Medical device preemption should be straightforward.  The statute could not be clearer.  Federal regulation supplants state laws that would impose requirements that are different from or in addition to the federal requirements.  But the law has evolved into a bit of a mess, with misreadings of certain approval/clearance pathways and inventions of exceptions, such as for “parallel” claims.

Gallego v. Tandem Diabetes Care, Inc., 2025 U.S. Dist. LEXIS 58993, 2025 WL 948292 (E.D.N.Y. March 28, 2025), cuts through some of the mess and ends up getting device preemption right.  The facts of Gallego are, as is typical with product liability cases, sad.  That sadness and attendant sympathy probably account for some of the distortions in the law, but Gallego indulges in no such distortions. 

The plaintiff’s decedent in Gallego was a diabetic who depended on an insulin pump.  After giving off an alarm, the pump ceased insulin delivery to the decedent and the decedent … well … became  a decedent.  A post-mortem physical examination of the pump showed that it had been dropped many times. The decedent’s estate contended that  if the pump had been manufactured with “thicker, more stable materials, so as to adequately hedge for the possibility that the pump would be dropped or other errors would be prevented, the cartridge could have been allowed to load and dispense properly, thus avoiding Decedent’s injuries and death.”  The estate filed a complaint in New York state court.  The defendant pump manufacturer removed the case to federal court.  The estate then filed an amended complaint, which contained causes of action for strict liability manufacturing defect, negligent design defect, negligence, strict liability failure to warn, breach of implied warranty of merchantability, and wrongful death.  The defendant moved to dismiss these claims on preemption grounds.

As a preliminary matter, there was a strange squabble as to the regulatory status of the insulin pump.  The plaintiff alleged that the pump was a Class III medical device subject to the Food and Drug Administration (FDA) premarket approval (PMA).  The defendant, by contrast, asserted that the pump had been cleared  by the FDA as a  Class II device with special controls under the FDA’s de novo premarket review pathway.  The defendant submitted FDA filings to prove up its position and invited the court to take judicial notice.  The court declined that invitation.  The existence of a dispute precluded judicial notice and – here is the punchline and that makes us wonder why the defendant took the position it took – the plaintiff lost under its interpretation. 

Section 360k of the Medical Device Amendments Act expressly preempts any state law that imposes a requirement on a Class III medical device that is “different from, or in addition to, any requirement” under the Food, Drug and Cosmetic Act (FDCA) and “relates to the safety or effectiveness of the device.”  Thus, to the extent that a product liability complaint alleges that a Class III medical device should have had something more, better, faster, stronger than what is required by federal law, it is necessarily preempted.  But at the same time, if a product liability claim merely seeks to enforce FDCA requirements, such a claim would be impliedly preempted.  That sounds like hard cheese for product liability plaintiffs.  But fear not, because SCOTUS dicta inspired courts to create the “parallel claim” preemption, which permits plaintiffs to squeeze into a “narrow gap” by suing for a flaw that violates both federal and state law.  Here is how the Gallego court described that narrow gap: “To fall into this narrow gap, a plaintiff must be suing for a device manufacturer’s violation of an FDA requirement to avoid express preemption by MDA section 360k(a), but the plaintiff must not be suing because the device manufacturer violated the FDA requirement to avoid implied preemption under FDCA section 337(a).”  The plaintiff in Gallego purported to navigate that “narrow gap.” In endeavoring to fend off preemption, the plaintiff argued that his “causes of action are all based on deviations from requirements in the FDA pre-approval process and/or violations of [f]ederal statutes and regulations.”  Heed our Homeric foreshadowing:  the plaintiff tried to avoid both the Scylla of express preemption and the Charybdis of implied preemption.  But, unlike Odysseus, the Gallego complaint got gobbled by Scylla and drowned by Charybdis.   

The difference between the many courts that misuse the parallel claim exception – to the point where the exception swallows the rule – and those that truly keep that gap narrow comes down to this: how specific must the alleged FDCA violation be?  The Gallego court observed that there was “no controlling authority prescribing the detail required to plead a parallel claim that avoids preemption, but the district courts within the Second Circuit have required that plaintiffs cite to a federal requirement specific to the device at issue that was violated and allege facts sufficient to link the violation of the alleged injury.” That arrives as bad news for the plaintiff in Gallego.  For the most part, the plaintiff in Gallego went the usual parallel claim route by referring to alleged departures from Current Good Manufacturing Practices (CGMP).  The Gallego court held that general CGMP violations do not cut the mustard because they were either too vague or the FDA did not  specifically impose such CGMP requirements to the insulin pump at issue: “Even accepting Plaintiff’’s allegation that Defendant violated ‘[IEC] technical standards for the safety and essential performance of medical electrical equipment,’ as pleaded, this factual allegation is irrelevant to the question of whether Defendant violated ‘device-specific federal requirements,’ Riegel, 451 F.3d at 116, because there are no allegations that FDA imposed the IEC standards on the X2 Pump through the PMA process or otherwise.” 

The Gallego complaint did not make it through the narrow gap; it was squashed by it.  Preemption ended all the claims.  The manufacturing defect claim was inadequately pleaded, asserting vague, general CGMP violations, that were not imposed via the PMA, some completely non-FDA standards, and did not specify which of the defendant’s device specifications were not met.  A defect could not be fairly inferred from the fact of malfunction.  As the Gallego court reasoned, “a Class III medical device cleared through a PMA process could theoretically fail to perform as intended or harm the end user notwithstanding the device manufacturer’s compliance with device-specific federal requirements.”  Similarly, the design defect claim failed because it “falls squarely within the MDA’s express preemption provision because Plaintiff fails to allege that the design defects were due to deviations from PMA requirements.”  If the gravamen of the complaint was that the pump should have been better designed to withstand multiple drops, then the allegations in the amended complaint “as pleaded, directly challenge the FDA-approved design for the X2 Pump and thus would impose design requirements that are ‘different from, or in addition to’ that which FDA approved through the PMA process.”  The failure to warn claim did “not allege that Defendant failed to comply with the labeling or other warning requirements that the FDA imposed through the PMA process nor does he plead a state duty that would parallel any such violation by Defendant.”   

The warranty claim was the usual boilerplate, make-weight, hanger-on.  It failed for the same reasons as the product liability claims.  It was too vague for the court “to determine whether Plaintiff has identified an FDA violation for the underlying defects sufficient to state a parallel claim.”  The plaintiff essentially said that the pump was not “reasonably fit,”  which was “in direct conflict with FDA’s determination that it had reasonable assurance of the product’s safety and effectiveness as an insulin pump.”

With the preemption-based dismissal of the substantive claims in the Gallego amended complaint, the wrongful death claim  was a goner because it needed to rest on a substantive claim.  Consequently, the court dismissed the entire complaint.  Everything save a piece of the negligent design claim was dismissed with prejudice.