906. Action to enjoin and restrain interstate shipments of a drug: designated as
Korjena.    U.  S. v. Jerome V.  Gladke   (Korjena Medicine Co.).    Perma-
nent injunction granted.    (Inj. No. 51.)
On March 1, 1943, the United States attorney for the Western District of New
York filed a complaint for an injunction against Jerome V. Gladke, trading as the
2 See also No. 902.
Korjena Medicine Company, Elmira, N. Y., alleging among other things, that,
since 1931, the defendant had been engaged in the busines
s of vending through-
out the United States a product known as Korjena,. and labeled in part as fol-
lows: "Korjena A dependable treatment for the reduction of excessive fat . . .
Korjena Medicine Co. Laboratories Elmira, N. Y. U. S. A. This treatment is
guaranteed dependable and may be taken with complete confidence. Contents
42 Korjena tablets . . . Active ingredients: phenolphthalein, calcium iodide,
sodium choleinate"; that the article contained approximately 1 grain of phenol-
phthalein, approximately .44 grain calcium iodide, calcium carbonate, and bile
salts; and that it was misbranded: (a) In that it was recommended as a depend-
able, safe, and adequate treatment for the reduction of excess fact, which state-
ment was false and misleading since it was not a dependable, safe, and adequate
treatment for the reduction of excess fat. (b) In that its label failed to bear
adequate directions for use, since the article was a laxative and the directions
which appeared on the label provided for continuous administration, whereas a
laxative should not be used continuously, (c) In that its label failed to bear
such adequate warnings against use in those pathological conditions wherein
use of the article might be dangerous to health, or against unsafe dosage or dura-
tion of administration, in such manner and form as are necessary for the protec-
tion of users since the article was a laxative and its label failed to warn that a
laxative should not be used when abdominal pain, nausea, vomiting, or other
symptoms of appendicitis are present, (d) That its label failed to disclose that
frequent or continued use of the article might result in dependence upon laxa-
tives, (e) That its label failed to disclose that, if a skin rash appeared, the use
of the article should be discontinued.
The complaint alleged further that on or about December 16, 1941, there was
filed in the United States District Court for the Western District of New York
an information charging a criminal violation of the Federal Food, Drug, and
Cosmetic Act against the defendant for shipment of Korjena in interstate com-
merce to Pittsburgh, Pa., and that on November 10, 1942, the defendant entered
a plea of guilty to count 1 of the information and was fined $200; and that while
the criminal information was pending as well as afterwards, the following
shipments of Korjena were made by the defendant from Elmira, New York:
On October 9, 11, and 27, 1942, and on November 25, 1942, shipments were made
to Los Angeles, Calif.; -on or about November 27, 1942, some 130 packages were
shipped to Tampa, Fla.; on or about December 12, 1942, some 63? dozen pack-
ages were shipped to Philadelphia, Pa.; on or about January 2, 1943, some 711
packages were shipped to Kansas City, Mo.; on or about January 2, 1943, some
11? dozen packages were shipped to Erie, Pa.; on or about January 9, 1943,
some 11 gross packages were shipped to Detroit, Mich.; on or about January 11,
1943, some 9? dozen boxes were shipped to Minneapolis, Minn.; and on or about
February 19, 1943, some 1 dozen boxes were shipped to St. Paul, Minn. It was
also alleged that the only difference in composition between the tablets in-
volved in the criminal case and those in the other shipments listed was that
the tablets in the criminal case contained the alkaloid strychnine, in addition
to the ingredients above set forth.
The complaint alleged further that on April 10, 1938, the Federal Trade Com-
mission directed the defendant and the Korjena Medicine Company to cease
and desist from certain unfair methods of competition in connection with the
sale of Korjena tablets, which were advertised as a fat-reducing agent and as
a remedy for obesity; and that an action was then pending in the United States
District Court for the Western District of New York, instituted on or about
October 21, 1941, demanding judgment in the sum of $10,000, and further de-
manding that this defendant be permanently enjoined from violating the terms
of the Federal Trade Commission order to cease and desist; and that the defend-
ant, with full knowledge that the labels constituted a violation of the Act, was
selling, and had no intention of discontinuing to sell, Korjena under its objec-
tionable label, but on the contrary was then, and so intended in the future,
continuing his business, 80 percent of which consisted in the shipping of the
product in interstate commerce; and that, unless restrained by the court, the
defendant would continue to' introduce and offer for introduction and delivery
in interstate commerce the misbranded article, and would in this manner con-
tinue to violate, evade, and defeat the purposes of the Act, with injury to the
public and to the plaintiff.
On March 1, 1943, an order to show cause and a temporary restraining order
were filed.
On March 30, 1943, no appearance, responsive affidavit, or pleading having
been filed, the court* ordered that the defendant, his agents, servants, and
employees, and all other persons in active concert or participation with him,
be permanently enjoined and restrained from directly or indirectly introducing
and delivering for introduction, and causing to be introduced and delivered for
introduction, into interstate commerce the article sold under the name Korjena.
as then labeled, in violation of the Federal Food, Drug, and Cosmetic Act.