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At the end of the term, the Supreme Court, in Ruan v. United States, 2022 WL 2295024,142 S. Ct. 2370 (2022), vacated the convictions of a couple of alleged “pill mill” doctors under the Controlled Substances Act upon finding that the government’s proof in their criminal trial did not meet the standard required

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We’ve seen many plaintiffs allege that drug and/or medical device manufacturers committed “fraud on the FDA” and bemoan that Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), prevents them from recovering based on such allegations.  Buckman still doesn’t prevent them from trying every form of evasive legal chicanery known to man to

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Here’s another quasi-guest post by Reed Smith’s blogger-in-training Dean Balaes.  This one provides a critique of the scary Park doctrine, aptly described here as “Frankenstein’s Monster,” that allows imposition of criminal liability on corporate officers for illegality they didn’t even know about.


In 1816, Mary Shelley and Lord Byron entered into a wager to

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As we mentioned before Bexis spoke earlier this week at the ACI Promotional Review Summit on the “Brave New World . . . Post-Amarin” – that is to say, about the First Amendment and off-label use/promotion.  Just about all our readers know that Bexis has been a long-time First Amendment advocate with respect to truthful off-label speech, since the beginning of this blog, and before.

We’re not going to rehash any of that.  There are, however, a couple of new First Amendment developments that we learned about at the conference that we want to pass along.  The first is that the Ninth Circuit (or at least a panel of that notably fractious court) has fallen into line behind Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011), and recognized that Sorrell strengthened First Amendment protections for commercial speech – at least where it’s truthful, which is the assumed cornerstone of our position on off-label promotion in the first place.

The new case is Retail Digital Network, LLC v. Appelsmith, ___ F.3d ___, 2016 U.S. App. Lexis 140, slip op. (9th Cir. Jan. 7, 2016).  It’s not about drugs, devices, or the FDCA, but rather about alcoholic beverage advertising.  At issue was another absolute ban on commercial speech that failed to take truth or falsity into consideration.  The state of California, in order to prevent kickbacks and other preferential treatment (taking the state’s professed interest at face value), flatly prohibits manufacturers of alcoholic beverages from any paid advertising at retail establishments.  Id. at *2-3 (citing Cal. Bus. & Prof. C. §25503(f)-(h)).  Almost 30 years ago the Ninth Circuit held this provision constitutional under the pre-Sorrell commercial speech test established in Central Hudson Gas & Electric Corp. v. Public Service Comm’n, 447 U.S. 557 (1980).  See Actmedia, Inc. v. Stroh, 830 F.2d 957 (9th Cir. 1986).  Retail Digital, however, held that Sorrell toughened First Amendment protections.  The Actmedia decision was “clearly irreconcilable” with Sorrell, because “Sorrell requires heightened judicial scrutiny of content-based restrictions on non-misleading commercial speech regarding lawful products, rather than the intermediate scrutiny” of Central HudsonRetail Digital, 2016 U.S. App. Lexis 140, at *3.

Continue Reading Latest First Amendment Off-Label Notes – Has DoJ Finally Come Around?

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I’m posting this at the behest of our DoJ readers.  Congratulations are in order.
Please congratulate Paul Shapiro, who, after a one-week trial, successfully prosecuted Dr. Abdur Razzak Tai, convicting him on all 13 counts of mail and wire fraud today.  Tai is a physician who specializes in cardiology and who practices medicine in

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A great Chicagoan, Ernie Banks, was famous for saying “Let’s play two” – an expression of pure joy about the game of baseball. Another great Chicagoan, Judge Richard Posner, recently came out with a pair of opinions that brought us some joy and reminded us of what good legal reasoning and writing looks like. In