3911. Adulteration and misbranding of Enca Cream.   U. S. v. 23 Gross Jars, etc.
(F. D. C. NO. 27212.    Sample Nos. 46583-K, 46584-K.)
LIBEL FILED :    May 13,1949, Western District of Pennsylvania.
ALLEGED SHIPMENT: On or about September 24, 1948, and April 8, 1949, by
Atlas Laboratories, Inc., from Akron, Ohio.
PRODUCT: 23 gross jars of Enca Cream, together with a number of booklets
entitled "presenting New Facts about Acne and its associated Skin Blemishes,"
and a number of counter display cards and window streamers, at Pitts-
burgh, Pa.
LABEL, IN PART: (Jar) "Active Ingredients: Tyrothricin, resorcin, zinc oxide,
petrolatum   Distributed by Morton Products, Inc.    Cleveland 14, Ohio."
NATURE OF CHARGE : Adulteration, Section 501 (c), the strength of the article
differed from that which it purported and was represented to possess since it
possessed no antiseptic properties against Staphylococcus aureus or Staphylo-
coccus pyogenes micro-organisms commonly associated with skin infections, as
stated and implied in the labeling.
Misbranding, Section 502 (a), certain statements on some of the cartons
containing the jars of the article, in a booklet enclosed in some of the cartons,
on the above-mentioned window streamers and display cards, and in a booklet
accompanying the article were false and misleading. The statements repre-
sented and suggested that the article would be effective in the treatment of
pimples, blackheads, and other externally caused minor skin blemishes, burn-
ing, itching skin, and acne and its associated skin blemishes. The article
would not be effective in the treatment of the conditions stated and implied.
Further misbranding, Section 502 (a), the statements "Base for the new
'wonder formula' * * * non-greasy vehicle," "Enca's greaseless cream base,"
and "Enca is greaseless" appearing in the above-mentioned booklet accom-
panying the article were false and misleading as applied to an article which
contained petrolatum, a grease; and certain other statements in the above-
mentioned booklet were false and misleading since they represented and sug-
gested that the article had antiseptic properties against organisms commonly
found in skin infections, whereas the article possessed no antiseptic properties
against Staphylococcus aureus or Staphylococcus pyogenes micro-organisms
commonly associated with skin infections.
DISPOSITION : On July 1, 1949, the manufacturer of the product, Morton Prod-
ucts, Inc., Cleveland, Ohio, having petitioned for the removal of the libel
action for trial in the Northern District of Ohio, the United States Court for
the Western District of Pennsylvania entered an order providing for such
removal. Following the removal, a motion to remand the case to the court of
original jurisdiction was filed, on behalf of the Government, with the United
States District Court for the Northern District of Ohio. On October 25, 1949,
the court handed down the following decision providing for the remanding
of the case:
JONES, District Judge: "This is a libel brought under favor of 21 U. S. C. A.
Sec. 334 (Pure Food and Drug Act) for the condemnation of the product and
advertising matter in the caption of this memorandum. Originally the action
was commenced in the Western District of Pennsylvania. Morton Products,
Inc., whose principal place of business is in this division, intervened as
claimant of the goods and petitioned that Court to remove this action to this
district. The Court allowed the motion and the action was transferred here.
The Government objected at all times to the removal and now has filed a mo-
tion to remand the action to the court of original jurisdiction.
"Apparently this action was removed to this district under favor of Section
1404 Title 28 U. S. C. A. If that section applies, the action was properly
transferred and the Government's motion must be overruled.
"The pertinent part of 1404 (a) is as follows: '* * * A district court may
transfer any civil action to any other district where it might have been
brought.'
"It is true that under Supreme Court decisions this action would be cov-
ered by the phrase 'any civil action,' but, by the clear and unambiguous words
of the statute, such civil action cannot be transferred to a district where
the action could not originally have been started.
"This libel having been brought under favor of 21 U. S. C. A. 334, the
articles may be condemned 'In any district court of the United States within
the jurisdiction of which the article is found.' Since the articles were found
in the Western District of Pennsylvania this action only could be commenced
in that district.   It could not, under Section 334, have been brought in this
district. Since this is so and since Section 1404 (a) may only be used to
transfer actions to districts where they could have been brought, it follows
that Section 1404 (a) could not be used to transfer this action here.
"It should also be noted that Section 1404 (b) provides for transfer of in
rem actions. However, the revisers' notes show that this section 1404 (b),
was meant to apply only to removal of causes between divisions within dis-
tricts and not to removal of actions between districts. Section 1404 (b), there-
fore, can have no application to this action.
"Since Section 1404 (a) does not apply, the special venue section of 21
U. S. C. A. does. This section allows removal in this type action to district
courts 'of reasonable proximity to claimant's place of business.' This phrase
has been interpreted to exclude the district or division in which claimant's
principal place of business is found.    (U. S. v. 600 Units?, 60 F. Supp.
144; U. S. v. Six Dozen Bottles?Dr. Peter Kurik, 55 F. Supp. 458;
U. S. v. 26 Dozen Bottles?Cervigards, 60 F. Supp. 626.) As this dis-
trict is the claimant's principal place of business, it follows that this action
has been removed to a district which has not been given authority under Section
334 to try the action.
"Claimant contends that even if this action is not properly here, that the
Court cannot re-examine the order of the District Court of the Western District
of Pennsylvania. The only case it cites, however, is one where the court,
to which the action was removed over protest of defendant, had proper venue
and jurisdiction to hear the action. In this cause, Section 334 does not permit
this Court to hear the action. In U. S. v. 26 Dozen Bottles ..... of Cervi-
gards, 60 F. Supp. 626, the Court to which the action was improperly removed,
remanded the action to the Court of original jurisdiction. There is adequate
authority for remanding an action when it has been improperly transferred
under 21 U. S. C. A. 334.
"This action will be remanded to the court of original jurisdiction."
An appeal from the above court decision was taken by the manufacturer to the
United States Court of Appeals for the Sixth Circuit, and on May 31, 1950,
the appeal was dismissed pursuant to the motion of the manufacturer.
The case was returned to the United States District Court for the Western
District of Pennsylvania, and, on January 23, 1953, judgment of condemnation
was entered and the court ordered that the product be destroyed.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF FALSE AND
MISLEADING CLAIMS*
3912. Action to enjoin and restrain the interstate shipment of misbranded
Dunkler Cancer Test Reagens. U. S. v. William Dunkler (William
Dunkler Laboratories).   Consent decree granting permanent injunction.
(Inj. No. 255.)
COMPLAINT FILED: October 29, 1952, Northern District of Illinois, against
William Dunkler, trading as the William Dunkler Laboratories, Chicago, 111.
NATURE OF CHARGE: That the defendant had been and was at the time manu-
facturing, preparing, packing, distributing, and selling drugs intended for use
in the diagnosis of cancer and labeled, in part, "Dunkler Cancer Test Reagens
I" and "Dunkler Cancer Test Reagens II"; that he had been and was at the
time introducing and delivering, and causing the introduction and delivery,
for introduction of the drugs into interstate commerce; and that the drugs
were misbranded as follows:
Section 502 (a), the labelings contained statements which represented and
suggested that the drugs constituted a reliable means of diagnosing cancer,
which statements were false and misleading since they did not constitute a
?See also Nos. 3902-3906, 3908-3911.
reliable means of diagnosing cancer; Sections 502 (b) (1) and (2), the drugs
failed to bear labels containing the name and place of business of the manu-
facturer, packer, or distributor, and accurate statements of the quantity of
the contents; and, Section 502 (e) (1), the label of the "Dunkler Cancer Test
Reagens II" failed to bear the common or usual name of the drug, ether.
The complaint alleged further that the continued introduction and delivery
of the drugs into interstate commerce was dangerous to the public and could
cause irreparable injury through failure to diagnose a cancerous condition,
which failure might well lead to such delay in obtaining treatment that ir-
reparable injury would occur; and that it was necessary that a temporary
restraining order issue ex parte, pending hearing for a preliminary injunction.
The complaint prayed that the court grant a temporary restraining order
restraining the defendant, his agents, servants, employees, representatives,
and all persons in active concert or participation with him from directly or
indirectly introducing or delivering the drug for introduction into interstate
commerce; that an order be entered directing the defendant to show cause why
the relief prayed for should not be granted; that upon the hearing of such
order, a preliminary injunction be granted; and that after further due pro-
ceedings, such preliminary injunction be made permanent.
DISPOSITION : On October 30, 1952, the court issued a temporary restraining
order, and on November 17, 1952, the defendant having consented to the entry
of a decree, judgment was entered that the defendant be perpetually enjoined
and restrained from directly or indirectly introducing or causing the intro-
duction or delivery into interstate commerce of articles of drugs misbranded
within the meaning of Section 502.