More Scholarship on Preemption

Preemption seems to be the topic of the day.  In addition to Catherine Sharkey’s article “Products Liability Preemption: An Institutional Approach,” the following pieces have been posted on SSRN:

Trevor Morrison (Cornell) has posted “The State Attorney General and Preemption” on SSRN. In this book chapter, Morrison

examines the implications of agency preemption for state attorneysgeneral, and vice versa. Its principal intended audience is not so muchthe courts as Congress and the federal agencies; its prescriptions areless about judicial doctrine (though there are implications along thoselines) than about choices the legislature and agencies could make tobetter accommodate the important functions of democraticallyaccountable state attorneys general. As to Congress, I suggest that itshould directly address whether any or all of the work of stateattorneys general should be preempted by any particular enactment itpasses, and should include a provision making clear the extent of itsintent to preempt. As to agencies, I suggest that, in the absence ofclear statutory language addressing the question, they should bereluctant to promulgate regulations preempting the investigatory orenforcement authority of state attorneys general. Unlike the SupremeCourt’s current “presumption against preemption,” the approach Iadvocate does not turn on the particular subject matter of the state orfederal law in question. Instead, it focuses on the identity of theactor enforcing the state law.

Peter Schuck (Yale) has posted “FDA Preemption of State Tort Law: Finding the Sweet Spot“ on SSRN.   He describes the contributions of this paper to the debate on FDA preemption as follows:

First, it augments prior analyses of the comparative institutionalcompetence, going beyond the common emphasis on relative expertise tostress the agency’s far greater democratic accountability and policylearning capacity.

Second, having made the case for broad FDA preemption in thedrug area, it proposes an exception to FDA preemption that is bothbroader and narrower than under existing law or the existingscholarship. The exception to preemption would be broader in that itwould go beyond fraud on the agency to encompass all disclosuredeficits on the part of drug manufacturers, whether fraudulent,negligent, or innocent. The exception to preemption would be narrowerin that in order to survive a motion to dismiss, the tort plaintiffwould have to meet a hyper-heightened pleading standard requiringgreater specificity with respect to both the allegations of disclosuredeficit and the supporting factual evidence than that required by thealready heightened standard that the Federal Rules of Civil Procedurenow imposes on federal court complaints alleging fraud.

The third proposed change concerns the status under statetort law of a regulatory compliance defense, which only Michigan hasadopted as a complete defenser state law. Although modifying FDApreemption principles as I propose would block much design and warningdefect litigation in state courts (at least prima facie) as a matter offederal law, there is much to be said for also effecting this change asa non-constitutional matter under state tort law by crafting aregulatory compliance defense consistent with my other proposedchanges. The paper concludes with a brief discussion of whether FDApreemption, properly designed, would leave a compensation void withrespect to those harmed by FDA-regulated drugs.

ADL