Ever since the FDA decided that discretion was the better part of valor – or read the handwriting on the wall – and decided not to appeal United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), to the United States Supreme Court, we’ve been wondering where the next First Amendment opportunity is going to come from. We doubted that the government would ever again be so stupid as to prosecute off-label promotion without a large dollop of fraud and/or falsity thrown in. Likewise, in private product liability actions, plaintiffs invariably allege (as opposed to prove) that any off-label promotion is false/fraudulent in one way or another.
The most promising spawning ground for future Caronias seems likely to be in False Claims Act (“FCA”) litigation. While FCA claims are ostensibly brought in the name of the government, agencies like the FDA have relatively little control over the allegations that FCA plaintiffs (called “relators”) make. Also, to increase their own take, such relators have the incentive to make the broadest allegations, which means they would like to avoid having to prove reliance on false information on a one-by-one basis. In pursuit of that objective, FCA relators have been trying for years to bring FCA claims over activities that aren’t really “false” at all in the dictionary sense of the word – but rather are allegedly illegal. Enter off-label promotion.
United States ex rel. Solis v. Millennium Pharmaceuticals, Inc., No. 2:09-cv-03010 (E.D. Cal.), is such a case. The allegations, as discussed in United States ex rel. Solis v. Millennium Pharmaceuticals, Inc., 2014 WL 1270581 (E.D. Cal. Mar. 26, 2014), are that the defendant drug manufacturer “caused” false claims to be submitted for federal reimbursement through off-label promotion that purportedly did not “properly disclose the dangers.” Id. at *2. The government declined to intervene, id. at *1, meaning: (1) that it thought the suit not worth pursuing, and (2) the relator was free to pursue whatever allegations he wanted. In Solis that turned out to be alleging promotion of off-label use through the dissemination of published articles in the medical literature. That may be “illegal” under the FDA’s constitutionally-suspect interpretation of the FDCA to ban off-label promotion categorically, but it’s damn hard to conceive of the distribution of peer-reviewed scientific articles as “false” in any sense that the First Amendment would recognize.
We’re not the only ones with an eye open for promising First Amendment openings to challenge the FDA’s ban on truthful scientific speech whenever it happens to involve off-label uses of the speaker’s FDA-regulated product. The Pharmaceutical Research & Manufacturers of America (“PhRMA”) is sick and tired of its members being shaken down for many millions of dollars by government “enforcement” actions seeking to monetize the FDA’s questionable interpretation. The risks are so great, due to penalties like debarment and the specter of FDA regulatory retaliation, that individual manufacturers can’t go to the mat with the FDA on First Amendment issues in government enforcement actions, and are forced to settle for ridiculous sums.
That’s not true in a private FCA action – particularly one that the government doesn’t think is worth the time and effort to pursue. Thus, on August 15, 2014, PhRMA filed an amicus curiae brief in Solis in support of the defendant’s motion to dismiss, arguing that the conduct in question was protected by the First Amendment, and therefore could not be the subject of an FCA (or any other type of) action.
PhRMA first placed Solis solely in the constitutional cross-hairs as a case alleging that the distribution of published, peer-reviewed scientific arguments could not possibly involve anything “false” under the First Amendment:
[N]either relator nor the government alleges that the speech at issue here − relaying reprinted articles about unapproved uses of the drug [in question] from peer-reviewed journals, and summarizing the results of clinical trials − was false or misleading. Relator and the United States do not even agree on why the FCA proscribes this speech, or how this speech somehow causes others to submit false claims. But their interpretations of the FCA share a critical flaw: both threaten core First Amendment rights and should be rejected under principles of constitutional avoidance.
PhRMA amicus br. at 2.
The relator was interpreting the FCA as deeming claims for reimbursement of off-label prescriptions “false” solely because the FDA interprets the FDCA as banning all off-label promotion. That interpretation had several steps: (1) truthful off-label promotion can “knowingly cause” submission of false claims, because (2) it is “reasonably foreseeable” that doctors would be influenced by such promotion to prescribe off-label; and (3) then submit claims for reimbursement of such off-label use to the government; therefore (4) the off-label promotion has “incited” the “illegal conduct” of submitting false claims. Id. at 5. Under this rationale it is “always foreseeable” that off-label promotion of any sort prompts “false” claims, because the whole point of promotion is to induce doctors to use drugs in the off-label manner being promoted. Id. PhRMA calls this approach unconstitutional. We would add “Orwellian” to the description, since inherent in this reasoning is calling the truth “false.”
Caronia shows up, for the first of many citations, squarely for the proposition that the FDCA does not – and cannot – ban all off-label promotion, specifically not information that is objectively true. PhRMA amicus br. at 3. PhRMA makes the same argument accepted in Caronia, and that readers have seen on this blog for years – the First Amendment does not permit the criminalizing (here through the FCA) of truthful off-label promotion:
These constitutional concerns are well-founded: “Speech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.” Sorrell [v. IMS Health Inc.], 131 S. Ct. [2653,] 2659 [(2011)]. Interpreting the FDCA to punish manufacturers for truthfully speaking about unapproved uses impermissibly restricts speech based on its content and the identity of the speaker, and thus triggers heightened scrutiny. Caronia, 703 F.3d at 164-65. The restriction is speaker-based because other individuals and entities − such as insurance companies, other doctors, and the government itself, among others − can and do speak to the same audiences about unapproved uses without running afoul of the law. Id. at 165 (“the FDCA permits physicians...
