United States v. ARTICLE CONSISTING OF 2 DEVICES, ETC., Civ. A. No. 981.

• Decision Date: 27 June 1966
• Docket Number: Civ. A. No. 981.
• Citation: 255 F. Supp. 374
• Parties: UNITED STATES of America, Libelant, v. An ARTICLE of Device CONSISTING OF 2 DEVICES, MORE OR LESS, LABELED IN PART: "LINDQUIST CHRONOSONIC ULTRASOUND MODEL 401B * * * SERIAL 9845 (OR 9846)" "Caution: Federal law restricts this device to sale by, or on the order of, a practitioner licensed by the law of the State in which he practices, to use or order the use of the device" "* * * Lindquist Model S Muscle Stimulator R. J. Lindquist Co. * * * Los Angeles, Calif. * * * Serial No. * * *." Harold M. Shock, Sr., Intervenor.
• Court: U.S. District Court — Western District of Arkansas

255 F. Supp. 374

UNITED STATES of America, Libelant,

v.

An ARTICLE of Device CONSISTING OF 2 DEVICES, MORE OR LESS, LABELED IN PART: "LINDQUIST CHRONOSONIC ULTRASOUND MODEL 401B * * * SERIAL 9845 (OR 9846)" "Caution: Federal law restricts this device to sale by, or on the order of, a practitioner licensed by the law of the State in which he practices, to use or order the use of the device" "* * * Lindquist Model S Muscle Stimulator R. J. Lindquist Co. * * * Los Angeles, Calif. * * * Serial No. * * *."

Harold M. Shock, Sr., Intervenor.

Civ. A. No. 981.

United States District Court W. D. Arkansas, Hot Springs Division.

June 27, 1966.

Charles M. Conway, U. S. Atty., Robert E. Johnson, Asst. U. S. Atty., Fort Smith, Ark., for plaintiff.

Fenton Stanley, Malvern, Ark., for defendant.

OPINION

MILLER, Chief Judge.

This is a civil in rem seizure action instituted by the United States under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. The original libel was filed on April 30, 1965, but described a device or devices that were not then in the possession of the claimant.

On May 21, 1965, the court granted leave to Harold M. Shock, Sr., to intervene in this case. The intervention was filed on June 14, 1965, and called the attention of the court to the fact that the devices listed in the libel of information were not within the jurisdiction of the court and were not in the possession of the claimant. Upon the filing of the intervention, the court granted the United States leave to amend the original libel, and on July 26, 1965, the libelant amended the description of the devices as set forth above, and the devices described in the caption hereof were seized and have been in the possession of the United States Marshal since that time.

Generally speaking, the devices consist of two separate articles or machines for the treatment of ailments, diseases and maladjustments of the human body by the use of ultrasound.

The articles enumerated in the caption were shipped in interstate commerce from R. J. Lindquist Company, 2419 West Ninth Street, Los Angeles, California, to Harold M. Shock, Sr., D.C., 1612 Main Street, Malvern, Arkansas, during the period between March 11, 1965, and May 10, 1965, and it is alleged:

"3. The aforesaid article of device was misbranded while held for sale after shipment in interstate commerce, within the meaning of the Federal Food, Drug, and Cosmetic Act, 21 U.S. C. 352(f) (1) in that its labeling fails to bear adequate directions for use and it is not exempt from such requirement since it fails to comply with all of the conditions for exemption prescribed by regulations 21 C.F.R. 1.106 (d)."

The prayer of the libel is that the court decree the condemnation of the articles and grant libelant the cost of this proceeding against the claimant; and that the article be disposed of as the court may direct pursuant to the provisions of the Act.

The case was tried to the court on May 3, 1966. At the conclusion of the trial it was submitted subject to the submission of briefs by counsel in support of their respective contentions. The briefs have been received and considered along with all of the evidence and exhibits adduced at the trial.

In the brief submitted by counsel for libelant, it is stated:

"The contested issue is whether the devices were misbranded because their labeling did not bear adequate directions for use, within the meaning of 21 U.S.C. 352(f) (1), and whether the exemption of 21 CFR 1.106 applies."

The devices bear the following label:

"Caution: Federal law restricts this device to sale by, or on the order of a practitioner licensed by the law of the State in which he practices, to use or order the use of the device."

It is uncontradicted that the devices were shipped by the R. J. Lindquist Company of Los Angeles, California, to the claimant at Malvern, Arkansas, during the period between March 11, 1965, and May 10, 1965; that the devices contain the label above set forth; and that the claimant is a duly licensed chiropractor with offices at Malvern, Arkansas.

In answer to an interrogatory submitted by the libelant the claimant testified that "the intended use by claimant of the devices seized was to prepare the patient for adjustment. The devices seized have been used only to prepare patients for adjustment and to help patients relax after adjustment." The claimant does not admit any potentiality for harmful effect through the use by him of the devices for such purposes. In answer to Interrogatory No. 16 the claimant stated that he is not licensed to practice medicine in the State of Arkansas; that he is licensed as a chiropractor in the State of Arkansas; and denied that the use of ultrasound devices does not come within the activities permitted by a chiropractor in the State of Arkansas.

The devices proceeded against fall within the definition of the term "device" as set forth in 21 U.S.C. § 321(h). The term "labeling" as used in the Act is sufficiently broad to include all written, printed, or graphic matter appearing upon any article or upon any of its containers or wrappers, or which accompanies the article in interstate commerce. 21 U.S.C. § 321(m). The devices were in the possession of the claimant at the time the libel was filed, and if they are misbranded, they are liable to condemnation, 21 U.S.C. § 334 (a).

Title 21, U.S.C. § 352(f) provides that a device shall be deemed to be misbranded "unless its labeling bears (1) adequate directions for use * * *." Section 1.106 of 21 C.F.R. of the regulations for the enforcement of the Act defines "adequate directions for use" as follows:

"`Adequate directions for use' means directions under which the layman can use a drug or device safely and for the purposes for which it is intended."

The claimant makes no contention that the Secretary has promulgated any regulation exempting the devices involved herein from the above definition of "adequate directions for use."

The libelant in its brief in reference to this provision stated:

"This provision of the law requires that the labeling state each and every purpose and condition for which the product is intended to be used, plus sufficient information to enable any layman to use it intelligently, effectively, and safely for each such purpose."

To sustain its contentions the libelant called two witnesses, Dr. L. A. Amick and Dr. Oscar Selke. The claimant called no witnesses, but by agreement with counsel for libelant introduced 47 exhibits consisting of treatises, directions and suggestions relative to the use of the devices, and the diseases, complaints and ailments for which the devices should be used. It is not clear from the evidence whether these exhibits accompanied the devices or whether they were sent by the seller to the claimant for study and guidance in the use of the devices.

The only ore tenus testimony adduced by either party was that of the physicians named above. Their testimony was to the effect that ultrasound is a deep heat modality and is used in making localized applications of heat in the tissues of the body; that ultrasound should be administered only after a careful medical examination and diagnosis to make certain that there are not present conditions for which the use of ultrasound is contraindicated, because the administration of ultrasound in the presence of such conditions could be harmful to the patient. Each of the physician witnesses enumerated a long list of such contraindications. Among the conditions mentioned were neurological defects, circulatory defects, tumors, bones, infections, nerves, pregnant uterus, rheumatic conditions, and eyes and face. They testified that many of these conditions, such as malignant tumors, infections, certain rheumatic conditions, pregnancy, and neurological and circulatory defects, could be reliably diagnosed only by a person with the training and experience of a medical doctor, and that the blind use of ultrasound without such an examination and diagnosis would be dangerous to the health of the patient.

Based upon the testimony of the two physicians, the libelant contends:

"* * * that no matter what directions are given, the layman does not and cannot possess sufficient knowledge and training to use ultrasound safely. No written directions are adequate to qualify the layman as a medical doctor, and therefore any written directions are inadequate to direct the use of ultrasound by the layman."

For that reason the manufacturer labeled the devices as hereinbefore set forth by restricting their use to a practitioner licensed by the law of the state in which he practices to use or order the use of the devices.

Thus, in effect the libelant contends that the claimant, a duly licensed chiropractor, is a layman and that the claimant "is not a practitioner licensed by law in Arkansas to use prescription devices such as ultrasound."

In answer to the contentions of the libelant that the directions for the use of the device are not adequate under which a layman could use the device safely, the claimant in his brief states:

"Wittingly or unwittingly F.D.A. has permitted itself to become a tool in the unfortunate battle between two honorable professional groups, both of which practice the healing art to a definite advantage of all mankind. This case represents another attempt on the part of F.D.A. to maneuver the Federal Courts into ruling whether or not a chiropractor, by the use of various modalities, is engaged in the illegal practice of medicine. Such decision is not for the Federal Courts to determine."

By the enactment of Sec. 72-401, Ark. Stats. (1957 Repl.), the General Assembly of the State of Arkansas created a State Board of Chiropractic Examiners. By Act 187 of the Acts of 1959, Sec. 72-121 (1965 Supp.), the General Assembly created the State Healing Arts Board, and provided that "no person shall be permitted or eligible to take an examination for a license to practice the healing arts,...