It is estimated that between 26.4 million and 36 million people abuse opioids worldwide, with roughly 2.1 million people in the United States suffering from substance use disorders related to prescription opioid pain relievers. Oxycodone is a well-known prescription pain reliever which can leave users 40 times more likely to develop a heroin abuse problem if they get off track and become addicted. Government officials and law enforcement have attempted to crack down on the opioid abuse epidemic, targeting those on the street as well as manufacturers of the drugs and physicians they believe are allowing patients to misuse.

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The government stated it could have issued Mallinckrodt a $2.3 billion fine for approximately 44,000 violations of the federal Controlled Substances Act, the statute establishing federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain substances is regulated, including recordkeeping violations, according to documents. However, it was difficult to prove the company intentionally contributed to the black market epidemic given its limited control over distribution of the drug, and this was reflected in the final settlement numbers.  Some believe the fine imposed won’t mean a thing to such a large company.  “These fines mean nothing to Fortune 500 companies,” Joseph T. Rannazzisi, retired supervisor of control diversion for opioids at the DEA, said. “Large corporations see these fines as the cost of doing business. Unless there are meaningful sanctions brought against these companies, they will continue to violate the law.”Nevertheless, the Justice Department hopes the case sets an example and encourages other manufacturers to be more cautious in their distribution practices.  “The Department of Justice has the responsibility to ensure that our drug laws are being enforced and to protect the American people,” Attorney General Jeff Sessions said. “Part of that mission is holding drug manufacturers accountable for their actions.”

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America’s Addiction to Opioids: Heroin and Prescription Drug AbuseMallinckrodt Agrees to Pay Record $35 Million Settlement for Failure to Report Suspicious Orders of Pharmaceutical Drugs and for Recordkeeping ViolationsJustice Department reaches first settlement with opioid manufacturer