The Department of Justice (DOJ) recently announced a $1.4 billion resolution with Reckitt Benckiser Group plc (RB Group), a global consumer goods conglomerate, to resolve potential criminal and civil liability related to the company’s marketing of the drug Suboxone. Providers use the opioid addiction treatment drug to avoid or reduce withdrawal symptoms for recovering opioid addicts. Prior to December 2014, RB Group wholly owned a subsidiary, Indivior Inc. (Indivior), previously known as Reckitt Benckiser Pharmaceuticals Inc., that marketed and sold Suboxone throughout the U.S. Indivior was indicted, and awaits trial on May 11, 2020, for allegedly engaging in an illicit nationwide scheme to increase prescriptions of Suboxone. As a result, RB Group has agreed to execute a non-prosecution agreement (agreement) to resolve any potential liability stemming from the conduct alleged in Indivior’s indictment. The agreement requires RB Group to forfeit $647 million in proceeds that it received from Indivior and not manufacture, market, or sell Schedule I, II, or III controlled substances in the U.S. for three years. In addition, RB Group has agreed to cooperate fully with all DOJ investigations and prosecutions related in any way to Suboxone. This settlement is the largest U.S. recovery in a case involving an opioid drug and includes civil settlements with the Federal Government and states totaling $700 million, and an administrative resolution with the Federal Trade Commission (FTC) for $50 million.
The Indivior indictment alleges that it promoted the film version of Suboxone (Suboxone Film) to Medicaid administrators, physicians, pharmacists, and others across the U.S. as being less-abusable, less-divertible, and safer around children, families and communities, than other buprenorphine drugs. However, such claims had never been proven. In addition, Indivior allegedly used its “Here to Help” internet and telephone program, in part, to connect opioid-addicted patients with physicians who Indivior knew were prescribing Suboxone and other opioids to more patients than allowed by federal law, at high doses, and in a careless and clinically unwarranted manner. To further its scheme, Indivior allegedly issued a “discontinuance” announcement for its tablet form of Suboxone, stating supposed “concerns regarding pediatric exposure” to tablets. However, Indivior’s executives had knowledge that the main reason for the discontinuance was to delay the Food and Drug Administration’s (FDA) approval of the generic tablet forms of the drug. The scheme resulted in successful and fraudulent conversion of thousands of opioid-addicted patients to Suboxone Film. Consequently, the Federal Government incurred substantial costs as state Medicaid programs expanded and maintained coverage of Suboxone Film.
Under the civil settlement resolving claims that the Suboxone marketing caused false claims to be submitted to government health care programs, RB Group has agreed to pay a total of $700 million which includes $500 million to the Federal Government and up to $200 million to states that opt to participate in the agreement. The U.S. alleges that from 2010 through 2014, RB Group directly, or through its subsidiaries, knowingly:
- Promoted the sale and use of Suboxone to physicians who were writing prescriptions without referring them to any counseling or psychosocial support, and for uses that were unsafe, ineffective, and medically unnecessary, and that were often diverted for uses that lacked a legitimate medical purpose;
- Promoted the sale or use of Suboxone Film to physicians and state Medicaid agencies using false and misleading claims that Suboxone Film was less susceptible to accidental pediatric exposure than tablets; and
- Submitted a petition to the FDA in 2012 claiming that the Suboxone Tablet had been discontinued “due to safety concerns” about the tablet formulation of the drug and took other steps to delay the entry of generic competition for Suboxone in order to improperly control Suboxone pricing, including pricing for federal health care programs.
The civil settlement resolves six pending lawsuits against RB Group brought under the False Claims Act (FCA) whistleblower provisions. The Civil Division’s Commercial Litigation Branch, the U.S. Attorney’s Office for the Western District of Virginia and for the District of New Jersey handled the civil settlement. For the criminal resolution, the U.S. Attorney’s Office for the Western District of Virginia and the DOJ’s Consumer Protection Brand, based on an investigation from the Virginia Attorney General’s Medicaid Fraud Control Unit, FDA Office of Criminal Investigation, U.S. Postal Services Office of Inspector General (OIG), and Department of Health and Human Services OIG, handled the matter.
Further, under a separate agreement with the FTC, RB Group has agreed to pay $50 million to resolve claims that it engaged in unfair methods of competition in violation of the FTC Act. The FTC alleged that RB Group engaged in anticompetitive activities to impede competition from generic equivalents of Suboxone. RB Group no longer markets or manufactures drug products. As part of a consent decree, RB Group has agreed to notify the FTC if it begins marketing drug products in the U.S. In addition, RB Group has agreed that if it files a Citizen Petition with the FDA regarding a drug product, it will simultaneously disclose all studies and data relevant to that Citizen Petition to the FDA and FTC. RB Group has also agreed not to withdraw a drug from the market or otherwise disadvantage a drug after obtaining approval to market another drug containing the same active ingredient.
The DOJ press release is available at: