3310. Misbranding of Ri-Co tablets.   U. S. v. 33 Bottles   *   *   *.   Claimant's
exceptions to the libel overruled.   Government's motion for summary
judgment granted.   Decree of condemnation and destruction.   Judg-
ment affirmed upon appeal.    (F. D. C. No. 22157.    Sample No. 48752-H.)
LIBEL FILED :   January 8,1947, District of Colorado,
AIXEGED SHIPMENT: On or about November 25, 1946, by the Alberty Food Prod-
ucts Co., from Hollywood, Calif.
PRODUCT:   33 bottles each containing 275 RirCo tablets at Denver, Colo.
LABEL, IN PAET :    "Ri-Co Tablets.   Homeopathic Combination."
NATURE OF CHARGE: Misbranding, Section 502 (f) (1), the labeling of the
article failed to bear adequate directions for use since the only direction
appearing in the labeling, namely, "Three tablets with a cupful of hot water.
Take four times daily. Before meals and on going to bed.," did not indicate
the purpose or condition for which the article was intended and, therefore,
was not adequate for intelligent and effective use.
DISPOSITION : On February 28,1947, pursuant to agreement between the Alberty
Food Products Co. and the Government, the libel proceedings were ordered
transferred to the United States District Court for the Northern District of
California. Thereafter, exceptions to the libel were taken by the claimant,
Alberty Food Products Co., and on September 30, 1947, the court overruled
the exceptions. On December 1, 1947, the claimant filed an answer denying
that the product was misbranded as alleged in the libel. On October 15, 1948,
the Government filed a motion for summary judgment, and after a hearing
in the matter, the court, on November 16, 1949, rendered the following oral.
opinion:
BLACK, District Judge:
The CLERK. "United States v. 33 Bottles of Ri-Co Tablets. Motion for
Summary Judgment, for decision."
Mr. HAUERKEN. "Ready."
Mr. DICKERMAN. "Your Honor, may I request I be heard briefly on a new
development that came to my attention this morning. It involves another
case, or another libel with the Food and Drug Law wherein the District
Court of the Northern District of Illinois granted motion for summary judg-
ment. I have a mimeographed copy of this opinion which I received this
morning.    I gave a copy to counsel."
The COURT. "You may hand it to me."
Mr. DICKEKMAN. "I wish to call the attention of the Court, the question
apparently was not raised as to whether the admiralty or civil rules applied."
The COURT. "In the matter of the United States of America v. 33 Bottles,
More or Less, of an Article Labeled in Part 'Ri-Co Tablets Homeopathic
Combination App. 275 Tablets,' Alberty Food Products Co., etc., Claimant,
the Government is asking for summary judgment. The claimant suggested
in the first instance that summary judgment is not applicable on the ground
that under the statutes the proceeding is to be considered as one in admiralty,
and that therefore the civil rules of Federal Procedure providing for summary
judgment do not authorize action by the Court as requested by the Government.
"I say that the claimant has suggested that summary judgment is not
applicable. Actually, counsel for claimant has further suggested to the Court
that condemnation is appropriate and should be ordered, but that the Court
should further provide that the claimant should be permitted to relabel the
bottles in accordance with the practice counsel says the claimant is now
following pursuant to a decision by the Federal Trade Commission. In effect,
then, I take it the question of whether or not this is a proceeding in admiralty
is, in so far as counsel is able to make it, somewhat academic. It might almost
be said that it is the law of this particular case that condemnation on the
record should enter, and that the issue is whether or not relabeling should
be permitted.
"I have looked at the authorities: the decision of the Supreme Court in
226 U. S., beginning at page 172; 33 Supreme Court, beginning at page 50; and
57 Law Edition, page 175, has been cited to the Court by the Government as
establishing that this proceeding is civil and is not one in admiralty. That
Supreme Court decision in substance held that the law then before the Supreme
Court likened the proceedings to one [in] admiralty in connection with the
seizure of the property by process in rem, and that decision of the United
States Supreme Court in effect was that after the seizure the matter became a
proceeding in law and was governed by the statutes and rules apart from
admiralty.
"Counsel for the plaintiff has pointed out that that decision was before the
enactment of the present statute. After reading the Supreme Court decision,
it seems to me that the principal therein enunciated, properly applied to the
present statute, strongly indicates that it is to be deemed a civil rather than
an admiralty matter after the seizure. It would therefore appear that sum-
mary judgment would be applicable.
"My view of the force and effect of that Supreme Court decision, which I
think was about 1912, is in harmony with the view of the Circuit Court of
Appeals for the Sixth Circuit, after the enactment of the present statute, which
decision was rendered June 22,1943, and is found in 136 Fed. Rep., 2nd Series,
beginning at page 523. The Court of Appeals of the Sixth Circuit, in sub-
stance, held that the proceeding was not intended to be likened to one in
admiralty beyond the seizure of the property by process in rem under the
statutes.
"Under the decisions cited to me, I am satisfied that the Federal Rules of
Civil Procedure are effective and that a summary judgment, upon proper
showing, can be entered.
"There has just been handed to me District Court decision from the Northern
District of Illinois, United States v. 17 Cases, More or Less, of Nue-Ovo, Re-
search Laboratories, Inc. In this decision, dated October 11, 1949, the judge
assumed that entry of a summary judgment was within his authority. It
does not appear, however, that anyone objected to his exercising the authority
providing the showing was sufficient. But independently of this most recent
decision, I am satisfied that the proceeding is, at this stage, not one in ad-
miralty. The main contention of the claimant is that by virtue of the Federal
Trade decision, the holding that its right to relabel these articles is established
be on the doctrine of res adjudicata. Such is a most interesting contention.
Counsel for claimant depends primarily upon the decision of the United States
v. Willard Tablet Company, 141 Fed. (2d), beginning at page 141, being a
decision by the Circuit Court of Appeals of the Seventh Circuit under date
of March 7, 1944. That court undoubtedly does hold that a decision by the
Federal Trade Commission is binding upon the court in an independent pro-
ceeding; and the court in that decision depended upon an earlier decision by
the Circuit Court of Appeals for the Eighth Circuit in Lee v. Federal Trade
Commission, 113 Fed. (2d) 583. However, the Circuit Court of Appeals for
the Ninth Circuit, under date of February 24,1942, in U. S. v. Research Labora-
tories, Inc., reversing a holding by myself at Tacoma, said the following:
It is Immaterial, if true, that the makers and advertisers of Nue-Ovo could have been
proceeded against by the Federal Trade Commission under the Federal Trade Commission
Act and could have been ordered to cease and desist from publishing and distributing the
circular entitled "What is Arthritis?" The power of the District Court to condemn
misbranded articles is not impaired, diminished, or in any wise affected by the possi-
bility that such misbranding may also be the subject of a cease and desist order, or
either by the fact, if it be a fact, that such an order has actually issued.
"I am bound and controlled by the decision of this circuit, regardless of.
whether I agree or disagree with its correctness.   I am only to be persuaded
by the decisions of the Seventh Circuit or the Eighth Circuit if they appeal
to my reason and are not at variance with the decisions of the Court of Appeals
for the Ninth Circuit.
"December 8, 1943, 139 Fed. Rep. (2d), page 197, in the Sekov Corporation
v. United States, the Circuit Court of Appeals for the Fifth Circuit cited with
approval the decision of 122 Fed. (2d) 42, U. S. v. Research Laboratories, of
this Ninth Circuit, which I have just mentioned."
Mr. HATTERKEN. "Your Honor, may I say a word?"
The COTJUT. "It stated this:
Appellant Sekov Corporation contends that the fact that it had been previously pro-
ceeded against by the Federal Trade Commission barred inquiry by the District Court
into the questions presented by the Government's libel. There is no merit in this con-
tention. The issues in that proceeding were not identical with those here presented.
Moreover, the power and duty of the District Court to condemn the misbranded articles
933396-51?2
was not impaired or diminished by the former proceeding. United States v. Research
Laboratories, 9 CIR., 126 Fed. (2d) 42, 45.
"While the decision of the Eighth Circuit in 113 Fed. (2d) 583, which I
previously mentioned, appealed to the Court of Appeals for the Seventh
Circuit in the Willard Tablet Company case, such decision in 113 Fed, (2d)
neither appealed to the Circuit Court of Appeals for the Fifth Circuit nor
to the Circuit Court of Appeals for the Ninth Circuit.
"Unquestionably I must hold that what the Federal Trade Commission did
in an independent and different proceeding is not res adjudicata here,. Ac-
tually, such would appear not to be res adjudicata for further reasons. In
the first place, what the Trade Commission did apparently was done pursuant
to stipulation. Other courts, in independent proceedings where the showing
is different, are very reluctant to consider themselves barred by a com-
mission's holding on a stipulation. Further than that, I do not find that the
Commission held anything. I am advised that the cease and desist order of
the Federal Trade Commission required this claimant to cease and desist
from disseminating advertisements in the United States mails or by any
means in commerce which represent
that the preparation "Ri-Co Tablets" constitutes an adequate or competent treatment
for arthritis, rheumatism, gout or rheumatic gout; or that said preparation will elimi-
nate uric acid from the system ; provided, however, that nothing herein shall be construed
as prohibiting the representation that according to the principles of the homeopathic
school of medicine the preparation is of value in ameliorating the symptoms of muscular
or ligamentous pain and stiffness due to arthritis or rheumatism except when such
symptoms are accompanied by a febrile condition.
"It is apparent that the Federal Trade- Commission did not hold that Ri-Co
Tablets were of value to ameliorate the symptoms of muscular or ligamentous
pain and stiffness due to arthritis or rheumatism. The most that the Federal
Trade Commission said was that it was. not preventing the claimant from
contending that such was of benefit. That is a far cry from any adjudication
that should be considered as res adjudicata.
"But even if the Federal Trade Commission had done what counsel feels
it did do, the Circuit Court of Appeals for the Ninth Circuit certainly told
me that any holding of any Federal Trade Commission was of no avail in
another and independent proceeding before the District Court. There is no
showing in behalf of the claimant before me that the tablets have any
efficiency or any value. All of the showing, so far as presented, is to the
effect that they are worthless.
"The application for summary judgment based upon the pleadings, however,
is upon the ground that the labels did not give adequate directions as re-
quired by the statute. The label did state that the tablets were to be taken at
certain intervals, without even a hint that the tablets were helpful for anything.
The Government's contention is that the directions, to be adequate, must not
only tell how often the alleged remedy is to be taken, but for what it is to be
used. The decisions of the Circuit Court of Appeals in this Circuit, both of the
District Courts and of the Court of Appeals, are to the effect that as to reme-
dies' directions, to be adequate they must not only say how often but for what.
"It seems to me that such holdings which are binding upon me are in
accord with reason and in harmony with the purpose of the Pure Food and
Drug Act.
"The condemnation asked will be ordered upon the ground that the direc-
tions printed did not comply with the statute, upon the ground that they
were inadequate.
"I am not holding that Ri-Co Tablets are worthless. That issue actually
was not presented to me. The Court has the authority, in its discretion, to
permit the claimant to relabel these tablets; but .certainly for the Court to
allow claimant which has violated the law to relabel tablets, the claimant
should make an affirmative showing that appeals to the judgment or con-
science or both of the Court. No showing whatsoever has been made. It
is conceded that the claimant has been held repeatedly to have violated the
law, either as to these tablets or other preparations. The claimant has not
attempted to persuade me that the tablets are good and that there would be
any loss to humanity or posterity if I allow condemnation to be effected.
Claimant has relied solely upon the Willard Tablet case, which is a holding
of the Northern Circuit and not binding on me, and which is contrary to a
.  holding of this Circuit which does control.
"I know no good reason that I should require the Government to turn over
these tablets for relabeling. Judgment and order will be presented in con-
formity with my announcement.
"Counsel, there was something you wished to say?"
Mr. HAXJEBKEN. "I presume it is too late inasmuch as your Honor has
announced judgment. I do feel your Honor has erroneously construed the
Research Laboratories Company case. I do not know whether your Honor
wants me to be heard on this or not, but I would like to show my views
on it."
The COXJET. "Well, counsel, I told you I am quite familiar with that case.
I am speaking now informally. It is not a part of my decision. I thought at
the time I rendered decision in Tacdma that I was right. It might not be
very hard for you to convince me that the Circuit Court was mistaken, but the
Circuit Court reversed me and I am bound by what it said and certainly it
said what I have quoted from it, because I read it verbatim. I have no
quarrel with that portion of the Circuit Court's holding. I think, as I pointed
out before to you, I have held the libel was so crudely and inexpertly drawn -
that it had no right to be considered by the Court and I dismissed it. The
Circuit Court of Appeals in reversing me admitted the following:
The libel is crudely and inexpertly drawn. It does not state directly and positively,
as a competently drawn libel would have stated, that the 143 packages of Nue-Ovo were
misbranded when introduced into or while in interstate commerce.
"But the Circuit Court of Appeals held that the crudeness and lack of
expertness in the drawing of the libel, while not to be commended, was not
as fatal as I thought it was. But I am satisfied now. Upon the problem you
present I have disagreed directly, with you and disagreed directly with the
doctrine of the Willard case on which you relied."
Mr. HAXJEBKEN. "The point I make in that, that violation, if any, was a
violation of the Federal Trade Commission Act and therefore there could be
no prosecution under the Food and Drug Act, as I recall that case. The
question was whether or not the pamphlets had accompanied the article in
interstate commerce. Wasn't that the case where it was held common origin,
common destruction, and approximately a shipment at the same time consti-
tuted a libel?   I think that is the case I have in mind."
The COUBT. "Well, whatever was there at issue, the Circuit Court of
Appeals announced the doctrine for this Circuit that answered your argument
far better than any counsel could hope to answer it, and the Circuit Court of
Appeals for the Fifth Circuit seemed to think that that doctrine was appropri-
ate because, as I say, it disregarded the decision in 113 Fed. (2d) the court
in the Willard case relied on."
Mr. HAXJEBKEN. "My concept of that ease is that a person could violate
both acts, and I think that is what those cases hold, that by the one action
you would be in violation of both acts."
The COURT. "I have no question of that, counsel, but both courts say in an
independent proceeding on different showings the court is not bound by what
the Federal Trade Commission may do, and that is particularly true when
what the Federal Trade Commission did, in so far as it did anything, was
on stipulation; and most particularly true when the Federal Trade Commis-
sion didn't do anything, but just merely negatively said that its order was
not to be construed as stopping you from doing something."
Mr. HAXJEBKEN. "I merely wanted to present that point, your Honor. I have
no desire to draw the matter out."
The
. COXJBT. "The Court will say this: It has been very interested in the
presentation by counsel on both sides. Counsel on each side have been very
helpful to the Court and have ably presented their various matters. I am
sure I understood the presentation of counsel for claimant. Under the law
as I see it, and the facts as presented, I am holding against him. He may be
right, but I do not think so. I thank counsel on both sides for your assistance
to the Court.
"That is all."
handed down its findings of facts and conclusions of law and on the same day
entered a decree providing for condemnation and destruction of the product.
Pursuant to the decree, the United States marshal destroyed the product
on December 14, 1949. The notice of appeal was filed by the claimant on
December 16, 1949. A motion to dismiss the appeal then was filed on behalf
of the Government in the United States Court of Appeals for the Ninth Cir-
cuit on the ground that the product was no longer in existence and that the
case therefore had become moot. On April 3, 1950, the appellate court denied
the motion, without prejudice to its renewal by the Government if so advised
on the hearing of the case on its merits. The case was argued before the
court of appeals on October 18, 1950, and on November 20, 1950, the court
handed down the following opinion affirming the judgment of the district court:
BONE, Circuit Judge: "Appellee filed a libel under which it seized appellant's
drug here involved (33 bottles of Ri-Co Tablets) charging therein that the
drug was 'misbranded' in violation of 21 U. S. C. A. Sec. 352 (f) (1) of the
Federal Food, Drug, and Cosmetic Act (referred to hereafter as the Act).
The specific ground of complaint was that the 'labeling' of the drug failed to
bear adequate directions for use since it did not state the purpose or condition
for which the drug was intended. The only directions for use on the label
attached to the bottle read as. follows: 'Three tablets with a cupful of hot
water.   Take four times daily.   Before meals and on going to bed.'
"At the hearing below two newspaper advertisements from daily publica-
tions in large cities were introduced. These ads show that appellant's drug
was there represented and recommended by appellant for use in the treatment,
mitigation, and cure of arthritis and rheumatism. The two advertisements
read as follows:
ROCKY MOTJNTIAN NEWS    Tuesday, Oct. 1, 1946-
ARTHRITIS
RHEUMATISM
RICO TABLETS
Another Alberty
Product
Do you suffer from ARTHRITIS or RHEUMATISM, two of the most painful ailments
that afflict mankind
These ailments arise from the same underlying cause-two   [sic]   much acidity that
permits deposits of urates in joints or muscles that cause excruciating pain.
Science has spent many years searching for remedies for these ailments.    If you have
tried many remedies without relief TRY RICO, a formula discovered by a famous Homeo-
pathic physician for relief of the pains of ARTHRITIS and RHEUMATISM.    For over
15 years this formula has been used by many eminent Homeopathic Physicians.
RICO is harmless and does not upset the digestive tract or affect the heart.
275 TABLETS
$2.00
In Colorado, include 2? state sales tax
SENT POSTPAID WHEN REMITTANCE ACCOMPANIES ORDER.
LEEDS HEALTH HOUSE
Under new ownership
Ethel Barnes and Helen Olson
725 15th St.?KE. 9214
2 doors from Denver Dry Goods.
SAN FRANCISCO CHRONICLE    Monday, June 7, 1948    Page 13-
TROUBLED with
Symptoms of
ARTHRITIS
RHEUMATISM
ALBERTY'S
RICO TABLETS
WHY SUFFER FROM THE PAINS OF THE SYMPTOMS OF ARTHRITIS AND
RHEUMATISM WHEN RICO MAY GIVE YOU AMAZING PALLIATIVE RELIEF
LIKE IT HAS DONE FOR COUNTLESS OTHERS
Some 25 years ago a famous Homeopathic Physician attacked this problem from the
homeopathic point of view. He combined certain ingredients according to the theories
of homeopathy for relieving certain symptoms of arthritis and rheumatism. This
formula has stood the test of time and it has been widely used by many Homeopathic
Physicians.
ALBERTY'S RICO TABLETS
Rico is made by the same formula originated by the famous Homeopathic Physician.
And, according to the principles of Homeopathy, improves the symptoms of muscular or
ligamentous pain and stiffness due to ARTHRITIS or RHEUM ATISM except when
accompanied by a febrile condition. They are not a SEDATIVE; do not upset the
DIGESTIVE TRACT OR AFFECT THE HEART.
Try RICO today-
an ALBERTY PRODUCT
$1.00, TWO WEEKS' SUPPLY.
ECONOMY SIZE, $2.00
San Francisco
HEALTH FOODS
Store
415 Sutter St.?Ex. 2-8477
"Appellant appeared as claimant of the drug and filed exceptions to the
libel. In essence the exceptions were that the Act does not require the labeling
of a drug to state the disease condition for which it is to be used. In this con-
nection it contended that the misbranding here charged was merely a failure
to include upon the label of the container information to consumers which
was not required by the Act to be included thereon either as directions for
its use or otherwise. As a consequence the libel failed to state a cause of
action because the alleged misbranding was not a misbranding at all. Appel-
lant's exceptions were overruled by the trial court. Appellant's subsequent
answer to the libel admitted that the seized Ri-Co Tablets were a drug that
had been shipped in interstate commerce.
"After the answer, appellee filed a motion for summary judgment which
asserted (1) there were no facts in dispute and (2) the only legal issue had
been decided in favor of appellee when the lower court overruled claimant's
exceptions to the libel. It supported this motion by ?(1) an affidavit of a
Food and Drug representative incorporating photostats of the complete label-
ing on the drug container and the two newspaper advertisements above noted,
and (2) the affidavits of four physicians (licensed to practice in California)
attesting to the complete worthlessness of Ri-Co Tablets in the treatment or
cure of arthritis or rheumatism or their symptoms.1
"Appellant filed no counter-affidavits, and after hearing the court granted
appellee's motion for summary judgment, made and entered Findings and
Conclusions and a Decree pursuant thereto. The Decree condemned the drug,
ordered it destroyed2 and awarded certain costs to appellee. The appeal is
from this Decree.*
"In urging reversal appellant presents five claims of error committed by the
lower court and it simplifies the problem in this case by stating that these
errors relate to only two basic issues.   Claims 4 and 5 both relate to the pro-
1?Despite the physicians' affidavits the lower court refused to consider the question
of the therapeutic qualities of the drug. It held that the misbranding charge in the
libel was sustained, and this ruling presents the controlling issue on this appeal.2?Pursuant to the decree the drug in question was destroyed by the United States
Marshal. Because of the Ri-Co Tablets are no longer in existence, appellee's brief sug-
gested absence of jurisdiction to entertain this appeal, but on argument appellee
advised the court that it was not urging this point and we disregard it. In this con-
nection we note that appellant did not seek a stay of the order of destruction.
8 In its findings the court sets forth that appellant had proposed to consent to a decree
of condemnation provided permission was given to relabel the drug so as to conform
with certain language in a Federal Trade Commission Order. In the exercise of its
discretion (under Sec. 334 (d) of the Act) the court denied this privilege. Appellant
states that it does not question that ruling on this appeal and it is not in issue here.
cedural question of whether a summary judgment was proper in this case.
Claims of error, 1, 2 and 3 all relate to the question of whether or not the
Act requires that the directions (on the bottles) for the use of the tablets
include a statement of the conditions for which the tablets are used.
"In appellant's argument on the issues as thus narrowed, it says:
With the exception therefore of the procedural issues of whether a summary judgment
can be granted in a condemnation proceeding and whether a summary judgment should
have been granted in this proceeding, the only issue before this court is the issue of
whether the Act requires that the directions for the use of the tablets include a
statement of the conditions for which they are used.
??- *
The directions printed on the label of Ri-Co Tablets are adequate for their use in all
conditions for which they are prescribed, recommended, suggested, or commonly and
effectively used. The Act does not require a label to include a statement of those
conditions and the decree should accordingly be reversed with instructions to dismiss
the libel. In the alternative, the decree should be reversed, and the question of whether
the directions are adequate for the intelligent and effective use of the tablets should
be left to the determination of the jury. [Emphasis supplied.] [As later appears, this
reference in the last sentence refers to the propriety of the summary judgment in this
case. ]
"As respects the legal sufficiency of the label appearing on its bottle, ap-
pellant clarifies its position by the further argument:
The Government * * * contends that no information could be more essential
to the consumer regarding a drug which he can purchase without prescription than a
statement of the conditions for which the drug is used. We agree that no one is likely
to purchase a drug without knowing the conditions for which the drug is used. That
knowledge, however, must be imparted to the consumer by means other than the label.
He must have it before he gets close enough to the label to be able to read its fine print.
In other words, he will not buy the drug unless he learns of the conditions for which
it is used from sources outside the label, as by prescription, recommendation, suggestion,
or common and effective usage. By the time he sees the label, he needs only to be
protected by being told how to use the drug for the condition for which he is purchasing
it. If "4 times daily" is an adequate direction for the use of the drug in that condition,
the label complies with the Act irrespective of whether it refers to that condition.
[Emphasis supplied.]
"The foregoing -argument conclusively shows that appellant relied ex-
clusively upon these 'outside sources,' namely, the newspaper advertisements,
to provide all of the information which could possibly enlighten prospective
purchasers of its drug concerning 'the conditions' for which the drug was to
be used by them.
"Appellant also offers some reasons for its failure to include on the bottle
label nothing more than the dosage recommended. In substance it argues
that: a statement of all conditions or symptoms for which the drug is used
would be so long that it could not be included within the limits of the label.
While it is true that Sec. 352 (f) (1) requires 'directions for use' on the label-
ing, and Sec. 321 (m) defines 'labeling' as including the 'label' on the imme-
diate container and all other 'accompanying' literature, still this use of the
more inclusive term 'labeling' is nullified by Sec. 352 (c) which deems a drug
misbranded unless all information required to appear on the labeling be placed
thereon in such manner as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use.
"The arguments in the preceding paragraph lack persuasiveness and merit.
THE BASIC ISSUE
"Two recent cases present a material bearing on the issue before us.
Kordel v. United States, 335 U. S. 345 and United States v. Urbuteit, 335 U. S.
355. The Kordel case involved the shipment and sale of a drug-a charge of
misbranding was made because of certain representations in 'accompanying'
leaflets, circulars and pamphlets supplied by Kordel, and distributed by his
vendors to consumers and users. These 'accompanying' documents contained
statements relative to the use and efficacy of the drugs.   As we understand
the doctrine announced in these cases it is that where literature of the
character above indicated is shipped in interstate commerce and distributed
to consumers as part of an integrated distribution program, the literature
which thus accompanies the drug and is distributed with it, constitutes an
essential supplement to the label attached to the package containing the drug
although this literature may have been shipped separately and at a different
time than the drug. This process made the product and the literature 'inter-
dependent' so far as 'labeling' is concerned. In short, the supplemental litera-
ture was considered a part of the label on the drug container.
"In the case at bar we face a different set of facts. Appellant did not resort
to the distribution of any sort of 'literature' to ultimate purchasers as a
'supplement' to its package label. Neither did it distribute such 'literature'
to purchasers, actual or prospective, to promote sales and to describe and
advertise the therapeutic qualities of its drug. Appellant used only the news-
paper advertisements and we think that it cannot be said that these advertise-
ments 'accompanied' appellant's drug into interstate commerce; and were
'distributed' by vendors, or ptherwise, to ultimate purchasers of the drug as
part of an 'integrated distribution program.' On the 'labeling' issue, this
distinction should be borne in mind.
"What we have already said leads us to disagree with appellant's contention
that by employing these 'remote' newspaper advertisements it fully supplied a
legally adequate 'labeling' which described the use of the drug in the treat-
ment or alleviation of arthritic or rheumatic conditions. It seems to us that
supporting appellant's views would be a long and drastic step toward nullify-
ing what we regard as salutary protective features of the act which Congress
designed to control and regulate the sale of drugs to a helpless public-help-
less because it is uninformed. (See comment on this phase of the law in
United States v. Various Quantities-Instant Alberty Food, 83 F. Supp. 882.)
The logic of the Kordel and Urbuteit cases would seem to repel the conclusion
that the therapeutic claims made only in random newspaper advertisements,
must be considered and deemed to be a part of, and to be 'accompanying' and
'supplementing,' the brief dosage statement appearing on the bottles contain-
ing appellant's drug. There is no hint in the record that these advertise-
ments were reproduced in pamphlet or leaflet form and shipped with the drug
on its interstate journey from appellant to its vendors to be distributed to
ultimate consumers. No claim is made that the reading matter in the news-
paper advertising appeared in any sort of literature (pamphlet, etc.) which
was made available by vendors to purchasers of the drug.
"A wholly justifiable inference is that many of those who suffer from pains
of arthritis and rheumatism-and they are legion-never heard of Bi-Co
Tablets, and undoubtedly never saw, or had a chance to see, appellant's news-
paper advertisements. It is certain that as to them, these advertisements
gave absolutely no notice of the existence of the drug, its dosage, uses and
therapeutic qualities. We proceed upon the assumption that the 'adequate
directions for use' mandate of Sec. 352 (f) (1) requires that all who might
want to use a drug to relieve the pains of arthritis and rheumatism are at
least entitled to a chance to somewhere find and examine a 'label' which is
complete enough to give them information which would lead them to purchase
a drug for that purpose, or, in other words, provide sufficient information at
the time of purchase upon which intelligent determination might be made as
to whether the drug is one which is prescribed, recommended, or suggested for
their particular form of arthritis or rheumatic ailment. We are persuaded
that the law requires this much.
"Since the kind of complete information we have indicated was not made
available to the general run of victims of arthritis and rheumatism by a proper
and adequate 'labeling' of appellant's drug, we must hold that it was 'mis-
branded' under Sec. 352 (f) (1) of the Act. This for the reason that what
appellant insists is a proper and adequate 'labeling' falls far short of legal
requirements. It failed to bear 'adequate directions for use' since it did ^not
state the purpose or condition for which the drug was intended.
THE  ISSTTE   OF   SUMMARY   JUDGMENT
"Appellant contends that a summary judgment was ah 'improper' remedy and
may not be obtained in this case because appellee is not 'a party seeking to
recover on a claim * * * or to obtain a declaratory judgment' (under
Rule 56, F. R. C. P.) this being a condemnation proceeding and not an orthodox
civil action. The contention rests on the language of the Act (See. 334 (b))
prescribing that procedure in condemnation cases 'shall conform, as nearly
as may be, to the procedure in Admiralty.' [Emphasis supplied.] The argu-
ment is predicated upon the holding in two district court cases.4
"The heart of this part of appellant's argument is presented in the statement
that 'this case presents a genuine issue of fact as to which Alberty is entitled
[as it requested] to a jury trial' (as in ordinary civil cases)-this because
the pleadings raised the question of whether directions given by Alberty for
the use of the tablets are 'adequate for its intelligent and effective use.' Appel-
lant supports this contention by reliance on two cases from this Circuit3 but
we think that they do not aid its case.
"Because of the nature of seizure cases, like the one at bar, a question
has arisen in the past as to whether Admiralty rules apply in such seizure
actions under the Act. After the enactment of the present statute the Sixth
Circuit (tJnited States v. 935 Cases, etc., 136 F. 2d 523) held that proceedings
of the character here involved are not intended to be likened to those in
admiralty beyond the seizure of the property by process in rem under the
statutes. See also 443 Cans of Frozen Egg Product v. United States, 226 U. S.
172, 183. As appellee points out, an imposing group of authorities now sup-
port the proposition that despite a contrary holding in certain of the earlier
cases dealing with enforcement of the 1938 Act, the better rule is that the
Rules of Civil Procedure apply in these seizure actions as soon as the property
proceeded against has been seized.6 We prefer to accept and adopt the principle
announced in these later cases and hold that the Admiralty rules do not apply
in seizure actions like this beyond apprehension of the property. The lower
court did not err in entering its Summary Judgment under Rule 56 (a) unless
it can be said that the labeling here involved was not a misbranding of the
drug, a view we have refused to accept.
"The record clearly discloses that a genuine issue of fact was not presented
to the court. The basic question presented and properly considered by the
lower court was whether the labeling on the drug failed to bear 'adequate
directions for use' in violation of Sec. 352 (f) (1) of the Act. Having con-
cluded, as a matter of law, that the labeling of the drug wholly and completely
failed to conform to the requirement of this Section, the court properly held
that the drug was misbranded. In this posture of the case it presented only
a question of law and this clearly justified entry of the summary judgment
as authorized in cases where the civil rules apply.
"The lower court correctly decided the case and its judgment is affirmed."