U.S. Probe of Drug Maker Falters As Company Resists

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To combat an escalating opioid epidemic, the Drug Enforcement Administration focused in 2011 on Mallinckrodt Pharmaceuticals, one of the nation’s largest manufacturers of the addictive painkiller oxycodone, the Washington Post reports. It was the first time DEA targeted a manufacturer of opioids for alleged violations of laws to prevent diversion of legal narcotics to the black market. It would become the largest prescription-drug case the agency has pursued. DEA and federal prosecutors contended 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 oxycodone sold in the state. U.S. investigators alleged internally 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.

Six years later, after four investigations in five states, the government has taken no legal action. Instead, the company has reached a tentative settlement 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,’ ” said an internal DOJ summary of the case. The case shows how difficult it is for the government to hold a drug manufacturer responsible for damage done by its product. DEA investigators appalled by rising overdose deaths worked for years to build the biggest case of their careers only to watch it falter on uncertain legal territory in the face of stiff resistance from the company. “They just weren’t taking this seriously, and people were dying,” said a former law enforcement official. “People were dying all over the place. It wasn’t their kids, their wives, their husbands, their brothers. It was some hillbilly in Central Florida, so who cares?” A Mallinckrodt spokesman said the company has worked hard to fight drug diversion.

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