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Shezad Malik MD JD
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Bard BellWether Trials Over Vaginal Mesh Injuries

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C.R. Bard Inc. will face its first federal-court trial in 2013 over claims that the company’s vaginal-mesh implants injured women. U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia, set a Feb. 5 trial date for the first of about 600 Bard Avaulta mesh federal cases. The plaintiffs are alleging that Bard’s Avaulta device caused pelvic organ damage.

The West Virgina court is overseeing the MDL consolidation of cases filed in federal courts across the U.S. against Bard, Johnson & Johnson and other makers of vaginal-mesh inserts.

Bard and Johnson and Johnson on the hook

Bard, based in Murray Hill, New Jersey, and a unit of New Brunswick, New Jersey-based J&J also face litigation in U.S. state courts over their mesh products.

Scope of the Vaginal Mesh Problem

More than 75,000 women a year have the devices inserted vaginally to treat pelvic organs that bulge, or prolapse, or to deal with incontinence.

FDA Mesh Warning

A U.S. Food and Drug Administration report in August 2011 found that vaginal-mesh products should be classified as posing a high risk to patients based on a review of side-effect reports submitted to regulators from January 2008 to December 2010.

FDA Demands More Study

In January, the FDA ordered 31 manufacturers, including Bard and J&J (JNJ), to study rates of organ damage and complications linked to the vaginal-mesh implants.

According to regulators, the companies must conduct three years of studies on the devices’ safety and effectiveness.

New Jersey Mesh Lawsuits

Some mesh lawsuits are pending in state court in Atlantic City, New Jersey. Superior Court Judge Carol Higbee is coordinating discovery in those cases.

Higbee has set a Nov. 5 trial for the first case against J&J’s Ethicon unit over claims that its Gynecare Prolift vaginal-mesh insert harmed women.

West Virginia Federal MDL

In February, the Judicial Panel on Multidistrict Litigation consolidated federal suits against pelvic mesh makers before Goodwin. The federal court is overseeing evidence-gathering efforts in cases against Bard, J&J, Boston Scientific Corp. (BSX) and the American Medical Systems unit of Endo Pharmaceutical Holdings Inc.

The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 2:10-MD-02187, U.S. District Court, Southern District of West Virginia (Charleston).