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

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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.

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Suspect in Tolson-Middletown murder investigation arrested

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Security camera footage of suspect in fatal Middletown shooting

On November 5, 2020, at approximately 11:55 AM, Johnathan Mihokovich was apprehended in Fauquier County, Virginia. Investigators with the Frederick County Sheriff’s Office assisted Fauquier County and the U.S. Marshalls office with the arrest.

Mihokovich was wanted on warrants obtained through Frederick County for failure to appear, possession of a controlled substance and two counts of Felony Distribution of a controlled substance. Mihokovich is also the main person of interest in the Homicide of Keith Tolson that occurred in the early morning hours of October 27, 2020. See Related Story

Mihokovich is currently being held at the Fauquier County Detention Center and the investigation into the Homicide of Keith Tolson continues. This is the only information that is being released at this time.

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Frederick County authorities seek ‘person of interest’ in Middletown shooting death

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The Frederick County Sheriff’s Office has identified the victim and a “person of interest” being sought for questioning regarding the shooting death in the Middletown McDonald’s parking lot in the early morning hours of October 27th.

The 41-year-old victim is now identified as Keith Tolson.

A person of interest being sought for questioning in Tolson’s death is Jonathan Daniel Mihokovich. The public is advised not to approach Mihokovich if encountered. Rather, call 911 or contact local law enforcement concerning Mihokovich’s whereabouts.

Mihokovich has four current warrants, three drug-related and one for failure to appear.

Above, security video of suspect; below, security footage of suspect vehicle identified as a Ford F-150 extended cab pickup. ‘Person of Interest’ Jonathan Mihokovich should NOT be approached. Call 911 or local law enforcement if spot or have information on whereabouts. Photos FCSO

Tolson was last seen running from the Liberty gas station across Reliance Road towards the McDonald’s restaurant and Econo Lodge hotel. Video evidence shows a pickup truck almost strike and then pursue the victim off the lot and out of camera frame. Shortly afterwards, witnesses report hearing two gunshots and called 9-1-1.

(Info from a release and source information)

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Commonwealth alters course in prosecution of George Good in Brinklow murder case

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In an unexpected development in the murder case of 20-year-old Tristen Brinklow, three charges against one of the men accused of Brinklow’s 2019 murder were nul-prosed by the prosecution Friday afternoon, October 30, in Warren County General District Court.

Those charges dropped against George Lee Good, 28, are First Degree murder, abduction and disposal of Brinklow’s body. However, Assistant Warren County Commonwealth’s Attorney Anna Hammond made it clear the move was not the end of Good’s involvement in the Brinklow murder case.

She informed Judge W. Dale Houff that new direct indictments to the Grand Jury were on the horizon for Good regarding the Brinklow murder. Good remains incarcerated in Rappahannock-Shenandoah-Warren County Regional Jail (RSW Jail) on other charges.

George Lee Good – Photo/RSW Jail website

Brinklow’s mother and two other relatives or friends were present to watch Friday’s hearing. Hammond spoke briefly with them in the courtroom during a recess during which Good and his attorney Aaron Burgin left the courtroom to consult privately. The prosecutor also met with them for a longer period in the Commonwealth Attorney’s Office following adjournment after the nul prosequi announcement. The Brinklow contingent did not seem upset by the prosecution’s strategic turn.

Burgin declined to comment on the prosecution’s move following the hearing, noting the promise of new direct felony indictments against his client regarding the case.

The other man charged in Brinklow’s murder, 35-year-old Richard Matthew Crouch has already been indicted on multiple felony counts, including First Degree Murder, by the Grand Jury. A scheduled October 13 Circuit Court hearing on Crouch’s charges was continued to November 9, on the 9 a.m. docket. In addition to First Degree Murder, felony charges against Crouch include Abduction by Force, Concealment of a Dead Body and Physical Defilement of a Dead Body.

As previously reported, in the criminal complaints against the men in the Brinklow murder case it is stated that after being informed of his Miranda Right not to self-incriminate, Crouch gave law enforcement officials a description of the circumstance of Brinklow’s death.

Richard Matthew Crouch – Photo/NRADC

“Mathew (sic) Crouch stated that he and George Good physically assaulted and bound Tristan (sic) Brinklow in a residence, within Front Royal. He stated this assault led to the death of Brinklow. Crouch stated they placed Brinklow into a refrigerator and attempted to conceal the refrigerator at Digs Landing by placing vegetation on and around the refrigerator,” the criminal complaints state, adding, “Crouch provided information against his penal interests, while under Miranda Advisement, and provided information not known to the general public but was confirmed by evidence at the crime scene.”

In a nod to the previous misspelling of Brinklow’s first name in earlier court documents, Hammond also made a motion to amend the spelling to the correct “Tristen” when Friday’s hearing first reconvened following the recess.

Tristen Brinklow, from his Facebook page sporting a perhaps now ironic warning reference to a ‘zombie apocalypse’ television show.

Trial or hearing dates on some of Good’s unrelated cases were set during an earlier portion of Good’s court appearance Friday afternoon handled by Assistant Commonwealth’s Attorney Matt Beyrau. Good will return to General District Court December 21-22 on a misdemeanor firearms charge and a January 20, 2021 date was set related to a jail assault charge against Good involving another inmate. Hearing discussion indicated Good has been involved in “a number of” inmate altercations during his incarceration.

Case background

Also as previously reported by Royal Examiner, files in the case date Brinklow’s murder to September 28-29, 2019. His body was discovered in the Rivermont area of southwestern Warren County just over two months later, on December 2. The body was not identified as Tristen Brinklow until December 16. Crouch and Good were charged for murder in the case on December 31. Both men were incarcerated without bond on unrelated violent crimes at the time the Warren County Sheriff’s Office brought the charges in the Brinklow case against them, Crouch at Rappahannock-Shenandoah-Warren County (RSW) Regional Jail and Good at the Northwestern Regional Adult Detention Center (NRADC) in Frederick County.

Good was arrested in Frederick County at a DUI check point on December 7 (2019). At the time he was wanted in connection with a non-fatal November 27 shooting on the 200 block of Cloud Street in a residential area adjacent to Front Royal’s Downtown Business District.

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Photos of Middletown murder suspect, suspect vehicle released

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Middletown murder suspect – Photos/Frederick County Sheriff’s Office

The investigation into the early morning shooting and killing of a 41-year-old white male continues. The victim (whose name is being withheld pending notification of next of kin) was last seen running from the Liberty gas station and across Reliance Road towards the McDonald’s restaurant and Econo Lodge hotel.

Video evidence shows a pickup truck almost strike and then pursue the victim off the lot and out of camera frame. Shortly afterwards, witnesses report hearing two gunshots and called 9-1-1.

The public is now being asked to assist investigators with identifying the suspect and/or the suspect vehicle.

The suspect photo has been pulled from video surveillance monitors, we are aware this takes away some quality of the image, but it clearly shows the suspect as a thin white male wearing a dark-colored long sleeve shirt, jeans, camo ball cap and appearing to have some slight “scruff” or facial hair growth. “NIKE” is written on the front of the shirt in green lettering that cannot be seen in the photo.

The suspect vehicle appears to be an older model gold or silver Ford F-150 extended cab pickup with the small seating area behind the driver and passenger. The vehicle has some rust on the lower portion of the passenger door and two decals (upper right corner & lower left corner) on the back glass.

Murder suspect’s vehicle – if you have info call Frederick County Crime Solvers at 540-665-8477 (TIPS)

Anyone who can identify this subject or knows the whereabouts of this truck, is asked to call the Frederick County Sheriff’s Office at 540-662-6162 or Frederick County Crime Solvers at 540-665-8477 (TIPS).

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Early morning shooting leaves one man dead at Reliance Road McDonald’s

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On October 27, 2020, at approximately 3:19 AM, deputies with the Frederick County Sheriff’s Office were dispatched to 85 Reliance Road for a report of shots fired. Arriving deputies located a white male down in the parking lot of the McDonald’s fast-food restaurant suffering from apparent gunshot wounds and now deceased.

A perimeter was established, to secure the area, and FCSO’s Criminal Investigations Division was contacted to respond to begin seeking out witnesses and processing evidence. This is an active investigation, only hours old, with new developments and evidence continuing to be discovered, and so no further details will be released at this time so as not to compromise the investigation. The victim is not being identified at this time pending notification of next of kin.

We would like to point out, for the peace of mind of the general public, and those living near the crime scene, that we do not believe this to be a random act of violence or of any lingering threat to other citizens in that area.

Anyone who believes they may have information about this shooting is asked to call investigator R. T. Swartz at 540-662-6162. Anyone wishing to remain anonymous may call local Crime Solvers at 540-665-TIPS (8477).

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Suboxone manufacturer Indivior’s former chief executive officer sentenced to jail time in connection with drug safety claims

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Shaun Thaxter, the former chief executive officer of Indivior PLC, was sentenced today in U.S. District Court in Abingdon to 6 months in federal prison. He was also ordered to pay a fine of $100,000 and forfeit $500,000. Thaxter pleaded guilty to a one-count misdemeanor information on June 30, 2020, for his role in causing the introduction into interstate commerce of misbranded shipments of the opioid drug Suboxone Film, a violation of the Federal Food, Drug, and Cosmetic Act. Acting United States Attorney Daniel P. Bubar announced the sentence today.

Thaxter served as Indivior’s top executive from 2009 until shortly before his guilty plea. This includes the time period prior to December 2014 when Indivior was known as Reckitt Benckiser Pharmaceuticals. When Indivior was known as Reckitt Benckiser Pharmaceuticals, it was a subsidiary of British conglomerate Reckitt Benckiser Group (RB Group). RB Group paid $1.4 billion in 2019 to resolve its liability to the United States related to the marketing of Suboxone. On July 24, 2020, an Indivior subsidiary called Indivior Solutions pleaded guilty to a one-count felony information for false statements related to health care matters, and together with Indivior, agreed to pay an additional $600 million to resolve liability to the United States related to the marketing of Suboxone. On August 26, 2020, Indivior’s former medical director, Timothy Baxter, pleaded guilty to a one-count misdemeanor information for a violation of the Federal Food, Drug, and Cosmetic Act related to the marketing of Suboxone. Indivior Solutions and Baxter have not yet been sentenced.

Suboxone Film is a drug product approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment. Suboxone’s active ingredient, buprenorphine, is a powerful and addictive opioid. Thaxter was charged in connection with Indivior’s misrepresentations regarding the safety of Suboxone Film.

“While Thaxter served for years as Indivior’s chief executive, he was in a position to ensure that doctors, patients, and insurers were dealt with honestly,” Acting United States Attorney Bubar said today. “Instead, Thaxter failed to prevent efforts to build profits through misleading safety claims, which led to millions of dollars in ill-gotten gains for Indivior. As the Court recognized today, this sentence should serve as a deterrence to other pharmaceutical executives. Today’s sentencing is also the product of years of work and could not have happened without the close federal and state law enforcement partnerships, for which we are grateful.”

“Families and communities across the Commonwealth continue to feel the devastating effects of the opioid epidemic,” said Virginia Attorney General Mark Herring. “Opioid manufacturers and their executive leadership must be held accountable for taking advantage of this country’s opioid crisis and putting profits over people. I want to thank my Medicaid Fraud Control Unit for their terrific work on this case as well as our local, state, and federal partners for their continued partnership on these cases.”

“Misrepresentations made about the drug, while Thaxter ran the company, misled MassHealth about the potential risk of accidental opioid exposure. It is inexcusable to willfully disregard requirements that treatment medications be prescribed carefully in order to protect patient health and safety,” said Elton Malone, Assistant Inspector General for Investigations with the Office of Inspector General of the U.S. Department of Health and Human Services. “With our law enforcement partners, we will continue investigating and bringing to justice those placing profits over patients in government healthcare programs.”

“Opioid addiction is a significant public health crisis and addressing opioid abuse continues to be one of FDA’s top priorities. Misleading information about relative product benefits undermines efforts to provide affordable treatment to those suffering from opioid addiction,” 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 whose schemes jeopardize public health and put Americans at risk.”

“The U.S. Postal Service spends billions of dollars per year in workers compensation and health care-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. To report fraud or other criminal activity involving the Postal Service, contact USPS OIG special agents at www.uspsoig.gov or 888-USPS-OIG.”’

According to court documents, Thaxter had authority over Indivior’s marketing and sales of Suboxone Film which, along with other Suboxone products, generated nearly all the company’s revenue. In 2012, Thaxter oversaw and encouraged Indivior’s efforts to secure formulary coverage for Suboxone Film from the Massachusetts Medicaid agency called MassHealth. Thaxter asked Indivior employees under his direction to devise a strategy to win preferred drug status for Suboxone Film and counteract a non-opioid competitor MassHealth was considering for opioid-addiction treatment. Certain Indivior employees subsequently shared false and misleading safety information with MassHealth officials about Suboxone Film’s risk of accidental pediatric exposure. 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.

The criminal cases against Thaxter, Indivior, and Baxter are being prosecuted by attorneys from the U.S. Attorney’s Office for the Western District of Virginia and the Department of Justice’s Civil Division, 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 criminal investigation of Thaxter was handled by the Virginia Medicaid Fraud Control Unit; FDA’s Office of Criminal Investigations; United States Postal Service – Office of Inspector General; and U.S. Department of Health and Human Services – Office of Inspector General.

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