BECTON, DICKINSON & CO. v. FOOD & DRUG ADMINISTRATION

Nos. 295, 296, Dockets 78-6109, 78-6137.

589 F.2d 1175 (1978)

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.

United States Court of Appeals, Second Circuit.

Decided December 22, 1978.


Attorney(s) appearing for the Case

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.


FRIENDLY, Circuit Judge:

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...

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