It’s the holiday season, and we’re getting in the festive spirit. We like old-school jingle in our jangle (even though that’s not necessarily holiday themed), more recent, unquestionably holiday-focused jingle jangle, and even first-gift of Christmas jingle, But there may be nothing more festive than a rock-solid preemption win—particularly one from California. We think this one will put a spring in your step and a sparkle in your smile. Continue Reading Jingle Jangle, California OTC Preemption
Back in our AUSA days we prosecuted many drug cases. That was a significant part of our job. The defendants were uniformly unsavory and many were violent. That being said, the mandatory minimum sentences were often crazily high. Sell 50.1 grams of crack and eat ten years. If you had a prior drug conviction (hardly
Unfortunately, the Third Circuit now seems to have a fetish with the presumption against preemption. Not long after the Supreme Court abolished that presumption in express preemption cases in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016), the Third Circuit refused to go along. See Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 771 n.9 (3d Cir. 2018) (finding Puerto Rico v. Franklin not controlling because it was not a product liability case). Since then, as we discussed here, every other circuit court to address the issue has recognized the demise of the presumption against preemption in express preemption cases – several of them doing so in product liability litigation. The Third Circuit stuck out like a sore thumb.
Then along came Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019). In our initial “breaking news” post when Albrecht was first decided, we pointed out an interesting fact. Among other things, Albrecht spent several pages restating and reworking the Court’s poorly reasoned Wyeth v. Levine, 555 U.S. 555 (2009), decision. See Albrecht, 587 U.S. at 310-13 (“describing” Levine for four pages). Levine, of course, had been the high water mark of the presumption against preemption, which it called a “cornerstone” of “pre-emption jurisprudence” generally. 555 U.S. at 565. But nowhere in Albrecht’s discussion of Levine – indeed, nowhere in the Albrecht decision anywhere – did the Court even mention any presumption against preemption. (If you don’t believe us, search Albrecht for “presum!”) As we said then, “conspicuously absent from that description is any express reference to any ‘presumption’ (as opposed to the older ‘assumption’) against preemption.” So on that issue, be believe that the Court in Albrecht actually pulled back from that presumption.Continue Reading Challenging The Role of the Presumption Against Preemption in Fosamax
We have no personal knowledge of the litigation concerning GLP-1 receptor agonist medications and the Blog has not posted on it yet, but we do know something about litigation over widely used prescription medications. Over the decades, there have been many drugs or classes of drugs that became “blockbusters” because they were widely prescribed to
Note: There is a table in this post that may be easier to view on a phone than on a computer.
Medical device preemption provides powerful protection from litigation involving Class III devices with premarket approval (or “PMA”).
These devices are a very small subset of FDA-regulated medical devices – around 1% — and they
Long ago, a senior partner told us that clear writing flows from clear thinking. That might be so, but clear thinking and clear writing do not necessarily produce the correct result. For example, you’d have a tough time finding a legal opinion written more clearly than Calchi v. Topco Assocs., LLC, 2024 U.S. Dist.
We do not mean the German Renaissance painter and thinker Albrecht Dürer. His work, while a poor cousin to that of some famous contemporaries to the south, remains as is. We mean the Supreme Court’s decision in Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019), which has been touted for the
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.
Even though lawyers who bill for their time defending product liability cases might favor those cases sticking around and plaintiffs getting many chances before inevitable dismissals with prejudice, we have been clear that we think plaintiffs should not get to re-plead around preemption once courts have defined the preempted path. There seems to be an
As regular blog readers know, we love a clean grant of a motion to dismiss on preemption grounds. They are relatively common, so it sometimes puzzles us that the plaintiffs’ bar keeps filing plainly preempted claims.
Perhaps some of these plainly preempted lawsuits get filed because the express preemption provision of the FDCA related to