The U.S. Food and Drug Administration’s January 2006 pronouncement favoring pre-emption of state law failure-to-warn claims against prescription drugs, 71 Fed. Reg. 3921, has spawned a number of judicial opinions and given renewed energy to the pre-emption debate.
Although fewer than a dozen cases have been decided since the FDA’s pronouncement — formally, the 2006 Preamble to its Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products — the better reasoned decisions bring into sharp focus the reasons for and against pre-emption. It’s anyone’s bet which of these decisions will reach the U.S. Supreme Court for final resolution.
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