More than 500 transvaginal mesh lawsuit claims against C.R. Bard may soon be resolved for a totaled $21 million, Bloomberg Businessweek reports.
According to a report on October 8th, the company announced its agreement in a July 24th filing with the U.S. Securities and Exchange Commission that noted charges totaling $262.7 million in product liability costs. $4.2 million in defense costs needed to prepare 200 cases for trial was also included.
A spokesperson for Bard stressed that the company’s policy prohibits the discussion of upcoming litigation, but that the settlement “is already out there. We announced it in July.”
According to Bloomberg, the decision to settle transvaginal mesh lawsuits followed an order from the federal judge presiding over claims in the U.S. District Court, Southern District of West Virginia that Bard prepare for the trials of 500 lawsuits alleging mesh erosion, chronic pain, pain during sexual intercourse and other complications. In the federal Bard litigation, a total of 9,745 lawsuits had been filed in the West Virginia proceeding as of September 15th.
Bard is not the only vaginal mesh manufacturer to settle claims over its pelvic implants, however. On September 30, Endo International Plc announced its decision to add $400 million to its reserve for mesh-related product liability suits involving its subsidiary, American Medical Systems (AMS). The agreement to pay that amount may take care of 20,000 suits that allege injuries caused by the company’s Apogee, Elevate and Perigee mesh implants. Plaintiffs in each case will walk away with $48,000, according to Bloomberg, while Bard claimants will reportedly leave with $43,000.
In the federal West Virginia litigation established for AMS products, court records show 18,700 lawsuits filed by women who claim to have suffered damages as a result of these products. Claims filed in both the litigations follow multiple warnings from the U.S. Food and Drug Administration (FDA) that mesh complications may be serious and “not rare.” On April 29th, the FDA proposed new regulations that would reclassify transvaginal mesh devices from ‘moderate-risk’ to ‘high-risk,’ requiring manufacturers to submit all devices for pre-approval, so that safety and effectiveness could be adequately surveyed by the agency.