An excerpt from a long report and recommendation released Wednesday by Magistrate Judge Ona Wang (S.D.N.Y.) in Cassava Sciences, Inc. v. Bredt; for more details, read the whole opinion:
At various dates in 2021, the Neuroscientist Defendants filed a Citizen Petition and sent publicly available letters to the Food and Drug Administration ("FDA") expressing "grave concerns about the quality and integrity of the laboratory-based studies surrounding" simufilam {a [Cassava-developed] drug intended to treat Alzheimer's disease} and claims about its efficacy. The Neuroscientist Defendants accuse Drs. Burns {Cassava's Vice President of Neuroscience} and Wang {Associate Medical Professor at the City University of New York … and Cassava's "academic collaborator"} (and others) of intentional data manipulation and misrepresentation in Cassava's preclinical and clinical studies, and request that the FDA halt the ongoing trials of simufilam pending an audit of these issues….
The inference the Neuroscientist Defendants draw after examining the data and empirical research is not that "Cassava is a fraud" or even that "simufilam is not effective," which would have been analogous to the statements [given as examples in a past Second Circuit precedent -EV]. Rather, the Neuroscientist Defendants drew a more measured and nuanced series of inferences from Cassava's own underlying research, on which Cassava relies to support clinical testing of simufilam in humans: namely, that the research may be unreliable, based on certain irregularities in the reporting of data in the research.
Numerous press releases and basic science papers are attached and incorporated into the [Complaint], as if all of these statements, taken together, could be sufficient to "prove" Cassava's scientific conclusions to be true (or not). This is part of the "ongoing discourse" referenced in [the precedent] that courts should avoid. Indeed, the parties' repeated filings concerning CUNY's subsequent investigation (and its results) are irrelevant to this analysis. Rather, the fact of the investigation, conducted well after the Neuroscientist Defendants raised their concerns, shows that these statements are also not yet verifiable.
The Neuroscientist Defendants' statements arise from—and refer to—Cassava's own published research, and call for further investigation after drawing inferences about Dr. Wang's and Dr. Burns's research and reported results. The resulting investigations and discourse among the scientists is aimed first at verifying the results of Cassava's scientists, after which different inferences may be drawn. The general and broader context also support a finding that these defendants' statements are protected by the First Amendment as non-actionable opinion.
Scientific discourse—even when it challenges the integrity of a fellow scientist's research—belongs first among the scientists, who are best suited to assess the underlying research, and the inferences to be drawn from it. See Underwager v. Salter (7th Cir. 1994) ("Scientific controversies must be settled by the methods of science rather than by the methods of litigation. More papers, more discussion, better data, and more satisfactory models—not larger awards of damages—mark the path toward superior understanding of the world around us."). Alzheimer's Disease and other dementias are terrible afflictions, and an effective cure or treatment would significantly benefit the lives of millions of people. But it is also important to ensure that funding is directed toward reliable, replicable research.
[Federal Rule of Civil Procedure] 8(a) requires a short and plain statement sufficient to put a defendant "on notice of the claim against him." Plaintiff asserts that the Neuroscientist Defendants' arguments for dismissal "are predicated on a misrepresentation of the facts alleged" and "nearly everything Bredt and Pit said in their petitions and everything that they republished was factually inaccurate." This conclusory statement, based on a [Complaint] that attaches and incorporates more than 100 exhibits (many of which contain multiple links) and spans nearly 1600 pages, is tantamount to dropping all of the scientific discourse—spanning years of research—in the lap of a randomly selected federal judge. That the parties happened to be referred to a randomly selected federal judge with a Ph.D. in science made the review of this motion only marginally more efficient. In any event, I have reviewed all of the Neuroscientist Defendants' statements and find that their factual statements are accurate restatements of representations made and data presented by Cassava or its scientists in press releases and peer-reviewed scientific papers, but the inferences and opinions drawn therefrom are in sharp dispute, and thus not actionable. Moreover, the level of debate and scrutiny among scientists suggests that the scientific discourse is ongoing and nonjusticiable. See, e.g., Georgia High School Ass'n v. Waddell (Ga. 1981) ("We now go further and hold that courts of equity in this state are without authority to review decisions of football referees because those decisions do not present judicial controversies.").
To elaborate on one line in the last paragraph, Judge Ona Wang has a Ph.D. in zoology (and an A.B. in biology).
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