United States v. An Undetermined Number of Unlabeled Cases
United States Court of Appeals for the Tenth Circuit
21 F.3d 1026 (1994)
- Written by Mary Phelan D'Isa, JD
Facts
Clinical Reference Laboratory, Inc. (CRL) used urine and saliva specimen containers in its HIV test kits that insurance companies would use to screen applicants for HIV-1 antibodies. CRL reported findings to the insurance companies as either non-reactive or inconclusive. CRL sought declaratory and injunctive relief after the Food and Drug Administration (FDA) told CRL that AIDS tests that did not use blood products or serum violated the Federal Food, Drug, and Cosmetic Act (FDCA); that the specimen containers used in the disapproved tests required premarket approval from the FDA; and that CRL should stop distributing the containers. CRL contended that the FDA lacked the authority to regulate the containers because they are not used nor intended to be used for medical diagnosis purposes as a prelude to medical treatment and the use of the containers to assess insurance risk removed them from the FDCA’s reach. The FDA countersued to seize and condemn the containers.
Rule of Law
Issue
Holding and Reasoning (Moore, J.)
Dissent (Cook, J.)
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