63 F.4th 240
3d Cir.2023Background
- Pacira BioSciences sued the American Society of Anesthesiologists (ASA), the editor-in-chief, and authors of three pieces in Anesthesiology (Feb. 2021) alleging trade libel based on statements that Pacira’s product EXPAREL (liposomal bupivacaine) is “not superior” or an “inferior analgesic.”
- Challenged materials: Hussain meta-analysis, Ilfeld narrative review, McCann editorial; also a CME module and a podcast that repeated those conclusions.
- Pacira alleged the Articles cherry-picked studies, used flawed methodology (e.g., “crude pooling”), failed to account for heterogeneity, ignored favorable studies, and that some authors had undisclosed conflicts of interest.
- The District Court dismissed under Rule 12(b)(6), holding the statements were nonactionable scientific opinions and thus not susceptible to defamatory meaning under New Jersey law.
- The Third Circuit affirmed: the contested statements were rhetorical/scientific opinions (tentative, disclosed, and directed at specialist readers), and Pacira’s critiques targeted reliability, not verifiability; amendment was futile.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether statements that EXPAREL is “not superior” or “inferior” are actionable false statements of fact or protected opinion | Pacira: statements assert falsifiable claims about product efficacy and are false/misleading | ASA/Authors: statements are tentative scientific conclusions/opinion based on disclosed data and methodology | Court: statements are nonactionable opinions (rhetorical/scientific conclusions) |
| Whether methodological disputes (cherry-picking, crude pooling, failure to assess heterogeneity) render statements verifiable falsehoods | Pacira: methodological flaws make conclusions false | Defendants: these are disputes about reliability, not verifiability; conclusions were disclosed as tentative | Court: disputes about reliability do not make conclusions verifiable falsehoods; verifiability lacking |
| Whether context (peer-reviewed journal, specialist audience, disclosure of data/methods) affects actionability | Pacira: publication and CME/podcast gave conclusions wider reach and presented assertions as fact | Defendants: journal context, disclosure, and expert audience show readers can independently assess and treat pieces as opinion | Court: context supports protection—audience and disclosed bases indicate nonactionable opinion |
| Whether leave to amend should be granted to plead additional facts (e.g., malice, undisclosed bias) | Pacira: additional factual allegations (conflicts, methodological errors) could cure defects | Defendants: core defect is legal (opinion), so amendment would be futile | Court: denial affirmed—amendment would be futile because statements are legally nonactionable opinions |
Key Cases Cited
- Dairy Stores, Inc. v. Sentinel Publ’g Co., 516 A.2d 220 (N.J. 1986) (trade libel and qualified-privilege principles; opinion/fact distinction)
- Lynch v. N.J. Educ. Ass’n, 735 A.2d 1129 (N.J. 1999) (opinion immunity and factors: content, verifiability, context)
- Ward v. Zelikovsky, 643 A.2d 972 (N.J. 1994) (rhetorical hyperbole and nonactionable opinion)
- Milkovich v. Lorain Journal Co., 497 U.S. 1 (1990) (opinion/fact distinction under the First Amendment)
- ONY, Inc. v. Cornerstone Therapeutics, Inc., 720 F.3d 490 (2d Cir. 2013) (scientific conclusions are tentative and typically protected; reliability vs. verifiability)
- Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993) (scientific conclusions subject to revision; standards for admissibility)
- Gertz v. Robert Welch, Inc., 418 U.S. 323 (1974) (constitutional value of false statements of fact)
- Novartis Consumer Health, Inc. v. Johnson & Johnson–Merck Consumer Pharms. Co., 290 F.3d 578 (3d Cir. 2002) (literal falsity in commercial speech can be shown by unreliable underlying studies)