Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Monday, February 25, 2013

Harmed patient not healed by $3.35M verdict.

By David Voreacos - Feb 25, 2013 11:44 AM CT  FiDA highlight
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 in the first verdict in more than 2,100 lawsuits filed over the device.
Jurors ordered J&J to pay $3.35 million to the nurse, Linda Gross, and her husband. Gross, 47, had 18 operations after the device was implanted.

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 jury ruled. Jurors decided that the company failed to warn Gross’s implanting surgeon. The verdict in Atlantic City state court came in the first trial of claims Ethicon’s Gynecare Prolift injured women.
“This verdict establishes that Johnson & Johnson and Ethicon failed to tell physicians and women the truth about the catastrophic complications that can result from the Prolift,” Gross attorney Adam Slater said in an interview.
Slater argued to jurors that company documents and e-mails showed Ethicon knew the mesh would cause pain and harm women. Gross blamed the mesh for constant pain that makes it hard to sit and for subsequent operations to remove mesh that hardened.
‘Doctors Knew’
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 on Feb. 15.
Superior Court Judge Carol Higbee is considering whether to allow Gross’s attorneys to pursue punitive damages, which are intended to punish the company. If so, the same jury would hear evidence and decide whether to award such damages. New Jersey caps punitive damages at five times compensatory damages, which in this case would be $16.75 million. Jurors delivered their verdict on the fifth day of deliberations.
Gross sought $3.38 million for lost earnings and past and future medical expenses. She also sought unspecified damages for pain and suffering.
Difficult Removal
The Prolift, made of a polypropylene mesh, was inserted through an incision in the vagina. In August, J&J stopped selling four mesh devices in the U.S., including the Prolift. J&J, based in New Brunswick, New Jersey, said in June that it would end sales worldwide because the products lacked commercial viability, not because of their safety and effectiveness.
Slater claimed that Gross’s 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 and was difficult for surgeons to remove.
Gross, of Watertown, South Dakota, testified on Jan. 31 that her life has changed dramatically for the worse since her mesh was implanted. She said she is in constant pain and can no longer sit comfortably, and she has prescriptions for 20 different medicines to help with her pelvic problems.
“Who you see standing here now is not who I was,” Gross told jurors. “I was eager and energetic, loved to go to work, loved to participate in church activities, school activities.”
Little Risk
Kevin Benson, the South Dakota surgeon who implanted her Prolift on July 13, 2006 to shore up pelvic muscles, was “so gung-ho” about the Prolift that she thought she needn’t worry. She understood from talking to Benson and reading a company brochure that she faced little risk and that the mesh could be removed easily, she said. Had she known all the risks, she said, she wouldn’t have chosen the Prolift.
Gross said she has had more than 400 visits to doctors and physical therapists for treatment, exams and tests, which have been “horrific.”
“I am fearful of dying because this pain is so bad,” she said.
On cross-examination, Jones sought to establish that before many of her surgeries, doctors warned that they may not help her pain. At one point, Gross shouted at Jones: “You’re trying to blame it on me, and it’s not right.”
Jurors saw the video deposition of Benson, who 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.
During jury deliberations, the jury reheard testimony from both Gross and Benson. During the trial, which began Jan. 10, jurors also heard from 11 company witnesses and several experts on each side.
Johnson & Johnson shares fell 2 cents to $76.23 at 12:40 p.m. in New York Stock Exchange trading.
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
To contact the editor responsible for this story: Michael Hytha at

Accessing justice is a high barrier for patients who experience failed implanted medical devices. they are hurt and medically impoverished. The surgeons are not legally required to report "adverse events" to the FDA unless there is a fatality.  Registry of the devices (if there is any) is held in a proprietary silo and data of implants success/failure is obscured for patients making life-changing decisions.  The monumental failure of Johnson & Johnson both for DePuy MoM (metal on metal hips) and Ethicon surgical mesh were preventable if marketing had not led science.  Why is this not criminal?  It is defrauding the government because taxpayers absorb the expen$ive accountability that the industry does not. FiDA Failed Implant Device Allicance  Joleen Chambers

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