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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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If Mallory v. Norfolk Southern Railway Co., slip op. (June 27, 2023), were a prescription medical product case, it would probably qualify as the worst judicial decision since the Blog was created – due to its potential scope.  Since it’s not, Wyeth v. Levine, 555 U.S. 555 (2009), retains that title.  But because it does not arise from what we do, Mallory is in certain ways worse.  Not only does it give free reign to all litigation tourism in Pennsylvania, but it opens the door to any other state potentially to do the same thing.Continue Reading Litigation Tourism Lives – Mallory Reversed

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Since 2018, we have blogged several times about the federal government’s crackdown on abusive False Claims Act (“FCA”) litigation via motions for dismissal, and how the abusive relators have tried to resist those efforts.  Last week the Supreme Court ruled that, yes, the government does have the power to shut down rogue litigation ostensibly being conducted in the name of the United States of America.

All the federal government has to do is intervene and give a coherent reason why.Continue Reading Final Report From One FCA Front – As Another Front Opens

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Politics makes strange bedfellows.  So does the law.  Weird cases also make weird law.  The Supreme Court decision in National Pork Producers Council v. Ross, No. 21–468, — S. Ct. — , 2023 WL 3356528 (U.S. May 11, 2023) (“NPP”), evidences each of those old saws.  Deciphering just what the Supreme Court held entails…

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Today’s post is a little different in its format from what our readers are used to. What follows is a lightly edited (primarily adding full citations) version of a webinar presentation Bexis made recently for the “HLTh” Action Group of the Product Liability Advisory Council. The availability of this type of cutting-edge presentations is yet another reason why drug and medical device manufactures would be well served by joining PLAC. We’ve never been much for adding images to our blogposts, but here we have put together Bexis’ slides and speakers notes so that our readers can follow them more easily.

This post is a deeper dive into a preemption-related concern that we have raised before − how and why defendants can, and should, reconcile the beneficial holdings in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court.

For those of you accessing the Blog on mobile devices, this post may be hard to read. So, here are links to both the slide images and the accompanying text.Continue Reading Logical Contradiction Doctrine:  Buckman for Textualists

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Readers may recall our dissection of the ridiculous application of offensive, non-mutual collateral estoppel in Freeman v. Ethicon, Inc., 2022 WL 3147194 (C.D. Cal. 2022).  Ultimately, the thumb that Freeman put on the scale didn’t matter, because the defendant won at trial despite that handicap.

We described the prior adverse decision that formed the ground for the collateral estoppel claim as “factual findings entered by a state-court judge after a bench trial in earlier false-advertising and unfair-competition litigation.”  That description doesn’t really do the prior decision (in)justice.  That decision, People v. Johnson & Johnson, 2020 WL 603964 (Cal. Super. Jan. 30, 2020), decided an action filed by the California attorney general that had essentially converted the allegations that product liability plaintiffs had been making against the defendants’ pelvic mesh into the basis for a statewide civil action under certain California consumer protection statutes.  Here is the result of that decision, in a nutshell:Continue Reading Interesting Pelvic Mesh Due Process Certiorari Petition

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The Supreme Court’s latest foray into the constitutional thicket of personal jurisdiction, Mallory v. Norfolk Southern Railway, No. 21-1168 – to decide whether states can force corporations to “consent” to general personal jurisdiction via foreign corporation registration statutes − was orally argued on November 8, 2022.  The transcript is available here.  Since Bexis has been involved (as amicus curiae) in Mallory since the trial court’s favorable decision (which he made sure was on Westlaw and Lexis) was first appealed in Pennsylvania, we thought we’d review the highlights of the oral argument.Continue Reading Mallory Oral Argument – Litigation Tourists’ Last Stand?

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Last term the newly empowered conservative majority on the Supreme Court demonstrated to all that precedent is not so precedential, even when it had stood for nearly fifty years.  They very nearly did it again, but just missed, targeting precedent on religious exemptions and vaccine mandates that has been around for more than twice as long.Continue Reading Vaccine Mandates and Religion at the Supreme Court

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Three times previously we have “reported from the front” on the federal government’s efforts to dismiss False Claims Act litigation – ostensibly (and often ostentatiously) filed in the government’s name – after the government has concluded that the particular case is more bother than it is worth.  The most recent of those posts was late last year, and reported on Polansky v. Executive Health Resources, Inc., 17 F.4th 376 (3d Cir. 2021).Continue Reading The FCA Front Moves To The Supreme Court

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At the end of the term, the Supreme Court, in Ruan v. United States, 2022 WL 2295024,142 S. Ct. 2370 (2022), vacated the convictions of a couple of alleged “pill mill” doctors under the Controlled Substances Act upon finding that the government’s proof in their criminal trial did not meet the standard required…

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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