Washington, DC: A potential $830 million settlement has been reached between thousands of women who have filed transvaginal mesh (TVM) injury lawsuits and TVM manufacturer Endo International PLC.
If approved, the agreement would resolve “a substantial majority” of the claims which allege the TVM devices, made by Endo subsidiary American Medical Systems (AMS) caused pain and bleeding. AMS estimates that if ratified, the settlement would end 20,000 such claims. Including these 20,000, there are over 40,000 claims pending.
In a written statement, Endo said the settlement was “subject to final documentation” and “not in any way an admission of liability or fault.” Currently, seven TVM manufacturers are facing litigation over allegations of pain, bleeding and in some cases, surgery to remove the TVM, brought by women who initially had the device implanted to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
Many women have experienced physical problems such as mesh erosion, pain and infection, bleeding, scarring, pain during sexual intercourse, organ perforation and urinary problems that require additional treatment and hospitalization. As well, TVM causes psychological concerns such as sexual and intimacy problems.
US District Judge Joseph Goodwin in the Southern District of West Virginia in Charleston, who is hearing the majority of the 40,000 cases, has called for a new bellwether process aimed at resolving hundreds of cases at a time. Currently, Bard and lead plaintiffs’ attorneys are determining 200 cases for bellwether trials that could begin next year.