapse as a high-risk device and require manufacturers to apply for premarket approval with the agency. The two orders would address the health risks associated with the mesh, which is used to treat women whose internal structures become so weak or broken that their organs drop from their normal position and bulge into the vagina.
The surgical mesh is classified as a moderate-risk device, the agency said at the time of the orders. Other manufacturers, such as Ethicon Inc., have been sued over allegedly defective mesh implants, spanning seven multidistrict litigations (MDLs) encompassing thousands of suits.