First Transvaginal Mesh trial against Johnson & Johnson set to begin week of January 7, 2013
January 7th, 2013 by dzwlaw
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‚Äôs 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.
‚ÄúShe 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,‚Äù Gross‚Äôs attorneys said in court papers filed in Atlantic City. ‚ÄúShe requires various daily medications to treat her severe chronic pain.‚Äù
J&J, based in New Brunswick, New Jersey, denies Gross‚Äôs 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‚Äôs biggest seller of health-care products, denies Gross‚Äôs allegations, according to an Ethicon spokesman,Matthew Johnson.
‚ÄúThe 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,‚Äù Johnson said in an e-mail.
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.
J&J began selling the Prolift without filing a newapplication under the agency‚Äôs so-called 510(k) application process, which requires companies to show that a device is‚Äúsubstantially similar‚Äù to others on the market.
The company determined on its own that it was substantially similar to the Gynecare Gynemesh, one of the company‚Äôs devices already approved by the FDA, J&J said last year in an e-mail.
The FDA disagreed with J&J‚Äôs interpretation and required a new application in August 2007, saying Prolift sales began‚Äúwithout appropriate‚Äù 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, ‚ÄúDeciding When to Submit a 510(k) for a Change to an Existing Device,‚Äù 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‚Äôs regulatory history.
‚ÄúWe‚Äôre entitled to say they were required to get 510(k) clearance, and they didn‚Äôt get it,‚Äù Gross‚Äôs attorney, David Mazie, told Higbee.
‚ÄúWe continually hear that we marketed the device without clearance,‚Äù William M. Gage, J&J‚Äôs lawyer, told the judge. That‚Äôs not true. We marketed it under the guidance.‚Äù
‚ÄúIf they‚Äôre going to go in and say we didn‚Äôt get clearance, we‚Äôve got to be able to say we did get clearance,‚ÄùGage said.
Higbee barred Adam Slater, the lawyer who will give an opening statement for Gross, from using words like ‚Äúfraud,‚Äù ‚Äúillegal‚Äù and ‚Äúsimilarly inflammatory language‚Äù in addressing the jury.
On Jan. 3, Mazie argued that J&J should not be allowed to let a psychiatrist testify that Gross suffers from a ‚Äúserious mental illness‚Äù that contributes to the excruciating pain she‚Äôs suffered. The doctor would testify that Gross refused to go a pain management center and wants to ‚Äúhold on to her pain‚Äù so she can continue to claim disability, Mazie said.
At the hearing on Jan. 4, Higbee said jurors can hear about Gross‚Äôs various medical problems.
‚ÄúI don‚Äôt foresee that defense counsel is going to stand up there and say this woman is responsible for her injuries,‚ÄùHigbee said. ‚ÄúI have very little doubt that that would be a mistake.‚Äù
Possible witnesses for Gross include Alex Gorsky, who became J&J‚Äôs chief executive officer last April and was elected chairman Nov. 30.
Gorsky joined J&J‚Äôs 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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