Opinion ID: 388200
Heading Depth: 1
Heading Rank: 2

Heading: the government's case against dr. evers

Text: 10 The government contends that Dr. Evers violated section 301(k) of the Act, 21 U.S.C. § 331(k), which prohibits any act with respect to a drug which is done while such (drug) is held for sale (whether or not the first sale) after shipment in interstate commerce and (which) results in such article being ... misbranded. 12 The government must therefore establish two separate elements: (1) that the act in question occurred while the drug was held for sale after shipment in interstate commerce; and (2) that the act resulted in the article being misbranded. See United States v. Sullivan, 332 U.S. 689, 695, 68 S.Ct. 331, 335, 92 L.Ed. 297 (1948). The focus of the government's case, as well as of Dr. Evers' defense and of the district court's opinion, is the second of these elements. In order to establish this element, that is, to demonstrate that Dr. Evers has misbranded Calcium EDTA, the government relies solely on section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). That section deems a drug to be misbranded unless its labeling bears ... adequate directions for use. 13 In brief, the government contends that Dr. Evers failed to provide adequate directions for use when he promoted and prescribed Calcium EDTA for the treatment of circulatory disorders, a use for which the drug has not been approved by the FDA. 11 In response to this charge, Dr. Evers (as well as certain of his patients, as intervenors) argues that as a licensed physician he has a right to prescribe any lawful drug for any purpose, whether or not that purpose has been approved by the FDA. The district court agreed with Dr. Evers and held that no misbranding could result from a doctor's prescription of a lawful drug to his own patients. The court relied for this holding on the intent of the statute, which seeks to avoid interference with the practice of medicine; on supposed limitations on the powers of Congress; and on the patient's constitutional right to privacy in the context of medical care. 453 F.Supp. at 1147-50. 12 However, the analysis urged by Dr. Evers and adopted by the district court misapprehends the thrust of the government's case against Dr. Evers, for the FDA has at no point contended, and the government does not argue on appeal, that the misbranding provisions of the Act prohibit a doctor from prescribing a lawful drug for a purpose for which the drug has not been approved by the FDA. To the contrary, the FDA has explicitly informed Dr. Evers that he could legally prescribe chelating drugs for the treatment of circulatory disorders. When Dr. Evers inquired of the FDA in early 1974 whether he could use Calcium EDTA for that purpose, the agency responded by letter that (u)se of a locally obtained drug for an indication which is not in the package insert is considered 'the practice of medicine,'  and that Dr. Evers therefore need not seek any exception to the regulations. 14 This advice to Dr. Evers rested on a discussion of the Act which appears in a notice of proposed rule making which the FDA issued in 1972 but on which it has never acted. See 37 Fed.Reg. 16503 (1972). As the agency explained in that notice: 13 Once (an approved) new drug is in a local pharmacy after interstate shipment, the physician may, as part of the practice of medicine, lawfully prescribe a different dosage for his patient, or may otherwise vary the conditions of use from those approved in the package insert, without informing or obtaining the approval of the Food and Drug Administration. 14 This interpretation of the Act is consistent with Congressional intent as indicated in the legislative history of the 1938 Act and the drug amendments of 1962. Throughout the debate leading to the enactment, there were repeated statements that Congress did not intend the Food and Drug Administration to interfere with medical practice and references to the understanding that the bill did not purport to regulate the practice of medicine as between the physician and the patient. Congress recognized a patient's right to seek civil damages in the courts if there should be evidence of malpractice, and declined to provide any legislative restrictions upon the medical profession. 15 Id. at 16503. 16 Of course, while the Act was not intended to regulate the practice of medicine, it was obviously intended to control the availability of drugs for prescribing by physicians. Id. at 16504. In order to extend this control to situations like the one before us, the FDA has proposed regulations and actively has sought legislation which would restrict the availability of lawful drugs for uses for which the drugs have not been approved by the FDA. See D. A. Kessler, Regulating the Prescribing of Human Drugs for Nonapproved Uses Under the Food, Drug, and Cosmetic Act, 15 Harv.J.Legis. 693 (1978); S. A. Shapiro, Limiting Physician Freedom to Prescribe a Drug for any Purpose: The Need for FDA Regulation, 73 Nw.L.Rev. 801 (1978). Nevertheless the government agrees with Dr. Evers that the provisions of the Act and the regulations of the FDA that are now in force do not prevent him from prescribing for uses not approved by the FDA drugs which have been approved by the FDA for some other purpose. 17 The object of the government's case against Dr. Evers is not, therefore, his prescription of Calcium EDTA for use in the treatment of circulatory disorders. Instead, the government seeks to challenge Dr. Evers' promotion and advertising of chelating drugs for that use. According to the government, Dr. Evers misbranded Calcium EDTA when he publicly advocated his use of chelating drugs for an unapproved purpose without providing adequate directions for such a use: 18 (T)he district court found, and the record confirms, that Dr. Evers had advertised his EDTA therapy as treatment for arteriosclerosis, and that he administered calcium EDTA to persons with arteriosclerosis. Thus, by his promotion of calcium EDTA for treatment of arteriosclerosis, Dr. Evers created a use for the drug that was different from its previously approved and labeled use in the treatment of lead poisoning. There were, however, no adequate directions for that use, as required by Section 502(f)(1). 19 Government's Brief at 15-16 (citations omitted). 20 Since the government relies for its case on Dr. Evers' promotion and advertising of chelating drugs for an unapproved use, and since the FDA itself interprets the Act to allow physicians to prescribe (while not promoting or advertising) lawful drugs for unapproved uses, we need not decide whether, as the district court apparently concluded, the Constitution prohibits federal interference with prescriptions by licensed physicians. The question before us is the narrower issue of whether Dr. Evers violated section 301(k) of the Act. In order to establish such a violation, the government must demonstrate the two elements required by that section. In terms of this case, we must find (1) that Dr. Evers held Calcium EDTA for sale after its shipment in interstate commerce, and (2) that Dr. Evers' promotion and advertising of Calcium EDTA without providing any more information than was contained on the drug's label and in the clinic's pamphlets failed to provide adequate directions for use and therefore constitutes misbranding under section 502(f)(1) of the Act. 21