We’ve only discussed Shady Grove Orthopedic Associates, P.A. v. Allstate Insurance Co., 559 U.S. 393 (2010), a couple of times. Shady Grove, displaced – in federal court – a variety of state-law limitations on class actions because those restrictions were at odds with Fed. R. Civ. P. 23, and in federal
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
In his latest off-label use-related law review article in 2021, Bexis pointed out:
[A]lthough states have traditionally been recognized to have broad authority to regulate the practice of medicine, aside from occasional attempts to restrict use of abortifacients, state-law interventions restricting the off-label uses of prescription medical products have been infrequent.
James M. Beck, “Off-Label
We weren’t expecting to find anything bloggable when we reviewed the Supreme Court’s recent unanimous decision in Smith & Wesson Brands, Inc. v. Estados Unidos Mexicanos, ___ U.S. ___, 2025 WL 1583281 (U.S. June 5, 2025). But we were struck by the familiarity of the allegations of illegal marketing that the Court in S&W held could not be passed off as “aiding and abetting.” These were the same tired and repetitive allegations of purported “illegal marketing” by independent actors in the distribution chain that we have seen in so many drug/device cases – sometimes masquerading as “public nuisance.”
We think our clients can use S&W against such allegations, at least by analogy.Continue Reading Unanimous Supreme Court Slaps Down Familiar Sounding Marketing Allegations In Landmark Gun Decision
We have learned, through repeated harsh experience (e.g., Mallory, Wullschleger, Harrington) that while the current Supreme Court can be described as “conservative,” that hardly means that it is pro-business. Indeed, it appears that when the issue is p-side forum-shopping, the Notorious RBG (opponent of all things preemption) was far more
The Supreme Court elucidated
It could be a first-year civil procedure question: The removability of a case to federal court is determined as of the moment of removal – nothing thereafter can defeat removal. See, e.g., St. Paul Mercury Indemnity. Co. v. Red Cab Co., 303 U.S. 283, 292 (1938) (a plaintiff cannot “deprive the district court of jurisdiction” “after removal” “by amendment of his pleadings”); 14A C. Wright & A. Miller, Federal Practice & Procedure §3721, at 213 (2d ed. 1985) (once “a case has been properly removed . . . plaintiff[s] cannot successfully do anything to defeat federal jurisdiction and force a remand”).
That is precisely what the petitioner in a pending United States Supreme Court matter, Royal Canin U.S.A., Inc. v. Wullschleger, No. 23-677, is asking the Court to hold. Oral argument in the Royal Canin case is occurring today. For more details, including copies of all pleadings, see the SCOTUSblog page.Continue Reading Under the Radar SCOTUS Removal Issue
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.
Last July we published a “Here’s Hoping” post that maybe the terrible decision in Atchley v. AstraZeneca UK Ltd., 22 F.4th 204 (D.C. Cir. 2022), allowing drug companies to be sued for purportedly “aiding and abetting” international terrorists (see our takedown of Atchley here), would fall in light of the Supreme Court’s
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?