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 resemblence 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

Like most Americans, we like our doctor.  We like doctors in general.  We are not looking to start another song battle with our friends over at the Abnormal Use blog, like when we competed to name as many law songs as possible, but there are certainly many excellent doctor songs.  Listen to this top 10, and we guarantee you’ll feel better:

  • Doctor, Doctor (Thompson Twins)
  • Dr. Robert (Beatles)
  • Bad Case of Loving You (Robert Palmer)
  • Dr. Funkenstein (Parliament)
  • Calling Dr. Love (KISS)
  • Doctor My Eyes (Jackson Browne)
  • Good Lovin’ (The Rascals)
  • Doctor Wu (Steely Dan)
  • Dr. Feelgood (Motley Crue)
  • I Need a Doctor (Dr. Dre/Eminem)

Bexis proposes adding the following songs to our medical play-mix: Mother’s Little Helper (Rolling Stones), Go To The Mirror, Boy (Who), DOA (Bloodrock), and Comfortably Numb (Pink Floyd).  Yes, Bexis really does have a dark side.

In addition, we must admit that there have been many fine medical shows (Dr. Kildare, Ben Casey, Marcus Welby, St. Elsewhere, ER, Grey’s Anatomy, House), whereas legal shows usually disappoint.  It is possible that we nitpick at legal shows too much.  Our experience and knowledge make us overly-demanding and cranky.  Even so, we thoroughly enjoyed LA Law.   Every Thursday night we gathered around a 19 inch tv (remember them?) with fellow clueless, struggling associates to watch the adventures of the McKenzie Brackman law firm, which had an odd mix of practice areas we have yet to see replicated in real life:  M&A, divorce, criminal law (blue collar, not white collar), tax, and anything to do with sex.  Richard Dysart, who played the part of presiding partner at McKenzie Brackman, once was the guest speaker at a legal charity dinner in L.A.  He told the audience we could all consider him as our senior partner, and he actually gave out his home phone number in case we ever needed to call him for advice.  Years later, another tv program showed us our curmudgeonly, crazy future as the Danny Crane character on Boston Legal, memorably portrayed by William Shatner.  Many of his victories were celebrated with a cigar on an outside deck.  (We’d hate to think of what would happen if all law firms had outside decks.)  And, while we’re at it, we should blow a kiss at Goliath, a legal show currently running on Amazon.  It stars Billy Bob Thornton and was co-created and written by an old AUSA colleague, Jonathan Shapiro.  Give it a look.  It is a smart, smoky, surly show that grabs you by the briefs.

Doctors are often codefendants in our cases.  We try very hard to resist the temptation to point fingers in their direction.  In the last ten years of litigating physical injury cases, we can think of only one time when part of our defense was to suggest medical malpractice, and that was a case where the doctor had been the sole defendant initially, and then he claimed that the problem was with our client’s medical device.  So after we were added to the case as a defendant, we really had no option but to return fire.  Much more often, we find that the interests of the doctor are well-aligned with those of the device or drug manufacturer.  The characterization of the underlying reality that works for doctors usually also works for our clients.  The legal defenses that work for the doctors are usually consistent with the ones that work for our clients.  Indeed, it is not unusual for us to find a medical malpractice case that has things to say that can end up being important and helpful for our clients.  That is true with the recent case of Doctors Co., insurer, for itself and for Annabell Torres, M.D. v. Plummer, 2017 Fla. App. LEXIS 599 (Fla. 5th D. Ct. App. January 20, 2017).  Doctors Co. is a wrongful death medical malpractice case.  The Florida appellate court overturned a plaintiff jury verdict, and at least one of the reasons why it did so is noteworthy for our practice area.

Continue Reading Just What the Doctor Ordered: Package Insert Does not Establish Standard of Medical Care

This guest post is from Liz Minerd, an associate at Reed Smith.  She previously wrote the post on the FDA’s off-label promotion meeting last November, so when she indicated that she’d like to write about the FDA’s “Midnight Memo” on the same topic, we were only too happy to say “yes.”  So here is some in-depth analysis of the FDA’s rather unusual decision to, in effect, comment on its own meeting.  As always, our guest posters deserve all the credit, and any blame, for their efforts.

*********

As this blog reported here, last week—two days before the change in administrations—the FDA released a memorandum entitled “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” available here. The Agency characterizes this 12th hour memorandum as a follow up to the two-day public meeting it held on November 9-10 regarding off-label promotion (or what the Agency refers to as “communications regarding unapproved uses of approved/cleared medical products”).  In particular, the Agency claims that it is issuing this memorandum to provide “additional background” in response to frustrations expressed by certain speakers during the November meeting regarding the Agency’s failure to adequately address the First Amendment in the public hearing notice.

However, the real purpose of the memorandum appears to be to set forth the Agency’s justification for their current restrictions on off-label promotion before a new administration and a new FDA commissioner could have a chance to revisit them. Indeed, after briefly noting the First Amendment concerns raised at the November meeting, the Agency spends the first twenty pages of the memorandum detailing its oft-repeated policy justifications for its current restrictions before addressing any of the First Amendment jurisprudence that has called those restrictions into question.  Its attitude is reflected in the memorandum’s first case citation—to the dissent in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).  [Memorandum, at p. 2. fn. 3]  The Agency’s lengthy policy discussion demonstrates that the outgoing policymakers at the FDA find very little benefit in communications from manufacturers regarding off-label uses even, though it recites that off-label uses can be the standard of care in some circumstances.  This attitude, that only the Agency can keep the public sufficiently safe, is classic governmental paternalism of the sort that the United States Supreme Court has repeatedly condemned in its First Amendment decisions over the past several decades.

For example, the Agency asserts that it seeks to “motivate” the creation of “robust scientific data” about the safety and effectiveness of drugs. [Memorandum at 4-5]  However, the current prohibitions only do so prior to approval of a product.  After approval—a time period usually much longer than the approval process itself—the current prohibitions prevent the same manufacturers from providing the same sorts of scientific data to the same audience.  Thus, the Agency’s current prohibitions actually interfere with the continued creation of robust scientific data after approval.  For example, a manufacturer can be required to post clinical trial results concerning an off-label use [Memorandum at 17-18], but is prohibited from informing doctors that they can view the results on ClinicalTrials.gov and decide whether their patients might benefit from the studied use.

Continue Reading Guest Post – Midnight Madness − The FDA Continues To Discount First Amendment Implications Of Restrictions On Off-Label Promotion

We haven’t digested it yet, so this isn’t a substantive post, but we wanted to make our readers aware that today the FDA made an announcement, which states in pertinent part:

We have also added a document to the docket for the public hearing titled “Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products,” which provides additional background on the issues the FDA is considering as part of our comprehensive review of our rules and policies relating to firm communications regarding unapproved uses of approved or cleared medical products, including a discussion of First Amendment considerations. We are requesting input on the Memorandum as it relates to the questions set forth in the initial notice of public hearing.

Thus, two days before a new administration takes office, the FDA has released an official document, albeit a “memorandum” with no particular regulatory significance, taking positions on the First Amendment protection (or more likely, lack of same) of truthful off-label speech by regulated entities – breaking literally years of silence.

Here is a link to the actual memorandum.  We haven’t read it yet, but we will – as certainly will many of you.  The timing suggests, rather blatantly, an attempt to put “agency” views on record before the change in administration potentially results in a much different approach.  Since we know from Wyeth v. Levine, 555 U.S. 555 (2009), that changes in FDA position adversely affects the scope of deference granted that position, the memorandum may also be a preemptive attempt to undercut that different approach in court.

We’ll have more to say later.

It is always nice to win a case, whether by motion or trial. But just in terms of pure exhilaration, it is hard to beat hearing the jury foreperson announce that, after a hard-fought trial, you win. But note that term “hard-fought.” Most trials really are hard. They really are expensive. They really are stressful. The road to even the most resoundingly wonderful verdict probably had a couple of nasty potholes. That was the case with Horrillo v. Cook Inc., 2016 U.S. App. LEXIS 21026 (11th Cir. Nov. 23, 2016). Prior to trial, there was at least one Daubert ruling that couldn’t have pleased the defense. Also, as reported by our friends in the Abnormal Use blog, there was a learned intermediary ruling that we do not like one bit. But all’s well that ends well, right?

In Horrillo, the plaintiff brought a product liability action on behalf of his deceased mother, who had undergone a surgery to clear her renal artery. The surgery went terribly wrong, as the patient sustained a stroke. The opinion also does not tell us whether the plaintiff ever sued the doctor. The surgeon used a stent manufactured by the defendant. That stent was designed for use in bile ducts, but the surgeon used it off-label in this case. That off-label use was apparently not all that uncommon. The plaintiff’s legal theories included negligence and negligent failure to warn, strict products liability and strict failure to warn, and breach of warranty. After a nearly four-week trial, the jury returned a verdict in favor of the defendant. The plaintiff then moved for a judgment notwithstanding the verdict, or, in the alternative, a new trial. The trial court denied those motions, and the plaintiff appealed to the 11th Circuit. Applying the appropriate standards of review, the 11th Circuit affirmed the trial court’s rulings and the defense verdict.

Continue Reading 11th Circuit Upholds Stent Defense Verdict