Pacira Pharma (PCRX) Seeks Court Injunction to Protect Clinical Integrity of EXPAREL in Face of Scientifically Flawed and Misleading Information Published in Anesthesiology

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.”

EXPAREL is the only long-acting local analgesic approved for infiltration, field block and interscalene brachial plexus nerve block in adult patients, and the FDA recently approved it as the first and only long-acting local analgesic approved with established safety for local infiltration in children aged six and over.

The product is separately reimbursed by the Centers for Medicaid and Medicare Services when used to treat Medicare surgical patients in the ambulatory surgery center environment, a policy that most major commercial payers have also adopted.

Background on the ComplaintPacira seeks to address three issues in its complaint:

1. The published meta-analysis is deeply flawed: Meta-analyses should only be conducted when the studies included are similar in terms of procedure type, patient population, and outcomes evaluated—this analysis combined a variety of administration techniques which included a variety of off-label uses with the largest subgroup being penile block for penile prothesis implant procedures, for which Pacira does not promote or provide educational support, and employed widely rejected methodologies. When proper methodologies are applied, the results are favorable to EXPAREL
2. Key financial and commercial conflicts were not disclosed: Financial and commercial disclosures allow transparency related to any potential bias in the publication process. 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.
3. Educational tools on the ASA website—including a continuing medical education (CME) course and a podcast—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.

Pacira seeks a preliminary injunction requiring the ASA to remove materials containing these misleading statements from its website in order to prevent the continued spread of misinformation. Pacira will also file a motion for expedited discovery to enable it to obtain crucial documents exposing the ASA’s unconscionable conflicts of interest and anti-EXPAREL bias.

The company’s motion for a preliminary injunction, which will be filed subsequent to the complaint, will be supported by several key declarants and experts, including William Rayburn, MD, former president of the Society for Academic Continuing Medical Education and former Associate Dean of Continuing Medical Education and Professional Development at the University of New Mexico School of Medicine, and Thomas Trikalinos, MD, PhD, Director of the Center for Evidence Synthesis in Health at Brown University.

The case, Pacira v. American Society of Anesthesiologists, was filed in the United States District Court for the District of New Jersey. Pacira is represented in this lawsuit by Latham & Watkins LLP. Copies of the pleadings and declarations are available at www.pacira.com/legal/ASAComplaint.

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