A transvaginal mesh lawsuit settlement announced this week may resolve $830 million worth of legal claims over pelvic implants from American Medical Systems, Reuters.com reports.
According to a recent article, Endo International Plc said on April 30th that it agreed to cover costs associated with “a substantial majority of the mesh litigation” involving products marketed by its subsidiary. This agreement follows a $54.5 million payment from Endo last year to resolve transvaginal mesh suits from women alleging mesh erosion, infection, vaginal scarring, organ damage and other side effects.
Despite Endo’s continued defense in these claims, to which it admits no liability or fault, the company has reportedly set aside $520 million to cover expenses related to the proceeding. An annual filing with the U.S. Securities and Exchange Commission on February 20th indicates that 22,000 lawsuits in the U.S. blame both Endo and American Medical Systems for pelvic mesh injuries. According to Reuters, several conditions must be met before the settlement can be implemented, including the confirmation of plaintiffs’ medical records.
Endo has set aside a pretax charge of $625 to cover costs associated with the transvaginal mesh lawsuit agreement, which may go into effect over the next year. Plaintiffs who may receive compensation through the settlement are happy with its results, Reuters suggests, with a statement from a mesh lawyer who said its results followed an “adversarial but respectful and professional negotiation on the part of all the parties.”
Since the U.S. Food and Drug Administration (FDA) issued its first transvaginal mesh alert in 2008, the number of lawsuits filed over devices from American Medical Systems has continued to increase. Court documents from April 15th show a total of 16,515 federal claims against the company now pending in the U.S. District Court, Southern District of West Virginia, where a federal litigation is now underway. Plaintiffs in these cases accuse the manufacturer of negligently designing, manufacturing and marketing its pelvic mesh, which they say was defectively designed given its risk for complications.