Following four consecutive losses, Johnson & Johnson and its Ethicon, Inc. subsidiary have finally emerged victorious at the conclusion of a Pennsylvania transvaginal mesh trial. While jurors in Philadelphia agreed that the companies’ TVT-Secure implant was defectively designed, they concluded that the device was not responsible for injuries alleged by the Plaintiff,
Plaintiff Kimberly Adkins received TVT-Secur mesh to treat stress urinary incontinence in July 2010. The mesh allegedly eroded into her vagina, resulting in chronic pain. In addition to finding that the implant was defectively designed, jurors also agreed that Ethicon failed to warn of its risks. However, Adkins was denied damages after jurors found that TVT-Secur was not the cause of her injuries.
“We’re obviously disappointed with the end result, but we proved that this is a product that should have never been on the market and that Ethicon and Johnson & Johnson behaved irresponsibly in putting a defective product on the market,” her attorney told Law360.com.
The June 9th decision marked the first time a jury has delivered a defense verdict in the pelvic mesh litigation now underway in the Philadelphia Court of Common Pleas. In April, another TVT-Secur recipient was awarded $20 million in punitive and compensatory damages by the jury hearing her case. Johnson & Johnson and Ethicon were ordered to pay damages of $2.16 million, $12.5 million and $13.5 million in three other transvaginal mesh trials.
More than 54,000 women are currently pursuing transvaginal mesh lawsuits against Johnson & Johnson and Ethicon in courts nationwide. Tens of thousands of additional cases have been filed against C.R. Bard, Inc., Cook Medical, Inc. and other device makers.
In 2008, the U.S. Food & Drug Administration (FDA) first warned that transvaginal mesh had been linked to at least 1,000 reports of serious injuries and complications during the previous three-year period. In July 2011, the agency disclosed that it had received more than 2,800 additional adverse event reports related to the products, including cases of injury, death, and malfunction. More than 1,500 incidents were associated with pelvic organ prolapse repairs, while 1,371 were associated with stress urinary incontinence repairs.
Among other things, the FDA noted that it no longer considered transvaginal mesh complications following prolapse repair to be rare, the reverse of its previous position. The agency also expressed doubt that prolapse repair with transvaginal mesh offered any additional benefits compared to traditional non-mesh repair.
In 2012, Ethicon announced it would end sales of TVT-Secur mesh and three other transvaginal mesh devices, citing commercial concerns rather than safety reasons. However, the FDA had previously ordered Ethicon and other vaginal mesh manufacturers to conduct further research into the risks associated with their products.