ExThera Exec Conceals Patient Deaths; Firm Reaches Prosecution Agreement
A former executive from ExThera Medical Corporation has been charged with concealing critical adverse events related to a medical device. This device, designed to filter blood, was used on cancer patients who traveled to Antigua for treatments. The executive, Sanja Ilic, served as the Chief Regulatory Officer for the company based in Northern California.
Charges Against Sanja Ilic and ExThera Medical
Sanja Ilic, 58, from Carlsbad, California, has agreed to plead guilty to charges of failing to report two patient deaths. These patient deaths occurred after using ExThera’s blood filtration device at a clinic in Antigua. Ilic allegedly acted with intention to defraud and mislead the Food and Drug Administration (FDA) by withholding crucial information.
Details of the Case
- Key Date: Events took place primarily in 2024.
- Victims: Two patients who died shortly after treatment with the device.
- Corporate Admission: ExThera entered a three-year deferred prosecution agreement (DPA) with the Department of Justice.
- Criminal Penalty: ExThera agreed to pay $750,000 fine and to establish an escrow account for potential civil litigation payments.
Ilic did not file necessary adverse event reports, understanding that doing so could incite regulatory scrutiny and jeopardize the company’s financial stability. ExThera had recently secured $10 million in funding and was on the brink of more lucrative distribution agreements.
Legal Consequences and Corporate Responsibility
The Department of Justice has outlined that ExThera’s actions were intentional. The company has promised ongoing cooperation with investigations and is required to implement compliance measures to prevent future violations of adverse event reporting mandates.
Ilic faces potential maximum penalties including three years in prison, a fine based on the greater of $250,000 or double the financial gain or loss, and possible forfeiture. The U.S. District Court will determine her sentence after taking into account various statutory factors.
Wider Implications and Ongoing Investigations
The FDA, along with other federal agencies, is investigating this case. This incident is part of a broader effort by the Health Care Fraud Unit’s New England Strike Force, which has been actively prosecuting health care fraud cases since its inception. Over 6,200 defendants have been charged collectively for defrauding health care programs out of more than $45 billion since March 2007.
For information on health care fraud measures, you can visit El-Balad or related authorities advocating for accountability in health care practices. This case emphasizes the importance of transparency in clinical practices and regulatory compliance for the protection of patient safety.
