2276. Adulteration and misbranding of prophylactics. IT. S. v. 43% Gross and
112% Gross of Prophylactics. Tried to the court. Decree of condemna-
tion. Product ordered released under bond. (F. D. C. No. 16888. Sample
Nos. 18372-H, 18373-H.)
LIBEL FILED :   July 21,1945, District of Minnesota.
ALLEGED SHIPMENT : On or about June 19,1945, by the Killashun Sales Division,
from Akron, Ohio.
PRODUCT: 43? gross and 112? gross of prophylactics at Minneapolis, Minn.
Examination of 108 samples from each of the 2 lots showed that 7.4 percent
and 11.1 percent, respectively, were defective in that they contained holes.
LABEL, IN PART :   "Xcello's Prophylactics," or "Silver-Tex Prophylactics."
NATURE OF CHARGE:   Adulteration, Section 501 (c), the quality of the article fell
below that which it purported and was represented to possess.
Misbranding,  Section 502  (a), the label statement  "Prophylactics"  was
false and misleading as applied to an article containing holes.
DISPOSITION : Gellman Brothers, Minneapolis, Minn., appeared as claimant, and
on November 27, 1945, the case came on for trial before the court. At the
conclusion of the testimony, the case was taken under advisement by the court,
and on February 11, 1946, after consideration of the briefs and arguments of
counsel, the court handed down the following opinion:
GTTNNAB H. NOBDBTE, District Judge: "The above cause came before this
Court on libel proceedings pursuant to 21 U. S. C. A. ? 334.
"Mr. Victor E. Anderson, United States Attorney, and Mr. Clifford F. Hansen,
Assistant United States Attorney, of St. Paul, Minnesota, appeared in behalf
of the United States of America; and Mr. Maurice Weinstein, of Milwaukee,
Wisconsin, (Mr. Balph Stacker, of St. Paul, Minnesota, of counsel) appeared
in behalf of the claimant.
on the theory that they were adulterated within the meaning of 21 U. S. C. A.
? 351 (c) and that they were misbranded within the meaning of 21 U. S. C. A.
352 (a). The goods were labeled 'Prophylactics' on the carton in which they
were contained, and the Government contends that such labeling constitutes
misbranding within the meaning of the Act. The articles consist of certain
rubber devices sold ostensibly for the purpose of preventing transmission of
venereal disease. The government witnesses testified that, of the Xcello
brand, 180 were tested and 14 contained holes; that 228 of the Silver-Tex brand
were tested and 16 contained holes. Medical witnesses testified that the
defective devices would not serve as a means for the successful prevention of
the transmission of venereal disease.
"Section 351 provides:
A drug or device shall be deemed to be adulterated-
(c) If * * * its strength differs from, or its purity or quality falls below, that
which it purports or is represented to possess.
"Section 352 provides:
A drug or device shall be deemed to be misbranded-
(a) If its labeling is false or misleading in any particular.
"The government inspection has established that the devices tested were
defective in the number indicated, and there can be no serious doubt that
the strength and quality of these particular defective articles fell below that
which they purported or were represented to possess. Furthermore, it seems
clear that, being labeled 'Prophylactics,' there was misbranding within the
meaning of the statute. These defective devices are nol efficacious in furnish-
ing protection from diseases.
"The problem presented, however, pertains to the right of the Government
to condemn the entire shipment. It appears that on or about June 19, 1945,
about 43? gross of the Xcello brand and 112?- gross of the Silver-Tex brand
were shipped from the manufacturer in Akron, Ohio, to a concern in Min-
neapolis. It is from this shipment that the samples were taken and the tests
made, as stated above. The Government took two samples-a pre-seizure
and a post-seizure. While the method by which the first sample was taken
is not entirely clear in the record, it does appear that, in taking the post-
seizure samples, the Government took one dozen articles from each of the
36 gross cartons of Xcellos, and from the three gross so selected 72 samples
were taken at random. Six, or about 8 per cent of the 72, were found to be
defective. In the pre-seizure test of the Xcello brand, 108 were selected and
8 were found to be defective, or about 8 per cent. The post-seizure samples
of the Silver-Tex brand were obtained by substantially the same method
of selection by which the Xcello post-seizure samples were selected. In the
post-seizure test of this brand, 120 samples were taken; four, or 3.33 per
cent, were defective. In the pre-seizure test of this brand, 108 were tested
and 12 were defective, or approximately 11.11 per cent. The average de-
fects, therefore, of all the tests Is approximately 7.37 per cent, but of the
entire shipment seized, a fraction of one per cent is definitely shown to be
defective, and claimant contends that the Government has failed to sustain
the burden of proof which rests on it in these proceedings in its attempt to
condemn the entire shipment. It should be pointed out that apparently the
only practical tests which the government representatives are able to make
with the facilities available to them results in the article's being rendered
useless after the test has been made. Concededly, the burden of proof rests
upon the Government. United States v. 5 One-Pint Bottles, et al. (D. O.
N. Y., 1934) 9 F. Supp. 990; United States v. 11? Dozen Packages, (D. C.
N. Y., 1941) 40 F. Supp. 208. But it does not follow that each individual
article in the shipment must be tested. Inspection and condemnation on the
basis of samples tested is clearly contemplated by the Act. In fact, the Act
speaks of samples and their availability for testing. 21 U. S. 0. A. ? 334 (c).
And the cases seem to contemplate that testing of samples is sufficient if the
samples are representative ones. Andersen & Co. v. United States, (9 C. C. A.,
1922) 284 F. 542; United States v. 200 Cases, et al., (D. C. Tex., 1923) 289 F. 157.
No serious question is raised in this proceeding as to the samples taken being
representative. But claimant contends that the Court cannot order the condem-
nation of good articles, and concededly some of the remaining articles are in all
probability free from defects.  However, in urging this contention, claimant fails
to distinguish between condemnation and the confiscation or sale of goods. Con-
demnation only sustains the Government's position that the goods as they
were composed in interstate shipment violate the provision and. purpose of
the Federal Food and Drug Act. After the decree, the claimant can separate
the good from the defective if it posts a bond, and thereby will be able to
retain the balance of the goods. 21 U. S. C. A. ?334 (d). The very fact
that part of the section of the Food and Drug Act which governs condemnation
and confiscation procedure contains a section which permits the separation
of the acceptable from the defective goods after condemnation indicates an
intent and recognition by Congress that some of the shipment may not violate
the Act, but nevertheless would be subject to a decree of condemnation to-
gether with the defective merchandise. In view of the fact that the tests
which the government representatives have applied render the articles useless,
it is highly improbable that the statute intended that only the defective
articles are to be condemned. The impracticability of such a libel action is
obvious and the impracticability of such a construction also seems clear. In
effect, it would prevent application of the Act to many situations to which
Congress intended it to be applied. But it is urged that the number of defectives
are so low in proportion to the total number of articles involved in this pro-
ceeding that a grave injustice would result to the claimant if the entire
shipment is condemned. Again, it may be reiterated that condemnation is
not necessarily confiscation, and that representative sampling is permitted
by the Act. Moreover, the Court is not required or permitted to establish any
formula as to what tolerance of defects should be allowed, if any, in every
type of libel proceeding before it determines that the Government has sus-
tained the burden of proof as to any particular shipment. Suffice it to say that,
on the state of the facts herein, and assuming that the same ratio of defec-
tives would be found in the entire shipment, it would follow that over 1,5C0
defective articles would be found in this shipment. Such a number, if sold
on the market, would constitute a potential menace to public health, and,
in view of the claimed purpose and object of the devices, that is, the prevention
of disease, are sufficient to sustain the libel proceedings herein.
"The purpose of the Federal Food and Drug Act requires that the Act
be interpreted liberally. 'One of the declared purposes of the Federal Food,
Drug and Cosmetic Act is to prohibit the movement in interstate commerce
of adulterated and misbranded foods, drugs, devices, and cosmetics. United
States v. Dotterweich, 320 U. S. 277, 280, 64 S. Ct. 134; * * *' United
States v. 1,851 Cartons, etc., (10 C. C. A., 1945) 146 F. 2d 760. Thereby
Congress hoped to 'prevent injury to the public health,' United States v.
Research Laboratories, (9 C. C. A., 1942) 126 F. 2d 42, by prohibiting the
'sale of inferior for superior articles,' United States v. 200 Cases, etc., (D. C.
Tex., 1923) 289 F. 157; and protecting the uninformed from buying an article
which was different from what it purported to be. United States v. Lexington
Mill & Elevator Co., 232 U. S. 399, 409, 34 S. Ct. 337, 58 L. Ed. 658, L. B. A.
1915B, 774; United States v. 5 One-Pint Bottles, etc., (D. C. N. T. 1934) 9 F.
Supp. 990. If claimant's contention were adopted here, this purpose could
not be carried out, for the practical difficulties involved would permit defec-
tive articles to move in commerce and to be sold to uninformed persons without
affording the protection represented.
"The Circuit Court of Appeals for the Ninth Circuit expressed its views
upon a similar problem with reference to food as follows:
It is further agreed that the court should not destroy 1,600 cases of good salmon be-
cause 400 cases of the same lot are found to be adulterated. In answer to this we need
only say that destruction does not follow condemnation as a matter of course. Section
10 of the Act provides for the restoration of the goods on payment of the costs and the
giving of a sufficient bond to the effect that the articles will not be sold or otherwise
disposed of contrary to the provision of the Act. Under this provision the defendant
in error may, and will doubtless be permitted to, separate the good from the bad, and
the burden of so doing should rest upon it, and not upon the government or the ultimate
consumer. If it cannot do this, it is its own misfortune, and it must suffer the conse-
quences.    Andersen & Co. v. United States (9 C. C. A., 1922) 284 F. 542, 545.
"United States v. 200 Cases, etc., (D. C. Tex., 1923) 289 F. 157, seems contra
to the Anderson case. But it proceeds upon the theory that the shipment
cannot be condemned unless every article therein has been shown to be de-
fective. For the reasons noted above in discussing claimant's contention to
the same effect, this case seems unsound.
tends that, upon reinspection pursuant to the bonding procedure provided for
in 21 U. S. C. A. ?334 (d), the articles will be rendered useless, or at least
their quality and strength impaired by the wear occasioned by any further
testing. But the purposes of the Act cannot be relaxed merely because of
difficulties which may be encountered upon reinspection. The claimant's own
testimony shows that these articles are inspected at the factory before ship-
ment, and it contends that such methods of testing are the most modern known
in this particular trade. No good reason is suggested why the same articles
cannot be again subjected to the testing to which they were subjected at the
factory before they entered the channels of interstate commerce. In any
event, these goods are sent into commerce labeled 'Prophylactics.' The Act
seeks to prevent the sale of articles labeled as prophylactics when in fact they
are not. The burden of separating the good from the bad under these circum-
stances should rest on the claimant. Certainly, if the manufacturer desires
to continue the labeling and representations as to the quality and strength of
its products, it will have to contend with whatever hardships or inconveniences
the violation of the law may entail.
"It follows from the foregoing that the Government is entitled to findings
of fact and conclusions of law in harmony with the foregoing, as prayed for
in its libel of information, with the right of the claimant to proceed under
Section 334 (d) in accordance with the provisions therein contained.
"An exception is allowed to the claimant."
On April 22, 1946, judgment of condemnation was entered and the product
was ordered released under bond to the claimant for the purpose of separating
the good portion of the product from the bad, under the supervision of the
Federal Security Agency.
The claimant subsequently took an appeal in the case to the United States
Circuit Court of Appeals for the 8th Circuit, and on March 4* 1947, the follow-
ing opinion was handed down by that court, which affirmed the district court's
decision:
WOODBOUGH, Circuit Judge: "This appeal is to reverse a judgment of con-
demnation entered after trial by the court upon a libel of information by the
United States against a shipment of rubber prophylactics transported in inter-
state commerce from Akron, Ohio, to Minneapolis, Minnesota, and there seized
from appellants who are the owners. The articles are sold ostensibly for the
purpose of preventing transmission of venereal disease and were labeled in part
Xcellos' Prophylactics and in part Silver Tex Prophylactics, and the condemna-
tion was ordered pursuant to the Federal Food, Drug and Cosmetic Act, Sec.
304, 21 U. S. C. A. 334, upon the findings and conclusions of the court that the
articles were adulterated within the meaning of 21 U. S. C. A. Sec. 351 (c) and
were misbranded within the meaning of 21 U. S. C. A. Sec. 352 (a).
"Before the information of libel was filed, agents of the government pur-
chased some of the articles and subjected them to tests, and after such filing
and the seizure of the articles the parties stipulated in writing that the owners
'cannot perfect the evidence required to proceed with said case until furnished
with a sample of said seized property,' and that representatives of the parties
'on inspecting said seized property can best determine what sample is neces-
sary to constitute a representative sample thereof and 'that the court may
make the attached order' to permit examination and taking of representative
samples of the articles. The court acted in accordance with the stipulation
and issued the order agreed upon by the parties. In consequence all of the
seized articles were not subjected to testing, and the findings and conclusions
of the court in respect to the charges of adulteration and misbranding were
drawn from the testimony showing the nature, uses and purposes of the articles,
the scale and processes of manufacture, the packing, labelling and shipment,
and the results of the tests of the samples taken pursuant to the stipulation
and order.
"It appears that the articles are produced in quantities of millions by the
manufacturer who has large investment in plant, machinery, material and
product, and as the case is said to present the first instance of reported decision
in the federal courts upon the application of the Act in interstate shipments of
rubber devices of the kind involved through condemnation proceedings, the
791264-48?4
grounds relied on to avoid condemnation were fully developed and argued at
the trial and on this appeal. The tests of the samples taken from the ship-
ment showed that it included a substantial percentage of 'leakers' having holes
in them not discernible to the naked eye but of such size as to permit the passage
of disease germs to and fro, which germs in the test carried to that extent
remained alive and propagated. But it was also shown that a much larger
percentage of the shipment in which the defective devices were indistinguish-
ably commingled were not 'leakers' and were, therefore, disease preventive and
prophylactic to the extent limited by the uses for which they are adapted. The
tests applied to the samples rendered them unfit for sale in ordinary course
and in some instances caused them to burst.
"The judgment of condemnation preserves to the owners the right accorded
by Sec. 334 (d) to repossess themselves of the shipment and separate the defec-
tive articles therefrom and upon bringing the shipment into compliance with
the Act under designated supervision, to sell the same.
"The position taken by the owners is that the Act does not confer the power
to order condemnation of the whole shipment of commingled sound and defec-
tive articles; that the designation of the articles as Prophylactic was not 'mis-
branding' even as to the 'leakers' shown to have holes in them, and that the
articles with the holes in the rubber of which they are composed, were not
adulterated.
"The trial court filed a written opinion with its findings and conclusions,
and the same is reported in 65 F. Supp. 534. It presents the issues in the case
and contains a fair statement of the evidence and the grounds of decision. It
also reflects careful consideration of all matters of defense asserted for the
owners and meets all substantial contentions for their position. We think it
continues to meet such contentions, notwithstanding additional briefs and argu-
ments submitted to and considered by us on this appeal. The additional con-
tention that the samples were not representative of the shipment is not sus-
tained. Our study of the record has satisfied us that the charges of the libel
of information are supported by substantial evidence and that the provisions
of the Act relied on authorized the court to enter the judgment of condemna-
tion of the whole shipment subject to the conditions for repossession, separa-
tion and restoration of the shipment to compliance contained in the judgment.
"We think that the judgment in accordance with the opinion of the trial court
(and with its separately filed findings and conclusions) was in all respects
correct and proper, and although we recognize the importance of the case to
the appellants and as a precedent, we think no good purpose would be served
by making a re-statement of it from the record before us. We approve the
statement of the case, the findings and conclusions, and the reasoning and
decision as set forth in the opinion of the trial court, and find no error therein,
and therefore affirm the judgment entered in accordance therewith.   Affirmed."