5202. Hoxsey treatment for internal cancer.   (Inj. No. 311.)   See also N. J. No.
5212 in this supplement.
COMPLAINT FOR INJ^TNCTION FILED: 5-28-57, W. Dist. Pa., against Hoxsey
Cancer Clinic, a corporation, Portage, Pa., John J. Haluska, president and
administrator, Philip Stager, treasurer, Samuel Einhorn, secretary, John
H. Benko, vice president, and, Delmar Randall and Harold Galbraith, osteo-
pathic physicians employed by the corporation.
An amended complaint was filed on 8-22-57.
ACCOMPANYING LABELING: Booklet entitled "What is Cancer? How Does It
Function?"; pamphlet entitled "Procedure and Information, Hoxsey Cancer
Clinic, Inc."; miscellaneous reprints of articles and letters written and dis-
tributed by John J. Haluska; monthly publication entitled "Globe Gazette";
and book entitled "The Pittsburgh Trial."
NATTOE or DBTJGS: The original complaint alleged that the essential part of
the Hoxsey treatment for internal cancer was either a combination of green
and red tablets or a combination of yellow and red tablets.
The eomplaint alleged also that the green tablets were composed of licorice,
burdock root, stillingia root, berberis root, pokeroot, cascara sagrada, prickly
ash bark, buckthorn bark, and red clover; that the yellow tablets were
composed of red clover, buckthorn bark, stillingia root, berberis root, pokeroot,
and pepsin; and that the red tablets were composed of potassium iodide.
The complaint alleged further that at times the potassium iodide was fur-
nished as a liquid solution or omitted entirely.
METHOD OF OPEBATION : The original complaint alleged that a typical method
used by the defendants in the promotion, sale, and distribution of the treat-
ment, in interstate commerce, was as follows: Interest in the treatment was
promoted by articles appearing in the Globe Gazette, edited by John J.
Haluska, and by articles published in the Defender magazine, edited by
Gerald B. Winrod. In response to an inquiry concerning the treatment,
from a person living outside Pennsylvania, an invitation to visit the clinic
was issued in a letter bearing the facsimile signature of defendant Harold
L. Galbraith as medical director of the clinic. When the prospective out-of-
state customer arrived on the premises of the clinic, he was interviewed
by the employees, at which time there was a discussion of his symptoms
and ailments. This was followed by laboratory tests of the blood and urine,
X-rays, and a physical examination of the customer. On that basis, the
prospective customer's condition was diagnosed as cancer without a biopsy.
The customer then was sold the Hoxsey treatment for internal cancer, com-
prised essentially of the above-described tablets, and the treatment was
delivered to the customer for transportation outside Pennsylvania.
On 8-22-57, the complaint was amended to include the allegation that,
upon entry of the temporary restraining order as described below, the
defendants did the following: With no notice to the persons going to the
?See also No. 5201.
clinic for the Hoxsey treatment, and without changing the labeling representa-
tions and suggestions that they were distributing the Hoxsey treatment for
internal cancer in man, the defendants discontinued the delivery of the above-
?described combinations of pills, which were, as the defendants had admitted,
the essential part of the Hoxsey treatment for internal cancer in man. In
substitution, the defendants delivered to people going to the clinic from outside
Pennsylvania a group of simple medications- usually brewer's yeast tablets,
ascorbic acid (vitamin O) tablets, antacid tablets, laxative tablets, and pain
pills-previously given as supportive treatment for the cancer medicines;
and, in lieu of the above combinations of tablets, the clinic gave a prescrip-
tion for a saturated solution of potassium iodide, to be filled by an outside
pharmacy.
OHABOE : The original complaint alleged that the defendants were engaged in
promoting, selling, distributing, and causing to be introduced and delivered
for introduction into interstate commerce the so-called Hoxsey treatment for
internal cancer, the essential part of which consisted of the combination of
green and red tablets or the combination of yellow and red tablets. It was
alleged also that when the tablets were caused to be introduced and delivered
into  interstate  commerce,  the  tablets were misbranded  as  follows:
502 (a)-the tablets were accompanied by the above labeling, which falsely
represented and suggested that the Hoxsey treatment for internal cancer
was an adequate and effective treatment for internal cancer in man;
502 (f) (1)-at times, no labeling accompanied the tablets, in which case the
labeling of the tablets failed to bear adequate directions for use in that
their labeling failed to state that the tablets were intended for the treatment
of cancer;
502 (f) (1)-with or without the above labeling, the tablets failed to bear
labeling stating adequate directions for use in that the directions as to
dosage and frequency and duration of administration were not adequate
for the treatment for which the tablets were intended, namely, cancer, since
the tablets were worthless for the treatment of cancer and adequate direc-
tions could not be given for the use of the above-described tablets in the
treatment of cancer.
The original complaint alleged also that the Hoxsey treatment for internal
cancer had been adjudged worthless for the treatment of cancer in man on
two previous occasions resulting in: (a) a decree of permanent injunction,
dated 10-26-53, issued by the United States District Court for the Northern
District of Texas (see D. D. N. J. No. 4654) and (b) a decree of condemnation,
pursuant to a jury verdict rendered on 11-16-56, in the United States District
Court for the Western District of Pennsylvania (see D. D. N. J. No. 5212);
that the defendants were in privity with the persons bound by the two
judgments and were themselves bound by them and precluded by the two judg-
ments from denying that the Hoxsey treatment was inadequate and ineffective
in the treatment of internal cancer in man; that the corporate defendant was
the successor to the Hoxsey Cancer Clinic, claimant in the seizure case, which
the individual defendants, Haluska, Stager, Einhorn, and Benko, together
with Newton C. Allen, operated from the time it opened until it was succeeded
by the corporation; that the individual defendants were financially interested
In the clinic and obtained profits from it; and, therefore, the defendants were
aware and bound by the above judgments and knew their activities were
^violative of the Act.
The amended complaint charged that the defendants, after the entry of the
temporary restraining order, caused to be introduced and delivered for in-
troduction into interstate commerce the substitute drugs which were mis-
branded under 502 (a):
(l>;in that the labeling represented and suggested that such drugs com-
prised the Hoxsey treatment for internal cancer, whereas the essential part of
the treatment had been discontinued; and
(2) in that the labeling failed to state the material fact that the Hoxsey
Cancer Clinic no longer distributed or delivered to out-of-state patients with
cancer the tablets that comprised the essential part of the Hoxsey cancer
treatment.
DISPOSITION : On 5-28-57, the court issued a temporary restraining order en-
joining the defendants against the commission of the acts complained of. By
agreement of the parties, the temporary restraining order was extended on
6-19-57 until trial on the issues. The defendants filed their answers to
the complaint on 7-15-57.
A pretrial conference was held on 8-22-57, at which time the court entered
an order amending the complaint to include the additional charges above.
Also, the Government moved for inclusion of the testimony of certain wit-
nesses who had testified in the above-mentioned seizure case in the trial on
the issues in this case. It was the opinion of the court that an order from the
United States Court of Appeals for the Third Circuit was necessary before
the testimony could be so incorporated, inasmuch as the seizure case (see
D. D. N. J. No. 5212) was being appealed to the court of appeals at that time.
Accordingly, the Government filed a motion in the United States Court of
Appeals for the Third Circuit for an order to permit the United States District
Court for the Western District of Pennsylvania to incorporate such testimony
in the instant case. The motion was granted by the court of appeals on
9-4-57.
On 9-6-57, the district court entered the following order:
MEMOBANDUM OBDEB
GOTIELET, Chief Judge: "It appears in this proceeding after pre-trial con-
ference that substantial dispute exists between the parties as to the legal
effect of the adjudication of Civil Action No. 13251, which involved the same
parties, and as to the intent of Judge Miller in his adjudication of the many
matters that were presented to him that justice would be best served if the
proceeding would be heard by the same judge who administered and adjudi-
cated the trial of the companion proceeding.
NOW, THEREFORE, this 6th day of September, 1957, the within proceed-
ing is assigned to the Honorable John L. Miller for trial on the 23rd day of
September, 1957, and all matters relative thereto shall be presented to said
member of the court for consideration, determination and adjudication."
The case came on for trial on 9-23-57. On 10-2-57, at the conclusion of the
Government's case, the court entered the following consent decree of per-
manent injunction:
MUXEB, District Judge: "The plaintiff's complaint praying for a permanent
injunction having come on for hearing and the testimony of the plaintiff
having been taken, the defendants indicated a desire to consent to the entry
of a decree of permanent injunction in the manner and form prayed for by
the plaintiff.
"IT IS THEREFORE ORDERED that the defendants, Hoxsey Cancer
Clinic, Inc., a corporation, and John J. Haluska, Philip Stager, Samuel Ein-
their officers, agents, servants, employees, representatives, and all other per-    (
sons in active concert or participation with them or any of them, be and they    v
are hereby perpetually enjoined and restrained from directly or indirectly, in-
troducing or causing to be introduced and delivering or causing to be delivered
for introduction into interstate commerce, and more particularly delivering or
causing to be delivered to any patient or customer living outside the Common-
wealth of Pennsylvania for transportation in interstate commerce, in violation
of Section 301 (a)  of said Act (21 U. S. O. 331 (a)), the articles of drug
known as the Hoxsey treatment for internal cancer, and any other articles
of drug, the labeling of which represents or suggests that the said drugs
comprise the Hoxsey treatment for internal cancer in man, and any other
drug or similar composition which-
(a)?are accompanied by the aforesaid labeling, namely, the booklet
entitled, "What is Cancer? How Does it Function?" a pamphlet entitled,
Procedure and Information. Hoxsey Cancer Clinic, Inc.," miscellaneous re-
prints of articles and letters written and distributed by John J. Haluska, a
monthly publication entitled the "Globe Gazette," and a book entitled,
"The Pittsburgh Trial," devoted substantially to the promotion of the
Hoxsey treatment;
(b)?are represented or suggested in their labeling to be adequate and
effective in the treatment of cancer in man;
(c)?are misbranded within the meaning of Section 502 (a) of the Act (21
U. S. C. 352 (a)) by reason of any false or misleading representations
or suggestions in the labeling of such drugs;
(d)?are misbranded within the meaning of Section 502 (f) (1) of the Act
(21 U. S. C. 352 (f) (1)) by reason of the failure of the labeling of said
articles to bear adequate directions for use because of the omission from
said labeling of a statement of the condition or disease, namely, cancer,
which said articles are intended to treat or prevent, and because the
directions as to how to take the medicines are not adequate for the condi-
tion for which the~said medicines are intended."