Transvaginal Mesh Settlements Reached to Resolve Nearly All AMS Cases

According to a recent report by Endo International, “substantially all” of the transvaginal mesh lawsuits pending against it’s American Medical Systems (AMS) subsidiary have been settled.

Tens of thousands of women nationwide were pursuing AMS mesh lawsuits after experiencing painful and debilitating complications associated with the use of bladder sling and transvaginal mesh products for repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI), including erosion of the mesh through the vagina, infections and other problems.

Earlier this year, Endo announced that it had reached agreements to settle more than 22,000 AMS cases for $830 million. However, this agreement still left thousands of claims unresolved.

In a press release issued on September 30, Endo indicates that an AMS mesh settlement has been reached with several major remaining plaintiff groups, resolving nearly all of the remaining cases involving their products.

AMS Mesh Settlements

Endo acquired AMS for about $2.6 billion in April 2011, as the lawsuits over vaginal mesh and bladder sling products previously sold by the company were beginning to mount. Among products marketed by AMS for transvaginal treatment of POP and SUI were the AMS Pedigree, AMS Apogee, and AMS Elevate implants.

In the statement released this week, the company says it has already paid $200 million in settlements and expects the final tally for all of its AMS mesh litigation to cost about $1.6 billion.

Although Endo maintains that the settlement is not an admission of liability or fault, the company indicates that it will invest in education of doctors and patients on the risks and benefits of transvaginal mesh products, and will continue to invest in clinical trials seeking evidence on whether its vaginal mesh are safe and effective for women suffering from pelvic organ prolapse or stress urinary incontinence.

“We are very pleased to resolve substantially all of the remaining U.S. vaginal mesh litigation claims facing our AMS business,” said Rajiv De Silva, president and chief executive officer of Endo in the press release. “These settlements will allow us to continue to invest in the growth of our business segments and pursue accretive M&A opportunities. We believe that these settlements will also allow the AMS business to continue its return to growth and enhance focus on the operations and profitability of this leading medical device franchise.”

Transvaginal Mesh Lawsuits

In addition to claims involving AMS mesh, more than 50,000 other lawsuits are pending nationwide against manufacturers of similar transvaginal mesh products, including Johnson & Johnson’s Ethicon subsidiary, Boston Scientific, C.R. Bard, Coloplast Corp, Cook Medical and Neomedic.

While some of the complaints are scattered throughout state courts nationwide, most of the litigation is pending in the federal court system, where seven different federal multidistrict litigations (MDLs) have been established before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia to reduce duplicative discovery in the cases, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

As part of the coordinated proceedings, Judge Goodwin has been preparing groups of cases for early trial dates involving several of the different manufacturers. Known as “bellwether” claims, the trials are designed to help the parties gauge the relative strengths and weaknesses of their cases.

While manufacturers have had some success in individual cases, juries have hammered the companies hard in cases where plaintiffs won, including several cases where punitive damages were awarded to punish the manufacturers for their actions surrounding the sale of the products and failure to warn about the risk of complications.

At least a half-dozen trials have resulted in multi-million dollar verdicts for plaintiffs, which could prove costly for the other manufacturers if transvaginal mesh settlements are not reached to resolve the litigation.

Given the lack of progress made by several of the manufacturers toward resolutions for cases, Judge Goodwin has indicated that he plans to speed up the vaginal mesh trial schedule over the next year, ordering that hundreds of individual cases against C.R. Bard, Boston Scientific and Ethicon be prepared and ready to go to trial by January 2015.

If settlements are not reached, it is expected that he will begin remanding cases back to U.S. District Courts nationwide for trials to be scheduled throughout 2015.