Transvaginal Device Maker C.R. Bard Settles Second Case Set for TrialSep 16, 2013
In advance of a trial set in New Jersey for later this month, C.R. Bard agreed to settle a case brought over injury claims related to its vaginal mesh implant products.
According to two people familiar with the settlement accord, C.R. Bard Inc. agreed to settle claims for an undisclosed amount, Bloomberg.com reported. The woman’s claims included that the vaginal mesh implant caused internal problems, such as urinary issues, said the two people, who requested anonymity as they are not authorized to speak publicly on the matter, according to Bloomberg.com. The trial was scheduled for September 23rd in Atlantic City, New Jersey, according to court documents.
This is the second vaginal mesh case C.R. Bard has settled since last month, when a federal jury in Charleston, West Virginia, ordered the device maker to pay $2 million to a woman who alleged that the C.R. Bard Avaulta transvaginal mesh device caused her injuries, Bloomberg.com reported. The jury concluded that the device maker should pay $250,000 in compensatory damages and $1.75 million in punitive damages. In that case, the plaintiff, who was implanted with an Avaulta Plus device, alleged that the device 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 California state court jury found C.R. Bard liable for a woman’s injuries, also related to Avaulta implants; that was the first case tried in a United States court. Jurors found that C.R. Bard should pay $5.5 million in damages; however, the device maker is only liable for $3.6 million under California law, Bloomberg.com wrote.
The plaintiff, 56, in this case, is a junior high school music teacher in Colorado who alleges that the Avaulta Plus began to erode, necessitating three surgeries over urinary problems, according to the filings.
C.R. Bard faces more than 8,000 claims involving the Avaulta vaginal mesh insert line. The lawsuits allege organ damage and painful intercourse when the devices erode, Bloomberg.com reported.
The Avaulta implants were pulled from the market in 2012 after the U.S. Food and Drug Administration (FDA) ordered all transvaginal mesh device makers to study organ damage, infection, and pain rates associated with the implants, according to Bloomberg.com. Other device makers, including Johnson & Johnson, Endo Health Solutions Inc., and Boston Scientific Corp., face similar claims over their transvaginal mesh devices.
While many cases against transvaginal device makers have been consolidated before U.S. District Judge Joseph Goodwin in Charleston for pretrial information exchanges, others have been filed in state courts in New Jersey, Missouri, and California.
Vaginal mesh devices received FDA clearance through the 510(k) expedited process under which a formal review for safety and efficacy is neither required nor performed. The FDA has since 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 transvaginal mesh may include:
- Dyspareunia (pain during sexual intercourse)
- Exposure, extrusion, or protrusion (mesh erosion through the vagina)
- Organ perforation
- Urinary problems