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Federal judge dismisses pelvic mesh suit

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A federal judge in Charleston has dismissed a lawsuit filed by a Texas woman who claimed Ethicon's transvaginal mesh products had caused her severe pelvic pain and other complications after it was implanted, saying she hadn't proven her case.

The suit was filed in July 2012 by Carolyn Lewis and her husband, Kenneth. Also named as plaintiffs in the original suit, filed in Texas, were Augustina Brown-Singletary of Virginia, Karin Harrison of Wisconsin, Patricia Headrick of Illinois, Katie Uszler of Wisconsin and Nevada resident Kelly Young, along with their husbands.

All but one of the women, Young, was implanted with Ethicon's Gynecare TVT. Young received Gynecare's Prolift+M.

The suit claimed Ethicon's transvaginal mesh products were prone to failure and could shrink, disintegrate or degrade after being implanted, causing the women implanted with the products severe pelvic pain when they emptied their bladder and during sex. It claimed Ethicon, a Johnson & Johnson subsidiary, knew or should have known the mesh products posed a substantial health risk, alleging the company intentionally withheld information and failed to adequately warn women of the risk of complication.

But one week into the trial, U.S. District Judge Joseph Goodwin issued a directed verdict in favor of the manufacturer. The decision came after the plaintiffs had rested their case, which included testimony from various experts as well as Lewis.

In his order, Goodwin said simply that he'd granted Ethicon's "oral motion for judgment as a matter of law" and dismissed the case.

Ethicon spokesman Matthew Johnson welcomed the directed verdict, calling it a "sound decision by the court."

"While we are always concerned when a patient experiences an adverse medical condition, TVT continues to be a safe and effective option for women suffering from the debilitating effects of stress urinary incontinence," Johnson said in a statement released shortly after Goodwin's decision was announced.

Transvaginal mesh is used to treat pelvic organ prolapse and urinary incontinence, but thousands of women implanted with it claim it's caused them serious health problems, in many cases requiring one or more surgeries to reverse its effects.

Nearly 40,000 cases filed in federal courts across the country seeking damages from six transvaginal mesh manufacturers — American Medical Systems, Boston Scientific, Coloplast, Cook Medical and C.R. Bard, as well as Johnson & Johnson's Ethicon — were transferred to West Virginia as part of a federal multi-district litigation.

Multi-district litigation consolidates cases with common questions of fact to one district, thereby saving time and money for the parties involved as well as the courts.

Goodwin was assigned to manage discovery and pretrial motions in the MDL and selected representative cases, including Lewis's, to serve as "bellwether trials" that allow both sides to assess the strengths and weaknesses of the MDL cases as a whole.

Lewis was implanted with Ethicon's TVT product in November 2009. Her attorneys had argued that the polypropylene material used in pelvic mesh products triggers an immune reaction in women causing tissue breakdown and inflammation, and had claimed its anchoring system caused nerve damage.

At least two bellwether trials previously resulted in compensation. In August, a federal jury in Charleston awarded Georgia resident Donna Cisson $1.75 million in punitive damages and $250,000 in compensatory damages from C.R. Bard, saying she'd been able to prove the company's Avaulta Plus Posterior BioSynthetic Support System was defective, while a North Carolina woman reached an out-of-court settlement with C.R. Bard.