Products Liability Law Daily Wrap Up, DESIGN AND MANUFACTURING DEFECTS—MEDICAL DEVICES—E.D.N.Y.: Suit against manufacturer of insulin pump dismissed, (Apr 30, 2026)

By Brian Craig, J.D.

The negligent defective design claim was preempted because the complaint failed to sufficiently plead a violation of the FDA's device-specific pre-market approval requirements.

In a wrongful death suit alleging negligent design with an insulin pump used to treat diabetes brought against Tandem Diabetes Care, Inc., manufacturer of the t:slim X2 insulin pump, the federal district court in Brooklyn, New York has dismissed all claims. The court held that the negligent defective design claim was preempted by federal law because the complaint failed to sufficiently plead a violation of the FDA’s device-specific pre-market approval (PMA) requirements. The court, which dismissed the claims with prejudice prohibiting any further amendments, also concluded that the complaint failed to establish the necessary causal link of the alleged PMA violation to the purported injury (Gallego v. Tandem Diabetes Care, Inc., No. 24-CV-146 (MKB) (E.D.N.Y. Apr. 27, 2026)).

The administrator of the estate for a diabetic patient who died in 2022 filed suit against Tandem Diabetes Care, Inc., which manufactures the t:slim X2 insulin pump used to treat diabetes. The insulin pump provides continuous glucose monitoring and insulin administration. The X2 Pump is a Class III medical device subject to the FDA’s pre-market approval (PMA) process. The complaint alleged that the diabetic patient did not receive the necessary insulin as a result of the X2 Pump’s failure and negligent defective design. The complaint asserted claims based on manufacturing defect, negligent defective design, negligence, strict products liability based on failure to warn, breach of implied warranty of merchantability, and wrongful death under New York law. After removal from New York state court, the federal district court dismissed the original complaint in March 2025. The administrator filed an amended complaint. The insulin pump manufacturer then moved to dismiss the amended complaint for failure to state a claim.

Defective design. The court concluded that the negligent design claim was preempted because the complaint failed to sufficiently plead a violation of the FDA's device-specific pre-market approval requirements. The court held that the plaintiff must allege facts that the manufacturer failed to comply with a PMA requirement set by the FDA as part of the pre-approval process governed screenings for failure modes that the manufacturer was required to conduct after receiving PMA to ensure continued compliance with the FDA-approved design specification.

In this case, the complaint alleged mechanical problems related to the X2 Pump’s cartridges. The allegations do not refer to any “device-specific” PMA requirement but instead attempt to remedy the deficiencies identified in the court’s earlier decision by including general phrases such as “mechanical issues” identified by the FDA during the PMA process for the subject pump and “alarms” required by the FDA as a part of the PMA process. The court concluded that the allegations did not elaborate on how the X2 Pump’s design failure to log a “mechanical pump malfunction and/or drive train failure” constitutes the manufacturer’s failure to comply with the other continuous glucose monitoring provisions. In addition, the court found that the amended complaint failed to plead how the X2 Pump’s design violated a federal requirement for design failure mode screening that applied post-approval by the FDA.

Causation. Even assuming the complaint properly pleaded a deviation from the PMA-approved design, the court concluded that the complaint failed to plausibly plead causation. A claim must specifically link a PMA deviation or violation of federal law to the alleged injury. Here, the complaint failed to sufficiently allege a causal link between the alleged lack of “proper alerts” and the death of the diabetes patient to survive preemption. The complaint alleged that the X2 Pump lacked appropriate alarms or alerts that would have prevented the injury. However, the complaint did not plausibly allege how a proper alert would have prevented the injury.

Wrongful death. Because the court found that the negligent defective design claim failed, the wrongful death claim also failed. Under New York law, wrongful death is an exclusively statutory cause of action. The wrongful death claim only survives if the negligent defective design claim is viable.

Dismissal with prejudice. Finally, the court dismissed the amended complaint with prejudice. The court denied leave to file a second amended complaint, concluding that any amendment would be futile because the claims were preempted. Therefore, the court granted the manufacturer’s motion to dismiss.

The case is No. 24-CV-146 (MKB).

Judge: Brodie, M.

Attorneys: Caitlin Anne Robin (Caitlin Robin and Associates PLLC) for Nelson Gallego. Jenny A. Covington (Carlton Fields, P.A.) for Tandem Diabetes Care, Inc.

Companies: Tandem Diabetes Care, Inc.

Cases: CourtDecisions MedicalDevicesNews DesignManufacturingNews NewYorkNews