Two Views on Regulatory Preemption
David Vladeck has written an issue brief on regulatory preemption. ACS Blog includes a video of Vladeck making the following case:
The quiet but insidious erosion of state tort law remedies — and the health and safety benefits that are associated with them — continues unabated. Our health and safety agencies have been subject to a hostile-takeover by an Administration that cares more about constituent-serving outcomes than their statutory mission to protect the public.
And here’s a paper by Peter Schuck focusing on the FDA, taking a very different view of the matter:
[C]omparative institutional competence [discloses not merely the agency’s] relative expertise [but also] stress[es] the agency’s far greater democratic accountability and policy learning capacity. Having made the case for broad FDA preemption in the drug area, [I] propose an exception to FDA preemption that is both broader and narrower than under existing law or the existing scholarship.
The [proposed] 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.
I look forward to seeing these leading legal scholars debate the issue further. Disclosure deficits are a real problem.