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Two executives of a Mundelein, Ill., company were convicted on April 13, 2006, of fraudulently selling uncleared surgical sterilizing devices that led to eye damage and to the loss of sight in one eye for 18 patients.
Ross A. Caputo was the president and CEO of AbTox, and Robert M. Riley, the vice president of regulatory affairs of AbTox, when the company received permission to market a small gas plasma sterilizer only for use in sterilizing flat stainless-steel surgical instruments without tubes or hinges. The defendants instead marketed a larger, unauthorized version of the sterilizer and promoted its use for a wide array of non-stainless-steel instruments.
AbTox showed the hospitals that purchased the larger, unauthorized units the clearance letter for the smaller, authorized unit. Because of the way AbTox marketed them, these larger units were used in an unauthorized manner to sterilize complex instruments, including cataract instruments which have small tubes that are used to put solution into a patient's eye. One unauthorized use was to sterilize ophthalmic instruments that had brass joints which reacted to the sterilizing agent and created a toxic residue. AbTox knew of the reaction, but did not advise users or seek proper corrective action. The blindness was caused by a harmful copper acetate residue that remained in the tube of the instrument after it was sterilized in the machine.
One hundred sixty-eight of the unauthorized units were sold to hospitals nationwide, including U.S. Department of Veterans Affairs hospitals and other government agencies, with sales totaling more than $18 million. Hospitals in Chicago, Columbia, Mo., and St. Louis, reported to AbTox that their sterilizer was suspected of causing injuries to several patients. The company failed to notify the Food and Drug Administration about these reports as required.
"These convictions are evidence of FDA's resolve to ensure the safety and efficacy of human medical devices. Our criminal investigators aggressively pursue those that endanger the public health by manufacturing and selling unsafe products," says FDA Associate Commissioner for Regulatory Affairs Margaret O'K. Glavin.
The conviction of the two men is the result of an investigation conducted by the FDA's Office of Criminal Investigations. The defendants were convicted of three counts of wire fraud, four counts of mail fraud, seven counts of selling an unapproved (adulterated) or mislabeled (misbranded) human medical device, and conspiracy to defraud the FDA. Riley was also convicted of one count of making a false statement to the FDA.
The defendants face significant penalties including incarceration, fines, and restitution. Sentencing will be at a later date. Two other defendants, Mark E. Schmitt, former director of marketing of AbTox, and Marilyn M. Lynch, former director of clinical services of AbTox, previously pleaded guilty in the case.
The defendants were found guilty after a nine-week trial in the Northern District of Illinois as the result of a successful prosecution under the direction of U.S. Attorney Patrick J. Fitzgerald for the Northern District of Illinois, in conjunction with the Veterans Affairs Office of Inspector General, the Naval Criminal Investigative Service, the Air Force Office of Special Investigations, and the FDA.