EXPAREL maker files suit against journal, editor, and authors.
Pacira Biosciences, maker of non-opioid pain management and regenerative health solutions, has filed a libel lawsuit against the Anesthesiology medical journal, its editor, and the authors of published papers, arguing the articles “were based on faulty scientific research” and as a result, its EXPAREL painkiller was wrongly depicted as ineffective.
The maker of EXPAREL claimed the papers that were made available in the February of Anesthesiology created a “bias” against EXPAREL (commonly used for surgeries) and “disparaged” the medication. As a result, Pacira’s customers have “canceled contracts, declined to purchase the drug or are considering removing it from hospital formularies,” according to the lawsuit. The company also said a podcast and information presented in an American Society of Anesthesiology continuing medical education program of contain “false and misleading conclusions.”
Evan Kharasch, the editor-in-chief of the journal, is cited as having a “significant bias against EXPAREL,” supporting the use of opioid painkillers. The lawsuit contends Kharasch used his position to “suppress information favorable to EXPAREL.” The medicine, which is administered to patients using a proprietary delivery technology, has been viewed as controversial among orthopedic surgeons.
“All three articles and the journal cover create the illusion of rigorous and reliable scientific analysis using carefully curated data and technical jargon,” the lawsuit states. “The truth is anything but. Each article is riddled with errors, some of which are such egregious deviations from standard practice as to make clear that the authors designed their analyses to arrive at a predetermined outcome.”
Pacira is currently seeking approval for additional uses for EXPAREL after it was recently given the go-ahead to market it for use by children six years of age and older. However, in 2020, the company also agreed to pay $3.5 million to resolve claims of handing out fake research grants to persuade physicians to prescribe the medication.
Dave Stack, Chief Executive Officer and Chairman of Pacira submitted a statement after filing the suit, saying in part, “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…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 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.”