Source: United States Department of Justice

The Justice Department announced today that Assertio Therapeutics Inc., formerly known as Depomed Inc., (Assertio), a pharmaceutical company headquartered in Lake Forest, Illinois, has agreed to pay $3.6 million to resolve claims that Assertio violated the False Claims Act (FCA) by causing the submission of false claims for the transmucosal immediate-release fentanyl (TIRF) drug Lazanda for individuals who did not have breakthrough cancer pain.

Lazanda, a fentanyl nasal spray, is approved by the FDA solely for break-through cancer pain in patients who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. The United States alleges that, between 2013 and 2017, Assertio, which was known as Depomed at the time, caused the submission of false claims to the Medicare and TRICARE programs by focusing its marketing on pain specialists who were prescribing high volumes of TIRF products, including those who were flagged for diversion or who were later indicted. The United States further alleges that Assertio placed high-volume TIRF prescribers on its speakers’ bureau and advisory boards and developed its “Signature Support Program” to ensure that Lazanda prescriptions would be approved by insurance companies, including Medicare Part D plans. The United States contends that Assertio’s marketing efforts caused prescribers to write Lazanda prescriptions for Medicare and TRICARE beneficiaries who did not have breakthrough cancer pain, resulting in the submission of false claims to Medicare and TRICARE from thirteen high-volume prescribers.

“This company took steps to boost its profits despite the risk of boosting the deadly opioid epidemic, said U.S. Attorney Edward R. Martin Jr. for the District of Columbia. “Our office will continue to seek out violations like this that demonstrate a brazen disregard for the safety of the public.”

“At a time when communities across the country are still dealing with the devasting impact of the opioid epidemic, pharmaceutical companies have a responsibility to uphold the highest standards of integrity,” said Acting Assistant Director Darren Cox of the FBI’s Criminal Investigative Division. “This settlement reflects the FBI’s unwavering commitment to protecting public health and holding those accountable who fuel addiction and defraud federal healthcare programs through deceptive marketing of powerful drugs like fentanyl.”

“Violations of the False Claims Act such as the illegal prescribing practices alleged in this settlement are especially egregious considering the opioid epidemic,” said Deputy Inspector General Christian J. Schrank of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “HHS-OIG will continue to work with our law enforcement partners to ensure health care providers and corporations involved in schemes that threaten patient safety are held accountable.”

The civil settlement includes the resolution of claims under the qui tam, or whistleblower, provisions of the FCA by Noelle Webb and Nicole Novellino, who previously worked at Assertio as sales representatives. The FCA authorizes private parties to sue on behalf of the United States for false claims and share in any recovery. The qui tam case is captioned United States ex rel. Webb et al. v. Assertio Therapeutics Inc., f/k/a Depomed, Inc., No. 1:17-02309 (D.D.C.). Pursuant to the settlement, relators will receive a $657,000 share of the settlement amount.

The Justice Department’s Civil Division, Commercial Litigation Branch (Fraud Section), and the U.S. Attorney’s Office for the District of Columbia handled this matter. The Federal Bureau of Investigation, led by its Washington Field Office; the Food and Drug Administration’s Office of Criminal Investigations; and the Department of Health and Human Services Office of Inspector General provided substantial assistance in the investigation and resolution.

Today’s settlement illustrates the government’s emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the FCA. 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).

Senior Trial Counsel Sarah Arni, Trial Attorney Matthew Arrow, and Assistant Director Natalie Waites of the Civil Division’s Fraud Section and Assistant U.S. Attorney Darrell Valdez for the District of Columbia handled this matter.

The claims resolved by the settlement are allegations only and there has been no determination of liability.

Source: United States Department of Justice Criminal Division

A federal grand jury in Knoxville, Tennessee returned an indictment on May 7, charging Regan Darby Prater, 27, with arson for firebombing the Highlander Center, a nonprofit research and education center in New Market, Tennessee; and with carrying an explosive device during the commission of the arson. Prater appeared in court today before U.S. Magistrate Judge Jill E. McCook and entered a plea of not guilty to the charges in the indictment. He was held pending trial, which has been set for July 15 in United States District Court, in Knoxville, Tennessee.

According to court documents, on March 29, 2019, Prater used an explosive to firebomb the Highlander Center’s administrative building, resulting in a fire that consumed the entire structure. Court documents also allege that Prater was inspired by the March 15, 2019, mass shootings in Christchurch, New Zealand, and left a symbol of the Iron Guard, a World War II-era Romanian Nazi organization, spraypainted in the Highlander Center’s parking lot. The same symbol appeared on the Christchurch gunman’s rifle as he livestreamed his attacks.

If convicted, Prater faces a minimum penalty of five years in prison and a maximum penalty of twenty years in prison on the arson charge, and an additional ten years in prison on the explosive charge.

Assistant Attorney General Harmeet K. Dhillon of the Justice Department’s Civil Rights Division; U.S. Attorney Francis M. Hamilton III for the Eastern District of Tennessee; and Special Agent in Charge Joseph E. Carrico of the FBI Nashville Field Office made the announcement.

The FBI Knoxville Resident Agency investigated the case, with assistance from the Tennessee Bureau of Investigation.

Assistant U.S. Attorneys Casey T. Arrowood and Anne-Marie Svolto of the Eastern District of Tennessee and Trial Attorneys Kyle Boynton and Katherine McCallister of the Civil Rights Division’s Criminal Section are prosecuting the case.

An indictment is merely an allegation. All defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.

Source: United States Department of Justice Criminal Division

Note: See superseding indictment here.

Two Honduran men were sentenced today to three years in prison for their roles in a scheme to illegally smuggle Honduran nationals into the United States.

According to court documents and evidence presented at trial, for almost a year, Hennessy Devon Cooper Zelaya, 29, and Rudy Jackson Hernandez, 38, both of Utila, Honduras, conspired with at least six others to bring Honduran nationals from Honduras to the United States via two vessels, the Masita III and the M/V Pop. The vessels sailed from Utila, Honduras to Louisiana. The aliens and/or their family members paid thousands of dollars to be brought illegally into the United States by boat. Upon arrival, the aliens were picked up by co-conspirators and driven further into the United States. The co-conspirators then placed some of the aliens in jobs at U.S. factories and other businesses knowing that the aliens lacked authorization to enter, remain, or work in the United States. The defendants were part of the vessels’ crew on multiple voyages.

In February 2022, the defendants attempted to illegally bring 23 Honduran nationals from Utila, Honduras, to Cocodrie, Louisiana, aboard the M/V Pop, a 65’ sportfishing vessel. During the voyage, the M/V Pop developed engine trouble and lost power. The co-conspirators then chartered a boat to bring fuel to the disabled vessel so that it could complete its journey to the United States. Before the chartered boat reached the disabled vessel, the U.S. Coast Guard interdicted the vessel approximately 75 miles off the coast of Louisiana and towed it to shore. Inside the vessel, law enforcement officers also found 24 kilograms of cocaine.

Cooper Zelaya and Jackson Hernandez were convicted after trial of conspiracy to unlawfully bring aliens to the United States for commercial advantage and private financial gain and attempting to bring aliens to the United States for commercial advantage and private financial gain.

The lead defendant in the case, Carl Allison, previously pleaded guilty in December 2023 to conspiracy to unlawfully bring aliens to the United States for financial gain and conspiracy to distribute five kilograms or more of cocaine hydrochloride. Three additional co-conspirators, all Honduran nationals, pleaded guilty last year for their roles in the scheme: Darrel Martinez, 41, and Josue Flores-Villeda, 36, pleaded guilty to the same charges as Allison; and Lenord Cooper, 40, pleaded guilty to conspiracy to aid and assist aliens to enter the United States unlawfully and attempting to bring aliens to the United States for commercial advantage and private financial gain. A fifth man, Honduran national Olvin Javier Velasquez Maldonado, was extradited from Honduras in April and is charged with one count of conspiracy to possess with intent to distribute five kilograms or more of cocaine. Maldonado’s trial is scheduled for June 16. An indictment is merely an allegation, and Maldonado is presumed innocent until proven guilty beyond a reasonable doubt in a court of law.

Matthew R. Galeotti, Head of the Justice Department’s Criminal Division, Acting U.S. Attorney Michael M. Simpson for the Eastern District of Louisiana, and Special Agent in Charge Eric DeLaune of U.S. Immigration and Customs Enforcement Homeland Security Investigations (HSI) New Orleans Field Office made the announcement.

The HSI Houma, Louisiana Field Office investigated the case, with assistance from the HSI Pittsburgh Field Office, HSI Atlanta Field Office, and Louisiana Bureau of Investigation. The HSI Human Smuggling Unit in Washington, D.C., U.S. Customs and Border Protection’s National Targeting Center International Interdiction Task Force, U.S. Coast Guard Investigative Service, U.S. Customs and Border Protection’s Air and Marine Operations, Louisiana State Police, Pennsylvania State Police, North Huntington Township Police, and Terrebonne Parish Sheriff’s Office also provided valuable assistance.

Deputy Chief Rami Badawy of the Criminal Division’s Human Rights and Special Prosecutions Section (HRSP) and Assistant U.S. Attorney Carter Guice for the Eastern District of Louisiana prosecuted the case. The Justice Department’s Office of International Affairs (OIA) and the Criminal Division’s Office of Overseas Prosecutorial Development, Assistance and Training (OPDAT) in Honduras provided assistance.

The sentencings are the result of the coordinated efforts of Joint Task Force Alpha (JTFA). JTFA, a partnership with the Department of Homeland Security (DHS), has been elevated and expanded by the Attorney General with a mandate to target cartels and other transnational criminal organizations to eliminate human smuggling and trafficking networks operating in Mexico, Guatemala, El Salvador, Honduras, Panama, and Colombia that impact public safety and the security of our borders. JTFA currently comprises detailees from U.S. Attorneys’ Offices along the border. Dedicated support is provided by numerous components of the Justice Department’s Criminal Division, led by HRSP and supported by the Money Laundering and Asset Recovery Section, the Office of Enforcement Operations, OIA, and OPDAT, among others. JTFA also relies on substantial law enforcement investment from DHS, the FBI, the Drug Enforcement Administration, and other partners. To date, JTFA’s work has resulted in more than 365 domestic and international arrests of leaders, organizers, and significant facilitators of alien smuggling; more than 334 U.S. convictions; more than 281 significant jail sentences imposed; and substantial seizures and forfeitures of assets and contraband including millions of dollars in cash, real property, vehicles, firearms and ammunition, and drugs.

This case is also supported by the Organized Crime and Drug Enforcement Task Forces (OCDETF) and the Extraterritorial Criminal Travel Strike Force (ECT) program. OCDETF identifies, disrupts, and dismantles the highest-level criminal organizations that threaten the United States using a prosecutor-led, intelligence-driven, multi-agency approach that leverages the strengths of federal, state, and local law enforcement agencies against criminal networks. The ECT program is a partnership between the Justice Department’s Criminal Division and HSI and focuses on human smuggling networks that may present particular national security or public safety risks, or present grave humanitarian concerns. ECT has dedicated investigative, intelligence, and prosecutorial resources. ECT also coordinates and receives assistance from other U.S. government agencies and foreign law enforcement authorities.

This case is part of Operation Take Back America, a nationwide initiative that marshals the full resources of the Department of Justice to repel the invasion of illegal immigration, achieve the total elimination of cartels and transnational criminal organizations and protect our communities from the perpetrators of violent crime. Operation Take Back America streamlines efforts and resources from the Department’s Organized Crime Drug Enforcement Task Forces and Project Safe Neighborhood.

Source: United States Department of Justice Criminal Division

A former corrections officer from the Southern Regional Jail in Beaver, West Virginia, was sentenced today for his role in an assault that resulted in the death of an inmate, identified by the initials Q.B., on March 1, 2022. Steven Nicholas Wimmer, 25, of Bluefield, was sentenced to nine years in prison, to be followed by three years of supervised release.

With his guilty plea, Wimmer acknowledged that he responded to a call for officer assistance after Q.B. tried to push past another correctional officer. The officers restrained and handcuffed Q.B. Officers, including Wimmer, then escorted Q.B. to an interview room, where officers struck and injured Q.B. while he was restrained, handcuffed and posed no threat to anyone. Wimmer admitted that officers struck Q.B. in the interview room in order to punish him for attempting to leave his assigned pod. Wimmer further admitted that he was a member of the conspiracy who injured Q.B. inside the interview room while Q.B. was restrained, handcuffed, and posed no threat.

Wimmer and former Southern Regional Jail corrections officer Andrew Fleshman pleaded guilty on Nov. 2, 2023, to conspiring with other officers to use unreasonable force against Q.B. Fleshman, 22, of Shady Spring, is scheduled to be sentenced on July 14. On Nov. 29, 2023, a federal grand jury indicted six other defendants in connection with the death of Q.B. In November 2024, former correctional officers Mark Holdren, Corey Snyder, and Johnathan Walters each pleaded guilty in connection with the use of unreasonable force against Q.B., resulting in his death. Sentencing hearings for Holdren, Snyder, and Walters are scheduled for June 16. On Aug. 8, 2024, Ashley Toney and Jacob Boothe each pleaded guilty to violating Q.B.’s civil rights by failing to intervene when other officers used unreasonable force. Sentencing hearings for Boothe and Toney are scheduled for June 9.

On January 27, a federal jury convicted defendant Chad Lester, a former Lieutenant at the Southern Regional Jail, on three obstruction of justice charges for his role in conspiring to cover up the death of Q.B. Lester is scheduled to be sentenced on May 15.

Assistant Attorney General Harmeet Dhillon of the Justice Department’s Civil Rights Division and Acting U.S. Attorney Lisa G. Johnston for the Southern District of West Virginia made the announcement.

The Federal Bureau of Investigation (FBI) Pittsburgh Field Office investigated the case.

Chief United States District Judge Frank W. Volk imposed the sentence. Deputy Chief Christine M. Siscaretti and Trial Attorney Tenette Smith of the Justice Department’s Civil Rights Division prosecuted the case in partnership with the U.S. Attorney’s Office for the Southern District of West Virginia.

A copy of this press release is located on the website of the U.S Attorney’s Office for the Southern District of West Virginia. Related court documents and information can be found on PACER by searching for Case No. 5:23-cr-134.