AMP INCORPORATED v. Gardner, 258

• Decision Date: 13 February 1968
• Docket Number: Docket 31829.,No. 258,258
• Citation: 389 F.2d 825
• Parties: 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.
• Court: U.S. Court of Appeals — Second Circuit

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.

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.

(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 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 falling within these classifications. S. 2800 contains ample authority to control them.

78 Cong.Rec. 8960 (73d Cong., 2d Sess., 1934). S. 2800 contained no provisions relating to new drugs, and did not require administrative approval of any products prior to their introduction into interstate commerce.

S. 2800 was succeeded by S. 5, 74th Congress, 1st and 2d Sess. (1935-36). That bill, as introduced in the Senate, included a definition of "drug" almost identical to that in the earlier bill. The definition drew some criticism during Senate debate over an amendment (which eventually passed) to insert the word "diagnosis" so as to make the definition read in part:

All substances, preparations, and devices intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.

79 Cong.Rec. 4841-4845 (74th Cong., 1st Sess., 1935). Senator Clark (Missouri) questioned the propriety of calling purely mechanical devices "drugs":

If the devices ought to be outlawed, they ought to be outlawed, and I have no objection to that; but to maintain that a purely mechanical device is a drug and to be treated as a drug in law and in logic and in lexicography is a palpable absurdity, in my opinion.

Id. at 4841. The following exchange subsequently took place between Senators Clark and Copeland:

Mr. Clark * * * The effect of the amendment inserting the word "diagnosis" is to declare by Federal law the scales used by a physician to test the weight of patients in connection with a diagnosis to be a drug * *

Mr. Copeland. Mr. President, I desire to state the effect of this amendment.

There are on the market certain electrical devices. A man takes hold of the handles of the machine, and the indicator spins around. It stops at "appendicitis," or it stops at "meningitis" * * * Such a device is manifestly a fraud upon society.

That is what the amendment is designed to deal with.

Id. at 4842.

The result of...