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Johnson & Johnson and its Ethicon subsidiary have agreed to pay nearly $117 million to resolve transvaginal mesh lawsuits filed by most states, resolving claims that alleged the manufacturers deceived state health systems about the risks and efficacy of the devices.
The settlement was announced last week by states attorneys general across the country, bringing an end to claims brought by 41 states and the District of Columbia. However, the agreement does not resolve claims by California, Kentucky, Mississippi and West Virginia, with claims involving those states still pending.
Over the past decade, problems have emerged with the design of several surgical mesh products sold by Johnson & Johnson and other manufacturers for treatment of pelvic organ prolapse and female stress urinary incontinence, which have been linked to reports of painful and devastating injuries, including infections, erosion of the mesh into the vagina and organ perforation.
More than 100,000 product liability lawsuits have been brought by individual women who experienced transvaginal mesh complications, and manufacturers like Johnson & Johnson, Bard, Boston Scientific and others have paid out billions in financial compensation to settle claims alleging that the mesh was defective and unreasonably dangerous.
“Health and safety must come before profits,” New York Attorney General Letitia James said in a press release announcing the settlement. “While Johnson & Johnson and its subsidiary were putting income before the health of people in need of care, women were put in danger.”
As part of this latest deal, Johnson & Johnson will pay $116.86 million to the participating states. In addition, the manufacturer can no longer call its transvaginal mesh products “FDA approved”, cannot say that risks linked to mesh can be eliminated by surgical experience or technique, must ensure training for doctors covers the risks associated with vaginal mesh, and must disclose an extensive list of mesh risks and complications.
Most of those requirements are considered moot, as the FDA announced it was removing all remaining transvaginal mesh products from the market in April, saying manufacturers have not proven they are safe or effective. In addition, Johnson & Johnson’s Ethicon unit has not had a vaginal mesh product on the market in some time.
The litigation over transvaginal surgical mesh has been one of the largest mass torts in U.S. history, with tens of thousands of women filing cases nationwide. Over the past few years, various different manufacturers have reached transvaginal mesh settlements to resolve most of the claims pending, but new claims continue to be filed by women who experience problems with the products.