Pacira Biosciences, Inc. c. American Society of Anesthesiologists, Inc., 2022 WL 336585 (DNJ 4 February 2022), is not an opinion on product liability. Instead, it occurs in the context of a motion to dismiss a commercial libel case brought by a pharmaceutical company. the Pacira The court decided that the truth/falseness of scientific ideas published in a medical journal (and discussed in other media) is a matter subject to the protection of the First Amendment and the publication of such ideas cannot be stopped or punished by law. lack of something that looks a lot like fraud.
Pacira appears to be the first case in the Third Circuit to address such issues, and the ruling is based on a pro-scientific Second Circuit speech ruling we blogged about here.
When we (we mean us, but also a lot of you) were in law school, a lot of us thought we were First Amendment advocates. Palsgraf was a curiosity, but the Pentagon Papers affair was history. But somewhere along the way, reality kicked in and we began to spend more time scrutinizing p-values and less time ruminating on Justice Holmes’ constitutional musings. Even so, from time to time, we still run into problems related to the First Amendment. We certainly encounter, almost daily, scientific claims and efforts to debunk them. We sometimes encounter plaintiffs who attempt to sue the opposing side of a scientific argument into submission, so that the Pacira The ruling should encourage raising the First Amendment as a defense in such situations.
What happened to Pacira? A February 2021 issue of Anesthesiology journal (no jokes about whether this post induces sleep!) contained several articles claiming to show that a particular painkiller was no superior to a standard local anesthetic. Articles included a meta-analysis, an account of selected clinical trials, and an editorial. There was also, inevitably, a podcast discussing the findings and conclusions of the articles.
Of course, none of this was good news for the maker of the painkiller in question. This manufacturer sued the journal’s editors and individual authors for commercial libel. According to the requester, the articles used flawed methodologies, including screening data, relying on flawed studies, discarding studies favorable to the drug, and refusing to acknowledge the limitations of the articles’ approach. 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 commercial defamation: (1) publication, (2) maliciously, (3) false claims of ownership or conduct of the plaintiff, (4) causing damage or harm. The element of falsity requires a threshold showing that the allegedly defamatory statement is a statement of fact “capable of objectively proving its truth or falsity”. The New Jersey Supreme Court emphasized that to avoid a chilling effect on the parole, a defendant should not be held liable for a statement that “could be construed as fact or opinion.”
What is a fact? What is a review? And, as Pontius Pilate solemnly requested, and beat the “poetess” Phillipa Fallon with groovy sung-asked in High School Confidential (1958), what is truth? In the Second Circuit case mentioned above – ONY, Inc. v. Cornerstone Therapeutics, Inc., 720 F.3d 490, 497 (2d Cir, 2013), the court held that while “statements concerning disputed and questionable scientific assumptions…are in principle matters of verifiable ‘facts’…they are more akin to matters of opinion, and are thus understood by the relevant scientific communities. Scientific conclusions published in academic journals are necessarily provisional and invite debate. They are more opinion than fact. Accordingly, unless the claimant alleges fraudulent data, scientific papers are speech-protected and unassailable. Allegations of unreliable methodology, failure to disclose unsubstantiated data supportive of the opposing view, and/or failure to disclose an alleged conflict of interest do not render the scientific papers and podcast unprotected. Since the plaintiff could not identify any false or defamatory misrepresentations of fact, the Pacira court dismissed the claim for commercial defamation. Because the amendment would be futile, the dismissal was with prejudice.
Interestingly, many of the flaws identified by the plaintiff in the scientific papers are the kinds of things we, the defense hackers, rely on in our Endless Fed. A. Obviously. 702 motions challenging the plaintiffs’ expert opinions. Are we concerned about the Pacira decision? No. There is a huge difference between deciding whether scientific theories are reliable enough to help a jury and whether they are outright lies.
Notice that there have been drug and device cases where plaintiffs’ expert theories were based on fraud. Really, don’t get us started on that.