Bloomberg News

J&J Failed to Warn of Vaginal Mesh Risks, Lawyer Says

January 10, 2013

Johnson & Johnson (JNJ:US) sold a defective vaginal mesh implant after testing it inadequately and failing to warn of all the risks, a lawyer for a South Dakota woman told a jury in the first of 1,800 such lawsuits to go to trial.

Linda Gross, 47, claims that she had 18 operations to repair damage caused by the Gynecare Prolift implanted in her on July 13, 2006, to shore up pelvic muscles. Her lawyer told jurors in Atlantic City, New Jersey, today that her chronic pain and other problems were risks that J&J’s Ethicon unit knew before first selling Prolift in March 2005.

“They knew every single catastrophe before it happened,” the attorney, Adam Slater, said in his opening statement. “They knew Linda Gross was going to happen.”

J&J, the world’s biggest seller of health-care products, is accused of failure to warn of the risks, defective design, deceit and negligence.

An attorney for New Brunswick, New Jersey-based J&J denied Gross’s claims in her opening statement.

J&J Attorney

“You heard a lot of allegations and accusations and some of them were no doubt disturbing,” J&J lawyer Christy Jones said. “Frankly, I imagine you’ve got some questions about Ethicon and Johnson & Johnson, and that’s understandable. Certainly, if those accusations were true, your concerns would be warranted. But they are not.”

Ethicon, she said, properly warned Gross and her surgeon of the risks associated with implanting a Prolift device, which helps women whose organs have fallen through the pelvic floor. Gross, she said, needed relief after her rectum fell, and her pelvic floor had been weakened by earlier surgeries.

“The Prolift did exactly what it was supposed to do,” Jones said. “It put her organs back in the correct anatomical position.”

J&J in August stopped selling four mesh devices in the U.S., including the Prolift. The company said in June that it would end sales worldwide based on the products’ commercial viability, not their safety and effectiveness.

FDA Directive

The U.S. Food and Drug Administration told J&J, C.R. Bard Inc. and 31 other manufacturers last January to study rates of organ damage and complications linked to vaginal mesh implants. Doctors implanted more than 70,000 such devices in U.S. women in 2010, threading them through incisions in the vagina to fortify pelvic muscles.

Gross can no longer work as a nurse because of her pain, and she has suffered many other physical complications because of the failure of the mesh in her body, Slater said.

Jones said Prolift “never caused anything that wasn’t expressly warned about at the time of the surgery in 2006. All of her injuries were warned about.”

Treatment Need

In 2006, Jones said, Gross had a condition that was “significantly affecting her life. She wanted and needed treatment. She and her doctor decided that the best, most effective treatment was Prolift. And it was. In fact, it cured her problem, the bowel problem.”

Slater said J&J failed to do any clinical testing to learn the risks of Prolift’s polypropylene mesh inside a woman’s pelvic area. He said the mesh hardens and contracts as tissue grows around it, causing scarring and chronic inflammation. Trying to remove the mesh is akin to removing reinforcing rebar rods from a concrete sidewalk, he said.

“They never ever studied how can you get this stuff out, what’s the best way to do it,” Slater said.

He said internal e-mails will show that company researchers knew for years the risks of the mesh, and Ethicon failed to take adequate steps to develop safer materials.

Application Process

J&J began selling (JNJ:US) Prolift without filing a new application under the FDA’s so-called 510(k) application process, which requires companies to show that a device is “substantially similar” to others on the market. The company determined on its own that it was substantially similar to the Gynecare Gynemesh, one of its devices already approved by the FDA.

The FDA disagreed with J&J’s interpretation and required a new application in August 2007, saying Prolift sales began “without appropriate” clearance.

J&J began sales after citing an agency guidance document, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” Jones said today. The FDA cleared the device in May 2008 after nine months of negotiations with J&J.

The company faced no sanctions because the FDA determined that it applied the guidance in good faith and promptly complied when the agency required a new application.

Slater told jurors today that Gross’s doctor wouldn’t have implanted Prolift had he known it didn’t have FDA clearance.

“If he had been warned and given that information, he wouldn’t have used it with Linda,” Slater said. “It wouldn’t have gotten in her body.”

The case is Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City).

To contact the reporters on this story: David Voreacos in Atlantic City, New Jersey, at dvoreacos@bloomberg.net; Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net


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Companies Mentioned

  • JNJ
    (Johnson & Johnson)
    • $101.96 USD
    • -0.15
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