An Indiana woman has been awarded $35 million, after the federal jury hearing her transvaginal mesh lawsuit found that Johnson & Johnson and its Ethicon, Inc. subsidiary committed negligence in designing and marketing Prolift mesh implants for the treatment of pelvic organ prolapse.
According to her 2012 filing in the U.S. District Court, Northern District of Indiana, Plaintiff Barbara Kaiser has experienced chronic pelvic pain ever since undergoing prolapse repair surgery in 2009. Among other things, she claimed that Johnson & Johnson and Ethicon were aware that Prolift was associated with high rates of failure and complications, yet never warned doctors and patients about these issues.
“Defendants actively and intentionally misled and continue to mislead the public, including the medical community, health care providers, and patients, into believing their Prolift is safe and effective, leading to the prescription for, and implantation of, their Prolift into plaintiff, Barbara Kaiser, and numerous other women,” the lawsuit states.
During her 9-day trial, Kaiser’s surgeon testified that he would not have used Prolift had he been aware of its risks.
Kaiser was awarded $10 million in compensation for her injuries, as well as $25 million in punitive damages for the defendants’ wanton and reckless disregard for her safety.
Johnson & Johnson and Ethicon are facing more than 55,000 product liability claims involving Prolift and other transvaginal mesh implants used to treat pelvic organ prolapse and stress urinary incontinence.
The companies have lost more than a half-dozen trials, with other verdicts ranging from $2.16 million to $20 million. Some juries have found for the defendants, while other cases have settled out-of-court.
Since 2008, the U.S. Food & Drug Administration has (FDA) issued several safety communications regarding transvaginal mesh devices, after the implants were tied to hundreds of injuries and complications, including many that proved permanent and life-changing. In 2011, the agency warned that transvaginal mesh complications associated with prolapse repair were not rare, a reversal of its previous position on the subject.
In 2016, the FDA reclassified mesh implants indicated for prolapse repair as Class III (high risk) medical devices, which among other things, barred such product from the FDA’s 510(k) approval program. This program allowed Prolift and similar mesh devices to come to market without the benefit of human trials because their manufacturers were able to convince the FDA that they were “substantially equivalent” to implants that had already gone through the agency’s stricter pre-market approval process.
In June 2012, Ethicon announced it would no longer market several transvaginal mesh implants in the United States, including the Prolift, Prolift+M, TVT Secur and Prosima devices. The company has never announced a transvaginal mesh recall, and indicated that the decision to stop selling the implants was made for commercial reasons, rather than safety concerns.