The government’s struggle to hold opioid manufacturers accountable – By Lenny Bernstein and Scott Higham April 2, 2017


Sixty-six percent of all oxycodone sold in Florida came from this company. But the DEA’s case against it faltered.

Mallinckrodt’s blue 30-milligram oxycodone tablets became so popular among drug users and dealers that they acquired a street name — “M’s,” for the company’s distinctive block-letter logo. (Illustration by Peter and Maria Hoey for The Washington Post)

 

To combat an escalating opioid epidemic, the Drug Enforcement Administration trained its sights in 2011 on Mallinckrodt Pharmaceuticals, one of the nation’s largest manufacturers of the highly addictive generic painkiller oxycodone.

It was the first time the DEA had targeted a manufacturer of opioids for alleged violations of laws designed to prevent diversion of legal narcotics to the black market. And it would become the largest prescription-drug case the agency has pursued.

Ultimately, the DEA and federal prosecutors would contend that the company ignored its responsibility to report suspicious orders as 500 million of its pills ended up in Florida between 2008 and 2012 — 66 percent of all oxycodone sold in the state. Government investigators alleged in internal documents that the company’s lack of due diligence could have resulted in nearly 44,000 federal violations and exposed it to $2.3 billion in fines, according to confidential government records and emails obtained by The Washington Post.

But six years later, after four investigations that spanned five states, the government has taken no legal action against Mallinckrodt. Instead, the company has reached a tentative settlement with federal prosecutors, according to sources familiar with the discussions. Under the proposal, which remains confidential, Mallinckrodt would agree to pay a $35 million fine and admit no wrongdoing.

“Mallinckrodt’s response was that ­‘everyone knew what was going on in Florida but they had no duty to report it,’ ” according to an internal summary of the case prepared by federal prosecutors and obtained by The Post.

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