Appeal from the United States District Court for the Western District of Wisconsin. Nos. 75-C-478 & 75-C-479 -- Robert W. Warren, Judge.
Cudahy, Eschbach and Coffey, Circuit Judges.
Under the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 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.
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. §§ 301 et seq., contending that the TRD is a "misbranded" device under 21 U.S.C. § 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 defendants' motion for a new trial.*fn1
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 burden of proof was on the defendants to show that the TRD was properly labeled as a "prescription device" under 21 C.F.R. § 801.109 (1983). Third, they argue that the court erred by instrucing 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.
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. § 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. § 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. § 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 §§ 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, ...