An Indiana jury has handed down a $35 million award against Johnson & Johnson concerning a defective transvaginal mesh case. The jury found Johnson & Johnson and its subsidiary Ethicon negligent in the design and marketing of the Prolift transvaginal mesh device. The jury found that the defendants were negligent in the design of Prolift as an unreasonably dangerous product
The 2012 lawsuit which resulted in this most recent jury verdict was filed after Barbara Kaiser experienced severe pelvic pain after undergoing pelvic prolapse repair surgery. The lawsuit accused J&J and Ethicon of concealing the problems with Prolift, which allegedly include high failure, injury, and complication rates and “frequent and often debilitating re-operations,” according to the Kaiser’s complaint. Prolift “caused severe and irreversible injuries, conditions, and damage to a significant number of women, including plaintiff,” according to the complaint.
In addition to the $10 million the jury awarded Barbara Kaiser, they saw fit to award punitive damages against Johnson & Johnson and its subsidiary Ethicon for $25 million. The punitive damages are a strong signal that the public will not tolerate company’s unethical behavior in failing to disclose when their products don’t work and are dangerous to the public welfare.
The FDA has issued several safety warnings since 2008 concerning the flood of complaints and reports of injuries caused by transvaginal mesh devices. 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.
This verdict comes two days after J&J lost its bid to overturn a $15 million verdict for Elizabeth Hyrmoc. Hyrmoc’s trial took place in November 2017 in New Jersey.
J&J and Ethicon still faced more than 13,600 mesh lawsuits as of Feb. 15, 2018. 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.