About a year ago we blogged about a strong preemption decision from the Eastern District of New York, Gallego v. Tandem Diabetes Care, Inc., 2025 WL 948282 (E.D.N.Y. March 28, 2025). Gallego involved a Class III insulin injection pump that sent a warning alarm to its user that insulin was no longer being delivered. The diabetic using the pump then spoke with a representative of the manufacturer who confirmed that the pump was not delivering insulin and that the user should replace the insulin cartridge. The user of the pump died later the same day, and his estate filed a lawsuit. As discussed in our prior post, the court dismissed with prejudice most of the estate’s claims, but it granted plaintiff leave to file a second amended complaint (SAC) that included a claim for negligent defective design and wrongful death. Today’s decision, Gallego v. Tandem Diabetes Care, Inc., 2026 WL 1130316 (E.D.N.Y. Apr. 27, 2026), applies another robust preemption analysis and dismisses the plaintiff’s remaining claims with prejudice.

The SAC alleged the pump was defectively designed because, although it delivered a warning alarm, it did not identify the correct problem with the pump. The defendant inspected the pump after the event and found that (1) “the device was unable to complete the cartridge load sequence, indicating that the drive train in the pump was not functioning properly,” and (2) “the device log did not show that a pump malfunction occurred, despite a pump and/or mechanical malfunction being classified as a critical event during the PMA process.” Id. at *3. The plaintiff contrasted those findings with the actual warning alarm delivered by the pump: “ALL DELIVERIES STOPPED! This cartridge cannot be used. Remove and replace with a new cartridge.” Id. at *2.  Based on the difference between the warning alarm given by the device and the information obtained from defendant’s post-event inspection, the SAC alleged the pump was defectively designed because the alarm referred to a cartridge delivery problem rather than a drive train problem.

The court began its preemption analysis by noting that most of the allegations in the SAC did not refer to any device-specific PMA requirements. Instead, the complaint included general, conclusory statements about “mechanical issues” and “alarms” identified during the PMA process. Id. at *8. But the SAC did not tie those allegations to any specific PMA requirements, and the court held that those general, non-specific references were insufficient to state a parallel claim.

Plaintiff tried to avoid dismissal by arguing that the alarm’s reference to the cartridge system rather than the drive train constituted a deviation from the PMA approval requirements. That argument failed:

The FDA approved critical event logging and alarms [which] the . . . [p]ump included, but Plaintiff still argues that the device’s design should have included a specific alarm for a ‘drive train failure or insufficient drive train’ mechanical malfunction.  These types of claims that challenge the FDA’s PMA approved design are preempted.

Id. at *9.  The plaintiff could not show how the warning alarm the decedent received was a deviation from any PMA requirements.

The SAC also included allegations that the pump’s design and manufacture did not comply with Current Good Manufacturing Practices (CGMPs).  But the court recognized that “[m]ost courts addressing [CGMP claims] in the Eastern District of New York have concluded that CGMPs do not form a sufficient basis for a parallel claim, and courts that have allowed such claims . . . have done so only when the alleged CGMP violation also gives rise to a violation of PMA requirements.” Id. at *10.  Since the plaintiff could not show a separate violation of a PMA requirement, the court would not recognize any alleged CGMP violation as a parallel claim.

The court went further and held that, even if it were to conclude that allegations of a CGMP violation could state a parallel claim, the plaintiff failed to state a viable claim. The SAC did not explain how a failure to log a mechanical pump malfunction constituted a CGMP violation, and the complaint did not show that the FDA imposed the CGMPs on the pump during the PMA process. Since plaintiff did not plead any specific violation of “device-specific” PMA requirements related to the CGMPs, the claim was preempted. Id. at *11.

The SAC also alleged that the pump’s failure to record and log the alleged malfunction constituted a violation of a post-approval requirement.  But the SAC did not identify any post-approval requirement imposed by the FDA.  Plaintiff tried to dodge this by making vague references to post-approval CGMPs, but provided no specifics as to how any post-approval actions violated any CGMPs. Plaintiff’s allegations were simply too vague to state a viable claim for violation of any post-approval requirement.

Finally, the court held that the plaintiff failed to plead a sufficient link between the alleged PMA defect in the warning alarm and the resulting death. Without that, there was no causation. Plaintiff did not dispute that the device provided a warning alarm that clearly indicated the pump was no longer delivering insulin.  There was no indication that a different warning alarm would have prevented the harm. “Regardless of the source of the malfunction . . . the [p]ump warning advised Decedent of insulin delivery failure. Plaintiff’s contentions that the alleged violation . . . caused the injury do not identify how the violation caused the alleged injury nor establish a causal link.”  Id. at *14.   

Since plaintiff failed to state a negligent design claim, and since a wrongful death claim in New York is predicated on “a wrongful act, neglect or default,” the wrongful death claim was subject to dismissal. Id.  Plaintiff did not seek leave to file a third amended complaint, and plaintiff did not suggest that additional facts could be asserted to avoid preemption. Noting that it need not grant amendments that are “futile” and “would fail to cure prior deficiencies or to state a claim under Rule 12(b)(6),” the court dismissed the remaining claims with prejudice. Id. at *15. We’ll add Gallego round two to our growing list of good preemption decisions from the federal courts in New York.