Vanda Pharmaceuticals Inc. et al v. Food and Drug Administration et al
| Vanda Pharmaceuticals Inc., Mary Talley Bowden and Ally Totah |
| Food and Drug Administration, Martin A. Makary, United States Department of Health and Human Services and Robert F Kennedy Jr |
| 4:2025cv01648 |
| April 9, 2025 |
| U.S. District Court for the Southern District of Texas |
| Andrew S Hanen |
| Civil Rights: Other |
| 28 U.S.C. § 2201 Declaratory Judgment |
| None |
Docket Report
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This docket was last retrieved on October 1, 2025. A more recent docket listing may be available from PACER.
| Document Text |
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| Filing 26 NOTICE of Dismissal as to Ally Totah, Mary Talley Bowden, Vanda Pharmaceuticals Inc., Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services by Ally Totah, Mary Talley Bowden, Vanda Pharmaceuticals Inc., filed. (Hughes, Paul) |
Filing 25
ORDER granting #23 Motion for Connor J. Suozzo to Appear Pro Hac Vice Note: Instructions to request Texas Southern CM/ECF registration through PACER are found #here.(Signed by Judge Andrew S Hanen) Parties notified. (jld4)
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| Filing 24 RESPONSE in Opposition to #20 MOTION to Dismiss (or, in the Alternative, to Transfer), filed by Mary Talley Bowden, Ally Totah, Vanda Pharmaceuticals Inc.. (Attachments: #1 DECLARATION OF MARY TALLEY BOWDEN, M.D., #2 DECLARATION OF MIHAEL H. POLYMEROPOULOS, M.D., #3 Proposed Order) (Hughes, Paul) |
| Filing 23 MOTION to Appear Pro Hac Vice for Connor J. Suozzo (Fee Paid: $100, receipt number ATXSDC-34174589) by Mary Talley Bowden, Ally Totah, Vanda Pharmaceuticals Inc., filed. Motion Docket Date 10/14/2025. (Hughes, Paul) |
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Filing 22
ORDER granting #21 Motion to Modify.(Signed by Judge Andrew S Hanen) Parties notified. (rsh4)
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| Filing 21 Joint MOTION to Modify Briefing Schedule by Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services, filed. Motion Docket Date 9/29/2025. (Attachments: #1 Proposed Order) (Pezzi, Stephen) |
| Filing 20 MOTION to Dismiss (or, in the Alternative, to Transfer) by Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services, filed. Motion Docket Date 9/12/2025. (Attachments: #1 Ex. 1 - FDA's Complete Response Letter (Aug. 16, 2019), #2 Ex. 2 - FDA Correspondence (Aug. 25, 2022), #3 Ex. 3 - FDA's 2025 Guidance, #4 Proposed Order) (Pezzi, Stephen) |
| Filing 19 MOTION for Extension of Time to Answer or Otherwise Respond to the Complaint (Current Deadline is Today, Aug. 15, 2025) by Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services, filed. Motion Docket Date 9/5/2025. (Attachments: #1 Ex. 1 - Vanda v. FDA (D.C. Cir. Aug. 15, 2025), #2 Proposed Order) (Pezzi, Stephen) |
| Filing 18 REPLY in Support of #13 MOTION to Stay Discovery and Case-Management Deadlines Pending Resolution of Defendants' Motion to Dismiss (or Transfer), filed by Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services. (Pezzi, Stephen) |
| Filing 17 RESPONSE in Opposition to #13 MOTION to Stay Discovery and Case-Management Deadlines Pending Resolution of Defendants' Motion to Dismiss (or Transfer), filed by Mary Talley Bowden, Ally Totah, Vanda Pharmaceuticals Inc.. (Attachments: #1 Proposed Order) (Hughes, Paul) |
| Filing 16 NOTICE Notice of Change of Law Firm Name by Mary Talley Bowden, Ally Totah, Vanda Pharmaceuticals Inc., filed. (Hughes, Paul) |
| Filing 15 NOTICE of Resetting AS TO LOCATION ONLY. Parties notified. Initial Conference set for 10/10/2025 at 09:30 AM by video before Magistrate Judge Yvonne Y Ho, filed. A Zoom link will be emailed to the parties the day before the hearing. (rlw4) |
| Filing 14 NOTICE of Resetting to allow #13 to be fully briefed. Parties notified. Initial Conference set for 10/10/2025 at 09:30 AM in Courtroom 704 before Magistrate Judge Yvonne Y Ho, filed. (rlw4) |
| Filing 13 MOTION to Stay Discovery and Case-Management Deadlines Pending Resolution of Defendants' Motion to Dismiss (or Transfer) by Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services, filed. Motion Docket Date 8/6/2025. (Attachments: #1 Proposed Order) (Pezzi, Stephen) |
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Filing 12
ORDER granting #11 Motion for Extension of Time Answer due by 8/15/2025.(Signed by Judge Andrew S Hanen) Parties notified. (rsh4)
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| Filing 11 Unopposed MOTION for Extension of Time to Answer or Otherwise Respond to the Complaint by Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services, filed. Motion Docket Date 6/27/2025. (Attachments: #1 Proposed Order) (Pezzi, Stephen) |
| Filing 10 NOTICE of Appearance by Stephen M. Pezzi on behalf of Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services, filed. (Pezzi, Stephen) |
| Filing 9 CERTIFICATE OF INTERESTED PARTIES by Mary Talley Bowden, Ally Totah, Vanda Pharmaceuticals Inc., filed. (Hughes, Paul) |
| Filing 7 CERTIFICATE OF SERVICE of #4 Order for Initial Conference - FORM, #5 MOTION to Appear Pro Hac Vice for Paul. W. Hughes (Fee Paid: $100, receipt number ATXSDC-33239206), #1 Complaint,, #3 Clerks Notice re Consent to Jurisdiction of Magistrate Judge, #6 Summons Issued as to USA by Mary Talley Bowden, Ally Totah, Vanda Pharmaceuticals Inc., filed. (Salgado, Richard) |
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Filing 8
ORDER granting #5 Motion for Paul W Hughes to Appear Pro Hac Vice Note: Instructions to request Texas Southern CM/ECF registration through PACER are found #here.(Signed by Judge Andrew S Hanen) Parties notified. (jld4)
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| Filing 6 Summons Issued as to All Defendants, U.S. Attorney and U.S. Attorney General. Issued summons returned to plaintiff by NEF, filed. (rlm4) |
| Filing 5 MOTION to Appear Pro Hac Vice for Paul. W. Hughes (Fee Paid: $100, receipt number ATXSDC-33239206) by Mary Talley Bowden, Ally Totah, Vanda Pharmaceuticals Inc., filed. Motion Docket Date 5/5/2025. (Hughes, Paul) |
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Filing 4
ORDER for Initial Pretrial and Scheduling Conference and Order to Disclose Interested Persons. Initial Conference set for 8/1/2025 at 09:30 AM by video before Magistrate Judge Yvonne Y Ho. (Signed by Magistrate Judge Yvonne Y Ho) Parties notified. (bkt4)
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| Filing 3 CLERKS NOTICE Regarding Consent to Jurisdiction of Magistrate Judge. Parties notified, filed. (bkt4) |
| Referral Judge Selected: Magistrate Judge Yvonne Y. Ho randomly selected to receive referrals. The selected Magistrate Judge is not assigned to this case until a District Judge refers the case or a motion or the parties consent to jurisdiction of the Magistrate Judge. Once a referral has been made, the name of the referral judge will appear at the top of the docket sheet. (bkt4) |
| Filing 2 Request for Issuance of Summons as to Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services, United States Attorney General, United States Attorney for the Southern District of Texas, filed. (Attachments: #1 Summons, #2 Summons, #3 Summons, #4 Summons, #5 Summons) (Salgado, Richard) |
| Filing 1 COMPLAINT against Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services (Filing fee $ 405 receipt number ATXSDC-33222270) filed by Vanda Pharmaceuticals Inc., Ally Totah, Mary Talley Bowden. (Attachments: #1 Exhibit A, #2 Exhibit B, #3 Exhibit C, #4 Exhibit D, #5 Exhibit E, #6 Exhibit F, #7 Exhibit G, #8 Exhibit H, #9 Exhibit I, #10 Exhibit J, #11 Exhibit K, #12 Exhibit L, #13 Civil Cover Sheet) (Salgado, Richard) |
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