The opinion of the court was delivered by: TENNEY
The principal question presented to the Court in this declaratory judgment action is whether certain items manufactured by plaintiff are "drugs" or "devices" within the meaning of the Federal Food, Drug, and Cosmetic Act, 52 Stat. 1040 (1938), 21 U.S.C. §§ 301-392 (1964). Plaintiff manufacturer and defendants, the Secretary of Health, Education and Welfare, and the Commissioner of Food and Drugs, have each moved for summary judgment, plaintiff claiming the items are "devices" and the defendants claiming they are "drugs". Both parties agree that there are no facts in issue. The Court is of the opinion that the items are properly characterized as drugs and, accordingly, plaintiff's motion for summary judgment will be denied and the defendants' cross-motion for summary judgment will be granted.
The products in issue are items used by surgeons for ligating or tying bleeding vessels during surgical procedures on the human body. The products consist of (a) a disposable instrument in the form of either a hemostat (clamp) or a long slender tube which is used to locate bleeders and apply a nylon ligature loop and a nylon lock in the shape of a minute button, (b) the nylon ligature loop, and (c) the nylon lock. The ligature consists of a length of filamentary material having a loop at one end for encircling a blood vessel. The "button" serves the function of a knot for maintaining the ligature loop in a tightened position. Under ordinary surgical procedures, a surgeon will tie off all severed vessels by a hand-tied surgeon's knot which is a reef knot.
Plaintiff claims that its products are mechanical instruments, that the nylon ligature loop and the locking device are merely components, parts or accessories thereof, and that therefore the whole product is a device. Defendants argue that plaintiff's hemostat and long slender tube constitute a new and unique method of administering or applying a nylon suture, that a suture is a "drug" within the meaning of the statute and that since such method "is not generally recognized among experts * * * as safe and effective for use under the conditions * * * recommended" by the manufacturer, it is a new drug under § 201(p) of the Act, 21 U.S.C. § 321(p) and 21 C.F.R. § 130.1(h)(5).
To a great extent, there is no difference between the treatment accorded products characterized as "drugs" and those denominated as "devices" under the Act. For example, the adulteration or misbranding of any drug or device is prohibited under sections 301, 501 and 502 of the Act, 21 U.S.C. §§ 331, 351, 352. The same sanctions (injunction, criminal prosecution and seizure) may be invoked as to both drugs and devices pursuant to sections 302, 303 and 304 of the Act, 21 U.S.C. §§ 332, 333, 334. However, a critical difference arises in that section 505 of the Act, 21 U.S.C. § 355, provides that no person shall introduce into interstate commerce a new drug unless an application with respect to the drug has been approved by the Secretary of Health, Education and Welfare. Prior to marketing a new drug commercially, an applicant must show that his product will be safe and effective for its intended use. There is no pre-market clearance requirement for devices; after distribution of the device, the Government has the burden of proving that the particular item is misbranded.
On January 19, 1966, plaintiff wrote to the Food and Drug Administration requesting classification of its products as drugs, new drugs or devices. (Complt.Exh.C.) By letter dated March 18, 1966, plaintiff was advised that the products were regarded as new drugs. (Complt.Exh.D.) On May 4, 1966, plaintiff filed a "Notice of Claimed Investigational Exemptions", IND No. 3283, pursuant to § 505(i) of the Act, 21 U.S.C. § 355(i).
On November 9, 1966, Dr. William J. Gyarfas, Acting Director of Dental and Surgical Adjuncts of the Food and Drug Administration, met with representatives of plaintiff to discuss the status of IND No. 3283. Plaintiff was advised of various deficiencies and was told that longterm studies concerning the possible cancer-producing effects of the nylon filament and button would be required. (Gyarfas affidavit at P12.) Plaintiff subsequently decided that its products were devices rather than new drugs and on January 6, 1967, defendants were informed that plaintiff was withdrawing IND No. 3283 for that reason. (Complt.Exh.E.)
Plaintiff proceeded to comply with the requirements of the Act relating to devices, and on January 31, 1967 a sample label was sent to the Division of Medical Devices of the Food and Drug Administration. (Complt.Exh.F.) On February 17, 1967, plaintiff was advised of suggested changes in the labeling of the products.
However, in a subsequent letter to plaintiff from Dr. Gyarfas on April 26, 1967, plaintiff was again advised that the products were considered drugs and that failure to comply with investigational drug regulations might result in the commencement of regulatory proceedings. Finally, on May 1, 1967, defendants' telegram recalled the February 17, 1967 letter concerning labeling.
In response to defendants' threats of initiation of regulatory action, the products were taken out of interstate commerce and the instant action was commenced. The complaint seeks a declaratory judgment declaring plaintiff's products to be devices and an injunction against enforcement of the "drug" and/or "new drug" provisions of the Act against plaintiff or its ligating products.
Jurisdiction of this action is based on 28 U.S.C. §§ 1331(a), 1337. Defendants concede that the declaratory judgment procedure is a proper one to challenge a final determination of the Commissioner of Food and Drugs. See Abbott Labs. v. Gardner, 387 U.S. 136, 87 S. Ct. 1507, 18 L. Ed. 2d 681 (1967); Gardner v. Toilet Goods Ass'n, 387 U.S. 167, 87 S. Ct. 1526, 18 L. Ed. 2d 704 (1967); Toilet Goods Ass'n v. Gardner, 387 U.S. 158, 87 S. Ct. 1520, 18 L. Ed. 2d 697 (1967).
Determination of the Essential Element of Plaintiff's Products.
As has been hereinbefore stated, plaintiff contends that the nylon loop and the locking device are merely components of the mechanical instruments. Defendants argue that plaintiff's products are actually sutures with the instruments merely being a new method of applying such sutures.
The Court is of the opinion that the hemostat or the tube is no more than a container for and method of applying the suture. It is the suture which does the work of tying off the blood vessels and it is the suture which remains in the body. If the suture were physically separate from the mechanical apparatus, this would not result in a loss of suturing effect but would merely alter the manner of administration of the suture.
If the suture itself is considered a drug for the purposes of the Act (the conclusion reached herein), then plaintiff's products are comparable to drugs administered by disposable syringes. The syringe alone is a device when used separately. 1 Toulmin, Foods, Drugs & Cosmetics § 4.13, at 54 n. 2, § 4.33, at 79 (2d ed. 1963). But a drug in a syringe will not become a component of a ...