Pacira Biosciences Inc v. American Society of Anesthesiologists Inc

63 F.4th 240
Court of Appeals for the Third Circuit·Decided March 24, 2023·No. 22-1411·Published·Cited by 9 cases

Opinion

PRECEDENTIAL

UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT

No. 22-1411

PACIRA BIOSCIENCES, INC., Appellant

v.

AMERICAN SOCIETY OF ANESTHESIOLOGISTS, INC.;

EVAN D. KHARASCH; NASIR HUSSAIN; RICHARD BRULL; BRENDAN SHEEHY; MICHAEL K.

ESSANDOH; DAVID L. STAHL; TRISTAN E. WEAVER; FARAJ W. ABDALLAH; BRIAN M. ILFELD; JAMES C. EISENACH; RODNEY A. GABRIEL; MARY ELLEN MCCANN

On Appeal from the United States District Court for the District of New Jersey (No. 2-21-cv-09264)

U.S. District Judge: Honorable Madeline C. Arleo

Argued March 6, 2023

Before: SHWARTZ, BIBAS, and AMBRO, Circuit Judges.

(Filed: March 24, 2023)

Michael Bern Allen M. Gardner Gregory G. Garre [ARGUED] Sarah Gragert Latham & Watkins 555 11th Street, N.W. Suite 1000 Washington, DC 20004

Counsel for Plaintiff-Appellant

John A. Boyle Kevin H. Marino Marino Tortorella & Boyle 437 Southern Boulevard Chatham, NJ 07928

Michael B. Carlinsky Kaitlin P. Sheehan Ellyde R. Thompson Quinn Emanuel Urquhart & Sullivan 51 Madison Avenue 22nd Floor New York, NY 10010

Robert Schwartz Kathleen M. Sullivan [ARGUED] Quinn Emanuel Urquhart & Sullivan 865 South Figueroa Street 10th Floor

Los Angeles, CA 90017

Counsel for Defendants-Appellees

David S. Bloomfield, Jr. Porter Wright Morris & Arthur 41 South High Street Suite 2900 Columbus, OH 43215

Counsel for Defendants-Appellees Nasir Hussain, Brendan Sheehy, Michael K. Essandoh, David L. Stahl, and Tristan E. Weaver

Eugene Volokh UCLA School of Law 385 Charles E. Young Drive Los Angeles, CA 90095

Counsel for Amicus Appellee Foundation for Individual Rights in Education Inc.

Leonard A. Nelson American Medical Association Office of General Counsel 330 North Wabash Avenue Suite 39300 Chicago, IL 60611

Counsel for Amici Appellee American Medical Association and Medical Society of New Jersey

Aaron A. Nichols Steven E. Tiller Whiteford Taylor & Preston Seven Saint Paul Street 19th Floor Baltimore, MD 21202

Counsel for Amicus Appellee American Society for Clinical Pharmacology & Therapeutics

Elizabeth A. McNamara Alison B. Schary Davis Wright Tremaine 1251 Avenue of the Americas 21st Floor New York, NY 10020

Counsel for Amici Appellee Association of American Publishers Inc., International Association of Scientific, Technical and Medical Publishers and Federation of American Societies for Experimental Biology

Aaron D. Lindstrom Barnes & Thornburg 171 Monroe Avenue N.W. Suite 1000 Grand Rapids, MI 49503

Counsel for Amicus Appellee Council of Medical Specialty Societies

OPINION OF THE COURT

SHWARTZ, Circuit Judge.

Pacira BioSciences, Inc. (“Pacira”) sued the American Society of Anesthesiologists, Inc. (“ASA”), the editor-in-chief of its medical journal, and the authors of three articles for statements made about one of Pacira’s drug products. 1 Pacira claims that the statements constitute trade libel. Because the District Court correctly concluded that the statements that form the basis of Pacira’s trade libel claim are nonactionable opinions, Pacira has failed to state a basis for relief. We will therefore affirm.

I

A

This trade libel action arises out of allegedly false and misleading statements about liposomal bupivacaine, a nonopioid pain medication that Pacira manufactures under the

1 The editor-in-chief is Evan D. Kharasch, and the authors are Nasir Hussain, Richard Brull, Brendan Sheehy, Michael K. Essandoh, David L. Stahl, Tristan E. Weaver, Faraj W. Abdallah, Brian M. Ilfeld, James C. Eisenach, Rodney A. Gabriel, and Mary Ellen McCann.

name EXPAREL. 2 The drug is a local anesthetic administered at the time of surgery to control post-surgical pain. According to Pacira, EXPAREL offers longer lasting pain relief than standard local anesthetics. As of 2020, EXPAREL sales represented nearly all of Pacira’s total revenue.

B

Pacira complains that Defendants published statements in a variety of forms, all of which conveyed their view that EXPAREL is “not superior” to standard analgesics or provides “inferior” pain relief. See Appellant’s Br. at 2, 40; JA62, 67. More specifically, Pacira points to the February 2021 issue of Anesthesiology, the ASA’s peer-reviewed academic journal that has over 50,000 subscribers. The cover of the February 2021 issue states that “Liposomal Bupivacaine Is Not Superior to Standard Local Anesthetics” and contains several articles that Pacira alleges make false and misleading statements disparaging EXPAREL. JA49. Pacira challenges three articles in Anesthesiology: (1) a meta-analysis of studies examining the efficacy of EXPAREL (the “Hussain Article”), which concludes that the drug is “not superior” to standard anesthetics, JA77; (2) a narrative review of clinical trials involving EXPAREL (the “Ilfeld Review”), which reaches a similar conclusion; and (3) an editorial based on the meta- analysis and narrative review (the “McCann Editorial”)

2 The facts are drawn from Pacira’s complaint, which we accept as true in accordance with our standard of review for motions under Fed. R. Civ. P. 12(b)(6). Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009).

(collectively, the “Articles”). 3 Pacira alleges that the Articles rely on studies that fail to isolate certain variables, reach unqualified conclusions about EXPAREL’s efficacy, and discredit industry-funded trials.

Pacira also raises specific issues about each of the Articles. As to the Hussain Article, Pacira contends that it “cherry-picked” studies that disfavor EXPAREL, JA51, employed a “flawed method” known as “crude pooling,” 4 JA52, and violated “the standards of medical research” by failing to account for the statistical heterogeneity 5 of the studies on which it relied, JA53. As to the Ilfeld Review, Pacira contends that it failed to discuss the “most relevant anesthesia procedure,” JA54, ignored studies favorable to EXPAREL with minimal explanation, and that two of its authors failed to disclose financial conflicts of interest. As to the McCann Editorial, Pacira alleges that it repeats the conclusions of the Hussain Article and Ilfeld Review, “criticize[s]” “EXPAREL’s cost” and “strongly insinuates that the FDA approved EXPAREL with insufficient evidence.” JA58.

3 Because the Articles are attached to the complaint as exhibits whose authenticity is not questioned, we may consider them. McTernan v. City of York, 577 F.3d 521, 526 (3d Cir. 2009).

4 According to Pacira, crude pooling is a methodology in which results from different studies, analyzing different populations, are grouped together.

5 In its complaint, Pacira explains that a heterogeneity analysis accounts for differences in population, type of medications, outcome definitions, and design across different studies.

In addition to publishing the Articles, the ASA offered a Continuing Medical Education program (the “CME”) that allowed participants to answer questions based on the Articles and receive credit to satisfy medical licensure requirements. Pacira alleges that these questions restate as fact the Articles’ conclusions, including that EXPAREL is “inferior” to standard anesthetics, JA62, and that studies favoring EXPAREL are biased. Finally, Anesthesiology produced a podcast (the “Podcast”) that also allegedly repeated the conclusions of the Articles “without acknowledging their many flaws.” JA65.

C

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Pacira Biosciences Inc v. American Society of Anesthesiologists Inc, 63 F.4th 240 (3d Cir. 2023).

63 F.4th 240 (Pacira Biosciences Inc v. American Society of Anesthesiologists Inc) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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