JNJ to Pay $3.3 Million in Vaginal Mesh Suit

Johnson & Johnson (JNJ) faced a verdict on a lawsuit brought against them over its vaginal mesh implant. The company has been ordered to pay a South Dakota woman $3.35 million for inadequate warning on its brochures. The implant is made by JNJ’s subsidiary, Ethicon Endo-Surgery Inc., which makes suture and wound closure devices. The company is based in Somerville, N.J.

This verdict is the first in approximately 1,800 vaginal mesh cases pending in New Jersey against JNJ and Ethicon.

The lawsuit, in state Superior Court in Atlantic City, N.J., was brought by Linda Gross, 47, of Watertown, S.D., in November 2008. It alleged that the Gyncare Prolift vaginal mesh was not safe and that JNJ and Ethicon were liable, among other things, for “their defective design, manufacture, warnings and instructions.”

The device was designed to treat pelvic organ collapse, which can occur when the tissue that holds the pelvic organs together is weakened or stretched and bulges into the vagina. This can happen after menopause, childbirth or a hysterectomy. Surgeons also used the device to treat stress incontinence, a severe form of urinary incontinence.

The U.S. Food and Drug Administration told JNJ, C.R. Bard Inc. and 31 other manufacturers in January 2012 to study rates of organ damage and complications linked to vaginal mesh implants. Physicians implanted more than 70,000 such devices in U.S. women in 2010.

“We will present evidence to the jury tomorrow in the punitive phase of the trial, which followed a mixed verdict by the jury,” said Sheri Woodruff, vice president of communications at Ethicon Surgical Care. “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.”