We have been mulling over Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024) and federal preemption.
Yes, we need a life, but let’s put that aside for the moment.
In particular, we’ve been reviewing a rash of complaints where plaintiffs contend that the FDA’s decisions about whether to grant or deny premarket approval
These days there are two topics that dominate legal conferences, presentations, and CLEs: artificial intelligence (AI) and Loper Bright. You will doubtless see us frequently bloviate about the former, but today’s case – American Clinical Laboratory Ass’n v. Food and Drug Administration, 2025 U.S. Dist. LEXIS 59869, 2025 WL 964236 (E.D. Tex. March
We recently examined one possible beneficial impact of the Supreme Court’s recent landmark decision in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024) – that it could bring about critical re-examination of the FDA’s questionably supported ban on truthful off-label speech.
Well here’s another one: Medtronic, Inc. v. Lohr, 518 U.S.
The Supreme Court’s recent landmark decision in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024), has generated more commentary than anyone could possibly read. Reed Smith alone has issued four Loper Bright alerts and established a resource center. Overall, we think that Loper Bright’s assertion that judges know better than administrative agencies how to interpret and apply those agencies’ organic statutes smacks of judicial triumphalism. However, it is what it is, and we’ll be living with it for some time.
Loper Bright essentially tells courts to ignore administrative interpretations and to give statutes “the reading the court would have reached if no agency were involved,” 144 S. Ct. at 2266 (citation and quotation marks omitted). One thing that we (and Mark Herrmann, who first suggested this topic) haven’t seen in any commentary on Loper Bright are the implications of that mandate on the FDA’s questionable basis for its ban on all “off-label promotion” – particularly truthful off-label speech – by the firms it regulates.Continue Reading Could Loper Bright Finally Do in FDA’s Rickety Off-Label Speech Ban?