Johnson & Johnson and Ethicon, Inc. have appealed a decision by a Pennsylvania judge to order a new hearing on damages in a transvaginal mesh lawsuit that went to trial earlier this summer.
The case, Adkins v. Ethicon, was decided in June when a jury in the Philadelphia Court of Common Pleas ruled for the companies. Even though jurors determine that Ethicon’s TVT-Secur mesh was defectively designed and found that the company had failed to warn plaintiff Kimberly Adkins about the implant’s risks, they denied her damages after concluding the transvaginal mesh device was not responsible for her injuries.
Adkins quickly motioned for a new damages hearing, arguing that the verdict was inconsistent with the evidence. The Court agreed and granted her motion in late July.
According to a report published today by The Legal Intelligencer, Johnson & Johnson and Ethicon have appealed that decision to the Pennsylvania Superior Court.
“We have filed an appeal to the Superior Court solely regarding the granting of a new hearing on damages, because we believe that it was not right to set aside what the jury decided,” one of the company’s attorneys told The Legal Intelligencer.
Ethicon is the main defendant in a mass tort program currently underway in Philadelphia that includes more than 100 transvaginal mesh lawsuits. Women pursuing these cases claim that vaginal mesh implants marketed by Ethicon and other defendants to treat stress urinary incontinence and pelvic organ prolapse were defective and erode in the vagina, leading to chronic pain, scarring, adhesions, infections, and other life-changing and permanent complications.
The Adkins’ verdict was the first time a Philadelphia jury had found in favor of Johnson & Johnson and Ethicon in a transvaginal mesh lawsuit. The companies had been ordered to pay damages of $2.16 million, $12.5 million, $13.5 million and $20 million at the conclusion of four previous trials.
More than 54,000 women are currently pursuing pelvic mesh lawsuits against Johnson & Johnson and Ethicon in courts nationwide. Tens of thousands of additional cases have been filed against Boston Scientific Corp., C.R. Bard, Inc., and other device makers.
The U.S. Food & Drug Administration (FDA) has issued several warnings regarding the use of transvaginal mesh devices, after the agency received thousands of adverse event reports involving the implants. In 2011, the FDA said it no longer considered complications associated with transvaginal prolapse repair to be rare, and expressed doubts that these devices offer any additional benefits over traditional, non-mesh methods of prolapse repair.
Most recently, the FDA issued new regulations that made transvaginal mesh indicated for prolapse repair ineligible for the agency’s 510(k) clearance protocols, which allowed the devices to come to market without the benefit of human clinical trials.
While it has never conducted a transvaginal mesh recall, Ethicon announced in 2012 that it would end sales of TVT-Secur mesh and three implants. In doing so, the company cited 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.