According to the law firm press release, Pacira is a specialty pharmaceutical company that develops, commercializes, and manufactures pharmaceutical products primarily for use in hospitals and ambulatory surgery centers worldwide. Its product pipeline includes EXPAREL, which has completed Phase III clinical trials for postsurgical analgesia-nerve block administration.
The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, and failed to disclose material adverse facts about the Company's business, operations, prospects and performance. Specifically, during the Class Period, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the Company was overstating the efficacy of its EXPAREL drug; (ii) the Company was improperly promoting its EXPAREL drug by touting its ability to be effective for up to 72 hours, when in fact, it is only approved for 24 hours of pain relief; (iii) the Company improperly claimed that EXPAREL is safe for use in cholecystectomy and colectomy procedures, when in fact, approved labeling does not provide instructions for, or indicate that EXPAREL will be safe and effective for postsurgical pain, if used in surgical procedures other than hemorrhoidectomy or bunionectomy; (iv) a substantial portion of the Company's revenues were derived from off label marketing; and (v) and as a result of the above, the Company's financial statements were materially false and misleading at all relevant times.
On September 25, 2014, the Company announced that it received a Warning Letter from the U.S. Food and Drug Administration's ("FDA") Office of Prescription Drug Promotion ("OPDP") referencing certain promotional materials relating to EXPAREL (the "Warning Letter"). In the Warning Letter, the FDA's OPDP stated that it has evidence that EXPAREL has been promoted for uses for which it does not have approval, and for which its labeling does not provide adequate directions for use, thus rendering EXPAREL "misbranded." The FDA noted that Pacira's advertising materials suggested that EXPAREL is safe and effective for use in cholecystectomy and colectomy procedures. However, the FDA said that the approved labeling for EXPAREL does not provide instructions for, or indicate that EXPAREL will be safe and effective for postsurgical pain, if used in surgical procedures other than a hemorrhoidectomy or bunionectomy. Further, the Warning Letter noted that a journal advertisement by Pacira claimed EXPAREL was able to provide pain-relief for up to 72 hours, while the drug is only approved for pain-relief up to 24 hours. The agency said these claims overstate EXPAREL's efficacy and are misleading.
On the news, Pacira stock fell $11.66, or almost 11%, on unusually heavy volume, to close at $94.62 on September 25, 2014.
On November 18, 2015, the Court issued an Order dismissing this case without prejudice. Plaintiffs were given leave to amend.