C.R. Bard, Inc. has reportedly settled another batch of transvaginal mesh lawsuits that were part of the federal multidistrict litigation underway in West Virginia federal court. As was the case with some previous settlements, the terms of this agreement remain confidential.
Around 5,700 product liability claims are pending against C.R. Bard in the U.S. District Court, Southern District of Western Virginia, where federally-filed lawsuits involving the company’s transvaginal mesh devices have been consolidated before U.S. District Judge Joseph R. Goodwin. Judge Goodwin is also presiding over multidistrict ligations involving pelvic mesh devices manufactured by
American Medical Systems, Inc. Ethicon, Inc., Boston Scientific Corp., Cook Medical, Inc. and Coloplast Corp.
According to Law360.com, Judge Goodwin dismissed 75 C.R. Bard vaginal mesh lawsuits on Monday, all with prejudice. Court records indicate that the dismissed cases have been “compromised and settled” for an undisclosed amount.
This is just the most recent transvaginal mesh settlement reported in the C.R. Bard litigation. In April, Judge Goodwin dismissed 149 cases that were also compromised and settled for undisclosed amounts.
In July 2015, Bloomberg News reported that C.R. Bard had spent $200 million to resolve 3,000 transvaginal mesh lawsuits. Plaintiffs involved in that accord each reportedly received $67,000. A smaller group of cases had been settled the previous year for about $43,000 per plaintiff.
Transvaginal mesh is used to surgically treat women suffering from pelvic organ prolapse and stress urinary incontinence. In 2008, the U.S. Food & Drug Administration (FDA) warned that such devices had been implicated in more than 1,000 serious injury reports during the previous three-year period. In July 2011, the agency disclosed that it had received over 2,800 additional adverse event reports related to the products, including cases of injury, death, and malfunction. More than 1,500 incidents were associated with pelvic organ prolapse repairs, while 1,371 were associated with stress urinary incontinence repairs.
The FDA’s 2011 alert also noted that the agency no longer considered transvaginal mesh complications following prolapse repair to be rare, the reverse of its previous position. The FDA also expressed doubt that prolapse repair with transvaginal mesh offered any additional benefits compared to traditional non-mesh repair.
Just last year, the FDA issued new rules that, among other things, made transvaginal mesh implants ineligible for the agency’s 510(k) clearance program. This program allows a medical device to come to market in the absence of human clinical trials when a manufacturer can show a device is “substantially equivalent” to another product previously approved by the FDA.