A pharmaceutical company was ordered by a judge on Friday to pay $1.086 billion in criminal fines and $450 million in criminal forfeiture for deceiving doctors about the safety of an opioid medication.
According to the U.S. Department of Justice, the pharmaceutical company faced the second-largest set of criminal financial penalties ever imposed for violations of the Federal Food, Drug, and Cosmetic Act.
Endo Health Solutions Inc., a company that had previously filed for bankruptcy, is facing penalties for its distribution of the opioid medication Opana ER with INTAC.
According to the U.S. Department of Justice, when the company pleaded guilty last month, it acknowledged that some sales managers were aware of sales representatives making claims about the abuse deterrence, tamper resistance, and crush resistance of Opana ER to prescribers. They also admitted that certain sales representatives were demonstrating the drug’s supposed crush-proof and tamper-resistant properties by striking non-medicated sample pills with hammers and conducting other demonstrations.
“The DEA Administrator, Anne Milgram, stated that companies like EHSI played a role in the ongoing opioid crisis by basing their business on dishonest claims and deceptive practices. She emphasized that EHSI prioritized profits over the health and well-being of the American population by intentionally misrepresenting opioid medications.”
Endo Health Solutions Inc.’s corporate affiliates successfully emerged from bankruptcy last month. However, the company will no longer continue its operations in its current form as it will not be able to emerge from bankruptcy.
The U.S. Department of Justice stated that as part of the approved bankruptcy plan, the new company has established voluntary trusts to settle opioid-related claims. These trusts, including public trusts, will provide over $450 million to state, municipal, and Tribal entities to support programs aimed at addressing the opioid crisis. Additionally, the Department of Justice will credit up to $450 million of these payments towards the agreed forfeiture amount. The EHSI affiliates that have successfully emerged from bankruptcy are now bound by an injunction that prohibits future sales and marketing of opioids. Furthermore, they are required to publish millions of documents pertaining to their involvement in the opioid crisis.