1326. Misbranding of Sugretus and Sunol.   U. S. v. Elmer J. Dailey (Dailey's Laboratories).
Plea of not guilty. Tried to the jury. Verdict of guilty. Fine of $250 on count 1;
imposition of sentence on count 2 suspended and defendant placed on probation
for 5 years.   (F. D. C. No. 11424.   Sample Nos. 57639-F, 57640-F.)
On July 5, 1944, the United States attorney for the Southern District of
California filed an information against Elmer J. Dailey, trading as Dailey's
Laboratories, San Diego, Calif., alleging shipment of a quantity of the above-
named products from the State of California into the State of Texas on or
about August 14, 1943.
Analysis of a sample of the Sugretus disclosed that it consisted of dark
gray, uncoated, compressed tablets with a slight aromatic odor, and that it
contained plant material, probably cactus, together with an iron compound.
It was alleged to be misbranded because of false and misleading statements
on its label and in an accompanying circular letter headed "Dailey's Labora-
tories," which represented and suggested that the article would be efficacious
in the cure, mitigation, treatment, or prevention of diabetes, Buerger's dis-
ease, and pancreas, liver, and kidney troubles; that it would make diabetics
sugar-free and keep them so; that its use would enable persons who were
using insulin and dieting to live normal lives, i.e., give up insulin and dieting;
and that it would build up the pancreas, liver, and kidneys.
Analysis of a sample of the Sunol disclosed that it consisted essentially of
volatile oils including oil of eucalyptus, camphor, and thymol dissolved in a
fatty oil. The article was alleged to be misbranded in that the statement,?"For soreness in Bunions," borne on its label, was false and misleading since
the article would not be efficacious in the cure, mitigation, treatment, or pre-
vention of soreness in bunions; and in that its label failed to bear any state-
ment of the quantity of the contents or of the active ingredients of the
article.
On July 15, 1944, the defendant entered a plea of not guilty, and on Sep-
tember 5, 1944, the case came on for trial before a jury. The trial was con-
cluded on September 7, 1944, on which date the court delivered the following
instructions to the jury:
?See also Nos. 1301-1307. 1312-1315, 1324, 1325.
instruct you with reference to the law that applies to this particular case.
"This criminal proceeding was brought under the provisions of the Federal
Food, Drug and Cosmetic Act, which was intended to prevent the movement
in interstate commerce of adulterated and misbranded foods, drugs, devices
and cosmetics.
"The statute prohibits the introduction or delivery for introduction into
interstate commerce of any food, drug, device, or cosmetic that is adulterated
or misbranded.
"In this Gase the government in Count I charges defendant with unlaw-
fully introducing and delivering for introduction into interstate commerce
three bottles containing an article known as 'Sugretus.'
"The government alleges the article to be misbranded in violation of the
statute and a drug within the meaning of the statute.
"Count II charges the same transaction with respect to another article
known as 'Sunol.'
"The government alleges this article to be misbranded in violation of the
statute and a drug within the meaning of the statute.
"In Count II the government further alleges that the label failed to bear
an accurate statement of the quantity of the contents and further that the
said label failed to bear the common or usual name of the active ingredients,
in violation of the statute.
"The Food, Drug, and Cosmetic Act provides that an article can be mis-
branded in a number of different ways. In Count I of this Information, that
is with respect to the article 'Sugretus,' the government has confined its
charges to false and misleading statements. An article can be misbranded,
however, in other ways.
"In Count II of this Information, the government has set forth three differ-
ent ways in which this article is misbranded.
"First: It is alleged that the article is misbranded because of certain
statements which it alleges are false and misleading.
"Second: It is alleged that the article is misbranded because the label
fails to bear a statement as to the quantity of contents.
"Third: It is alleged that it is an article fabricated from two or more
ingredients, and fails to bear a statement as to the common or. usual name of
each active ingredient.
"It is not necessary that you find from the evidence that the article is
misbranded in all three of these ways. If you should find that the article is
misbranded in any one of these three manners, then you must find the de-
fendant guilty under Count II. If, for example, from the evidence you find
that the article 'Sunol' fails to bear a statement on its label of the quantity
of contents, or that it is fabricated from two or more ingredients and fails
to bear a statement of the common or usual name of active ingredients, then
you must find the defendant guilty with respect to Count II whether or not
you believe that the statements alleged to be false and misleading are in
fact false and misleading.
"If you find from the evidence that in any particular this drug is mis-
branded, then the law has been violated. It is not necessary that every mis-
branding be proved.
"There is "no dispute that the articles set forth in the information were
shipped in interstate commerce by the defendant as alleged.
"It has been stipulated that the articles were introduced and shipped in
interstate commerce.
"I, therefore, charge you that the sole question for you to determine
from the evidence in the case, is whether or not there was a misbranding in
violation of the statute, as alleged by the government.
"If, after hearing the evidence in this case, you reach the1 conclusion as to
Count I that the drug or product known as 'Sugretus' was harmless, that
does not excuse the defendant if you find that he placed statements upon
said article or drug which were false concerning curative, therapeutic, and
mitigating effects of said product, as the danger and injury to the public
from representations of this kind is considerable, in that it induces persons
frequently to rely in serious cases upon preparations without healing virtue
when, but for this reliance, they would no doubt secure proper advice and
treatment for the illnesses which affect them.
"With respect to Count II of the Information, you are instructed that the
term 'relief is not of definitive connotation or entirely free from ambiguity;
in a common sense it connotes permanent removal of organic or functional
disturbance as distinguished from alleviation of discomfort. The represen-
tation that an article or drug is 'for' or a 'treatment for* a disease is equiva-
lent to labeling it as a cure or remedy.
"The statute under which this case has been tried condemns every state-
ment in the labeling of the article 'Sugretus,' and the article 'Sunol' which
may mislead or deceive. Deception may result from the use of statements
not technically false or which may be literally true. The aim of the statute
is to prevent that resulting from indirection and ambiguity, as well as from
statements that are false. It is not difficult to choose statements that will
not deceive.
"If you find from the evidence that there are any false and misleading
. statements in the labeling involved in this case, your verdict should be for
the government, as I have stated before.
"In determining whether or not any statements made in the labeling of
'Sugretus' and 'Sunol' are misleading, you should take into account, among
other things, not only representations made or suggested by such statements,
but also the extent to which the labeling may fail to reveal facts material
in the light of such representations.
"If you find from the evidence that there is a material weight of medical
and scientific opinion contrary to any of the representations made in labeling
'Sugretus' or 'Sunol,' you may find that said articles are misbranded.
"If you find that the circular introduced in evidence in this case, and
contained in the package admitted to have been shipped in interstate com-
merce by the defendant, as alleged in Count I, contains statements describing
the curative, therapeutic or mitigating effects of the article or drug, and find
that such statements are likely to mislead in any particular, you should find
the defendant guilty of misbranding on Count I.
"What these labels and circular mean, you are to test by taking the
language of each of them and imparting to that language the meaning of the
^rords singly and together that would be conveyed to you as ordinary men,
not as men who are skilled in medical, chemical, or pharmaceutical science
capable of making nice distinctions or nice discriminations, but rather the
meaning that comes to you as ordinary men unskilled, but seeking, we will
assume, some sort of remedy or remedial help from the afflictions that
flesh is heir to. Now, in that connection, you should examine the language
used in the light of the purpose of this law, which is to protect human kind
against the consequence of human weakness, or human failing, or human
credulity, or the disposition to believe, or of human gullibility. You should
examine it in the light of the disposition of the ordinary human kind to wish
to believe in the potency of remedial agents to relieve them of ills from which
they are actually or conceivably suffering.
"Under the Food and Drug Act the term 'drug' includes any substance or
mixture of substances intended to be used for the cure, mitigation or pre-
vention of diseases of mankind. The aim of the Act is to prevent indirection
and ambiguity in the labeling of drugs, as well as to prevent statements
which are literally false. It is not difficult to choose statements, designs, or
devices concerning the curative, therapeutic or mitigating effect of any
article or drug which will not deceive. Those which are ambiguous or likely
to mislead should be read favorably to the accomplishment of the purposes
of the Act, and if you find the labels and circular used by the defendant,
Elmer J. Dailey, describing the curative, therapeutic and mitigating effect
of the articles or drugs 'Sugretus' and 'Sunol' contain statements that are
likely to mislead, in any particular, you should find the defendant guilty of
misbranding.
"Of course, if you do not so find, you should find the defendant not guilty."Witnesses, those who are supposed to know more than the ordinary
person about such subjects, such as chemists and physicians, have been per-
mitted to give their opinions as to various matters. Opinion evidence is not
binding upon you, but should be considered in connection with all other evi-
dence in this case. Should you believe it, you may accept and follow it. By an
opinion, I mean a statement or a conclusion arrived at by the witness from
experience or from knowledge, as distinguished from testimony concerning the
direct fact.
"That is, I might say that this building was constructed of brick.   That
would be a statement of fact.  If I would say it was worth twenty thousand
or a hundred thousand dollars, that would merely be my opinion.
"You are the sole judges of the value of opinion evidence. Of course, an
opinion is worthless unless it is the honest opinion of the man who states it.
If you deem it is his honest opinion, then its value depends upon how much
he knows about the subject concerning which he is testifying. If he is fairly
experienced, fairly grounded in his subject, if his opinion is the result of
mature reflection, if he is a man of strong logical intellect, his opinion would
be entitled to great value. If, on the other hand, he is incapable of logical
thinking, or if he is not well grounded in his subject, nor familiar with the
facts upon which his conclusion is assumed to be based, then, of course, his
opinion would be of little or no value; and it is for you to decide what value
you will give to the opinion evidence that you have heard.
"It is not necessary for the government to prove the defendant inten-
tionally misbranded the articles in any particular. Intent is immaterial in a
charge of misbranding as is charged in this case.
"So, if you find from the evidence that the labels and circular contained
false and misleading statements in any particular, then you must render your
verdict accordingly.
"Now, a great deal of the evidence of the witnesses who have testified
concerning their own ailments is in the nature of opinion evidence. Those
witnesses who testified that they had well-known, easily discernible dis-
eases, or easily-told diseases, I will say, such as headaches and constipation,
or something of that sort, of course, there will be very little reason to doubt
that they knew what they had. But if one testified that he thought he had
some more obscure disease, more difficult to diagnose, and his diagnosis of
what he had depended entirely upon his own opinion, and he was unable to
make such a diagnosis, his opinion would be of very little value. Those are
matters for you to take into consideration in weighing the testimony of the
witnesses.
"You are the sole judges of the facts of this case, also of the credibility of
each and every witness who has testified before you, and the weight that
you will give his testimony. In determining the credibility of any witness
you have a right to take into consideration his or her manner and appearance
while giving his or her testimony, his or her means of knowledge of the facts
to which he or she has testified; any interest or motive he or she may have
for his or her testimony, if shown, and the probability or improbability of
the truth of his or her statements when measured in connection with all other
evidence in the case. If you believe that any witness has wilfully sworn
falsely as to any material fact, then you have a right to wholly disregard the
testimony of such witness, except insofar as the same may be corroborated by
other credible evidence or by facts and circumstances proven or admitted
in' the case.
"In order to convict the defendant of the crime charged in the indictment,
it is incumbent upon the government to prove to you beyond a reasonable
doubt and to a moral certainty the truth of each and every material allegation
of the indictment. The law raises no presumptions against a defendant, but
every presumption of law is in favor of his innocence.
"A reasonable doubt as applied to evidence in criminal cases, is such a
doubt as you may entertain as reasonable men after a thorough review and
consideration of all the evidence, a doubt for which a reason arising from the
evidence, or from the want of evidence, exists. It is not, however, a fanciful
conjecture of the mind, nor the mere possibility of a doubt, but it is a sub-
stantial, well-founded doubt. It is that state of the case which, after a full
and fair review of all the evidence, leaves the mind of a juror in such condi-
tion that he cannot say he feels an abiding conviction to a moral certainty
of the guilt of the accused. It is an actual, sincere mental hesitation caused
by insufficient or unsatisfactory evidence.
"While it is true that the government is required to prove the guilt of the
defendants beyond a reasonable doubt, it is not required to prove their guilt
to a mathematical certainty. All that the court and the jury can act upon is
belief to a moral certainty and beyond a reasonable doubt.
"Now, if, after fully and fairly considering all of the evidence in this
case you entertain such a reasonable doubt as I have defined as to the guilt
or innocence of this defendant, then it becomes your duty to resolve that?(
doubt in favor of the defendant and to return a verdict of not guilty.  On the?^
other hand, if, after so considering all of the evidence in the case you are
satisfied beyond a reasonable doubt and to a moral certainty that the de-
fendant has committed the acts as charged and constituting the crime set
forth in the Information, then it becomes your duty to render a verdict
of guilty.
"After you retire to the jury room you will select one of your number to
act as foreman, and you will proceed with your deliberation. After you had
agreed upon a verdict you will have it signed by your foreman and return
it to open court. And any verdict rendered, of course, will be the unanimous
verdict of the jury.
"A form of verdict has been prepared for your guidance."
The jury thereupon retired and, after due deliberation, returned a verdict
of guilty. On September 15, 1944, the court imposed a fine of $250 on count 1
and suspended the imposition of sentence on count 2, placing the defendant on
probation for 5 years.