Pharmaceutical Company Hit With $1.5 Billion Penalty For Misleading Doctors About Opioid Safety

In a significant ruling, a judge on Friday ordered Endo Health Solutions Inc. to pay $1.536 billion in criminal fines and forfeiture for misleading doctors about the safety of its opioid medication Opana ER with INTAC. The U.S. Department of Justice noted that this is the second-largest set of criminal financial penalties ever imposed on a pharmaceutical company for violating the Federal Food, Drug and Cosmetic Act.

Endo Health Solutions, which had previously filed for bankruptcy, admitted during its guilty plea last month 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.

DEA Administrator Anne Milgram emphasized in a statement that the opioid crisis faced today originated, in part, from companies like Endo Health Solutions building their business on false claims and deceptive business practices, prioritizing 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.