March 10, 2009
On Wednesday, March 4, 2009, the Supreme Court released a decision holding that federal approval of labels giving warnings about the effects of drugs does not pre-empt lawsuits bringing state law claims of inadequate warnings. Wyeth v. Levine, — U.S. —-, No. 06-1249 (Mar. 4, 2009), available at http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf (last accessed Mar 5, 2009). This decision sets the stage for additional state law litigation based on failure to warn claims, and makes it more difficult for courts to find federal preemption.
In this case, the plaintiff, Diana Levine, was administered the drug Phenergan, an antihistamine used to treat nausea. Although Phenergan is corrosive and can cause irreversible gangrene if it enters a patient’s artery, it was injected into Levine’s vein by means of the "IV-push" method, whereby the drug is injected directly into the patient’s vein. Phenergan entered Levine’s artery likely because the needle hit an artery (known as "inadvertent intra-arterial injection"), resulting in amputation of her arm. The labeling for this drug, which was approved by the Food and Drug Administration (FDA) as required by federal law, included warnings as to the health risks from inadvertent intra-arterial injection, and in particular warned of risks from using the "IV-push" method for intravenous administration of the drug, although it did not ban use of the "IV-push" method.
After being held liable in Vermont state court for failing to adequately warn of the risks from intra-arterial injection, Wyeth sought certiorari with the U.S. Supreme Court on the grounds that the claims were pre-empted based on the conflict between the failure-to-warn claims and the FDA’s approval of the labeling for Phenergan.
Under recent Supreme Court jurisprudence, pre-emption has been applied under three different theories: if an express pre-emption provision applies, if a federal statute occupied the field at issue, or if there is a conflict between the state law and the federal statutes or regulations. There was no express pre-emption provision at issue in this case, and Wyeth had dropped its argument concerning field pre-emption. Therefore, the sole issue in Levine was whether the state-law claims impermissibly conflict with Wyeth’s federal labeling duties, either because it would have been impossible to comply with both the state-law duty to amend the labeling and the FDA regulations, or because the state tort action would create "an unacceptable ‘obstacle to the accomplishment and execution of the full purposes and objectives of Congress.’" Majority Op. (slip op.) at pp. 6-7 (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)).
The majority opinion held that it was not impossible for Wyeth to comply with both the state-law duty to include strengthened warnings on the risks of intra-arterial injection and the FDA labeling requirements. Id. at pp. 11-16. The majority imposed upon Wyeth the obligation to produce "clear evidence" that it would have been impossible to include additional warnings on the label and also comply with the FDA labeling regulations. Id. at pp. 15-16. While a manufacturer is generally prohibited from altering the FDA-approved label, the majority relied on a "changes being effected" ("CBE") regulation that allows a manufacturer to add or strengthen a warning or contraindication (i.e., a banned use) without waiting for FDA approval. Id. at pp. 11, 15.
Wyeth argued that the CBE regulation was inapplicable because it is limited to changes that "reflect newly acquired information" or, as the majority opinion pointed out, "new analyses of previously submitted data." Id. at 12. While there was scant evidence produced of newly acquired information or new analyses to support a strengthened warning, the majority opinion relied on the principle that manufacturers are responsible for the content of their labels, and stated that "Wyeth could have analyzed the accumulating data and added a stronger warning about IV-push administration of the drug." Id. at p. 13.
Characterizing the impossibility pre-emption as a "demanding defense," the reasoning in Levine could require a defendant to show that there was no possible manner in which it could comply with both the state-law duties and the federal requirements. Id. at p. 16. As was the case in Levine, if there is any potential avenue by which the defendant could comply with stricter state-law requirements and also stay in compliance with the federal requirements, a court may not find pre-emption under the theory of impossibility.
The majority opinion also rejected the argument that the state-law claims would obstruct the purposes and objectives of federal drug-labeling regulations. Id. at pp. 17-25. The majority opinion relied heavily on the legislative intent when Congress passed the statutory authorities for the FDA’s regulations. The majority noted that Congress did not include an express pre-emption clause that covered the labeling requirements at issue in this case, and therefore inferred that "Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness." Id. at p. 18. Building on this inference, the majority determined that state-law actions were not viewed by Congress as obstacles to the effectiveness of the federal labeling requirements.
The majority also dismissed a pronouncement by the FDA in 2006 that the FDA’s approval of specific labels establishes both a "floor" and a "ceiling" such that any conflicting or contrary state law is pre-empted as conflicting with the FDA’s "statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs." Id. at p. 19. Although the majority conceded that the Court will defer to an agency’s views as to the impact of state laws on federal objectives, especially when the subject matter is technical or complex, it refused to defer to "an agency’s conclusion that state law is pre-empted." Id. at p. 20 (emphasis in original). Stating that "agencies have no special authority to pronounce on pre-emption absent delegation by Congress," id. at p. 20, the majority dismissed the 2006 pronouncement as procedurally defective and inconsistent with the FDA’s historical position on the subject. Id. at pp. 20-23.
Limiting the scope of this opinion, the majority noted that this case did not involve the "pre-emptive effect of a specific agency regulation bearing the force of law," which allowed it to distinguish prior Supreme Court decisions that held that state tort actions were pre-empted if they were inconsistent with agency decisions. This limitation holds open the possibility that state tort actions would still be pre-empted if there was evidence of historically consistent positions by the relevant agency as to the conflict between the state tort suits and the federal scheme, or if there was evidence of detailed documentation (such as through a formal rulemaking process) of the multiple factors that were considered by the agency in crafting the federal scheme. In contrast, the majority here decided that the agency’s pronouncements in support of pre-emption were "entitled to no weight," and further stated that the FDA provided little attention to the issue of whether a stronger warning was needed concerning the "IV-push" method or intra-arterial injection. Majority Op. (slip. op.) at pp. 25-25; see also Concurrence by Justice Breyer (slip op.) at pp. 1-2 (emphasizing that pre-emption of state tort claims concerning drug labeling if the FDA makes detailed "determinations in lawful specific regulations describing, for example, when labeling requirements serve as a ceiling as well as a floor.").
The dissent by Justice Alito strongly attacks the majority opinion on this point. It states that the majority opinion mischaracterized the nature of the claims decided in the state court. According to the dissent, instead of simply seeking a "stronger" warning on the label of Phenergan, the plaintiff sought liability, and the jury awarded damages, on the grounds that intravenous administration of the drug was not safe and should not have been allowed by the FDA. Alito Dissent (slip op.) at pp. 2-3. The dissent contends that this type of determination under state law is in direct conflict with the federal regulatory structure set up to determine the safety and effectiveness of these drugs. Id. at pp. 5-6. These determinations, which are made by juries almost certainly without any scientific or medical backgrounds, would interfere with the careful balancing conducted by the FDA’s experts in determining the costs and benefits of how the drug should be administered by medical professionals. Id. at pp. 18-19; see also id. at pp. 10-17 (listing the extensive history concerning the FDA’s awareness of the risks of intra-arterial injection and the numerous warnings included relating to this risk).
This case will likely have significant impacts on cases that involve the issue of implied pre-emption of state-law duties or claims by federal statutes, regulations, or agency actions. Although a finding of implied pre-emption will likely be more difficult in many cases as a result of the Court’s decision in Levine, such a result is not foreclosed if clear evidence is presented that the state-law actions would interfere or obstruct the federal scheme. For instance, a defendant could meet this burden by showing that the federal requirements specifically disallow or foreclose the type of actions or conduct sought by the state-law claims. A defendant could also provide evidence that the duties sought to be imposed by state law will directly contradict policy considerations made by federal agencies or officials. In short, the Supreme Court in Levine has made the issue of implied pre-emption a highly factual-specific and contextual determination.
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