U.S. v. Undetermined No. of Unlabeled Cases, 92-3458

• Decision Date: 15 April 1994
• Docket Number: No. 92-3458,92-3458
• Parties: UNITED STATES of America, Plaintiff-Appellee, v. An UNDETERMINED NUMBER OF UNLABELED CASES, etc., Defendant, Clinical Reference Laboratory, Inc., Claimant-Appellant.
• Court: U.S. Court of Appeals — Tenth Circuit

Page 1026

21 F.3d 1026

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

No. 92-3458.

United States Court of Appeals Tenth Circuit.

April 15, 1994.

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. Secs. 301-394. CRL contends the containers do not constitute devices within the meaning of 21 U.S.C. Sec. 321(h) because CRL performs the tests for insurance risk assessment purposes and not for medical diagnosis. Also, CRL contests their designation as class III devices subject to premarket approval by the Food and Drug Administration. We affirm the district court's holding the containers are "devices." However, because we conclude the containers are not class III devices, we hold they are not adulterated due to CRL's failure to seek premarket approval.

CRL employs a series of laboratory protocols to help life insurance companies screen applicants for various health risks. One of these protocols detects HIV-1 antibodies in saliva and urine specimens. Formerly, to obtain the necessary samples, CRL purchased specimen containers, repackaged them into kits which included instruction sheets, and forwarded them along with consent forms to insurers to collect specimens. CRL reported its HIV findings to the insurance companies as either "non-reactive" for normal results or "inconclusive" for any other result.

The FDA maintains AIDS tests which do not use blood products or serum violate the Act. Furthermore, specimen containers used in these disapproved tests must receive premarket approval by the FDA. Accordingly, the FDA told CRL to cease distribution of the containers used in detecting HIV antibodies or face enforcement action. In response, CRL filed an action requesting declaratory and injunctive relief on the grounds the FDA lacked authority to regulate the containers. The FDA countered with its own action seeking to seize and condemn the containers. According to the FDA, the containers were adulterated as defined in 21 U.S.C. Sec. 351(f)(1)(B) because they were class III devices which had not received premarket approval.

The district court consolidated the actions and ultimately granted summary judgment for the government on the issue of whether it had authority to pursue the seizure action. 791 F.Supp. 1499. The court determined the containers satisfied the statutory definition of device, 21 U.S.C. Sec. 321(h), because they were used to diagnose disease. In addition, the court found the containers constituted new devices categorized into class III under 21 U.S.C. Sec. 360c because CRL repackaged and relabeled the containers. The court ruled CRL's failure to seek premarket approval as required for class III devices caused the containers to be adulterated pursuant to 21 U.S.C. Sec. 351(f) and subject to seizure by the FDA. In a subsequent summary judgment motion, the court declared the containers adulterated and ordered them condemned and destroyed.

This court reviews de novo a grant of summary judgment. Mock v. T.G. & Y. Stores Co., 971 F.2d 522, 528 (10th Cir.1992). Summary judgment is appropriate where no genuine issue of material fact exists and judgment turns on a matter of law. Id. Here, the parties dispute the law and not the facts. The focus of this court's inquiry is whether the Act empowered the FDA to take the actions it did and not the efficacy of those actions. See United States v. An Article of Drug ... Bacto-Unidisk, 394 U.S. 784, 791-92, 89 S.Ct. 1410, 1414-15, 22 L.Ed.2d 726 (1969) (considering whether definition of "drug" in the Act permitted challenged FDA regulations rather than wisdom of those regulations). We must liberally construe the Act consistent with its overriding purpose to protect the public health. Id. at 798, 89 S.Ct. at 1418.

I.

CRL contends the specimen containers do not qualify as devices regulated by the Act because CRL neither used them nor intended to use them for medical diagnosis as the containers were not part of a prelude to medical treatment. Essentially, CRL argues the containers' use for insurance risk assessment and CRL's subsequent actions removed the containers from the statute's reach. CRL maintains it did not provide a firm answer about the presence of HIV and reported findings only to the insurer. Moreover, CRL expressly informed applicants the test did not furnish a medical diagnosis. All of these actions, CRL claims, are inconsistent with the meaning of "diagnosis."

The Act includes in its definition of "device" an article "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease." 21 U.S.C. Sec. 321(h)(2). To qualify as a device under the statute, an article must serve either a diagnostic or therapeutic purpose. The definition does not define the term "diagnosis" nor limit diagnostic devices to those used prior to medical treatment. In comparison, the regulatory definition of "in vitro diagnostic products," articles "intended for use in the collection, preparation, and examination of specimens taken from the human body," explicitly ties diagnosis with later medical treatment. See 21 C.F.R. Sec. 809.3(a) (in vitro diagnostic products "intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae"). However, this regulation does not narrow the broad language of the Act. The plain meaning of "diagnosis" disregards context and bears no connection to medical treatment. A diagnosis is "the art or act of identifying a disease from its signs and symptoms" or alternatively an "investigation or analysis of the cause or nature of a condition, situation, or problem." Webster's Third New International Dictionary 622 (1981). Therefore, the Act regulates as a "device" an article intended for use in diagnosis regardless of whether medical treatment will follow.

CRL used the specimen containers as part of a protocol which seeks to identify the presence of HIV antibodies. The fact CRL's results were inconclusive does not eliminate the diagnostic nature of CRL's inquiry. See United States v. 25 Cases, More or Less, of an Article of Device, 942 F.2d 1179, 1181-83 (7th Cir.1991) (term "diagnosis" in 21 U.S.C. Sec. 321(h)(2) brings within definition of "device" an article which screens for possible symptoms of disease but does not provide final identification of condition). Also, the fact insurance companies rather than health professionals considered CRL's findings to make business rather than medical decisions does not erase the diagnostic character of CRL's activities or the containers' use. Therefore, we conclude the specimen containers at issue are devices within the meaning of 21 U.S.C. Sec. 321(h)(2) and subject to FDA regulation.

II.

The amount of regulation governing a device depends upon its classification. The Act divides devices into three classes of which only class III must earn premarket approval. 21 U.S.C. Sec. 360c(a)(1). A device not introduced into interstate commerce for commercial distribution prior to ...