ATLANTIC CITY, New Jersey A jury on Monday said Johnson & Johnson should pay a South Dakota woman $3.35 million for failing to adequately warn her doctor of the potential dangers of a vaginal mesh implant made by the company's Ethicon subsidiary, and for misrepresenting the product in brochures.
It was the first verdict among some 1,800 vaginal mesh cases pending in New Jersey against Ethicon and J&J and could have an impact on thousands of lawsuits against other manufacturers of similar products.
The lawsuit, in state Superior Court in Atlantic City, New Jersey, was brought by Linda Gross, 47, of Watertown, South Dakota, in November 2008. It alleged that the Gyncare Prolift vaginal mesh was not safe and that J&J and Ethicon were liable, among other things, for "their defective design, manufacture, warnings and instructions."
The Ethicon product, before being taken off the U.S. market last year, was used to treat pelvic organ collapse, a condition for which the plaintiff, a nurse, was treated in November 2008.
That condition occurs when tissue that holds the pelvic organs in place is weak or stretched and bulges into the vagina. There are different types of this prolapse condition, which usually occurs after menopause, childbirth or a hysterectomy. The vaginal mesh was also used by many doctors to treat a severe form of urinary incontinence, called stress incontinence.
Gross, a nurse, filed her lawsuit after having surgery in 2006 to install a Gyncare Prolift for pelvic prolapse. She alleged the surgery led to a variety of problems, including mesh erosion, scar tissue, inflammation and "neurologic compromise to ... structures and tissue."
She said she had to seek medical treatment and had 18 operations to repair the damage caused by the mesh.
Ben Anderson, a member of the trail team for the plaintiff, called the jury verdict "a strong statement to Johnson & Johnson and Ethicon that they cannot put profits before women's safety."
The verdict, by a panel of six women and three men, followed a six-week trial before Judge Carol Higbee. After the verdict was delivered, the judge ruled that she will allow arguments on punitive damages. Those hearings are scheduled for Tuesday at 9:30 a.m.
Sheri Woodruff, a spokeswoman for Ethicon, said, "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."
She said she could not comment further.
In addition to the lawsuits against Ethicon and J&J in New Jersey, about 11,000 other claims have been filed against a variety of manufacturers of vaginal mesh, according to Florida attorney Bryan Aylstock.
Those claims have been consolidated into five cases that are pending in federal court in West Virginia, according to Aylstock, co-lead counsel in one of the West Virginia cases.
The defendants in those cases are Ethicon, C.R. Bard Inc, Boston Scientific Corp, Coloplast, and Endo Health Solutions' American Medical Systems Inc.
Last year, jurors in a state court in Bakersfield, California, said C.R. Bard was liable for $3.6 million in the first case over the vaginal mesh devices to go to trial. The panel found the plaintiff and her husband were entitled to a total of $5.5 million for her medical expenses, pain, suffering and other damages resulting from Bard's Avaulta Plus device.
Last June, J&J announced that it had stopped selling the vaginal mesh following lawsuits that allege it caused infections and bleeding. On Monday, the company said there were 4,000 lawsuits against J&J involving the vaginal mesh product pending in the United States.
Morningstar analyst Damien Conover said plaintiff attorneys generally pick a particularly strong case to argue first and that the judgment against J&J was sizable. But, he added that subsequent plaintiffs' cases coming to trial might be less forceful, and that J&J, with annual revenue approaching $70 billion, could easily withstand eventual financial hits from the litigation.
"The size of the caseload presents a significant legal risk to J&J, although it's hard to quantify," Conover said.
Conover said J&J has taken recent charges of more than $4 billion for recalls of defective artificial hips, without badly denting the company's share price. He said charges are likely to be considerably less for the vaginal mesh litigation, "So I don't think this is a big overhang" for the company.
J&J shares closed down 0.89 percent, or 68 cents, at $75.57 on the New York Stock Exchange.
The case is Gross v. Gynecare Inc., Superior Court of Atlantic County, New Jersey, Atl-L-6966-10.
(Additional reporting by Ransdell Pierson; Editing by John Wallace and Dan Grebler)