Last Wednesday, Endo International PLC announced that it had agreed to pay $830 million to resolve legal claims from thousands of women who have filed transvaginal mesh (TVM) injury lawsuits.
The settlement agreement covers “a substantial majority” of the mesh litigation brought against Endo International subsidiary American Medical Systems, although neither company admitted fault or liability in agreeing to this settlement.
The Endo agreement is still not finalized, as it is awaiting confirmation of medical records for plaintiffs. Endo claims that it initially set aside $520 million to cover all legal claims arising from their mesh devices.
There are seven other large TVM manufacturers other than Endo International and American Medical Systems that have been dealing with extensive lawsuits over these devices, used to treat pelvic organ prolapse as well as stress urinary incontinence. These women allege that the TVM devices cause pain and bleeding.
Johnson & Johnson is the world-wide leader in prolapse mesh, and then AMS, Boston Scientific, and Bard, which recently settled the last of four bellwether cases.
By the end of February of this year, Endo and American Medical have defended a combined 22,000 lawsuits over transvaginal mesh litigation. Last year, Endo agreed to pay $54.5 million to settle an undisclosed number of transvaginal mesh cases.
Many women experience physical problems such as mesh erosion, pain and infection, scarring, pain during sexual intercourse, organ perforation, and urinary problems that require additional treatment and hospitalization.
Currently, Bard has 200 cases for bellwether trials set to being next year.
Last Tuesday, the U.S. Food and Drug Administration (FDA) said that it would consider proposals to tighten the safety standards in place for mesh used to treat pelvic organ prolapse. If finalized, it would force mesh manufacturers to submit data proving that the device meets safety standards and effectiveness before it is allowed onto the market.
Makes you begin to wonder why the FDA didn’t take action and require this earlier. What do you think about this news?
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