Photo of Susanna Moldoveanu

Last week, FDA released for comment a draft guidance titled Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers.  FDA guidances are nonbinding recommendations without force of law, and this is only a draft.  Nonetheless, it addresses a frequent and important problem in our industry.Continue Reading FDA Releases Draft Guidance on Responding to Internet Hogwash

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Standing should not be a political issue.  Ensuring that someone who initiates a lawsuit has enough of a connection to the alleged harm for which they seek redress from a court is a key part of the broader constitutional concept of justiciability.  Because federal courts are courts of limited jurisdiction, they cannot decide just any

Photo of Michelle Yeary

No one can argue with that title because Bruno v. Bluetriton Brands, Inc., was most definitely dismissed completely on preemption grounds.  2024 U.S.Dist. LEXIS 98451 (C.D. Cal. May 6, 2024).  In so ruling, the court handed class action plaintiffs a significant defeat on of their latest litigation endeavors:  “microplastics” in water.  It’s not a

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When we tell people what we do, we often get a response, from lawyers and non-lawyers alike, to the effect of, “so you do class actions.”  The somewhat canned response is that “serial product liability litigations” or “mass torts” rarely involve certified classes other than settlement classes because individual factors in personal injury cases almost

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We have been following – and commenting about − the unprecedented attacks on the FDA’s authority to approve drugs (and by extension all the products the agency regulates) in the Alliance for Hippocratic Medicine v. FDA litigation pretty much since the first bizarre district court rulings about a year ago in Alliance for Hippocratic Medicine v. FDA, 668 F. Supp.3d 507 (N.D. Tex. 2023), aff’d in part & vacated in part, 78 F.4th 210 (5th Cir. 2023), cert. granted in part and denied in part, 144 S. Ct. 537 (2023) (hereafter “AHM I” and AHM II”).Continue Reading A Couple of Thoughts about the Comstock Act

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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?

Photo of Lisa Baird

Of late, the Fifth Circuit has come in for some criticism over rulings involving science, the FDA, and medicines.  But apparently even it has its limits—and Article III standing is one.

In Children’s Health Defense v. FDA, No. 23-50167, 2024 U.S. App. LEXIS 1528, 2024 WL 244938 (5th Cir. 1/23/24), a non-profit and several