A West Virginia jury hit Johnson & Johnson subsidiary Ethicon Inc. with $3.27 million in damages in a product liability suit over Ethicon’s transvaginal mesh sling. The jury found that Ethicon did not warn doctors and patients of the device’s potential risks.
Law360 reports that the jury found in favor of the plaintiff on all counts, including strict liability, design defect, failure to warn and negligence. The jury did not award punitive damages.
The plaintiff, Jo Huskey, sued Ethicon in 2012, alleging the polypropylene mesh in her TVT-O sling eroded, causing severe, ongoing pain. The mesh could not be entirely removed through surgery.
Transvaginal mesh devices were approved by the Food and Drug Administration (FDA)
Transvaginal mesh devices were approved by the Food and Drug Administration (FDA) for the treatment of pelvic organ prolapse, but thousands of women who received the implants have sued the manufacturers over injuries and complications including mesh erosion through the vagina (also called exposure, extrusion, or protrusion); bleeding, infection, organ perforation, pain during sexual intercourse, and urinary problems.
Many of these women have needed additional surgery to remove the device and repair organ damage. In 2011, the FDA warned that transvaginal mesh devices devices may actually be more harmful than alternative methods for treating pelvic organ prolapse.
Ethicon said it will appeal the verdict. Thousands of other pelvic mesh cases are consolidated in a multidistrict litigation in West Virginia federal court and in state courts across the country, Law360 reports.
Some transvaginal mesh device manufacturers mesh manufacturers have chosen to settle cases en masse rather than letting them go to trial. In April, Endo International PLC reached an $830 million settlement that resolves most of the 22,000 vaginal mesh suits against its American Medical Systems Inc. subsidiary.
Cases have also been filed against Coloplast Corp., C.R. Bard Inc., and Boston Scientific.