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Case TitleVANDA PHARMACEUTICALS, INC. v. FOOD AND DRUG ADMINISTRATION
DistrictDistrict of Columbia
CityWashington, DC
Case Number1:2022cv03807
Date Filed2022-12-22
Date ClosedOpen
JudgeChief Judge James E. Boasberg
PlaintiffVANDA PHARMACEUTICALS, INC.
Case DescriptionVanda Pharmaceuticals submitted a FOIA request to the FDA for records concerning the drug tasimelteon and the manufacture or production of tasimelteon. The agency acknowledged receipt of the request but after hearing nothing further from the agency, Vanda Pharmaceuticals fields suit.
Complaint issues: Failure to respond within statutory time limit, Adequacy - Search, Litigation - Attorney's fees

DefendantFOOD AND DRUG ADMINISTRATION
DefendantUNITED STATES FOOD AND DRUG ADMINISTRATION
Documents
Docket
Complaint
Complaint attachment 1
Complaint attachment 2
Complaint attachment 3
Complaint attachment 4
Complaint attachment 5
Complaint attachment 6
User-contributed Documents
 
Docket Events (Hide)
Date FiledDoc #Docket Text

2022-12-221COMPLAINT against FOOD AND DRUG ADMINISTRATION ( Filing fee $ 402 receipt number ADCDC-9751709) filed by VANDA PHARMACEUTICALS, INC.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Civil Cover Sheet, # 4 Summons, # 5 Summons, # 6 Summons)(Hughes, Paul) (Entered: 12/22/2022)
2022-12-232LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by VANDA PHARMACEUTICALS, INC. (Hughes, Paul) (Entered: 12/23/2022)
2022-12-27Case Assigned to Judge James E. Boasberg. (zljn) (Entered: 12/27/2022)
2022-12-273SUMMONS (3) Issued Electronically as to FOOD AND DRUG ADMINISTRATION, U.S. Attorney and U.S. Attorney General (Attachments: # 1 Notice and Consent)(zljn) (Entered: 12/27/2022)
2023-01-044RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the United States Attorney. Date of Service Upon United States Attorney on 12/30/2022. Answer due for ALL FEDERAL DEFENDANTS by 1/29/2023. (Hughes, Paul) (Entered: 01/04/2023)
2023-01-245NOTICE of Appearance by Bradley Silverman on behalf of FOOD AND DRUG ADMINISTRATION (Silverman, Bradley) (Entered: 01/24/2023)
2023-01-306ANSWER to Complaint by FOOD AND DRUG ADMINISTRATION.(Silverman, Bradley) (Entered: 01/30/2023)
2023-01-31MINUTE ORDER: The Court ORDERS that the parties shall confer and propose a joint briefing schedule by February 14, 2023. So ORDERED by Judge James E. Boasberg on 1/31/2023. (lcjeb2) (Entered: 01/31/2023)
2023-01-31Set/Reset Deadlines: Joint Proposed Briefing Schedule due by 2/14/2023. (nbn) (Entered: 01/31/2023)
2023-02-147Joint STATUS REPORT by FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) (Entered: 02/14/2023)
2023-02-14MINUTE ORDER: The Court ADOPTS the parties' 7 Joint Status Report and ORDERS that they shall file a further joint status report by February 28, 2023. So ORDERED by Judge James E. Boasberg on 2/14/2023. (lcjeb2) (Entered: 02/14/2023)
2023-02-14Set/Reset Deadlines: Joint Status Report due by 2/28/2023. (nbn) (Entered: 02/15/2023)
2023-02-288Joint STATUS REPORT by FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) (Entered: 02/28/2023)
2023-03-01MINUTE ORDER: The Court ADOPTS the parties' 8 Joint Status Report and ORDERS that they shall file a further joint status report by March 14, 2023. So ORDERED by Judge James E. Boasberg on 3/1/2023. (lcjeb2) (Entered: 03/01/2023)
2023-03-01Set/Reset Deadlines: Joint Status Report due by 3/14/2023. (nbn) (Entered: 03/01/2023)
2023-03-149Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) (Entered: 03/14/2023)
2023-03-15MINUTE ORDER: The Court ADOPTS the parties' 9 Joint Status Report and ORDERS that they shall file a further joint status report by July 3, 2023. So ORDERED by Judge James E. Boasberg on 3/15/2023. (lcjeb2) (Entered: 03/15/2023)
2023-03-15Set/Reset Deadlines: Joint Status Report due by 7/3/2023. (nbn) (Entered: 03/17/2023)
2023-03-1610MOTION to Vacate Order by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Ex, A, # 2 Ex. B)(Silverman, Bradley) (Entered: 03/16/2023)
2023-03-2011RESPONSE re 10 MOTION to Vacate Order filed by VANDA PHARMACEUTICALS, INC.. (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4, # 5 Exhibit 5)(Hughes, Paul) (Entered: 03/20/2023)
2023-03-28MINUTE ORDER: The Court ORDERS that the parties shall confer to see if they can reach a further agreement on a processing schedule. They shall then submit a further Joint Status Report by April 4, 2023. In the event that agreement is not reached, the Court will resolve the pending Motion to Vacate. So ORDERED by Chief Judge James E. Boasberg on 3/28/23. (lcjeb4) (Entered: 03/28/2023)
2023-03-28Set/Reset Deadlines: Joint Status Report due by 4/4/2023. (nbn) (Entered: 03/28/2023)
2023-03-2912Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) (Entered: 03/29/2023)
2023-03-29MINUTE ORDER: The Court ORDERS that: 1) The parties' 12 JSR is ADOPTED; 2) The 10 Motion to Vacate is DENIED; and 3)The parties shall submit a further JSR by July 3, 2023. So ORDERED by Chief Judge James E. Boasberg on 3/29/23. (lcjeb4) (Entered: 03/29/2023)
2023-03-29Set/Reset Deadlines: Joint Status Report due by 7/3/2023. (nbn) (Entered: 03/29/2023)
2023-07-0313Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) (Entered: 07/03/2023)
2023-07-05MINUTE ORDER: Having reviewed the parties' 15 Joint Status Report, the Court ORDERS that they shall file their next one on August 3, 2023. So ORDERED by Chief Judge James E. Boasberg on 7/5/2023. (lcjeb4) (Entered: 07/05/2023)
2023-07-05MINUTE ORDER: Per the parties' 13 Joint Status Report, the Court ORDERS that Plaintiff shall file any motion to compel by July 26, 2023. So ORDERED by Chief Judge James E. Boasberg on 7/5/2023. (lcjeb4) (Entered: 07/05/2023)
2023-07-05Set/Reset Deadlines: Joint Status Report due by 8/3/2023. (znbn) (Entered: 07/07/2023)
2023-07-05Set/Reset Deadlines: Motion to Compel due by 7/26/2023. (znbn) (Entered: 07/07/2023)
2023-07-2614Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) (Entered: 07/26/2023)
2023-07-27MINUTE ORDER: The Court ADOPTS the parties' 14 Joint Status Report and ORDERS that they shall file a further joint status report by September 26, 2023. So ORDERED by Chief Judge James E. Boasberg on 7/27/2023. (lcjeb4) (Entered: 07/27/2023)
2023-07-28Set/Reset Deadlines: Joint Status Report due by 9/26/2023 (lsj) (Entered: 07/28/2023)
2023-09-2615Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) (Entered: 09/26/2023)
2023-09-26MINUTE ORDER: The Court ADOPTS the parties' 15 Joint Status Report and ORDERS that they shall file a further joint status report by November 27, 2023. So ORDERED by Chief Judge James E. Boasberg on 9/26/2023. (lcjeb4) (Entered: 09/26/2023)
2023-09-26Set/Reset Deadlines: Status Report due by 11/27/2023. (nbn) (Entered: 09/26/2023)
2023-10-1916NOTICE of Appearance by Charles H. Seidell on behalf of VANDA PHARMACEUTICALS, INC. (Seidell, Charles) (Entered: 10/19/2023)
2023-11-2717Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) (Entered: 11/27/2023)
2023-11-28MINUTE ORDER: The Court ADOPTS the parties' 17 Joint Status Report and ORDERS that they shall file a further joint status report by January 29, 2024. So ORDERED by Chief Judge James E. Boasberg on 11/28/2023. (lcjeb4) (Entered: 11/28/2023)
2023-11-28Set/Reset Deadlines: Joint Status Report due by 1/29/2024. (znbn) (Entered: 11/28/2023)
2024-01-2918Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) (Entered: 01/29/2024)
2024-01-29MINUTE ORDER: The Court ADOPTS the parties' 18 Joint Status Report and ORDERS that they shall file a further joint status report by March 29, 2024. So ORDERED by Chief Judge James E. Boasberg on 1/29/2024. (lcjeb4) (Entered: 01/29/2024)
2024-01-29Set/Reset Deadlines: Joint Status Report due by 3/29/2024. (znbn) (Entered: 01/29/2024)
2024-03-2919Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) (Entered: 03/29/2024)
2024-04-01MINUTE ORDER: The Court ADOPTS the parties' 19 Joint Status Report and ORDERS that they shall file a further joint status report by May 28, 2024. So ORDERED by Chief Judge James E. Boasberg on 4/1/2024. (lcjeb4) (Entered: 04/01/2024)
2024-04-01Set/Reset Deadlines: Joint Status Report due by 5/28/2024. (znbn) (Entered: 04/01/2024)
2024-05-2820Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) (Entered: 05/28/2024)
2024-05-28MINUTE ORDER: The Court ADOPTS the parties' 20 Joint Status Report and ORDERS that they shall file a further joint status report by August 28, 2024. So ORDERED by Chief Judge James E. Boasberg on 5/28/2024. (lcjeb4) (Entered: 05/28/2024)
2024-05-28Set/Reset Deadlines: Joint Status Report due by 8/28/2024. (znbn) (Entered: 05/28/2024)
2024-08-2821Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) (Entered: 08/28/2024)
2024-08-29MINUTE ORDER: The Court ADOPTS the parties' 21 Joint Status Report and ORDERS that they shall file a further joint status report by October 28, 2024. So ORDERED by Chief Judge James E. Boasberg on 08/29/2024. (lcjeb2) (Entered: 08/29/2024)
2024-08-29Set/Reset Deadlines: Joint Status Report due by 10/28/2024. (znbn) (Entered: 08/29/2024)
2024-10-1422MOTION to Consolidate Cases by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Philips Declaration, # 2 Ex. 1, # 3 Ex. 2, # 4 Ex. 3, # 5 Ex. 4, # 6 Ex. 5, # 7 Text of Proposed Order)(Silverman, Bradley). Added MOTION to Stay on 10/15/2024 (znmw). (Entered: 10/14/2024)
2024-10-2223Consent MOTION for Extension of Time to File Response/Reply as to 22 MOTION to Consolidate Cases MOTION to Stay by VANDA PHARMACEUTICALS, INC.. (Attachments: # 1 Text of Proposed Order)(Hughes, Paul) (Entered: 10/22/2024)
2024-10-23MINUTE ORDER: The Court ORDERS that: 1) The Consent 23 Motion for Extension of Time is GRANTED; and 2) Plaintiff shall file its Response by November 8, 2024. So ORDERED by Chief Judge James E. Boasberg on October 23, 2024. (lcjeb4) (Entered: 10/23/2024)
2024-10-23Set/Reset Deadlines: Joint Status Report due by 11/8/2024. (znbn) (Entered: 10/24/2024)
2024-10-2824Joint STATUS REPORT by VANDA PHARMACEUTICALS, INC.. (Hughes, Paul) (Entered: 10/28/2024)
2024-10-29MINUTE ORDER: The Court ADOPTS the parties' 24 Joint Status Report and ORDERS that they shall file a further joint status report by January 21, 2025. So ORDERED by Chief Judge James E. Boasberg on 10/29/2024. (lcjeb4) (Entered: 10/29/2024)
2024-10-29Set/Reset Deadlines: Joint Status Report due by 1/21/2025. (znbn) (Entered: 10/29/2024)
2024-11-0825Memorandum in opposition to re 22 Motion to Consolidate Cases,, Motion to Stay, filed by VANDA PHARMACEUTICALS, INC.. (Attachments: # 1 Text of Proposed Order)(Hughes, Paul) (Entered: 11/08/2024)
2024-11-1226ENTERED IN ERROR.....Consent MOTION for Extension of Time to Reply by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) Modified on 11/13/2024 pursuant to docket entry 27 (znmw). (Entered: 11/12/2024)
2024-11-1227ERRATA by UNITED STATES FOOD AND DRUG ADMINISTRATION re 26 Motion for Extension of Time to. (Silverman, Bradley) (Entered: 11/12/2024)
2024-11-1328Consent MOTION for Extension of Time to File Reply by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) (Entered: 11/13/2024)
2024-11-13MINUTE ORDER: The Court ORDERS that: 1) The Consent 28 Motion for Extension of Time is GRANTED; and 2) Defendant shall file its reply by November 22, 2024. So ORDERED by Chief Judge James E. Boasberg on 11/13/2024. (lcjeb4) (Entered: 11/13/2024)
2024-11-2229REPLY to opposition to motion re 22 Motion to Consolidate Cases,, Motion to Stay, filed by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Supp. Philips Decl., # 2 FOIA Request)(Silverman, Bradley) (Entered: 11/22/2024)
2024-11-29MINUTE ORDER: The Court ORDERS that the parties in these cases shall appear for a zoom hearing on the pending Motions to Consolidate on December 5, 2024, at 3:00 p.m. So ORDERED by Chief Judge James E. Boasberg on 11/29/2024. (lcjeb4) (Entered: 11/29/2024)
2024-12-05Minute Entry for proceedings held before Chief Judge James E. Boasberg: Motion Hearing held via Zoom on 12/5/2024 re (22 in 1:22-cv-03807-JEB, 22 in 1:22-cv-03807-JEB) MOTION to Consolidate Cases MOTION to Stay filed by UNITED STATES FOOD AND DRUG ADMINISTRATION, (11 in 1:24-cv-02204-JEB, 11 in 1:24-cv-02204-JEB) MOTION to Consolidate Cases or in the Alternative, Motion to Stay MOTION to Stay filed by FOOD AND DRUG ADMINISTRATION, (11 in 1:24-cv-02205-JEB, 11 in 1:24-cv-02205-JEB) MOTION to Consolidate Cases or in the Alternative MOTION to Stay filed by FOOD AND DRUG ADMINISTRATION, (13 in 1:24-cv-02203-JEB, 13 in 1:24-cv-02203-JEB) MOTION to Consolidate Cases or in the Alternative MOTION to Stay filed by FOOD AND DRUG ADMINISTRATION, (25 in 1:22-cv-03808-JEB, 25 in 1:22-cv-03808-JEB) MOTION to Consolidate Cases MOTION to Stay filed by UNITED STATES FOOD AND DRUG ADMINISTRATION, (12 in 1:24-cv-02202-JEB, 12 in 1:24-cv-02202-JEB) MOTION to Consolidate Cases or in the Alternative MOTION to Stay filed by FOOD AND DRUG ADMINISTRATION. Oral discussions heard, Minute Order forthcoming. (Court Reporter Tammy Nestor) (znbn) (Entered: 12/05/2024)
2024-12-05MINUTE ORDER: As discussed in today's hearing, the Court ORDERS that: 1) Defendant's 22 Motion to Consolidate is GRANTED; 2) Case Nos. 22-3808, 24-2204, and 24-2205 are CONSOLIDATED with Case No. 22-3807. All filings shall be made in No. 22-3807, and the Clerk shall administratively close Nos. 22-3808, 24-2204, and 24-2205; 3) Defendant shall process a total of 700 pages per month in these consolidated cases; and 4) The parties shall submit a Joint Status Report by January 31, 2025, and every 60 days thereafter until further Order of the Court. So ORDERED by Chief Judge James E. Boasberg on December 5, 2024. (lcjeb4) (Entered: 12/05/2024)
2024-12-05Cases Consolidated. This case has been consolidated with case 22cv3413 JEB pursuant to 12/5/2024 Minute Order on Motion to Consolidate Cases. From this date forward, all pleadings shall be filed ONLY in the lead case, 22cv3413 JEB. Parties are advised NOT to elect the SPREAD TEXT option when filing in ECF, as this will result in repetitive docketing. (znmw) (Entered: 12/10/2024)
2025-01-3130Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Silverman, Bradley) (Entered: 01/31/2025)
2025-04-0131Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Truong, John) (Entered: 04/01/2025)
2025-04-0232NOTICE of Appearance by Sarah Patricia Hogarth on behalf of VANDA PHARMACEUTICALS, INC. (Hogarth, Sarah) (Entered: 04/02/2025)
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