Pacira Biosciences has filed a libel lawsuit against the American Society of Anesthesiologists (ASA) and other defendants seeking pecuniary damages and the retraction of three articles published in the Society’s February issue of the Anesthesiology journal. According to Pacira, ASA published articles that “seriously disparage[d]” Exparel, a non-opioid pain medication that can prolong post-surgery pain relief and the only liposomal bupivacaine product approved by the United States Food and Drug Administration (FDA), which Pacira manufactures.
Pacira believes that the articles, as well as a related podcast and continuing medical education (CME material), “contain false and misleading conclusions, based on faulty scientific research that does not satisfy applicable standards within the scientific community. These conclusions create the false impression that EXPAREL — a drug approved by the FDA and used by over eight million patients over the past nine years — is not an effective pain medication.”
Pacira argues that the authors of the papers “knew or recklessly disregarded the fact that [their] statements about EXPAREL were false or misleading.”
Pacira alleged that it has suffered financial damages as “both existing and potential customers who have seen the disparaging articles, have either canceled contracts for EXPAREL, declined to purchase EXPAREL, or are considering removing EXPAREL from hospital formularies.”
Pacira also alleges that several editors and authors involved with Anesthesiology failed to disclose payments from some of the company’s competitors. According to the company, three authors and the editor-in-chief failed to disclose previous or current and ongoing relationships, either between themselves or their employers, with manufacturers who make products that could or would compete with Exparel, including over $14 million in research funding involving competing treatment modalities.
Pacira went even further, though, alleging that Anesthesiology editor-in-chief Evan Kharasch has long favored the use of opioids and even goes so far as to allege that he has used his position to advance a “pro-opioid agenda” and antagonize alternative medications. They allege that Anesthesiology “rejected publication of a letter to the editor that reported favorable experience with EXPAREL, and which expressed concern about the over-generalizations contained in the meta-analysis published in the February 2021 issue.”
The three articles in question were: a meta-analysis that said while Exparel showed a statistically significant improvement in post-op pain compared to another anesthetic, the improvement was clinically irrelevant; a paper reviewing 76 randomized controlled trials that found evidence did not support the use of the drug; and an editorial claiming the drug was not cost-effective.
According to Pacira, the CME course and podcast mentioned above “restate as a fact, the flawed conclusions of the Anesthesiology articles: Guidelines clearly state the importance of avoiding any commercial bias in CME materials in order to ensure the highest level of scientific credibility.”
The Complaint and Memorandum in Support of Pacira’s Motion for Preliminary Injunction can be found here and here, respectively. Each of the documents goes into great detail about specifics being alleged by Pacira in the suit.