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Bard Transvaginal Mesh Manufacturers Face February 2013 Trials

Defective Medical Devices

With hundreds if not thousands of lawsuits filed against transvaginal mesh manufacturers, the first trial date has been set for cases to be heard against C.R. Bard Inc. February 5, 2013 is the first date set for bellwether trials filed by women who claims injuries after they were implanted with Bard’s Avaulta medical device. The cases are part of the 600 cases consolidated in multidistrict litigation (Bard No. 2187) before U.S. District Judge Joseph R. Goodwin of Charleston, West Virginia. The company also makes Avaulta BioSynthetic, Avaulta Plus and Avaulta Solo as well as pelvic repair meshes including PelviSoft, PelviLace, Palvitex, Uretex, Align, Acellular Collagen Matrix, Faslata Allograft, and Pelvicol.

Bard is a unit of New Brunswick, New Jersey-based Johnson & Johnson. Hundreds of cases are still being filed in state courts around the country. In Atlantic City, New Jersey, Superior Court Judge Carol Higbee has set a November 5 trial date for the first bellwether litigation to be heard against Ethicon, a unit of Johnson & Johnson, over its Gynecare Prolift vaginal mesh.

The women claim injuries such as mesh erosion and shrinkage, pelvic and nerve pain, organ perforation, and infection, among other complications, and that Bard sold a defective and dangerous medical device and has been doing so since 2005.

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The outcomes of these early cases, which represent similar complaints by other plaintiffs, will indicate how future cases will be tried and may serve as the basis for a settlement.

There are three other mesh manufacturers named in the multidistrict litigation or MDL consolidated before Judge Goodwin – American Medical Systems, Boston Scientific Corp. and Ethicon Inc. Bard has been in the same court since 2010.

An early version of synthetic mesh, used in women to treat prolapse and incontinence, was the ProteGen mesh by Boston Scientific; however that was recalled from the market for being defective.  That did not stop most of today’s transvaginal mesh manufacturers to name it as a ‘predicate device’ to serve as the model for the others to follow that are on the market today. Rep. Edward Markey has legislation pending that devices cannot name a recalled predicate medical device as a basis for approval.

Synthetic vaginal mesh remains on the market even though an expert panel recommended it be reclassified as Class III or high-risk last fall because of the number of adverse reports coming forward to the agency. Just short of a recall, in January the FDA ordered mesh manufacturers to begin studying the rate of complications after implant surgery. The surveys must continue for three years. Unfortunately, the evaluations are being done after surgery and not before.

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