NORWICH PHARMACEUTICALS, INC. v. BECERRA et al
NORWICH PHARMACEUTICALS, INC. |
XAVIER BECERRA, ROBERT M. CALIFF, M.D. and UNITED STATES FOOD AND DRUG ADMINISTRATION |
SALIX PHARMACEUTICALS, INC. |
1:2023cv01611 |
June 5, 2023 |
US District Court for the District of Columbia |
Randolph D Moss |
Administrative Procedure Act/Review or Appeal of Agency Decision |
05 U.S.C. § 702 Administrative Procedure Act |
None |
Docket Report
This docket was last retrieved on November 1, 2023. A more recent docket listing may be available from PACER.
Document Text |
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Set/Reset Hearings: Motion Hearing set for 10/6/2023 at 11:00 AM in Courtroom 8- In Person before Judge Randolph D. Moss. (zglw) |
Filing 48 NOTICE of Plaintiffs Renewed Request For Oral Argument by NORWICH PHARMACEUTICALS, INC. re #4 Motion for Preliminary Injunction,, (Landmon, Chad) |
MINUTE ORDER: Upon consideration of Plaintiff's renewed request for oral argument, Dkt. #48 , it is hereby ORDERED that the parties shall appear for oral argument on Plaintiff's motion for a preliminary injunction, which has been consolidated for a full consideration of the merits, Dkt. #4 , Defendants' cross-motion for summary judgment, Dkt. #37 , and Intervenor's cross-motion to dismiss, or, in the alternative, for summary judgment, Dkt. #39 , on October 6, 2023 at 11:00 a.m. in Courtroom 8. Signed by Judge Randolph D. Moss on 8/2/2023. (lcrdm1) |
Filing 47 SEALED REPLY TO OPPOSITION filed by NORWICH PHARMACEUTICALS, INC. re #4 Motion for Preliminary Injunction,, (This document is SEALED and only available to authorized persons.)(zjm) |
Filing 46 SEALED OPPOSITION filed by NORWICH PHARMACEUTICALS, INC. re #37 Motion for Summary Judgment (zjm) |
MINUTE ORDER: Upon consideration of Plaintiff's unopposed motion for leave to file document under seal #43 , it is hereby ORDERED that the motion is GRANTED. Plaintiff's Opposition to FDA and Intervenor Salix's Motion for Summary Judgment, and Reply in Support of Plaintiff's Motion for Preliminary Injunction (Opposition and Reply) is hereby filed under seal. Plaintiff shall file public, redacted versions of its Opposition and Reply, according to the following procedure: On or before July 31, 2023, counsel for Plaintiff shall serve proposed public versions of the Opposition and Reply on counsel for all parties. The other parties shall then have five business days from the date of such service to notify Plaintiff of any objections to Plaintiff's proposed public version or of any additional information contained in such documents that they believe to be confidential under the Stipulated Protective order. Two business days after such deadline, Plaintiff shall file a public version of the Opposition and Reply with the confidential information redacted from public view. Signed by Judge Randolph D. Moss on 7/27/2023. (lcrdm1) Modified on 8/1/2023 (zglw). |
Filing 43 SEALED MOTION FOR LEAVE TO FILE DOCUMENT UNDER SEAL filed by NORWICH PHARMACEUTICALS, INC. (This document is SEALED and only available to authorized persons.) (Attachments: #1 Opposition to FDA and Intervenor Salixs Motion for Summary Judgment, and Reply in Support of Plaintiffs Motion for Preliminary Injunction, #2 Text of Proposed Order)(Landmon, Chad) |
MINUTE ORDER: Upon consideration of Plaintiff's motion to admit Matthew J. Becker pro hac vice, Dkt. #42 , it is hereby ORDERED that the motion is GRANTED. Matthew J. Becker is hereby granted leave to appear pro hac vice in this case. Counsel should register for e-filing via PACER and file a notice of appearance pursuant to LCvR 83.6(a)/LCrR 44.5(a). #Click for Instructions. Signed by Judge Randolph D. Moss on 7/21/2023. (lcrdm1) |
Filing 42 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Matthew J. Becker, Filing fee $ 100, receipt number ADCDC-10219620. Fee Status: Fee Paid. by NORWICH PHARMACEUTICALS, INC.. (Attachments: #1 Declaration of Matthew J. Becker, #2 Exhibit Certificate of Good Standing, #3 Text of Proposed Order)(Landmon, Chad) |
Filing 41 REDACTED DOCUMENT- Certified Index of Administrative Record by XAVIER BECERRA, ROBERT M. CALIFF, MD, UNITED STATES FOOD AND DRUG ADMINISTRATION. (Schonfeld, Gabriel) |
Filing 40 REDACTED DOCUMENT- to #37 Cross MOTION for Summary Judgment , #4 MOTION for Preliminary Injunction Combined Memorandum (Redacted) in Opposition to Plaintiff's Motion for a Preliminary Injunction and for Summary Judgment, and in Support of Federal Defendants' Cross-Motion for Summary Judgment by XAVIER BECERRA, ROBERT M. CALIFF, MD, UNITED STATES FOOD AND DRUG ADMINISTRATION. (Schonfeld, Gabriel) |
Filing 45 SEALED DOCUMENT filed by XAVIER BECERRA, ROBERT M. CALIFF, MD, UNITED STATES FOOD AND DRUG ADMINISTRATION. (This document is SEALED and only available to authorized persons.)(zjm) |
Filing 44 SEALED OPPOSITION filed by XAVIER BECERRA, ROBERT M. CALIFF, MD, UNITED STATES FOOD AND DRUG ADMINISTRATION re #4 Motion for Preliminary Injunction, (zjm) |
MINUTE ORDER: Upon consideration of Defendants' sealed motion for leave to file document under seal, Dkt. #38 , it is hereby ORDERED that the motion is GRANTED. Defendants' exhibit is hereby filed under seal. Signed by Judge Randolph D. Moss on 7/8/2023. (lcrdm1) |
Filing 39 RESPONSE re #4 MOTION for Preliminary Injunction and Cross-Motion to Dismiss or, in the Alternative, for Summary Judgment filed by SALIX PHARMACEUTICALS, INC.. (Attachments: #1 Exhibit A, #2 Exhibit B, #3 Exhibit C, #4 Exhibit D, #5 Exhibit E)(Salmons, David) |
Filing 38 SEALED MOTION FOR LEAVE TO FILE DOCUMENT UNDER SEAL filed by XAVIER BECERRA, ROBERT M. CALIFF, MD, UNITED STATES FOOD AND DRUG ADMINISTRATION (This document is SEALED and only available to authorized persons.) (Attachments: #1 Combined Memorandum in Opposition to Plaintiff's Motion for a Preliminary Injunction and for Summary Judgment, and in Support of Federal Defendants' Cross-Motion for Summary Judgment, #2 Certified Index of Administrative Record, #3 Text of Proposed Order)(Schonfeld, Gabriel) |
Filing 37 Cross MOTION for Summary Judgment by XAVIER BECERRA, ROBERT M. CALIFF, MD, UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: #1 Text of Proposed Order Proposed Order)(Schonfeld, Gabriel) |
Filing 36 PROTECTIVE ORDER: Upon consideration of Plaintiffs' motion for stipulated protective order, Dkt. #34 , it is hereby ORDERED that the motion is GRANTED. See document for details. Signed by Judge Randolph D. Moss on 7/6/2023. (lcrdm1) |
Filing 35 NOTICE of Appearance by Gabriella McIntyre on behalf of NORWICH PHARMACEUTICALS, INC. (McIntyre, Gabriella) |
Filing 34 STIPULATION PROPOSED PROTECTIVE ORDER REGARDING ACCESS TO THE ADMINISTRATIVE RECORD by NORWICH PHARMACEUTICALS, INC.. (Landmon, Chad) |
Filing 33 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the United States Attorney. Date of Service Upon United States Attorney on 6/7/2023. Answer due for ALL FEDERAL DEFENDANTS by 8/6/2023. (Landmon, Chad) |
Filing 32 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed on United States Attorney General. Date of Service Upon United States Attorney General 6/12/23. (Landmon, Chad) |
Filing 31 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. UNITED STATES FOOD AND DRUG ADMINISTRATION served on 6/13/2023 (Landmon, Chad) |
Filing 30 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. ROBERT M. CALIFF, MD served on 6/13/2023 (Landmon, Chad) |
Filing 29 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. XAVIER BECERRA served on 6/13/2023 (Landmon, Chad) |
Filing 28 NOTICE of Appearance by Aaron Savit on behalf of NORWICH PHARMACEUTICALS, INC. (Savit, Aaron) |
Filing 27 NOTICE of Appearance by Matthew S. Murphy on behalf of NORWICH PHARMACEUTICALS, INC. (Murphy, Matthew) |
Filing 26 NOTICE of Appearance by Karon Nicole Fowler on behalf of SALIX PHARMACEUTICALS, INC. (Fowler, Karon) |
Filing 25 NOTICE of Appearance by Wan-Shon Lo on behalf of SALIX PHARMACEUTICALS, INC. (Lo, Wan-Shon) |
Filing 24 NOTICE of Appearance by Michael Abernathy on behalf of SALIX PHARMACEUTICALS, INC. (Abernathy, Michael) |
Filing 23 NOTICE of Appearance by William R. Peterson on behalf of SALIX PHARMACEUTICALS, INC. (Peterson, William) |
Filing 22 NOTICE of Appearance by Ross Ericson Blau on behalf of NORWICH PHARMACEUTICALS, INC. (Blau, Ross) |
Filing 21 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Wan-Shon Lo, Filing fee $ 100, receipt number ADCDC-10152704. Fee Status: Fee Paid. by SALIX PHARMACEUTICALS, INC.. (Attachments: #1 Declaration of Wan-Shon Lo, #2 Text of Proposed Order)(Salz, Amanda) |
MINUTE ORDER: Upon consideration of Amanda L. Salz's motion to admit Wan-Shon Lo pro hac vice, Dkt. #21 , it is hereby ORDERED that the motion is GRANTED. Wan-Shon Lo is hereby granted leave to appear pro hac vice in this case. Counsel should register for e-filing via PACER and file a notice of appearance pursuant to LCvR 83.6(a) #Click for instructions. Signed by Judge Randolph D. Moss on 6/20/2023. (lcrdm1) |
MINUTE ORDER: Upon consideration of Plaintiff's motion to admit Ross E. Blau pro hac vice, Dkt. #14 , it is hereby ORDERED that the motion is GRANTED. Ross E. Blau is hereby granted leave to appear pro hac vice in this case. Counsel should register for e-filing via PACER and file a notice of appearance pursuant to LCvR 83.6(a) #Click for instructions. Signed by Judge Randolph D. Moss on 6/18/2023. (lcrdm1) |
MINUTE ORDER: Upon consideration of Plaintiff's motion to admit Matthew S. Murphy pro hac vice, Dkt. #13 , it is hereby ORDERED that the motion is GRANTED. Matthew S. Murphy is hereby granted leave to appear pro hac vice in this case. Counsel should register for e-filing via PACER and file a notice of appearance pursuant to LCvR 83.6(a) #Click for instructions. Signed by Judge Randolph D. Moss on 6/18/2023. (lcrdm1) |
MINUTE ORDER: Upon consideration of the parties' joint status report, Dkt. #8 , it is hereby ORDERED that Plaintiff's motion for a preliminary injunction, Dkt. #4 , will be consolidated with a full consideration of the merits under Federal Rule of Civil Procedure 65(a)(2). It is further ORDERED that the following schedule will govern summary judgment briefing: (1) Defendants shall file their combined opposition to Plaintiff's motion for a preliminary injunction (consolidated with the merits and treated as a summary judgment motion) and cross-motion to dismiss, or, in the alternative, for summary judgment, on or before July 7, 2023; (2) Defendants shall file a certified index of administrative record and serve the administrative record on counsel for Plaintiff on or before July 7, 2023; (3) Plaintiff shall file its reply and cross-opposition on or before July 26, 2023; (4) Defendants shall serve on Plaintiff's counsel designations of any additional record materials that will be cited in Defendants' cross-reply on or before August 14, 2023; (5) Defendants shall file their cross-reply on or before August 16, 2023; and (6) Plaintiff shall file the joint appendix of administrative record on or before August 16, 2023. It is further ORDERED that the deadline for Defendants to answer or otherwise respond to the complaint is STAYED pending resolution of the parties' cross-motions for summary judgment. Signed by Judge Randolph D. Moss on 6/18/2023. (lcrdm1) |
MINUTE ORDER: Upon consideration of Plaintiff's motion to admit Aaron Zvi Savit pro hac vice, Dkt. #16 , it is hereby ORDERED that the motion is GRANTED. Aaron Zvi Savit is hereby granted leave to appear pro hac vice in this case. Counsel should register for e-filing via PACER and file a notice of appearance pursuant to LCvR 83.6(a) #Click for instructions. Signed by Judge Randolph D. Moss on 6/18/2023. (lcrdm1) |
MINUTE ORDER: Upon consideration of Plaintiff's motion for leave to admit Gabriella M. McIntyre pro hac vice, Dkt. #15 , it is hereby ORDERED that the motion is GRANTED in part and DENIED in part. Under the comment to Local Rule 83.2(c)(2), "as a general matter, attorneys who engage in the practice of law from an office located in the District of Columbia and who file papers in this Court should be a member of the Bar of this Court and the District of Columbia Bar." Ms. McIntyre works out of an office in the District of Columbia and is a member of the District of Columbia Bar. Dkt. 15-1 at 1. Accordingly, Ms. McIntyre may not "file papers" in this Court until she has become a member of the Bar of this Court. However, because the comment to Local Rule 83.2(c)(2) only addresses the filing of papers, not appearing more generally, Ms. McIntyre may still appear before this Court while his application is pending. Gabriella M. McIntyre is therefore granted leave to appear pro hac vice in this case, except that she may not file papers in it. Counsel should register for e-filing via PACER and file a notice of appearance pursuant to LCvR 83.6(a) #Click for instructions. Signed by Judge Randolph D. Moss on 6/18/2023. (lcrdm1) |
MINUTE ORDER: Upon consideration of Salix Pharmaceuticals, Inc.'s motion to intervene, Dkt. #12 , and Plaintiff's consent thereto, Dkt. #17 , it is hereby ORDERED that the motion is GRANTED. Signed by Judge Randolph D. Moss on 6/18/2023. (lcrdm1) |
MINUTE ORDER: Upon consideration of Amanda L. Salz's motion to admit William R. Peterson pro hac vice, Dkt. #19 , it is hereby ORDERED that the motion is GRANTED. William R. Peterson is hereby granted leave to appear pro hac vice in this case. Counsel should register for e-filing via PACER and file a notice of appearance pursuant to LCvR 83.6(a) #Click for instructions. Signed by Judge Randolph D. Moss on 6/18/2023. (lcrdm1) |
MINUTE ORDER: Upon consideration of Amanda L. Salz's motion to admit Karon N Fowler pro hac vice, Dkt. #18 , it is hereby ORDERED that the motion is GRANTED. Karon N. Fowler is hereby granted leave to appear pro hac vice in this case. Counsel should register for e-filing via PACER and file a notice of appearance pursuant to LCvR 83.6(a) #Click for instructions. Signed by Judge Randolph D. Moss on 6/18/2023. (lcrdm1) |
MINUTE ORDER: Upon consideration of Amanda L. Salz's motion to admit Michael J. Abernathy pro hac vice, Dkt. #18 , it is hereby ORDERED that the motion is GRANTED. Michael J. Abernathy is hereby granted leave to appear pro hac vice in this case. Counsel should register for e-filing via PACER and file a notice of appearance pursuant to LCvR 83.6(a) #Click for instructions. Signed by Judge Randolph D. Moss on 6/18/2023. (lcrdm1) |
Filing 20 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Karon N. Fowler, Filing fee $ 100, receipt number ADCDC-10148059. Fee Status: Fee Paid. by SALIX PHARMACEUTICALS, INC.. (Attachments: #1 Declaration of Karon N. Fowler, #2 Text of Proposed Order)(Salz, Amanda) |
Filing 19 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- William R. Peterson, Filing fee $ 100, receipt number ADCDC-10148035. Fee Status: Fee Paid. by SALIX PHARMACEUTICALS, INC.. (Attachments: #1 Declaration of William R. Peterson, #2 Text of Proposed Order)(Salz, Amanda) |
Filing 18 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Michael J. Abernathy, Filing fee $ 100, receipt number ADCDC-10147988. Fee Status: Fee Paid. by SALIX PHARMACEUTICALS, INC.. (Attachments: #1 Declaration of Michael J. Abernathy, #2 Text of Proposed Order)(Salz, Amanda) |
Filing 17 RESPONSE re #12 MOTION to Intervene filed by NORWICH PHARMACEUTICALS, INC.. (Landmon, Chad) |
Filing 16 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Aaron Z. Savit, Filing fee $ 100, receipt number ADCDC-10136697. Fee Status: Fee Paid. by NORWICH PHARMACEUTICALS, INC.. (Attachments: #1 Declaration of Aaron Savit, #2 Certificate of Good Standing, #3 Text of Proposed Order)(Landmon, Chad) |
Filing 15 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Gabriella M. McIntyre, Filing fee $ 100, receipt number ADCDC-10136645. Fee Status: Fee Paid. by NORWICH PHARMACEUTICALS, INC.. (Attachments: #1 Declaration of Gabriella M. McIntyre, #2 Certificate of Good Standing, #3 Text of Proposed Order)(Landmon, Chad) |
Filing 14 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Ross E. Blau, Filing fee $ 100, receipt number ADCDC-10136630. Fee Status: Fee Paid. by NORWICH PHARMACEUTICALS, INC.. (Attachments: #1 Declaration of Ross E. Blau, #2 Certificate of Good Standing, #3 Text of Proposed Order)(Landmon, Chad) |
Filing 13 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Matthew S. Murphy, Filing fee $ 100, receipt number ADCDC-10136483. Fee Status: Fee Paid. by NORWICH PHARMACEUTICALS, INC.. (Attachments: #1 Declaration of Matthew S. Murphy, #2 Certificate of Good Standing, #3 Text of Proposed Order)(Landmon, Chad) |
Filing 12 MOTION to Intervene by Salix Pharmaceuticals, Inc.. (Attachments: #1 Memorandum in Support, #2 Exhibit Complaint, #3 Text of Proposed Order)(Salmons, David) |
Filing 11 NOTICE of Appearance by Amanda Leigh Salz on behalf of Salix Pharmaceuticals, Inc. (Salz, Amanda) (Main Document 11 replaced on 6/13/2023) (zjm). NOTICE of Appearance by Amanda Leigh Salz on behalf of Salix Pharmaceuticals, Inc. (Salz, Amanda) (Main Document 11 replaced on 6/13/2023) (zjm). |
Filing 10 NOTICE of Appearance by David B. Salmons on behalf of Salix Pharmaceuticals, Inc. (Salmons, David) (Main Document 10 replaced on 6/13/2023) (zjm). |
Filing 9 NOTICE of Appearance by Gabriel Schonfeld on behalf of All Defendants (Schonfeld, Gabriel) |
Filing 8 Joint STATUS REPORT AND STIPULATED [PROPOSED] SCHEDULING ORDER by NORWICH PHARMACEUTICALS, INC.. (Landmon, Chad) |
Filing 7 STANDING ORDER: The parties are hereby ORDERED to comply with the directives set forth in the attached Standing Order. See document for details. Signed by Judge Randolph D. Moss on 6/9/2023. (lcrdm1) |
MINUTE ORDER: In light of Plaintiff's pending motion for a preliminary injunction, Dkt. #4 , Plaintiff is directed to ensure that Defendants are promptly served. Once Defendants have been served, the parties are ORDERED to meet and confer regarding a briefing schedule for the preliminary injunction motion and to file a joint status report on or before June 12, 2023 with a proposed briefing schedule. Signed by Judge Randolph D. Moss on 6/8/2023. (lcrdm1) |
Filing 6 SUMMONS (5) Issued Electronically as to XAVIER BECERRA, ROBERT M. CALIFF, MD, UNITED STATES FOOD AND DRUG ADMINISTRATION, U.S. Attorney and U.S. Attorney General (Attachments: #1 Notice and Consent)(zcb) |
Case Assigned to Judge Randolph D. Moss. (zcb) |
Filing 5 REQUEST FOR SUMMONS TO ISSUE to the U.S. Attorney & U.S. Attorney General by NORWICH PHARMACEUTICALS, INC. re #1 Complaint, Notice of QC- New Case,, filed by NORWICH PHARMACEUTICALS, INC.. Related document: #1 Complaint, filed by NORWICH PHARMACEUTICALS, INC., Notice of QC- New Case,,. (Attachments: #1 Summons)(Landmon, Chad) |
NOTICE OF ERROR re #1 Complaint; emailed to clandmon@axinn.com, cc'd 2 associated attorneys -- The PDF file you docketed contained errors: 1. Attorney is provisional. Please renew your membership. See https://www.dcd.uscourts.gov/attorney-renewal., 2. Missing summonses-government. When naming a government agent or agency as a defendant, you must supply a summons for each defendant & two additional summonses for the U.S. Attorney & U.S. Attorney General. Please submit using the event Request for Summons to Issue., 3. COMPLIANCE DEADLINE is by close of business today. This case will not proceed any further until all errors are satisfied. (cb, ) |
Filing 4 MOTION for Preliminary Injunction by NORWICH PHARMACEUTICALS, INC.. (Attachments: #1 Memorandum in Support, #2 Declaration of Chad Landmon, #3 Exhibit 1 to Landmon Declaration, #4 Exhibit 2 to Landmon Declaration, #5 Exhibit 3 to Landmon Declaration, #6 Exhibit 4 to Landmon Declaration, #7 Exhibit 5 to Landmon Declaration, #8 Exhibit 6 to Landmon Declaration, #9 Exhibit 7 to Landmon Declaration, #10 Exhibit 8 to Landmon Declaration, #11 Declaration of Tunie Zaku, #12 Text of Proposed Order)(Landmon, Chad) |
Filing 3 LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by NORWICH PHARMACEUTICALS, INC. (Landmon, Chad) |
Filing 2 NOTICE of Appearance by Chad A Landmon on behalf of NORWICH PHARMACEUTICALS, INC. (Landmon, Chad) |
Filing 1 COMPLAINT against XAVIER BECERRA, ROBERT M. CALIFF, MD, UNITED STATES FOOD AND DRUG ADMINISTRATION ( Filing fee $ 402 receipt number ADCDC-10116586) filed by NORWICH PHARMACEUTICALS, INC.. (Attachments: #1 Exhibit 1, #2 Civil Cover Sheet, #3 Summons to Becerra, #4 Summons to Califf, #5 Summons to FDA)(Landmon, Chad) (Attachment 2 replaced on 6/6/2023) (zcb). |
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