Press Release: 3/6/2026

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

 



Thursday, March 5, 2026



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For Immediate Release



 



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.



According to court documents, Sanja Ilic, 58, of Carlsbad, Calif., is charged with one count of failing to report adverse events with intent to defraud or mislead the FDA.  Ilic will appear in federal court in Boston at a later date.



Ilic was the Chief Regulatory Officer of ExThera, a Northern California-based medical technology company. ExThera manufactured a blood filtration device that removed pathogens from patients’ bloodstreams. Despite Ilic’s experience, training and knowledge of FDA adverse event reporting, Ilic intentionally concealed reportable adverse events, including the deaths of two patients treated with the blood filtration device at a clinic in Antigua.



Prior to the start of treatments at the Antigua clinic, Ilic circulated an email to ExThera’s leadership and regulatory staff demonstrating that she understood potential adverse events, including “life-threatening” complications, that patients could experience from use of the Device. Ilic understood that disclosure of such information would have triggered regulatory scrutiny from the FDA, caused clinical trial partners to potentially withdraw their participation and jeopardized ExThera’s and Ilic’s future financial prospects. Rather than comply with her legal obligation to report the events, Ilic concealed this critical information from the FDA. Ilic and ExThera potentially stood to lose financially if negative adverse event reports related to the Antigua clinic were filed with the FDA.



Following public reporting about the blood filtration device and after ExThera terminated Ilic, ExThera filed several adverse event reports with the FDA relating to use of the Device to treat cancer outside the United States.



As part of the deferred prosecution agreement, ExThera admitted that, through Ilic, it acted with intent to defraud and mislead the FDA. ExThera will be required to, among other obligations, provide ongoing cooperation with and disclosures to the Justice Department; implement a compliance and ethics program to prevent violations of the Food, Drug, and Cosmetic Act’s adverse event reporting requirements; and report to the Justice Department regarding remediation and implementation of these compliance measures.  



ExThera also agreed to pay a criminal penalty of $750,000 which has been adjusted based on ExThera’s ability to pay. ExThera will establish an escrow account and deposit $750,000 within 60 days. In the event ExThera is not able to pay amounts owed, if any, in any related civil litigation, the money in escrow shall be used to pay amounts owed. ExThera also agreed to entry of a forfeiture order of $5,694,750.



The government reached this resolution with ExThera based on a number of factors, including the nature and seriousness of the offense conduct, and that ExThera has only minimal remaining operations. ExThera did not voluntarily and timely self-disclose the conduct to the Justice Department but did receive credit for accepting responsibility, cooperating with the investigation and engaging in timely remedial measures.



Ilic faces up to three years in prison, one year of supervised release and a fine of the greatest of $250,000 or twice the gross gain or twice the gross loss.  She is also subject to forfeiture and restitution. Sentences are imposed by a federal district court judge based upon the U.S. Sentencing Guidelines and other statutory factors.



United States Attorney Leah B. Foley; Assistant Attorney General A. Tysen Duva of the Justice Department’s Criminal Division; Fernando McMillan, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations, New York Field Office; Ted E. Docks, Special Agent in Charge of the Federal Bureau of Investigations, Boston Division; Roberto Coviello Special Agent in Charge of the Department of Health and Human Services, Officer of Inspector General; Michael J. Krol, Special Agent in Charge of Homeland Security Investigations in New England; and Nicholas Bucciarelli, Acting Inspector in Charge of the U.S. Postal Inspection Service, Boston Division made the announcement.



Assistant U.S. Attorneys Mackenzie A. Queenin and Sarah Hoefle of the Health Care Fraud Unit are prosecuting the case, along with Assistant Chiefs Kevin Lowell and William Schurmann and Trial Attorneys John Howard and Sarah Rocha of the Justice Department’s Fraud Section.



More information can be found at https://www.justice.gov/opa/pr/justice-department-expands-health-care-fraud-unit-target-health-care-fraud-massachusetts.