Caronia, Off-Label Promotion, And The First Amendment

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.

Stuff

The big developments – the Caronia opinion , and the Supreme Court’s grant of certiorari in Bartlett – along with other distractions, such as our ABA Blawg 100 award, have left us with a pile of unblogged stuff that we think is of interest to our readers.

Today we’re taking a crack at that pile.  We apologize in advance if these discussions aren’t as detailed (and thus aren’t as useful) as our usual posts.

California Leans Daubert

California has long gone its merry, idiosyncratic way in the Daubert/Frye wars.  The California Supreme Court has fashioned something called “Kelly/Leahy” after the names of the two most important opinions.  However, in Sargon Enterprises, Inc. v. University of Southern California, ___ P.3d ___, 2012 WL 5897314 (Cal. Nov. 26, 2012), the court spoke about California expert admissibility with a distinct Daubert accent.  Sargon (great name – it evokes space aliens, unknown elements, or even ancient Sumer) is a drug/medical device case only in the loosest sense.  It’s about an alleged “breach of a contract for the [defendant] to clinically test a new implant the [plaintiff] had patented.”  Id. at *1.  The expert testimony at issue involved lost profits.  Id. at *2.  The testimony was vague and tautological, involving the expert’s supposition that the defendant, because it was “innovative,” would have joined the “big six” dental implant manufacturers.  But he measured “innovation” according to “the proof is in the pudding” – successful companies were “innovative,” less successful ones less so.  Why was the plaintiff company “innovative” even though it was small?  That opinion was a bunch of gobbledygook and jargon amounting to “because I think so.”  See Id. at *3-5.  The trial court threw the expert out.  The Court of Appeals reversed and found the testimony admissible, then the California Supreme Court granted review.

This blog doesn't care all that much about the ins and outs of calculating lost profits, but we do care about the standards for expert admissibility.  Sargon is noteworthy for the court’s repeated reliance on the federal precedent that we have (usually) come to know and love, starting with “[u]nder California law, trial courts have a substantial 'gatekeeping' responsibility.”  Sargon, 2012 WL 5897314, at *14 (footnote citing Joiner and Kuhmo Tire omitted).  That leads to “[e]xclusion of expert opinions that rest on guess, surmise or conjecture is an inherent corollary to the foundational predicate for admission of the expert testimony.”  Id.

We also read that the “court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.”  Id. at *15 (again citing Joiner).  Daubert itself follows hard on the heels, with “the gatekeeper's focus must be solely on principles and methodology, not on the conclusions.”  Id. at *16.  Then we get a second helping of Kuhmo:  “the gatekeeper's role is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.”  Id.  And, just like federal law, review of expert exclusion decisions is “for abuse of discretion.”  Id.  The court ultimately held that the opinion was properly excluded and that the trial court had done all the right Daubert-type things like holding a hearing:

The trial court did not abuse its discretion in the sense of making a ruling that was irrational or arbitrary. It presided over a lengthy evidentiary hearing and provided a detailed ruling . . . .  The trial court also excluded the expert testimony for proper reasons. It properly found the expert’s methodology was too speculative for the evidence to be admissible. . . .  [The expert’s] reasoning was circular. He concluded that the Big Six were innovative because they were successful, and that the smaller companies (excluding [plaintiff]) were not innovative because they were less successful.  In essence, he said that the smaller companies were smaller because they were not innovative. The trial court properly considered this circularity in the reasoning as a basis to exclude the testimony

Id. at *20.

There’s a large body of case-law under Daubert and by and large we like it.  States going off on their own tangents are a source of uncertainty that the other side can exploit.  Thus we commend California’s evident embrace of most things Daubert in the Sargon decision.

Repairing Some of the Levaquin Damage – But Not Nearly Enough

We’ve been following the Levaquin litigation mostly from afar (for which we should be grateful), and often in white-knuckled silence, as one problematic ruling after another was handed down.  The not-all-that-surprising result was that a test case called Schedin (under which still more adverse rulings may be found) produ ced a finding of not just liability, but liability for punitive damages.

Well, recently, the Eighth Circuit got a shot at the Levaquin [fill in descriptive noun of your choice].  Unfortunately, while it addressed some of the most egregious errors, it didn’t repair anywhere near all the damage.  See In re Levaquin Products Liability Litigation, ___ F.3d ___, 2012 WL 5971181 (8th Cir. Nov. 30, 2012).

 

Most importantly, the court of appeals held as a matter of law that there wasn’t enough evidence to justify the imposition of punitive damages (which reduced the size of the verdict by well over half):

As a matter of law, the record evidence failed to establish [that the defendant] deliberately disregarded the risk of tendon injuries in elderly patients taking corticosteroids, as required for punitive damages under Minnesota law.  By warning of that risk in its package insert, [defendant] actively sought ways to prevent the dangers associated with its product.  The 2001 warning also was published in the PDR, a reference widely used by physicians.  Regardless of [defendant’s other] alleged actions . . ., we cannot characterize [it] as hiding information it openly published.  The 2001 warning was in [the prescriber’s] physical possession and was specific and clear if read.  For drug warnings to succeed in protecting patients, doctors must order their practice and their continuing medical education so as to find time to learn about new and updated warnings for the drugs the doctor is prescribing.

Id. at *7 (emphasis added).  That’s good, we like cases holding that punitive damages are barred by warnings, even if inadequate.  Moreover, because the plaintiffs undoubtedly threw all the mud in their possession against the wall in this bellwether trial, this ruling probably kills punitive damages for the rest of the Levaquin MDL.  It’s pretty hard to conceal deliberately something that you specifically warn about.

Still, since the District Court construed the Minnesota punitive damages bifurcation statute narrowly and allowed in all sorts of prejudicial evidence only “tangentially” related to the compensatory claims, In re Levaquin Products Liability Litigation, 2010 WL 4867588, at *3 (D. Minn. Nov. 23, 2010), we think that the entire verdict should have been reversed.  We know how punitive damages work in practical terms, and we have no doubt that admission of evidence purportedly relevant only to “motive and intent” id., seriously prejudiced the presentation of the entire case before the jury.

Then there’s failure to warn.  The plaintiffs were allowed to proceed on two theories, including a bizarre failure to “include comparative . . . toxicity information in the package insert” claim.  2010 WL 4867588, at *3.  The Eighth Circuit pointedly did not endorse the comparative labeling claim.  Id. (“we need not address whether the district court erred in denying [defendant's] motions based upon [plaintiff’s] comparative toxicity theory”).  The court found “harmless error” because the plaintiff could recover on the other, more standard, warning theory.  Id.

We think that’s a cop-out.  In the first place, the FDA strictly regulates when a manufacturer can make product comparisons.  See 21 C.F.R. §§201.57(c)(2)(iii); 201.80(c)(3)(v) (requiring “substantial evidence derived from adequate and well-controlled studies”).  In the second place, before Levaquin, no state anywhere had held that the pharmaceutical duty to warn included an obligation to recommend somebody else’s product as “safer.”  Comparative warning claims were rejected in Baycol litigation.  In re Baycol Products Litigation, 532 F. Supp.2d 1029, 1040-43 (D. Minn. 2007).  This issue thus provokes one of our largest pet peeves – federal courts exercising diversity jurisdiction have no power to “predict” novel and expansive theories of tort liability.  Yes, even in the Eighth Circuit.  E.g., Leonard v. Dorsey & Whitney LLP, 553 F.3d 609, 612 (8th Cir. 2009) (“[o]ur duty is to conscientiously ascertain and apply state law, not to formulate new law based on our own notions of what is the better rule”).

We have the same objection to allowing liability on the other, more normal warning claim – because the defendant actually did warn.  It “changed the tendon warning in the package insert” to make it stronger.  Levaquin, 2010 WL 4867588, at *4.  Nonetheless, liability was affirmed:

Courts disagree about whether simply changing the package insert warnings insulates a drug manufacturer from failure-to-warn liability, and Minnesota courts have not decided this issue.  Many courts considering the question have held a properly worded package insert is a sufficient warning as a matter of law, at least when it is combined with an entry in the PDR.

Id.  That should have been the end of it.  The plaintiff should have gone home empty-handed.  Since Minnesota state courts admittedly have not recognized such liability, and it’s certainly not the majority rule elsewhere, a federal court supposedly applying state law can’t go making things up.  Leonard, supra.  Only by characterizing the question as whether warnings “insulate[]” the defendant, 2010 WL 4867588, at *4, rather than whether plaintiff could maintain a claim on the first place for inadequate warnings in the presence of an adequate package insert, could the court pretend that it was declining to make new law.  Of course, it was really making new – and quite bad – law.

We make the same observation about causation.  The prescriber never testified that he relied on Dear Doctor letters, and the court conceded that it was a “stretch” to base warning causation upon speculation that he might have “relied on his colleagues’ comments about particular drugs.”  Levaquin, 2010 WL 4867588, at *6.  We reiterate.  That should have been the end of it.  The opinion cites no Minnesota law allowing causation to be premised on either warning letters or through some sort of gestaldt from colleagues.  Federal courts should not create new grounds for liability from whole cloth.

So overall, we’re quite disappointed in the outcome.  Assuming that Schedin was the MDL plaintiffs’ preferred bellwether case, we have to conclude that these are very weak cases, indeed – a conclusion supported by plaintiff losses in two subsequent Levaquin trials.  The courts should not be bending over backwards to encourage liability where none should exist.

Restricting Cross-Jurisdictional Class Action Tolling − Backwards

Anybody who follows this blog at all closely knows that we hate cross-jurisdictional class action tolling.  It’s the subject of one of our more obscure scorecards.  Sorry, but we don’t find any merit in a doctrine that rewards the mere filing of meritless litigation - we see too much of it already.  Fortunately, most courts haven't adopted it either.

That’s why the otherwise far afield FDIC v. Countrywide Financial Corp., 2012 WL 5900973 (C.D.Cal. Nov. 21, 2012), caught our eye.  Not only did the court reject cross-jurisdictional class action tolling (as does California, see Jolly v. Eli Lilly & Co., 751 P.2d 923, 936-37 (Cal. 1988)), but it did so despite the plaintiff having filed a federal statutory action that would ordinarily be subject to American Pipe class action tolling.  The earlier class action, however, was cross-jurisdictional, having been filed in state court:

American Pipe tolling cannot apply to a class action filed in state court, even if the claims in the state class action are federal.  The complaint in [the earlier case] expressly did not seek to meet the requirements of Rule 23.  The class action could continue if it complied with California procedural rules. . . .  A rule restricting American Pipe tolling effect to class actions filed in federal court is also more consistent with the practices of the states themselves.  Very few states toll the claims of individuals based on a class action filed in another jurisdiction (called “cross-jurisdictional tolling”).  The reasoning of those courts that reject cross-jurisdictional tolling is equally applicable to the situation here.

2012 WL 5900973, at *13-14 (citations omitted).

So there you have it.  Judicial rejection of cross-jurisdictional class action tolling works both ways.  Not only do federal class actions not toll the statute of limitations in subsequent actions filed in state court, but state class actions don’t toll federal statute of limitations, even as to a claim that, had both actions been in federal court, would have benefited from the ill-considered American Pipe rule.

FCA, FDA, What's The Difference?

Here is another post by Reed Smith's Eric Alexander, quasi-member of our blog.  At this point, we think he's only holding off becoming a full blogger because as long as he doesn't have his own blogger account, somebody else (like Bexis) has to take the time to input his posts.

*****************

            We welcome ourselves back after our hiatus.  Not that blogging/blawging is not real work, but we sometimes have clients pay for our quips—and, perhaps, occasional legal insights.  Plus, the product liability decisions have been fairly slim, particularly after more venerable—they would say venerated—posters call “dibs.”  So, we wade into the wonderful world of the False Claims Act (FCA).  We products lawyers might say that we sometimes view FCA cases as red headed stepchildren if we were not a little afraid of retribution from the soulless GLA (Ginger Liberation Army).  Since we will not say such a thing, we will say that FCA cases do not involve plaintiffs with real or trumped-up physical injuries or state court judges and juries.  They do involve issues of compliance with FDA regulations, some Latin phrases, and often a “U.S.” on the other side of the v.  That makes them relevant to what we do and what this ABA-nominated blog does.  (Non-products lawyers can vote too.  There is no hair color or prevalence requirement.  That comes from a footnote in the Harper v. Virginia Board of Elections on poll taxes.  Bexis says it is precedential; McConnell says it is only dicta because it does not use a form of the words “hold” or “find.”)

            U.S. ex rel. Polansky v. Pfizer, Inc., No. 04 Civ. 0704 (BMC), 2012 U.S. Dist. LEXIS 163557 (E.D.N.Y. Nov. 15, 2012), is the final dismissal of a FCA case filed in 2004 that was on its Fifth Amended Complaint at the end.  Setting aside why it took eight years and six complaints to get rid of what was ultimately not a cognizable claim, this is a nice decision.  We cannot quite set aside that the U.S. chose to intervene in this case and the chance that its intervention increased the lifespan and defense costs of the case.  The basic claim was that the defendant promoted its product (Lipitor) off-label, allowing for Medicare and Medicaid to pay for prescriptions written and filled for patients who were not within the approved indication for the product.  That part is pretty standard.

            In Polansky , however, the plaintiff’s view of who was and who was not within the label was not at all standard.  Rather, it hinged on the reproduction in the Indications and Usage section of the 2005 label of a table summarizing the 2002 Guideline from the National Cholesterol Education Program—a program launched by the National Heart, Lung and Blood Institute of the National Institutes of Health.  (The Guideline is actually the Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III).)  Id. at **2-3 & 6.  We could use acronyms if it would help clarify.  Like most treatment guidelines, this gave various criteria for when “to consider drug therapy” and included a healthy dose of clinical judgment—the Judge pulled out a [sic] on the label’s use of “judgement.”  Id. at **6-7 & 15.  Plaintiff maintained that any promotion for a patient outside of the “consider” column of the table, even 1 mg/dL of LDL, was off-label promotion and triggered FCA liability.  Id. at *7.  This table dropped out of the label with its PLR revision in 2009, but the plaintiff still maintained that the label had this restriction because it said “(see current NCEP Guidelines)” in the Dosage and Administration section.  Id. at **11-12.

            The court saw through this nonsense for both versions of the Lipitor label.  Not only do guidelines not impose “mandatory limitations” by nature of only being guidelines and not edicts, but this one was pretty clear that it “should not be viewed as a standard of practice” and “should not override a clinician’s considered judgment in the management of individuals.”  Id. at **8 & 16.  The labels (in Indications or elsewhere) did nothing to limit use only any patient population defined by any portion of the NCEP Guidelines, so the off-label argument fell flat.  It was also pretty easy to find that the label without the table or any mention of the NCEP Guideline in the Indication section did not impose some Guideline-based limit on permissible use for the FCA.  Id. at *14.  [FDA inside baseball aside:  It also would have been easy to go to Drugs@FDA and pull up the Medical Officer Review and Approval Letter from 1996 to see that the original approved indication for hypercholesterolemia was not linked to any NCEP Guideline, let alone the one from six years later.  Or to look at the language before the table in the 2005 label, which clearly referenced the “Guidelines, summarized in Table 6” in connection with advice about trying “diet and other nonpharmacological measures” first.]  Particularly since the FCA is intended to punish “quasi-criminal conduct,” tenuous arguments about off-label promotion do not state claims for FCA violations.  “The False Claims Act, even in its broadest application, was never intended to be used as a back-door regulatory regime to restrict practices that the relevant federal and state agencies have chosen not to prohibit through regulatory authority.”  Id. at **19 & 21.

            This is really why we are writing about the case.  We think the words “State product liability law” could replace the first four words of that quote and it would still be true.  We know that, particularly for an implied preemption analysis, regulatory requirements and state product liability cases involving drugs and devices can exist in parallel.  We also know that plaintiffs like to say compliance with regulatory requirements means nothing for the viability of their claims—although some legislatures have disagreed, as we’ve discussed here.  Then they will try to turn any arguable non-compliance, whether it relates to the scope of promotion, the sampling frequency of finished product at the factory, or the 1% of 15-day reports being filed in 16 days, into proof of negligence or design defect.  Except in rare instances, product liability claims for prescription drugs and devices are really about warnings and the adequacy of warnings is usually measured by the content of the label itself.  The Polansky court had a pretty good handle on how labels actually work.

            First, if you want to know who is supposed to use the drug, you might look at the Indications and Usage section.  If you want to know who is not supposed to use the drug, you might look at a section with a clever title like Contraindications or Limitations of Use.  Together, it is not that hard to figure out what use is on-label and what use if off-label.  As the court said, “There is a distinction between off-label marketing to achieve a treatment not contemplated by the label (e.g., hair growth or curing cancer), and marketing to a patient population not specifically mandated by the label.”  Id. at **19-20.  Put another way, there is a difference between references in the label that are “merely informational and advisory” and language that imposes “restrictive limitations.”  Id. at *22.  Second, what the label does and does not say—Levine’s gross misunderstanding of CBE labeling changes notwithstanding—typically reflects FDA’s judgment.  The inclusion of the table summarizing the NCEP Guidelines in a post-approval labeling change was “because the FDA has determined to pass along that advice through the label” and FDA “could have easily required” explicit restrictions on use in the Lipitor label, as it “commonly” does with other labels.  Id. at *17.  That sounds like what actually happens.

            It is nice to see a judge with a proper understanding of how drug labels, FDA, and cockamamie theories about off-label marketing should fit together.  We would like to see more of the judges handling product liability cases with similar issues follow the lead of the judges handling FCA cases and dismiss complaints premised on nonsensical interpretations of labels and regulations.  We would also like to see judges kick bad cases without allowing serial amendments of defective cases.  The unpublished decision in U.S. ex rel. Fox Rx, Inc., v. Omnicare, Inc., 1:11-cv-00962-WSDD (N.D. Ga. Aug. 29, 2012), which we learned of because it was in a “Statement of Recent Decision” filed by the U.S. Dept. of HHS as a defendant in another case, comes to mind.  This is an FCA case with allegations that the defendant, a specialty pharmacy attendant to nursing homes, dispensed atypical antipsychotic drugs off-label, among other allegations of bad Medicare practices.  While most of the grounds for dismissing the off-label claims were denied, the court recognized that the complaint lacked detailed allegations that the prescriptions were ever submitted for reimbursement claims, something even us non-FCA lawyers know matters because the C in FCA stands for Claims.  But the plaintiff was permitted to file a Third Amended Complaint to try to fix the problem.  We guess that three strikes was not an out, like in baseball before the rule changes in the late 1880s.  (Bexis is a longtime member of SABR’s Nineteenth Century Baseball committee; we hear their keg parties are awesome.)

            We have heard from colleagues of some recent FCA dismissals for the same defendant pharmacy that were with prejudice.  Where a fundamental part of the plaintiff’s case depends on some overly technical alleged violations of FDA regulations that do not really matter to whether the product is safe and effective and marketed appropriately is makes sense to put the case to bed, whether it be a FCA case or a products case.

            We have certainly heard arguments from product liability plaintiffs and their purported regulatory experts about how even one observation in a post-inspection FDA form 483 (put there so the inspector had something to write) means that the jury should go straight to calculating damages.  While it is possible to walk from some alleged non-compliance with an aspect of cGMP or some quirky interpretation of the label along the path to products being adulterated or misbranded, the judges with product liability cases should be able to see through the regulatory fog as decisively as the Polansky judge did.  Sometimes, without the fog, you can see the path is full of crap before you step in it.

The Learned Intermediary Doctrine – a Plaintiff with No Evidence Loses

We talk a lot about the learned intermediary doctrine.  It’s rooted in the reality of the physician-patient relationship.  Patients gain access to prescription drugs only through doctors who have the expertise to understand and weigh the risks and benefits of the drugs.  The learned intermediary doctrine, accordingly, says that pharmaceutical companies’ duty is to warn doctors, not patients, about the risks of prescription drugs.  The plaintiff still bears the burden to prove proximate causation.  But in these cases it is with regard to the prescriber, so the plaintiff must prove that the doctor would have made a different prescribing decision if she had the information that plaintiff claims she should have had. 

Although this seems like a simple proposition, from time to time (maybe more often than that), courts mistreat the learned intermediary doctrine.  We told you about one court, for instance, mangling it so much that the doctrine became an affirmative defense with the burden on the defendant not the plaintiff.  The court allowed the case to survive summary judgment, reasoning that a jury could simply choose to disbelieve the prescriber’s testimony that, knowing what the plaintiff said he should have known, he still would have prescribed.  So much for plaintiff’s burden.

This is not to say that all courts get it wrong.  Many get it right.  The Court of Common Pleas in Philadelphia did here, granting judgment to the defendant because the prescriber had passed away, leaving the plaintiff with no way to prove that the prescriber would have acted differently with the allegedly proper warning.  This leaves you with the morbid impression that you’re better off with a prescriber who is dead rather than alive and well and saying the right things.  See what bad law can do.  A Texas court in the Zyprexa litigation also got it right (for the most part) here, granting judgment to a defendant because, among other things, the prescriber knew the alleged risk so a different warning couldn’t have mattered.  The Fifth Circuit affirmed, explaining that the plaintiff has the burden to prove that the learned intermediary would have acted differently with a different warning. 

Now comes another circuit court, the second circuit in McClamrock v. Eli Lilly & Co., 2012 U.S. App. Lexis 24539 (2d Cir. Nov. 29, 2012), issuing a good learned intermediary decision (applying North Carolina law) from the Zyprexa litigation.  It’s a short opinion.  But it’s from a circuit court, so that’s good.  And it has one sentence that’s very good.  It explains in no uncertain terms which side has the burden to prove proximate causation – that is, to satisfy the learned intermediary doctrine – and what happens when that side does nothing about it:

Because [the plaintiff] would have the burden of establishing proximate cause at trial, his failure to offer any evidence that [his prescriber] was unaware that diabetes was a risk associated with Zyprexa when he prescribed it warranted granting summary judgment in favor of Eli Lilly. 

Id. at *2-3.  In other words, when there’s no evidence at all that a different warning would have changed things, like with the deceased prescriber in the Court of Common Pleas opinion, plaintiffs lose.  The defense doesn’t have to prove a thing. 

That’s how the learned intermediary doctrine works.

Now, the Second Circuit’s opinion in McClamrock is unpublished, which can limit its value.  But then again Lexis published it.  And now so have we (sort of).  And it has the added benefit of being right.  So that’s something, and maybe you can make something of it. 

Second Circuit Reverses Off-Label Promotion Conviction On First Amendment Grounds

The long wait is over.  Here is the Second Circuit's decision in United States v. Caronia, No. 90-5006-cr, slip op. (2d Cir. Dec. 3, 2012).  By a 2-1 vote, Mr. Caronia's conviction for off-label promotion is reversed on First Amendment grounds.  The ruling is unmistakable.  There was no question that off-label promotion had occurred.  Slip op. at 14-16.  The sole basis for vacating the conviction was the government's failure to prove that any of the alleged promotion was false.

Interestingly, even the government tried to run for cover from the First Amendment, arguing on appeal that off-label promotion only "plays an evidentiary role" in a criminal prosecution for misbranding.  Slip op. at 27 (emphasis original). Thus:

The government contends that Caronia was not prosecuted for his speech, but that Caronia's promotion of [an] off-label use served merely as “evidence of intent,” or evidence that the “off-label uses were intended ones[] for which [the drug’s] labeling failed to provide any directions.”

Id.

The majority in Caronia didn't buy the change of tactics.  "[T]hat is not what happened in this case."  Id. at 28.

[The government clearly prosecuted Caronia for his words − for his speech.  A pharmaceutical representative’s promotion of an FDA-approved drug’s off-label use is speech.  As the Supreme Court has held:  “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).  Here, the proscribed conduct for which Caronia was prosecuted was precisely his speech in aid of pharmaceutical marketing.

Caronia, slip op. at 31 (emphasis added).  As we pointed out in our very first Sorrell post, the First Amendment chickens are coming home to roost.

The Court then quite explicitly rejects an off-label  promotion ban as required by the FDCA, because to do so would be unconstitutional:

[W]e decline the government’s invitation to construe the FDCA's misbranding provisions to criminalize the simple promotion of a drug’s off-label use by pharmaceutical manufacturers and their representatives because such a construction − and a conviction obtained under the government's application of the FDCA − would run afoul of the First Amendment.

Caronia, slip op. at 33.

"Content-based" governmental restrictions on speech are "subject to strict scrutiny" and "presumptively invalid.  Id. at 34.  "Criminal regulatory schemes, moreover, warrant even more careful scrutiny."  Id.  The Second Circuit then followed Sorrell's two-step First Amendment analysis. 

First, we conclude that the government’s construction of the FDCA’s misbranding provisions imposes content- and speaker-based restrictions on speech subject to heightened scrutiny.  Second, we conclude the government cannot justify a criminal prohibition of off-label promotion even under [the] less rigorous intermediate test.

Caronia, slip op. at 39.

First, the FDA's regime banning off-label promotion is "content based" − that is, based upon what is being discussed and thus not neutral:

 

[I]t distinguishes between "favored speech" and "disfavored speech on the basis of the ideas or views expressed."  Under this construction, speech about the government-approved use of drugs is permitted, while certain speech about the off-label use of drugs − that is, uses not approved by the government − is prohibited, even though the off-label use itself is not.  Indeed, the content of the regulated speech drives this construction of the FDCA; as in Sorrell, the "express purpose and practical effect" of the government's ban on promotion is to "diminish the effectiveness of [off-label drug] marketing by manufacturers."

Caronia, slip op. at 40 (citing Sorrell, other citations omitted).  It is also speaker-based, as anybody no matter how medically ignorant, can advocate off-label uses, except the manufacturers:

[T]his construction is speaker-based because it targets one kind of speaker – pharmaceutical manufacturers − while allowing others to speak without restriction. . . .  B]ecause off-label prescriptions and drug use are legal, the government's application of the FDCA permits physicians and academics, for example, to speak about off-label use without consequence, while the same speech is prohibited when delivered by pharmaceutical manufacturers.  This construction "thus has the effect of preventing [pharmaceutical manufacturers] − and only [pharmaceutical manufacturers] − from communicating with physicians in an effective and informative manner."

Caronia, slip op. at 40-41 (again citing Sorrell, with other citations omitted).  Finally, Caronia was worse than Sorrell, from a First Amendment standpoint, because "this case involves a criminal regulatory scheme subject to more careful scrutiny.  Id. at 41.

Caronia goes on to invalidate the FDA's off-label speech ban under the less strict Central Hudson commercial speech test.  The first two prongs were easy:  "promoting off-label drug use concerns lawful activity (off-label drug use), and the promotion of off-label drug use is not in and of itself false or misleading."   Slip op. at 42 (there's a footnote that the dissent suggests that off-label promotion is inherently misleading, but even the government did not so argue).

The third prong is also satisfied, since the government has "substantial" interests “in preserving the effectiveness and integrity of the FDCA’s drug approval process, and . . . in reducing patient exposure to unsafe and ineffective drugs.”  Id. at 42-43.  Again, that's not something that this blog has ever disputed, either.  It all comes down to whether the FDA's ban on truthful speech is a legitimate way, under the First Amendment, to pursue those interests.

• “As off-label drug use itself is not prohibited, it does not follow that prohibiting the truthful promotion of off-label drug usage by a particular class of speakers would directly further the government’s goals.”  Caronia, slip op. at 44.
• “[P]rohibiting off-label promotion by a pharmaceutical manufacturer while simultaneously allowing off-label use ‘paternalistically’ interferes with the ability of physicians and patients to receive potentially relevant treatment information; such barriers to information about off-label use could inhibit, to the public’s detriment, informed and intelligent treatment decisions.”  Id.
• “While some off-label information could certainly be misleading or unhelpful, this case does not involve false or misleading promotion.  Moreover, in the fields of medicine and public health, ‘where information can save lives,’ it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed.”  Id. at 46.
• “If the government’s objective is to shepherd physicians to prescribe drugs only on-label, criminalizing manufacturer promotion of off-label use while permitting others to promote such use to physicians is an indirect and questionably effective means to achieve that goal.”  Id. at 47
• “[T]he government’s construction of the FDCA to impose a complete and criminal ban on off-label promotion by pharmaceutical manufacturers is more extensive than necessary to achieve the government’s substantial interests.”  Id. at 48.
• The government has plenty of non-infringing alternatives:  FDA warnings about off-label uses; disclaimers; safety tiers between various off-label uses (like Medicare does), listing known or suspected off-label uses in the approval process; and ceilings or caps on the number of off-label prescriptions before FDA approval is mandatory, and even prohibitions of some off-label uses.  Id. at 48-50.
• “In the absence of any support, such conclusory assertions are insufficient to sustain the government's burden of demonstrating that the proposed alternatives are less effective than its proposed construction of the FDCA.”  Id. at 50-51.

Thus the FDA's off-label promotion ban, even if construed as involving only commercial speech, is unconstitutional under the First Amendment.  The court therefore construes the FDCA as allowing truthful promotion of off-label uses. 

[W]e 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.

Caronia, slip op. at 51.

If adopted by the Supreme Court (and this is one of the few cases that a grant of certiorari can be described as "likely"), the analysis in Caronia will kill the FDA's speech-specific ban on off-label promotion - and along with it the government's monetization of that ban to collect billions of dollars in fines for what is First-Amendment protected activity.  The states and their accompanying False Claims Act relators should see the money spigot shut off as well.  Finally, in our product liability cases - in the Second Circuit immediately, and in other circuits once this rationale is adopted - plaintiffs will no longer be able to assert off-label promotion, in and of itself, as something that's tortious.  Ever since New York Times v. Sullivan, tort litigation cannot be based on First-Amended protected conduct.

A great day today for the good guys!

PS:  There's a "sky is falling" dissent that we'll discuss in the future, but right now, we have to get back to our paying work.