Monday, July 21, 2008

Catherine Sharkey on FDA Preemption of State Law Products Liability Claims

Catherine_sharkey Professor Catherine Sharkey (NYU) has published part I of her essay, What Riegel Portends for FDA Preemption of State Law Products Liability Claims, on Northwestern Colloquy, an extension of the Northwestern University Law Review.  Here's an excerpt:

When such policy predilections undergird preemption decisions—even, as in Riegel, in the narrowest realm of express preemption based upon clear statutory text, let alone in the comparatively unbounded realm of implied preemption—it is time to consider alternative models to that of courts’ being left to their own devices under the guise of imputing congressional motives.

This Essay presents that alternative, building upon my previously articulated “agency reference model,” which provides a framework for courts to decide implied conflict preemption cases by seeking guidance from the relevant federal regulatory agency.  The basic question at the core of implied conflict preemption inquiries is whether or not state common law actions are irreconcilable with, or would stand as an obstacle to, or frustrate, the command of federal regulatory directives and goals. To answer this question, courts need a fine-grained account of the precise regulatory review conducted by the agency and evidence as to its compatibility with state law tort claims.  The agency reference model aims, as a general matter, to facilitate input from federal agencies on these issues.

As the Court moves beyond Riegel and the realm of express preemption to tackle implied conflict preemption in the pharmaceutical context in the upcoming Wyeth v. Levine case,  the time is ripe to consider such a model.  Indeed, where, by definition, statutory text alone will not resolutely decide the implied conflicts in products liability cases, articulation of an analytic framework for where the courts should turn is a pragmatic necessity. Drawing upon some suggestive gestures toward agency input in Riegel, this Essay applies the agency reference model to the concrete setting of the regulation of pharmaceutical drugs and extends the model by specifying searching judicial review of evidence taken from the FDA’s regulatory record (record evidence) to substantiate FDA findings of implied conflicts between state common law failure-to-warn claims and the federal regulation of the safety and efficacy of drugs.


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