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Endo International, a pharmaceutical company headquartered in Malvern, has agreed to pay the government up to $465 million to settle civil and criminal investigations into the sale and marketing of opioid drugs, federal authorities announced Thursday. did.
As part of the deal, which must be approved by a bankruptcy judge, Endo’s affiliates will plead guilty to one misdemeanor count of introducing a counterfeit drug into interstate commerce. The proposed settlement does not prevent prosecutors from charging individuals in connection with the marketing of the opioid Opana ER.
The agreement comes after Endo filed for New York state bankruptcy protection in 2022, facing debts totaling $9.5 billion and thousands of opioid lawsuits filed by cities and states. At the request of the Food and Drug Administration, Endo discontinued sales of Opana ER in 2017. The company is best known for producing the painkiller Percocet.
Under the restructuring plan, Endo’s lending group will buy the company’s assets and operate it as a new business.
“Bankruptcy protection is not a free pass to avoid criminal activity, civil fraud, or tax liability,” Damian Williams, an attorney for the Southern District of New York, said Thursday. “Today’s settlement will hold Endo accountable for past wrongdoing, pay federal debt, and alleviate the nation’s opioid crisis by funding evidence-based treatment programs at the state and local level. and ensure that payments are distributed to individuals harmed by the opioid epidemic.”
The proposed agreement states that between April 2012 and May 2013, certain Endo sales representatives sold a reformulated version of the opioid Opana ER to prescribers, and that the drug’s “abuse-deterrent and crush-resistant properties” It is stated that the product was advertised as “claiming compatibility and/or tamper resistance.” The Food and Drug Administration had prohibited the company from using such language on its labels.
Sales representatives were aware of the promotion, and representatives even used hammers to hit demonstration rods to show that the drug was shatter-resistant, according to the contract.
Authorities said Endo would pay $365 million over 10 years, or $200 million if paid immediately after the new company emerges from bankruptcy. The company has agreed to pay up to an additional $100 million based on performance.
The agreement leaves only a civil lawsuit alleging that the company sold Opana ER to a number of “high-volume opioid prescribers” who Endo knew were prescribing Opana ER “for non-medically recognized indications.” The criminal case will also be settled.
Endo said in a statement that the company is cooperating with the Justice Department’s investigation and that the civil settlement “does not include any admission of liability or wrongdoing.”
“Since 2013, Endo has actively strengthened its U.S. compliance program by adopting new policies, enhancing other policies, and developing additional training and risk management procedures,” the company said.
The Justice Department also requested that Endo “curb the marketing and sale of opioids and turn over millions of documents related to the role of opioids in the opioid crisis for release in a public online archive.” He also mentioned that he agreed to the injunction.
More than 640,000 people have died from opioid overdoses since 1999, according to the federal Centers for Disease Control and Prevention.
Correction: A previous version of this article incorrectly stated the amount Endo would pay under the settlement.
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