Endo International, a pharmaceutical company headquartered in Malvern, has agreed to pay more than $2 billion to resolve civil and criminal investigations into the sale and marketing of opioid drugs, federal authorities announced Thursday.
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. This settlement does not prevent prosecutors from prosecuting individuals in connection with the marketing of the opioid Opana ER.
The agreement comes after Endo filed for bankruptcy protection in New York state 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.
The deal announced Thursday will see Endo's group of lenders 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 its past wrongdoing, pay its 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.”
According to the draft agreement, between April 2012 and May 2013, certain Endo sales representatives sold a reformulated version of the opioid Opana ER to prescribers, promoting the drug's “abuse-deterrent and pressure-resistant properties.” advertised as “crushable and/or tamper-resistant.'' The Food and Drug Administration had prohibited the company from using such language on its labels.
Sales managers were aware of the promotion, and representatives even used hammers to hit the demo rods to demonstrate that the drug was pressure-crushable, according to the contract.
Authorities announced that Endo Health Solutions Inc., an Endo affiliate, has agreed to pay more than $1 billion in criminal fines and $450 million in criminal forfeiture. Mr. Endo will also pay $476 million to settle a civil lawsuit alleging that the company sold Opana ER to “high-volume opioid prescribers,” including a $476 million settlement that Mr. Endo said was “medically approved. This included those who knew that they were prescribing the drug for an indication for which it was not indicated.
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.
