The legal claim revolves around a drug named EXPAREL, designed to provide post-surgical pain relief with a single dose aimed at the surgical site. The treatment was created for patients at least 18 years old. The drug previously completed Phase III clinical trials for its use as an analgesic.
Class action lawsuit basics
The lawsuit claimed that the company, as well as specific directors and officers, made material omissions and or misstatements about EXPAREL. The law firm filed the suit in an attempt to recover losses suffered by investors who bought company securities between April 9, 2012, and Sept. 24, 2014.
The class action lawsuit made several specific allegations, including that while EXPAREL was only approved for 24-hour pain relief, the company – as well as certain directors and officers – advertised the treatment as being effective for as many as 72 hours. In addition, they allegedly exaggerated how successful EXPAREL was at relieving pain.
The class action suit further claimed the company, officers and directors concealed that off-label marketing was a major contributor to the drug's revenue. Finally, the legal action alleged that even though EXPAREL was not approved for use in colectomy and cholecystectomy, the aforementioned parties asserted the drug was safe and effective for use with these procedures.
FDA Warning Letter
The company announced on Sept. 25, 2014, that it had received a Food and Drug Administration Warning Letter. Dave Stack, president, chief executive officer and chairman of Pacira, responded to the notification.
"We take regulatory compliance very seriously and believe that our current labeling supports the claims being challenged by the FDA," he said in a statement. "We plan to explain our position to the FDA and will provide an update upon resolution of these issues."
The markets also reacted to this key development, as company shares fell more $11.66, or more than 10 percent, to close at $94.62 each on Sept. 25, 2014.
Individuals interested in learning more about the suit can contact The Rosen Law Firm. Those who want to serve as lead plaintiff have until Dec. 2, 2014 to contact the court.