Court Rejects Pacira Biosciences’ Trade Libel Claim Over Article in Leading Medical Journal About EXPAREL

[The following facts are drawn from the Complaint.]Trade libel proceedings stem from misleading and false statements about liposomal bucaine. Plaintiff is the manufacturer of EXPAREL, a painkiller. {EXPAREL can be administered as an intra-operative local anesthetic to reduce 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 claims stem from the issue February 2021 of AnesthesiologyASA’s peer-reviewed academic journal. On the cover of the February 2021 issue, it states “Liposomal Bupivacaine is not superior to standard local anesthetics”. It also contains articles that make false or misleading claims about EXPAREL. Plaintiff challenges the publication of three articles in AnesthesiologyThe Articles include (1) a meta analysis of EXPAREL studies (the “Hussain Article”), (2) a narrative review EXPAREL trials (“the Ilfeld Review”) and (3) an editorial that is based on both the narrative review and meta-analysis (collectively the “Articles”) Plaintiff claims that all three Articles used flawed methods, including cherry-picking data and relying upon studies Plaintiff considers to be deficient. They also improperly discredit studies favoring EXPAREL. Finally, they failed to adequately limit their conclusion that EXPAREL was not effective.

The ASA offered a [Continuing Medical Education]The Articles program was linked with the participants, who could ask questions and earn credit towards satisfying the medical licensure requirements. Plaintiff claims that the questions reaffirm and correct the false and misleading conclusions of the Articles. Finally, Anesthesiology produced a podcast that allegedly repeated the conclusions of the Articles without acknowledging their flaws (the “Podcast”)….

Falsity is an element [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.” Scientific conclusions that are published in academic journals have a “tentative” nature. They can be republished by other scientists, who will then be able to respond to the findings, conduct their experiments or analyze or discredit the scientific design. The peer-review process—not a courtroom—thus provides the best mechanism for resolving scientific uncertainties.

Accordingly, scientific conclusions have been declared protected speech by courts in the sense that they can be drawn from science.[n] … from non-fraudulent data, based on accurate descriptions of the data and methodology underlying those conclusions, on subjects about which there is legitimate ongoing scientific disagreement.” … “Scientific controversies must be settled by the methods of science rather than by the methods of litigation.” …. This holds true especially when, like here, the challenged statement was made in a peer reviewed journal that “directly addressed scientific community” and not an advertisement for consumers.

The Court does not find any reason to change these established precedents, as there is no clear guidance from Third Circuit. The plaintiff is not allowed to claim trade libel for claiming that the scientist who wrote the article was unable to verify the facts. A scientific conclusion that is based solely on data from an academic publication and not fraudulent can’t be proved false by litigation. To hold otherwise would chill robust and open debate about the efficacy of drugs within the medical community—particularly here, where Plaintiff seeks retraction of the articles in question, removal of related materials from the Internet, and compensatory and punitive damages against the scientists who published their academic opinions.

Plaintiff does not—and cannot—dispute the existence of “ongoing scientific disagreement” concerning the effectiveness of EXPAREL. Plaintiff disagrees with the scientific conclusions of a professional medical organization and 12 scientists. This is the core of this case. The Court must therefore determine whether Plaintiff has identified any aspect of the Articles, CME, or Podcast that bring their conclusions outside the protected realm of scientific opinion….

Plaintiff claims that Hussain Article’s conclusion that EXPAREL “not superior” than standard analgesics can be defamatory. The Court disagrees.

Plaintiff doesn’t claim that any data used in the Hussain Article was falsified. Plaintiff simply claims that there were methodological problems in the Article which led to an incorrect conclusion. Plaintiff claims, among other things that the authors used deficient studies, ignored studies that were favorable for EXPAREL and failed to consider the possibility that EXPAREL might be different across various types of surgery procedures. Plaintiff also asserts that they chose “methodologies which would bias the results” in the Complaint.

Plaintiff attempts to explain these apparent flaws of methodology using “false description data” but this is not the case. Plaintiff claims that Hussain Article failed to reveal certain data and studies favorable to EXPAREL. However, a scientific conclusion does not have to account for all data. NotTo receive protection, the plaintiff relied upon. Plaintiff also claims that Hussain Article incorrectly stated that EXPAREL studies were “characterized with low levels of heterogeneity”, but that authors didn’t actually evaluate the heterogeneity among the studies. The Article does not claim to have evaluated the heterogeneity of pain scores, but it expressly states that it didn’t.

These arguments, despite Plaintiff’s assertions to the contrary, are merely disputes over method and do not suggest any falsification of underlying data. While Plaintiff has perhaps identified grounds for legitimate scholarly debate, it cannot breach the legal protection otherwise afforded to scientific conclusions….

Plaintiff also challenges the Ilfeld Review conclusion that liposomal bupivacaine does not offer a superior anesthetic to the other options. These arguments are flawed in the same way as those of Plaintiff.

Plaintiff claims the Ilfeld Review omitted studies and data that were favorable to EXPAREL and failed to account for the “biases, problems”, and other factors of those studies. Plaintiff doesn’t claim that the defendants distorted the results of the underlying research. It instead claims that the biases and methodological weaknesses of those studies meant that they should not be taken as true. This attack on the selection and analysis of data in scientific articles cannot be used to support trade libel claims, as discussed previously.

Plaintiff claims, in addition to the conflict of interest allegations against two Ilfeld Review authors that they failed disclose. Although the Court recognizes that there may be a significant undisclosed conflict, it could provide additional support for a plaintiff who can otherwise allege defamatory statements. However, it must also prove “actual malice”. The Court acknowledges that an undisclosed conflict of interest may provide some support to a plaintiff who is otherwise able to allege a defamatory statement. However, a plaintiff still has the threshold obligation of proving that a scientific conclusion can be used for such purposes. {The conflicts in the Complaint seem to be at most tenuous. Plaintiff alleges that Brian Ilfeld’s employer—a large public research university—received funding from one of Plaintiff’s competitors but does not suggest that Ilfeld himself received any such funding. The Complaint takes further issue with Ilfeld’s receipt of grant funding from the United States Department of Defense, which is a government agency—not a pharmaceutical company that competes with Plaintiff. The Complaint cites Ilfeld’s public online profile as evidence that the grants were for “congressionally directed medicine research”. This is to investigate alternative pain treatments, such as post-amputation pain phantom, and for other types of pain. Ilfeld has also received funding from Plaintiff previously. In the Complaint Rodney Gabriel claims that he received only one consulting payment from Plaintiff in 2019. This is a conflict which appears unlikely. de minimis and is, at most, a factor that could be considered in assessing the presence of malice.} Plaintiff has failed to do so here with respect to the Ilfeld Review….

Plaintiff also failed to allege an actionable lie arising out of the McCann Editorial CME or Podcast. Plaintiff initially claimed that the publications contained or repeated the falsehoods in Hussain Article, Ilfeld Review. Pl. Opp. Opp. However, a mere summary or repetition of an otherwise protected scientific opinion is not an independently defamatory statement—at least where the secondary statement was not made in connection with a consumer-facing advertisement, and did not “misstate[]The article’s conclusion.

Plaintiff suggests two statements from the McCann Editorial, and CME materials that go beyond the scopes of the other challenged Articles. Plaintiff first alleges the McCann Editorial is “suggestive”.[s]Pacira has been able to make a lot of money from ineffective drugs. … Plaintiff does not, however, identify any particular statement concerning Plaintiff’s marketing practice that is demonstrably false beyond the insinuation that EXPAREL is not “an improvement over existing, inexpensive drugs.” That statement is consistent with both the Hussain Article & Ilfeld Review conclusions that EXPAREL “is not superior” to other local anesthetics.

Plaintiff also notes that CME materials claim that “a large percentage of randomized controlled trials demonstrated that liposomal bupivacaine infiltration into the surgical site is effective.” inferiorAnalgesia to the peripheral nerve block with local painkillers,” while the Hussain Article only states that EXPAREL “is not superior.” According to Defendants, Ilfeld Review stated that, after canvassing randomized, controlled trials it discovered that:[n]Inety-two per cent of the trials (11 out of 12), suggested that a peripheral nerve block was possible with unencapsulated bupivacaine. SuperiorAnalgesia for infiltrated liposomal bupivacaine. CME materials follow the Ilfeld Review’s summaries of relevant studies.