Jury finds for Plaintiff in J&J vaginal mesh trial

J&J Failed to Warn of Vaginal Mesh Risks, N.J. Jury Rules

By David Voreacos – Feb 25, 2013 10:28 AM CT.

Johnson & Johnson (JNJ)’s Ethicon unit failed to properly warn of the risks of a vaginal mesh implant and made fraudulent misrepresentations to a South Dakota nurse who sued, a New Jersey jury ruled.
Jurors ordered J&J to pay $3.35 million to Linda Gross, the nurse, and her husband. Linda Gross, 47, had 18 operations after the device was implanted.
The jury ruled that J&J, the world’s biggest seller of health-care products, didn’t defectively design the mesh and didn’t make fraudulent misrepresentations to Gross’s doctor.
The verdict in state court in Atlantic City came in the first of more than 2,100 lawsuits to go to trial over claims that Ethicon’s Gynecare Prolift injured women.
Gross claimed that J&J failed to warn her and her doctor of the risks and made fraudulent misrepresentations to her. Her lawyers said company documents and e-mails showed Ethicon knew the mesh would cause pain and harm women. She blamed the mesh for constant pain that makes it hard to sit and for subsequent operations to remove mesh that hardened.
“We’ve established during this trial that this is something that never should have been sold,” Gross attorney Adam Slater told jurors in his summation on Feb. 15. “You had the words of the people at the company saying it shouldn’t have been sold. You saw them talking about that before it ever went on the market, that it was unreasonably dangerous.”
J&J claims the Prolift is safe and effective and it warned of the risks.
“Our position is that the Prolift is a safe and effective product, that Ethicon adequately warned doctors of the risks, that doctors knew of the risks,” J&J attorney Christy Jones said in her closing arguments.
Gross sought $3.38 million for lost earnings and past and future medical expenses. She also sought unspecified damages for pain and suffering.
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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First Transvaginal Mesh trial against Johnson & Johnson set to begin week of January 7, 2013

http://www.dzwlaw.com/mesh/

Johnson & Johnson (JNJ) is set to face its first trial over its vaginal mesh implant in a case brought by a South Dakota woman who blames the product for constant pain and 18 subsequent operations.

The lawsuit by Linda Gross, 47, is the first of 1,800 in state court in New Jersey to go to trial today over whether J&J’s Ethicon unit adequately warned of the risks of the device. Several manufacturers, who make the devices to shore up pelvic muscles, face lawsuits by women who blame them for organ perforation, pain, scarring and nerve damage.

“She can no longer sit comfortably for more than a few minutes without having to either stand up or lay down to try to reduce the level of pain,” Gross’s attorneys said in court papers filed in Atlantic City. “She requires various daily medications to treat her severe chronic pain.”

J&J, based in New Brunswick, New Jersey, denies Gross’s claims for failure to warn of the risks, defective design and negligence.

In August, the company stopped selling four mesh devices in the U.S., including the Gynecare Prolift that Gross had implanted on July 13, 2006. The former nurse claims her pain ruined her quality of life and keeps her from working.

J&J, the world’s biggest seller of health-care products, denies Gross’s allegations, according to an Ethicon spokesman,Matthew Johnson.

“The evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of pelvic mesh products to treat debilitating conditions affecting many women,” Johnson said in an e-mail.

Jury Selection

Jury selection began today when more than 100 potential jurors began filling out questionnaires. Lawyers will select a jury panel Jan. 9, with opening statements expected the next day. The trial is scheduled to last more than a month.

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 implants. Doctors implanted more than 70,000 mesh devices in U.S. women in 2010, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs.

J&J said in June that it would end sales worldwide based on their commercial viability, not their safety and effectiveness.

Superior Court Judge Carol Higbee has wrestled in recent days with what lawyers for Gross and J&J can tell jurors about how the company introduced the Prolift device in March 2005.

No Application

J&J began selling the Prolift without filing a newapplication under the agency’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 the company’s devices already approved by the FDA, J&J said last year in an e-mail.

The FDA disagreed with J&J’s interpretation and required a new application in August 2007, saying Prolift sales began“without appropriate” clearance, an agency spokeswoman, Morgan Liscinsky, said last year in an e-mail.

J&J has said it began sales after citing an agency guidance document, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” according to Liscinsky and Johnson.

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, Liscinsky said. The FDA cleared the device in May 2008 after nine months of negotiations with J&J.

Addressing Jury

Higbee heard arguments Jan. 4 about what jurors could hear about the device’s regulatory history.

“We’re entitled to say they were required to get 510(k) clearance, and they didn’t get it,” Gross’s attorney, David Mazie, told Higbee.

“We continually hear that we marketed the device without clearance,” William M. Gage, J&J’s lawyer, told the judge. That’s not true. We marketed it under the guidance.”

“If they’re going to go in and say we didn’t get clearance, we’ve got to be able to say we did get clearance,”Gage said.

Higbee barred Adam Slater, the lawyer who will give an opening statement for Gross, from using words like “fraud,” “illegal” and “similarly inflammatory language” in addressing the jury.

‘Mental Illness’

On Jan. 3, Mazie argued that J&J should not be allowed to let a psychiatrist testify that Gross suffers from a “serious mental illness” that contributes to the excruciating pain she’s suffered. The doctor would testify that Gross refused to go a pain management center and wants to “hold on to her pain” so she can continue to claim disability, Mazie said.

At the hearing on Jan. 4, Higbee said jurors can hear about Gross’s various medical problems.

“I don’t foresee that defense counsel is going to stand up there and say this woman is responsible for her injuries,”Higbee said. “I have very little doubt that that would be a mistake.”

Possible witnesses for Gross include Alex Gorsky, who became J&J’s chief executive officer last April and was elected chairman Nov. 30.

Gorsky joined J&J’s Janssen unit in 1988 as a sales representative, according to a company biography. He left the company in 2004 to join Basel, Switzerland-based Novartis AG (NOVN), where he headed North American pharmaceuticals.

Four years later, he returned to J&J. He was named global chairman of the devices and diagnostics groups in 2009.

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 Newark, 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.