“Off label use” is a bit of an odd thing. The FDA does not regulate the practice of medicine, but it does get involved in the labeling of medical devices and pharmaceuticals through the applicable pre-marketing review processes, and those labels identify the use (or uses) intended for that medical product. That use (or
It is a whole lot harder to file documents under seal than it used to be. We recall an MDL in the early 2000s where the parties filed everything under seal over the course of multiple years—litigating for the viewing pleasure of our “friends and family,” as the district judge often chided us. Times have
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?
When Bexis sends around his weekly list of potentially bloggable cases, we always lunge for the criminal matters, which are fairly rare. Cases brought under Title 21 bring us back to our days at the U.S. Attorney’s office, where we knew nothing of billable hours, MDL case management orders, fancy office coffee machines, or an
We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. It’s an interesting topic; Eric recently wrote a paper on it, and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. From these exercises we concluded that a 50-state survey on intangibles as “products” for product liability purposes would be both doable and useful.Continue Reading How the Fifty States View Electronic Data as a “Product”
Time and time again, we have opposed efforts by one side of a scientific dispute – typically involving a prescription medical product – to attempt to sue the other side of that dispute into silence. We came to that position through the crucible of litigation, since plaintiffs in the Bone Screw litigation sought to sue a variety of medical societies because they supported the (at the time) off-label use of bone screws for pedicle fixation. We have tried to be consistent.Continue Reading Agree To Disagree – Don’t Sue the Other Side of a Scientific Dispute into Silence
About two months ago, we marveled at the notion that challenges to facially neutral state and local government vaccine requirements were still percolating through the legal system. We probably should not have been surprised by the persistence of frivolous litigation. After all, our day job entails defending litigations that can last years longer than they
Like most judicial clerks (and, for that matter, judges) we found writing dissents more fun than writing majority opinions. Dissents free one from the need to articulate a consensus. Moreover, since a dissent does not establish a precedent that others must at least pretend to follow, the dissent’s author can be less precise and can let the rhetorical fireworks fly. To reverse the Spider Man rubric, with lack of responsibility comes great power to write colorfully.
We clerked on the Ninth Circuit. The Ninth Circuit is often unjustly maligned. And yet the fact is that the Ninth Circuit more often than not gets things right. Put another way, not every Ninth Circuit dissent hits the mark. We certainly do not agree with the dissent to the denial of rehearing en banc in California Chamber of Commerce v. Council for Education and Research on Toxics, 2022 WL 14725243 (9th Cir. Oct. 26, 2022). But it is a fun read.
The underlying Ninth Circuit decision enjoined certain Proposition 65 litigation on first amendment grounds, and we discussed that decision last May. Here is a brief refresher: Proposition 65 requires postings of warnings about substances “known to the state [of California] to cause cancer.” You see those warnings pretty much everywhere in California. In truth, the warnings are so ubiquitous as to be useless. Continue Reading Ninth Circuit Dissent from Denial of En Banc re Injunction against Prop 65 Lawsuit: Sturm und Drang und Wrong
Despite our use of plural pronouns, almost all of our posts come from a single author. We occasionally have guest posts by multiple authors or a post that pairs one of us with a subject matter expert. For this post, however, all seven authors of the Blog are joining together.
We are just simple defense
California’s Proposition 65, which has spawned litigation over scientifically questionable “known to the state [of California] to cause cancer” warnings on such everyday products as cola drinks, coffee, beer, and soy sauce, see Riva v. Pepsico, Inc., 82 F. Supp.3d 1045, 1062 (N.D. Cal. 2015), took one on the chin recently in the Ninth Circuit at the hands of free speech under the First Amendment.
We can’t say it was unexpected – indeed, Prop 65 was one of the targets of the First Amendment’s prohibition on governmentally compelled speech that we identified in our 2019 post on American Beverage Ass’n v. City & County of San Francisco, 916 F.3d 749 (9th Cir. 2019) (en banc) (“ABA”). And lo it has come to pass.Continue Reading Ninth Circuit – First Amendment Prevails Over Prop 65