59 Pages Posted: 1 Oct 2009
Date Written: September 17, 2009
In its 2009 Wyeth v. Levine decision, the Supreme Court held that a decision by the Food and Drug Administration (“FDA”) to approve the marketing and label for a drug called Phenergan did not preempt a state-law failure-to-warn tort suit against the drug’s manufacturer. The Court so held despite the fact that in 2006 the FDA issued a regulatory preamble expressing its view that state failure-to-warn tort suits interfered with the FDA’s regulation of drug labeling, and so should be preempted. After summarizing the holding of Wyeth and the academic debate surrounding agency preemption, this article argues that Wyeth, or at least the majority opinion in Wyeth, did little to dispel the continuing muddle that is agency preemption law. While the Wyeth majority did not defer to the FDA’s views on preemption, it did not establish any clear principles for when deference is or is not due an agency, nor did it effectively distinguish earlier decisions where the Court had deferred to agencies on preemption issues. The Court also did not provide much guidance on the hotly debated topic of when agencies should be permitted to themselves adopt regulations preempting state law. Clarity is thus sorely needed here.
Turning to the underlying issues, the article argues that arguments favoring agency preemptive authority are based on a misunderstanding of federalism. The basic purpose of our federal system of dual sovereigns is not to advance utilitarian goals such as efficiency and experimentation, it is to retain competing loci of governmental authority to the federal government, as a protection against tyranny. Seem in this light, it is precisely the efficiency of agencies that poses the greatest threat to federalism, because of the vast practical ability of agencies to preempt important areas of state law. In this light, Congress should be the preferred institution from which preemption should flow both because state interests are better represented in Congress, and, frankly, because of congressional inefficiency and inertia. Ultimately, however, it must be conceded that since the New Deal no federal institution, whether it be agencies, Congress, the President, or even the courts, has demonstrated any serious commitment to maintaining state authority. Given this reality, the article concludes by suggesting that if the vitality of federalism is to be preserved, perhaps the Court as a whole should take seriously Justice Thomas’s suggestion, advanced in a concurring opinion in Wyeth, that the Court reconsider the part of its modern preemption doctrine which invalidates any state law which “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.”
Keywords: preemption, federalism, Wyeth v. Levine, FDA drug regulation, administrative law, agencies
Suggested Citation: Suggested Citation
Bhagwat, Ashutosh Avinash, Wyeth v. Levine and Agency Preemption: More Muddle or Creeping to Clarity? (September 17, 2009). Tulsa Law Review, Forthcoming. Available at SSRN: https://ssrn.com/abstract=1474470