The FDA is reporting that two executives of AbTox, a Mundelein, Illinois, company have been of Ã¢â‚¬Å“fraudulently selling uncleared surgical sterilizing devices that led to eye damage in eighteen patients, causing them to lose sight in one eye.Ã¢â‚¬Â
Ross Caputo and Robert Riley were president and CEO and vice-president of regulatory affairs of AbTox when the company received permission Ã¢â‚¬Å“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.Ã¢â‚¬Â
In marketing the larger unauthorized device, hospitals that purchased it Ã¢â‚¬Å“were shown by AbTox the clearance letter for the smaller, authorized unit.Ã¢â‚¬Â
The larger units were used in an unauthorized manner because AbTox marketed them that way; Ã¢â‚¬Å“to sterilize complex instruments, including cataract instruments that have small tubes which are used to put solution into the patientÃ¢â‚¬â„¢s eye.Ã¢â‚¬Â
One unauthorized use was to Ã¢â‚¬Å“sterilize ophthalmic instruments that had brass joints which reacted to the sterilizing agent creating a toxic residue.Ã¢â‚¬Â
AbTox was aware of the toxic reaction Ã¢â‚¬Å“but did not advise users or seek proper corrective action.Ã¢â‚¬Â
Patient blindness was then caused by a harmful copper acetate residue that remained in the tube of the instrument after sterilization by this machine.
According to the FDA: Ã¢â‚¬Å“One hundred sixty eight (168) of the unauthorized units were sold to hospitals nationwide, including Department of Veterans Affairs hospitals and other government agencies, totaling over $18 million in sales. Ã¢â‚¬Å“
Although several hospitals (Chicago, Ill., Columbia, Mo., and St. Louis, Mo.) reported to AbTox that its sterilizer was suspected of causing injuries to several patients, the company Ã¢â‚¬Å“failed to notify the FDA about these reports as required.Ã¢â‚¬Â
Ã¢â‚¬Å“These convictions are evidence of FDAÃ¢â‚¬â„¢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 productsÃ¢â‚¬Â, said Margaret OÃ¢â‚¬â„¢K. Glavin, FDAÃ¢â‚¬â„¢s Associate Commissioner for Regulatory Affairs.
The conviction resulted from an investigation conducted by the FDAÃ¢â‚¬â„¢s Office of Criminal Investigations (OCI).
The two men were convicted of Ã¢â‚¬Å“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.Ã¢â‚¬Â
Sentencing is scheduled for a later date with both men facing Ã¢â‚¬Å“significant penalties including incarceration, fines, and restitution.Ã¢â‚¬Â
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 guilty verdicts followed a nine-week trial in the U.S. District Court for the Northern District of Illinois that was prosecuted by Patrick J. Fitzgerald, United States Attorney for the Northern District of Illinois, in conjunction with the US Department of VeteranÃ¢â‚¬â„¢s Affairs Ã¢â‚¬â€œ 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.