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# FDA, Federal Prosecutors Take Tougher Stance on Safety Reporting: Analysis
- URL: https://www.fdaweb.com/fda-federal-prosecutors-take-tougher-stance-on-safety-reporting-analysis/
- Published: 2026-05-27T12:00:00.000Z
- Updated: 2026-09-14T13:39:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161214

FDA and federal prosecutors are signaling a tougher stance on failures to report patient safety issues to regulators, according to a new legal analysis from Cooley LLP examining the recent criminal enforcement action against medical device maker ExThera Medical Corporation and one of its former executives ([see earlier story](https://www.fdaweb.com/exthera-regulatory-chief-charged-with-concealing-adverse-events/)).

Former ExThera chief regulatory officer **Sanja Ilic** was charged with concealing serious adverse events — including two patient deaths — from FDA in connection with a blood filtration device used on cancer patients treated outside the U.S., [federal prosecutors recently said. ](https://www.justice.gov/usao-ma/pr/chief-regulatory-office-exthera-medical-charged-concealing-adverse-events-including?ref=fdaweb.com)She agreed to plead guilty to one count of failing to report adverse events with intent to defraud or mislead FDA.

In a [client alert](https://investigations.cooley.com/2026/05/26/doj-targets-failure-to-report-adverse-events-lessons-from-the-exthera-enforcement-action/?ref=fdaweb.com) published Tuesday, the law firm said the case demonstrates that the U.S. Department of Justice and FDA continue to treat adverse event reporting as a major compliance priority, particularly when regulators believe companies intentionally withheld information tied to patient harm.

According to prosecutors, two U.S. cancer patients traveled to Antigua in 2024 to receive treatment using the device. Both patients later deteriorated and died. Federal authorities alleged the executive learned of the adverse events but intentionally failed to report them to FDA in order to protect a $10 million commercial agreement tied to the product and avoid regulatory scrutiny.

The case ended with both corporate and individual penalties. The former executive faces up to three years in prison, according to the Cooley analysis. ExThera entered into a three-year deferred prosecution agreement and agreed to forfeit roughly $5.7 million in profits, along with a reduced $750,000 criminal penalty.

Cooley said the enforcement action reflects a broader pattern in which FDA reporting violations can escalate from Warning Letters and civil compliance actions into criminal prosecutions when regulators believe companies intentionally concealed safety information or endangered patients.

The law firm pointed to other recent enforcement cases, including the 2024 criminal resolution involving Magellan Diagnostics. In that matter, DoJ alleged the company concealed malfunctions in blood-lead testing devices that produced falsely low lead readings, potentially masking dangerous lead exposure in patients.

The alert also emphasized DOJ’s continuing focus on individual accountability in corporate enforcement cases. Cooley noted that the ExThera prosecution targeted not only senior corporate leadership but also a regulatory affairs executive directly responsible for FDA submissions and safety reporting.

The authors said the case should serve as a warning to employees working in regulatory affairs, pharmacovigilance and product safety roles that they may face personal criminal liability if the government concludes adverse events were intentionally withheld from regulators.

Cooley further noted that life sciences companies are now operating under FDA’s revised Quality Management System Regulation, or QMSR, which took effect in February and aligns U.S. medical device quality standards more closely with international requirements.

The law firm said companies should review compliance programs, employee training and internal reporting structures to ensure adverse event reporting obligations are handled promptly and accurately.