Tuesday, June 09, 2009

Sharkey On "Agency-Forcing" Measures

Catherine Sharkey recently posted her forthcoming article in the Duke Law Journal, "Federalism Accountability: 'Agency-Forcing' Measures," at SSRN. Here's the obligatory link.

The easy part of our work today is telling you the gist of Sharkey's thesis. We'll simply reproduce the abstract of the article:

"This Article takes as its starting point the 'agency reference model' for judicial preemption decisions, adopting the foundational premise that courts should take advantage of what federal agencies, which are uniquely positioned to evaluate the impact of state regulation and common law liability upon federal regulatory schemes, have to offer. The Article’s main focus is on the federalism dimension of the debate: Congress’s and federal agencies’ respective ability to serve as loci of meaningful debate with state governmental entities about the impact of federal regulatory schemes on state regulatory interests. Notwithstanding the dismal track record of federal agencies, which seems to be characterized by total neglect of states’ regulatory interests, the Article sides with agencies over Congress and trains its focus on reform of the agency rulemaking process. Given that the 1999 Federalism Executive Order provides a blueprint for timely and meaningful consultation with the states, issuance of federalism impact statements, and robust interchanges during the notice-and-comment period, what is needed now is an effective enforcement mechanism.

"The Article advocates a variety of 'agency-forcing' measures designed to enhance the ability of Congress, the executive, and especially the courts, to ensure that agencies abide by executive mandates and other reforms, and to provide a check on overt politicization or inaction on agencies’ part. The Article introduces the concept of 'indirect challenges' to agency rulemaking, arising outside of the Administrative Procedure Act’s domain of direct challenges to agency action at a later juncture when a defendant asserts a preemption defense to state common law tort actions."

The hard part of our work today is commenting on the article.

Here's what we've noticed: The theorists care about "law and poetry." The doctrinalists care about "the tenets of tort law." And we care about "how are we gonna win?"

Sharkey's got something for everyone!

For theorists, she has a conception of how the three branches of government can force federal agencies to be more accountable to states' rights.

For doctrinalists, she analyzes what states currently do to try to cause agencies to respect state interests in the rule-making process.

And for schleppers (that's us!), she's got a description of Wyeth v. Levine.

Schleppers of the world, unite! And turn to page 162 of the article: "[T]he majority and dissent embrace at least one dimension of the agency reference model: namely an examination of the contemporaneous agency record to determine precisely the risks weighed by the FDA. Implied preemption rests on the critical significance of agency attention to the question of dangers posed by the particular administration of the drug at issue in Wyeth."

Sharkey says (and she agrees with us, so she's in good company) that "[d]efining a necessary and sufficient agency record to establish impossibility preemption will dominate the next wave of litigation." Id. at 163 n.248. "Consistent with my argument here, the FDA's regulatory record with respect to SSRI drugs should be front and center. For a review of the FDA regulatory record with respect to SSRI drugs -- including findings from internal scientific reviews and several advisory committees convened to study the matter as well as denials of numerous citizen petitions seeking review, see Richard A. Nagareda, FDA Preemption: When Tort Law Meets the Administrative State, 1 J. Tort L. 1, 27-30 (2006)."

Long-time schleppers that we are, we noticed Nagareda's article back when it came out.

And we'll watch with interest as courts decide over the coming years which agency records are sufficient to establish preemption, which are not, and how manufacturers and the FDA respond to the pressures now placed on the adequacy of the FDA's administrative record.

No comments: