Endo International has agreed to pay $830 million to settle litigation over vaginal mesh implants alleged by thousands of women to have caused bleeding, organ damage, and pain during sex. The estimated 20,000 claims involve the Perigee, Apogee, and Elevate implants from Endo subsidiary American Medical Systems (AMS).
"The settlements, once final, will resolve a substantial majority of the AMS vaginal mesh-related claims," Endo officials said in a statement.
Endo will pay complainants an average of $40,000 each, pending confirmation of the extent of injuries based on medical records, according to a report by Bloomberg Business Week. The plaintiffs can ask for additional compensation if they can prove that they suffered severe injuries or had to undergo multiple procedures to have the implants removed.
The announcement by the company comes one day after the FDA proposed reclassifying surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) from Class II (moderate risk) to Class III (high-risk), thus requiring premarket approval (PMA). About 70,000 vaginal mesh devices were inserted by surgeons in 2010 alone. The implants are designed to alleviate symptoms of pelvic organ prolapse and stress incontinence.
Endo said it had previously established a product liability reserve of $520 million to cover all claims against the devices. The settlement will cost the company an incremental pre-tax, non-cash charge of $625 million in the first quarter, raising the product liability accrual to roughly $1.1 billion in total, which the company expects to be spent through 2016.
In an interview with Reuters, Joe Rice of Motley Rice, one of the law firms representing the plaintiffs, described the deal as the result of "adversarial but respectful and professional negotiation on the part of all the parties."
Endo says the settlement should not be taken “in any way an admission of liability or fault.”
“Endo’s top priority is the safety and efficacy of its products and supporting the patients and physicians who use them,” Endo said in its statement. “The company continues to support the FDA’s recommendations that physicians be well trained and patients fully understand the risks associated with the use of mesh products.”
After a wave of lawsuits, the FDA earlier ordered Endo, C.R. Bard, Johnson & Johnson, Boston Scientific, Coloplast, and other manufacturers to study post-market rates of organ damage and complications. The companies are currently in the process of settling separate cases.