Today’s decision, Croci v. Zoll Medical Corp., 2025 WL 2307728 (S.D.N.Y. Aug. 11, 2025), is a straightforward, preemption-based 12(b)(6) dismissal of a complaint involving a Class III medical device.  The case involves claims about a Life Vest, which is worn externally and monitors the wearer’s heart rate. The device is able to detect ventricular tachycardia and ventricular fibrillation, and it can deliver a therapeutic shock to restore the wearer’s heart rate to a normal rhythm.  The complaint alleged that the decedent experienced problems with the Life Vest, and that a representative of the Life Vest’s manufacturer visited the decedent’s home to “desensitize the device.”  Id. at *1.  Shortly after the alleged visit from the representative, the decedent experienced a cardiac arrest and died.

The complaint included a laundry list of allegations, including that the defendants “negligently designed, assembled, labeled, inspected, adjusted, and serviced the Life Vest, failed to provide sufficient warnings and instructions, and inadequately trained or supervised their staff.”  Id.  Based on those allegations, the plaintiff brought claims for negligence, strict products liability, breach of warranty, and pecuniary loss to the estate.  Since the Life Vest is a Class III medical device subject to the Medical Device Amendment’s express preemption provision in 21 U.S.C. § 360k(a), the defendants moved to dismiss on that basis.

It was undisputed that the Life Vest received PMA clearance from the FDA, so the only question was whether any of plaintiff’s claims could pass the parallel claims requirement under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Before addressing that question, the court discussed conflicting precedent regarding the sufficiency of general allegations about Current Good Manufacturing Practices (CGMP) in the context of parallel claims. While some courts have permitted parallel claims based solely on CGMP allegations, others have pointed out that these generalized regulations are “too open ended to impose clear, enforceable duties.” Id. at *5, citing Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582, 589 (E.D.N.Y. 2009) (which we blogged about here) and Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 284 (E.D.N.Y. 2009). In reconciling the different approaches, the court observed that the “key distinction is not the reliance on CGMPs, but rather the existence of a particular violation of federal regulations and factual support connecting that violation to the plaintiff’s injury.”  Id.  The court held that a plaintiff may rely on CGMPs if “the allegations identify a specific federal obligation and a parallel state-law duty.”  Id.  The court then elaborated on how a plaintiff can satisfy that standard:  

To avoid preemption and satisfy the Twombly and Iqbal pleading standards, plaintiffs suing with regard to a PMA-approved device cannot simply make the conclusory allegation that a defendant’s conduct violated FDA regulations. Accordingly, in reconciling the foregoing, to successfully plead a parallel claim, a plaintiff must: identify a state-law duty that is identical to a particular federal requirement; allege a violation of that federal requirement; and present facts plausibly linking that violation to their injuries.

Id. at *5 (internal quotation marks and citations omitted). Croci thus continues a favorable TwIqbal trend in the New York federal district courts.

Having clarified the standard, the court then addressed whether plaintiff’s negligence and strict liability claims could survive preemption. Since those were “rooted in generalized duties derived from state negligence and strict liability law, allowing them to proceed would directly regulate the device’s operation and use, thereby conflicting with federal law.”  Id. at *6.  Those claims were squarely preempted.  Plaintiff’s general allegations that the defendants failed to service the Life Vest and train their staff were also preempted. Those allegations were rooted in general tort duties that would impose requirements “different from, or in addition to, those imposed by §360k(a).”  Id.

Plaintiff’s claim that the defendants failed to service the Life Vest fared no better.  Plaintiff tried to tie that claim to CGMP requirements regarding the receipt and review of complaints by alleging that the defendants’ failure to appropriately address complaints about the Life Vest “could have” resulted in a defect persisting in the device. But that sort of “general, speculative” allegation was not sufficient to satisfy the Twombly and Iqbal pleading requirements, and plaintiff did not identify a parallel state law duty imposing identical requirements.

Plaintiff’s design defect claim was also preempted. Plaintiff did not claim that the defendants deviated from the FDA-approved design. Instead plaintiff alleged only that the Life Vest was unreasonably dangerous and defective. That claim was squarely preempted, as it challenged the FDA’s judgment regarding the safety of the Life Vest design and attempted to impose requirements different from or in addition to those approved by the FDA.

Same result for manufacturing defect and failure to warn.  The complaint did not include any specificity regarding alleged manufacturing defects. It made the general assertion that the defendants “failed to properly assemble” the Life Vest. That claim was too general to state a cognizable claim. For failure to warn, the complaint did not allege that the defendants violated any federal standards, and it is well established that claims that FDA-approved labeling was inadequate are expressly preempted. Id. at *8.

Finally, the express and implied warranty claims both failed. An implied warranty claim in New York requires that a product “was not reasonably fit for the ordinary purpose for which it was intended.” Id. at *9. That claim could not survive preemption, as it would directly contravene the FDA’s judgment in approving the Class III device. The express warranty claim was simply boilerplate that didn’t include any specifics, so it was also subject to dismissal.

Plaintiff did not oppose the dismissal of the claim for pecuniary loss to the estate, so the court dismissed that one as well. The dismissal of all counts was without prejudice and with leave to amend, so we may see this one again. Stay tuned. Meanwhile, this is the latest case on the blog’s  PMA Preemption Scorecard.