Mallinckrodt Plc, a manufacturer of the generic opioid painkiller oxycodone, said on Monday it had agreed to pay $35 million to resolve U.S. probes into its monitoring and reporting of suspicious orders of controlled substances.
Mallinckrodt confirmed the proposed settlement after The Washington Post published a report on the probe, the first time the U.S. Drug Enforcement Administration had targeted an opioid manufacturer over violations of laws intended to prevent the diversion of drugs to the black market.
Mallinckrodt said the settlement was subject to additional review and approval by the U.S. Justice Department and DEA.
The accord came as authorities grapple with the nation's opioid drug epidemic. In 2015, more than 15,000 people died in the United States from overdoses involving prescription opioids, according to the U.S. Centers for Disease Control and Prevention.
Among the most common drugs involved in those deaths was oxycodone.
The company has been under investigation since at least 2011, when Mallinckrodt said it received subpoenas from the DEA requesting documents relating to its suspicious order monitoring program for controlled substances.
The U.S. Attorney's Office in Detroit had been investigating the possibility that Mallinckrodt failed to report suspicious orders of controlled substances from 2006 to 2011 in violation of the Controlled Substances Act.
The U.S. Attorney's Office in Syracuse, New York, was also investigating whether Mallinckrodt failed to maintain appropriate records and security measures in connection with manufacturing of drugs at a facility in Hobart, New York.
In a statement on Monday, Mallinckrodt said it denied allegations it violated the law and said the proposed settlement contained no admission of liability.
"In discussions with the government, the company has responded to unfounded claims and successfully refuted factual inaccuracies, reaching an agreement in principle that is agreeable to the government," Mallinckrodt said.
Acting U.S. Attorney Daniel Lemisch in Detroit said his office "works diligently to use all the legal tools available to us to hold corporations responsible for their actions," particularly in a highly regulated industry such as opioid manufacturing.
"As this case is still in settlement negotiations, we cannot comment on the specifics of the matter," he said in a statement.
Mallinckrodt said the proposed settlement would not have a material effect on its financial condition.
Shares of Mallinckrodt were largely unchanged at $44.51, down 0.13 percent.
(Reporting by Nate Raymond in Boston; Editing by Andrew Hay)