In our first-on-the-web quickie analysis of United States v. Caronia, ___ F.3d ___, 2012 WL 5992141 (2d Cir. Dec. 3, 2012), we didn’t have time to do much more than unwrap the Second Circuit’s early Christmas present. Now that we’ve had a little more opportunity to consider some (but not nearly all) of the implications of Caronia, we offer the following.
First and foremost, whatever anybody else might say, truthful off-label promotion is not all of a sudden “legal in the Second Circuit.” Caronia was one individual’s successful appeal of a criminal conviction for conspiracy to introduce misbranded drugs in interstate commerce. It was not a declaratory judgment action. Neither the FDA nor the Department of Justice has been enjoined from doing anything. The brave Mr. Caronia’s conviction has simply been vacated and remanded, rather than the action dismissed. Theoretically, if it could prove falsity, the Agency could even (ignoring such things as the statute of limitations or double jeopardy) prosecute the poor guy again. What Caronia actually held (as opposed to the court’s reasoning) was this:
[T]he government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.
2012 WL 5992141, at *15. It did this by construing the FDCA (and with it, the FDA’s regulations) “narrowly” to avoid having to declare them unconstitutional. That narrowing interpretation required that truth be a defense to a misbranding claim in the context of off-label promotion.
[E]ven if speech can be used as evidence of a drug’s intended use, we decline to adopt the government’s construction of the FDCA’s misbranding provisions to prohibit manufacturer promotion alone as it would unconstitutionally restrict free speech. We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.
Id. (emphasis added). Although it’s by no means 100% sure, it looks like Caronia’s narrowing interpretation (the court invoked a legal doctrine of construing a statute narrowly to avoid constitutional challenge, id. at *10) carves out a truth exception to the statute itself. So we’re probably incorrect to speak of a constitutionally mandated truth “defense.” That would imply that the burden of proving truth is on the defendant. By construing the statute as exempting “truthful off-label promotion,” it appears that falsity is now an element of off-label-related misbranding, with the burden of proof correspondingly falling on the government.
But we repeat, we’re only making inferences from what the Caronia decision appears to hold. It’s possible that truth as a defense (with the burden of proof on the defendant) could also be constitutionally permissible. We leave that to those with more experience in criminal and constitutional law than ourselves.
One thing that is clear – Caronia being a criminal case – so far the FDA’s civil enforcement mechanisms are untouched. Nor does Caronia have any direct impact on the government’s ongoing monetization of its First Amendment violations by way of the False Claims Act. Caronia is not a FCA case (even less does it involve a state FCA analogue). Nor, of course, does Caronia have anything other than persuasive effect outside of the Second Circuit. And in this regard even “Second Circuit” should be treated with caution. Both the DOJ and private FCA plaintiffs are adept at forum shopping. A company based outside of Connecticut, New York, and/or Vermont (the states of the Second Circuit) could easily face suits brought in its home state over promotional activities that occurred in a Second Circuit state.
And finally, Caronia is not a product liability action involving allegations of truthful (at least, according to our side) off-label promotion. Despite our best efforts, since we (well, Bexis) first conceived of a First Amendment defense in this context back in the mid-1990s, precedent recognizing the defense in product liability remains unfortunately rare.
Nonetheless, Caronia is the best jumping off point yet for the accomplishment of all of the above things.
If we don’t screw it up.
Anybody out there who uses Caronia as an excuse for engaging in problematic off-label promotion is not doing our side any favors. We need to be purer than Caesar’s wife for the duration, until the First Amendment protection of truthful scientific speech concerning off-label indications well established. As for suggestions on how to stay squeaky clean, we again recommend the FDA’s own Guidance on Reprint Practices, which we thoroughly reviewed here back in 2009. While that guidance directly relates to only scientific articles and textbooks, as we mentioned at the time, it contains a number of safeguards that could be adapted to any type of legal off-label promotion to ensure its accuracy and balance.
Why be careful?
Well in addition to the obvious (prosecution, fines, jail time, debarment, civil litigation, etc.) it would be unfortunate indeed to give the government evidence that it failed to marshal in Caronia. We sincerely doubt that the Solicitor General’s office, when presented with Caronia, will be very happy. Conversely, from our side, Caronia is a pretty good case on which to have the Supreme Court review the First Amendment protection of truthful off-label promotion.
First of all, most court records, and not just criminal records, are a lot messier than Caronia when it comes to the most important point – the truthfulness of the speech. That was the problem we ran into back in Bone Screw – it was easy for the plaintiffs to muddy the issue with claims that, in one way or another, the speech in question was (or at least a jury could conceivably find) false. See, e.g., In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781, 793-94 (3d Cir. 1999); Baker v. Danek Medical, 35 F. Supp.2d 865, 867-68 (N.D. Fla. 1998). It turned out that there were plenty of quicker and cheaper ways of winning those cases than pursuing the First Amendment angle. Not so in Caronia. The government didn’t even attempt to establish falsity. Rather the prosecution’s case was that all off-label promotion was illegal and proving that such promotion took place was enough. Caronia, 2012 WL 5992141, at *6-7.
Second, despite having its usual overwhelming resource advantage, the prosecution apparently did not take the First Amendment challenge in Caronia seriously before or at trial. In particular, First Amendment jurisprudence places the burden on the government to justify that an impingement upon free speech is narrowly tailored to achieve the government’s objective. Id. at *11 (“government cannot completely suppress information when narrower restrictions on expression would serve its interests as well”). If there’s any evidence in the Caronia record to support the proposition that banning truthful speech is essential to achieving those objectives (public health, preserving the FDA’s approval process), it’s very well hidden, since neither the majority opinion nor the more pro-government dissent cites to it.
Third, we like the atmospherics. Mr. Caronia is quite sympathetic as criminal defendants go. He only responded to inquiries. He told the truth. Nobody got hurt. Heck, the drug in question was never even prescribed, since the doctor who made the inquiries was wearing a wire for the government. Caronia, 2012 WL 5992141, at *4 (two conversations were “recorded” “between Caronia and Dr. Stephen Charno, a physician who, as a government cooperator, posed as a prospective . . . customer”). In short, it was a sting operation. Frankly, to us, the government acted sleazier than anything the defendant did – going to all this trouble over something that wasn’t very serious, and then prosecuting the lesser light after more active participants pleaded guilty. Id. at *6. For his horrible crime, Caronia received probation and was fined the grand sum of $25. Id. at *7. If this is how the DoJ spends its money, no wonder it tries to use drug and device manufacturers as ATMs.
So, assuming Caronia goes up, the government’s not in exactly a strong position to run some parade of horribles past the Supreme Court. There’s nothing in the record to support those arguments. Nor does the record reflect any evidence that the alternatives to the FDA’s speech ban mentioned by the court – providing independent safety information about questionable off-label uses, disclaimers, creating safety tiers among off-label uses (like Medicare does), disclosure of known off-label uses in the approval process, ceilings or caps on off-label use that would require submission for FDA approval, target bans of specific off-label uses – would be ineffective at achieving the government’s legitimate objectives. Caronia, 2012 WL 5992141, at *15 (pointing out “the absence of any support” for the government’s “conclusory assertions”). It really would be criminal (from our perspective) for anybody to engage in...
