Approximately 20K Vaginal Mesh Lawsuits Settled By Endo For $830MM
A transvaginal mesh settlement will resolve an estimated 20,000 lawsuits brought against a device manufacturer by thousands of women who say the mesh caused them to suffer bleeding, painful intercourse, and other complications after being implanted as a treatment for pelvic organ prolapse (POP) or urinary stress incontinence (USI).
Endo International Plc., and subsidiary American Medical Systems will pay $830 million to resolve “a substantial majority of the mesh litigation” pending against the company. According to documents filed with the U.S. Securities Exchange Commission, approximately 22,000 vaginal mesh lawsuits had been filed against Endo as of February 2014.
In a statement released by Endo, that the settlement covers about 20,000 lawsuits filed over the Elevate, Perigee, and Apogee mesh implants. Bloomberg reports that over 23,000 claims remain, including those that have been consolidated in multidistrict litigation to U.S. District Court for the Southern District of West Virginia under District Judge Joseph Goodwin, In re American Medical Systems Inc. Pelvic Repair Systems Products Liability Litigation, 12-md-02325.
Bloomberg reports that in a filing with the U.S. Securities and Exchange Commission that it was setting $520 million aside for the litigation, and that insurance may cover some or all of settlement costs. The company has a total of $1.1 billion in reserve for legal costs connected to the vaginal mesh litigation. Under the terms of the settlement, plaintiffs will receive about $40,000 per case, Bloomberg reports, however, it will also allow those who underwent multiple surgeries because of severe injuries caused by the mesh to seek more for their specific claims.
The agreement in principal came just days after the U.S. Food and Drug Administration (FDA) proposed two new orders to better regulate mesh devices used to treat POP. If the orders are accepted, transvaginal mesh devices used to treat POP will be reclassified as class III, high-risk devices and manufacturers will be required to apply for premarket approval for the FDA to evaluate device safety and efficacy.
According to the FDA’s news release, deputy director of science and chief scientist at the Center for Device and Radiological Health, William Maisel, M.D., M.P.H. said, “The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products. If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”
In 2012, the government agency ordered about 30 transvaginal mesh makers to conduct about 522 postmarket surveillance studies to evaluate the specific efficacy and safety concerns of the mesh being used for repair of POP, including organ damage and serious complications.
Mesh manufacturers C.R. Bard, Boston Scientific Corp., Endo, and Coloplast A/S are currently in settlement talks over cases consolidated to the West Virginia MDL, though Coloplast agreed to pay about $16 million to settle 400 mesh injury lawsuits in March.
If you were implanted with vaginal mesh speak call 1-888-217-3033 to find out if you qualify for the settlement.