Federal appeals courts have generally held that the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act pre-empt tort claims relating to medical devices that have undergone the Food and Drug Administration’s rigorous pre-market approval process, when the tort claim would impose requirements that conflict or interfere with the requirements embodied in the FDA’s approval of the device.

But a recent ruling by a federal district court raises the possibility that a medical device manufacturer could lose the benefit of federal pre-emption if a fact-finder determines that the manufacturer failed to disclose a known danger in an approved device. The ruling raises challenging issues regarding the interplay of federal and state law.

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