Arbor Pharmaceuticals, LLC v. Cochran et al
| Arbor Pharmaceuticals, LLC |
| Norris W. Cochran, IV, Janet Woodcock and United States Food and Drug Administration |
| 1:2021cv00810 |
| February 25, 2021 |
| US District Court for the Northern District of Georgia |
| William M Ray |
| Other Statutes: Administrative Procedures Act/Review or Appeal of Agency Decision |
| 05 U.S.C. § 702 |
| None |
Docket Report
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This docket was last retrieved on April 21, 2021. A more recent docket listing may be available from PACER.
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| Filing 31 Consent MOTION for Order Establishing Page Limits for Combined Summary Judgment Briefs by Norris W. Cochran, IV, United States Food and Drug Administration, Janet Woodcock. (Attachments: #1 Text of Proposed Order)(Kennedy, Scott) |
Filing 30
ORDER GRANTING #29 Unopposed Motion for Leave to File Matters Under Seal. The Court ORDERS that the Clerk of the Court shall enter on the docket under seal the copy of the administrative record labeled "Un-redacted Administrative Record As Supplemented," which has been filed under provisional seal in three parts at Dkt. Nos. 28-1, 28-2, and 28-3. Signed by Judge William M. Ray, II on 4/12/2021. (cmd)
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| Filing 29 Unopposed MOTION for Leave to File Matters Under Seal re: #28 Notice of Filing Un-Redacted Administrative Record As Supplemented with Brief In Support by Norris W. Cochran, IV, United States Food and Drug Administration, Janet Woodcock. (Attachments: #1 Brief in Support, #2 Text of Proposed Order)(Kennedy, Scott) Modified on 4/12/2021 to edit text. (cmd) |
| Filing 28 SEALED NOTICE Of Filing Un-Redacted Administrative Record As Supplemented Under Provisional Seal by Norris W. Cochran, IV, United States Food and Drug Administration, Janet Woodcock re #26 Notice of Filing, #27 Notice of Filing, (Attachments: #1 Exhibit Un-Redacted Administrative Record As Supplemented - Part 1 (FDA001-199), #2 Exhibit Un-Redacted Administrative Record As Supplemented - Part 2 (FDA200-479), #3 Exhibit Un-Redacted Administrative Record As Supplemented - Part 3 (FDA480-485))(Kennedy, Scott) Modified on 4/12/2021 to remove "Provisionally" per #30 Order. (cmd) |
| Filing 27 NOTICE Of Filing Supplemental Redacted Administrative Record and Certified Index by Norris W. Cochran, IV, United States Food and Drug Administration, Janet Woodcock (Attachments: #1 Exhibit Supplemental Redacted Administrative Record)(Kennedy, Scott) |
| Filing 26 NOTICE Of Filing Redacted Administrative Record by Norris W. Cochran, IV, United States Food and Drug Administration, Janet Woodcock (Attachments: #1 Exhibit Redacted Administrative Record - Part 1 (FDA001-199), #2 Exhibit Redacted Administrative Record - Part 2 (FDA200-479))(Kennedy, Scott) |
| Filing 25 MOTION for Summary Judgment Following Consolidation Under Fed. R. Civ. P. 65(a)(2) with Brief In Support by Arbor Pharmaceuticals, LLC. (Attachments: #1 Brief Memorandum in Support of Arbor's Post-Consolidation Motion for Summary Judgment, #2 Text of Proposed Order Proposed Order)(Shumsky, Michael) --Please refer to http://www.gand.uscourts.gov to obtain the Notice to Respond to Summary Judgment Motion form contained on the Court's website.-- |
| Filing 24 NOTICE Of Filing by Norris W. Cochran, IV, United States Food and Drug Administration, Janet Woodcock of Certified Index to Administrative Record (Attachments: #1 Exhibit Certified Index to Administrative Record)(Kennedy, Scott) |
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Filing 23
ORDER granting #22 Motion to Modify Scheduling Order. Defendants shall compile the certified Administrative Record by March 26, 2021. By April 2, 2021, Plaintiff shall inform Defendants of any additional information it believes should be redacted from the Administrative Record before its public filing. By April 9, 2021, Defendants shall file the final agreed-upon redacted version of the Administrative Record on the public docket or notify the Court that disagreements on the redactions remain. All other provisions of the Courts March 16, 2021 scheduling order #21 shall remain in effect. Signed by Judge William M. Ray, II on 3/25/21. (rlb)
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| Filing 22 Joint MOTION for Order Modifying The Court's March 16, 2021 Scheduling Order by Arbor Pharmaceuticals, LLC. (Attachments: #1 Text of Proposed Order Jointly Proposed Order)(Shumsky, Michael) |
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Filing 21
SCHEDULING ORDER granting #20 Joint Motion for Order. Defendants' production of the AR due by 3/26/2021. Plaintiff's MSJ due by 4/9/2021. Defendants' combined opposition and cross-motion due by 4/30/2021. Plaintiff's combined reply and opposition due by 5/21/2021. Defendants' reply due by 6/4/2021. The deadline for Defendants to file a responsive pleading to the Complaint is SUSPENDED pending the Court's resolution of the parties' cross-motions for summary judgment. Signed by Judge William M. Ray, II on 3/16/2021. (cmd)
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| Filing 20 Joint MOTION for Scheduling Order by Norris W. Cochran, IV, United States Food and Drug Administration, Janet Woodcock. (Attachments: #1 Plaintiff's Proposed Order, #2 Defendants' Proposed Order)(Kennedy, Scott) Modified on 3/16/2021 to edit motion relief selected and text. (cmd) |
| Submission of #3 MOTION to Waive Standard Procedures to District Judge William M. Ray, II. (cmd) |
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Filing 19
ELEVENTH AMENDMENT TO GENERAL ORDER 20-01 RE: COURT OPERATIONS UNDER THE EXIGENT CIRCUMSTANCES CREATED BY COVID-19 AND RELATED CORONAVIRUS. Signed by Judge Thomas W. Thrash, Jr. on 03/09/2021 (dgs) (ADI)
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| Filing 18 TRANSCRIPT of Temporary Restraining Order Hearing held on March 1, 2021, before Judge William M. Ray, II. Court Reporter, Wynette C. Blathers. A full directory of court reporters and their contact information can be found at www.gand.uscourts.gov/directory-court-reporters. Transcript may be viewed at the court public terminal or purchased through the Court Reporter before the deadline for Release of Transcript Restriction. After that date it may be obtained through PACER. Redaction Request due 3/29/2021. Redacted Transcript Deadline set for 4/8/2021. Release of Transcript Restriction set for 6/7/2021. (Attachments: #1 Notice of Filing Transcript) (wxb) |
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Filing 17
ORDER: The Court states that it has not made a final decision on the equitable relief sought by Arbor Pharma, even on a preliminary basis. Merely, the Court declines to issue the TRO that Arbor Pharma requests merely 1 week into the life of this case. The consideration of Arbor Pharma's #2 Motion for a preliminary injunction is deferred until the parties have had an opportunity to engage in discovery and will be set down for an evidentiary hearing upon request of the parties. But, the #2 Motion for TRO sought by Arbor Pharma is herein DENIED. Signed by Judge William M. Ray, II on 3/4/2021. (cmd)
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Filing 16
ORDER GRANTING #8 Application for Admission Pro Hac Vice as to Michael Shumsky. Signed by Judge William M. Ray, II on 3/3/2021. If the applicant does not have CM/ECF access in the Northern District of Georgia already, they must request access at http://pacer.gov. If they have electronically filed in this district in a previous case, please omit this step.(cmd)
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Filing 15
ORDER GRANTING #10 Application for Admission Pro Hac Vice as to Michael Heesters. Signed by Judge William M. Ray, II on 3/3/2021. If the applicant does not have CM/ECF access in the Northern District of Georgia already, they must request access at http://pacer.gov. If they have electronically filed in this district in a previous case, please omit this step.(cmd)
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| APPROVAL by Clerks Office re: #10 APPLICATION for Admission of Michael Heesters Pro Hac Vice (Application fee $ 150, receipt number AGANDC-10770390). Attorney Michael Heesters added appearing on behalf of Arbor Pharmaceuticals, LLC (cdg) |
| APPROVAL by Clerks Office re: #8 APPLICATION for Admission of Michael D. Shumsky Pro Hac Vice (Application fee $ 150, receipt number AGANDC-10769524). Attorney Michael D. Shumsky added appearing on behalf of Arbor Pharmaceuticals, LLC (cdg) |
| Clerk's Certificate of Mailing to Michael Shumsky re #16 Order on Application for Admission PHV. (cmd) |
| Clerk's Certificate of Mailing to Michael Heesters re #15 Order on Application for Admission PHV. (cmd) |
| Filing 14 NOTICE of Appearance by Armen Adzhemyan on behalf of Norris W. Cochran, IV, United States Food and Drug Administration, Janet Woodcock (Adzhemyan, Armen) |
| Filing 13 Minute Entry for Zoom proceedings held before Judge William M. Ray, II: Motion Hearing held on 3/1/2021 TAKING UNDER ADVISEMENT #2 MOTION for Temporary Restraining Order. (Court Reporter Wynette Blathers)(jkl) |
| Filing 12 RESPONSE in Opposition re #2 MOTION for Temporary Restraining Order , MOTION for Preliminary Injunction filed by Norris W. Cochran, IV, United States Food and Drug Administration, Janet Woodcock. (Attachments: #1 Exhibit 1, #2 Exhibit 2)(Kennedy, Scott) Modified on 3/2/2021 to edit text. (cmd) |
| Filing 11 NOTICE of Appearance by Scott P. Kennedy on behalf of Norris W. Cochran, IV, United States Food and Drug Administration, Janet Woodcock (Kennedy, Scott) |
| Filing 10 APPLICATION for Admission of Michael Heesters Pro Hac Vice (Application fee $ 150, receipt number AGANDC-10770390).by Arbor Pharmaceuticals, LLC. (Marshall, Edward) Documents for this entry are not available for viewing outside the courthouse. |
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Filing 9
ORDER Setting Hearing on Motion re #2 MOTION for Temporary Restraining Order: Motion Hearing set for 3/1/2021 at 02:00 PM on Zoom before Judge William M. Ray, II. It is further Ordered that Plaintiff must immediately and without delay provide notice of the hearing to counsel and representatives of all Defendants, including the Zoom instructions. Signed by Judge William M. Ray, II on 2/26/2021. (cmd)
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| Filing 8 APPLICATION for Admission of Michael D. Shumsky Pro Hac Vice (Application fee $ 150, receipt number AGANDC-10769524).by Arbor Pharmaceuticals, LLC. (Marshall, Edward) Documents for this entry are not available for viewing outside the courthouse. |
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Filing 7
TENTH AMENDMENT TO GENERAL ORDER 20-01 RE: COURT OPERATIONS UNDER THE EXIGENT CIRCUMSTANCES CREATED BY COVID-19 AND RELATED CORONAVIRUS. Signed by Judge Thomas W. Thrash, Jr. on 1/27/2021. (cmd)
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| Filing 6 Electronic Summons Issued as to United States Food and Drug Administration. (cmd) |
| Filing 5 Electronic Summons Issued as to Janet Woodcock. (cmd) |
| Filing 4 Electronic Summons Issued as to Norris W. Cochran, IV. (cmd) |
| Submission of #2 MOTION for Temporary Restraining Order, MOTION for Preliminary Injunction to District Judge William M. Ray, II. (cmd) |
| Filing 3 MOTION to Waive Standard Procedures by Arbor Pharmaceuticals, LLC. (cmd) |
| Filing 2 MOTION for Temporary Restraining Order, MOTION for Preliminary Injunction with Brief In Support by Arbor Pharmaceuticals, LLC. IMMEDIATE HEARING REQUESTED (Attachments: #1 Brief in Support, #2 Exhibit A - Rowland Declaration, #3 Text of Proposed Order)(cmd) |
| Filing 1 COMPLAINT filed by Arbor Pharmaceuticals, LLC. (Filing fee $402, receipt number AGANDC-10766859) (Attachments: #1 Exhibit A - Annora Letter (w FR notice), 2-17-21, #2 Exhibit B - Windels Letter (w FR Notice), 2-17-21, #3 Exhibit C - Annora CP, 6-6-20, #4 Exhibit D - Windels CP, 6-10-20, #5 Exhibit E - 2013 Nymalize PI, #6 Exhibit F - 2020 Nymalize PI, #7 Exhibit G - Nymalize Approval Letter, #8 Exhibit H - Labeling and Labeling Review, #9 Exhibit I - Arbor's response to CPs, 6-29-20, #10 Exhibit J - Brevibloc letter with FR attached, 5-5-10, #11 Exhibit K - Protonix Final Decision, 11-28-16, #12 Civil Cover Sheet)(cmd) Please visit our website at http://www.gand.uscourts.gov/commonly-used-forms to obtain Pretrial Instructions and Pretrial Associated Forms which includes the Consent To Proceed Before U.S. Magistrate form. |
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