The other day, we posted about, inter alia, the Department of Justice’s proposed jury instruction, in the Vascular Solutions case in Texas conceding the legality of truthful off-label promotion. In that post we asked, “Has anybody else seen the United States government make such a statement in a filed court document before?” Friend of the blog Andy Tauber at Mayer Brown took the time to respond affirmatively. He pointed out that, deep in its principal brief in the Caronia case, back in 2010 (that is, even before Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011)), the government conceded: “Promoting an approved drug for off-label uses is not itself a prohibited act under the FDCA, nor is it an element of any prohibited act.” Brief of United States, United States v. Caronia, Nos. 09-5006, 10-0750, 2010 WL 6351497, at *51 (2d Cir., filed Oct. 8, 2010).
Four years later, the government more or less reiterated its Caronia statement in a False Claims Act case with First Amendment implications, United States ex rel. Solis v. Millennium Pharmaceuticals, Inc., No. 2:09-cv-03010 (E.D. Cal.). On August 28, 2014, the government filed a brief that stated:
[O]ff-label promotion by a manufacturer is not by itself a violation of federal law. The promotion of an approved drug for an unapproved use, without more, does not violate the False Claims Act, nor is it among the comprehensive list of prohibited acts in the Food, Drug, and Cosmetics Act (FDCA).
United States’ Statement of Interest in Opposition to Amicus Curiae Brief, at 2.
Both of these statements are notable in that they are not even limited – as was the 2016 Vascular Solutions jury instruction − to truthful, non-misleading statements. On the other hand the government’s statements in Caronia and Millennium were made in support of arguments that truthful off-label promotion could be “evidence of intent” – an argument that did not fare well in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039, at *26 (S.D.N.Y. Aug. 7, 2015) (finding evidence of intent “beside the point” because in most cases a person’s motivation to engage in off-label promotion will be “obvious”; “[p]romoting such use, in fact, was transparently [the] intent” in Caronia). The most recent concession in Vascular Solutions, by contrast, stands alone, uninfluenced by any government claim of relevance to intent.
What these three government concessions do mean is that the days of courts making general, global statements that off-label promotion is “prohibited” should come to an end. Even last year we encountered courts still echoing a position that the government no longer holds. See Travelers Indemnity Co. v. Cephalon, Inc., 620 F. Appx. 82, 85 (3d Cir. 2015) (off-label promotion “generally prohibit[ed]”); United States ex rel. Modglin v. DJO Global Inc., ___ F. Supp.2d ___, 2015 WL 4111709, at *3 (C.D. Cal. May 8, 2015) (“FDCA . . . expressly prohibit[s] . . . manufacturers from marketing a PMA-approved device for an off-label use”). Such judicial observations, which can appear in anything from product liability, to FCA, to securities cases, are no longer true (if they ever were) – not even the government holds this position any longer. We now have three specific instances governmental concessions with which to repudiate such statements.