Pacira Pharmaceuticals seeks court injunction to defend its rights to share information about Exparel consistent with its FDA-approved indication

Pacira Pharmaceuticals has filed a lawsuit against FDA seeking to exercise its lawful rights to communicate truthful and non-misleading information about its flagship product, Exparel (bupivacaine liposome injectable suspension). Exparel was approved in 2011 for administration into the surgical site to produce postsurgical analgesia.

The complaint outlines the company’s belief that FDA has violated the Administrative Procedure Act (APA), Fifth Amendment, and its own guidance materials and precedent by threatening enforcement action for promoting Exparel consistent with its approved indication. In addition, the lawsuit alleges that FDA violated the First Amendment rights of Pacira and the co-plaintiffs by restricting the exchange of truthful and non-misleading speech.

Dave Stack, president, CEO, and chairman of Pacira, remarked: “Exparel is an effective alternative to opioid-based postsurgical pain management, which is critically important to patient care as our nation battles an opioid addiction epidemic. In filing this lawsuit, we aim to restore our lawful right to communicate truthful and non-misleading information about Exparel consistent with the broad indication, for administration into the surgical site for postsurgical analgesia, granted by FDA in 2011. It is unfortunate that the Agency’s unwillingness to respond to repeated requests for discussion around these issues have left us with no choice but to take legal action.”