TortsProf Blog

Editor: Christopher J. Robinette
Widener Commonwealth Law School

Friday, May 26, 2006

FDA Preemption

Mary Davis, one of the leading scholars on FDA preemption, has placed on SSRN a draft paper exploring the FDA's recent preemption-by-preamble attempt.  The abstract:

Federally approved prescription drug labeling has not been considered conclusive on the reasonableness or adequacy of the label for assessing tort liability on the manufacturer because federal regulations in this field set a minimum standard rather than an optimal one. That fundamental statement of black-letter tort law is under attack. The Food and Drug Administration (FDA) has promulgated a regulation which revises the format for prescription drug labeling, and, in the process, has taken the position that the regulation displaces, or preempts, state products liability laws that seek to assess liability on the manufacturer for a label’s warning adequacy. In the FDA’s 100 year history, it has not taken the position that federal regulations preempt common law tort claims based on prescription drug labeling until now. This Article explains the applicability of preemption doctrine to prescription drug product liability actions, explores the importance of the change in FDA position on that doctrine, and provides direction to courts seeking to discover the boundaries of federal preemption in this critical area.

The article does not yet have a full conclusion, but the start that's there suggests that Professor Davis is not fond of the idea of preemption:

it is clear that no labeling regulation can create the perfect incentive for manufacturers to seek better and more complete information regarding the adverse side effects of the prescriptions we take.  In a world where United States patients receive proper medical care from doctors and nurses only 55 percent of the time, pharmaceutical companies are in control  of the research conducted on their products pre- and post-marketing, pharmaceutical sales representatives have increasing influence on the drugs that physicians prescribe, and the pharmaceutical industry is the largest lobbying group in the United States, the products  liability litigation system is a critical component to create incentives for greater access to risk information to insure the public’s health.

Legislation, Reforms, & Political News, Products Liability | Permalink

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Thanks for posting this info. The draft article offers one of the more in-depth discussions of the issue that I've seen to date.

Posted by: DW | May 26, 2006 10:55:19 AM

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