Jury deliberations are now underway in Philadelphia, Pennsylvania, where testimony has concluded in the state's sixth trial involving a transvaginal mesh lawsuit filed against Johnson & Johnson and its Ethicon, Inc. subsidiary.
The case, which is among more than 130 pelvic mesh lawsuits pending in a mass tort program now underway in the Philadelphia Court of Common Pleas, was filed on behalf of a woman who says Ethicon's TVT mesh devices mangled her urethra and left her to endure life-long incontinence.
Like others pursuing transvaginal mesh lawsuits against Ethicon and Johnson & Johnson, she claims that the implants were defectively designed and alleges that the companies failed to warn doctors and patients about their potential risks. (In Re: Pelvic Mesh Litigation, Case No. 140200829.)
"We look forward to the verdict, as it may provide some clues as to how other juries might decide similar cases involving TVT transvaginal mesh devices," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices.
Ethicon and Johnson & Johnson have so far prevailed in just one Pennsylvania transvaginal mesh trial. Four Philadelphia juries have awarded Ethicon plaintiffs $13.6 million, 17.5 million, and $20 million in damages.
Transvaginal mesh implants are approved for use in women who suffer from pelvic organ prolapse and stress urinary incontinence. In 2008, the U.S. Food & Drug Administration (FDA) warned the implants had been associated with at least 1,000 reports of serious injuries and complications over a three-year period. In July 2011, the agency reported that complications related to transvaginal prolapse repair had tripled since 2008 and reversed its stance that such complications were rare.
In 2016, the FDA finalized regulations that reclassified pelvic mesh indicated for transvaginal prolapse repair as Class III (high risk) medical devices. The agency also made the implants ineligible for its 510(k)-clearance program, which had previously allowed transvaginal mesh manufacturers to market the products without first conducting human clinical trials.
Johnson & Johnson and Ethicon are facing more than 55,000 transvaginal mesh lawsuits in courts nationwide. Women involved in this litigation are alleged to have suffered a wide range of painful complications, including the erosion of mesh into the vaginal wall, adhesions and scarring, chronic infections, permanent pain, and incontinence, following implantation of the companies' products.