Former ExThera Medical Corporation Executive Admits to Concealing Patient Deaths from FDA and Company Enters Deferred Prosecution Agreement

A former California executive was charged today and has agreed to plead guilty in connection with failing to file adverse event reports with the intent to defraud and mislead the Food and Drug Administration (FDA) in connection with a blood filtration device. used on cancer patients who traveled to Antigua for treatment. A plea hearing has not yet been scheduled by the court. Separately, ExThera Medical Corporation (ExThera) has entered into a three-year deferred prosecution agreement (DPA) with the Department of Justice in connection with a criminal information filed in the District of Massachusetts charging it with failure to file adverse event reports with the intent to defraud or mislead the FDA. According to court documents, Sanja Ilic, 58, of Carlsbad, California, was the Chief Regulatory Officer of ExThera, a Northern California-based medical technology company. ExThera manufactured a blood filtration device that removed pathogens from a patient’s bloodstream. In or around 2024, Ilic concealed reportable adverse events from the FDA with the intent to defraud and mislead, including the deaths of two patients treated with the blood filtration device at a clinic in Antigua.

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