The CHURCH OF SCIENTOLOGY OF CALIFORNIA, Plaintiff-Appellant,
v.
Elliot RICHARDSON* et al., Defendants-Appellees.
*Elliot Richardson has been substituted for his predecessor in office, Robert
H. Finch, pursuant to Fed.R.Civ.P. 25(d)(1).
No. 24276.
United States Court of Appeals, Ninth Circuit.
Jan. 11, 1971.
Suit by nonprofit corporation organized for ostensible purpose of
disseminating religious doctrine to enjoin the Food and Drug Administration
from refusing admission of skin galvanometers, known as E-meters, into the
United States, to enjoin return of the devices to the country of origin and for
damages. The United States District Court for the Central District of
California, Manuel L. Real, J., granted the government's motion for summary
judgment and denied a motion for relies from the judgment. The nonprofit
corporation appealed. The Court of Appeals, James M. Carter, Circuit Judge,
held that in determining the intended use of the E-meters, for determining
applicability of the Federal Food, Drug, and Cosmetic Act, the court
could validly consider claimant's publications which discussed applications of
the device, and claims in such publications regarding applications of the
device in practice of religion were presumed to be true, and there was no
infringement of First Amendment rights in examination of allegedly religious
literature.
Affirmed.
[1] CONSTITUTIONAL LAW
Exercise of religious freedom does not include freedom to violate Federal Food,
Drug, and Cosmetic Act. Federal Food, Drug, and Cosmetic Act, ss 201(h),
502, 801(a), 21 U.S.C.A. ss 321(h), 352, 381(a).
[2] CUSTOMS DUTIES
Determination by Secretary of Health, Education and Welfare that "device"
within Federal Food, Drug, and Cosmetic Act has been misbranded and may
therefore not be imported is not subject to judicial alteration unless
arbitrary and capricious. Federal Food, Drug, and Cosmetic Act, ss 201(h),
502(f), 801(a), 21 U.S.C.A. ss 321(h), 352(f), 381(a).
[3] CUSTOMS DUTIES
In determining whether E-meters, i. e., skin galvanometers, which Secretary of
Health, Education and Welfare regarded as "devices" within Federal Food, Drug,
and Cosmetic Act appeared to be misbranded and thus subject to prohibition of
importation, Secretary could consider: (a) plaintiff's literature which
contained diagnostic and therapeutic claims, (b) plaintiff's admission that
devices were ineffective for any medical therapeutic purpose, (c) absence of
instructions for use on labeling of devices, and (d) prior adjudication that E-
meters were in fact misbranded devices. Federal Food, Drug, and Cosmetic Act,
ss 502(f) (1), 801(a), 21 U.S.C.A. ss 352(f) (1), 381(a).
[4] CUSTOMS DUTIES
E-meters, i. e., skin galvanometers, even if harmless in themselves, could not
be considered harmless, where ignorant and gullible persons might rely upon
them instead of seeking professional advice for conditions which E-meters were
represented to relieve or prevent, and branding provisions of Federal Food,
Drug, and Cosmetic Act, including provision authorizing prohibition of
importation, were therefore applicable. Federal Food, Drug, and Cosmetic Act,
ss 502, 801(a), 21 U.S.C.A. ss 352, 381(a).
[5] CONSTITUTIONAL LAW
In determining intended use of E-meters, i. e., skin galvanometers, for
determining applicability of Federal Food, Drug, and Cosmetic Act provision
authorizing refusal of importation, court could validly consider claimant's
publications which discussed applications of device, and claims in such
publications regarding applications of device in practice of religion were
presumed to be true, and there was no infringement of First Amendment rights in
examination of allegedly religious literature. Federal Food, Drug, and
Cosmetic Act, s 502(f), 21 U.S.C.A. s 352(f); U.S.C.A.Const. Amend.
1; 42 U.S.C.A. ss 1981, 1983.
[5] CUSTOMS DUTIES
In determining intended use of E-meters, i. e., skin galvanometers, for
determining applicability of Federal Food, Drug, and Cosmetic Act provision
authorizing refusal of importation, court could validly consider claimant's
publications which discussed applications of device, and claims in such
publications regarding applications of device in practice of religion were
presumed to be true, and there was no infringement of First Amendment rights in
examination of allegedly religious literature. Federal Food, Drug, and
Cosmetic Act, s 502(f), 21 U.S.C.A. s 352(f); U.S.C.A.Const. Amend.
1; 42 U.S.C.A. ss 1981, 1983.
[6] FEDERAL COURTS
Where prior case was mentioned by district court as one upon which government
could have reasonably relied in taking the action complained of in instant
case, but res judicata was not mentioned by district court, subsequent reversal
of prior case did not require reversal in instant case on ground of
misapplication of res judicata.
[7] CUSTOMS DUTIES
Labels of disclaimer, to-wit: "Not intended or effective for the diagnosis,
treatment or prevention of any disease," found on about half of devices, were
not controlling in determining whether devices were mislabeled within Federal
Food, Drug, and Cosmetic Act, and thus subject to prohibition of importation,
but were to be considered together with any extrinsic evidence of intended use
of device. Federal Food, Drug, and Cosmetic Act, s 502(f), 21
U.S.C.A. s 352(f).
*216 Marvin Zinman (appeared), Los Angeles, Cal., for appellant.
Larry Dier (appeared), Asst U.S. Atty., William Matthew Byrne, Jr., U.S.
Atty., Frederick M. Brosio, Jr., Chief, Civ. Div., Los Angeles, Cal., for
appellees.
Before ELY, CARTER and TRASK, Circuit Judges.
JAMES M. CARTER, Circuit Judge:
This appeal involves an alleged deprivation of rights protected by the United
States Constitution and the Civil Rights Act of 1964 (42 U.S.C. 1981,
1983).
Appellant is a California non-profit corporation, organized for the ostensible
purpose of disseminating religious doctrine known as 'Scientology.' [FN1] The
'Hubbard E-meter' is an instrument that is allegedly essential to the practice
of Scientology. The E-meter is manufactured in the United Kingdom and is, in
fact, a simple skin galvanometer that crudely measures changes in electrical
resistance in the human body. The Food and Drug Administration refused to
allow the importation of E-meters because they were deemed to be 'devices'
(21 U.S.C. 321(h)) that appeared to be 'misbranded' in that they did not
bear adequate instructions for use (21 U.S.C. 352(f)(1)). The refusal was
based, inter alia, on a successful condemnation action against certain E-meters
in the District Court for the District of Columbia (United States v. An Article
of Device . . . E-meter (D.C.Civ.No. DC1-1963 (1967))). The E-meters here in
question were seized and detained by Post Office and Customs officials on the
ground that they were in violation of the Federal Food, Drug, and Cosmetic Act.
FN1. For a thorough presentation of the tenets and practices of
'Scientology' see Founding Church of Scientology v. United States (1969)
133 U.S.App.D.C. 229, 409 F.2d 1146.
After the instruments were seized, appellant received a hearing before the
Food and Drug Administration in Los Angeles on August 6, 1968. The hearing
examiner concluded that the E-meters did not bear adequate instructions for use
and, therefore, that they could not be imported into this country. Upon
considering the record of the hearing and other available information, the Food
and Drug Administration concluded that the E-meter devices appeared to be
misbranded within the meaning of 21 U.S.C. 352(f)(1), as alleged in the
notice of seizure, and made the determination of misbranding.
Appellant then filed this suit: (a) to enjoin the F.D.A. from refusing
admission of the E-meters into the United States; (b) to enjoin the F.D.A. from
compelling the return of the devices to their country of origin; and (c) for
$20,000.00 in damages to persons in the class affected. The district court
granted the Government's motion for summary judgment. Thereafter, appellant
filed a motion for relief from judgment on the basis that, in the interim, the
D.C. District Court's earlier condemnation of certain E-meters had been
reversed by the D.C. Circuit Court of Appeals in Founding Church of
Scientology v. United States, 133 U.S.App.D.C. 229, 409 F.2d 1146, cert.
denied 396 U.S. 963, 90 S.Ct. 434, 24 L.Ed.2d 427 (1969). The motion was
denied. We affirm.
Discussion
The Government may refuse admission to any 'device' offered for importation if
it appears to be 'misbranded' (21 U.S.C. 381(a)). The term 'device' is
defined as 'instruments, apparatus, and contrivances * * * intended (1) for use
in the diagnosis, cure, mitigation, treatment, or prevention of disease in
man * * *. (21 U.S.C. 321(h)).' A device is considered to be 'misbranded'
if, inter alia, its labeling *217 does not bear adequate directions for use
(21 U.S.C. s 352(f)).
1. Issues of Fact
Appellant contends that the district court erred in granting summary judgment
because there were material issues of fact remaining. Appellant urges that
these issues of fact were: (a) whether the E-meter was used in the religious
practices of Scientology; and (b) whether the E-meters were misbranded?
The issue of the E-meters' alleged religious use is irrelevant here. The
district court held that the exercise of religious freedom does not include the
freedom to violate the Federal Food, Drug, and Cosmetic Act. We agree.
The 'misbranding' issue can be most accurately described as a question of
scope of judicial review. The district court held that the E-meter was a
'device' within s 321(h) because it is intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease in man. [FN2] All
'devices' are subject to the Act's branding requirements (21 U.S.C. s 352).
FN2. The Seventh Circuit upheld the same finding with regard to a similar
skin galvanometer in United States v. Ellis Research Labs (7 Cir. 1962)
300 F.2d 550.
Section 381(a) requires only that the device appear to be misbranded, and
vests such determinations in the discretion of the Secretary of Health,
Education, and Welfare. The Secretary's determination of misbranding is not
subject to judicial alteration unless it was arbitrary and capricious.
Sugarman v. Forbragd (9 Cir. 1968) 405 F.2d 1189.
First, there were no allegations in the complaint that the Secretary's
determination of misbranding was arbitrary or capricious. The real issue
tendered by the complaint was an asserted violation of civil rights, to wit
religious freedom.
[3] Second, the district court found the action was not arbitrary or
capricious. In determining that the E-meters appeared to be misbranded, the
Secretary could consider: (a) appellant's literature that contains diagnostic
and therapeutic claims for the E-meter; (b) appellant's admission that the
devices are ineffective for any medical therapeutic purpose; (c) the absence of
instructions for use on the labeling of the devices; and (d) the prior
adjudication by the D.C. District Court that the E-meters were in fact
misbranded devices. In view of this evidence, the district court concluded
that appellant had failed to establish any arbitrary or capricious action by
the Secretary. We agree.
[4] Appellant argues that Sugarman's limitation on judicial review is
inapplicable here because the Secretary has ignored the Congressional mandate
to exempt from the Act's branding requirements any device as to which labeling
would not be necessary for the protection of the public health (21 U.S.C. s
352(f)). Appellant contends that E-meters are non-injurious and, therefore,
should have been exempted. We think that the Hubbard E-meter is akin to the
device in issue in Drown v. United States (9 Cir. 1952) 198 F.2d 999. In
Drown, this court held:
'While the instruments may be harmless in themselves, their danger lies in the
possibility that 'ignorant and gullible persons are likely to rely upon them
instead of seeking professional advice for conditions they are represented to
relieve or prevent'.' (198 F.2d at 1006).
In this sense, appellant's E-meters cannot be considered harmless and,
therefore, the Act's branding provisions are applicable. See also United
States v. Ellis Research Labs. (7 Cir. 1962) 300 F.2d 550.
2. First Amendment Violations
[5] Appellant contends that, in making the determination of 'misbranding,'
the court must have considered and evaluated Scientology's religious
literaturein *218 violation of its First Amendment rights. The district
court found that the appellant had conceded that the E-meter devices were
ineffective for any medical or therapeutic purposes. Appellant asserts that
the devices are used solely as a confessional aid in Scientology, and that
the detention of the devices by the Government unlawfully interferes with
appellant's religious freedom.
In Founding Church, supra, the D.C. Circuit held that the court could not
constitutionally evaluate the truth or falsity of the medical claims made in
Scientology's 'religious' literature, citing United States v. Ballard
(1944) 322 U.S. 78, 64 S.Ct. 882, 88 L.Ed. 1148. The statute in issue there
was 21 U.S.C. s 334(a), which provides that a device is misbranded if its
'labeling' bears false or misleading claims. The court reversed the decree of
condemnation on the ground that 'some of that literature was at least prima
facie religious doctrine, and that the jury, as it was instructed, could have
found against the E-meter by finding false statements in 'labeling' which was
at the same time religious doctrine.' 409 F.2d at 1164. The court
specifically reserved, however, the issue of whether 'a drug or device used in
a religion is subject to condemnation as 'misbranded' if its labeling is found
to lack * * * adequate directions for use (21 U.S.C. s 352(f)).' 409
F.2d at 1162.
In determining the E-meter's intended use, the court could validly consider
the appellant's publications that discuss the device's applications. Nature
Food Centres, Inc. v. United States (1 Cir. 1963) 310 F.2d 67; United States
v. Article of Drug . . . Capsules (3 Cir. 1966) 362 F.2d 923; Alberty Food
Prod's v. United States (9 Cir. 1952) 194 F.2d 463. Unlike the 'mislabeling'
section involved in Founding Church, the court here could determine the E-
meter's intended use without evaluating the truth or falsity of any related
'religious' claims. To the contrary, appellant's claims in its literature
regarding the applications of the device in the practice of religion were
presumed to be true for the purpose of determining its intended use. We find
no infringement of First Amendment rights.
3. Potpourri
[6] Appellant contends that the district court misapplied the doctrine of
res judicata by allegedly relying completely on the district court result in
Founding Church. Appellant is mistaken. The district court's opinion does
not contain any mention of the doctrine of res judicata. The court only
referred to the district court decision in Founding Church as a fact, among
others, that the Government could have reasonably relied upon in deciding to
refuse admission to the E-meters pursuant to 21 U.S.C. s 381(a). During the
pendency of the appeal in the District of Columbia, such reliance would seem to
be quite proper. The subsequent reversal by the D.C. Circuit does not require
reversal here, because the doctrine of res judicata was never applied.
[7] Finally, appellant asserts that the E-meters are not misbranded because
they bear disclamatory labels, to wit: 'Not intended or effective for the
diagnosis, treatment, or prevention of any disease.' Such labels, however,
were found to appear on less than half of the devices seized. Furthermore,
labels of disclaimer are not controlling, but are to be considered together
with any extrinsic evidence of the device's intended use (e.g. publications,
advertisements, etc.) Alberty Food Prod's v. United States (9 Cir. 1952) 194
F.2d 463. There is ample evidence to support the court's finding of the E-
meter's intended use.
We find appellant's allegations of error to be without merit. The judgment of
the district court is affirmed.