Mallinckrodt Pharmaceuticals, one of the largest manufacturers of the narcotic painkiller oxycodone, has reached a tentative agreement to pay $35 million to settle investigations into the company's monitoring programs for controlled substances. The settlement includes no admission of wrongdoing.
The Drug Enforcement Administration and the U.S. Attorneys' Office for the Eastern District of Michigan and Northern District of New York were conducting the investigations.
The DEA first began investigating Mallinckrodt in 2011. Eventually federal prosecutors and the DEA would argue the company shirked its legal obligation to report suspicious drug orders as 500 million of the company's oxycodone pills were disseminated throughout Florida, amounting to 66 percent of all oxycodone sold in the state. 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 a comprehensive report from The Washington Post.
"Mallinckrodt has been and is a leader in developing and sharing best practices related to its innovative suspicious order monitoring program that exceeds DEA requirements," said the pharmaceutical company in a statement. "The company denies government allegations that it violated applicable laws in connection with its suspicious order monitoring program, and the settlement contains no admission of liability for civil penalties for relevant conduct."
Mallinckrodt said it doesn't anticipate the settlement to have a material effect on its financial condition. The pharmaceutical company reported a $489 million profit on $3.4 billion in revenue in fiscal year 2016, according to The Washington Post.
The agreement is subject to additional review by the DEA and Department of Justice.
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