As we roll out of bed on the day after Thanksgiving, we are often confronted with contradictory thoughts. For instance, “why did I have that third plate at dinner?” might be followed by “How can I eat some leftovers for breakfast?” Leftovers are as much of an American tradition on this day as watching videos
Off-Label Use
So-Called “Death Panel” Affirmance Explores Off-Label Use Boundary
Although they have nothing to do with the Affordable Care Act, health-care-related so-called “death panels” do exist. These panels are operated by state agencies and private health insurance companies, and they decide whether to reimburse as “medically necessary” (or some similar definition) any type of medical care that comes into question. They’re an unfortunate necessary…
Feds Make Ominous First Amendment Waiver Argument
We’ve complained before about the federal government’s monetization of First Amendment violations in the context of truthful promotion of off-label uses:
[T]he government has ruthlessly monetized its questionable ban on truthful off-label promotion for quite a few years now. Indeed, the government has used this ban as the basis for a creeping administrative takeover of
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Potentially, the Mother of All Off-Label Uses, as FDA Backs Down
Researchers at Temple University here in Philly recently published a scientific article, “Learning Impairments, Memory Deficits, and Neuropathology in Aged Tau Transgenic Mice Are Dependent on Leukotrienes Biosynthesis: Role of the cdk5 Kinase Pathway,” in the scientific journal Molecular Neurobiology. That sounds pretty dense, but what the article concludes is that the generic drug…
Third Time Not Quite the Charm
This post is from the non-Reed Smith side of the blog.
We’ve posted on two other occasions about the Shuker v. Smith & Nephew case as the Eastern District of Pennsylvania systematically dismantled the case on the grounds of preemption and pleading deficiencies. You can find those posts here and here. Unfortunately, the recent…
FDA Proposes to Delay Off-Label “Intended Use” Rule
Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but it is also true for drug and device litigation regulation. Such drug and device regulation can be just as important, if not considerably more important, than whatever current political…
Double Preemption Win in Amiodarone Litigation
With PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), preemption arguments in cases involving generic prescription drugs has become a little like shooting fish in a barrel, as our generic preemption scorecard documents. Still, that’s no reason not to praise good results. …
Off-Label Marketing Case Tossed
FDA Weighs in on Off-Label Use and Preemption
Back in 2013, Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. 2013), made it to #9 on our worst cases of the year list – which is pretty good (actually, pretty bad) for a trial court decision. Purporting to apply Stengel v. Medtronic Inc., 704 F.3d 1224, 1228-31 (9th Cir. 2013)…