MDDI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Johnson & Johnson Wins Out in Vaginal Mesh Lawsuit

A federal judge in West Virginia has sided with Johnson & Johnson's Ethicon subsidiary in a vaginal mesh-related lawsuit, ending a jury trial after agreeing with an Ethicon legal motion that plaintiff Carolyn Lewis had failed to make her case.

Ethicon spokesman Matthew Johnson said in an email that U.S. District Judge Joseph Goodwin made a "sound decision" on Tuesday.

"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.

The ruling came less than two weeks after a U.S. magistrate judge in West Virginia ruled that Ethicon negligently destroyed an unspecified number of documents that could have provided evidence in Lewis' case and a host of vaginal mesh-related lawsuits pending in federal court.

The case was initially filed by plaintiff Carolyn Lewis, who was treated with the Gynecare TVT mesh sling, and her husband in July 2012.

On the sixth day of jury trial, Goodwin sided with Ethicon's lawyers when it came to their argument that a case had been made. (Click here to see Ethicon's motion on the matter.)

Ethicon's motion for a judgment from Goodwin said: "Plaintiff provided no evidence that Mrs. Lewis' implant roped, frayed and curled."

J&J's Ethicon subsidiary has been less lucky elsewhere.

Last year, a New Jersey trial related to Ethicon's Gynecare Prolift mesh required the company to pay $11 million in compensatory and punitive damages.

In March 2012, FDA said that the company had been selling its Prolift device for three years without proper regulatory clearance.

Johnson & Johnson agreed to stop selling vaginal mesh products in 2012.

The devices were supposed to treat urinary incontinence. But the FDA from 2008 through 2010 received reports of thousands of serious complications, including mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems.

Other companies that have faced lawsuits over vaginal mesh products include American Medical Systems, Boston Scientific Corp., C.R. Bard, Cook Medical, Endo Health, and Coloplast.

Filed Under
500 characters remaining