DUBLIN, Sept. 30, 2014 -- Endo International plc has agreed to pay more than $400 million to resolve lawsuits alleging its vaginal-mesh implants eroded in some women and left them in pain, according to Bloomberg news. Endo announced that it has reached master settlement agreements with several of the remaining leading plaintiffs' law firms to resolve claims relating to vaginal mesh products sold by Endo's AMS subsidiary. The agreements, were entered into solely by way of compromise and settlement and are not in any way an admission of liability or fault. The settlements are expected to resolve substantially all the AMS U.S. vaginal mesh-related claims.
"We are very pleased to resolve substantially all the remaining U.S. vaginal mesh litigation claims facing our AMS business," said Rajiv De Silva, president and chief executive officer of Endo. "These settlements will allow us to continue to invest in the growth of our business segments and pursue accretive M&A opportunities. We believe that these settlements will also allow the AMS business to continue its return to growth and enhance focus on the operations and profitability of this leading medical device franchise."
The deal resolves more than 10,000 suits for an average of about $48,000 apiece, according to Bloomberg.
Endo previously established a pre-tax product liability reserve of about $1.2 billion. As a result of these additional agreements described above, the Company expects to increase its pre-tax product liability accrual for all known, pending and estimated future claims primarily related to vaginal mesh products to approximately $1.6 billion in total. AMS expects to fund the payments under all settlements in 2014, 2015, 2016 and 2017.
To date, the company has paid approximately $200 million into qualified settlement funds pursuant to the terms of previously announced agreements. As the funds are disbursed out of the qualified settlement accounts from time to time, the product liability accrual will be reduced accordingly.
Endo's top priority is the safety and efficacy of its subsidiaries' products and supporting the patients and physicians who use them. 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. Endo and AMS remain committed to the safety and efficacy of AMS's transvaginal mesh products, and AMS will continue developing its Women's Health business and devices product suite so that women have appropriate access to innovative, safe and effective therapies. AMS's commitment to these treatment solutions is demonstrated by its ongoing and significant investments in developing clinical evidence to support the restoration of quality of life AMS's mesh solutions provide.
AMS will also continue to invest in educational activities as part of an overall effort to continue to encourage patients and physicians to discuss the risks and benefits of AMS's surgical mesh.