The legal challenge, led by the firm Hagens Berman, centers on a period where Beta Bionics management aggressively marketed the iLet device as the most automated and low-maintenance option on the market. While executives dismissed a 2025 FDA inspection as a routine administrative hurdle involving complaint definitions, the complaint alleges they were suppressing data on serious hypoglycemic events. By February 2026, a formal FDA warning letter revealed the company had failed to report malfunctions leading to severe health outcomes, violating critical safety protocols.

Reed Kathrein, the Hagens Berman partner heading the investigation, indicated that the core of the case involves whether the company prioritized revenue streams over patient safety. The FDA’s findings suggest a failure to analyze quality data or implement necessary corrective actions for device failures. With the lead plaintiff deadline set for November 3, 2026, the firm is also soliciting testimony from whistleblowers who may possess non-public information regarding the company’s internal handling of safety complaints.