Justice Dept. reaches settlement with drugmaker in opioid case

The Washington Post

WASHINGTON — The Justice Department and Mallinckrodt Pharmaceuticals reached a $35 million settlement Tuesday of charges that the company had failed to report signs that large quantities of its highly addictive oxycodone pills were diverted to the black market in Florida, where they helped stokethe opioid epidemic.

The agreement is the first with a major manufacturer of the opioids that have sparked a crisis of overdoses and addictions across the country. The Justice Department said the deal establishes “groundbreaking” new standards that require the company to track its drugs as they flow through the supply chain to consumers in an effort to control the epidemic.

The company had argued that once it passed the drugs to wholesale distributors, it was not responsible for illegal diversion of the painkillers as they were sent to retailersand then pain patients.

“The Department of Justice has the responsibility to ensure that our drug laws are being enforced and to protect the American people,” Attorney General Jeff Sessions said in a statement. “Part of that mission is holding drug manufacturers accountable for their actions. Mallinckrodt’s actions and omissions formed a link in the chain of supply that resulted in millions of oxycodone pills being sold on the street.”

The Washington Post reported a tentative settlement between the two sides in April, highlighting the frustration of DEA investigators who had spent six years trying to hold Mallinckrodt responsible for its role in the epidemic. At one point, the government calculated that it could have assessed the company $2.3 billion in fines for nearly 44,000 violations of the federal Controlled Substances Act, according to confidential government documentsobtained by The Post.

Between 2008 and 2012, Mallinckrodt pumped 500 million pills into Florida, 66 percent of all oxycodone sold in the state.

Nearly 180,000 people died of overdoses to prescription painkillers between 2000 and 2015, and the abuse of pharmaceutical opioids is widely blamed for a crisis that now involves many thousands of overdoses on heroin and fentanyl.