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Deference to Agency Decisions: Lessons from Recent Pharmaceutical Pre-emption Decisions

By Vivian M. Quinn and Elizabeth A. Brophy
October 30, 2006

One question that has been raised in pre-emption decisions is the degree of deference to be shown an agency's explicit statement that it intends certain failure-to-warn claims to be pre-empted. For example, in the pharmaceutical arena, the Food and Drug Administration ('FDA') through the Department of Justice ('DOJ') filed amicus briefs in several lawsuits to reiterate its position on pre-emption of state law tort claims. In these briefs, the United States stressed that in the context of warnings, 'more is not always better.' Amicus Brief for the United States, Kallas v. Pfizer, No. 04-00998 (D. Utah Sept. 29, 2005) at 28. The FDA's regulation of prescription drugs ensures each drug's optimal use by requiring inclusion of only scientifically substantiated warnings. Id. Plaintiffs' failure-to-warn claims therefore 'stand as an obstacle' to the FDA's accomplishment of its congressionally mandated purpose of ensuring the public health and are therefore pre-empted. See Id. The FDA has also stated its position on pre-emption in the preamble to its Rulemaking for Labeling requirement, which became effective on June 30, 2006. See 21 C.F.R. '10.85(d)(1) (2006). See articles infra by Lasker and Le Gower.

Recent pre-emption decisions, many of which are discussed infra and in the October 2006 issue of this publication, have shown varying amounts of deference given to the FDA's position. See, e.g., Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514, 525 (E.D. Pa. 2006) (stressing that the FDA's final rule is entitled to considerable deference. See Le Gower article infra at 3); Jackson v. Pfizer, Inc., 432 F. Supp. 2d 964, 968 (D. Neb. 2006) (affording little to no deference to the FDA's repeated statements that, under the facts presented, pre-emption of plaintiffs' claims was required to protect the overall public health and safety and declining to give the amicus briefs filed by the FDA in prior Zoloft' cases 'force of law'); In re: Bextra and Celebrex Marketing Sales Practices and Prod. Liab. Litig., Civ. Action No. 05-1699 (N. D. Ca. Aug. 16, 2006) (dismissing failure-to-warn claim based in large part on deference to the FDA's view on pre-emption).

This article examines how the courts use agency decisions to make a pre-emption determination.

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