The beast part may be a bit of an exaggeration, but it serves the purpose of depicting what at least on the surface are two very opposite things. But if you delve more deeply, you find a lot of similarities. So many similarities that the two things shouldn’t really be opposites at all. That’s what happens in the fairy tale. The beast is really a prince. But life’s not a fairy tale. And neither is pharmaceutical litigation. And if it were, it wouldn’t be a Disney version, it would be one of those original Grimm Brothers’ stories – the dark and twisty ones. And that’s what we have today. Two cases that come to opposite conclusions but based on the same allegations about the same failure to warn about the same drug. We should be talking about a beauty and a prince. Instead we have a beauty and a beast . . . or at least maybe a frog.

Within two days of each other, two decisions were handed down in cases involving the generic prescription drug amiodarone manufactured by the same company – Hernandez v. Sandoz Inc.,  2017 U.S. Dist. LEXIS 120938 (N.D. Ill. Aug 1, 2017) and Tutwiler v. Sandoz Inc., 2017 WL 3315381 (N.D. Ala. Aug. 3, 2017). Both were second bites of the apple. In Hernandez, defendants moved for reconsideration of the court’s prior ruling rejecting preemption and allowing a failure to warn claim premised on defendants’ failure to provide medication guides per federal regulations. We blogged about that earlier decision here. In Tutwiler, the court had previously dismissed that same claim but plaintiff included it in her amended complaint. Defendants moved to dismiss again. Both courts stuck to their prior decisions.

Our prior post on Hernandez explains how we think the court got preemption wrong – notably by applying the Seventh Circuit’s awful PMA, medical device express preemption decision in Bausch v. Stryker to a pharmaceutical drug case and finding a parallel violation claim. On reconsideration, defendants argued that the court misapplied Bausch. In response, the court cited other district courts within the Seventh Circuit to also have applied Bausch to pharmaceutical cases, including another amiodarone case that we blogged about here. Hernandez, at *5-7. The old adage two wrongs don’t make a right comes to mind.

Unable to make the court see that this is really an implied preemption case – plaintiff was seeking to enforce an FDCA requirement regarding distribution of medication guides – defendants were left to argue that the claim isn’t really parallel to a state law duty to warn. There is no Illinois state law duty to warn pharmacists so they can in turn warn consumers. In fact, in prescription drug cases, the manufacturer’s duty is to warn the prescribing physician – not the consumer. Id. at *9n.4. From the court’s description of plaintiff’s allegations, plaintiff alleges both traditional failure to warn the prescriber and failure to warn the consumer by failing to provide medication guides. Id. at *9. The court then seems to conflate all those allegations into one plausible failure to warn claim. See id. (“The court remains convinced that plaintiff has sufficiently alleged each of the elements necessary to establish a failure to warn claim under Illinois law despite focusing much of his complaint on his allegations that defendant’s actions violated the FDCA.”). By alleging both failure to comply with the FDCA and failure to warn the prescriber plaintiff got to dodge both preemption and learned intermediary. But those are two separate claims and they should both fail.

And that’s how you turn the beast/frog into a prince. You apply both preemption and learned intermediary like in Tutwiler. First, in this case the court already dismissed plaintiff’s traditional failure to warn claim – the failure to warn plaintiff’s prescriber – under Mensing. These are after all generic prescription drugs and the Supreme Court has said they don’t survive conflict preemption. Which is presumably why plaintiffs in these cases are focused on the medication guide allegation. In Tutwiler, plaintiffs argued that failure to provide the medication violated the “duty of sameness” on which Mensing rests making Mensing inapplicable. Id. at *2. As we noted above, failure to warn based on failing to adhere to an FDCA requirement should also be impliedly preempted under Buckman or the prohibition of private causes of action to enforce the FDCA.

But the Tutwiler court said it didn’t need to consider preemption because the claim is barred by the learned intermediary doctrine. In Alabama, like in Illinois, in a prescription drug the case the duty to warn runs to the physician. Id.

[I]t does not follow . . . that if the manufacturer inadequately warns the physician, it owes an independent duty to warn the patient directly. This is the reason why this Court previously stated that “it appears unlikely that Plaintiff can state a failure-to-warn claim based on Defendant’s failure to provide a Medication Guide to her pharmacy that avoids the application of both the learned-intermediary doctrine and Mensing.”

Id. And there’s the beauty.

There is one thing that both Hernandez and Tutwiler agree on – plaintiffs’ off-label promotion claims are fraud claims that must be pleaded to the heightened standard required by Federal Rule of Civil Procedure 9(b). Both plaintiffs tried to argue that these were negligent marketing claims. Hernandez, at *3; Tutwiler, at *2. But both courts were unpersuaded by those labels given the context of the allegations. Hernandez, at *4 (“Plaintiff’s complaint is a sprawling and, at times, confusing collection of largely unnecessary allegations that, for the most part, seem to attempt to assert a fraudulent misrepresentation claim as it relates to off-label promotion.”; Tutwiler, at *2 (Plaintiff “claims that Defendant engaged in a ‘concerted and systemic effort to persuade physicians’ . . . that the drug was safe and efficacious for off-label uses). Plaintiff Hernandez is getting another chance to re-plead his fraud claims with specificity. Since this was Plaintiff Tutwiler’s second attempt, and her complaint still failed “to identify a single statement in any promotional material to support [Plaintiff’s] contention that Defendant unlawfully promoted amiodarone for [an off-label use],” her claim is dismissed.

They say beauty is fleeting – and so too is a beautiful case. The beast/frog on the other hand lives to see another day.


Last week, we summarized PhRMA’s comments on the FDA’s proposed amendments to regulations regarding “intended uses.”  PhRMA showed how the FDA’s insistence that it could read manufacturer’s minds about intended uses made no sense on an evidentiary basis and ran afoul of First Amendment considerations.  Today, we’ll tip our cyber caps to the Advanced Medical Technology Association (AdvaMed), which also issued well thought-out comments on the FDA’s proposal.  You can read the AdvaMed July 18, 2017 comments here

 

To begin with, the AdvaMed letter excels at doing that thing that judges yell at dumb litigators for not doing in their motions — stating what relief is sought.  AdvaMed puts it plainly: “FDA should abandon the Final Rule and instead return to its original and unambiguous proposal to remove the reference to ‘knowledge’ as set forth in FDA’s September 25, 2015 proposed rule regarding the definition of ‘intended uses.’”  What’s wrong with the FDA’s proposed rule?  It’s bad in its totality, including its reliance the “totality of the evidence” standard.  AdvaMed correctly states that “the ‘totality of the evidence’ standard is more outcome determinative than prescriptive.”  We are reminded of how Justice Black called judicial balancing tests pretentious cover-ups for courts doing whatever they felt like doing.  A totality of the evidence test would mean that the FDA would administer rough justice on a case-by-case basis, sans principle and sans predictability. 

 

That lack of predictability is particularly pernicious where the chilled communications are so critical to public health.  AdvaMed provides concrete examples of communications pertaining to both approved and unapproved medical devices that any right-minded person (and any person who thinks they might someday benefit from advanced drugs and devices – that is, everyone) would favor.  Such communications include training and technical support, educational meetings about clinical trials and development data, feedback from doctors on investigational development, information about real-world experiences with devices, and engagement with health care professionals on device innovation and improvement.  Plaintiff lawyers love to say that drug and device manufacturers have a duty to be the foremost experts on their own products.  The communications potentially chilled by the FDA’s vague, overbroad content-less regulation on “intended uses” are all necessary to facilitate such expertise.        

 

AdvaMed makes the same constitutional argument that PhRMA made, though with some different wrinkles.  AdvaMed discusses the Washington Legal Foundation case from 1998.  The FDA, which raps companies on the knuckles if they are poor at signal detection, should have seen that 1998 case as a very clear signal that its chokehold on truthful off-label communications was unconstitutional.  AdvaMed also does a fine job of applying the Central Hudson requirement that regulation of commercial speech must be narrowly-tailored to serve the governmental interest.   In its request for comments on the proposed rule, the FDA supplied examples of speech restrictions that mostly related to “activities and communications involving the distribution or promotion of illicit drugs.”  There are already non-speech sanctions (including the Controlled Substances act, as well as mail or wire fraud statutes) available to address such criminal activity. 

 

For one brief moment of lucidity, the FDA recognized that a manufacturer’s knowledge that a third party was using a product off-label was not the same thing as the manufacturer’s intent that such product be used off-label.  Then the FDA reversed field, and now we have this new proposed rule.  AdvaMed makes clear that “it is inappropriate to hold manufacturers responsible for the use of their products by third parties over whom they have no control.”  Fairness says as much.  So does a concern for unintended consequences.  The FDA has more than once acknowledged that collaboration between manufacturers and health care practitioners is essential to help develop new life-enhancing or –saving products.  But if manufacturers will be put on the hook for everything they know such collaborators are doing, how can the nature or frequency of such collaboration be unaffected?      

 

AdvaMed concludes its comments with a request that, if the FDA won’t do the right thing and completely back off its wrong-headed “totality of the evidence” test, it should at least issue three clarifications of what would NOT show an intended use: (1) legitimate scientific exchange, (2) truthful, nonmisleading communications, and (3) mere knowledge of third party unapproved uses.  In short, the AdvaMed comments are everything the FDA’s proposed rule is not: clear, fair, and protective of speech and scientific development.   

 

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. The tortured path of this ‘logic’ should, by itself, render this off-label regulatory regime questionable, but the FDA’s recent reaffirmance of it amounts to incoherent defiance.

The FDA takes the position that a company’s truthful, non-misleading statements about off-label use can constitute evidence of an intended use outside the label.  Even while acknowledging that off-label use can be absolutely necessary for some maladies, and even while getting repeatedly clobbered by courts holding that truthful, non-misleading communications about off-label use are protected by the First Amendment, the FDA stubbornly asserts the power to clamp down on such speech.

The FDA’s effort to keep its clamp-down power has been clumsy.  In 2015, the FDA proposed a rule regarding the scope of intended use.  (We have been covering this issue all along. For example, here is a 2015 post by Bexis discussing how the FDA tip-toed into this area, hiding the off-label issue in a notice ostensibly about cigarettes.  Good idea.  After all, in the eyes of the anti-tobacco crowd, the First Amendment hardly exists for some companies.)  One silver lining in the FDA’s proposed rule was that the FDA would “not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm’s knowledge that such product was being prescribed or used by doctors for such use.”  What a refreshing and rare connection to fairness and reality! It did not last. In the Final Rule published earlier this year, the FDA insists on its right to consider evidence of mere knowledge of off-label use as part of a dreaded “totality of the evidence” standard.  Let the chilling commence.

But the effective date of this misguided Final Rule has been postponed until March 19, 2018.  In the meantime, interested parties may comment.  An extraordinarily thoughtful comment comes from the PhRMA organization, which represents pharmaceutical manufacturers.  Perhaps some will resist reading PhRMA’s July 18, 2017 letter with objectivity, being biased about alleged bias, but you can read it here.  You can see for yourself how the FDA’s not-so Final Rule runs counter to reality and the rule of law.

Here, in summary, are PhRMA’s main points:

1.  FDA cannot establish an intended use absent an external statement by the manufacturer about that use.

The PhRMA letter does a nice job of marshaling precedent and historical practice to prove that the intended use of a product “can be manifested only if the manufacturer conveys that intent to someone who is in a position to buy” the product.  Without that limiting principle, the FDA could attempt to establish a broader intended use via various internal communications.  This is a concern we feel acutely when defending our clients against private party litigations.  One reason that discovery is so ludicrously expensive and burdensome is that plaintiffs want to collect every internal document mentioning the product at issue, looking for some stray someone at sometime saying something that sounds bad, even though it does not represent a final position, or the position of the company at all. Mind-reading is a fool’s errand.  The only reliable evidence is what the company actually said and did in terms of persuading others how to use its products.  Forest Gump might say that ‘off-label is as off-label does.’  A more limited approach focusing on external statements makes sense, serves fairness and judicial economy and, perhaps most important, is fully supported by cases going back at least as far as 1920, ranging to include foods, drugs, and tobacco. For example, in American Health Prods. Co. v. Hayes, 574 F. Supp. 1498, 1505 (S.D.N.Y. 1983), the court read the term “intended” to refer to specific marketing representations.  The PhRMA letter cites several other cases, and offers a compelling argument for a circumscribed interpretation of intended use – one based on reality rather than cynicism and innuendo.  Even aside from the FDA regulatory issue, we wonder whether PhRMA’s argument might support our side in discovery disputes, or might assist us in drafting jury instructions where plaintiffs managed to smuggle allegations of off-label promotion into the case.

2.  Overly restrictive regulation of truthful, non-misleading communications to health care practitioners about unapproved uses violates the First and Fifth Amendments.

Over the last decade-plus, courts have been constantly reminding all of us, including the FDA, that the First Amendment protects commercial speech, and that truthful, non-misleading communications about off-label uses are included in such protection.  The hits just keep on coming.  Not to put too fine a point on it, the FDA’s position on off-label communications has been thoroughly undermined by recent cases.  The FDA’s exercise in wish-fulfillment simply cannot coexist with the SCOTUS opinion in Sorrell, which applied heightened scrutiny in striking down a law that restricted pharmaceutical manufacturer communications with healthcare professionals. The FDA’s “totality of the evidence” standard, besides being vague and overbroad, is certainly not the least restrictive means to protect the integrity of its drug approval process.  The Second Circuit’s Caronia decision directly refutes the FDA’s policing of truthful, non-misleading communications about off-label uses.  Apparently, all that the FDA can do in the face of Caronia is wish that it would go away.  The SDNY decision in Amarin is similarly fatal to the FDA’s position.  The PhRMA letter rips into the FDA’s efforts to prop up the proposed rule, laying waste to dicta and distinguishing away the few cases cited by the FDA.  If this debate was a little league game, it would be called on the basis of the slaughter rule.  But our concern is whether the FDA will dispassionately listen to the arguments and pay attention to the law.  In truth, we are not certain that the FDA will approach this issue with even the fairness we expect to get in a little league game.

More than once we’ve said that we read law review articles so you don’t have to.  We separate the wheat from the chaff. The wheat is scarce.  That is because law review articles usually drown the little bits of objective description of what the cases DO say with enormous chunks of pie-in-the-sky suggestions of what the cases SHOULD say.  Such suggestions almost always go nowhere.  When they do go somewhere, as in the famous long-ago Fordham Law Review article that advocated market-share liability, they go someplace very bad.  Have we mentioned that law review articles, whether written by professors or students, tend to be pro-plaintiff?

But the law review article at issue today, Conners, “Illuminating the Off-label Fable: How Off-label Promotion May Actually Help Patients,” 13 Journal of Law, Economics & Policy 91 (Winter 2017), is one you might actually want to read yourself.  It is a sane, clear-eyed appraisal of why off-label use of drugs or devices can be necessary, why truthful communication about benefits of off-label use can be necessary, and why current FDA regulation of off-label communications is incoherent and harmful to patients.

The first paragraph of the law review article sets the agenda nicely:

“The current framework of the off-label use of pharmaceuticals is as follows: physicians are free to prescribe off-label as they see fit; the Food and Drug Administration (“FDA”) acknowledges the value of off-label use (going so far as to say physicians could have an obligation to prescribe off-label in certain circumstances); but, per FDA policy, drug manufacturers are restricted from sharing truthful and non-misleading information about off-label uses.  The scheme, on its face, is inconsistent and, as could be expected, raises significant concerns regarding free speech, consumer protection, and public safety.”

The article sets forth –

* the importance of off-label prescriptions (one out of every five)
* the FDA’s position that “when a manufacturer promotes a drug for a use that has not been approved, the manufacturer is guilty of misbranding and as having an intent to defraud or mislead”
* the evolving protection of commercial speech promoting pharmaceuticals, from Virginia Board of Pharmacy to Thompson to Sorrell to Caronia to Amarin to Pacira.  Courts keep relying on the First Amendment to shut down the FDA’s efforts to shut down truthful off-label communications, and the FDA keeps pretending that the court rulings are case-specific and do not affect the FDA’s overall policy against off-label promotion.

The article makes the FDA seem either clueless or defiant.

Last week, we discussed a Ninth Circuit case about the intersection of the First Amendment and regulation of alcohol advertising.  We wondered whether the court’s ruling had any implications for regulation of drug marketing.  We also wondered whether the recent SCOTUS decision in Matal, which struck down the anti-disparagement provision in copyright law, had any implications for regulation of off-label communications.  We are still wondering.  The Conners article does not spend as much time wondering about the future path of first amendment jurisprudence.  Instead, it makes the point that the FDA’s truculence and incoherence on the issue are bad for patient welfare.  Here are the main points:

* barriers to truthful off-label communications ensure that poorer patients will get less access to life-saving medications.
* regulatory compliance has been reduced to guesswork
* uncertainty about the scope of regulation reduces investment in new drug research

The article reminded us of something we learned in our Elements of the Law class taught by Edward Levi at the University of Chicago Law School back in 1982.  Levi introduced us to the writings of Jeremy Bentham, the utilitarian philosopher.  Bentham favored freedom of expression, abolition of slavery, equal rights for women, and decriminalizing homosexual acts.  On the other side of the ledger, he wrote an article mocking the Declaration of Independence, and he called the concept of natural rights “nonsense upon stilts.”  We studied Bentham in our Elements class because Bentham eloquently made the point that the law needed clear ex ante rules to guide future conduct.  Otherwise, all we have is “dog law.”  When you come home from work and find that Fido has piddled on the kitchen floor, there is a temptation to whack Fido’s behind with a rolled up Times, Inquirer, or Picayune. Bad dog! But poor Fido does not put the punishment and offense together. FDA punishment of off-label communications is sort of like that. It is not predictable.

Or maybe we’ve got the analogy wrong.  Maybe it is the FDA that is piddling on the First Amendment.

Last week we bashed a Ninth Circuit Daubert decision.  We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the chorus of defense hacks who bemoan the Ninth Circuit’s supposedly liberal, pro-plaintiff bias. You see, we began our legal career out West and would still be there but for a simple twist of fate.

When we clerked for the great and good Circuit Judge William A. Norris in Los Angeles, we were in the Ninth Circuit. Norris possessed both high principles and brilliant technical reasoning.  He grew up in a western Pennsylvania Gold Star family, served in the military, graduated from Princeton U. and Stanford Law, clerked for Justice Douglas, became a preeminent litigator who would beat you whether the issues were constitutional, administrative, or commercial, ran Bobby Kennedy’s 1968 California Primary campaign that saw success turn into tragedy, founded a major museum of contemporary art, and became a judicial giant who produced brilliant opinions and a lineup of SCOTUS clerks.

Norris did not fret over the Ninth Circuit’s reputation for SCOTUS reversals.  He tried to get things right.  Sometimes that meant getting out ahead of SCOTUS, as with his Watkins decision, which anticipated equal protection of gay rights. Working with Judge Norris was a privilege.  If there is an ounce of value to our legal writing, then most of that ounce comes from sessions sitting next to Norris in front of a computer screen, editing opinions word by word.  He insisted that the writing be concise and powerful.  He would bark out in joy whenever we eliminated unnecessary words.  Clear writing came from clear thinking, and Norris’s lightning fast brain always took a logical path through complexity.

Norris passed away this last January, filling us with grief and leaving us feeling like a judicial orphan.  A few months before his death, Judge Norris completed his autobiography, Liberal Opinions: My Life in the Stream of History.  It is a remarkable and uplifting story. Norris carved out a sparkling career in the law.  He also offered splendid advice, including the need to go with one’s gut.  (But do not follow this advice if your gut is an idiot.) We were startled to see on page 188 a quote from this blog defending the Ninth Circuit’s reputation.  Judge Norris’s approval meant – means – a lot to us.

The Ninth Circuit is vast.  It contains multitudes.  When we took our first deposition in San Diego, in a case involving (so help us) stolen dirt, we were in the Ninth Circuit.  When we interviewed a witness in the FBI’s Honolulu office, we were in the Ninth Circuit. When we traveled with DCIS agents and postal inspectors to Las Vegas to round up a check-stealing ring, we were in the Ninth Circuit.  When we did a presentation on litigation and pop culture at the hotel that was the setting for the Twin Peaks television show and movie (Snoqualmie Falls, Washington) we were in the Ninth Circuit.  When we took home the Drug and Device Law Infants from Cedars Sinai Hospital in Beverly Hills, we were in the Ninth Circuit. So were we when we carried those kids on backpacks through Yosemite Valley and, later, hiked alongside them past Yellowstone’s geysers.   (Now we’re just getting sentimental.). Here’s the point: is it any wonder that the Ninth Circuit has, not just the most opinions of any Circuit, but the broadest range of issues and a sometimes perplexing array of outcomes?  Petulant calls to divide this magnificent Circuit, which contains one-fifth the country’s population, make no sense.  How to divide?  Create a California-only Circuit? That would be unprecedented.  Plus, we’d certainly get more Circuit splits.  What’s good about that? Why do we insist on dwelling in echo-chambers, occasionally stepping outside only to hurl invectives? The Ninth Circuit is a model, not a problem.

Which is not to say that the Ninth Circuit is free from mistakes.  We already mentioned Wendell.  Today, we are discussing a case that seems headed for the Supreme Court.  We do not know if it contains mistakes – it turns on a nice issue of first amendment law, and we know just enough about that area to know there are plenty of people out there who know more.  Retail Digital Network, LLC v. Prieto, 2017 WL 2562047 (9th Cir. en banc June 14, 2017), matters to us because it turns on an interpretation of the SCOTUS Sorrell decision from 2011.  We have blogged about Sorrell several times.  For example, check out this post.

Here is a brief Sorrell refresher.  Vermont passed a law preventing pharma retailers from accessing information about which physicians prescribe which drugs. Data miners, who gathered and disseminated such information, challenged the Vermont statutes as violating the first amendment.  SCOTUS struck the statute down.  Our favorite part of the decision is that “[s]peech in aid of pharmaceutical marketing … is a form of expression protected by the Free Speech clause of the First Amendment.”  The Sorrell court held that the Vermont statute disfavored marketing, that is, speech with a particular content, and disfavored specific speakers, namely pharmaceutical manufacturers. In arriving at its result, the Sorrell court did not exactly follow the dance-steps set out in the Central Hudson commercial speech test.  The Sorrell court referenced “heightened scrutiny,” which is different terminology from the “intermediate scrutiny” in Central Hudson.

So what?  What indeed. When we first discussed the Sorrell case, we wondered what the case meant for constitutional protection of truthful off-label communications.  We also wondered whether Sorrell had expanded protection of free speech beyond Central Hudson.

It is that latter question that the Ninth Circuit en banc panel confronted in Retail Digital Network.  That case involved regulation of the marketing of alcohol, not pharmaceuticals, but the animating principles are potentially important for both.  California law prohibits alcohol manufacturers and wholesalers from providing anything of value to retailers in exchange for advertising their products.  In a pre-Sorrell Ninth Circuit case called Actimedia, the Ninth Circuit had applied the Central Hudson test to uphold California’s law, holding that it directly advanced important state interests in separating alcohol manufacturing, wholesale, and retail interests, as well as the state’s interest in temperance. The district court felt bound by Actimedia, and upheld the statute.  The original Ninth Circuit panel in Retail Digital Network held that Sorrell had created a more demanding first amendment test, that, consequently, Actimedia was no longer good law, and that the district court needed to consider whether the California statute could survive Sorrell‘s  “heightened scrutiny.”  The en banc panel reversed the original panel’s reversal of the district court. (Got that?).

The en banc panel reasoned that Sorrell had not really changed the Central Hudson test in any substantive way.  The “heightened scrutiny” phrase was merely intended by SCOTUS to mean more heightened than rational basis review.  In other words, “heightened” equals “intermediate.”  Thus, Actimedia was still good law.  Mostly.  The Retail Digital Network en banc panel concluded that Actimedia was correct that the California statute advanced the state’s interest in separating manufacturing, wholesale, and retail players in the alcohol industry.  California has a legitimate interest in ensuring that advertising payments are not disguised forms of kickbacks and methods of securing vertical and horizontal integration harmful to consumers.  But the en banc panel no longer bought the proposition that restriction of payments for retail advertising would reduce overall  alcohol consumption.  At best, such a restriction might indirectly serve the temperance goal, and that does not cut it under Central Hudson.  Still, the California statute survives.

What to think about the Retail Digital Network opinion?  From our point of view, whether applying “heightened” or “intermediate” scrutiny, we think truthful off-label statements should be protected speech.  The term “promotion,” which seems meant to be pejorative, should not alter the analysis.  We’re not sure that the en banc opinion pays enough attention to the Sorrell discussion of content- and speaker-specific regulations. It’s perhaps too simplistic to say that all commercial speech is content- and speaker-specific. The FDA would be the first to say that it is regulating what manufacturers say, but not what doctors or researchers say.  Will SCOTUS reverse the en banc panel’s reversal of the original panel’s reversal of the district court’s strike-down of the statute?  (Got that?). Keep in mind that the Ninth Circuit en banc panel is joining the Second, Fourth, Sixth, and Eighth Circuits in holding that the Central Hudson test for commercial speech lingers beyond the Sorrell holding.  Moreover, the make-up of the Ninth Circuit panel (remember, Ninth Circuit en banc panels do not include all the active judges in the Circuit) is interesting.  The only dissenter was Chief Judge Thomas. (The Chief Judge is always on en banc panels).  All the other judges voted that Central Hudson still supplies the test.  Among those judges in the majority were Kozinski and Reinhardt. When those two judges, universally considered among the most brilliant judges from the conservative and liberal schools, respectively (yes, we know that is a vast simplification, but forgive us), agree on something, one should be slow to predict SCOTUS reversal.

Then again, Monday’s SCOTUS decision in Matal v. Tam, which struck down the rule against trademarks that disparage persons, might have something to say about Retail Digital Network.  Most commentators have discussed what the Matal case means for the Washington D.C. National Football League team.  But Matal also applied a very muscular version of the Central Hudson test in holding that the non-disparagement provision was not a sufficiently “narrowly drawn” means of advancing “a substantial interest.”  One such asserted substantial interest in Matal was the orderly flow of commerce.  That is not exactly the same interest sustained by the Ninth Circuit in Retail Digital Network, but it is pretty close.  Stay tuned.

Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues. There was no way we wanted to give his opponents any ammunition by saying nice things about Dr. Gottlieb before his confirmation.

Not so now.

Given what Dr. Gottlieb has said – and is saying – we doubt that the FDA’s absolutist ban on truthful industry speech about off-label uses (pejoratively called “promotion”) will continue much longer in its current form.  For instance, on the FDA’s website, Dr. Gottlieb is quoted here as giving a speech saying:

The question we need to ask ourselves is this: Should a patient receive one or even two-year-old care just because the wheels of my government institution and its meticulous work may take longer to turn than the wheels of clinical science?  Some people believe that patients should be treated only according to the clinical evidence included in a drug’s approved indications.  Yet this evidence may be two or maybe three years old, especially in a fast-changing field like cancer, where off label use of medicines provide important opportunities for patients to get access to the latest clinical practice and for doctors to tailor their patients’ treatment plans based on medical need and personal preferences.

*          *          *          *

Efforts to limit prescription and scientific exchange to indications only specified on a label could retard the most important advances in 21st century medicine.  The development and deployment of drugs is becoming more and more closely linked to understanding of mechanism of action, which means that physicians can use drugs in more sophisticated ways that cannot all be anticipated on a label, or easily or quickly studied in prospective studies. . . .  More important, medicine is becoming more personalized as tools like genomics make it possible to tailor treatments on an individual basis. Physicians will not be able to always wait for FDA to approve a new label for every one of their patients, and drug companies will not be able to conduct a trial to explore every possible contingency.  In the future, personalization of care could mean that we will have much more off-label use of new medicines, guided by the latest literature, at least until our regulatory approaches are able to fully adapt to a different paradigm where treatment is highly specific to individual patients.  Yet policy forces are tugging in exactly the opposite direction by placing restrictions on the exchange of some of the most pertinent information.

(Emphasis added).  Defendants in cases involving off-label-use-related allegations should consider having their FDA experts review and, if appropriate, rely upon the current FDA Commissioner’s positions – particularly to rebut contrary views offered by former FDA officials.

Dr. Gottlieb’s non-FDA writings show similar solicitude for scientific speech – whether or not that speech originates with FDA-regulated manufacturers.  In an article for the American Enterprise Institute, Dr. Gottlieb criticized FDA policies that “prohibited” a manufacturer with a drug undergoing supplemental FDA approval for a new use from “distributing the findings or educating doctors on the new use through sponsored medical education.”  “[A] more measured approach to the regulation of promotion” would allow “sharing of useful information that falls within the bounds of appropriate clinical care.”

Those who pursue a rigid adherence to restrictions on the exchange of off-label information, and who fail to recognize that the sharing of scientific evidence can sometimes have important public health benefits, are guilty of pursuing a rigid standard that does not take measure of the consequences. . . .  [E]stablishing the FDA label as the only determinant for acceptable scientific speech loses sight of the fact that these labels are slow to incorporate important medical results about the effectiveness of medical products. They are not the sole basis for medical practice.

In another AEI article a few years later – shortly after the government lost United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) − Dr. Gottlieb’s criticism of the FDA’s prohibition of truthful speech about off-label uses was even more pointed.

When this [off-label] speech is truthful, nonmisleading, and promulgated in an educational context, it is quite possible that the speech would be deemed constitutionally protected by the courts under doctrines that recognize commercial speech as being subject to First Amendment considerations.

(Footnote omitted).  Basically, Dr. Gottlieb took issue with whether scientific speech concerning off-label uses could ever be considered illegal “promotion”:

A core principle of America’s constitutional speech protections is that the government should not establish what is orthodox, especially when it comes to politics, the arts, religion, and science.  The founders recognized that these matters are by their nature iterative, and that it would be dangerous in a democratic society for the government to use its resources to pick a side in these debates.  Matters that are subject to their own evolution − a core feature of how new science unfolds − are better addressed by adding voices to the debate, not suppressing them.

Dr. Gottlieb even urged FDA regulated manufacturers to stand up and challenge the constitutionality of off-label informational restrictions promulgated by the FDA – the agency he now leads:

[T]he drug industry needs to be willing to take the prerogative to challenge the facts in some of these cases and have that day in court. When investigations turn on the sharing of truthful, nonmisleading information about widely accepted uses of drugs, in fast moving fields like cancer, there is a legitimate question about whether public health is being served by suppressing this sort of information.  However, until these cases are challenged in court, there will remain ambiguity around where the appropriate lines rest, what speech is constitutionally protected commercial speech or clearly violative, and how public health is best served.

(Emphasis added).  Not long after that, a company took up Dr. Gottlieb’s challenge, and the result was Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015).

To some extent, where one stands depends upon where one sits, but Dr. Gottlieb has enough of a track record on truthful manufacturer speech about off-label uses of drugs and medical devices, and the constitutional and medical implications of suppressing it, that we are more hopeful now than we have ever been that the FDA will see reason, respect the First Amendment, trust physicians, and change its science-suppressing ways.

With that in mind, we examine the newest First Amendment precedent rejecting governmental prohibition of a manufacturer’s truthful speech about its product, Ocheesee Creamery LLC v. Putnam, 851 F.3d 1228 (11th Cir. 2017).  Ocheesee is a food (skim milk) case, but doesn’t involve the FDA – it doesn’t even involve the federal government.  Instead, Ocheesee is a demonstration that, when given the chance, state regulators are still equally capable of behaving just as badly towards the First Amendment as the feds, albeit on a smaller scale.

It may be that Ocheesee doesn’t involve interstate commerce, see 851 F.3d at 1231 n.1, or it may be that there is something peculiar about milk regulation that we don’t know, but the State of Florida (not the FDA or any other federal entity) came down on the plaintiff, described as “a small dairy creamery located on its owners’ farm” that “sells all-natural dairy items,” like a ton of bricks.  Id.  Apparently, the process of “skimming” the cream from whole milk “depletes almost all the vitamin A naturally present in whole milk because vitamin A is fat-soluble and is thus removed with the cream.”  Id.  Thus Florida agricultural regulations require vitamin A to be added to skim milk before it can be sold as “skim milk.” Id.

That was a problem for the plaintiff because, as a matter of philosophy, this business “prides itself on selling only all-natural, additive-free products.”  Id.  It therefore “refuse[d] to replace the lost vitamin A in its skim milk” with a vitamin A additive as Florida law required.  Id.  The State of Florida thus prevented the plaintiff from calling its product “skim milk,” even though that “product contains no ingredients other than skim milk.”  Id.  Instead (and ironically) the state sought to require the plaintiff to call its product “imitation milk.”  Id. at 1232.  Not surprisingly, the plaintiff refused and sued instead.

Readers attuned to the First Amendment no doubt see the problem already.  Calling such a product “skim milk” is truthful.  The State of Florida – like the FDA with truthful off-label speech – sought to suppress the plaintiff’s truthful speech in a commercial context, using the public health (vitamin A is not just good for you, but essential to health) as its reason for doing so.  Who wins – the First Amendment right to engage in truthful commercial speech, or the state’s public-health-based rationale for suppressing such speech?

In Ocheesee, freedom of speech prevailed.  851 F.3d at 1233 (“The sole issue on appeal is whether the State’s actions prohibiting . . . truthful use of the term ‘skim milk’ violate the First Amendment.  We hold that they do.”).

First, the lay of the constitutional land.  Ocheesee applied the now-venerable “Central Hudson” intermediate scrutiny test for constitutionality of governmental restrictions of commercial speech.  851 F.3d at 1233 (citing Central Hudson Gas & Electric Corp. v. Public Service Comm’n, 447 U.S. 557, 563-64 (1980)).  Thus, Ocheesee did not apply the more speech protective tests enunciated in Sorrell v. IMS Health Inc., 564 U.S. 552 (2011) (“heightened scrutiny”) (see our discussions here, here, here, and here); and Reed v. Town of Gilbert, 135 S.Ct. 2218 (2015) (“strict scrutiny”) (see our discussion here).  That doesn’t mean that the Eleventh Circuit was unaware of these cases – quite the contrary:

There is some question as to whether under the Supreme Court’s decisions in Sorrell and Reed an analysis to determine if the restriction is content based or speaker focused must precede any evaluation of the regulation based on traditional commercial speech jurisprudence, and if so, whether this would alter the Central Hudson framework.  In Sorrell, the Supreme Court found the restriction at issue to be content based but nevertheless cited, articulated, and applied the Central Hudson test.  And in Reed, the Court arguably broadened the test for determining whether a law is content based. . . .  We need not wade into these troubled waters, however, because the State cannot survive Central Hudson scrutiny, and in any event the [plaintiff] does not argue the State’s restriction was content based or speaker focused.

851 F.3d at 1235 n.7.  Thus, the favorable First Amendment decision in Ocheesee sets a floor for the protection of truthful commercial speech in the Eleventh Circuit that parties arguing Sorrell and Reed may exceed.

Under the Central Hudson criteria, as a “threshold question,” the government (which always has the burden of proof) had to establish that the suppressed speech either concerned “unlawful” conduct or was “false or inherently misleading.”  851 F.3d at 1235-36.  It failed because selling the plaintiff’s product was not unlawful – the state would have allowed its sale under the “imitation” description.  Id. at 1237.  Note the parallel to off-label speech – doctors are free to engage in off-label use, and products so used may be lawfully sold.  “[T]he only difference between the two courses of conduct is the speech.”  Id.

Nor could the speech be considered false or misleading.  The state could not simply “define” a product in whatever way it chose, and declare anything not meeting that definition “misleading.”  The court rejected such “self-evidently circular” reasoning:

Such a per se rule would eviscerate Central Hudson, rendering all but the threshold question superfluous.  All a state would need to do in order to regulate speech would be to redefine the pertinent language in accordance with its regulatory goals.

Id. at 1238.  Again, any resemblance to the FDA’s salami slicing of “intended uses” is entirely intentional.  Consumer “unfamiliarity is not synonymous with misinformation.”  Id. at 1239 (citation and quotation marks omitted).

Next up in Ocheesee was the three-pronged “intermediate scrutiny” Central Hudson test:  (1) was the asserted governmental interest substantial? (2) did the regulation directly advance the that substantial governmental interest? And (3) was the restriction on speech more extensive than is necessary to serve that interest?  851 F.3d at 1235-36.

As in off-label promotion cases, the “substantiality” of the government’s “interest in combating deception and in establishing nutritional” – that is to say product safety and effectiveness – “standards” was concededly “substantial.”  Id. at 1240.  Ocheesee jumped over the second prong and went right to the third, “because the measure is clearly more extensive than necessary to achieve its goals.”  Id.

In all commercial speech cases, “the preferred remedy is more disclosure, rather than less.”  Id. (Supreme Court citation omitted).  Florida’s flat ban on use of the term “skim milk” failed because a disclaimer would serve the same purpose in a “less restrictive” and “more precise” way.  Id.  “[A]llowing skim milk to be called what it is and merely requiring a disclosure that it lacks vitamin A” was sufficient “to serve [the state] interest in preventing deception and ensuring adequate nutritional standards.”  Id.

The First Amendment thus prevailed where the speech is truthful – without the court going even having to go to the trouble of relying on heightened (Sorrell) or strict (Reed) scrutiny, both of which would be argued in truthful off-label speech cases.  Visions of shattered backboards come to mind.  We don’t think Dr. Gottlieb wants the FDA to end up like Bill Robinzine, so we’re looking for a more reasonable off-label speech policy to emerge from the FDA, before a court has to do so for the agency.

Today we give you something rare from the Philadelphia Court of Common Pleas — a defense win on preemption. The Philadelphia CCP has been the source of some rather vexing decisions over the years and has certainly taken its share of criticism. Criticism that we think has been rather overstated. Don’t get us wrong, we’ve vehemently voiced our disapproval of several Philadelphia CCP decisions over the years. But there are plenty of times when Philadelphia judges get it right. That happened two weeks ago in Caltagirone v. Cephalon, Inc., 2017 WL 1135576 (Pa. CCP Mar. 23, 2017).

Plaintiff was prescribed an opioid medication to treat his migraines. The drug was approved for use to treat pain related to cancer, so the prescription was off-label. We use that term a lot, but it is worth stopping to remind ourselves what that really means. The FDA-approved labeling for the drug says its intended use is for treating pain in cancer patients. In other words, that was the patient population in which the drug was studied and the data presented to and examined by the FDA and therefore, the indication for which it was approved. Once a drug or device is on the market, however, doctors, who are not governed by the FDA, are free to use those products for any reason they find is medically necessary. Indeed, much of what we know today about drugs and devices comes from physicians using them in the field in ways that they were not originally intended (aspirin as a blood thinner being among the most well-known example). When you break it down like that, it is not surprising that doctors treating patients with migraines who have not been receptive to standard treatments would look to alternative pain medications, such as an opioid with proven success in alleviating pain in cancer patients. In this context, the drug is still being used to treat pain, just a different type of pain.

Back to Caltagirone. The opioid prescribed to plaintiff, in addition to being labeled for use with cancer patients, was also known to be highly addictive. Id. at *1 & 5. The drug was prescribed to plaintiff for 7 years during which time he was in and out of drug treatment programs due to opioid and other drug addictions. Plaintiff ultimately died from his drug addiction. Id. at *1.

Plaintiff’s claims were for negligence, fraud, misrepresentation, and violation of the UTPCPL. The basis for each claim was an allegation that defendants illegally promoted the drug for off-label uses, which was forbidden by the FDA. Id. at *2. The first thing the court does is negate plaintiff’s premise by holding that “generally off-label sales, promotions and prescriptions are proper.” Id. at *3. Further, at the motion to dismiss stage, the court had to accept as true the material facts pleaded by plaintiff. But a critical material fact was missing from plaintiff’s complaint – any allegation that any off-label promotion was false. A false or misleading statement or omission is a requirement for each of plaintiff’s claims under state law. However, plaintiff only alleges that defendants marketed the drug off-label, not that that off-label promotion was false in any way. Because there is no state-law duty to avoid off-label promotion, plaintiff’s claims “could not exist in the absence of federal laws and regulations.” Id. In other words, plaintiff is suing “because the conduct of promoting the drug for migraine headaches violates the FDCA,” not because defendant has breached any state-law duty. Therefore, plaintiff’s action is a private attempt to enforce the FDCA; the type of action that is barred by Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).

While the court dismissed the case with prejudice as preempted, because defendants also asserted that it was barred by the learned intermediary doctrine, the court addressed that issue as well.

Plaintiff argued that the doctrine should not apply because plaintiff’s doctor was not learned because he was given “misinformation” by defendants. Id. at *4. The court saw that for the disingenuous argument that it was. Not only did the prescribing doctor have access to the risk and precaution information provided by defendants and his own medical training and judgment – in this case, the doctor had “actual knowledge” that his patient had become addicted and continued to prescribe the drug for many years. Id. at *5. The physician is the customer under the learned intermediary rule. Id. And it is the physician’s “duty to read and consider the materials from [other medical sources] and writings from the Defendant manufacturers.” Id. The fact that the prescriber may also have read or seen off-label promotion, didn’t change the fact that it was his duty to use all his training and experience, combined with his personal knowledge of the patient, which here included knowledge of addiction (the harm complained of), to treat the plaintiff. The court usefully also noted that the treater has a duty to know what other medications the patient is taking. Id. Keep in mind this strong statement of the learned intermediary’s duty the next time you are arguing this issue in Philadelphia.

Happy birthday to Eric Idle, one of the funniest members of the Monty Python troupe.  In addition to writing bizarre, hilarious comedy skits, Idle also wrote songs.  When he proposed a song for The Life of Brian,  he ran into resistance.  The song seemed insufficiently catchy.  That song was “Always Look on the Bright Side of Life,” one for the ages.  It manages to be simultaneously profound and absurd.   In honor of Idle, we decided today to discuss a case that is similarly profound and absurd.   The case is New York v. Richard Z., 20 I 7 N. Y. Misc. LEXIS 9 I 8; 20 I 7 N Y Slip Op 30498(U) (Oneida Cty March 9, 2017), and has nothing to do with product liability.  Or does it?

 

Our clients get vilified anytime there is a hint of off label use.  Never mind that off label use can be enormously beneficial for patients.  It can even be the standard of care.  We’ve said that several times and the point is made in Bexis’s book.   But now we have the ultimate proof: in Richard Z, a court ordered prison doctors to make off-label use of a medicine available to a prisoner.  The facts are weird and icky, but the point is nonetheless unmistakable.  The prisoner was apparently in prison for some sort of sexual assault.  The opinion supplies no details, but since the prisoner had been in civil confinement for over nine years, and in prison for 30 years before that, we are guessing he had done something(s) really bad.  It is well known that sexual assaulters have a very high rate of recidivism.  That probably accounts for all those years of civil confinement.      

 

The prisoner wanted to get out of stir, and requested a particular chemical therapy.  That therapy involved an antiandrogen that would substantially reduce his sexual urges, and that has been proven in scientific tests to assist in the reduction of recidivism to less than 3%.  A couple of outside experts supported the chemical treatment, opining that such treatment would likely place the prisoner “at a low risk for future sexual offense recidivism and violent recidivism to the point that he could be released to the community on strict supervision”.   But a prison doctor opposed administering the particular requested/recommended therapy, the use of which for these particular purposes would have been off label.  The prison scheduled an “informed consent” conference relative to the chemical treatment of the prisoner.  The prison doctor elicited responses that suggested the prisoner would be taking the drug under compulsion and that “he would not have chosen to take this medication by himself” and “that he knew he had other choices.”  But to the court it was “abundantly clear” that these responses were “coaxed” from the prisoner via  “a carefully guided inquiry” by the prison doctor in an effort to dissuade the prisoner from taking the off label treatment.  The doctor “was acting according to her own subjective views and beliefs thereby substituting those views and opinions” for the prisoner’s .  It was also clear to the court that the prisoner was intelligent, educated, and engaged, and that he “clearly understands the off-label use of this prescription and its risk.”

 

The court concluded that the prison doctor lacked “experience and training in this area,” had misinterpreted her duties in this case, and that she and the prison were attempting “to avoid compliance with the clear and unequivocal expert opinions.”  The court relied on “many studies that show that antiandrogens greatly assist in repressing sexual urges and allow release of sex offenders safely into the community.”  The prison doctor had “substituted her subjective opinion” for the prisoner’s informed consent, and was “both inexperienced in the field of treating sexual offenders and has not kept current with medical advancements and evolving scientific understanding.”  That evolving scientific understanding supported the off label use of the drug, and denying that off label use to the prisoner would be “precluding him from attaining his liberty.”

 

Off label use was not only permissible, it was ordered. 

We recently read a recent (3/15) Bloomberg piece (here, for those with a subscription) entitled “Off-Label Promotion Could Mean More Drug Company Liability.”  This article consists largely of the interviews with two avatars of the other side of the “v.”:  fellow blogger Max Kennerly (who regularly writes intelligent critiques of our posts) and Lou Bogrod, with whom we’ve tangled before over off-label issues.  Needless to say, we disagree with the “more liability” spin they put on any would-be FDA retreat on off-label promotion.

Here’s why – and we apologize to all of you who can’t read the article we’re responding to, but it’s behind a paywall, but Michael Bloomberg didn’t get to be a billionaire by giving things away that he could charge for (that’s what we do).  Like the Bloomberg article, we’re also limiting our focus to product liability, recognizing that truthful off-label promotion also arises frequently in False Claims Act cases.

The first contention is that, once truthful off-label promotion is legal, “drug companies would lose the protection afforded by preemption.”  We don’t think that’s grounds for “more liability.”  First of all, “drug companies” – at least those making innovative branded drugs, don’t have much of a preemption defense.  The Supreme Court unfortunately took care of that in Wyeth v. Levine, 555 U.S. 555 (2009), limiting preemption to cases of “clear evidence” that the FDA would have rejected the label change in question.  There are other possible preemption grounds concerning design defect claims (which we’ve advocated here), but off-label promotion doesn’t involve design.  So, while there may be liability issues raised concerning specific instances of off-label promotion, we don’t see any basis for calling it “more” liability than already exists for on-label promotion.  Most branded drug warnings don’t have a preemption defense now.

Indeed, the result could very well be less liability. Even if truthful off-label promotion were to become broadly legal, the off-label use itself remains off-label.  The FDA, however, can order a drug’s label to contain statements (usually warnings) about an off-label use.  21 C.F.R. §§201.57(c)(6)(i), 201.80(e) (both phrased in terms of “required by” the FDA).  That’s important because, as we discussed in more detail here, only the FDA can do this.  Drug companies are not allowed to discuss off-label uses in their labels whenever they want.  Without the FDA telling them to, that is a form of misbranding.

Continue Reading What If We Win? Off-Label Promotion & Product Liability

We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v. Plaintiffs Legal Committee, where the United States Supreme Court affirmed that “off-label use is generally accepted” and that under the law, “[p]hysicians may prescribe drugs and devices for off-label uses,” 531 U.S. 341, 351 & n.5 (2001), was one of our Bone Screw cases.  Thus, we follow medical malpractice decisions, like Doctors Co. v. Plummer, ___ So.3d___, 2017 WL 242577 (Fla. App. Jan. 20, 2017), which we discussed recently, for what they have to say about off-label use.  In malpractice cases, the dark side often attempts to equate “intended uses” listed in FDA-approved drug/device labeling with the medical standard of care.  As we mentioned in that post, arguments that FDA-approved product labeling equals the medical standard of care are really  attempts to turn off-label use itself into a tort.

The Doctors Co. decision prompted us to look back over our 9+ years of blogging output for where we addressed this issue previously.  Surprisingly, there was only one, a 2007 Bexis piece that (even more surprisingly) didn’t cite any caselaw.  We also found a 2009 law review article by our erstwhile co-founder, Mark Herrmann, which might have been prompted by the earlier blogpost.  But nothing was on the blog itself that could qualify as useful research.

We rectify that today.

Continue Reading FDA-Approved Labeling ≠ Medical Standard Of Care