California Company Charged with Conspiring to Sell Misbranded N95 Masks to Hospital in Early Months of COVID-19 Pandemic

BOSTON – A California company, and three individuals who owned and managed the company, have been charged and have agreed to plead guilty to charges relating to the shipment of facemasks that were misbranded as N95 respirators during the earliest phase of the COVID-19 pandemic in the United States.  

Advoque Safeguard LLC (ASG) was charged with one count of conspiracy to introduce misbranded devices into interstate commerce with intent to defraud or mislead, in violation of the Federal Food, Drug and Cosmetic Act. Jason Azevedo, 33, of Cedar Creek, Texas; Paul Shrater, 51, of Simi Valley, Calif.; and Andrew Stack, 52, of Santa Cruz, Calif., were charged with one count of introduction of misbranded devices into interstate commerce. Plea hearings have not yet been scheduled by the Court.  

Earlier this month, a second company, JDM Supply LLC (JDM), and two individuals, Daniel Motha and Jeffrey Motha, were charged and agreed to plead guilty in connection with this investigation. In addition, in August 2023, another individual, Jason Colantuoni, pleaded guilty to conspiracy to commit price gouging.  

According to the charging documents, in the spring of 2020, during the earliest phase of the COVID-19 pandemic in the United States, ASG and JDM conspired to ship facemasks that were misbranded as National Institute of Occupational Safety and Health (NIOSH)-approved, N95 respirators. It is alleged that one hospital, identified as “HOSPITAL 1,” accepted and paid for hundreds of thousands of purported N95 masks that were manufactured by ASG and sold to HOSPITAL 1 by JDM.  (HOSPITAL 1 did not use the masks, which were eventually returned to ASG.) It is further alleged that ASG and JDM misled the hospital into believing that the ASG masks were NIOSH-approved N95s, when in fact they were not. In August 2020, a NIOSH lab tested a sample of the ASG masks that had been shipped to HOSPITAL 1. All 10 ASG masks tested between 83.94% and 93.24% filtration efficiency, and thus fell under the 95% minimum level of filtration efficiency required for N95 respirators.  

The charge of conspiracy to introduce or deliver for introduction into interstate commerce a misbranded device with intent to defraud or mislead provides for a fine of $500,000 or twice the pecuniary gain or loss of the offense, whichever is greater and up to five years of probation.  The charge of introduction or delivery for introduction into interstate commerce a misbranded device provides for a sentence of up to one year in prison; up to one year of supervised release; and a fine of $100,000. Sentences are imposed by a federal judge based upon the U.S. Sentencing Guidelines and statutes which govern the determination of a sentence in a criminal case.

Acting United States Attorney Joshua S. Levy; Ketty Larco-Ward, Inspector in Charge of the U.S. Postal Inspection Service, Boston Division; Fernando McMillan, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations; Christopher Algieri, Special Agent in Charge of the U.S. Department of Veterans Affairs Office of Inspector General, Northeast Field Office; Jodi Cohen, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division; and Michael J. Krol, Acting Special Agent in Charge of Homeland Security Investigations in New England made the announcement today. Assistant U.S. Attorneys Bill Brady and Howard Locker of the Health Care Fraud Unit are prosecuting the case.

On May 17, 2021, the Attorney General established the COVID-19 Fraud Enforcement Task Force to marshal the resources of the Department of Justice in partnership with agencies across government to enhance efforts to combat and prevent pandemic-related fraud. The Task Force bolsters efforts to investigate and prosecute the most culpable domestic and international criminal actors and assists agencies tasked with administering relief programs to prevent fraud by augmenting and incorporating existing coordination mechanisms, identifying resources and techniques to uncover fraudulent actors and their schemes, and sharing and harnessing information and insights gained from prior enforcement efforts. For more information on the department’s response to the pandemic, please visit https://www.justice.gov/coronavirus and https://www.justice.gov/coronavirus/combatingfraud. 
    
Anyone with information about allegations of attempted fraud involving COVID-19 can report it by calling the Department of Justice’s National Center for Disaster Fraud Hotline via the NCDF Web Complaint Form.

The details contained in the charging documents are allegations. The defendants are presumed innocent unless and until proven guilty beyond a reasonable doubt in a court of law.