A California woman has been charged in federal court for failing to report adverse events, including patient deaths, related to a blood filtration device used on cancer patients who traveled from the United States to Antigua for treatment. Sanja Ilic, 58, of Carlsbad, California, was the Chief Regulatory Officer at ExThera Medical Corporation and is accused of intentionally concealing information from the Food and Drug Administration (FDA).
Court documents state that Ilic will plead guilty to one count of failing to report adverse events with intent to defraud or mislead the FDA. She is expected to appear in federal court in Boston at a later date.
ExThera Medical Corporation, based in Northern California, manufactured a blood filtration device designed to remove pathogens from patients’ bloodstreams. Despite her experience and training regarding FDA reporting requirements, Ilic allegedly concealed critical information about adverse events—including two patient deaths—from the FDA after treatments at an Antigua clinic.
Before treatments began at the clinic, Ilic reportedly circulated an email within ExThera outlining potential “life-threatening” complications associated with use of the device. The press release notes that she understood disclosure could have led to regulatory scrutiny by the FDA and potentially jeopardized clinical trial partnerships as well as financial prospects for both herself and ExThera.
After public reports surfaced about issues with the device and following Ilic’s termination from ExThera, the company filed several adverse event reports with the FDA concerning its use outside of the United States.
ExThera has entered into a three-year deferred prosecution agreement with federal authorities. As part of this agreement, ExThera admitted that it acted through Ilic with intent to defraud and mislead regulators. The company will implement compliance measures aimed at preventing future violations of adverse event reporting laws and must cooperate with ongoing Justice Department oversight.
The agreement also requires ExThera to pay a $750,000 criminal penalty—an amount adjusted according to its ability to pay—and establish an escrow account for these funds within 60 days. Additionally, if there are unpaid amounts resulting from related civil litigation, money from this escrow account will be used for payment. A forfeiture order totaling $5,694,750 was also agreed upon by ExThera.
Authorities considered several factors when reaching this resolution with ExThera: seriousness of offense conduct; minimal remaining operations; lack of voluntary self-disclosure; acceptance of responsibility; cooperation during investigation; and timely remedial actions taken by the company.
Ilic faces up to three years in prison along with supervised release and significant fines if convicted. Sentencing decisions will be made by a federal district court judge according to U.S. Sentencing Guidelines.
“This case marks the first resolution involving a corporate defendant by our Health Care Fraud Unit’s New England Strike Force since partnering with Massachusetts,” said officials involved in announcing today’s charges.
More details about efforts targeting health care fraud can be found on the Justice Department website: https://www.justice.gov/opa/pr/justice-department-expands-health-care-fraud-unit-target-health-care-fraud-massachusetts.