Pacira BioSciences Seeks Court Injunction to Protect Clinical Integrity of EXPAREL in the Face of Scientifically Flawed and Misleading Information Published in Anesthesiology

Complaint challenges the American Society of Anesthesiologists for promoting biased, analytically misguided studies in its journal, on its website, and through CME activity

PARSIPPANY, N.J., April 14, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX) today filed a lawsuit against the American Society of Anesthesiologists (ASA) and various other defendants seeking pecuniary damages and the retraction of three articles that create the false and misleading impression that EXPAREL (bupivacaine liposome injectable suspension) is not an effective analgesic. The articles, included in its official medical journal, Anesthesiology, were published in print and on the ASA website under the summary headline, “Liposomal Bupivacaine Is Not Superior to Standard Local Anesthetics.” This headline appeared on the cover of the publication’s February 2021 print issue.

The Complaint establishes that the ASA published articles that were not only scientifically unsound, but that also failed to disclose that certain authors were accepting payments from competing pharmaceutical or drug device manufacturers. Inaccurate or incomplete financial disclosures are a violation of ethical standards established by the medical and scientific research communities and raise serious questions regarding the objectivity of the published work.

“EXPAREL has been used in more than 8 million U.S. patients and is backed by scores of published studies that demonstrate safe and effective, long-lasting pain control, including decreased opioid requirements, improved patient outcomes, and the migration of surgical cases to outpatient sites of care,” said Dave Stack, Chief Executive Officer and Chairman of Pacira. “While pain trials are notoriously difficult to execute, and mixed evidence can be identified for all studied analgesics, the three Anesthesiology articles overwhelmingly overlook the positive body of literature that exists for EXPAREL.”

Mr. Stack continued, “We cannot allow this misrepresentation of the clinical effectiveness of EXPAREL to continue to be promoted in the journal and on the website of the American Society of Anesthesiologists, at the risk of confusing stakeholders along the patient care continuum about the value of EXPAREL compared to current treatment modalities. Requests for discussion with the ASA and the editor of Anesthesiology were repeatedly dismissed. This left us with no choice but to take legal action in order to ensure this false and misleading information is not inappropriately cited as an accurate reference in other scientific manuscripts and cannot be used to limit access to patients and providers who require low- and no-opioid care.”