After suffering serious kidney disease associated with the drug Lialda, Mark Blackburn sued the drug’s manufacturer, Shire US Inc. and related entities, for failure to warn under Alabama law. His complaint alleges that Shire’s labeling for Lialda was inadequate because the Warnings and Precautions section of the labeling failed to provide information about periodic testing necessary to protect against renal harm. Federal regulations allow drug manufacturers to update their products’ labeling, without prior approval, to strengthen warnings and precautions, and as the Supreme Court has held that a state-law failure-to-warn claim against the manufacturer of a prescription drug is not preempted absent clear evidence that the Food and Drug Administration would not have approved a labeling change to include the warning. Accordingly, both the district court and the Eleventh Circuit rejected Shire’s argument that Mr. Blackburn’s failure-to-warn claim is preempted.
After the appeals court ruled against it, Shire filed a petition in the Supreme Court. Serving as co-counsel in the Supreme Court, we filed an opposition to the petition, explaining that the petition misreads the Eleventh Circuit’s short nonprecedential decision and that the decision is correct. The Court will consider whether to grant or deny the petition at the start in October 2023, at the start of its next term.