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Aside from promulgating regulations, imposing rigorous standards on myriad product manufacturers, and conducting research and studies on all such products, the FDA also takes an active role in participating in an array of product liability litigations both on the state and federal levels. Often, the FDA's position and “expertise” on an issue carry great weight with the courts and consequently can affect the outcome of litigation. Thus, defense counsel involved in product liability matters in which the FDA historically has had an interest should keep abreast of the FDA's positions on the relevant issues.
Three areas of product liability litigation in which the FDA has involved itself are cases in which 1) the question was presented whether the Food, Drug, and Cosmetic Act, 21 U.S.C. '' 301 to 399 (2003), (FDCA) broadly preempts state common law tort claims; 2) there was an issue as to what deference courts should accord to the FDA's “expertise” in matters of drug labeling and advertising; and 3) the FDA brought matters regarding a party's compliance with federal law, or lack thereof, to the courts' attention. (These areas of the FDA's involvement in product liability litigation are by no means exhaustive. Therefore, the reader is encouraged to investigate further the FDA's evolving positions on other relevant issues.)
The FDCA's Preemption of State Common Law Tort Claims
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