Dive Brief:

• Johnson & Johnson’s Ethicon unit must pay $80 million in damages to a plaintiff who sued over injuries she said were caused by the company's pelvic mesh device in the latest trial over chronic pain and other complications allegedly caused by its pelvic mesh implants.
• As of March 31, J&J and Ethicon faced about 29,500 plaintiffs with direct claims in pending U.S. lawsuits over injuries allegedly due to the company’s pelvic mesh devices used to treat stress urinary incontinence and pelvic organ prolapse, the company said in a regulatory filing.
• In April, a jury in the same state court awarded $120 million to another plaintiff alleging injury from mesh implants.

Dive Insight:

Patricia Mesigian had Ethicon's Prolift mesh device implanted in 2008 to treat organ prolapse. But she said the product eroded, leaving her suffering from pelvic pain, infection, inflammation, scar tissue and the inability to have sexual relations without pain. 

The state jury's $80 million award against Ethicon includes $50,000 in punitive damages. According to docket information for the Court of Common Pleas in Philadelphia, Mesigian was awarded $50,000 in punitive damages and $30,000 in compensatory damages over injuries related to the Prolift mesh device. Prolift was removed from the market in 2012. 

Ethicon told MedTech Dive in an emailed statement the company would be appealing the verdict along with an April jury verdict of $120 million awarded to another mesh plaintiff in another mesh case in the same state court.

"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 these verdicts," company spokesperson Mindy Tinsley told MedTech Dive in an email. 

"While Ethicon empathizes with women who experience medical complications, these verdicts and the damages awarded are inconsistent with the science and Ethicon’s actions," Tinsley said.

"We believe the evidence showed Ethicon’s devices were properly designed and that Ethicon acted appropriately and responsibly in the research, development and marketing of the products," she said. "Unfortunately, the juries were not permitted to hear critical evidence related to the FDA's review and classification of these devices, which we believe significantly influenced the verdict and punitive awards in these cases." 

But Mesigian's lawyer, Tom Kline, of Kline & Specter, PC, said the jury found the Prolift mesh defective and that the company failed to provide adequate warning of its risks.

"In this largest transvaginal compensatory jury verdict to date, this jury resoundingly found that Johnson & Johnson terribly injured another one of thousands of women implanted with its defective transvaginal mesh device, recognizing not only the severity of the injury but the abhorrence of the conduct,” Kline said in a statement.

The verdict was the eighth time a Philadelphia jury decided against the company in a vaginal mesh case with awards now totaling $346 million, Kline said.

And J&J's Ethicon's unit is far from alone in its mesh device woes.

Other companies with pelvic mesh woes include Boston Scientific, which said pelvic mesh litigation was a drag on its first-quarter results, after FDA last month ordered the company and Danish device maker Coloplast to immediately stop selling surgical mesh products indicated for transvaginal repair of pelvic organ prolapse. The agency simultaneously rejected the premarket approval applications submitted by the only two remaining market players.

The action came two months after FDA's Obstetrics and Gynecology Devices Panel said there was insufficient data to determine the device's long-term safety and effectiveness, and that doctors should be more selective in choosing patients. FDA cited the panel's recommendation that mesh companies demonstrate superior product effectiveness and comparable safety to native tissue repair at 36 months in ordering Boston Scientific and Coloplast to stop selling their products, saying both failed to provide data meeting the standard.

FDA in 2016 moved transvaginal mesh into the highest-risk Class III device category, after an earlier meeting of the same FDA panel resulted in the agency in 2012 to issue '522' postmarket study mandates to 34 manufacturers, including former mesh makers C.R. Bard and J&J's Ethicon, prompting nearly all to chose to exit the market.

In its latest quarterly report, J&J said pelvic mesh cases filed in federal courts against the company have been consolidated into multi-district litigation in the U.S. District Court for the Southern District of West Virginia. The company has settled or resolved a majority of the cases, J&J said.

J&J also said class actions and individual personal injury cases have been brought in various countries outside of the United States, including the United Kingdom, the Netherlands, Belgium, Israel, Australia and Canada, seeking damages for alleged injury resulting from Ethicon's pelvic mesh devices.

Dana Elfin contributed to this story.