A new report reveals that Boston Scientific is facing nearly 300 lawsuits over injuries allegedly caused by its transvaginal mesh products. According an article published online by Mass. Market, some 170 Boston Scientific transvaginal mesh lawsuits are consolidated in a federal multidistrict litigation in Charleston, West Virginia, along with similar suits against C.R. Bard, Johnson & Johnson and American Medical Systems. Boston Scientific has also been named more than 100 additional transvaginal mesh injury claims pending in Massachusetts state court in Middlesex County.
All of the lawsuits allege transvaginal surgical mesh products marketed by Boston Scientific caused women to suffer painful and debilitating injuries when they were used in surgeries to treat pelvic organ prolapse and stress urinary incontinence. Plaintiffs claim the company consistently underreported problems and withheld information about the complications associated with its pelvic mesh products from federal regulators, doctors and patients, according to Mass. Market.
Transvaginal Mesh Controversy
The U.S. Food & Drug Administration (FDA) has been conducting a safety review of transvaginal mesh since 2008. Last July, the agency said in a Safety Communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh products made by Johnson & Johnson and other companies from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. According to the FDA, even when women undergo surgery, sometimes multiple surgeries, to have defective mesh removed, complications continue because it is almost always impossible to completely remove the device.
According to the Mass. Market report, the FDA originally placed transvaginal mesh products in its Class II device category, meaning they didn’t need thorough clinical human trials to prove their safety before they were put on the market. Manufacturers only needed to show a product was “substantially equivalent” to another already approved by the agency. In January, the FDA asked transvaginal mesh manufacturers to conduct post-market safety studies of their products. The agency is now considering moving transvaginal mesh for POP repair to a higher risk medical device category.
Transvaginal Mesh Lawsuits
In addition to the federal litigation in West Virginia and the Boston Scientific cases pending in Massachusetts, transvaginal mesh manufacturers are facing additional lawsuits in other jurisdictions. Both C.R. Bard and Johnson & Johnson are named in transvaginal mesh lawsuits in state court in Atlantic City, New Jersey. The first trial in that litigation, a case involving Gynecare Prolift made by Johnson & Johnson’s Ethicon unit, is scheduled to go to trial on November 5. American Medical Systems faces lawsuits in Delaware and Minnesota state courts over its Perigee, Apogee and Elevate surgical mesh products.
The first bellwether trial in the West Virginia litigation, involving lawsuits against C.R. Bard, is scheduled to start on February 5, 2012. Bellwether trials will help determine how much responsibility the mesh manufacturers bear for plaintiffs’ injuries, and how much any damages are worth.