United States v. Guardian Chemical Corporation

• Decision Date: 15 April 1969
• Docket Number: Dockets 32789,No. 368,32790.,369,368
• Citation: 410 F.2d 157
• Parties: UNITED STATES of America, Appellee, v. GUARDIAN CHEMICAL CORPORATION and Alfred E. Globus, Appellants.
• Court: U.S. Court of Appeals — Second Circuit

410 F.2d 157 (1969)

UNITED STATES of America, Appellee, v. GUARDIAN CHEMICAL CORPORATION and Alfred E. Globus, Appellants.

Nos. 368, 369, Dockets 32789, 32790.

United States Court of Appeals Second Circuit.

Argued March 5, 1969.

Decided April 15, 1969.

Selma M. Levine, Washington, D. C. (Benjamin Wm. Mehlman, New York City, Joel E. Hoffman, Peter J. Hoagland, Wald, Harkrader & Rockefeller, Washington, D. C., on the brief), for appellants.

Robert Kraft, Asst. U. S. Atty., Brooklyn, N. Y. (Vincent T. McCarthy, U. S. Atty., Jerome C. Ditore, Asst. U. S. Atty., Brooklyn, N. Y., Joanne S. Sisk, Atty., Dept. of Health, Education and Welfare, Washington, D. C., on the brief), for appellee.

Before LUMBARD, Chief Judge, SMITH, Circuit Judge, and McLEAN, District Judge.^*

McLEAN, District Judge:

On October 20, 1965, a two-count information was filed in the United States District Court for the Eastern District of New York against defendants. The first count charged them with introducing a new drug into interstate commerce on November 14, 1962 without first having obtained approval of an application required for new drugs by 21 U.S.C. § 355(b). The second count charged them with introducing into interstate commerce on November 14, 1962 a drug which was misbranded within the meaning of 21 U.S.C. §§ 352(e) (2), 352(f) (1) and 353(b) (4). After a trial before Judge Dooling and a jury in May 1968, the jury returned a verdict of not guilty on Count 1 as to both defendants, and of guilty on Count 2 as to both. Each defendant was sentenced to pay a fine of $1,000. Imposition of a prison sentence as to defendant Globus was suspended and he was placed on probation for five years.

Defendants maintain that the evidence was insufficient to warrant conviction on Count 2 and that the court should have directed a verdict of acquittal. Defendants also complain of the court's charge and of the prosecutor's summation. Our study of the record convinces us that these points are not well taken. Accordingly, we affirm the judgment.

The same shipment formed the basis of each count. On November 14, 1962, defendants shipped from Long Island City, New York, to Holzer Hospital, Gallipolis, Ohio, bottles containing a product bearing the trade name Renacidin. It was manufactured by defendant Guardian Chemical Corporation, of which defendant Globus is chairman, president and treasurer.

The history of this product has an important bearing upon the issues presented for decision here. The facts in this respect were not disputed at the trial. They may be briefly summarized as follows.

Guardian Chemical Corporation (Guardian) first manufactured the product in 1955 or thereabouts. Guardian did not call it Renacidin at that time. Guardian sold it in liquid form for use in cleansing pipes and tubes which carry milk in pasteurizing and milking apparatus. The liquid acted to dissolve deposits which clogged the tubes.

In 1957 a Cincinnati urologist, Dr. Mulvaney, suggested to Globus that the product would be useful in dissolving calcium deposits which tend to plug catheters. Globus thought well of this suggestion. He decided to call the liquid Renacidin and to market it for cleansing catheters which had been removed from the human body. He had no thought at that time of using it to treat bodily conditions themselves.

In 1957 Dr. Mulvaney, at an American Urological Association meeting which Globus attended, described his technique in using Renacidin to irrigate catheters while they were still inserted in the human body ("in-dwelling" catheters) and in treating kidney stones. Subsequently in 1959, Dr. Mulvaney published an article on the subject. Other urologists began to use Renacidin in the treatment of kidney stones, and bladder stones as well, and other articles appeared.

In 1960 Globus prepared a brochure entitled "Renacidin — Solvent for Many Types of Urinary Calcifications." It described at some length the advantages of Renacidin in the treatment of bladder and kidney stones. Guardian distributed this brochure to the medical profession in 1961.

Also in 1961 or early in 1962, Globus prepared another brochure in somewhat more abbreviated form. This recommended Renacidin for preventing the formation of bladder stones "by dissolving stone-forming nuclei." Guardian sent this brochure to urologists.

Finally, prior to October 1962, Globus prepared a rather extensive article on Renacidin elaborating upon its beneficial properties in preventing the formation of obstructions in the urinary tract and in dissolving them. Guardian distributed this brochure at a convention of the American Medical Association in Los Angeles in November 1962.

Beginning no later than 1959, Guardian began selling Renacidin to doctors, hospitals and pharmaceutical jobbers. By the time Globus wrote his article in 1962, Guardian had sold more than 100,000 quarts (30,000 to 40,000 bottles) to such purchasers. From the beginning of the marketing of Renacidin, the label on the bottle was unchanged. The label on the bottles shipped on November 14, 1962 with which we are concerned in this case was no different from the one which Guardian used in 1957. It described Renacidin as:

"Especially Manufactured for Removing Calcium Deposits in Rubber and Plastic Catheters and Tubing."

It made no mention of the use of the product to cleanse catheters while they were still inserted in the body or to its use in treating bladder or kidney stones.

The particular shipment in question here was made on November 14, 1962 to fill an order from Holzer Hospital. There was no evidence that the hospital informed defendants before it ordered the Renacidin as to the use to which the hospital intended to put it. The parties stipulated, however, that if Mossman, the hospital pharmacist who ordered it, were called, he would testify that he ordered the Renacidin for use by the hospital's urologist for irrigating in-dwelling catheters and for dissolving kidney stones in the human body. It was also stipulated that at some time between November 14, 1962 and January 7, 1963, defendants sent to Mossman, at his request, copies of the two brochures heretofore mentioned which recommended the use of Renacidin for these purposes.

We turn now to the rather complex provisions of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., which govern this case. They are quoted in the margin. 21 U.S.C. § 331(a) prohibits the introduction into interstate commerce of any drug that is misbranded. In essence, a "drug" is an article intended for use in the treatment of disease in man.¹ A drug is misbranded unless certain information appears on its "label" or on its "labeling." These two words are not synonymous. "Label" is defined in Section 321 (k), in substance, as printed matter upon the immediate container of an article. "Labeling" includes not only "labels" but also printed matter "accompanying such article."

The data which the label or the labeling must contain is prescribed by Sections 352 and 353 of the Act. The subsections of Sections 352 and 353 which are relevant here are 352(e), 352(f) and 353(b).² In substance, their requirements amount to this. The "label" of the drug must bear the common name of each active ingredient. If the drug is not one which for safety's sake should be administered only by a physician, its "labeling" must bear adequate directions for its use. On the other hand, if it is one which only a physician should administer, its "label" must bear the words "Caution: Federal law prohibits dispensing without prescription."

Another refinement must be noted. In order to "accompany" an article and thus constitute "labeling" for it, printed pamphlets or brochures need not be shipped along with the article. They may be sent out either before or after the article and still "accompany" it, as long as the distribution of the drug and the brochures are parts of an "integrated distribution program." Kordel v. United States, 335 U.S. 345, 69 S.Ct. 106, 93 L.Ed. 52 (1948); United States v. Urbuteit, 335 U.S. 355, 69 S.Ct. 112, 93 L.Ed. 61 (1948); Cf. United States v. 24 Bottles "Sterling Vinegar & Honey, etc.," 338 F.2d 157 (2d Cir. 1964).

How do all these rules apply to this case? As far as the question of what constituted the "labeling" is concerned, the jury could find on the evidence that at least the two brochures which defendants sent to doctors both before and after November 14, 1962, were distributed by defendants as part of an integrated program which included the sale and distribution of the Renacidin. Consequently, assuming for the moment that Renacidin is indeed a drug, the brochures constituted its labeling. The information, or lack of it, in the brochures could therefore be properly considered in determining whether or not the product was misbranded.

There is more doubt about Globus' longer article which defendants handed out at the American Medical Association convention in November 1962. It seems to stretch the meaning of words beyond the limit of elasticity to say that this dissertation "accompanied" the Renacidin. In our view, however, it makes no difference whether or not this article is considered labeling. If it was not, it was immaterial, as far as the question of misbranding goes. If it was, it did not affect the result one way or the other. Despite its length, the article added little to the previous brochures on any point relevant to the misbranding issue, or at least the jury could have so found.

Still on the assumption that Renacidin is a drug, we turn briefly to the evidence bearing upon whether it was misbranded. Under Section 352(e) we are to look only to the "label" which must state "the common or usual name of each active ingredient." There may be some question as to whether the Renacidin label failed to comply with this requirement. It did, at least, make some attempt to do so. It bore a heading "Active Ingredient," after which the following words appeared:

"Edible,

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