J&J Faces First Vaginal Mesh Implant Trial in New Jersey
By David Voreacos & Jef Feeley – Jan 7, 2013 12:00 AM ET
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 is scheduled to begin today. More than 100 potential jurors are expected to fill out questionnaires. Lawyers will select a jury panel on 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.
J&J began selling the Prolift without filing a new application 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.
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.
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).
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