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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. Lederle Laboratories , 2008 WL 972657 (W. His testimony is thus irrelevant and inadmissible. Wyeth Laboratories, Inc. ,

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. This scenario was the “third hypothetical” in our “ Learned Intermediary Rule 201 ” post back in 2008. The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. Today we examine it in more detail.