Catch of the Week: Indivior Agrees to Pay $600 Million to Settle Opioid Fraud Case

The latest in our Catch of the Week series features Indivior Solutions’ (“Indivior”) agreement to pay $600 million to resolve criminal and civil liability associated with the marketing of the opioid-addiction-treatment drug Suboxone. This is in addition to the $1.4 billion resolution with Indivior’s former parent, Reckitt Benckiser Group PLC (“RB Group”) that was previously announced in 2019. Suboxone is a drug product used by recovering opioid addicts to reduce withdrawal symptoms when they are treated for opioid addiction.

The DOJ announced the agreement last week after Indivior pleaded guilty to making false statements related to healthcare matters.  The indictment alleged Indivior deceived doctors and healthcare benefit programs into believing the film version of Suboxone, which has an opioid component, was safer and less susceptible to abuse than similar drugs. Indivior was also accused of using an internet and phone program, which was purported to be a recovery resource, to connect opioid addicts to doctors that were prescribing Suboxone at suspiciously high rates.

In total, these enforcement action have resulted in $2 billion in penalties, which represents the most significant DOJ enforcement action so far against an opioid company. As part of its criminal guilty plea, Indivior also admitted to making false statements to promote the film version of Suboxone to MassHealth, Massachusetts’ Medicaid program, relating to the safety of Suboxone Film around children.

The settlement also resolved six separate cases brought by whistleblowers under the False Claims Act, alleging that Indivior caused false claims to be submitted to government healthcare programs including by promoting the sale of Suboxone to physicians who were prescribing it outside of medically accepted indication, misrepresenting the likelihood of Suboxone being diverted, and taking steps to delay generic competition for Suboxone.

In addition to its financial aspects, the agreement with Indivior Inc. includes unique provisions that:

• Require Indivior Inc. to disband its Suboxone sales force and not reinstate it;
• Require Indivior Inc.’s CEO to personally certify, under penalty of perjury, on an annual basis that during the prior year (a) Indivior was in compliance with the Food Drug and Cosmetic Act and did not commit health care fraud or (b) list all non-compliant activity and the steps taken by Indivior to remedy these acts;
• Prohibit Indivior Inc. from using data obtained from surveys of health care providers for marketing, sales, and promotional purposes;
• Require Indivior Inc. to remove health care providers from their promotional programs who are at a high risk of inappropriate prescribing; and
• Make Indivior subject to contempt sanctions by the court and reinstatement of the dismissed charges if it violates the agreement.

In its press release, DOJ Deputy Assistant Attorney General Michael Granston reinforced the DOJ’s strong commitment to prosecuting those who seek to illicitly benefit from the Opioid Crisis: “The opioid crisis is a public health emergency. Prevention and access to effective treatments for opioid addiction are critical to fighting this epidemic. When a drug manufacturer claims to be part of a solution for opioid addicts, we expect honesty and candor to government officials, as well as to the physicians and patients making important treatment decisions based on those representations.”

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Tagged in: Catch of the Week, Criminal Proceedings, FCA Federal, Healthcare Fraud, Medicaid, Pharma Fraud, Whistleblower Case,