Monday, October 20, 2008

Backdoor Preemption by Administrative Regulation?

The Wall Street Journal reported last week that Bush administration officials "are pushing to rewrite a wide array of federal rules with changes or additions that could block product-safety lawsuits by consumers and states."

At issue is the practice of administrative agencies writing preemption clauses into proposed regulations, sometimes at OMB's behest, even though authorizing legislation does not contain a preemption provision.  According to the WSJ, former administration domestic policy adviser Jay Lefkowitz said that the administration decided not to press its preemption agenda in Congress, because it might lose.  It apparently has decided to take matters into its own hands.

The administration has argued that the clauses are evidence of federal preemption of plaintiffs' state tort claims, as long as defendants comply with federal law, thus undermining plaintiffs' claims--and protecting corporate defendants--in areas where the federal government regulates. 

The Trial Lawyers Association (now the American Association for Justice) was quite critical in its report, after undercovering evidence of the practice through FOIA requests.  The Chamber of Commerce's Institute for Legal Reform has been supportive of administration preemption efforts.

The Court may weigh in next month in Wyeth v. Levine, a case involving the federal preemptive effects of the Federal Food, Drug, and Cosmetic Act's labelling requirements.  The FDA's preemption clause plays a bit role in briefing on the larger conflict preemption issue, but the administration's amicus brief addresses it squarely in Argument C.2., running from page 26 to page 27 (of the brief, not of the pdf file).  The administration writes:

In the preamble to a January 2006 rule concerning the labeling of drugs, FDA explained that the government's "long-standing view[]" is that "FDA approval of labeling under the [FDCA] * * * preempts conflicting or contrary State law," especially considering that "FDA interprets the [FDCA] to establish both a 'floor' and a 'ceiling'" for labeling.  71 Fed. Reg. at 3934, 3935. 

SDS

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