ExThera Hit With $5.6M Forfeiture After Executive Concealed Deadly Blood Filter Device Side Effects

A Northern California medical technology firm has been hit with a $5.6 million (£4.19 million) forfeiture order after one of its top executives admitted she concealed patient deaths from the US Food and Drug Administration (FDA) in connection with a blood filtration device used on cancer patients, according to the US Department of Justice.

The fallout from the case highlights serious concerns about how adverse events involving medical devices are reported to federal regulators.

Sanja Ilic, the 58‑year‑old former chief regulatory officer of ExThera Medical Corporation, agreed to plead guilty to a federal criminal charge for failing to file required adverse event reports with the intent to defraud and mislead the FDA.

At the same time, ExThera entered a deferred prosecution agreement (DPA) with the DOJ over its role in concealing critical safety information.

Deadly Events Were Suppressed

According to court documents, Ilic concealed reportable adverse events in 2024 involving at least two patients who died after being treated with ExThera's blood filtration device at a clinic in Antigua.

The device was designed to remove pathogens from a patient's bloodstream, and the company was testing its use to treat cancer in patients who travelled outside the United States for treatment.

Before the Antigua clinic began treatments, Ilic had circulated an internal email to ExThera leadership and regulatory staff that outlined the 'life‑threatening' complications that patients could experience when using the device. Some clinic patients and their doctors reported serious medical issues, including deaths, after treatment.

Rather than report these adverse events to the FDA, according to legal requirements, Ilic understood that disclosing them could trigger regulatory scrutiny, jeopardise clinical trial participation, and harm the company's financial prospects.

At the time, ExThera had recently secured $10 million (£7.48 million) in capital and was positioning itself for future distribution agreements.

Intent to Defraud Regulators

Ilic's conduct is significant because federal law requires manufacturers and responsible officials to report serious injuries or deaths associated with medical devices so the FDA can evaluate safety risks. Instead, Ilic suppressed critical safety information in order to defraud and mislead regulators, according to the Justice Department.

According to prosecutors, it is unlawful and dangerous to conceal adverse event reports from the FDA, given the potential risk such concealment poses to patients and public health.

By withholding information that would have prompted regulatory review, Ilic and ExThera sought to avoid scrutiny that might have derailed ongoing studies and commercial plans.

In legal filings, ExThera acknowledged that it acted with intent to defraud and mislead the FDA through Ilic's actions, and the company agreed to a series of stringent compliance requirements in its DPA.

Deferred Prosecution and Penalties

As part of the deferred prosecution agreement, ExThera must cooperate fully with the Department of Justice and disclose information about its remedial actions.

It also must implement a compliance and ethics programme to ensure future adherence to the Food, Drug, and Cosmetic Act's adverse event reporting requirements, and report on progress to the DOJ.

ExThera agreed to pay a $750,000 (£561,000) criminal penalty, adjusted based on its financial position, and to deposit that amount into an escrow account within 60 days. The $5.6 million (£4.19 million) forfeiture order may be used to satisfy amounts owed in related civil litigation tied to the conduct described in court filings.

The DOJ noted the resolution was influenced by several factors, including the seriousness of the conduct and the fact that ExThera has 'minimal remaining operations.' The company also received credit for accepting responsibility, cooperating with authorities, and implementing remedial measures, albeit after its former executive was terminated.

Charges Against the Former Executive

Ilic was charged with one federal count of failure to report adverse events with the intent to defraud or mislead the FDA. She faces a maximum of three years in prison, up to one year of supervised release, and potential fines equivalent to the greater of $250,000 (£187,000) or twice the gross gain or loss tied to the offence. She is also subject to forfeiture and restitution as determined by a federal judge under the sentencing guidelines.

The FDA, FBI, Department of Health and Human Services Office of Inspector General, Homeland Security Investigations, and the US Postal Inspection Service all participated in the investigation.

Broader Implications for Medical Device Safety

This case underscores ongoing challenges in how medical device companies report and manage serious adverse events. The FDA has previously issued warnings to manufacturers when concerns arise about investigational devices, and compliance failures can jeopardise patient safety.

Experts say transparency in adverse‑event reporting is crucial to protecting patients because it allows regulators to identify patterns of risk that might otherwise go unnoticed until many patients are harmed. Cases such as this highlight why strict enforcement of reporting rules matters, especially when devices are marketed or used outside traditional clinical settings.

Patient Safety and Regulatory Enforcement

The Justice Department's action against ExThera and its former executive sends a message to the medical technology industry about the importance of reporting safety issues. Concealing adverse outcomes, particularly those involving patient deaths, carries significant legal and ethical consequences.

Prosecutors emphasised that medical device makers must be held accountable when they fail to meet federal obligations and risk patient health by obscuring critical safety information, reinforcing the role of regulatory oversight in safeguarding the public.