Vanda Pharm., Inc. v. Food & Drug Admin.

539 F.Supp.3d 44

VANDA PHARMACEUTICALS, INC., et al., Plaintiffs,

v.FOOD & DRUG ADMINISTRATION, et al., Defendants.

Civil Action No. 19-301 (JDB)

United States District Court, District of Columbia.

Signed May 6, 2021

Andrew A. Lyons-Berg, Michael Branch Kimberly, Paul Whitfield Hughes, III, McDermott Will & Emery LLP, Washington, DC, for Plaintiff Vanda Pharmaceuticals, Inc.

Andrew A. Lyons-Berg, Paul Whitfield Hughes, III, McDermott Will & Emery LLP, Washington, DC, for Plaintiffs December Guzman, Cathy Hartwig, Louisa Jenness.

James William Harlow, David Michael Morrell, U.S. Department of Justice, Washington, DC, for Defendants.

MEMORANDUM OPINION

JOHN D. BATES, United States District Judge

The underlying dispute in this case involved plaintiff Vanda Pharmaceuticals, Inc.’s ("Vanda") challenge under the Administrative Procedure Act ("APA") to the Food and Drug Administration's ("FDA") partial clinical hold on Vanda's human testing of the as-yet unapproved digestive drug tradipitant. In that litigation, as is required in any action brought under the APA, the FDA filed an index to the administrative record, and the parties filed a joint appendix containing copies of the record documents they cited to or relied upon in their briefing. One volume of the joint appendix was filed under seal with this Court's permission. The underlying litigation between Vanda and FDA concluded when this Court granted FDA's cross-motion for summary judgment over a year ago, but now non-party law firm Robbins Geller Rudman & Dowd LLP ("RGRD") has moved to intervene for the limited purpose of unsealing much of the administrative record. Both Vanda and FDA oppose unsealing the records, and Vanda also opposes intervention. For the following reasons, the Court will permit RGRD to intervene and will partially grant its motion to unseal, while also allowing Vanda to redact or withhold its proprietary information to avoid any competitive harm from disclosure.

Background

The factual background underlying the dispute between Vanda and FDA is laid out in full in this Court's January 2020 decision granting FDA's cross-motion for summary judgment, see Vanda Pharms., Inc. v. FDA, 436 F. Supp. 3d 256, 262–63 (D.D.C. 2020), but some recapitulation is appropriate to provide relevant context here. In September 2016, Vanda submitted an Investigational New Drug Application ("IND") to FDA to begin clinical trials on tradipitant—an experimental drug that has not yet been approved by FDA—for the treatment of the digestive disorder gastroparesis. Id. at 262. After conducting a six-month animal toxicity study of the drug on rats and a three-month study on dogs, Vanda filed an IND to conduct a four-week clinical trial on human subjects, which FDA granted. Id. In 2018, Vanda proposed extending its four-week trial by twelve months, but FDA denied that request because the drug had not undergone the requisite nine-month nonrodent toxicity study to prove to FDA that the drug was safe for long-term human experimentation. Id. Vanda continued pressing for approval to extend its human trial, but FDA refused to authorize any human testing in excess of three months and ultimately placed a partial clinical hold on Vanda's proposed twelve-month trial. Id. at 263.

Vanda filed suit under the APA in February 2019, alleging that FDA's decision to halt Vanda's trial lacked "an adequate scientific basis" and impermissibly applied "non-binding ... guidance as a binding regulation." Id. Pursuant to Local Civil Rule 7(n), which governs the submission of the administrative record in APA cases filed in this District, FDA filed an index listing all of "the contents of the administrative record" it relied upon in reaching its partial clinical hold decision. See Local Civ. R. 7(n) ; Admin. R. Certified Index [ECF No. 38]. After summary judgment briefing concluded, and again in compliance with Local Civil Rule 7(n), the parties jointly filed a two-volume appendix "containing copies of those portions of the administrative record that [they] cited or otherwise relied upon" in their briefs. See Local Civ. R. 7(n). Vanda submitted a motion to file Volume One of the appendix—"contain[ing] extremely sensitive proprietary information about tradipitant's development and therapeutic characteristics"—under seal, see Pls.’ Sealed Mot. for Leave to File Vol. 1 of the Admin. R. App. Under Seal [ECF No. 42], which the Court granted, see Min. Order (Oct. 16, 2019). Volume Two was filed on the public docket. See Admin. R. App. [ECF No. 43]. The Court held a hearing on the parties’ cross-motions for summary judgment and ruled in favor of FDA in January 2020. See Vanda, 436 F. Supp. 3d at 262–64. Vanda did not timely appeal, and the case was closed.

Meanwhile, RGRD represents a putative class of Vanda shareholders in a securities-fraud action in the Eastern District of New York. See Gordon v. Vanda Pharms. Inc., Case No. 1:19-cv-01108-FB-LB, 2021 WL 911755 (E.D.N.Y. Mar. 10, 2021). Vanda's motion to dismiss that case was recently denied in relevant part, advancing the litigation to discovery. See id. at *4. As part of its representation in that case, RGRD filed a Freedom of Information Act ("FOIA") request with FDA in July 2019 for fifteen documents that formed part of the sealed Volume One of the joint appendix in this case. See Mem. of Law in Supp. of Mot. for Leave to Intervene & Unseal Jud. Records ("RGRD's Mot.") [ECF No. 51-1] at 5. Some sixteen months later, FDA issued a response refusing to release any of the requested documents, stating it "lacks authority to consider the releasability" of any records sealed under this Court's Order. Id. Ex. 4, RGRD's Mot. [ECF No. 51-6] at 2.¹

RGRD then filed the present motion to intervene in this case to unseal fifty-nine documents from the administrative record "for the benefit of the public interest." RGRD's Mot. at 1. The set of "Challenged Documents" in dispute has since evolved over the course of briefing on the motion. First, FDA and Vanda pointed out that twenty-seven of the fifty-nine documents RGRD initially sought to unseal were "listed on the corrected certified index of the administrative record but not contained in the joint appendix submitted to the Court," and are therefore not "judicial records" subject to unsealing. See Defs.’ Opp'n to RGRD's Mot. to Unseal Jud. Records ("Defs.’ Opp'n") [ECF No. 57] at 5 & n.2, 7–8; Vanda's Opp'n to RGRD's Mot. for Leave to Intervene & Unseal Docs. ("Vanda's Opp'n") [ECF No. 58] at 11–12.² Upon becoming aware of that fact, in its reply brief RGRD withdrew its motion as to any document "not included in the joint appendix." Reply Mem. of Law in Further Supp. of Mot. for Leave to Intervene & Unseal Jud. Records ("Reply") [ECF No. 60] at 15.

In the same reply brief, RGRD also sought to add one more document to the thirty-two remaining Challenged Documents—namely, the FDA's "Remand Response," which appears in the sealed volume of the joint appendix as Item 82. Id. at 24. Even though FDA and Vanda did not have an opportunity specifically to oppose unsealing the Remand Response, they conceded that the thirty-three Challenged Documents listed in RGRD's initial motion that are included in the joint appendix are judicial records, and the same logic applies to the Remand Response. See Defs.’ Opp'n at 7; Vanda's Opp'n at 12. The Court will thus consider the Remand Response among the Challenged Documents in dispute—bringing the total number to thirty-three—for the sake of judicial efficiency in avoiding further litigation over this single document.³

Both Vanda and FDA oppose RGRD's motion. Vanda asks this Court to reject RGRD's request at the gate and deny the motion to intervene as untimely. Vanda's Opp'n at 1. FDA, for its part, "take[s] no position on RGRD's motion to intervene." Defs.’ Opp'n at 1. But both FDA and Vanda assert that the balance of interests weighs against unsealing and, in the alternative, that the Court should permit Vanda to review and redact any documents the Court decides to unseal. See Vanda's Opp'n at 23; Defs.’ Opp'n at 12. RGRD agrees that Vanda should have the opportunity to redact confidential information prior to unsealing. See Reply at 16. RGRD's motion has now been fully briefed and is ripe for decision. For the following reasons, the Court will grant RGRD's motion to intervene and will grant its motion to unseal with respect to certain documents. Given Vanda's commercial interest in the Challenged Documents, however, and with the apparent consent of RGRD, the Court will permit Vanda to review and redact all documents prior to their unsealing.

RGRD's Motion to Intervene

Before proceeding to the merits of RGRD's motion to unseal, the Court will address the dispute over whether RGRD should be permitted to intervene in this matter. Federal Rule of Civil Procedure 24(b) provides that a district "court may permit anyone to intervene who ... has a claim or defense that shares with the main action a common question of law or fact." Fed. R. Civ. P. 24(b)(1)(B). However, the D.C. Circuit has "eschewed strict readings of the phrase ‘claim or defense’ " and embraced "a flexible reading of Rule 24(b)" when the proposed third-party intervention does not fit the mold of a non-litigant seeking to stake a claim in an ongoing civil action. See EEOC v. Nat'l Children's Ctr., Inc., 146 F.3d 1042, 1046 (D.C. Cir. 1998) (citing Nuesse v. Camp, 385 F.2d 694, 704 (D.C. Cir. 1967) ). Specifically, "third parties may be allowed to permissively intervene under Rule 24(b) for the limited purpose of seeking access to materials that have been shielded from public view ... by seal." Id. The only statutory requirement for the court's exercise of discretion over a motion to permissively intervene is that "the court must consider whether the intervention will unduly delay or prejudice the adjudication of the original parties’ rights." Fed. R. Civ. P. 24(b)(3).

Where intervention is sought only for a collateral...