Two Abtox execs convicted in unapproved sterilization device scheme

Convicted of fraudulently selling uncleared surgical sterilizing devices that led to eye damage in 18 patients

May 3, 2006 — MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM) — COSTA MESA Calif. — The US FDA announced today that 2 executives of AbTox, a Mundelein IL company, were convicted April 13 2006, of fraudulently selling uncleared surgical sterilizing devices that led to eye damage in 18 patients, causing them to lose sight in 1 eye.

Mr. Ross Caputo was President & CEO of AbTox, and Mr. Robert Riley was VP 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 nonstainless-steel instruments, FDA officials said.

The defendants face significant penalties that include 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 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, FDA officials said, to sterilize complex instruments, including cataract instruments that have small tubes which are used to put solution into the patient’s eye.

FDA officials claim that 1 unauthorized use was to sterilize ophthalmic instruments that had brass joints, which reacted to the sterilizing agent, creating a toxic residue. AbTox knew of the reaction but did not advise users or seek proper corrective action, claims the FDA. The blindness was caused by a harmful copper acetate residue that remained in the tube of the instrument after sterilization by this machine.

Some 168 of the unauthorized units were sold to hospitals nationwide, including Dept of Veterans Affairs hospitals and other govt agencies, totaling over $18 mln in sales. Hospitals in Chicago IL, Columbia MO and St. Louis MO, 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, officials note.

“These convictions are evidence of the 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,” said Margaret O’K. Glavin, FDA’s Associate Commissioner for Regulatory Affairs.

The conviction of these 2 men is the result of an investigation conducted by the FDA’s Office of Criminal Investigations. The defendants were convicted of 3 counts of wire fraud, 4 counts of mail fraud, 7 counts of selling an adulterated (unapproved) or misbranded (mislabeled) human medical device, and conspiracy to defraud the FDA. Mr. Riley was also convicted of 1 count of making a false statement for lying to the FDA, officials announced.

The defendants were found guilty after a 9-week trial in the N District of Illinois as the result of a successful prosecution under the direction of Patrick J. Fitzgerald, US Attorney for the N District of Illinois, in conjunction with the US Dept of Veteran’s Affairs — Office of Inspector General, Investigations, Naval Criminal Investigative Service (NCIS), and Air Force Office of Special Investigations, along with the FDA.

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