June 6, 2019, Trial News
State law claims preempted only when FDA formally rejects drug label change, SCOTUS holds
In a unanimous decision, the U.S. Supreme Court held that a judge, not a jury, must decide whether there is clear evidence that the FDA would have rejected a drugmaker’s label change when there is a conflict between the plaintiffs’ state law claims and federal law requirements that would preempt the state law claims. The Court further explained that clear evidence requires that the drugmaker “fully informed the FDA” of why it proposed a label change and that the FDA then informed the drugmaker that it would not approve such a change.
In a unanimous decision, the U.S. Supreme Court held that a judge, not a jury, must decide whether there is clear evidence that the FDA would have rejected a drugmaker’s label change when there is a conflict between the plaintiffs’ state law claims and federal law requirements that would preempt the state law claims. The Court further explained that clear evidence requires that the drugmaker “fully informed the FDA” of why it proposed a label change and that the FDA then informed the drugmaker it would not approve such a change. (Merck Sharp & Dohme Corp. v. Albrecht, 2019 WL 2166393 (U.S. May 20, 2019).)
Merck Sharpe & Dohme Co. manufactures Fosamax, which is used to treat and prevent osteoporosis in postmenopausal women. The drug works by slowing the breakdown of old bone cells to reduce the risk of fractures and allow new bone cells to grow. However, the process may put women at risk for a different type of bone fracture—atypical femoral fractures (AFF)—because the slowed cell breakdown may cause usually minor fractures to become full bone breaks.
The FDA approved Fosamax in 1995, without a warning about AFF. At the time, there was theoretical evidence of the risk, but stronger scientific evidence was developed after Fosamax first entered the market. In 2008, the drugmaker submitted to the FDA an updated warning that included the AFF risk, but it was worded as “stress fractures,” which the FDA rejected, stating that Merck’s justification for adding the warning was inadequate. In 2011, an AFF warning was added to the Fosamax label—after the FDA rejected the “stress fracture” wording again, and Merck agreed to use the term “atypical femoral fractures.”
The plaintiffs in the case are more than 500 individuals who suffered AFF after taking Fosamax between 1999 and 2010. The plaintiffs allege state law failure-to-warn claims against Merck for not adding the AFF warning to the label before 2011. Merck contended there was clear evidence that the FDA would have rejected adding the warning to the drug label before 2011. Therefore, the drugmaker argued, federal law preempts the plaintiffs’ claims because it could not have complied with both state law and federal law.
The district court agreed and granted summary judgment for the defendant. On appeal, the Third Circuit reversed, finding that clear evidence was a matter of convincing the factfinder that the agency would have rejected the label and that it was a question for the jury to decide. The U.S. Supreme Court granted Merck's petition for certiorari to resolve whether the question of clear evidence was for a judge or jury to answer.
Much of the discussion about clear evidence centered on Wyeth v. Levine (555 U.S. 555 (2009)), in which the Supreme Court established this standard for determining whether the FDA would have rejected adding a warning to a drug’s label. The Court in Levine concluded that the FDA’s authority to approve or reject a label change did not automatically preempt claims under a state’s law, noting that Congress enacted the Federal Food, Drug, and Cosmetic Act and its amendments to protect consumers and that it could have included an express preemption provision if it had intended to override state law. Furthermore, Congress recognized that a drugmaker has a duty to warn consumers about a drug’s risk once it becomes apparent. Although the FDA can reject a warning, without clear evidence that it would have done so, it is not necessarily impossible for a drug manufacturer to comply with both federal and state law labeling requirements.
In Merck, the Court reinforced the clear evidence standard and clarified that it “is evidence that shows the court that the drug manufacturer fully informed the FDA of the justification for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.”
The Court also held that the clear evidence preemption determination is a matter of law for a judge to decide, not a weight-of-the-evidence issue for a jury. A judge must determine whether the federal and state laws at issue “irreconcilably conflict.” Explaining that the preemption question involves legal skills, the Court concluded that “judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination.” Even though facts may sometimes be relevant to this determination, the court acknowledged, “these factual questions [are] subsumed within an already tightly circumscribed legal analysis.”
This analysis requires an agency action to review—and the Court pointed out that this action must be within the realm of the agency’s congressionally delegated authority. While the Court did not explore the exact boundaries of an agency action in the FDA context, it did note that this would include formally rejecting a proposed label that would have sufficed under a state law.
Washington, D.C., attorney Matthew Wessler, who coauthored AAJ’s amicus brief in support of the plaintiffs, said, “For a decade, if not longer, it was not at all clear what kind of evidence was required before a court could hold that certain injury or defect claims were preempted under the medical device and drug laws, and Merck clarified some basic standards that need to apply before a court can agree with a drug manufacturer that it was impossible for it to comply with a state law obligation. And that is significant because courts had tended to just defer to drug manufacturers’ own claims that it would be impossible instead of actually requiring them to present clear evidence that the FDA itself had specifically rejected a proposed label that would have complied with state law. . . . The upshot of that is manufacturers now will face a stricter standard before they can establish preemption, and courts likely will not defer to manufacturer claims of preemption as easily as they have over the last 10 years.”
As to what evidence will qualify under the standard, Wessler explained that it’s still unclear but that the Court’s reference to “congressionally delegated authority” is especially important. “Justice Breyer, in his opinion, did cabin the scope and nature of the evidence that will count for impossibility preemption. He made clear—and not just him, but a six-member majority of the court signed on to this—that the only evidence that will count is actual congressionally authorized FDA action. That would include an actual promulgated rule that prohibits the manufacturer from including a particular warning on its label, or some other congressionally delegated action that the FDA has taken addressing the specific label and telling the manufacturer that it’s not allowed to include a proposed warning. And it takes off the table all sorts of informal communications that the FDA might make to a manufacturer; it takes off the table any effort to argue impliedly that the FDA through some regulatory action has rejected the label. So it has narrowed the scope and category of evidence that will count, but what specifically will satisfy that standard is something that I think is going to have to percolate down below in the lower courts as they grapple with this new standard.”