Thousands of transvaginal mesh lawsuits filed against American Medical Systems, Inc. are moving forward as a federal court set new dates for the multi-district litigation’s bellwether trials. A court order issued on Tuesday indicated that the first trial is scheduled to begin on June 2, 2014 and the second will begin on July 7.
American Medical Systems is a subsidiary of Endo Pharmaceuticals, an international healthcare company. More than 16,000 transvaginal mesh lawsuits have been filed against the company. Mesh lawsuits have also been filed against Johnson & Johnson, Boston Scientific, and C.R. Bard.
Transvaginal surgical mesh is used for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence in women. In 2008, the Food and Drug Administration (FDA) issued a warning letter to physicians regarding complications associated with the placement of mesh products. During the past 3 years, the FDA has received over 1,000 adverse event reports related to mesh products from 9 different manufacturers.
Transvaginal mesh products were approved by the FDA under the 510(k) expedited process, allowing the products to enter the market as FDA-approved without extensive trials or testing. It was not until last year that the FDA ordered over 30 manufacturers of transvaginal mesh products to conduct post-market safety tests.
Endo Pharmaceuticals, American Medical Systems’ parent company, was recently ordered to pay nearly $200 million to resolve criminal and civil charges over the company’s false marketing of Lidoderm, a topical, pain-relieving patch.
The government alleged that Endo promoted Lidoderm for off-label uses, causing federal health care programs to pay false claims. The patch was only approved by the FDA for the relief of post-herpetic neuralgia. A large part of the company’s $192.7 million settlement involved False Claims Act charges filed under the qui tam or whistleblower provision of the False Claims Act.
“Big pharmaceutical companies will underplay the dangers of their manufactured drugs and devices, and unfortunately some will take extreme measures to hide these risks from the public,” commented Robert Price, a drug and medical device attorney with the Levin, Papantonio law firm and a member of the TVM Plaintiffs Steering Committee. Unfortunately, these companies often focus on profit over consumer safety.”