Source: US Food and Drug Administration
Department of Justice
U.S. Attorney’s Office
Western District of Virginia
FOR IMMEDIATE RELEASE
Thursday, December 17, 2020
Action Follows Sentencing of Former CEO and Corporate Resolutions
ABINGDON, Virginia – Timothy Baxter, the former medical director of Indivior PLC, was sentenced today in federal court in Abingdon, Virginia, to six months home detention, 100 hours of community service, and a $100,000 criminal fine 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 United States 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.”
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.
“Sadly, we continue to feel the devastating effects of the opioid crisis in communities across the Commonwealth,” said Attorney General Mark Herring. “Opioid manufacturers and their leadership must be held accountable for the role that they played in creating and prolonging this epidemic by putting profits over people. I want to thank my Medicaid Fraud Control Unit, as well as our local, state, and federal partners for all of their hard work and collaboration on this important case.”
“Opioid addiction is a serious public health crisis in the United States and the FDA is continuing to take steps to combat and address this significant issue. When companies and their leadership provide misleading information about the benefits of their products, it undermines efforts to provide affordable treatment, especially to those suffering from opioid addiction,” said Catherine Hermsen, Assistant Commissioner of the FDA’s Office of Criminal Investigations. “We will continue to investigate and work to protect against those whose schemes jeopardize public health and put Americans at risk.”
“The U.S. Postal Service spends billions of dollars per year in workers compensation / health care related costs, most of which are legitimate,” said U.S. Postal Service Office of Inspector General Special Agent in Charge Kenneth Cleevely, Eastern Area Field Office. “However, when corporations, medical providers, pharmacies, and other organizations 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. To report fraud or other criminal activity involving the Postal Service, contact our special agents at www.uspsoig.govor 888-USPS-OIG.”
“Baxter’s knowing false and misleading representation of Suboxone is no small issue— especially at a time when our country battles the ongoing opioid crisis,” said Elton Malone, Assistant Inspector General for Investigations with the Office of Inspector General of the U.S. Department of Health and Human Services. “These Indivior prosecutions should send a message to pharmaceutical companies who fail to uphold the duties and integrity expected of them. We will continue to work with our law enforcement partners to hold corporations and their executives accountable.”
The criminal cases against Baxter, Thaxter, and Indivior were prosecuted by attorneys from the U.S. Attorney’s Office for the Western District of Virginia, Department of Justice’s Civil Division, Virginia Attorney General’s Medicaid Fraud Control Unit, and Federal Trade Commission including Albert P. Mayer, Randy Ramseyer, Kristin L. Gray, Joseph S. Hall, Janine M. Myatt, Garth W. Huston, Carol Wallack, Charles J. Biro, and Matthew J. Lash. The investigation was handled by the FDA’s Office of Criminal Investigations; Virginia Medicaid Fraud Control Unit; United States Postal Service – Office of Inspector General; and U.S. Department of Health and Human Services – Office of Inspector General.
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).
USAO – Virginia, Western