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 constutitional 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 Cæsar’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 ReprintPractices, 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 impingment 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 egregious off-label promotion and thus to hand the government anything with which to supplement the meager record that it seems to have constructed for itself.
* * * *
We also promised to take a look at the dissent in Caronia, since the dissent would contain the arguments we’re most likely to see from the government, should the case be appealed further. The dissent’s primary argument is really an attempt to dodge the whole speech ban issue, by characterizing it not a ban at all, but merely as “using speech as evidence of motive or intent.” Caronia, 2012 WL 5992141, at *15. The majority dealt with that argument with extensive citations to the record demonstrating that, in this particular case, the government used the off-label promotion (the speech) itself as the offense, and not merely as evidence of an intent to misbrand the drug in some other (unspecified and frankly impossible to discern) way. Id. at *9-10.
But even if the government had only used speech as "evidence of intent," we don’t think that makes any difference in the context of off-label promotion. The speech/evidence would relate to “intended use” and only to that (no other element of the misbranding offense is mentioned). That’s what the FDA’s regulation 21 C.F.R. §201.5 explicitly states. But the intended uses of a drug are not really in dispute in this sort of litigation. The on-label ones are those stated in the label itself. Where, as in Caronia, the existence of the off-label promotion is not disputed, the unlabeled “intended use” is likewise undisputed. See 2012 WL 5992141, at *18 (intended use was undisputed). So the entire distinction collapses because “intended use” is congruent with misbranding (since an off-label use by definition does not have the “adequate directions for use” necessary to avoid a misbranding charge).
So, to us, the “evidence of intent” argument smacks of a distinction without a difference, since the evidence relates to an element of an offense that is not seriously in dispute. That off-label promotion was the heart and soul of the government’s case belies it solely being relevant to the undisputed element of “intended use.” The dissent cites a case, Wisconsin v. Mitchell, 508 U.S. 476, 489 (1993), but a quick look at Mitchell shows that intent was very much in dispute – it was a hate crime case, and the speech was used as evidence of motivation specifically by racial animus. Likewise the FDCA cases cited by the dissent are inapposite. Both Whitaker v. Thompson, 353 F.3d 947 (D.C. Cir. 2004), and United States v. Writers & Research, Inc., 113 F.3d 8 (2d Cir. 1997), involved products that had no FDA approval for anything being promoted for medical use, and United States v. An Article ... Consisting of 216 Individually Cartoned Bottles, 409 F.2d 734 (2d Cir. 1969), was not only a totally unapproved product, but had nothing to do with the First Amendment as it preceded the first commercial speech case by seven years. As the majority took pains to point out, its ruling did not extend First Amendment protection to promotion of completely unapproved products for medical uses. Caronia, 2012 WL 5992141, at *15 (decision “is limited to FDA-approved drugs for which off-label use is not prohibited”).
Thus, it's plain that much of the dissent is directed at a straw man – promotion not of off-label uses, but of unapproved products – those without any evidence (in the form of FDA approval) of safety or effectiveness for anything medical. Snake oil is one thing; off-label use is something else entirely. The dissent’s failure to cite even a single real off-label use case is telling. Evidently none of them support the dissent’s argument.
Besides, as the dissent acknowledges, id. at *17, the FDA’s intended use language has been “unchanged for sixty years.” Sixty years ago, First Amendment protection of corporate speech of this nature was not even a glimmer on the horizon. Plainly, the FDA regulation upon which the Agency’s wholesale prohibition of truthful speech is based was drafted with no consideration whatever of First Amendment concerns that did not exist at the time.
Later, the dissent goes after another straw man:
There might be no law forbidding the consumption of arsenic. But this would not endow Abby and Martha with a First Amendment right to offer arsenic-laced wine to lonely old bachelors with the intent that they drink it.Caronia, 2012 WL 5992141, at *21. Really. There is a law against murder, however. More to the point, its difficult to see what truthful speech could accompany an offer of an arsenic-laced product. Reductio ad absurdum can sometimes be a valid form of argument, but here it’s just absurd.
In this context, where the FDA and DoJ treat off-label promotion as prima facie proof of an unapproved “intended use” without need for any other evidence – and plainly did so in the Caronia prosecution − the dissent’s proffered distinction between “direct regulation” of speech and “speech as evidence of intent” is (as the majority rightly held) truly a distinction without a difference. The right of free speech is simply too important to be chilled by such hair splitting.
Finally, at around page *23, the shoal of red herrings disperses and we reach the dissent’s First Amendment analysis. Oddly, the dissent doesn’t address “heightened scrutiny” under Sorrell v. IMS Health, Inc., 131 S.Ct. 2653 (2011), which was a separate and independent basis for the majority’s ruling. Caronia, 2012 WL 5992141, at *12-13. Instead, the dissent jumps right to intermediate scrutiny of commercial speech under Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980). So after noting this gaping hole in the dissent’s analysis, we’ll do the same.
The dissent invokes the “central feature of the FDCA” – the FDA’s “rigorous premarket approval process.” Caronia, 2012 WL 5992141, at *23. Fine. We don’t disagree that this is a “substantial” government interest under First Amendment analysis. Neither did the Caronia majority. Id. at *13 (“preserving the effectiveness and integrity of the FDCA's drug approval process” satisfied this prong of Central Hudson). The dissent then states, with no analysis, that the ban on truthful off-label promotion “directly advances” this interest. But as the majority points out, the FDA’s ban is shot through with holes – literally anybody, other than the FDA-regulated manufacturer, may advocate an off-label use for any reason. Caronia, 2012 WL 5992141, at *12 (pointing out, in the context of the prohibition being “speaker-based” under Sorrell, that “physicians and academics” are free to discuss off-label use). But it’s worse than that. If we wanted, this blog could promote off-label uses for any reason at all, with no valid evidence at all, because we aren’t FDA regulated.
A speech ban that’s shot full of holes simply doesn’t “directly advance” the government’s interest in suppressing whatever information is being banned. See Greater New Orleans Broadcasting Ass’n v. United States, 527 U.S. 173, 190 (1999) (ban on casino advertising failed because of the number of exceptions); Rubin v. Coors Brewing Co., 514 U.S. 476, 489-90 (1995) (ban on advertising the “proof” of alcoholic beverages failed for same reason); Bad Frog Brewery, Inc. v. New York State Liquor Authority, 134 F.3d 87, 99 (2d Cir. 1998) (ban on one form of vulgarity failed because of “the wide currency of vulgar displays”). We could cite more, but that’s enough to make the point.
Without acknowledging these cases, the dissent seeks to avoid them by arguing that only manufacturers could “undermine” FDA approval by “not participating in it.” Caronia, 2012 WL 5992141, at *24. Oh really? We seem to recall the FDA making the same arguments recently before Congress in connection with pharmaceutical compounding. Similar arguments didn’t stop the Supreme Court from striking down the FDA’s ban on advertising of such compounding under Central Hudson in Thompson v. Western States Medical Center, 535 U.S. 357 (2002). Thus, we don’t think that concerns over the FDA’s ability to force manufacturers to seek approvals of drugs (or intended uses of drugs) alone suffices to overcome the First Amendment. Given the myriad of medically accepted off-label uses out there (many rare diseases have no on-label treatments at all), it hasn't been all that effective in any event.
Rather, we think that the key question under Central Hudson is whether something more narrowly tailored than a flat global ban on any statements (truthful or otherwise) about off-label use by regulated manufacturers (the FDA's apparent unwritten definition of “promotion” – which may in itself be too vague to survive Due Process) could accomplish that purpose just as well.
The prohibition of off-label promotion is thus not simply a “paternalistic” attempt to shield physicians and patients from truthful information. Rather, it is a necessary tool for the effective functioning of a regulatory system that the Supreme Court has endorsed as legitimate.
Caronia, 2012 WL 5992141, at *25. OK, prove it. In a Central Hudson challenge, the government bears the burden of proof. Despite Mr. Caronia’s long-standing First Amendment objections, and the prosecution’s overwhelming resource advantage, nothing in the record bears out this quasi-apocalyptic declaration. Why are none of the alternatives offered by the majority not effective? Id. If the dissent were an expert report, it would fail Daubert. General Electric Co. v. Joiner, 522 U.S. 136, 146 (1997) (“nothing . . . requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert”). For instance, the dissent states that “[a] ceiling on off-label prescriptions would require collecting data from countless numbers of doctors and patients.” Coronia, 2012 WL 5992141, at *25. Perhaps, but that kind of data collection was exactly what Sorrell was about. Data miners already collect and sell prescription-specific data to drug companies, so the existence of any huge practical problem is questionable. It’s simply speculation in the absence of any record basis.
The dissent also states that a ban on off-label use “would constitute an unprecedented intrusion into the practice of medicine, and would result in perhaps an even greater restriction on speech.” Coronia, 2012 WL 5992141, at *25. We agree with the first part of that statement (indeed, as to devices, the FDA lacks that authority, 21 U.S.C. §396), but the second part doesn’t follow. A ban on the act of off-label use – assuming it could be enacted (Ohio did it in an abortion-related context) – has nothing to do with speech.
Finally, the dissent states:
Congress intended the FDA approval process to prevent dangerous products with false or misleading labels from entering the market, and also to provide a base of reliable, objective information about prescription drugs that could help physicians and patients identify potentially misleading claims.
Coronia, 2012 WL 5992141, at *26. We think that’s completely tautological. It assumes what it’s trying to prove. The whole point of Coronia is that a ban on truthful off-label promotion is unconstitutional. To the extent that the dissent equates truthful speech with “false or misleading labels,” it’s positively Orwellian – that proposition, “truth is false,” would fit in nicely with the other slogans on the wall of the Ministry of Truth. The only way to justify such a statement, from a First Amendment perspective, is to argue that off-label promotion is inherently misleading. That just isn’t so. Even the district court in Caronia didn’t buy that. United States v. Caronia, 576 F.Supp.2d 385, 397 (E.D.N.Y. 2008) (“[p]romotion of off-label uses is not inherently misleading simply because the use is off-label”), rev’d on other grounds, 2012 WL 5992141 (2d Cir. Dec. 3, 2012). Literally dozens of cases have held that off-label promotion isn’t inherently false, fraudulent, or misleading. We complied them here not too long ago. We agree with the conclusion of one of the first First Amendment cases involving off-label promotion:
In asserting that any and all scientific claims about the safety, effectiveness, contraindications, side effects, and the like regarding prescription drugs are presumptively untruthful or misleading until the FDA has had the opportunity to evaluate them, FDA exaggerates its overall place in the universe. It is certainly the case that by statute, no drug may be introduced or delivered into interstate commerce without FDA approval, and that the claims that a manufacturer may make about a drug through labeling, advertising and other forms of promotion are subject to FDA regulatory authority. However, the conclusions reached by a laboratory scientist or university academic and presented in a peer-reviewed journal or textbook, or the findings presented by a physician at a CME seminar are not “untruthful” or “inherently misleading” merely because the FDA has not yet had the opportunity to evaluate the claim. . . . [T]he FDA is not a peer review mechanism for the scientific community.Washington Legal Foundation v. Friedman, 13 F. Supp.2d 51, 67 (D.D.C. 1998), vacated in part as moot after the FDA abandoned its position, 202 F.3d 331 (D.C. Cir. 2000). In short, there is no legal basis for the dissent’s implication that off-label promotion, by its nature, is inherently misleading.
* * * *Finally, we need to comment on the 360 article on Caronia (subscription required) that appeared on December 4, 2012). It’s about preemption, and we found it rather narrow and one-sided. As to preemption, everyone should remember that the availability of this defense varies widely among FDCA-regulated products.
Thanks to Wyeth v. Levine, 555 U.S. 555 (2009), there’s not much of a preemption defense for branded pharmaceuticals. With respect to them, we think that if the FDA’s off-label promotion ban is struck down, in the long term that can only help preemption arguments, to the extent that such arguments may otherwise be made. That’s because implied preemption is dependent upon conflicts between the common-law and FDA requirements. Right now, the FDA doesn’t impose requirements on off-label promotion. The Agency simply bans it. If the First Amendment precludes a ban, then we have to believe that the FDA will – kicking and screaming, perhaps − eventually accept reality and impose what it believes are First Amendment-compliant “time, place and manner” restrictions on such promotion. Whatever form those future restrictions might take, they will be “requirements” having preemptive effect. That has to help conflict preemption arguments, since the more requirements there are, the more opportunities there are for common-law claims to conflict with them.
Then there are medical devices. Each and every word that Caronia said about the First Amendment in the context of prescription drugs is equally applicable to medical devices. The FDA’s “intended use” regulation for medical devices, 21 C.F.R. §801.4, is worded identically to the earlier regulation for drugs. The same flat prohibition is in effect. With respect to preemption, under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), there’s very little preemption with respect to Class I and II medical devices. Therefore, our observations with respect to branded prescription drugs apply.
With respect to Class III/PMA medical devices, thanks to Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), there already is a lot of preemption, particularly of warning claims. The chief value of Caronia with respect to product liability claims involving PMA devices has to do with the “parallel violation” claim exception that courts have recognized to preemption. To the extent that a medical device plaintiff purports to allege “parallel” claims based on off-label promotion, the First Amendment would provide it with a separate defense, unrelated to preemption, that would bar such claims. Under New York Times Co. v. Sullivan, 376 U.S. 254 (1964), state common law cannot impose liability upon the exercise of First Amendment-protected speech. Therefore, to the extent that the FDA can’t ban truthful off-label promotion, neither can private plaintiffs via claims purporting to "parallel" FDA requirements.
So in the context of PMA medical devices, the primary importance of the First Amendment defense is not because it might change preemption one way or the other, but because it would independently eliminate certain claimed “parallel” claims that might otherwise survive preemption.
Finally, as to generic drugs, preemption of warning claims is based on the FDCA’s “sameness” requirement. The First Amendment could thus affect preemption in two ways. First, to the extent that plaintiffs argue that truthful off-label promotion isn’t preempted because it’s beyond “sameness” – those claims would be independently barred to the extent that the promotion is truthful, and thus First Amendment protected, under the NYT v. Sullivan rationale. However, to the extent that the FDA does eventually start imposing First Amendment-compliant requirements on off-label promotion, the “sameness” requirement would apply those changes equally to generic drugs (absent expressly contrary language, which if not accompanied by a statutory amendment could raise its own set of problems). Thus, under “sameness,” any FDA “time, place, manner” regulation of off-label promotion would appear to have preemptive effect, to the extent plaintiffs alleged any different sort of tort requirement.
At least that’s how we see Caronia right now (we haven't even begun to parse through things like the FCA). We’ll keep following the emergence of the long-awaited First Amendment defense to off-label promotion (both criminal and civil) with our customary great interest. Whenever we find anything else of interest – such as the extended analysis of “secondary dissemination” of purely scientific speech in Genzyme Corp. v. Shire Human Genetic Therapies, Inc., ___ F. Supp.2d ___, 2012 WL 5974049, at *3-6 (D. Mass. Nov. 29, 2012) (not an off-label promotion case), we’ll be sure to pass it along.