Time and time again, we have opposed efforts by one side of a scientific dispute – typically involving a prescription medical product – to attempt to sue the other side of that dispute into silence. We came to that position through the crucible of litigation, since plaintiffs in the Bone Screw litigation sought to sue a variety of medical societies because they supported the (at the time) off-label use of bone screws for pedicle fixation. We have tried to be consistent.
- Supporting scientific articles as First Amendment-supported speech, here in 2009.
- Celebrating scientific free speech, here, on the Fourth of July in 2013.
- Criticizing attempts to sue publishers of scientific content, here in 2011, and again, here in 2013.
- Opposing attempts to use False Claims Act litigation to adjudicate scientific debate, here, in 2014.
- Praising the defeat of governmental attempts to compel products to be labeled with “warnings” of doubtful scientific validity, here, in 2019.
- Condemning attempts to sue those who set certification standards, here, in 2022.
- Rejecting anti-vaxxers attempting to sue the Center for Disease Control, here, also in 2022.
- Ridiculing a blatantly unconstitutional Missouri statute that sought to silence pharmacists critical of ivermectin and hydroxychloroquine as treatments for COVID-19, just yesterday.
Thus it should not be surprising that the area of scientific free speech is one of the few instances in which we are willing to disagree with the litigation position of a drug or device company. We did so here a little over a year ago, taking the position that:
Scientific conclusions published in academic journals are necessarily tentative and invite debate. They fall more in the range of opinion rather than fact. Consequently, unless the plaintiff alleged fraudulent data, scientific articles are protected speech and immune from suit. Allegations of unreliable methodology, failure to disclose data not relied upon favorable to the opposing viewpoint, and/or failure to disclose purported conflict of interest do not make the scientific articles and podcast non-protected speech.
That post was lauding Pacira Biosciences, Inc. v. American Society of Anesthesiologists, Inc., 2022 WL 336585 (D. N.J. Feb. 4, 2022), which rejected a pharmaceutical trade libel claim against a peer-reviewed medical article and the journal that published it.
Now the Third Circuit, in a published opinion has agreed – and so do we. Pacira BioSciences, Inc. v. American Society of Anesthesiologists, Inc., ___ F.4th ___, 2023 WL 2621131 (3d Cir. March 24, 2023).
Scientific literature about the risks and benefits of prescription medical products does not – at least in the absence of academic fraud such as the actual falsification of data (see, here) – subject the speaker to tort liability. The gist of the articles at issue in Pacira was that the plaintiff’s drug was either “inferior” or “not superior” to available alternatives. 2023 WL 2621131, at *1. Plaintiff alleged “cherry-picked” data, various instances of “flawed” methodology, and “fail[ure] to disclose financial conflicts of interest.” Id. In addition to the articles themselves, the defendants allegedly “offered a Continuing Medical Education program (the “CME”) that allowed participants to answer questions based on the Articles.” Id. at *2. In short, the corporate plaintiff in Pacira made many of the same types of accusations that personal injury plaintiffs make.
Still First Amendment protected, held the Third Circuit. First Amendment free speech cases are not decided under Fed. R. Evid. 702. Rather, this attack on scientific speech implicated “important interests in the free flow of information and are thus subject to the same privileges, or limitations, that render certain statements nonactionable.” Id. at *2 (citing, inter alia, Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748 (1976), for the proposition that “society and consumers both have a strong interest ‘in the free flow of commercial information’”).
The key ruling was that this type of discourse – involving the benefits (or lack of same) of a prescription drug – are First Amendment-protected scientific speech:
One such limitation is that opinion statements are generally nonactionable. Statements of pure opinion, which are those based on stated facts or facts that are known to the parties or assumed by them to exist, do not provide a basis for relief. Mixed opinions, which are opinions based on undisclosed facts or assumptions, are similarly nonactionable unless they imply false underlying objective facts.
Pacira, 2023 WL 2621131, at *3 (citations and quotation marks omitted). The challenged “inferior”/”not superior” statements were “nonactionable subjective expressions.” Id. (citation omitted).
Relying heavily on ONY, Inc. v. Cornerstone Therapeutics, Inc., 720 F.3d 490 (2d Cir. 2013) (the featured case in our earlier Fourth of July post), Pacira recognized scientific speech as “subject to perpetual revision,” and thus incapable of being a false statement of “fact.” Pacira, 2023 WL 2621131, at *3
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 that it engages with empirically verifiable facts about the universe. At the same time, however, it is the essence of the scientific method that the conclusions of empirical research are tentative and subject to revision, because they represent inferences about the nature of reality based on the results of experimentation and observation.
Id. (quoting ONY, 720 F.3d at 496). Similarly, “[s]ubstantial undisclosed conflicts of interests . . . have no bearing on whether the statements may be actionable as a threshold matter,” regardless of their potential relevance to intent, had the First Amendment not applied. Id. at *4, n.15.
“[V]erifiability” is also not the same as “reliability.” 2023 WL 2621131, at*4. “[A]llegations” amounting to “disagreements about the reliability of the methodology and data underlying the statements” cannot be a basis for liability. Id. (footnote omitted). Such methodological complaints – unless involving outright fabrication of data (see id. at *4, n.14)– cannot create liability for scientific speech. “[M]ere disputes about the reliability of a scientific study’s disclosed methodology cannot create an actionable falsehood . . ., as such disputes do not address whether the statements themselves are verifiable.” Id. (footnote omitted). Once again, the First Amendment does not turn on a Rule 702-type analysis.
[C]ritiques about the Articles’ data and methodology may be the basis of future scholarly debate, but they do not form the basis for [civil liability]. . . . To conclude otherwise would risk “chilling” the natural development of scientific research and discourse. Thus, the verifiability factor supports our conclusion that the statements are nonactionable opinions.
Id. at *5. “Requiring that a statement be verifiable ensures that defendants are not punished for exercising their First Amendment right to express their thoughts.” Id. at *4 n.11 (citation and quotation marks omitted). Only “if there is consensus” – in which case there would not be litigation to start with – could scientific speech qualify as verifiable. Id. n.12.
Finally, context also matters. Statements directed to trained medical personnel – like the kind of warnings governed by the learned intermediary rule in product liability litigation – are more likely to qualify as First Amendment protected scientific speech.
The statements here were made in a peer-reviewed journal for [medical] specialists. While statements are not protected solely because they appear in a peer-reviewed journal, such journals are often directed to the relevant scientific community. Their readers are specialists in their fields and are best positioned to identify opinions and choose to accept or reject them on the basis of an independent evaluation of the facts. Such is the case here.
Pacira, 2023 WL 2621131, at *5 (citations, quotation marks, and footnote listing “other contexts,” including product liability, in which this is so, omitted). The medical specialists who were the defendant journal’s intended audience “have the expertise to assess their merits” and “thus are equipped to evaluate the opinions the authors reached” – including claims regarding “industry funding” (note, the article criticized such funding). Id. The professional audience for the scientific speech thus further “support[ed] the conclusion that the statements are nonactionable opinions.” Id. at *6.
Trade libel may not be product liability, but the First Amendment holdings in Pacira deal with the same sort of litigation-based attacks on scientific speech that we often encounter in product liability litigation. When the other side sues over pure scientific speech – attacking the methodology of academic articles directed to doctors and other scientists – the same “chilling effect” exists. Pacira further reinforces our view that nobody should be able to use litigation to sue the other side of an ongoing scientific debate into silence.