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# ExThera Regulatory Chief Charged With Concealing Adverse Events
- URL: https://www.fdaweb.com/exthera-regulatory-chief-charged-with-concealing-adverse-events/
- Published: 2026-03-05T12:00:00.000Z
- Updated: 2026-09-14T13:34:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160773

The former chief regulatory officer at medical technology company ExThera Medical Corp. has been charged with concealing serious adverse events — including two patient deaths — from FDA in connection with a blood filtration device used on cancer patients treated outside the U.S., [federal prosecutors said 3/5](https://www.justice.gov/usao-ma/pr/chief-regulatory-office-exthera-medical-charged-concealing-adverse-events-including?ref=fdaweb.com).

The U.S. Department of Justice said **Sanja Ilic** of Carlsbad, CA, agreed to plead guilty to one count of failing to report adverse events with intent to defraud or mislead FDA. Prosecutors allege she intentionally withheld safety information tied to a blood filtration device manufactured by ExThera and used on U.S. cancer patients who traveled to a clinic in Antigua for treatment.

Separately, ExThera entered into a three-year deferred prosecution agreement with the government after being charged with failing to file required adverse event reports about the device. Authorities said the case represents the first corporate resolution by the New England Strike Force of the Justice Department’s Health Care Fraud Unit since it began partnering with the U.S. Attorney’s Office for the District of Massachusetts.

According to court documents, Ilic oversaw regulatory compliance at the company and was responsible for reporting adverse events to FDA related to the blood filtration device, which was designed to remove pathogens from patients’ bloodstreams.

Prosecutors say Ilic was aware before treatments began at the Antigua clinic that patients could experience serious complications from the device. In an email circulated to company leadership and regulatory staff, she acknowledged the risk of potentially “life-threatening” adverse events.

Despite that knowledge, authorities allege she concealed reportable events from the agency, including the deaths of two patients treated at the clinic. Investigators said Ilic believed disclosure would likely trigger regulatory scrutiny, potentially cause clinical trial partners to withdraw from studies and threaten the company’s financial prospects.

The Justice Department said both Ilic and ExThera stood to lose financially if the adverse events tied to the Antigua clinic were reported.

After media reports surfaced about the device and Ilic was terminated, ExThera filed multiple adverse event reports with the FDA concerning its use in treating cancer patients outside the United States, prosecutors said.

Under the deferred prosecution agreement, ExThera admitted that the company, through Ilic, acted with intent to defraud or mislead FDA. The company agreed to cooperate with the Justice Department, implement a compliance and ethics program designed to prevent violations of adverse event reporting requirements under the Food, Drug, and Cosmetic Act, and report on remediation efforts.

ExThera also agreed to pay a $750,000 criminal penalty, and to a forfeiture order of about $5.7 million.

If convicted, Ilic faces up to three years in prison, one year of supervised release and a fine of up to $250,000, or twice the gross gain or loss tied to the offense, according to prosecutors.