Pharmaceutical

Jury awards plaintiff $2 million for transvaginal mesh injuries in trial against C.R. Bard

vaginal mesh sling Jury awards plaintiff $2 million for transvaginal mesh injuries in trial against C.R. BardA jury in Charleston, W.V., ordered C.R. Bard to pay a Georgia nurse $2 million for severe injuries and pain she alleged she received from an Avaulta transvaginal mesh device that she had implanted in 2009 to correct a form of pelvic organ prolapse.

Plaintiff Donna Cisson, 55, was the first plaintiff who filed a product-injury complaint against a transvaginal mesh manufacturer in federal court to have her case tried. Her case was the first to be tried out of more than 23,000 lawsuits against Bard and five other transvaginal mesh manufacturers that have been consolidated for multidistrict litigation (MDL) in federal court in West Virginia. More than 4,000 of those complaints name Bard as a defendant.

The jury in Ms. Cisson’s case deliberated for 12 hours across two days before reaching its decision, awarding the plaintiff $250,000 in compensatory damages and $1.75 million in punitive damages.

Like the thousands of other women with lawsuits against mesh manufacturers pending, Ms. Cisson agreed to have the mesh device implanted to shore up pelvic organs that had dropped into her pelvic region. She alleged that the device, which was designed to become incorporated with surrounding tissue, eroded in her body, causing intense pain, bleeding, and bladder spasms.

Ms. Cisson had to undergo multiple surgeries to have the mesh removed from her body. Many women with transvaginal mesh implants must undergo several surgeries to fully remove the devices, and in some cases the mesh cannot be completely extracted.

Lawyers for Ms. Cisson argued that C.R. Bard knew its transvaginal mesh devices could potentially harm patients, but chose to hide those defects. According to Ms. Cisson’s lawsuit, C.R. Bard made its Avaulta mesh devices from a petroleum-based plastic that carried a warning that it should not be permanently implanted in humans.

A Bard spokesman said that the company disagreed with the verdict and will appeal it. “Our Avaulta mesh products are safe and effective medical devices, cleared by the FDA,” he said.

Nevertheless, Bard withdrew its transvaginal mesh devices from the market last year after the U.S. Food and Drug Administration (FDA) issued a warning to doctors and patients about the potential risks of the mesh. The agency warned patients and doctors that about 10 percent of women implanted with transvaginal mesh experienced mesh erosion within one year of surgery. The FDA then ordered transvaginal mesh makers to conduct further studies of organ damage, infection, and pain during sexual intercourse caused by mesh devices.

Source: Bloomberg