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 and academics, for example, to speak about off-label use without consequence”).  The restriction thus “has the effect of preventing [pharmaceutical manufacturers] − and only [pharmaceutical manufacturers] − from communicating with physicians in an effective and informative manner.” Id. (quoting Sorrell, 131 S. Ct. at 2663). And the restriction is content-based because it penalizes companies for disseminating information only about unapproved uses.

PhRMA amicus br. at 3 (footnotes omitted).

The particular speech involved in Solis, distribution of scientific articles and summarization of clinical trial results, is particularly protected as scientific speech.  Everyone involved in such research, except the manufacturer of the drug being studied, “can speak about the reprints and trial results as much as they wish.”  Id. at 4.  The government has had its biggest problems when it’s tried to ban this kind of scientific speech as “off-label promotion.”

If that is what the FDCA means, it is hard to imagine a more discriminatory restriction on speech that performs a vital role in the practice of medicine.  The government long ago “admit[ted] to the importance of ensuring the availability of [peer-reviewed medical journal articles discussing unapproved uses] to physicians and health care providers making prescription and treatment decisions.”   Washington Legal Foundation v. Henney, 56 F. Supp.2d 81, 85 (D.D.C. 1999), vacated as moot by 202 F.3d 331 (D.C. Cir. 2000).  And “the fear that people would make bad decisions if given truthful information cannot justify content-based burdens on speech.”  Sorrell, 131 S. Ct. at 2670-71 (internal quotation marks omitted).

PhRMA amicus br. at 4.

To avoid constitutional problems PhRMA advocates that the court emulate the judicial restraint taken in Caronia and take one of two steps to reconcile the FDCA with the constitution:

  • Construe the FDCA as prohibiting, at most, only false speech (that’s what Caronia did, as we discussed here).
  • Construe the meaning of “false” in the FCA as excluding off-label promotion.

PhRMA amicus br. at 4.

The “reasonably foreseeable” incitement rationale for truthful off-label promotion supposedly creating “false” claims can’t fly because foreseeability isn’t enough for “incitement” – the unlawful conduct must be “imminent.”  Id. at 5-6.  No way that happens where the speech identified the use as off-label and did not say “boo” about government reimbursement.  Id. at 6.  There is no “imminence” where scientific speech promotes an off-label use (which is itself legal and often the medical standard of care) to a doctor.  Rather any connection to submission of a “false” claim is “remote and attenuated”:

Physicians who received the reprints or other information from the manufacturer in this case received precisely the type of educational information that a trained physician would wish to receive about his patients.  Physicians were not only free to disregard these reprints; their Hippocratic Oath obligated them to use their own, independent medical judgment as to whether a given prescription was warranted.  And after those physicians prescribed the FDA-approved drug for an unapproved use, hospitals then made additional, independent determinations whether the prescriptions were reimbursable.

PhRMA amicus br. at 6.  “Foreseeability” is a tort concept, not a First Amendment concept.

PhRMA then addresses the “evidence” excuse that the government likes to trot out to argue that it’s ban isn’t really a ban because the government has discretion when to prosecute (and which Caronia rejected).  This “evidence” rationale is particularly inapposite to the FCA context because of the additional step of somebody else seeking federal reimbursement.  The relator “does not − and cannot − point to any act (other than truthful speech) by the manufacturer that allegedly ‘caused physicians to submit false claims.’  The only basis for liability identified in the Complaint is the manufacturer’s speech itself—as relator repeatedly acknowledges.”  Id. at 7.

The only cases advanced for the contrary proposition, involving an assault combined with racist speech and speech promoting an entirely unapproved drug, were just that – combination cases.  In both situations the speaker was also engaged in other criminal activity.  That’s not the case when the speech is solely off-label promotion.  Somebody else must make an independent medical judgment that the off-label use is therapeutically proper in a given patient.  Then another somebody else must come to an independent conclusion that the doctor’s use is also reimbursable under some relevant federal program.  That’s not “evidence” of action – or of anything.  It’s speech only, and at best an “incitement” of other persons that fails under the First Amendment’s “imminence” prong.  Beyond that, it’s truthful, and independently protected as scientific speech.

When PhRMA’s brief came in, the government went bonkers.  It filed a responsive brief on August 28, characterizing PhRMA’s relatively straightforward First Amendment argument as seeking “a constitutional right to knowingly cause other parties to submit false claims to the government, as long as a party does so by its speech.”  United States’ Statement Of Interest In Opposition To Amicus Curiae Brief Submitted By [PhRMA], copy here, at 2.  Yet it didn’t point to anything in the promotion that went beyond an off-label use (entirely legal) or that even mentioned reimbursement.

Interestingly the government made what – for it – is a huge concession right at the beginning:

[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).

Government br. at 2 (emphasis added).  We’ve seen all too many courts make overbroad statements like “the FDCA prohibits off-label promotion.”  E.g., Mendez v. Shah, 2014 WL 2921023, at *6 (D.N.J. June 27, 2014); Blankenship v. Medtronic, Inc., 2014 WL 1226491, at *4-5 (E.D. Mo. March 25, 2014); Eidson v. Medtronic, Inc., 981 F. Supp.2d 868, 884 (N.D. Cal. 2013); Brady v. Medtronic, Inc., 2014 WL 1377830, at *6 (S.D. Fla. April 8, 2014) (taking one from each circuit).  Well, you know what?  So that it could make its “evidence” argument, the Department of Justice just agreed with us that every one of these cases is flat wrong.

After Caronia the government has been knocked off its prior absolutist rhetoric and now claims only that off-label promotion can be “evidence” of [fill in the blank of whatever illegal activity is at issue].  So the government stated in Solis that “promotional speech may be used as evidence to prove that a manufacturer knowingly caused the drug to be put to a certain use and billed to a Government health care program for such use, under circumstances in which the use is not covered and the claim is not eligible for reimbursement.”  Government br. at 2.

The rabbit goes into the hat with “knowingly causes.”  The promoter doesn’t do anything illegal.  It doesn’t tell anybody else to do anything illegal.  The government conveniently forgets that off-label use is legal.  The government cites (br. at 3) Wisconsin v. Mitchell, 508 U.S. 476, 489 (1993).  The speech in that case was racial epithets that increased an assault into a hate crime.  The government cites (br. at 4) United States v. Barnett, 667 F.2d 835 (9th Cir. 1982).  The speech at issue in Barnett was how to manufacture an illegal drug – an illegal act in and of itself.  The government also cites (br. at 4) Rice v. Paladin Enterprises, Inc., 128 F.3d 233 (4th Cir. 1997), often described as the “hitman case.”  The speech in Rice was advertisements soliciting murder for hire – another illegal act.

Repeat:  off-label use is legal.  Murder, assault, and making illegal drugs are not.

Based on this false analogy of speech about legal acts with speech about illegality, the government claims that the sky (or at least the Republic) will fall if it can’t use “foreseeability,” as opposed to the First Amendment’s incitement standard, as the test for “knowingly causes”:

If a course of conduct were constitutionally protected as long as it was effectuated through the use of speech, vast areas of federal and state law would be invalidated.  For example, the Sherman Act’s basic criminal prohibition against “contact[]s, combination[s] …, and conspirac[ies] in restraint of trade” (15 U.S.C. § 1) would become largely unenforceable [sic], because anti-competitive agreements are normally carried out through and embodied in speech among the participants.  Similarly, criminal conspiracy law would fall by the wayside, if statements by two parties agreeing to a criminal course of action were to be treated as protected speech.

Government br. at 3.  This would happen because, the government argues, “the types of statements that underlie anti-competitive agreements and criminal conspiracies may all be perfectly truthful.”  Id.  Wow.  That’s pretty scary.  But the analogy only works if the speech is about something illegal, which off-label promotion simply isn’t.

Repeat:  off-label use is legal.  Restraint of trade and whatever is the object of a “criminal” conspiracy are not – the former by statute and the latter by the definition of the offense.  The only way to make the huge logical leap from legality to illegality in Solis is by jumping to something that’s ot mentioned in most (if not all) off-label promotion at all – reimbursement of the prescription sought by yet another person.  This Tinker-to-Evers-to-Chance form of “causation” requires use of foreseeability.  There’s no way that meets the imminence test.  It would be like banning advertisements for rifle ranges, karate, or maybe the movie Scarface, because someone might decide to do something illegal with the knowledge (truthful) so obtained.

PhRMA recently replied to the government’s brief in Solis, see here.  Not without reason it contends that the government “grossly misstated” its argument.  PhRMA Reply br. at 1.  Where speech is sought to be banned due to its effects (here “knowingly cause”) on the actions of third persons, “the First Amendment demands a direct causal nexus between the speech and the claim.”  Id.

Rather than respond to this argument, the government attacks a straw man: it accuses PhRMA of advocating a First Amendment right to shield all speech from sanction, no matter how closely connected to unlawful conduct.  But there is an obvious distinction between speech (even truthful speech) that incites illicit conduct − which is unprotected − and speech that encourages lawful conduct in the form of medically appropriate treatment − which the First Amendment plainly protects.

Id.

Thus, the government’s argument “is at least as radical as the position [it] invents for PhRMA.”  Id.  Why is that?  Because the scope of the government’s foreseeability-based causation test for a “false claim,” which ignores truthfulness, would turn anybody’s speech about off-label use into a FCA action:

[T]he government’s interpretation has no rational stopping point.  FCA liability would attach to any speech to doctors about any unapproved use of any FDA-approved medicine. Fellow doctors, patient advocacy groups, insurance companies, and the medical journals themselves all foreseeably distribute the same information to doctors as manufacturers do.  They all would be just as liable for inciting false claims under the government’s stated theory.

Id. at 1-2 (emphasis original).  Only the applicability of the First Amendment’s imminence test for incitement prevents the government (or FCA relators) from suing into silence anybody saying anything about off-label use.

PhRMA’s position in Solis thus came down to this:  all the defendant did was speak truthfully.  It didn’t break the law (the government having admitted that off-label promotion isn’t per se illegal).  It didn’t tell anybody else to break the law (off-label use being 100% legal).  Nothing was being prosecuted except the defendant’s speech.  Absent evidence satisfying the “imminence” standard for incitement, a truthful speaker cannot be punished for the illegal acts of others, even if those acts were “influenced” in some tort-foreseeable way by the speech.

If that isn’t the law, then free speech isn’t nearly as free as almost everybody in the country thinks it is.

Solis might well be the next Caronia.  Despite the government’s best efforts to avoid scrutiny, because it couldn’t control the FCA relator’s allegations in Solis, the question of liability for truthful off-label promotion is once again squarely presented.  PhRMA hopes, and the government fears, that the constitutional infirmities in the FDA’s ban on all off-label promotion will again be litigated and more importantly appealed.  We’re on the next bench behind.  We think that, under the Supreme Court’s decisions in Sorrell and Thompson v. Western States Medical Center, 535 U.S. 357 (2002), the FDA’s goose is already cooked, as Caronia demonstrates.  The First Amendment protection of truthful off-label promotion is bound to be recognized, sooner or later.  Once that is settled, assuming it ever is, then under New York Times Co. v. Sullivan, 376 U.S. 254 (1964), tort plaintiffs will have no more ability to predicate liability on such truthful speech than the government does.