INSIGHT: Supreme Court Muddies the Waters on Preemption

More than a decade after its decision in Wyeth v. Levine, the U.S. Supreme Court finally addressed the issue of federal preemption in the context of pharmaceutical product liability claims in Merck Sharp & Dohme Corp. v. Albrecht.

Unfortunately, the court’s decision in Albrecht is less than clear and threatens to perpetuate some of the uncertainty that followed its earlier decision in Wyeth.

Judges, Not Juries, Should Answer Question

In Albrecht, the majority opinion authored by Justice Stephen Breyer garnered an unexpected coalition that included not only Justices Ruth Bader Ginsburg, Elena Kagan, and Sonia Sotomayor, but also Justices Clarence Thomas and Neil Gorsuch. These Justices agreed on the fundamental issue before the court, holding that whether federal law preempts state-law tort claims is an issue that should be decided by judges, not juries.

In so ruling, the court noted the preemption question was “primarily” a question of law and that judges were more competent than juries to interpret the administrative record. Accordingly, the court held that preemption was akin to other issues that are committed to judges rather than juries, such as the proper construction of patent claims and whether a criminal defendant’s confession is made voluntarily.

No Evidentiary Standard

However, in the process of making this clear cut decision, the majority also made statements regarding the standard for preemption that are likely to spur additional debate and confusion among litigants and the lower courts.

In Wyeth, the Supreme Court indicated that to establish that federal law preempted state-law tort claims, the proponent of the defense must produce “clear evidence.” In the years following the decision, much debate occurred in the lower courts regarding the meaning of this phrase and whether it was intended to impose a particular evidentiary standard.

In Albrecht, the court made clear that the language in Wyeth did not impose an evidentiary standard. As the court observed, because the preemption issue is primarily a question of law that should be decided by judges, not juries, it would make no sense to interpret the language in Wyeth as imposing an evidentiary standard.

Implications of Wyeth

Nonetheless, the court suggested that Wyeth implied certain requirements for preemption. In particular, the court in Albrecht indicated that federal law preempted state-law claims where the record showed the manufacturer had submitted proposed warnings to the FDA and the FDA rejected those warnings.

However, as Justice Samuel Alito observed in his separate opinion concurring in the judgment, the majority’s discussion regarding the standard for preemption was less than clear. Alito maintained that the majority opinion essentially implied that the “clear evidence” language in Wyeth was merely a “rhetorical flourish” and that the majority’s discussion of the preemption standard left many questions unanswered.

Foremost among these was whether FDA inaction could be a basis for preemption, given that the statutory framework required the FDA to impose additional labeling requirements when it was presented with information regarding risks not reflected in product labeling. More fundamentally, as Alito noted, the majority’s statements regarding the standard were well outside the scope of the question presented.

Accordingly, the decision in Albrecht is likely to raise further questions regarding what sort of administrative record is sufficient to establish the preemption defense. Moreover, it is likely to further encourage manufacturers faced with uncertainty to make increasing numbers of submissions to the FDA proposing additional warnings accompanying their products, even where the manufacturers believe that no additional warnings are necessary.

Unintended Consequences

To the extent the court in Albrecht made clear that such submissions may form the basis for a preemption defense, manufacturers may err on the side of over-submitting proposed warnings to the FDA in order to obtain the benefit of the defense.

However, such submissions may have unintended consequences. Aside from the obvious cost of the additional demands placed on the agency, as the FDA has observed, where such submissions result in overwarning, there may be potential public health consequences. As the agency has noted, overwarning in pharmaceutical product labeling can discourage patients and physicians from utilizing medications that may be beneficial. Accordingly, there are costs associated both with underwarning and overwarning in pharmaceutical labeling.

Moreover, courts after Albrecht are likely to continue to struggle in deciding what sort of record before the FDA is sufficient to establish preemption.

The Albrecht court arguably left the door open to a wide variety of potential arguments regarding the nature of agency action (or inaction) sufficient to trigger the preemption defense.

However, at the same time, the court made clear that such questions are committed to the courts, which cannot abdicate their responsibility by allowing juries to decide preemption questions.

This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.

Author Information

Douglas G. Smith is a partner in the Chicago office of Kirkland & Ellis LLP. He has litigated cases at both the trial and appellate stage in state and federal courts throughout the country, including commercial, mass tort, product liability, securities, bankruptcy, environmental, and intellectual property cases. The views expressed in this column do not necessarily represent those of Kirkland & Ellis LLP or its clients.