For some long-awaited events, a little time and distance can add a measure of clarity. Not always – many still are processing the Game of Thrones finale, with no end in sight. But over the past few weeks pharmaceutical products liability lawyers have had the opportunity to acquire some Zen and enlightenment about the Supreme Court’s highly anticipated preemption decision in Merck Sharp & Dohme, Inc. v. Albrecht, 2019 WL 2166393 (U.S. May 20, 2019). An initial description of the decision is here.
Here are some time-enhanced questions and reflections:
Thank you SCOTUS for removing the jury from the preemption litigation process. Juries are great, but the Third Circuit’s decision to invest them with authority to decide whether a claim is preempted was aberrational and ill-considered.
As the Supreme Court reasoned, judges’ legal training, knowledge and experience make them far better qualified to contextualize evidence of agency action. Having the jury decide what the FDA would have done with certain data, or why it did or did not take certain action at any given point in time, inevitably seems excessively speculative. Preemption should not hinge on jury guesswork and neither should tort liability. That seemed an implicit consideration in the decision.
What about preemption decisions in state courts? The Supreme Court did not need to address whether its requirement that judges decide the preemption issue is binding on the states – whether a contrary state allocation of responsibility would be precluded. Is the manner of deciding the preemption issue purely procedural? Is it bound up with the delineation of rights and obligations under the Supremacy Clause in prescription drug cases? Would allowing state court juries to decide whether a failure-to-warn claim is preempted by agency action threaten uniformity?
If the issue remains open, it seems fairly academic. Even if state courts were free to adopt a different rule, there is no good reason to do so. Jurors in the heat and passion of a personal injury trial are ill-suited to evaluate the meaning and operation of a statutory and regulatory scheme, the nuances of administrative law, and the import or likelihood of agency action. In other words, “in this context, [the] better-positioned decisionmaker is the judge.” Moreover, any underlying factual determinations − or as the Court put it, “brute contested facts” or “subsidiary factual disputes” – are properly considered subsumed within the court’s focused legal analysis. The Court’s “sound administration of justice” reasoning seems both universal and bulletproof.
The Court did not venture a broader discussion of policy or pragmatism in the allocation of adjudicative responsibility. But obviously deferring resolution of the preemption defense until trial, rather than making the issue amenable to summary adjudication, is an inefficient way to litigate. Indeed, as framed by the Third Circuit, the issue would have been virtually summary judgment−proof. It would be surprising if a state court disagreed.
My appreciation for the Court’s effort to elaborate on the “clear evidence” standard is a bit more muted. The Court acknowledged that it was cleaning up after the regrettably opaque explication of the “clear evidence” “standard” in Wyeth v. Levine, 555 U.S. 555 (2009), but the clarification was not very clear. Indeed, the Alito concurrence (three judges) found the majority opinion’s discussion of “clear evidence” itself to be “opaque” and described Wyeth’s use of the phrase as merely a “rhetorical flourish.”
The Court said that “in a case like Wyeth” impossibility preemption requires the “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.”
Perhaps this formulation incrementally improves on the Wyeth “guidance.” But it, too, will generate a host of questions and years of interpretive litigation. What exactly is “a case like Wyeth”? What is the required mechanism for this dialogue with the FDA, and how direct must that communication be?
The Court observed that the question of “method” was “not now before us.” But the Alito concurrence strongly suggested a flexible and pragmatic approach to this analysis; the Thomas concurrence, in contrast, reflected a narrow, rigid approach. So though Albrecht walked back the Wyeth language, it seems the various Justices embrace significantly different views on how, substantively, the preemption analysis operates and what types of agency action will trigger it. It is no wonder that the Court remanded the ultimate decision of the preemption issue back to the Third Circuit rather than wrestle with the question itself.
The opinion also exposed the rift between the Justices on the fundamental nature and scope of impossibility preemption. The majority opinion suggested that impossibility preemption exists when one sovereign requires an activity the other forbids. The Thomas concurrence theorized the issue with less polarity, juxtaposing “physical impossibility” with “logical contradiction.” The Alito concurrence implied a far looser – one is tempted to say more liberal – approach to the meaning of impossibility. Query what this split means for the scope of “frustration-of-purpose” preemption.
On one “clear evidence” point the Court was clear and seemingly unanimous – the Third Circuit was wrong to conceive of “clear evidence” as an expression of the level of persuasion required to support a finding. The Court found labels such as “clear and convincing” “highly probable” and “preponderance of the evidence” to be irrelevant because the issue was one of law, and the Court declined to “further define” the required showing. Presumably, any underlying or “subsumed” fact findings by the district court will be guided by a preponderance standard (and reviewed for clear error), but the Court did not specifically say so.
In assigning the preemption question to district courts, the Court reasoned in part that uniformity is a “virtue” in determining “the scope and effect of federal agency action.” Hopefully that theme will regain currency in substantive preemption analysis, as too narrow a preemption standard also threatens balkanization and chaos. Allowing serial juries too much authority to reach results inconsistent with the FDA’s label assessments can produce a 50-state patchwork of warnings and further variability as individual juries within the states reach inconsistent results, each based on their own independent vision of what drug labels should say.
The remand decision promises to be interesting. The District Court found “clear evidence” based on Wyeth, and the Third Circuit found a triable issue of fact. The Third Circuit can, theoretically, decide the legal issue de novo on remand, or it could, in turn, remand to the District Court for application of the Supreme Court’s guidance in the first instance.
Either way, Merck’s preemption case is strong. In 2008, the FDA allowed Merck to address the risk as an adverse reaction but not as a warning/precaution, which requires a higher level of scientific proof of a causal connection. The strong inference is that the agency considered the scientific evidence insufficient in 2008 to justify a warning and did not become convinced to change its mind until subsequent scientific developments, including a comprehensive review of the scientific evidence by its own expert panel, in 2010.
Plaintiffs’ primary argument against impossibility was supposition that the FDA rejected Merck’s proposed warning not for lack of proof of causation, but because it was dissatisfied with the text of Merck’s warning. The cynicism behind that argument is striking – it assumes the FDA in 2008 elevated form and technicality over safety and disregarded its statutory obligations and fundamental mission of protecting the public health. The Alito concurrence decimated this argument by invoking the “presumption of regularity” and a 2007 statutory amendment heightening the FDA’s obligation to act whenever the science is not accurately reflected in the label.
Plaintiffs’ argument also is inconsistent with the FDA’s response to Merck’s proposed warning in 2011. Now convinced that the science did justify a warning, the FDA rejected Merck’s proposed language – and ordered it back to the drafting board.
The Supreme Court’s guidance on “clear evidence” was long awaited and much anticipated, but not all that clear on the surface and even murkier with more depth. Perhaps, as with the Game of Thrones finale, some disappointment was inevitable. In both cases, we’ll look forward to the sequel.