AMS Transvaginal Mesh Litigation Cases settle for $830 million

Endo International Plc, along with its subsidiary American Medical Systems, Inc., have agreed to pay approximately $830 million to resolve nearly 20,000 claims by individuals who suffered severe complications from the use of AMS’ transvaginal mesh medical device. The settlement, reached only in principle, covers the majority of the mesh-related litigation against the companies and was entered into with several plaintiffs’ law firms, including Motley Rice LLC, Blasingame, Burch, Garrard & Ashley, P.C., Levin Simes LLP, and Clark, Love and Hutson, G.P.

The news of this resolution was published on the heels of the Food and Drug Administration issuing two proposed orders to address the health risks associated with transvaginal mesh used to repair pelvic organ prolapse, or the weakening of a woman’s bladder, uterus and bowel after childbirth, aging or other causes. According to the FDA’s news release, if finalized, “the orders would reclassify surgical mesh for transvaginal pelvic organ prolapse from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness."

As of April 15, 2014, the Judicial Panel on Multidistrict Litigation reported over 16,000 AMS mesh cases alone coordinated in federal court under U.S. District Judge Joseph Goodwin in the Southern District of West Virginia. In July 2013, Judge Goodwin had selected the following bellwether cases for trial: Fontes v. American Medical Systems, Inc., 2:12-cv-02472, Serrano v. American Medical Systems, Inc., 2:12-cv-03719, Jilovec v. American Medical Systems, Inc., 2:12-cv-05561, and Weiler v. American Medical Systems, Inc., 2:12-cv-05836. The trials were set to commence on June and July of 2014, however, the parties seemingly utilized the period prior to trial to negotiate the terms of a settlement as evidenced by this settlement and Endo’s agreement to pay $54.5 million to resolve an undisclosed number of transvaginal mesh-related cases last year. 

Joe Rice of Motley Rice stated that this resolution would be implemented over the next twelve months. The settlement of each case, however, is subject to several conditions, such as verification that plaintiffs were implanted with the device and confirmation of medical records. Nevertheless, it is estimated that average award per plaintiff will be $40,000. In a statement released by Endo, the company said that it will incur a pre-tax, noncash charge of $625 million in the first quarter to help cover the costs of the settlement.

Since TVM was first introduced into the market over 20 years ago, millions of women have undergone the procedure. Due to  injuries caused by the implantation of these devices, over 43,000 actions in 7 separate multi-district litigations are now pending in front of Judge Goodwin, including those individuals with claims against Endo and AMS. With the news of the this settlement and the FDA’s proposed order classifying certain transvaginal mesh devices as ‘high-risk,’ it appears more likely that other manufacturers of transvaginal mesh devices implicated in these litigations will also seek global resolutions.

The case is: In re: American Medical Systems, Inc., Case No. 2:12-md-2325 (S.D. W.Va.)

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