Two weeks before the FDA reclassified transvaginal mesh as a high-risk device and issued orders that manufacturers submit a rigorous premarket approval application addressing safety concerns, on Dec. 22, 2015, Philadelphia jurors were reaching a verdict on the first case to be tried in Philadelphia’s mass tort program over pelvic mesh products. Their decision was right in line with the medical news that was soon to follow.
Jurors awarded Indiana woman Patricia Hammond, 65, a total of $12.5 million in her lawsuit against Johnson and Johnson and its division, Ethicon. Of that amount, $5.5 million was awarded in compensation for damages related to the company’s Prolift pelvic mesh product including several corrective surgeries Hammond has undergone since the mesh was implanted in 2009 and other ongoing health problems, most specifically the inability to have sex. Jurors hit Johnson and Johnson with an additional $7 million in punitive damages for marketing an unsafe product.
The jury found the the company guilty both of negligence in designing the implant and for failure to warn the plaintiff’s surgeon of the risks of the product.
“The FDA ruling confirms what we have been seeing from Plaintiffs in this litigation – transvaginal mesh used to treat pelvic organ prolapse is responsible for serious, chronic injuries for the women in which it was implanted,” says Leigh O’Dell of Beasley, Allen, Crow, Methvin, Portis & Miles, P.C., and member of the Plaintiffs’ Steering Committees for the multidistrict litigation (MDL) against seven transvaginal mesh manufacturers. “The biggest tragedy in these cases is that these injuries could have been avoided, if this product had been properly tested, and patients and doctors had been fully informed about the risk involved in using transvaginal mesh.”
In Philadephia’s mass tort program alone, there are 180 cases of women who have filed suit against Johnson and Johnson, alleging that failed pelvic mesh implants have caused them ongoing health problems. There are approximately 8,000 pelvic mesh suits pending in New Jersey state court and 35,000 in federal court.
Patricia Hammond’s lawyer, Shanin Specter of the Center City law firm Kline & Specter, told Philly.com, “Every American depends on Johnson & Johnson to put safety ahead of selling. They aren’t doing that, and they need to engage in some honest soul-searching.”