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  5. 791 F.Supp. 1499 (1992)
 

CLINICAL REFERENCE LABORATORY, INC. v. SULLIVAN

Civ. A. Nos. 91-2313-L, 91-2412-L.

791 F.Supp. 1499 (1992)

CLINICAL REFERENCE LABORATORY, INC., Plaintiff, v. Louis W. SULLIVAN, M.D., Secretary of Health, David A. Kessler, M.D., Commissioner, U.S. Food and Drug Administration, and U.S. Food and Drug Administration, Defendants. UNITED STATES, Plaintiff, v. AN UNDETERMINED NUMBER OF SPECIMEN CONTAINERS, CONSENT FORMS, AMERICAN RED CROSS BROCHURES, INSTRUCTION SHEETS, etc., Defendants.

United States District Court, D. Kansas.

April 10, 1992.

Attorney(s) appearing for the Case

John C. Monica, Shook, Hardy & Bacon, Kansas City, Mo., Ronald L. Bodinson, Timothy M. O'Brien, Shook, Hardy & Bacon, Overland Park, Kan., Donald E. Segal, Thomas Hylden, Micha Barach, Ann K. Pollock, and Bruce F. Mackler, Baker & Hostettler, Washington, D.C., for plaintiff.

Robert A. Olsen, Office of U.S. Atty., Kansas City, Kan. and Steven A. Keller, Office of Consumer Litigation, Washington, D.C., for defendants.

MEMORANDUM AND ORDER

LUNGSTRUM, District Judge.

At issue in these cases is the scope of the regulatory authority of the United States Food and Drug Administration (FDA) over medical articles. This dispute arose when Clinical Reference Laboratory, Inc. (CRL), a Kansas corporation that performs in-house laboratory testing for insurance risk assessment purposes, began using a risk assessment protocol for the Human Immunodeficiency Virus Type-1 (HIV-1)

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