852. Adulteration and misbranding of Leunbach' Paste. IT. S. v. Merz & Company
Chemical 'Works, Inc., and Adolph G. Schickert. Plea of guilty by Adolph
G. Scnlckert, sentence 18 months In jail. Plea of nolo contendere by cor-
poration. Sentence suspended. (F. D. C. No. 5505. Sample Nos. 5032-E,
5033-E,12877-E, 14055-E to 14057-E, incl.. 14059-E, 20127-E, 28933-E, 28934-E,
32419-E, S2420-E, 32473-E to 32475-E, incl., 33525-E.)
On October 31,1941, the United States attorney for the District of New Jersey
filed an information against Merz & Company Chemical Works, Inc., East Orange,
N. J., and Adolph G. Schickert, alleging shipment within the period from on or
about March 16, 1989, to on or about September 11, 1940, from the State of New
Jersey into the States of Ohio, Georgia, California, Pennsylvania, and the District
of Columbia, of quantities of Leunbach' Paste complete outfit and Leunbach' Paste
refill tubes which were misbranded. On March 31, 1942, the grand jury for the
District of New Jersey presented an indictment based on the same charges
against the defendants. (The information which had been filed on October 31,
1941, was dismissed at the conclusion of the case.)
Examination showed that the Leunbach' Paste complete outfit contained a
tube of paste and instruments for its application, and the refill tubes contained
the same paste. Analysis of a sample of this paste showed that it contained
potassium iodide, small proportions of thymol, benzoin, and myrrh incorporated
in a soap base, alcohol, and water.
Portions of the article were alleged to be adulterated in that its purity fell
below that which it purported and was represented to possess, in that the article
by virtue of the use for which it was recommended and the conditions under
which it was to be used, that is, injection into the cervix and pregnant uterus
under conditions of the strictest asepsis, purported and was represented to be
sterile, whereas it was not sterile but was contaminated with viable micro-
organisms.
All of the shipments were alleged to be misbranded in that the article was dan-
gerous to health when used in the dosage or with the frequency or duration pre-
scribed, recommended, or suggested in the labeling. (The labeling of this product
is set out substantially in Drugs and Devices Notices of Judgment No. 607.)
It was alleged to be further misbranded in that its labeling was false and
misleading in its representations and suggestions that it was a safe and appro-
priate treatment for the therapeutic termination of pregnancy, whereas it was
not a safe and appropriate treatment for the therapeutic termination of preg-
nancy, but was unsafe and dangerous, and capable of producing serious and
even fatal consequences.
On October 14, 1942, Adolph Schickert entered a plea of guilty, and a plea of
nolo contendere was entered on behalf of the corporation. On October 30, 1942,
the court sentenced Schickert to serve 6 months on each of the 17 counts in the
indictment, the periods imposed on the first 3 counts to be served consecutively,
totaling 18 months, and the periods imposed on the remainder of the counts to
be served concurrently with that imposed on count 1. On November 6, 1942, the
court ordered sentence suspended as to the corporation.