(Adds further details on settlement, comment from Mallinckrodt
By Nate Raymond
April 3 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
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
Among the most common drugs involved in those deaths was
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
"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)