Thursday is normally the day for our longer and meatier posts. However, the crush of business at the moment really is a crush. So we’re putting up something today that, frankly, doesn’t require as much work. Yesterday we provided our opinions about the latest First Amendment briefing in the Caronia off-label promotion case. We remarked that we were gratified that the industry itself – instead of just interest groups (kudos to the Washington Legal Foundation for engaging in a fairly lonely battle on this issue for years), criminal defendants, and miscellaneous bloggers like us – appeared to be getting into the game.
Our desire to see more First Amendment challenges to the FDA’s suppression of truthful commercial speech in this area is tempered by a countervailing concern not to see any newcomers screw up the law. Large companies with correspondingly large cases and large legal budgets, we don’t worry about much, but many FDA regulated entities whose free speech rights are being chilled by the threat of FDA enforcement aren’t so big.
So we’ve decided to do our bit to help by collecting the best First Amendment/off-label use litigation references that we know about and offering the here. That’s our toolkit.
First, some cases. For anyone even thinking about an FDA-related First Amendment challenge, the Supreme Court’s decisions in Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), and Thompson v. Western States Medical Center, 535 U.S. 357 (2002), are absolutely required reading. The relevant test, at least up until Sorrell, was stated in Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557, 566 (1980).
There are too many lower court opinions to cite them all, but a good place to start is with WLF v. Friedman, 13 F. Supp.2d 51 (D.D.C. 1998), partially mooted, 202 F.3d 331 (D.C. Cir. 2000), and WLF v. Henney, 56 F. Supp. 2d 81 (D.D.C. 1999), which are really part of the same case. Not as closely on point, but from an appellate court is, Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999). In the same category as Pearson we’d put Alliance for Natural Health U.S. v. Sebelius, 714 F. Supp.2d 48 (D.D.C. 2010). The District of Columbia federal courts are a frequent forum for litigating FDA issues, and they’ve been pretty friendly to the First Amendment so far.
There’s also a helpful discussion of the issue in United States v. Caputo, 517 F.3d 935 (7th Cir. 2008), but it’s dictum.
It’s not all sweetness and light though, as the district court decision being appealed in Caronia demonstrates, United States v. Caronia, 576 F. Supp.2d 385 (E.D.N.Y. 2008).
And finally, it has nothing to do with the First Amendment, but Richardson v. Miller, 44 S.W.3d 1 (Tenn. App. 2000), has what we’d describe as the most thorough discussion of off-label use by a court in a...
