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J&J told to pay $3.35 million in first vaginal mesh case
A New Jersey jury has ordered a Johnson & Johnson subsidiary to pay $3.35 million in the first of 2,100 lawsuits over its vaginal mesh implant, and will now weigh punitive damages that may total as much as $16.75 million.
The Atlantic City jury Monday found that J&J's Ethicon unit failed to warn a South Dakota woman's surgeon of the risks tied to its Gynecare Prolift vaginal mesh implant and fraudulently misled her. Linda Gross, a 47-year-old nurse, sued along with her husband, complaining of constant pain and 18 operations she had 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 surgeon, the jury ruled.
"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.
Superior Court Judge Carol Higbee ruled Gross's lawyers can ask jurors for punitive damages. Compensatory damages pay victims for losses and injuries. Punitives are used to punish defendants for willful and wanton behavior. State law caps punitive damages at five times compensatory damages, or $16.75 million, although jurors won't learn of the cap.
Jurors, ruling after five days of deliberations, awarded Gross $1.1 million for her pain and suffering; $180,000 for lost wages; $500,000 for future lost wages; $385,000 for past medical treatment; $1 million for future medical treatment; and $180,000 for her husband's loss of companionship and conjugal affections.
The U.S. Food and Drug Administration told J&J, C.R. Bard Inc. and 31 other manufacturers in January 2012 to study rates of organ damage and complications linked to vaginal mesh implants. Doctors implanted more than 70,000 such devices in U.S. women in 2010 to shore up pelvic muscles.
Slater argued to jurors that company documents and emails 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.
J&J, based in New Brunswick, N.J., claimed during the trial that Prolift is safe and effective, and the company warned adequately of risks.
"We will present evidence to the jury tomorrow in the punitive phase of the trial, which followed a mixed verdict by the jury," Sheri Woodruff, vice president of communications at Ethicon Surgical Care, said Monday in a statement. "While we are always concerned when a patient experiences medical conditions like those suffered by the plaintiff, all surgeries for pelvic organ prolapse present risks of complications."
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, N.J., 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' 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, S.D., testified 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."
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 Gross 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.
The case is Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City).