Today’s somewhat unusual guest post is by Reed Smith‘s Matt Loughran.  It concern’s the Supreme Court’s 6-3 decision to permit the government to continue enforcement of its requirement that healthcare workers (at least those in facilities that accept Medicare/Medicaid, which is most of them) be vaccinated to avoid infecting themselves and their patients with COVID-19.  First, we recognize that we may be too strident in discussing what we consider the Court’s unprecedented judicial triumphalism − the view that courts and litigation can solve social problems better than the coequal bra ..read more

We light up a cigar maybe once a month. Of course, they’re no damned good for us. If we had any doubts, the headache and swamp-breath the next day would remove them. Still, a spirit of convivial dissipation tells us to smoke’em if we’ve got’em. No need to warn us off cigars, or the inevitable accompaniments of brown liquor, rich food, and bad behavior. That would be futile. The current issue of Cigar Aficianado has Sean Connery as James Bond on the cover. Connery, though our favorite incarnation of 007, is an odd choice, because Connery’s Bond smoked cigarettes (think of the introduction of “B ..read more

Administrative law is having a moment. Next year is the 75th anniversary of the Administrative Procedure Act (“APA”). We have mixed feelings about attending the party. The games will be saddled with unclear and unevenly applied rules. Instead of goody bags, we will be forced to disgorge treasure on the way out. But if there will be cake…. Enough constituencies now feel aggrieved by agency overreach so that current judicial nominees face probing questions about their positions on Chevron and Auer deference. The former is about deferring to agency interpretations of ambiguous statutes, while the ..read more

We seem to be having an administrative law moment at the DDL blog. That subject matter area is seldom sexy. It can be, frankly, quite dry. But administrative law can have a huge impact on drug and device law. Yesterday, Bexis discussed cases holding that agency rules that did not undergo required notice and comment procedures could not then be used to clobber defendants via False Claim Act claims. As the former Vice President once said in another context (because we are a G-rated, family-friendly blog, we will delete the expletive) this is a big deal. How else could administrative law ride to ..read more

We might not have even read the Supreme Court’s recent – and long and convoluted − agency deference decision, Kisor v. Wilkie, ___ S. Ct. ___, 2019 WL 2605554 (U.S. June 26, 2019), except that it tripped several of our automatic searches by citing both Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).  See Kisor, 2019 WL 2605554, at *5 n.2.  Kisor, after all, has nothing to do with prescription medical product liability litigation, it being an appeal from a denial of government benefits. But Kisor cited Riegel and Mensing as part of a st ..read more

We’ll get right to the point.  In Merck & Co. v. United States Department of HHS, ___ F. Supp.3d ___, 2019 WL 2931591 (D.D.C. July 8, 2019), the court held that the direct-to-consumer pricing regulation proposed by the Centers for Medicare & Medicaid Services (“CMS”) – on which we’ve commented here, and here – was an ultra vires exercise of nonexistent regulatory power.  Here are the key rulings: As to the existence of statutory authorization – nope.  “The plain statutory text simply does not support the notion − at least not in a way that is textually self-evident − tha ..read more