4628 A finding by the federal Food and Drug Administration (FDA) that an artificial heart valve, the way it was manufactured, and its labeling met federal requirements pre-empts a state action against the manufacturer on theories of negligent design, negligent failure to warn, and strict liability; since the patient consented to implantation of the valve on the advice of her physician, rather than in reliance on any statement by the manufacturer, a breach of warranty action against the manufacturer could not be established.CitationBLANCO v BAXTER HEALTHCARE (Heart Valve) 158 CA4 1039 [See: 21 USC 360 etseq; Armstrong v Optical 50 CA4 580, T/AT 12/96; Steele v Collagen 54 CA4 1474, T/AT 6/97]
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