5313. Micro-Dynameter device.    (F. D. C. No. 36854.    S. No. 87-417 L.)
QUANTITY:   1 device at Mount Vernon, Wash.
SHIPPED :   2-21-52, from Chicago, 111., by Ellis Research Laboratories, Inc.
LABEL IN PART:    "Model SA-1   Micro-Dynameter."
ACCOMPANYING LABELING: Bulletins and pamphlets entitled "Supplement to
Micro-Dynameter Handbook Drugs," "Bulletin T-2 Operating Instructions
Model "S" Micro-Dynameter,'" "New Science in Body Analysis The Micro-
Dynameter," "Supplement Micro-Dynamics * * * Opinions . . . Statements
. . . Clinical Notes * * * The main object," "Bulletin of the Micro-Dynameter
* * * New Device Detects Hidden Disease," "Bulletin of Micro-Dynameter
Research Association Devoted to Scientific Body Analysis No. 2-S," "Bulletin
of Micro-Dynameter Research Association Devoted to Scientific Body Analysis
No. 8, September 1946," "Bulletin of Micro-Dynameter Research Association
For Improving Clinical Results No. 1 * * * June 1951," "Bulletin of Micro-
Dynameter Research Association For Improving Clinical Results No. 7,"
"Bulletin of Ellis Research Laboratories, Inc. The Micro-Dynameter No.
M-3 September 1946," "Bulletin of Ellis Research Laboratories, Inc. The
Micro-Dynameter No. 11    September 1950," "Bulletin of Ellis Research Lab-
oratories, Inc. The Micro-Dynameter No. M-2 Re-issue Jan., 1951," "Journal '
of Micro-Dynameter Research No. J-3," "Journal of Micro-Dynameter Research
No. J-4," "Journal of Micro-Dynameter Research No. J-5," "Journal of Micro-
Dynameter Research No. J-6," "Journal of Micro-Dynameter Research No.
J-7," "Book Review Number Micro-Dynameter News Vol. 1 Chicago July
1946 No. 1," "Supplement Micro-Dynamics * * * 1935 * * * Clinical
Notes . . . Statements . . . Opinions * * * Results Count," and "Bulletin T-3
Operating Instructions Model "SA-1" Micro-Dynameter"
RESULTS OF INVESTIGATION : The device appeared to be essentially a gal-
vanometer for measuring electrical currents and electrical potentials of small
magnitude.
LIBELED :    6-29-54, W. Dist. Wash., libel amended 10-17-55.
CHARGE: 502 (a)-the labeling accompanying the device, when shipped, con-
tained false and misleading representations that the device was effective for
diagnosing acidosis, alkalosis, anemia, angina pectoris, arthritis, asthma,
brain injury, brain tumor, cancer, cerebral palsy, cholecystitis, chronic bron-
chitis, colitis, convulsions, cystitis, diabetes, epilepsy, gallbladder, gallstones,
gingivitis, hay fever, heart disease, hernia, hypertension, hypotension, im-
pinged nerves, infantile paralysis, influenza, insanity, intestinal "flu," kidney
disorders, leukemia, migraine headaches, neuritis, pyorrhea, rheumatism,
sciatica, strep, infection, stomach ulcers, thyroid condition, tuberculosis, and
uremia; that the device was effective for treating asthma, blindness, cancer,
uterine hemorrhage, palpitation of the heart, anemia, diabetes, dyspnea, hyper-
tension, impaired vision, paralysis, polyarthritis, sarcoma of the uterus, strep. ,
infection, tuberculosis, and uric acidosis; that the Micro-Dynameter device \
would measure the results of treatment, show what is actually going on deep
down in the tissues of the body, was an aid to more accurate disease analysis,
was a precision instrument for new clinical measurements, would measure
nerve and tissue changes, and would give readings over a diseased area pro-
portional to the extent of the disease, and thus disease could be mathematically
diagnosed; that the Micro-Dynameter device would locate within the human
body the cause of disease, help point to the correct differential diagnosis, pro-
vide the ability to make an accurate prognosis, provide the practitioner with
the ability to restore at least 90 percent of previously unhelped cases to health
by following its indications, tell patients how sick they really were and whether
they could get well, give instantaneously the state of health or disease within
the body, and determine the patient's recuperative ability; and that the device
was the most scientific analytical instrument, would locate the exact origin
or focus of disorder via an electrical method which was ultramodern and 100
percent accurate, and was the greatest step forward toward getting sick people
well since December 18, 1895; and 502 (f) (1)-the labeling of the device
failed to bear adequate directions for use, and it was not entitled to any
exemption from that requirement.
DISPOSITION : Ellis Research Laboratories, Inc., intervened in the case and filed
an answer denying that the device was misbranded. Thereafter, upon motion
of the parties, the United State District Court for the Western District of
Washington entered an order on 3-15-55, removing the case for trial to the
United States District Court for the Northern District of Indiana. Interroga-
tories were served upon the intervenor, and after objection to certain inter- (
rogatories had been sustained, answers to the remaining interrogatories were v
filed.
On 11-5-56, upon the consent of the parties that a condemnation decree
might be entered without any adjudication as to any issue of fact or law, judg-
ment of condemnation was entered and the court ordered that the device and
accompanying labeling be turned over to the Department of Health, Education,
and Welfare.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM
OFFICIAL OR OWN STANDARDS*