Endo agrees settlement on US charges on opioid crisis

US officials announced Thursday an agreement with Endo Health Solutions (EHSI) to settle civil and criminal claims over the mislabeling of its pain reliever drug Opana, which has contributed to the opioid epidemic.

Under a proposed criminal agreement, Endo, an affiliate of Ireland-based Endo International, agreed to plead guilty in US court to a one-count misdemeanor on introducing mislabeled drugs into interstate commerce, the Department of Justice said in a news release.

"Companies that profit from the opioid abuse epidemic by misrepresenting the safety of their opioid products and using reckless marketing tactics to increase sales threaten the health and safety of Americans," said deputy assistant attorney general Brian Boynton.

In the criminal plea, Endo Health Solutions admitted that in 2012 and 2013 the company's sales representatives touted the purported abuse deterrence of Opana ER despite lack of clinical data supporting the claim.

The civil settlement resolves allegations that Endo from 2011 to 2017 marketed Opana to health care providers that it knew were prescribing Opana for non-medically accepted problems, the Justice Department press release said.

The criminal claim against EHSI included a fine of $1.1 billion and $450 million in criminal forfeiture. There was also a civil claim of $475.6 million.

Under the agreement reached Thursday, EHSI will pay the government nearly $465 million over 10 years.

"To be clear, the settlement agreements filed today resolve all of the government's claims, with EHSI's payment obligation not to exceed $464.9 million," a company spokesman said.

Endo noted that the civil agreement "does not include any admission of liability or wrongdoing by EHSI," according to a company statement.

"The Company remains committed to operating with integrity and maintaining a culture of compliance and ethics," Endo said.

More than 700,000 people have died of opioid overdoses between 1999 and 2022, according to the US Centers for Disease Control and Prevention.