J&J Ordered to Pay $5.7 Million Over Incontinence Implant

Johnson & Johnson
Johnson & Johnson, based in New Brunswick, New Jersey, faces more than 30,000 lawsuits accusing Ethicon of making improperly designed vaginal inserts that damaged women’s organs and made sex painful. Photographer: Andrew Harrer/Bloomberg

Johnson & Johnson was ordered by a California jury to pay $5.7 million to a woman who said one of the company’s Abbrevo vaginal-mesh implants eroded inside her, forcing her to have surgery, in the first verdict over that device.

Jurors in state court in Bakersfield deliberated for more than three days before concluding Thursday that J&J’s Abbrevo mesh sling was defectively designed and officials of J&J’s Ethicon unit failed to properly warn doctors and consumers about the device’s risks. The panel awarded Coleen Perry $700,000 in compensatory damages and $5 million in punitive damages over the mishandling of the device.

The verdict is the first to find fault with the Abbrevo sling, which J&J introduced in 2010 as its latest innovation for treating incontinence in women. Analysts say the market for such devices is expected to top $1.7 billion by 2017.

“The message here is that Johnson & Johnson can’t defend the safety and reliability of its newest” incontinence sling, Richard Freese, one of Perry’s lawyers, said Thursday.

J&J officials said they planned to appeal the verdict because company executives don’t think they mishandled the device.

“The evidence showed the TVT Abbrevo midurethral sling was properly designed and Ethicon acted appropriately and responsibly in the research, development and marketing of the product,” Matthew Johnson, an Ethicon spokesman, said in an e-mailed statement.

Organ Damage

J&J, based in New Brunswick, New Jersey, faces more than 30,000 lawsuits accusing Ethicon of making improperly designed vaginal inserts that damaged women’s organs and made sex painful.

In June 2012, J&J voluntarily pulled four lines of mesh inserts, including the Prolift implant, off the market. It still sells the Abbrevo and other incontinence-sling lines.

The decision to stop selling the Prolift and other mesh inserts came six months after regulators ordered J&J and more than 20 other makers of such devices to study organ damage and other health complications blamed on the products, which treat incontinence and shore up weakened pelvic muscles.

Many of the vaginal-mesh cases against J&J and other implant makers have been consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia, for information exchanges and bellwether trials. J&J alerted Goodwin in 2012 that it was ending sales of some lines of inserts.

Settlement Talks

Boston Scientific Corp., C.R. Bard Inc. and other makers of vaginal inserts targeted in suits had talks last year about settling cases over the devices, according to people familiar with the discussions. J&J has refused to participate in settlement talks about its inserts, the people said.

In the California case, Perry, a retired caterer, said she got her Abbrevo sling implanted in 2011 to treat incontinence. Erosion problems with the device forced her to have surgery to remove part of it the following year, according to court testimony.

Along with the findings about the device being defectively designed and Ethicon officials’ failure to adequately warn about its risks, the California jury concluded that company officials “negligently misrepresented” facts about the sling’s safety, Freese said.

J&J’s lawyers argued during the eight-week trial that the Abbrevo sling was the “gold standard” for treating incontinence and that Ethicon officials properly tested it before putting it on the market.

A jury in state court in Dallas last year concluded the design of a TVT-O incontinence sling implanted in a woman was flawed and she deserved $1.2 million in compensatory damages. The TVT-O sling remains on the market.

The California case is Perry v. Luu, 1500-CV-279123-LHB, Superior Court of California, Kern County (Bakersfield). The J&J consolidated cases are In re Ethicon Pelvic Repair System Products Liability Litigation, 12-md-2327 U.S. District Court, Southern District of West Virginia (Charleston).

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