Pacira Biosciences, Inc. v. American Society of Anesthesiologists, Inc., 2022 WL 336585 (D. N.J. Feb. 4, 2022), is not a product liability opinion. Instead, it occurs in the context of a motion to dismiss a trade libel case brought by a pharmaceutical company. The Pacira court decided that the truth/falsity of scientific ideas published in a medical journal (and discussed in other media) poses a question subject to First Amendment protection and publication of such ideas cannot be shut down or punished absent something very like fraud.
Pacira appears to be the first case in the Third Circuit to address such issues, and the decision relies on a pro-scientific speech decision from the Second Circuit that we blogged about here.
When we (we mean us, but also many of you) were in law school many of us thought about being First Amendment lawyers. Palsgraf was a curiosity, but the Pentagon Papers case was history. But somewhere along the way reality intervened, and we started spending more time scrutinizing p values and less time fretting over Justice Holmes’s constitutional musings. Even so, every once in a while we still encounter First Amendment issues. We certainly encounter, on virtually a daily basis, scientific claims and efforts to debunk them. We sometimes encounter plaintiffs attempting to sue the opposing side of a scientific debate into submission, so the Pacira decision should encourage raising the First Amendment as a defense in such situations.
What happened in Pacira? A February 2021 issue of the Anesthesiology journal (no jokes about whether that publication induces sleep!) contained several articles purporting to show that a particular pain medication was not superior to a standard local anesthetic. The articles included a meta-analysis, a narrative of certain clinical trials, and an editorial. There was also, inevitably, a podcast discussing the findings and conclusions of the articles.
None of this was good news for the manufacturer of the pain drug in question, of course. That manufacturer sued the publishers of the journal and the various authors for trade libel. According to the plaintiff, the articles employed flawed methodologies, including cherry-picking data, relying on deficient studies, discounting studies favorable to the drug, and refusing to acknowledge approach limitations to the articles. The defendants filed a 12(b)(6) motion to dismiss.
Under New Jersey law, plaintiffs must allege four elements to state a valid cause of action for trade libel: (1) publication, (2) with malice, (3) of false allegations regarding the plaintiff’s property or conduct, (4) causing damages or harm. The element of falsity requires a threshold showing that the allegedly defamatory statement is a statement of fact “capable of objective proof of truth or falsity.” The New Jersey Supreme Court has emphasized that to avoid a chilling effect on speech, a defendant should not be held liable for a statement that “could be construed as either fact or opinion.”
What is fact? What is opinion? And, as Pontius Pilate portentously asked, and as beat “poetess” Phillipa Fallon groovily sung-asked in High School Confidential (1958), what is truth? In the Second Circuit case referenced above – ONY, Inc. v. Cornerstone Therapeutics, Inc., 720 F.3d 490, 497 (2d Cir, 2013), the court reasoned that while “statements about contested and contestable scientific hypotheses … are in principle matters of verifiable ‘fact,’ … they are more closely akin to matters of opinion, and are so understood by the relevant scientific communities.” 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. Because the plaintiff could not identify any false, defamatory misstatements of fact, the Pacira court dismissed the trade libel complaint. Because amendment would be futile, the dismissal was with prejudice.
It is interesting that many of the flaws that the plaintiff identified in the scientific articles are the sort of things we defense hacks rely on in our endless Fed. R. Evid. 702 motions challenging plaintiff expert opinions. Does that fact make us anxious about the Pacira decision? No, it does not. There is a huge difference between deciding whether scientific theories are sufficiently reliable to assist a jury vs. whether they are out and out lies.
Mind you, there have been drug and device cases where the plaintiff expert theories were grounded in fraud. Truly, don’t get us started on that.