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U.S. v. ARTICLE CONSISTING OF 2 DEVICES

June 27, 1966

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.



The opinion of the court was delivered by: Miller, Chief Judge.

OPINION

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 C.F.R. § 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 "[u]nless 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 ...

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