Court dismisses Pacira Biosciences commercial libel claim over article in leading medical journal

[The following facts are drawn from the Complaint.] This commercial defamation action stems from allegedly false and misleading statements published in a leading medical journal about liposomal bupivacaine, a painkiller that the plaintiff manufactures under the name EXPAREL. {EXPAREL is a local anesthetic given at the time of surgery to control pain. Pacira is the only FDA-approved liposomal bupivacaine manufacturer, which means that compared to standard bupivacaine, EXPAREL is enclosed in a liposomal chamber.}

The plaintiff’s allegations stem from the February 2021 issue of Anesthesiology, the official peer-reviewed academic journal of the ASA. 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. The 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 the EXPAREL trials (the “Ilfeld Review”); and (3) editorial based on meta-analysis and narrative review (collectively, “Articles”). Plaintiff generally alleges that each of the papers used flawed methodologies, among other things, by selecting data, relying on studies that Plaintiff considers deficient, wrongly 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] article-linked program, for which participants could access questions about the articles and receive credit towards meeting the requirements for obtaining a medical license (the “CME”). The plaintiff alleges that these questions restate as fact the erroneous and misleading conclusions drawn from the articles. Finally, Anesthesiology produced a podcast that allegedly repeated the Articles’ findings 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 objectively proving its truth or falsity,” as opposed to an opinion protected by the First Amendment…. While “statements about disputed and questionable scientific assumptions…are in principle matters of verifiable ‘facts,’…they are more closely akin to matters of opinion and are thus understood by the relevant scientific communities”. By their nature, scientific conclusions published in an academic journal are “provisional” and made “available to other scientists who may respond by attempting to replicate the experiments described, conducting their own experiments, or analyzing or refuting the validity of the experimental design or the validity of inferences drawn from the results.” The peer review process – not a courtroom – therefore provides the best mechanism for resolving scientific uncertainties.

Accordingly, the courts have determined that scientific conclusions constitute protected speech to the extent that they are “drawn[n] …from non-fraudulent data, based on accurate descriptions of the data and methodology underlying these conclusions, on topics about which there is ongoing legitimate scientific disagreement.” … “Scientific controversies should be settled by the methods of science rather than the methods of litigation.” …. This is especially true where, as in the present case, a disputed statement has been published in a peer-reviewed journal “aimed at the scientific community”, e.g. opposition to consumer advertising.

In the absence of clear guidance from the Third Circuit, the Court finds no reason to depart from these well-reasoned precedents. In the absence of an allegation that the author of a scientific article falsified the data from which she drew her conclusions, a plaintiff cannot support a commercial defamation action by alleging that a methodological flaw led to a scientifically “incorrect” answer. In other words, a scientific conclusion based on non-fraudulent data in an academic publication is not a “fact” that can be proven false by litigation. To hold otherwise would chill a robust and open debate about drug efficacy within the medical community – particularly here, where the plaintiff seeks retraction of the articles in question, removal of related material from the Internet, and damages. compensatory and punitive measures against scientists who have published their academic opinions.

The applicant does not and cannot dispute the existence of a “permanent scientific disagreement” concerning the efficacy of EXPAREL. Indeed, the crux of this action is the plaintiff’s disagreement with the scientific findings attributed to a professional medical association and 12 members of the scientific community. The Court must therefore determine whether the Plaintiff has identified any aspect of the Articles, CME or Podcast that brings their conclusions outside the protected realm of scientific opinion….

Plaintiff argues that the general conclusion of the Hussain article that EXPAREL is “not superior” to standard painkillers is likely to have defamatory meaning. The Court disagrees.

Critically, the plaintiff does not allege that the Hussain article falsified any of the data on which it relied. Instead, the plaintiff simply argues that the paper’s methodological flaws led to an incorrect conclusion. Among other things, the plaintiff claims that the authors relied on flawed studies, wrongly ignored studies favorable to EXPAREL, failed to examine whether the effectiveness of EXPAREL might differ between different types of surgical procedures and used an erroneous method known as “raw pooling”. The complaint itself makes it clear that the plaintiff’s main grievance is the article’s selection of “methodologies that would skew the results”.

The plaintiff’s attempt to reframe these perceived flaws in the methodology as “misrepresentations of the data on which the studies are based” is futile. For example, the plaintiff argues that the Hussain article “failed to disclose” certain studies and data favorable to EXPAREL. But a scientific conclusion need not account for every piece of data that has been not count for protection. The applicant further argues that the Hussain article incorrectly states that the EXPAREL studies were “characterised by low levels of heterogeneity” but that the authors did not actually assess the heterogeneity of “pain scores” among studies. However, the article never claims to have assessed the heterogeneity of pain scores and, in fact, expressly discloses that it did not.

Notwithstanding the characterization of the plaintiff, these arguments constitute a simple dispute over methodology and in no way suggest that any underlying data has been falsified. While Plaintiff may have identified grounds for legitimate scientific debate, it cannot violate the legal protection otherwise given to scientific findings….

Like the Hussain article, the plaintiff challenges the Ilfeld review’s conclusion that liposomal bupivacaine is not a superior alternative to other anesthetics. The plaintiff’s arguments suffer from the same shortcomings.

Plaintiff primarily argues that the Ilfeld review improperly excluded studies and data favorable to EXPAREL while failing to properly account for the “biases and problems” of the studies it relied on. It is important to note that Plaintiff does not allege that Defendants misrepresented the conclusions of the underlying studies in any way; rather, he argues that these studies should not have been taken at face value due to the presence of biases, methodological flaws, and evidence to the contrary. As noted above, such attacks on the selection and analysis of data from a scientific paper cannot support a claim for commercial libel.

In addition, the plaintiff alleges that two authors of the journal Ilfeld failed to disclose certain conflicts of interest. The Court recognizes that an undisclosed material conflict of interest may provide additional support to a plaintiff who is otherwise able to allege a defamatory statement and must prove “actual malice”. However, the mere presence of an undisclosed conflict does not eliminate the plaintiff’s threshold obligation to show that a scientific conclusion is likely to have a defamatory meaning. {Be that as it may, the alleged conflicts in the Complaint seem tenuous at best. 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 such funding. The complaint further challenges Ilfeld’s receipt of a grant from the United States Department of Defense, which is a government agency and not a pharmaceutical company in competition with the plaintiff. Upon closer examination of Ilfeld’s public online profile, upon which the complaint relies, the impugned grants appear to be for “congress-directed medical research” into alternative treatments for postoperative pain in general and for post-amputation phantom limb pain in particular. It should also be noted that Ilfeld has also received funding from the applicant in the past. Finally, the complaint alleges that co-author Rodney Gabriel received a single consulting payment from Plaintiff’s competitor in 2019, a conflict that appears de minimis and is, at most, a factor that could be taken into account in assessing the presence of malice.} Plaintiff failed to do so here with respect to the Ilfeld examination….

Finally, plaintiff has not alleged an actionable lie arising out of the McCann op-ed, the CME, or the podcast. Plaintiff initially contends that these publications “contain or repeat” the falsehoods alleged in the Hussain article and the Ilfeld review. pl. Opp. at 27. However, a mere summary or repetition of otherwise protected scientific advice is not an independent defamatory statement – at least where the secondary statement was not made in connection with a consumer advertisement and is not ‘has not “deformed[] the conclusions of the article.

Plaintiff suggests that two statements in the McCann editorial and the CME documents go beyond the scope of the other impugned articles. First, the plaintiff alleges that McCann’s editorial “suggests[s] that Pacira is lining his pockets with the revenue from an ineffective drug. “…Plaintiff does not, however, identify any particular statement regarding Plaintiff’s marketing practice that is patently untrue beyond the insinuation that EXPAREL is not ‘an improvement over existing, inexpensive drugs’. And this statement fully agrees with the conclusions of the Hussain article and the Ilfeld review that EXPAREL is “not superior” to standard local anesthetics.

Second, the applicant notes that the CME documents state that “a high percentage of randomized controlled trials have shown that infiltration of the surgical site with liposomal bupivacaine provides inferior analgesia to peripheral nerve block with local anaesthetics”, whereas Hussain’s article only states that EXPAREL is “not superior”.[n]ine-two percent of trials (11 of 12) suggested that peripheral nerve block with unencapsulated bupivacaine provides superior analgesia with infiltrated liposomal bupivacaine. The CME documents are therefore entirely consistent with the summary of relevant studies in the Ilfeld review.

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