Bloomberg News

J&J Tested Vaginal Mesh and Warned of Risks, Lawyer Says

February 15, 2013

Johnson & Johnson (JNJ:US)’s Ethicon unit properly designed a vaginal mesh implant and adequately warned of its risks, a company lawyer told jurors weighing a lawsuit by a woman who blames the device for her 18 surgeries.

Christy Jones urged state jurors in Atlantic City, New Jersey, to reject a lawsuit by Linda Gross, who contends Ethicon’s design of her Gynecare Prolift was defective. Gross claims J&J failed to warn her and her doctor of the risks. The case is the first of 1,800 such lawsuits to go to trial.

“Prolift has been studied and studied extensively,” Jones said today in her closing argument. “It is not a defective or unreasonably dangerous product. Our position is that Prolift is a safe and effective product, that Ethicon adequately warned doctors of the risks, that doctors knew of the risks.”

Gross accuses J&J, the world’s biggest seller of health- care products, of hiding Prolift’s risks before she had it implanted on July 13, 2006, to shore up pelvic muscles. Her attorney, Adam Slater, claims her chronic pain and other health problems were risks Ethicon knew about before first selling Prolift in March 2005.

“What we’ve established during this trial is this is something that shouldn’t have been sold,” Slater said in his summation of a trial that began Jan. 10. “We know that there was a failure to warn, and there was causation as a result of the failure to warn. We know that tragic decision to put in the Prolift destroyed Linda’s life.”

Caused Pain

The Prolift, made of a polypropylene mesh, was inserted through an incision in the vagina. Slater said Ethicon knew the device caused pain and often became exposed through the vaginal skin. He said it hardened in women’s bodies, caused pain, and was difficult for surgeons to remove.

Slater said Ethicon failed to warn doctors of risks it knew and didn’t tell them how to remove mesh. He said the written instructions were “completely inadequate” and should have warned of 28 complications not mentioned.

He cited the testimony of Gross’s implanting surgeon who said he didn’t know all the risks, and wouldn’t have used the Prolift if he had. Gross, a mother of three, worked as a nurse in South Dakota.

“If Linda had gotten a much more extensive discussion of the risks, she would have said, ‘I’m not doing it,’” he said.

Gross had many operations to remove the mesh and can’t comfortably sit for long. She stood throughout the arguments.

Sales End

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

Jurors will weigh these questions: Was Prolift defectively designed? Did J&J fail to provide adequate warnings to Gross, and to her implanting surgeon? Did J&J make a fraudulent misrepresentation to Gross? If the answer is yes to any of those questions, were they a proximate cause of Gross’s injuries?

If answering yes to any of those sets of questions, jurors would then consider damages for Gross’s pain, suffering, lost wages and medical expenses, as well as the loss of companionship and conjugal affections for her husband. Gross worked as a nurse in South Dakota.

Superior Court Judge Carol Higbee said today that she won’t rule on whether Gross may be entitled to punitive damages unless the jury awards compensatory damages.

Organ Damage

The U.S. Food and Drug Administration told J&J, C.R. Bard Inc. (BCR:US) and 31 other manufacturers last January to study rates of organ damage and complications linked to vaginal mesh implants. In 2010, doctors implanted more than 70,000 such devices in women in the U.S.

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 told jurors. Her “chronic, debilitating nerve pain,” he said was directly related to inflammation from her mesh.

Gross had “chronic pain syndrome” and jurors heard that some doctors advised her about the “inadvisability of removing whatever small amounts of mesh might remain, not only because it probably would not relieve the pain, but it might exacerbate her existing pain syndrome,” Jones said.

‘No Impact’

“She wanted the pain, the mesh out, no matter what, and that’s understandable,” Jones said. “The fact of the matter is, though, removal of the mesh had no impact on the pain.”

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

“They were rushing to market, and in the rush, they threw aside the rules, they threw aside the need to go to 510(k),” Slater said.

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

To contact the reporter on this story: David Voreacos in Atlantic City, New Jersey, at dvoreacos@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)
    • $107.88 USD
    • -0.11
    • -0.1%
  • BCR
    (CR Bard Inc)
    • $147.11 USD
    • -0.12
    • -0.08%
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