Bloomberg News

Bard Faces First Federal Trial Over Vaginal Mesh Next Year

May 02, 2012

C.R. Bard Inc. will face its first federal-court trial next year 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 federal cases contending that Bard’s Avaulta device caused organ damage. Goodwin is overseeing a consolidation of cases filed in federal courts across the U.S. against Bard, Johnson & Johnson and other makers of vaginal-mesh inserts.

The order of trials for the first federal cases over Avaulta “will be determined after completion” of pretrial information exchanges between Bard and the plaintiffs, Goodwin said in his order yesterday.

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. 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.

Scott Lowry, a Bard spokesman, didn’t immediately return a call for comment on the judge’s decision to set the trial date.

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. Women’s groups are demanding that the devices be recalled.

More Study

In January, the FDA ordered 31 manufacturers, including Bard and J&J (JNJ:US), to study rates of organ damage and complications linked to the vaginal-mesh implants. The companies must conduct three years of studies on the devices’ safety and effectiveness, regulators said. Some women contend the devices eroded and shrank over time, causing pain and injuries.

Some mesh suits blaming Bard and J&J for injuries 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.

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

Endo’s AMS unit also faces claims in state courts in Delaware and Minnesota over its Perigee, Apogee and Elevate surgical mesh products, according to court filings.

‘Day In Court’

Goodwin has appointed Bryan Aylstock, Fred Thompson III and Henry G. Garrard III to lead a group of plaintiffs’ lawyers who will oversee the progress pretrial information exchanges over the consolidated federal cases.

Aylstock, a Pensacola, Florida-based lawyer, said he was pleased Goodwin set the first trial over Bard’s mesh product for early next year.

“We have a lot of women who have suffered devastating consequences from the Avaulta product and they deserve their day in court,” the plaintiffs’ lawyer said in a telephone interview.

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).

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net


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