July 17, 2013 — American Medical Systems (AMS), a unit of Endo Pharmaceuticals Inc., has agreed to pay $54.5 million to settle an undisclosed number of vaginal mesh lawsuits, according to filing with the U.S. Securities and Exchange Commission (SEC). AMS is currently facing thousands of lawsuits from women who were injured by the Elevate, Perigee, and Apogee mesh implants, which are used to treat stress urinary incontinence and pelvic organ prolapse.
AMS estimated that their potential liability from all current an future vaginal mesh lawsuits will be at least $160 million. Currently, there are 8,614 cases pending in the federal litigation, and 70 cases have been closed. All of the lawsuits are centralized in a Multi-District Litigation (MDL) in the U.S. District Court for the Southern District of West Virginia.
Plaintiffs in the lawsuits allege that design defects have led to a variety of complications and side effects, including erosion, infection, organ perforation, chronic pain, recurrent incontinence, additional surgery, and permanent complications.
AMS officials stated that the settlements are not an admission of liability, and they “intend to continue to vigorously defend themselves in the remaining mesh product liability cases and in any new cases that may arise.”
The company agreed to the settlements only a few months after a jury found that Johnson & Johnson and its Ethicon unit must pay more than $11 million in damages to a woman who was injured by the Gynecare Prolift. Last year, a jury in New Jersey found that C.R. Bard must pay a woman $3.6 million for injuries caused by the Avaulta Plus.
In 2008, the U.S. Food and Drug Administration (FDA) notified manufacturers about reports of complications. In 2011, the FDA issued another warning that serious complications were “not rare.” They also required manufacturers to conduct additional safety studies. Soon after, several manufacturers withdrew vaginal mesh products from the market.
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