A Philadelphia jury has ordered Ethicon, Inc. to pay $13.5 million to a transvaginal mesh plaintiff who suffered serious complications related to the erosion of the company’s TVT midurethral sling. This marked the second loss for the Johnson & Johnson unit in the state’s pelvic mesh mass tort program.
The verdict followed two weeks of testimony in the Philadelphia Court of Common Pleas, during which time jurors were told the TVT sling was defective due to small pores and other problems that made the device more likely to erode.
“It is conclusive evidence of reckless disregard. Reckless, reckless, reckless. You know these things, and you don’t act. You don’t fix the product. You don’t decline to sell it. You don’t tell doctors about the risk, and you don’t tell patients about the risks,” the plaintiff’s attorney told the panel during closing arguments.
In the end, the jury of eight women and four men unanimously agreed with the plaintiff, awarding her $3 million in compensatory damages and $10.5 in punitive damages.
Attorneys for Johnson & Johnson and Ethicon have promised an appeal.
Currently, some 179 transvaginal mesh lawsuits are pending in the mass tort proceeding underway in Philadelphia. In December, the jury hearing the litigation’s first Ethicon trial awarded $12.5 million to another woman who had been implanted with the company’s Prolift pelvic mesh device. The judgment included $5.5 million in compensatory damages for the plaintiff’s ongoing health issues, as well as $7 million in punitive damages.
Ethicon is currently named a defendant in more than 29,000 vaginal mesh lawsuits that have been consolidated in a multidistrict litigation currently underway in the U.S. District Court, Southern District of West Virginia. C .R. Bard, American Medical Systems, Boston Scientific and other device manufacturers are also facing massive litigations at both the state and federal court level. Nationwide, a number of cases have gone to trial, several of which have resulted in multimillion-dollar judgements for plaintiffs. There have also been settlements reported in certain groups of cases.
Just last month,the U.S. Food & Drug Administration (FDA) announced that it had reclassified transvaginal mesh used in pelvic organ prolapse repair as a high-risk medical device. The agency acted after a years-long review determined that the products are associated with a high rate of adverse events. This new designation –Class III – means that pelvic mesh intended for use in prolapse repair will be subject to greater regulatory scrutiny, and no longer eligible for the 510(k) approval program