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A jury has ordered medical device manufacturer C.R. Bard Inc. to pay $2 million to a woman who filed suit after allegedly suffering serious injuries caused by the company’s controversial Avaulta Plus vaginal mesh implant, according to a Bloomberg News report published online.
After deliberating for 12 hours over two days, the jury awarded Georgia public health nurse Donna Cisson $250,000 in compensatory damages for her injuries, with $1.75 million in punitive damages. Cisson had to undergo surgery to remove the mesh and allegedly experienced serious pain, bleeding and bladder spasms as a result of the product.
Despite the ruling, Bard stuck by the safety of their devices, mentioning they may even explore an appeal.
“We disagree with the verdict reached by the jury and believe there are compelling grounds for reversal. We will appeal,” Bard spokesman Scott Lowry said in an emailed statement. “Our Avaulta mesh products are safe and effective medical devices, cleared by the FDA.”
The multi-million dollar ruling comes after Cisson’s first lawsuit against Bard in July ended in a mistrial. During the two-week trial, Cisson’s attorneys argued before a Charleston, West Virginia, judge that Bard officials “put profits ahead of safety” by disregarding warnings about defects with their Avaulta implants. Although the company was well-aware that its vaginal implants were being manufactured out of plastic and were not suitable to be permanently implanted in humans, Cisson’s lawyers argued, they moved forward with production and marketing anyway.
New Jersey-based Bard is currently preparing for another Avaulta Plus vaginal implant bellwether trial set to begin August 19.
Thousands of patients have filed suits claiming Bard’s Avaulta Plus vaginal mesh, used to treat pelvic organ prolapse, can cause painful sexual intercourse as well as organ damage that may require corrective surgery once the allegedly defective device begins to erode. In 2012, Bard pulled the Avaulta implants from the market after the FDA asked all medical device makers to study the rates of organ damage, infection and pain during intercourse in vaginal mesh recipients.
Last year, a California jury found Bard liable for a woman’s injuries determined to be linked to an Avaulta implant and ordered the company to pay $5.5 million in damages. Under California law, however, Bard is liable for only $3.6 million of that award.