The Supreme Court’s highly anticipated decision in Wyeth v. Levine1 declined to find state-law claims of negligent and strict liability failure to warn preempted by federal law. In so finding, the Levine Court determined that there was no express or implied/conflict preemption of state law claims for negligence and strict liability based on the drug’s inadequate warning. Some commentators have suggested that conflict preemption may still be found in the drug context if a case arises in which the FDA has exercised substantially more control and review over the approved drug, citing to the differing results in Medtronic v. Lohr2 and Riegel v. Medtronic.3 Given that Lohr and Riegel turned on the interpretation of express preemption,4 however, evidence of additional regulatory involvement and oversight by the FDA may not be sufficient salvation for conflict preemption in the drug arena.
Life after Levine has already begun. On March 9, the Supreme Court vacated and remanded two preemption cases back to the Third Circuit in light of their decision in Levine. In the first, Pennsylvania Employees Benefit Trust Fund v. Zeneca, the Third Circuit found that state law false advertising claims were preempted by federal law because the FDA had exclusive authority to determine drug advertisements. In the second, Colacicco v. Apotex, the Third Circuit found that federal guidelines for drug labeling preempted state law claims brought by families of two individuals who committed suicide while taking antidepressants. The state law failure to warn claims asserted that the warnings regarding suicide and worsening depression were not strong enough. Drug and device manufacturers are taking note as well; after the Levine decision, counsel for the manufacturer in the NuvaRing MDL advised the court that the manufacturer intends to withdraw its motion for summary judgment on preemption grounds, with leave to re-file. The Levine decision also seems to have breathed new life into the arguments of those opposed to Riegel’s preemption. On March 11, 2009, U.S. Representatives Frank Pallone, Jr. (D-NJ) and Henry A. Waxman (D-CA) introduced legislation to effectively “reverse” the Supreme Court’s finding of preemption in Riegel.5
This advisory offers a summary of the United States Supreme Court’s opinion in Wyeth v. Levine, comments about the future of the preemption defense in pharmaceutical products liability cases and offers some strategic recommendations for asserting the defense after Levine.
Summary of Wyeth v. Levine
Diana Levine sued Wyeth under theories of common-law negligence and strict liability based on Phenergan’s inadequate warning. Although Wyeth asserted Levine’s claims were preempted, the trial court rejected this assertion, and the jury rendered a verdict in favor of Levine. On appeal to the Supreme Court of the United States, Wyeth made two arguments that preemption was required: first, that it was not possible to comply with the state-law duty to modify Phenergan’s label without violating federal law; and second, that recognition of such a state-law tort action would place an unacceptable “obstacle to the accomplishment and execution of the full purposes and objectives of Congress” because it would effectively substitute a jury’s determination regarding labeling for the expert judgment of the FDA. The Supreme Court rejected both arguments.
With respect to the first claim for preemption, the Court dismissed Wyeth’s assertions that had it unilaterally strengthened the warning on its label, it would have violated federal law and subjected Wyeth to liability for unauthorized distribution or misbranding. In so ruling, the Court noted that the FDA regulations have a provision to permit a manufacturer to make certain changes to its label before receiving agency approval—the “changes being effected” or CBE regulation. The CBE regulation specifically allows a manufacturer to change the label to “add or strengthen a . . . warning,” among other things.6 Even with this provision, however, the FDA retains the authority to reject changes made subject to the CBE regulation. The Court thus ruled that “absent clear evidence that the FDA would not have approved a change to Phenergan’s label,” it would not conclude that it was impossible for Wyeth to comply with both federal and state requirements.7
With respect to Wyeth’s second argument for preemption, the Court rejected the contention that permitting state law claims would frustrate the accomplishment of congressional objectives regarding drug labeling. It observed that Congress could have created an express preemption provision at some point during the statute’s 70-year history if it believed that state-law suits posed an obstacle to its objectives. The Court found the deafening congressional silence with respect to preemption for drugs instructive, particularly in light of the express preemption Congress created for medical devices. Wyeth then asserted that the 2006 preamble to the FDA regulation governing the content and format of prescription drug labels expressed a clear intent by the FDA that approved labeling should preempt state law actions. The Court refused deference to the preamble language, noting that, while an agency’s views about the impact of tort law on federal objectives have in some cases been given some weight, the Court had never “deferred to an agency’s conclusion that state law is preempted.” [Emphasis in original.] The Court also noted that the preamble did not have the force of law, unlike agency regulations that resulted in preemption.8 Because the Court found little evidence of congressional intent to create preemption for drug labeling—and despite the apparent conflict found in the FDA’s 2006 preamble—the Court determined that the common law claims would not stand as an obstacle to the accomplishment of Congress’s purposes in the FDCA.
The Future of Pharmaceutical Preemption
The Levine Court’s finding that FDA’s preemptive intent expressed in the preamble to 71 Fed. Reg. 3922 (2006) did not warrant deference, combined with rather derisive language suggesting that the Court was unlikely to give deference to it in the future, suggests that, if preemption in the drug warning context is not dead, it is not faring well. While the Court’s analysis focused a great deal on the existence of the CBE requirements—allowing unilateral enhancement of warnings—simply arguing that the CBE requirements are inapplicable may be insufficient to get around Levine. Other shortcomings the Court observed in Wyeth’s case, however, are instructive and may provide the framework for successful preemption arguments in the future.
Pre-Litigation Strategy Post-Levine
For companies trying to avoid falling within the parameters of Levine, the key message is “Make a record.” Before litigation ever rears its head, drug and device manufacturers should consider what their interactions with the FDA will look like in a post-Levine world. Clearly, discussions between the FDA and the manufacturer and the extent of FDA involvement in the minutiae of the drug’s progression to market will become more and more important. With respect to labeling, manufacturers should be cognizant of the time lapsed between the FDA’s approval of the label for a drug or device; the more recent the approval, the more likely a manufacturer could argue successfully that there was insufficient newly acquired information to warrant a change to the label, as well as assert that the FDA’s labeling determination was authoritative. Manufacturers should also look at what data might be construed by a court as “newly acquired information” in light of Levine. In reviewing literature and reports of adverse events, manufacturers should take into account the potential applicability of Levine. Even if a manufacturer determines that the data does not meet its definition of “newly acquired information,” it should consider creating a record with the FDA regarding its decisions on labeling. Informal consultations with the agency, as well as more formal review processes, should be carefully memorialized and maintained with an eye toward creating a court record in future litigation. Finally, manufacturers should look at when and how supplements are submitted to the FDA, with the understanding that determinations not to voluntarily supplement under the CBE requirements are likely to be viewed with disfavor in future litigation. In sum, creating a record to support both decisions that did result in changes to labeling and, especially, decisions that did not result in changes should be on the mind of every manufacturer living in this post-Levine world.