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Endo International reaches settlements with Department of Justice
By Sarah Lizee
Olympia, Wash., Feb. 29 – Endo International plc has reached a settlement with the Department of Justice to resolve criminal and civil investigations related to the company’s sales and marketing of the opioid drug Opana ER with Intac, according to a statement from the DOJ.
The DOJ said it has also reached an agreement in Endo’s bankruptcy case to settle its monetary claims arising from the criminal and civil settlements, as well as additional tax and health care related claims.
Under the bankruptcy agreement, the government will be paid up to $464.9 million over 10 years.
The settlement is subject to approval by the U.S. Bankruptcy Court of the Southern District of New York.
Under a proposed criminal resolution, Endo agreed to plead guilty in federal court in the Eastern District of Michigan to a one-count misdemeanor information charging it with violating the Federal Food, Drug and Cosmetic Act by introducing misbranded drugs into interstate commerce.
The DOJ said the criminal resolution includes the second-largest set of criminal financial penalties ever levied against a pharmaceutical company, including a criminal fine of $1.086 billion and an additional $450 million in criminal forfeiture. The proposed resolution includes a corporate criminal release regarding conduct relating to the sale, marketing, and distribution of Opana ER, but does not release any individual criminal liability.
Endo also agreed to a civil settlement of $475.6 million to resolve its civil liability under the False Claims Act. The civil settlement will address alleged losses to federal health care programs that paid for Opana ER.
Endo is a Dublin, Ireland-based specialty pharmaceutical company that filed bankruptcy on Aug. 16, 2022. The Chapter 11 case number is 22-22549.
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