FOOD AND DRUG ADMINISTRATION       
^_ P.i.s...
0     ?    ? -
NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT
[Given pursuant to section 705 of the Food, Drug, and Cosmetic Act]
3201-3220
DRUGS AND DEVICES
The cases reported herewith were instituted in the United States district
courts by the United States attorneys, acting upon reports submitted by the Fed-
eral Security Agency, and include, where indicated, the results of investigations
of the Agency, prior to the institution of the proceedings. Published by direc-
tion of the Federal Security Administrator.
PAUL B. DUNBAR, Commissioner of Food and Drugs.
WASHINGTON, D. C, January 2, 1951
CONTENTS *
Page
Drugs actionable because of poten-
tial danger when used accord-
ing to directions 
188
Drugs actionable because of failure
to bear adequate directions or
warning statements 
190
Drugs and devices actionable be-
cause of deviation from official
or own standards 
  195
Page
Drugs and devices actionable be-
cause of false and misleading
claims 
196
Drugs for human use 
196
Drugs for veterinary use 
201
Index . 
203
?For presence of a habit-forming narcotic without warning statement, see Nos. 3202,
3204-3206; omission of, or unsatisfactory, ingredients statements, Nos. 3202, 3203, 3207,
3211, 3213, 3219 ; failure to bear a label containing an accurate statement of the quantity
of the contents, Nos. 3202-3207; failure to bear a label containing the name and place of
business of the manufacturer, packer, or distributor, Nos. 3202, 3204-3207; cosmetic,
actionable under the drug provisions of the Act, No. 3215.
187
917959-51-
DRUGS<ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED   Y~
ACCORDING TO DIRECTIONS
3201. Misbranding of procaine hydrochloride 2% and adulteration and misbrand-
ing of Salicyline No. 2 tablets.  U. S. v. C. B. Kendall Co., Inc., Claude B.
V&v* Kendall, and Ralph E. Monteith.   Pleas of nolo contendere.   Fines of
$1,800 against corporation, $1,800 against defendant Monteith, and $900
against defendant Kendall.    (F. D. C. No. 28097.   Sample Nos. 23084-K,
23086-K,   23441-K,   23774-K,   23776-K,   23778-K,   23973-K,   43464-K,
43465-K.)
INDICTMENT RETURNED :   On or about March 13, 1950, Southern District of In-
diana, against C. B. Kendall Co., Inc., Indianapolis, Ind., Claude B. Kendall,
president of the corporation, and Ralph E. Monteith, chief chemist for the
corporation.
ALLEGED SHIPMENT :   Between the approximate dates of February 23, 1948, and
January 20, 1949, from the State of Indiana into the States of Louisiana,
Texas, and Illinois.
LABEL, IN PAET :    "Procaine Hydrochloride 2?,   Kendall" and "Tablets   Salicy-
line No. 2    *    *    *    Kendall."
NATURE OF CHARGE: Procaine hydrochloride 2?.   Misbranding, Section 502 (j),
the article was dangerous to health when used in the dosage and with the
frequency prescribed, recommended, and suggested in its labeling, namely,
"Average Dose:   As required, inject subcutaneous or intradermal" and "Aver-
age Dose:   As required, subcutaneous or intradermal," since such use of the
article in such dosage and frequency may result in destruction of body tissue
because of the acidity of the article.
Salicylme No.-2 tablets. Adulteration, Section 501 (c), the strength of the
article differed from that which it purported and was represented to possess
since each tablet was represented to contain 5,000 units of vitamin D, whereas"
each tablet contained less than 5,000 units of vitamin D. Misbranding, Sec-
tion 502 (a), the label statement "Bach tablet contains: * * * Vitamin
D 5,000 units" was false and misleading.
DISPOSITION : On May 26, 1950, pleas of nolo contendere were entered on behalf
of each of the defendants, and on July 14, 1950, after consideration of the
written statements and oral comments of counsel, the court found the defend-
ants guilty as charged and imposed the fines hereinbefore reported. In sen-
tencing the defendants, the court made the following statement:
STECKLEE, District Judge: "This case has certainly given the Court a great
deal of concern, not by reason of the particular facts in this case, but in addi-
tion to that, this seems to be the home of some of the largest pharmaceutical
manufacturers in the world. It is my understanding that this city is begin-
ning to be known somewhat as a pharmaceutical city, along with Philadelphia
and a few other large cities.
"I fully realize that the company, without penalty of the Court, will be
seriously injured by reason of the civil actions which no doubt will be brought,
claims that will be made. On the other hand, the Court can't lose sight of
the fact that any company that is engaged in the drug business is under the
strictest duty to maintain the integrity of that industry. The public has no way
at all of protecting itself against the use of harmful drugs, if they are harm-
ful, particularly when they are given under the prescription of the doctor,
or injected by a doctor. Usually, I would say, the doctor in those circum-
stances would be innocent, too, if something was wrong with the drug.
"The penalty in a case like this, as far as punishing the corporation, would    f
be, primarily, to serve as a reminder ever in the future to exercise the strictest   ' ^
policies in respect to the work of the personnel in reference to their particular
duties, such as the measuring, the weighing, the checking and double checking.
"I understand that the company has made extensive additions in the way of
equipment since this alleged crime was committed. The Court is taking that
into consideration.
"I might also say that there are cases like this all over the United States
that happen all the time with a drug company. I have had placed before me
a number of judgments that have been rendered by other courts, not only by
your counsel but by the counsel for the government. Fines are assessed from
$20 up to as high as a thousand dollars on a number of counts. Some of the
cases impose as high as $15,000 penalty on these companies.
"As far as punishing the individuals, I think there is a growing trend on the
part of the courts to begin to punish the individuals, those that actually have
charge of the company, and the technicians in charge, by sentences. I think
that is not the majority rule, however. Of course, most of the courts seem
to take the other view and punish the defendants with monetary assessments
against them. It has been very difficult for the Court to try to ascertain what
would be a correct amount of penalty to impose in this case. The Court is
taking into consideration the size of the company, the net income of the com-
pany, the fact that the company has made additions to its equipment.
"As I understand this case, it appears to me that it was somewhat of a case
of negligence on the part of someone in the company in not checking the appa-
ratus that measured the amount of hydrochloric acid. . . .
"The man that is president of the company must not only bear the penalties
that go with operating the company, but he is also given the right to enjoy
the benefits of being the head of the company. I think the one calls for the
other. You have a right to enjoy the profits and the growth of the company
as the president. Perhaps the owner of the company must also stand the
penalties that come with it. It is hard to decide whether the president of the
company, though he may not be actually involved in doing the thing, -making
up the capsules, or measuring the chemicals and shipping them himself, -
wrapping the packages, etc., - it is hard to decide whether or not he should be
indicted.
"I am inclined to think that the intent of the law is to keep the same
company from doing the same thing over, more so than to deter others from
doing it, because in a scientific industry like this, they are constantly making
new developments, and I think the reason that the penalty is imposed is to
make that particular company ever mindful of the fact that they must check
and double check. I understand that some of the drug firms make three
different types of checks whenever they have a complaint, and that prior to
this offense, this company did not do that, did not make the different types of
analyses, and that now, however, you are making the various types of analyses.
"All those things indicate progress as far as the drug industry is concerned,
the pharmaceutical profession. I know some of the largest in the country have
had penalties against them. I have gone back and looked in the record. I
have found practically all of them have had penalties assessed at one time
or another."
"Mr. Cox. But not the President. I haven't seen any where the President
has."
"The COTJBT. There have been a number where the officials have . . .
"Even in the food industry I found a case where the Roma Macaroni Com-
pany had ten thousand dollars assessed against the President, a similar fine
assessed against one of the other officials, or against the corporation. One of
the technicians was released.
"I realize that under the law, intent is not an element in this case. That
nray be unfortunate from the standpoint of the defendant, but from the stand-
point of the public it is a safeguard, and the mere fact that the drug reaches
the status of being in interstate commerce, then and there you are guilty of
having committed a pure food and drug law violation if the transaction comes
within the scope of the act.
"Well, this is a case involving ten counts against each of these defendants,
and if one were to sit down and figure up the maximum that could be imposed,
the Court could virtually put the company out of business, but the Court,
under the circumstances, has no such intention.
"It is a matter in which the Court feels, however, that the company should
pay a penalty sufficient that the public will fully realize they are being
protected by the courts. It is a case, by the same token, where the company
will have a reminder in the future to guard against the occurrence of the
same thing.
"I don't believe that these men are criminals. They don't look like it; they
don't appear to be criminals; I don't think there is anything criminal about
them. It is a matter where they are engaged in a business that has a lot of
hazards and we are all free to choose the type of business we would like
to go into.
"S'o, it is the judgment of the Court, based upon the findings of the ?Gourt
in this case, there having been a plea of nolo contendere made in the case, that
the defendant, the C. B. Kendall Company, Inc., is guilty as charged in the
indictment, and that the defendant corporation be fined in the sum of $100
on the first eight counts of the indictment, and that the defendant corporation
be fined in the sum of $500 each on each of the last two indictments.
"I might explain that under the law the penalty could be twice the sum
provided in the Act. The Act provides $1,000. I am merely explaining that
to show you that as far as the Court is concerned, you are not being given
the absolute maximum penalty. I am making no apologies. It is a matter
that the Court feels they should pay this additional penalty as a corporation.
"It is the judgment of the Court, based upon the plea of Defendant Ralph E,
Monteith, his plea being that of nolo contendere, and the finding of the Court
in this case, that the defendant Ralph Monteith is guilty as charged in the
indictment and that he be sentenced to pay a fine in the amount of $100 on
each of the first eight counts and that he be sentenced to pay a fine of $500
on each of the last two counts, Counts 9 and 10.
"It is the judgment of the Court, based upon the plea of the Defendant Claude
B. Kendall, and based upon the findings of the Court that the Defendant
Claude B. Kendall is guilty as charged in the indictment, that he be sentenced
to pay a fine of $50 on each of the first eight counts, and that he be sentenced
to pay a fine of $250 on each of the last two counts.
"Do you understand the fines?"
"The DEFENDANTS.    Yes, sir."
"The COURT. That is almost a $5,000 fine. I feel it is reasonable. I don't
think it is too low; I. don't think it is too high for a company of this size. I
do believe this company will gain by this experience in the future."
DRUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS