Judge: William D. Claster, Case: 30-2019-01121146-CU-PL-CXC, Date: 2022-08-05 Tentative Ruling
Defendants Corcept Therapeutics Inc.'s Notice of Motion and Motion to Maintain Confidentiality and Seal Protected Documents ROA 210
Defendant Corcept Therapeutics Inc.’s unopposed motion to seal is GRANTED. The clerk is ordered to permanently seal ROA 205, the conditionally sealed copy of Exhibit D to the declaration of Vincent J. Moccio in support of Plaintiff Maren S. Miller’s motion for leave to file a fourth amended complaint.
This is a pharmaceutical case largely sounding in Corcept’s purported failure to warn of dangers allegedly associated with Korlym, a name-brand drug it manufactures. Exhibit D to the Moccio Declaration is a compilation of “MedWatch” reports—adverse event reports submitted by Corcept to the FDA as part of Corcept’s mandatory reporting duties. These reports were obtained by Plaintiff in the course of discovery. She relied on them in her motion for leave to file a fourth amended complaint, and the Court granted her motion.
A court may order a record to be filed under seal only if it expressly finds facts establishing:
(Cal. Rules of Court, rule 2.550(d).)
Corcept first argues that the parties have stipulated to a protective order, and under the terms of that order, Exhibit D is designated confidential. But “mere agreement of the parties alone is insufficient to constitute an overriding interest to justify sealing.” (McNair v. National Collegiate Athletic Assn. (2015) 234 Cal.App.4th 25, 36.) Rather, the agreement must be coupled with “a specific showing of serious injury.” (Id., at p. 35.)
As to that specific showing, Corcept contends “significant portions” of Exhibit D are protected from disclosure by federal law, citing 21 C.F.R. §§ 20.2, 20.20(a), 20.60, 20.61, and 20.63. From a review of these regulations, it appears they bind the FDA, not Corcept. For example, § 20.2 is titled “Production of records by Food and Drug Administration employees.” To the extent federal law protects information in Exhibit D from disclosure, it protects that information from disclosure by the FDA. This is not sufficient to overcome the public’s right to access court records.
Corcept also argues the public disclosure of Exhibit D would dissuade patients from participating in monitoring programs for use of Korlym. (Corcept reports alleged adverse events it learns about in these monitoring programs to the FDA.) The Court does not see how disclosure of Exhibit D would affect patient participation, as even the sealed version of Exhibit D redacts patient-identifying information.
Corcept next argues the public disclosure of Exhibit D would harm the FDA’s ability to gather information through the MedWatch process because Corcept and similarly situated companies would have less incentive to trust that the confidentiality of information provided to the FDA will be maintained. The Court does not follow this argument. Corcept states in its papers that its self-reporting duties are mandatory. Does Corcept intend to shirk duties imposed on it by federal law if Exhibit D is disclosed?
Finally, Corcept argues the public disclosure of Exhibit D would put Corcept at a business disadvantage by confusing the public about the safety of Korlym. The argument is not fully explained in Corcept’s moving papers, but its opposition to Plaintiff’s motion for leave to amend provides context. Corcept contends the MedWatch reports are simply event reports, not analyses. They do not reach any conclusions that a particular adverse effect was actually caused by Korlym. The disclosure of Exhibit D could mislead the public into believing that Korlym is in fact unsafe or in fact causes adverse effects not previously disclosed when the reports themselves say no such thing.
So framed, the Court accepts that Corcept has identified an interest that overcomes the public interest in access to the record, that the interest supports sealing the record, that the interest will be prejudiced if the record is not sealed, that the proposed sealing is narrowly tailored, and that no less restrictive means exists to protect the interest.
The Court stresses, however, Corcept’s request to seal Exhibit D comes in the context of a motion for leave to amend the complaint. Should the Court be required to consider the MedWatch reports as a basis for a merits decision in this case, the sealing analysis may not proceed in the same way.