Opinion ID: 1941660
Heading Depth: 3
Heading Rank: 2

Heading: The FDA's New Statement on Preemption

Text: ¶ 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.