Reckitt Benckiser Agrees to Pay $1.4 Billion in Record-Setting Settlement Over Suboxone Marketing

The U.S. Department of Justice on Thursday announced that it has reached a settlement with Reckitt Benckiser Group in which the global consumer goods conglomerate will pay $1.4 billion to resolve potential criminal and civil liability related to the marketing of Suboxone, the opioid addiction treatment drug produced by the company’s former subsidiary Indivior.

The resolution, the largest recovery by the U.S. in a case involving opioids, includes forfeiture of $647 million in proceeds, $700 million in civil settlements with the federal government and various states, and $50 million toward an administrative resolution with the Federal Trade Commission.

Indivior marketed and sold Suboxone throughout the U.S. as a subsidiary of Reckitt Benckiser until December 2014, at which point it was spun off. In April 2019, an Abingdon, Virginia, federal grand jury indicted Indivior on charges of engaging in an illicit scheme to increase Suboxone prescriptions. Indivior is accused in the indictment of promoting the film version of Suboxone to physicians, pharmacists, Medicaid administrators and others as less divertable, less abusable, and safer around children, families and communities than other buprenorphine drugs. Such claims are unsubstantiated, DOJ said in a news release.

Indivior is also accused of:

• Using a “Here to Help” internet and phone program to connect patients with doctors known to prescribe Suboxone and other opioids to more patients than allowed by federal law, and at high doses
• Announcing a “discontinuance” of the tablet form of Suboxone primarily to delay the FDA from approving generic forms of the drug

A criminal trial on the matter is scheduled to begin next May.

In addition to forfeiting $647 million in proceeds, Reckitt Benckiser has agreed to not manufacture, market or sell Schedule I, II or III controlled substances in the U.S. for three years, per terms of its non-prosecution agreement.

“This is a landmark moment in our fight to hold drug companies responsible for their role in the opioid crisis,” Virginia Attorney General Mark Herring said in a news release. “We will not allow anyone to put profits over people, or to exacerbate or exploit the opioid crisis for their own benefit. The Virginia Medicaid Fraud Control Unit’s expertise, capacity, and diligent investigation, combined with strong relationships with local, state, and federal partners, helped make this resolution possible.”