6581. Hope's Worm-Rid.    (Inj. No. 368.)
COMPLAINT FOR INJUNCTION FILED: 12-28-59, E. Dist. Mo., against the Hope 
Co., a corporation, Clayton, Mo., Hope J. Anderson, president and treasurer 
of the Hope Co., and Na-Spra, Inc., Maplewood, Mo.
NATUEB OF BUSINESS: The Hope Co. promoted and sold a drug intended for 
use without a prescription in the treatment of worm infestation in humans. 
Each 5-cc. teaspoonful of syrup contained piperazine citrate equivalent to 500 
mg. piperazine hexahydrate. The Hope Co. and Hope J. Anderson solicited 
orders for the drug by means of form letters; they prepared and arranged 
for the printing of all labeling of the drug, and furnished the formula and 
labels to Na-Spra, Inc. Na-Spra, Inc., manufactured the drug according to 
the formula supplied by the Hope Co. and Hope ?T. Anderson, and packaged 
the drug in 4-oz. bottles to which the labels supplied by the Hope Co. and 
Hope J. Anderson were affixed. All customer orders for the drug were ini- 
tially received by the Hope Co. and Hope J. Anderson, and after such receipt 
instructions were issued by the Hope Co. and Hope J. Anderson pursuant to 
which shipments of the drug were made to the customers by Na-Spra, Inc., in 
the name of the Hope Co.   Na-Spra, Inc., would inform the Hope Co. anfl
Hope J. Anderson when the shipments of the drug were made and after re- 
ceipt of such information the Hope Co. and Hope J. Anderson would bill the 
customers direct.
CHASGE: The complaint alleged that the article of drug designated by the 
name of "Hope's Worm-Bid" was a new drug within the meaning of 201 (p) 
in that its composition in respect to piperazine hexahydrate was such that the 
drug was not generally recognized among experts, qualified by scientific train- 
ing and experience to evaluate the safety of drugs, as safe for use under the 
conditions prescribed, recommended, and suggested in the labeling of the drug, 
gaamely, for use without a prescription in the treatment of worm infestation 
in humans.
The complaint alleged further that when caused to be introduced and de- 
livered for introduction into interstate commerce by the defendants, the drug 
was in violation of 505(a) in that the drug so labeled was a new drug for 
which no application filed pursuant to 505(b) was effective.
The complaint alleged further that the defendants violated 301(d) by their 
acts of causing the introduction and delivery for introduction into interstate 
commerce of such drug, so labeled, which was in violation of 505(a).
DISPOSITION: On 12-28-59, a temporary restraining order was issued. On 
1-18-60, the defendants appeared and filed an answer denying that the article 
was a new drug. Subsequently, the defendants filed interrogatories and the 
Government filed answers.
On 1-21-60 and 1-22-60, the Government's motion for a preliminary injunc- 
tion was heard and, at that time, the parties stipulated that no new drug-ap- 
plication had been filed with respect to this drug and that the record of the 
hearing for a preliminary injunction would become a part of the record of this 
suit on final hearing.
On 2-22-60, the defendants filed an amended answer containing the previous 
denials and further alleging that the Federal Food, Drug, and Cosmetic Act 
was unconstitutional, especially the provisions relating to new drugs and re- 
lating to the United States District Court's jurisdiction to restrain violations 
of the Act.
On 3-31-60, a preliminary injunction was granted. During a hearing held 
6-3-60 and 6-6-60, on the motion for a permanent injunction, the Govern- 
ment's motion to quash the defendant's subpoena of two Food and Drug Ad- 
ministration officials was taken under advisement by the court, and, upon the 
oral motion of the Government, the court ruled that the defendants were to 
inform the court within 5 days concerning the testimony that the defendants 
expected to obtain from the subpoenaed officials.
On 8-16-60, the court sustained the Government's motion to quash and 
rendered the following memorandum opinion:
WEBEE, District Judge:
MEMORANDUM
"There is presently pending, and unruled upon, the matter of the issuance of 
subpoenas to Dr. Ralph G. Smith, Director of the New Drug Branch of the 
Food and Drug Administration, and Dr. William H. Kessenich, Director of the 
Bureau of Medicine of the Food and Drug Administration, and the Motion filed 
by plaintifE to quash said subpoenas. After a hearing upon the Motion to 
Quash, the Court requested of defendant a statement as to evidence and proof 
expected from the above witnesses, for the reason that they both reside in
Washington, D.C., and are the heads of governmental departments. Defendant 
has filed said statement of expected proof and the Court has reviewed same 
and determines as follows:
"1. Defendant states that their testimony would be of probative value and 
that from a review of prior statements, testimony and published declarations, 
it is expected they will testify to facts to sustain defendant's answer to plain- 
tiff's Petition. This is testimony which can be introduced by other witnesses 
and if prior statements, testimony and published declarations were incon- 
sistent, it would amount to an effort by defendant to impeach its own witness 
or witnesses. The matter of probative value of the testimony is involved in 
the remaining statements of expected proof under paragraph 5 thereof and will 
be dealt with in the succeeding paragraphs of this Memorandum.
"2. Sub-paragraphs (a), (b) and (c) of paragraph 5 of defendant's expected 
proof call for the testimony of these witnesses to show standards, tests and 
rules for determining whether or not a drug is safe or a new drug. The 
statutes determine such standards. See Title 21, ??321(p) and 355(a). 
Therefore, such proof is immaterial as the Court will be guided by the statu- 
tory definitions.
"3. Sub-paragraphs (d) and (e) of paragraph 5 of defendant's expected 
proof do not concern the question at issue in this cause. The issue is not 
whether the drug could be used upon the market for testing and is not its use 
in order to determine its known effect, but the question is whether or not the 
drug in question is generally recognized among qualified experts as safe for use 
under the conditions prescribed, recommended or suggested on the labeling 
thereof.   Therefore, such proof is incompetent and irrelevant.
"4. Sub-paragraphs (f), (h), (m), (r), (u) and (v) of paragraph 5 of de- 
fendant's expected proof are matters which can likewise be proven by other 
witnesses, and in fact, proof thereon has already been offered in this cause 
and therefore would be no more than cumulative.
"5. Sub-paragraphs (g), (o) and (w) of paragraph 5 of defendant's expected 
proof call for matters which are the final conclusion to be passed on by this 
Court and therefore invade the province of the Court and would be incompetent 
and irrelevant.
"6. Sub-paragraphs (i), (j), (1), (s) and (t) of paragraph 5 of defendant's 
expected proof are immaterial to the issue as to whether or not the drug is 
generally recognized among qualified experts and therefore such evidence is 
incompetent.
"7. Sub-paragraph (k) of paragraph 5 of defendant's expected proof is 
inconsistent with sub-paragraph (j) and exactly the reverse thereof and 
therefore immaterial, incompetent and irrelevant.
"8. The Court has conferred with counsel for the government concerning 
sub-paragraphs (n), (p) and (q) of paragraph 5 and the government will 
admit that there has been no report to the Food and Drug Administration of 
any illness or adverse complaint as a result of the use of Hope's Worm-Rid 
from the date of its first shipment to the time of the granting of the pre- 
liminary injunction herein and that there is no such thing as a drug devoid 
of any toxic effects to some persons. Sub-paragraph (q) is cumulative to 
(p) aforesaid.
"Therefore, the Motion to Quash will be sustained."
On 5-12-61, the court made the following findings of fact and conclusions 
of law:
WEBEE, District Judge:
STATEMENT
"This matter was tried before the Court upon plaintiff's Complaint for 
Permanent Injunction. The Complaint alleges that the defendants have 
caused to be introduced and delivered for introduction into interstate com- 
merce a drug known as 'Hope's Worm-Rid,' in violation of 21 U.S.C. 331(d). 
A permanent injunction against the continuance of these activities is sought 
under Section 302 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
332(a)) on the ground that the drug is a 'new drug' for which no new drug
application has been filed pursuant to Section 505(b) of the Act (21 U.S.C. 
355(b)).
"The defendants have admitted by their Answer and by stipulation that 
they are manufacturing, advertising, and selling Hope's Worm-Rid in inter- 
state commerce; that this drug contains, as its active ingredient, piperazine 
citrate; and that they have not filed an effective application for this drug 
under section 505(b) of the Act (21 U.S.C. 355(b)). The sole factual issue 
in dispute is whether this drug is a 'new drug' within the meaning of 
21 U.S.C. (p)(l).
"A temporary restraining order was issued herein and upon motion of the 
plaintiff and the taking of testimony a preliminary injunction was granted. 
By stipulation the testimony taken at the hearing for the preliminary injunc- 
tion is included as part of the record of the trial for the permanent injunction.
"The Court, having heard the evidence submitted by the parties and being 
now fully informed, adopts the following as its Findings of Fact and Con- 
clusions of Law.
FINDINGS OF FACT
"1. The defendant, the Hope Company, is a corporation organized and 
existing under the laws of the State of Illinois and doing business at Clayton, 
Missouri.
"2. The defendant, Hope J. Anderson, an individual, is the president and 
treasurer of the Hope Company and is primarily responsible for its policies 
and activities.
"3. The defendant, Na-Spra, Inc., is a corporation organized and existing 
under the laws of the State of Missouri and doing business at Maplewood, 
Missouri.
"4. The defendants have been engaged in the business of preparing, selling, 
and causing to be introduced and delivered for introduction into interstate 
commerce an article designated by the name 'Hope's Worm-Rid,' which is 
manufactured in accordance with the following formula:
Piperazine Hexahydrate-51.6 lbs.
Citric Acid 
-30 lbs.
Methyl Paraben -43.2 grams
Propyl Paraben -21.6 grams
Sugar 
-270 lbs.
Cherry Flavor 
-300 cc.
Amaranth Color -22.8 grams
Water 
-to make 60 gallons
The active ingredient of the final product is piperazine citrate.
"5. The article, Hope's Worm-Rid, when caused to be introduced and de- 
livered for introduction into interstate commerce is, by its labeling, offered 
for sale over-the-counter to lay persons, without the need for a physician's 
prescription, for use in the cure and treatment of pin and roundworm disease 
infections in humans.
"6. Hope's Worm-Rid is an article intended for use in the cure and treat- 
ment of diseases in man.
"7. The use of piperazine citrate in the quantities prescribed, recommended 
or suggested in the labeling of Hope's Worm-Rid may cause a variety of toxic 
side effects including sensitivity reactions such as hives; serum sickness; 
neurological disturbances such as disturbances of vision, muscular weakness, 
staggering, dizziness, and in-co-ordination of movement; and nausea, vomiting 
and diarrhea.
"8. These toxic reactions may require treatment by a physician with drugs 
which may be dispensed only on a physician's prescription.
"9. Except in rare instances pinworm and roundworm infections cannot 
be accurately diagnosed except by a physician.
"10. The symptoms of pinworms and roundworms include one or more 
of a variety of generalized symptoms such as abdominal pain, headaches, 
fatigue, nail biting, nervousness, irritability, 'not doing well,' loss of weight, 
and itching in the anal region. There are a wide variety of other diseases 
which exhibit one or more of these symptoms which are not amenable to treat- 
ment with Hope's Worm-Rid.   The distribution of Hope's Worm-Rid, without
the requirement of a physician's prescription may therefore result in its use 
by many persons not suffering from either pinworms or roundworms. These 
persons would be subjected to the risk of the toxic effects of piperazine 
citrate without any medical justification.
"11. On the basis of the facts set out in Findings of Fact 4 through 10, 
the six highly qualified physicians and pharmacologists who testified for the 
plaintiff stated that they did not recognize the use of piperazine citrate as 
prescribed, recommended and suggested on the label and labeling for 'Hope's 
Worm-Rid' as being safe. This conclusion was reached by balancing the ex- 
pected benefits to health from unrestricted sales against the dangers involved 
in such a use. They further testified that this is the consensus of medical 
and pharmacological opinion.
"12. Witnesses for the defendants stated that piperazine citrate has been 
safely and effectively used in the treatment of pinworms and roundworms 
under the supervision of physicians and that it is a safe drug. One witness 
testified that in his opinion its use as prescribed, recommended and suggested 
in the labeling of Hope's Worm-Rid is safe and generally recognized as safe.
"13. The testimony of the experts in this case establishes the existence 
of a difference of expert opinion concerning the safety of Hope's Worm-Rid 
for use under the conditions prescribed, recommended and suggested in its 
label. It is not, therefore, generally recognized among experts qualified by 
scientific training and experience to evaluate the safety of drugs, as safe for 
use under such conditions.
"14. Defendants have not filed a New Drug Application with the Secretary 
of Health, Education, and Welfare which has become effective with respect to 
Hope's Worm-Rid.
"15. The defendants will, unless enjoined, continue to market Hope's 
Worm-Rid in interstate commerce under its present labeling.
CONCLUSIONS OF LAW
"1. This Court has jurisdiction of the parties and the subject matter of this 
action under the provisions of 21 U.S.C. 332(a).
"2. The article designated as Hope's Worm-Rid is a 'drug' within the 
meaning of 21 U.S.C. 321 (g).
"3. The existence of a genuine difference of medical opinion among experts, 
qualified by scientific training and experience to evaluate the safety of a drug, 
on the question of whether a drug is safe, requires a conclusion that the drug 
is not generally recognized as safe under such conditions; The Merritt Corpo- 
ration v. Folsom, 165 F. Supp. 418 (D.D.C., 1958) ; United States v. 854 Bulk 
cartons * * * Trim Reducing Aid Cigarettes, 178 F. Supp. 847 (D.N.J., 1959).
"4. The drug, Hope's Worm-Rid, is a 'new drug' within the meaning of 21 
U.S.C. 321(p)(l).
"5. Said 'new drug' when caused to be introduced and delivered for intro- 
duction into interstate commerce by the defendants is in violation of 21 U.S.C. 
355(a) in that no application filed pursuant to 21 U.S.C. 355(b) is effective.
"6. By causing the introduction and delivery for introduction into inter- 
state commerce of said 'new drug,' without an effective application, the de- 
fendants have been violating the provisions of 21 U.S.C. 331 (d).
"7. The United States of America is entitled to a permanent injunction re- 
straining the defendants, their officers, agents, servants, employees and repre- 
sentatives and all persons in active concert or participation with them or any 
of them from introducing or causing to be introduced and delivering and 
causing to be delivered for introduction into interstate commerce, said drug 
which is designated as Hope's Worm-Rid, and labeled for use without a 
prescription in the treatment of worm infestation in humans, or any other drug 
of similar composition and labeling unless and until an application filed pur- 
suant to 21 U.S.C. 355(b) is effective with respect to such drug under such 
conditions. An order will be entered granting an injunction as prayed in the 
Complaint."
On the same day, the court issued a decree of permanent injunction enjoin- 
ing the defendants from directly or indirectly introducing and causing to be 
introduced and delivering and causing to be delivered for introduction into
interstate commerce, the drug which was designated as "Hope's Worm-Bid" 
and labeled for use without a prescription in the treatment of worm infestation 
,in humans, or any other drug of similar composition and labeling unless and 
until an application filed pursuant to 505(b) is effective with respect to such 
drug.