U.S. v. An Article of Device

• Citation: 731 F.2d 1253
• Decision Date: 04 April 1984
• Docket Number: No. 83-1404,83-1404
• Parties: UNITED STATES of America, Plaintiff-Appellee, v. AN ARTICLE OF DEVICE ... "Toftness Radiation Detector," Toftness Post-Graduate School of Chiropractic, Inc., a corporation, and Irwing N. Toftness, an individual, Defendants-Appellants.
• Court: United States Courts of Appeals. United States Court of Appeals (7th Circuit)

Page 1253

731 F.2d 1253

UNITED STATES of America, Plaintiff-Appellee, v. AN ARTICLE OF DEVICE ... "Toftness Radiation Detector," Toftness Post-Graduate School of Chiropractic Inc., a corporation, and Irwing N Toftness, an individual Defendants-Appellants.

No. 83-1404.

United States Court of Appeals Seventh Circuit.

Argued Dec. 7, 1983.

Decided April 4, 1984.

E. Campion Kersten, Kersten & McKinnon, Milwaukee, Wis., for defendants-appellants.

Don O. Burley, U.S. Dept. of Justice, Washington, D.C., for plaintiff-appellee.

Before CUDAHY, ESCHBACH and COFFEY, Circuit Judges.

CUDAHY, Circuit Judge.

Under the Food, Drug, and Cosmetic Act, 21 U.S.C. Secs. 301 et seq. (the "Act"), a prescription medical device is "misbranded" if it cannot be used safely and effectively for its intended purposes. The Toftness Radiation Detector ("TRD") is a chiropractic instrument which purportedly detects electromagnetic radiation from the human body and focuses that radiation so that a chiropractor can detect conditions which require chiropractic treatment. The government sued to condemn the TRD as "misbranded" under the Act and to enjoin the TRD's inventor from producing, distributing or using the TRD. After a trial in the district court, a jury rendered a verdict for the government, and this appeal followed.

I

Defendant-appellant Irwing N. Toftness is a licensed chiropractor who practices in Cumberland, Wisconsin, and who invented the TRD. The TRD, which is patented, consists of a plastic cylinder containing a series of plastic lenses. According to Toftness, low levels of electromagnetic radiation emanate from the human body, and that radiation emanates most strongly from areas of neurological disturbance. The TRD is supposed to be capable of detecting and focusing this radiation through the plastic lenses. When a trained user holds the TRD close to a patient's skin, the user is supposed to detect this radiation by rubbing his or her fingers on the detection plate and feeling resistance to the movement of the fingers. After locating the points of disturbance, the chiropractor can then make adjustments to the body to alleviate these neurological disturbances.

Toftness is also the president of defendant-appellant Toftness Post-Graduate School of Chiropractic, Inc. Only licensed chiropractors who have completed a training course at the Toftness School may use the TRD. The course lasts several weeks and costs $400. At the time of the trial in this case, approximately 700 chiropractors had attended the TRD course and had signed leases for the TRD. The fifteen year leases of the instrument call for payment of $700 for the first year and $100 for each of the next fourteen years. The leases also provide that the use of the instrument should be limited to research purposes and that the user should keep careful research records and forward those records to the school.

The government brought this action under the Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. Secs. 301 et seq., contending that the TRD is a "misbranded" device under 21 U.S.C. Sec. 334(a)(1). We shall explain the statutory and regulatory framework in more detail below, but the heart of the government's case is its contention that the TRD simply does not work and is therefore "misbranded." Government witnesses testified at trial that the TRD is incapable of detecting any radiation coming from the human body. Defense witnesses testified in turn about their experimental use of the TRD and their purported success in treating patients while using the TRD. The jury rendered a verdict for the government, and the district court denied the defendant's motion for a new trial. ¹

This appeal followed, and appellants here argue that the district court erred with respect to three issues. First, appellants contend that the district court improperly instructed the jury that the TRD was, as a matter of law, a "device" as defined in 21 U.S.C. Sec. 321(h) and thus subject to the provisions of the Act. Second, appellants argue that the district court erroneously instructed the jury that the burden of proof was on the defendants to show that the TRD was properly labeled as a "prescription device" under 21 C.F.R. Sec. 801.109 (1983). Third, they argue that the court erred by instructing the jury not to "pile inference on inference." For the following reasons, we conclude that the district court did not err in these three matters and we affirm its judgment.

II

The first issue on appeal is whether the TRD is a "device" as defined in section 201(h) of the Act, 21 U.S.C. Sec. 321(h), and thus subject to the Act's misbranding provisions. The district court instructed the jury that the TRD is a "device," and appellants contend that the district court erred in directing a verdict on this point. According to appellants, the TRD is not subject to the misbranding provisions because its intended uses are limited to research purposes. In our view the district court properly directed a verdict on this issue because the appellants' attempted rebuttal was based on a misreading of the Act. The Act's definition of "device" includes instruments used for research so long as the intended uses of the instrument in question include the diagnosis and treatment of diseases or other conditions.

To determine whether the TRD is a "device" under the Act, we begin with section 304(a)(1) of the Act, 21 U.S.C. Sec. 334(a)(1), which permits the government to seize any misbranded "article of ... device" in interstate commerce. Section 201(h) of the Act, 21 U.S.C. Sec. 321(h), defines "device" to include:

instruments, apparatus, and contrivances, including their components, parts, and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (2) to affect the structure or any function of the body of man or other animals.

The FDA has issued regulations which further elaborate on this definition by defining "intended uses." The regulations provide in relevant part:

The words "intended uses" or words of similar import in Secs. 801.5, 801.119, and 801.122 refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.

21 C.F.R. Sec. 801.4 (1983). The dispute here concerns the language: "use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man." 21 U.S.C Sec. 321(h)(1). Defendants appear to offer two distinct but closely related theories supporting their contention that the TRD does not fall within that definition of "device." First, they introduced evidence showing that the TRD was not intended to be used as the sole means of diagnosing patients or of evaluating the success of their treatments. Second, they introduced evidence tending to show that the TRD was intended only for research use instead of for diagnosis or treatment.

In response, the government refers us to evidence showing that the TRD was intended for use in the diagnosis and treatment of patients by chiropractors. That evidence includes the instructions that Dr. Toftness prepared for use of the TRD, the financial arrangements through which chiropractors were trained in the use of the TRD and permitted to use it and the testimony of the appellants' witnesses showing that they had made chiropractic adjustments to patients on the basis of TRD readings. The instructions for the use of the TRD contain, in various versions, directions for sensing points of maximum radiation, for interpreting those radiation readings and for making appropriate chiropractic adjustments. The financial arrangements include the tuition for instruction in the proper use of the TRD and the fifteen year leases for the instrument itself. Further, several of appellants' witnesses testified that they had actually made chiropractic adjustments to patients based upon readings from the TRD and that they had measured the effectiveness of treatment through use of the TRD. That evidence supported appellants' contention that the TRD is "effective," see infra Part III, but it also supported the government's argument that the TRD is a "device."

On the other hand, the appellants point out that the instructions stated that the TRD was to be used only in conjunction with standard chiropractic techniques such as "Chiropractic Palpation" or "Line of Drive." The instructions also directed the user to keep careful records of all adjustments on "Daily Research Cards." There was, in addition, evidence showing that TRD users have not advertised that they use the TRD, that they have not charged patients more money for use of the TRD in diagnosis or treatment and that the users have informed patients that they were testing this new instrument. Appellants, based on this evidence, argue that the intended use of the TRD until now has been solely for research and that users have simply tested the device by using it and comparing their findings from its use against findings made using established techniques.

To avoid the directed verdict, appellants needed either to cast doubt on the government's evidence of intended use or to introduce other evidence rebutting the government's evidence. However, the appellants stipulated to much of the evidence supporting the government's position, and they introduced some of it themselves. ² It would have been impossible for any reasonable jury to have rejected this evidence. Therefore, to avoid the directed verdict, appellants rely on the evidence...