Consumer foods company Reckitt Benckiser Group, PLC (“RB Group”) has agreed to pay $1.4 billion to resolve civil and criminal allegations under the False Claims Act (“FCA”) regarding alleged false marketing of the opioid addiction treatment drug Suboxone. Suboxone is a drug product used for recovering opioid addicts to avoid or help reduce withdrawal symptoms while also undergoing treatment. Under the FCA, any person who knowingly submits false claims to the government is liable with a penalty imposed on each false claim. The FCA allows private persons to file suit on behalf of the government under the qui tam or whistleblower provisions. The complaint is filed under seal with the court for 60 days, which gives the government the opportunity to decide if it wants to intervene in the lawsuit. If there is a recovery, the whistleblower is entitled to receive a percentage of the overall recovery.
Resolving six lawsuits against RB Group in the Western District of Virginia and the District of New Jersey under the qui tam provisions of the FCA, the civil settlement alleges that from 2010 through 2014, RB Group directly or through its subsidiaries “(a) promoted the sale and use of Suboxone to physicians who were writing prescriptions without any counseling or psychosocial support and for uses that were unsafe, ineffective, and medically unnecessary; (b) promoted the sale or use of Suboxone to physicians and state Medicaid agencies using false and misleading claims that Suboxone was less susceptible to abuse than other products; and (c) submitted a petition to the Food and Drug Administration on Sept. 25, 2012, claiming that 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 pricing of Suboxone, including pricing to federal healthcare programs.” RB Group has agreed to pay $700 million to the federal government and to the states that opted to participate in the agreement.
The criminal investigation alleged that until December 2014, RB Group’s subsidiary, Indivior Inc. engaged in an illicit nationwide scheme to increase prescriptions to Suboxone. According to the indictment, Indivior promoted the “film” version (administered sublingually daily) of Suboxone to physicians, pharmacists, Medicaid administrators, and others as a less-abusable drug, even though such claims have never been established. To resolve these allegations, RB Group has agreed to forfeit $647 million of proceeds and not to manufacture, market or sell controlled substances in the U.S. for three years.
Lastly, RB Group has agreed to pay $50 million to resolve claims that it engaged in unfair methods of competition in violation of the Federal Trade Commission (“FTC”). In the Western District of Virginia, the complaint alleged that there were anticompetitive activities by RB Group that were used to impede competition from generic versions of Suboxone. As a result of the complaint, RB Group no longer manufactures or markets drug products.
This settlement is the largest recovery for an opioid drug in U.S. history. The implications of this settlement highlight the importance of compliance with federal law. If you have knowledge of fraud being committed against the government, consider speaking with a FCA attorney today to see if you have a viable qui tam case. Josh Borsellino is a Texas attorney who understands the rules and regulations under the FCA. He works on a contingency fee basis meaning that you owe him nothing unless there is a recovery. Call him today at 817.908.9861 or 432.242.7118.