From Judge Madeline Cox Arleo (D.N.J.), writing today in Pacira Biosciences, Inc. v. Am. Soc'y of Anestheologists, Inc.:
[The following facts are drawn from the Complaint.] This trade libel action arises out of allegedly false and misleading statements published in a leading medical journal about liposomal bupivacaine, a pain medication that Plaintiff manufactures under the name EXPAREL. {EXPAREL is a local anesthetic administered at the time of surgery to control pain. Pacira is the only FDA-approved manufacturer of liposomal bupivacaine, meaning that as compared to standard bupivacaine, EXPAREL is encased in a liposomal chamber.}
Plaintiff's allegations stem from the February 2021 issue of Anesthesiology, the ASA's official, peer-reviewed academic journal. The cover of the February 2021 issue states that "Liposomal Bupivacaine Is Not Superior to Standard Local Anesthetics" and contains several articles that allegedly contain false and misleading statements disparaging EXPAREL. Plaintiff specifically challenges three articles published in Anesthesiology: (1) a meta-analysis of studies conducted on EXPAREL (the "Hussain Article"); (2) a narrative review of EXPAREL trials (the "Ilfeld Review"); and (3) an editorial based on the meta-analysis and narrative review (collectively, the "Articles"). Plaintiff generally alleges that each of the Articles employed flawed methodologies by, among other things, cherry-picking data, relying on studies that Plaintiff believes were deficient, improperly discrediting studies favorable to EXPAREL, and failing to properly limit their conclusions that EXPAREL is not effective.
The ASA also offered a [Continuing Medical Education] program linked to the Articles, for which participants could access questions about the Articles and receive credit to satisfy medical licensure requirements (the "CME"). Plaintiff alleges that these questions restate as fact the flawed and misleading conclusions reached by the Articles. Finally, Anesthesiology produced a podcast that allegedly repeated the conclusions of the Articles without acknowledging their flaws (the "Podcast")….
The element of falsity [in a trade libel case] requires a threshold showing that the allegedly defamatory statement is a statement of fact "capable of objective proof of truth or falsity," as opposed to an opinion protected by the First Amendment…. 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." By their nature, scientific conclusions published in an academic journal are "tentative," and made "available to other scientists who may respond 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 peer-review process—not a courtroom—thus provides the best mechanism for resolving scientific uncertainties.
