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From Products Liability Law Daily, October 1, 2014

Settlement of remaining American Medical Systems vaginal mesh product claims announced

By Susan Lasser, J.D.

Endo International plc (Endo) announced that it reached master settlement agreements with several of the remaining plaintiffs who had filed suit against the company’s subsidiary, American Medical Systems, Inc. (AMS), alleging that AMS’s vaginal mesh products were defective. According to a news release issued by Endo, the settlement agreements were not an admission of liability or fault, and were expected to resolve substantially all of the AMS U.S. vaginal mesh-related claims (In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2325).

Endo had previously established a pre-tax products liability reserve of approximately $1.2 billion. The company said that it expected to increase its pre-tax products liability accrual for all known, pending, and estimated future claims in the most part related to vaginal mesh products as a result of the newly reached agreements. Endo said that it anticipated increasing the reserve amount to about $1.6 billion in total. The news release also reports that AMS expects to fund the payments under all settlements in 2014, 2015, 2016, and 2017. To date, the company has paid approximately $200 million into qualified settlement funds pursuant to the terms of previously announced agreements.

According to the news release, Endo’s "top priority is the safety and efficacy of its subsidiaries’ products and supporting the patients and physicians who use them." The company also maintained that AMS would continue to develop its women’s health business and products.

Background. Endo International plc is a global specialty healthcare company that develops, manufactures, markets, and distributes branded pharmaceutical, generic and device products through its operating companies. Its global headquarters are in Dublin, Ireland, and its U.S. headquarters are in Malvern, Pennsylvania. American Medical Systems (AMS) is headquartered in Minnetonka, Minnesota, and is a diversified supplier of medical device technology for the treatment of incontinence, sexual dysfunction, benign prostatic hyperplasia (BPH), and other pelvic disorders. The subsidiary "is focused on improving access and outcomes with the goal of restoring patient quality of life," according to the news release.

Complaint. The plaintiffs in the action against AMS included women (patients) who had one or more of AMS’s pelvic mesh products inserted in their bodies to treat certain medical conditions—primarily pelvic organ prolapse and stress urinary incontinence—and were subsequently injured due to alleged product failures. Alleged defects, as outlined in the master complaintinclude the following: (1) the use of polypropylene and collagen material in the products and the immune reactions that result from this material, causing adverse reactions and injuries; (2) the design of the products to be inserted transvaginally, into and through an area of the body with high levels of bacteria that can adhere to the mesh causing immune reactions and subsequent tissue breakdown and adverse reactions and injuries; (3) biomechanical issues with the products’ design, including, but not limited to, the propensity of the products to contract or shrink inside the body, which in turn can cause the inflammation of surrounding tissue, and cause it to become fibrotic and contract, resulting in injury; (4) the propensity of the transvaginal mesh devices for "creep," or to gradually elongate and deform when subject to prolonged tension inside the body; (5) the products’ inelasticity, causing them to be improperly mated to the delicate and sensitive areas of the vagina and pelvis where they were implanted, and causing pain upon normal daily activities that involve movement in the pelvic region; and (6) the propensity of the products to degrade and fragment over time, causing a chronic inflammatory and fibrotic reaction, and resulting in continuing injury over time.

In addition to design defect allegations, the patients alleged that the manufacturer failed to warn of these and other of the products’ propensities and risks, and failed to adequately test the products, as well as underreported the propensity of the products to fail. Further, the patients maintained that "suitable alternatives" existed that did not have the same frequency or severity of risks as did the manufacturer’s products. The patients alleged seventeen claims against AMS, including: negligence; strict liability—design defect; strict liability—manufacturing defect; strict liability—failure to warn; strict liability—defective product; breach of express warranty; breach of implied warranty; fraudulent concealment; negligent misrepresentation; and punitive damages.

The case number is MDL No. 2325.

MainStory: TopStory MedicalDevicesNews SettlementAgreementsNews DamagesNews DesignManufacturingNews WarningsNews WestVirginiaNews

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