Mallinckrodt Pharmaceuticals on Tuesday reached a $35 million settlement with the U.S. Department of Justice to resolve allegations the drugmaker failed to identify and report suspicious drug orders for the highly addictive opioid oxycodone.
Here are four things to know.
1. Between 2008 and 2012, about 500 million oxycodone pills manufactured by Mallinckrodt were disseminated across Florida, amounting to 66 percent of all oxycodone sold in the state, according to The Washington Post.
2. The settlement contains no admission of wrongdoing and comes after the announcement of a tentative settlement in April.
"While Mallinckrodt disagreed with the U.S. government's allegations, we chose to resolve the legacy matter in order to eliminate the uncertainty, distraction and expense of litigation and to allow the company to focus on meeting the important needs of its patients and customers," said Michael-Bryant Hicks, general counsel for Mallinckrodt.
3. The deal resolves claims Mallinckrodt did not meet its obligations to alert the Drug Enforcement Administration of suspicious orders of controlled substances.
"In the midst of one of the worst drug abuse crises in American history, the Department of Justice has the responsibility to ensure that our drug laws are being enforced and to protect the American people," said Attorney General Jeff Sessions. "And as a result of today's settlement, we are sending a clear message to drug companies: this Department of Justice will hold you accountable for your legal obligations and we will enforce our laws. I believe that will prevent drug abuse, prevent new addictions from starting, and ultimately save lives."
4. The DEA initiated an investigation into Mallinckrodt in 2011. At one point, federal investigators alleged the company could be held accountable for nearly 44,000 federal violations, possibly exposing the drugmaker to more than $2 billion in fines, according to the Post.
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