J&J Vaginal-Mesh Design Suit Thrown Out for Lack of Evidence

Feb 18, 2014 5:36 pm ET

(Updates woman’s claims starting in 11th paragraph.)

Feb. 18 (Bloomberg) -- Johnson & Johnson persuaded a judge to throw out a woman’s lawsuit arguing a vaginal-mesh implant was defectively designed, ending the first trial of claims the device caused patients’ injuries.

U.S. District Judge Joseph Goodwin in Charleston, West Virginia, today granted judgment for J&J on Carolyn Lewis’s claims that a TVT Retropubic sling implanted to treat incontinence was improperly designed, according to court records.

J&J, based in New Brunswick, New Jersey, is facing more than 12,000 federal-court claims that the TVT Retropubic slings and its other vaginal-mesh inserts degraded over time, causing pain and injuries. The cases have been consolidated before Goodwin for pretrial information exchanges. Lewis’s case was the first sling suit to go to trial. More than a million women have had the slings inserted since the device was approved in 1998, J&J’s lawyers said in court filings.

The judge concluded Lewis’s attorneys “failed to present sufficient evidence to support her claim that a defect in the device caused her injury,” Matthew Johnson, a spokesman for J&J’s Ethicon unit said in an e-mailed statement. Ethicon makes and sells the slings.

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. 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 alone, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs, according to court filings.

Thousands of women contend they’ve been injured by the devices and have sued J&J, Murray Hill, New Jersey-based Bard; Endo Health Solutions Inc. of Chadds Ford, Pennsylvania; and Natick, Massachusetts-based Boston Scientific Corp.

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.

Design Challenged

Last year, a New Jersey jury ruled that J&J must pay $11.1 million in damages to a woman who blamed a Prolift device for her injuries in the first case over any of the company’s implants to go to trial.

Lawyers for Lewis, 59, contend Ethicon officials knew the sling’s design allowed the mesh to shrink and fray, causing it to damage women’s bladders and vaginas, according to court filings. The Texas resident had surgery last year to remove the device after suffering vaginal pain during intercourse and continued incontinence problems, according to court filings, according to court filings.

J&J’s lawyers countered in court filings that the U.S. Food & Drug Administration found the TVT Retropubic sling to be a safe and effective for use in women and the device continues to be the “gold standard” for incontinence treatments.

The case is Lewis v. Johnson & Johnson, 12-cv-04301, U.S. District Court, Southern District of West Virginia (Charleston).

--With assistance from David Voreacos in federal court in Newark, New Jersey. Editors: Fred Strasser, Michael Hytha