Two Executives Convicted in Unapproved Sterilization Device Scheme

According to information released by the Food and Drug Administration (FDA), two executives of a Mundelein, Ill.-based company were convicted on April 13, 2006, of fraudulently selling uncleared surgical sterilizing devices that led to eye damage in 18 patients, causing them to lose sight in one eye.

Ross Caputo was president and CEO of AbTox, and Robert Riley was 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 lumens (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.

The hospitals that purchased the larger unauthorized units were shown by AbTox the clearance letter for the smaller, authorized unit. These larger units were used in an unauthorized manner, because AbTox marketed them that way, to sterilize complex instruments, including cataract instruments that have small tubes which are used to put solution into the patients eye. One unauthorized use was to sterilize ophthalmic instruments that had brass joints which reacted to the sterilizing agent, creating a toxic residue. According to the FDA, 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 sterilization by this machine.

One hundred sixty eight of the unauthorized units were sold to hospitals nationwide, including Department of Veterans Affairs hospitals and other government agencies, totaling more than $18 million in sales. 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 FDA about these reports as required.

These convictions are evidence of FDAs 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, said Margaret OK. Glavin, FDAs associate commissioner for regulatory affairs.

The conviction of these two individuals is the result of an investigation conducted by the FDAs Office of Criminal Investigations (OCI). The defendants were convicted of three counts of wire fraud, four counts of mail fraud, seven counts of selling an adulterated (unapproved) or misbranded (mislabeled) human medical device, and conspiracy to defraud the FDA. Riley was also convicted of one count of making a false statement for lying 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, formerly director of marketing of AbTox, and Marilyn M. Lynch, formerly director of clinical services of Abtox, previously pled guilty in this 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 Patrick J. Fitzgerald, United States Attorney for the Northern District of Illinois, in conjunction with the US Department of Veterans Affairs Office of Inspector General, Investigations (VA-OIG), Naval Criminal Investigative Service (NCIS), and the Air Force Office of Special Investigations (OSI), along with the FDA.

Source: FDA