FOR IMMEDIATE RELEASE
TUESDAY, NOVEMBER 18, 2008
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FORMER MEDICAL DEVICE COMPANY MANAGER PLEADS GUILTY TO MAKING A FALSE STATEMENT AND FELONY MISBRANDING
BOSTON, MA - A Chicago, Illinois man was convicted today in federal court of making a false statement and felony misbranding of a medical device.
United States Attorney Michael J. Sullivan; Mark Dragonetti, Resident Agent in Charge of the Food & Drug Administration, Office of Criminal Investigations and Susan J. Waddell, Special Agent in Charge of the U.S. Department of Health and Human Services, Office of the Inspector General, announced today that DARNELL MARTIN, age 35, of Chicago, Illinois, pled guilty before U.S. District Judge Young to one count of making a false statement and 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 MARTIN 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”). An HDE product may only be used in medical facilities that have established a local institutional review board (“IRB”), which must approve the device before its use.
On or about May 18, 2007, MARTIN falsified an IRB approval. As a result, a number of the HDE devices were shipped, billed and used by a medical facility in Wisconsin, when in fact that hospital’s IRB had not approved the use of the device at that time. In addition, the prosecutor told the Court that MARTIN also 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 written mixing instructions to surgeons, medical technicians and others.
Judge Young scheduled sentencing for May 13, 2009. MARTIN faces up to 5 years imprisonment, to be followed by 3 years of supervised release and a $250,000 fine on the false statement charge and 3 years imprisonment, to be followed by 1 year of supervised release and a $10,000 fine on the misbranding charge.
The case was investigated by the FDA - Office of Criminal Investigations and the Department of Health and Human Services, Office of Inspector Genera and the U.S. Department of Health and Human Services, Office of the Inspector General. It is being prosecuted by Assistant U.S. Attorney Jeremy Sternberg of Sullivan’s Health Care Fraud Unit.
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