MD AG Announces Settlement with Drug Distributor to Settle Allegations of Improper Marketing and Sale of Suboxone
Maryland Attorney General Brian E. Frosh today announced a $300 million settlement with Indivior plc and Indivior Inc. (Indivior) to settle allegations that Indivior falsely and aggressively marketed and promoted Suboxone, resulting in improper expenditures of state Medicaid funds. 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. Indivior will pay a total of $300,000,000.00 to resolve civil fraud allegations impacting Medicaid and other government healthcare programs, of which $203,735,800.00 will go to Medicaid. Of that amount, $90,682,800.00 is to be paid to the 50 states, plus Washington D.C. and Puerto Rico, as their share of the Medicaid recovery. Maryland’s share of the settlement is $5,880,884.25 in restitution and other recoveries.
“Suboxone has been critical in helping individuals addicted to opioids through withdrawal and recovery,” said Attorney General Frosh. “But, Indivior, its subsidiaries, and officers misled the public about Suboxone’s risks, promoted its use to physicians, and defrauded state Medicaid programs out of hundreds of millions of dollars to increase its bottom line.”
The settlement resolves allegations that, from 2010 through 2015, Indivior, directly or through its subsidiaries:
- promoted the sale and use of Suboxone to physicians writing prescriptions that were not for a medically accepted purpose;
- knowingly promoted the sale or use of Suboxone Sublingual Film as less susceptible to diversion and abuse than other buprenorphine products; and,
- submitted a petition to the Food and Drug Administration fraudulently claiming that Suboxone Tablet had been discontinued “due to safety concerns” and took other steps to fraudulently delay the entry of generic competition to improperly control pricing of Suboxone, including pricing to the states’ Medicaid programs.
The civil settlement resolves six whistleblower lawsuits pending in federal courts in Virginia and New Jersey. In addition, Indivior Solutions pleaded guilty last year to a one-count felony information and, together with its parent companies Indivior Inc and Indivior plc, agreed to pay a total of $289 million to resolve criminal liability associated with the marketing of Suboxone. Also last year, Indivior plc’s former CEO Shaun Thaxton and Indivior’s former medical director pleaded guilty and were each sentenced on single counts of violations of the Federal Food, Drug and Cosmetic Act for causing the distribution of misbranded Suboxone Film into interstate commerce.
This settlement follows the Reckitt Benckiser Group plc (Reckitt) $1.4 Billion settlement with the federal government and the states in 2019, which resolved Reckitt’s potential criminal and civil liability related to substantially similar allegations involving Suboxone. The 2019 settlement resulted in a total civil settlement of $700,000,000.00, of which $400,000,000.00 was paid to the federal and state governments to resolve Medicaid fraud allegations resolved in the settlement.
In making today’s announcement, Attorney General Frosh thanked the Medicaid Fraud Control Unit, specifically Assistant Attorney General Zak Shirley and paralegal Harouna Boncana for their work on the case.
