NASHUA – The U.S. Department of Justice will collect $1.4 billion from the company that formerly manufactured the opioid addiction treatment drug Suboxone.

The settlement is the largest recovery for a drug related to the opioid epidemic in U.S. history.

“The opioid epidemic continues to be a serious crisis for our nation, and I’m proud of the work the Department of Justice and our partners are doing to address this epidemic,” Principal Deputy Associate Attorney General Claire Murray stated.

“Opioid addiction and abuse is an immense public health crisis and taking steps to address it is one the FDA’s highest priorities,” U.S. Food & Drug Administration Commissioner Dr. Norman Sharpless said. “Providing misleading information about product benefits puts the public at risk.”

Suboxone is a drug product approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment. Suboxone and its active ingredient, buprenorphine, are powerful and addictive opioids.

Reckitt Benckiser Group (RB) has agreed to pay the $1.4 billion amount, according to both the company and the federal government. Until December 2014, this global conglomerate manufactured Suboxone.

“While RB has acted lawfully at all times and expressly denies all allegations that it engaged in any wrongful conduct, after careful consideration, the board of RB determined that the agreement is in the best interests of the company and its shareholders,” the company’s statement reads.

The Allegations

Until December 2014, a subsidiary of RB marketed and sold Suboxone throughout the U.S. In December 2014, RB spun of the subsidiary that made Suboxone and the two companies are no longer affiliated.

The company that now makes Suboxone is Indivior Inc. On April 9, a federal grand jury sitting in Abingdon, Virginia, indicted Indivior for allegedly engaging in an illicit nationwide scheme to increase prescriptions of Suboxone. The criminal trial against Indivior is scheduled to begin on May 11, 2020.

Indivior is presumed innocent until proven guilty.

According to the federal indictment, Indivior-including during the time when it was a subsidiary of RB- allegedly promoted the film version of Suboxone to physicians, pharmacists, Medicaid administrators, and others across the country as being safer than other buprenorphine drugs, even though such claims have never been established.

The indictment further alleges that Indivior touted its “Here to Help” internet and telephone program as a resource for opioid-addicted patients. Instead, the indictment alleges, Indivior used this program to connect patients to doctors it knew were prescribing Suboxone and other opioids to more patients than allowed by federal law, at high doses, in a clinically unwarranted manner.

The indictment alleges Indivior’s scheme was highly successful, fraudulently converting thousands of opioid-addicted patients over to Suboxone Film and causing state Medicaid programs to expand and maintain coverage of Suboxone Film at substantial cost to taxpayers.

The RB Settlement

The $1.4 billion settlement includes the forfeiture of proceeds totaling $647 million, civil settlements with the federal government and individual states totaling $700 million, and an administrative resolution with the Federal Trade Commission for $50 million.

“This is a non-criminal resolution and is on the basis that there is no admission of any violation of law or any wrongdoing by RB or any RB Group employee,” the company’s statement emphasizes.

Authorities, however, said the firm needed to be accountable for its actions.

“We are confronting the deadliest drug crisis in our nation’s history. Opioid withdrawal is difficult, painful, and sometimes dangerous; people struggling to overcome addiction face challenges that can often seem insurmountable,” Assistant Attorney General Jody Hunt said. “Drug manufacturers marketing products to help opioid addicts are expected to do so honestly and responsibly.”

“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 added. “We will not allow anyone to put profits over people, or to exacerbate or exploit the opioid crisis for their own benefit.”

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