Amid bankruptcy, opioid maker Endo agrees to settlement over mislabeling claims
The criminal case against Endo Health Solutions alleged that certain sales representatives touted the drug Opana ER’s supposed abuse deterrence without any evidence. Photo courtesy of West Virginia Attorney General’s Office/Twitter
Opioid manufacturer Endo Health Solutions reached an agreement with the U.S. government Thursday to resolve criminal and civil cases stemming from its contribution to the opioid epidemic.
The Justice Department announced in a statement that Endo, which already is dealing with Chapter 11 bankruptcy, agreed to plead guilty in a Michigan federal court to violating the Federal Food, Drug and Cosmetic Act for mislabeling the drug Opana ER.
The criminal resolution includes a fine of $1.1 billion and another $450 million in criminal forfeiture.
Endo also agreed to a civil settlement of $475.6 million to resolve alleged losses to federal health care programs that paid for Opana ER.
“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,” Principal Deputy Assistant Attorney General Brian Boynton said in a statement.
“With today’s announcement of a criminal guilty plea and a substantial civil settlement, the Justice Department re-affirms its commitment to holding accountable those whose illegal conduct contributed to the opioid crisis.”
The federal government also reached an agreement to resolve all of Endo International’s monetary claims against the debtors in its bankruptcy case. The company and several of its affiliates filed for Chapter 11 bankruptcy in the Southern District of New York in 2022.
The bankruptcy agreement provides payment for claims for unpaid taxes and for costs endured by federal health care agencies to treat people harmed by Endo’s products. Under the agreement, Endo will pay the government up to $464.9 million over 10 years.
Other conditions of the resolution state that Endo must no longer operate in its current form and must turn over millions of documents related it its role in the opioid crisis.
The criminal case against Endo alleges certain sales representatives between 2012 and 2013 pitched Opana ER to prescribers by touting the drug’s purported abuse deterrence and tamper and crush resistance without any evidence.
The approved labeling for Opana ER also did not have adequate information for health care providers to safely prescribe the drug, according to the settlement.
Endo voluntarily withdrew Opana ER from the market in 2017.
The civil case alleged Endo targeted health care providers that it knew were prescribing Opana ER for non-medically accepted use from 2011 to 2017.
The case accused Endo of seeking to increase its revenue from Opana ER by focusing its marketing on providers who prescribed the highest levels of Opana ER — and opioids in general.
The settlement is the latest blow against the pharmaceutical giant. The company just prior to its bankruptcy settled its claims in San Francisco federal court along with pharmaceutical companies AbbVie and Teva, which also have faced scrutiny for their role in the opioid epidemic.
The company earlier that same year was forced to pay $25 million to the state of Alabama as part of a $276 million settlement in a suit the state filed against Endo, McKesson Corporation and Johnson & Johnson.
Endo reached a settlement with the state of New York in September 2021 for $50 million.