ExThera Medical Executive Pleads Guilty to Concealing Patient Deaths from FDA in Blood Filtration Device Case
核心洞察
ExThera Medical Corp (搜索).'s former Chief Regulatory Officer Sanja Ilic has agreed to plead guilty to failing to report adverse events, including two patient deaths, with intent to defraud the FDA in connection with a blood filtration device used on cancer patients.
The blood filtration device was used to remove pathogens from cancer patients' bloodstreams at a clinic in Antigua, where patients traveled from the United States for treatment.
ExThera Medical Corp (搜索). has entered a three-year deferred prosecution agreement and will pay $750,000 in criminal penalties while implementing compliance measures to prevent future FDA reporting violations.
A former ExThera Medical Corp (搜索). executive has agreed to plead guilty to concealing patient deaths from the FDA in a case involving a blood filtration device used on cancer patients, marking a significant enforcement action against medical device regulatory violations.
Sanja Ilic, 58, of Carlsbad, California, who served as Chief Regulatory Officer of the Northern California-based medical technology company, is charged with one count of failing to report adverse events with the intent to defraud or mislead the FDA. The charge stems from her concealment of reportable adverse events, including the deaths of two patients treated with ExThera's blood filtration device at a clinic in Antigua.
Device and Treatment Context
ExThera manufactured a blood filtration device designed to remove pathogens from patients' bloodstreams. The device was used on cancer patients who traveled from the United States to a clinic in Antigua for treatment. According to prosecutors, before treatments began at the Antigua clinic, Ilic circulated an email to ExThera's leadership and regulatory staff demonstrating her understanding of potential adverse events, including "life-threatening" complications that patients could experience from device use.
Regulatory Violations and Intent
Despite Ilic's experience, training, and knowledge of FDA adverse event reporting requirements, prosecutors allege she "intentionally concealed reportable adverse events" that occurred in 2024. U.S. Attorney Leah Foley stated that "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."
The prosecution emphasized that rather than comply with legal obligations to report the events, Ilic concealed 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," Foley noted.
Corporate Resolution and Penalties
Separately, ExThera Medical Corp (搜索). has entered into a three-year deferred prosecution agreement with the Department of Justice. As part of this agreement, ExThera admitted that through Ilic's actions, it acted with intent to defraud and mislead the FDA.
The company will pay a criminal penalty of $750,000, adjusted based on ExThera's ability to pay, and establish an escrow account with this amount within 60 days. ExThera also agreed to a forfeiture order of $5,694,750. If the company cannot pay amounts owed in related civil litigation, the escrowed funds will be used for those payments.
Compliance Requirements and Remediation
Under the deferred prosecution agreement, ExThera must provide ongoing cooperation and disclosures to the Justice Department and implement a comprehensive compliance and ethics program to prevent violations of the Food, Drug, and Cosmetic Act's adverse event reporting requirements. The company must also report to the Justice Department regarding remediation and implementation of these compliance measures.
Following public reporting about the blood filtration device and after ExThera terminated Ilic, the company filed several adverse event reports with the FDA related to use of the device to treat cancer outside the United States.
Legal Consequences and Significance
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. She is also subject to forfeiture and restitution. A plea hearing has not yet been scheduled by the court.
This case represents 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. The government reached this resolution with ExThera based on several factors, including the nature and seriousness of the offense and the company's minimal remaining operations.
While ExThera did not voluntarily and timely self-disclose the conduct to the Justice Department, the company received credit for accepting responsibility, cooperating with the investigation, and engaging in timely remedial measures.