2939. Adulteration and misbranding of Indoform and Pluri-B, and alleged
adulteration and misbranding of vitamin D.   U. S. v. Pasadena Research
Laboratories, Inc., and Russell R. Bavouset.   Pleas of not guilty.   Tried
A/T\     *? ^e cour**   Defendants found guilty on five counts and not guilty on
V'W^"0 counts.   Corporation fined $3,000; individual defendant placed on
I    v^    probation for five years.   Judgment of district court affirmed on appeal

IS to circuit court of appeals.    (F. D. C. No. 21441.    Sample Nos. 27131-H,
29953-H, 30694-H, 58019-H.)
INFORMATION FILED: March 18, 1947, Southern District of California, against
Pasadena Research Laboratories, Inc., Pasadena, Calif., and Russell R.
Bavouset, secretary-treasurer.
?See also No. 2935.
Mijffikt) SHIPMENT: On or about July 16* September 17* November 19* 1945, and
June 18,1946, from the State of California into the States Of Wydining, Nevada,
Washington, and Arizona.
LABEL, IN PAST : "Indoform Each cc. Contains: * * * Posterior Pituitary
3 Int'l. Units * * * Thyroid Substance 1 gr."; "Pluri-B * * * Bach
cc. Contains: Thiamine Hydrochloride ... 50 Mgms." and "Pluri-B * * *
For intramuscular or Intravenous Use"; and "Sterile Injectable Vitamin D
(In Oil)    *   * ?  *   500,000 U. S. P. Units Per cc."
NATURE OF CHARGE: Ihdofofih. Adulteration, Section 501 (c), tile strength
of the article differed from that which it purported and was represented to
possess, namely, 3 International Units of posterior pituitary and 1 grain of
thyroid substance per cubic centimeter, since each cubic centimeter of the
article contained less than 3 International Units of posterior pituitary and no
thyroid substance. Misbranding, Section 502 (a); the label statement "Each
cc. Contains: * * * Posterior Pituitary 3 Int'l. Units * * * Thyroid
Substance 1 gr." was false and misleading.
Pluri-B, one lot. Adulteration, Section 501 (c), the strength of the article
differed from that which it purported and was represented to possess, namely,
50 milligrams of thiamine hydrochloride per cubic centimeter, since each cubic
centimeter contained less than that amount of thiamine hydrochloride. Mis-
branding, Section 502 (a), the label statement "Each cc. Contains: * * *
Thiamine Hydrochloride ... 50 Mgms." was false and misleading.
Pluri-B, remaining lot. Adulteration, Section 501 (c), the purity and qual-
ity of the article fell below that which it purported and was represented to
possess, in that it purported and was represented to be suitable and appro-
priate for intramuscular and intravenous administration, a use which requires
a product free from undissolved material, whereas the article contained
undissolved material.
Vitamin D. Alleged adulteration, Section 501 (c), the strength of the article
differed from that which it purported and was represented to possess, namely,
500,000 U. S. P. units of vitamin D per cubic centimeter, since each cubic
centimeter contained less than that amount of vitamin D. Alleged misbrand-
ing, Section 502 (a), the label statement "Vitamin D *? * * 500,000 U. S. P.
Units per cc." was false and misleading.
DISPOSITION: July 7, 1947. Pleas of not guilty having been entered on behalf
of the defendants, the case was tried before the cotirt and the defendants were
found guilty bri all counts, with the exception of counts 5 and 6 involving
adulteration and misbranding of vitamin D. The corporation was fined $3,000;
sentence was suspended as to the individual defendant, and he was placed on
probation for a period of 5 years. The order provided that during the proba-
tionary period, the defendant was to donate $5 or more each month to an ap-
proved charity of his own choice and to obey all laws, Federal, State, and
local. An appeal was taken to the United States Circuit Court of Appeals
for the Ninth Circuit, and on July 16, 1948, that cotirt affirmed the decision
of the district court and handed down the following opinion:
GABRECHT, Circuit Judge: "The appellants were found guilty on five counts
of an information charging violations of the Federal Food, Drug, and Cosmetic
Aet, 21 USCA ? 301 et seq., hereinafter referred to as the Act, in that they
'did . . . unlawfully cause to be introduced . . . into interstate com-
merce' adulterated and misbranded drugs. The corporate appellant was fined
$3,000, and the appellant Bavouset was placed on five years' probation, imposi-
tion of sentence upon him having been suspended.
"The trial was without a jury, a jury trial and special findings of fact having
been specifically waived in writing.
1. THE FACTS
(A)  "INDOFOBM"
"It was stipulated as to Counts I and II that a number of vials of 'Indof orm'
were shipped by the appellants on or about September 17,1945, from Pasadena,
California, to Dr. Joseph C. Bunten, Cheyenne, Wyoming. One vial was
picked up as a sample by Ralph M. Davidson, a Federal Food and Drug Inspec-
tor, on or about January 24,1946, from Dr. Bunten, and was sealed and mailed
to the Food and Drug Administration at Washington, D. 0., hereinafter referred
to as the Administration.
"The vials carried labels announcing that each cubic centimeter of the
drug contained three International Units of posterior pituitary and one grain
of 'thyroid substance.'
"On February 18, 1946, Arnold E. Mason, at that time employed by the
Administration as pharmacologist and analyst, examined the contents of the
sample vial. He testified that he 'found practically no posterior pituitary
in that product, an almost immeasurable quantity.' After conducting the
test, Mason replaced the bottle into a locked refrigerator until the next day,
when he wrapped it and put a seal on it. The vial was sent to San Francisco,
according to his testimony.
"Mason was asked hypothetical questions, objected to by the appellant, as
to whether the drug had contained three international units on the date of
shipment, September 17, 1945. The questions assumed that the product had
not been exposed to the 'destructive temperature' of 212 degrees, had been
handled in 'a normal and careful manner,' and had been tested as Mason had
already stated on the stand. Mason answered that it was his opinion that on
the date in question 'there was a quantity of posterior pituitary which was not
measurable by the standard methods of measuring it, or there was none.'
"On March 27, 1946, Andrew G. Buell, a chemist for the Administration,
stationed at San Francisco, broke Mason's seal on the paper wrapper around
the vial and examined the product for 'thyroid content.' He testified that
'There was no thyroid present whatsoever.' After he made his examination,
he 'immediately' put his seal on the bottle. The seal was dated March 28, the
day after he examined the contents.
(B)   THE DEFICIENT PLURI-B
"As stipulated, a number of vials that form the basis of Counts III and IV
were shipped by the appellants to Dr. Clement Swaim, Reno, Nevada, on July
16, 1945. Inspector Frank A. Griebling, of the Administration, picked up two
of these vials, which contained Pluri-B, from Dr. Swaim, on August 30, 1945.
"The inspector sealed the vials and contents with official seals, and forwarded
them by mail to the Vitamin Division of the Administration at Washington.
"Hubert H. Capps, a chemist of the Administration, examined one of the
vials on September 24,1945. Although the label on the vial sets forth that this
'Sterile Solution of Pluri-B' contains 50 milligrams of Thiamine Hydrochloride,
per cubic centimeter, Capps testified that he found it contained approximately
only 33 milligrams per cc.
"The Government chemist also stated that at the time he received the vial,
it had the same cap that it had at the time he was testifying, 'or one
very similar to it,' adding that 'since this does not appear to be broken, I think
that it did have that identical cap.' He also said, however, that he did not
make any examination of the cap to determine whether or not it was punc-
tured in any way, 'other than just looking at it.'
"During the direct examination of Capps, he was asked the following hypo-
thetical question, which the appellants contend was improper because it as-
sumed facts none of which 'are supported by any evidence whatever':
Now, assuming that the product received ordinary and reasonable care, and was not
exposed to excessive heats, such as heats any more than would be normal from shipping
and the weather, and basing upon what you found on September 24, 1945, the amount of
the B-l or thiamine chloride that you found, have you an opinion as to what percentage
or what amount that product, substance, or solution had on or about July 16, 1945, the
date it was originally shipped
"Capps replied that he believed that it did not contain more than 33 milli-
grams of thiamine hydrochloride per cubic centimeter,
(C)  THE CONTAMINATED PLURI-B
"According to the stipulation, a number of vials with labels, which form the
subject-matter of Count VII, were shipped by the appellants on June 18, 1946,
to Dr. P. M. Ryerson, Phoenix, Arizona. The vials contained 'Pluri-B,' and,
according to the labels, the contents were 'for intramuscular or intravenous use.'
"On or about July 12,1946, Maurice P. Kerr, an inspector for the Administra-
tion, collected a sample consisting of six vials and their contents, each at
random from different boxes of the shipment in Dr. Ryerson's possession. The
inspector marked the labels, sealed the vials with official seals, and forwarded
them by express to the Adminstration at Washington.
"Dr. Frank H. Wiley, chief of the chemical section of the medical division of
the Administration, holding a doctor's degree in biochemistry, testified that he
received the sample on July 23, 1946. He put the vials up to a light and found
'with the naked eye' that all six of them 'were very badly contaminated with
undissolved material.'
"Dr. Wiley was asked the following hypothetical question, which the appel-
lants assert was 'bad and improper because it did not include a sufficient factual
basis to support an opinion':
Q. ? . . . Dr. Wiley, taking the two vials, . . . which I understand you
examined about six weeks after the shipment in question here, from your knowledge of
sterile solutions and from your observation of sterile solutions, your experience, are you
able to express an opinion to this court as to whether or not the contents of those two
vials, . . . did contain the undissolved particles you noticed there then as of the
date they were shipped, namely, on or about June 18, 1946? Your answer is yes or no.
A. Yes.
Q.    .    .    .    Will you please relate your opinion
"The appellants object that in the foregoing questions 'no mention whatever
was made of the conditions to which the drug had been subjected after shipment
by appellants.'
"Dr. Wiley's answer to the question was as follows:
A. From experience with these materials and from general information of so-called
supersaturated solutions, of which this is an example, I would say that this undissolved
material was undoubtedly present on June 18th when the material was shipped. There
is only one external factor of which I know that would hasten or increase the crystalli-
zation of this material, and that would be refrigeration. I doubt very much if the mail
bag in which this material was transmitted to Washington was in a refrigerator car.
"The appellants comment that 'even if the question was proper Wiley's
opinion given in response thereto is not entitled to any weight whatever.'
"Other evidence relating to the drugs in question will be referred to in appro-
priate places in the discussion that follows.
2. THE CANON OF CONSTBUCTION
"The Act is remedial, and should be liberally construed so as to carry out its
beneficent purposes.
"In United States v. Dotterweich, 320 U. S. 277, 280, the Court said of this
statute:
The purposes of this legislation thus touch phases of the lives and health of people
which, in the circumstances of modern industrialism, are largely beyond self-protection.
Regard for these purposes should infuse construction of the legislation if it is to be
treated as a working instrument of government and not merely as a collection of English
words.    [Cases cited.]
"As we will point out hereafter, we are here being asked to accept defensive
refinements that we believe are as gossamer-like as the traditional 'shadow of
a shade' of the ancient legal commentators. We have recently had occasion
to construe this same statute and have endeavored to do so in the liberal spirit
commanded by the Supreme Court. Research Laboratories, Inc. v. United
States [CCA 9], 167 F. 2d 410, 421. In the instant case, we do not feel disposed
to depart from that same generous norm of interpretation, which we believe
accords with public policy and with the spirit of the law itself.
3. THE GOVERNMENT'S BURDEN AND THE APPELLATE FUNCTION
"The appellants seem to be laboring -under a fundamental misconceptiott
regarding (1) the degree of proof required from the appellee and (2) the duty?,
of this court in the evaluation of the evidence.   Because these misapprehien-?(
sions are basic, we will endeavor to clear them away at the outset.
(A) "REASONABLE" VERSUS "POSSIBLE" DOUBT
"While the appellants professedly recognize the rule that the Government
must prove its case beyond a reasonable doubt, their briefs are replete with
expressions which seem to indicate that in reality the standard actually in-
. sisted upon is, that the appellee's evidence should remove all possible doubt.
"For example, we are twice told that "The Government failed to, eliminate
the possibility of the drugs having lost their strength . . . or having un-
dissolved material formed or introduced in it . . . between the dates of
shipment and the dates of the Government tests.' Again, after enumerating
many dire vicissitudes through which the drugs in question might have passed-
such as improper handling, the use of hypodermic needles containing certain
chemicals, and the like-the appellants suggest: 'Any one of the above things
may have occurred even while in the inspector's hands, or during shipment by
the inspector to Washington, D. C   [Italics supplied.]
"Elsewhere we find a variation of the same theme: 'Furthermore, there was
no evidence precluding the possibility that the drugs became adulterated and
misbranded at some time after they had been shipped by appellants from
Pasadena, California.' [Italics supplied.] Finally, in the reply brief we find
the statement that 'still the Government cannot prevail because the Government
introduced no evidence to show that any of the above things did not happen/
"While in other portions of their briefs the appellants do complain that the
Government failed to adduce certain affirmative evidence, their insistence also
upon the lack of negative evidence indicates that they are holding the appellee
to too strict a standard of proof; namely, the proof of several negatives.
"In Henderson v. United States [CCA 9], 143 F. 2d 681, 682, we said:
The proof in a criminal case need not exclude all doubt. If that were the rule, crime
?would be punished only by the criminal's own conscience, and organized society would
be without defense against the conscienceless criminal and against the weak, the cow-
ardly and the lazy who would seek to live on their wits. The proof need go no further
than reach that degree of probability where the general experience of men suggests
that it has passed the mark of reasonable doubt.
See also Rose v. United States [CCA 9], 149 F. 2d 755, 759.
(B)   THE  WEIGHT  OF  THE EVIDENCE
"In the second place, the appellants' briefs contain frequent references to
the weight of the evidence. For example, complaint is made that 'The finding
of guilty by the Trial Court is, therefore, contrary to the weight of the evi-
dence' ; that certain allegedly contradictory testimony by Mason 'does nothing
more, it is submitted, than detract from the weight, of any of Mason's testi-
mony' ; that 'the findings of guilty by the Lower Court are contrary to the
weight of the evidence'; that 'Mason was biased and gave contradictory testi-
mony' ; and that 'the best evidence is the testimony of Bavouset,' etc.
"While as to this question, too, the appellants elsewhere in their briefs assert
a total lack of evidence to support the Government's case, their constant in-
sistence on the irrelevant question of the weight of the evidence indicates that
a certain confusion on this subject exists in their minds.
. "To clarify the matter for once and for all, we wish to restate plainly that
this court is not concerned with the weight of the testimony adduced below.
'Questions of credibility were for the trial court.' Newman v. United States
[CCA 9], 156 F. 2d 8, 10, certiorari denied sub. nom. Cain v. United States, 329
U. S. 760.
(C)  THE PRESUMPTION SUPPORTING THE TRIAL COURT'S JUDGMENT
"As a corollary to the above proposition, there need be only briefly mentioned
the equally familiar doctrine relative to the weight that even in a criminal case
It is a familiar principle, which it is, our duty to apply, that an appellate court will
indulge all reasonable presumptions in support of the rulings of a trial court ana
therefore that it will draw all inferences permissible from the record, and in determining
whether evidence is sufficient to sustain a conviction, will consider the evidence ipost
favorably to the prosecution.    {Cases cited.]
4. THE IDENTITY OF THE SAMPLES
"The appellee 'has no quarrel' with the proposition that the burden is on the
Government to establish that in reasonable probability the testimony of its
witnesses regarding the condition of the drugs as of the date of analysis
substantially reflects their condition on the date of shipment.
"The controversy between the parties arises in the application of this familiar
principle to the facts at bar. The appellants seem to insist on what would
amount to a mathematical demonstration that there was no tampering with
the vials anywhere along the line, from the date the products left the custody
of the appellants to the date when the drugs were examined and analyzed in
Washington or San Francisco. The appellee, on the other hand, asserts that
it has undertaken 'to establish the identity of the samples as of the time of
shipment, by circumstantial evidence relating to their interstate shipment, the
identity of the consignees and the condition of the drugs when received by the
Government chemists, together with the reasonable inferences flowing from
such evidence.'
"We will now examine these divergent assertions in greater detail.
(A) "THE CHAIN OF POSSESSION"
"The appellants contend that the opinions of the Government's witnesses,
based on tests made after the drugs had been shipped to Washington are
'absolutely worthless because the expert witnesses had no knowledge that the
alleged adulteration or misbranding did not occur enroute to the doctor's office,
or in the doctor's office, or in the hands of the Government inspectors who picked
up the drugs, or enroute to Washington, D. C, when shipped there by the
Government inspectors.'
"Carried to its logical conclusion, this 'chain of possession' theory would
require the Government to prove affirmatively that each one of the many mail
clerks, Administration clerks and experts, doctors, nurses, express company
employees, 'and others,' handled and cared for the goods so that changes could
not occur while the drugs were in their custody. It must also be shown that
the products 'were not tampered with,' say the appellants.
"Such a rigorous exaction regarding proof is supported neither by reason
nor by authority. If the Government was obliged to establish the absence of
'tampering' by every one who had any contact whatsoever with the drugs, the
Act would be incapable of enforcement.
"In Lestico v. Kuehner [Minn.], 283 N. W. 122, 125, the court derided 'the
unique theory' that it was incumbent to show the 'chain of possession' of a
punctured tire casing offered in evidence after it had been repaired, 'during the
whole period from accident to trial.'   The court said:
The tire had been removed and repaired in Minneapolis.   The thought of objections
and sustaining rulings was that no sufficient foundation could be laid except by testimony
not only as to genuineness, but also the absence of tampering, from every person through
whose hands the casing had passed in the meantime.
There is no such rule and never has been.   [Italics supplied.]
"In quoting authorities to support their position, the appellants significantly
omit two pertinent passages from their excerpts. From the opinion in United
States v. S. B. Penick & Go. [OCA 2], 136 F. 2d 413, 415, they delete the
following sentences:
But there is no hard and fast rule that the prosecution must exclude all possibility that
the article may have been tampered with. [Citing Lestico v. Kuehner, supra] * * *
Here the samples were taken in the ordinary course of business for the very purpose
of being retained as samples; they were put in the usual place where samples were
kept to remove them from accident or meddling and there they remained, so far as
appear[s], undisturbed. We think this showing was sufficient to justify admission in
evidence of the bottles and their contents and that it was for the jury to decide how
likely it was that some other substance had been substituted for what was originally
put in the bottles.    [Cases cited.]
"Similarly, the appellants omit the following sentences from the very middle
of their quotation from 32 C. J. S. ? 607, at pages 457-458:
However, it is not necessary that the article be identically the same as at the time
in controversy. It is unnecessary to show an absence of tampering on the part of every
person through whose hands the article has passed; as long as the article can be identi-
fied it is immaterial in how many or in whose hands it has been. A direct statement
that the article was in the same condition at the time of an occurrence as at a subse-
quent time is not required if it sufficiently appears that it must have been in substan-
tially the same condition.
(B)   THE PRESUMPTION  OF  BEGULAEITT
"Buttressing the natural and reasonable inferences that may be drawn from
the stipulations and the testimony regarding the marking, sealing and opening
of the vials in question, there are certain well-established presumptions regard-
ing the regularity not only of the acts of public servants but also of the acts
Of private individuals.
I. OF THE ACTS OF PUBLIC SERVANTS
"In United States v. Chemical Foundation, 272 U. S. 1, 14-15, the familiar
rule as to the acts of public officers is thus stated:
The presumption of regularity supports the official acts of public officers and, in the
absence of clear evidence to the contrary, courts presume that they have properly dis-
charged their official duties.    [Cases cited.]     [Italics supplied.] x
"In the instant case, this presumption of official regularity would apply not
only to the methods used by the Government chemists and analysts in handling
the vials, but also to the care and to the absence of tampering on the part of
the postal employees through whose hands the shipments passed. Boerner v.
United States [DC NT], 30 F. Supp. 635, 637, affirmed, 117 F. 2d 387, certiorari
denied, 313 U. S. 587.
II. OF THE ACTS OF PRIVATE INDIVIDUALS
"While the appellants reluctantly concede that there 'may' be a presumption
supporting the official acts of public servants, they insist that 'there is no
presumption whatever' with respect to 'shippers,' doctors, nurses, 'and others.'
"We do not agree.
"In United States Bank v. Dandridge, 25 U. S. 64, 69-70, Mr. Justice Story
said:
By the general rules of evidence, presumptions are continually made, in cases of
private persons, of acts even of the most solemn nature, when those acts are the
natural result or necessary accompaniment of other circumstances. In aid of this
salutary principle, the law itself, for the purpose of strengthening the infirmity of
evidence, and upholding transactions, intimately connected with the public peace, and
the security of private property, indulges its own presumptions. It presumes, that
every man, in his private and official character, does his duty, until the contrary is
proved [cases cited] ; it will presume that all things are rightly done, unless the
circumstances of the case overturn this presumption, according to the maxim, omnia
presumuntur rite et solemniter esse acta, donee prooetur in contrarium.
"This early decision and the doctrine that it enunciates were referred to
with approval in International Shoe Company v. Federal Trade Commission,
280 U. S. 291, 302, where reference was made to 'the familiar presumption of
rightfulness which attaches to human conduct in general.' 2
"This presumption that even private individuals do their duty and exercise
due care should apply a fortiori to doctors and nurses, whose professional train-
ing and traditions teach them to be meticulous in the handling of preparations
that are to be administered to their patients.
"Indeed,-in the instant case, this presumption is supported by the affirmative
testimony of one of the appellants' own witnesses.   Dr. Roland N. Icke, director
of research at the appellants' laboratories, said while under cross-examination:
Q. ... It has been your practice and observation of most doctors that they try
to keep their bottles in proper places, has it not, Doctor 
1?See also Bowles v. Glick Bros. Lumber Co. [CCA 9], 146 F. 2d 566, 571, certiorari
denied, 325 U. S. 877; Dunn v. Ickes [CA DC], 115 F. 2d 36, 37, n. 8, certiorari denied,
311 U. S. 698; Middlesboro Liquor & Wine Co., Inc. v. Berkshire [CA DC], 133 F.
2d 39   42
2?See also Powell Bros. Truck Lines v. Piatt [CCA 10], 92 F. 2d, 879, 880; 31 C. J. &
S 150 e, page 840.
A. I believe most of them do; yes.
Q. And it is rare that you find a doctor but what he adheres to the cautions that he
has been instructed ; isn't that correct -
A. Yes.
"The appellants have n?t pointed out, nor have we been able to find, a single
scintilla of evidence in the record to indicate that any of the vials were
mishandled by a single postal clerk, expressman, doctor, nurse, Government
analyst, Administration mail clerk, or any one else who had any connection
with the sealing, labeling, consignment, transmission, unwrapping, unsealing,
or testing of the products in question.
"The only suggestions of mishandling are in the form of dire possibilities
conjured up by resourceful counsel.  But possibilities are not proof.
5. THE SO-CALLED "DISCLAIMER"
(A) SHOULD "THYROID SUBSTANCE" CONTAIN IODINE
"It will be recalled that, although the label on the vials of 'Sterile Indoform'
announced that each cubic centimeter of the contents carried one grain of
'thyroid substance,' Buell, the Administration's chemist, found 'no thyroid
present whatsoever.'
"The appellants seek to avoid the impact of Buell's testimony by pointing out
that, according to his own statement, the only thing that he examined the
product for 'was for the therapeutically active ingredients of thyroid, which
were the organically combined iodine products.' In other words, he examined
'only for iodine.'
"Buell also testified, however, that the label statement regarding 'thyroid
substance' means that each cubic centimeter contains 'one grain of the active
constituent of the thyroid,' 'as organically combined iodine.' 'The activity of
thyroid,' he explained, 'depends on the organically combined iodine present in
the thyroid.'
"The appellants freely admit that there never was any iodine in 'Indoform.'
They point to Buell's own testimony, however, that there would be present in
a thyroid gland 'other things' besides iodine. From this the appellants argue
that the words 'thyroid substance' do not necessarily imply that the preparation
contains iodine.
(B)   AT BEST THE LABEL TELLS ONLY A HALF-TEUTH
"The appellants seek to bolster up this argument by pointing out that the
label itself contains the notation:
This preparation does not contain any known therapeutically useful constituent.
Since iodine is a therapeutically useful ingredient, they say, the label itself
indicates that iodine is not present.
"There are two answers to this argument. In the first place, this so-called
disclaimer itself is untruthful. The appellant Bavouset himself admitted on
the stand that posterior pituitary, which, as we have seen, is one of the in-
gredients of 'Indoform,' does have therapeutic value. He also testified that he
'didn't manufacture' whole ovarian, another constituent, to be a meaningless
product. The appellants seek-without avail, we think-to weaken the effect
of this testimony by Bavouset's later lame and somewhat cryptic explanation
that 'In this particular solution, this form would not be measurable.' In any
event, we cannot say that the court erred if it believed from the evidence-as
we do-that posterior pituitary and whole ovarian do have some therapeutic
value.
"Assuming, however, for the sake of the argument, that the 'disclaimer' does
tell the truth, it cannot cure the vice of the half-truth or equivocation in the
use of the expression 'thyroid substance' in a preparation that contains no
iodine. Section 321 (n) of 21 USCA provides that omissions as well as repre-
sentations shall be taken into account in determining whether the labeling is
misleading.
"In Research Laboratories v. United States, supra, 167 F. 2d at page 418,
we held that 'the scientific half-truths in the labeling alone make out a case
of actionable misbranding.'
. ? 
 "Specific reference to self-contradictory labels is found, in H. N. Heusner &
Soii v. Federal Trade Commission [CCA 8], icfe F. 2d $9$, 5S>7:
Accordingly,  the petitioner, a Pennsylvania jnanufacturer of cigars whien cdntain
$nly Pennsylvania tobacco, but,are b;
Cease 
and
 desist from using the wbfd "Hava
id modify this order so as to permit tie
appropriate "qualification," i. e.;..the legend: "Notice.    These Cigars are made in the
United States and only of United States tobacco."    .     ,
?    .?u .
 The .difficulty pf. petitioner's position lies in the fact that the implicatioii .of the
wor?[ "Havana" is totally false\ Tn? purchaser can be giiiSed by either label or legend,
but not by both.    [Emphasis supplied.] 8
"So here, the fiufchaser of 'Inddfofm* could be guided by either the labeling
'thyroid substance/ which implies the presence df a therapeutic ingredient, or
by the 'disclaimer' of the presence of any such ingredient. Obviously, the
implication of presence and the negation 6f presence cannot both be true.
"In the language of the day, this 'Indoform' label strikes us as a bit of
scientific 'double-talk.'
"The Supreme Court has repeatedly denounced equivocation and evasion by
those who come within the reach of a statute that enunciates Governmental
policy. Whether the subterfuge is accomplished by suppression of contradic-
tion, the vice is the" same.
"Referring to the Food and Drugs Act of 1906, the Supreme Court, in United
States v. 95 Barrels df Vinegar, 265 TJ. S. 438, 442-443, used the following
language:
The statute is plain and direct. Its comprehensive terms condemn every statement,
design and device 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 which are false. It is not difficult to choose statements, designs and devices
which will not deceive. Those which are ambiguous and liable to mislead should be
read favorably to the accomplishment of the purpose of the act.*
"So here, it would have been 'not difficult to choose statements' that would
not deceive. The simple legend, 'This preparation does not contain iodine,'
would have been sufficient.
6. THE HYPOTHETICAL QUESTIONS
"The appellants object to certain hypothetical questions that were propounded
to three of the Government's experts. These questions have already been
quoted by us, either verbatim or in substance, in our outline of the facts.
(A)   THE QUESTIONS PRESENTED SUFFICIENT FACTS IN EVIDENCE
"The appellants' first two attacks upon these hypothetical questions may be
considered together. They are (1) that the question addressed to Dr. Wiley did
not contain sufficient facts to afford ground for a reasonable conclusion or
Opinion, and (2) that the question asked of Mason and Capps assumed facts not
in evidence.
"From the facts already stated, supplemented by the reasonable inferences
flowing therefrom and by the presumptions of regularity that, as we have seen,
are firmly recognized in the law, it is clear that the hypothetical questions
referred to were not Objectionable. We need not labor the factual aspects
further.
"Moreover, it should be remembered that the rule requiring a factual basis
for a hypothetical question is not applied with iron rigidity.
"In Permanente Metals Corporation v. Pista I CCA 9], 154 F. 2d 568, 569,
we said:
Moreover, it has been held in California, as elsewhere, that where a witness answers
a hypothetical question not founded on all the facts of the case, the defect goes not to
the competency of the evidence but merely affects its weight.
"And in the earlier case of Travelers Ins. Co. v. Drake [CCA 9], 89 F. 2d 47,
50, this court used the following language regarding the factual latitude that
might be allowed:
The question may be framed upon any theory of the interrogator, which can reasonably
be deduced from the evidence; any assumptions may be indulged on any fact within
3?See also El Moro Cigar Co. v. Federal Commission [CCA 4], 107 F. 2d 429, 431;
Progress Tailoring Co. v. Federal Trade Commission [CCA 7], 153 F. 2d 103. 105.
4?See also Donaldson v. Read Magazine, 333 U. S. 178, 188-189.
the evidence, upon ?which: opinion is desired by the interrogator; and facts not deemed
material may be omitted. [Many cases cited.] The truth of facts assumed by the
hypothetical question as -within the probable range of the evidence, as a basis to support
the hypothetical question, is a question of fact for the determination of the jury to find
with the other submitted facts upon a fair submission of the issue, and it must determine
?whether the basis upon which the hypothetical question rests has been established.
[Authorities cited.] When the question assumes a state of facts -which the evidence
directly, fairly, and reasonably tends to establish, and does not transcend the range of
the evidence, it is not objectionable.    TCases cited.] B
(B)   THE QUESTIONS DID NOT DEAL WITH "ULTIMATE ISSUES"
"The appellants further urge that all the hypothetical questions violated the
'rule of law' 'excluding the opinions of experts as to the ultimate issues of fact
to be determined.'
"This objection is not well grounded. A glance at the questions discloses
that in none of them is there any reference to 'misbranding' or 'adulterating,'
which are the ultimate issues in this case. Dr. Wiley was asked whether he
thought that the two vials of Pluri-B contained the undissolved particles on
June 18, 1946, the date on which they were shipped. The question addressed
to Mason was whether the 'Indoform' contained three international units of
posterior pituitary on September 17, 1945. The hypothetical question directed
to Capps related to the amount of thiamine hydrochloride in the Pluri-B on
the date when it was shipped by the appellants, July 16, 1945.
"All these questions dealt with supporting or evidentiary facts, and not.
ultimate issues.   It is true that the facts inquired about were related to the
ultimate issues; else the hypothetical questions would have been irrelevant,
and the appellants would now be clamoring that the questions were improper
on the ground of immateriality.
"In Travelers Ins. Co. v. Drake [CCA 9], supra, 89 F. 2d at page 49, this
court said:
While the jury is the sole judge of the facts as to the issue of death and cause of
?death, that does not, however, make objectionable the opinion of a medical expert in
aid to the jury to find the ultimate fact.    [Many cases cited.] a
"Furthermore, this court has repeatedly held that the fairness of a hypotheti-
cal question is largely a matter that lies within the discretion of the trial judge.1
(O)   THE TRIAL JUDGE IS PRESUMED TO CONSIDER ONLT COMPETENT EVIDENCE
"Even if certain deficiencies had crept into any of the hypothetical questions-
which we most certainly do not concede-in this and in other circuits it is
presumed that the trial judge considered only competent evidence in arriving
at his judgment
"In Hoffman v. United States [CCA 9], 87 F. 2d 410, 411, we said:
This case was tried by the judge and presumably he would consider only material
and competent testimony.8
7. THE APPELLANTS' ADMITTED LACK OF TESTING EQUIPMENT
"Capps said on the stand that he tested the contents of one of the vials in
evidence for thiamine hydrochloride, and that he used a 'Thiachrome procedure.'
This test was made on September 24,1945.
"Immediately following Capps as a witness was the appellant Bavouset. The
latter was cross-examined at some length regarding a hearing of the Adminis-
tration conducted by a Mr. Howe on November 7, 1945. The record shows the
following:
Q. And did you not likewise state to Mr. Rowe at the hearing on or about November
7, 1945, with regard to the Pluri-B and the thiamine deficiency, that you did not have
" See also Moyer v. Aetna Life Ins. Co. [CCA 3], 126 F. 2d 141, 144.
?See also Francis v. Southern Pacific Company [CCA 10], 162 F. '2d 813, 817,
afiirmed, 333 U. S. 445 ; United States v. 7 Jugs, etc., of Dr. Salsbury's Bakos [DC Minn.],
53 F. Supp. 746, 760.
7?Travelers Ins. Co. v. Drake |"CCA 9], supra, 89 F. 2d at page 50; United States v.
Aspinwall [CCA 9,] 96 F. 2d, 867, 869; Permanente Metals Corporation v. Pista
rCCA 9], supra, 154 F. 2d at pages 569-570. Cf. Moyer v. Aetna Life Ins. Co. [CCA 3].
126 F. 2d at page 144.
8?See also United States v. David [CCA 7], 107 F. 2d 519, 522 ; Murray v. United States
[CCA 8], 117 F. 2d 40, 45; Gates v. United States  [CCA 10], 122 F. 2d 571, 578,
certiorari denied, 314 U.  S. 698; Daniel v. United States  [CCA 8], 127 F. 2d 1,
certiorari denied, 317 U. S. 641.
have to, therefore, revise your manufacture and procedure
A. We did hot have the equipment, Now, about the revision of manufacturing
procedure, that goes on almost every "day.
"The appellee refers to this lack as constituting 'poor manufacturing controls.'
In resisting this charge, the appellants, in their reply brief, run into another
admission:
When the Government uses the term "poor manufacturing controls" it undoubtedly
refers to the fact tha;fc appellants did not, always test their products at the conclusion
of the manufacture.    [Emphasis supplied.]
"All this, we think, further supports the trial court's judgment that the
appellants' products in question were so deficient or contaminated as to result
in a violation of the Act.
8. CONCLUSION
"While in the foregoing discussion we have copiously referred to the tran-
script, we have not attempted to give a complete summary of the evidence. To
have done so would have unduly lengthened this opinion.
"Our careful study of the entire record, however, has convinced us that there
was no error in the judgment below, and it is accordingly affirmed."