Preamble Preemption and the Challenged Role of Failure to Warn and Defective Design Pharmaceutical Cases in Revealing Scientific Fraud, Marketing Mischief, and Conflicts of Interest

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In January 2006, the Bush administration articulated a position in favor of a broad conflict preemption doctrine that would immunize pharmaceutical manufacturers from civil liability when the Food and Drug Administration (“FDA”) had previously granted permission to place a prescription drug on the market. This was accomplished through a preamble to a new regulation in the Federal Register related to prescription drug labeling formats that declared compliance with FDA requirements for drug labeling preempts state tort law claims, without any notice and comment period for the public or interest groups to respond. If federal preemption was held to apply to pharmaceutical companies, a preemption defense could obliterate failure to warn or defective design drug cases. Because federal law does not recognize private litigants with a cause of action, if the FDA or the manufacturer negligently fails to consider a potential danger posed by a pharmaceutical drug, it is the “injured consumer alone who will pay the price.” In addition, because the Supreme Court has found that product liability claims premised on fraud on the FDA are implicitly preempted, such implied preemption would mean that even if market approval was obtained through intentional misrepresentation on the part of the manufacturer, by, for example, failing to report studies indicating substantial risks, injured consumers cannot recover any compensation for their injuries when a plaintiffs’ theory of liability is solely based on fraud on the FDA. The position taken by the Bush administration in the 2006 preamble has been noted not only to be contrary to Congress’s intent in enacting the FDA and against well-established state and federal law, but also against the FDA’s prior position recognizing common law suits as protecting consumers. This has resulted in organizations such as the prestigious New England Journal of Medicine criticizing the Bush administration’s “politicalization” of the FDA. On June 25, 2007, the United States Supreme Court granted certiorari in Riegel v. Medtronic on the issue of whether FDA pre-market approval of a medical device preempts state-law tort claims relating to the safety or efficacy of the device. Then on September 25, 2007, the Court granted certiorari in Warner- Lambert Co., LLC v. Kent on the narrow issue of whether any reference to “fraud on the FDA,” whether in state legislation or common law, is void as a result of implied preemption. While the Riegel case can be clearly distinguished from pharmaceutical cases in that the pertinent federal statute involved contains an express preemption provision, and Warner- Lambert Co., LLC v. Kent deals with a narrow self-contained issue—essentially whether any reference to “fraud on the FDA” in state legislation or common law is void as a result of implied preemption —these cases are certainly part of the broader debate over the extent to which the Bush administration and Congress may preclude the states from imposing consumer regulations that are more stringent than the federal government’s and viewed as pitting the states against the manufacturers. Given that federal circuit courts and state courts are split on this issue, no question exists that sooner or later the Supreme Court will hear the sister issue of whether pharmaceutical failure to warn or defective design lawsuits are preempted if a prescription drug has been approved by federal law.

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