ATLANTIC CITY, N.J. — Johnson & Johnson'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 Monday.
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, juror ruled. The company failed to warn Gross's implanting surgeon, the jury said. 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.
"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-ails 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 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 in 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.
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'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, S.D., 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."
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.