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United States v. Guardian Chemical Corp.

decided: April 15, 1969.


Lumbard, Chief Judge, Smith, Circuit Judge, and McLean, District Judge.*fn*

Author: Mclean

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 ...

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