Over the last decade or more, the U.S. Food and Drug Administration has made a number of statements supportive of the pre-emptive effect of its regulatory decisions on private, state-law tort litigation. The first major FDA pronouncement on pre-emption came in an amicus curiae brief filed in the Buckman Co. v. Plaintiffs’ Legal Committee case. No. 98-1768, 2000 WL 1364441 (U.S., filed Sep. 13, 2000, Brief for the United States as Amicus Curiae Supporting Petitioner). The FDA supported implied pre-emption of fraud-on-the-FDA claims because such claims interfered with agency enforcement discretion and potentially distorted the information that the FDA desired to receive.

Other FDA-inspired amicus curiae briefs followed. Principally, the FDA took the position that once it had made an affirmative decision that certain labeling statements were not in the public interest, tort claims asserting that the FDA had approved products without the same warnings were pre-empted by reason of their conflict with the prior FDA decision.

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