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Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

Further, “both doctors testified that they still prescribe [the drug] for patients with conditions similar to plaintiff’s condition.” 2009), reversed a plaintiff’s verdict for entry of judgment n.o.v. Schering Corp. , 2d 1140, 1148 (N.J. 1993) (dissenting opinion). at 1150 (citations omitted). Hoffmann-La Roche, Inc. Mason , 27 So.3d

FDA 59
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Who Needs a Lawyer in the Eleventh Circuit?

Drug & Device Law

The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.” 341 (2001).