Johnstown Resident Pleads Guilty to Theft from a Program Receiving Federal Funds

Source: United States Department of Justice Criminal Division

This release was published following the 43-day government shutdown during which the plea occurred.

JOHNSTOWN, Pa. – A resident of Johnstown, Pennsylvania, pleaded guilty in federal court to a charge of stealing funds from a program or entity receiving federal funding, First Assistant United States Attorney Troy Rivetti announced.

Brett Smith, 41, pleaded guilty to one count before United States District Judge Stephanie L. Haines on October 1, 2025.

In connection with the guilty plea, the Court was advised that Smith, the former manager of a Johnstown apartment complex that houses the elderly, deposited rental payments and coins from the complex’s laundry machine into his own bank account. The complex receives federal funding from the United States Department of Housing and Urban Development (HUD) in the form of Section 8 Housing Assistance Payments.

Judge Haines scheduled sentencing for February 3, 2026. The law provides for a maximum total sentence of up to 10 years in prison, a fine of $250,000 or an alternative amount, or both. Under the federal Sentencing Guidelines, the actual sentence imposed is based upon the seriousness of the offense and the prior criminal history, if any, of the defendant.

Assistant United States Attorney Nicole A. Stockey is prosecuting this case on behalf of the government.

The HUD Office of Inspector General and Federal Bureau of Investigation conducted the investigation that led to the prosecution of Smith.
 

Former Deputy Sheriff Sentenced for Production of Child Sexual Abuse Material

Source: United States Department of Justice Criminal Division

NEW BERN, N.C. – A U.S. Federal Judge sentenced a former deputy sheriff from Harnett County Sheriff’s Office to 23 years followed by 15 years of supervised release, and $10,000 in restitution, for producing child sexual abuse material (CSAM). 

“This defendant disgraced his badge and betrayed the community he swore to protect,” said U.S. Attorney Ellis Boyle. “Law enforcement officers who engage in crimes of child exploitation are no different that the predators they should be stopping. Our office will zealously pursue those who fuel the demand for child sexual abused material, no matter their title or position.”

“Those who are sworn to uphold the law and protect our communities carry a profound responsibility,” said Homeland Security Investigations Charlotte Special Agent in Charge Cardell T. Morant who also oversees North and South Carolina. “When that responsibility is violated in such a horrific manner, it erodes public trust and inflicts irreparable harm. HSI is committed to working alongside our partners to hold these offenders accountable and safeguard the vulnerable.”

“The North Carolina SBI is working around the clock with our local and federal partners to investigate and eliminate child sex exploitation in North Carolina. It is especially alarming when a law enforcement officer is charged with violating the laws they have sworn to uphold.  The NC SBI remains committed to protecting children and families from sexual predators wherever and whoever they may be,” said Chip Hawley, NC SBI Director.

“I want to thank the United States Attorney’s Office and the Department of Homeland Security for their dedication and professionalism throughout this investigation and prosecution. Their joint efforts helped assist in our mission to keep Harnett County safe and ensure justice is served,” said Harnett County Sheriff Wayne Coats.

According to court documents and other information presented in court, the North Carolina State Bureau of Investigation (SBI) and the Department of Homeland Security, Homeland Security Investigations, working with the Harnett County Sheriff’s Office, investigated Johnathan A. Edwards, 37.  In October 2023, investigators discovered that Edwards had sexually exploited children on the website Omegle while investigating allegations that he had sexually harassed a Harnett County Detention Center inmate. In Edwards’s Google account, investigators found videos showing Edwards video-chatting minor children on Omegle and encouraging them to undress and sexually abuse themselves, often after the children disclosed that they were 13 or 14 years old. In November 2023, Omegle shut down following allegations that the website had failed to take any precautions to protect children.

This case was brought as part of Project Safe Childhood, a nationwide initiative to combat the growing epidemic of child sexual exploitation and abuse launched in May 2006 by the Department of Justice. Led by U.S. Attorneys’ Offices and CEOS, Project Safe Childhood marshals federal, state, and local resources to better locate, apprehend and prosecute individuals who exploit children via the Internet, as well as to identify and rescue victims. For more information about Project Safe Childhood, please visit Justice.gov/PSC.

Assistant U.S. Attorneys Charity Wilson and Erin Blondel prosecuted the case. The SBI, the Department of Homeland Security – Homeland Security Investigations, and the Harnett County Sheriff’s Office investigated the case.

Related court documents and information can be found on the website of the U.S. District Court for the Eastern District of North Carolina or on PACER by searching for Case No. 5:24-CR-73-FL-BM.

McKeesport Felon Pleads Guilty to Possession of Firearm and Ammunition

Source: United States Department of Justice Criminal Division

This release was published following the 43-day government shutdown during which the plea occurred.

PITTSBURGH, Pa. – A resident of McKeesport, Pennsylvania, pleaded guilty in federal court on October 2, 2025, to a charge of violating a federal firearms law, First Assistant United States Attorney Troy Rivetti announced.

Thomas Thornton, 48, pleaded guilty before United States District Judge Christy Criswell Wiegand to a one-count Indictment charging Thornton with possession of a firearm and ammunition by a convicted felon.

In connection with the guilty plea, the Court was advised that, on December 19, 2024, Thornton discharged 10 rounds of ammunition from a stolen 9mm semi-automatic pistol into an occupied residence within the City of Pittsburgh. Officers with the Pittsburgh Bureau of Police arrested Thornton within minutes of the shooting. Following the execution of a search warrant on Thornton’s vehicle, officers recovered the 9mm pistol Thornton used in the shooting. Thornton was previously convicted on federal drug trafficking and firearms offenses, and was also on federal supervised release at the time of the instant offense. Federal law prohibits possession of a firearm or ammunition by a convicted felon.

Judge Wiegand scheduled Thornton’s sentencing for February 4, 2026. The law provides for a maximum total sentence of up to 15 years in prison, a fine of up to $250,000, or both. Under the federal Sentencing Guidelines, the actual sentence imposed would be based upon the seriousness of the offense and the prior criminal history of the defendant.

Assistant United States Attorney V. Joseph Sonson is prosecuting this case on behalf of the United States.

The Pittsburgh Bureau of Police and Bureau of Alcohol, Tobacco, Firearms and Explosives conducted the investigation that led to the prosecution of Thornton.

This case is part of Project Safe Neighborhoods (PSN), a program bringing together all levels of law enforcement and the communities they serve to reduce violent crime and gun violence, and to make our neighborhoods safer for everyone. On May 26, 2021, the Department launched a violent crime reduction strategy strengthening PSN based on these core principles: fostering trust and legitimacy in our communities, supporting community-based organizations that help prevent violence from occurring in the first place, setting focused and strategic enforcement priorities, and measuring the results.
 

Wenatchee Man Sentenced to Thirty Months Imprisonment for Aggravated Identity Theft and False Statements in Passport Application

Source: United States Department of Justice Criminal Division

Spokane, Washington – United States Attorney Pete Serrano announced that on September 24, 2025, District Court Judge Thomas O. Rice sentenced Brandon Wilkerson, of Wenatchee Washington, to thirty months in prison for aggravated identity theft and false statements on a passport application.

As set out in court documents, in October 2021, Wilkerson attempted to get a passport in his name but was denied in January 2022 because he was subject to a pending state warrant of arrest for felony unlawful possession of a firearm under Washington state law. In March 2022, Wilkerson stole his brother’s identity and applied for a passport under his brother’s name which was subsequently approved unknowing of the fraud. Wilkerson then used the passport to travel to Brazil, where he married a Brazilian national under his brother’s name. Wilkerson subsequently applied for legal status for the Brazilian national, again falsely and fraudulently using his brother’s name. Wilkerson was Indicted for this offense on March 19, 2024 and later placed into custody after violating the terms of his pre-trial release for committing a new criminal offense.

“Mr. Wilkerson knew that he could not get a valid passport in his own name because of his prior misconduct, so, under false pretenses, he fraudulently assumed the identity of his brother hoping the United States would not notice when he and his spouse tried to enter the United States,” said US Attorney Pete Serrano. “Mr. Wilkerson’s crime has serious consequences: the risks and dangers to our community of people entering the United States under false identities cannot be overstated. While this may seem like a Hollowood story, Catch Me if You Can, Mr. Wilkerson will not have a Hollywood ending thanks to the work from the men and women in our office and our partner law enforcement offices.”

“The Diplomatic Security Service will investigate and pursue anyone who applies for or obtains a United States passport using false documents,” said Special Agent in Charge Jonathan Kazmar of the DSS San Francisco Field Office. “The U.S. passport is America’s premier identity document. Domestic criminals and foreign adversaries often attempt to fraudulently acquire U.S. passports to carry out criminal activities, including terrorism and human trafficking, inside our borders. These crimes threaten the national security of the homeland and are the focus of the Administration’s re-doubled enforcement efforts across the United States.”

This case was investigated by the U.S. Department of State’s Diplomatic Security Service. The case was prosecuted by Assistant United States Attorney Jeremy J. Kelley.

Madison County Man Sentenced for Production of Child Pornography

Source: United States Department of Justice Criminal Division

LEXINGTON, Ky. – A Richmond, Ky., man, Glen Long, Jr., 48, was sentenced by U.S. District Judge Karen Caldwell to 360 months in prison, for the production of child pornography.  

According to his plea agreement, on July 28, 2023, a victim’s mother went to law enforcement after she discovered that her minor child had been sending nude images to an unknown adult male via the internet in exchange for money for Roblox, a video game. Law enforcement obtained the victim’s cellphone, reviewed the explicit messages, and identified the adult male as Long. Long knew that the victim was 14 years old and lied about his own age, falsely telling the victim that he was 16 years old. When confronted by law enforcement, Long admitted that he used the minor victim to produce explicit visual depictions of child pornography. 

Under federal law, Long must serve 85 percent of his prison sentence. Upon his release from prison, he will be under the supervision of the U.S. Probation Office for life. 

Paul McCaffrey, Acting United States Attorney for the Eastern District of Kentucky; Rana Saoud, Special Agent in Charge, Department of Homeland Security, Homeland Security Investigations (HSI); and Sheriff Mike Coyle, Madison County Sheriff’s Office, jointly announced the sentence.

The investigation was conducted by the HSI and Madison County Sheriff’s Office. Assistant U.S. Attorney Erin Roth is prosecuting the case on behalf of the United States.

The U.S. Attorney’s Office prosecuted this case as part of Project Safe Childhood, a nationwide initiative launched in 2006 by the Department of Justice to combat the growing epidemic of child sexual exploitation and abuse. Led by U.S. Attorneys’ Offices and the Criminal Division’s Child Exploitation and Obscenity Section (CEOS), Project Safe Childhood marshals federal, state, and local resources to better locate, apprehend, and prosecute individuals who exploit children via the Internet as well as to identify and rescue victims. For more information about Project Safe Childhood, please visit www.projectsafechildhood.gov.

 

– END –

Coeur d’Alene Physician Found Guilty in Telemarketing Medicare Fraud Conspiracy

Source: United States Department of Justice Criminal Division

Yakima, Washington – United States Attorney Pete Serrano announced that on September 29, 2025, a federal jury found Dr. David Antonio Becerril, age 69, of Coeur d’Alene, Idaho, and formerly of Selah, Washington, guilty of sixteen counts of conspiracy, fraud, and false statements in connection with Dr. Becerril’s participation in a telemarketing health care fraud scheme. Chief United States District Judge Stanley A. Bastian presided over the trial, which began on September 22, 2025. At sentencing, which is set for January 20, 2026, Dr. Becerril faces a maximum term of 20 years in prison.

According to evidence presented at trial and court documents, between February 2018 and September 2019, Dr. Becerril, a licensed Washington physician, participated in a scheme and conspiracy to obtain millions of dollars by falsely billing Medicare for medically unnecessary genetic tests and durable medical equipment, including back, knee, shoulder, and ankle braces. The evidence at trial showed that Dr. Becerril signed false and fraudulent orders for genetic tests and braces for elderly Medicare beneficiaries that Dr. Becerril had never seen, spoken to, heard of, or had any contact with whatsoever, and which included deceased patients as well as elderly patients who had no limbs for the braces they were prescribed by Dr. Becerril.

The evidence presented at trial also detailed the scheme and involvement of Real Time Physicians, LLC (Real Time) whose telemarketers contacted the elderly Medicare beneficiaries and obtained their personal information and beneficiary numbers. Dr. Becerril, using an internet portal provided by Real Time, certified false and fraudulent prescriptions for braces and genetic tests for the beneficiaries, signing prescriptions and other documents prepared by Real Time that contained false medical information and made it appear that he was treating the beneficiaries. Real Time then sold the phony prescriptions to genetic testing labs and durable medical equipment companies, who then billed Medicare, sharing the proceeds with Real Time. Real Time paid Dr. Becerril $20 for each phony prescription he falsely certified to be used to fraudulently bill Medicare.

According to the evidence presented at trial, Medicare was billed over $3.2 million for fraudulent prescriptions signed by Dr. Becerril, who never once spoke to, treated, or interacted with a patient, and paid out more than $1.3 million before the fraud was uncovered. Dr. Becerril reviewed the Real Time prescriptions for, on average, 26 seconds before signing them and falsely attesting to their medical necessity, and that he never once declined to sign a Real Time prescription for Medicare beneficiaries with which he had no contact and had never heard of. Dr. Becerril was paid over $37,000 by Real Time for his false certifications as a medical doctor on hundreds of prescriptions for DME and genetic testing, which equated to being paid thousands of dollars per hour for his participation in the fraud scheme over approximately 19 months.

In June 2022, the Department of Justice announced that Marc Sporn, 61, of Delray Beach, Florida, the former owner of Real Time and other similar companies, was sentenced to 14 years in federal prison for his role in the conspiracy to fraudulently bill Medicare.

“By participating in this telemedicine fraud scheme, Dr. Becerril placed his own personal financial gain before the legitimate medical needs of patients, violating the trust of Medicare enrollees and wasting valuable taxpayer dollars,” said Acting Special Agent in Charge Jeffrey C. McIntosh of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). “HHS-OIG is proud to work alongside our federal law enforcement partners to investigate and hold accountable medical providers who defraud taxpayer-funded health care programs.”

“Medicare fraud is fraud against the American taxpayer. This office will continue to vigorously investigate and prosecute those who would attempt to line their own pockets by defrauding the federal healthcare programs relied upon by our senior citizens, our active-duty military, and our veterans,” stated U.S. Attorney Pete Serrano. “This fraud is especially egregious as it was perpetrated by a medical doctor betraying his oath to do no harm. I want to thank our law
enforcement partners, in particular the phenomenal work done for years on this case by multiple special agents with the U.S. Department of Health and Human Services, Office of Inspector General, and without whom we would not have been able to bring Dr. Becerril to justice.”

The case was investigated by Health and Human Services Office of Inspector General. This case was prosecuted by Assistant United States Attorneys Courtney R. Pratten and Tyler Tornabene and Health Care Fraud Contractor Echo Fatsis. 

United States v. David A. Becerril, 1:23-CR-02029-SAB

Former Riverside School Paraeducator Pleads Guilty to 12 separate Counts of Child Exploitation Involving Multiple Minor Victims

Source: United States Department of Justice Criminal Division

Spokane, Washington – United States Attorney Pete Serrano announced on October 15, 2025, that former Riverside School District employee Dallas Michael Shuler pled guilty to 12 felony counts pertaining to the online exploitation of children.

As indicated in court pleadings and hearings, in May of 2024, the FBI Spokane Office was contacted due to a child sexual abuse material video which had been posted online. When questioned about the video, Mr. Shuler indicated he had been in contact with the minors depicted in the video and had requested they produce the sexually explicit material. Further investigation into Mr. Shuler’s electronic devices and online accounts showed Mr. Shuler had engaged in hands-on sexual abuse of at least three minor children and had filmed the abuse. He also engaged in online sexual exploitation of children with dozens of additional victims, many of whom were contacted and victimized through Snapchat. The charges pled to encompass sexual exploitation against 37 different minor children.

United States Attorney S. Peter Serrano stated the following: “Abuse of any kind against a child is an egregious violation. My office is ready to aggressively prosecute those who exploit children in any way. Mr. Shuler’s conduct was a shocking breach of trust, particularly considering his position in an elementary school. I commend those who acted quickly in investigating and prosecuting this case. No child should experience what the children in this case unfortunately went through. I stand with our law enforcement partners in working to end the exploitation of children.”

“As a school district employee, Mr. Shuler was entrusted with the children of this community, whom he held a responsibility to safeguard and guide as a role model,” said W. Mike Herrington, Special Agent in Charge of the FBI Seattle field office. “It was a horrifying betrayal of that trust to abuse his access to children by exploiting them both in person and online, including by filming graphic and explicit videos. Tragically, no prosecution can undo the harm these children suffered or fully erase its record from the Internet. Still, our case team, partner law enforcement agencies, and prosecutors hope that this case can help prevent harm to other vulnerable children by sending a warning to would-be predators that we will hold them accountable for their crimes.”

This case is being brought as part of Project Safe Childhood, a nationwide initiative launched in May 2006 by the U.S. Department of Justice to combat the growing epidemic of child sexual exploitation and abuse. Led by the U.S. Attorneys’ Offices and the Criminal Division’s Child Exploitation and Obscenity Section, Project Safe Childhood marshals federal, state and local resources to better locate, apprehend and prosecute individuals, who sexually exploit children, as well as to identify and rescue victims.

This case is being investigated by the FBI. It is being prosecuted by Assistant United States Attorney Rebecca R. Perez. Sentencing is currently scheduled for January 21, 2026. 

2:24-CR-72-TOR

Mt. Oliver Felon Sentenced to More Than Four Years in Prison for Possession of Firearm

Source: United States Department of Justice Criminal Division

This release was published following the 43-day government shutdown during which the sentencing occurred.

PITTSBURGH, Pa. – A resident of Pittsburgh’s Mt. Oliver area pleaded guilty in federal court to possessing a firearm as a convicted felon and was sentenced to 51 months of incarceration, to be followed by three years of supervised release, First Assistant United States Attorney Troy Rivetti announced.

Kyreese Thomas, 24, pleaded guilty to one count of violating federal firearms law before United States District Judge Cathy Bissoon on October 6, 2025.

In connection with the guilty plea, the Court was advised that Thomas was one of two men who, on May 23, 2024, fired a gun at a residence in the Homestead neighborhood of Pittsburgh. Thomas used a stolen 9mm Ruger pistol with an obliterated serial number to shoot at the home, then attempted to flee the scene with his co-defendant by vehicle. Law enforcement officers were able to stop the vehicle and found Thomas in the front passenger seat with the Ruger under the seat. Gunshot residue was found on Thomas’s hand, and ballistic testing matched the firearm to spent shell casings found near the scene of the shooting. Thomas has two prior convictions for possessing a firearm as a prohibited person in Allegheny County and was on parole for one of those convictions, as well as a prior conviction involving possession of contraband while incarcerated, when he committed the instant offense.

Judge Bissoon agreed to allow Thomas to proceed to sentencing on the same date as his guilty plea. Prior to imposing sentence, the Court noted the defendant’s extensive criminal history for his young age.

Assistant United States Attorney Barbara K. Doolittle prosecuted this case on behalf of the government.

First Assistant United States Attorney Rivetti commended the Bureau of Alcohol, Tobacco, Firearms and Explosives; Munhall and Homestead police departments; and Allegheny County Sheriff’s Department for the investigation leading to the successful prosecution of Thomas.

Mexican Citizen Sentenced to 120 Months in Prison for Attempting to Entice a Minor for Sex Online

Source: United States Department of Justice Criminal Division

Spokane, Washington – Earlier today, United States District Court Judge Thomas O. Rice sentenced Timoteo Roque Roque to 120 months of imprisonment to be followed by a lifetime term of supervised release for the crime of Attempted Online Enticement of a Minor.

According to information disclosed in court documents and proceedings, on July 28, 2024, an undercover (UC) Internet Crimes Against Children (ICAC) Task Force Officer (TFO) was participating in an undercover enticement operation in Chelan County with a goal of identifying those who were baiting children online for illegal sex. The UC ICAC TFO was online portraying a 13-year-old child and received communication from the defendant, Roque Roque. During the communications, Roque Roque affirmed that he was interested in having sexual contact with minors and agreed to pay $250 for 30 minutes of sex with the child at a local hotel; he also agreed to bring condoms for the meet. Roque Roque later sent the UC a text saying he was at the hotel, but he saw a police vehicle and he thought it was a trap. He left the hotel, but continued communicating with the UC, who was purporting to be a 13-year-old child. He returned to the hotel about six hours later, once again with the agreement to pay $250 for sex with the child. Upon arrest, Roque-Roque ultimately admitted he was communicating with who he believed to be a 13 year old and traveled to the hotel twice in order to have sex with the child.

Roque Roque was illegally present in the United States at the time of this crime. He is a citizen and national of Mexico who was arrested and deported from the United States previously at San Luis, Arizona, on July 15, 2019.

“Investigations and prosecutions like these remain a high priority for my office, we simply have to protect our children from predators.” U.S. Attorney Pete Serrano said. “Thanks to the excellent, collaborative investigative work by local and federal law enforcement, Mr. Roque Roque is now being held accountable for attempting to pay a local minor for sex while illegally present in the United States.”

“This illegal alien represents the worst of the worst type of criminal who sought to conduct heinous abuse of a child, but fortunately in this case, the ‘child’ Roque Roque sought to harm was not real,” said HSI Seattle acting Special Agent in Charge April Miller. “It is deeply troubling to learn although he was removed in 2019, he was roaming our streets seeking victims. HSI is committed to holding those who pose the greatest risk to public safety accountable for their actions and protecting the vulnerable.”

This case was brought as part of Project Safe Childhood, a nationwide initiative to combat the growing epidemic of child sexual exploitation and abuse launched in May 2006 by the Department of Justice. Led by United States Attorney’s Offices and the Criminal Division’s Child Exploitation and Obscenity Section (CEOS), Project Safe Childhood marshals federal, state, and local resources to better locate, apprehend and prosecute individuals who exploit
children via the Internet, as well as to identify and rescue victims. For more information about Project Safe Childhood, please visit www.projectsafechildhood.gov

This case was investigated by the Homeland Security Investigations, Washington State Patrol, and the Seattle Police Department Internet Crimes Against Children (ICAC) Task Force, with assistance from the Chelan County Prosecutor’s Office. This case was prosecuted by Assistant
United States Attorney Alison Gregoire.

Aesculap Implant Systems Agrees to Pay $38.5M to Resolve False Claims Act Allegations Related to Knee Implant Failures and Enters into a Non-Prosecution Agreement Related to the Introduction of Two Adulterated Medical Devices into Interstate Commerce

Source: United States Department of Justice Criminal Division

Medical device company Aesculap Implant Systems LLC (Aesculap), based in Center Valley, Pennsylvania, has agreed to pay $38.5 million to resolve allegations under the False Claims Act that the company sold knee replacement devices that it knew would fail prematurely at a higher than acceptable rate, resulting in false claims to Medicare and Medicaid. The settlement further resolves allegations that the company paid unlawful remuneration to a physician to induce him to use the knee implants. Additionally, Aesculap agreed to a non-prosecution agreement with the United States in connection with its distribution of two medical devices without the required clearance from the U.S. Food and Drug Administration (FDA).

“Medical device failures — and their potential to harm patients — are of paramount concern to the Department of Justice,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “The Department will hold accountable medical device companies that knowingly sell products prone to failure that present risks to patients and waste taxpayer dollars.”

“Doctors who implant medical devices need complete and accurate information about those devices to ensure they choose the best and safest options for their patients,” said U.S. Attorney David Metcalf for the Eastern District of Pennsylvania. “A company that knows its product has a propensity to prematurely fail must not mislead doctors or government regulators or conceal material information about those known issues. Medicare and other federal programs should not be required to pay charges for devices that are unduly risky, and that may require painful and expensive surgeries to fix.”

“Transparency in medical device marketing is essential to safeguarding patient care,” said Deputy Inspector General for Investigations Christian J. Schrank of the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG). “Undermining this process to increase profits is a serious violation of federal law that flouts the health and safety of patients. HHS-OIG will continue to work with our law enforcement partners to uncover and dismantle illegal arrangements that exploit the Medicare system for financial gain at the expense of patients.”

“Certain medical devices require FDA notification and clearance before distribution to the public,” said Acting Special Agent in Charge Ronald Dawkins of the FDA Metro Washington Field Office. “Distributing such medical devices without FDA clearance and in violation of the Federal Food, Drug, and Cosmetic Act can put patients at risk. The FDA’s Office of Criminal Investigations (OCI) worked with the Justice Department and HHS-OIG to ensure a just resolution, and we commend the exceptional work done by the team.”

The civil settlement announced today resolves allegations that, from July 30, 2010, to June 17, 2023, Aesculap sold the VEGA System® Knee System, a line of prosthetic implants used in knee replacement surgeries, while knowing that it would fail prematurely at a higher than acceptable rate and, therefore, was not reasonable and necessary for use during knee replacement surgeries. In such surgeries, physicians remove arthritic bone in the knee and implant a device, which is fixed in place with bone cement. The United States alleged that the Vega was prone to becoming loose from patient’s bone prematurely, often shortly after surgery. Patients experiencing loosening could have pain, instability, and difficulty walking, and such patients required a revision surgery to remove and replace the Vega implant. The United States alleged that Aesculap knew shortly after the Vega was released in the United States that bone cement did not properly adhere to the implant. Despite this knowledge, Aesculap sold the Vega to physicians and hospitals in the United States without disclosing this known problem with the device. The United States also alleged that Aesculap failed to take steps to record, track, or report adverse events for the Vega and did not take adequate steps to remediate the problem. As of April 2024, Aesculap stopped selling all of its knee replacement devices, including the Vega, in the United States.

The settlement also resolves allegations that Aesculap knowingly and willfully made unlawful payments to an orthopedic surgeon located in Georgia who experienced problems with the Vega with the intent to induce him to use and recommend the Vega Knee System, in violation of the Anti-Kickback Statute, 42 U.S.C. 1320a-7b(b). This remuneration took the form of consulting payments, free international travel, and entertainment, among other things.

In addition to the civil settlement, Aesculap agreed to enter into a non-prosecution agreement related to the introduction of two medical devices into interstate commerce in violation of the Food, Drug and Cosmetic Act (FDCA) from March 2017 until August 2017. The two devices at issue are the ELAN-4 Air Drill, a high-speed surgical drill used for bone cutting, sawing, and drilling, and the JS Series SterilContainer S2, a reusable sterilization container for medical instruments. According to the non-prosecution agreement, Aesculap tasked an employee with shepherding both medical devices through the FDA clearance process, but the employee never submitted any documentation to FDA. He then forged multiple documents to reflect both devices were cleared by FDA to be marketed in the United States when FDA had not done so resulting in the illegal introduction of both devices into interstate commerce. The employee previously pleaded guilty to violating the FDCA and was sentenced to prison.

The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by John Marien and Michael McGee, who served as third-party distributors for Aesculap. Under those provisions, private parties can file an action on behalf of the United States and receive a portion of any recovery. The qui tam case is captioned United States ex rel. Marien & McGee v. Aesculap Inc., et al., No. 5:19-cv-1618 (E.D. Pa.). Marien and McGee will receive a share totaling $4,475,000 in connection with the settlement.

The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section; the Civil Division’s Enforcement and Affirmative Litigation Branch; and the U.S. Attorney’s Office for the Eastern District of Pennsylvania with assistance from HHS-OIG and FDA’s Office of the Chief Counsel and FDA-OCI.

The investigation and resolution of this matter illustrates the government’s emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to HHS at 800-HHS-TIPS (800-447-8477).

The civil matter was handled by Senior Trial Counsel Nicholas C. Perros of the Civil Division’s Commercial Litigation Branch, Fraud Section and Assistant U.S. Attorneys Charlene K. Fullmer and Erin E. Lindgren of the Eastern District of Pennsylvania.

The criminal matter was handled by Trial Attorneys Max J. Goldman and Bryson N. Gillard of the Enforcement and Affirmative Litigation Branch.

Except for the facts that Aesculap admitted as part of the non-prosecution agreement, the claims resolved by the settlement are allegations only and there has been no determination of liability.