Pacira Biosciences Inc v. American Society of Anesthesiologists Inc

Citation: Not availableDocket: 22-1411

Court: Court of Appeals for the Third Circuit; March 24, 2023; Federal Appellate Court

Original Court Document: View Document

SummaryOriginalCytator Case TreatmentBackward CitatorAnalysis

EnglishEspañolSimplified EnglishEspañol Fácil

Pacira Biosciences, Inc. filed a trade libel lawsuit against the American Society of Anesthesiologists (ASA), its medical journal editor, and authors of three articles for allegedly false statements regarding Pacira's drug, EXPAREL, a liposomal bupivacaine designed for post-surgical pain management. Pacira claims these statements imply that EXPAREL is not superior to traditional analgesics and provide inferior pain relief. The controversy centers on the February 2021 issue of ASA's journal, which contains an article asserting that "Liposomal Bupivacaine Is Not Superior to Standard Local Anesthetics." The U.S. District Court for the District of New Jersey ruled that the statements in question are nonactionable opinions, leading to the dismissal of Pacira's claims. The Third Circuit Court of Appeals affirmed this decision, concluding that Pacira failed to establish a valid basis for relief.

A meta-analysis (the "Hussain Article") and a narrative review (the "Ilfeld Review") conclude that EXPAREL is not superior to standard anesthetics. Pacira alleges that these studies fail to isolate key variables, make unqualified claims about EXPAREL’s efficacy, and discredit industry-funded research. Specific criticisms include the Hussain Article's purported "cherry-picking" of studies, flawed "crude pooling" methodology, and neglect of statistical heterogeneity. The Ilfeld Review is challenged for not addressing the most relevant anesthesia procedures, overlooking favorable studies, and having authors with undisclosed financial conflicts. The McCann Editorial allegedly reiterates the previous articles' conclusions, questions EXPAREL’s cost, and insinuates insufficient FDA approval evidence. These articles are included in Pacira’s complaint, which is accepted as true for the motion to dismiss. In addition, the ASA offered a Continuing Medical Education (CME) program that purportedly presented the articles' conclusions as facts, asserting EXPAREL’s inferiority to standard anesthetics. A related podcast similarly repeated these conclusions without acknowledging flaws. Pacira's complaint, alleging trade libel, was dismissed by the District Court on grounds that the statements did not suggest defamatory meanings, as scientific conclusions based on nonfraudulent data are not provable as false. Pacira appeals the dismissal. While trade libel and defamation are related claims, they address different harms—defamation concerns reputation, while trade libel addresses harm to product reputation. The District Court had jurisdiction under 28 U.S.C. 1332(a)(1), and appellate jurisdiction exists under 28 U.S.C. 1291.

Plenary review is applied when assessing a district court's order to dismiss a claim for failure to state a claim, requiring the complaint to be interpreted in the plaintiff's favor. A trade libel claim under New Jersey law necessitates proving four elements: (1) publication, (2) malice, (3) false allegations about the plaintiff's property or product, and (4) special damages. Trade libel, also known as product disparagement or slander of title, shares similar protections and limitations with defamation, including the existence of a qualified privilege. Opinion statements are generally nonactionable, particularly those based on known or assumed facts, while mixed opinions are also nonactionable unless they imply false underlying facts. The determination of whether a statement is a nonactionable opinion is a legal threshold, evaluated based on content, verifiability, and context. The statements in question—claiming EXPAREL is 'not superior' and is an 'inferior analgesic'—are deemed nonactionable opinions, as they represent rhetorical hyperbole rather than definitive claims. If a statement can be interpreted as either fact or opinion, it is to be construed as an opinion to prevent chilling free speech.

Determining whether a statement is the "best" is subjective and opinion-based, as established in Hughes v. Panasonic, where claims of "superior image and color quality" were deemed nonactionable opinions. The verifiability of such statements is crucial; they must be capable of being proven true or false. The court referenced that scientific conclusions are inherently tentative and subject to revision, as demonstrated in ONY, Inc. v. Cornerstone Therapeutics, which emphasized that empirical research conclusions are not definitive. The statements in question are presented as tentative scientific conclusions, with the Hussain Article acknowledging limitations in its study, such as variabilities and publication bias, which affect its findings. The Ilfeld Review similarly recognizes the evolving nature of medicine and notes gaps for future research. Furthermore, the distinction between "verifiability" and "reliability" is critical; verifiability concerns a statement's truth potential, while reliability pertains to the trustworthiness of the underlying methodology. Allegations by Pacira regarding the reliability of studies, including claims of omitted favorable data and methodological flaws, do not constitute actionable falsehoods as they do not address verifiability. Lastly, while undisclosed conflicts of interest may indicate "actual malice," they do not impact the fundamental question of whether the statements are actionable.

Pacira contends that the Hussain Article inaccurately states that studies on EXPAREL exhibited "low levels of heterogeneity." The District Court clarified that the Article did not assess heterogeneity for pain scores and explicitly stated this limitation. Under the Lanham Act, liability arises from "literally false" commercial statements, which may be established if the underlying studies lack reliability to substantiate the claims made. However, the current inquiry focuses on whether the statements qualify as nonactionable opinions. While Pacira's criticisms regarding the Article's data and methodology could fuel scholarly debate, they do not support a trade libel claim under New Jersey law, as such a conclusion could hinder scientific discourse.

The context of the statements further indicates they are nonactionable opinions. New Jersey courts evaluate the medium of dissemination and the target audience, assessing whether the statements can be proven true or false before considering the reliability of the underlying data. Pacira's challenges to the Defendants' studies do not resolve whether claims about the product's superiority are verifiable. The statements were made in a peer-reviewed journal aimed at anesthesiology specialists, who are equipped to critically evaluate such opinions.

Furthermore, the District Court correctly dismissed Pacira's complaint and denied its request to amend, as such amendments would be futile given that the statements are deemed nonactionable opinions as a matter of law. Even pejorative opinions regarding EXPAREL's cost in the McCann Editorial are constitutionally protected. The court refrained from establishing a blanket immunity for scientific statements in academic journals against trade libel claims and did not address the Defendants' potential immunity or jurisdictional issues. Consequently, the court affirmed the District Court's decision.