5447. Elip tablets.    (F.D.C. No. 34887.    S. Nos. 37-389/90 L.)
QUANTITY : 39 bags, 1,200 tablets each, at Baldwin, N.Y., in possession of Bald-
win Laboratories, and 94 12-tablet vials at Baldwin, N.Y., in possession of
Elip Distributing Co.
SHIPPED :    6-6-52, from Bast Newark, N.J.
LABEL IN PAET: (Bag) "Elip Tablet"; (vial) "Elip Tablets * * * Active In-
gredients :   Potassium Bitartrate, Sulfur, Rhubarb."
ACCOMPANYING LABELING: Window sign bearing the words "Elip For Piles"
and counter display placards bearing the words "An Internal Preparation For
The Relief of Piles."
RESULTS OP INVESTIGATION : The tablets in the bags represented the remainder
of a bulk shipment which had been made to Baldwin Laboratories at Baldwin,
N.Y., from East Newark, N.J.; and the tablets in the vials represented a por-
tion of such bulk shipment which had been sold by Baldwin Laboratories to
Elip Distributing Co. and repackaged into vials by that company.
The above-described window sign was on display in the window of Baldwin
Laboratories, and the counter display placard was used by the Elip Distribut-
ing Co. in preparing the vials of tablets for sale. The vials were attached to
the placards in units of six.
LIBELED :    3-20-53, E. Dist. N.Y.; amended libel 1-10-55.
CHARGE: 502(a)-while held for sale, the labeling of the article in the bags
and vials contained false and misleading representations that the article was
an adequate and effective treatment for piles and the discomfort and itching
of rectal irritation caused by piles; and 502(f) (2)-the labeling of the article
failed to bear a warning against its use for bleeding piles.
DISPOSITION : The Elip Distributing Co. and Ira Lichtenstein, t/a Baldwin
Laboratories, claimants, filed an answer to the original libel, denying that the
article was misbranded as alleged. Interrogatories were served by the Govern-
ment upon the claimants on 10-20-53; and the claimants, without answering
the interrogatories, made a motion for summary judgment. The matter was
argued before the court on 1-13-54, and on 2-11-54 the court handed down the
following decision in denial of the motion:
BYEBS, District Judge: "This is a claimant's motion in a condemnation pro-
ceeding under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301, et
seq.) for summary judgment.
'?The basis of the motion is a holding by the U.S. Post Office Department
that the subject matter of the libel was not falsely and fraudulently labeled.
"Fraud is not alleged in the libel, nor was such an allegation requisite under
the law. U.S. v. 5 cases, etc., 156 Fed (2) 493 Cf. U.8. v. Dotterweich, 320
U.S. 277.
"It is clear that such a departmental holding is not res judicata.
"Motion denied.    Settle order."
Following the decision, the claimants filed answers to the interrogatories.
The amended libel was filed, to which the claimants filed an answer, denying
that the article was misbranded; they again advanced the defense of res
judicata based upon the prior Post Office proceedings. The Government/
moved to strike the allegations in the answer relating to the res judicata
defense; and on 9-6-55, the court granted the Government's motion to strike.
The case came on for trial before the court without a jury on 12-18-56;
and at the conclusion of the trial, the case was taken under advisement by
the court. On 4-5-57, the court handed down the following opinion (150 F.
Supp. 648) :
BBTTCHHAUSEN, District Judge: "The libelant instituted this action to con-
demn a quantity of drugs and advertising material, upon the ground that the
drugs were misbranded or mislabelled, in violation of the Pure Food and
Drug Act.
" 'The purpose of the law is to protect the public, the vast multitude which
includes the ignorant, the unthinking, and the credulous who, when making a
purchase, do not stop to analyze. It was enacted to make self-medication
safer and more effective, and to require that drugs moving in interstate
commerce be properly labeled so that their use as prescribed may not be
dangerous to the health of the user.' United States v. 62 Packages, etc., 48 F.
Supp. 878, 887, affirmed 142 F. 2d 107, certiorari denied 323 U.S. 731.
"The term 'labeling' applies to the matter printed or written upon the article
itself, and upon the containers or wrappers accompanying it (21 U.S.C.
321 (m)). A drug is deemed misbranded 'if its labeling is false or misleading
in any particular' also if the labeling fails to include adequate warnings as
to its use (21 U.S.C. 352(a) (f)).
"It is not disputed that the claimant Ira Lichtenstein, doing business as
Baldwin Laboratories, conceived the formula for the drugs or tablets in ques-
tion ; that the formula consisted of a mixture of flowers of sulphur, rhubarb
root and cream of tartar; that the said claimant engaged Jabert Pharmacal
Company, Inc. to manufacture the tablets, and that the said claimant con-
tracted with the claimant Elip Distributing Corporation to market them,
including packaging and advertising.
"The contention is that in the process of marketing the tablets, the claim-
ants deceived the public in asserting that the tablets would relieve the ailment,
known as 'Piles.'
"It is interesting to note that the manufacturer made no such assertion. Its
label on the gross shipment to the distributors made no mention of such ailment
but designated the tablets as 'laxatives.' The distributors did not use that
label but prepared a different label, inserted it in each package or vial of 12
tablets, reading, in part:
Blip Tablets-A palliative
treatment for discomfort
and itching of rectal irri-
tation caused by piles.
"The counter display cards contained the statement:
An internal preparation for
the relief of piles. Price
62.  Elip Reg. U.S. Pat. Off.
"A neon sign in the window of Baldwin Laboratories read: 'Blip for Piles.'
"During the trial, the claimants stipulated that the labeling should contain
a warning against using the tablets for bleeding piles.
" 'Elip,' the designation used by the claimants in promoting the product is
'pile' spelled backwards.
"The three medical experts produced by the Government, expert proctolo-
gists, testified that Elip tablets are laxatives and not particularly mild and
that the only complete cure for piles is surgery.
"The claimant Lichtenstein, a pharmacist, admitted that surgery was the
only known complete cure for piles, but denied that Elip was held out as a
cure. He said that he conceived the tablet as a mild laxative softening the
digested matter passing over the pile area, and containing an astringent for
washing the affected area.
"Either he or his medical witness also asserted the qualities of the tablets
were such that the laxative did not operate until it reached the large intes-
tine, thus guaranteeing a complete movement and that there were certain
germ killing qualities in the drug.
"Apparently no certain medication has been discovered to date which will
cure piles nor are the specific causes known. They are known as hemorrhoids
in medical terminology, and consist of swollen veins in the lower end of the
large intestine, or anus, brought on by such causes as constipation, infection,
overstraining, heredity, childbirth, tension, worry and diet.
"If they protrude, they are known as external as distinguished from internal
hemorrhoids, and when dilated they are very painful. Very often they bleed.
Temporary relief comes with the lessening of congestion. Sometimes, as with
common colds, piles cure themselves.
"A controlled experiment was conducted at Bellevue Hospital by Dr. Max
P. Cowett, a distinguished proctologist. He testified that twenty-eight pa-
tients, interspersed between hospital and clinic patients were treated with
Blip tablets for a period of almost four months. An additional twenty were
given placebos in the form of milk sugar tablets. The results were uncom-
plimentary to Elip. Several of those using the tablets grew worse, or com-
plained of abdominal cramps, with increased bowel movements, and tenesmus,
or bowel frustration. The experiment with some patients had to be discon-
tinued. Several required either surgery or sclerosing. None of the patients
on either the Elip or the placebo benefited during the treatment.
"Various newspaper and periodical advertisements were submitted in evi-
dence as proof of the intent of the labels, although not as evidence of the
labeling itself. Such evidence is competent. Colgrove v. United States,
9 Cir., 176 F. 2d 614, certiorari denied 338 U.S. 911; Research Laboratories v.
United States, 167 F. 2d 410, certiorari denied 335 U.S. 843; United States v.
Vitamin Industries, Inc., D.O. Nebr., 130 F. Supp. 755.
"In newspaper advertising and throwaways, the claimant made claims for
the tablets such as: 'Piles checked in 72 hours with tablets * * * in 72
hours the bleeding stopped * * * Elip brings sure relief from pile misery
* * * the only internal pile remedy.'
"It is plain that the claimants entered into a campaign of 'bait advertising.'
A product, manufactured as a laxative, without any changes by the promoters,
is held out to the unsuspecting public as a remedy for another condition, piles.
The recklessness of the claimants and their utter disregard of those whom
they catered to is evidenced by their admission that the tablets could not aid
anyone afilicted with bleeding piles. That the element of large profit was not
absent from this enterprise is inferable. The tablets cost the claimants about
one-tenth of a cent each and were sold by the claimants at $2 per package of
12 tablets. It is fairly apparent that if the claimants had informed the pur-
chasers that the product was nothing more than a laxative, they would have
been obliged to compete with the large number of producers of that article
and would not have interested the pile sufferers.
"A decree is directed for the relief demanded in the libel."
In accordance with the above opinion, judgment of condemnation was entered
on 6-10-57, and the product was ordered destroyed.