Pharmaceutical Company Faces Second-Largest Penalty Ever For Opioid Marketing Misconduct

Endo Health Solutions Inc. has been ordered to pay a total of $1.536 billion in fines and forfeiture by a judge for misleading doctors about the safety of its opioid medication Opana ER with INTAC. According to the U.S. Department of Justice, this is the second-largest set of criminal financial penalties ever levied against a pharmaceutical company for violations of the Federal Food, Drug and Cosmetic Act.

During its guilty plea last month, Endo Health Solutions, which had previously filed for bankruptcy, admitted that certain sales managers were aware of sales representatives making false claims about Opana ER’s abuse deterrence, tamper resistance and crush resistance when marketing the drug to prescribers. The company also acknowledged that some sales representatives demonstrated the supposed crush-proof and tamper-resistant properties of Opana ER by striking non-medicated sample pills with hammers.

“The opioid crisis we continue to face today originated, in part, from companies like EHSI building their business on false claims and deceptive business practices,” DEA Administrator Anne Milgram said in a statement, emphasizing that Endo Health Solutions prioritized profits over the health and well-being of the American people by intentionally misrepresenting opioid medications.

While Endo Health Solutions’ corporate affiliates emerged from bankruptcy last month, the company will cease to operate in its existing form and will not emerge from bankruptcy.

The confirmed bankruptcy plan includes the funding of voluntary trusts to settle opioid-related claims, with public trusts set to pay over $450 million to state, municipal and tribal entities to help fund programs to abate the opioid crisis.