Endo Health Unit Pays $55 M in Vaginal Mesh Settlements

An Endo Health Solutions Inc. unit agreed to pay $54.5 million to settle some lawsuits in its vaginal-mesh implants injury cases that eroded in some women and left them incontinent and in pain. According to Endo’s American Medical Systems Inc.'s securities filing, the medical-device maker is resolving a number of suits over the company’s vaginal-mesh devices, which include the Perigee, Apogee and Elevate implants.

American Medical System Lawsuits Over 5,000

The settlement doesn’t affect the majority of about 5,000 vaginal-mesh suits filed against AMS that have been consolidated for pre-trial proceedings before a federal judge in West Virginia. The first trial of a federal AMS case is set for December.

Vaginal Mesh Lawsuits Growing

AMS’s products are designed to treat the collapse of pelvic organs as well as urinary incontinence. Endo acquired AMS for $2.9 billion in 2011.

Endo is one of four companies facing a total of 29,000 suits by women who claim the vaginal implants injured them. Those cases have been consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia. C.R. Bard Inc. is set to face its first trial over the devices before Goodwin starting July 8.

Vaginal Mesh Verdicts

A California jury last year found Bard liable for $3.6 million in damages over a woman’s injuries tied to its Avalta Plus vaginal implant. It was the first case over a Bard device to go to trial.

A New Jersey jury decided in February Johnson & Johnson and its Ethicon unit must pay more than $11 million in damages, including more than $3.3 million in punitive damages, to a woman who blamed the company’s Gynecare Prolift implant for her injuries.

JNJ officials pulled four of its lines of vaginal implants off the worldwide market last year in the face of rising numbers of suits over the devices.

Limited Settlement

AMS’s settlement resolves claims filed by a small group of plaintiffs’ lawyers representing women who filed cases both in federal and state courts.

FDA Investigation and Report

A U.S. Food and Drug Administration report in August 2011 found vaginal-mesh products should be classified as posing high risk to patients based on a review of side-effect reports from January 2008 to December 2010. Women’s groups are demanding that the devices be recalled.

The FDA last year ordered 31 manufacturers, including Endo, Bard and J&J, to study rates of organ damage and complications linked to the implants. The companies must conduct three years of safety studies, regulators said.

The consolidated AMS cases are In re American Medical Systems Inc. Pelvic Repair Systems Products Liability Litigation, 12-md-02325, U.S. District Court, Southern District of West Virginia (Charleston).