5212. Black tablets and red tablets for use in the treatment of cancer.   (F. D. C.
No. 37908.    S. Nos. 4-052/3 M.)
QUANTITY :   10 ctns., 26,332 black tablets each, and 4 drums, 62,900 red tablets
each, at Portage, Pa., in possession of Hoxsey Cancer Clinic.
SHIPPED :   Between 3-4-55 and 3-11-55, from Detroit, Mich.
LABEL IN  PAET:    (Ctn.)   "Hoxsey-100 SO Tablets   Black   Control Number
06980"; (drum) "Name   Special Tablets    SO Red   06949   Laetotaba [sic]."
ACCOMPANYING LABELING:   The leaflets, reprints, and magazine accompanying
the tablets are enumerated below, in the court's instructions to the jury.
LIBELED :   3-25-55, "W. Dist. Pa.; amended, 6-5-56.
CHARGE:   The tablets were charged to be misbranded under 502  (a).   The
charges are stated in the court's instructions to the jury and in the court's
decision of 5-28-57, both set forth below.
DISPOSITION : The Hoxsey Cancer Clinic, Portage, Pa., and Dr. Newton C. Allen
filed as claimants. On 4-15^-55, claimants filed exceptions, a motion for a more
definite statement, and a motion to dismiss. Thereafter, on 4-26-55, claimants
filed a motion for an order for the protection of the parties and deponents and
to quash subpoena ad testificandum and subpoena duces tecum.
On 5-18-55, the court handed down the following memorandum opinion:
MILLER, District Judge: "This is a motion and a supplemental motion 'for
an Order for the Protection of the Parties Deponents and to Quash Subpoena
ad Testificandum and Subpoena Duces Tecum.' As the caption indicates,
this action was instituted by a libel against 10 cartons of tablets. The libel
was filed March 25, 1955. A pleading entitled 'Exceptions, motion for more
definite statement and motion to dismiss' was filed April 15, 1955. The
questions raised by the exceptions pleading have not been decided by the
court and are not discussed herein, for the reason that counsel for the de-
ponents and for the government have agreed that the exceptions should be
argued at the regular argument day of this court, rather than at the time fixed
for argument of the instant motions. (R. 26). On April 19, 1955, there was
filed a notice to take depositions pursuant to Fed. R. Civ. P. 30 in Room No. 3,
United States Court House, Pittsburgh, Pennsylvania, (Allegheny County),
upon Dr. Newton C. Allen, Senator John J. Haluska, Dr. Gertrude N.
Chalmers, Dr. J. H. Benko, and Ann Shatrosky, R. N., all of Portage, Cambria
County, Pennsylvania. On April 21, 1955, the above-named individuals were
served with subpoenas requiring them to appear as indicated by the afore-
*See also Nos. 5202, 5204, 5207, 5211.
^mentioned notice for the taking of depositions and to bring with them sped-   ,
tied records, memoranda and other documents.
"The instant motion of the deponents was filed on April 26,1955, and argu-
ment was heard thereon on April 28, 1955. It was then agreed (R. 24, 25)
that the argument should be continued, as requested by counsel for deponents,
until May 10, 1955, with the understanding and agreement of counsel that
if the ruling should be that the depositions are to be taken, the records and
witnesses would be available on the following morning at 10:00 o'clock at
any place that the court would designate and that no further subpoenas
or notice would be necessary to any of the parties. At the argument on
May 10, 1955, counsel for the deponents filed the instant supplemental motion
asserting for the first time, in support of the relief requested, the deponents'
constitutional privilege against self incrimination. No order was made be-
cause the court wished to reserve judgment on the new issue thus raised.
"The questions raised by deponents' first motion will be discussed first.
"1) Deponents assert that the notice to take depositions and the sub-
poenas are void because, at this stage of the cause, the admiralty rules, rather
than the Rules of Civil Procedure, are applicable. This contention must
fail. United States v. 5 cases, 179 F. 2d 519 (2d Cir.), cert, denied 339 U. S.
963 (1950) ; United States v. 38 Cases, 99 F. Supp. 460, 464-65 (S. D. N. Y.
1951).
"2) Deponents object to the taking of depositions other than in Cambria
County, the county seat of which is approximately 70 miles from Pittsburgh.
It is true that under Fed. R. Civ. P. 45 (d) (2), witnesses who are not
parties should not be required to appear for the taking of depositions other
than in the county where they reside or are employed or transact their busi-
ness, without an order of court. However, the question now is whether such
an order should be made.
"The words 'convenient place' referred to in Fed. R. Civ. P. 45 (d) (2) do
not refer solely to the convenience of the witnesses. Producers Releasing
Corp. de cuba v. PRC Pictures, Inc., 176 F. 2d 93 (2d Cir. 1949). Because
of the issues raised by deponents' supplemental motion and the opinion of this
court, indicated below, as to the proper procedure for the raising of such >
issues, it is apparent that the only convenient place in this district for the
discovery which the government seeks is at the place where this court sits,
at Pittsburgh, Pennsylvania. Apparently, at least one court has uniformly
followed the practice of having depositions taken at the court house in the
constructive presence of the court so that objections to questions can be ruled
on at once. Kirshner v. Palmer, 7 F. R. D. 252-53 (S. D. N. Y. 1945). This
procedure seems appropriate in the instant case.
"3) Deponents have urged that depositions should not be taken while
their exceptions are pending. This assertion is foreclosed by the agreement
of counsel referred to above. (R. 26). In any event, the court is of the
opinion that discovery should not be postponed merely because exceptions
to the libel are pending in the instant case.
"4) Deponents assert that the discovery sought is intended to harass and
embarrass them. However, it has not been shown in what respects the dis-
covery sought is so harassing or embarrassing as to preclude the taking of
dispositions or the production' of documents. Deponents' assertion is, there-
fore, rejected without prejudice to their right to raise the question of harass-
ment or embarrassment with specificity at the time of taking of depositions.
"5) The same may be said with respect to the claim that the notice and
subpoenas are unreasonable, oppressive, too sweeping in their terms, and call
for irrelevant matter.
"6) It is claimed that the records sought for production are not in the
'possession and control' of any of the deponents other than Dr. Allen. If the
records are not in the possession or control of such other deponents, that is
clearly a matter to be asserted in answer to the discovery sought; it in no way
renders the subpoenas or the notice to take depositions objectionable.
"7 & 8) The objections that the discovery sought is violative of doctor-patient
and/or attorney-client privileges may be asserted at the time and place of the
taking of depositions, at which time deponents may show in what respects the
disclosure of what information or records would be violative of what privileges.
"9) The supplemental motion asserts that if the deponents are required to (
answer, they will be compelled to testify against themselves in violation of  v
their constitutional privilege against self incrimination. It has often been
held that the privilege against self incrimination is a personal one which may
be raised only for oneself and by oneself and not by one's counsel. See Haines
v. United States, 188 F. 2d 546, 551 (9th dr.), cert, denied 342 U. S. 888 (1951) ;
Ziegler v. United States, 174 F. 2d 439, 447 (9th Cir.), cert, denied 338 U. S. 822
(1949); United States v. Johnson, 76 F. Supp. 538, 540 (M. D. Pa. 1947) ; Board
of Comm'rs v. Maretti, 117 Atl. 482, 487 (N. J. Ch. 1922). As stated in Com-
munist Party v. McGrath, 96 F. S. 47, 52 (D. C), pet. for extension of stay
order denied 340 U. S. 950 (1951):
A witness' privilege against self-incrimination must be claimed personally,
at the time the alleged incriminating questions are propounded, not before
they are asked at all.
This court is of the opinion that the privilege against self incrimination cannot
properly be raised by the instant motion for a protective order under Fed. R.
Civ. P. 30 and to quash the subpoena, but rather, that the witnesses must re-
fuse to answer and produce records, claiming the privilege under oath, where-
upon the government may test the claimed privilege by a motion for an ap-
propriate order, United States v. Fishman, 15 F. R. D. 151 (S. D. N. T. 1953) ;
Mumford v. Croft, 93 A. 2d 506 (Del. Super. Ct. 1952). As stated in the Mum-
ford case at 93 A. 2d 507-08:
Although objections to interrogatories have been permitted as a means of
claiming the privilege against self-incrimination, I am of the opinion that
the assertion of the privilege, as a reason for not answering interroga-
tories in a civil case, is not properly before the Court upon objections filed
by the attorney for the party claiming the privilege. The privilege is a
personal one to be claimed by the party and not by his attorney. . . . The
privilege is an "option of refusal, not a prohibition of inquiry." The
plaintiffs are entitled to have the oath of the defendants either in answer-
ing the interrogatories or in asserting their privilege not to answer. If
either of the defendants were called by the plaintiffs at the trial of this-
case, he or she would be obliged to take the oath, await the question and
then claim the privilege under oath. . . . The rules of evidence which
would govern privileged matters at trial govern such matters when they
arise during discovery. ... I think, therefore, that the issue of whether
the defendants should be obliged to answer these interrogatories should
be presented by a refusal to answer and a claim of privilege under oath,,
followed by an application by the plaintiffs, under Rule 37 (a), for an order
compelling an answer.    ...
"Paul Harrigan & Sons, Inc. v. Enterprise Animal Oil Co., 14 F. R. D.
333 (E. D. Pa. 1953) and Porter v. Heend, 6 F. R. D. 588, 590 (N. D. 111.
1947) appear to be authority for the proposition that the privilege against self
incrimination could be properly raised by the instant motions. However,,
neither the Porter nor the Harrigan & Sons case discusses an assertion that
the claim of privilege must be made personally and under oath, and no case
suggests that to follow the procedure outlined in the Fishman and Mumford
cases would be a violation of constitutional rights, an abuse of discretion, or an
unwise procedure. Indeed, it is generally held that it is not a violation
of constitutional rights to require witnesses to appear and be sworn. United
States v. Benjamin, 120 F. 2d 521, 522 (2d Cir. 1941) ; Mulloney v. United
States, 79 F. 2d 566, 578-80 (1st Cir. 1935) ; O'Connell v. United States, 40
F. 2d 201, 205 (2d Cir.), appeal dismissed per stipulation 296 U. S. 667
(1930) ; United States v. Haas, 126 F. Supp. 817, 818 (S. D. N. Y. 1954) ;
United States v. Scully, 119 F. Supp. 225, 227 (S. D. N. Y. 1954) ; United States
v. Manno, 118 F. Supp. 511, 517 (N. D. 111. 1954) ; United States v. Mangiara-
cina, 92 F. Supp. 96. 97 (W. D. Mo. 1950) ; United States v. Miller, 80 F.
Supp. 979, 981 (E. D. Pa. 1948) ; United States v. Wilson, 42 F. Supp. 721, 722
(D. Del. 1942) ; United States v. Burk, 41 F. Supp. 916, 918 (D. Del. 1941).
"This court is of the opinion that the procedure outlined in the Fishman and
Mumford cases is sound and appropriate in the case at bar. Accordingly, an
order is entered requiring deponents to appear for the taking of depositions
?t the United States Courts and Post Office Building in Pittsburgh, Pennsyl-
vania, and to bring with them those records specified in the subpoenas which
are in their possession or control. Upon being sworn, deponents may raise
the questions which they have sought to raise by the instant motions, not (
inconsistently with this opinion. The question of whether the records sought
should be produced to the interrogating party, or to the court, may be deter-
mined when and if questions of privilege are raised. See Brown v. United
States, 276 U. S. 134, 144 (1928) ; Consolidated Rendering Co. v. Vermont, 207
U. S. 541, 552-53 (1908) ; United States v. White, 137 F. 2d 24, 26 (3d Cir.
1943), rev'd on other grounds 322 U. S. 694 (1944) ; Corretjer v. Draughon,
88 F. 2d 116 (1st Cir. 1937) ; 8 Wigmore, Evidence ?2200 (5) (3d ed. 1940).
"An appropriate order is entered."
After hearing arguments- on the exceptions to the libel, the court entered
the following memorandum opinion on 8-2-55:
MTT.T.EB, District Judge: "This case is before the court upon 'exceptions,
motion for more definite statement, and motion to dismiss,' filed by Hoxsey
Cancer Clinic, Portage, Pennsylvania, and Dr. Newton C. Allen, the claimants
herein. The court's jurisdiction is based upon the Federal Food, Drug, and
Cosmetic Act, ?304 (a), 52 Stat. 1044 (1938), as amended, 21 U. S. C. A.
?334 (a).
"The following facts appear from the libel: The articles in question were
shipped from Detroit, Michigan, to Portage, Pennsylvania, at specified times
via specified carriers, accompanied by specifically designated printed matter.
The articles are drugs which were misbranded while held for sale after
shipment in interstate commerce, within the meaning of the Federal Food,
Drug, and Cosmetic Act, in that the articles are the essential part of the
Hoxsey Treatment for Internal Cancer, and the specified printed matter
accompanying the drugs contains representations and suggestions that the
Hoxsey Treatment is adequate and effective in the treatment of internal
cancer in humans, which representations and suggestions are false. The
articles are further misbranded in that a specified leaflet accompanying them
contains statements which represent and suggest that, as the result of litiga-
tion with the United States Government, there is in effect a decree which *
permits the offering of the Hoxsey Treatment for Internal Cancer as beneficial,
effective, and having value in the treatment of cancer so long as qualifying
statements are made to the effect that there is a conflict of medical opinion
as to the truth of such representations. Such statements are false and mis-
leading since, as the result of such litigation, there is not in effect such
a decree but, on the contrary, the United States Court of Appeals for the
Fifth Circuit has rendered an opinion which forbids the use of any claims,
however qualified, that the Hoxsey Treatment for Internal Cancer would be
effective in the treatment of cancer. The injunctive decree under which
the Hoxsey Cancer Clinic is now operating, entered October 26, 1953, contains
an unequivocal prohibition against any labeling claims for the Hoxsey Treat-
ment for Internal Cancer, or any like drugs or combination of drugs, in the
treatment of cancer. The articles are in the possession of Hoxsey Cancer
Clinic, Portage, Pennsylvania, or elsewhere within this court's jurisdiction.
The articles are held illegally within this court's jurisdiction and are liable to
seizure and condemnation pursuant to the Federal Food, Drug, and Cosmetic
Act.
"At the oral argument upon the exceptions, a number of the paragraphs
thereof were waived by counsel for claimants. The remaining paragraphs
which were not waived are as follows:
3. The facts averred in the libel are insufficient to constitute a cause of
action.
7. The third paragraph of the libel does not sufficiently, fully and dis-
tinctly allege the manner in which the alleged leaflets are cause of "mis-
branding" of the seized drugs and "labeling thereof" under the Federal
Food, Drug and Cosmetic Law.
9. Paragraph number three of the libel does not allege any facts to
establish sufficiently, fully and distinctly how and in what manner the
seized drugs are the "essential part of the Hoxsey Treatment for Internal ,
Cancer" administered by the Hoxsey Cancer Clinic of Portage, Pennsyl- i
vania.
11.?Paragraph number three of the libel does not allege any facts to
establish sufficiently, fully and distinctly how and why the Hoxsey
treatment for Internal Cancer as administered by the Hoxsey Cancer
Clinic, Portage, Pennsylvania, is not adequate and effective in the treat-
ment of internal cancer in humans.
12.?Paragraph number four does not sufficiently, fully and distinctly
state how and why the said seized articles are the essential part of the
Hoxsey Treatment for Internal Cancer, nor does said paragraph number
four state sufficiently, fully and distinctly the specific statements of the
various leaflets which libellant avers substantiate the allegations of mis-
representation and falsity, so set forth.
13.?The allegations of paragraph number four do not sufficiently, fully
and distinctly reveal how the said Decree of the United States Court
of Appeals for the Fifth District apply and affect the Hoxsey Cancer
Clinic of Portage, Cambria County, Pennsylvania.
14.?The libel does not have attached to it the various leaflets, written,
printed and graphic matter, which are alleged to have accompanied the
seized drugs and which are alleged to constitute mislabeling and mis-
branding under the Federal Food, Drug and Cosmetic Act.
15.?The said libel does not contain a list or description identifying the
ingredients of the seized drugs.
18. Paragraph number three of the libel does not sufficiently, fully and
distinctly reveal, how, in what manner and how the seized drugs are
held for sale after shipment in interstate commerce within the meaning
of the Federal Food, Drug and Cosmetic Act.
"? 304 (a) of the act, supra, 21 U. S. C. A. ? 334 (a), provides:
Any article of . . . drug . . . that is . . . misbranded when introduced
into or while in interstate commerce or while held for sale (whether or
not the first sale) after shipment in interstate commerce . . . shall be
liable to be proceeded against while in interstate commerce, or at any time
thereafter, on libel of information and condemned in any district court of
the United States within the jurisdiction of which the article is found. ...
"? 502 of the act, 52 Stat. 1050, as amended, 21 U. S. C. A. ? 352 provides:
A drug . . . shall be deemed to be misbranded-
(a) If its labeling is false or misleading in any particular.
"? 201 of the act, 52 Stat. 1041, as amended, 21 U. S. C. A. ? 321 (m), pro-
vides :
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.
"The elements thus specified as prerequisite to a 'cause of action' clearly
are all alleged in the libel. The contention that the facts averred in the libel
are insufficient to constitute a cause of action is without merit.
"The remaining paragraphs of the exceptions relate to claimants' contention
that the libel is insufficiently definite and specific under Admiralty Rule 21.
Claimants contend, and plaintiff has not disputed, that the question of the
sufficiency of the allegations has been properly raised under Admiralty Rule 27
or under Fed. R. Civ. P. 12 (e).
"What has been said in Marshall Hall Grain Go. v. United, States Shipping
Board Emergency Fleet Corp., 14 F. 2d 141,142 (D. Mass. 1926) is appropriate
lere:
It must be quite apparent from the above summary of the allegations that,
if the libelants' proofs come up to their allegations, it would be impossi-
ble to rule, as a matter of law, that each had not made out a prima facie
case of liability, entitling it to relief in the admiralty court.
"The objection that the libel alleges conclusions of law is without merit.
Allegations in the words of the applicable statute are proper. United States v.
The Antoinetta, 153 F. 2d 138, 141-42 (3d Cir. 1945), cert, denied 328 U. S.
863, rehearing denied 329 U. S. 820 (1946).   In Seven Cases v. United States,
239 U. S. 510, 518 (1916), the Court held, with respect to allegations which ap-   /
pear to have been no more detailed than those here involved:
With respect to the sufficiency of the averments of the libels, it is enough
to say that these averments should receive a sensible construction. There
must be a definite charge of the statutory offense, but we are not at liberty
to indulge in hypercriticism in order to escape the plain import of the words
used.
"Clearly, all of the matters required to be averred under Admiralty Rule 21
have been averred; the question raised by claimants relates to the specificity
with which such matters must be pleaded. In Colonial Sand & Stone Co. v.
Muscelli, 151 F. 2d 884, 885 (2d dr. 1945), the court held:
True, it has been a common custom in the admiralty not to confine plead-
ings to the "ultimate," "constitutive," or "operational," facts on which
the right or defense depends, as is required in other branches of the
law; but to set out a discursive narrative of the pleader's version of the
events. That custom is more honored in the breach than in the observ-
ance; but, assuming that long tolerance has sanctioned it, there is no
warrant for making it compulsory, and every reason to sustain a pleading
which is adequate under ordinary canons.
"No reason has been suggested to the court why any greater specificity
should be required in a libel than in a complaint. The discovery rules of the
Federal Rules of Civil Procedure are as available to claimants in this action
as they are to parties in an action instituted by complaint, and much of the
information which claimants seek to have libelant plead can be obtained through
the use of the discovery rules. Cf. Prescan v. Aliquippa & Southern R. R.,
16 F. R. D. 272 (W. D. Pa. 1954) ; Byers v. Olander, 7 R. F. D. 745, 746 (W. D.
Pa. 1948). The pleading here attacked is more than sufficient 'to afford fair
notice to the adversary of the nature and basis of the claim asserted and a ;
general indication of the type of litigation involved.' Cf. Continental Collier-
ies, Inc. v. Shooer, 130 F. 2d 631, 635 (3d Cir. 1942).
"For the foregoing reasons claimants' exceptions must be dismissed. An
appropriate order is entered."
Thereafter, on 9-14-55, the claimant filed a motion to correct the transcript
relating to depositions and, on 9-22-55, filed a motion to suppress the deposition
of Harry M. Hoxsey which had been taken on 9-15-55, in Dallas, Tex. The
Government filed a motion to compel deponents to answer oral interrogatories
and a motion to compel deponents to obey subpoenas duces tecum. On 2-29-56,
the court handed down the following memorandum opinion:
MUXES, District Judge: "This case is now before the court upon motions of
Newton C. Allen, D. O., a claimant herein, to suppress the deposition of
Harry M. Hoxsey, N. D., taken September 15, 1955, in Dallas, Texas, to compel
transcription and delivery of deposition, and to correct the transcript relating
to depositions, and upon libelant's motion to compel deponents to answer oral
interrogatories and to compel two of the deponents to obey subpoenas duces
tecum.
"With respect to the motion to suppress the Hoxsey deposition, government
counsel have admitted the truth of the averment that they failed to give notice
of the taking of the deposition as required by Fed. R. Civ. P. 30 (a). There-
fore, Dr. Allen's motion to suppress the Hoxsey deposition will be granted.
Associated Transport, Inc. v. Riss d Co., 8 F. R. D. 99 (N. D. Ohio 1948).
"Claimant's motions to compel transcription and delivery of deposition and
to correct the transcript relating to depositions have not been mentioned by
counsel in argument or briefs. Therefore, those motions will be dismissed
without prejudice.
"The deponents, Allen, Haluska, Shatrosky, Benko, and Chalmers, were by   ,
subpoenas served upon them and by an order of this court of May 18, 1955,   (
required to appear for the taking of depositions by government counsel and to
bring with them records as specified by the subpoenas. Deponents appeared
for the depositions and were duly sworn, but refused to produce the records
and refused to answer many questions. Extensive objections to producing the
records and answering the questions were made by and on behalf of deponents,
the only objection of any substance being the claim of privilege against self
incrimination.
"With respect to deponent Shatrosky, however, there were no unanswered
questions to which the government has moved to compel answers. Libelant's
claim is that deponent Shatrosky answered 'I don't know' to a number of
questions the answers to which she must have known. It is not absolutely
clear from the transcript of her testimony that this is so. Moreover, this is
not a motion to punish for contempt such as was made in the case upon which
libelant relies: Crosley Radio Corp. v. Hieb, 40 F. Supp. 261 (S. D. Iowa 1941).
There being no questions unanswered by deponent Shatrosky to which libelant
has moved the court to compel answers, the motion to compel answers will be
denied as to her.
"With respect to deponents Benko and Chalmers, the court is of the opinion
that the claim of privilege must be fully sustained, and the government's
motion to compel answers must be denied. As stated in Hoffman v. United
States, 341 U. S. 479,486-87 (1951) :
If the witness, upon interposing his claim, were required to prove the
hazard in the sense in which a claim is usually required to be established
in court, he would be compelled to surrender the very protection which
the privilege is designed to guarantee. To sustain the privilege, it need
only be evident from the implication of the question, in the setting in
which it is asked, that a responsive answer to the question or an explana-
tion of why it cannot be answered might be dangerous because injurious
disclosure could result.
"In the setting of this case, the court is of the opinion that deponents might
reasonably fear that answering any questions might be dangerous. Deponents
are all allegedly or admittedly officers or employees of the Hoxsey Cancer
Clinic of Portage, which is alleged in this action to have acquired certain drugs
in interstate commerce and to have falsely represented the same as being useful
in the treatment of cancer. Thus, the gist of this action is a federal crime.
Act of June 25, 1938, ? 303, 52 Stat. 1043, as amended, 21 U. S. C. A. ? 333.
Therefore, the more germane libelant's questions may be to the subject matter
of this action, the more readily apparent it is that answers thereto could be
incriminating. Deponents thus find themselves in the situation discussed in
Maffle v. United States, 209 F. 2d 225, 228-29 (1st Cir. 1954) :
The witness may have reason to believe that he himself is under suspicion
and that it will be the purpose of the interrogator to worm out of him
all the self-incriminatory disclosures possible. In that case, the situation
of the witness approaches that of an accused person at a criminal trial,
who may elect to keep silent altogether. The witness may be willing to
answer certain formal preliminary inquiries, as to matters generally
known, such as his name, residence, age, et cetera. But he may have a
justified apprehension of danger in answering further. He may not have
the acuteness to see what an innocuous-looking question, put by a re-
sourceful cross-examiner, is leading up to. Yet he might not be unrea-
sonable in believing that the question was asked for a purpose and that
the purpose was to lead him into a booby trap in which he would make
some disclosures useful to the prosecution in weaving a case against him.
Just where the line should be drawn in such a case, in the application of
the privilege, might be a question; but it is certainly clear that it should
be drawn well short of the point where the interrogator might have a
substantial chance of striking pay dirt.
"See also, Aiuppa v. United States, 201 F. 2d 287, 294 (6th Cir. 1952) ;
Marcello v. United States, 196 F. 2d 437,441 (5th Cir. 1952).
"The same considerations apply to the motion to compel answers with
respect to deponent Allen, except with reference to certain unprivileged mat-
470085-58?3
ters which will be discussed below. The court has not failed to note the
extraordinary position taken by Dr. Allen in this action. Dr. Allen, as claim-
ant of the articles seized in this action, has filed an answer to the libel and
a number of motions. Yet, upon the taking of Dr. Allen's deposition, he
not only failed to claim the seized articles, but refused to answer questions
which would connect him in any way with them. However, whatever may be
the effect of Dr. Allen's ambivalent position on his standing as a party to
this action, the court is of the opinion that it cannot be held to abrogate
his constitutional privilege.
"Libelant earnestly contends that deponent Haluska's claim of privilege
was not made in good faith and should not be sustained because of certain
public statements made by him shortly after the taking of his deposition on
May 20, 1955. It appears from the Legislative Journal for May 24, 1955, for
the Senate of the Commonwealth of Pennsylvania, that Senator Haluska
represented on the floor of the Senate that he had been 'compelled' to 'use
the Fifth Amendment' in this case in order to protect the 'private communi-
cations' of the Hoxsey Cancer Clinic's patients, and that he would 'talk
freely' if only this court would order the records in question to be brought in.
Of course, as libelant contends, such representations were patently absurd:
(1) Senator Haluska had already been ordered by this court on May 18,
1955, to appear for the taking of his depositions and to bring with him the
records listed in the subpoena; (2) a great many of those records and most
of the questions which he refused to answer had nothing to do with the clinic's
patients; (3) the blanket patient-physician privilege which he asserted does
not exist under the laws of Pennsylvania (Act of June 7, 1907, P. L. 462, ? 1,
28 Pa. P. S. ? 328) or of the United States; (4) a desire to protect the private
communications of others, clearly constitutes no proper basis for the claim of
privilege against self incrimination.
"Two days later, May 26, 1955, in Senator Haluska's newspaper column, 'AS
I SEE IT,' in the Portage Dispatch, the following statement appears:
As the administrator of this clinic, I assure the people that I have nothing
to hide, and I shall only be too happy to tell the government, in fact,
the entire world of all our proceedings at our institution. I shall be
happy to tell the government just who the Hoxsey Clinic of Portage is.
There are no secrets in our lives but we want to make these announce-
ments, not to a few attorneys, but to a jury of men and women who would
be privileged to decide honestly whether or not the Hoxsey Clinic has
given false hope to those poor victims who are told they must die, or
whether they have been treated successfully by having their lives ex-
tended and pain relieved.
"Of course, the proper time and place for the Senator to have told 'the
government, in fact, the entire world of all our proceedings at our institu-
tion' was upon his deposition under oath, taken pursuant to order of this
court, at which time the Senator was willing to tell substantially nothing
about his connection with the clinic or its affairs. If the Senator's news-
paper statement could be believed, it would appear that his claim of privilege
against self-incrimination was based entirely upon a contemptuous disregard
for and refusal to comply with the lawful discovery procedures and order
of this court.
"This court cannot condone or justify the flagrant and cynical abuse of
the great constitutional privilege evidenced by Senator Haluska in this case.
But an insuperable difficulty inheres in the government's position. To require
Senator Haluska to show which of the conflicting statements which he has
made in support of his refusal to answer questions and produce documents
is the true one would be tantamount to requiring him to show not merely
that the discovery to which he has refused to submit could be incriminating,
but that it would be incriminating. So to require would be to compel him
to incriminate himself in order to sustain his privilege not to do so. There-
fore, the court is of the opinion that the government's motion as to deponent
Haluska must be denied, except with respect to unprivileged matters.
"The unprivileged matters to which the court has alluded in connection
with deponents Allen and Haluska are the records of the Hoxsey Cancer
Clinic of Portage and/or of Hoxsey Cancer Clinic, Inc.   It has been abundantly
shown that the scope of the activities and membership of the clinic in Portage
are of such an impersonal character that the clinic cannot be said to embody
the purely personal and private interests of its constituents. Therefore, no
claim of privilege with respect to the records of the clinic can be sustained,
regardless of whether such records may incriminate deponents as individuals
or as officers or employees of the clinic. See Rogers v. United States, 340
U. S. 367, 371-72 (1951) ; United States v. Fleischman, 339 U. S. 349, 358
(1950) ; United States v. White, 322 U. S. 694, 701, 704 (1944) ; United States
v. Field, 193 F. 2d 92 (2d Cir.), cert, denied 342 U. S. 894 (1951), cert, dis-
missed 342 U. S. 908 (1952) ; Fulford v. United States, 155 F. 2d 944, 947
(6th Cir. 1946) ; United States v. Onassis, 133 F. Supp. 327 (S. D. N. T. 1955) ;
United States v. Onassis, 125 F. Supp. 190, 210 (D. C. D. O. 1954) ; but cf.
United States v. Lawn, 115 F. Supp. 674 (S. D. N. Y. 1953) ; In re Subpoena
Duces Tecum, 81 F. Supp. 418 (N. D. Cal. 1948).
"The lists of records required by the subpoenas are not explicitly limited to
records of the Hoxsey Cancer Clinic of Portage and/or of the Hoxsey Cancer
Clinic, Inc. The order enforcing the subpoenas duces tecum as to deponents
Allen and Haluska must be so limited. However, it is for the court, not the
deponents, to determine questions of ownership and privilege. Therefore,
deponents shall be ordered to submit the records under subpoenas as to which
they may claim ownership solely in their individual capacities to the court for
its determination of the validity of any such claim. See Brown v. United
States, 276 U. S. 134, 144 (1928) ; Consolidated Rendering Co. v. Vermont, 207
U. S. 541, 552-53 (1908) ; United States v. White, 137 F. 2d 24, 26 (3d Cir. 1943),
rev'd on other grounds 322 U. S. 694, supra; Corretjer v. Draughon, 88 F. 2d 116
(1st Cir. 1937) ; 8 Wigmore, Evidence ? 2200 (5) (3d ed. 1940).
"With respect to any of the clinic's records under subpoena which are not
produced, deponents Allen and Haluska may be compelled to answer under
oath questions relating to the location and custody of such records; with
respect to records which are produced, they may be required under oath to
answer questions relating to their identity and authenticity. See United
States v. Field, supra; Pulfordv. United States, supra. 155 F. 2d at 947; Lumber
Products Ass'n v. United States, 144 F. 2d 546, 553 (9th Cir. 1944), rev'd on
other grounds si<b nom. United Brotherhood of Carpenters v. United States,
330 U. S. 395 (1947) ; Carotene Products Co. v. United States, 140 F. 2d 61, 66
(4th Cir.), aff'd on other grounds 323 U. S. 18 (1944) ; United States v. Illinois
Alcohol Co., 45 F. 2d 145 (2d Cir. 1930), cert, denied 282 U. S. 901 (1931) ;
United States v. Austin-Bagley Corp., 31 F. 2d 229 (2d Cir. 1929) ; United
States v. Sclafani, 126 F. Supp. 654 (E. D. N. Y. 1954) ; United States v. Lawn,
supra, 115 F. Supp. at 677; United States v. Greater New York Live Poultry
Chamber of Commerce, 34 F. 2d 967 (S. D. N. Y. 1929), aff'd on other grounds
47 F. 2d 156 (2d Cir.), cert, denied 283 U. S. 837 (1931) ; Cf. Heike v. United
States, 227 U. S. 131 (1913) ; Wilson v. United States, 221 U. S. 361 (1911).
"Libelant also contends that deponents Allen and Haluska have waived their
privilege against self incrimination with respect to certain topics through state-
ments and answers which were made by them. However, the answers which
libelant seeks to compel might well be more incriminating than the answers
already given. To hold that deponents have waived their privilege in these
circumstances would serve only to cause witnesses in other cases .justifiably to
fear to answer non-incriminating questions lest they be held to have waived
their privilege not to answer incriminating questions. This is not a case
where witnesses have given self incriminating answers and have then refused
to disclose details which would not further incriminate them. See, e. g., Rogers
v. United States, supra, 340 U. S. at 372-75.
"Libelant may submit an order in conformity with this opinion. An order
with respect to claimant's motions is entered."
On 4-2-56, the court ordered Newton C. Allen and John J. Haluska to
respond to the subpoenas duces tecum that had been served on 4-18-55.
The case came on for trial on 10-8-56. After submission of evidence by both
parties, the court instructed the jury on 11-15-56, as follows:
MILLER, District Judge: "Members of the jury, under the Constitution of the
United States, Congress has been given power to regulate commerce between
the various states. In the exercise of its constitutional powers, Congress has
enacted the Federal Food, Drug and Cosmetic Act, sometimes referred to as
the Food and Drug Act, one of the purposes of which is to keep interstate com-
merce free from misbranded articles of the type specified by the statute, for
the protection of the general public.
"In this case, we are involved with a requirement of the law that a consumer
in any applicable instance must be both adequately and truthfully informed
- of what he is purchasing.
"One of the means by which the provisions of the law may be enforced is
through a seizure and condemnation procedure, in which the Government takes
possession of the articles claimed to be misbranded and if, after a trial such as
this, it is found that the requirements of the statute are violated, such articles
may be destroyed under an order of condemnation.
"The seizure and condemnation procedure is the one which the Government
is following here.   The statute in part provides as follows:
Any article of food, drug, device or cosmetic that is . . . misbranded when
introduced into or while in interstate commerce or while held for sale . . .
after shipment in interstate commerce shall be liable to be proceeded
against while in interstate commerce, or at any time thereafter, on libel
of information and condemned in any district court of the United States
within the jurisdiction of which the article is found.
"The present lawsuit is confined to the alleged misbranding of a large quantity
of black and red pills, contained in a number of cartons and drums found upon
the premises of the Hoxsey Cancer Clinic at Portage, Pennsylvania, and there
seized by the Government pursuant to a warrant of seizure and monition issued
out of this court.
"The warrant of seizure and monition was authorized by this court upon a
libel of information filed by the Government, in which the Government claims,
1. That the pills which were seized and which are now in this courtroom are
drugs within the meaning of the Federal Statute; 2. That at the time of the
seizure of the pills at the Hoxsey Cancer Clinic at Portage, Pennsylvania, they
were being held for sale, after having been shipped in interstate commerce;
3. That at the time of their seizure at the Hoxsey Cancer Clinic in Portage,
Pennsylvania, the pills were accompanied by certain pieces of written, printed
and graphic matter, which were used bv the Hoxsey Cancer Clinic to promote
the sale of the Hoxsey internal cancer treatment, and that the printed materials
constituted labeling within the statute.
"It is contended that the alleged labeling contained statements and repre-
sentations causing the pills to be misbranded while held for sale, after shipment
in interstate commerce.
"An answer to the libel was filed by the Hoxsey Cancer Clinic of Portage,
Pennsylvania, and Dr. Newton C. Allen, Medical Director of the Clinic, as
owner and claimant of the pills in question.
"The answer of the Clinic and Dr. Allen admits some of the allegations of the
Government's libel but denies certain of the material averments.
"The parties have agreed that the pills in question are drugs within the
meaning of the Federal Food and Drug Act. I instruct you that a drug, under
the statute, is an article intended for use in the diagnosis, cure, mitigation,
treatment or prevention of disease in man.
"In connection with this stipulation of the parties, I call to your attention
that there is no dispute about the ingredients of the pills. It is conceded that
the red pills are composed of the following ingredients: Potassium iodide, red
clover tops, stillingia root, berberis root, poke root, buckthorn bark, and pepsin;
and the black pills are composed of these ingredients: Potassium iodide, licorice,
red clover tons, burdock root, stillingia root, berberis root, poke root, cascara
sagrada, prickly ash bark, and buckthorn bark.
"You may also take it as established as a fact in this case, in accordance
with the admission of counsel for the claimant, that the red and black pills are
the essential part of the Hoxsey cancer treatment for internal cancer in man.
"In order for the Government to succeed in this action, it is necessary that
the pills were held for sale at the Hoxsey Cancer Clinic in Portage, Pennsyl-
vania, after shipment in interstate commerce.
"In this case, it is admitted in the answer of Dr. Allen and the Hoxsey Cancer
Clinic that the pills were shipped in interstate commerce, from the Testagar
Company in Detroit, Michigan, to Portage, Pennsylvania, and therefore you
need not concern yourself with the question of interstate transportation.
"The Hoxsey Cancer Clinic and Dr. Allen deny, however, that the pills were
held for sale at the Portage Clinic, even though they had been shipped in inter-
state commerce. It is the position of the claimant and the Clinic th?t the
articles of drugs, the red and black tablets, were not held for sale after shipment
in interstate commerce, but were intended to be prescribed in conjunction with
the treatment and methods suggested, after diagnosis of each case by a
physician in charge.
"The concept, held for sale, as used in the Federal Statute, is a wide one and
is not restricted simply to over-the-counter transactions. The act does not
provide for any exception to be made in the case of drugs alleged to be mis-
branded, which are dispensed through a Clinic or a licensed physician.
"For the purpose of the Federal Food and Drug Act, every specified article
which has been shipped in interstate commerce, which is not intended for con-
sumption by the party who receives it, but is intended for a further distribution
to others, is held for sale.
"It is immaterial, under the statute and under the evidence in the present
case, if none of the pills involved was in fact sold or that some of them may have
been given to patients free of charge. Under the law, it does not matter that
the exact charge for pills cannot be identified. The fee charged at the Clinic
included payment for the pills as well as for professional services. I therefore
instruct you, under the law and under the evidence in this case, that these
pills were held for sale at the Hoxsey Cancer Clinic, after having been shipped
in interstate commerce.
"The essential issue in the case and the one which you must primarily concern
yourselves with is whether the black and red Hoxsey pills are misbranded,
under the Federal Statute.
"The statute provides that a drug is misbranded if its labeling is false or
misleading in any particular.
"The term, labeling, as used in the Act, is not confined to the actual labels
affixed to the containers of the drugs, but includes in addition to the actual
labels such other written, printed or graphic matter, which accompanies the
drug article which is held for sale after shipment in interstate commerce.
"In the present case, the Government says that an assortment of five different
pamphlets, leaflets and magazines constitute the labeling which accompanied
the drug in this case.   Those pamphlets include the following:
"1. A leaflet, 'Hoxsey Cancer Clinic, 4507 Gaston Avenue, Dallas 10, Texas,
Courtesy of Hoxsey Cancer Clinic, Portage, Cambria County, Pennsylvania,
Specializing in the Treatment of Cancer, Precancerous and Chronic Diseases.'
That has been marked Exhibit 24.
"2. A leaflet, 'Procedure and Information, Hoxsey Cancer Clinic, 911 Cald-
well Avenue, Portage, Pennsylvania.'   That is Exhibit No. 41.
"3. A leaflet, reprint from Man's Magazine, Volume 2, No. 6, August 1954,
'I Conquered Cancer,' by Allen Bernard, Exhibits 25 and 40.
"4. A leaflet, Hoxsey Cancer Clinic, 4507 Gaston Avenue, Dallas 10, Texas,
'Findings of the Doctors who Investigated the Facilities, Procedure and Treat-
ment at the Hoxsey Cancer Clinic, April 10 and 11, 1954.'   That is Exhibit 43.
"5. A magazine, The Defender Magazine, March 1955, Volume 29, No. 11,
containing the speech by Senator Haluska.   That is Exhibit 39.
"The exhibits which I have mentioned are here in this brown envelope for
your convenience.
"The foregoing leaflets and magazines, all of which have been admitted in
evidence, are of the type which under the law could constitute labeling. How-
ever, before such articles of literature would become labeling under the statute,
you would have to find, by the preponderance of the credible evidence, that
they accompanied the pills which were held for sale at the Hoxsey Cancer
Clinic.
"That is the preliminary question you must decide with respect to the
printed matter involved here.
"In determining whether or not this printed matter, or any of it, accom-
panied the drugs, you should keep in mind that it is not necessary that the
alleged labeling be displayed with or physically attached to the drug.   It is
sufficient if you find that the printed matter had a functional role in the dis-
tribution or sale of the Hoxsey red and black pills.
"In making this determination, you will consider all of the testimony bear-
ing on the location of the leaflets and magazines, the contents of the same, the
purposes for which they were intended, and the uses to which they were put.
"An article of literature accompanies an article of drug whenever its pur-
pose is to supplement or explain the drug or its use. Thus, you must consider
both the physical relationship between the literature and the drugs and the
textual relationship of the literature with the drug.
"If, having done so, you are satisfied by the fair weight or preponderance
of the credible evidence that the literature was associated with the drug in
such a way as to become a part of the system by which the pills were dis-
tributed or sold to patients, you should conclude that such literature constitutes
labeling.
"The evidence of the Government showed that copies of each of the pieces
of literature involved here were found at the time of the seizure on the desk
in the lobby of the Portage Clinic, near a waiting room which was used by the
patients and other persons. Other copies of the Defender Magazine were
found in a drug room at the back of the premises. The Government's evidence
as to the location of the literature was not disputed, as I recall the evidence.
From the fact of their presence on the table, it was intended that the articles
would be read by patients and persons in the Clinic.
"The Government's contentions are that the aforesaid leaflets and maga-
zines are false and misleading in three respects, which are set forth in detail
in the libel. It is contended, one, that the foregoing leaflets and magazines
contain representations and suggestions that the Hoxsey treatment for internal
cancer is adequate and effective in the treatment of internal cancer in humans,
which representations and suggestions are false and misleading, since it is
contended that the Hoxsey treatment is not adequate and effective in the treat-
ment of internal cancer in humans.
"The leaflet, 'Hoxsey Cancer Clinic, Dallas, Texas'-this is two-'Courtesy
Hoxsey Cancer Clinic, Portage, Pennsylvania, Specializing in the Treatment
of Cancer, Precancerous and Chronic Diseases,' represents and suggests that
as the result of previous litigation there is in effect a decree which permits the
offering of the Hoxsey treatment for internal cancer as beneficial and effective
and having value in the treatment of cancer so long as qualifying statements
are made to the effect that there is a conflict of medical opinion as to the truth
of such representations.
"It is the Government's position that such representations are false and
misleading because, as a result of such litigation, there is not in effect such a
decree but a decree which forbids the making of any claim, however qualified,
that the Hoxsey treatment for internal cancer is effective in the treatment of
cancer and that the decree which pertains to the Hoxsey Cancer Clinic of
Dallas, Texas, contains, actually, an unequivocal prohibition against any
claims of effectiveness for the Hoxsey cancer treatment for internal cancer.
"3. The Government also contends that the leaflet, 'Hoxsey Cancer Clinic,
Dallas, Texas, Courtesy of Hoxsey Cancer Clinic, Portage, Pennsylvania,' is
false and misleading in that it represents and suggests that one Dr. Stanley
Reimann made a survey of cancer cases in Pennsylvania and concluded that
persons who received no treatment live longer than patients treated with
surgery, X-ray and radium and that surgery, X-ray and radium generally do
more harm than good in the treatment of cancer.
"The Government contends that these alleged representations are false and
misleading in that Dr. Reimann made no such survey, with no such results,
and that the article misrepresented Dr. Reimann's belief as to the effectiveness
of X-ray, radium and surgery in the treatment of cancer.
"As I have stated, it is the Government's burden to establish its case by the
fair weight or preponderance of the credible evidence. However, it is not
required that the Government prove every one of the charges it has made in the
libel. It is sufficient if the Government satisfies you, by the fair weight or
preponderance of the credible evidence, that the alleged labeling was false and
misleading in .any one of the ways set forth, inasmuch as the Food and Drug
Act applies to labeling that is false or misleading in any particular.
"It is therefore your duty to examine all of the evidence in the case and
reach a conclusion whether or not the pills have been misbranded by the
alleged labeling. In performing your duty, there are certain rules and princi-
ples which you should keep in mind.
"You are the sole judges of the facts. In the exercise of this judgment, you
must confine yourselves exclusively to your recollection of the testimony of
the witnesses plus your evaluation of the exhibits or documentary evidence.
You are not to be influenced in this exercise of judgment by the recollection
of counsel or the recollection of the court on the facts. It is for you to say
what the facts are from what you have heard from the witness stand.
"It is the responsibility of the court to instruct you as to the law which is
applicable to the case and to assist in focusing your thinking on the real issues
of the case. During the course of the trial, in ruling on questions of law raised
by counsel, the court may have commented on pertinent evidence or testimony.
These comments of the court on purely factual matters you will completely
disregard. You may and should consider the argument made to you by coun-
sel for the Government and counsel for the claimant.
"As has been stated, the Government contends that the alleged labeling
represents and suggests that the Hoxsey treatment, being essentially the red
and black tablets, is adequate and effective in the treatment of internal cancer
in humans. It is for you to determine whether or not the alleged labeling makes
such representations.
"In so determining, you are required to decide what their effect would be
upon an ordinary consumer or purchaser under the circumstances attending
the distribution of the pills. Thus you may consider what effect these various
articles of literature would have upon the minds of persons suffering from in-
ternal cancer, who had come to the Hoxsey Clinic of Portage, Pennsylvania, in
search of relief for their illness.
"In your deliberations and in arriving at your verdict, you will bear in mind
that in an action of this kind the plaintiff has the burden of establishing his
case by a preponderance of the credible evidence.
"In considering this case, you will examine all of the material evidence in
order to determine its relevancy and the true state of facts. You will weigh
all of the evidence in the case, so as to reconcile, if possible, such evidence as
may have seeming or apparent conflicts. And in considering and weighing
the evidence, you should use the same judgment, reason, common sense and
general knowledge of men and affairs as you would in everyday life. In
speaking of the burden of proof, I have referred to the requirement of pre-
ponderance of the evidence. This is a term which you no doubt will readily
understand. It has been defined as that evidence which after a consideration
of all the evidence is in the judgment of the jury entitled to a greater weight.
"Or stated in another way, the phrase, preponderance of the evidence, means
that evidence which points to a certain conclusion appears to the jury to be
more credible and probable than evidence to the contrary. It means such
evidence as when weighed with that which opposes it has more convincing
force and from which it results that the greater probability is in favor of the
party upon whom the burden rests.
"In your consideration of this case, you must also take into account the
credibility of the witnesses, of which, incidentally, you are the sole judges.
With that the court has nothing to do.
"You may judge the credibility of a witness by the manner in which he gives
his testimony, his demeanor upon the stand, the reasonableness or unreason-
ableness of his testimony, his means of knowledge as to any fact about which
he testifies, his interest in the case, the feeling he may have for or against any
of the parties, or any circumstances tending to shed light upon the truth or
falsity of such testimony.
"And it is for you to say what weight you will give to the testimony of any
and all witnesses. If you believe that any witness has wilfully sworn falsely
to any material fact in this case, you are at liberty to disbelieve the testimony
of that witness in whole or in part, or believe it in part and disbelieve it in
part, taking into consideration all of the facts and circumstances of the case.
"If you are sympathetic or prejudiced in favor of or against any party, you
should not allow it to influence you in your verdict.
"In arriving at your verdict you should be guided alone by the evidence
and the law of the case, as the court has given it to you. You were asked at
various times to refrain from reading newspaper articles or listening to
broadcasts pertaining to this case.   In deliberating upon your verdict, you
tions on the law as given you by the court.   Any other matter is not relevant. ?"
"Let us turn to the issue of whether the alleged labeling is false or mis- (
leading as to an existing court decree, which pertains to a lawsuit in which the
Hoxsey Cancer Clinic of Dallas, Texas, was involved. The discussion of this
decree is found in the pamphlet, 'Hoxey Cancer Clinic, Dallas, Texas, Courtesy
of Hoxsey Cancer Clinic, Portage, Pennsylvania, Specializing in the Treatment
of Cancer, Precancerous and Chronic Diseases.' A copy of the decree which
was in existence on the day of the seizure has been introduced in evidence for
your examination.
"The Government's position is that the pamphlet indicates that claims as
to the beneficial effect of the Hoxsey treatment could be made under certain
circumstances, whereas in fact that decree prevents the making of such
claims under any conditions.
"Looking at the same pamphlet again, the Government's further contention
is that it is false and misleading with respect to an alleged survey made by
Dr. Reimann, concerning cancer cases in Pennsylvania. This pamphlet con-
tains certain statements made by a Dr. Miley, regarding what Dr. Reimann
had done. There has been testimony that Dr. Miley did in fact make such
statements, but Dr. Reimann testified he had not made any such survey and
he was not of the opinion, as indicated, that X-ray and surgery did more harm
than good in the treatment of cancer patients.
"It is contended by the claimant that the statement correctly quotes Dr.
Miley. With respect to the statements made by Dr. Miley, as I recall the
evidence, certain data had been collected but Dr. Reimann stated that the
work had stopped and the data collected was insufficient to justify any con-
clusions. However, one is not justified in using a statement that is false or
misleading merely because it is put forward as a quotation by some other
person.
"The words, 'false,' and 'misleading,' are used in the statute in their ordinary
sense and the statute is plain and direct.   The word 'false' means untrue.
The word 'misleading' is broader than the word false and includes any state-
ment that may deceive or lead astray, even though it is not technically untrue. /
The term 'misleading' covers any word or phrase which by indirection and *
ambiguity may deceive and lead astray, and it covers half truths.
"In determining whether the alleged labeling is misleading, any words or
phrases or articles which are ambiguous and liable to be misleading should
be read by you in a manner which will accomplish the purpose of the statute.
In other words, where two meanings are possible, you need not accept that
interpretation which would result in the articles not being misbranded in that
particular instance.
"On the question of whether the labeling falsely states that the Hoxsey
cancer treatment is adequate and effective in the treatment of internal cancer
in man, the evidence has been voluminous. The Government first brought
before you physicians, pharmacologists, surgeons, and researchers in the field
of cancer. In general, the consensus of these experts was that the Hoxsey
cancer pills and the respective ingredients thereof were ineffective in the treat-
ment of internal cancer. The testimony of the Government's experts was
to the effect that at the present day modern science, in spite of efforts in
research and investigation, recognizes that internal cancer may be adequately
and effectively treated by surgical removal or by destruction by radiotherapy,
including X-rays and radium and radioactive substances. As you will recall,
the Government's witnesses said that progress had been made in the field of
chemotherapy, being the treatment of cancer and diseases by means of drugs,
but at the present time chemotherapy is not known to cure cancer, although
in some instances, as with nitrogen mustard, it is known to have a palliative
effect on certain types of cancers.
"The Government's expert witnesses were agreed that there was no evidence
that potassium iodide, one of the ingredients of the Hoxsey cancer pills, was
useful to alleviate or cure cancer; that since cancer was believed to be many
diseases, no one drug would be effective in the treatment of all internal
cancers.
"One of the Government's witnesses, I believe Dr. Goldzeher, testified as to
the experiments he had conducted some years ago as to the effect of potas-(
sium on cancers in mice and humans.   In general, he said his experiments had x-
proved that potassium did not help in the treatment of cancer but tended
to worsen the condition.
"Opposed to the evidence of the Government's witnesses, claimant intro-
duced the testimony of Dr. H. K. Hill and Dr. Eva Hill, both of whom had
received the Hoxsey treatment. Both doctors stated that they had used
potassium iodide in prescribing for patients. Dr. Max Gerson stated that he
used potassium in his Clinic for the treatment of cancer in man. Dr. Allen,
Medical Director of the Portage Clinic, and Dr. West, director of research
at the Hoxsey Cancer Foundation in Dallas, Texas, also stated that they
had observed improvement in patients suffering from cancer who had received
the Hoxsey treatment.
"Witnesses having special professional qualifications have been permitted
to express opinions as experts on the effectiveness of the pills here in question.
They have been permitted to express opinions concerning the question in issue
because they are experts, having special knowledge of a field in which ordinary
persons lack experience or training. However, you are required to weigh
and evaluate the testimony of an expert witness, whether called by the Govern-
ment or by the claimant, exactly as you weigh and evaluate the testimony
of any other witness, taking into account his interest in the case, his ex-
perience and training, his learning and standing in the profession, and the
probability and reasonableness of the things to which he has testified.
"I charge you that the mere fact that some of the experts may have no
personal experience with the use of the drugs in question does not nullify
the weight to be attached to their testimony, if you find such persons were
qualified in their fields and based their testimony on their general knowledge
of medicine, that the drugs could perform the things claimed for them.
"In addition to the testimony of experts, the Government produced witnesses
pertaining to various patients who had been treated at the Hoxsey Cancer
Clinics. The Government's case centered on the seven patients who, as the
Government contends, were set forth as having been treated effectively in the
alleged labeling. It is the Government's position that these patients were
not helped by the Hoxsey treatment and therefore che claims set forth in the
literature are false and misleading.
"Reviewing the cases briefly, you will recall it is the Government's position
that the Seago baby was suffering from a type of cancer which is known
to regress spontaneously. In the case of Laura Bullock, now Morgan, I be-
lieve, Verne Haluska Kielbowick, and Glenn E. Freeman, the Government
, contends that they received adequate medical treatment before visiting
the Hoxsey Clinic; that is, they received either surgery or X-ray or radium
sufficient to effect their improvement and has produced medical testimony
to this effect. In addition, the Government contends that two of the described
persons, Mr. Dyer and Kathy Allison, died as a result of cancer while they
were still being held out as cured. It is the Government's position that
Richard Metzgar, who it says is described as a cured sufferer of Hodgkin's
disease in the alleged labeling was not suffering from cancer in the first
instance but an inflammation of the lymph. You will recall the testimony
pertaining to the other case histories which was produced by the Government.
"In defense to the Government's contentions, the claimant contends that
the Hoxsey black and red tablets are adequate and effective in the treatment
of internal cancer in man. To support its case, the defense produced testimony
pertaining to a number of patients, including some described in the alleged
labeling. In general, this testimony was intended to show that the physical
condition of the persons involved improved following their taking the Hoxsey
treatment. Those testifying for the claimant included Mr. Glenn Freeman,
who said that following surgical removal of a brain tumor his symptoms did
not disappear until he began taking the Hoxsey treatment; Mr. Allison said
that his daughter Kathy's pain was alleviated and her condition improved
after she took the medicine although she eventually died. Similar testimony
was given on behalf of the defense by Mrs. Bullock, now Morgan, and Mrs.
Kielbowick. There was also testimony pertaining to the recovery of the
Seago baby and Richard Metzgar. You are aware of the Government's
contention with respect to these persons.
"Others, not described in the alleged labeling, indicated they .also received
benefit from the Hoxsey treatment as evidenced by improvement in their own
physical condition after taking the Hoxsey preparation.   You will recall the
testimony of those persons. The Government's contention primarily is that
these persons had received adequate treatment, surgery or radiation, prior
to their going to the Hoxsey Clinic or that they did not have cancer or that
they have not improved by virtue of the Hoxsey treatment.
"This case is concerned with the Government's contention that the Hoxsey
red and black pills are not adequate or effective in the treatment of internal
cancer. Therefore, the treatment of external or skin cancer by the Hoxsey
Cancer Clinics has no bearing whatever on this issue unless the cancer had
spread to other parts of the body.
"Under the statute, drugs which are misbranded while held for sale after
shipment in interstate commerce may be destroyed, regardless of the intention
or motive of the persons distributing the drugs. The good faith of the Hoxsey
Cancer Clinic or of the claimant or his sincere belief that the red and black
pills are effective in treating internal cancer is not a defense to this action,
if the pills were in fact misbranded. Nor would a base motive establish
that the pills were misbranded. It should also be pointed out that the di-
agnostic abilities or lack thereof of the staff of the Hoxsey Cancer Clinic are
not in question and any evidence bearing thereon cannot be considered by you
as germane to the issue of misbranding.
"The question whether a person suffering from internal cancer has received
adequate and effective treatment is essentially a medical question. Here the
Hoxsey Cancer Clinic and the claimant have relied to a great extent on the
testimony of certain patients or members of their families that following
treatment by the Hoxsey method such persons improved in physical condition
and that certain symptoms disappeared. It is your duty to evaluate such
testimony, in the light of all of the evidence. In doing so, you should keep
in mind the testimony as to the probable or likely effect on the person's
physical condition of prior radiation or surgery where either had been admin-
istered, the ability of a lay person or one not skilled in medical science to
correctly judge what treatment had caused his improvement, if there has been
improvement, and the testimony relating to the nature of the disease of
cancer as it may bear on this question. You should, of course, keep in mind
the medical testimony offered by both parties.
"To summarize, the issues which yon must decide in this case are:
"First, did the articles of literature referred to, which were found at
the Hoxsey Clinic in Portage, Pennsylvania, accompany the red and black
pills as labeling
"If you decide that the literature did not constitute labeling, then your
verdict should be for the claimant. If you determine that the literature was
labeling which accompanied the pills, you should proceed to consider whether
the labeling was false or misleading in any one of the following ways:
"A. Was the labeling false and misleading with respect to the terms of the
court decree which has been described
"B. Was the labeling false and misleading with respect to the alleged
survey by Dr. Stanley Reimann
"C. Was the labeling false and misleading with respect to the adequacy
and effectiveness of the Hoxsey cancer treatment in the treatment of internal
cancer in humans
"If you find, by the fair weight or preponderance of the credible evidence,
that the red and black pills were accompanied by labeling which was false
or misleading in any one of the foregoing ways, your verdict should be for the
United States.
"If you find that the labeling was not false or misleading in any of the
aforesaid particulars, then your verdict should be in favor of the claimant.
"Your verdict should represent the conscientious, considered judgment of
each juror. I think that you know that your verdict must be unanimous.
When you retire to deliberate, consider the evidence, and each of you should
discuss your views on the evidence freely and openly, in the light of reason
and common sense, bearing in mind at all times that you would violate your
sworn duty if you based your verdict on anything but the evidence heard in
the courtroom and these instructions on the law.
"Members of the jury, there is one matter I failed to mention. I will
mention it at this time.
"The Government has introduced evidence tending to show that Harry
M. Hoxsey had some financial or proprietary interest in the Hoxsey Cancer
Clinic of Portage, Pennsylvania.
"The relationship of Harry M. Hoxsey and the Hoxsey Cancer Clinic of
Portage, Pennsylvania, is a question to be determined by the court and not
by you, the members of the jury. I therefore instruct you to disregard any
and all evidence tending to show whether Harry M. Hoxsey had a financial
or proprietary interest or any interest in the Hoxsey Cancer Clinic at Portage,
Pennsylvania.
"Certain requests for charge have been submitted to me by counsel for
the Government.   Those that I have approved I shall read to you.
"The points submitted by the Government which I approved read as follows:
"Written, printed and graphic material accompanies a drug if the printed
matter is textually related to the drug and is used to explain the claimed merits
of the drug to the public or is used to illustrate the purposes and conditions for
which the drug is to be used.
"Another point that I approve is as follows:
"The drugs are misbranded if any one of the claims in the labeling is either
false or misleading in any particular.
"Another point I approve reads as follows:
"In determining whether the labeling is false or misleading for any of the
reasons claimed, you will take into account whether the labeling is likely to
create a false or misleading impression as to the merits of the Hoxsey drugs
on the mind of a person who reads the labeling.
"Another point which I approve reads as follows:
"You must completely disregard all cases presented by the claimant in this
trial which relate to skin cancer or external cancer, unless you are satisfied
that adequate proof has been presented by competent medical testimony that
this cancer had spread into the body and thereafter it had been adequately
and effectively treated by the Hoxsey method.
"All of those matters have been covered in my charge and the affirmance of
the points submitted by the Government you will consider in what I have said
about those points in my charge to you."
The jury returned a verdict for the Government, and the court entered a decree
of condemnation on 11-16-56.
On 11-19-56, the claimant filed a motion for new trial and motion for judgment.
The court, on 5-28-57, ruled as follows (152 F. Supp. 360) :
MILLER, District Judge: "This is an action by the United States under the
seizure and condemnation provisions of the Federal Food, Drug and Cosmetics
Act, 21 U. S. C. A. ? 301, et seq., for the destruction of a large quantity of red
and black medicinal tablets and their labeling. It is alleged that the tablets
were misbranded while held for sale at the premises of the Hoxsey Cancer
Clinic at Portage, Pennsylvania, after having been shipped in interstate com-
merce. 21 U. S. O. A. ? 334 (a). Upon a libel of information filed by the gov-
ernment, a warrant of seizure and monition was issued from this court, and
on March 25, 1955, the tablets and certain pamphlets, magazines, and leaflets
alleged to be the labeling were seized at the clinic. An answer to the libel has
been filed on behalf of the Hoxsey Cancer Clinic and Dr. Newton O. Allen as
claimants. The cause was tried before the court and a jury and after lengthy
contested proceedings resulted in a verdict in favor of the United States. The
claimants have filed a motion for judgment in accordance with their motion for
a directed verdict and in the alternative a motion for a new trial. In the
interim, execution of the order of condemnation entered on November 16,1956,
has been deferred.
"The Hoxsey Cancer Clinic is an institution at Portage, Pennsylvania, in the
Western District of Pennsylvania, specializing in the treatment of cancer and
cancerous diseases in humans by means of drugs and chemicals. It maintains
a staff of physicians, nurses and administrative personnel. Persons from many
parts of the nation suffering from cancer visit the clinic in hope of obtaining
relief.    These persons are not admitted as patients but visit the clinic for a
day or a few days at most during the course of which interviews and examina-
tions are conducted. The examinations include blood tests, X-rays, rectal or
vaginal inspection and other accepted medical procedures which do not involve
surgery. Biopsies are rarely if ever performed. If as a result of the inter-
views and examinations superficial or skin cancer is diagnosed an escharotic
compound-not the subject of this action-is prescribed as the chief means of
treatment. If internal cancer is diagnosed, a prescription for the red or black
tablets, depending on the nature of the cancer, is written out by the physician
in charge. Other supportive medications, such as vitamins, are usually pre-
scribed. The tablets and medications are received by the patient at the drug
counter of the clinic and are taken home with him for consumption according
to given directions. The basic fee for the cancer treatment, including exam-
inations and medications, is $400. In addition laboratory fees of from $5 to
$18 and X-ray fees at $10 per picture are charged. If the patient acquires
additional tablets no further charge is made except for laboratory or X-ray
services. The tablets involved in this action, concededly 'drugs' within the
meaning of the Food and Drugs Act, were prepared by a Michigan pharmaceu-
tical house at a cost of less than $2 a thousand and were transported in inter-
state commerce. The red tablets are composed of potassium iodide, red clover
tops, stillingia root, berberis root, poke root, buckthorn bark and pepsin; the
black tablets of potassium iodide, licorice, red clover tops, burdock root,
stillingia, berberis root, poke root, cascara sagrada, prickley [sic] ash bark and
buckthorn bark. The tablets are the essential part of the Hoxsey treatment for
cancer and potassium iodide is considered by claimants the chief curative
component.
"The clinic began its operations in February, 1955, in an atmosphere of great
local interest. When the seizure was effected on March 25,1955, patients were
being received for examination and treatment. The medications, the subject
of this action, were then located in the drug and sterilization rooms at the
rear of the clinic in their original containers from which they were eventually
to be transferred to small envelopes for distribution to patients. Copies of the
leaflets and printed matter described above in the caption and seized with the
tablets were found on a table in the foyer of the clinic which adjoined a waiting
room used by patients and persons visiting the clinic. The bundled copies of
the 'Defender' magazine were seized in one of the rear rooms. The government,
centering its attack only on Hoxsey medications used in the treatment of in-
ternal cancer, contends that the leaflets and printed matter caused the red and
black tablets to be misbranded in three particulars: by making false or mis-
leading representations with respect to the adequacy or effectiveness of the
tablets in the mitigation and treatment of internal cancer; with respect to the
terms of an existing court decree prohibiting entities not parties to this action
from making such labeling claims for similar drugs distributed in interstate
commerce; with respect to a survey allegedly discounting the effectiveness of
X-rays, radium and surgery in treating cancer patients. The issues submitted
to the jury were whether the printed matter and leaflets constituted 'labeling'
within the meaning of the Food and Drugs Act and if so, whether the labeling
was false or misleading in any of those three particulars.
THE  MOTION  EOB  JUDGMENT
"Under ? 304 (a) of the Food and Drugs Act, 21 U. S. C. A. ? 334 (a), any
article of drug that is misbranded while held for sale after shipment in inter-
state commerce is subject to federal seizure and condemnations procedures in
accordance with the act. Under ? 502, 21 U. S. C. A. ? 352, a drug is misbranded
if its labeling is false or misleading in any particular, and labeling is defined
in ? 201, 21 U. S. C. A. ? 321, as meaning all labels and other written, printed
or graphic matter upon the article or its container or 'accompanying such
article.' In their first point in support of the motion for judgment, claimants
present the contention that the leaflets and printed matter involved in this
action were not labeling in the statutory sense. In Kordell v. United States,
1948, 335 U. S. 345, 350, the Supreme Court said:
One article or thing is accompanied by another when it supplements or
explains it, in the manner that a committee report of the Congress accom-
panies a bill. No physical attachment one to the other is necessary. It is
the textual relationship that is significant.
That case and United States v. Urbuteit, 1948, 335 U. S. 355, establish that if
the written, printed or graphic matter is used in the distribution or sale of a
drug which has been shipped in commerce to explain the drug's use or useful-
ness, it may be considered labeling in a functional sense, even though there
is a separation between the article and the printing. It is unnecessary to
determine here how wide the separation may be before written, printed or
graphic matter ceases to 'accompany' the drug article. In the present instance,
the literature was prominently displayed and available for reading by or dis-
tribution to patients or other persons at the very place where the Hoxsey
medications were distributed. In addition, undisputed evidence demonstrated
that the literature was sometimes mailed to patients. Under such circum-
stances, this court will not permit the yards of distance between the clinic's
waiting room and the drug rooms or the intervening plaster walls to be the
measurement of the application of the federal regulatory law. The pamphlet
entitled, 'Hoxsey Cancer Clinic'1 states that its purpose is to acquaint the
public with the clinic and its method of treating cancer 'in terms the average
layman can understand.' It contains the statement 'we do feel that we have
the most advanced and efficient method of treating cancer today'-a method
not including X-ray, surgery or radiation. It describes the procedure to be
followed by prospective patients desiring consultations or treatment. The
leaflet, 'Procedure and Information'2 lists the fees charged by the clinic for
the cancer treatment and laboratory and X-ray services. The article from
'Man's Magazine' entitled, 'I Conquered Cancer's details what appear to be a
disinterested person's statement and report on the case histories of seven
persons who were, the article indicated, treated successfully by the Hoxsey
method after other treatment had failed. It includes a report on Mrs. Verne
Kielbowick, sister of John Haluska, a former member of the Pennsylvania
legislature and Administrator of the Portage Clinic. Mrs. Kielbowick attributed
the recovery of her health to the Hoxsey remedy and is quoted as saying:
If anybody doubts that Hoxsey cures cancer, let him come to Patton and
talk to the Haluskas.
The pamphlet, 'Findings of Doctors' * contains the statement:
[0]ur investigation has demonstrated to our satisfaction that the Hoxsey
Cancer Clinic at Dallas, Texas, is successfully treating pathologically
proven cases of cancer, both internal and external, without use of surgery,
radium, or X-ray.
The 'Defender' magazine5 includes a reproduction of a speech by former
Senator Haluska to the Pennsylvania Senate in which he referred repeatedly
to cures of cancer victims by the use of the Hoxsey treatment. It will be seen
therefore that the materials consistently extolled the merits of the Hoxsey
drugs in terms which the average layman would understand and which would
be appealing to persons afflicted with the disease of cancer. Although modestly
disclaiming that the drugs were a 'cure-all' and putting the case for the tablets
in terms of 'you be the judge,' the literature nevertheless explained what the
drugs were for and implied that they were effective and superior medicines.
The facts were clear and great liberality was shown in permitting the jury
to pass upon the contention that the literature was not labeling.
"In their second point, claimants argue that the drug articles in question
were not 'held for sale after shipment in interstate commerce' within the
meaning of ? 304 (a), supra. However, they concede that the red and black
tablets were shipped in interstate commerce and were the 'essential part'
of the Hoxsey treatment for internal cancer in humans and that in the ordi-
nary case a charge of $400 was made for a complete course of treatment
exclusive of laboratory fees and Xi-ray charges. Upon those undisputed
facts it would seem clear that the articles were held for sale.   Claimants
1 Government Exhibit 24.
a Government Exhibit 41.
? Government Exhibit 42.
*?Government Exhibit 43.
*?Government Exhibit 39.
urge nevertheless that the drugs were intended, not for sale in the statutory-
sense, but for prescription by physicians in the pursuit of a local practice/
of medicine with which the act was not intended to deal and with which
this court could not interfere.   In this contention they are wrong.
"The overriding purpose of the federal Food and Drugs Law was to pro-
tect the lives and health of the public by keeping misbranded, adulterated
and impure foods and drugs out of the channels of interstate commerce.
The coverage of the statute was enlarged by the Act of 1938 to every article
that had gone through interstate commerce until it finally reached the ulti-
mate consumer by making its prohibitions applicable to such articles 'while
held for sale after shipment in interstate commerce.' United States v. Sulli-
van, 1947, 332 U. S. 689, 697. It may be that physicians are not understood
as holding for sale the drugs which they may administer or prescribe in
connection with their treatment of patients. But the potentiality of harm
to the public from misbranded drugs is not less because the intervening
agency of distribution may be a physician rather than a layman. The terms
'while held for sale' have been given an expansive rather than a technical
construction, Kocmond v. United States, 7 Cir., 1952, 200 F. 2d 370, cert,
den. 345 U. S. 924; United States v. 1800.2625 Wine Gallons, 1954, D. C. W. D.
Mo., 121 F. Supp. 735, and must be deemed to include the operations of the
claimants in distributing their drug tablets at the Hoxsey Cancer Clinic.
It is not the holding for sale in a technical legal sense which gives rise to
the federal jurisdiction in cases arising under ? 304 (a) but the fact that the
channels of commerce have been used. United States v. 1800.2625 Wine
Gallons, supra. Since interstate transportation has been admitted, the ban
of the section applies to the tablets here involved regardless of the claims of
the Hoxsey Cancer Clinic and Dr. Newton C. Allen, its medical director. If
forfeiture works any interference with claimants' practice of medicine it is
a mere incident of their violation of the law in making representations con-
cerning their drugs which the jury found were unwarranted, false or
misleading.6
"The only other point which is urged in support of the motion for judgment
may be dismissed without much discussion.   Claimants say that the proper i
standard to be applied in determining whether there was a misbranding of
the Hoxsey tablets while they were 'held for sale' is to be found in subsec-
tion (k) of ? 301 of the act, 21 U. S. C. A. ? 331 (k), which prohibits:
The alteration, mutilation, destruction, obliteration, or removal of the
whole or any part of the labeling of, or the doing of any other act with
respect to a food, drug, device, or cosmetic, if such act is done while
such article is held for sale (whether or not the first sale) after ship-
ment in interstate commerce and results in such article being adulterated
or misbranded.
Claimants construe that language very narrowly and say that the government
failed to sustain its burden of proof because it did not show that anything
affirmative was done to the drugs themselves, which remained undisturbed
in their original containers. Section 301 sets forth 'Prohibited Acts' and
?303, 21 U. S. C. A. ?333 makes violation of the provisions of ?301 a
criminal offense. Section 301 had no real application in this civil proceeding
for condemnation of misbranded drugs under ?304 (a). In any event, the
bringing into association of the alleged labeling and the drugs was a sufficient
act 'with respect to' the drugs which in this case rendered them misbranded.
THE MOTION FOB A NEW TEIAL
"Although more than twenty overlapping reasons have been assigned in the
motion for a new trial, all except those set forth under points 4, 6, 8,15 and 17
were expressly abandoned by counsel for claimants on argument. Points 4 and
6 deal with asserted errors in the admission of evidence; the remaining points
present alleged errors in the charge to the jury. The objections to the evidence
are dealt with first.
?When Congress intended to exempt licensed practitioners from the operation of the(
Act, it spoke plainly enough.    See $ 503 (b)  (2), 21 U. S. C. A. 353 (b)  (2).
"The testimony of Shanley and Chilledge, federal food and drug agents.
Shanley at the Portage Clinic and Gulledge at the Dallas Clinic, posing as
cancer patients, were examined in the customary manner, told they had can-
cer and given a supply of the Hoxsey medication to take home and consume.
Neither had cancer. The testimony was offered to show the similarity of
procedures at the two clinics and the inadequacy of the procedures. The evi-
dence, with other evidence in the case, was relevant as bearing on the relation-
ship between the two clinics and on the question whether there was privity
between the Portage Clinic and the Dallas Clinic and Harry N. [sic] Hoxsey,
against whom and the Dallas Clinic a prior injunctive decree had been entered.
When the application of the doctrine of collateral estoppel was exclusively re-
served to the court at the end of the case by withdrawing the question of
privity from the jury, the testimony of Shanley and Gulledge, say the claim-
ants, stuck out like a sore thumb. In a case of long duration involving con-
tested issues of legal and factual complexity, it was impossible to foresee the
exact boundaries of the case to be submitted. The members of the jury were
told they were not to concern themselves with the question of privity; they
were told that the question of misbranding did not depend on the intention of
motives of those distributing the drugs and that the diagnostic abilities of the
staff of the clinic were not in question. Under the circumstances, this was
sufficient.
"The evidence revealing the deaths of Crescens Elemmer (sic), James Barger
and Nicolei Lupanov (sic). These persons were cancer victims who were
treated according to the Hoxsey method. The account of their medical his-
tory, illness and death by relatives and physicians was pertinent in showing
whether they had been thus effectively treated for their disease. It was not
suggested to the jury that their deaths were conclusive on the question.
Similar testimony was admitted in United States v. Kaadt, 7 Cir., 1948, 171 F.
2d 600, 603, a case involving a claimed cure for diabetes.
"The cross-examination of Doctor West. On direct examination, West
(employed as director of research at the Hoxsey institution in Dallas, Texas)
supported the claim of merit for potassium iodide, the principal ingredient of
the Hoxsey medicines, which, according to his statement, had produced good
results in a large number of cases by a process of strangulation or asphyxiation
of abnormal tissue. The testimony of the government's expert medical wit-
nesses and researchers had indicated that potassium iodide was either of no
effect or harmful in the treatment of cancer. Without first interrogating West
as to a past criminal record, government counsel placed in evidence a certified
copy of a complaint and record7 revealing that on May 14, 1953, the witness
pleaded guilty to a charge of practicing medicine without a license in the City
of Los Angeles. This procedure did not amount to a reversible error. 3 Wig-
more on Evidence (3d Ed.) ? 980. In addition it was shown through official
records of the State of New York8 that West had been denied permission in
1951 to practice medicine in New York because of insufficient training. Both
matters affected the qualifications of the witness, which were directly in issue,
and were properly received.
"In their motion for a new trial, claimants renew their argument relating
to the holding for sale of the tablets in question, this time contending that
whether the tablets were held for sale within the meaning of the statute
should have been determined by the jury and not by the court as a matter of
law. The court has adverted to and discussed the 'held for sale' requirement
of ?304 (a) extensively and has pointed out that there was no substantial
dispute as to the important factors for determining whether there was a
statutory holding for sale: a substantial charge was made for the course
of treatment by the Hoxsey method and the treatment included prescription
of the tablets as its essential part. The tablets at the time of the seizure had
not yet reached the hands of the ultimate consumers and were therefore held
for sale. Kocmond v. United States, supra, 200 F. 2d at 373. Nothing remained
for the jury.
"Claimants take the view that the court erred in telling the jury to consider
in determining whether the Hoxsey medications were misbranded the im-
pression which the various articles of literature would have upon the minds
7 GoYernment Exhibit 210.
? Government Exhibit 209.
of victims of internal cancer who came to the clinic as patients. Although
exception was taken to this point in the charge, claimants did not either before {
or afterwards suggest to the court what other standard they thought proper.
However, the given instruction was appropriate. Claimants designedly or at
least willingly made the labeling available for the use of unfortunate persons
who were afflicted with cancer or who thought they were and who had come
to the clinic for help. The literature would naturally appeal to those persons
as it was undoubtedly intended to. They were the persons upon whom it
would have its greatest effect because they were likely to be less critical, and
less apt to question the representations by laymen and others reported in the
leaflets. It is therefore only fitting that the truth or falsity of the literature
or its misleading nature be measured by its significance to them and not to
persons who for one reason or another would be likely to form a more critical
judgment. In this conclusion, the court is supported by plentiful authority.
United States v. Vitamin Industries, Inc., 1955, D. C. Neb., 130 F. Supp. 755, 767;
United States v. 28 Articles, 2 Cir., 1951, 192 F. 2d 308, 310; United States v.
Kaadt, supra, 171 F. 2d at 603; United States v. Hoxsey Cancer Clinic, 5 Cir.,
1952, 198 F. 2d 273, 276, cert. den. 344 U. S. 928, rehearing den. 345 U. S. 914.
"The next argument is that it was a reversible error to tell the jury that
the question whether one suffering from internal cancer has received adequate
and effective treatment was 'essentially a medical question.' A new trial
will not be awarded for this reason. Claimants argue that the statement
required the jury to give more credence to the doctors who testified than
to the patients themselves who were called by claimants to testify as to
their physical conditions before and after receiving the Hoxsey treatment.
Assuming this would have been improper, claimants' assignment is merely an
instance of the long discountenanced practice of leveling attacks at an isolated
portion of the charge without regard to what was said before and after.
The issues to be decided were made clear to a jury which after many weeks
of trial was well aware of the contentions and proofs of both parties and
equipped with more knowledge about the disease of cancer than most laymen
would ever acquire. They were told to evaluate claimants' evidence in light ,
of all the testimony, including that of the doctors offered on both sides. There ^
is no just cause for complaint.
"There remains to be considered only the assignments raising the propriety
of the submission to the jury of certain statements in the printed matter as
separate instances of misbranding. The first of these9 set forth a summary
of a report by Dr. George Miley, described as medical director of the Gotham
Hospital, New York, and having impressive qualifications, to a Congressional
Committee relating to a survey of cancer patients in Pennsylvania allegedly
conducted by Dr. Stanley Reimann. The substance of the report, as sum-
marized, was that Reimann's survey 'over a long period of time' had established
that cancer patients fared better if they did not receive treatment by radium,
X-ray or ordinary surgery. All of this, including the making of such a survey,
was denied by Dr. Reimann who was called as a witness for the government
and who also testified that he had notified the committee that Miley's report
was inaccurate. The literature did not note his protest. See 21 U. S. C. A.
?321 (n). Claimants urge that no instance of misbranding was shown
because the report had in fact been made as set forth in the literature.
However, at least by indirection the printed matter created an impression
that it was a fact that such a survey had been made and that the survey
justified the conclusions asserted. It would naturally tend to have greater
effect upon a susceptible reader not only because the author of the report was
a member of the medical profession but also because of the dignity of the
forum to which the report was addressed. On the evidence the jury could
have found that the facts implied in claimants' literature were untrue. It
is not possible for claimants to escape responsibility for those implications
now. Drawn as they were, the statements made a more persuasive appeal
to cancer sufferers than if the representations implied had been made directly
by claimants alone and for that reason, it has been said, they are not less
but more obnoxious to the law. United States v^ John J. Fulton Co., 9 Cir.,
1929, 33 F. 2d 506; cf. United States v. David Roberts Veterinary Co. Inc., 7
Cir., 1939, 104 F. 2d 785, 789; cf. Moretrench Corporation v. Federal Trade(
9 Government Exhibit 24, p. 8.
Commission, 2 Cir., 1942, 127 F. 2d 792, 795. In submitting the issue to the
jury, the court merely followed the explicit canon of construction of the act
which the Supreme Court long ago set forth in United States v. 95 Barrels of
Vinegar, 265 U. S. 438, 442:
The statute is plain and direct. Its comprehensive terms condemn every
statement, design and device which may mislead or deceive. Deception
may result from the use of statements not technically false or which may
be literally true. The aim of the statute is to prevent that resulting
from indirection and ambiguity, as well as from statements which are
false. It is not difficult to choose statements, designs and devices which
will not deceive. Those which are ambigious [sic] and liable to mislead
should be read favorably to the accomplishment of the purpose of
the act. . . .
"The second challenged statement is found in the printed matter M under the
heading 'Court Rulings.' In the text appears a discussion of proceedings insti-
tuted by the United States against the Hoxsey Cancer Clinic of Dallas, Texas,
and Harry N. [sic] Hoxsey in the District Court for the Northern District of
Texas. Then follows the statement that the District Court in obedience to
the mandate of the Court of Appeals (198 F. 2d 273), on June 29,1953, entered
a decree of injunction restraining the distribution in interstate commerce
of the Hoxsey medications containing labeling representing that the substances
were effective or of value in the treatment of cancer 'without appropriate
qualifying statements revealing the conflict of medical opinion as to the truth
of such representations.' What the printed matter failed to mention was
that in mandamus proceedings instituted against the District Judge, the
Court of Appeals determined that its mandate had not been obeyed and re-
quired the lower court to expunge from its decree the qualifying phrase quoted
above. (207 F. 2d 567.) This was done on October 26, 1953.11 Claimants
do not deny the false or misleading character of the representations made
in the literature but simply suggest that the omissions were not material.
This contention boils down to an argument that the misrepresentations could
not possibly be 'labeling'-i. e., printed matter accompanying the drug in
the sense of explaining its use or usefulness. Kordel v. United States,
supra. The Court of Appeals for the Fifth Circuit after carefully weigh-
ing the evidence in the case had actually concluded as a fact that the drugs,
substantially identical to those involved here, were of no value in the
treatment of cancer, but the literature created the impression that the Court
had taken an indecisive stand. It is the view of this court that the considered
judgment of such a tribunal of the United States with respect to the merits
of the very substances in question would necessarily be of significance to any
person interested enough to read about the Hoxsey remedy and particularly to
those who were confronted with the choice of accepting or declining the Hoxsey
treatment. By implying that a court of the United States had sanctioned
the making of claims of effectiveness for the drugs, the literature gave the
impression that the Hoxsey remedy in fact had merit and in this sense directly
explained its usefulness. At most, the question is one upon which reasonable
persons could differ.
"The vital issue in this case was the efficacy of the Hoxsey treatment for
internal cancer in humans. No claim is made that the question of the adequacy
and effectiveness of the tablets was improperly submitted to the jury. Claim-
ants were given the fullest opportunity to state their case for the drugs but
their evidence was rejected by the jury. The court is not called upon in this
opinion to discuss the sufficiency of the government's expert and lay testimony
showing that the drugs were without merit in the treatment of cancer and
observes only that the verdict of the jury is supported by persuasive and over-
whelming evidence. The Hoxsey medications have again been weighed and
found wanting.
"The motions for judgment and a new trial will be denied."
On 7-9-57, the claimant filed a second motion for a new trial, alleging that
improper and prejudicial matter was communicated to a member of the jury
30 Government Exhibit 24, pp. 5-8.
u Government Exhibit 121.
was discussed before the juror; and that there was misconduct on the part o^
the juror in that the matter was not called to the attention of the court. The
claimant filed notice of appeal on 7-16-57.
On 8-23-57, the district court entered a decision with respect to the claimant's
second motion for a new trial, as follows:
MILLER, District Judge: "On May 28, 1957, an opinion and order was filed
denying the claimant's motion for new trial. The claimant on July 9, 1957,
pursuant to Rule 59 and Rule 60 of the Federal Rules of Civil Procedure, filed
a second motion for a new trial and on July 16,1957, filed notice of appeal. The
filing of the notice of appeal vests jurisdiction over the cause appealed in the
Court of Appeals and this court has no power to take other action affecting
the cause without permission of the Court of Appeals, except insofar as juris-
diction is expressly reserved in the district court by statute or the Federal
Rules of Civil Procedure. See In the Matter of Federal Facilities Realty
Trust Company, et al., Appellant vs. Jac6b Kulp, et ah, Appellees, 227 F. 2d 651
(7Cir.)."
On 8-29-57, the claimant filed a motion to remand the cause to the trial
court, so that a hearing on the second motion for a new trial might be had in
the district court. The United States Court of Appeals for the Third Circuit,
after a hearing, entered an order denying the motion on 9-4-57.
On 9-5-57, the claimant filed a motion for amplification of the order, denying
the motion to remand, and on 9-10-57, filed a motion to strike the Defender
Magazine as part of the record on appeal. These motions were denied by
the court of appeals on 9-23-57.
On 10-4-57, the claimant and the Government filed an agreement to dismiss
the appeal; the court of appeals entered an order on 10-7-57 dismissing the
appeal, the costs to be assessed against the appellant.
On 10-22-57, the district court entered an order directing the marshal to
destroy the tablets and the accompanying labeling.