C.R. Bard just agreed to settle a case brought over serious injury claims related to its vaginal mesh implant products. The settlement came in advance of the trial, which was scheduled to begin in New Jersey later this month.
Two people familiar with the settlement accord told Bloomberg.com that C.R. Bard Inc. agreed to the settlement, which includes an undisclosed amount. The woman’s claims included that the C.R. Bard vaginal mesh implant caused her internal problems including urinary problems, said the two people, who requested anonymity as they are not authorized to speak publicly on the matter, Bloomberg.com reported. Court dockets indicate that the trial was scheduled for September 23rd in Atlantic City, New Jersey.
This is the second vaginal mesh case C.R. Bard has settled since last month when a federal jury in Charleston, West Virginia, ordered that the device maker pay $2 million to a woman who brought a lawsuit alleging that the C.R. Bard Avaulta transvaginal mesh devices caused her injuries, Bloomberg.com wrote. That jury concluded that the device maker should pay $250,000 in compensatory and $1.75 million in punitive damages. The plaintiff was implanted with an Avaulta Plus device she alleged damaged her organs and led to other issues. The case was the first to be tried in federal court, according to Bloomberg.com.
Last year, a state court jury in California found C.R. Bard liable for a woman’s injuries, also allegedly related to Avaulta implants, in the first case tried in a United States court. Jurors found that the device maker should pay $5.5 million in damages; however, under California law, the device maker is only liable for $3.6 million, Bloomberg.com wrote.
According to court filings in this case, the plaintiff, 56, is a junior high school music teacher in Colorado who alleges that the Avaulta Plus eroded, resulting in her having to undergo three surgeries to resolve urinary problems. C.R. Bard is facing more 8,000 claims over the Avaulta line of vaginal mesh products and involving allegations that the devices cause organ damage and painful intercourse when the devices erode, Bloomberg.com reported.
In 2012, the Avaulta implants were pulled from the market after the U.S. Food and Drug Administration (FDA) ordered transvaginal mesh device makers to study adverse health effects such as organ damage, infection, and pain rates associated with the devices, according to Bloomberg.com. Other device makers—Johnson & Johnson, Endo Health Solutions Inc., and Boston Scientific Corp.—face similar claims over their transvaginal mesh devices.
While many cases against makers of transvaginal mesh devices have been consolidated before U.S. District Judge Joseph Goodwin in Charleston for pretrial processing, other cases have been filed in state courts in New Jersey, Missouri, and California, according to Bloomberg.com
Vaginal mesh devices received FDA clearance through the 510(k) expedited process under which formal safety and efficacy reviews are neither required nor performed. The FDA has stated that complications linked to transvaginal mesh implants are “not rare,” warning that use of these devices may actually be more harmful when compared to alternative methods for treating pelvic organ prolapse (POP), one of the conditions for which the devices received clearance. The agency also recently reported that the most common complications associated with these devices may include:
- Bleeding
- Dyspareunia (pain during sexual intercourse)
- Exposure, extrusion, or protrusion (mesh erosion through the vagina)
- Infection
- Organ perforation
- Pain
- Urinary problems
