Supremes May Hear Label Preemption Case: Attorneys

The Supreme Court is likely to decide at the beginning of its term in 10/2023 whether to hear Shire’s appeal from an 11th Circuit Court of Appeals decision in a case involving state failure-to-warn law and the Highlights section of a drug’s labeling. That’s the projection of attorneys Ari Feinstein and Jane Dai (Knobbe Martens) in an online post.

The question Shire wants the high court to consider is whether a state law claim is preempted if it places a duty on a drug manufacturer to unilaterally change FDA-approved language that appears in the Highlights section of a drug label. The question arises from a suit involving the company’s Lialda (mesalamine), indicated to treat ulcerative colitis.

At issue is a statement in the Highlights section of the labeling saying that renal impairment may occur from using the drug, and renal function should be assessed at the beginning of treatment and periodically during treatment.

A patient who was prescribed Lialda for Crohn’s disease and later developed stage-four kidney disease sued Shire in Alabama federal court alleging, in part, a state law failure-to-warn claim. The patient argued that the recommendation for periodic kidney testing was deficient and that Shire should have used the “changes being effected” (CBE) regulation to change the label to recommend testing at more specific intervals.

Feinstein and Dai say Shire moved to have the case dismissed, arguing that federal law preempted the failure-to-warn claim since the company cannot legally change the label without FDA approval. The district court held that federal law prohibited the company from unilaterally changing the Highlights section, but also found that Shire could have used the CBE process to change the recommendation for periodic testing in the full prescribing information of the Lialda labeling.

Ultimately, the district court granted summary judgment to Shire on state law grounds, saying that the patient failed to establish a causal link between the allegedly inadequate warning and kidney cancer.

On appeal, the 11th Circuit disagreed with the district court’s basis for granting summary judgment, and certified two state law questions to the Alabama Supreme Court. On return from the state supreme court, the attorneys write, the 11th Circuit rejected Shire’s alternative argument that it was precluded from changing the warning because it was in the label Highlights section.

Appealing to the Supreme Court, Feinstein and Dai write, Shire said the 11th Circuit decision “is plainly wrong, to put it mildly” and that drug manufacturers “will now face increased pressure to make unilateral and potentially confusing revisions to the Highlights sections of their drug labels, even though FDA has admonished that such unilateral changes are impermissible precisely because the need for agency oversight is paramount in this context.”

The attorneys conclude that if the Supreme Court declines to hear the appeal, Shire’s warnings that drug manufacturers could face increased pressure to make unilateral revisions to the Highlights sections of their drug labels to reduce their risk exposure to failure-to-warn claims (and other state tort claims) could become a reality. “If the Supreme Court decides to hear the case,” they say, “it will have an opportunity to clarify the bounds of federal preemption of state tort claims based on (allegedly) inadequate drug labels.”