Chief Regulatory Officer for ExThera Medical Charged with Concealing Adverse Events, Including Deaths, from FDA; ExThera Medical Corporation Resolves Investigation

Chief Regulatory Officer for ExThera Medical Charged with Concealing Adverse Events, Including Deaths, from FDA; ExThera Medical Corporation Resolves Investigation

Defendant and corporation failed to notify FDA of adverse events related to blood filtration device including two patients' deaths at a clinic in Antigua

BOSTON - A California woman was charged today and has agreed to plead guilty in the District of Massachusetts for failing to report adverse events with the intent to defraud or mislead the Food and Drug Administration ("FDA") in connection with a blood filtration device used on cancer patients who traveled from the United States to Antigua for treatment. Separately, ExThera Medical Corporation ("ExThera") has entered into a three-year deferred prosecution agreement 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 in connection with the device. Today's announcement marks the first resolution of a corporate defendant by the Health Care Fraud Unit's New England Strike Force since announcing its partnership with the District of Massachusetts.

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