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Rose v. Brown & Williamson Tobacco Corp.9/29/2005 reaching an over-broad application of the holding in the case.
The FDA case was decided in connection with an attempt by the FDA to regulate tobacco and tobacco products after many years of the FDA's informing Congress that tobacco and tobacco products were beyond the FDA's regulatory authority. Nonetheless, in 1996, the FDA issued final rules relating to the sale and distribution of tobacco and tobacco products to children and adolescents. The FDA contended that it had authority to do so pursuant to the Food, Drug and Cosmetic Act (hereafter referred to as the "FDCA") because the FDA had determined that nicotine is a drug and that tobacco products are "drug delivery devices." A group of entities involved in the tobacco industry instituted litigation challenging the FDA's regulations arguing, inter alia, that the FDA lacked jurisdiction to regulate the marketing of tobacco products. The Supreme Court held that: "...the FDA's claim to jurisdiction contravenes the clear intent of Congress." (FDA, 529 US at 132).
The focus of the controversy was the fact that, if the FDA applied the provisions of the FDCA to tobacco products, it would have been necessary to ban all tobacco products from the market place rather than merely regulating the sale and distribution of tobacco products to children and adolescents. Such a ban would have resulted, at least on a short term basis, in a tremendous over-supply of tobacco and equally tremendous hardships on individual farmers who had been engaged in growing tobacco crops. Clearly this was precisely the type of hardship Congress had intended to prevent when it chose to include tobacco as a protected crop in the Agricultural Adjustment Act of 1938.
In reaching its decision, the Supreme Court specifically pointed out that, over the years, Congress had, on several occasions, considered and rejected bills to grant the FDA authority over tobacco products and, instead, opted to directly enact provisions concerning the labeling and marketing of tobacco and tobacco related products which accomplished much the same purpose as the regulations the FDA was attempting to promulgate. The Court thus concluded that, by enacting legislation concerning the labeling and marketing of tobacco products "Congress expressly preempted any other regulation of the labeling of tobacco products concerning their health consequences, even though oversight of labeling is central to the FDCA's regulatory scheme. And in addressing the subject, Congress consistently evidenced its intent to preclude any federal agency from exercising significant policymaking authority in the area." (Id. at 157.)
Defendants in the instant case argued that the doctrine of "conflict preemption" precludes negligence claims from being asserted against cigarette manufacturers because imposing liability upon them for tort claims pursuant to state law would enable state tort law to stand as an obstacle to Congress's legislative purpose and objective of keeping tobacco products available for purchase by consumers in the United States. Defendants, however, ignore the context of the case which was being argued before the Supreme Court and the cautionary language set forth by the Supreme Court in its decision. In fact, the Supreme Court itself stated: "...our inquiry into whether Congress has directly spoken to the precise question at issue is shaped, at least in some measure, by the nature of the question presented." (Id. at 159.) Additionally, the Supreme Court pointed out: "... in our anxiety to effectuate the congressional purpose of protecting the public, we must take care not to extend the scope of the statute beyond the point where Congress indicated it would stop." (Id. at 161 [internal citations
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