This section contains the nature of the case and procedural background.

Charles Riegel and his wife (Ps), brought suit against Medtronic (D) after a D catheter ruptured in Charles Riegel’s coronary artery during heart surgery. The catheter is a Class III device that received FDA premarket approval. Ps alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. The District Court held that the MDA pre-empted Ps' claims of strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter, and their claim of negligent manufacturing insofar as the claim was not premised on the theory that D had violated federal law. The Second Circuit affirmed.

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