Question of the Week — Is DOJ’s Blockbuster $1.4 Billion Opioid Settlement Just the Tip of the Iceberg?
On July 11, DOJ announced a record-breaking $1.4 billion settlement with Reckitt Benckiser Group plc (RB Group) over allegations that its former subsidiary Indivior Inc. inflated prescriptions of its opioid-withdrawal drug Suboxone through numerous unestablished representations about the drug’s safety and addictiveness. The settlement resolves RB Group’s potential civil and criminal liability, but Indivior still faces a criminal trial scheduled to begin on May 11, 2020.
It is the largest recovery in a case involving opioids in the history of United States, and according to the government, it may be a harbinger of more to come: “Opioid addiction and abuse is an immense public health crisis and taking steps to address it is one the FDA’s highest priorities,” said Acting FDA Commissioner Ned Sharpless, M.D., in the press release announcing the settlement. “The FDA, including criminal investigators in our Office of Regulatory Affairs and the lawyers in our Office of Chief Counsel, will continue to work with the Department of Justice to investigate and hold accountable those who devise and participate in schemes to the detriment of the public health.”
That aggressive stance is unsurprising, given the federal government’s focus on countering the opioid epidemic, which costs the United States an estimated $78.5 billion per year. DOJ, in particular, has signaled a growing desire to aid victims and hold culpable actors accountable. In October 2018, it awarded nearly $320 million grants to fight opioid abuse across the country, and in May, DOJ intervened in five whistleblower lawsuits alleging Insys Therapeutics paid doctors and nurses kickbacks to promote its opioid painkiller Subsys. With the recent interventions and settlement, it is clear the multi-billion-dollar opioid industry is in DOJ’s crosshairs, and more record-breaking settlements could be on the way.
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Tagged in: Anti-Kickback and Stark, FDA Fraud, Healthcare Fraud, Medicaid, Medicare, Other Government Health Programs, Pharma Fraud, Provider Fraud,