Court Reinstated Lawsuit Over Vascular Closure Device
The 3rd Circuit ruled that state-level product liability claims against a device maker were not preempted by federal law.
Updated on Oct. 5, 2026 in Healthcare
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A federal appellate court has revived a lawsuit alleging that the Terumo Angio-Seal vascular closure device caused injuries due to manufacturing defects. The ruling clarifies that state law claims regarding product liability are not preempted by Food and Drug Administration requirements.
Why it matters
The decision provides a pathway for plaintiffs to pursue negligence claims against medical device manufacturers when products fail to meet federal safety standards. It limits the scope of federal preemption defenses often used by companies in medical injury litigation.
The 3rd Circuit U.S. Court of Appeals issued its opinion on October 2, 2026, following a procedure performed in December 2021. The case involves allegations that the device did not meet Food and Drug Administration manufacturing requirements.
The players
Harold Berk
He is the plaintiff who alleged that he suffered injuries caused by a vascular closure device during a 2021 procedure.
3rd Circuit U.S. Court of Appeals
This federal appellate court has jurisdiction over cases originating from Delaware, New Jersey, and Pennsylvania.
Food and Drug Administration
This federal agency is responsible for protecting public health by ensuring the safety and efficacy of medical devices.
The details
The court found that Harold Berk, who underwent a transcatheter aortic valve replacement, had adequately alleged that his injuries stemmed from a defective device. By reversing the lower court, the panel held that federal law does not automatically block state-level negligence and liability claims in this context.
Timeline
Harold Berk underwent a heart valve replacement procedure in December 2021.
The appellate panel issued an opinion reinstating the lawsuit on October 2, 2026.
Market Landscape
The ruling updates the interpretation of the Medical Device Amendments of 1976 as it pertains to manufacturer liability. This decision positions medical device firms against a more robust landscape of potential state-level litigation for manufacturing defects.
Patients who have experienced complications from medical devices may find it easier to hold manufacturers accountable for quality control failures. This ruling reinforces the ability of consumers to seek legal recourse for injuries caused by defective medical hardware.
The takeaway
This appellate decision clarifies that federal oversight does not grant absolute immunity to medical device manufacturers facing state-law claims. It underscores the importance for patients to document potential product defects clearly when filing personal injury litigation.
Further reading
For more on industry legal trends, visit the United States Healthcare section.
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