US executives guilty of sterilisation fraud

Two executives of AbTox in the US have been convicted of fraudulently selling uncleared surgical sterilising devices that led to 18 patients losing sight in one eye, following an investigation by the US Food and Drug Administration’s (FDA) Office of Criminal Investigations (OCI).

Ross Caputo, former president and ceo, and Robert Riley, former vice-president of regulatory affairs, marketed a larger, unauthorised version of an authorised small gas plasma steriliser for flat stainless-steel surgical instruments without lumens (tubes) or hinges. They sold 168 units to hospitals in the US, bringing in over $18m revenue for AbTox.

The clearance letter for the smaller, authorised unit was shown when the larger units were sold to the hospitals, and these larger units were subsequently used to sterilise cataract instruments that feature small tubes used to put solution into a patient’s eye and ophthalmic instruments with brass joints that reacted to the sterilising agent, thus creating a harmful copper acetate residue that remained in the tube of the instrument after sterilisation. It was this residue that caused the blindness in the 18 patients.

AbTox knew of the reaction that caused this residue, but did not advise users or seek proper corrective action, and although numerous hospitals reported to AbTox that they suspected their steriliser to be causing injuries to patients, the company failed to provide the FDA with the requisite notice of these reports.

Caputo and Riley were convicted of three counts of wire fraud, four counts of mail fraud, seven counts of selling an adulterated (unapproved) or misbranded (mislabelled) human medical device, and conspiracy to defraud the FDA. Riley was also convicted of one count of making a false statement to the FDA.

Sentencing is due to take place on 12 July, and both could face at least 10 years’ imprisonment.