The E-Meter Papers

E-meter Case, January 11, 1971

      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
         437 F.2d 214; 1971 U.S. App. LEXIS 12446

                      January 11, 1971

CORE TERMS: misbranded, religious, labeling, misbranding,
capricious, prevention, diagnosis, judicata, disease, seized,
labels, branding, First Amendment, civil rights, mitigation,
harmless, falsity, enjoin, cure, wit, religious freedom,
condemnation, galvanometer, therapeutic, ineffective, religion,

JUDGES: [**1]

Ely, Carter and Trask, Circuit Judges.


OPINION: [*216] 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." n1 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 inportation 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 [**2]
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.

n1 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 [**3] 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.


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. 352(f)]. [**4]

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 321(h) because it is
intended for use in the diagnosis, cure, mitigation, treatment,
or prevention of disease in man. n2 All "devices" are subject to
the Act's branding requirements [21 U.S.C. 352].

n2 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.

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 [**6] had failed to
establish any arbitrary or capricious action by the Secretary. We

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.
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

2. First Amendment Violations

Appellant [**7] contends that, in making the determination of
"misbranding," the court must have considered and evaluated
Scientology's religious literature [*218] in 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.
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 [**8] 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. 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 Products 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

Appellant contends [**9] 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. 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.

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, [**10] etc.) Alberty Food Products
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

We find appellant's allegations of error to be without merit. The
judgment of the district court is affirmed.

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