2655. Adulteration of Cornocide (corn remedy). U. S. v. Denver Pharmaceutical
Mfg. Co., Inc., and Samuel Garber, David Kaplan, and Samuel Sherman.
Pleas of guilty. Fines of $600 against corporation, $50 each against de-
fendants Garber and Kaplan,  and $20 against defendant Sherman.
(F. D. C. No. 21471.   Sample Nos. 8580-H, 8581-H.)
INFORMATION FILED : September 17,1948, Eastern District of New York, against
the Denver Pharmaceutical Mfg. Co., Inc., Long Island City, N. Y., and against
Samuel Garber, president, David Kaplan, treasurer," and Samuel Sherman,
secretary.
ALLEDGED SHIPMENT : On or about May 23, 1946, from the State of New York
into the State of New Jersey.
NATURE OF CHARGE: Adulteration, Section 501 (a) (4), the article contained,
for purposes of coloring only, coal-tar colors, Butter Yellow (Colour Index
No. 19) and Sudan IV (Colour Index No. 258), which had not been listed for
use in drugs in accordance with the regulations, and were other than ones from
batches that had been certified in accordance with the regulations.
DISPOSITION :   On December 8, 1948, pleas of guilty were entered on behalf of   /
all defendants.   On January 13,1949, the court imposed a fine of $600 against    ^
the corporation, and January 20, 1949, the court imposed fines of $50 each
against defendants Garber and Kaplan and $20 against defendant Sherman.
DRUGS  AND  DEVICES  ACTIONABLE   BECAUSE  OF
DEVIATION FROM OFFICIAL OR OWN STANDARDS*
2656. Action to enjoin and restrain the interstate shipment of isotonic solution
of sodium chloride, water for injection, epinephrine hydrochloride injec-
tion, aminophylline, sodium ascorbate and dextrose injection, sodium
iodide and sodium salicylate, sodium iodide and sodium salicylate with
colchicine, sodium cacodylate, and sodium thiosulfate. U. S. v. Bristol
Laboratories, Inc.   Tried to the court.   Case dismissed.   (Inj. No. 198.)
COMPLAINT FILED : On or about September 25, 1948, Northern District of New
York, against Bristol Laboratories, Inc., Syracuse, N. Y. The complaint alleged
that the defendant had been and was then shipping in interstate commerce
drugs which were adulterated and misbranded.
NATURE OF CHARGE: Adulteration, Section 501 (b), the isotonic solution of
sodium chloride, water for injection, epinephrine hydrochloride injection,
aminophylline, and sodium ascorbate and dextrose injection purported to be and
were represented as drugs, the names of which are recognized in the United
States Pharmacopoeia, and the sodium iodide and sodium salicylate, sodium
iodide and sodium salicylate with colchicine, sodium cacodylate, and sodium
thiosulfate purported to be and were represented as drugs, the names of which
are recognized in the National Formulary; and the purity and quality of the
drugs fell below the official standards therefor since they were not and had
not been substantially free of undissolved material which could be detected
readily without magnification when tested in accordance with the method
prescribed by the standards; and the differences of the drugs in quality and
purity from the standards were not plainly stated, or stated at all, on their
labels.
Misbranding, Section 502 (a), the names of the drugs, isotonic solution of
sodium chloride, water for injection, epinephrine hydrochloride injection,
aminophylline, and sodium ascorbate and dextrose injection, and the statement
"U. S. P." appearing in the labeling of a number of such drugs, were false and
misleading since" such names and statement represented and suggested that
the drugs conformed to the specifications of the United States Pharmacopoeia,
whereas they did not conform to such specifications.
PRATER OF COMPLAINT: That a preliminary injunction issue, restraining the
defendant from commission of the acts complained of; and that, after due
proceedings, the preliminary injunction be made permanent.
DISPOSITION : Pursuant to a motion filed on behalf of the defendant, the court
on October 8,1948, entered an order directing the Government to show cause why
an order should not be made requiring it to answer the following interroga-
tories :
?See also No. 2654.
1.?State when said drug was introduced into interstate commerce by the de-
fendant in violation of the Federal statute as alleged in the complaint.
2.?Where did the plaintiff obtain samples of said drug and on what date and
from whom
3.?Was the sample obtained by the plaintiff contained in a vial or ampule
4.?What was the size of the vial or ampule in which the drug was contained
5.?What was the lot number or numbers on the label on the vial or ampule
in which said drug was contained? If the plaintiff obtained more than one
sample, state the number of samples it obtained of said drug, and if they where
in different vials or ampules, state the size of each of the vials and ampules
and the respective lot numbers shown on the labels.
6.?State in detail what was done with each sample of said drug prior to their
examination.
7.?State when and where such examination was made and by whom made.
8.?State in detail the qualifications of the person making such examination.
9.?State in detail the method employed by such person in making the exami-
nation and attach copy of any report covering said examination made by said
person.
10.?If more than one examination was made by the same person, or if more
than one person made the examination of said drug, state the names of all
persons making the examination, the qualifications of said persons, and attach
reports of all examinations made by either or all of said persons covering all
samples of said drug.
11.?State the nature, chemical, and physical properties, size and number of
the undissolved particles found in each of said samples examined by the
plaintiff.
12.?Describe in detail any and all devices and techniques used in the examina-
tion of said drug during the examination.
13.?How were the ampules or vials of each sample of said drug treated or
handled by plaintiff before examination
14.?Set forth in detail each of the steps followed in making each of said
examinations.
15.?State how much time was consumed in the actual examination of each
of said samples of said drug.
16.?How many of such examinations were made on the dates above set forth
by each of the persons whose names are above set forth
17.?What other work had been performed by each of said persons on each
of said dates prior to examining said drugs
18.?How long after each of said persons began work on each of said dates
was said drug examined
19.?What test had been made of the vision of each of the persons above named,
and when was each of said tests made and by whom? What was the result
of each such test
20.?What in detail, is the interpretation which plaintiff places upon the
terms "substantially free" of "undissolved material," "detected readily," "with-
out magnification," "without excessive magnification," and "normal vision"
21.?When was said interpretation adopted? Has said interpretation been
changed at any time since 1942? If so, what were the changes in said inter-
pretation, and when were said changes made
22.?What has been the care and treatment of each of said samples of said
-drugs which were examined since the date of each of said examinations
23. If a 100 watt incandescent lamp was used, what was the rated voltage
at the time it was being operated
In addition, the order of October 8 directed the Government to show cause
why an order should not be made requiring it to make discovery of (1) samples
of each of the lots of the allegedly adulterated drugs named in the complaint;
(2) the solution and the container used in testing each of the drugs; and (3)
photostatic copies of any reports made showing the results of the test and a
description of the manner in which the tests were made. A motion also was
filed by the defendant to have the complaint made more definite and certain.
On October 26,1948, an answer to the motion was filed giving the information
requested. On the same date, answers to certain of the interrogatories, together
with information on certain of the matters requested by way of discovery,
were filed by the Government, accompanied by objections to answering the
other interrogatories and to making discovery of certain matters. The objec-
tions and briefs and arguments of counsel were taken under advisement by the
court, and on November 13,1948, the court handed down the following opinion:
BEENNAN, District Judge: "Several motions have been made in this action, all
of which have been disposed of by the action of the parties, except the matter
of answering certain interrogatories heretofore served upon the plaintiff by
the defendant. The propriety of the interrogatories comes before this Court
through the medium of an order to show cause, which was returnable on Octo-
ber 11, 1948.   This decision is directed to that question alone.
"The defendant seeks to propound some twenty-three interrogatories, the
answers to which defendant claims are required in order to prepare for trial
properly.
"The plaintiff has already filed answer to interrogatories Nos. 1 to 8 inclu-
sive, 13, 22 and part of 9, so that no discussion of same is made in this memo-
randum.
"This is an action in which the sale or introduction of certain drugs in inter-
state commerce is sought to be restrained by injunction, for the reason that
same, as manufactured by the defendant, fails to meet the requirements of
the Federal Food, Drug and Cosmetic Act. A proceeding looking to the granting
of a temporary injunction has been commenced by the plaintiff, and same is
held in abeyance since it is evident that a trial upon the merits may be had
without undue delay.
"The test to which the drugs might be subjected in order to ascertain whether
or not they comply with the provisions of law appears on its face to be capable
of conflicting constructions, and its application will apparently become a basis
of dispute in this litigation.
"It is unnecessary to discuss in detail the law applicable to the dispute
arising upon this motion. The defendant relies upon Rule 33 of the Federal
Rules of Civil Procedure, and the provisions of Rule 26, as referred to therein.
.Both rules have been many times subject to judicial interpretation, and it is
sufficient to say that the weight of judicial precedents is that they shall be
applied with liberality to the end that the parties may not be surprised upon
the trial of the action. In deciding this motion the Court has in mind such a
construction and application of the rule, and it also has in mind that the
plaintiff, in applying for a temporary injunction, would be required to establish
affirmatively a basis for that relief which would, in effect, give to the defend-
ant a somewhat detailed basis of the action prior to the trial thereof.   It would
seem, therefore, that no serious objection should be made to the answering of
any interrogatory which calls for evidence which would be required to be
produced upon the temporary injunction proceeding. The cases of U. S. vs.
300 Cans, etc., 7 F. R. D. 36, and U. S. v. 88 Gases, etc., 5 F. R. D. 503, have been
considered.
"A consideration of the disputed interrogatories follows:
"Interrogatory No. 9. This interrogatory has been partially answered, and
the plaintiff apparently objects to the attaching of a copy of any report cover-
ing the examination made by the plaintiff of the drugs manufactured by the
defendant. No valid reason exists for such objection. The report would nec-
essarily become part of the temporary injunction proceeding. It is the basis
of the action.   The interrogatory is allowed.
"Interrogatory No. 10 is allowed.
"Interrogatory No. 11 is disallowed, since the reports in Interrogatories Nos.
9 and 10 will cover the substance of the interrogatory, if, in fact, a record
were made of the size and number of the undissolved particles.
"Interrogatory No. 12 is allowed. The information called for may possibly
be covered in the answers to Interrogatories Nos. 9 and 10.
"Interrogatory No. 14 is allowed.
"Interrogatory No. 15 is allowed.
"Interrogatories Nos. 16, 17 and 18 are disallowed. They call for details
which would seem to be unnecessary at this time. Their propriety may arise
on cross examination.
"Interrogatory No. 19. This interrogatory assumes that tests have been
made of the vision of the persons conducting the tests. As phrased it would
seem to call for unnecessary details. It would seem, however, that the defend-
ant is entitled to know, and the plaintiff is required to show, that the persons
conducting the tests possessed and used normal vision, as that term is defined
in the test prescribed. The interrogatory is re-framed as follows: 'What means
or precautions were taken to establish as a fact that the person or persons at
the times of making the tests possessed and used normal vision in the conduct
thereof?' The interrogatory as re-framed, if accepted by the defendant, is
allowed.   The interrogatory as propounded is disallowed.
"Interrogatory No. 20. It is apparent that the expressions in the interroga-
tory 'without excessive magnification' was intended to read 'without accessory
magnification.' The interrogatory is allowed as to all of the terms therein,
except 'Detected readily,' 'without magnification' and 'without accessory
magnification.' These three terms define themselves. The other terms in the
interrogatory may be the subject of dispute which might arise from a difference
in interpretation between a chemist and a manufacturer. Such dispute, if it
exists, should be openly defined prior to the trial of the issues. The interroga-
tory is allowed, with the exception of the three expressions or terms excluded
as above set forth.
"Interrogatory No. 21 is allowed.
"Interrogatory No. 23 is allowed.
"Order may be submitted accordingly."
Answers to the interrogatories were subsequently filed in accordance with
the foregoing opinion. An answer to the complaint was filed on behalf of the
defendant, denying that the products were adulterated or misbranded and
alleging that the sections of the act involved were unconstitutional and void
because (1) such sections attempted to delegate legislative power to persons
848936-49?2
Formulary, (2) such sections set forth no standard for the guidance of the
person to whom the legislative power was delegated, (3) such sections pur-
ported to require compliance with standards adopted after the effective date of (
such sections and failed to set forth any requirements for notice or hearing prior
to adoption of the standards or for judicial review thereof, and (4) the drug
standards involved in the case were vague, uncertain, arbitrary, and capricious.
In addition the defendant's answer alleged that the drug standards were
illegal and void, in that enforcement of the standards would be in violation
of the Administrative Procedure Act because the defendant had neither notice
nor opportunity for hearing prior to adoption of the standard and no opportunity
for judicial review thereafter.
The case came on for trial on January 17, 1949, and at the conclusion of the
testimony for the Government on January 25, 1949, the court granted the de-
fendant's motion for dismissal of the case on the ground (1) that the standards
involved were indefinite and (2) that the evidence was insufficient to show
such violation of the Act as would warrant the granting of the relief prayed for.
2657. Action to enjoin and restrain the interstate shipment of Eamba or Kamba
Tonic. U. S. v. John L. Denney. Tried to the court. Injunction granted.
Action for violation of injunction tried to the court. Defendant placed
on 6 months'probation.   (Inj. No. 98.)
COMPLAINT FILED : May 25, 1944, Southern District of California, against John
L. Denney, Fresno, Calif., alleging that the defendant was engaged in the
manufacture, production, and sale of a product known as Eamba and Kamba
Tonic; that the product was manufactured from a herb of the rose family,
probably of Chamaebatia foliolosa, commonly known as bear grass or mountain
misery; that it was prepared in three forms, a ground dried herb, the water
extract of the herb preserved with sodium benzoate, and the distilled form
which is the condensate obtained when boiling the herb with water in the
preparation of the water extract of the herb.
The complaint alleged further that the defendant had been and was still
shipping the products in interstate commerce under labeling which represented
that the herb form was an antitoxin and antiseptic for internal and external
use; that it was a tonic and would cure many conditions and diseases, especially
arthritis; that the liquid preparation was an antiseptic for internal and ex-
ternal use and was effective as a treatment for disorders of the stomach and
bowels, for constipation, hemorrhoids, and arthritis; that the herb and liquid
products were capable of destroying poison and bacteria and were beneficial
for internal and external troubles, carbuncles, skin diseases, arthritis, bronchial,
lung, ear, and eye troubles, sinus and hay fever, scalds, burns, cuts, bruises,
boils, athlete's foot, dandruff, constipation, female trouble, gall bladder, stomach
ulcers, sleeping sickness, mastitis in cows, dysentery and pneumonia in calves
and poultry, streptococcus in chickens and turkeys, and pneumonia and paral-
ysis in chickens; that the products contained 24,000 International Units of
vitamin A and "a lot of vitamin Bi"; that they were "preventive medicine
accepted by the United States through the mails as being OK" ; that they were
recommended for eczema, poison oak and ivy, neuralgia, arthritis, and other
rheumatisms, open sores, and all forms of skin diseases; that they would clear
up the average case of arthritis in about 3 months ; that they would kill poisons
and cleanse the system; and that "most of the demand for the herb is for
arthritis though it is wonderful for stomach ailments and in fact any ailment."
NATURE OF CHARGE: Misbranding, Section 502 (a), the statements in the label-
ing above referred to were false and misleading; Section 502 (b) (2), the
labels failed to bear a statement of the quantity of the contents; and, Section
502 (e), the labels failed to bear a statement of the common or usual names of
the active ingredients.
Adulteration, Section 501 (c), the strength of the articles differed from, and
their quality fell below, that which they purported and were represented to
possess since they were not "antitoxin" and "antiseptic," as represented.
PRAYER OF COMPLAINT: That the defendant be restrained and enjoined from
shipping in interstate commerce the drugs "Kamba" or "Kamba Tonic."
DISPOSITION: On or about August 30,1945, a default decree was entered grant-
ing the injunction. On September 26, 1945, the defendant filed a motion to
set aside the default decree, which was granted on October 8,1945.
On December 5, 1946, a decree for a permanent injunction was entered en-
joining the defendant from introducing or causing to be introduced into inter-
state commerce any herb concoction, distillate, or other preparations under
the name of "Kamba" or "Kamba Tonic" or any preparation made from the
genus of herbs known as Chamaebatia. On December 27, 1946, the writ of
injunction in accordance with said decree was issued.
On or about April 23, 1947, a complaint was filed charging violation of the
writ of injunction. On October 3, 1947, the matter having been tried before
the court, the defendant was found guilty of contempt and was sentenced to 6
months' imprisonment. The sentence was suspended, and the defendant was
placed on probation for 6 months.