In highly unusual move, Pacira sues medical journal for libel over its non-opioid painkiller
A New Jersey biotech whose only approved drug is used as a painkiller after surgeries is suing a scientific journal, its editors and a handful of authors for libel after the publication printed numerous papers and editorials that the company says discredited the drug.
Pacira Biosciences filed the complaint against the American Society of Anesthesiologists in the US District Court for New Jersey on Wednesday afternoon. A February issue of the group’s journal Anesthesiology printed three articles and other content full of “bias” that “seriously disparaged” the drug Exparel, Pacira claimed.
The articles, as well as a related podcast, “contain false and misleading conclusions, based on faulty scientific research that does not satisfy applicable standards within the scientific community,” Pacira wrote in the suit. “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 said it suffered financial damages related to the papers, claiming that both current and prospective customers have canceled contracts or decided against purchasing Exparel. The biotech also alleges that several editors and authors involved in the publication of the papers in question failed to disclose payments from competing companies.
On top of that, Pacira claimed editor-in-chief Evan Kharasch has for years favored the use of opioid painkillers and used his position to advance a “pro-opioid agenda” so as to vilify alternative medicines. Exparel is a non-opioid painkiller used as a regional anesthetic after surgeries.
Among the three papers in question was a meta-analysis that said Exparel showed a statistically significant improvement in post-op pain compared to another anesthetic, but that the improvement was clinically irrelevant. Pacira said the analysis “cherry-picked selective studies that are likely to provide an unfavorable view” of their drug and employed a method known as “crude pooling” they say is widely recognized as “flawed.”
There was also a paper examining 76 randomized controlled trials that said evidence did not support the use of the drug, as well as an editorial claiming the drug was not cost-effective.
Libel lawsuits are notoriously difficult to prove, given the need to show both knowingly publishing or saying false statements, as well as intent to do reputational harm. Companies often make threats or demand retractions of statements or papers they view as unfavorable, but it’s unclear how often those threats are followed through with lawsuits.
This is also not the first time Pacira has generated controversy, as they paid out $3.5 million to settle allegations over paying doctors fraudulent research grants to prescribe the drug between 2012 and 2015, STAT reported at the time. Pacira also sued the FDA in 2014 after the agency posted a warning letter over the company’s marketing practices.
Exparel was first approved in 2011 in adults, and last month saw its label expanded into children over 6 years old.