Attorney General Schmitt Announces Settlement with Indivior Over False Marketing Related to Suboxone
Missouri Attorney General Eric Schmitt announced that on April 30, 2021, Missouri and other states reached an agreement with Indivior plc and Indivior Inc. (collectively “Indivior”) to settle allegations that Indivior falsely and aggressively marketed and promoted the drug Suboxone, resulting in improper expenditures of state Medicaid funds. Suboxone is a drug approved for use by patients recovering from opioid addiction to avoid or reduce withdrawal symptoms while they undergo treatment. Suboxone and its active ingredient, buprenorphine, are powerful opioids.
Indivior will pay a total of $300 million to the collective states to resolve the civil fraud allegations impacting Medicaid and other government healthcare programs, of which approximately $204 million will go to Medicaid. The states will receive a total of nearly $91 million as their share of the Medicaid recovery with the remaining paid to the federal government. As part of the settlement, the state of Missouri will receive $712,107.57 in restitution and damages. The Attorney General’s Medicaid Fraud Control Unit handled this case.
“Indivior and its executives were falsely and aggressively marketing Suboxone, a powerful opioid, in order to game the Medicaid system and fraudulently receive Medicaid payouts. Suboxone is used to aid in recovery from opioid addiction, and Indivior’s actions preyed on that vulnerable population,” said Attorney General Schmitt. “As a result of the efforts of my Office’s Medicaid Fraud Control Unit, Missouri will receive $712,000 in restitution and damages.”
Indivior Inc. (formerly known as Reckitt Benckiser Pharmaceuticals, Inc.) is a Delaware corporation headquartered in Richmond, Virginia, and is a wholly owned subsidiary of Indivior plc. The civil 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 were not for a legitimate medical purpose, were issued without any counseling or psychosocial support, were for uses that were unsafe, ineffective, and medically unnecessary and that were often diverted;
- Knowingly promoted the sale or use of Suboxone Sublingual Film based on false and misleading claims that the Film was less subject to diversion and abuse than other buprenorphine products and that the Film was less susceptible to accidental pediatric exposure than Suboxone Sublingual Tablets; and
- Submitted a petition to the Food and Drug Administration on September 25, 2012, fraudulently claiming that Suboxone Tablet had been discontinued “due to safety concerns”. Indivior also made efforts to fraudulently delay the entry of generic competition for various forms of Suboxone in order to improperly control pricing of Suboxone.
To ensure future compliance, Indivior was required to execute a five-year Corporate Integrity Agreement with the U.S. Department of Health and Human Services-Office of Inspector General, requiring Indivior to implement numerous accountability and auditing provisions.
In addition to this civil settlement, Indivior Solutions, a subsidiary of Indivior, previously pleaded guilty to one felony count in federal court and was sentenced to pay a total of $289 million in fines, forfeiture, and restitution to resolve criminal liability for the illegal marketing of Suboxone. In its guilty plea, Indivior Solutions admitted to making false statements to promote Suboxone Film to the Massachusetts Medicaid program relating to the safety of Suboxone Film around children.
Individuals at Indivior were also held criminally liable in the U.S. District Court for the Western District of Virginia. Indivior plc’s former CEO Shaun Thaxter pleaded guilty to one misdemeanor count and was sentenced to six months in prison and $600,000 in fines and forfeiture. Indivior’s former medical director, Tim Baxter, pleaded guilty to one misdemeanor count and was sentenced to six months home detention, 100 hours of community service, and a $100,000 criminal fine.
This settlement with Indivior follows a 2019 settlement with the former company Reckitt Benckiser Group plc (“Reckitt”) for $1.4 Billion with the federal government and the states, which resolved Reckitt’s potential criminal and civil liability related to substantially similar allegations involving Suboxone.
A National Association of Medicaid Fraud Control Units (“NAMFCU”) Team participated in settlement negotiations.
The Missouri MFCU receives 75 percent of its funding from the U.S. Department of Health and Human Services under a grant award totaling $2,818,808 for Federal fiscal year 2021. The remaining 25 percent, totaling $939,601 is funded by the State of Missouri.