J&J Jury Begins Deliberating in First Vaginal Mesh Trial

A New Jersey jury ended its initial day of deliberations on the first lawsuit to go to trial over whether Johnson & Johnson’s Ethicon unit properly designed a vaginal mesh implant and adequately warned of its risks.

A panel of six women and three men is weighing a lawsuit by Linda Gross, a South Dakota nurse. She contends Ethicon’s design of her Gynecare Prolift was defective and blames the device for 18 surgeries. Gross claims J&J failed to warn her and her doctor of the risks and made fraudulent misrepresentations to her.

“Would Linda have chosen a different procedure if she knew everything that Ethicon knew? Absolutely,” Gross attorney Adam Slater argued in state court in Atlantic City in his summations on Feb. 15. “They obviously failed to warn.”

J&J, the world’s biggest seller of health-care products, claims Prolift is safe and effective, and Ethicon warned properly of the risks. The case is the first of 1,800 such lawsuits to go to trial. Gross, 47, seeks $3.38 million for lost earnings and past and future medical expenses. She also seeks damages for pain and suffering. Deliberations resume tomorrow.

Slater claims that her chronic pain and other health problems were risks Ethicon knew about before first selling Prolift in March 2005. 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.

Implanting Surgeon

Jurors today watched again the video deposition of Dr. Kevin Benson, the South Dakota surgeon who implanted her Prolift on July 13, 2006, to shore up pelvic muscles. He did three follow-up surgeries to remove portions of the mesh to help her with her pain. Other doctors also removed parts of her mesh.

The Prolift, made of a polypropylene mesh, was inserted through an incision in the vagina.

In closing arguments, both sides said Benson’s testimony helped their failure-to-warn case.

J&J attorney Christy Jones said Benson’s deposition showed he warned Gross that complications of her Prolapse surgery could include pain, infection, urinary retention and sexual pain.

“He testified that he knew of all of those, and he testified that he told Ms. Gross about those,” Jones argued. “Whether or not he told her is not what’s important here. What’s important here is that in fact he knew, because the responsibility of Ethicon is to warn the doctors of the risk.”

Slater countered that Ethicon knew far more of the risks than it disclosed to doctors, including Benson. During the deposition, Slater asked if Benson’s recommendations to Gross in 2006 would have been different if he had known then what he knows now about the risks of mesh.

‘More Robust’

“It would have been a much more robust discussion about everything that can go on,” Benson said.

Benson said he no longer uses mesh for the type of condition that Gross had in 2006. He also said that while his talk about risks probably took 15 or 20 minutes, it now would probably consist of two one-hour discussions.

Superior Court Judge Carol Higbee hasn’t ruled yet whether Gross can seek punitive damages if jurors award her compensatory damages. New Jersey caps punitive damages at five times compensatory damages or $350,000, whichever is higher.

Pain, Suffering

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, Jeff.

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.

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.

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

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