Medical Device Company And Executives Plea To An Information Relating To Misbranded Medical Devices
The Office of the United States Attorney for the District of Vermont stated that two Vermont men pled guilty on June 30, 2016 in U.S. District Court in Rutland to information charging them with Class A Misdemeanors relating to the introduction of misbranded medical devices into interstate commerce. AADCO Medical, Inc., a medical device supply company operating out of Randolph, has additionally pled guilty to the same charge.
According to the information and plea agreements filed with the Court, from May 2011 through August 2012, AADCO Medical, Robert Marchione, and Anthony Skidmore allegedly introduced and caused the introduction and delivery of six medical lamps as surgical lamps without having complied with the Food and Drug Administration’s requirements that notice be submitted to the FDA prior to the introduction of such devices into interstate commerce. The misbranded lamps were sold to medical providers in New York, N.Y., Buffalo, N.Y., and Chapel Hill, N.C.
AADCO was ordered to pay a total of $53,070, which included restitution to the victims of $47,945.00, a criminal fine of $5,000.00, and an assessment of $125.00. Mr. Marchione and Mr. Skidmore were each fined $5,000.00.
“The FDA’s regulatory requirements for medical devices are designed to ensure the health and safety of patients,” said Jeffery J. Ebersole, Special Agent in Charge, FDA Office of Criminal Investigations’ New York Field Office. “The FDA will continue to aggressively pursue those who place patient’s health at risk for their own profit by compromising the integrity of the legitimate supply chain.” United States Attorney Eric S. Miller commended the investigative efforts of the FDA and Homeland Security.
The matter was investigated by Special Agent Matthew Carbone of the FDA’s Office of Criminal Investigations, and by a Special Agent from Homeland Security Investigations. The case was prosecuted by Assistant United States Attorney Owen C.J. Foster and FDA Associate Chief Counsel Scott Kaplan. AADCO Medical was represented by Kevin Henry, Mr. Marchione was represented by George Ostler, and Mr. Skidmore was represented by Paul Volk.