EDNY Doubles Down on Preemption in Insulin Pump Liability Case
The Eastern District dismissed Gallego v. Tandem Diabetes Care, citing federal preemption for FDA-approved devices.
Why it matters: The ruling solidifies a key precedent limiting state law liability claims against Class III medical device makers. Legal teams must account for robust federal preemption defenses in future medical device litigation strategies.
- On April 27, 2026, EDNY dismissed the Gallego v. Tandem Diabetes Care case with prejudice.
- Claims involved the t:slim X2 insulin pump, a Class III device approved through FDA premarket review.
- The court found all state law tort and warranty claims preempted by federal law under the Medical Device Amendments.
- Wrongful death claims based on preempted theories were also dismissed.
The U.S. District Court for the Eastern District of New York has again affirmed the strength of federal preemption in medical device litigation. In a decision dated April 27, 2026, the court dismissed with prejudice the Second Amended Complaint in Gallego v. Tandem Diabetes Care—reiterating that state law claims cannot override federal regulations governing FDA-approved devices.
- The litigation arose after Jillian Rose Castro Figueroa died using Tandem's t:slim X2 insulin pump, a Class III medical device subject to FDA’s rigorous premarket approval process.
- The plaintiff alleged a mechanical failure in the pump that resulted in Figueroa's death, pressing claims for strict liability, negligence, failure to warn, and breach of implied warranty of merchantability.
- The court found that all these claims sought to impose requirements "different from, or in addition to" federal standards—a core trigger for preemption under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA).
- As a result, both the product claims and the wrongful death allegations based on them were dismissed with prejudice.
This case reinforces a significant hurdle for plaintiffs seeking to bring state law claims against manufacturers of FDA-approved medical technologies, as detailed in a recent legal analysis. Federal preemption remains a primary defense against product liability suits in this sector.
By the numbers:
- April 27, 2026 — Date of dismissal
- Class III — FDA classification for t:slim X2 insulin pump
- 1 case — All claims in Gallego v. Tandem dismissed under federal preemption