1080. Action to restrain interstate shipment of Dr. Paddock's Medicines.    U. S.
v. Edward K. Paddock.    Permanent injunction granted.     (Inj. No. 131.)
COMPLAINT FILED: On or about May 29, 1946, Western District of Missouri,
against Edward E. Paddock, a physician, Kansas City, Mo. It was alleged in
the complaint that the defendant had been engaged since 1932 in the business of
distributing through the mails in interstate commerce various drugs known
as Dr. Paddockfs Medicines, consisting of yellow-coated tablets containing as
active ingredients 3? grains of extract of oxgall and 5 grains of sodium
salicylate, blue-coated tablets containing as an active ingredient 5 grains of
sodium succinate, and brown-coated laxative tablets containing 5 grains of
cascara sagrada. It was also alleged that in order to inform purchasers of
the uses of the drugs and to facilitate their sale, the defendant caused to be
printed a booklet entitled "The Gall Bladder and Liver"; leaflets entitled
"Appreciation" and "Heartfelt Gratitude"; a pamphlet entitled "Special Diet
Directions" ; form letters designated 'SDear Friend," "Dear Reader," and "Dear
Sufferer"; and combination order and report blanks requesting information as
to age, weight, history, and physical condition of a person ordering the drugs,
and bearing on the reverse side "Some Anatomical Explanations." It was fur-
ther alleged that the literature and the drugs were distributed by the defendant
by means of advertisements in newspapers; that in response to inquiries from
the readers of the advertisements, the defendant would mail the literature and
solicit orders for his drugs; and that by reason of these facts the literature con-
stituted labeling accompanying the drugs.
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in the
labeling of the drugs were false and misleading in that they represented and
suggested that the drugs, when used singly or in combination, together with
the diets outlined in the pamphlet entitled "Special Diet Directions" would be
a competent and palliative and symptomatic treatment for all gall bladder
conditions; that the drugs would be efficacious in the cure, mitigation, treat-
ment, and prevention of gallstones and an irritable and over-excited nervous
system due to gall bladder trouble; that the drugs would insure that the user
would obtain the greatest measure of relief possible; that the drugs would
treat successfully partial obstruction of the bile flow; and that the drugs con-
stituted a palliative and symptomatic treatment which would aid nature. The
drugs, when used singly or in combination, with or without the diets outlined
in the above pamphlet would not be a competent and palliative and sympto-
matic treatment for all gall bladder conditions; and the drugs would not be
efficacious for the purposes represented.
Further misbranding, Section 502 (a), certain additional statements in the
labeling were misleading since they created the impression that the drugs would
cause no harm and could be used with safety to all; that the user could com-
pare his symptoms before and after treatment to tell whether or not he was
improving; that the user might safely temporize with gall bladder disorders
and gallstones; that partial obstruction of the bile flow may be treated by the
drugs; and that the drugs might be used safely and effectively without an
accurate diagnosis. The drugs could cause harm and could not be used with
safety by all, in that they contained a laxative and should not be used in the
presence of symptoms of appendicitis; that the use of the drugs might cause
dependence upon laxatives; that the drugs contained oxgall, and in cases of
partial obstruction of the bile flow the drugs might increase the bile flow to
such an extent that obstruction might become complete, causing pain, possible
destruction of the liver, and even death; that the user could not compare
symptoms before and after treatment and tell whether or not he was improving,
for gallstones may be present and dangerous without causing painful symp-
toms ; that the user might not safely temporize with gall bladder disorders or
gallstones, for an emergency operation may be necessary in such conditions; and
that the drugs could not safely and effectively be used without an accurate
diagnosis, for such use might result in delaying proper treatment and might lead
to unnecessary suffering and possible death.
PRAYER OP COMPLAINT :   That a temporary restraining order issue followed by a     (
temporary injunction, and that, after due proceedings, a permanent injunction      ^-
?See also Nos. 1953,1955, 1957,1961, 1968-1970,1977-1979.
issue enjoining the defendant from distributing in interstate commerce the
drugs he had on hand or would subsequently acquire.
DISPOSITION :   The defendant having filed a motion to dismiss or, in the alterna-
tive, to strike certain averments of the complaint, the court, on June 21, 1946,
handed down the following opinion overruling the motion:
REEVES, District Judge: "Pursuant to our arrangement, I have examined the
authorities on the motion to dismiss, or in the alternative, to strike certain
averments of the complaint, and have reached the following conclusion:
"The Food & Drug Act, designed to protect the health of the public, should
be liberally construed to effectuate the purposes of the Congress. The litera-
ture and advertising matter covered by the motion was obviously designed by
the defendant to serve as a labeling of his product It had that unquestioned
purpose. Under the decisions, such advertising matter may serve the two-fold
purpose of advertising, and, at the same time, labeling. The provisions of the
law could not be evaded by first placing the advertising and labeling matter in
the hands of a prospective purchaser in advance of the purchase. It was the
Congressional purpose to prevent fraud on the public. The usual and practical
method of the producer was to send the labeling and advertising matter along
with the product so that both would reach the purchaser at the same time. The
identical result could be reached by sending the labeling matter in advance, or
even subsequently. When both of them finally reached the consumer, there
was the deception that the law seeks to prevent.
"If the law is as contended by the defendant, then the whole purpose of the
law could be defeated by placing in the hands of the consumer, through
separate channels, the labeling matter and the product. Such evasions could
not be permitted.
"There is no conflict of jurisdiction between the Federal Trade Commission
and the Court, as indicated in United States v. Research Laboratories, 126 F.
2d, 42, 1. c. 45. Advertising and labeling circulars may be the same and yet
perform the two offices of advertising and labeling. The courts have juris-
diction over the labeling function, whereas the Federal Trade Commission
would have jurisdiction at the same time over the same circular because of its
advertising function.
"The motion to dismiss, or, in the alternative, to strike, should be and will
be overruled."
The case came on for trial before the court on June 26, 1916, and at its con-
clusion on June 27, the matter was taken under advisement by the court. After
consideration of the briefs of the parties, the court, on September 28, 1946,
handed down the following opinion, findings of fact, and conclusions of law:
OPINION
REEVES, District Judge: "This is an action under Section 332 (a) Title 21
U. S. C. A. to restrain the defendant from violations of Section 331 of said Title
21 U. S. C. A., in the following particular: The introduction of certain alleged
misbrauded drugs into interstate commerce. The issues were made up by an
, answer of the defendant which denied 'that he is transporting misbranded
drugs in interstate commerce   *   *   *.'
' "The evidence on the part of the plaintiff tended to show that the defendant
has been continuously frOm 1932 until the present time engaged in the business
of distributing through the mails in interstate commerce drugs to be used
in the treatment of gallstones, gall bladder diseases and diseased liver condi-
tions, and that said drags consisted of yellow coated tablets, blue coated tablets
and brown coated tablets, and that such drugs were within the meaning of
Section 321 (g) (2), Title 21 U. S. C. A. The evidence supported the averments
of the complaint that certain exhibits proffered in the complaint and in evidence
were regularly sent through the mails either with the drug thus distributed or
prior or subsequent to its distribution and that the drugs and the literature
came into the hands of patrons or purchasers of the drug and that such litera-
ture was intended by the defendant to be used in connection with the treatment
advised by the defendant. As an illustration of the literature thus distributed
through the mails to be associated with the drug when used, was one as
follows:
[Exhibit H]  HEARTFELT GRATITUDE from NORTH . . . SOUTH . . . EAST and
WEST [Printed in large type]
and this was followed by a statement, blocked off in the advertisement, (also in
large type) as follows:?,
??       ??.
Does Gall Bladder Irritation, Gall Distress and Sluggish Bile Threaten You[    Then
read  MY  30  YEARS   OF  TREATING    Earlier   Symptoms  to  Avoid  Development  of
GALLSTONE TROUBLES.
The two words GALLSTONE TROUBLES were printed in very large type.
"Four physicians who were specialists in the administration of internal
medicines, and particularly familiar with gall bladder and liver complaints,
testified that the drugs distributed by the defendant were ineffective for the
purposes advertised and asserted by the defendant in his literature. And,
moreover, that said drugs would be inefficacious in the prevention or the avoid-
ance of the development of gallstone trouble. In fact, the testimony of these
experienced physicians indicated that the drugs administered or delivered for
administration by the defendant would act in a degree as an irritant and
would be harmful in their use. Moreover, said witnesses further testified that
diagnosis of gallbladder and liver trouble could not be satisfactorily made
" without a preliminary objective and subjective examination of the patient.
"On the part of the defendant two physicians were called who were not
presently engaged in the practice of medicine and who had had little experience
in the treatment of gall bladder and liver complaints. The witnesses for the
defendant tended to support the contention of the defendant that his drugs
were not misbranded and that they were useful and efficient as stated by him in
his literature. The further contention is made by counsel for the defendant
that the literature transmitted through the mails in interstate commerce was
in no sense a labeling of the drugs but was purely advertising matter.
"1. The word 'labeling' has been defined in the Federal Food, Drug and
Cosmetic Act, (New) Section 321, paragraph (m), Title 21 U. S. C. A. as
follows:
(m) The term "labeling" means all labels and other written, printed, or graphic matter
(1) upon any article or any of its containers or wrappers, or (2) accompanying such
article.
As said by the Court of Appeals, 7th Circuit, in United States v. Lee, 131 F. 2d,
464,1. c. 466:
The word "accompany" is not defined in the Act, but we observe that among the
meanings attributed to the word are "to go along with," "to go with or attend as a
companion or associate," and "to occur in association with," * * * There can be
no question that among the usual characteristics of labeling is that of informing a pur-
chaser of the uses of an article to which the labeling relates, and that the basic char-
acter of the Federal Food, Drug, and Cosmetic Act is not directly concerned with the
sale of the products therein described, or whether the literature is carried away by the
purchaser. It was enacted to protect the public health and to prevent fraud, and it
ought to be given a liberal construction. Consequently, we are impelled to the conclusion
that misbranding is cognizable under the Act if it occurs while the articles are being
held for sale.
Other discussions of the subject would indicate that it was the purpose of
Congress to treat advertising matter as labeling, if used by the patron or pur-
chaser, precisely in the same way as if the matter were accompanying the drug
in the first instance.
"2. There is the further contention by the defendant that the testimony on
behalf of the government did not point out that the particular formulas of the
defendant were harmful. In the first place, in the trial of the case, it was
assumed by all of the witnesses, both for the plaintiff and the defendant, on
direct examinations and cross-examinations, that the precise formulas were
in controversy and were under discussion by the expert witnesses, and, in the
second place, the testimony on behalf of the government was that, without re-
gard to precise formulas, the particular constituents of the formula or formulas
were harmful and dangerous unless prescribed after a careful diagnosis of the
patient's troubles.
"3. The defendant testified over the objection of counsel for the government
that the years of his treatment 'by mail had not been attended by complaints
from patients or patrons. Objection was properly made to such testimony
and -same should have been excluded. Moreover, certain medical books or
texts were offered in evidence by the defendant over the objections of the
plaintiff. It is the rule in this circuit, as in practically all of the states, that
medical books are not competent as evidence.
"The overwhelming preponderance of the testimony was that the labeling
and the literature treated as labels on the drugs introduced by the defendant
into interstate commerce constituted a misbranding of drugs and that the gov-
ernment was entitled to have the defendant restrained from the further intro-
duction of said drugs in interstate commerce.
"The attention of the court has been called to the fact that since the case
was tried and submitted the defendant has deceased.   The government, there-
fore, could proceed no further in the case. Since the government was entitled,
at the time the case was tried, to a judgment or decree as prayed, and, in view
of the death of the defendant, a decree will be entered nunc pro tunc as of the
date the case was submitted.
FINDINGS   OF  FACT
"1. All of the literature used by the defendant and offered in evidence,
whether used over the container of the drug or in the packages, actually
physically accompanying the drug, or whether sent before, or subsequently,
served the function of labeling and should be treated as such.
"2. Such literature and drugs were introduced and were being introduced
by the defendant in interstate commerce through the mails as alleged in tbe
complaint.
"3. Said literature was intended by the defendant as a labeling of his drug
and actually served that purpose as well as for advertising matter.
"4. Said literature as labeling matter misrepresented the efficaciousness
of said drug or drugs and operated as a fraud upon the public.
CONCLUSIONS OF LAW
"1. The defendant having misbranded his drugs by labels attached thereto
or accompanying same, and such misbranding having been done in interstate
commerce, the defendant should be enjoined from further violations of Section
331, Title 21 U. S. C. A."
On or about October 14, 1946, a decree was entered permanently enjoining
the defendant, his agents, and all persons at that time or thereafter, acting
by, through, or under the defendant, from distributing in interstate commerce
or exporting in foreign commerce a large supply of the tablets which he had
on hand at his place of business in Kansas City, Mo., or at any other point, or
any other quantity of drugs subsequently acquired, which were misbranded;
and it was further ordered that the decree take effect as of September 27,
1946.