The Supreme Court of the United States recently decided Merck Sharp & Dohme Corp. v. Albrecht et al., in an effort to further clarify the “clear evidence” standard as it relates to pre-emption of federal law over state law. Nine years prior to the Court’s decision in Albrecht, the Supreme Court decided Wyeth v. Levine, 555 U.S. 555 (2009)., where the “clear evidence” standard was established requiring a drug manufacturer to demonstrate “clear evidence” that the FDA would not have approved a change to the drug’s warning label, in order to preempt a state law claim for an inadequate warning.
In Wyeth, the Supreme Court decided an issue pertaining to an antinausea drug, “Phenergan,” and the failure of the manufacturer to amend warnings accompanying the drug to reflect new research indicating the risks of administering Phernergan by an IV-push method. The manufacturer chiefly argued that it could not comply with federal law and state law simultaneously, stating that the Food and Drug Administration (“FDA”) did not permit the amendment of warnings without approval, while state law mandated that a drug manufacturer warn consumers of the change-related risks associated with using the drug.
Ultimately, the Wyeth Court found the manufacturer’s contentions to be meritless, as it was possible for the manufacturer to comply with both federal and state mandates given the “changes being effected” (“CBE”) regulation that governs drugs approved by the FDA. The Court found that the agency’s CBE regulation permitted certain preapproval labeling changes that add or strengthen a warning to improve drug safety. Pursuant to the CBE regulation, Wyeth could have unilaterally added a stronger warning about IV-push administration, and there was no evidence that the FDA would ultimately have rejected such a labeling change.
The Court established the “clear evidence” standard, requiring that a drug manufacturer show “clear evidence” that the FDA would not have approved the change to the drug’s warning label in order to establish the defense of preemption. The Court did not discuss what constituted “clear evidence,” or whether it would be considered by a judge or jury. These omissions thus lead to varying lower court applications of the standard.
Albrecht presented the Court with a similar issue and sought to reconcile this confusion. Chiefly, the Supreme Court was to determine whether a judge or jury should be permitted to decide if the FDA improperly disapproved of an amendment to the drug “Fosamax’s” warning label in the face of evidence that existed detailing the potential dangers of the drug. “Fosamax” was a drug manufactured by Merck Sharp & Dohme Corp (“Merck”) primarily prescribed to treat and prevent osteoporosis in postmenopausal women. Following their development of “atypical femoral fractures,” more than 500 individuals who took Fosamax commenced suit against Merck, alleging that state laws imposed a legal duty to warn them about the risk of atypical femoral fractures associated with using Fosamax. Merck conceded that the CBE regulation would have permitted them to try to change the label to add a warning, yet the FDA would have rejected that attempt, rendering their efforts moot. In their defense, Merck argued that federal law should pre-empt the state law failure to warn claim asserted by plaintiffs, as FDA regulations would have made it impossible for Merck to also comply with state law. The District Court agreed with Merck’s pre-emption argument and granted summary judgment to Merck. However, The Third Circuit ultimately disagreed and opted to vacate and remand.
Given the inherent complexity of administrative agency processes, the Supreme Court held that judges are more aptly equipped to evaluate the nature and scope of an agency’s determination. Since judges are normally familiar with principles of administrative law, such a mandate produces greater uniformity among courts; upon a drug manufacturer’s attempt to use a pre-emption defense as their basis for their inability to amend a drug’s warning label, a judge, rather than a jury should make the determination of whether the FDA was justified in prohibiting the amendment.
Though the decision was merely a clarification of Wyeth, Albrecht serves to further vest power in the judiciary, and should aid drug manufacturers in their attempt to utilize the pre-emption defense in the future. By placing the “clear evidence” determination firmly in the hands of the bench, drug manufacturers may now be able to avoid liability for failure to amend warning labels on drugs they manufacturer, so long as they provide the proper information to FDA, and the FDA finds that such an amendment is not justified. For more information on this topic, please contact MK&C’s Tom Emala at (973) 822-1110. Special thanks are in order to MK&C’s Summer Associate Angel Hierrezuelo for editorial and research work on this article.