Thursday, July 04, 2013

Celebrating Free Speech on the Forth of July

The Fourth of July is the time to celebrate everything American – baseball, apple pie, almost anything that’s red, white and blue (ironically so are the Russian, French, and British flags), the Declaration of Independence, the Constitution, and the Supreme Court making decisions that infuriate us one day and exhilarate us the next.  And regardless what decisions we love or we hate, we can get up on our soap box (literal or cyber) and disclaim our reasons.

That’s free speech.

And free speech is one of the linchpins of preserving everything else that makes America what we hope America can be.

So we thought we’d devote today’s post about an interesting free speech case, ONY Corp. v. Cornerstone Therapeutics, Inc., 2013 WL 3198153 (2d Cir. June 26, 2013) (also available here in slip).  No, this is not another screed about off-label use, although it’s related.  ONY has nothing to do with the FDA, or even the federal government.  It’s a Lanham Act (and related state-law torts) case in which the plaintiff manufacturer accused a competing manufacturer of making inaccurate statements about the comparative effectiveness of their respective products.

Why do we care?

Because the means by which this alleged false advertising was carried out was the preparation of scientific articles published in peer-reviewed scientific journals.  We’ve posted before about our firm belief that scientific articles are “core” speech that is fully protected under the First Amendment, and Bexis has written law review articles on the subject:  J. Beck, “Constitutional Protection Of Scientific And Educational Activities From Tort Liability:  The First Amendment as a Defense To Personal Injury Litigation,” 37 Tort & Ins. L.J. 981 (2003); A. Blackwell & J. Beck, “Drug Manufacturers’ First Amendment Right to Advertise and Promote Their Products for Off-Label Use: Avoiding a Pyrrhic Victory,” 58 Food & Drug L.J. 429, 446-47, 454 (2003).

We’re happy to say that the Second Circuit found the scientific articles in question in ONY to be First Amendment protected speech and affirmed dismissal of the action.

What happened was that the manufacturer defendant commissioned a comparative clinical study of its product and the defendant’s product.  It hired a contract research organization (“CRO,” also named as a defendant) to create a study and recruit physician investigators and subjects for the study.  The resultant data was analyzed.  The investigators (also defendants) then “present[ed] findings . . .  at various medical conferences.”  2013 WL 3198153, at *2.  Still later, the investigators “decided to publish some of the findings from the same data set in a peer-reviewed journal.”  Id.  The journal that published their article was “the leading journal in the field.”  Id.

Among other things, the plaintiff claimed that this article “contain[ed] five distinct incorrect statements of fact” about its product.  Id.  Plaintiff also raised questions about the circumstances of publication:

Plaintiff also alleges that the circumstances surrounding the article’s publication were unusual:  [One investigator] is an Associate Editor, and [another] is a member of the editorial board. . . .  Plaintiff alleged in its complaint that one of the two peer reviewers objected to its publication, but the other peer reviewer recommended the article for publication, and the Editor-in-Chief broke the tie.  Plaintiff does not allege, however, that the publication of the article . . . was a departure from accepted or customary procedure.  Further, the article was published in an “open access” format, which allows it to be viewed electronically by the general public without paying the typically applicable fee or ordering a subscription; the fees associated with such publication were paid by [the manufacturer defendant].

The article’s conclusions were not unqualified.  The authors considered . . . [scientific] objection[s]. . . .  Finally, the authors disclosed that the study was sponsored by [the manufacturer defendant], that [one author] was an employee of [defendant CRO], that [defendant manufacturer] hired [defendant CRO] to conduct the study, and that all three physician defendants had served as consultants to [defendant manufacturer].

ONY, 2013 WL 3198153, at *2-3.

The Second Circuit held that peer reviewed scientific articles were “statements of pure opinion” that are protected by “an absolute privilege” under the First Amendment.  Id. at *4.  They qualified as “opinion” even though they were scientific and thereby subject to falsification through the scientific method, because the nature of science is that everything is a hypothesis subject to perpetual challenge:

Most conclusions contained in a scientific journal article are, in principle, capable of verification or refutation by means of objective proof.  Indeed, it is the very premise of the scientific enterprise. . . .  [H]owever, it is the essence of the scientific method that the conclusions of empirical research are tentative and subject to revision. . . .  Importantly, those conclusions are presented in publications directed to the relevant scientific community, ideally in peer-reviewed academic journals that warrant that research approved for publication demonstrates at least some degree of basic scientific competence.  These conclusions are then available to other scientists who may respond by attempting to replicate the described experiments, conducting their own experiments, or analyzing or refuting the soundness of the experimental design or the validity of the inferences drawn from the results.

Id. at *5 (citation and quotation marks omitted).  Importantly, the Second Circuit recognized that scientific disputes should be settled through scientific means, rather than by one side trying to sue the other into silence:

In a sufficiently novel area of research, propositions of empirical “fact” advanced in the literature may be highly controversial and subject to rigorous debate by qualified experts.  Needless to say, courts are ill-equipped to undertake to referee such controversies.  Instead, the trial of ideas plays out in the pages of peer-reviewed journals, and the scientific public sits as the jury.

Id.  Courts are “reluctant to recognize causes of action grounded on statements of fact that are best evaluated by an informed reader.”  Id.

Therefore, even though “verifiable” in one sense, in the context of the First Amendment, propositions maintained in scientific articles are “opinion” and thus fully protected:

[W]hile statements about contested and contestable scientific hypotheses constitute assertions about the world that are in principle matters of verifiable “fact,” for purposes of the First Amendment . . . they are more closely akin to matters of opinion, and are so understood by the relevant scientific communities.

ONY, 2013 WL 3198153, at *6.

There are important caveats to this holding.
First caveat:  “[I]t is relevant that plaintiff does not allege that the data presented in the article were fabricated or fraudulently created.”  Id.  Academic fraud – the falsification of the underlying data points – might lead to a different result.  But where the plaintiffs claimed only “the inferences drawn from [the] data” were “wrong,” and that different methodology (including other “variables”) should have been used, the First Amendment barred turning such quibbles into litigation.  Id.  As long as an article contains “an accurate description of the data . . . and the methods used,” science, not litigation, should resolve the controversy.  Id.

We therefore conclude that, to the extent a speaker or author draws conclusions from non-fraudulent data, based on accurate descriptions of the data and methodology underlying those conclusions, on subjects about which there is legitimate ongoing scientific disagreement, those statements are not grounds for a [legal] claim.

ONY, 2013 WL 3198153, at *6.  It is not an exception to the First Amendment that the “way they were presented and the conclusions drawn from them were allegedly misleading.”  Id.

Second caveat:  The court pointed out that “the authors readily disclosed the potential shortcomings of their methodology and their potential conflicts of interest.”  Id. at *6.  Such disclosures were sufficient to maintain First Amendment protection:

To the extent plaintiff alleges harm arising from the relationship between the authors and [the corporate defendants], we agree with the district court that the disclosure of a conflict of interest, which was included in the article’s original publication, suffices to put a reasonable reader on notice that the article’s conclusions may have been influenced by the authors’ professional associations.

Id. at *6 n.5.  Again, without these disclosures, the result in ONY might have been different.

Add these things together – no falsification of the underlying data, accurate disclosure of the methodology used to interpret the data, disclosure of financial ties to the manufacturer, and a discussion of methodological “shortcomings” – and the scientific article in question was immune from challenge through any theory of liability under the First Amendment:

Our conclusion that the article's contents are not actionable under the Lanham Act also leads us to conclude that the statements are not actionable under [consumer protection statutes] or . . . state common law. . . .  Our conclusion that what is non-actionable opinion under the Lanham Act is also non-actionable as a [state] tort or under [consumer fraud statutes] is buttressed by the [state law] that the protection afforded by the guarantees of free press and speech in the [state] Constitution is often broader than the minimum required by the Federal Constitution.

ONY, 2013 WL 3198153, at *6 (specific New York law references removed).

Third caveat:  There were no allegations that any “promotional materials misstated the article’s conclusions.  Id. at *7.  Instead of alleging any “distortion” of the article, plaintiff claimed that the defendant’s promotion “present[ed] accurately the article’s allegedly inaccurate conclusions.”  Id.  Because the promotion did not interject any additional claims of falsity, it was likewise First Amendment protected:

We are therefore presented with a much easier case than we would be if a plaintiff alleged that a defendant distorted an article’s findings in its promotional materials.  On these facts, we conclude that the district court did not err in dismissing plaintiff's [promotion-based] claim with prejudice in light of its correct conclusions that (a) the article itself was not actionable and (b) the [promotion-based] claim did not separately allege any additional misleading statements.

ONY, 2013 WL 3198153, at *7.

ONY was decided on a motion to dismiss.  From personal experience, we know and expect that when plaintiffs in product liability cases bring scientific articles into question they will almost always make allegations falling into one, if not all, of these three caveats.  However, we also know that the facts established during discovery often don’t back up allegations in complaints.  Thus, we recommend using ONY as a template for determining if a First Amendment-based partial summary judgment motion might be appropriate with respect to claims that scientific articles were misused.

And then there’s the FDA.  To the extent that it seeks to prosecute off-label promotion involving the presentation of scientific articles, we think that the first two caveats (involving the contents of the articles themselves) almost always won’t preclude a First Amendment defense, so if a manufacturer keeps its promotional nose clean (see our suggestions, here), ONY provides another basis for a First Amendment defense – this time based on “core” speech protection rather than commercial speech.

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