Opioid manufacturer Endo Health Solutions Inc. (EHSI) has agreed to global restitution for its sales and marketing practices related to its opioid drug. The United States and EHSI have reached a resolution to settle the criminal and civil investigations concerning their opioid drug, Opana ER.
The Justice Department has also reached an agreement in EHSI's bankruptcy case to settle monetary claims arising from the civil settlements. EHSI filed for Chapter 11 bankruptcy on Aug. 16, 2022. U.S. Attorney Damian Williams for the Southern District of New York commented on the matter, stating, "Chapter 11 is an important tool for businesses to preserve value for their stakeholders. Bankruptcy protections are not a free pass to evade responsibility for criminal misconduct, civil fraud, or taxes." He further added that "Today’s settlement ensures that Endo takes responsibility for its past misconduct, pays its federal debts, helps abate the nation’s opioid crisis by funding evidence-based treatment programs at the state and local level and distributes payments to individuals harmed by the opioid epidemic."
Under this bankruptcy resolution, the government will receive up to $464.9 million over a period of ten years. The company's secured lenders will purchase its assets and operate the business under a new corporate structure. This plan requires approval from the U.S. Bankruptcy court in the Southern District of New York. EHSI has admitted guilt in violating the Federal Food, Drug, and Cosmetic Act (FDCA) by introducing misbranded drugs into the market. This settlement marks the second-largest set of criminal financial penalties ever imposed on a pharmaceutical company with a criminal fine of $1.086 billion and $450 million in criminal forfeiture being levied against EHSI for their practices. In addition, under the False Claims Act, EHSI has agreed to settle its civil liability for $475.6 million.
Between April 2012 and May 2013, the company's sales representatives marketed Opana ER to prescribers without sufficient clinical data supporting their claims about the drug's benefits. Sales managers at EHSI were aware of these false claims but did not take action to prevent the dissemination of this falsified information. In 2017, EHSI withdrew the drug from the market.
