Thursday, February 20, 2014

J&J Says It Prevails in Suit Over Vaginal-Mesh Sling

J&J Says It Prevails in Suit Over Vaginal-Mesh Sling

Johnson & Johnson said a judge threw out a woman’s lawsuit arguing a vaginal-mesh implant was defectively designed, ending the first trial of claims the sling caused patients’ injuries.
U.S. District Judge Joseph Goodwin in Charleston, West Virginia, today granted a directed verdict for J&J on Carolyn Lewis’s claims that a TVT Retropubic sling implanted to treat incontinence was improperly designed, Matthew Johnson, a spokesman for J&J’s Ethicon unit, said in an e-mail. Ethicon made and sold the sling. The ruling couldn’t be confirmed in court records and a lawyer for the plaintiff didn’t immediately return a call seeking comment.
Lewis had sought to have a jury rule on whether the sling’s design caused painful deformities to her vagina. It was the first case over the TVT Retropubic sling to go to trial.
J&J, based in New Brunswick, New Jersey, is facing more than 12,000 federal-court claims the TVT Retropubic and its other vaginal-mesh inserts eroded and shrank over time, causing pain and injuries. Those cases have been consolidated before Goodwin for pretrial information exchanges.
The judge concluded that Lewis’s attorneys “failed to present sufficient evidence to support her claim that a defect in the device caused her injury,” Johnson said in the e-mailed statement.

Organs Studied

Thomas Cartmel, one of Lewis’s lawyers, didn’t immediately return a call for comment today on the decision to throw out the case, which came before J&J would have been forced to present evidence in its defense during the week-long trial.
Last year, the U.S. Food and Drug Administration ordered J&J, C.R. Bard Inc. (BCR) and 31 other vaginal-implant makers to study rates of organ damage and complications linked to the implants.
Doctors inserted more than 70,000 mesh devices in the U.S. in 2010, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs.
Thousands of women contend they’ve been injured by meshes that have eroded. Patients have sued J&J, Murray Hill, New Jersey-based Bard; Endo Health Solutions Inc. (ENDP) of Chadds Ford, Pennsylvania; and Natick, Massachusetts-based Boston Scientific Corp. (BSX)
J&J officials decided last year to stop selling some lines of vaginal-mesh implants after being hit with a wave of suits over the devices. J&J, the world’s biggest maker of medical products, contended in court filings that its Prolift and TVT Retropubic devices are safe and effective and that the company gave adequate warning of any risks associated with them.
Last year, a New Jersey jury ruled that J&J must pay $11.1 million in damages to a woman who blamed Prolift for her injuries in the first case over any of the company’s implants to go to trial.
The case is Lewis v. Johnson & Johnson, 12-cv-04301, U.S. District Court, Southern District of West Virginia (Charleston).

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