Written by: Ari Feinstein & Jane Dai, Ph.D.

On June 2, 2023, drug manufacturer Shire US Inc. and related entity Shire LLC (collectively, “Shire”) asked the Supreme Court to review an Eleventh Circuit ruling involving the interplay between state tort law and FDA regulations regarding drug labels. As framed by Shire, the question presented to the Supreme Court 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.” In order to appreciate what is at stake in this case, a brief summary of the key facts and procedural posture is necessary.

Shire’s Lialda is an FDA-approved brand-name drug for the treatment of ulcerative colitis. The Highlights section of the Lialda label includes “Warnings and Precautions: Renal impairment may occur. Assess renal function at the beginning of treatment and periodically during treatment.” Mark Blackburn was prescribed Lialda for treatment of Crohn’s disease, and was later diagnosed with stage-four kidney disease. Blackburn sued Shire in the United States District Court for the Northern District of Alabama, alleging, in relevant part, a state law failure-to-warn claim. Blackburn argued that the FDA-approved recommendation on the Lialda label for “periodic” kidney testing was deficient and that Shire should have utilized FDA’s “Changes Being Effected” (CBE) regulation to alter the label to recommend testing at more specific intervals. In district court, Shire moved to dismiss, arguing that federal law preempts Blackburn’s failure-to-warn claim, since it would require a change to the Highlights section of Lialda’s label that would be prohibited absent prior FDA approval. The district court agreed that federal law prohibited Shire from unilaterally changing the Highlights section, but it determined Shire could have changed the recommendation for “periodic” testing in the Full Prescribing Information section of the Lialda label through the CBE process. Ultimately, the district court granted summary judgment to Shire on state law grounds, holding that Blackburn had failed to establish a causal link between the allegedly inadequate warning and his injury. Blackburn v. Shire U.S., Inc., Case No. 2:16-cv-00963-MHH, 2020 WL 2840089 (N.D. Ala. June 1, 2020).

On appeal from the district court, the Eleventh Circuit disagreed with the district court's basis for entering summary judgment in favor of Shire and certified two state law questions to the Alabama Supreme Court. Blackburn v. Shire U.S., Inc., 18 F. 4th 1310, 1321 (11th Cir. 2021). On return from the Alabama Supreme Court, the Eleventh Circuit “reject[ed] Shire's alternative argument that it was precluded from changing the warning because it was contained in the “Highlights” section of the LIALDA label.” Blackburn v. Shire U.S., Inc., No. 20-12258, 2022 WL 16729466, at *3 (11th Cir. Nov. 7, 2022) (citation omitted).

In its petition to the Supreme Court, Shire argues the Eleventh Circuit’s 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 the FDA has admonished that such unilateral changes are impermissible precisely because the need for agency oversight is paramount in this context.” Arguing that the Supreme Court should decline to hear the case, Blackburn claims that Shire mischaracterizes both Blackburn’s arguments and the Eleventh Circuit’s decision. According to Blackburn, his claim and the Eleventh Circuit decision “concern[] the inadequacy of the Warnings and Precautions section [of the drug label.]”

If the Supreme Court declines to hear this case, Shire’s warnings that drug manufacturers could face increased pressure to make unilateral revisions to the Highlights sections of their drug labels in order 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, it will have an opportunity to clarify the bounds of federal preemption of state tort claims based on (allegedly) inadequate drug labels. The Supreme Court will likely decide whether to grant or deny the petition at the start of its next term in October 2023.

Editor: Brenden S. Gingrich, Ph.D.