Pharmaceutical

Bard settles transvaginal mesh lawsuits

2012 TVM serious complications Bard settles transvaginal mesh lawsuitsC.R. Bard has agreed to settle nearly 100 lawsuits related to its transvaginal mesh (TVM) devices that were pending in U.S. District Court in West Virginia. Thousands of TVM cases are consolidated under U.S. District Judge Joseph R. Goodwin. In addition to Bard, cases are pending against other medical device manufacturers including Johnson & Johnson and Boston Scientific.

In August 2013, Bard was hit with a $2.2 million jury verdict in the first transvaginal mesh lawsuit to go to trial in the consolidated multidistrict litigation (MDL). A jury found that the company’s Avaulta Plus Posterior BioSynthetic Support System TVM, used to treat pelvic organ prolapse and stress urinary incontinence, was responsible for causing serious internal injuries. The plaintiff in that case was Donna Cisson.

Since the TVM litigation began, the U.S. Food and Drug Administration (FDA) has classified TVM as a high-risk device. Previously, TVM was approved under the fast track 510(k) clearance procedure, which allows medical devices to gain approval without actual patient testing if they are similar to other already approved devices. The new designation will require TVM to undergo more rigorous testing prior to being approved for use.

The case is In Re: C.R. Bard Inc. Pelvic Repair Systems Product Liability Litigation, case number 2:10-md-02187, in U.S. District Court for the Southern District of West Virginia.

Source: Law360