On March 4, 2009, the Supreme Court of the United States handed down its decision in Wyeth v. Levine, the most highly anticipated product liability ruling of the session. In a 6-3 ruling delivered by Justice Stevens, the Court held that the Food and Drug Administration's (FDA) approval of a prescription drug label did not pre-empt state tort law claims challenging the adequacy of the label's warning. Wyeth manufactures Phenergan, an antihistamine used to treat nausea. Plaintiff Diana Levine, a professional musician, brought suit against Wyeth for failure-to-warn after suffering injuries that caused her to lose her right arm. Levine was administered Phenergan via IV-push injection after a second visit to her local clinic for nausea and a migraine. As a result of the injection, Phenergan entered Levine's artery. Shortly thereafter, Levine developed gangrene in her arm, which later required amputation.
Phenergan could be administered in two ways: (1) through the 'IV-push' method, whereby the drug is injected directly into a patient's vein; or (2) through the 'IV-drip' method, whereby the drug is administered through an intravenous drip. The Phenergan label warned that gangrene could result if Phenergan was inadvertently injected into an artery instead of the vein. Levine claimed that Phenergan's warning label was defective because it failed to warn and instruct clinicians against use of the IV-push method. The trial court found that the risk of inter-arterial injection could be virtually eliminated through the use of IV-drip, rather than IV-push administration, and ruled in favor of Levine. The Vermont Supreme Court affirmed, holding that the jury's verdict "did not conflict with the FDA's labeling requirements for Phenergan because [Wyeth] could have warned against IV-push administration without prior FDA approval, and because federal labeling requirements create a floor, not a ceiling, for state regulation."
At issue in Wyeth was whether "the FDA's drug labeling judgments pre-empt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use." Wyeth argued that Levine's state-law failure-to-warn claims were pre-empted by federal law and offered two theories to support its assertion: First, that it would have been impossible for Wyeth to comply with the state-law duty to strengthen Phenergan's warning without violating federal law; and second, that recognizing Levine's state-law claims would create an unacceptable obstacle to the accomplishment and execution of Congress's objectives. The Supreme Court rejected both theories.
The Supreme Court prefaced its analysis with a restatement of what the Court described as the "two cornerstones" of conflict pre-emption jurisprudence. First, "'the purpose of Congress is the ultimate touchstone in every pre-emption case.'" Second, "in all pre-emption cases, and particularly in those in which Congress has legislated in a field which the States have traditionally occupied," the Court must "start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." Here, the Court concluded that it was not the clear and manifest purpose of Congress to pre-empt state law claims with respect to warnings for prescription drugs. The Court also determined that it was not impossible for Wyeth to comply with both state and federal law obligations and that Levine's claims did not create an obstacle to the accomplishment of Congress's purposes in the Food, Drug and Cosmetic Act (FDCA).
The absence of a pre-emption clause for prescription drug labeling in the FDCA was the major factor in the Court's decision in Wyeth. By way of contrast, in 1976 Congress enacted the Medical Device Amendments (MDA) to the FDCA, which created a scheme of federal safety oversight for medical devices. According to the MDA, no State or political subdivision of a State may establish any requirement for a medical device intended for human use which is: "(1) different from, or in addition to, any requirement applicable under [federal law]," and "(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under [federal law]." Just last year, in Riegel v. Medtronic, the Supreme Court found that the language of the MDA spoke clearly regarding conflict pre-emption, and it therefore barred common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received pre-market approval from the FDA.
The clear and manifest purpose of Congress that the Supreme Court found in the explicit pre-emption language in the MDA in Riegel is precisely what it found missing in the FDCA in Wyeth. The Court emphasized that "when Congress enacted an express pre-emption provision for medical devices in 1976, see § 521, 90 Stat. 574 (codified at 21 U.S.C. § 360k(a)), it declined to enact such a provision for prescription drugs." According to the Court, Congress's silence on the issue of pre-emption in the prescription drug context, its failure to apply the pre-emption clause to the entire FDCA in 1976, "coupled with its certain awareness of the prevalence of state tort litigation, [was] powerful evidence that Congress did not intend FDCA oversight to be the exclusive means of ensuring drug safety and effectiveness." It should be noted that there are several legislative efforts already under way to remove the express pre-emption language in the MDA in response to the Riegel decision.
The Supreme Court rejected Wyeth's argument that in place of express pre-emption statutory language, the Court could rely on the preamble to a 2006 FDA regulation governing the content and format of prescription drugs. The FDA's 2006 preamble provides that "FDA approval of labeling, whether it be in the old or new format, pre-empts conflicting or contrary State law, regulations, or decisions of a court of law for purposes of product liability litigation." The preamble further stated that the "FDA believes that State laws conflict with and stand as an obstacle to achievement of the full objectives and purposes of Federal law when they purport to compel a firm to include in labeling or advertising a statement that FDA has considered and found scientifically unsubstantiated." Wyeth "recognized that an agency regulation with the force of law can pre-empt conflicting state requirements," but found "an agency's mere assertion that state law is an obstacle to achieving its statutory objectives" to be insufficient.
The Court explained that although in prior cases it had given "some weight" to an agency's views, it had "not deferred to an agency's conclusions that state law is pre-empted," and, instead, "attended to an agency's explanation of how state law affects the regulatory scheme." The Court took issue with the FDA's apparent "dramatic change in position" in 2006, finding that in December 2000 the FDA had issued its notice of proposed rulemaking and "explained that the rule would not contain policies that have federalism implications or that pre-empt State law." The Court emphasized that the FDA had reversed its position "without providing a reasoned explanation, including any discussion of how state law has interfered with the FDA's regulation of drug labeling during the decades of coexistence," and thus merited no deference.
Following Wyeth, the frequently asserted federal pre-emption defense will be less likely to prevail in the absence of express pre-emption language in the congressional act. The bar for a successful implied pre-emption defense in regulated industries outside the context of prescription labeling has clearly been raised. The Wyeth decision left room for an agency to opine on whether its judgments should pre-empt state law, but required that the agency first explain how state law impacts the federal regulatory scheme. Also, if an agency chooses to change course, the Court emphasized that the agency must offer the "States or other interested parties notice or opportunity for comment," which the FDA failed to do in this case. The Court also noted that the weight accorded to an agency's opinion would depend on its "thoroughness, consistency, and persuasiveness."
The Wyeth decision delivered a clear message to pharmaceutical manufacturers that they, not the FDA, bear primary responsibility for the adequacy of the warning at all times. The Court emphasized that the FDA's "changes being effected" (CBE) regulation not only permits but requires pharmaceutical manufacturers to be proactive and "to change a product label to add or strengthen a warning about its product without prior FDA approval so long as it later submits the revised warning for review and approval." In Wyeth, the Supreme Court determined that the FDA set minimum safety standards that states are free to increase. In short, the states (and, therefore, most often juries in a specific and often tragic case) -- and not the FDA (with its resources, expertise and experience) - will decide the appropriate balance between the risks and benefits of a particular drug.
In prescription drug failure-to-warn cases, defense attorneys must now rely upon defenses other than implied pre-emption to safeguard their pharmaceutical clients, such as the Learned Intermediary Defense and any available presumptions with respect to warnings.