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Prevor v. Food and Drug Administration

United States District Court for the District of Columbia
895 F. Supp. 2d 90 (2012)

Written by Alex Ruskell, JD

Facts

The Food and Drug Administration (FDA) determined that a combination drug/device product manufactured by Prevor (plaintiff) was a drug covered by the Food, Drug, and Cosmetic Act. The product was an emergency spray intended to wash off chemical burns. Ten percent of the product was a drug that was intended to neutralize the burning chemical, and 90 percent was water in a compressed spray canister intended to wash off the chemicals. Prevor sued, arguing that the FDA’s decision to define the product as primarily a drug and not a device was arbitrary and capricious.

Rule of Law

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Issue

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Holding and Reasoning (Collyer, J.)

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A "yes" or "no" answer to the question framed in the issue section;
A summary of the majority or plurality opinion, using the CREAC method; and
The procedural disposition (e.g., reversed and remanded, affirmed, etc.).

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