The litigation, pending in the U.S. District Court for the Central District of California under the name Holtzman v. Beta Bionics, Inc., accuses the medical device manufacturer and its executives of violating federal securities laws. Plaintiffs allege that the company misled shareholders regarding the safety and regulatory status of the iLet insulin pump.

According to the complaint, the device's automated dosing algorithm reportedly delivered excessive insulin, leading to hundreds of life-threatening hypoglycemic events. The lawsuit further contends that Beta Bionics failed to disclose thousands of patient complaints to the FDA. Although the company received an FDA Form 483 in June 2025 regarding over 18,000 unreported complaints, it allegedly downplayed the severity of these regulatory findings. Consequently, the firm now faces scrutiny over its quality management system and failure to implement corrective actions, with Kahn Swick & Foti, LLC providing legal guidance to affected investors.