Becton, Dickinson and Co. v. Food and Drug Administration, s. 295
| Decision Date | 22 December 1978 |
| Docket Number | Nos. 295,296,D,s. 295 |
| Citation | 589 F.2d 1175 |
| Parties | BECTON, DICKINSON AND COMPANY, Plaintiff-Appellee, v. FOOD AND DRUG ADMINISTRATION, Donald Kennedy, Commissioner of Food and Drugs, William C. Lubas and Richard N. James, Investigators, Food and Drug Administration, Defendants-Appellants. UNITED STATES of America, Plaintiff-Appellant, v. BECTON, DICKINSON AND COMPANY, a corporation doing business as Bard-Parker, Division of Becton, Dickinson and Company and Wesley J. Howe, William L. Clark, James A. Levy and Kenneth J. Summa, Individuals, Defendants-Appellees. ockets 78-6109, 78-6137. |
| Court | U.S. Court of Appeals — Second Circuit |
Catherine G. O'Sullivan, Washington, D.C. (U.S. Dept. of Justice, Washington, D.C., John H. Shenefield, Asst. Atty. Gen., John J. Powers, III, Dept. of Justice, Richard M. Cooper, Chief Counsel, Kenneth C. Baumgartner, Associate Chief Counsel, Food and Drug Administration, Rockville, Md., of counsel), for defendants-appellants.
Charles T. Beeching, Jr., Syracuse, N.Y. (Bond, Schoeneck & King, Syracuse, N.Y., Henry H. Melchor, Syracuse, N.Y., Geoffrey R. W. Smith, Covington & Burling, Washington, D.C., of counsel), for defendants-appellees.
Frank E. Samuel, Jr., Vice President and Gen. Counsel, and Howard M. Holstein, Asst. Gen. Counsel, Washington, D.C., of counsel, for Health Industry Manufacturers Association, Washington, D.C., Amicus Curiae, in support of plaintiff-appellee Becton, Dickinson and Co.
Before MOORE, FRIENDLY and GURFEIN, Circuit Judges.
This appeal by the United States on behalf of the Food and Drug Administration (FDA), its Commissioner, and two FDA investigators, and on its own behalf, from an order of the District Court for the Northern District of New York, 448 F.Supp. 776 (1978), requires us to construe certain provisions relating to "restricted devices" which were added to the Federal Food, Drug, and Cosmetic Act by the Medical Device Amendments of 1976 (hereafter "Amendments"), 90 Stat. 539.
The overall purpose of the Amendments is explained in the Report of the House Committee on Interstate and Foreign Commerce, H.R. Rep. No. 94-853 on H.R. 11124, 94th Cong. 2d Sess. (1976) (hereafter "Report"). See also Report of the Senate Committee on Labor and Public Welfare, Sen. Rep. No. 94-33 on S. 510, 94th Cong. 1st Sess. 2-7 (1975); Report of the Committee of Conference, H.R. Rep. No. 94-1090 on S. 510, 94th Cong. 2d Sess. 51 (1976), U.S.Code Cong. & Admin.News 1976, p. 1070. The Food and Drugs Act of 1906, 34 Stat. 768, had not dealt with "devices". However, during the next 30 years there developed "a growing awareness that the absence of any authority to regulate the safety and reliability of medical devices presented a serious danger to the American public." Report 6. In recognition of this, the Federal Food, Drug, and Cosmetic Act of 1938, 52 Stat. 1040, in addition to expanding federal authority to regulate food and drugs, provided for the regulation of cosmetics and "devices" as defined in § 201(h), 52 Stat. 1041. The provisions dealing with devices were generally more limited than those pertaining to drugs. The 1976 Amendments greatly augmented the authority over devices in an effort "to assure the safety and effectiveness of medical devices intended for human use". Report 3.
The then feeble provisions of the 1938 Act for inspection of factories, warehouses, or other establishments, § 704, 52 Stat. 1057, requiring permission of the owner, applied to devices on the same basis as to food and drugs. The parity continued when, in 1953, Congress put teeth into the inspection section by eliminating the need to obtain the owner's permission. 67 Stat. 476-77. However, when § 704 was again strengthened in 1962, 76 Stat. 792-93, the additional authority to inspect all things in the establishment, with certain specified exceptions, bearing on possible violations of the Act "(including records, files, papers, processes, controls, and facilities)" the point here at issue was limited to "prescription drugs". That term is not included in the Act's list of definitions but, since the 1962 amendments, has been used in the misbranding section, § 502(n), 76 Stat. 791, and its substance also appears in an exemptive section, § 503(b), which was enacted as part of the original Act, 52 Stat. 1052, and extensively amended in 1951, 65 Stat. 648-49.
The keystone of the 1976 Amendments is § 513(a), which classifies "devices intended for human use" into three categories. Class I consists of devices for which sections of the existing statute as amended and certain new sections, including § 520, "are sufficient to provide reasonable assurance of the safety and effectiveness of the device." Class II devices are those for which these provisions "are insufficient to provide reasonable assurance" but "for which there is sufficient information to establish a performance standard to provide such assurance". Class III devices are those for which only premarket approval provides reasonable assurance of safety and effectiveness.
Section 520, with which we are here concerned, is entitled "GENERAL PROVISIONS RESPECTING CONTROL OF DEVICES INTENDED FOR HUMAN USE." Sub-section (e), entitled "Restricted Devices", reads as follows:
if, because of its potentiality for harmful effect or the collateral measures necessary to its use, the Secretary determines that there cannot otherwise be reasonable assurance of its safety and effectiveness. No condition prescribed under subparagraph (B) may restrict the use of a device to persons with specific training or experience in its use or to persons for use in certain facilities unless the Secretary determines that such a restriction is required for the safe and effective use of the device. No such condition may exclude a person from using a device solely because the person does not have the training or experience to make him eligible for certification by a certifying board recognized by the American Board of Medical Specialists or has not been certified by such a Board. A device subject to a regulation under this subsection is a restricted device.
(2) The label of a restricted device shall bear such appropriate statements of the restrictions required by a regulation under paragraph (1) as the Secretary may in such regulation prescribe.
The Amendments also modified the provision in § 704(a) allowing inspection of "all things" in an establishment, including records, files, papers, etc. so that this should apply not only to "prescription drugs" as theretofore but also to "restrictive devices." 1
In April, 1977, FDA inspectors commenced a routine inspection of a Becton, Dickinson & Co. (B-D) facility at Hancock, N.Y., which concededly was engaged in the manufacture of "devices" intended for use by or on the prescription of a physician or other licensed practitioner, and asked to review production, control and complaint records under the authority of § 704(a) as amended. After initially refusing access, B-D permitted the FDA inspectors to view these records. The inspectors were able to see only a few, however, before B-D abruptly declined to allow further access. The FDA then sought and obtained a warrant dated May 6, 1977, from the district court. Upon their return with the warrant the inspectors were allowed access to some of B-D's complaint files, which the inspectors found to disclose deficiencies of some seriousness. When they returned the following day, further access to B-D's records and files was refused.
On May 17, 1977, B-D filed a complaint in the District Court for the Northern District of New York seeking relief in the form of: 1) a declaration that the FDA lacks authority to inspect records, files, papers, or other documents at the Hancock facility relating to "restrictive devices" until such time as regulations are properly promulgated by the FDA under the 1976 Medical Devices Amendments; 2) an injunction against such an inspection until proper regulations are adopted; and 3) an order vacating the Warrant of Inspection of May 6, 1977. The Government moved for dismissal for failure to state a claim upon which relief can be granted and B-D for summary judgment. On September 6, 1977, the Government brought an action seeking injunctive relief against further refusals to allow inspection; it moved for a preliminary injunction and defendants for dismissal for failure to state a claim. On April 11, 1978, the district court granted summary judgment to B-D on its complaint and dismissed the Government's. 2 This appeal followed.
If one were to look only at the words of the Statute, the decision of the district court would be plainly correct. When Congress in 1976 enlarged the record inspection provision of § 704(a) to include records relating to "restricted devices", it was using a term that had not theretofore been in the Act but was defined in the Amendments. Section 520(e)(1) tells us that "restricted devices" means "(a) device subject to a regulation under this subsection." The Secretary is authorized to impose restrictions on sale, distribution, or use in a regulation if, because of the device's "potentiality for harmful effect or the collateral measures necessary to its use, the Secretary determines that there cannot otherwise be reasonable assurance of its safety and effectiveness." The adoption of regulations under § 520(e) is governed by the Administrative Procedure Act, 5 U.S.C. § 553, as supplemented by § 520(d) of the Federal Food, Drug, and Cosmetic Act. Admittedly, however, no regulations under § 520(e) have yet been adopted in the manner required by the APA and § 520(d...
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