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

"The peer-review process—not a courtroom—... provides the best mechanism for resolving scientific uncertainties."

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From Judge Madeline Cox Arleo (D.N.J.), writing today in Pacira Biosciences, Inc. v. Am. Soc'y of Anestheologists, Inc.:

[The following facts are drawn from the Complaint.] This trade libel action arises out of allegedly false and misleading statements published in a leading medical journal about liposomal bupivacaine, a pain medication that Plaintiff manufactures under the name EXPAREL. {EXPAREL is a local anesthetic administered at the time of surgery to control 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 allegations stem from the February 2021 issue of Anesthesiology, the ASA's official, peer-reviewed academic journal. 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. 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 EXPAREL trials (the "Ilfeld Review"); and (3) an editorial based on the meta-analysis and narrative review (collectively, the "Articles"). Plaintiff generally alleges that each of the Articles employed flawed methodologies by, among other things, cherry-picking data, relying on studies that Plaintiff believes were deficient, improperly 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] program linked to the Articles, for which participants could access questions about the Articles and receive credit to satisfy medical licensure requirements (the "CME"). Plaintiff alleges that these questions restate as fact the flawed and misleading conclusions reached by the Articles. Finally, Anesthesiology produced a podcast that allegedly repeated the conclusions of the Articles 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 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." By their nature, scientific conclusions published in an academic journal are "tentative," and made "available to other scientists who may respond by attempting to replicate the described experiments, conducting their own experiments, or analyzing or refuting the soundness of the experimental design or the validity of the inferences drawn from the results." The peer-review process—not a courtroom—thus provides the best mechanism for resolving scientific uncertainties.

Consequently, courts have determined that scientific conclusions are protected speech to the extent they are "draw[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 is especially true where, as here, a challenged statement occurred in a peer-reviewed journal "directed at the scientific community," as opposed to an advertisement directed at consumers.

With no clear guidance from the Third Circuit, the Court finds no cause to depart from these well-reasoned precedents. Absent an allegation that the author of a scientific article falsified the data from which she drew her conclusions, a plaintiff cannot sustain a claim for trade libel by alleging that some methodological flaw led to a scientifically "incorrect" answer. Stated differently, a scientific conclusion based on nonfraudulent data in an academic publication is not a "fact" that can be proven false through 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. Indeed, the crux of this action is Plaintiff's disagreement with scientific conclusions attributed to a professional medical association and 12 members of the scientific community. 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 contends that the Hussain Article's overall conclusion that EXPAREL is "not superior" to standard analgesics is susceptible to defamatory meaning. The Court disagrees.

Critically, Plaintiff does not allege that the Hussain Article falsified any of the data it relied upon. Instead, Plaintiff simply argues that methodological flaws in the Article led to an incorrect conclusion. Among other things, Plaintiff asserts that the authors relied on deficient studies, improperly disregarded studies favorable to EXPAREL, failed to consider whether the effectiveness of EXPAREL may differ across different types of surgical procedures, and employed a flawed method known as "crude pooling," The Complaint itself makes clear that Plaintiff's primary grievance is the Article's selection of "methodologies that would bias the results."

Plaintiff's attempt to reframe these perceived flaws in methodology as "false descriptions of data on which the studies rely," is unavailing. For example, Plaintiff contends 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 was not relied on to receive protection. Plaintiff further argues that the Hussain Article falsely states that studies into EXPAREL were "characterized by low levels of heterogeneity" but that the authors did not actually assess the heterogeneity for "pain scores" amongst the studies. However, the Article never claims to have assessed the heterogeneity for pain scores and, in fact, expressly discloses that it did not.

Notwithstanding Plaintiff's characterization, these arguments amount to a mere dispute over methodology and in no way suggest that any underlying data was falsified. While Plaintiff has perhaps identified grounds for legitimate scholarly debate, it cannot breach the legal protection otherwise afforded to scientific conclusions….

Like the Hussain Article, Plaintiff challenges the Ilfeld Review's conclusion that liposomal bupivacaine is not a superior alternative to other anesthetics. Plaintiff's arguments suffer from the same shortcomings.

Plaintiff chiefly contends 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 did rely upon. Importantly, Plaintiff does not allege that Defendants distorted the findings of the underlying studies in any way; it instead argues that those studies should not have been taken at face value due to the presence of bias, methodological flaws, and contrary evidence. As discussed above, such attacks on a scientific article's selection of and analysis of data cannot support a claim for trade libel.

Moreover, Plaintiff alleges that two authors of the Ilfeld Review failed to disclose certain conflicts of interest. The Court acknowledges that a substantial undisclosed conflict of interest may provide some further 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 a plaintiff's threshold obligation to demonstrate that a scientific conclusion is capable of defamatory meaning. {Regardless, the conflicts alleged in the Complaint appear to be 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 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. Upon closer examination of the public online profile for Ilfeld, which the Complaint relies upon, the offending grants appear to be for "congressionally directed medical research" into alternative treatments for postoperative pain generally and post-amputation phantom limb pain specifically. It also bears noting that Ilfeld received funding from Plaintiff in the past as well. 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 considered in assessing the presence of malice.} Plaintiff has failed to do so here with respect to the Ilfeld Review….

Finally, Plaintiff has failed to allege an actionable falsehood arising from the McCann Editorial, CME, or Podcast. Plaintiff initially argues that these publications "contain or repeat" the alleged falsehoods in the Hussain Article and Ilfeld Review. Pl. Opp. at 27. 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 conclusions."

Plaintiff suggests that two statements in the McCann Editorial and CME materials go beyond the scope of the other challenged Articles. First, Plaintiff alleges that the McCann Editorial "suggest[s] that Pacira is lining its pockets with revenue from an ineffective drug." … 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." And that statement fully accords with the conclusions of the Hussain Article and Ilfeld Review that EXPAREL is "not superior" to standard local anesthetics.

Second, Plaintiff notes that the CME materials state that "a high percentage of randomized control trials showed that infiltration of the surgical site with liposomal bupivacaine provides inferior analgesia to a peripheral nerve block with local anesthetics," whereas the Hussain Article states only that EXPAREL is "not superior." As Defendants observe, the Ilfeld Review states that after canvassing randomized, controlled trials, it found that "[n]inety-two percent of trials (11 of 12) suggested a peripheral nerve block with unencapsulated bupivacaine provides superior analgesia to infiltrated liposomal bupivacaine." The CME materials are therefore entirely consistent with the Ilfeld Review's summary of the relevant studies.

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  1. On the one, I'm glad to see this meritless and in all likelihood frivolous suit meet a quick demise. On the other, I'm incensed on defendants' behalf that they had to endure the stress and expense—not to mention possible harm to their own professional reputations—caused by this suit. I hope they can recoup their fees or otherwise make Pacira feel some kind of economic pain (no pun intended), but I'd understand if they'd just prefer to take the W and call it a day instead of prolonging this ordeal further.

    1. The editor in chief of Anesthesiology was personally named, along with many other individuals. All of whom are known to be upstanding scientists within our field. Pacira has shot itself in the foot, and any reading I make of the relevant literature still favors my friends at the Journal. The drug does not enter use at any hospital until each local Pharmacy and Therapeutics committee reviews the role of the drug for the hospital formulary, with considerations of clinical need, safety, alternatives, cost-effectiveness, and development of use protocols to ensure best use (unlike TV shows, not everything that pops into a doctor's mind is instantly transformed into clinical action). While I had considered whether it should be on formulary a few years back, Pacira has ensured that I know very well the breadth of dozens of studies on the drug; statistical improvements exist, but clinically meaningful improvements for patients (at $350 a dose cost, and who knows how much charged to the insurer/patient) are elusive, and measured as a matter of a few added hours of numbness before the need for the inevitable post-op opiate dose.

  2. I think the one quibble is it might have been going to far to say that libel can arise only from falsified data. It might, for example, potentially arise from falsified methodology or from conclusions that go far outside both.

    But if the data and methodology are accurately stated and the conclusions arise from them, with some leeway for being a bit imperfect, I agree scientific publications should be immune from libel claims.

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