A third Pennsylvania jury has ruled against Johnson & Johnson and Ethicon, Inc. in a lawsuit involving one of the companies’ controversial transvaginal mesh devices. In a verdict delivered late last month, jurors in the Philadelphia Court of Common Pleas ordered the device makers to pay $2.16 million to a woman who suffered serious and permanent complications following implantation of Ethicon’s Gynecare Prolift mesh implant.
The verdict marked the fourth consecutive loss for Johnson & Johnson and Ethicon in Pennsylvania’s pelvic mesh mass tort program. The unanimous jury verdict was returned on May 26th, before noon on the second day of deliberations. According to Law360.com, the panel of eight women and four men found that the risks associated with Prolift mesh outweighed its benefits. They also agreed the device was behind the chronic vaginal pain and pain during sexual intercourse that Sharon Beltz has endured since she received the implant in 2006 to treat pelvic organ prolapse and stress urinary incontinence.
However, the jury did find that the mesh performed as expected and was not defectively designed. The judgment was the smallest so far awarded to a Pennsylvania transvaginal mesh patient, as well as the first not to include punitive damage.
The latest verdict came just a month after another Pennsylvania jury ordered Johnson & Johnson and Ethicon to pay $20 million in punitive and compensatory damages to a woman who suffered complications related to Ethicon’s Gynecare TVT-Secur implant. Philadelphia juries awarded pelvic mesh plaintiffs $12.5 million and $13.5 million in two earlier trials.
Johnson & Johnson and Ethicon are named defendants in more than 54,000 transvaginal mesh lawsuits pending 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 implants had been linked to at least 1,000 reports of serious injuries and complications over a three-year period. In July 2011, the agency disclosed that it had received more than 2,800 medical device reports related to the products, including reports of injury, death, and malfunction. More than 1,500 reports 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, a change from its previous position. The agency also expressed doubt that prolapse repair involving transvaginal mesh was safer or more effective compared to traditional non-mesh repair.
In 2012, Ethicon announced it would stop marketing the Prolift product and three other transvaginal mesh devices, citing changing market dynamics” rather than safety concerns. However, the FDA had previously ordered more than 20 vaginal mesh manufacturers, including Ethicon, to conduct further research into the risks associated with their products.