On March 4, the United States Supreme Court handed down its much-anticipated decision in Wyeth v. Levine, holding that plaintiff Diana Levine’s state-law based failure-to-warn claims were not preempted by an FDA warning label. In response to the question of whether FDA judgments in the field of drug labeling “preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use,” the Court concluded that FDA’s approval of the label for Wyeth’s drug, Phenergan (promethazine), did not afford a complete defense to Levine’s claims.
Levine sought damages for pain and suffering and lost income resulting from the amputation of her forearm due to complications developed from the administration of Phenergan via IV-push rather than IV-drip method. Although Phenergan’s label warned that gangrene could result from an inadvertent intra-arterial injection of the drug, Levine successfully argued in a Vermont state court that Wyeth’s failure to include an explicit warning against IV-push rendered the drug unsafe. That jury found Phenergan’s labeling defective and awarded Levine $7.4 million.
On appeal, Wyeth argued to the Supreme Court that it would have been impossible to comply with both a state law–imposed duty to change Phenergan’s labeling and the warnings specifically approved by FDA. According to Wyeth, the conflict between state-law labeling requirements imposed by a jury and federal law requirements imposed by FDA regulations under which the label was approved required the dismissal of Levine’s claims. In addition, Wyeth argued that the state court’s verdict was an obstacle to achieving the full purpose and objective of Congress. Thus, Wyeth asserted that Levine’s state law claims should be dismissed on the basis of both conflict and obstacle preemption.
As a foundation of its opinion, the Court majority gave credence to “wo cornerstones of preemption jurisprudence. First, the majority emphasized that “the purpose of Congress is the ultimate touchstone in every preemption case.” After reviewing the legislative history of the federal regulation of pharmaceuticals, the Court concluded that there is not and has never been any Congressional intent to preempt state law in this area. In support of its conclusion, the Court noted that despite ample opportunities to do so, Congress has never enacted an express preemption provision in the context of prescription drugs, in contrast to the regulation of medical devices. Second, the Court relied upon the presumption against preemption in instances in which Congress has legislated in a field that states have traditionally occupied—here, the health and safety of its citizens.
In rejecting Wyeth’s contention that state law–based claims are federally preempted by conflict preemption, the Court found that FDA’s “changes being effected” (CBE) regulations provided Wyeth with the ability to comply with both federal and state law. To that end, the majority held that through the CBE process Wyeth could have unilaterally strengthened Phenergan’s warnings with reference to the IV-push administration method, subject to subsequent FDA approval, and that Phenergan would not have been misbranded if Wyeth had done so. The Court also emphasized that drug manufacturers have the primary responsibility for drug labeling, as opposed to FDA, and that drug manufacturers maintain a duty to ensure drug warnings are adequate as long as the drug is on the market. However, the Court noted that the ultimate authority remains with FDA to reject any labeling changes made by a drug manufacturer under the CBE regulations. Vital to the Court’s decision was its recognition that there was a lack of evidence that FDA would not have approved strengthened warnings regarding the IV-push method had Wyeth proposed them.
The Court also rejected Wyeth’s argument that Levine’s claims should be dismissed under the theory of obstacle preemption. Wyeth maintained that the purposes and objectives of federal drug labeling regulations would be obstructed if it had to comply with a state court’s imposition of additional warnings beyond those imposed by FDA. Turning aside this contention, the Court reiterated that Congress has never enacted an express preemption provision for the many decades in which the federal government has regulated the approval and use of prescription drugs. In so holding, the Court said that Congress “did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.”
Wyeth relied on a 2006 preamble to an FDA labeling regulation as evidence of the agency’s policy in favor of the preemption of state court lawsuits challenging FDA-approved drug labels. But the Court found that failure to notify states or interested parties or provide them opportunity to comment on FDA’s preamble made such pronouncements devoid of the weight or deference Wyeth sought to ascribe to this expression of FDA intent. Moreover, the majority stressed that FDA’s 2006 preamble contradicted FDA’s longstanding position that state law was not preempted in this area, a position it held at the time of Ms. Levine’s injury.
While each of Wyeth’s preemption arguments was rejected in this decision, the Court has not completely foreclosed future preemption challenges to state law–based failure-to-warn claims. Preemption claims remain viable in cases in which a factual record evidences FDA’s actual rejection of a proposed labeling change that a state court is asked to find necessary for a drug’s labeling to be sufficient. A federal preemption defense may also be viable when FDA rejects a labeling amendment made by a drug manufacturer pursuant to the CBE process.
Additionally, plaintiffs’ state law-based claims against generic drug manufacturers continue to be at risk for dismissal on the grounds of federal preemption. In regulations proposed in January 2008 and approved in August 2008 after notice and a comment period, FDA stated that generic drug manufacturers may not utilize CBE regulations to affect changes to a generic drug’s labeling, which must remain identical to the brand drug’s labeling. Thus, an implied preemption defense may continue to be available to generic drug makers even after the Wyeth v. Levine decision.