Photo of Bexis

The rumblings began shortly after the industry First Amendment victory over the FDA in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015).  A couple of anonymous, obviously plaintiff-side, comments to our “breaking newsAmarin post suggested that the Amarin First Amendment victory for truthful off-label promotion might have a downside.  Both comments raised the same issue:  what happens to “impossibility” preemption in the drug warning context once First Amendment protection is extended to truthful pharmaceutical promotion?

One response would be that, if such speech is fully protected, as the Supreme Court indicated in Sorrell v. IMS Health, Inc. – “[s]peech in aid of pharmaceutical marketing, however, is a form of expression protected by the Free Speech Clause of the First Amendment” − 131 S. Ct. 2653, 2660 (2011), then it’s game over.  The same First Amendment protection equally precludes private suits under New York Times Co. v. Sullivan, 376 U.S. 254 (1964).  “What a State may not constitutionally bring about by means of a criminal statute is likewise beyond the reach of its civil law.”  Id. at 277.  See also In re Asbestos School Litigation, 46 F.3d 1284, 1294-96 (3d Cir. 1994) (First Amendment precluded product liability action).  Sullivan also roundly rejected the “commercial” overtones of otherwise fully protected speech as a basis for suppressing it through tort litigation:

The publication here was not a ‘commercial’ advertisement. . . .  That the [defendant] was paid for publishing the advertisement is as immaterial in this connection as is the fact that newspapers and books are sold. . . .  To avoid placing such a handicap upon the freedoms of expression, we hold that if the allegedly [tortious] statements would otherwise be constitutionally protected from the present judgment, they do not forfeit that protection because they were published in the form of a paid advertisement.

376 U.S. at 266 (citations and quotation marks omitted).

That makes sense, since most litigation over pharmaceutical labeling is, at bottom, a fight over science – both sides’ experts battle over whether drug X causes adverse condition Y.  Scientific speech has long been fully First Amendment protected.  “Under the First Amendment there is no such thing as a false idea.”  Gertz v. Robert Welch, Inc., 418 U.S. 323, 339 (1974).  See, e.g., Miller v. California, 413 U.S. 15, 23 (1973) (listing “scientific speech” as a category of fully protected speech); American School of Magnetic Healing v. McAnnulty, 187 U.S. 94, 106 (1902) (government may not decide that one side of medical controversy, such as the benefits of smallpox vaccination or homeopathy, is “fraudulent”); Universal City Studios, Inc. v. Corley, 273 F.3d 429, 446-47 (2d Cir. 2001) (“it is settled that the First Amendment protects scientific expression and debate just as it protects political and artistic expression”).  We could cite a dozen more cases standing for the fully First Amendment protected nature of scientific speech, but that’s not the point of this post.

Back in August, we also noticed the same point being made by Lou Bograd, one of the more creative plaintiff-side lawyers around.  He was quoted by 360 in this story as saying:

If it’s the case that drug companies have the First Amendment right to make truthful statements about off-label uses, and the FDA cannot prohibit them, then it follows that they would have the First Amendment right to truthfully communicate the risks of their products even if that information isn’t on the label of the brand-name products.

So we wrote a post about all that, on the assumption that the comments were directed against the concept of “impossibility” preemption in product liability litigation involving generic drugs.  Where else would plaintiffs’ lawyers be so desperate as to advance an argument predicated on the absolute First Amendment-protected status of the very speech that they simultaneously have to claim is somehow “defective”?

Now, Mr. Bograd has taken pen to paper and fleshed out his musings in an article in a widely circulated ATLA publication.  L. Bograd, “Be Careful What You Wish for:  Drugmakers, the First Amendment, & Preemption,” 51 Trial 24 (Nov. 2015).  It’s available on Westlaw, but oddly doesn’t seem to have a separate WL citation.

Sure enough, we were dead in the red as to where we thought that argument was directed.  It’s an attempt to set up the First Amendment protection as some sort of defense to impossibility preemption under PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).  The article’s thesis is, “[i]f the First Amendment protects [FDA regulated entities’] right to truthfully promote the drugs they sell, it also must protect their constitutional right to provide truthful warnings about their products’ risks, even if the FDA has not approved those warnings.”  Id. (no internal pagination provided).  Therefore, according to the article, “federal law cannot prohibit generic drug companies from providing truthful warnings about the risks of the products they sell.”  Id.

If ATLA is publishing this, we on the defense side can expect to see the argument start popping up in litigation.  Thus, we’ve decided to revisit our prior post in a little more depth.

Our response to the thesis being put forward is, first (as already stated) that the initial statement being true, the First Amendment precludes courts from litigating the subsequent propositions under Sullivan.  The First Amendment precludes state (or federal) law from seeking adjudication of the “truth” of fully protected speech.  Plaintiffs don’t get to have courts enforce their version of the “truth” against our clients as protected speakers – no more than creationists can sue scientists into submission, or Christians can sue Jews.  The premise that pharmaceutical speech is fully First Amendment protected ends the discussion, except for, “here, plaintiff, please sign the stipulation of dismissal, and we won’t seek costs against you based on your concession.”

Our second response is that, assuming all the statements are true, the article’s premise that Mensing/Bartlett is somehow called into question is false.  Keep in mind the Supreme Court’s basis for impossibility preemption.  It’s what we’ve previously called the “independence principle.”  It is impossible to comply with an immediate common-law tort duty to change a warning where, procedurally, an FDA-regulated manufacturer must first receive permission from the FDA permission which cannot possibly be granted instantaneously) before making that change.

[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.

Mensing, 131 S. Ct. at 2581.  That point was not only reiterated in Bartlett, 133 S. Ct. at 2470 (warning-based design claim preempted because “federal law prohibits generic drug manufacturers from independently changing their drugs’ labels”), but also extended to design claims.  Id. at 2475 (“redesign was not possible” because any redesigned substance “would be a new drug that would require its own NDA to be marketed”).

By contrast, the FDA position in Amarin was much different than a mere requirement to seek prior FDA approval – approval which may well be granted after however much time the Agency needs to evaluate the proposal.  The FDA’s off-label promotion position that failed in Amarin (and will probably eventually fail in the Supreme Court as currently constituted) was a total ban – a prior restraint − backed by criminal penalties, fines, and the threat of False Claims Act civil actions.  decision.  See Amarin, 2015 WL 4720039, at *5-6.  That’s a world of difference, in First Amendment terms, from simply requiring a prospective speaker consult the government before speaking, where the government can be expected ultimately to approve the speech.  Remember, the Bograd article’s argument is predicated on the “truthfulness” of the speech in question.

The FDA requirement that created impossibility preemption for generic drugs is the bare fact of agency review – nothing more is needed to make simultaneous compliance impossible – not the potential outcome of that review.  The most analogous First Amendment cases involve various kinds of governmental permits that have independent non-speech justification (like the FDA’s public health rationale), for requiring a permit before speaking.  The potential for favorable administrative consideration being the opposite of a ban, then the existing administrative requirements aren’t conceptually different, except in terms of complexity, from other licenses or permits.  Absent an ulterior motive to suppress speech, governmental permitting requirements are constitutional.  “The permit procedure . . . need only be viewpoint-neutral and a reasonable time, place, and manner regulation.”  Jews for Jesus, Inc. v. Port of Portland, 172 Fed. Appx. 760, 763 (9th Cir. 2006).  Accord, e.g., Stokes v. City of Madison, 930 F.2d 1163, 1170 (7th Cir. 1991) (parade permit regarding sound amplification constitutional).  These are simply the first two appellate decisions produced by a quickie Westlaw search that turned up 84 other cases where “reasonable time place and manner” existed in the same paragraph as “permit” or “permission.”

This time, place, and manner argument would only be strengthened if plaintiffs were to take the position that only “commercial speech” is involved – something not addressed in the Bograd article.  The lesser degree of First Amendment protection afforded to “commercial speech” hasn’t been enough to salvage the FDA’s flat ban on off-label promotion, but would provide more leeway for courts to find the mere fact of FDA pre-review “reasonable.”  The existence of FDA pre-review is all that is needed for generic impossibility preemption.  The permit cases we just cited all involved fully protected speech, so what would be a reasonable TPM as applied to commercial speech can be argued a fortiori from those cases.

So the second response to the Bograd article’s thesis is reasonable time, place, and manner.  The FDA has sufficient constitutional justification to require that the label (indeed, just about all aspects) of a generic product be the “same” as something that the Agency has already intensively studied, and that its permission be obtained before making changes, however justified.  All the usual public health reasons why the FDA’s approval process exists in the first place support prior agency review as both a reasonable TPM, and the basis for impossibility preemption in generic drug litigation.  Conversely, the flat ban on truthful speech that the court considered in Amarin is the antithesis of any sort of time, place, and manner restriction – reasonable or otherwise.

Third, what the plaintiff actually did in Amarin would itself give rise to preemption if state law purported to require companies to take such steps.  Here’s how the court in Amarin described the hoops through which the regulated manufacturer-plaintiff voluntarily chose to jump:

The FDA does, however, encourage manufacturers to request advisory comments . . . with respect to promotional materials aimed at healthcare professionals. . . .  The FDA’s Office of Prescription Drug Promotion (the “OPDP”) reviews such materials to ensure, inter alia, that they are not false or misleading; it provides written comments on proposed materials, reviews complaints of alleged violations, and initiates enforcement actions as to materials it finds false or misleading.

2015 WL 4720039, at *6 (footnotes omitted).  That’s one.

The FDA also refused to approve Amarin’s request to include the [study] results in the [drug’s] label.  It “reserve[d] comment until the application is otherwise adequate.  In the penultimate sentence of the [rejection letter], the FDA stated: “This product may be considered to be misbranded under the [FDCA] if it is marketed with this change before approval of this supplemental application.”

Id. at *12.

That’s two.

Thus plaintiff Amarin approached the FDA, sought Agency blessing for its promotional materials, but the FDA refused.  Sound familiar?  It should, since that’s exactly what the plaintiffs (supported by the FDA) argued was a way around preemption in Mensing.  What was done voluntarily in Amarin is a variant of the informal “take steps” approach that the Supreme Court rejected, in Mensing as a ground for avoiding impossibility preemption:

[T]he agency asserts that a different avenue existed for changing generic drug labels.  According to the FDA, the Manufacturers could have proposed − indeed, were required to propose − stronger warning labels to the agency if they believed such warnings were needed. If the FDA had agreed that a label change was necessary, it would have worked with the brand-name manufacturer to create a new label for both the brand-name and generic drug.

131 S. Ct. at 2576 (citations omitted).  The option of going to the FDA (as occurred in Amarin), and seeking its agreement to a label change is insufficient to make simultaneous compliance with state and federal duties “possible” under Mensing:

The federal duty to ask the FDA for help in strengthening the corresponding brand-name label, assuming such a duty exists, does not change this analysis.  Although requesting FDA assistance would have satisfied the Manufacturers’’ federal duty, it would not have satisfied their state tort-law duty to provide adequate labeling. State law demanded a safer label; it did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label.

Id. at 2578.

The reasonable time, place, and manner procedure in Amarin only violated the First Amendment because of its result, not its process.  Nothing in Amarin can be read to invalidate the FDA’s advisory procedures under the First Amendment.  Only the overbearing outcome – the FDA’s ban on speech – was struck down.  Conversely, the Supreme Court held in Mensing that the existence of similar procedures was not a way around preemption.  Thus, Mr. Bograd’s thesis suffers from a fundamental disconnect between means and ends.  The First Amendment nowhere requires the sort of simultaneity of state- and federally-mandated duties that is essential if impossibility preemption is to be avoided.

Fourth, and finally, if the whole ball of wax in a generic preemption product liability action boils down to a First Amendment dispute over what the FDA can require generic manufacturers to do to modify their warnings, there’s good reason to want that dispute decided in federal court.  In this respect, we reiterate what we said in our prior post.  Mr. Bograd’s argument, if raised in a state-court setting, may well provide defendants with a basis in federal question jurisdiction for removing that action to federal court.

We’ve blogged before about the potential availability of federal question jurisdiction in certain types of prescription medical product liability litigation under Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005).  Our side, frankly, hasn’t had much luck with this.  Cases recognizing Grable-based federal question jurisdiction have been few and far between.  Indeed, now Grable isn’t even the last word.  The Supreme Court’s latest
iteration of the test for federal question jurisdiction in the absence of an express federal claim is found in Gunn v. Minton, 133 S. Ct. 1059 (2013).

[F]ederal jurisdiction over a state law claim will lie if a federal issue is: (1) necessarily raised, (2) actually disputed, (3) substantial, and (4) capable of resolution in federal court without disrupting the federal-state balance approved by Congress.

Id. at 1065.

Most Grable-based attempts to remove cases to federal court have foundered on prong three – substantiality.  With some exceptions, device-specific claims of “parallel-claim” FDCA violations, tied causally to the timing of a particular plaintiff’s medical history haven’t been enough to overcome the substantiality requirement.  A few other cases have, such as NASDAQ OMX Group, Inc. v. UBS Securities, LLC, 770 F.3d 1010 (2d Cir. 2014).  Significantly, it wasn’t just the removing defendant claiming substantiality in NASDAQ OMX, but also the relevant government agency.  Specifically, the SEC stated that the federal interests involved in NASDAQ OMX “strongly signal[ed] the substantial importance of the[] federal issues” at stake in the litigation.  Id. at 1025.

The SEC’s position in NASDAQ OMX thus approximates the FDA’s objections to the First Amendment protection for truthful off-label promotion – protection which any plaintiff advancing the Bograd article’s arguments must embrace.  Consider, for instance, the FDA’s full-throated statements in Amarin, which characterized First Amendment protection for truthful off-label promotion as “a frontal assault . . . on the framework for new drug approval that Congress created in 1962” with “the potential to eviscerate [the] FDA drug approval regime.”  2015 WL 4720039, at *25.  In a prior Amarin post we mentioned another statement by the Agency that:

In discharging its regulatory responsibilities, however, FDA has reviewed other alternatives − including all of those identified in Caronia, 703 F.3d at 168 − but has found them all inadequate to meet public health needs, and therefore not viable less restrictive alternatives to the regulatory approach adopted by FDA.

Quoting FDA brief at 38.

We hardly believe that First Amendment protection of truthful promotional speech (on- or off-label) means that the sky is falling, but the FDA certainly does.  More explosive Agency rhetoric on the same issue occurred in the Solis case.  We discussed it here.  The FDA claimed that recognizing free speech rights to off-label promotion would mean that “vast areas of federal and state law would be invalidated.”  Such agency statements helped establish Gunn/Grable substantiality of the federal issue in NASDAQ OMX.

The final factor of the Gunn/Grable federal jurisdiction test, that the federal dispute be “capable of resolution in federal court without disrupting the federal-state balance approved by Congress,” would also be present where a plaintiff is asserting the First Amendment to avoid generic preemption.  As the Bograd article states, the First Amendment  argument is “a ray of hope” for plaintiffs.  They have little else.  With almost every other argument against generic preemption having failed, no state law issues complicate federal question jurisdiction.  Facts don’t matter much, either.  With First Amendment protection conceded as the predicate to the article’s argument, the effect of such protection presents a purely legal issue of federal constitutional law.  Amarin demonstrates (if any demonstration were needed) the competence of federal courts to decide First Amendment issues.

In a sense we welcome Mr. Bograd’s position.  Having the plaintiffs’ side concurrence in our fundamental constitutional position can only make the eventual driving of a First Amendment stake through the heart of the FDA’s ban on truthful off-label promotion that much easier.  Moreover, accepting full First Amendment protection of the speech at issue simultaneously drives the same First Amendment stake through plaintiffs’ own claims under Sullivan.  Once First Amendment protection is conceded, plaintiffs can no longer use the governmental power of the courts and the common law to decide if it’s “true” or not, nor may the law penalize our clients’ exercise of that protected speech.