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