2140. Pso-Ridisal. Suit for injunction. Fred B. Collier and Dlanne I. Collier
(Nu-Basic Products Co.) v. Paul V. McNutt, Federal Security Adminis-
trator, et al.   Complaint dismissed.
On September 20,1944, Fred B. Collier and Dianne I. Collier, trading as the
Nu-Basic Products Co., at Royal Oak, Mich., filed a petition for an injunction
against Paul V. McNutt, Federal Security Administrator, Paul B. Dunbar,
Commissioner of the Food and Drug Administration, and George P. Larrick,
Acting Commissioner of the Food and Drug Administration. The complainants
petitioned that the defendants and their agents be restrained and enjoined from
instituting legal proceedings with respect to the complainants' product known
as Pso-Ridisal.
A motion to dismiss the action and for summary judgment was fited on
behalf of the defendants. On November 7, 1944, the court entered an order
granting -such motion, and in connection with such order, made the following
findings of fact and.conclusions of law:
MATTHEW F. MCGUIBE, District Judge:
FINDINGS  OF FACT  AND  CONCLUSIONS OF LAW
?'This cause having come on to be heard on plaintiffs' motion for a preliminary
injunction, and defendants' motion to dismiss the action and for summary
judgment, the Court hereby files its Findings of Fact and Conclusions of L*aw
as follows:   -
THE COURT FINDS
"1. The plaintiffs are, and were during the times mentioned in the petition
for injunction, the owners of the Nu-Basic Products Company, which manufac-
tures and sells in interstate commerce a drug product known as Pso-Ridisal
for external use for diseases of the skin.
"2. The said drug consists of a mineral oil emulsion, sulfanilamide, carbolic
acid (phenol), and other ingredients, and has been introduced into interstate
commerce
under the names Sulfa-Seb and Sulfa-Ped, as well as under the name
Pso-Ridisal.
"3. On January 21, 1942, a shipment of Pso-Ridisal was seized pursuant to
a libel of information filed by the Government under the Federal Food, Drug
and Cosmetic Act in the United States District Court for the Northern District
of Illinois. The libel alleged that the drug was misbranded because its labeling
was false and misleading. The plaintiffs herein appeared as claimants of
the seized article, and by consent a decree of condemnation based on said
misbranding was entered on April 12, 1944.
"4. On January 28, 1944, a shipment of Pso-Ridisal was seized pursuant to
a libel of information filed under the said Act in the United States District
Court for the Western District' of Missouri. The libel alleged that the drug
was misbranded because its labeling was false and misleading. The plaintiffs
herein appeared as claimants of the seized article, said action was thereafter
removed to the United States District Court for the Northern District of
Illinois, and said article so seized was condemned by consent decree of con-
demnation based on said misbranding on April 26, 1944.
"5. On November 10, 1943, shipments of said drug bearing the names Sulfa-
Seb and Sulfa-Ped were seized pursuant to a libel of information filed under
the said Act in the United States District Court for the Western District of
Missouri. The libel alleged that the drug was misbranded because its labeling
was false and misleading and because its labeling failed to bear adequate
warnings against unsafe dosage or methods of use in a manner and form
necessary for the protection of users. After trial, the said Court, on April 3,
1944, entered a decree based on said false and misleading labeling condemning
the labeling of said drug.
"6. After the entry of the decrees above mentioned, applications were made
by plaintiffs herein to the courts in which said actions had been filed praying
that the seized articles be delivered to them to be brought into compliance
with the provisions of the Federal Food, Drug, and Cosmetic Act under the
supervision of an officer or employee of the Food and Drug Administration,
which applications were granted upon the execution of sufficient bond condi-
tioned-as required by law. Thereafter, the plaintiffs herein submitted to the
Food and Drug Administration for, approval a proposed form of labeling to
accompany the seized articles, which form of labeling the Food and Drug
Administration, after due consideration, did not approve.
"7. Thereafter, the plaintiffs herein continued distributing its product in
interstate commerce under the name Pso-Ridisal accompanied by labeling
differing in minor respects from that which had accompanied the said drug
involved in the actions above mentioned.
"8. On or about June 13, 1941, the Federal Security Administrator dele-
gated to the Commissioner of Food and Drugs authority to make determina-
tions of probable cause under Section 304 (a) of the said Act (21 U. S. C.
?334 (a)).
"9#On July 29, 1944, the Commissioner of Food and Drugs determined
that he had probable cause to believe, and that he did believe, on the basis
of facts found by employees and officials of the Food and Drug Administra-
tion, that the labeling of said drug Pso-Ridisal would be and was in a mate-
rial respect misleading to the injury or damage of the purchaser or con-
sumer.   Thereafter, a number of seizures of said drug with such labeling
were made pursuant to libels of information filed in different district courts
of the United States.
"10. The plaintiffs herein, -from the filing of said libel actions last above
mentioned until the argument on plaintiffs' motion for a preliminary injunc-
tion and defendants' motion to dismiss this action and for summary judg-
ment, did not, pursuant to Section 304 (b) of the Federal Food, Drug, and
Cosmetic Act (21 U. S. C. 334 (b)), apply to the court of one jurisdiction
wherein one of said libel actions had been brought for an order consolidat-
ing all of said libel actions for trial in a district selected by the plaintiffs
herein where one of such libel actions was pending.
"11. One of said seizure actions last above mentioned was commenced
by the Government in the United States District Court for the Western Dis-
trict of Missouri, entitled 'United States v. 1233 Bottles Pso-Ridisal'. The
plaintiffs herein appeared as claimants in said action and by motion filed
on or about September 8, 1944, sought to have said action dismissed on the
ground that other seizure actions involving said drug and founded on the
same of similar allegations of misbranding were already pending in other
district courts of the United States. The said District Court denied said
application on September 16, 1944.
"12. On or about September 8,1944, the plaintiffs herein filed in the United
States District Court for the Western District of Missouri an action entitled
'Fred B. Collier et al. v. The United States of America, Federal Food and
Drug Administration', praying an injunction restraining the further seizure
of shipments of said drug. Said action was dismissed by said District Court
on plaintiffs' motion on September 9, 1944.
"13. On or about September 16, 1944, the plaintiffs herein filed an action
in the United States District Court for the Northern District of Illinois,
entitled 'Fred B. Collier et al. v. Paul V. McNutt, Federal Security Adminis-
trator', praying that the said Administrator be enjoined from instituting a
new libel proceedings against said drug Pso-Ridisal and from harassing or
interfering with the plaintiffs' business. Said action was dismissed on motion
of the plaintiffs on or about September 29, 1944.
"14. On or about September 20, 1944, the plaintiffs herein filed a petition
in the United States District Court for the District of Columbia against
the defendants herein seeking to restrain and enjoin them from instituting
new libel proceedings and from further seizures of the product Pso-Ridisal,
and from harassing and interfering with plaintiffs' operation of their busi-
ness and the business of their distributors and dealers and from instituting
any action based upon the same alleged misbranding which was the subject
matter of the proceedings already instituted against the plaintiffs' said prod-
uct ; and prayed that a preliminary injunction be granted.
"15. On or about October 16, 1944, the defendants herein moved to dis-
miss this action and for summary judgment on the grounds that the petition
of plaintiffs herein failed to state facts which entitled plaintiffs to the relief
sought therein, and that this Court did not have jurisdiction of the subject
matter of this action.
THE COURT FILES THE FOLLOWING CONCLUSIONS OF LAW
"1. On or about June 13, 1941, the Federal Security Administrator, pur-
suant to the authority vested in him by law, delegated to the Commissioner
of Food and Drugs, Federal Security Agency, authority to make determina-
tions of probable cause contemplated by Section 304 (a) of the Federal
Food, Drug, and Cosmetic Act (21 U. S. C. 334 (a)).
"2. The institution of multiple libel for condemnation actions against plain-
tiffs' product Pso-Ridisal was authorized by law inasmuch as. the Commis-
sioner of Food and Drugs of the Federal Security Agency had determined,
pursuant to said Section 304 (a) of said Act (21 U. S. C. 334 (a)), that he
had probable cause to believe and that he did believe, from facts found by
officers and employees of the Food and Drug Administration, that the label-
ing of said drug Pso-Ridisal would be and was in a material respect .mis-
leading to the injury or damage of the purchaser or consumer.
"3. The actions of defendants complained of by plaintiffs herein were not
illegal, were not in excess of the authority vested in defendants by law, and
did not constitute an abuse of lawful duty.
"4. The petition filed by plaintiffs herein does not disclose any cause of     (
action against the defendants named therein since said defendants do not     \
and are not authorized to institute libel for condemnation or other suits in
any court of the United States, and there is no mandatory duty vested in
United States Attorneys or the Department of Justice to institute libel for
condemnation or other suits on referral by or recommendation of defendants.
"5. The plaintiffs herein have not established that they have suffered or
will suffer any irreparable or legal injury by the institution of libel for
condemnation actions under the Federal Food, Drug, and Cosmetic Act
against their product Pso-Ridisal.
"6. Since the petition filed by plaintiffs herein sought to restrain defendants,
officials of the Federal Government, from performing their statutory func-
tions, the action instituted by plaintiffs herein was a suit against the United
States which had not consented to be sued, and this Court does not have
jurisdiction of the subject matter of this action.
"7. The petition filed by plaintiffs herein establishes no grounds for
equitable relief and fails to state facts which entitle the plaintiffs to the
relief sought by them.
"8. The motion made by plaintiffs herein for a preliminary injunction
should be denied.
"9. The motion made by defendants herein to dismiss this action and for
summary judgment should be granted.
"Let the foregoing Findings of Fact and Conclusions of Law be filed, and
order and decree be entered accordingly."
DRUGS FOR VETERINARY USE*