The U.S. Supreme Court has a unique opportunity to clarify the standards for asserting that federal law preempts state-law tort claims.

In Merck Sharp & Dohme Corp. v. Albrecht, the court is considering whether the Food and Drug Administration’s decision rejecting certain proposed pharmaceutical labeling preempts plaintiffs’ state-law product liability claims. Specifically, plaintiffs allege that Merck should have warned of the danger of atypical fractures associated with its osteoporosis medication.

Merck maintains, however, that such claims are preempted by federal law because the company proposed, and the FDA rejected, certain warnings regarding fractures in patients taking its pharmaceutical product.

Wyeth Standard

While the trial court granted summary judgment on preemption grounds, the U.S. Court of Appeals for the Third Circuit reversed that decision. The Third Circuit reasoned that a defendant must show by “clear and convincing” evidence that plaintiffs’ claims were preempted, relying on language from the Supreme Court’s earlier decision in Wyeth v. Levine, which stated that there must be “clear evidence” to establish preemption.

The Third Circuit interpreted this standard as requiring a “high probability” that the agency would have rejected proposed labeling warning of the injury at issue. In doing so, the court arguably imposed a standard that was more stringent than that suggested by the Wyeth court and more stringent than that dictated by the U.S. Constitution.

Third Circuit: Issue for the Jury

In addition, the Third Circuit made clear that, in its view, claims regarding preemption are properly submitted to a jury. Accordingly, part of the Third Circuit’s reasoning for imposing such a high standard was that, in the event the standard is not satisfied, the preemption question may be submitted to the jury. As a result, under the Third Circuit’s decision, whether the FDA would have rejected additional warnings is an issue that would be addressed by a civil jury, rather than the trial court.

The Third Circuit’s decision thus tees up for Supreme Court review at least two important questions that warrant clarification: (1) the appropriate standard for establishing preemption, and (2) whether such questions are properly submitted to a jury.

These questions arise frequently in the product liability context and have the potential to impact a large number of cases. Moreover, the standard the Third Circuit articulated has the potential to unduly constrain the preemption doctrine, undermining the FDA’s authority to decide in a uniform, nationwide manner technical questions regarding the appropriate warnings that should accompany pharmaceutical products, and allowing lay juries to second-guess FDA decison-making.

Hints From Oral Argument

However, based on oral argument, it appears that the Supreme Court might not address these important questions in its forthcoming decision. During argument, the court focused almost entirely on a narrow factual issue: whether the proposed labeling Merck submitted to the FDA, which expressly warned of “stress fractures,” was sufficiently comprehensive to encompass “atypical fractures.” Many of the Justices suggested that Merck’s proposed language was sufficiently general to encompass atypical fractures and therefore the claims were preempted.

There was little discussion regarding the underlying legal issues—i.e., the appropriate standard for assessing preemption claims and whether such questions were appropriately submitted to a jury.

To the extent such questions were addressed at all, the justices indicated a skepticism regarding submitting preemption issues to a jury. Justice Stephen Breyer, in particular, indicated that it was problematic to allow civil juries to supersede the FDA’s authority to approve uniform warnings accompanying pharmaceutical products and impose different rules in different states. In addition, he noted that in many contexts mixed questions of fact and law are within the sole province of judges to decide.

However, it is not clear whether the court will address these fundamental legal questions or will limit its analysis to the narrow factual question regarding the record before it.

Clarification of these fundamental legal issues would be welcome. It is not clear that the Supreme Court intended to impose a particularly stringent standard for preemption in Wyeth. Likewise, it is not clear that preemption issues should be submitted to a jury.

Both issues are significant in the sense that preemption issues arise frequently in product liability cases like those at issue in the Merck litigation and because such litigation is prevalent. Supreme Court guidance on these issues would therefore be beneficial for both practitioners and the lower courts that are called upon to decide such questions.

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.