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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
Issue
Holding and Reasoning (Collyer, J.)
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