Not too long ago we read a non-drug/device decision, Hale v. State Farm Mutual Automobile Insurance Co., 2018 WL 3241971 (S.D. Ill. July 3, 2018), which left us shaking our heads.  How this suit could not be a blatant First Amendment violation is beyond us.

But that’s not really the point of this post.

The alleged “facts” are downright bizarre:  The plaintiffs were sore losers in previous litigation against the same defendant.  They had managed, through the use of now-discredited legal gamesmanship – a nationwide class action involving the extraterritorial application of the Illinois consumer protection statute – to obtain a verdict of over a billion dollars on claims involving State Farm and allegedly inferior replacement parts used in car repairs.  Thankfully, plaintiffs couldn’t hold it.  In Avery v. State Farm Mutual Automobile Insurance Co., 835 N.E.2d 801 (Ill. 2005), the court rejected extraterritoriality and nationwide consumer fraud class actions. Id. at 855 (“we conclude that the circuit court erred in certifying a nationwide class that included class members whose claims proceedings took place outside Illinois”).  The nominal vote was 4-2, with one justice not participating, but even the dissent agreed on this issue.   Id. at 864 (“I agree with the ultimate result reached by my colleagues − I, too, would find that the circuit court erred in certifying the nationwide class”) (concurring and dissenting opinion).  There were a slew of other issues in this contentious case, but with rejection of the nationwide extraterritorial class, any basis for the boxcar, billion-dollar verdict disappeared.

But plaintiffs (or their lawyers) didn’t give up.  Instead they filed a RICO action alleging that State Farm was “racketeering” when it gave large amounts of campaign contributions – Hale contains nothing to suggest that any state-law campaign finance violations were involved − to support the election of a particular “pro-business” candidate to the Illinois Supreme Court, while the Avery appeal was pending:

In essence, plaintiffs allege that defendants secretly recruited [the candidate] to run for an open seat on the Illinois Supreme Court, where the Avery . . . appeal was pending; that defendants organized and managed his campaign behind the scenes; that defendants covertly funneled millions of dollars to support his campaign through intermediary organizations over which [defendants] exerted considerable influence.

Hale, 2018 WL 3241971, at *1.  You get the drift.  Next came the predictable allegations that everything was covered up so no recusal occurred.  Id.  The new justice supposedly “broke” a “deadlock” – yeah, right, in a case where the main result was unanimous − and “voted to overturn the judgment.”  Id.  All this purportedly nefarious politicking supposedly “deprived [plaintiff plaintiffs] of their constitutionally-guaranteed right to be judged by a tribunal uncontaminated by politics.”  Id.

It’s not the point of this post to debate the intricacies of RICO causation, damages, or enterprises.  We don’t think Hale should ever have gone that far.  We’ve previously advocated the First Amendment protection of purely scientific speech, because we don’t believe that one side to a scientific debate should be allowed to sue the other into submission.  That was our primary interest when Citizens United v. Federal Election Com’n, 558 U.S. 310 (2010), was handed down.  We frankly didn’t dream that core political speech of the sort at issue in Hale could give rise to private prosecutions under RICO.

But be that as it may. If it’s open season on the opposition’s campaign contributions, can the defense side play, too?  After all, in most judicial elections, contributions from the defense are dwarfed by what our politically minded adversaries are able to raise and spend.  It’s no secret.  Here, for example, is the “Campaign Finance Online Reporting” of the Pennsylvania Secretary of State.  You can type in the name of your most (or least) favorite judge and relevant election year and see everybody from whom s/he reported receiving contributions.  Or you can click on “contributions made” and track the donations by your favorite plaintiffs’ lawyer or firm.  Our clients have just as much of a “constitutionally-guaranteed right to be judged by a tribunal uncontaminated by politics” as do plaintiffs.  Are there RICO violations here?

But maybe that’s not enough.  Perhaps it’s too diffuse to assert a RICO violation just because the other side’s contributions made up 90%+ of the total contributions to a particular judge sitting on a particular case.  Maybe there needs to be a “pending” matter to focus things more precisely.  Still, our side might be able to play.  Consider all of those “civil enforcement” actions nominally brought by cities, counties, and states against our clients – where the real vigorish goes to the contingent fee, private counsel brought in to prosecute the action for the government.  We’ve complained about those actions, as well, without much success.  If it turns out that contingent fee counsel (or those acting in concert with counsel) made large political contributions to the particular politicians who later authorized the filing of one of those suits against a client, does the client have a RICO counterclaim under the same rationale as Hale?

Our bottom line is that suits like Hale are abuses of the judicial system and attempts to sue over the other side’s First Amendment protected political activity.  We’re, frankly, shocked that Hale survived summary judgment.  But if plaintiffs insist on opening up that Pandora’s Box, our side should consider whether it wants to play, too.

Gather round brothers and sisters, and hear the word of the Texas Court of Appeals. Today’s sermon addresses the intersection of religion and regulation.  Take out your hymnal, and turn to Hawkins v. State, 2018 Tex. App. LEXIS 7863 (Texas Ct. App., 14th Dist. Sept. 27, 2018).  Consider the case of Mr. Hawkins, hereinafter referred to as “the defendant,” but who self-identified as a bishop of the Genesis II Church of Health and Healing.  A primary teaching of said church was the amazing curative power of “MMS,” which variously stands for Miracle Mineral Solution, Master Mineral Solution, or  Miracle Mineral Supplement. (We think of MMS as an abbreviation either for the more prosaic Multimedia Messaging Service or the sillier Make Me Smile.  But who are we to depart from church doctrine?).  MMS is a sodium chloride product typically used as a disinfectant.  It is an industrial bleaching agent.  The defendant held monthly seminars and taught his flock how to mix and consumer MMS.  And what bounty shall this marvelous MMS elixir deliver?  Why, nothing less than a cure for cancer, HIV, heart disease, autism, and Ebola.  So sayeth the defendant.

 

The state of Texas heard this preaching and, lo, announced that it was Bad.  The state filed an action under the Deceptive Trade Practices Act (DTPA). The main prayer for relief was to enjoin the defendant and his followers to refrain from promoting MMS.  Justice in Texas was swift.  The state’s prayer was answered.  The MMS folly was put asunder.  The injunction was issued.  Thusly were poor innocents spared the fate of dousing their innards with bleach and tumbling into the fiery pit of disease and despair.

 

But the defendant gnashed his teeth against this ruling, and filed an appeal.  Alas, his teeth must still be gnashing, because the Court of Appeals decreed that the trial court’s ruling was Right and Good.

 

As a preliminary matter, the trial court quickly disposed of a raft of frivolous arguments, such as that the court had no jurisdiction over a sovereign church, that the government lawyers were unauthorized to practice law, that a church cannot be a dba, and that there was no contract between church and state.  For anyone who clerked and had to attend to tax objector appeals, this litany of beefs will seem familiar.  Sometimes the hardest part for a court or opponent is first to figure out exactly what the argument is, then restate it cogently, then bash it with solid precedent (which is much preferable to the jawbone of an ass, though we have occasionally encountered or even employed that weapon, too, in our almost two score of legal practice).

 

The actual substantive argument by the defendant is the most interesting: that “no one has the right to prevent a church or its believers from teaching its belief and offering its sacraments if the sacraments do not consist of controlled or illegal substances.”  Ah, at last we arrive at the type of lofty issue we might have encountered in Con Law class.  But the religious freedom claim here is framed exceedingly weakly.  The state brought the DTPA action on the grounds that the defendant had engaged in false, misleading, and deceptive ads and practices by promising benefits of MMS that it in fact lacks, by failing to disclose the utter lack of scientific research supporting such claims, and, worst, by failing to disclose the health risks of MMS.  Religious freedom is not a freedom to poison fellow citizens.  That much is clear.   We’d also say that religious freedom is not a freedom to lie to one’s fellow citizens, but even with the passing of Christopher Hitchens we’d expect some debate on that proposition.  But more to the point, religious freedom does not call off neutral application of the state’s police powers.

 

Whereupon the Hawkins court consulted a Higher Authority – the federal Food and Drug Administration.  In 2010, the FDA issued a safety alert about MMS, warning that it was an industrial bleach used for stripping textiles, and that consumption of MMS could lead to nausea, vomiting, diarrhea, and severe hydration.  At least one person suffered a life-threatening reaction after drinking MMS.  That’s the FDA warning against physical harm, not taking sides in some religious schism.

 

What’s the church’s position? According to at least some MMS labels, reactions such as nausea and vomiting were “evidence that MMS is working.”  Indeed, MMS seems to work in mysterious ways.  Some of the most damning evidence resides on the defendant’s website.  Those who adhered to the ways of MMS would know how to fix 95% of mankind’s maladies.  The church claimed to be “superior to health insurance.”  (Okay, our mind might be open about that one.). Learn about MMS, and you can call yourself a Reverend.  Dispense MMS to 50 unlucky people, and you can call yourself Doctor.

 

But the defendant probably should not call himself Lawyer.  For all of his arguments fell on deaf ears.  Hawkins was not a case of religious discrimination.  The police power of the state had not been exercised arbitrarily or capriciously.  Render unto Caesar, etc.  Little wonder that the appellate court wasted little ink in affirming the trial court’s ruling and offering an easy Amen.

 

We’ve complained before about the federal government’s monetization of First Amendment violations in the context of truthful promotion of off-label uses:

[T]he government has ruthlessly monetized its questionable ban on truthful off-label promotion for quite a few years now. Indeed, the government has used this ban as the basis for a creeping administrative takeover of pharmaceutical and medical device public relations practices.  Don’t believe us?  Just take a look at the Office of Inspector General’s list of “corporate integrity agreements.”

Then, in the wake of the First Amendment win in Amarin Pharma, Inc. v. FDA, 119 F. Supp. 3d 196 (S.D.N.Y. 2015), we noted an interesting provision in the settlement that ended that litigation:

. . .[N]othing in this Order shall be construed to limit Amarin’s to free speech concerning Vasepa.

That got us thinking, and we commented about OIG’s corporate integrity agreements (“CIAs”) in the wake of a hypothetical First Amendment invalidation of the FDA’s ban on truthful promotion of off-label uses:

Well, come the millennium, those CIAs – most of them, anyway – will still be there. What then? Will the government take the position, again backed by threats of debarment, that regardless of the First Amendment, companies have limited their rights voluntarily by what they agreed to in particular CIAs?

We thus recommended addition of First Amendment non-waiver provisions in all future deals with the government that touched upon off-label promotion.  After all, the government has hardly been consistent in its positions regarding the First Amendment and truthful off-label promotion.

We hope all of you out there were listening, because the federal Office of Inspector General (“OIG”) recently made just such a waiver argument in an action, Patient Services, Inc. v. United States, No. 3:18-cv-00016-MHL, pending in the Eastern District of Virginia. Patient Services does not involve a CIA or off-label promotion, but the arguments are the same.  According to the complaint in Patient Services:

  1. PSI is a non-profit charitable foundation that operates Patient Assistance Programs (“PAPs”), which provide financial and other assistance to indigent patients who have chronic and often life threatening diseases that require expensive treatment and management. . . .  Since 2002, OIG has provided public guidance directing how PAPs should be structured and operate in accordance with its view of the Anti-Kickback statute.

  2. Specifically, since 2002, and like all other PAPs, PSI has operated pursuant to an Advisory Opinion from OIG that provides specific guidance as to how PSI should operate and structure its programs to avoid a risk of an enforcement action. . . . The 2017 Modified Advisory Opinion, however, imposes new and oppressive restrictions that cripple PSI’s ability to carry out its charitable efforts.  In particular, the 2017 Modified Advisory Opinion imposes new restrictions that prevent PSI from communicating with donors, potential donors or their purported “affiliates” about new or modified programs to treat chronic diseases affecting indigent populations.

Cutting out the legal jargon, the government is threatening PAP charities with prosecution to keep them from discussing the medical conditions they seek to combat with “donors” – who may also be manufacturers of products used to treat those conditions.  To operate, Patient Services must have an OIG advisory opinion, which it did through 2014.   Then, according to the complaint, OIG changed the rules.  “OIG specifically required [plaintiff] to make a series of certifications to retain an advisory opinion.”  Complaint ¶81.  In order to keep operating, the plaintiff accepted the certifications (nearly “two dozen” of them), and in the litigation, challenged them on First Amendment grounds.  Id. ¶¶82-84.

If, instead of charities and mandatory OIG “certifications,” we were to substitute FDA regulated manufacturers and CIAs involving off-label promotion restrictions, it would be the same situation we warned about previously.  That’s why the Patient Services interests us.

In a recent brief in Patient Services, OIG now argues that, regardless of what the First Amendment may or may not protect, the plaintiff waived its First Amendment rights when it agreed – under threat of prosecution − to the certifications.  Deleting as many case-specific facts as possible, OIG’s argument goes:

[T]his case . . . involves a negotiated waiver of First Amendment rights. . . .  In Lake James [Community Volunteer Fire Dept., Inc. v. Burke County, N.C., 149 F.3d 277, 280 (4th Cir. 1998)], . . . a fire department’s “agreement to consent to citizens’ petitions and not to challenge them in court [wa]s [an] enforceable” waiver of its First Amendment rights.  Id.  Notably, the court applied this standard notwithstanding the fire department’s argument that it had been put to the choice between agreeing to a contract that included what it perceived to be unconstitutional provisions and going without the contract and the benefits it provided. . . .  Because the case ultimately involved a negotiated waiver of constitutional rights, the court applied the test, described below, to determine the enforceability of that waiver.

Just so here. [Plaintiff] agreed to the three provisions about which it now complains, i.e., to the extent these provisions affect [its] rights, it is because [plaintiff] waived those rights. . . .  Indeed, the negotiations were conducted by the Agency and counsel for [plaintiffs]. . . .

Under Lake James, a negotiated waiver of First Amendment rights is valid if it (1) is a “knowing waiver,” that is (2) “voluntarily given,” (3) and which does “not undermine the relevant public interest.”  149 F.3d at 280.  . . . Judicially noticeable facts and facts included in the administrative record – namely, the size and sophistication of [plaintiff] . . ., the fact that it was assisted by counsel, and the fact that negotiations stretched on for years – indicate that any waiver of First Amendment rights was both knowing and voluntary.

OIG brief at 9-11 (factual citations omitted) (emphasis added).

So there you have it.  Even if we win, and truthful off-label promotion is declared constitutionally protected from government interference, OIG is prepared to argue that existing CIAs – even though negotiated under threat of federal debarment – remain enforceable.  Almost all manufacturers with CIAs far exceed the charitable plaintiff in Patient Services in terms of “size and sophistication,” and all were “assisted by counsel” in the “negotiations” that produced CIAs in which they agreed to refrain from all off-label promotion, including truthful promotion.  So, even though those CIAs were about as voluntary as breathing, expect the OIG to argue otherwise, because it is arguing just that, right now.

Amarin was smart when it insisted on a First Amendment non-waiver provision when it settled with the government.  Of course, it also had a more favorable negotiating position, having won a First Amendment decision that the government was loathe to appeal.  Anyone subject to a CIA who doesn’t have such a provision, however, must be prepared to fight a second front, against OIG, even after Sorrell v. IMS Health Inc., 564 U.S. 552 (2011), is applied to truthful off-label promotion on a nationwide basis.

Be prepared – and watch what happens with constitutional waiver in the Patient Services case.

Researchers at Temple University here in Philly recently published a scientific article, “Learning Impairments, Memory Deficits, and Neuropathology in Aged Tau Transgenic Mice Are Dependent on Leukotrienes Biosynthesis: Role of the cdk5 Kinase Pathway,” in the scientific journal Molecular Neurobiology.  That sounds pretty dense, but what the article concludes is that the generic drug zileuton (branded name Zyflo) has been shown – in a transgenic mouse study – to reduce both physical evidence of Alzheimer’s disease, and its mental symptoms.  To wit:

[A]ged tau transgenic mice were randomized to receive zileuton . . . starting at 12 months of age for 16 weeks and then assessed in their functional and pathological phenotype.  Compared with baseline, we observed that untreated tau mice had a worsening of their memory and spatial learning.  By contrast, tau mice treated with zileuton had a reversal of these deficits and behaved in an undistinguishable manner from wild-type mice.

“Learning Impairments” Article, at Abstract (emphasis added).  In lay terms, it might just successfully treat (we hesitate to throw the “c” word around) Alzheimer’s disease.

Nothing else works very well at treating Alzheimer’s disease.

Zileuton/Zyflo has been on the market since 1996, indicated for treatment of asthma, and is thus available for generic production under Hatch-Waxman.

Since this drug has already been FDA approved, it may also be used off-label, right now, to treat Alzheimer’s patients under the therapeutic rationale explained in the “Learning Impairments” article.  With the drug’s basic safety profile already established by FDA approval and twenty-something years of clinical use, the primary issue in any such off-label use is effectiveness – does it actually benefit Alzheimer’s patients – rather than safety.

Let’s assume, for the moment, that zileuton/Zyflo actually has therapeutic value for treating Alzheimer’s in humans.  This is a drug that can be produced generically, so who is going to finance the Phase III human studies necessary to provide the “substantial evidence” that the FDA requires for a label change adding a new indication?  If any generic manufacturer can take a “free ride” on studies sponsored – at great expense – by someone else, then there is not much incentive for anyone to spend that money.  Thus, this extremely consequential new indication may become a regulatory orphan.  Of course, if the drug shows sufficient promise, other sources of funding could become available – third party payers who pay for the medical needs of Alzheimer’s patients, or even the research fund that is supported by the recently issued Alzheimer’s semipostal stamp.

If this off-label use is truly beneficial, then it would (in the absence of any better treatment option) likely become the medical standard of care despite being off-label.  Eventually, the FDA would be forced to engage in some ad hoc, retrospective approach in order to reconcile the label with clinical practice.  That’s how the FDA finally resolved the regulatory conundrum of so-called “pedicle screws,” where regulation fell behind clinical practice – a retrospective study supported the safety and effectiveness of off-label spinal use, but only after manufacturers endured a decade of meritless product liability litigation.  See 63 Fed. Reg. 40025-41 (FDA Jul. 27, 1998).

While further studies are being performed, however, what happens to scientific communication?  This could be (or it could not be – too early to tell for sure) an historic breakthrough in treatment of Alzheimer’s.  If it is, does the FDA continue to prohibit any manufacturer of zileuton/Zyflo from informing the medical community of information on the effectiveness of the off-label treatment, such as optimal dosage and administration practices?  We’ve frequently decried the unconstitutionality of such speaker- and topic-based restrictions on manufacturer scientific communications under the First Amendment.  However, for the most part the FDA’s refusal to conform to current First Amendment norms has flown under the public’s radar, allowing the agency to get away with dilatoriness, and the rest of the government to monetize the FDA’s unconstitutional stance with through “false” claims litigation that isn’t really about falsity.

Alzheimer’s, however, is the elephant in the room.  Without some sort of effective treatment, our health care system cannot indefinitely support the cost of palliative Alzheimer’s care.  Almost everybody knows somebody suffering from dementia, or else someone suffering through the heartbreak of caring for someone with dementia.  The FDA will run into a political and medical buzz saw if its retrograde attitude towards truthful off-label promotion gets in the way of making information about an effective (we hope) treatment for Alzheimer’s available to the public.

And now – but probably not coincidentally – it looks like the FDA is finally getting off the regulatory schneid.  A couple of days ago, the agency issued a “statement” from the commissioner about what was billed as a “new effort” “to advance medical product communications to support drug competition and value-based health care.”  The big news in the statement is rather buried in regulatory-speak, but it is legitimate big news:

Additionally, it’s our [FDA’s] belief that giving companies clear guidelines for providing payors with truthful and non-misleading information about unapproved products and unapproved uses of approved or cleared products will help facilitate communications that can allow payors to provide coverage for these new products and new uses more quickly after FDA approval or clearance.  And our hope is that these communications can also help companies and payors establish pricing structures that benefit patients as well as health plans.

(Emphasis added).  That’s a reference to (among other things) off-label use.  Specifically, the FDA is now approving “truthful and non-misleading” off-label promotion when directed to an audience of third party payors.

The details of this regulatory retreat from Moscow are found in the FDA’s new final guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, & Similar Entities − Questions & Answers, available here.  That’s another mouthful, so we’ll call it the “Off-Label Promotion (OLP) Guidance,” since that’s really what it is.

The FDA is now allowing those who market prescription drugs and medical devices (see id. at 16 explaining the identical treatment of all classes of medical devices) to provide information about off-label uses of these products to “payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis.”  OLP Guidance at 1 (footnote omitted)

This audience includes public and private sector payors, formulary committees (e.g., pharmacy and therapeutics committees), drug information centers, technology assessment committees, pharmacy benefit managers, third party administrators, and other multidisciplinary entities that, on behalf of health care organizations, review scientific and/or technology assessments to make drug or device selection or acquisition, formulary management, and/or coverage and reimbursement decisions on a population basis.

OLP Guidance at 5 (footnotes omitted).

That’s the who.

The “what” is just about everything.  The kind of information that regulated drug and device manufacturers can now provide to third-party payors about off-label uses is defined as:

“any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug.  Such analysis may be comparative to the use of another drug, to another health care intervention, or to no intervention. . . .  [Off-label promotion] may include comparative analyses of the economic consequences of a drug’s clinical outcomes to alternative options (including the use of another drug) or to no intervention.

[The information] can be presented in a variety of ways that can include, but are not limited to, an evidence dossier, a reprint of a publication from a peer-reviewed journal, a software package comprising a model with a user manual, a budget-impact model, a slide presentation, or a payor brochure.

OLP Guidance at 4-5.

The “when” varies a bit depending on whether what kind of off-label use is at issue.  The FDA has drawn what we believe to be a new distinction between “material differences” from the labeling that “relate[] to an approved indication” and so-called “unapproved indications.”  Id. at 7.  In our experience, the FDA has always considered any variance from labeling limitations to be off-label use.  But now, as to approved indications, “material differences from the FDA-approved labeling (e.g., new or increased risks, different dosing/use regimens, different endpoints, more-limited/targeted patient populations)” are treated differently, and somewhat less stringently.  Id. at 6.  A presentation “should include an accurate overview of the design of the economic analysis, including a statement of the study objectives.”  Id. at 11 (going into considerable detail).

As to promotion of uses involving such “material differences” from labeling, a basis in “competent and reliable scientific evidence” is sufficient.  Id. at 10.  In determining the sufficiency of the scientific basis, the FDA will be deferring to “existing current good research practices for substantiation developed by authoritative bodies.”  Id.  The prior FDA requirements of “substantial evidence” is nowhere mentioned.  It appears to be gone as a restriction on off-label promotion under the OLP Guidance.  Promotion of “material differences” must include a “conspicuous and prominent statement describing” those differences.  Id. at 14.

However, off-label promotion “regarding unapproved products and unapproved uses of approved/cleared products” is also now allowed by the FDA.  Id. at 18-20.  As to this type of what might be considered “true” off-label uses, distribution of the following information to third-party payers is now OK with the FDA:

  • “Product information (e.g., drug class, device description and features).”
  • “Information about the indication(s) sought, such as information from the clinical study protocol(s) about endpoint(s) being studied and the patient population under investigation (e.g., number of subjects enrolled, subject enrollment criteria, subject demographics).”
  • “Anticipated timeline for possible FDA approval/clearance/licensure of the product or of the new use.”
  • “Product pricing information.”
  • “Patient utilization projections (e.g., epidemiological data projection on incidence and prevalence).”
  • “Product-related programs or services (e.g., patient support programs).”
  • “Factual presentations of results from studies, including clinical studies of drugs or devices or bench tests that describe device performance (i.e., no characterizations or conclusions should be made regarding the safety or effectiveness of the unapproved product or the unapproved use).”

Id. at 18-19.

This kind of off-label promotion should be accompanied by a variety of disclaimers and other information to ensure that the off-label nature of the uses involved is understood:

  • “A clear statement that the product or use is not approved/cleared/licensed, and that the safety or effectiveness of the product or use has not been established.”
  • “Information related to the stage of product development” and “whether a marketing application for the product or new use has been submitted to FDA or when such a submission is planned.”
  • “[M]aterial aspects of study design and methodology and . . . material limitations related to the study design, methodology, and results. Firms should also ensure that results are not selectively presented.”
  • “A prominent statement disclosing the indication(s) for which FDA has approved, cleared, or licensed the product and a copy of the most current FDA-required labeling.”

Id. at 19.  Significantly, there is no prerequisite that an FDA application for marketing be either pending or contemplated, although if this is the case, it should be disclosed.

As to off-label promotion of these so-called “unapproved uses” (and also drugs and devices that have not yet received any FDA regulatory OK), the FDA tries to salvage what it can of the justifications it used to advance in opposition to our side’s First Amendment arguments about truthful off-label promotion:

FDA believes that the categories of information . . . are, on the one hand, broad enough to encompass the information that payors may need to make informed coverage and reimbursement decisions and, on the other hand, limited enough to maintain appropriate incentives for firms to conduct robust studies to evaluate the safety and efficacy of unapproved products and unapproved uses of approved/cleared/licensed medical products. . . .  FDA believes that the risk that payors will be misled is relatively low.  Payors are a sophisticated audience with established procedures to carefully consider the full range of relevant evidence about new uses of medical products.

OLP Guidance 21-22.

Finally, the OLP Guidance reminds us that “[f]irms’ communications to other audiences about unapproved products or unapproved uses of approved/cleared/licensed products could raise additional or different considerations and are beyond the scope of this guidance.” Id. at 22.

In conclusion, let’s look at that last point a bit. The OLP Guidance punches another huge hole in the FDA’s previous attempts to ban regulated entities from distributing truthful information about off-label uses to anybody.  As discussed at some length in Greater New Orleans Broadcasting Ass’n, Inc. v. United States, 527 U.S. 173, 192-94 (1999), the number and nature of exceptions to a speech prohibition adversely affect both the prohibition’s rationality and its ability to advance the governmental interest that motivates it.  We fail to see how any constitutionally valid distinction can exist between providing the identical information, with identical disclaimers and limitations, to one “sophisticated” audience (third-party payors) while prohibiting that information’s distribution to another “sophisticated” audience – that being medical doctors that directly prescribe these drugs and devices.

And that’s just within the rubric of commercial speech.  Greater New Orleans also cautioned, “decisions that select among speakers conveying virtually identical messages are in serious tension with the principles undergirding the First Amendment.”  Id. at 194.  We now have Sorrell v. IMS Health, Inc., 564 U.S. 552 (2011), for the proposition that, with respect to pharmaceutical detailing, we’re not just dealing with commercial speech.

Thus, we believe that, as a practical matter, the OLP Guidance effectively dooms any First Amendment defensibility of an FDA ban on the same truthful information being distributed, in the same fashion, to the rest of the medical community beyond third-party payors.  Conversely, to those regulated entities that seek to inform physicians of truthful scientific information about their products, we believe that the OLP Guidance can serve as a roadmap to success in an Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015), situation by establishing that off-label promotion is “truthful,” “not misleading,” and therefore protected against governmental enforcement activity.  After all, just as third-party payers are sophisticated professionals interested in possible effective treatments for Alzheimer’s disease, so are the doctors directly involved in treating Alzheimer’s patients.

Today’s guest post by Reed Smith associate Jennifer Eppensteiner concerns an interesting First Amendment development.  Everybody knows how California’s wildly overwrought Proposition 65 has turned that state’s products, from beer to bacon, into billboards for remote and scientifically suspect cancer warnings.  Well, how about a ruling that requiring scientifically unsound warnings on products is compelled false speech in violation of the First Amendment?  As always our guest posters deserve 100% of the credit (and any blame) for their posts.

***********

It is probably a safe bet to say that many of the blog’s readers settle in to enjoy these posts with a cup (or, on anticipated longer days after long nights, carafe) of coffee.  Readers in California may soon be drinking coffees with warning labels – no, not of the Jackie Chiles Java World “Caution: Hot!” variety – but a cancer warning, courtesy of Proposition 65 (“Prop 65”).  Coffee consumers are a passionate bunch, so the recent Los Angeles Superior Court proposed ruling to this effect has been widely publicized.  Readers may not be familiar, however, with another recent Prop 65 ruling, one with an arguably better outcome for product manufacturers.  That’s why I’m here today.

The outcomes in drug and medical device litigation often turn on the label. Regardless of how detailed a warning is, in what font and size it’s printed, and whether it comes in a bold, black box, plaintiffs always insist that the warnings were insufficient.  They sometimes base their position on nothing more than attorney argument, and often they cite isolated information that is against the great weight of authority, such as an anecdotal case report or an outlier study with small sample sizes and inconclusive results.

Thankfully, the Eastern District of California recently recognized that requiring a manufacturer to include a cancer warning based on the questionable finding of a single organization, when all other regulatory and governmental bodies had found the opposite, would violate the manufacturer’s First Amendment rights by forcing it to say something that was false, and with which it disagreed. Nat’l Assoc. of Wheat Growers v. Zeise, et al., Civ. No. 2:17-2401, 2018 WL 1071168, at *7 (E.D. Cal. Feb. 26, 2018).  Before the court was a motion for preliminary injunction, requesting the court do two things:  (1) stop the State of California from identifying glyphosate on a list of cancer-causing products; and (2) enjoin the warning requirement of Prop 65 from being enforced against Plaintiffs with regards to glyphosate.  Id. at *1.

Before we get into the court’s reasoning, some background on Prop 65. Officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, Prop 65 purports to protect California’s drinking water sources from being contaminated with chemicals known to cause cancer, birth defects or other reproductive harm, and requires businesses to inform Californians about exposures to such chemicals.  Under Prop 65, the Governor of California is required to publish a list of chemicals “known to the State” to cause cancer, as determined by certain outside entities.  Id.  Prop 65 also prohibits any person in the course of doing business from knowingly and intentionally exposing anyone to the listed chemicals without a prior “clear and reasonable” warning.  Id.  The prohibition, and corresponding warning requirement, takes effect 12 months after the chemical has been listed.  Id.  Private persons are authorized to file suit to enforce Prop 65, adding to the overwarning problem.

Glyphosate is a widely-used herbicide used to control weeds in various settings.  Id. at *1, n.1.  Glyphosate can even be used on coffee plantations.  But I digress.  Plaintiffs or their members sell glyphosate-based herbicides, use glyphosate in their cultivation of crops that are incorporated into food products sold in California, or process such crops into food products sold in California.  Id.  In 2015, the International Agency for Research on Cancer (“IARC”) of the World Health Organization (“WHO”) classified glyphosate as “probably carcinogenic” to humans based on evidence that it increased cancer rates in animal studies and limited evidence that it could cause cancer in humans.  Id. at *2.  In this case, the IARC is the outlier.  Several other organizations, including the United States Environmental Protection Agency (“EPA”) and other agencies within WHO found no evidence that glyphosate causes cancer.  Id.  Still, relying on the IARC’s “probably carcinogenic” classification, California’s Office of Environmental Health Hazard Assessment (“OEHHA”) issued a Notice of Intent to List Glyphosate in November 2015 and subsequently began listing glyphosate as a chemical known to state of California to cause cancer in July 2017.  Id.  The warning requirement would therefore take effect in July 2018.  Id.

After finding that Plaintiffs’ First Amendment claim was ripe for the court’s consideration, the court turned to the issue of injunctive relief. Injunctive relief, “an extraordinary and drastic remedy,” requires that the moving party establish several familiar elements:  (1) it is likely to succeed on the merits, (2) it is likely to suffer irreparable harm in the absence of preliminary relief, (3) the balance of equities in tips in its favor, and (4) an injunction is in the public interest.  Id.

Regarding the likelihood of success on the merits, the court first distinguished between the State’s listing of glyphosate as a chemical “known to” cause cancer and the subsequent warning requirement.  The former is government speech; the latter is commercial speech.  Id. at *5.  This distinction is significant because the “[t]he Free Speech Clause restricts government regulation of private speech; it does not regulate government speech.”  Id. (citing Pleasant Grove City v. Summum, 555 U.S. 460, 467 (2009).  So, while Plaintiffs could not demonstrate likelihood of success on the merits with regards to the listing of glyphosate, a different analysis was required for the warning requirement itself, which would have the effect of compelling commercial speech – the labeling of a product.  Id.

Commercial speakers receive protection of the First Amendment, subject to some limitations.  The government may require commercial speakers to disclose “purely factual and uncontroversial information” about commercial products or services, as long as the “disclosure requirements are reasonably related” to a substantial government interest and are neither “unjustified [n]or unduly burdensome.”  Id. (citing In Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626, 651 (1985)).  As explained above, only the IARC found that the evidence warranted branding glyphosate as “probably carcinogenic.”  On the other hand, the court noted that

…the EPA has reviewed studies regarding the carcinogenicity of glyphosate multiple times and has determined each time that there was no or insufficient evidence that glyphosate causes cancer, most recently in September 2016. Several international agencies have likewise concluded that there is insufficient evidence that glyphosate causes cancer, including the European Commission’s Health and Consumer Protection Directorate–General, multiple divisions of the World Health Organization besides the IARC, and Germany’s lead consumer health and safety regulator.

Id. at *7.  Based on the great preponderance of scientific opinion, the court reasoned that it was “inherently misleading for a warning to state that a chemical is known to the state of California to cause cancer based on the finding of one organization … when apparently all other regulatory and governmental bodies have found the opposite, including the EPA.”  Id.  Accordingly, the court found that “here, given the heavy weight of evidence in the record that glyphosate is not in fact known to cause cancer, the required warning is factually inaccurate and controversial.”  Id.

After finding that the required warning would be false and misleading, the court found the scales tipped in Plaintiffs’ favor on the issues of irreparable harm, balancing of the equities, and public interest factors.  The court granted Plaintiffs’ request for a preliminary injunction enjoining the warning requirement of Prop 65.  Jackie Chiles would agree that requiring such a warning would be an infringement on Plaintiffs’ constitutional rights.  That’s outrageous, egregious, preposterous!

Remember, as well, that the First Amendment equally applies to tort litigation.  The blog has discussed the product liability implications of New York Times Co. v. Sullivan, 376 U.S. 254, 265 (1964), several times.  This is another such instance.  To the extent that, as in Nat’l Assoc. of Wheat Growers v. Zeise, the First Amendment prevents the government from forcing a product manufacturer to “speak” falsely based on the results of an outlier study, it equally precludes private plaintiffs from seeking damages for a manufacturer’s failure to include the same false information on a product warning.

Where might that come in useful?

Like a lot of large firms, Reed Smith has a number of blogs. We don’t mention them much because, DDL has product liability pretty well covered, and the others mostly don’t overlap a lot with what we do.  But occasionally….

The other day, Reed Smith’s Health Industry Washington Watch blog described a couple of pieces of legislation that, without much fanfare, passed a subcommittee of the House of Representatives (Energy and Commerce Health Subcommittee ) while everyone was distracted, watching the Senate’s struggles to keep the government functioning.

We’re interested because both of them, were they ever to be enacted into law, could affect our sandbox.

The first bill, H.R. 2026, is the Pharmaceutical Information Exchange (“PIE”) Act (see here for more information)  This bill would be another step forward in the now decades-long struggle to legalize truthful manufacturer communications about off-label uses.  It’s not very long – one paragraph:

Health care economic information or scientific information provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs for coverage, reimbursement, or other population-based health care management, shall not be considered false or misleading or any other form of misbranding . . ., if it is based on competent and reliable scientific evidence and relates to an investigational new drug or an investigational use of an approved drug. In order for information relating to an investigational use of an approved drug to be provided pursuant to this subparagraph, there must have been submitted to the Secretary a supplemental application for approval of such use, or the study or studies needed to support the submission of a supplemental application for such use must have been completed with the intention that a supplemental application will be submitted to the Secretary for approval of the use.  For purposes of this subparagraph, scientific information includes clinical and pre-clinical data and results relating to an unapproved drug therapy, or drug indication, or other condition of use being investigated or developed.

We’re not sure why, but as phrased PIE only applies to drugs, but not medical devices.  [subsequent note:  This has been fixed by this amendment, so that PIE applies to both drugs and devices.]

As passed by the House, PIE allows off-label communications basically to third-party payors (“TPPs”), about off-label uses.  Communications can begin when “the study or studies needed to support the submission of a supplemental application [to the FDA] for such use . . . have been completed.”  If the supplemental application has been submitted, great, but it doesn’t need to be.  And more than just studies can be discussed – so can “clinical and pre-clinical data and results,” as long as it qualifies as “competent and reliable scientific evidence.”

PIE still doesn’t comport with the First Amendment, since it limits both the audience and the circumstances under which manufacturers may speak about truthful scientific information, while not imposing any limits on anyone else.  Thus it still discriminates both by topic and speaker under Reed v. Town of Gilbert, 135 S. Ct. 2218, 2230 (2015).  Nonetheless PIE would be a decent step in the right direction in terms of litigation.

First, it would greatly reduce litigation by TPPs over alleged off-label promotion.  Second, it would be another exception to the FDA’s increasingly tattered prohibition of truthful off-label speech, and each exception makes the ban itself less defensible against First Amendment challenges.  See Greater New Orleans Broadcasting Ass’n, Inc. v. United States, 527 U.S. 173, 190 (1999) (holding the “regulatory regime is so pierced by exemptions and inconsistencies that the Government cannot hope to exonerate it”).  Third, it makes the other side’s rhetoric against off-label promotion less credible, particularly on occasions when the exact same information is already being transmitted to TPPs.  Indeed, one could argue that a prescribing physicians’ medical practice is a “similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs for . . . other population-based health care management.”

The second bill is called the Over-the-Counter Monograph Safety, Innovation, and Reform Act (“OM-SIRA”).  Apparently the subcommittee passed a “discussion draft” that doesn’t even have an “H.R.” number.   Without making a word-for-word comparison, this draft appears substantively the same as S.2315, which is available here.  OM-SIRA deals with nonprescription drugs that are marketed without an approved new drug application.  Yes, there are such things, and we blogged about preemption issues related to them here.  And preemption is what piques our interest about OM-SIRA.  As summarized by the Reed Smith blog, OM-SIRA:

would create a system for future changes to drug monographs through an administrative order procedure with the opportunity for development meetings or other consultations, submission of comments on proposed orders, and dispute resolution procedures.

This means that OTC drugs under OM-SIRA would be subject to the administrative proceedings created by the bill before their manufacturers could modify those products or their labels.  Interestingly, the FDA can act unilaterally to modify a label, but not OTC manufacturers.  §505G(b)(4)(B)).   Manufacturers can act unilaterally only as to “minor” changes that do not affect “safety and effectiveness”  §505G(c).

If OM-SIRA were enacted in its present form, it appears to us that the administrative approval procedures in the bill would provide a basis for implied impossibility preemption under the “independence principle” of PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013).  Since implied preemption operates independently of express preemption, it would not be subject to the partial savings clause in 21 U.S.C. §379r(e), which would be very good thing for defendants in such litigation.

With respect to both bills, we’ll see what happens.  Maybe Congress won’t be PIE in the sky this time around.

We’ve been aware of the other side attempting to construct a First Amendment counter-argument to our preemption defense for some time.  It first cropped up in a 2015 360 article by a P-side thought leader (no, not necessarily an oxymoron) soon echoed by a comment to one of our posts on the Amarin First Amendment decision. DDL, and we addressed it here.  Late the same year, we addressed it again, this time in response to an ATLA article, and set forth our views in more detail.

In a nutshell, the plaintiffs’ position is that, assuming truthful promotional speech about drugs is constitutionally protected (as we agree), our clients purportedly have a state-law tort “duty” to ignore the FDA and put on our labels whatever any particular plaintiff claims is “truthful” in any given case, even if we would otherwise be required to obtain FDA pre-approval.  The First Amendment’s protection, these articles have argued, dissolves impossibility preemption because the First Amendment eliminates any FDA “prior restraint” on protected speech.

This argument has some rather glaring flaws, starting with the other side’s necessary concession that the speech in question is constitutionally protected, which in and of itself would preclude state-law tort liability under New York Times Co. v. Sullivan, 376 U.S. 254 (1964).  Further, an FDA pre-approval requirement, designed to make sure that only truthful speech appears on drug labeling (which is quite broadly defined), would seem to be a reasonable time, place and manner requirement – given its public health-based rationale.

That was where things stood the end of 2015.  Not much happened (from our perspective) for almost two years.  We thought the primary target of any argument the First Amendment defeats impossibility preemption would be generic preemption.  After all, generic plaintiffs don’t have much more to lose, so why not give this a flyer?  But, nothing.  Nor did we see the argument being made anywhere else − until a few weeks ago.

In their infinite wisdom, the other side decided to debut their First Amendment argument against preemption in the Depakote litigation.  It first raised its ugly head in Swanson v. Abbott Laboratories, 2017 WL 5903362 (S.D. Ohio Nov. 28, 2017).  Previous rulings in Depakote cases had found preemption of certain warning claims under the Levine “clear evidence” standard, and also preempted design defect claims under the Mensing/Bartlett impossibility rationale.  See Rheinfrank v. Abbott Laboratories, Inc., 680 F. Appx. 369, 385-88 (6th Cir. 2017); Rheinfrank v. Abbott Laboratories, Inc., 137 F. Supp.3d 1035, 1040-41 (S.D. Ohio 2015); Rheinfrank v. Abbott Laboratories, Inc., 119 F. Supp.3d 749, 766-70 (S.D. Ohio 2015), aff’d, 680 Fed. Appx. 369 (6th Cir. 2017); In re Depakote, 87 F. Supp.3d 916, 922-23 (S.D. Ill. 2015).

The same preemption arguments were made – and prevailed – supporting summary judgment in Swanson.  2017 WL 5903362, at *7-8.  The new wrinkle was plaintiffs arguing “that Defendants have not met their burden in proving impossibility because the First Amendment protects their right to communicate non-FDA approved information through other means.”  Id. at *8.  The court found plaintiffs’ reliance on off-label promotion cases “irrelevant” to a product liability case involving no such thing:

Such cases, however, are not applicable in the instant matter. . . .  [T]he ability to promote off-label uses is irrelevant as to whether the FDA’s rejection of a labeling change for an on-label use constitutes clear evidence of conflict with state law.

Id.  “Labeling” includes Dear Doctor letters.  Id.  Therefore, “[t]o hold that Defendants First Amendment right prevents preemption is contrary to case law finding preemption based on FDA regulations.”  Id. (pointing out that Mensing and Bartlett also involved FDA-approved labeling).

The same defendant also obtained summary judgment in Willis v. Abbott Laboratories, 2017 WL 5988215 (W.D. Ky. Dec. 1, 2017).  Again, preemption was a big part of the win.  The defendant’s showing of “clear evidence” in Willis was no different than that which had prevailed both in the district court and on appeal in Rheinfrank. Willis, 2017 WL 5988215, at *4.  Plaintiff threw the First Amendment hail Mary – arguing that, “because [defendant] has a First Amendment right to speak in a truthful and non-misleading manner about Depakote, it cannot claim that the FDA’s rejection of its label changes made it ‘impossible’ for it to comply with” state law.  Id. at *5.  Again, the argument fell woefully short:

The plaintiffs cite to no standard the Court should look to in evaluating whether [defendant] has a First Amendment right to include a warning about developmental delay in the Depakote label or whether the FDA’s rules and practices regarding drug labeling unconstitutionally infringe upon that right. . . .  Instead, they cite to a line of cases which pertain exclusively to the marketing, as opposed to labeling, of drugs and seek to apply them to the present case. . . .  The Court finds each of these cases, as well as the other out-of-circuit district court cases cited, to be distinguishable and unpersuasive.  The plaintiffs essentially ask the Court to find that the FDA’s authority to reject proposed label changes regarding drug safety amounts to an unconstitutional suppression of a drug manufacturer’s speech.  None of the cases cited by the plaintiffs support such a broad proposition, and understandably so, given the recognition courts have long given to the role of the FDA in regulating the labeling of drugs.

Id. (citations omitted).  Likewise, the FDA’s control of “labeling” extended to the other means (such as “Dear Doctor” letters) that plaintiffs claimed the defendant should have employed.  Id.  The First Amendment simply didn’t force the defendant to speak in the manner that plaintiffs demanded.

“Comparatively,” the Supreme Court preemption precedent on which the defendant relied (chiefly Mensing/Bartlett) “spoke directly on the FDA’s power to regulate what speech appears in a drug’s ‘label’ and when that power takes preemptive effect over what is required by state tort law.”  Id. at *6.  Thus, the application of the First Amendment to FDA administrative actions was not analogous to preemption in product liability litigation:

The plaintiffs’ argument would require the Court to cast aside both cases and the scheme of preemption that they endorse.  The Court is not persuaded that the First Amendment requires it to do so.  Therefore, the Court rejects the plaintiffs’ First Amendment argument.

Id.

We find it somewhat odd to see the plaintiffs’ First Amendment argument trotted out for the first time in a branded drug preemption case.  Compared to generic plaintiffs, those in Depakote aren’t nearly as devoid of alternative arguments.  In any event, our dismissive opinion of that argument is only reinforced by these decisions.  First Amendment principles are implicated by absolute FDA bans applicable to drug marketing.  Free speech is not impinged in nearly the same way by the FDA having a say over what goes into drug labeling.  Indeed, to the extent that plaintiffs invoke the First Amendment to pursue some state-law duty that would force the defendants to speak by changing their labels, they would be standing free speech on its head.

There is more to Swanson and Willis than just their preemption rulings, however.  In Swanson, plaintiffs tried nitpicking which alleged birth defect risks extended past the first trimester, as opposed to which did not.  That argument was quickly shut down.  “Plaintiffs’ claim that [defendant] failed to warn that Depakote use’s risk continued during pregnancy beyond the first trimester is too intertwined with the [preempted] developmental delay claim to remain.”  2017 WL 5903362, at *10.  As far as other products being “safer,” they simply weren’t an option in Swanson:

[I]n 1996, Plaintiff did not have other bipolar medication options that would have worked for her. . . .  Plaintiffs’ treating physician during her hospitalizations, testified that no other bipolar medications available in 1996 were viable options to treat [her].

Id.  Thus, “no dispute of material fact remain[ed] for the jury to decide.”  Id.  Given how bad the facts were for the plaintiff in Swanson, we’re surprised (and pleased) that the other side didn’t just drop the case.

Willis is a substantially longer decision than Swanson.  Additional rulings in Willis put no stock in the peculiar “clear evidence” preemption standards propounded in In re Fosamax, 852 F.3d 268 (3d Cir. 2017).  Willis, 2017 WL 5988215, at *6.  “[T]he Sixth Circuit has already determined that the evidence in Rheinfrank, which is identical to the evidence in this case, met the ‘clear evidence’ standard.  Therefore, whatever ‘clear’ means, it has been met.”  Id.  The court accepted the defendant’s regulatory evidence that the FDA’s rejection of proposed label changes extended to autism, id. at *7, and rejected a variety of evidentiary attacks on that evidence. Id. at *8-9.  Plaintiffs’ attempt to construct a “design defect” claim out of “the drug’s indications” also failed:

[T]he lack of contraindications for the drug would still not be considered a part of its design but rather its “warnings and instructions.”  Thus, the Court will not let the plaintiffs’ claim proceed under a theory that the failure to contraindicate Depakote made the drug’s design defective.

Id. at *10.

Daubert motions in Willis only knocked out one of the plaintiffs’ three experts, id. at *12-15, but those causation motions did succeed in significantly limiting the scope of the injuries at issue – by removing from consideration the only birth defect that the minor plaintiff allegedly suffered.  Id. at *15.  Thus, plaintiffs remaining warning-based claims – for negligent misrepresentation and fraud failed for lack of cognizable injury.  Id. at *16 (plaintiff “cannot assert a claim for negligent misrepresentation, as he suffered no cognizable injury that was allegedly caused by the misrepresentations”), *17 (same result for fraud).


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.