AMP INCORPORATED v. Gardner, No. 258

CourtUnited States Courts of Appeals. United States Court of Appeals (2nd Circuit)
Writing for the CourtSMITH, KAUFMAN, and HAYS, Circuit
Citation389 F.2d 825
PartiesAMP INCORPORATED, Plaintiff-Appellant, v. John W. GARDNER, Secretary of Health, Education and Welfare, and James L. Goddard, Commissioner of Food and Drugs, Defendants-Appellees.
Docket NumberDocket 31829.,No. 258
Decision Date13 February 1968

389 F.2d 825 (1968)

AMP INCORPORATED, Plaintiff-Appellant,
v.
John W. GARDNER, Secretary of Health, Education and Welfare, and James L. Goddard, Commissioner of Food and Drugs, Defendants-Appellees.

No. 258, Docket 31829.

United States Court of Appeals Second Circuit.

Argued January 10, 1968.

Decided February 13, 1968.


Jay L. Seitchik, Harrisburg, Pa. (Marshall M. Holcombe, Harrisburg, Pa., William C. Conner, of Curtis, Morris & Safford, New York City, on the brief), for plaintiff-appellant.

James G. Greilsheimer, Asst. U. S. Atty., So. District of New York (Robert M. Morgenthau, U. S. Atty., and Martin Paul Solomon, Asst. U. S. Atty., Paul Hyman, Attorney, Food and Drug Administration, on the brief), for defendants-appellees.

Before SMITH, KAUFMAN, and HAYS, Circuit Judges.

J. JOSEPH SMITH, Circuit Judge:

This appeal from a summary judgment presents the question whether two products manufactured by appellant, AMP Incorporated, are "new drugs" within the meaning of the Federal Food, Drug, and Cosmetic Act ("the Act"), 52 Stat. 1040 (1938), as amended, 21 U.S.C. §§ 301-392.

389 F.2d 826

Both of the products are intended to be used in a new method of tying off, or ligating, severed blood vessels during surgery. The conventional ligating method is to hand-tie ligatures around severed vessels by means of a surgeon's knot (which is a reef knot). AMP's products both consist of a disposable applicator, a nylon ligature loop, and a nylon locking disk. In one product, the applicator is a hemostat; in the other, it is a long slender tube. The ligature is applied by inserting the hemostat or tube into the body and placing the loop around the severed vessel, then tightening the loop and locking it in place with the disk. The excess nylon thread is cut off, and the disk and the rest of the thread remain in the patient's body.

In response to a request by AMP for classification of its products, the Food and Drug Administration advised AMP that the products were regarded as "new drugs." Under section 505 of the Act, as amended, 21 U.S.C. § 355 (Supp.1967), new drugs may not be introduced into interstate commerce without approval by the Secretary of Health, Education and Welfare. AMP subsequently decided to take the position that the products were "devices" rather than "new drugs" within the meaning of section 201(g), (h), and (p) of the Act, as amended, 21 U.S.C. § 321(g), (h), and (p) (Supp.1967), and proceeded to comply with the requirements of the Act relating to devices.1 Under threat of regulatory proceedings should it fail to comply with the statutory and regulatory requirements pertaining to drugs, AMP sought a judgment declaring its products to be devices and an injunction barring enforcement of the "drug" and "new drug" provisions of the Act against AMP or its ligating products.2 The District Court for the Southern District of New York, Judge Tenney, determined that the products should be classified as "new drugs," and gave summary judgment for the defendants, John W. Gardner, Secretary of Health, Education and Welfare, and James L. Goddard, Commissioner of Food and Drugs. AMP Incorporated v. Gardner, 275 F.Supp. 410 (1967). We affirm, having concluded that the construction of the Act arrived at by Judge Tenney is essentially correct.

Section 201, as amended, provides in relevant part that for the purposes of the Act:

(g) (1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, of any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C) of this paragraph; but does not include devices or their components, parts, or accessories.
* * * * * *
(h) The term "device" * * * means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended (1) for use in the diagnosis, cure mitigation, treatment, or prevention of disease in man or other animals; or (2) to affect the structure or any function of the body of man or other animals.
389 F.2d 827
(p) The term "new drug" means —
(1) Any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, * * * or
(2) Any drug the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

We begin by conceding arguendo the validity of AMP's contention that the hemostat and the tube, taken alone, are "instruments" and thus "devices" within the meaning of the Act. But we do not agree that the nylon thread and disk are such "components, parts, or accessories" of the hemostat and the tube as to make them "devices" as well. As Judge Tenney pointed out by way of analogy, a syringe may be a "device" under the Act, but that does not make a drug in a syringe a "device" for purposes of the Act simply because it is packed for use in the syringe. It is the thread and disk applied to the patient's body which are essential, and on which we must focus our attention.3

This would be an easy case were it not for the provision in section 201(g) that the term "drug" "does not include devices," for apart from that exclusion the Act's definition of "drug" is so broad as to cover easily AMP's nylon disk and thread.4 The Act's definitions of "device" and "drug" are parallel, except for the use of "instruments, apparatus, and contrivances," rather than the broader word "articles," in defining "device."5 In determining what things Congress meant to set apart as "instruments, apparatus, and contrivances," we take as our guide Judge Learned Hand's observation that "unless they explicitly forbid it, the purpose of a statutory provision is the best test of the meaning of the words chosen." Cawley v. United States, 272 F.2d 443, 445 (2 Cir. 1959).

In the early versions of the Act, there was no separate definition of "device." S. 2800, 73d Congress, 2d Sess. (1934), as reported by the Senate Committee on Commerce, provided in section 2(b):

The term "drug," for the purposes of this Act and not to regulate the legalized practice of the healing art, includes (1) all substances and preparations recognized in the United States Pharmacopoeia, Homoeopathic Pharmacopoeia of the United States, or National Formulary or supplements thereto; and (2) all substances, preparations, and devices intended for use in the cure, mitigation, treatment, or prevention of disease in man or other
389 F.2d 828
animals; and (3) all substances and preparations, other than food, and all devices intended to affect the structure or any function of the body. Emphasis added.

See also S. 1944, 73d Congress, 1st Sess. (1933), and S. 2000, 73d Congress, 2d Sess. (1934).

Senator Copeland, who introduced all three bills, said in his prepared statement introducing S. 2800:

The present law defines drugs as substances or mixtures of substances intended to be used for the cure, mitigation, or prevention of disease. This narrow definition permits escape from legal control of all therapeutic or curative devices like electric belts, for example. It also permits the escape of preparations which are intended to alter the structure or some function of the body, as for example, preparations intended to reduce excessive weight. There are many worthless and some dangerous devices and preparations
...

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31 practice notes
  • United States v. Sene X Eleemosynary Corp., Inc., No. 79-2661-Civ-SMA.
    • United States
    • United States District Courts. 11th Circuit. United States District Courts. 11th Circuit. Southern District of Florida
    • 29 Octubre 1979
    ...GS-3 is not generally recognized as safe and effective by qualified experts for use as promoted by the defendants. AMP Inc. v. Gardner, 389 F.2d 825, 831 (2nd Cir.) cert. denied, sub nom. AMP Inc. v. Cohen, 393 U.S. 825, 89 S.Ct. 86, 21 L.Ed.2d 95 (1968); United States v. 41 Cases . . . Nar......
  • US v. 789 CASES, Civ. No. 90-1777 (JP).
    • United States
    • United States District Courts. 1st Circuit. District of Puerto Rico
    • 20 Agosto 1992
    ...other grounds, 412 U.S. 645, 93 S.Ct. 2488, 37 L.Ed.2d 235 (1973); AMP Inc. v. Gardner, 275 F.Supp. 410, 412 n. 1 (S.D.N.Y.1967), aff'd, 389 F.2d 825 (2d Cir.), cert. denied, 393 U.S. 825, 89 S.Ct. 86, 21 L.Ed.2d 95 (1968). To stop the government from enforcing the GMP regulations because i......
  • United States v. 14 CASES, ETC.,(BAG)" NAREMCO MEDI-MATIC, Civ. A. No. 2806.
    • United States
    • United States District Courts. 8th Circuit. Western District of Missouri
    • 29 Enero 1974
    ...Pharmacal Distributors, Inc. v. U.S. Department of Health, Education and Welfare, 408 F.2d 95, 99 (7th Cir. 1969); AMP, Inc. v. Gardner, 389 F.2d 825 (2d Cir.), cert. denied 393 U.S. 825, 89 S.Ct. 86, 21 L.Ed.2d 95 (1968); United States v. 354 Bulk Cartons . . . Trim Reducing-Aid Cigarettes......
  • United States v. General Nutrition, Inc., No. CR-84-174E.
    • United States
    • United States District Courts. 2nd Circuit. United States District Court of Western District of New York
    • 27 Mayo 1986
    ...medical and related products which might cause widespread danger to human life out of interstate commerce." AMP Incorporated v. Gardner, 389 F.2d 825, 829 (2d Cir.), cert. denied, 393 U.S. 825, 89 S.Ct. 86, 21 L.Ed.2d 95 (1968); cf., United States v. Generix Drug Corp., 460 U.S. 453, 103 S.......
  • Request a trial to view additional results
31 cases
  • United States v. Sene X Eleemosynary Corp., Inc., No. 79-2661-Civ-SMA.
    • United States
    • United States District Courts. 11th Circuit. United States District Courts. 11th Circuit. Southern District of Florida
    • 29 Octubre 1979
    ...GS-3 is not generally recognized as safe and effective by qualified experts for use as promoted by the defendants. AMP Inc. v. Gardner, 389 F.2d 825, 831 (2nd Cir.) cert. denied, sub nom. AMP Inc. v. Cohen, 393 U.S. 825, 89 S.Ct. 86, 21 L.Ed.2d 95 (1968); United States v. 41 Cases . . . Nar......
  • US v. 789 CASES, Civ. No. 90-1777 (JP).
    • United States
    • United States District Courts. 1st Circuit. District of Puerto Rico
    • 20 Agosto 1992
    ...other grounds, 412 U.S. 645, 93 S.Ct. 2488, 37 L.Ed.2d 235 (1973); AMP Inc. v. Gardner, 275 F.Supp. 410, 412 n. 1 (S.D.N.Y.1967), aff'd, 389 F.2d 825 (2d Cir.), cert. denied, 393 U.S. 825, 89 S.Ct. 86, 21 L.Ed.2d 95 (1968). To stop the government from enforcing the GMP regulations because i......
  • United States v. 14 CASES, ETC.,(BAG)" NAREMCO MEDI-MATIC, Civ. A. No. 2806.
    • United States
    • United States District Courts. 8th Circuit. Western District of Missouri
    • 29 Enero 1974
    ...Pharmacal Distributors, Inc. v. U.S. Department of Health, Education and Welfare, 408 F.2d 95, 99 (7th Cir. 1969); AMP, Inc. v. Gardner, 389 F.2d 825 (2d Cir.), cert. denied 393 U.S. 825, 89 S.Ct. 86, 21 L.Ed.2d 95 (1968); United States v. 354 Bulk Cartons . . . Trim Reducing-Aid Cigarettes......
  • United States v. General Nutrition, Inc., No. CR-84-174E.
    • United States
    • United States District Courts. 2nd Circuit. United States District Court of Western District of New York
    • 27 Mayo 1986
    ...medical and related products which might cause widespread danger to human life out of interstate commerce." AMP Incorporated v. Gardner, 389 F.2d 825, 829 (2d Cir.), cert. denied, 393 U.S. 825, 89 S.Ct. 86, 21 L.Ed.2d 95 (1968); cf., United States v. Generix Drug Corp., 460 U.S. 453, 103 S.......
  • Request a trial to view additional results

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