California Attorney General Rob Bonta announced a $300 million settlement against Indivior, resolving claims that it falsely and aggressively marketed Suboxone, resulting in improper use of state Medicaid funds. Suboxone is a drug approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment. California was a part of the team of states that negotiated the settlement which will be paid to all 50 states, the District of Columbia and Puerto Rico.
Indivior will pay a total of $300 million to resolve various civil fraud allegations impacting Medicaid and other federal healthcare programs, with $203,735,800 going to Medicaid. The amount paid to the states, plus D.C., and Puerto Rico, will be $90,682,800 for their Medicaid recovery.
Indivior Inc. is a Richmond, Virginia based company and a wholly owned subsidiary of British drug manufacturer, Indivior plc, which was formerly known as Reckitt Benckiser Pharmaceuticals, Inc. In 2019, DOJ was a part of the team of states that resolved similar allegations against Reckitt Benckiser Group plc and Reckitt Benckiser LLC – both companies that are part of the corporate structure that later spun off Indivior as an independent entity. The 2019 settlement resulted in a total civil settlement of $700 million, of which $400 million was paid to the federal and state governments to resolve Medicaid fraud allegations. California’s share was $2,853,221.01.
In today’s settlement, it is alleged that Indivior falsely marketed Suboxone, a drug approved by the FDA to treat opioid addiction. This resolves allegations that from 2010 through 2015, Indivior, directly or through its subsidiaries promoted the sale and use of Suboxone to physicians who were writing prescriptions that lacked a legitimate medical purpose, were issued without any counseling or psychosocial support and were for unsafe, ineffective and medically unnecessary purposes. The allegations also stated that Indivio 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. Indivior also submitted a petition to the FDA on September 25, 2012, fraudulently claiming that the Suboxone Tablet had been discontinued “due to safety concerns” about the formulation of the drug and took other steps to fraudulently delay the entry of generic competition of Suboxone in order to improperly control pricing of Suboxone, including pricing to state Medicaid programs.
The civil settlement resolves six whistleblower lawsuits against Indivior 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 $289 million to resolve the company’s criminal liability. Last year, Indivior plc’s former CEO Shaun Thaxton and Indivior’s former medical director both 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.
Read the statement from the California Attorney General