The lawsuit, spearheaded by the firm Hagens Berman, centers on claims that Beta Bionics concealed thousands of safety complaints related to its flagship iLet device. While management characterized regulatory scrutiny as routine, the company allegedly failed to report life-threatening hypoglycemic events and other malfunctions to the FDA. The deception reportedly unraveled on February 24, 2026, when the FDA published a scathing warning letter issued to CEO Sean Saint. The agency cited systemic failures in the company’s quality data analysis and a disregard for mandatory reporting requirements concerning serious adverse health outcomes.
Before these disclosures, company leadership repeatedly insisted that their complaint-handling systems met or exceeded federal expectations. Hagens Berman partner Reed Kathrein stated that the investigation is now focused on whether the company prioritized revenue over patient safety. With the deadline for lead plaintiff applications set for November 3, 2026, the firm is also soliciting information from whistleblowers who may possess non-public details regarding the company’s internal reporting practices.
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