Indivior Solutions sentenced as part of $2 billion dollar resolution of false safety claims concerning Suboxone

ABINGDON, Virginia — Indivior Solutions was sentenced to pay $289 million in criminal penalties in connection with a previous guilty plea related to the marketing of the opioid-addiction-treatment drug Suboxone, the Department of Justice announced today.

U.S. District Judge James P. Jones of the Western District of Virginia entered the sentence against Indivior Solutions pursuant to a plea agreement. Together with Indivior’s civil penalties, it will pay $600 million to resolve its civil and criminal liability.  Altogether, the investigation and prosecution of Indivior Solutions and its parent companies, Indivior Inc. and Indivior plc, and two former Indivior executives (its CEO and Medical Director) and a resolution with Indivior’s former parent, Reckitt Benckiser Group plc, resulted in recoveries of more than $2 billion.

Suboxone, which contains the powerful opioid buprenorphine, is a drug product approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment for opioid-use disorder. In connection with its guilty plea, Indivior Solutions admitted to making false statements to the Massachusetts Medicaid program (MassHealth) related to the relative safety of Suboxone Film, a version of Suboxone, around children.

“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.”

Indivior Solutions, a subsidiary of Indivior Inc., pleaded guilty on July 24, 2020, to a one-count felony criminal information charging false statements relating to health care matters.  Indivior Inc. agreed to terms complementing the Indivior Solutions guilty plea and agreed to implement prospective measures that include 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.

On June 30, 2020, Indivior’s former CEO, Shaun Thaxter, pleaded guilty to a one-count misdemeanor information related to Indivior’s false and misleading representations to MassHealth. On October 22, 2020, the court sentenced Thaxter to a six-month term of incarceration and $600,000 in criminal fines and forfeiture.

On August 26, 2020, Indivior’s former medical director, Tim Baxter, pleaded guilty to a one-count misdemeanor information related to Indivior’s false and misleading representations to MassHealth. Baxter’s sentencing hearing is scheduled for December 17, 2020, before Judge Jones in Abingdon, Virginia.

“When a drug manufacturer claims to be part of the solution to the national opioid epidemic, we expect it to make honest representations to government officials, physicians and patients, who have to make crucial treatment decisions,” said Acting United States Attorney Daniel P. Bubar of the Western District of Virginia.  “Instead, Indivior made false statements about Suboxone’s safety to increase its sales.  I’m proud of the close relationship we have with our federal and state partners that led to today’s important result.”

In its guilty plea, Indivior Solutions, which employed marketing and sales personnel for the Indivior group of companies, admitted that in October 2012 it sought to convince MassHealth to expand Medicaid coverage of Suboxone Film in Massachusetts and sent MassHealth a misleading chart and  false data indicating that Suboxone Film had the lowest rate of accidental pediatric exposure (i.e., children taking medication by accident) of all buprenorphine drugs in Massachusetts, when in fact it did not. 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. MassHealth announced it would provide access to Suboxone Film for patients with children under the age of six shortly after Indivior provided the false and misleading information to agency officials.

“Opioid manufacturers and distributors must be held accountable for their illegal actions in the course of this national crisis that continues to devastate families and communities across the Commonwealth,” said Attorney General Herring. “I want to thank my Medicaid Fraud Unit for their hard work on this important case and I also want to thank our local, state, and federal partners for their help and collaboration. No dollar amount or criminal punishment alone will fix this epidemic, but my team and I remain dedicated to holding these pharmaceutical companies accountable for illegal conduct related to the sales of opioids.”

“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.”

“The U.S. Postal Service spends billions of dollars per year in workers compensation-related costs, most of which are legitimate, said Kenneth Cleevely, Special Agent in Charge of the Eastern Field Office for the U.S. Postal Service Office of Inspector General.. “However, when medical providers or companies choose to flout the rules and profit illegally, special agents with the USPS OIG will work with our law enforcement partners to hold them responsible.”

“Pharmaceutical companies that falsely promote their drugs, intended to treat opioid addiction, as superior to other alternatives only worsens the opioid crisis that has touched far too many lives in the U.S. Such actions potentially narrow access to treatment for those who need it,” said Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration. “We will continue to investigate and bring to justice those who devise and participate in these schemes to the detriment of the public health.”

“Suboxone is a vital treatment for patients recovering from opioid addiction, and Indivior thwarted lower-cost generic alternatives to maintain its lucrative monopoly of the drug,” said Gail Levine, a Deputy Director of the FTC’s Bureau of Competition. “Working closely with the DOJ, the FTC was able to secure compensation for patients harmed by Indivior’s anticompetitive scheme and ensure that the company does not engage in similar conduct in the future.”

The criminal case against Indivior was prosecuted by Randy Ramseyer of the U.S. Attorney’s Office for the Western District of Virginia; Albert P. Mayer and Carol Wallack of the Department of Justice Civil Division’s Commercial Litigation Branch; Charles J. Biro and Matthew J. Lash of the Department of Justice Civil Division’s Consumer Protection Branch; Kristin L. Gray, Joseph S. Hall and Janine M. Myatt of the Virginia Medicaid Fraud Control Unit of the Office of the Attorney General; and Garth W. Huston of the Federal Trade Commission.  This matter was investigated by the Virginia Attorney General’s Medicaid Fraud Control Unit; FDA’s Office of Criminal Investigation; the United States Postal Service Office of Inspector General; and the Department of Health and Human Services Office of Inspector General.

The joint effort advances the goals of the Department’s Prescription Interdiction & Litigation (PIL) Task Force to deploy all available criminal, civil, and regulatory tools to hold opioid manufacturers accountable for unlawful practices and to ensure that prescription opioid products are marketed truthfully.

For more information about the U.S. Attorney’s Office for the Western District of Virginia, visit its website. Additional information about the Consumer Protection Branch and the Civil Fraud Section and their enforcement efforts may be found at www.justice.gov and www.justice.gov/fraud. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services Office of Inspector General at 800-HHS-TIPS (800-447-8477). To report fraud or other criminal activity involving the Postal Service, contact USPS OIG special agents at www.uspsoig.gov or 888-USPS-OIG.