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Endo Health Agrees to $54.5 Million in Transvaginal Mesh Settlements

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On the heels of the $11.1 million verdict awarded to South Dakota plaintiff Linda Gross, a settlement has been reached in a limted number of other transvaginal mesh lawsuits. Endo Health Solutions, Inc. (ENDP), parent company of American Medical Systems (AMS), has agreed to pay $54.5 million to settle a small number of the thousands of lawsuits brought by women injured by AMS mesh products.

Women who have filed lawsuits against AMS complain of mesh complications like erosion, extrusion, pain, infections, organ perforation, and urinary problems. Plaintiffs claim that mesh manufacturers manufactured defective products that failed to provide adequate warnings about the risks, and should have conducted additional safety studies on their products.

Terms of the ENDP Agreement

The ENDP settlement agreement was completed on June 14, 2013. In it, ENDP agrees to pay $54.5 million into a settlement fund held in escrow by a mutually agreed upon escrow agent. The company makes a point to note that they are not admitting fault by agreeing to settle a limited number of cases: “The Agreement was entered into solely by way of compromise and settlement and is not in any way an admission of liability or fault by the Company or AMS. The Company and AMS intend to continue to vigorously defend themselves in the remaining mesh product liability cases and in any new cases that may arise.”

In the vaginal mesh MDLs, which includes claims made against AMS, Boston Scientific, Coloplast, C. R. Bard, Cook Medical, and Johnson & Johnson (Ethicon), Judge Joseph R. Goodwin has scheduled the first bellwether trials to begin this year with more scheduled into 2014.

Vaginal Mesh Manufacturers Face Thousands of Lawsuits

According to a Bloomberg article, AMS faces about 5,000 vaginal mesh lawsuits, most of which were consolidated in West Virginia on February 7, 2012. Many of these were filed after the July 13, 2011 FDA warning alerting physicians that complications with transvaginal mesh were not rare. The FDA also questioned whether surgery with mesh was any more effective than traditional surgery without mesh.

To try to answer that question, mesh manufacturer Boston Scientific recently contributed $1 million toward a study with the Pelvic Floor Disorders Network (PFDN) to analyze data from women treated with hysterectomies or vaginal mesh implant surgery. The results aren’t expected until 2017, however, and further are litigation-driven and potentially subject to the manufacturer’s bias.

Meanwhile, litigation continues to move forward, with hope that more settlement agreements may be coming soon.

Other Verdicts in Favor of Plaintiffs

So far, in addition to the verdict awarded to Linda Gross, one other transvaginal mesh lawsuit was decided in favor of the plaintiff. In July 2012, a California state court awarded 53-year-old Christine Scott $5.5 million in damages. This was the first transvaginal mesh lawsuit to go to trial in the U.S. Scott claimed she suffered from serious complications after her mesh surgery, including organ perforation. She had to undergo at least eight correctional surgeries.