Opinion ID: 2572676
Heading Depth: 1
Heading Rank: 2

Heading: does the modernization act preclude conflict preemption?

Text: The supremacy clause of article VI of the United States Constitution grants Congress the power to preempt state law. State law that conflicts with a federal statute is `without effect.' ( Cipollone v. Liggett Group, Inc. (1992) 505 U.S. 504, 516, 112 S.Ct. 2608, 120 L.Ed.2d 407 ( Cipollone ), quoting Maryland v. Louisiana (1981) 451 U.S. 725, 746, 101 S.Ct. 2114, 68 L.Ed.2d 576.) It is equally well established that [c]onsideration of issues arising under the Supremacy Clause `start[s] with the assumption that the historic police powers of the States [are] not to be superseded by ... Federal Act unless that [is] the clear and manifest purpose of Congress.' ( Cipollone, at p. 516, 112 S.Ct. 2608.) Thus, `[t]he purpose of Congress is the ultimate touchstone' of pre-emption analysis. ( Ibid. ) The United States Supreme Court has explained that federal preemption arises in three circumstances: First, Congress can define explicitly the extent to which its enactments pre-empt state law. [Citation.] Pre-emption fundamentally is a question of congressional intent, [citation] and when Congress has made its intent known through explicit statutory language, the courts' task is an easy one. [¶] Second, in the absence of explicit statutory language, state law is pre-empted where it regulates conduct in a field that Congress intended the Federal Government to occupy exclusively. Such an intent may be inferred from a `scheme of federal regulation ... so pervasive as to make reasonable the inference that Congress left no room for the States to supplement it,' or where an Act of Congress `touch[es] a field in which the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject.' [Citation.] Although this Court has not hesitated to draw an inference of field pre-emption where it is supported by the federal statutory and regulatory schemes, it has emphasized: `Where ... the field which Congress is said to have pre-empted' includes areas that have `been traditionally occupied by the States,' congressional intent to supersede state laws must be `clear and manifest.' [Citations.] [¶] Finally, state law is pre-empted to the extent that it actually conflicts with federal law. Thus, the Court has found pre-emption where it is impossible for a private party to comply with both state and federal requirements, [citation] or where state law `tands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.' ( English v. General Electric Co. (1990) 496 U.S. 72, 78-79, 110 S.Ct. 2270, 110 L.Ed.2d 65, fn. omitted; see Crosby v. National Foreign Trade Council (2000) 530 U.S. 363, 372-373, 120 S.Ct. 2288, 147 L.Ed.2d 352; Olszewski v. Scripps Health (2003) 30 Cal.4th 798, 814, 135 Cal.Rptr.2d 1, 69 P.3d 927.) The first and second forms of preemption are inapplicable here. The savings clause in the Modernization Act demonstrates both that Congress did not expressly preempt California law, and that it did not occupy the field of labeling of over-the-counter drugs. Thus the issue here concerns the third form of preemption, referred to as conflict preemption. Congress has the power to preclude conflict preemption, allowing states to enforce laws even if those laws are in direct conflict with federal law or frustrate the purpose of federal law. ( Geier v. American Honda Motor Co., Inc. (2000) 529 U.S. 861, 872, 120 S.Ct. 1913, 146 L.Ed.2d 914 [ Geier ].) The Court of Appeal here, relying on the language of the Modernization Act, concluded that Congress had so exercised its power. The Modernization Act, in 21 United States Code section 379r(a), prohibits states from enacting any requirement ... that is different from or in addition to, or that is not identical with, a requirement under this chapter. Section 379r(d)(2) then provides that section 379r does not apply to certain state initiative measures; Proposition 65 comes within this exemption. From this language the Court of Appeal reasoned that California may establish requirements different from, and thus in conflict with, the FDA requirements. A Proposition 65 requirement, however, may be different from, in addition to, or ... not identical (21 U.S.C. § 379r(a)) to an FDA requirement without actually conflicting with the federal requirement. Here, for example, if the FDA had simply required the warning that [n]icotine can increase your baby's heart rate, but had not prohibited other warnings, a Proposition 65 warning that nicotine is known ... to cause birth defects or other reproductive harm (Cal.Code Regs., tit. 22, § 12601, subd. (a)) would not conflict with the federal requirement. The product label could simply contain both warnings. Thus, contrary to the Court of Appeal's view, recognizing conflict preemption would not nullify the savings clause of section 379r. The United States Supreme Court's decision in Geier, supra, 529 U.S. 861, 120 S.Ct. 1913, established a strong presumption that Congress does not ordinarily intend to bar conflict preemption. The issue in that case was whether the 1984 version of the Federal Motor Vehicle Safety Standard promulgated by the Department of Transportation relating to airbags preempted a state common law tort action alleging that the defendant manufacturer should have equipped its car with airbags. The federal standard provided for a variety of passive restraints and a gradual phasing-in of airbags. It was based in part on the Transportation Department's fear of a consumer backlash if it were to require airbags on all cars at that time. The controlling statute in Geier, supra, 529 U.S. 861, 120 S.Ct. 1913, like the statute in the case here, prohibited states from establishing standards not identical to federal standards. (15 U.S.C. former § 1392(d).) It further provided, however, that compliance with a federal safety standard does not exempt any person from any liability under common law. (15 U.S.C. former § 1397(k).) The United States Supreme Court held that this savings clause removed tort actions from the scope of the express preemption clause, but did not foreclose conflict preemption. ( Geier, supra, 529 U.S. at p. 869, 120 S.Ct. 1913.) The high court went on to say: Nothing in the language of the savings clause suggests an intent to save state-law actions that conflict with federal regulations. The words `compliance' and `does not exempt' [citation] sound as if they simply bar a special kind of defense, namely, a defense that compliance with a federal standard automatically exempts a defendant from state law whether the Federal Government meant that standard to be an absolute requirement or only a minimum one. [Citation.] It is difficult to understand why Congress would have insisted on a compliance with-federal-regulation precondition to the provision's applicability had it wished the Act to `save' all state-law tort actions, regardless of their potential threat to the objectives of federal safety standards promulgated under that Act. ( Geier, supra, 529 U.S. at pp. 869-870, 120 S.Ct. 1913.) Geier also gave some weight to the Department of Transportation's conclusion that allowing tort suits against manufacturers who had complied with the department's airbag rules would stand as an obstacle to the accomplishment of federal objectives. ( Geier, supra, 529 U.S. at p. 883, 120 S.Ct. 1913.) It explained its deference to the department's conclusion: Congress has delegated to DOT authority to implement the statute; the subject matter is technical; and the relevant history and background are complex and extensive. The agency is likely to have a thorough understanding of its own regulation and its objectives and is `uniquely qualified' to comprehend the likely impact of state requirements. ( Ibid. ) Geier concluded that the savings clause in that case preserved state tort law only when the federal regulation was intended to provide a minimum standard, not when it was intended to establish an absolute standard. Plaintiff here seeks to confine Geier by pointing to differences between the savings clause at issue in Geier and the savings clause in the Modernization Act. He notes also the difference between preempting a common law tort action, as was involved in Geier, and preempting a state regulation. But later cases confirm that Geier is not a narrow holding limited to automobile safety standards; instead it established a general rule upholding conflict preemption even if the applicable federal law contains a savings clause. (See Sprietsma v. Mercury Marine (2002) 537 U.S. 51, 63, 123 S.Ct. 518, 154 L.Ed.2d 466; Buckman Co. v. Plaintiffs' Legal Comm. (2001) 531 U.S. 341, 352, 121 S.Ct. 1012, 148 L.Ed.2d 854.) The United States Supreme Court has never interpreted a savings clause so broadly as to permit a state enactment to conflict with a federal regulation scheme. [5] The language of the Modernization Act's savings clause does not express an intention to preclude all conflict preemption. The legislative history suggests an intent to preclude conflict preemption in pursuit of national uniform labeling. [6] In light of that language, history, and the principles established by Geier, supra, 529 U.S. 861, 120 S.Ct. 1913 and other United States Supreme Court decisions, we conclude that the savings clause of 21 United States Code section 379r(d)(2), does not entirely exclude conflict preemption. We do not, however, go as far as the United States Attorney General urges in his amicus curiae brief and hold that the savings clause, by nullifying the preemptive effect of 21 United States Code section 379r(a), left the law of implied preemption, so far as Proposition 65 is concerned, as if neither were enacted. Such an interpretation would allow the FDA to pursue a goal of national uniformity in warnings, and to further that goal by preempting all Proposition 65 warnings. Section 379r(a) and (d)(2), however, establish that a Proposition 65 warning cannot be preempted solely because it is not identical with the federal requirement. If the FDA's directive here prohibiting nonidentical labels is to be sustained, it must be on a basis relevant to consumer health, and not because the Proposition 65 label would frustrate the FDA's policy favoring national uniformity.