Endo Health Solutions (ENDP) Inc. has agreed to pay $54.5 million to settle some of the lawsuits alleging that their vaginal mesh implants eroded inside thousands of women, leaving them in severe pain and incontinent.
In a recent securities filing, officials of Endo’s American Medical Systems Inc. (AMS), said that the medical device maker agreed to the payments in an effort to resolve an unidentified number of lawsuits regarding the company’s vaginal mesh devices, which include the Perigee, Apogee and Elevate implants.
According to Bloomberg News, this settlement does not affect the majority of the approximately 5,000 vaginal mesh complaints filed against AMS, which have been consolidated into a multidistrict litigation (MDL) in West Virginia District Court.
According to court filings, the first trial of a federal AMS case is set for December.
Endo acquired AMS for $2.9 billion in 2011. According to Endo officials earlier this year, suits filed over the implants had risen to about 5,100 from approximately 2,900 a year ago.
AMS’s products are designed to treat the collapse (or prolapse) of pelvic organs, as well as to treat urinary incontinence.
Endo and three other companies are facing a total of 29,000 lawsuits filed by women who claim they were injured by the vaginal implant devices. All of these cases have been consolidated before U.S. District Court Judge Joseph Goodwin in Charleston, West Virginia.
C.R. Bard (BCR) is set to face its first trial of this type before Goodwin beginning July 8th.
Last year, a California jury found Murray Hill, New Jersey based Bard liable for $3.6 million in damages over a woman’s injuries tied to its Avalta Plus vaginal implant. It was the first Bard implant case to go to trial.
In February, an Atlantic City jury decided Johnson & Johnson (JNJ) 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 due to the increasing number of lawsuits over these devices.
A U.S. Food and Drug Administration (FDA) 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 these devices be recalled.
Last year, the FDA ordered 31 manufacturers, including Endo, Bard and J&J, to study rates of organ damage and complications linked to their implants. Regulators say that the companies must conduct three years of safety studies.
It is unclear how this settlement will impact next week’s hearings once trial gets under way on July 8. Feel free to contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).
