C.R. Bard Agrees to Settle 500 Lawsuits over Transvaginal Mesh
C.R. Bard recently agreed to settle more than 500 transvaginal mesh lawsuits over its Avaulta implant and several others, which may resolve a good portion of the litigation, MassDevice.com reports.
According to an article on July 29th, the company agreed to resolve the complaints in the second quarter of 2014. Bard did not disclose how much the settlements were for, but did acknowledge paying $259 million during the quarter for “product liability matters.” Lawsuits that were resolved similarly allege injuries caused by the company’s surgical mesh, which has been associated with mesh erosion, chronic pain, pain during sexual intercourse, scarring, infection and other side effects.
According to a regulatory filing with the U.S. Securities and Exchange Commission, C.R. Bard said it “anticipates that multiple additional trials, including a possible consolidated trial, may occur in early 2015. Additional state court trials are scheduled throughout the second half of 2014.”
Some 12,400 Vaginal Mesh Lawsuits Now Filed in U.S., Bard Estimates
As of July 7th, Bard estimated that 12,400 plaintiffs had filed claims involving its mesh products, including the Avaulta implant. The company was also preparing to defend five class action cases in the U.S., and four in Canada.
A Case List updated on July 15th by the U.S. Judicial Panel on Multidistrict Litigation (JPML) indicated that 8,667 claims have now been filed against Bard in West Virginia federal court. A total of 1,517 cases had also been filed at the state court level, in a litigation established in New Jersey’s Atlantic County Superior Court as of July 28, 2014.
As C.R. Bard and other companies begin to settle pelvic mesh lawsuits, the U.S. Food and Drug Administration (FDA) has begun to address public concern over the devices. In April 2014, the regulator drafted a proposal that would reclassify the devices as Class III, requiring manufacturers to submit all products for pre-marketing safety testing and approval.
A month later, the FDA rejected a petition from Public Citizen that asked for a complete market withdrawal of transvaginal mesh used in pelvic organ prolapse repair. The agency said that while it did agree with the consumer group’s concerns, they should have instead sought to reclassify the devices as Class III through its formal process for reclassification.
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