Homyk v. ChemoCentryx, Inc.

Background

Lead plaintiff Indiana Public Retirement System asked the court to authorize disclosure to the U.S. Food and Drug Administration of deposition exhibits and testimony designated confidential by defendants ChemoCentryx, Inc. and Thomas J. Schall under the case’s stipulated protective order. The requested material included the first 49 deposition exhibits and testimony from Dr. Richard Glassock, a member of a Data Monitoring Committee connected to the FDA’s review of ChemoCentryx’s application for avacopan, and Dr. Willis Maddrey, a liver expert retained by ChemoCentryx who analyzed data from the related Phase III clinical trial.

The plaintiff sought the material to support a request for FDA testimony by affidavit or sworn declaration. The FDA had rejected the plaintiff’s request for deposition testimony under its regulations, finding that the plaintiff had not adequately explained why the testimony was in the public interest and noting that the information appeared available from other sources. The FDA nevertheless stated that, if authorized and agreed upon, it might provide testimony by affidavit or sworn declaration.

Legal standard

The court explained that Federal Rule of Civil Procedure 26(c) permits protective orders, for good cause, to protect parties from undue burdens and to restrict disclosure or discovery. The court stated that a protective order should be read reasonably and in a common-sense manner, with its limits connected to its purpose. Because the parties’ dispute concerned the meaning of their protective order, the court analyzed whether the requested disclosure fit within that order’s specified exceptions.

Analysis

The plaintiff relied principally on Paragraph 7.2(f), which permits disclosure during depositions to witnesses in the action when disclosure is reasonably necessary and the witness has signed an agreement to follow the protective order, unless the designating party agrees or the court orders otherwise. The court concluded that providing confidential material to third-party FDA witnesses for written testimony was not analogous to disclosure during a deposition. Disclosure outside a deposition would deny defendants the opportunity to monitor the documents’ use and cross-examine the witness about them. The provision’s separate reference to “transcribed” deposition testimony also indicated that the parties had not created an exception broad enough to cover written testimony.

The court further held that, even if Paragraph 7.2(f) could apply to written testimony, the plaintiff had not shown that disclosure was reasonably necessary. The plaintiff did not explain what the confidential exhibits and testimony would add beyond publicly released FDA materials concerning the clinical trial and the FDA’s review, or beyond DMC meeting minutes to which the FDA had access. The court also found that the FDA’s possible interest in reviewing the material did not control whether the court should order disclosure over defendants’ objections. The record did not show that the FDA had committed to providing written testimony, creating a possibility that confidential information would be shared with a nonparty that never testified.

The court rejected the plaintiff’s reliance on Paragraph 7.2(g), which permits disclosure to an author or recipient of a document, or to a custodian or other person who otherwise possessed or knew the information. The fact that the FDA may have received underlying clinical-trial data did not establish that FDA employees possessed or knew the internal communications and opinions about that data contained in the confidential materials.

The court rejected defendants’ arguments that the potential FDA testimony was inadmissible or irrelevant. Relevant information does not need to be admissible to be discoverable. The court emphasized, however, that the narrower question before it was whether to authorize disclosure of the confidential deposition material, and the plaintiff had not shown that the proposed disclosure was consistent with the protective order.

Disposition

The court denied the lead plaintiff’s request for a court order allowing it to share with the FDA any material designated confidential by defendants under the protective order. The order did not decide whether the plaintiff needed FDA testimony or whether defendants’ objections would support quashing the FDA subpoena. The order was signed by Lisa Cisneros, United States Magistrate Judge.