VANDA PHARMACEUTICALS INC. v. FOOD AND DRUG ADMINISTRATION et al
| District Of Columbia District Court | |
| Judge: | Christopher R Cooper |
| Case #: | 1:23-cv-02812 |
| Nature of Suit | 890 Other Statutes - Other Statutory Actions |
| Cause | 05:702 Administrative Procedure Act |
| Case Filed: | Sep 25, 2023 |
| Last checked: Saturday Mar 23, 2024 4:31 AM EDT |
|
Defendant
XAVIER BECERRA
|
Represented By
|
|
Defendant
ROBERT M. CALIFF, M.D.
|
Represented By
|
|
Defendant
DEPARTMENT OF HEALTH AND HUMAN SERVICES
|
Represented By
|
|
Defendant
FOOD AND DRUG ADMINISTRATION
|
Represented By
|
|
Plaintiff
VANDA PHARMACEUTICALS INC.
|
Represented By
|
GPO
Sep 10 2024
MEMORANDUM OPINION granting FDA's 8 Motion to Dismiss as to Vanda's APA claims and DENYING without prejudice to renewal FDA's 8 Motion to Dismiss as to Vanda's Appointments Clause claim. Vanda's 24 Motion for Summary Judgment and FDA's 27 Cross-Motion for Summary Judgment are hereby DENIED as premature. Vanda's 25 Motion to Complete and Supplement the Administrative Record is hereby DENIED as moot. The FDA is directed to file a status report in 60 days. See full Memorandum Opinion for details. Signed by Judge Christopher R. Cooper on 9/10/2024. (lccrc1) |
| Docket last updated: 11 hours ago |
| Thursday, May 01, 2025 | ||
|
order
Order on Motion for Leave to File
Thu 05/01 12:08 PM
MINUTE ORDER denying42 Motion for Leave to Renew Partial Summary Judgment. Having fully considered the parties' submissions, the plaintiff's motion is hereby DENIED. Signed by Judge Christopher R. Cooper on 5/1/2025. (lccrc1) |
||
| Tuesday, April 29, 2025 | ||
| 44 | 44
respm
Reply to opposition to motion
Tue 04/29 9:58 PM
REPLY to opposition to motion re42 Motion for Leave to File, TO RENEW PARTIAL SUMMARY JUDGMENT AND TO SET A DEADLINE FOR FDA TO RESOLVE CITIZEN PETITION filed by VANDA PHARMACEUTICALS INC.. (Hughes, Paul) |
|
| Tuesday, April 22, 2025 | ||
| 43 | 43
respm
Response to motion
Tue 04/22 6:32 PM
RESPONSE re42 MOTION for Leave to File filed by XAVIER BECERRA, ROBERT M. CALIFF, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION.(Schonfeld, Gabriel) |
|
|
Att: 1
Text of Proposed Order
|
||
| Tuesday, April 08, 2025 | ||
| 42 | 42
motion
Miscellaneous Relief
Tue 04/08 9:40 AM
MOTION FOR LEAVE TO RENEW PARTIAL SUMMARY JUDGMENT AND TO SET A DEADLINE FOR FDA TO RESOLVE CITIZEN PETITION by VANDA PHARMACEUTICALS INC..(Hughes, Paul) |
|
|
Att: 1
Memorandum in Support,
|
||
|
Att: 2
Text of Proposed Order
|
||
| Tuesday, March 25, 2025 | ||
| 41 | 41
misc
Status Report
Tue 03/25 1:06 PM
STATUS REPORT Regarding Anticipated Citizen Petition Decision by FOOD AND DRUG ADMINISTRATION, ROBERT M. CALIFF, DEPARTMENT OF HEALTH AND HUMAN SERVICES, XAVIER BECERRA. (Schonfeld, Gabriel) |
|
| Tuesday, January 21, 2025 | ||
|
order
.Order
Tue 01/21 9:44 AM
MINUTE ORDER: In light of the parties'40 Joint Status Report, the Court hereby sets the following briefing schedule: Vanda's motion for summary judgment shall be filed 45 days after FDA's final citizen petition response. FDA's opposition and cross-motion for summary judgment shall be filed 45 days after Vanda's motion. Vanda's opposition and reply shall be filed 30 days after FDA's opposition. FDA's reply shall be filed 14 days after Vanda's reply. Signed by Judge Christopher R. Cooper on 1/21/2025. (lccrc1) |
||
| Monday, December 30, 2024 | ||
| 40 | 40
misc
Status Report
Mon 12/30 1:51 PM
Joint STATUS REPORT by VANDA PHARMACEUTICALS INC.. (Hughes, Paul) |
|
| Tuesday, November 12, 2024 | ||
| 39 | 39
misc
Status Report
Tue 11/12 3:03 PM
STATUS REPORT Regarding Ratification by FOOD AND DRUG ADMINISTRATION, ROBERT M. CALIFF, DEPARTMENT OF HEALTH AND HUMAN SERVICES, XAVIER BECERRA. (Schonfeld, Gabriel) |
|
| Thursday, September 12, 2024 | ||
|
utility
Set/Reset Deadlines
Thu 09/12 11:55 AM
Set/Reset Deadlines: Status Report due by 11/12/2024 (lsj) |
||
| Tuesday, September 10, 2024 | ||
| 38 | 38
46
pgs
order
Memorandum & Opinion
Tue 09/10 7:26 PM
MEMORANDUM OPINION granting FDA's8 Motion to Dismiss as to Vanda's APA claims and DENYING without prejudice to renewal FDA's8 Motion to Dismiss as to Vanda's Appointments Clause claim. Vanda's24 Motion for Summary Judgment and FDA's27 Cross-Motion for Summary Judgment are hereby DENIED as premature. Vanda's25 Motion to Complete and Supplement the Administrative Record is hereby DENIED as moot. The FDA is directed to file a status report in 60 days. See full Memorandum Opinion for details. Signed by Judge Christopher R. Cooper on 9/10/2024. (lccrc1) |
|
| Tuesday, July 16, 2024 | ||
| 37 | 37
misc
Transcript
Tue 07/16 8:42 AM
TRANSCRIPT OF MOTION HEARING before Judge Christopher R. Cooper held on July 11, 2024; Page Numbers: 1-79. Date of Issuance:July 16, 2024. Court Reporter/Transcriber Lisa A. Moreira, RDR, CRR, Telephone number (202) 354-3187, Transcripts may be ordered by submitting the[LINK:Transcript Order Form] For the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purchased from the court reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter. NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days. The policy, which includes the five personal identifiers specifically covered, is located on our website at www.dcd.uscourts.gov. Redaction Request due 8/6/2024. Redacted Transcript Deadline set for 8/16/2024. Release of Transcript Restriction set for 10/14/2024.(Moreira, Lisa) |
|
| Thursday, July 11, 2024 | ||
|
minutes
Motion Hearing
Thu 07/11 11:50 AM
Minute Entry for proceedings held before Judge Christopher R. Cooper: Motion Hearing held on 7/11/2024 re8 Cross MOTION to Dismiss or, Alternatively, to Stay . Oral arguments heard. The Court takes the motion under advisement. (Court Reporter: Lisa Moreira) (zalh) |
||
| Wednesday, July 10, 2024 | ||
| 36 | 36
notice
Notice of Supplemental Authority
Wed 07/10 10:58 PM
NOTICE OF SUPPLEMENTAL AUTHORITY by VANDA PHARMACEUTICALS INC.(Hughes, Paul) |
|
|
Att: 1
Exhibit A - Dakota Resource Council v. US Dep't of Interior
|
||
| Wednesday, July 03, 2024 | ||
|
order
.Order ~Util - Set/Reset Deadlines/Hearings
Wed 07/03 1:43 PM
MINUTE ORDER: In light of a scheduling conflict, the hearing on the8 Motion to Dismiss set for July 15, 2024 is hereby VACATED and RESET for July 11, 2024 at 10:00 AM in Courtroom 27A (In Person) before Judge Christopher R. Cooper. Signed by Judge Christopher R. Cooper on 7/3/2024. (lccrc1) |
||
| Tuesday, July 02, 2024 | ||
|
order
Order on Sealed Motion for Leave to File Document Under Seal
Tue 07/02 6:48 PM
MINUTE ORDER granting34 Sealed Motion for Leave to File Document Under Seal. Upon consideration of the Joint Motion for Leave to File Joint Appendix under Seal, it is hereby ordered that the joint appendix shall be entered on the docket under seal. Signed by Judge Christopher R. Cooper on 7/2/2024. (lccrc1) |
||
| Monday, July 01, 2024 | ||
| 35 | 35
notice
Notice (Other)
Mon 07/01 5:39 PM
NOTICE of Filing Joint Addendum of Federal Agency Materials by VANDA PHARMACEUTICALS INC. re33 Reply to opposition to Motion,28 Response to motion,31 Response to motion,24 Motion for Summary Judgment,27 Motion for Summary Judgment,30 Reply to opposition to Motion (Hughes, Paul) |
|
| 34 | 34
motion
Sealed Motion for Leave to File Document Under Seal
Mon 07/01 5:29 PM
SEALED MOTION FOR LEAVE TO FILE DOCUMENT UNDER SEAL filed by VANDA PHARMACEUTICALS INC. (This document is SEALED and only available to authorized persons.)(Hughes, Paul) |
|
|
Att: 1
Confidential Joint Appendix,
|
||
|
Att: 2
Text of Proposed Order
|
||
|
order
.Order ~Util - Set/Reset Hearings
Mon 07/01 3:44 PM
MINUTE ORDER: The Court will hear argument on the8 Motion to Dismiss on July 15, 2024, at 10:00 AM in Courtroom 27A (In Person) before Judge Christopher R. Cooper. Argument will be limited to 90 minutes total. The parties may discuss any issues raised in their briefs, but the Court is specifically interested in hearing from the parties on exhaustion and the alleged Appointments Clause violation. In particular, the parties shall be prepared to answer the following questions with regard to those two issues: (1) How does 21 C.F.R. § 10.45(b) interact with § 10.45(e) with respect to exhaustion of Citizen Petitions? (2) Why don't Association of American Physicians & Surgeons v. FDA , 358 F. App'x 179 (D.C. Cir. 2009), and Center for Food Safety v. Hamburg , 696 F. App'x 302 (9th Cir. 2017), resolve that (a) interested parties are required to exhaust administrative remedies through Citizen Petitions before challenging FDA actions in court; and (b) this exhaustion requirement is consistent with 5 U.S.C. § 704, as interpreted in Darby v. Cisneros , 509 U.S. 137 (1993)? (3) Should the Court excuse any exhaustion requirement in this case? Is there any evidence that the FDA's approval of the MSN generic has substantially harmed Vanda? Does the FDA have any estimated timeline for when it will resolve Vanda's pending Citizen Petition? (4) Assuming exhaustion is required, should Vanda also be required to exhaust its Appointments Clause challenge, or should exhaustion of this constitutional claim be excused either because it falls outside the FDA's expertise or because exhaustion would be futile? (5) Is Dr. Iilun C. Murphy a properly appointed inferior officer? Doesn't the legislative history show that 21 U.S.C.A. § 379d-3a was intended to empower the FDA to recruit and retain expert employees, not appoint inferior officers? Or should the Court place greater weight on the fact that § 379d-3a comports with the Appointments Clause's procedural requirements, see Lucia v. SEC , 585 U.S. 237, 264-65 (2018) (Breyer, J., concurring in the judgment in part and dissenting in part) (suggesting that the "means of appointment that Congress chooses is... instructive")? (6) What would the appropriate remedy be for an Appointments Clause violation in this case? Signed by Judge Christopher R. Cooper on 7/1/2024. (lccrc1) |
||
| Monday, June 17, 2024 | ||
| 33 | 33
respm
Reply to opposition to motion
Mon 06/17 2:48 PM
REPLY to opposition to motion re27 Cross MOTION for Summary Judgment filed by XAVIER BECERRA, ROBERT M. CALIFF, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION. (Schonfeld, Gabriel) |
|
| Monday, June 03, 2024 | ||
| 32 | 32
respm
Reply to opposition to motion
Mon 06/03 10:29 PM
REPLY to opposition to motion re25 MOTION to Complete and Supplement the Administrative Record filed by VANDA PHARMACEUTICALS INC..(Hughes, Paul) |
|
|
Att: 1
Declaration of Paul W. Hughes,
|
||
|
Att: 2
Exhibit 5,
|
||
|
Att: 3
Exhibit 6
|
||
| 31 | 31
respm
Response to motion
Mon 06/03 10:19 PM
RESPONSE re27 Cross MOTION for Summary Judgment filed by VANDA PHARMACEUTICALS INC..(Hughes, Paul) |
|
|
Att: 1
Declaration of Paul W. Hughes,
|
||
|
Att: 2
Exhibit 5,
|
||
|
Att: 3
Exhibit 6
|
||
| 30 | 30
respm
Reply to opposition to motion
Mon 06/03 10:14 PM
REPLY to opposition to motion re24 MOTION for Summary Judgment filed by VANDA PHARMACEUTICALS INC..(Hughes, Paul) |
|
|
Att: 1
Declaration of Paul W. Hughes,
|
||
|
Att: 2
Exhibit 5,
|
||
|
Att: 3
Exhibit 6
|
||
| Monday, May 20, 2024 | ||
| 29 | 29
respm
Response to motion
Mon 05/20 6:38 PM
RESPONSE re25 MOTION to Complete and Supplement the Administrative Record filed by XAVIER BECERRA, ROBERT M. CALIFF, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION.(Schonfeld, Gabriel) |
|
|
Att: 1
Text of Proposed Order
|
||
| 28 | 28
respm
Response to motion
Mon 05/20 6:36 PM
RESPONSE re24 MOTION for Summary Judgment filed by XAVIER BECERRA, ROBERT M. CALIFF, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION.(Schonfeld, Gabriel) |
|
|
Att: 1
Text of Proposed Order
|
||
| 27 | 27
motion
Summary Judgment
Mon 05/20 6:35 PM
Cross MOTION for Summary Judgment by XAVIER BECERRA, ROBERT M. CALIFF, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION.(Schonfeld, Gabriel) |
|
|
Att: 1
Memorandum in Support,
|
||
|
Att: 2
Text of Proposed Order
|
||
| Friday, May 03, 2024 | ||
|
order
Order on Motion for Extension of Time to File Response/Reply
Fri 05/03 8:52 AM
MINUTE ORDER granting26 Motion for Extension of Time. Defendants shall respond to the motion to complete and supplement by May 20, 2024. Plaintiff shall reply by June 3, 2024. Signed by Judge Christopher R. Cooper on 5/3/2024. (lccrc1) |
||
| Thursday, May 02, 2024 | ||
| 26 | 26
motion
Extension of Time to File Response/Reply
Thu 05/02 2:09 PM
Consent MOTION for Extension of Time to File Response/Reply as to25 MOTION to Complete and Supplement the Administrative Record - Motion to Synchronize With Summary Judgment Briefing by XAVIER BECERRA, ROBERT M. CALIFF, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION.(Schonfeld, Gabriel) |
|
|
Att: 1
Text of Proposed Order
|
||
| Monday, April 22, 2024 | ||
| 25 | 25
motion
Miscellaneous Relief
Mon 04/22 11:03 PM
MOTION to Complete and Supplement the Administrative Record by VANDA PHARMACEUTICALS INC..(Hughes, Paul) |
|
|
Att: 1
Memorandum in Support,
|
||
|
Att: 2
Declaration of Paul W. Hughes,
|
||
|
Att: 3
Exhibit 1,
|
||
|
Att: 4
Exhibit 2,
|
||
|
Att: 5
Exhibit 3,
|
||
|
Att: 6
Text of Proposed Order
|
||
| 24 | 24
motion
Summary Judgment
Mon 04/22 10:58 PM
MOTION for Summary Judgment by VANDA PHARMACEUTICALS INC..(Hughes, Paul) |
|
|
Att: 1
Memorandum in Support,
|
||
|
Att: 2
Declaration of Paul W. Hughes,
|
||
|
Att: 3
Exhibit 1,
|
||
|
Att: 4
Exhibit 2,
|
||
|
Att: 5
Exhibit 3,
|
||
|
Att: 6
Exhibit 4,
|
||
|
Att: 7
Text of Proposed Order
|
||
| Thursday, April 18, 2024 | ||
| 23 | 23
misc
Administrative Record
Thu 04/18 1:48 PM
ADMINISTRATIVE RECORD - Certified Index of Supplemental Administrative Record re Ratification by XAVIER BECERRA, ROBERT M. CALIFF, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION. (Schonfeld, Gabriel) |
|
| Tuesday, March 26, 2024 | ||
| 22 | 22
9
pgs
order
Order on Motion for Protective Order
Tue 03/26 9:26 AM
ORDER granting20 Motion for Protective Order. See full Order for details. Signed by Judge Christopher R. Cooper on 3/26/2024. (lccrc1) |
|
| Monday, March 25, 2024 | ||
| 21 | 21
misc
Administrative Record
Mon 03/25 8:40 PM
ADMINISTRATIVE RECORD - Certified Index by XAVIER BECERRA, ROBERT M. CALIFF, MD, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION. (Schonfeld, Gabriel) |
|
| 20 | 20
motion
Protective Order
Mon 03/25 2:57 PM
Joint MOTION for Protective Order by XAVIER BECERRA, ROBERT M. CALIFF, MD, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION.(Schonfeld, Gabriel) |
|
|
Att: 1
Proposed Stipulated Protective Order
|
||
| Friday, March 01, 2024 | ||
| 19 | 19
respm
Reply to opposition to motion
Fri 03/01 4:43 PM
REPLY to opposition to motion re8 Cross MOTION to Dismiss or, Alternatively, to Stay MOTION to Stay filed by XAVIER BECERRA, ROBERT M. CALIFF, MD, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION. (Schonfeld, Gabriel) |
|
| Friday, February 16, 2024 | ||
| 18 | 18
30+
pgs
respm
Memorandum in opposition to motion
Fri 02/16 7:59 PM
Memorandum in opposition to re8 Motion to Dismiss,, Motion to Stay, filed by VANDA PHARMACEUTICALS INC..(Hughes, Paul) |
|
|
Att: 1
Declaration of Paul W. Hughes,
|
||
|
Att: 2
Exhibit 1 to Hughes Declaration,
|
||
|
Att: 3
Exhibit 2 to Hughes Declaration,
|
||
|
Att: 4
Exhibit 3 to Hughes Declaration,
|
||
|
Att: 5
Exhibit 4 to Hughes Declaration,
|
||
|
Att: 6
Text of Proposed Order
|
||
| Friday, January 26, 2024 | ||
|
order
Order on Motion for Summary Judgment Order on Motion for Miscellaneous Relief Order on Motion to Compel Set/Reset Deadlines
Fri 01/26 4:38 PM
MINUTE ORDER granting10 Motion for Relief from Local Civil Rule 7(n) and denying13 Cross Motion to Compel Substantive Response to Motion for Summary Judgment. Following a hearing on these cross-motions, the Court will amend the December 15, 2023 briefing schedule as follows. Defendants'8 Motion to Dismiss will proceed under the current briefing schedule. Plaintiff shall file its opposition by February 16, 2024, and Defendants shall file their Reply by March 1, 2024. Because the "administrative record is not necessary for decision regarding [the] motion to dismiss," the Court will waive Local Civil Rule 7(n) for this motion. Connecticut v. U.S. Dept of the Interior , 344 F. Supp. 3d 279, 294 (D.D.C. 2018). The Court strikes Plaintiff's6 Motion for Summary Judgment because it was drafted without the benefit of the administrative record. The Court further directs the parties to re-brief the motion according to the following schedule: Defendants shall serve the administrative record and file a certified list of that record by March 25, 2024; Plaintiff shall file its Motion for Summary Judgment by April 22, 2024; Defendants shall file their Combined Opposition and Cross-Motion for Summary Judgment by May 20, 2024; Plaintiff shall file its Combined Opposition and Reply by June 3, 2024; and Defendants shall file their Reply by June 17, 2024. So ordered by Judge Christopher R. Cooper on 1/26/2024. (lccrc1) |
||
| Thursday, January 25, 2024 | ||
| 17 | 17
notice
Notice of Appearance
Thu 01/25 10:46 AM
NOTICE of Appearance by Sarah Patricia Hogarth on behalf of VANDA PHARMACEUTICALS INC. (Hogarth, Sarah) |
|
|
minutes
Status Conference
Thu 01/25 4:07 PM
Minute Entry for Status Conference held before Judge Christopher R. Cooper on 1/25/2024. Forthcoming Order. (Court Reporter: Tammi Sefranek) (lsj) |
||
| Wednesday, January 24, 2024 | ||
| 16 | 16
respm
Reply to opposition to motion
Thu 01/25 12:00 AM
REPLY to opposition to motion re13 Cross MOTION to Compel Substantive Response to Motion for Summary Judgment filed by VANDA PHARMACEUTICALS INC.. (Hughes, Paul) |
|
| 15 | 15
9
pgs
respm
Memorandum in opposition to motion
Wed 01/24 5:05 PM
Memorandum in opposition to re13 Motion to Compel filed by XAVIER BECERRA, ROBERT M. CALIFF, MD, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION.(Schonfeld, Gabriel) |
|
|
Att: 1
Text of Proposed Order
|
||
| 14 | 14
respm
Reply to opposition to motion
Wed 01/24 5:02 PM
REPLY to opposition to motion re10 MOTION for Relief from Local Civil Rule 7(n) filed by XAVIER BECERRA, ROBERT M. CALIFF, MD, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION. (Schonfeld, Gabriel) |
|
|
order
.Order ~Util - Set/Reset Hearings
Wed 01/24 1:57 PM
MINUTE ORDER: In light of the10 Motion for Relief from Local Civil Rule 7(n) and13 Cross Motion to Compel Substantive Response to Motion for Summary Judgment, the Court hereby sets a status conference for January 25, 2024 at 3:00 PM in Courtroom 27A (In Person) before Judge Christopher R. Cooper. Signed by Judge Christopher R. Cooper on 1/24/2024. (lccrc1) |
||
|
utility
Set/Reset Hearings
Wed 01/24 3:26 PM
Set/Reset Hearings: Status Conference set for 1/25/2024 at 03:00 PM in Courtroom 27A- In Person before Judge Christopher R. Cooper. (znbn) |
||
| Thursday, January 18, 2024 | ||
| 13 | 13
motion
Compel
Thu 01/18 11:47 PM
Cross MOTION to Compel Substantive Response to Motion for Summary Judgment by VANDA PHARMACEUTICALS INC..(Hughes, Paul) |
|
|
Att: 1
Memorandum in Support,
|
||
|
Att: 2
Text of Proposed Order
|
||
| 12 | 12
19
pgs
respm
Memorandum in opposition to motion
Thu 01/18 11:41 PM
Memorandum in opposition to re10 Motion for Miscellaneous Relief from Local Civil Rule 7(n) filed by VANDA PHARMACEUTICALS INC..(Hughes, Paul) |
|
|
Att: 1
Text of Proposed Order
|
||
| Wednesday, January 17, 2024 | ||
|
order
.Order ~Util - Set/Reset Deadlines
Wed 01/17 3:45 PM
MINUTE ORDER: Plaintiff is hereby directed to respond to Defendants'10 Motion for Relief from Local Civil Rule 7(n) by end of day on January 18, 2024. Signed by Judge Christopher R. Cooper on 1/17/2024. (lccrc1) |
||
| Friday, January 12, 2024 | ||
| 11 | 11
misc
Errata
Fri 01/12 9:01 PM
ERRATA - Exhibits to Combined Memorandum of Law by XAVIER BECERRA, ROBERT M. CALIFF, MD, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION re9 Memorandum in Opposition,8 Motion to Dismiss,.(Schonfeld, Gabriel) |
|
|
Att: 1
Exhibit #1 - Ratification of ANDA 211654,
|
||
|
Att: 2
Exhibit #2 - OGD Director Appointment Memorandum
|
||
| 10 | 10
motion
Miscellaneous Relief
Fri 01/12 7:08 PM
MOTION for Relief from Local Civil Rule 7(n) by XAVIER BECERRA, ROBERT M. CALIFF, MD, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION.(Schonfeld, Gabriel) |
|
|
Att: 1
Text of Proposed Order
|
||
| 9 | 9
30+
pgs
respm
Memorandum in opposition to motion
Fri 01/12 7:04 PM
Memorandum in opposition to re6 Motion for Summary Judgment,,,,,, filed by XAVIER BECERRA, ROBERT M. CALIFF, MD, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION.(Schonfeld, Gabriel) |
|
|
Att: 1
Text of Proposed Order
|
||
| 8 | 8
motion
Dismiss
Fri 01/12 7:02 PM
Cross MOTION to Dismiss or, Alternatively, to Stay by XAVIER BECERRA, ROBERT M. CALIFF, MD, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION.(Schonfeld, Gabriel) |
|
|
Att: 1
Memorandum in Support,
|
||
|
Att: 2
Text of Proposed Order
|
||
| Friday, December 15, 2023 | ||
|
order
Order on Motion for Extension of Time to Answer Order on Motion for Extension of Time to File Response/Reply Order on Motion for Briefing Schedule Set/Reset Deadlines
Fri 12/15 10:33 AM
MINUTE ORDER granting7 Motion for Extension of Deadlines and Entry of Briefing Schedule. The parties shall file briefs according to the following schedule: Defendants' Combined Motion to Dismiss (or Alternatively, to Stay) and Opposition to Plaintiff's Motion for Summary Judgment is due January 12, 2024; Plaintiff's Combined Reply in Support of Summary Judgment and in Opposition to Defendants' Motion to Dismiss (or Alternatively, to Stay) is due February 16, 2024; Defendants' Reply in Support of their Motion to Dismiss (or Alternatively, to Stay) is due March 1, 2024. Signed by Judge Christopher R. Cooper on 12/15/2023. (lccrc1) |
||
| Monday, December 11, 2023 | ||
| 7 | 7
motion
Extension of Time to File Answer Extension of Time to File Response/Reply Briefing Schedule
Mon 12/11 5:38 PM
Joint MOTION for Extension of Time to File Answer re1 Complaint,,,,,, , Joint MOTION for Extension of Time to File Response/Reply as to6 MOTION for Summary Judgment , Joint MOTION for Briefing Schedule on Vanda's Motion for Summary Judgment and Defendants' Forthcoming Cross-Motion to Dismiss by XAVIER BECERRA, ROBERT M. CALIFF, MD, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION.(Schonfeld, Gabriel) |
|
|
Att: 1
Text of Proposed Order
|
||
| Thursday, December 07, 2023 | ||
| 6 | 6
motion
Summary Judgment
Thu 12/07 6:03 PM
MOTION for Summary Judgment by VANDA PHARMACEUTICALS INC..(Hughes, Paul) |
|
|
Att: 1
Memorandum in Support,
|
||
|
Att: 2
Declaration of Paul W. Hughes,
|
||
|
Att: 3
Text of Proposed Order,
|
||
|
Att: 4
Exhibit 1,
|
||
|
Att: 5
Exhibit 2,
|
||
|
Att: 6
Exhibit 3,
|
||
|
Att: 7
Exhibit 4,
|
||
|
Att: 8
Exhibit 5,
|
||
|
Att: 9
Exhibit 6,
|
||
|
Att: 10
Exhibit 7,
|
||
|
Att: 11
Exhibit 8,
|
||
|
Att: 12
Exhibit 9,
|
||
|
Att: 13
Exhibit 10,
|
||
|
Att: 14
Exhibit 11,
|
||
|
Att: 15
Exhibit 12,
|
||
|
Att: 16
Exhibit 13,
|
||
|
Att: 17
Exhibit 14,
|
||
|
Att: 18
Exhibit 15,
|
||
|
Att: 19
Exhibit 16,
|
||
|
Att: 20
Exhibit 17,
|
||
|
Att: 21
Exhibit 18,
|
||
|
Att: 22
Exhibit 19,
|
||
|
Att: 23
Exhibit 20,
|
||
|
Att: 24
Exhibit 21,
|
||
|
Att: 25
Exhibit 22,
|
||
|
Att: 26
Exhibit 23,
|
||
|
Att: 27
Exhibit 24,
|
||
|
Att: 28
Exhibit 25,
|
||
|
Att: 29
Exhibit 26,
|
||
|
Att: 30
Exhibit 27,
|
||
|
Att: 31
Exhibit 28,
|
||
|
Att: 32
Exhibit 29,
|
||
|
Att: 33
Exhibit 30,
|
||
|
Att: 34
Exhibit 31,
|
||
|
Att: 35
Exhibit 32,
|
||
|
Att: 36
Exhibit 33,
|
||
|
Att: 37
Exhibit 34,
|
||
|
Att: 38
Exhibit 35,
|
||
|
Att: 39
Exhibit 36,
|
||
|
Att: 40
Exhibit 37,
|
||
|
Att: 41
Exhibit 38,
|
||
|
Att: 42
Exhibit 39,
|
||
|
Att: 43
Exhibit 40,
|
||
|
Att: 44
Exhibit 41,
|
||
|
Att: 45
Exhibit 42,
|
||
|
Att: 46
Exhibit 43,
|
||
|
Att: 47
Exhibit 44,
|
||
|
Att: 48
Exhibit 45,
|
||
|
Att: 49
Exhibit 46,
|
||
|
Att: 50
Exhibit 47,
|
||
|
Att: 51
Exhibit 48,
|
||
|
Att: 52
Exhibit 49,
|
||
|
Att: 53
Exhibit 50,
|
||
|
Att: 54
Exhibit 51,
|
||
|
Att: 55
Exhibit 52,
|
||
|
Att: 56
Exhibit 53,
|
||
|
Att: 57
Exhibit 54,
|
||
|
Att: 58
Exhibit 55,
|
||
|
Att: 59
Exhibit 56,
|
||
|
Att: 60
Exhibit 57,
|
||
|
Att: 61
Exhibit 58,
|
||
|
Att: 62
Exhibit 59,
|
||
|
Att: 63
Exhibit 60,
|
||
|
Att: 64
Exhibit 61,
|
||
|
Att: 65
Exhibit 62,
|
||
|
Att: 66
Exhibit 63,
|
||
|
Att: 67
Exhibit 64,
|
||
|
Att: 68
Exhibit 65,
|
||
|
Att: 69
Exhibit 66,
|
||
|
Att: 70
Exhibit 67,
|
||
|
Att: 71
Exhibit 68,
|
||
|
Att: 72
Exhibit 69,
|
||
|
Att: 73
Exhibit 70,
|
||
|
Att: 74
Exhibit 71
|
||
| Friday, November 03, 2023 | ||
|
order
Order on Motion for Extension of Time to Answer Set/Reset Deadlines
Fri 11/03 2:14 PM
MINUTE ORDER granting5 Motion for Extension of Time to Answer. Defendants shall answer or otherwise respond to the complaint by December 11, 2023. Signed by Judge Christopher R. Cooper on 11/3/2023. (lccrc1) |
||
| Monday, October 30, 2023 | ||
| 5 | 5
motion
Extension of Time to File Answer
Mon 10/30 5:34 PM
Unopposed MOTION for Extension of Time to File Answer re1 Complaint,,,,,, by XAVIER BECERRA, ROBERT M. CALIFF, MD, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION.(Schonfeld, Gabriel) |
|
|
Att: 1
Text of Proposed Order
|
||
| 4 | 4
notice
Notice of Appearance
Mon 10/30 5:21 PM
NOTICE of Appearance by Gabriel Schonfeld on behalf of All Defendants (Schonfeld, Gabriel) |
|
| Tuesday, September 26, 2023 | ||
| 3 | 3
service
Electronic Summons Issued as to AUSA,USAG
Tue 09/26 2:36 PM
SUMMONS (6) Issued Electronically as to XAVIER BECERRA, ROBERT M. CALIFF, MD, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION, U.S. Attorney and U.S. Attorney General(zcb) |
|
|
Att: 1
Notice and Consent
|
||
|
utility
Case Assigned/Reassigned
Tue 09/26 12:13 PM
Case Assigned to Judge Christopher R. Cooper. (zcb) |
||
| Monday, September 25, 2023 | ||
| 2 | 2
notice
LCvR 26.1 Certificate of Disclosure - Corporate Affiliations/Financial Interests
Mon 09/25 2:19 PM
LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by VANDA PHARMACEUTICALS INC. (Hughes, Paul) |
|
| 1 | 1
42
pgs
cmp
Complaint
Mon 09/25 1:57 PM
COMPLAINT against XAVIER BECERRA, ROBERT M. CALIFF, MD, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION ( Filing fee $ 402 receipt number ADCDC-10374387) filed by VANDA PHARMACEUTICALS INC..(Hughes, Paul) |
|
|
Att: 1
Exhibit 1,
|
||
|
Att: 2
Exhibit 2,
|
||
|
Att: 3
Exhibit 3,
|
||
|
Att: 4
Exhibit 4,
|
||
|
Att: 5
Exhibit 5,
|
||
|
Att: 6
Exhibit 6,
|
||
|
Att: 7
Exhibit 7,
|
||
|
Att: 8
Exhibit 8,
|
||
|
Att: 9
Exhibit 9,
|
||
|
Att: 10
Exhibit 10,
|
||
|
Att: 11
Exhibit 11,
|
||
|
Att: 12
Exhibit 12,
|
||
|
Att: 13
Exhibit 13,
|
||
|
Att: 14
Exhibit 14,
|
||
|
Att: 15
Exhibit 15,
|
||
|
Att: 16
Exhibit 16,
|
||
|
Att: 17
Exhibit 17,
|
||
|
Att: 18
Exhibit 18,
|
||
|
Att: 19
Exhibit 19,
|
||
|
Att: 20
Exhibit 20,
|
||
|
Att: 21
Exhibit 21,
|
||
|
Att: 22
Exhibit 22,
|
||
|
Att: 23
Exhibit 23,
|
||
|
Att: 24
Exhibit 24,
|
||
|
Att: 25
Exhibit 25,
|
||
|
Att: 26
Exhibit 26,
|
||
|
Att: 27
Exhibit 27,
|
||
|
Att: 28
Exhibit 28,
|
||
|
Att: 29
Exhibit 29,
|
||
|
Att: 30
Exhibit 30,
|
||
|
Att: 31
Exhibit 31,
|
||
|
Att: 32
Exhibit 32,
|
||
|
Att: 33
Exhibit 33,
|
||
|
Att: 34
Exhibit 34,
|
||
|
Att: 35
Exhibit 35,
|
||
|
Att: 36
Exhibit 36,
|
||
|
Att: 37
Exhibit 37,
|
||
|
Att: 38
Exhibit 38,
|
||
|
Att: 39
Exhibit 39,
|
||
|
Att: 40
Exhibit 40,
|
||
|
Att: 41
Exhibit 41,
|
||
|
Att: 42
Exhibit 42,
|
||
|
Att: 43
Exhibit 43,
|
||
|
Att: 44
Exhibit 44,
|
||
|
Att: 45
Exhibit 45,
|
||
|
Att: 46
Exhibit 46,
|
||
|
Att: 47
Exhibit 47,
|
||
|
Att: 48
Exhibit 48,
|
||
|
Att: 49
Exhibit 49,
|
||
|
Att: 50
Exhibit 50,
|
||
|
Att: 51
Exhibit 51,
|
||
|
Att: 52
Exhibit 52,
|
||
|
Att: 53
Exhibit 53,
|
||
|
Att: 54
Exhibit 54,
|
||
|
Att: 55
Exhibit 55,
|
||
|
Att: 56
Exhibit 56,
|
||
|
Att: 57
Exhibit 57,
|
||
|
Att: 58
Exhibit 58,
|
||
|
Att: 59
Exhibit 59,
|
||
|
Att: 60
Exhibit 60,
|
||
|
Att: 61
Exhibit 61,
|
||
|
Att: 62
Exhibit 62,
|
||
|
Att: 63
Exhibit 63,
|
||
|
Att: 64
Exhibit 64,
|
||
|
Att: 65
Exhibit 65,
|
||
|
Att: 66
Exhibit 66,
|
||
|
Att: 67
Civil Cover Sheet,
|
||
|
Att: 68
Summons,
|
||
|
Att: 69
Summons,
|
||
|
Att: 70
Summons,
|
||
|
Att: 71
Summons,
|
||
|
Att: 72
Summons,
|
||
|
Att: 73
Summons
|
||