Wednesday, May 22, 2019

Court Clarifies Preemption Standard in Pharmaceutical Failure-to-Warn Cases

The Supreme Court ruled on Monday that a drug manufacturer, in order to escape state-tort failure-to-warn liability, must show that "it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug's label to include that warning." The Court also ruled that this was a legal question for a judge, not an evidentiary (factual) question for the jury.

The ruling clarifies the standard that the Court set for "impossibility" preemption cases ten years ago in Wyeth v. Levine. In that case, the Court held that in order to show that a drug manufacturer could not simultaneously comply with federal and state requirements on drug warning labels--and that federal law therefore preempted state law--the manufacturer had to show "clear evidence" that the FDA would not have approved a change to the drug label (even as state law required it). Lower courts had trouble with the "clear evidence" standard--what it meant, and who (judge or jury) should apply it. Monday's case, Merck Sharp & Dohme Corp. v. Albrecht, clarified things a little.

The issue pits the FDA's authority to approve the contents of drug-label warnings, or to say that a manufacturer cannot include certain warnings, against state tort standards that require warnings in order to avoid failure-to-warn liability. As the Court explained:

The central issue in this case concerns federal preemption, which as relevant here, takes place when it is "impossible for a private party to comply with both state and federal requirements." The state law that we consider is state common law or state statutes that require drug manufacturers to warn drug consumers of the risks associated with drugs. The federal law that we consider is the statutory and regulatory scheme through which the FDA regulates the information that appears on brand-name prescription drug labels.

The Court in Wyeth v. Levine held that a manufacturer had to show "clear evidence" that the FDA would not have approved a warning in order to demonstrate that it couldn't simultaneously comply with federal law (rejecting a warning) and state law (requiring it). The Court on Monday elaborated:

In a case like Wyeth, showing that federal law prohibited the drug manufacturer from adding a warning that would satisfy state law requires the drug manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug's label to include that warning.

But the Court said that this isn't a traditional evidentiary or factual standard. Instead, it's a legal question, and it goes to the judge, not the jury. At bottom, then, a judge has to decide "whether the relevant federal and state laws 'irreconcilably conflic[t]."

This could be tough for manufacturers, given FDA labeling options. Under FDA regs there are at least two ways that a manufacturer might add a warning: through the FDA approval process; or through the "changes being effected" ("CBE") process, which allows a manufacturer unilaterally to strengthen a warning when there is "newly acquired information" about the drug (subject to later FDA review and approval). Moreover, the Court has been clear: the manufacturer bears ultimate responsibility for appropriate and sufficient warnings.

In this case, Merck went back and forth with the FDA on adding a warning about atypical femoral fracture to its label for Fosamax, an oral drug that slows the breakdown of old bone cells and thus helps postmenopausal women avoid osteoporotic fractures. Merck added a "precaution" about "low-energy femoral shaft fracture" through the FDA-approval process, but the FDA rejected Merck's request to cross-reference a longer discussion that focused on "the risk of stress fractures associated with Fosamax." (The FDA explained that "[i]dentification of 'stress fractures' may not be clearly related to the atypical subtrochanteric fractures that have been reported in the literature.") Merck added that change itself through the CBE process, but made no changes to the "Precautions" section of the label--the section at issue in this case.

On remand, then, the judge will have to apply the refined Wyeth v. Levine standard to these facts.

Justice Breyer wrote the majority opinion, joined by Justices Ginsburg, Sotomayor, Kagan, and Gorsuch.

Justice Thomas concurred, expressing his "skeptic[ism] that 'physical impossibility' is a proper test for deciding whether a direct conflict exists between federal and state law." Instead, he would look to a "logical contradiction" between the two.

Justice Alito, joined by Chief Justice Roberts and Justice Kavanaugh, concurred in the judgment only. He wrote to emphasize that Congress enacted legislation after Wyeth v. Levine that may bear on the preemption analysis, and to argue that the facts are somewhat more complicated than the majority opinion reflects. (Justice Alito dissented in Wyeth v. Levine. He was joined by Chief Justice Roberts and Justice Scalia.)

https://lawprofessors.typepad.com/conlaw/2019/05/court-clarifies-preemption-standard-in-pharmaceutical-failure-to-warn-cases.html

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