Research Study Conclusions Held to Be Non-Actionable Opinion
By Robert D. Balin and Eric Feder
“See now the power of truth; the same experiment which at first glance seemed to show one thing, when more carefully examined, assures us of the contrary.” –Galileo Galilei
Generally, under the law of defamation, a speaker may be liable for making false statements of fact that are harmful to reputation, but will not be liable if those statements are merely expressions of the speaker’s opinion, which cannot be proven true or false. Recently, the 2nd Circuit Court of Appeals was confronted with how that doctrine applies to scientific conclusions contained in academic journal articles. The court acknowledged that “[s]cientific academic discourse poses several problems for the fact-opinion paradigm of First Amendment jurisprudence.” But, in a significant win for scientists and the journals that publish their studies, the court ultimately affirmed that courts—and lawsuits—are not the appropriate forum for resolving disputes within the scientific community.
In ONY, Inc. v. Cornerstone Therapeutics, Inc., 720 F.3d 490 (2d Cir 2013), the plaintiff pharmaceutical company alleged that the “conclusions” published in a scientific research article—specifically, speculation about why plaintiff’s drug was associated with a higher mortality rate in infants than a competitor’s drug—were false and misleading. In affirming the District Court’s dismissal of the plaintiff’s claims, the 2nd Circuit held that “as a matter of law, statements of scientific conclusions about unsettled matters of scientific debate cannot give rise to liability for damages sounding in defamation.”
ONY is a pharmaceutical company that manufactures an animal-derived lung surfactant used to treat pre-term infants suffering from respiratory distress syndrome (RDS), which is a leading cause of death in premature infants. One of ONY’s competitors, Chiesi Farmaceutici, commissioned a group of neonatologists to conduct a retrospective study comparing the mortality rates of thousands of pre-term infants with RDS who had been treated at 236 different hospitals with the surfactants manufactured by ONY, Chiesi and one other competing company. The neonatologists then authored an article about their study’s findings, which they submitted to the Journal of Perinatology, a leading medical journal that is published by Nature America.
In September 2011, after undergoing peer review, the article was published on the Journal’s website. The article included a “Conflicts of Interest” section that disclosed that Chiesi sponsored the study. Based on the study’s finding that ONY’s surfactant was “associated with a 49.6% greater likelihood of death” among infants with RDS than the surfactant manufactured by Chiesi, the authors of the article concluded that, while all three of the studied surfactants were effective in treating RDS, ONY’s surfactant was “associated with a significantly greater likelihood of death” than Chiesi’s. In the article, the authors set forth the study’s methodology (and its limitations) in detail and sought to explain the mortality rate differences, speculating that the “most likely explanation” was due to the higher dosage administered to infants treated with Chiesi’s surfactant. Following publication of the article on the Journal’s website, Chiesi’s distributor circulated reprints of the article to existing and potential customers as part of its marketing efforts.
ONY’s representatives wrote to the Journal disputing the article’s conclusions, attacking the methods of the study, and demanding that the Journal article be retracted. Nature America declined to retract the article. Consistent with common practice, however, the Journal eventually published the letters criticizing the study, as well as written responses to the criticism from the authors of the article.
ONY filed suit in December 2011 in the District Court for the Western District of New York, asserting a claim of injurious falsehood against Nature and the editor of the Journal. ONY also brought several claims against Chiesi and its distributor arising out of their post-publication marketing uses of the article, including for false advertising under Lanham Act § 43(a) and violation of the New York state deceptive practices act, as well as claims against the authors of the study, the provider of the database used in conducting the study, and even the American Academy of Pediatrics (based on its affiliation with the Journal).
In its complaint, ONY did not challenge the mortality rate statistics themselves. Instead, ONY complained that the article’s “conclusions” concerning the comparative mortality rates of the competing surfactants were “unreliable” and “misleading.” Specifically, ONY claimed that the article had omitted certain key data from the study that would—in ONY’s view—have demonstrated that the mortality rate differences were due to factors other than the relative effectiveness of the surfactants.
All defendants filed pre-answer motions to dismiss the complaint on the ground (among others) that the challenged conclusions from the study constituted non-actionable opinions, not assertions of fact. The District Court agreed with the defendants and dismissed the complaint. ONY appealed to the 2nd Circuit.
The 2nd Circuit Decision
In its decision, the 2nd Circuit grappled with where scientific discourse falls along the fact-opinion divide. On one level, scientific conclusions would seem to be quintessential statements of fact that can be proven true or false. After all, as the court noted, “it is the very premise of the scientific enterprise that it engages with empirically verifiable facts about the universe.” On the other hand, “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.” The court explained that, ordinarily, scientific conclusions are presented to the relevant scientific community in peer-reviewed publications. Other scientists may then respond to the research 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.”
The court noted that “the traditional dividing line between fact and opinion is not entirely helpful,” because “[i]n 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.” Thus, the court held, scientific conclusions typically “are more closely akin to matters of opinion, and are so understood by the relevant scientific communities.”
The District Court had held that “any perceived fault in the method by which the authors reached their conclusions should be subjected to peer review rather than judicial review.” The Circuit Court agreed, concluding that “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.” (Indeed, as the 2nd Circuit noted, that is precisely what occurred here, independently of the litigation. The Journal published ONY’s sharp criticism of the article and the underlying study, as well as the response by the article’s authors—leaving it to readers to debate the relative merits of the two sides and to other scientists to ultimately replicate or refute the study.)
In reaching its holding that scientific conclusions are protected expressions of opinion, the appellate court was careful to note that the plaintiff did not allege that the data presented in the article were fabricated or fraudulent. Falsified data, the court noted, would cause the ordinary process of scientific debate to break down, because other scientists would be unable to accurately assess the methods and conclusions of the underlying study. But when the data and the methods used are accurately described, “the validity of the author’s conclusions may be assessed on their face by members of the relevant discipline or specialty.” The court further held that even if scientific conclusions were theoretically actionable, the claim would be “weakest when, as here, the authors readily disclosed the potential shortcomings of their methodology and their potential conflicts of interest.”
Because the statements at issue were deemed to be protected opinion, the 2nd Circuit affirmed the dismissal of ONY’s claims.
As Galileo would surely agree, scientific conclusions do not present objective “truth” that can readily be evaluated for falsity by a court, because the very same data underlying those conclusions, “when more carefully examined” by other scientists, may lead to alternative conclusions. Thus, the remedy for claims of “bad science” is “more science,” not litigation. In fact, intervention by courts would serve only to disrupt the process of robust scientific debate. As the district judge in this case acknowledged, “[t]he chilling effect of protracted litigation can be especially severe for scholarly journals.” The 2nd Circuit’s decision re-affirms that scientists, researchers and academic journals must be accorded breathing room to engage in, and contribute to, scientific debates—without having to look over their collective shoulder for potential plaintiffs unhappy with their conclusions.
Originally published in the June 2013 issue of the MLRC MediaLawLetter
Robert D. Balin of Davis Wright Tremaine LLP, together with Victor Hendrickson (formerly at Davis Wright Tremaine, now Senior Counsel at Fuse Networks LLC) and Nelson Perel of Webster Szanyi LLP, represented publisher Nature America and the editor of the Journal of Perinatology.