Gostanian Anthony
Boston University School of Law, USA.
Am J Law Med. 2010;36(1):248-68.
In Wyeth v. Levine, the Supreme Court held that an FDA-approved drug label did not preempt state tort law. Although the Supreme Court did not defer to the FDA's position, language in the opinion, and Breyer's concurring opinion, suggest that the FDA may be able to abrogate Wyeth v. Levine using the administrative law doctrine originally announced in Chevron v. Natural Resources Defense Council. That is, the FDA may claim deference to its position in a future case involving the same legal questions. This Note explains how Wyeth impacts the Chevron doctrine and identifies how the FDA assertion that drug labels preempt state law may win in a future case.
在惠氏公司诉莱文案中，最高法院裁定，经美国食品药品监督管理局（FDA）批准的药品标签不能取代州侵权法。尽管最高法院并未遵从FDA的立场，但多数意见中的措辞以及布雷耶大法官的协同意见表明，FDA或许能够运用最初在“雪佛龙美国公司诉自然资源保护委员会”案中宣布的行政法原则来撤销惠氏公司诉莱文案的判决。也就是说，FDA可能会在未来涉及相同法律问题的案件中要求其立场得到遵从。本笔记解释了惠氏案如何影响“雪佛龙原则”，并指出FDA关于药品标签可取代州法律的主张在未来案件中可能获胜的方式。
