PHILADELPHIA – A Philadelphia jury has handed down a $120 million verdict in favor of a plaintiff who claimed she suffered pain, incontinence and an inability to have sexual intercourse with her husband, after being implanted with pelvic mesh manufactured by Johnson & Johnson and its subsidiary, Ethicon, Inc.
The verdict, comprised of $20 million in compensatory damages and $100 million in punitive damages, is the seventh result delivered in favor of pelvic mesh plaintiffs in Philadelphia courts and more than double the formerly-largest jury award for a pelvic mesh trial in Philadelphia, $57 million.
It brings the total amount of damages awarded to pelvic mesh plaintiffs in Philadelphia to more than $270 million.
Tracie Palmer of Kline & Specter, a member of counsel for plaintiff Susan McFarland, issued a statement on the trial result.
“This verdict speaks volumes. This is a product still on the market and the jury’s message to Johnson & Johnson is take this product off the market for the health and safety of America’s women,” Palmer said.
A spokeswoman for Ethicon explained the company intends to appeal the verdict.
“While Ethicon empathizes with women who experience medical complications, this verdict and the damages awarded are inconsistent with the science, Ethicon’s actions, and previous verdicts related to our TVT-O product, which continues to be the gold standard of treatment for stress urinary incontinence,” Mindy Tinsley said.
“We believe the evidence showed Ethicon’s TVT-O device was properly designed and that Ethicon acted appropriately and responsibly in the research, development and marketing of the product. We respect the legal process, but we want to reiterate that jury verdicts are not medical, scientific or regulatory conclusions about a product and Ethicon will appeal this verdict.”
In 2008, McFarland, an Altoona resident, was suffering from pelvic floor-related medical issues and was subsequently implanted with the defendants’ Gynecare TVT-O pelvic mesh implant device. The mesh is used to counteract the effect of pelvic organ prolapse, a condition in which organs sometimes drop due to age or injury and which can result in urinary incontinence.
However, McFarland said the mesh malfunctioned and damaged her pelvis’ soft tissue before puncturing her vagina. She explained this required her to undergo revision surgery to remove broken pieces of the implant, but she allegedly suffered chronic and lasting pain preventing her from sexual contact with her spouse.
Counsel for McFarland argued the defendants rushed the mesh device to market without conducting proper testing to determine if it was safe for patient use.
McFarland’s case initially resulted in a mistrial last September, with the jury firmly deadlocked on the liability of the mesh product in causing her injuries. A retrial began in March before ending this week in the large jury verdict.
The verdict arrives only days after the Food & Drug Administration ordered pelvic mesh product manufacturers to immediately cease sales of their products, as there was no “reasonable assurance” that they were safe.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair pelvic organ prolapse. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
“Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”
Earlier this month in a separate case, a jury found in favor of Johnson & Johnson and Ethicon in a similar pelvic mesh trial.
Philadelphia County Court of Common Pleas case 130701577
From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nick.malfitano@therecordinc.com