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" and
The Ethicon product, before being taken off the U.S. market last year, was used to treat urinary incontinence and pelvic organ collapse, a condition for which the plaintiff, a nurse, was treated in November 2008. That condition happens 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.
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 18 operations to repair the damage caused by the mesh.
Ben Anderson, the lawyer representing Gross, 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. The judge was expected to decide later today whether to allow a hearing on punitive damages.
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 they caused infections and bleeding.
According to the U.S Food and Drug Administration, some 75,000 women received mesh repairs for pelvic organ prolapse in 2010, and about 200,000 more received the mesh implants for stress urinary incontinence.
Tim Nelson, a senior analyst for Nuveen Asset Management, said the size of the award to Gross was surprising. But he said the many lawsuits over the product pose little risk to J&J's finances or its shares.
"That's because big companies like J&J can drag out these cases forever" and thereby whittle down judgments through appeals or other means, he said. "So it's hard to generalize one award to multiple cases. My guess is that it won't be a huge issue for the company."
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