A judge on Friday ordered a pharmaceutical company to pay $1.086 billion in criminal fines and $450 million in criminal forfeiture for misleading doctors about the safety of an opioid medication.
It was the the second-largest set of criminal financial penalties ever levied against a pharmaceutical company for violations of the Federal Food, Drug and Cosmetic Act, according to the U.S. Department of Justice.
Endo Health Solutions Inc., which previously filed for bankruptcy, was hit with penalties related to the distribution of the opioid medication Opana ER with INTAC.
When the company pleaded guilty last month, it “admitted that certain sales managers were aware that the sales representatives were making claims of purported abuse deterrence, tamper resistance and/or crush resistance when marketing Opana ER to prescribers, and that certain sales representatives were striking non-medicated sample pills with hammers and conducting other demonstrations to convey the message that Opana ER was, in fact, crush proof and tamper resistant,” according to the U.S. Department of Justice.
“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. “By intentionally misrepresenting opioid medications, EHSI prioritized profits over the health and well-being of the American people.”
Endo Health Solutions Inc. corporate affiliates emerged from bankruptcy last month. The company will cease to operate in its exisitng form and will not emerge from bankruptcy.
“In addition, as part of the confirmed bankruptcy plan, the new company has funded voluntary trusts in settlement of opioid-relating claims, including public trusts that will pay over $450 million to state, municipal and Tribal entities to help fund programs to abate the opioid crisis,” according to a statement from the U.S. Department of Justice. “The department is crediting up to $450 million of such payments against the agreed forfeiture amount. The EHSI affiliates that have emerged from bankruptcy are subject to an injunction restraining future opioid sales and marketing and requiring the publication of millions of documents relating to its role in the opioid crisis.”
