EXPAREL was approved in 2011 for administration into the surgical site to produce postsurgical analgesia.
The complaint outlines the Company’s belief that the 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. Additionally, the lawsuit alleges that the FDA violated the First Amendment rights of Pacira and the co-plaintiffs by restricting the exchange of truthful and non-misleading speech.
Pacira president, CEO, and chairman Dave Stack said: "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 the 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."
Background on the Complaint
In September 2014, the FDA issued Pacira a Warning Letter related to certain promotional materials. At FDA’s insistence, Pacira took certain actions to address the immediate FDA concerns and minimize further disruption to its business, but at the same time presented the Agency with evidence in defense of its marketing practices and requested multiple follow-up discussions.
Over the last year, Pacira repeatedly sought a dialogue with the FDA to address points of misunderstanding and disagreement, and repeatedly was denied. Six weeks ago, while continuing to deny the Company’s requests for a meeting, and declining to offer further insight into its interpretation of the EXPAREL label, the Agency issued a close-out letter, indicating that it regarded the matter of the Warning Letter to be closed.
Pacira brings three counts in its complaint:
1. The unilateral attempt by the FDA to narrow the approved broad indication for EXPAREL without observing the procedure required by law for modifying a drug’s label violates The Administrative Procedure Act (APA).
2. The FDA regulations as applied to Pacira are vague, deprive the company of fair notice of what is prohibited, and operate as a retroactive, ex post facto penalty, all in violation of the Due Process Clause of the Fifth Amendment.
3. FDA’s actions attempting to forbid Pacira from sharing truthful and non-misleading information regarding both the efficacy and the administration of EXPAREL violate the Company’s First Amendment right to engage in truthful and non-misleading speech.
Pacira seeks declaratory relief as well as a preliminary and/or permanent injunction preventing the FDA and other defendants from taking any action to violate the Company’s aforementioned rights. The Company’s motion for an injunction, which will be filed subsequent to the complaint, will be supported by several key declarants, including Larry Goldkind, MD, a former Deputy Director of the Division of Anti-inflammatory, Analgesic and Ophthalmic Drug Products in the FDA’s Center for Drug Evaluation and Research (CDER), and Dr. Lee-Jen Wei, Professor of Biostatistics at the Harvard T.H. Chan School of Public Health.
Pacira and the individual physician plaintiffs are represented in this lawsuit by Ropes & Gray LLP. Pacira is also represented by Latham & Watkins LLP and Lowenstein Sandler LLP.