Products Liability Law Daily Wrap Up, PREEMPTION—MEDICAL DEVICES—3rd Cir.: Manufacturing defect and negligence claims against medical device manufacturer were not preempted by federal law, (Oct 7, 2026)

By Nicholas Kaster, J.D.

A 2024 inspection report presented by the claimant supported a plausible inference that the Angio-Seal was not produced pursuant to the rigorous PMA requirements imposed on the manufacturer by the FDA.

The U.S. Court of Appeals for the Third Circuit has ruled that manufacturing defect and negligence claims brought against Terumo Medical Corporation over its Angio-Seal vascular closure device were not preempted by the Medical Device Amendments (MDA) of the Federal Food, Drug, and Cosmetics Act (FDCA), vacating and remanding a decision of the federal district court. The Third Circuit, however, affirmed the district court’s holding that the failure to warn claims were preempted (Berk v. Terumo Medical Corporation, No. 25-2920, (3rd Cir. Oct. 2, 2026)).

Background. In 2021, the claimant underwent a transcatheter aortic valve replacement (TAVR) procedure to insert a new aortic valve in his heart. At the end of the procedure, medical staff placed a Terumo Angio Seal device in the man’s left femoral artery. The claimant later filed an action in the federal district court in Delaware alleging that the Angio-Seal failed to properly implant in his artery wall, leading to significant internal bleeding, a severely harmful hematoma, five surgical interventions and over $1 million in medical expenses. After a series of motions, the claimant filed a second amended complaint, and proceeded to file various discovery-related motions, including a request for a protective order to facilitate his receipt of unredacted reports from the FDA. The district court dismissed the claimant’s second complaint, reasoning that the claims were preempted, and that he had not sufficiently pleaded that Terumo had violated FDA requirements in the production of its Angio-Seal. The claimant’s discovery-related motions were denied in light of the court’s dismissal of his complaint, though he was granted leave to refile his complaint and any related discovery motions [see Products Liability Law Daily’s Oct. 9, 2024, analysis].

In his third amended complaint (TAC), the claimant alleged products liability manufacturing defect, negligence, failure to warn, and violations of the New Jersey Products Liability Act (NJPLA) for manufacturing defects and inadequate warnings. Specifically, the claimant alleged that his failed Angio-Seal lacked sufficient tensile strength and included a 2022 Food and Drug Administration (FDA) inspection report of the Puerto Rican factory that produced the device to support his claims. Terumo moved to dismiss, arguing that the Federal Food, Drug, and Cosmetics Act of 1938 (FDCA) preempted the claims. The claimant then filed a supplemental memorandum, seeking to add a July 2024 report that was an update to the FDA’s earlier 2022 factory inspection that he had included with his complaint. The district court granted the claimant’s motion to include the updated 2024 factory report, but then dismissed the complaint, concluding that the claimant had not cured the deficiencies identified in his second amended complaint. The current appeal ensued.

Failure to warn claims. The Angio-Seal is a Class III medical device, meaning that, pursuant to the Medical Device Amendments (MDA) of the FDCA, it is subject to the FDA’s premarket approval (PMA) procedures. Courts have explained that the PMA process is “rigorous” and involves a thorough review of the device’s safety and efficacy, its ingredients and manufacturing process, and its labeling.

Once a device has received premarket approval, the MDA forbids 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 MDA also includes an express preemption clause, which prevents a state from imposing any requirements on covered medical devices that are “different from, or in addition to” any requirements already imposed by the FDA, and any requirement that “relates to the safety or effectiveness of the device.” Therefore, courts have routinely held that this clause preempts common law causes of action for negligence and strict products liability relating to a medical device, because those causes of action would impose requirements different than, or in addition to, those already imposed by the FDA’s premarket approval process.

Not all state claims are preempted, however, because even for Class III devices, the MDA’s express preemption provision does not reach “parallel” claims, i.e., claims premised on state requirements that merely incorporate applicable federal requirements and therefore are not “different from, or in addition to,” federal requirements. So, a claim that alleged a medical device failed to conform with FDA requirements prescribed by its PMA, or violated other FDA requirements, would not be preempted.

The Third Circuit held that the district court properly concluded that the failure to warn claims were expressly preempted. The claimant alleged that the manufacturer’s brochure with safety information used too small a font to be easily legible, and that it had a duty to warn him about the severe adverse side effects that might ensue as a result of using the Angio Seal. The PMA process includes review of the device’s proposed labeling and the claimant did not allege that the manufacturer’s warning label or informational brochure deviated from the Angio-Seal’s PMA requirements, or that it violated any other FDA requirements. Because the claimant sought to impose different or additional requirements on the Angio-Seal labeling—larger font size, more detailed information about adverse events—the Third Circuit held that his failure to warn claims were preempted.

The claimant’s arguments to the contrary failed because he relied exclusively on cases that addressed failure to warn claims in the context of prescription drugs, which have different statutory regulation than medical devices do.

Products liability and negligence claims. Unlike his failure to warn claims, the claimant’s products liability and negligence claims all alleged that the failed Angio-Seal did not conform to its FDA requirements because it was defectively manufactured. The claimant argued that the tensile strength of the Angio-Seal was insufficient, and that Terumo violated FDA requirements by failing to maintain proper quality assurance procedures at the Puerto Rican factory where the Angio-Seals are produced.

The claimant relied heavily on a 2022 FDA inspection report of the factory, which identified two “non-conforming” procedures being employed at the factory for quality control of the products, but the report nevertheless stated that “[n]o significant objectionable observations resulted from [the] review.” However, the district court had also allowed the filing of a 2024 follow-up inspection report of the same factory, which contained information that could plausibly support an inference that the manufacturer had violated FDA requirements, as the claimant alleged. In contrast to the relatively mild concerns articulated in the 2022 inspection report, the 2024 report pointed to several inadequacies in the factory operational procedures. The report indicated that the factory “has not established adequate receiving, in-process and finished device acceptance activities for these components that are critical for the devices intended use” and listed three component ingredients for which the factory has inadequate procedures.

Tensile strength was the specific default that the claimant alleged in his TAC, and further, the 2024 inspection report noted that the factory had received “at least nine (9) documented complaints dating from February 2022 that state in their narrative that the suture has been broken.” The Third Circuit found this especially significant given that the claimant alleged that his Angio-Seal failed due to issues with its tensile strength in December 2021, a mere two months from the date of other tensile related issues identified in the report. In total, the 2024 report contained four observations that record ways in which the factory failed to establish adequate procedures, including ones related to “corrective and preventative action,” ensuring “sampling methods are adequate for intended use,” and ensuring “received product and services conform to specified requirements.”

At a motion to dismiss stage, said the Third Circuit, the claimant was entitled to reasonable inferences in his favor, and the 2024 inspection report he presented supported a plausible inference that the Angio-Seal was not produced pursuant to the rigorous PMA requirements imposed on Terumo by the FDA, as he alleged. Thus, the Third Circuit held that his manufacturing defect and negligence claims were not preempted by the MDA.

Accordingly, the Third Circuit vacated the district court’s judgment to the extent that it dismissed the manufacturing defect and negligence claims. The Third Circuit, however, affirmed the lower court’s judgment as to the failure to warn claims. The case was remanded for further proceedings consistent with this opinion.

The case is No. 25-2920.

Judge: Per Curiam.

Attorneys: Harold R. Berk (Harold R. Berk, P.C.) for Harold R. Berk. Peter L. Choate (Tucker Ellis LLP) for Terumo Medical Corporation.

Companies: Terumo Medical Corporation

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