Leah B. Foley United States Attorney for the District of Massachusetts | Department of Justice
A California woman has been charged in Massachusetts federal court for failing to report adverse events, including patient deaths, linked to a blood filtration device used on cancer patients. The device was manufactured by ExThera Medical Corporation and used at a clinic in Antigua for U.S. patients seeking treatment abroad.
Sanja Ilic, 58, of Carlsbad, California, served as Chief Regulatory Officer at ExThera. According to court documents, she is accused of intentionally concealing adverse event reports from the Food and Drug Administration (FDA), despite her training and experience with FDA reporting requirements. Prosecutors allege that Ilic hid critical information—including two patient deaths—from the agency.
Before treatments began at the Antigua clinic, Ilic circulated an email within ExThera indicating her awareness of possible serious complications from use of the device. Prosecutors say that disclosing these events could have triggered regulatory scrutiny from the FDA and jeopardized both ExThera’s clinical partnerships and financial prospects. Instead of reporting as required by law, Ilic withheld this information.
After media coverage about the device surfaced and following Ilic’s termination from ExThera, the company filed several adverse event reports with the FDA related to its use outside the United States.
ExThera Medical Corporation has entered into a three-year deferred prosecution agreement after being charged with failure to file adverse event reports with intent to defraud or mislead regulators. As part of this agreement—the first such corporate resolution since a new partnership between federal prosecutors and health care fraud investigators in New England—ExThera admitted wrongdoing through actions taken by Ilic.
The company will be required to cooperate with ongoing Justice Department investigations, implement compliance measures designed to prevent future violations of FDA reporting rules, and regularly report on its remediation efforts. Additionally, ExThera agreed to pay a $750,000 criminal penalty based on its current ability to pay; these funds will be placed in escrow for up to 60 days and may also be used toward any related civil litigation costs if needed. The company also consented to forfeiture totaling $5,694,750.
Prosecutors considered several factors when determining this resolution: while ExThera did not voluntarily disclose its conduct early on, it received credit for accepting responsibility after investigation began and for taking remedial steps. The company now has only minimal operations remaining.
Ilic faces up to three years in prison if convicted as well as supervised release and fines that could reach $250,000 or more depending on statutory calculations involving gross gain or loss connected with her offense. She may also face restitution payments and asset forfeiture orders upon sentencing by a federal judge.
United States Attorney Leah B. Foley stated: “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.”
More details about expanded health care fraud enforcement efforts can be found at https://www.justice.gov/opa/pr/justice-department-expands-health-care-fraud-unit-target-health-care-fraud-massachusetts.
