Opinion ID: 425939
Heading Depth: 1
Heading Rank: 2

Heading: fda's jurisdiction over lethal injections

Text: 16 The Commissioner of FDA refused to investigate appellants' allegations or to assess and respond to the evidence they presented. Instead, he asserted that FDA did not have jurisdiction to interfere with state governments' use of prescription drugs for the purpose of causing death by injection. We disagree. 17 In determining whether FDA has jurisdiction over a particular drug or practice, the Supreme Court has counselled us to inquire not merely    into statutory purpose, but also into the various sorts of supervision [needed] to effectuate the goals of the Act   . Toilet Goods Ass'n, Inc. v. Gardner, 387 U.S. 158, 163-164, 87 S.Ct. 1520, 1524-1525, 18 L.Ed.2d 697 (1967). Jurisdiction is to be analyzed in terms of consumer protection, not dialectics. United States v. Urbuteit, 335 U.S. 355, 357-358, 69 S.Ct. 112, 113-114, 93 L.Ed. 61 (1948). Congress clearly intended that the Act's coverage be as broad as its literal language indicates   . United States v. Bacto-Unidisk, 394 U.S. 784, 798, 89 S.Ct. 1410, 1418, 22 L.Ed.2d 726 (1969). Thus the Act has been held to apply to situations where drugs are held by retailers, United States v. Sullivan, 332 U.S. 689, 696-697, 68 S.Ct. 331, 335-336, 92 L.Ed. 297 (1948), wholesalers, DeFreese v. United States, 270 F.2d 730 (5th Cir.1959), cert. denied, 362 U.S. 944, 80 S.Ct. 810, 4 L.Ed.2d 772 (1960), bailees, United States v. Wiesenfeld Warehouse Co., 376 U.S. 86, 92, 84 S.Ct. 559, 563, 11 L.Ed.2d 536 (1964), and physicians, United States v. Evers, 643 F.2d 1043 (5th Cir.1981). As explained by the court in United States v. 10 Cartons, Labeled in Part Hoxsey, 152 F.Supp. 360, 365 (W.D.Pa.1957), it is not the holding for sale in a technical legal sense which gives rise to the federal jurisdiction    but the fact that the channels of commerce have been used. See also United States v. Sene X Eleemosynary Corp., 479 F.Supp. 970, 981 (S.D.Fla.1979) ([t]he 'held for sale' standard of section 301 has long been afforded a liberal reading). 18 On appeal, FDA does not focus its energies on the argument that the unapproved use of drugs for lethal injection is outside the general jurisdictional provisions of the Act. Instead, FDA argues that state-sanctioned use of lethal injections comes within a commonly recognized exception to the Act's broad and protective coverage: the practice-of-medicine exemption. FDCA's legislative history expresses a specific intent to prohibit FDA from regulating physicians' practice of medicine. 13 According to the Commissioner, FDCA does not regulate physicians in their practice because physicians are licensed by the states. Letter from the Commissioner at 3, JA 88. Since state prisons are also licensed by the states, the Commissioner thought that FDA did not have jurisdiction to regulate the use of drugs in capital punishment systems. Id. at 2-3, JA 87-88. 19 The problem with the Commissioner's analogy is his starting point: that the practice of medicine is exempt because physicians are licensed by the states. There is scant legislative history on the subject, 14 but the few sentences that can be found are more fairly read as reflecting Congress' recognition that the states do regulate the practice of medicine and that a physician cannot be eligible for the practice-of-medicine exemption if he has not been so licensed. The practice-of-medicine exemption itself, however, cannot be attributed to the states' licensing of their physicians. 20 The better explanation for the practice-of-medicine exemption is that Congress did not want to interfere with physicians' treatment of their patients. New uses for drugs are often discovered after FDA approves the package inserts that explain a drug's approved uses. Congress would have created havoc in the practice of medicine had it required physicians to follow the expensive and time-consuming procedure of obtaining FDA approval before putting drugs to new uses. 15 Thus Congress exempted the practice of medicine from the Act so as not to limit a physician's ability to treat his patients. 16 21 If FDA were correct that physicians' use of drugs is not within FDA's jurisdiction simply because physicians are licensed by the states, then it would necessarily follow that FDA could have no authority to regulate drugs that state-licensed physicians administer to prison inmates in experimental clinical investigations and no authority to regulate drugs that state-licensed veterinarians use to put animals to their death. But FDA has in fact regulated drugs used in prison clinical investigations, see 21 C.F.R. Sec. 50.44 (1983), and in veterinary practices, see United States v. Beauthanasia-D. Regular, [1979 Transfer Binder] Food Drug Cosm.L.Rep. (CCH) p 38265 (D.Neb.1979). In both situations FDA has rejected arguments that it does not have authority to regulate unapproved uses of approved drugs. 17 Nonmedical use of lethal injections therefore cannot fall within the practice-of-medicine exemption simply because the states license their prison facilities. 18 22 FDA did suggest cursorily in both its brief on appeal, brief for appellee at 26 n. 25, and its initial Letter from the Commissioner, JA 86-88, that the use of drugs for lethal injections, even if not covered by the practice-of-medicine exception, falls outside the jurisdictional ambit of the FDCA. The dissent to this opinion has graciously elaborated FDA's alternative argument; while acknowledging the inapplicability of the practice-of-medicine exception, the dissent argues that FDA jurisdiction depends upon the existence of misbranding under Sec. 331(k), which cannot be established under the facts of this case. Dissent at 1198. 23 Section 331(k) prohibits any action taken upon a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded. 21 U.S.C. Sec. 331(k). The dissent contends that no misbranding could have occurred in the present case because the drugs that prisons hold for use in lethal injections cannot be deemed to be held for sale under any conceivable interpretation of the English language. Dissent at 1199. 24 This rhetorical flourish masks what is in essence a plain meaning argument, and we do not fulfill our interpretive role when we look only to the statutory language. Inquiry into the statutory scheme and legislative history of the FDCA and subsequent amendments reveals a specific congressional intent to prevent misbranding of drugs at each stage of the distribution process from manufacturer to patient. Accord United States v. Evers, 643 F.2d 1043, 1049 (5th Cir.1981). In the first place, Section 331(b) of the FDCA, which prohibits any misbranding in interstate commerce, should be sufficiently broad to cover the actions of the state prisons in this case, given the modern constitutional understanding of the breadth of congressional power under the commerce clause. Moreover, Congress enacted the held for sale provision of Section 331(k), on which the dissent relies, to expand, not to limit, the ambit of the FDCA. Prior to addition of this language in 1938, the FDCA had been open to an interpretation, under the more restrictive reading of the phrase interstate commerce then prevailing, that excluded from the Act's coverage the penultimate actor in the distribution chain if that entity had neither received nor transmitted a misbranded drug in interstate commerce. Filling this potential gap in the statute's protective scheme, Congress enacted Section 331(k) with the specific and explicitly stated intent to extend the protection of consumers contemplated by the law to the full extent constitutionally permissible. H.R.Rep. No. 2139, 75th Cong., 3d Sess. 3 (1938). The drugs that states use have moved through the channels of interstate commerce, see Memorandum in Support of Defendant's Motion to Dismiss at 15, JA 141, and Congress thus is well within its constitutional powers when it seeks to regulate the use to which these drugs are put. In light of Congress' express intent to exercise these powers to the hilt in Section 331(k), it would be both ironic and impermissible for this court to construe that section so as to limit FDA's jurisdiction in this case. 19 25 In apparent recognition of the broad scope of the term held for sale, the dissent must strain to argue that Section 331(k) nonetheless does not apply because the prison officials in this case are not the penultimate actors at whom this section is aimed, but rather the ultimate consumers of the drug and thus beyond the strictures of the Act. This view blinks reality. The ultimate consumer is not the last person to purchase the drug, but the last person to consume the drug--usually a patient, as United States v. Evers notes, 643 F.2d at 1049, but in this case the prisoner who receives the lethal injection. That the prisoner might be an unwilling consumer does not change the fact that the prisoner is the one who will suffer an excruciating death if this unapproved administration is conducted improperly. Styling the ultimate purchaser as the ultimate consumer, the dissent would free from the strictures of the FDCA any use to which the purchaser wished to put the drugs. Such a reading thwarts the ultimate purpose of Section 331 of the FDCA--protection of those who consume drugs from the potential harm of misbranding by anyone in the chain of distribution. 20 26 FDA admits that it has jurisdiction over all state laws that purport[ ] to legitimize the lawful shipment of an unapproved drug in interstate commerce, or that purport[ ] to permit its misbranding after shipment   . Brief for appellee at 20 n. 21. The states' lethal injection statutes purport to mandate the use of certain prescription drugs for a purpose not listed on their label. The activity of the states falls within the jurisdictional ambit of Section 331 of the FDCA, and the practice-of-medicine exception does not immunize this activity from the FDCA's prohibition of misbranding. FDA therefore must have jurisdiction to regulate such activity. 21