Friday, February 1, 2008

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 attorneys general, and vice versa. Its principal intended audience is not so much the courts as Congress and the federal agencies; its prescriptions are less about judicial doctrine (though there are implications along those lines) than about choices the legislature and agencies could make to better accommodate the important functions of democratically accountable state attorneys general. As to Congress, I suggest that it should directly address whether any or all of the work of state attorneys general should be preempted by any particular enactment it passes, and should include a provision making clear the extent of its intent to preempt. As to agencies, I suggest that, in the absence of clear statutory language addressing the question, they should be reluctant to promulgate regulations preempting the investigatory or enforcement authority of state attorneys general. Unlike the Supreme Court's current "presumption against preemption," the approach I advocate does not turn on the particular subject matter of the state or federal law in question. Instead, it focuses on the identity of the actor 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 institutional competence, going beyond the common emphasis on relative expertise to stress the agency's far greater democratic accountability and policy learning capacity.

Second, having made the case for broad FDA preemption in the drug area, it proposes an exception to FDA preemption that is both broader and narrower than under existing law or the existing scholarship. The exception to preemption would be broader in that it would go beyond fraud on the agency to encompass all disclosure deficits on the part of drug manufacturers, whether fraudulent, negligent, or innocent. The exception to preemption would be narrower in that in order to survive a motion to dismiss, the tort plaintiff would have to meet a hyper-heightened pleading standard requiring greater specificity with respect to both the allegations of disclosure deficit and the supporting factual evidence than that required by the already heightened standard that the Federal Rules of Civil Procedure now imposes on federal court complaints alleging fraud.

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


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