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 afederal criminal chargefor 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.

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.

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.

Source: International Business Times UK