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Case TitleVANDA PHARMACEUTICALS, INC. v. FOOD AND DRUG ADMINISTRATION
DistrictDistrict of Columbia
CityWashington, DC
Case Number1:2022cv00938
Date Filed2022-04-06
Date Closed2023-03-27
JudgeJudge Christopher R. Cooper
PlaintiffVANDA PHARMACEUTICALS, INC.
Case DescriptionVanda Pharmaceutical submitted a FOIA request to the FDA for records concerning the agency's reviews of its new drug application for Hetlioz. The agency acknowledged receipt of the request and told Vanda Pharmaceutical that it would withhold the reviews under Exemption 5 (privileges). Vanda Pharmaceutical filed an administrative an administrative appeal to the Department of Health and Human Services. More than a year later, HHS upheld the FDA's decision. Vanda Pharmaceutical then filed suit.
Complaint issues: Litigation - Attorney's fees

DefendantFOOD AND DRUG ADMINISTRATION
DefendantUNITED STATES FOOD AND DRUG ADMINISTRATION
DefendantWASHINGTON LEGAL FOUNDATION
Documents
Docket
Complaint
Complaint attachment 1
Complaint attachment 2
Complaint attachment 3
Complaint attachment 4
Complaint attachment 5
Complaint attachment 6
Complaint attachment 7
Opinion/Order [25]
User-contributed Documents
 
Docket Events (Hide)
Date FiledDoc #Docket Text

2022-04-061COMPLAINT against FOOD AND DRUG ADMINISTRATION ( Filing fee $ 402 receipt number ADCDC-9153650) filed by VANDA PHARMACEUTICALS, INC.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Civil Cover Sheet, # 7 Summons)(Hughes, Paul) (Entered: 04/06/2022)
2022-04-062LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by VANDA PHARMACEUTICALS, INC. (Hughes, Paul) (Entered: 04/06/2022)
2022-04-07Case Assigned to Judge Christopher R. Cooper. (zsb) (Entered: 04/07/2022)
2022-04-113SUMMONS (1) Issued Electronically as to FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Notice and Consent)(znmw) (Entered: 04/11/2022)
2022-04-124RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the United States Attorney. Date of Service Upon United States Attorney on 4/11/2022. Answer due for ALL FEDERAL DEFENDANTS by 5/11/2022. (Hughes, Paul) (Entered: 04/12/2022)
2022-05-115ANSWER to Complaint by FOOD AND DRUG ADMINISTRATION.(Quinn, Thomas) (Entered: 05/11/2022)
2022-05-116NOTICE of Appearance by Thomas Anthony Quinn on behalf of FOOD AND DRUG ADMINISTRATION (Quinn, Thomas) (Entered: 05/11/2022)
2022-05-12MINUTE ORDER: Before the Court in this FOIA case are a complaint and an answer. It is hereby ORDERED that the parties promptly confer and file a joint proposed schedule for briefing or disclosure by May 27, 2022. Signed by Judge Christopher R. Cooper on 5/12/2022. (lccrc2) (Entered: 05/12/2022)
2022-05-277Joint STATUS REPORT by FOOD AND DRUG ADMINISTRATION. (Quinn, Thomas) (Entered: 05/27/2022)
2022-05-31MINUTE ORDER: In light of 7 the Joint Status Report, the following deadlines shall apply: Defendant's motion for summary judgment is due by 7/1/2022; Plaintiff's combined cross-motion for summary judgment and opposition to Defendant's motion is due by 8/1/2022; Defendant's combined reply and opposition is due by 8/22/2022; Plaintiff's reply is due by 9/12/2022. Signed by Judge Christopher R. Cooper on 5/31/2022. (lccrc2) (Entered: 05/31/2022)
2022-07-018MOTION for Summary Judgment , Memo in Support, Statement of Material Facts, and Proposed Order by FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Declaration Kotler Decl., # 2 Declaration Phillips Decl., # 3 Declaration Farchione Decl.)(Quinn, Thomas) (Entered: 07/01/2022)
2022-07-299Consent MOTION for Extension of Time to file plaintiff's cross motion for summary judgment and response by VANDA PHARMACEUTICALS, INC.. (Attachments: # 1 Text of Proposed Order)(Hughes, Paul) (Entered: 07/29/2022)
2022-08-01MINUTE ORDER granting the plaintiff's 9 Consent Motion for Extension of Time to File Cross-Motion for Summary Judgment. The plaintiff has informed the Court that it plans to move for limited discovery and to hold the current briefing schedule in abeyance. Any motions seeking such relief shall be due by August 15, 2022. The Court hereby extends the deadline for plaintiff's cross-motion and response to 7 days after the Court's order on that discovery motion. So Ordered by Judge Christopher R. Cooper on 8/1/2022. (lccrc2) (Entered: 08/01/2022)
2022-08-0110MOTION for Discovery by VANDA PHARMACEUTICALS, INC.. (Attachments: # 1 Memorandum in Support, # 2 Declaration of Paul W. Hughes, # 3 Declaration of Jonathan Jarow, # 4 Declaration of Daniel Combs, # 5 Exhibit A, # 6 Exhibit B, # 7 Exhibit C, # 8 Exhibit D, # 9 Exhibit E, # 10 Text of Proposed Order)(Hughes, Paul) (Entered: 08/01/2022)
2022-08-1511ENTERED IN ERROR.....Memorandum in opposition to re 10 Motion for Discovery, filed by FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order)(Quinn, Thomas) Modified on 8/16/2022, corrected entry refiled as 12 (zjm). (Entered: 08/15/2022)
2022-08-1512Memorandum in opposition to re 10 Motion for Discovery, CORRECTED filed by FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order)(Quinn, Thomas) (Entered: 08/15/2022)
2022-08-2213REPLY to opposition to motion re 10 MOTION for Discovery filed by VANDA PHARMACEUTICALS, INC.. (Hughes, Paul) (Entered: 08/22/2022)
2022-10-2714ORDER denying Plaintiff's 10 Motion for Discovery. See the full order for details. Further, as stated in the Court's August 1, 2022 Minute Order, Plaintiff shall file its Cross-Motion for Summary Judgment and Response to Defendant's Motion for Summary Judgment by November 3, 2022. Signed by Judge Christopher R. Cooper on 10/27/2022. (lccrc2) (Entered: 10/27/2022)
2022-11-0315NOTICE of Appearance by Andrew A. Lyons-Berg on behalf of VANDA PHARMACEUTICALS, INC. (Lyons-Berg, Andrew) (Entered: 11/03/2022)
2022-11-0316MOTION for Summary Judgment by VANDA PHARMACEUTICALS, INC.. (Attachments: # 1 Memorandum in Support, # 2 Declaration of Paul W. Hughes, # 3 Exhibit Index, # 4 Exhibit 1, # 5 Exhibit 2, # 6 Exhibit 3, # 7 Exhibit 4, # 8 Exhibit 5, # 9 Exhibit 6, # 10 Exhibit 7, # 11 Exhibit 8, # 12 Exhibit 9, # 13 Exhibit 10, # 14 Exhibit 11, # 15 Exhibit 12, # 16 Exhibit 13, # 17 Exhibit 14, # 18 Exhibit 15, # 19 Exhibit 16, # 20 Exhibit 17, # 21 Exhibit 18, # 22 Exhibit 19, # 23 Exhibit 20, # 24 Exhibit 21, # 25 Text of Proposed Order)(Lyons-Berg, Andrew) (Entered: 11/03/2022)
2022-11-04NOTICE OF ERROR re 16 Motion for Summary Judgment; emailed to alyonsberg@mwe.com, cc'd 9 associated attorneys -- The PDF file you docketed contained errors: 1. Please note the following for future filings; do not refile document , 2. • DO NOT REFILE. Counsel is reminded that log in and password should match signature page. (zjm, ) (Entered: 11/04/2022)
2022-11-0417MOTION for Leave to File Amicus Brief by Washington Legal Foundation. (Attachments: # 1 Text of Proposed Order, # 2 Exhibit Proposed Amicus Brief)(Masslon, John) (Entered: 11/04/2022)
2022-11-07MINUTE ORDER granting 17 Motion for Leave to File. Signed by Judge Christopher R. Cooper on 11/7/2022. (lccrc2) (Entered: 11/07/2022)
2022-11-0718AMICUS BRIEF by WASHINGTON LEGAL FOUNDATION. (zjm) (Entered: 11/15/2022)
2022-11-2219Unopposed MOTION for Extension of Time to TO FILE COMBINED REPLY AND OPPOSITION AND TO MODIFY REMAINDER OF BRIEFING SCHEDULE by FOOD AND DRUG ADMINISTRATION. (Quinn, Thomas) (Entered: 11/22/2022)
2022-11-2220Unopposed MOTION for Extension of Time, MOTION to Modify BRIEIFING SCHEDULE by FOOD AND DRUG ADMINISTRATION. (Quinn, Thomas). Added MOTION for Extension of Time to on 11/22/2022 (zed). (Entered: 11/22/2022)
2022-11-28MINUTE ORDER granting 20 Motion for Extension of Time to File Combined Reply and Opposition and to Modify Briefing Schedule. Defendant shall file its combined reply and opposition by December 21, 2022 and Plaintiff shall file its reply by January 31, 2023. Absent extraordinary circumstances, the Court will not look favorably on future requests for extension. Signed by Judge Christopher R. Cooper on 11/28/2022. (lccrc2) (Entered: 11/28/2022)
2022-12-2121Memorandum in opposition to re 16 Motion for Summary Judgment,, filed by FOOD AND DRUG ADMINISTRATION. (Quinn, Thomas) (Entered: 12/21/2022)
2022-12-2122REPLY to opposition to motion re 8 MOTION for Summary Judgment , Memo in Support, Statement of Material Facts, and Proposed Order filed by FOOD AND DRUG ADMINISTRATION. (Quinn, Thomas) (Entered: 12/21/2022)
2023-01-3123REPLY to opposition to motion re 16 MOTION for Summary Judgment filed by VANDA PHARMACEUTICALS, INC.. (Hughes, Paul) (Entered: 01/31/2023)
2023-03-2724ORDER denying Defendant's 8 Motion for Summary Judgment and granting Plaintiff's 16 Motion for Summary Judgment. See full Order and accompanying Memorandum Opinion for details. Signed by Judge Christopher R. Cooper on 3/27/2023. (lccrc2) (Entered: 03/27/2023)
2023-03-2725MEMORANDUM AND OPINION re 24 ORDER denying Defendant's 8 Motion for Summary Judgment and granting Plaintiff's 16 Motion for Summary Judgment. Signed by Judge Christopher R. Cooper on 3/27/2023. (lccrc2) (Entered: 03/27/2023)
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