In November 2020, the United States Department of Justice announced that Indivior Solutions would pay $289 million in criminal penalties in connection with its previous guilty plea related to the marketing of its drug Suboxone. This means that when combined with the civil penalties, Indivior Solutions is set to pay $600 million to resolve its liability. However, when you combine the entire investigation and prosecution of Indivior Solutions, its parent companies (Indivior Inc. and Indivior plc), two former Indivior executives (its CEO and its medical director), as well as its former parent company Reckitt Benckiser Group plc, the sum total of recoveries is north of $2 billion.
Indivior Solutions pleaded guilty on July 24, 2020, to a one-count felony criminal information charging false statements to the Massachusetts Medicaid program (MassHealth) related to the relative safety of Suboxone Film, a version of Suboxone, around children. Indivior Inc. also agreed to terms complementing the Indivior Solutions guilty plea and agreed to implement prospective measures, including permanently disbanding Indivior Inc.’s Suboxone sales force and taking steps to prevent promoting Suboxone to health care providers at a high risk of inappropriate prescribing. The agreement reached with Indivior Inc. also required that Indivior Inc.’s CEO annually certify, under penalty of perjury, that during the prior year Indivior was in compliance with the Food Drug and Cosmetic Act and did not commit any health care fraud or, alternatively, list all non-compliant activity and the steps taken by Indivior to remedy those acts.
In its guilty plea, Indivior Solutions, which employed marketing and sales personnel for the Indivior group of companies, admitted that in October 2012 it tried to convince MassHealth to expand Medicaid coverage of Suboxone Film in Massachusetts and to that end, sent MassHealth a misleading chart and false data, indicating that Suboxone Film had the lowest rate of accidental pediatric exposure (children taking medication by accident) of all buprenorphine drugs in Massachusetts. However, that was not true. Indivior Solutions further admitted that sending the false and misleading information occurred in the context of marketing and promotional efforts directed at MassHealth, which were overseen by top executives. The tactic engaged by Indivior worked, as shortly after receiving the false information from the company, MassHealth announced it would provide access to Suboxone Film for patients with children under the age of six.
“Combating the opioid epidemic is a top priority for the Department of Justice,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division. “We will hold drug manufacturers accountable when they make misrepresentations that could affect consumers’ access to opioid addiction treatments.”
“The purposefully false assurances of Indivior Solutions leading to potential misuse of potent substances such as Suboxone have only added to the opioid epidemic plaguing our nation,” said Elton Malone, Assistant Inspector General for Investigations with the Office of Inspector General of the U.S. Department of Health and Human Services. “This sentencing, along with law enforcement’s continued focus on this public health crisis, should serve as a warning that large companies cannot rely on their corporate veils to protect them from prosecution.”
Individual Guilty Pleas
As mentioned above, Indivior’s former CEO and former medical director have both pled guilty to one-count misdemeanor Informations related to the false and misleading representations made by the company to MassHealth. Shaun Thaxter, the former CEO, was sentenced in October 2020 to six months of incarceration and $600,000 in criminal fines and forfeiture. Tim Baxter, the former medical director, is scheduled to be sentenced before the end of the year.