Record $35M Settlement Reached With UK Pharmaceutical Manufacturer: DOJ

DETROIT, MI — The Justice Department said Tuesday it has reached a record $35 million settlement with United Kingdom-based pharmaceutical manufacturer Mallinckrodt LLC, one of the world’s largest manufacturers of generic manufacturer, to settle charges that it violated federal drug laws.

The settlement, reached in U.S. District Court in Detroit, is the first of such magnitude reached with a drug maker to resolve claims that it didn’t satisfy obligations to detect and notify the U.S. Drug Enforcement Administration of suspicious oxycodone orders, according to a statement from the U.S. Attorney’s Office.

Mallinckrodt denied violating federal drug laws and admitted no liability in the settlement. (For more local news, click here to sign up for real-time news alerts and newsletters from Detroit Patch, click here to find your local Michigan Patch. Also, like us on Facebook, and if you have an iPhone, click here to get the free Patch iPhone app.)

The monitoring requirements exist to prevent excessive sales of controlled substances such as the pain killer oxycodone, which helped trigger a nationwide heroin and opioid epidemic and a spike in overdose deaths.

The settlement also addresses violations in the company’s manufacturing batch records at its plant in Hobart, New York, the government said.

From 2008 until 2011, Mallinckrodt supplied its distributors, who in turn funneled excessive and increasingly large quantities of oxycodone bills to U.S. pharmacies and pain clinics, the government said.

Under the terms of the settlement, Mallinckrodt must monitor and report diversion of these substances at critical links in the controlled substance supply chain, the government said.

“This settlement continues our fight against the opioid epidemic by requiring all in the supply chain not to participate in suspicious orders: physicians, pharmacies, distributors and now — manufacturers,” acting U.S. Attorney Daniel Lemisch said in the statement.

Tim Plancon, special agent in charge of the DEA’s Detroit field office, said the settlement reflects the agency’s “commitment to the public health and safety by holding DEA-registered manufacturers accountable and requiring them to do their due diligence by knowing the downstream customer.”

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