Phenergan is a drug approved by the FDA in 1955. Its label for use was also approved

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Phenergan is a drug approved by the FDA in 1955. Its label for use was also approved by the FDA. One form of Phenergan is used to treat nausea. It can be administered either by the "IV-push" method, where the drug is injected intravenously directly into a patient's vein, or by the "IV-drip" method, where it is administered intravenously using a drip feed and a saline solution. Diane Levine had Phenergan by IV-push into a vein to treat nausea. Because the needle penetrated an artery, she developed gangrene, a known problem from the IV-push injection.
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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