Former Medical Director of Suboxone Manufacturer Indivior Sentenced in Connection with Drug Safety Claims

Timothy Baxter, the former medical director of Indivior PLC, was sentenced today in federal court in Abingdon, Virginia, to six months of home detention and 100 hours of community service in connection with the company’s marketing of an opioid drug.

Baxter pleaded guilty in August 2020 to a one-count misdemeanor Information related to Indivior’s false and misleading representations to the Massachusetts Medicaid program (MassHealth) regarding Suboxone, a drug approved for recovering opioid addicts to avoid or reduce withdrawal symptoms. In connection with his guilty plea to causing the introduction into interstate commerce of misbranded drugs under the Federal Food, Drug, and Cosmetic Act, Baxter admitted that he failed to prevent Indivior from sending false and misleading information to MassHealth related to the relative safety of Suboxone Film, a version of Suboxone, around children. 

“In this administration, the Department of Justice has augmented its important and ongoing drug enforcement efforts with a series of new initiatives targeted at illegal conduct involving prescription opioid drugs,” said Deputy Attorney General Jeffrey A. Rosen.  “The Department’s multi-pronged prosecution of Indivior’s unlawful promotion of Suboxone is a prime example of how to combat this crisis through diverse strategies.  The net effect of the Department’s Indivior-related cases will bolster ongoing efforts to punish criminal conduct in the opioid space, deter further criminal conduct among opioid manufacturers and their top executives, and contribute significantly to the Department’s objective to stem the tide of this epidemic.”

“When Timothy Baxter failed to ensure Indivior provided honest and accurate information to a state Medicaid program about Suboxone, it resulted in overstated safety claims and criminal conduct,” said Acting U.S. Attorney Daniel P. Bubar.  “Baxter’s failure was especially egregious, given his role in the company as global medical director.  Today’s sentence ought to be a deterrent to other pharmaceutical executives against providing anything less than truthful information about their products.  We could not have done this case without the hard work of and cooperation with the Virginia Attorney General’s Office and our federal partners, for which we are incredibly grateful.” 

“The Opioid crisis continues to be a critical public health issue with the toll of addiction—in lost lives and broken families—affecting every community in America. Addressing this crisis is one of the FDA’s highest priorities,” said FDA Commissioner Stephen M. Hahn, M.D. “Medication-assisted treatments incorporating drugs like Indivior’s Suboxone, in combination with counseling and behavioral therapy, are an important tool in combating opioid use disorder but can quickly become part of the problem if not used responsibly. When companies and their leadership provide misleading information about relative product benefits, they can ultimately risk more misuse, abuse, diversion, and accidental exposure to opioid drugs as well as make treatment more difficult to obtain for those suffering from this crisis. We will continue to work with the Department of Justice to investigate and hold accountable those who devise and participate in schemes to the detriment of the public health.”

According to court documents, Baxter helped oversee Indivior’s efforts in 2012 to secure formulary coverage for Suboxone Film from MassHealth. Indivior employees devised a strategy to win preferred drug status for Suboxone Film and counteract a non-opioid competitor MassHealth was considering for opioid-addiction treatment. A certain Indivior employee subsequently shared false and misleading safety information with MassHealth officials about Suboxone Film’s risk of accidental pediatric exposure. Baxter failed to prevent this course of conduct carried out by an employee under his supervision. Two months after receiving that false and misleading information, MassHealth announced it would provide access to Suboxone Film for Medicaid patients with children under the age of six.

Indivior’s former CEO, Shaun Thaxter, was sentenced in October 2020 to six months in prison and a $600,000 criminal fine and forfeiture after he pleaded guilty to the same charge. U.S. District Court Judge James P. Jones of the Western District of Virginia handed down the sentences for both Baxter and Thaxter. The cases follow corporate criminal and civil resolutions announced by the Department earlier this year. In total, payments made by Indivior Solutions and its parent companies, Indivior Inc. and Indivior plc, along with payments made under a 2019 resolution with Indivior’s former parent, Reckitt Benckiser Group plc, will exceed $2 billion. That amount represents the second-largest monetary resolution obtained by the Department of Justice in a case involving an opioid drug.

The criminal case against Indivior was prosecuted by the U.S. Attorney’s Office for the Western District of Virginia; the Department of Justice Civil Division’s Commercial Litigation Branch; the Department of Justice Civil Division’s Consumer Protection Branch; the Virginia Medicaid Fraud Control Unit of the Office of the Virginia Attorney General; and 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 at https://www.justice.gov/usao-wdva. Additional information about the Consumer Protection Branch and the Civil Fraud Section and their enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch and http://www.justice.gov/civil/fraud-section. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).