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.
Blue Ridge Narcotics & Gang Task Force investigation nets dealer arrest in Culpeper
CULPEPER, VA – The Blue Ridge Narcotics and Gang Task Force has concluded a three-month long investigation with the arrest of a Culpeper, VA resident. William E. Settle III, 36, was arrested by the Blue Ridge Narcotics and Gang Task Force following a search warrant executed at his residence. Through the course of the investigation, Blue Ridge Narcotics and Gang Task Force officers learned that Settle would routinely travel outside the Commonwealth to a fentanyl source of supply. Settle would then transport the fentanyl back to the Commonwealth for distribution and sale.
On July 26, members of the Blue Ridge Narcotics and Gang Task Force obtained a search warrant for Settle’s residence located along the 600 block of Highview Court in Culpeper, VA. During a search of the residence, 50 capsules of fentanyl with a street value of $1500.00, $1,750.00 in currency, and 2 firearms were seized. Settle was arrested and charged with one felony count of possession with intent to distribute schedule I/II drug, one felony count of possession of a schedule I/II drug, one felony count of possession of a firearm while possessing schedule I/II drug, one misdemeanor count resisting arrest, one misdemeanor count of obstruction of justice. Settle was also served with outstanding failure to appear warrants out of Culpeper. Additional charges are pending. Settle was transported to the Culpeper County Jail where he is being held without bond.
The Blue Ridge Narcotics and Gang Task Force is composed of law enforcement personnel from the Culpeper, Orange, Rappahannock Sheriff’s Departments, Culpeper, and Warrenton Police Departments and the Virginia State Police Bureau of Criminal Investigation, Culpeper Field Office.
New DNA technology being utilized in 23-year-old Strasburg murder-infant abduction case
On Monday, July 26, the Culpeper Field Office of the Virginia State Police issued a statement on new DNA technology being utilized to seek new leads in a 23-year-old murder/child abduction case that occurred in the Town of Strasburg. VSP noted the ongoing cooperation of the child’s father, Daniel E. Pompell, in its investigation. Anyone with possible information regarding the July 1998 murder of Sylena Jo Dalton and abduction of then 10-week-old Allyson Kathleen Dalton is urged to contact VSP Senior Special Agent Mike Jones at (540) 829-7400 or by email at email@example.com.
Below is the VSP release in its entirety:
“Tomorrow marks 23 years since on July 27, 1998, a 10-week-old baby girl disappeared and her mother was violently murdered at their apartment in the Town of Strasburg. The Virginia State Police (VSP) Bureau of Criminal Investigation’s (BCI) Culpeper Field Office is awaiting results from new, advanced DNA testing utilized as a part of the still ongoing criminal investigation.
“As technology has changed and advanced, so have our tactics in working to solve these tragic crimes,” said Capt. John A. Defilippi, VSP BCI Culpeper Field Office commander. “The DNA testing will provide additional information that will greatly aid us with advancing this case. But we are still encouraging anyone with information related to Allyson’s disappearance and Sylena’s death to still come forward with information.”
The infant, Allyson Kathleen Dalton, was last seen at approximately 7:45 a.m. on July 27, 1998, at her mother’s second-floor apartment in the 100 block of Charles Street in Strasburg. She was with her mother, Sylena Jo Dalton, at the time.
Later that same day, at 2:25 p.m., one of the mother’s coworkers found 20-year-old Sylena stabbed to death on a couch inside the residence. Allyson was unaccounted for and has not been seen since that morning. Investigators believe Sylena was killed between 9:15 a.m. and 10:30 a.m., that morning of July 27, 1998. Neighbors told police that no screams were heard nor was there any disturbance made that morning at the apartment. No murder weapon was found at the scene.
Allyson’s father, Daniel E. Pompell, told state police agents he stopped at the residence on the morning of the murder. Witnesses confirm seeing him outside the apartment with a bundle under his arm. State Police are appreciative of Mr. Pompell’s continued cooperation related to the ongoing investigation as state police persist in efforts to locate his daughter.
Anyone with information about the case is encouraged to contact VSP Senior Special Agent Mike Jones at (540) 829-7400 or by email at firstname.lastname@example.org.
(From a Virginia State Police release)
UPDATE: EDA and McDonald agree to $9-million debt exemption to her bankruptcy claim
On Tuesday, July 20, U.S. Western District Harrisonburg Division Bankruptcy Court Judge Rebecca B. Connelly issued a “Non-Dischargeable Consent Order Judgement” in Jennifer McDonald’s bankruptcy filing. The judge’s order decrees that “The Warren EDA is granted judgment against and is entitled to recover from Debtor, the sum of $9,000,000; and this judgment shall survive discharge of the Debtor in this Chapter 7 bankruptcy …”
The preface to Judge Connelly’s ruling notes that “In the interest of resolving this matter and avoiding litigation uncertainty, risks, and costs, but without the Debtor admitting the Warren EDA’s allegations, the Warren EDA and the Debtor have engaged in arm’s length negotiations and agree that the Warren EDA’s non-dischargeable claim is in the amount of $9,000,000 …”
The bottom line appears to be that the EDA and its former executive director have agreed that $9 million is the amount of the EDA’s civil court claim against McDonald, without her agreeing that she actually did anything wrong to justify the claim. So, that amount will be subject to collection in the civil action claim by the EDA outside the bankruptcy court process. The bankruptcy court order notes that any amount the EDA was to recover in the bankruptcy action would apply to achieving its $9-million civil claim in Warren County Circuit Court.
A reading of an “Exhibit A1 – the Stipulation” explaining detail of the “Non-Dischargeable Consent Order Judgement” further elaborates that McDonald as “The Debtor waives any right to contest the validity, enforceability, extent, and scope of the terms of the Stipulated Non-Dischargeable Judgment … and waives any right to seek relief from this Stipulation on any grounds” based on any applicable law.
Remaining at issue between the parties appears to be how the EDA will collect that $9-million dollar judgement the parties have agreed to. A number of McDonald-owned properties were frozen by the court early in the civil process, while properties co-owned with other family members were not. Since that order several relatives were named as co-defendants. The “Stipulation” also notes that the EDA-McDonald agreement order “shall not release or discharge any entity other than the Debtor from any liability owed to the Warren EDA” under its Amended Complaint in civil court against all co-defendants.
No ‘Summary Judgement’ against ITFederal
Also, on the EDA vs. McDonald et al. civil action side, on July 14, Harrisonburg-based presiding Circuit Court Judge Bruce D. Albertson dismissed an EDA motion for a “Summary Judgement” ruling against Truc “Curt” Tran’s ITFederal LLC. Plaintiff and defense attorneys made oral arguments on the EDA motion before Albertson on June 10. The bottom line here appears to be that the court has ruled there is not enough substantive information in the plaintiff’s original complaint to rule ITFederal immediately liable for the claim against it.
ITFederal’s $10-million EDA loan to achieve the development of its 30-acre parcel (valued at about $2 million but gifted to ITFederal by the EDA for one dollar) at the Royal Phoenix Business Park/former Avtex Superfund site, with as much as another $2 million in developmental expenses, was the largest single claim in the initial EDA financial scandal civil action.
The EDA alleges that the ITFed loan was achieved under false pretenses as part of the over-arching embezzlement-misappropriation of funds conspiracy allegedly orchestrated by McDonald as EDA executive director after former federal Sixth Congressional District Representative Robert Goodlatte brought Tran here with much ballyhoo for a fall 2016 ITFederal ribbon cutting at the Avtex site. And now the EDA claim against ITFederal, which remains current on its EDA loan payments of about $40,000 a month with an estimated $2 million spent on site, will, unlike the EDA claim against McDonald, continue as a contested part of the EDA’s civil action.
See related EDA meeting, 2018-19 audit story – “Financial Scandal Era Audits near completion as EDA ponders Budget Adjustments”
Legality of Meza council appointment will be re-argued orally third week of September
A date of September 22, at 10:30 a.m. has been set by Warren County Circuit Court Judge William W. Sharp to again hear oral arguments in support of plaintiff (Paul Aldrich) and defense (Jacob Meza, Town of Front Royal) filings on the court’s decision to re-hear a citizen challenge of Meza’s appointment/election to council on January 4th, four days after the term he did not run for reelection to, expired. Plaintiff counsel David Downes was seeking an August date further in front of the November 2nd Special Election to fill the final year of the council seat term vacated by Chris Holloway when he was elected mayor in November 2020, taking office January 1, 2021.
Meza is not running to continue into that final year of Holloway’s old council seat term. With the filing deadline passed, only Warren County Republican Committee Treasurer Amber Morris and Bruce Rappaport, a conservative independent who lost the Republican Committee endorsement to Morris, have filed to be on the ballot in the November Special Election.
Speaking of “elections”, how the term “elected” in Section 47 of the Front Royal Town Charter upon which the plaintiff case is based, is finally interpreted by the court could cast a larger shadow over the judge’s final ruling on the issue. In a letter to plaintiff attorney Downes and defense counsel Heather Bardot dated July 15, Judge Sharpe addresses his promise to resolve the case prior to the November 2, 2021, Special Election to fill the final year of the old Holloway council seat term.
“I intend to keep my word … the citizens of the Town of Front Royal deserve to have this matter resolved,” the judge wrote of that pre-Election Day resolution of the case promise, continuing, “As I have already noted, though the Complaint in this case challenges the validity of Mr. Meza’s office, if the Plaintiff’s position is right, then it is quite possible that the validity of the claims to office of other current council members and the mayor may also be in question.”
A potential impact on the mayor’s or other council members seats stems from initial May 25th hearing discussion on whether the relevant Section 47 wording could be interpreted as preventing elected town officials from running in General Elections for one year after their previous term had expired.
That Section 47 wording is: “No member of the council of the Town of Front Royal shall be appointed or elected to any office under the jurisdiction of the council while he is a member of the council, or for one year thereafter.” (underscore added)
However as previously observed during the May hearing, with an 84-year precedent in place of council members and mayors running for re-election since the 1937 passage of the Town Charter, the likelihood of such a judicial re-interpretation might seem remote. In fact, Downes noted that the plaintiff is not pursuing such an interpretation of the Charter wording, adding that what he termed “a methodical analysis” of relevant historical documents, which he cited as “the Virginia Constitution of 1776, the Virginia House of Delegates Rules of Procedure from 1912, Robert’s Rules of Order from 1915, the Town Charter of 1937” among others “shows that the framers of the charter were clearly addressing an election by councilmen and not a general election by the public.”
In addition to jurisdictional issues and legal standing of the plaintiff to challenge Meza’s “appointment” or “election” by his four Republican Committee colleagues to council on January 4, it continues to be the context of the words “appointed” and “elected” as it applies to council actions in Charter Section 47 around which the case revolves.
Much of the written arguments filed by the two sides in the wake of Judge Sharp’s decision to re-examine and re-hear those arguments, echo points made during the May 25 hearing. As reported in Royal Examiner’s story on that hearing, “Bardot pointed to the absurdity of the Section 47 wording” if it was interpreted to mean council could “appoint” someone who was already a council member to a council seat. So, she asserted that Charter Sections 6D and 9 applied to filling council seats, rather than Section 47.
In her Demurrer filing for dismissal, Bardot pointed to Section 6D wording on filling council vacancies: “The council may fill any vacancy that occurs within the membership of council for the unexpired term, provided that such vacancy is taken within 45 days of the office becoming vacant,” Section 6D states. No reference to a one-year hiatus per appointments is made here, Bardot noted.
Citing the inclusion of the words “appointed or elected” Judge Sharp’s initially ruled that Section 47 applied only to paid staff appointments, not council member appointments. Sharpe said it seemed clear that the Town Charter’s intent, dating to its 1937 adoption, was not to prevent council members from running for re-election for a year. So, the court sided with Bardot’s stance for the defense that Sections 6 and 9 of the Charter were the applicable sections on council appointments, rather than Section 47.
In the first round of oral arguments, as he likely will again on September 22, Downes countered that it was “dangerous to take one word out of context” in trying to decipher the intent of town fathers 84 year ago. The plaintiff counsel argued that the Section 47 wording referred to two distinct and different actions: 1/ appointment to a town staff position while being a council member, or within a year of having been a council member; and 2/ “election” as in acquiring a council majority consensus for reappointment to a council seat within a year of leaving council voluntarily, like Meza by not seeking reelection, or involuntarily, as in being voted out of office by the public.
Some have contended Meza did not run in 2020 because he may have believed he would have lost after a controversial year in office surrounding his employer Valley Health and his flip-flopping on recusals from discussion and votes in authorizing a $60-million County-Town EDA loan to help finance construction of a new hospital without a Maternity Unit.
Plaintiff Paul Aldrich and his counsel contend Meza’s appointment/election by four of his County Republican Committee colleagues (the vote was 4-1) was the very type of political cronyism Section 47 of the Town Charter was designed to prevent.
And so the two legal sides continue to circle and counter the other’s points of contention on jurisdiction, authority of the plaintiff’s challenge and how long-dead town fathers used the English language 84 years ago.
Stay tuned, as a final decision on these issues has been promised by the court before November 2, 2021, one might guess by the end of September or early October at the latest.
Non-fatal Hill Street stabbing report leads to charges against roommate of victim
In the early morning hours of Thursday, July 15, 2021, officers with the Front Royal Police Department responded to a residence in the 400 Block of Hill Street for a report of a stabbing. When officers arrived, they located a male victim, identified as Mario Frazier, who was bleeding from an apparent stab wound to his neck. Frazier provided a statement to officers identifying the offender as 61-year-old Front Royal resident, Anthony “Tony” Herbert. Frazier, who shares a residence with Herbert, stated there was an argument and physical altercation leading to the stabbing. The victim was transported to Warren Memorial Hospital, where he was treated for non-life-threatening puncture wounds.
Herbert was quickly located and apprehended by Front Royal Police officers without further incident. Herbert was transported to Rappahannock Shenandoah Warren (RSW) Regional Jail, where he was held without bond on a Malicious Wounding charge. He has a scheduled court date of September 21, 2021, at 10 a.m. in Warren County General District Court.
(From a July 15 FRPD Press Release)
FRPD traffic stop leads to chase, multiple charges against Virginia Avenue resident
On Tuesday evening, July 13, 2021, at approximately 7:50 p.m., a Front Royal Police Department officer observed a red Jeep Liberty speeding on John Marshall Highway. The officer initiated a traffic stop and the driver pulled over to the side of the road.
As the officer began exiting his marked patrol vehicle, the driver of the Jeep Liberty quickly pulled off, driving east on John Marshall Highway towards Linden. The officer pursued, and the driver made an abrupt U-turn near ESA Lane and began traveling back into town. Additional officers from the Front Royal Police Department and Warren County Sheriff’s Office followed the vehicle as the driver continued north onto Commerce Avenue and several other streets until coming to a sudden stop in the 200 block of Virginia Avenue. The driver then fled on foot, where he was apprehended after a short foot chase.
The driver was identified as a 51-year-old Front Royal resident, Otis Lee Allen. Allen was taken into custody and transported to Rappahannock Shenandoah Warren (RSW) Regional Jail without further incident. Allen was released on a $3,000 secured bond with a scheduled court date of August 3, 2021, at 10:00 a.m. in Warren County General District Court.
(From an FRPD release)