Abtox Executives Sentenced

The Chicago Tribune reports that two executives of Abtox (Mundelein, IL) have been sentenced today for their roles in selling to hospitals unapproved sterilizers that caused blindness in 18 patients. CEO Ross Caputo received 10 years in prison and VP/Chief Compliance Officer Robert Riley received six years. They also must reimburse hospitals $17 million for the fraudulent sales. Abtox had FDA approval for a small sterilizer but executives fraudlently claimed they had approval for a larger one, and that it could sterilize a number of devices when in reality it was only safe for stainless steel devices. Some hospitals used it to sterilize a small tube used in eye surgery, but the tube reacted poorly to the sterilant, leading to the blindness cases. Stiff sentences like these are appropriate because acting without regard to patient safety needs to be highly discouraged.
Device talk Tags: