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.

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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.