Inspections, Compliance, Enforcement, and Criminal Investigations
April 14, 2009: Former Medical Device Company Manager Pleads Guilty to Felony Misbranding
BOSTON—A Winchester, Massachusetts man was convicted today in federal court of felony misbranding of a medical device.
United States Attorney Michael J. Sullivan and Mark Dragonetti, Resident Agent in Charge of the Food & Drug Administration - Office of Criminal Investigations; Susan J. Waddell, Special Agent in Charge of Health and Human Services, Office of the Inspector General - Office of Investigations; and Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation - Boston Field Division announced today that SHANE DOYLE, age 32, of Winchester, Massachusetts, pled guilty before U.S. District Judge Woodlock to one count of felony misbranding.
At today’s plea hearing, the prosecutor told the court that had the case proceeded to trial, the government’s evidence would have proven that DOYLE worked for a medical device company based in Hopkinton, Massachusetts which manufactured and sold certain medical devices that are designed to promote bone growth. These devices were approved by the FDA only pursuant to a Humanitarian Device Exemption (“HDE”), which is quite narrow and restrictive. The prosecutor told the court that DOYLE, in his capacity as a territory manager for his employer, promoted the use of these devices in a manner that was different from its FDA approved use; namely he promoted a combination of the HDE devices with a bone void filler, and in furtherance of that promotion provided mixing instructions to surgeons, medical technicians and others.
Judge Woodlock scheduled sentencing for July 23, 2009. DOYLE faces up to three years’ imprisonment, to be followed by one year of supervised release and a $250,000 fine.
The case was investigated by the FDA - Office of Criminal Investigations and the Department of Health and Human Services, Office of Inspector General and the FBI. It is being prosecuted by Assistant U.S. Attorney Jeremy Sternberg of Sullivan’s Health Care Fraud Unit.