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U.S. v. UNDETERMINED NO. OF UNLABELED CASES

No. 92-3458.

21 F.3d 1026 (1994)

UNITED STATES of America, Plaintiff-Appellee, v. An UNDETERMINED NUMBER OF UNLABELED CASES, etc., Defendant, Clinical Reference Laboratory, Inc., Claimant-Appellant.

United States Court of Appeals, Tenth Circuit.

April 15, 1994.

Attorney(s) appearing for the Case

Donald E. Segal (John C. Monica and Laura D. Stith, Shook, Hardy & Bacon, Kansas City, MO and Timothy M. O'Brien, Shook, Hardy & Bacon, Overland Park, KS, with him on the briefs), Akin, Gump, Strauss, Hauer & Feld, Washington, DC, for claimant-appellant.

Steven A. Keller (Stuart E. Schiffer, Acting Asst. Atty. Gen., U.S. Dept. of Justice, Washington, DC and Margaret Jane Porter, Chief Counsel, Christopher McHenry and Diane Maloney, Asst. Chief Counsel for Enforcement, U.S. Food & Drug Admin., Rockville, MD, with him on the briefs), Trial Atty., Office of Consumer Litigation, U.S. Dept. of Justice, Washington, DC, for plaintiff-appellee.

Before MOORE, Circuit Judge, McWILLIAMS, Senior Circuit Judge, and COOK, Senior District Judge.

JOHN P. MOORE, Circuit Judge.

Clinical Reference Laboratory, Inc. appeals a grant of summary judgment holding certain urine and saliva specimen containers used in HIV-testing are adulterated "devices" subject to seizure pursuant to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-394. CRL contends the containers do not constitute devices within the meaning of 21 U.S.C. § 321(h) because CRL performs the tests for insurance risk assessment purposes...

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