Endo International, a pharmaceutical company whose U.S. headquarters is in Malvern, Pennsylvania, has agreed to pay the government up to $465 million to settle civil and criminal investigations into the sales and marketing of an opioid drug, federal authorities said Thursday.
As part of the deal — which must be approved by a bankruptcy judge — an Endo affiliate would plead guilty to a single misdemeanor charge of introducing misbranded drugs into interstate commerce. The settlement would not prevent prosecutors from charging individuals in connection with the marketing of the opioid Opana ER.
The agreement comes after Endo filed for bankruptcy protection in New York in 2022, facing $9.5 billion in total debt and thousands of opioid lawsuits filed by cities and states. At the request of the Food and Drug Administration, Endo stopped selling Opana ER in 2017. The company is best known for making the painkiller Percocet.
Under the reorganization plan, a group of Endo’s lenders would purchase the company’s assets and operate as a new business.
“Bankruptcy protections are not a free pass to evade responsibility for criminal misconduct, civil fraud, or taxes,” Damian Williams, the U.S. attorney for the Southern District of New York, said Thursday. “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.”
The proposed agreement says that from April 2012 through May 2013, some Endo sales representatives marketed a reformulated version of the opioid Opana ER to prescribers by touting the drug’s “purported abuse deterrence, crush resistance and/or tamper resistance,” despite the fact that the Food and Drug Administration had prohibited the company from using such language on its label.
Sales managers were aware of this promotion, the agreement says, and representatives even used hammers to hit demonstration rods to show the drugs were crushproof.
Authorities said Endo would pay $365 million over 10 years, or $200 million if paid immediately after the new company exits bankruptcy. The company agreed to pay up to $100 million more depending on business performance.
The agreement settles criminal claims as well as civil claims that the company marketed Opana ER to “high volume prescribers of opioids,” including many that Endo knew were prescribing the drugs “for non-medically accepted indications.”
Endo said in a statement that the company has cooperated with the Justice Department’s investigations and that the civil settlement “does not include any admission of liability or wrongdoing.”
“Since 2013, Endo has proactively strengthened its U.S. compliance program, including by adopting new policies, enhancing others, and developing additional training and risk management procedures,” the company said.
The Justice Department also noted that Endo has agreed to an injunction that “restrains opioid marketing and sales and requires Endo to turn over millions of documents related to its role in the opioid crisis for publication in a public online archive.”
More than 640,000 people have died from opioid overdoses since 1999, according to the federal Centers for Disease Control and Prevention.
