An update on FDA preemption of state law claims.

• Author: Haston, Tripp

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which appears anywhere in the labeling, in those cases where a drug's sponsor has used Highlights consistently with FDA draft guidance regarding the "brief summary" in direct-to-consumer advertising ("Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements," 69 FR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.

1. Background: A Primer on Preemption

   Under the Supremacy Clause of the United States Constitution, U.S. Const. art VI, cl. 2, "state law is naturally preempted to the extent of any conflict with" federal law. Crosby v. National Foreign Trade Council, 530 U.S. 363, 372 (2000). "[F]ederal preemption of state law can occur in three types of situations: (1) when Congress explicitly preempts state law ('express preemption'), (2) where preemption is implied because Congress has occupied the entire field ('field preemption'), and (3) where preemption is implied because there is an actual conflict between federal and state law ('conflict preemption')." Colacicco v. Apotex Inc., 432 F. Supp. 2d 514, 523 (E.D. Pa. 2006) (citing Schneidewind v. ANR Pipeline Co., 485 U.S. 293, 299-300 (1988); and Pokorny v. Ford Motor Co., 902 F.2d 1116, 1121-22 (3d Cir. 1990)). For purposes of conflict preemption, a conflict exists where (1) the state law "stands as an obstacle to the accomplishment and execution or the full purposes and objectives of Congress" or (2) it is "impossible for a ... party to...