751. Action to enjoin and restrain interstate shipments of a drug designated as
Dependon Products Intrauterine Paste and the same drug designated as
Dependon Products Paste. ~U. S. v. Anne At. Jenks doing business as De-
pendon Products and Jenks Physicians' Supplies. Permanent injunction
granted.    (Inj. No. 35.)
On October 16, 1942, the United States attorney for the District of Minnesota
filed a complaint against Anne M. Jenks, doing business as Dependon Products
and Jenks Physicians' Supplies at White Bear Lake, Minn., alleging that since
1930 the defendant had been the sole owner and operator of said business and
had been engaged in the sale and distribution of gynecological specialties; that
about the latter part of 1938 the defendant had become engaged in the sale and
distribution in interstate commerce of an article labeled in part, "Dependon
Products Intrauterine Paste"; that the article was offered for sale for injection
into the pregnant uterus and as an effective medicament for the treatment of
abnormal conditions which prevail in a nonpregnant uterus; that it was a
viscous yellowish liquid consisting of a water solution of potassium soap,
alcohol, glycerin, and iodine compounds and was a drug within the meaning of
the law; that accompanying said drug in interstate commerce so as to consti-
1 For reduction of quality because of extraneous material, see No. 756 (triple-distilled
water) ; omission of, or unsatisfactory, active ingredients statements, Nos. 754, 756-758,
761, 764, 775, 782, 790, 791, 793; inconspicuousness of warning statement, No. 754 ; omis-
sion of name and place of business of manufacturer, packer, or distributor, No. 758; omis-
sion of accurate statement of quantity of contents, Nos. 758, 760; deceptive packaging, No.
782, 790, 791.
533413-43 1
dosage, frequency, and duration of administration.2
The complaint alleged further: I. That the drug was misbranded: (1) In that
it was dangerous to health when used in the dosage or with the frequency or
duration prescribed, recommended, or suggested in the labeling for the purposes
of terminating pregnancy, for inducing labor, and for removing the retained
portions of the products of conception. (2) In that the words "Intrauterine
Paste," borne on the label, and statements in an accompanying circular represented
and suggested that it was safe and appropriate for introduction into the uterine
cavity for the purposes of terminating pregnancy, for inducing labor, and for
removing retained portions of the products of conception; whereas it was not
safe or appropriate for such purposes but was unsafe and dangerous and was
capable of producing serious or even fatal consequences. (3) In that the fol-
lowing statements, "For Dysmenorrhea From 5 to 10 cc's of the Paste applied
shortly before the period is considered helpful in some cases. The insertion of
the Cannula may be considered to act as a dilatation. For Endometritis Cervi-
cal and Uterine Discharges. Application of from 5 to 10 cc's of the paste, as
needed, is suggested by many physicians," represented and suggested that it was
an effective medicament for the treatment of dysmenorrhea, endometritis, and
cervical and uterine discharges; whereas it was not an effective medicament for
such purposes.
II. (1) That in or about December 1941, and since that time up to the filing
of the complaint, the drug had been subject to numerous libel or seizure actions
commenced by the Government in various Federal judicial districts throughout
Che country for the purpose of condemning the quantities seized as misbranded
within the meaning of the law; that in at least five instances decrees in favor of
the United States had been entered condemning, forfeiting, and ordering destruc-
tion of the seized goods; and that other cases were awaiting trial. [These have
since been terminated by the entry of decrees in favor of the Government.]    (2)
3 The following statements appeared in the circular : "For Physicians Only Nod-Nep-Ed
Sterile Intrauterine Paste * * * Non-Toxic * * * Instillation of the Paste
may be made by means of a Cannula attached to the tube, or by transferring the Paste to
a syringe and then attaching the special syringe type Cannula to the syringe. * * *
When using the Paste to terminate a pregnancy, or to induce labor it is usually considered
that best results are obtained when the available space in the uterus is filled with the
Paste. * * ? Dependon Intrauterine Paste should b? used only by a Physician, with
adequate and continuous supervision of the case. For Therapeutic Termination of Preg-
nancy * * * Technique of Application of Paste-With self-supporting vaginal specu-
lum in place, very slowly pass Cannula thru cervix until the tip has reached the uterine
cavity. During this procedure keep expelling small amounts of the Paste. Thus the canal
is continually lubricated and readily opened. After Cannula has reached the uterine
cavity, even more slowly continue its insertion until a slight back pressure is felt-then
slightly withdraw Cannula and turn it to one side (quarter turn)-now instill the desired
amount
 of Paste into the uterus. If the uterus tips forward, the Cannula is turned to point
downward. Undue pressure in applying the Paste must be avoided-should tension, pain,
bleeding or expulsion of Paste develop, arrest instillation. After Paste instillation keep
patient in Trendelenburg's position (hips higher than shoulders) for some moments. Later
when Patient is resting she should be advised to place feet higher than her head. Should
the cervical canal be enlarged, a small amount of sterile cotton may be placed so as to
retain the Paste. The use of a rubber plug for this purpose is not recommended. Treat-
ment during early stages of pregnancy: Dependon Intrauterine Paste may be used in the
very early stages. Extreme gentleness and care is advised at this difficult tim-e. It is
essential that the Paste be deposited at the vault of the uterus, otherwise some bleeding;
but no evacuation may be the result. Depending on the size of the uterus, from 10 to 15
cc's applied after effects of sedatives are noted, is suggested. Treatment during later
stages of pregnancy: (after eight weeks)-Best dosage is usually from 7 to 10 cc's per
month of pregnancy. Larger dosages (up to capacity of uterus to receive Paste) often
produce stronger and quicker action. Maximum dosage, ordinarily should not exceed 30
to 40 cc's. Precautions-Always before using Paste a careful diagnosis should be made.
* ? * * Under some conditions the Paste may not bring on the desired results. * * *
It may also be observed that unless the Paste is properly placed and in sufficient amount,
no results following its use may be looked for. In cases where the Paste fails to bring
the desired results, and there are no contra-indications for its use, it is the usual practice
to repeat the treatment after a few days * * * Then pains set in with rhythmic and
sustained contractions. * * * In a few cases, spotting may be looked for, following
the Paste treatment. This condition may ordinarily be expected to shortly correct itself.
However, if spotting continues over a period of weeks, the possibility of only partial
expulsion should be considered and proper therapy instituted. Generally massage of the
uterus is sufficient. * * * Comments of Physicians indicate that practically every
ease is uneventful, and that in the very rare event that the Paste fails to bring the desired
results no harm develops from the trial of the Paste treatment. We believe this is due to
the fact that Dependon Intrauterine Paste is nontoxic and sterile. For Induction of
Labor. Dosage is usually from 30 to 40 cc's, accompanied by quinine or other indicated
therapy. For Incomplete Miscarriage. Usually from 10 to 15 cc's of the Paste is sufficient.?Proper therapy should accompany use of Paste. * * * When using Dependon Intra-
uterine Paste it is suggested that a syringe be employed in some cases. * * * pressure
can be accurately controlled. ? * * In cases where Paste Is used for the therapeutic
termination of pregnancy * ? * as the ability to conceive seems to be greatly
enhanced following use of Dependon Intrauterine Paste,"
the defendant the drug was dangerous to health and misbranded in violation of
the law, she in complete disregard of the decrees which had been entered con-
demning the drug had continued to introduce or deliver it for introduction into
interstate commerce. (3) That in or about April 1942, the defendant relabeled
her product under the name of "Dependon Products Paste," but that it was in fact
the same drug as that formerly known as Dependon Products Intrauterine Paste;
and that although she was not shipping it under the former designation, she
was continuing to ship the same product under the latter designation to and
through States other than Minnesota.
III.?That the drug labeled "Dependon Products Paste" was misbranded: (1)
In that it was dangerous to health when used in the dosage prescribed, recom-
mended, and suggested in the labeling, namely, "The use of this product in uterine
therapy (which is still medically controversial) should be by physicians only
* * * maximum dosage * * * in pregnant uterus 30 C. C. actual dosage
to be determined by the physician for the individual patient." (2) In that the
statements, "Dependon Products Paste * * * The use of this product in
uterine therapy (which is still medically controversial) should be by Physicians
only. * * * Maximum dosage to be determined by the Physician for the
individual patient. Undue pressure in applying paste must be avoided," repre-
sented and suggested that it was safe and appropriate for introduction into the
pregnant uterus; whereas it was not safe and appropriate for such purpose but
was unsafe and dangerous and capable of producing serious injury or even fatal
consequences. (3) In that the said statements represented and suggested that
it was an effective medicament for the treatment of abnormal conditions in a
nonpregnant uterus; whereas it was not an effective medicament for such
purposes.
IV.?That the shipments subsequent to 1938 of Dependon Products Intrauterine
Paste and subsequent to April 1942 of Dependon Products Paste were in violation
of section 301 of the act which makes it a criminal offense to cause the intro-
duction or delivery for introduction into interstate commerce of an adulterated or
misbranded drug; and that in order to protect the public of the United States from
dangers inherent in the use of the article it was necessary that an injunction
issue; and praying that after proper notice and hearing a preliminary injunction
issue restraining such unlawful acts by the defendant, and that after due pro-
ceedings the preliminary injunction be made permanent.
On October 29, 1942, the defendant having filed an answer denying the mate-
rial allegations of the complaint and having appeared by counsel, the case came on
for hearing to show cause why a temporary injunction should not issue. As
a result of the hearing, the court found in substance that the defendant was
engaged in the distribution in interstate commerce of the drug product alleged
in the complaint, that it was offered for the purposes therein alleged, that the
court had jurisdiction to restrain violations of section 301 of the act "for cause
shown," and that irreparable injury need not be established as a prerequisite to
the issuance of such preliminary injunction. The court stated further that the
position taken by the Government was supported by the sworn statement of three
leading doctors and that sufficient cause for the issuance of a temporary
injunction had been shown; and on October 31, 1942, a temporary injunction
against the defendant was entered.
On January 5, 1943, the case came on for trial on the merits as to why a
permanent injunction should not issue, the trial continuing until and through
January 18, 1943. During the trial no evidence was introduced on behalf of
the defendant in opposition to the contentions of the Government; and on Janu-
ary 19, 1943, the court after consideration of the evidence submitted by the
Government in the form of files, records, and exhibits, of the testimony of wit-
nesses, and of arguments of counsel, made the following Findings of Fact, Con-
clusions of Law, and Order for Judgment (BEEL, District Judge):
FINDINGS OF FACT
"Defendant, Anne M. Jenks, resides in the City of White Bear Lake, Ramsey
County, State of Minnesota, and within the jurisdiction of this court, where for
a number of years she has been engaged under the name and style of Dependon
Products and Jenks Physicians' Supplies in the sale and distribution in inter-
state commerce of gynecological specialties.
state commerce an article which has been labeled in part as 'Intrauterine Paste
Gynecological Soap' and 'Dependon Products Paste'; said article has been com-
posed mainly of potassium soap or other soft soap base, with small quantities
of alcohol, iodine, and distilled water added, although its formula and composi-
tion has not been entirely consistent; said article is offered for sale and intended
for use by licensed physicians in the performance of therapeutic abortions, in
the treatment of incomplete abortions and miscarriages, for the induction of
labor and as a medicament for the treatment of endometritis, cervicitis, dysmen-
orrhea, and cervical and uterine discharges.
Ill
"In connection with the interstate distribution of the said article, defendant
has distributed written, printed, and graphic matter in the form of circulars con-
taining suggestions and recommendations as to usage, technique of use, dosage,
frequency, and duration of administration-at times, by enclosing the same in
the retail cartons containing said article, and at times by enclosing the same
in the shipping carton in which several of said retail cartons have been shipped
in interstate commerce, and at other times by sending such matter by separate
mail at or about the same time the article itself was shipped: that where the
latter practice has been followed, the article and such matter, although sepa-
rately shipped, arrived at destruction at or about the same time.
"Such written, printed, and graphic matter as well as the various labels which
have been affixed to said article, represent and suggest that said article is safe
and appropriate for introduction into the pregnant uterus, for the purpose of
inducing labor, terminating pregnancy, and removing the retained portions of
the products of conception.
"Such written, printed, and graphic matter as well as the various labels which
have been affixed to said article, represent and suggest that said article is an
effective medicament for the treatment of cervicitis, endometritis, dysmenorrhea,
and cervical and uterine discharges.
"Said article when used for the purposes of the induction, of labor, termination
of pregnancy, and the removal of the retained portions of the products of con-
ception, is unsafe and dangerous to health and has caused fatalities and serious
injury. Among the specific dangers which are involved in and have resulted
from its use are the extensive destruction of tissue, hemolysis or the destruction
of the cellular portions of the blood, systemic potassium poisoning, extensive
hemorrhage and prolonged bleeding, sterility, peritonitis, pulmonary embolism,
damage to kidneys, liver and other internal organs, and increased susceptibility
to infection.
VII
"The dangers to health hereinbefore enumerated in Paragraph VI for the most
part are the result of the physiological action of the soap ingredient present
in said article or any article of drug having soap as a base.
VIII
"The dangers to health hereinbefore enumerated in Paragraph VI are present
when said article is used by licensed physicians or anyone, in any quantity, or
for any duration, or with any frequency of usage, for the treatment of any condi-
tions which prevail in the pregnant uterus.
"Said article is ineffective for the treatment of cervicitis, endometritis, dys-
menorrhea, and cervical and uterine discharges, or the treatment of any other
condition prevailing in a non-pregnant uterus.
injunction should issue restraining defendant and any of her agents or associates
from introducing or delivering for introduction into interstate commerce, and
from causing the introduction or delivery for introduction into interstate com-
merce of said article or an article of substantially similar composition.
"The dangers inherent in the use of said article, or any other article having a
soap for its base, with or without small quantities of iodine, alcohol, and dis-
tilled water added, when used for introduction into a pregnant uterus, and its
ineffectiveness when used for the conditions suggested in a non-pregnant uterus,
make essential the issuance of a permanent injunction restraining henceforth the
interstate distribution of said article for introduction into a pregnant or non-
pregnant uterus, or for any other purpose unless application therefor is made
to the court."
CONCLUSIONS OF  LAW
"The court is specifically authorized by section 302 (a) of the Federal Food,
Drug, and Cosmetic Act to restrain the introduction or delivery for introduction
or the causing of the introduction or delivery for introduction into interstate
commerce of a drug which is misbranded.
"Cause has been shown justifying the issuance of a permanent injunction.
Ill
"Said article, whether labeled in part 'Intrauterine Paste Gynecological Soap'
or 'Dependon Products Paste' is a drug within the meaning of section 201 (g)
(2) and (3) of said act'
"The written, printed, or graphic matter distributed by defendant enclosed
either in retail cartons containing said drug or within shipping packages con-
taining said retail cartons, or shipped separately from said drug accompanies
said drug within the meaning of section 201 (m) of the act and hence consti-
tutes 'labeling.' The labels which have been affixed by defendant to said drug
also constitute 'labeling' within the meaning of section 201 (m).
"Said drug is misbranded within the meaning of section 502 (a) of said act
in that its labeling is false and misleading, for the reason that it represents and
suggests that said drug when used for induction of labor, termination of preg-
nancy, or the removal of the retained portions of the products of conception, is
safe and appropriate; whereas in truth and in fact it is unsafe and dangerous
and has caused serious and fatal consequences.
Said drug is misbranded within the meaning of section 502 (a) of said act in
that its labeling is false and misleading for the reason that it represents and
suggests that said drug is an effective medicament for the treatment of cervicitis,
endometritis, dysmenorrhea, and uterine and cervical discharges; whereas in
truth and in fact it is ineffective for such purposes.
VII
"Said drug is misbranded within the meaning of section 502 (j) in that it is
dangerous to health when used in any dosage or with any frequency or with any
duration of administration prescribed, recommended, or suggested in its labeling,
for the purposes of induction of labor, termination of pregnancy, and removal of
the retained portions of the products of conception.
"Upon the basis of the foregoing Findings of Fact and Conclusions of Law,
"It is hereby Ordered, That a Permanent Injunction be entered accordingly,
without costs to either party."
PERMANENT INJUNCTION
"It is hereby Ordered and Decreed, That defendant, her employees, servants,
agents, distributors, assigns, and any and all persons in active concert or participa-
tion with them be, and they are, hereby permanently enjoined from introducing
or delivering for introduction into interstate commerce and from causing the
introduction or delivery for introduction into interstate commerce of the article
of drug, labeled in part, 'Intrauterine Paste' or 'Dependon Products Paste,' or
under any other name, containing soft soap or other soap base with or without
distilled water, iodine, and alcohol or other ingredients added, under labeling
recommending or suggesting its use for introduction into the uterus for the pur-
pose of terminating pregnancy, treating incomplete abortions or miscarriages,
for inducing labor, or as a medicament for the treatment of dysmenorrhea,
endometritis, cervicitis, cervical or uterine discharges, or for any intrauterine or
cervical therapy whatever.
"In order to effectuate the purposes of the act and to prevent the article of drug
from being used in uterine and cervical therapy, defendant, her employees,
servants, agents, distributors, assigns, and any and all persons in active concert
or participation with them, are specifically enjoined from introducing or deliver-
ing for introduction or causing the introduction or delivery for introduction into
interstate commerce of said article of drug or any similar article of drug for any
purpose whatsoever in violation of the Federal Food, Drug, and Cosmetic Act, and
amendments thereto."