主题：给美国联邦法官当实行生的日子 -- meow

地方法院无法受理该案的原因就是Medical Devices Amendments of 1976(MDA)特别规定了Medical Device的批准和监察受FDA管辖，因此是Preempted。可见2001年的BUCKMAN COMPANY, PETITIONER v. PLAINTIFFS’ LEGAL COMMITTEE案

http://www.law.cornell.edu/supct/html/98-1768.ZO.html

问题是Preemption的前提是Conflict，Preemption理论上只保护厂家符合规章的活动，比方说药物的FDA批准，严格按照cGMP的生产等等。被FDA确认的Fraud和Negligence理论上是不在Preemption范畴内的，见Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961, 966 (6th Cir. 2004)

http://www.altlaw.org/v1/cases/1132534

关键的判决就是这一段“Thus, in this setting, it makes abundant sense to allow a State that chooses to incorporate a federal standard into its law of torts to allow that standard to apply when the federal agency itself determines that fraud marred the regulatory-approval process. In the final analysis, the exemptions are invalid as applied in some settings (e.g., when a plaintiff asks a state court to find bribery or fraud on the FDA) but not in others (e.g. claims based on federal findings of bribery or fraud on the FDA). ”

灰色的地方在于牵涉到医药器械的案子大多牵涉广泛，事实复杂，要在法律上证明Fraud和Negligence是很难的。以Merck的Vioxx案来说，到现在为止还在继续扯皮，有胜有负。不过最少Merck已经拿出48亿美金用于和解，所以说法律无能为力是不完全正确的。

• 我也不知到耶， 也许没有案例吧。