THIS ARTICLE ORIGINALLY APPEARED HERE IN VOL. 12 NO. 2 OF PRO TE: SOLUTIO.
The Supremacy Clause of the United States Constitution declares federal law to be the "supreme Law of the Land."1 Thus, when federal law and state law conflict, the state law is preempted, or rendered without effect.2 Under the Supremacy Clause, Congress has the authority to expressly preempt state law by including preemptive language in federal statutes. The Federal Food, Drug and Cosmetic Act (FDCA) contains several express preemption provisions that prohibit states from imposing certain regulatory requirements on food, non-prescription drugs, medical devices and cosmetics that do not mirror the requirements imposed by federal law.3 These provisions apply not only to state statutes and regulations but also to legal claims brought by plaintiffs under state law.
The purpose of this article is to explore express preemption in the context of consumer protection actions, which are becoming more prevalent for drug and device manufacturers. State consumer protection acts (CPAs) historically have been viewed as a way for states to exercise their police powers over consumer health and safety by providing a private right of action for violations of the FDCA.4 More recently, though, plaintiffs have begun to rely on CPAs to go beyond the FDCA and impose requirements on manufacturers that do not exist under federal law. Additionally, many CPAs empower state attorneys general and, in some cases, private plaintiffs to seek injunctive relief preventing manufacturers from marketing, labeling or selling their products in a manner that would violate the CPA, even if the manufacturer's conduct is in compliance with the FDCA. Thus, while a judgment in a typical product liability action may induce a manufacturer to alter its conduct, a consumer protection action presumably requires a change in conduct, and thus could require a manufacturer to violate federal law. This is the type of inconsistency that the FDCA's express preemption provisions were designed to prevent. Therefore, it is critical that manufacturers are able to identify the competing federal and state requirements implicated by a consumer protection action when evaluating the viability of an express preemption defense.
The First Step to Preemption: Identifying Applicable Federal Requirements
"The purpose of Congress is the ultimate touchstone in any preemption case."5 Courts typically presume that Congress did not intend to preempt state law, especially on matters related to the states' historic police powers.6 However, no such presumption exists where Congress has enacted an express preemption statute.7 The existence of such a statute is clear evidence of Congress's preemptive intent with respect to a certain subject matter."[W]hen Congress has made its intent known through explicit statutory language, the courts' task is an easy one."8
The FDCA contains express preemption provisions covering food,9 medical devices,10 non-prescription drugs11 and cosmetics.12 One court has explained that "[t]he whole point of [the FDCA's preemption provisions] is that it is not up to private litigantsor judgesto decide what is 'false or misleading.' It is up to the FDA."13 These statutes all share a common thread of prohibiting any "state or political subdivision of a state" from "establish[ing] or continu[ing] in effect any requirement" that is "different from or in addition to, or that is otherwise not identical with, a requirement" under the FDCA or other applicable law.14 The first step in the preemption analysis, then, is to identify any federal statutes or regulations that impose requirements that would be impacted by the plaintiff's lawsuit.
In Riegel v. Medtronic, Inc., the United States Supreme Court was asked to decide whether the premarket approval (PMA) process for Class III medical devices enacted under the Medical Device Amendments to the FDCA constituted a federal requirement for express preemption purposes.15 The Court first noted that the FDA's regulations provide that "[s]tate or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act ..."16 Thus, the critical inquiry was whether the PMA process imposed device-specific requirements.
The Court then looked to its prior decision in Medtronic, Inc. v. Lohr, in which it had held that the "substantially equivalent" standard enacted in 21 U.S.C. § 510(k) did not constitute a federal requirement and instead reflected "entirely generic concerns about device regulation generally."17 The Riegel Court distinguished the PMA process from the substantial equivalency standard, reasoning that premarket approval imposes specific requirements on individual devices and is focused on safety, not just equivalence.18 In other words, while devices that enter the market after substantial equivalency review have not been formally tested for safety or efficacy, the FDA may approve a device under the PMA process only after it determines that the device offers "reasonable assurances of safety and effectiveness."19 Once PMA is granted, a device must be made with almost no deviations from the specification in its approval application.20 Accordingly, the Riegel Court concluded that the PMA process for Class III devices constitutes a federal requirement that expressly preempts any conflicting state requirements.21
The court in Mills v. Warner-Lambert, Inc. relied on Riegel's analysis of the PMA process for medical devices in concluding that the New Drug Application (NDA) process and monograph systems used to approve nonprescription drugs also constitute federal requirements for preemption purposes.22 The plaintiffs in Mills filed suit under Texas' CPA alleging that the defendants' over-the-counter lice treatments amounted to "snake oil" and did not actually kill lice.23 In reviewing the defendants' preemption argument under the FDCA, the court first noted that one of the products in question originally was approved through the NDA process.24 The other two drugs, on the other hand, had been approved through the FDA's monograph system.25 To determine whether...