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One of the intriguing things about cases decided by a jurisdiction’s highest court is that pronouncements by such courts can often have far-reaching implications.  Sometimes they pan out, as the application of the First Amendment to the FDA’s ban on off-label promotion seems to be doing following Sorrell v. IMS Health, Inc., 564 U.S.

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Sometimes we get an opinion back from a court, and the reasoning leaves us scratching our heads and wondering, “Where did that come from?”  In the opinion, the court has decided the case on something that neither party ever argued.  We blogged about a case like that once, here.  In that case at least,

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We’ve blogged about the United States Supreme Court’s pending personal jurisdiction cases before.  Well, they pend no longer.  Yesterday the Court unanimously (with a couple of concurrences) ruled that resident plaintiffs injured by products originally manufactured and sold elsewhere could sue a nationwide company like Ford – that “purposefully avail[ed] itself of the privilege

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We recently came across the law review article, E. Lindenfeld, “Clear Evidence Clarified,” 75 Food & Drug L.J. 346 (2020).  Since it cited and critiqued a number of our blogposts, we thought it was appropriate to reply.

Our initial impression is that the Lindenfeld article is comparatively reasonable – that is, compared to some prior

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Since we were involved in the Medtronic Infuse wars, we’ve been quite aware of Justice Gorsuch’s textualist views towards statutes since he wrote Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015).  In Caplinger he got a close look at the damage the Supreme Court had done to the plain meaning of the