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N.J. Biotech Seeking Journal Retractions Eases Immediate Demands

— Pacira drops motion for preliminary injunction but not its case for retraction

MedpageToday
Vials of Exparel (bupivacaine liposome) in front of the Pacira Biosciences logo

Pacira BioSciences has backed down a bit in its lawsuit against the American Society of Anesthesiologists (ASA), withdrawing its motion to force immediate retraction of a trio of articles about the company's opioid alternative drug.

Pacira is suing the ASA -- and a dozen editors and authors of the society's official journal, Anesthesiology -- claiming several articles published in the journal created the incorrect impression that bupivacaine liposome (Exparel) is not an effective analgesic. The Parsippany, New Jersey-based biotech is seeking retractions of what it says are false and misleading statements made about Exparel in the of Anesthesiology, as well as unspecified damages, .

However, the ASA Thursday that Pacira had dropped its motion for a preliminary injunction to immediately force the retractions. The ASA stated that it was pleased with the reversal, and that it stands by the articles under question.

"Although Pacira started this lawsuit, ASA will not shy away from refuting Pacira's claims and from exposing the important issues with Pacira's controversial drug," the ASA stated in its announcement.

At the end of last month, the ASA filed a motion that asked the court to schedule a prompt hearing on Pacira's motion for a preliminary injunction. The ASA asked the court to let it and the other defendants in the case file a full response to Pacira's motion by mid-June and return to court in mid-July for oral argument.

"Instead of agreeing to give ASA and the other defendants that opportunity to respond, Pacira withdrew its motion," the ASA stated.

The ASA further stated that it and the other defendants may soon file motions to dismiss in the case.

For its part, Pacira is moving forward with its suit, even though it is no longer seeking a preliminary injunction to immediately force the retractions.

Pacira's drug Exparel is a non-opioid pain medication used to prolong post-surgery pain relief and is approved by the FDA for both adult and pediatric patients. The company alleges that the Anesthesiology articles in question reflect a bias against Exparel among the journal's editorial staff, and that it has suffered harm because of what was written.

The conclusions of the articles "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 stated in its complaint. "As a result, Pacira has suffered and will continue to suffer significant pecuniary harm as both existing and potential customers who have seen the disparaging articles, have either canceled contracts for Exparel, declined to purchase Exparel, or are considering removing Exparel from hospital formularies."

The publicly-traded company noted in its complaint that sales of Exparel represented about 96% of its total revenues in 2019 and 2020.

In reporting its first quarter financial results last week, Pacira stated that Exparel net product sales were $114.7 million for the first 3 months of this year, up from $101.3 million for the first quarter of 2020. The company's total revenues were $119.0 million for the first quarter of 2021, up from $105.7 million for the same period last year.

Pacira declined app's request for comment on withdrawal of its motion for a preliminary injunction. The ASA declined to comment beyond what it stated in its announcement.

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    Jennifer Henderson joined app as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.