Phenergan is a drug approved by the FDA in 1955. Its label for use was also approved
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As a result, her forearm and hand were amputated.
1. The dissent in this case argued that the FDA was far more qualified than a state court jury to decide what drug warning was adequate. Expert analysis, under a regulatory scheme, which determined that the instructions were "safe" and "effective" should control the outcome, not the judgment of non-experts. Do you think that position has merit?
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The Legal Environment of Business
ISBN: 978-0538473996
11th Edition
Authors: Roger E Meiners, Al H. Ringleb, Frances L. Edwards
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