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The title is ridiculous, but unfortunately true.

Muldoon v. DePuy Orthopaedics, Inc., is a suit over “hip-replacement surgery conducted in 2007.”  2024 WL 1892907, at *1 (N.D. Cal. April 30, 2024) (“Muldoon II”).  Suit was not filed, however, until 2015 – undoubtedly Muldoon is another example of the flotsam and jetsam dredged up by MDL lawyer solicitation.Continue Reading 15 Years After the Fact, This MDL Remand Case Is Still at the Pleading Stage

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On March 18, 2024, the Supreme Court heard argument in a matter, National Rifle Association of America v. Vullo, No. 22-842, that from its caption would seem to have nothing to do with our sandbox.

But it might.

One of the issues before the Supreme Court in NRA is whether administrative action, labeled only as “guidance” (in NRA, certain letters issued by the head of the New York State banking agency) were sufficiently coercive – despite not being presented as anything “final” – that they could unconstitutionally restrict speech in violation of the First Amendment.  Appellant NRA, represented by the American Civil Liberties Union (among others), contends that the defendant “issued formal guidance letters” that “promised enforcement leniency” and  “urged” the banks it regulated to cease doing business with the NRA for political reasons.  Petitioner’s Br., at 1.  Even though this “guidance” neither had nor claimed to have force of law, it had the desired effect – causing regulated entities to do what the government wanted for “fear of losing our license to do business.”  Id. at 8 (citation and quotation marks omitted).

To us, the analogy is obvious. The FDA also relies heavily on “guidance” that it likewise considers non-“final,” and has similarly done so in ways that impinge on First Amendment-protected speech.Continue Reading Could the Supreme Court Blindside the FDA on the First Amendment?

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Sometimes there are decisions that we begin to read with an expectation—perhaps based on a thumbnail from Bexis—that we will have a strong impression.  Not surprisingly, the expected impression is usually negative.  This was the case with Apter v. HHS, No. 22-40802, 2023 U.S. App. LEXIS 23401 (5th Cir. Sept. 1, 2023), which concerned

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The case we discuss today, Doe v. Ladapo, 2023 WL 3833848 (N.D. Fla. 2023), appeared in our daily search results because it briefly addresses off-label use of prescription drugs. Invalidating a state statute that would have prohibited a particular off-label use, the court explained that “[o]ff-label use of drugs is commonplace” and the fact

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The Orthopedic Bone Screw litigation would never have occurred – and Bexis might never have found his way to prescription medical product liability litigation – if not for the Kessler-era FDA’s ill-considered salami slicing of the “intended use” of that product.  In that instance, the FDA had limited its cleared “intended use” to disc spaces