Friday, December 15, 2006

FDA Preemption: When Tort Law Meets the Administrative State

Ssrn_25Richard Nagareda has posted on SSRN a paper entitled FDA Preemption: When Tort Law Meets the Administrative State (also available at Berkeley Electronic Press).  It's in the first issue of the Journal of Tort Law, a newly launched electronic peer-reviewed journal published by the Berkeley Electronic Press.  Here's the abstract:

Conventional wisdom holds that regulation by the administrative state generally establishes minimum standards for product manufacturers that tort liability may usefully supplement. This account of the relationship between tort law and the administrative state has come under increasing attack in recent decades. This Article focuses on what many regard as among the most controversial settings for such attacks today: contentions that regulatory action by the federal Food and Drug Administration (FDA) operates to preempt product liability suits under state law against the manufacturers of medical devices and prescription drugs.

The Article initially explores the debate over FDA preemption as a doctrinal matter, drawing on insights from litigation over medical devices to parse the more difficult preemption issues presented in suits over prescription drug labeling. As to the latter, the Article focuses on recent litigation over an alleged causal link between the leading class of antidepressant drugs and suicide by some drug users.

The Article then shifts from doctrine to institutional design, explaining why tort law and the administrative state have come into conflict in recent years and considering how law reform might approach preemption questions based on a richer understanding of the two areas. The challenge for the future involves using the prospect of preemption to bolster the predicates for preemption itself within the regulatory system. Fresh thinking about preemption would challenge the pharmaceutical industry to act on its depictions of tort liability run amok by embracing enhanced information disclosure and policing of fraud in the regulatory process – the logical predicates for the kind of optimal risk regulation by the FDA that should carry preemptive effect. Under this approach, the prospect of preemption would function as a preference-revealing device for regulated industry and thereby position it to settle by way of its revealed behavior the seemingly intractable academic debate about the consequences of pharmaceutical liability.

There are implications for tort theory as well. A major trend in tort theory has been to think about tort liability as a form of privatized regulation. The approach offered here seeks to initiate a conversation about how the regulatory sphere might partake of the capacity of tort litigation to update information about the risks posed by pharmaceutical products in the marketplace.


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