Janssen Pharmaceuticals v. A.Y.


(U.S., filed March 8, 2021): Urging the Court to address whether FDA regulations permit a manufacturer unilaterally to implement an off-label warning via a CBE or does the addition of an off-label warning require FDA approval.

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Court denied cert

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More Work Remains on Tort Reform

This letter-to-the-editor was originally published by The Herald-Dispatch in Huntington, WV. West Virginia was a mainstay on the American Tort Reform Foundation’s “Judicial Hellholes®” list for nearly 20 years, finally […]