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Shezad Malik MD JD
Shezad Malik MD JD
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AMS Transvaginal Mesh Lawsuits to be Consolidated

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The Trans Vaginal Mesh (TVM) saga continues and another Multidistrict litigation is pending. American Medical Systems (AMS), a pelvic mesh manufacturer, is filing motions for the centralization and consolidation of all transvaginal mesh lawsuits filed in federal district courts throughout the United States.

There are currently at least 85 AMS mesh lawsuits filed on behalf of 133 different people, which are pending in 20 different federal district courts. The complaints all involve allegations of design defects associated with various AMS surgical mesh products, including the AMS Apogee, AMS BioArc, AMS Elvate, In-Fast Unltra, MiniArc, Monarc, AMS Perigee, SPARC and Straight-In mesh. The medical devices are implanted in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

On November 23, AMS filed a motion with the U.S. Judicial Panel on Multidistrict Litigation to consolidate all of the cases for pretrial proceedings in the U.S. District Court for the Eastern District of Minnesota. In the alternative, the medical device manufacturer has proposed that the cases be centralized in the Southern District of West Virginia.

AMS claims that centralizing the cases as part of an MDL, or multidistrict litigation, would serve the convenience of the parties, prevent duplicative discovery and avoid conflicting pretrial rulungs from different judges.

All of the lawsuits allege that problems with the design, manufacturing, testing, marketing or labeling of the AMS vaginal mesh products caused plaintiffs to experience severe complications and permanent injuries.

In July, the FDA issued a warning about the risk of transvaginal mesh problems, especially when used for repair of pelvic organ prolapse. A number of women have filed adverse event reports with the FDA after experiencing infection and erosion of the mesh through the vagina.

From January 1, 2008 through December 31, 2010, the FDA reports that it received 2,874 reports of complications linked to the use of surgical mesh devices meant to treat pelvic organ prolapse (POP) or female stress urinary incontinence (SUI). A review of available data has led the FDA to conclude that there is no evidence that vaginal mesh implants provide any additional benefits when compared to more traditional surgeries to fix POP and SUI.

AMS argues that the cases should be centralized in Minnesota, where they maintain their headquarters and where most of the documents and witnesses are located.The first federal lawsuit involving AMS mesh was filed in September 2008 in the U.S. District Court for the Northern District of California, where 23 of the AMS cases are currently pending.

Only 4 lawsuits are pending in Minnesota, where AMS has proposed the litigation be centralized, and there are only 2 pending in the Southern District of West Virginia, which was identified as the alternative location.

Over the past year, a growing number of Bard Avaulta vaginal mesh lawsuits have also been filed by women who have experienced gynecological problems. All of the complaints involve similar allegations that C.R. Bard’s Avaulta Anterior and Posterior BioSynthetic Support System, which was introduced in 2007, was negligently designed and that the company failed to warn patients of possible complications that can result in severe pain and disfigurement.

In October 2010, the federal Bard Avaulta litigation was consolidated as part of an MDL for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia.