24525. Alleged Misbranding of Gizzard Capsule. TT. S. v. 18 Packages, et 
al., of Gizzard Capsule. Tried to the court; judgment for claim- 
ant.     Libel ordered dismissed and product delivered to claimant.
(F. & D. no. 33165.    Sample nos. 3330-B, 3331-B, 3332-B.)
On August 8, 1934, the United States attorney for the Western District of 
Missouri, acting upon a report by the Secretary of Agriculture, filed in the 
district court a libel (amended January 24, 1935) praying seizure and con- 
demnation of 47 packages of Gizzard Capsule at Kansas City, Mo., alleging that 
the article had been shipped in interstate commerce in part on or about October 
3, 1933, and in part on or about March 6, 1934, by the Geo. H. Lee Co., from 
Omaha, Nebr., and charging misbranding in violation of the Food and Drugs 
Act as amended.
Analysis showed that the article consisted essentially of kamala, nicotine 
(66 milligrams per tablet), copper oxide (371 milligrams per tablet), a small 
proportion of chenopodium oil, and graphite.
The article was alleged to be misbranded in that the following statements 
regarding its curative or therapeutic effects were false and fraudulent: (Pack- 
age) "For * * * Large Tape Worms and Pin (Ceca) Worms in Chickens 
and Turkeys * * * For the Removal of * * * Large Tape and Pin 
(Ceca) Worms in Poultry * * * delivers the medicine, undiluted, fresh 
and full strength directly upon the worms in the intestines"; (circular) 
"For * * * Large Tape and Pin Worms in Chickens and Turkeys * * * 
To lay well, hens must be reasonably free from worms * * * Worm your 
flock with Gizzard Capsules; * * * to expel the worms * * * the 
exact full strength dose of worm medicine is emptied into the intestines and 
reaches the worms."
On February 1, 1935, the Geo. H. Lee Co., having appeared as claimant for 
the property and a jury having been waived, the case was submitted to the court 
on the pleadings, evidence, written briefs, and arguments of counsel. On Febru- 
ary 2, 1935, the court made the following findings of fact and conclusion of 
law in favor of the claimant (Otis, District Judge) :
'This case was instituted by the filing here of a libel on August 8, 1934. f 
'Thereafter, on January 4, 1935, an amended libel was filed. In the amended 
libel it is alleged that certain packages of what was called in the caption and 
in the body of the libel 'Gizzard Capsules', which it is alleged were at the time 
of the filing of the amended libel in the possession of the McPike Drug Com- 
pany of Kansas City, Missouri, were packages of a product which had been 
misbranded in violation of the Food and Drugs Act, in that there appeared 
•upon the packages and within the packages certain statements with reference 
to the product which were false and fraudulent.
"The George H. Lee Company has filed in this proceeding its answer to the 
allegations of the amended libel and its claim to the packages therein referred 
to.    In its answer it denies certain of the allegations of the amended libel.
"The libel is based upon that part of the Food and Drugs Act which declares 
that an article shall be deemed to be misbranded if the package or label shall 
bear or contain any statement, design, or device regarding the curative or 
therapeutic effect of the medicine or any of the ingredients or substance con- 
tained therein which is false and fraudulent:. The libel charges that the 
packages referred to in it were labeled and that they were accompanied by 
circulars in each of which it was represented that the product was for large 
tape worms and pin (Ascaridia) worms in chickens and turkeys. It alleges 
that those statements contained in the label and circular were false and that 
they were made fraudulently. The answer of the claimant denies that the 
statements in the libel and circular either were false or fraudulent
"The controverted issues of fact not disposed of by the stipulation and the 
admissions in the answer are two. The first of these is: Were the statements 
made in the labels and circulars false? The second is: Were those statements 
made fraudulently? The burden is upon the plaintiff in this case to prove 
both that the statements made in the labels and circulars were false and that 
they were made fraudulently,—to prove those charges and allegations by the 
preponderance or greater weight of the credible testimony.
"It may be regrettable that such issues of fact as these especially the first, 
must be submitted to a judicial tribunal, but however regrettable that is, the 
law does that In some countries I have been informed in a case of this 
kind the judge of the court would call to his assistance a lay judge, so-called, 
learned in the field of science, to aid him in determining such an issue. That 
is not our system. A judge trained only in the law, necessarily must have 
some difficulty in deciding such an issue of fact as the first of the two issues 
which this case presents.
"It is represented in the labels and in the circulars also—I shall not here- 
after speak of the circulars since they do not complicate the case in any way— 
that the drug called 'Gizzard Capsule' is 'for large round worms, large tape 
worms and in (Ascaridia) worms in chickens and turkeys.' The word 
'remedy' does not appear but it may be added because it certainly is implied.
"The evidence clearly discloses the fact that poultry, particularly chickens 
and turkeys, sometimes are infested with certain parasites known as round 
worms, large tape worms and pin worms. They are injurious to the poultry 
which they infest. It is desirable to lessen or entirely to prevent, if that is 
possible, the injury which follows from the presence of these parasites in the 
digestive tract of the chicken or turkey. Any remedy which entirely removes 
large tape worms and therefore puts an end to the injury resulting from their 
presence if labeled a remedy for large tape worms, certainly could not be said 
to be falsely so labeled. Any remedy which, although it may not entirely 
remove such tape worms, may not completely put an end to the injury resulting 
from their presence, but which lessens that injury, whether permanently or 
temporarily, if labeled a remedy for large tape worms, cannot be said to be 
falsely labeled. I cannot believe that anyone reasonably could question that 
conclusion. The remedy for a disease may not be a complete cure for the 
disease, but if it lessens the injury which the disease causes, whether tempo- 
rarily or permanently, is a remedy for that disease and may be truthfully so 
described. Even a layman may think of many remedies for human diseases 
which are universally used and whose benefits have been universally recognized 
which do not cure the disease but only temporarily ameliorate its ravages or 
perhaps permanently lessen its ill effects. If we may take some very homely 
illustrations, I do not suppose that aspirin cures headaches but it certainly is a 
remedy for headaches, having temporarily beneficial effects. I don't suppose 
Smith's Cough Drops cure colds—I am not trying to advertise Smith's Cough
Drops—but they certainly are a remedy for bad colds and temporarily amelio- 
rate their effects. Passing from such homely illustrations, I have read that 
for that very severe human disease known as diabetes there is no cure at all 
but that the injury resulting from it is very greatly stayed by a relatively 
newly discovered drug known as insulin which puts off the final fatal day and 
greatly ameliorates the condition of suffering and yet it is not a cure.
"I say that there cannot be any controversy but that any remedy, whether 
for a human being or for an animal or for a bird which lessens]the injury from* 
any particular disease or lessens the injury caused by any Particular parasite, 
if it is represented that it is a remedy for that disease or for that parasite is 
not falsely so represented. So, the question is this: Does this remedy called 
'Gizzard Capsule' lessen the injurious effects resulting from the presence in the 
digestive tract of a chicken or turkey of large tape worms? Does it lessen 
the injurious effects resulting from their presence? If it does, then it is not 
falsely labeled when it is represented that it is a remedy for large tape worms.
"Now, with this somewhat narrowed issue in mind I consider the testimony 
of the witnesses. For the plaintiff there was testimony here of several gentle- 
men ; for the claimant, several. The witnesses for the plaintiff all were scien- 
tific men connected with the Department of Agriculture. The witnesses for the 
claimant were, some of them, learned in science to some extent at least, and 
some lay witnesses also. All the witnesses impressed me as honorable men, 
endeavoring to tell the truth as they believed the truth to be. It is no reflec- 
tion upon the witnesses for the claimant to say that the witnesses for the 
plaintiff from the standpoint of training were the better qualified, and perhaps 
also the less interested. I have always believed that the scientific men con- 
nected with the Government were men of fine ability. That belief is stronger 
now than it has been before by reason of the appearance and the testimony 
of the witnesses who were here for the plaintiff. They are very exceptional 
and very able men, highly learned and very fair.
"When all of the testimony is considered, can it be said that it has been 
proved here by the preponderance or greater weight of the credible testimony 
that the injury resulting from the presence of large tape worms in poultry, 
are not lessened by this remedy by the contents of these Gizzard Capsules 
"Well, what is the injury which results from the presence of tape worms 
in chickens? All I know about it is what I have learned here. I never 
before knew that chickens had tape worms and I am sorry to learn it now. 
These tape worms have been described by the witnesses, pictures of them have 
been offered in evidence here, specimens of them have been offered in evidence 
here. A tape worm, it appears, consists of a head and a neck and a body, if 
you may use that word; I think it was used by the witnesses. It may be of 
varying lengths. Large tape worms, it appears, are in length from a half 
inch to four or five or six or more inches. It fastens itself upon the interior 
wall of the intestine of the bird and the head of it and part of its body may 
penetrate at least the inner surface of that; wall. It injures the bird in 
two ways—it seems to me from the evidence it injures it in two ways. 
The chief injury which it does is that it perforates the intestinal wall 
of the bird and may cause some infection in that wall. That is the chief 
injury which it does. It is a strange sort of an organism, this tape worm. 
It absorbs its own nutriment, not only at the head but in every segment of 
its body. The nutriment upon which it lives is that which it draws either 
from the body of the bird or from the food which it has ingested. I do not 
know whether this remedy here in question destroys the heads of tape worms 
or does not. I should be inclined to believe that the plaintiff's witnesses, 
being the better qualified perhaps and better prepared and less interested 
right, that is to say that the heads are not destroyed by this remedy. I can- 
not believe, however, that the presence of a foreign body in the digestive tract 
in' the intestine which may be half an inch or six inches in length, which 
absorbs food values that otherwise would go to the bird, especially if multiplied 
by hundreds—I cannot believe that they have no injurious effects whatever 
on that account. The intestine of a chicken seems to be small. To say that 
the health of a chicken is not injured by the presence of a great quantity of 
foreign matter in the intestine attached to the wall of the intestine, and every 
part of which absorbs something that otherwise would feed the chicken, to say 
that that is of no injury whatever seems to me would be a conclusion that a 
scientist could hardly reach. Certainly if a human being had any such mass 
of stuff in his intestines it would not be thought to be otherwise than in- 
jurious to his health.    I am unable to escape the conclusion from this testi-
mony that this remedy, this Gizzard Capsule and its contents, or rather its 
contents does have the effect of sweeping out of the intestine at least the 
bodies as I have described them, of large tape worms. Almost that was con- 
ceded by the witnesses for the plaintiff. The principal of the witnesses for 
the plaintiff, said—I understood him to say at least, that the reason this drug 
did not remove or affect the heads of parasitic forms was that it could not 
reach them, that it only sheered them away from the intestinal walls, swept 
them away. If it does, it cannot be said that it does not to some degree at 
least lessen the injury resulting from the presence of the parasites known as 
large tape worms. It may be only temporarily that it does that, but it does 
it temporarily. If it lessens the injury resulting from the presence of the 
parasites, and if on that account it improves the health of the bird it is not 
falsely labeled when it is labeled a remedy for large tape worms.
"This remedy is also labeled a remedy for pin worms. Without taking up 
too much time I think it cannot be said that the plaintiff has proved by the 
preponderance or greater weight of the credible testimony that this remedy 
does not have some benefit in removing some portion of the pin worms which 
may infest a chicken. I have no doubt that the quantity of such worms in a 
given chicken, whether the number is great or small, may have something to 
do with the injury resulting from their presence; at least there has been no 
evidence that the number of such worms has nothing to do with the injurious 
effects on the chicken. I suppose that one worm is less injurious than a 
thousand and that six are less injurious than a hundred. I am not prepared 
to say that this remedy is clearly shown to be meritorious so far as pin 
worms are concerned. I say only that it has not been proven that it is not 
of some value with respect to them.
"I do not need to say that the purpose of the Pure Food and Drugs Act 
which is to deprive persons of the use of the channels of Interstate Commerce 
for furtherance of fraud in any matter of misrepresentations as to foods and 
drugs, that with that purpose every citizen should have the greatest sympathy. 
I have, but that sympathy with the purpose of that law cannot change or 
alter in any way the rules of law which are applicable to cases of this 
character.
"Now, I come to the second issue of fact, although from what I have said 
It appears that it is not necessary to pass upon that issue of fact. That issue 
is: Was there fraud in the preparation and publication of these labels and 
circulars? There could not be fraud if they were not false. Therefore, the 
determination of the first issue determines the second but the second issue 
could be determined upon other considerations, even if it had been determined 
that the labels were false and that the circulars were false. If the manufac- 
turer or vendor of these Gizzard Capsules honestly and sincerely believed 
that they were remedies for tape worms and pin worms, then that manufac- 
turer could not have been guilty of fraud, even if they were wholly valueless 
and inefficacious. It was proper for the manufacturer to endeavor to satisfy 
himself as to whether the remedy was good for tape worms and pin worms. 
The point I am making is that the manufacturer was not bound by the con- 
clusions reached by the scientists in the Department of Agriculture. They 
render a great service but they are not given the power to decide questions 
finally and ultimately. They can be decided only by courts. The question as 
to whether a given label is false or a given circular is false, is a question for 
the courts. The claimant manufacturer had a right to make his own investi- 
gations and it made those investigations, and if from them it sincerely be- 
lieved this remedy was one that was effective for tape worms and pin worms 
it was not bound to discontinue its business until it could convince the sci- 
entists in the Department of Agriculture. It was under no obligation to do 
that It had a right to continue its business and to submit the issue ultimately 
to a court. Even if I should believe that the conclusion testified to by the 
witnesses for the Government were correct that these capsules were of no 
value whatever against tape worms and pin worms, I could not believe that 
the claimant here did not have some support for its contention that it hon- 
estly believed that they were effective remedies. Investigations which were 
made by representatives of the claimant were as thorough as some made by 
the Department of Agriculture, perhaps by men not so well trained. They 
were reported to the officers of the claimant by the men who made the 
investigations and they were honestly reported to the claimant. There can 
be no question about that last statement.    If these investigations had not
been honestly reported to the claimant, if the results were falsely represented 
by the men who made the investigations, they certainly would have done a 
better job of making the false statements than they testified to. They testified 
to the results almost as variable as testified to by the witnesses for the 
Government.
"I have no doubt that the Government has not proved that there was no 
fraud in the preparation and circulation of the labels and circulars referred 
to in the libel.
"1. In addition to the facts which in a general way already have been found, 
I find that the label and circular referred to in the amended libel introduced 
in evidence, in so far as they represent that the remedy called 'Gizzard Capsule' 
was a remedy for large tape worms, do not contain false representations and 
are not false.
"2. "I find that in so far as the label speaks of the 'Gizzard Capsule' as a remedy 
for pin worms it has not been proven that so much of the label and so much of 
the circular in which like language appears is false.
"3. I find that the claimant in this case, the George H. Lee Company, in 
publishing and circulating and attaching to its package labels and circulars 
referred to in the amended libel, was not guilty of any fraud and that the 
labels and circulars are not fraudulent.
"Conclusion of law.—Upon the facts found I conclude as a matter of law 
that the plaintiff is not entitled to the relief asked in the amended libel.
"Counsel for the claimant may prepare and submit to the Court for approval 
an entry a form of judgment in this case.
"To the conclusions of law which the court has stated and also to the findings 
_ offact, and to each of them, the plaintiff is allowed an exception."
X)n February 18, 1935, judgment was entered ordering that the libel be dis- 
missed and the product delivered to the claimant.
M. L. WILSON, Acting Secretary of Agriculture.