Opinion ID: 1941660
Heading Depth: 2
Heading Rank: 4

Heading: Obstacle to Congressional Purposes and Objectives

Text: ¶ 24. Defendant next contends that state common-law liability for its use of an FDA-approved label presents an obstacle to federal objectives. We hold that plaintiff's claim does not interfere with any objective that can legitimately be ascribed to Congress. We agree with the reasoning in the cases cited above, supra, ¶¶ 14-15, that federal labeling requirements pursuant to the FDCA create a floor, not a ceiling, for state regulation. Defendant presents a new FDA rule containing language disputing this reasoning, but this statement does not alter our conclusion that there is no conflict between federal objectives and Vermont common law.
¶ 25. In the absence of a conflict that makes it impossible for a regulated entity to comply with both state and federal law, federal law will preempt state law only if it stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. Freightliner, 514 U.S. at 287, 115 S.Ct. 1483 (quotations omitted). We must therefore examine what the full purposes and objectives of Congress were with respect to federal labeling requirements for prescription drugs. We agree with the McNellis court that a system under which federal regulations merely set minimum standards with which manufacturers must comply is fully consistent with Congress' primary goal in enacting the FDCA, which is to protect consumers from dangerous products, United States v. Sullivan, 332 U.S. 689, 696, 68 S.Ct. 331, 92 L.Ed. 297 (1948), as well as Congress' stated intent that the FDCA `must not weaken the existing laws,' but on the contrary `it must strengthen and extend that law's protection of the consumer.' United States v. Dotterweich, 320 U.S. 277 [282, 88 L.Ed. 48] (1943) [quoting S.Rep. No. 152, 75th Cong., 1st Sess., p. 1]. 2005 WL 3752269, at ; see also Witczak, 377 F.Supp.2d at 731 (Congress certainly did not intend to bar drug companies from protecting the public when enacting the FDCA; its goal was to protect the public. . . . Any contrary interpretation of Congress's intent is perverse.). ¶ 26. In fact, Congress has expressed its purposes clearly, not only in the general sense that the statute was intended to protect the public, but also more specifically, with respect to the FDCA's preemptive effect. In the 1962 amendments to the FDCA, Congress included a clause expressly limiting the preemptive effect of the statute: Nothing in the amendments made by this Act to the Federal Food, Drug, and Cosmetic Act shall be construed as invalidating any provision of State law . . . unless there is a direct and positive conflict between such amendments and such provision of State law. Drug Amendments of 1962 (Harris-Kefauver Act), Pub.L. No. 87-781, § 202, 76 Stat. 780, 793 (1962). ¶ 27. This amendment essentially removes from our consideration the question of whether common-law tort claims present an obstacle to the purposes and objectives of Congress. Congress intended that the FDCA would leave state law in place except where it created a direct and positive conflict between state and federal law. Drug Amendments § 202. This language simply restates the principle that state law is superseded in cases of an actual conflict with federal law such that `compliance with both federal and state regulations is a physical impossibility.' See S. Blasting Servs., Inc. v. Wilkes County, 288 F.3d 584, 591 (4th Cir.2002) (interpreting direct and positive conflict language in the preemption clause of a federal statute governing explosive materials to allow states to impose more stringent requirements than those contained in the federal regulations) (quoting Hillsborough County v. Automated Med. Labs., Inc., 471 U.S. 707, 713, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985)). [4] In other words, under any circumstances where it is possible to comply with both state law and the FDCA, the state law in question is consistent with the purposes and objectives of Congress. Thus, our discussion above regarding defendant's impossibility argument, supra, ¶¶ 21-23, provides a complete answer to the question of preemption. ¶ 28. We recognize that our dissenting colleague has reached the opposite conclusion. There is little to say, beyond what we have already said, except that we respectfully disagree with his analysis of the FDCA, the FDA's regulations, and the specific context of this lawsuit. Numerous courts have concluded, over the course of decades, that the FDCA provides a floor, not a ceiling, for state regulation. See supra, ¶¶ 14-15. While the dissent cites favorably the minority view, we agree with the majority view. There is much to be said for the policy arguments employed by courts adopting this minority view, including the argument that permitting too much state activity in this area will make beneficial drugs less available to consumers. Similarly, there is merit to the majority perspective that eliminating lawsuits like the one at issue here would leave consumers without recourse in the event the FDA cannot move quickly enough to require strengthened warnings when they are appropriate. Our view is that neither policy argument is relevant here. The plain language of the statute indicates that Congress did not intend to interfere with state prerogatives except where doing so is absolutely necessary, see supra, ¶¶ 25-27, and the plain language of the regulation makes such interference unnecessary here, see supra, ¶¶ 12-13. This analysis is consistent with the constitutionally rooted presumption against preemption. To look more broadly at arguments relying on assumptions about safety and economic efficiency is to apply the opposite presumption  the presumption that Congress could not possibly have intended to allow states to intrude on what seems, intuitively, to be an area of federal expertise. It is neither our responsibility, nor that of the FDA, to question the policy judgments of Congress. The litigation at issue here does not pose a direct and positive conflict with federal law, and thus, there is no basis for federal preemption.
¶ 29. Defendant, after oral argument in this case, cited a new FDA regulation that contains a statement relating to the preemptive effect of the FDCA. The substance of the regulation changes certain aspects of labeling requirements for prescription drugs, but these changes are irrelevant to this appeal because the new rule did not take effect until June 2006. Food and Drug Administration, Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Supplementary Information, 71 Fed.Reg. 3922, 3922 (Jan. 24, 2006). The rule's Supplementary Information section, however, contains a broad statement regarding the preemption of state common-law failure-to-warn claims. Id. at 3933-36. In this statement, the FDA asserts that recent cases rejecting preemption of these claims, including those cited above, pose an obstacle to the agency's enforcement of the labeling requirements. Id. Among the interpretations the agency claims are incorrect are: (1) those rejecting preemption on the basis of § 314.70(c); and (2) those stating that federal labeling requirements are minimum standards and that [s]tate law serves as an appropriate source of supplementary safety regulation for drugs by encouraging or requiring manufacturers to disseminate risk information beyond that required by FDA under the act. Id. at 3934. ¶ 30. We are ordinarily required to defer to an agency's interpretation of a statute it administers. Chevron, U.S.A., Inc. v. Natural Res. Def. Council, 467 U.S. 837, 844, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984) (We have long recognized that considerable weight should be accorded to an executive department's construction of a statutory scheme it is entrusted to administer. . . .). Plaintiff, however, urges us not to defer to the FDA's statement because it was adopted without the requisite comment period and lack[s] the force of law. Presumably, if we were to credit plaintiff's argument, we would owe the statement only the limited deference due to agency statements made outside the agency's rulemaking authority. See United States v. Mead Corp., 533 U.S. 218, 226-27, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001) (stating that Chevron deference applies only when it appears that Congress delegated authority to the agency generally to make rules carrying the force of law, and that the agency interpretation claiming deference was promulgated in the exercise of that authority). We need not decide this difficult question of administrative law, however, because we conclude that irrespective of the level of deference we might apply, the statement would not affect the outcome of this appeal. ¶ 31. Under Chevron, deference to an agency's interpretation is appropriate only when a statute is silent or ambiguous with respect to the specific issue the agency has considered; otherwise, the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. 467 U.S. at 842-43, 104 S.Ct. 2778. Moreover, [t]he judiciary is the final authority on issues of statutory construction and must reject administrative constructions which are contrary to clear congressional intent. Id. at 843 n. 9, 104 S.Ct. 2778. If a court, employing traditional tools of statutory construction, ascertains that Congress had an intention on the precise question at issue, that intention is the law and must be given effect. Id. When an agency's interpretation is not the type of interpretation entitled to Chevron deference, we must still grant it some respect, but only a respect proportional to its `power to persuade.' Mead, 533 U.S. at 235, 121 S.Ct. 2164 (quoting Skidmore v. Swift & Co., 323 U.S. 134, 140, 65 S.Ct. 161, 89 L.Ed. 124 (1944)). ¶ 32. Under either standard, the FDA's statement deserves no deference. We have already concluded, supra, ¶¶ 26-27, that Congress intended the FDCA to preempt only those state laws that would make it impossible for manufacturers to comply with both federal and state requirements. Nothing in the FDA's new statement alters our conclusion that it would be possible for defendant to comply with both its federal obligations and the obligations of state common law. The regulatory framework for prescription drug labeling allows drug manufacturers to add or strengthen a warning to increase the safe use of the drug product without prior FDA approval. See supra, ¶¶ 10-13 (citing 21 C.F.R. § 314.70(c)(6)(iii)(C)). Even if the new rule eliminated or altered this provision, the change in the regulation did not take effect until June 2006. [5] Without such a change, it is possible for manufacturers to comply with both FDA regulations and duties imposed by state common law, and there is no direct and positive conflict between state and federal law. ¶ 33. The FDA does not attempt to establish such a conflict or explain the inconsistency between its position and the language of the preemption amendment. The statement cites the amendment, but then proceeds as if Congress had not spoken on the issue of preemption. The agency relies on Geier to support its disregard of Congress's direct and positive conflict language, asserting that [t]he existence of a legislative provision addressing pre-emption does not bar the operation of ordinary principles of implied preemption. 71 Fed. Reg. at 3935 (citing Geier, 529 U.S. at 869, 120 S.Ct. 1913). Geier does state that implied preemption applies even when a statute addresses preemption expressly, 521 U.S. at 869, 117 S.Ct. 2329, but it does not allow courts or agencies to preempt state laws that have been expressly preserved by Congress. Instead, it simply stands for the proposition that Congress's intent not to preempt a provision of state law cannot be inferred from either (1) an express preemption clause that does not include the state law in question in its scope, or (2) a clause that prevents regulated entities from using compliance with federal law as a defense in state common-law suits. Id. at 869-70, 117 S.Ct. 2329. According to Geier, the former clause does not support a negative inference that Congress must have intended to preserve laws it did not expressly preempt; the latter indicates only that Congress intended to preserve some common-law claims, not that it intended to allow even claims that conflict with federal requirements. Id. But see id. at 870, 120 S.Ct. 1913 (stating that even the latter clause would preserve[] those actions that seek to establish greater safety than the minimum safety achieved by a federal regulation intended to provide a floor). ¶ 34. Here, we are not attempting to infer the effect of statutory language that only indirectly addresses the specific state law at issue. Instead, we are interpreting an unambiguous express preemption clause that specifically preserves the type of state law at issue. Under these circumstances, ordinary preemption principles must give way to Congress's intent to preserve state laws that do not create a direct and positive conflict with federal law. Drug Amendments § 202. There is no such conflict here. Accordingly, the FDA's statement is neither an authoritative interpretation of an ambiguous statutory provision entitled to deference, Chevron, 467 U.S. at 842-43, 104 S.Ct. 2778, nor a persuasive policy statement entitled to respect. Mead, 533 U.S. at 235, 121 S.Ct. 2164. Plaintiff's claim does not impose conflicting obligations on defendant or present an obstacle to the objectives of Congress. We therefore agree with the trial court that the claim is not preempted by federal law.