Endo International Plc has agreed as of August 7, 2017 to set aside an additional $775 million to resolve the remaining lawsuits alleging the company’s vaginal-mesh implants eroded in some women, leaving them incontinent and in pain related to the Transvaginal Mesh Multidistrict Litigation pending in the US District Court of West Virginia, see the Mass Tort Nexus briefcase, American Medical Systems MDL 2325 TVM Litigation Link, a subsidiary of Endo sold to Boston Scientific in 2015.
The agreement to fund settlement of the remaining 22,000 mesh suits means the company has now set aside more than $2.6 billion to finalize the litigation claims related to the American Medical Systems flawed medical devices, according to document filed with the U.S. Securities and Exchange Commission.
This comes a year after Dublin-based Endo shut down one of its units that makes mesh implants, used to support internal organs or treat incontinence, after being hit with many thousands of complaints over the devices.
“We believe it is a very important milestone for Endo to have reached agreements to resolve virtually all known U.S. mesh product liability claims,” Paul Campanelli, Endo’s president and chief executive officer, said Monday in a statement.
Other mesh-insert makers, including Johnson & Johnson and Boston Scientific Corp., still face thousands of claims in the U.S. and worldwide from women who blame the devices for injuring them. More than 100,000 transvaginal mesh lawsuits have been filed, making it one of the largest mass torts in history. About 75% of mesh lawsuits are consolidated in West Virginia federal court through seven multi-district litigation (MDL) cases. The rest are contained in state courts, including those in Pennsylvania and West Virginia.
J&J, based in New Brunswick, New Jersey, said in SEC filings in February that it was defending 54,800 cases over its inserts while Marlborough, Massachusetts-based Boston Scientific said that same month it faced 43,000 mesh claims. Both companies have settled some mesh suits. The U.S. Food and Drug Administration increased regulatory restrictions on the mesh inserts after concluding in 2014 they were high-risk. The agency ordered Endo’s American Medical Systems unit, J&J and other mesh makers to study organ-damage rates linked to the devices. J&J dropped some of its mesh lines in 2012.
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). Endo paid $150 million in legal settlements related to its vaginal mesh in the 4th quarter of 2016 and now more payments are on the way. The company recorded a $834 million pretax charge to increase the estimated product liability accrual. It had already set aside $1.4 billion to cover the legal costs at the end of the previous settlements.
In 2015 Endo sold the men’s health portion of its American Medical Systems device unit to Boston Scientific for $1.6 billion, and renamed the remaining portion Astora Women’s Health. Endo had acquired AMS for $2.9 billion in 2011, making the purchase a significant misjudgment of corporate strategy in what was even then a highly litigated medical device area, as TVM was widely known as a product that was prone to high numbers of adverse events and regulatory scrutiny.
Endo International/American Medical Systems Settlement History
Endo International plc (Endo) acquired device maker American Medical Systems Holdings, Inc. (AMS) in 2011. Endo has agreed to pay out roughly $2.6 billion to settle cases claiming injuries from its vaginal mesh devices, which include the Perigee, Apogee and Elevate implants. The company has previously ceased production of AMS transvaginal mesh.
The following settlements amounts were agreed to by Endo in attempts to resolve mesh implants made by AMS:
$775 million settlement to resolve 22,000 mesh lawsuits in August 2017. This settlement resolves the remaining lawsuits against AMS mesh implants.
Approximately 450 mesh lawsuits resolved through two separate settlements in April and May 2015.
$400+ million to settle more than 10,000 mesh lawsuits (~$48,000 per case) in October 2014. With the move, Endo said that it resolved “substantially all” the remaining lawsuits against its AMS unit. The $400 million was in addition to $1.2 billion already pledged by Endo to cover mesh litigation.
$830 million settlement to resolve around 20,000 mesh lawsuits (~40,000 per case) in May 2014. The settlement came a day after the FDA said transvaginal mesh should be reclassified as a high-risk medical device and subject to stronger regulatory scrutiny. “The settlements, once final, will resolve a substantial majority of the AMS vaginal mesh-related claims,” Endo said in a statement at the time.
$55 million paid in June 2013 to settle an undisclosed number of lawsuits, according to a filing with the U.S. Securities and Exchange Commission.