Reckitt Benckiser Group Pays $700 Million to Settle Allegations of Improper Marketing and Sale of Suboxone

October 25, 2019

Maine's share of the settlement funds will be approximately $5 Million

AUGUSTA - Attorney General Aaron M. Frey announced today that Maine and other states have reached settlement with the pharmaceutical distributor Reckitt Benckiser Group (Reckitt) to settle allegations that the company, either directly or through a subsidiary, improperly marketed and otherwise promoted the drug Suboxone, resulting in improper expenditures of state Medicaid funds, as described further below. As part of the settlement, Maine will recover approximately $5 Million in restitution and other penalties.

"The opioid crisis is one of the biggest challenges facing our state, so allegations that a company would improperly market Suboxone outside of a complete treatment plan are concerning," said Frey. I applaud the work of our Medicaid Fraud Control Unit in assisting with this settlement agreement and recovering significant resources for the state.

Reckitt is an English public limited company headquartered in Slough, England, the United Kingdom. Reckitt had, until December 23, 2014, a subsidiary named Reckitt Benckiser Pharmaceuticals, Inc. (RPI). RPI distributed, marketed, and sold Suboxone in the United States, including Suboxone Sublingual Tablets and Suboxone Sublingual Film. Suboxone contains a combination of buprenorphine (an opioid) and naloxone (an opioid antagonist) and was approved to suppress opioid withdrawal symptoms as part of a complete treatment plan to include counseling and psychosocial support. In 2014, RPI was spun off as a separate corporation and renamed Indivior, Inc. The settlement described in this statement is with Reckitt, alone.

Reckitt will pay a total of $700 million dollars in resolution of various civil fraud allegations impacting Medicaid and other government healthcare programs, of which over $400 million will go to the Medicaid program. Additionally, Reckitt will enter into a separate non-prosecution agreement with the United States Attorneys Office for the Western District of Virginia and the United States Department of Justices Consumer Protection Branch.

The federal and state civil settlements resolve the following allegations:

(a) That Reckitt directly or through its subsidiaries knowingly promoted the sale and use of Suboxone to physicians who were writing prescriptions (1) to patients without any counseling or psychosocial support, such that the prescriptions were not for a medically accepted indication; and (2) for uses that were unsafe, ineffective, and medically unnecessary and that were often diverted for uses that lacked a legitimate medical purpose. Such prescriptions lacking a legitimate medical purpose are also not for a medically accepted indication.

(b) That Reckitt directly or through its subsidiaries knowingly promoted the sale or use of Suboxone Sublingual Film based on false and misleading claims that Suboxone Sublingual Film was less subject to diversion and abuse than other buprenorphine products and that Suboxone Sublingual Film was less susceptible to accidental pediatric exposure than Suboxone Sublingual Tablets. Physicians relied on these false and misleading claims in prescribing Suboxone Sublingual Film, and state Medicaid agencies relied on these false and misleading claims to their detriment in making formulary and prior authorization decisions.

(c) That Reckitt directly or through its subsidiaries knowingly submitted a petition to the Food and Drug Administration on September 25, 2012, fraudulently claiming that Suboxone Sublingual Tablet had been discontinued due to safety concerns about the tablet formulation of the drug and took other steps to fraudulently delay the entry of generic competition for various forms of Suboxone in order to improperly control pricing of Suboxone, including pricing to federal healthcare programs.

The investigation resulted from a number of qui tam actions, three of which were originally filed in the United States District Court for the Western District of Virginia.