Products Liability Law Daily Wrap Up, PREEMPTION—MEDICAL DEVICES—D. Nev.: Products liability action against Abbott Labs over its Trifecta heart valve preempted by federal law, (Dec 11, 2025)

By Nicholas Kaster, J.D.

The court denied the claimant’s request for leave to amend the complaint.

The Food, Drug, and Cosmetic Act preempted a claimant’s products liability action against Abbott Laboratories over its allegedly defective Trifecta replacement heart valve, a federal district court in Nevada ruled. Because the claimant failed to identify a violation of a particular FDA requirement, as he was required to do to meet the narrow exception to federal preemption, the court dismissed the case (Purohit v. Abbott Laboratories, Inc., No. 2:25-cv-01026-JAD-EJY (D. Nev. Dec. 8, 2025)).

Background. The Trifecta Valve is a replacement heart valve that received Class III premarket approval from the FDA more than a decade ago. But in recent years, Abbott Labs received reports that some Trifecta Valves were deteriorating faster than expected. So Abbott Labs voluntarily removed the Trifecta Valve from the market. While it was on the market, the claimant received a Trifecta Valve to replace his faulty aortic valve. Nine years later, he went to an emergency room complaining of increasing shortness of breath and bilateral lower extremity swelling. Doctors diagnosed him with several heart-related conditions, and the claimant received aortic-valve replacement surgery to replace his Trifecta Valve.

The claimant sued Abbott Labs, which purchased the device’s manufacturer, asserting a single claim of strict products liability under Nevada law. The claimant asserted that the Trifecta Valve had a manufacturing defect and Abbott Labs was strictly liable for it. Abbott Labs moved to dismiss for failure to state a claim, arguing that federal law preempts any state law claim that imposes a requirement on a Class III medical device that “is different from, or in addition to, any requirement” imposed by the FDA. According to Abbott Labs, the products liability claim effectively sought to impose such an impermissible requirement because the claimant did not allege that his Trifecta Valve deviated from any specific FDA requirement. The claimant argued that the presence of a defect, his allegation that Abbott Labs knew of the defect, and the Trifecta Valve’s withdrawal from the market were sufficient to show that the manufacturer failed to comply with FDA requirements.

Preemption by amendments. In determining the preemptive scope of a federal law, the “ultimate touchstone” in preemption analysis is congressional purpose. But preemption analysis “starts with the assumption that the historic police powers of the States are not to be superseded by Federal Act unless that is the clear and manifest purpose of Congress.”

Congress enacted the Medical Device Amendments to the Food, Drug, and Cosmetic Act in response to the inability of the common law tort system to manage the risks associated with dangerous medical devices. The Amendments thus swept back some state obligations and imposed a regime of detailed federal oversight. The oversight regime tasked the FDA with screening new medical devices before they enter the market. The FDA divides medical devices into classes based on their risk, with Class III devices posing the highest risk. The FDA performs a cost-benefit analysis when deciding whether to give premarket approval to a Class III device. But the FDA’s premarket approval of a Class III device does not guarantee that every device manufactured in that process will work—it may approve a device that offers great potential medical benefits knowing that it will sometimes fail. And once a Class III device has received premarket approval, the Amendments forbid the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute that would affect safety or effectiveness.

The Amendments also expressly preempt state laws that impose any requirement on a Class III device that “is different from, or in addition to, any requirement” imposed by the FDA. The U.S. Supreme Court has interpreted this preemption clause to mean that only “parallel” claims are not preempted, which are state law claims alleging that a Class III medical device deviated from an FDA requirement for that device and that deviation simultaneously violated state tort law.

Failure to allege violation of particular requirement. The court held that the FDCA expressly preempted the claimant’s action because he failed to allege a violation of any particular FDA requirement.

The Trifecta Valve is a Class III medical device. To avoid having his state law products liability claim preempted, said the court, the claimant was required to plausibly allege that his Trifecta Valve deviated from a particular FDA requirement.

The claimant seemed to point to allegations that could support a typical products liability claim: his heart valve needed to be replaced, and Abbott Labs voluntarily withdrew this product from the market after evidence emerged that this product deteriorated faster than rival devices. But Abbott Labs contended that such allegations were insufficient to establish a non-preempted parallel claim.

The claimant cannot rely on the defect or the Trifecta Valve’s withdrawal from the market alone to suggest that the manufacturer deviated from FDA requirements, the court stated. In his complaint, the claimant alleged that his Trifecta Valve deviated from FDA requirements because it had “potential early structural valve deterioration.”

However, said the court, the Ninth Circuit’s decision in Weber v. Allergan, Inc., 940 F.3d 1106 (9th Cir. 2019) stands for the proposition that a defect alone does not establish that a manufacturer deviated from FDA requirements. As the Weber court explained, “to survive [federal] preemption, a plaintiff cannot simply demonstrate a defect or a malfunction and rely on res ipsa loquitur to suggest only... that the thing speaks for itself.” Instead, for a state law claim to survive express preemption, a plaintiff must show that the defendant deviated from a particular pre-market approval or other FDA requirement applicable to the Class III medical device.

In his response brief, the claimant contended that he alleged a parallel claim because his claim was based on the same defect that led Abbott Labs to withdraw the Trifecta Valve from the market. But a recall or withdrawal from the market doesn’t alone show noncompliance with a particular FDA requirement, said the court. Courts have widely recognized that “product recalls do not create a presumption that FDA requirements have been violated.” The FDA approves products knowing that there is a possibility that a fully compliant product can fail. So the withdrawal of a product from the market does not automatically mean the product didn’t meet FDA requirements.

The complaint thus lacks the necessary allegations for the claim to be considered a parallel one, the court determined. The only relevant allegation in the complaint was that the device was not manufactured in conformity with the FDA’s premarket approval specifications and requirements for such devices because it “was found to have potential early structural valve deterioration in patients who received these valves.” But the claimant did not identify which FDA requirement was violated or how his Trifecta Valve specifically deviated from those requirements. Without linking these allegations to a violation of a particular FDA requirement, said the court, the claimant failed to allege facts sufficient to avoid federal preemption.

Amending the complaint would be futile. The claimant sought leave to amend his complaint to add “more detail” to his claim. Abbott Labs opposed that request because the claimant did not identify what details he would add to his complaint if given a chance to amend. Although the court “shall grant leave to amend freely when justice so requires,” leave to amend should be withheld if the deficiencies cannot be cured and further amendment would be futile.

A more “detailed” products liability claim would not save the complaint, the court determined. Only an amendment identifying a particular FDA requirement that was violated would state a parallel claim here, and the exception to federal preemption in this context is “narrow.” But in his request to amend, the claimant did not identify any such requirement or explain how “more detail” would allege a parallel claim. And given the claimant’s current allegations, said the court, he likely could not allege such a claim without identifying a wholly new theory of why the Trifecta Valve was defective. The court therefore denied the claimant leave to amend “because further amendment would be futile.”

Accordingly, the claimant’s case was dismissed as preempted by the FDCA.

The case is No. 2:25-cv-01026-JAD-EJY.

Judge: Dorsey, J.

Attorneys: Brian Westphal (Schneider Raich Law PLLC) for Ravindranath V. Purohit. Jaclyn Setili Wood (Reed Smith LLP) for Abbott Laboratories Inc.

Companies: Abbott Laboratories Inc.

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