A New Jersey jury on Thursday ordered Johnson & Johnson to pay punitive damages of $7.76 million to a former nurse who blames its vaginal mesh implant for years of "living hell" despite unsuccessful repair surgeries.
The award adds to the $3.35 million in compensatory damages awarded by the state Superior Court jury on Monday, making a total of $11.1 million in damages.
It's the first verdict in about 4,000 lawsuits filed against the giant health products maker based in New Brunswick, N.J.
Johnson & Johnson said the decision isn't supported by the evidence.
"We will vigorously pursue an appeal," Sheri Woodruff, a spokeswoman for the company's Ethicon surgical products subsidiary, said in a statement.
Ethicon sold its Prolift brand of implants from 2005 until 2012, when it pulled them from the market amid mounting lawsuits.
At least one plaintiff has won a lawsuit against one of the other 30-plus makers of the once-popular implants, which are used to lift sagging pelvic organs back into place to relieve pain and other problems.
The plaintiff, Linda Gross, 47, of Watertown, S.D., testified during the seven-week trial that she had undergone 18 revision surgeries — all without success — since having J&J's Prolift vaginal mesh device implanted in 2006. Severe pain and other complications forced the hospital hospice nurse to stop working.
"Linda Gross cannot turn back the clock and make her misery and pain disappear," her lead attorney, Adam Slater of the Mazie Slater firm in Roseland, N.J., said in a statement. "But she and countless victims like her can take some comfort in knowing that a jury ... decided ... that the corporation responsible for their suffering should be severely punished financially."
Introduced more than a decade ago, mesh implants, made of a porous synthetic or biologic material, were implanted in hundreds of thousands of women. They are tied to ligaments or bone to serve as a sort of sling to lift and support the organ involved.
The devices were touted as a safer, easier alternative to hysterectomy or other surgery to repair pelvic organ prolapse. The condition occurs when a pelvic organ — the bladder, uterus, vagina, bowel or rectum — droops as muscles supporting it weaken, usually due to childbirth. Aging, obesity and other factors can also trigger it.
The sagging organs can cause painful intercourse, lower backache, constipation and stress incontinence, or bladder leakage usually induced by coughing, sneezing, lifting heavy objects or exercising.
Mesh implants have helped many women. However, thousands of women who got them later complained of complications, including severe pain, infections and bleeding, and underwent follow-up surgeries to try to fix those problems.
Johnson & Johnson faces about 1,800 lawsuits filed in New Jersey, its home state, and about 2,200 filed in other courts. Altogether, the company and other makers of the implants face tens of thousands of lawsuits in state and federal courts around the U.S., according to attorneys for Gross.
The jury in Atlantic City awarded the compensatory damages after five days of deliberations, then heard additional evidence on Tuesday as both sides argued whether punitive damages should be imposed as well. The jury then deliberated from Tuesday afternoon through midday Thursday.
J&J noted in a statement that the verdict on compensatory damages was "mixed," because the jurors appeared to reach conflicting conclusions in considering multiple questions on the verdict sheet.
On one hand, the jurors ruled that Prolift was not defectively designed and that Johnson & Johnson did not make any misrepresentations about the product to surgeons using it, according to J&J. On the other hand, the jury ruled that the company did not give surgeons adequate warnings about risks of the product and that a misrepresentation was made to Gross.
"Ethicon acted appropriately and responsibly in the research, development and marketing of the Prolift pelvic organ prolapse repair kit," the company's statement said. "All surgeries for pelvic organ prolapse present risks of complications."
The company added that Ethicon's devices "are among the most studied products for these conditions."
Attorney Rochelle Rottenstein of the Rottenstein Law Group, which represents hundreds of women claiming they've been hurt by vaginal mesh, said the punitive damages award might be overturned or reduced.
"Still, the award should give vaginal mesh manufacturers an idea of the jury's mindset," she said, and that could nudge the implant makers to settle some cases.
Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma.