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The FDA and Feasible Alternative Designs

Drug & Device Law

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. 151, 163-68 (2001)) (lengthy discussion of FDA regulatory process omitted). Wyeth Laboratories, Inc. , 2d 397 (6th Cir.

FDA 59
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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

The law presumes that licensed doctors know what they are doing. The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . .