In its sixth and highest awarding pelvic mesh suit to date in Pennsylvania, Johnson & Johnson subsidiary Ethicon, Inc. received an order to pay $51.7 Million in damages. The Philadelphia Court of Common Pleas ordered the verdict after a Pennsylvania woman, implanted with 2 defective pelvic mesh devices, alleged the product caused perforations to her urethra, constant pain, and chronic urinary incontinence.
The 51-year-old plaintiff, who was diagnosed with incontinence in 2005, was forced to undergo multiple revision surgeries to remove the mesh between 2011 and 2016. The product had eroded into fragments and dispersed throughout her urethra. She cited defective product design and failure to warn as the basis for her case.
This came only days after J&J attempted to repress more than 100 pending cases in the Philadelphia mass tort program. Based on a recent Supreme Court decision, New Jersey-based J&J argued that Philadelphia cases are invalid due to the company’s lack of tangible links to the state. Not only did the jury disregard this plea, but they then slammed J&J with its largest verdict yet.
J&J’s Defense Doesn’t Wash in Pennsylvania
The $51.7 Million award, which includes $7.1 Million in compensatory and $50 Million in punitive damages, is the latest of several multimillion-dollar PA verdicts against Ethicon in the last 2 years.
In all trials, evidence proved sufficient enough to show that plaintiffs’ symptoms resulted from Ethicon’s careless manufacturing, manipulation of information regarding product defects, and deliberate cover-up of these complications.
Johnson & Johnson still vehemently denies any connection between its devices and women’s torturous and debilitating injuries and plans to appeal.
“We believe the evidence showed Ethicon’s TVT and TVT-Secur devices were properly designed,” said Kristen Wallace, a J&J spokeswoman. “Ethicon acted appropriately and responsibly in the research, development, and marketing of the products, and the products were not the cause of the plaintiff’s continuing medical problems.”
J&J defended its products’ design and promotional efforts, and has relied heavily on challenging questions of jurisdiction. Due to a Supreme Court decision in Bristol Myers Squibb v. Superior Court of California, which threw out cases involving out-of-state residents, J&J can take advantage of a get-out clause that prevents state courts from asserting jurisdiction over nonresidents.
FDA Warns ‘High Risk’ of Costly and Traumatizing Side Effects
The Bristol Myers Squibb decision has raised the stakes in some cases, forcing plaintiffs to find ties between pelvic mesh and the state in which they sued. The nonresident plaintiffs in Pennsylvania, for example, have successfully connected Ethicon to the state through a Pennsylvania-based manufacturer that makes the plastic filaments used in pelvic mesh.
As for the medical complications associated with its mesh products, J&J is having a hard time arguing the facts. Previous product liability cases have linked pelvic mesh (also known as transvaginal mesh) implants with outcomes such as chronic inflammation, pain during intercourse, erosion, mesh migration, and vaginal scarring, prompting urgent and corrective procedures even years after insertion. After seeing significant increases in adverse events, the FDA has reclassified pelvic mesh as a high-risk device.
Ironically, 1 of the issues the product is designed to treat rather than aggravate is stress incontinence, a condition suffered by more than 50 percent of older American women.
The exact number is unknown, but doctors believe thousands of women are implanted with the devices. About 54,000 women nationwide have filed pelvic mesh lawsuits against Ethicon, some still pending. If J&J is unable to escape liability for the remaining Philadelphia cases, we can expect scores of similar outcomes in the future.