Pacira BioSciences has launched a libel suit against the American Society of Anesthesiologists and its peer-reviewed medical journal accusing them of promoting biased and scientifically false studies related to the company's drug, Exparel.
The NJ-based biotech is seeking monetary damages and the retraction of three articles that create the false and misleading impression that its non-opioid pain management drug, Exparel, is not an effective analgesic.
The articles, included in ASA's 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.” Pacira's complaint claims that the ASA published articles were not only scientifically unsound, but 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," said the company.
According to Pacira, after seeing the articles, customers have cancelled contracts, declined to purchase and considered removing Exparel — which was approved by the U.S. FDA in 2012 — from hospital formularies.
The company said they had no choice but to take legal action after requests for discussion with the ASA and the editor of Anesthesiology were repeatedly dismissed.