May 3, 2021 - SACRAMENTO – California Attorney General Rob Bonta last week announced a $300 million settlement against Indivior plc and Indivior Inc. (collectively, “Indivior”) resolving claims that Indivior falsely and aggressively marketed Suboxone, resulting in improper use 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. 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 $90,682,800.00 for their Medicaid recovery. California’s share of the settlement is $1,644,217.97 in restitution and other recoveries.
“Our country is battling a global pandemic in the midst of an ongoing opioid epidemic. Doctors and the public should be able to trust that what a company says their product can do is the truth, especially when the company claims it can be used during the treatment of something as serious as opioid addiction,” said Attorney General Bonta. “Today’s settlement should send a message that false marketing and improper use of California’s Medicaid dollars will have costly consequences.”
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 Food and Drug Administration (FDA) to treat opioid addiction. Suboxone and its active ingredient, buprenorphine, are powerful opioids, and companies that unlawfully promote medication-assisted opioid addiction treatments such as Suboxone risk misuse, abuse, diversion and accidental exposure.
Today’s settlement 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;
- 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; and
- 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.
Today’s settlement was negotiated by the California Department of Justice’s Division of Medi-Cal Fraud and Elder Abuse (DMFEA), working with a team of other states. Through the DMFEA, DOJ works to protect Californians by investigating and prosecuting those who perpetuate fraud on the Medi-Cal program. DMFEA also investigates and prosecutes those responsible for abuse, neglect, and fraud committed against elderly and dependent adults in the state. DMFEA regularly works with whistleblowers, the California Department of Health Care Services, and state and federal law enforcement agencies to investigate and prosecute Medi-Cal provider fraud and elder abuse, and fraud by entities other than Medi-Cal providers when their actions result in fraudulent claims.
A copy of the settlement agreement with Indivior is available here.
The DMFEA receives 75 percent of its funding from the U.S. Department of Health and Human Services under a grant award totaling $41,264,032 for Federal fiscal year 2020-2021. The remaining 25 percent, totaling $13,754,675 for fiscal year 2020-2021, is funded by the State of California. The Federal fiscal year is defined as October 1, 2020, through September 30, 2021.
Source: CA. DOJ