Pardi v. Tricida, Inc.

Background

Lead Plaintiff Jeffrey M. Fiore filed an administrative motion asking the court to seal portions of exhibits attached to his reply supporting his motion for class certification. Renibus Therapeutics, Inc., an interested non-party, supported the motion. The Food and Drug Administration also supported it; the FDA had designated the documents as confidential during discovery.

Legal standard

Because the documents related to class certification, the court applied the “compelling reasons” standard. Under that standard, the party seeking to protect information must provide specific reasons that outweigh the public’s general interest in access to court records. The party that designated the documents as confidential—in this case, the FDA—bore the burden of showing that compelling reasons supported sealing.

Court’s analysis

Renibus stated that the information consisted of nonpublic clinical-trial data, including details about the trials’ structure, execution, results, and analysis. It also included specific FDA guidance about strategies for obtaining approval of veverimer. The FDA said that protecting the information supported its interest in receiving timely and accurate information from regulated entities and furthered its regulatory and public-safety missions.

The court had previously found that similar information contained confidential clinical-trial data whose disclosure could cause competitive harm. After reviewing the proposed redactions, the court found that the request was narrowly tailored and that the limited confidential information satisfied the compelling-reasons standard.

Disposition

The court granted Plaintiff’s motion to seal as to the information identified by Renibus.