Opinion ID: 1941660
Heading Depth: 3
Heading Rank: 1

Heading: The Purposes and Objectives of Congress

Text: ¶ 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.