Court Reinstated Lawsuit Over Vascular Device
Manufacturers of medical devices face heightened legal liability risk after a federal appellate ruling.
Updated on Oct. 5, 2026 in Healthcare
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The 3rd Circuit U.S. Court of Appeals reinstated a lawsuit alleging injuries caused by a Terumo Angio-Seal vascular closure device. The ruling determined that state-level product liability and negligence claims are not preempted by federal regulations.
Why it matters
This decision limits the scope of federal preemption defenses for medical device manufacturers facing claims of non-conformance. Operators should note that the court focused on alleged manufacturing defects that failed to meet established FDA requirements.
The 3rd Circuit U.S. Court of Appeals decision involves one specific vascular closure device case. It marks a shift in how product liability claims are assessed relative to federal standards.
The players
Terumo
A global medical technology company that develops and manufactures cardiovascular devices and surgical equipment.
Harold Berk
The plaintiff in the reinstated litigation who underwent a medical procedure in 2021.
3rd Circuit U.S. Court of Appeals
A federal appellate court covering Delaware, New Jersey, and Pennsylvania that reviews decisions from district courts.
Food and Drug Administration
The federal agency responsible for regulating medical devices and ensuring manufacturing compliance.
The details
The court found that Harold Berk’s claims regarding a defect in the Terumo Angio-Seal device were sufficiently pleaded. By ruling that state law claims for manufacturing negligence are not preempted by federal law, the court established that manufacturers must ensure their products strictly adhere to FDA-approved specifications. This creates a path for plaintiffs to pursue damages when they can demonstrate a deviation from those regulatory mandates.
Timeline
December 2021: Harold Berk underwent a heart valve replacement procedure.
October 2, 2026: The appellate panel issued an opinion reinstating the lawsuit.
Market Landscape
This decision narrows the scope of federal preemption protections previously interpreted under the Medical Device Amendments of 1976. It signals that companies cannot rely solely on federal approval to shield themselves from state-level manufacturing liability claims.
Operators in the medical device sector should review their manufacturing quality systems to ensure they align with FDA specifications. Consult with qualified legal counsel to evaluate how this ruling impacts your firm's exposure to state-level product liability claims.
The takeaway
Product liability risk now includes a higher threshold for proving federal preemption, making precise manufacturing documentation critical. Monitor your firm's internal compliance logs to ensure every unit aligns exactly with its FDA-cleared manufacturing protocols.
Further reading
For broader trends in industry regulation, visit our Healthcare section.
Source note: This article includes information reported by Harrismartin.
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