An Update on FDA Preemption of State Law Claims

By Haston, Tripp; Ayers, Marc James | Defense Counsel Journal, January 2007 | Go to article overview

An Update on FDA Preemption of State Law Claims


Haston, Tripp, Ayers, Marc James, Defense Counsel Journal


On January 24, 2006, the United States Food & Drug Administration ("FDA") made explicit and certain what it had been saying in more focused contexts for numerous years: its regulations and final decisions concerning the labeling of prescription pharmaceuticals and biologics preempted conflicting state laws and tort actions. (1) Released in a preamble to a new regulation concerning the labeling of prescription pharmaceuticals and biologics, the FDA comprehensively explained how and why its decisions and regulations had such preemptive effect (hereinafter "Preemption Preamble"). (2) Specifically, the FDA stated:

   Consistent with its court submissions
   and existing preemption principles,
   FDA believes that at least the following
   claims would be preempted by its
   regulation of prescription drug labeling:
   (1) Claims that a drug sponsor breached
   an obligation to warn by failing to put in
   Highlights or otherwise emphasize any
   information the substance of which
   appears anywhere in the labeling; (2)
   claims that a drug sponsor breached an
   obligation to warn by failing to include
   in an advertisement any information the
   substance of which appears anywhere in
   the labeling, in those cases where a
   drug's sponsor has used Highlights
   consistently with FDA draft guidance
   regarding the "brief summary" in direct-to-consumer
   advertising ("Brief
   Summary: Disclosing Risk Information
   in Consumer-Directed Print
   Advertisements," 69 FR 6308 (February
   2004)) (see comment 112); (3) claims
   that a sponsor breached an obligation to
   warn by failing to include
   contraindications or warnings that are
   not supported by evidence that meets
   the standards set forth in this rule,
   including [section] 201.57(c)(5)(requiring that
   contraindications reflect "[k]nown
   hazards and not theoretical
   possibilities") and (c)(7); (4) claims that
   a drug sponsor breached an obligation to
   warn by failing to include a statement in
   labeling or in advertising, the substance
   of which had been proposed to FDA for
   inclusion in labeling, if that statement
   was not required by FDA at the time
   plaintiff claims the sponsor had an
   obligation to warn (unless FDA has
   made a finding that the sponsor
   withheld material information relating
   to the proposed warning before plaintiff
   claims the sponsor had the obligation to
   warn); (5) claims that a drug sponsor
   breached an obligation to warn by
   failing to include in labeling or in
   advertising a statement the substance of
   which FDA has prohibited in labeling or
   advertising; and (6) claims that a drug's
   sponsor breached an obligation to
   plaintiff by making statements that FDA
   approved for inclusion in the drug's
   label (unless FDA has made a finding
   that the sponsor withheld material
   information relating to the statement).
   Preemption would include not only
   claims against manufacturers as
   described above, but also against health
   care practitioners for claims related to
   dissemination of risk information to
   patients beyond what is included in the
   labeling. (3)

Far from being real news, the FDA had maintained similar preemption positions in legal proceedings since at least 2000 concerning various pharmaceuticals. (4) Furthermore, numerous courts had previously concluded that the FDA's regulations and labeling decisions preempted state law claims. (5) Nevertheless, the FDA's "Preemption Preamble" has generated substantial scrutiny and legal analysis by supporters, detractors, and the courts in the past nine months. This article provides some background and an update on the differing outcomes U.S. courts have reached on the impact of the Preemption Preamble on state law pharmaceutical products cases.

I. Background: A Primer on Preemption

Under the Supremacy Clause of the United States Constitution, U. …

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An Update on FDA Preemption of State Law Claims
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