Did Pacira Lie to Investors or a Federal Judge?
/By Pat Anson, PNN Editor
The war of words between Pacira BioSciences and the American Society of Anesthesiologists (ASA) continues to escalate, with new allegations that the drug company either lied to its investors or a federal judge.
New Jersey-based Pacira filed a lawsuit in April over three articles in the ASA journal Anesthesiology that disparaged Pacira’s flagship product Exparel, an injectable non-opioid analgesic used for postoperative pain. An editorial and two peer-reviewed research articles said Exparel worked no better than other bupivacaine products, even though it costs 10 times more.
Pacira filed a libel complaint against the ASA in federal court seeking a retraction and damages for “significant pecuniary harm.” The company said “multiple existing customers” had either stopped using Exparel or were considering it because of the journal articles.
If true, that would be a significant blow to Pacira, since Exparel accounted for 96% of the company’s revenues in 2020.
The ASA filed a motion last week asking a federal judge to dismiss the case, calling the lawsuit “an egregious and unjustified public relations campaign that seeks to chill scientific research and debate.”
‘Nothing to Worry About’
The ASA motion quotes a statement from a May 4 earnings call, in which Pacira CFO Charlie Reinhart told analysts that “we don’t have anything to worry about” and “actually things are going very, very well,” despite the negative reviews of Exparel in the medical journal.
In a preliminary report released last week, Pacira even boasted about sales of the drug. “Exparel sales continue to significantly outperform the elective surgery market recovery, with May marking our fourth consecutive month of sequential growth in average daily sales,” the company said in a statement that didn’t mention the lawsuit.
“In other words, Pacira is lying either to a federal judge or its investors,” the ASA said in a press release Monday.
A Pacira spokesperson declined to respond to the ASA statement, telling PNN that “our corporate policy is not to comment on pending litigation.”
Exparel was first approved by the FDA in 2011 as a local anesthetic for post-operative pain in adults. Its use has since been expanded to include children and as a nerve blocking agent. Pacira says over 8 million patients have been treated with Exparel. The drug is primarily sold to hospitals and ambulatory surgical centers. One of the biggest purchasers is the U.S. Department of Defense.
In the past, Pacira has gone to great lengths to promote Exparel and silence critics. In 2014, the company filed a lawsuit against the FDA after the agency sent a warning letter to Pacira for off-label marketing of Exparel. In 2020, Pacira agreed to pay $3.5 million to resolve allegations that it gave kickbacks to doctors to promote Exparel in research articles.
