Outsourcing v. FDA
| Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners, doing business as FarmaKeio Superior Custom Compounding |
| Food & Drug Administration and Marty Makary, Commissioner, U.S. Food and Drug Administration |
| Novo Nordisk, Incorporated |
| Pharmaceutical Research and Manufacturers of America, Association for Accessible Medicines, Andrew Von Eschenbach, Margaret Hamburg, Stephen Ostroff and Robert Califf |
| 25-10758 |
| June 20, 2025 |
| U.S. Court of Appeals, Fifth Circuit |
| Other Statutes |
Opinions
We have the following opinions for this case:
| Description |
|---|
| Outsourcing Facilities Association v. FDA |
| Outsourcing Facilities Association v. FDA |
Docket Report
RSS Track this Docket
This docket was last retrieved on December 9, 2025. A more recent docket listing may be available from PACER.
| Document Text |
|---|
| Filing 126 APPEARANCE FORM FILED by Attorney Eva Temkin for Amicus Curiae Pharmaceutical Research and Manufacturers of America in 25-10758 [25-10758] (RSM) [Entered: 12/09/2025 02:46 PM] |
| Filing 125 ATTORNEY NOT PARTICIPATING. Eva Temkin is designated as inactive in this case. Reason:not participating. [25-10758] (RSM) [Entered: 12/09/2025 01:00 PM] |
| Filing 124 Paper copies of Amicus Brief filed by Pharmaceutical Research and Manufacturers of America, Association for Accessible Medicines and Amicus Curiae Pharmaceutical Research and Manufacturers of America in 25-10758 received. Paper copies match electronic version of document? Yes # of Copies Provided: 7. [25-10758] (RSM) [Entered: 12/09/2025 12:35 PM] |
| Filing 122 APPEARANCE FORM FILED by Attorney Sean Michael Marotta for Amicus Curiae Robert Califf in 25-10758, Attorney Sean Michael Marotta for Amicus Curiae Stephen Ostroff in 25-10758, Attorney Sean Michael Marotta for Amicus Curiae Margaret Hamburg in 25-10758, Attorney Sean Michael Marotta for Amicus Curiae Andrew Von Eschenbach in 25-10758 [25-10758] (RSM) [Entered: 12/05/2025 11:47 AM] |
| Filing 120 APPEARANCE FORM FILED by Attorney(s) Bonnie Elizabeth Devany for party(s) Amicus Curiae Pharmaceutical Research and Manufacturers of America, in case 25-10758 [25-10758] (RSM) [Entered: 12/05/2025 11:37 AM] |
| Filing 118 APPEARANCE FORM FILED by Attorney(s) Wesley Weeks for party(s) Amicus Curiae Association for Accessible Medicines, in case 25-10758 [25-10758] (RSM) [Entered: 12/05/2025 10:54 AM] |
| Filing 116 APPEARANCE FORM FILED by Attorney(s) Megan Leef Brown for party(s) Amicus Curiae Association for Accessible Medicines, in case 25-10758 [25-10758] (RSM) [Entered: 12/05/2025 10:52 AM] |
| Filing 114 CLERK ORDER granting Motion to extend time to file reply brief filed by Appellants Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners [ # 110 ] Reply Brief deadline updated to 12/30/2025 for Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association [25-10758] (EMF) [Entered: 12/03/2025 11:57 AM] |
| Filing 110 UNOPPOSED MOTION filed by Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association to extend time to file reply brief until 12/30/2025 [110]. Date of service: 12/03/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Graham, Hixson, Houle, McDonald, Quallen, Randolph, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; Attorney for Amici Curiae: Marotta, Temkin; US mail - Attorney for Appellant: Kustoff [25-10758] (Andrew Michael Grossman ) [Entered: 12/03/2025 08:43 AM] |
| Filing 109 PROPOSED SUFFICIENT BRIEF filed by Amici Curiae Mr. Robert Califf, Mr. Stephen Ostroff, Ms. Margaret Hamburg and Andrew Von Eschenbach [ # 108 ] Date of service: 12/02/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Graham, Hixson, Houle, McDonald, Quallen, Randolph, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Kustoff, Raile, Shapiro; Attorney for Amici Curiae: Marotta, Temkin [25-10758] (Sean Michael Marotta ) [Entered: 12/02/2025 03:27 PM] |
| Filing 108 SUFFICIENT AMICUS CURIAE BRIEF FILED by Mr. Robert Califf, Ms. Margaret Hamburg, Mr. Stephen Ostroff and Andrew Von Eschenbach. The Consent is Included in the Brief. # of Copies Provided: 0 Sufficient Brief deadline satisfied [25-10758] REVIEWED AND/OR EDITED - The original text prior to review appeared as follows: AMICUS CURIAE BRIEF FILED by Mr. Robert Califf, Mr. Stephen Ostroff, Ms. Margaret Hamburg and Andrew Von Eschenbach. The Consent is Included in the Brief. Additionally the Brief requires INSUFFICIENT FOR: MISSING SUPPLEMENTAL CERTIFICATE OF INTERESTED PARTIES. Instructions to Attorney: PLEASE READ THE ATTACHED NOTICE FOR INSTRUCTIONS ON HOW TO REMEDY THE DEFAULT. # of Copies Provided: 0 Sufficient Brief due on 12/15/2025 for Amici Curiae Andrew Von Eschenbach, Margaret Hamburg, Stephen Ostroff and Robert Califf. [25-10758] REVIEWED AND/OR EDITED - The original text prior to review appeared as follows: AMICUS CURIAE BRIEF FILED by Andrew von Eschenbach, Margaret Hamburg, Stephen Ostroff and Robert Califf. Date of service: 12/01/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Graham, Hixson, Houle, McDonald, Quallen, Randolph, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Kustoff, Raile, Shapiro [25-10758] (Sean Michael Marotta ) [Entered: 12/01/2025 07:00 PM] |
| Filing 107 APPEARANCE FORM for the court's review. Lead Counsel? Yes. [25-10758] (Sean Michael Marotta ) [Entered: 12/01/2025 06:50 PM] |
| Filing 106 AMICUS CURIAE BRIEF FILED by Association for Accessible Medicines and Pharmaceutical Research and Manufacturers of America. The Consent is Included in the Brief. # of Copies Provided: 0 [25-10758] REVIEWED AND/OR EDITED - The original text prior to review appeared as follows: AMICUS CURIAE BRIEF FILED by Pharmaceutical Research and Manufacturers of America and Association for Accessible Medicines. Date of service: 12/01/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Graham, Hixson, Houle, McDonald, Quallen, Randolph, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; US mail - Attorney for Appellant: Kustoff [25-10758] (Eva Temkin ) [Entered: 12/01/2025 06:47 PM] |
| Filing 105 APPEARANCE FORM for the court's review. Lead Counsel? No. [25-10758] (Bonnie Elizabeth Devany ) [Entered: 12/01/2025 06:22 PM] |
| Filing 104 APPEARANCE FORM for the court's review. Lead Counsel? Yes. [25-10758] (Eva Temkin ) [Entered: 12/01/2025 06:17 PM] |
| Filing 103 APPEARANCE FORM for the court's review. Lead Counsel? No. [25-10758] (Wesley Weeks ) [Entered: 12/01/2025 03:56 PM] |
| Filing 98 APPEARANCE FORM for the court's review. Lead Counsel? Yes. [25-10758] (Megan Leef Brown ) [Entered: 12/01/2025 10:36 AM] |
| Filing 115 RECORD EXCERPTS FILED by Appellee Novo Nordisk, Incorporated. [25-10758] (EMF) [Entered: 12/03/2025 04:19 PM] |
| Filing 102 APPELLEE'S BRIEF FILED by Novo Nordisk, Incorporated. E/Res's Brief deadline satisfied. Reply Brief due on 12/15/2025 for Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association [25-10758] (EMF) [Entered: 12/01/2025 02:01 PM] |
| Filing 101 UNOPPOSED MOTION filed by Appellee Novo Nordisk, Incorporated to place record excerpts under seal [101], to place brief under seal [101]. Date of service: 11/24/2025 [25-10758] (EMF) [Entered: 12/01/2025 01:58 PM] |
| Filing 100 APPELLEE'S BRIEF FILED by FDA and Mr. Marty Makary, Commissioner, U.S. Food and Drug Administration. E/Res's Brief deadline satisfied [25-10758] (EMF) [Entered: 12/01/2025 01:50 PM] |
| Filing 99 UNOPPOSED MOTION filed by Appellees FDA and Mr. Marty Makary, Commissioner, U.S. Food and Drug Administration to place brief under seal [99]. Date of service: 11/24/2025 [25-10758] (EMF) [Entered: 12/01/2025 01:44 PM] |
| Filing 97 MOTION AND/OR DOCUMENT UNDER TEMPORARY SEAL pending a ruling by the court filed by Appellee Novo Nordisk, IncorporatedThis document is unopposed. Date of service: 11/24/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Graham, Hixson, Houle, McDonald, Quallen, Randolph, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; US mail - Attorney for Appellant: Kustoff [25-10758] (Benjamin C. Block ) [Entered: 11/24/2025 06:12 PM] |
| Filing 96 MOTION AND/OR DOCUMENT UNDER TEMPORARY SEAL pending a ruling by the court filed by Appellees FDA and Mr. Marty Makary, Commissioner, U.S. Food and Drug AdministrationThis document is unopposed. Date of service: 11/24/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Graham, Hixson, Houle, McDonald, Quallen, Randolph, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; US mail - Attorney for Appellant: Kustoff [25-10758] (Caroline W. Tan ) [Entered: 11/24/2025 05:11 PM] |
| Filing 94 APPEARANCE FORM FILED by Attorney(s) Christine Houle for party(s) Appellee Novo Nordisk, Incorporated, in case 25-10758 [25-10758] (NMF) [Entered: 11/20/2025 02:17 PM] |
| Filing 92 APPEARANCE FORM FILED by Attorney(s) Matthew Chauvin Quallen for party(s) Appellee Novo Nordisk, Incorporated, in case 25-10758 [25-10758] (NMF) [Entered: 11/20/2025 12:57 PM] |
| Filing 90 APPEARANCE FORM FILED by Attorney(s) Emma Keteltas Graham for party(s) Appellee Novo Nordisk, Incorporated, in case 25-10758 [25-10758] (NMF) [Entered: 11/20/2025 12:49 PM] |
| Filing 89 APPEARANCE FORM for the court's review. Lead Counsel? No. [25-10758] (Christine Houle ) [Entered: 11/19/2025 01:51 PM] |
| Filing 88 APPEARANCE FORM for the court's review. Lead Counsel? No. [25-10758] (Matthew Chauvin Quallen ) [Entered: 11/19/2025 01:49 PM] |
| Filing 87 APPEARANCE FORM for the court's review. Lead Counsel? No. [25-10758] (Emma Keteltas Graham ) [Entered: 11/19/2025 01:32 PM] |
| Filing 86 CLERK ORDER granting Motion to extend time to file appellee's brief filed by Appellee Novo Nordisk, Incorporated [ # 82 ] Appellee's Brief due on 11/24/2025 for Appellee Novo Nordisk, Incorporated [25-10758] (MBC) [Entered: 11/05/2025 04:00 PM] |
| Filing 82 UNOPPOSED MOTION filed by Appellee Novo Nordisk, Incorporated to extend time to file brief of appellee until 11/24/2025 [82]. Date of service: 10/31/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Hixson, McDonald, Randolph, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Kustoff, Raile, Shapiro; US mail - Attorney for Appellant: Kustoff [25-10758] (Benjamin C. Block ) [Entered: 10/31/2025 01:20 PM] |
| Filing 81 COURT ORDER denying Motion to suspend briefing notice pending the restoration of appropriations to the Department of Justice filed by Appellees FDA and Mr. Marty Makary, Commissioner, U.S. Food and Drug Administration [ # 76 ]; However, the deadline for filing their brief is sua sponte extended by fourteen days [81] Appellee's Brief due on 11/24/2025 for Appellees Food & Drug Administration and Marty Makary, Commissioner, U.S. Food and Drug Administration [25-10758] (LEF) [Entered: 10/28/2025 11:25 AM] |
| Filing 76 UNOPPOSED MOTION filed by Appellees FDA and Mr. Marty Makary, Commissioner, U.S. Food and Drug Administration to suspend briefing notice dated 07/15/2025 [76]. Date of service: 10/27/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Hixson, McDonald, Randolph, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; US mail - Attorney for Appellant: Kustoff [25-10758] (Caroline W. Tan ) [Entered: 10/27/2025 11:55 AM] |
| Filing 75 One Paper copy of SEALED Record Excerpts filed by Appellants Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners in 25-10758 , One Paper copy of REDACTED Record Excerpts filed by Appellants Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners in 25-10758 received. Paper copies match electronic version of document? Yes (IF THE COURT SHOULD CALL FOR ADDITIONAL PAPER COPIES IN THE FUTURE, THE RECORD EXCERPTS MUST BE TABBED.) # of Copies Provided: 1. [25-10758] (SME) [Entered: 09/17/2025 08:47 AM] |
| Filing 74 One Paper copy of SEALED Appellant Brief filed by Appellants Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners in 25-10758 , One Paper copy of REDACTED Appellant Brief filed by Appellants Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners in 25-10758 received. Paper copies match electronic version of document? Yes # of Copies Provided: 1. [25-10758] (SME) [Entered: 09/17/2025 08:43 AM] |
| Filing 72 CLERK ORDER granting Motion to file record excerpts in excess pages. filed by Appellants Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners [ # 68 ] The clerk is granting your unopposed motion for the Court subject to possible reconsideration by the merits panel at a later date. [25-10758] (EMF) [Entered: 09/11/2025 09:00 AM] |
| Filing 68 UNOPPOSED MOTION filed by Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association to file record excerpts in excess pages [68]. Date of service: 09/09/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Hixson, McDonald, Randolph, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Kustoff, Raile, Shapiro [25-10758] (Andrew Michael Grossman ) [Entered: 09/09/2025 03:21 PM] |
| Filing 66 REDACTED RECORD EXCERPTS FILED. # of Copies Provided: 0. [25-10758] REVIEWED AND/OR EDITED - The original text prior to review appeared as follows: REDACTED RECORD EXCERPTS FILED by Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association. Date of service: 09/08/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Hixson, McDonald, Randolph, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Kustoff, Raile, Shapiro [25-10758] (Andrew Michael Grossman ) [Entered: 09/08/2025 03:12 PM] |
| Filing 65 REDACTED APPELLANT'S BRIEF FILED. # of Copies Provided: 0. [25-10758] REVIEWED AND/OR EDITED - The original text prior to review appeared as follows: REDACTED APPELLANT'S BRIEF FILED by North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association. Date of service: 09/08/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Hixson, McDonald, Randolph, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Kustoff, Raile, Shapiro [25-10758] (Andrew Michael Grossman ) [Entered: 09/08/2025 03:08 PM] |
| Filing 63 APPEARANCE FORM FILED by Attorney Thomas Ross Brugato for Appellee Novo Nordisk, Incorporated in 25-10758 [25-10758] (RLJ) [Entered: 09/05/2025 10:03 AM] |
| Filing 61 APPEARANCE FORM FILED by Attorney(s) Daniel Gerard Randolph for party(s) Appellee Novo Nordisk, Incorporated, in case 25-10758 [25-10758] (RLJ) [Entered: 09/05/2025 09:56 AM] |
| Filing 60 CLERK ORDER granting Motion to extend time to file appellee's brief filed by Appellee Novo Nordisk, Incorporated [ # 55 ]. Appellee's Brief due on 11/10/2025 for Appellee Novo Nordisk, Incorporated [25-10758] (CAG) [Entered: 09/05/2025 08:27 AM] |
| Filing 67 DOCUMENT RECEIVED - NO ACTION TAKEN. No action will be taken at this time on the motion to file record excerpts in excess of optional contents received from Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association because the motion must be filed as a separate docket event [25-10758] (RSM) [Entered: 09/09/2025 01:49 PM] |
| Filing 56 PROPOSED SUFFICIENT RECORD EXCERPTS filed by Appellants Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners in 25-10758 [ # 42 ] Record Excerpts have been deemed insufficient. Corrections required: INSUFFICIENT FOR: OPTIONAL CONTENTS EXCEED THE 40 PAGE LIMIT - MOTION PENDING. Instructions to Attorney: PLEASE READ THE ATTACHED NOTICE FOR INSTRUCTIONS ON HOW TO REMEDY THE DEFAULT. Sufficient Record Excerpts deadline updated to 09/23/2025 for Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association [25-10758] REVIEWED AND/OR EDITED - The original text prior to review appeared as follows: PROPOSED SUFFICIENT RECORD EXCERPTS filed by Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association [ # 42 ] Date of service: 09/03/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Hixson, McDonald, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Kustoff, Raile, Shapiro [25-10758] (Andrew Michael Grossman ) [Entered: 09/03/2025 03:10 PM] |
| Filing 55 UNOPPOSED MOTION filed by Appellee Novo Nordisk, Incorporated to extend time to file brief of appellee until 11/10/2025 [55]. Date of service: 09/03/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Hixson, McDonald, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; US mail - Attorney for Appellant: Kustoff [25-10758] (Benjamin C. Block ) [Entered: 09/03/2025 10:56 AM] |
| Filing 54 APPEARANCE FORM for the court's review. Lead Counsel? No. [25-10758] (Thomas Ross Brugato ) [Entered: 09/03/2025 09:34 AM] |
| Filing 53 APPEARANCE FORM for the court's review. Lead Counsel? No. [25-10758] (Daniel Gerard Randolph ) [Entered: 09/03/2025 08:43 AM] |
| Filing 52 CLERK ORDER granting Motion to extend time to file appellee's brief filed by Appellees FDA and Mr. Marty Makary, Commissioner, U.S. Food and Drug Administration [ # 47 ] Appellee's Brief due on 11/10/2025 for Appellees Food & Drug Administration and Marty Makary, Commissioner, U.S. Food and Drug Administration [25-10758] (MBC) [Entered: 08/29/2025 03:49 PM] |
| Filing 50 COURT ORDER granting Motion to place brief under seal [ # 40 ]; granting Motion to place record excerpts under seal [ # 40 ] Miscellaneous due on 09/08/2025 for Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association for redacted record excerpts. [25-10758] (RSM) [Entered: 08/29/2025 01:09 PM] |
| Filing 47 UNOPPOSED MOTION filed by Appellees FDA and Mr. Marty Makary, Commissioner, U.S. Food and Drug Administration to extend time to file brief of appellee until 11/10/2025 [47]. Date of service: 08/28/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Hixson, McDonald, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Kustoff, Raile, Shapiro [25-10758] (Caroline W. Tan ) [Entered: 08/28/2025 09:03 PM] |
| Filing 40 UNOPPOSED MOTION to place brief under seal [40], to place record excerpts under seal [40]. Date of service: 08/25/2025 [25-10758] (SR) [Entered: 08/28/2025 01:31 PM] |
| Filing 42 SUFFICIENT RECORD EXCERPTS FILED. Sufficient Record Excerpts deadline satisfied [25-10758] REVIEWED AND/OR EDITED - The original text prior to review appeared as follows: RECORD EXCERPTS FILED by Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association. Record Excerpts NOT Sufficient as they require final judgment and a motion to exceed tohe optional contents page limitation. Optional contents exceed page limitations by 11 pages. Instructions to Attorney: PLEASE READ THE ATTACHED NOTICE FOR INSTRUCTIONS ON HOW TO REMEDY THE DEFAULT. # of Copies Provided: 0 Sufficient Record Excerpts due on 09/08/2025 for Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association [25-10758] (SR) [Entered: 08/28/2025 02:22 PM] |
| Filing 41 APPELLANT'S BRIEF FILED by North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association. # of Copies Provided: 0 A/Pet's Brief deadline satisfied. Appellee's Brief due on 09/24/2025 for Appellees Food & Drug Administration, Marty Makary, Commissioner, U.S. Food and Drug Administration and Novo Nordisk, Incorporated [25-10758] (SR) [Entered: 08/28/2025 02:10 PM] |
| Filing 39 MOTION AND/OR DOCUMENT UNDER TEMPORARY SEAL pending a ruling by the court filed by Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities AssociationThis document is unopposed. Date of service: 08/25/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Hixson, McDonald, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Kustoff, Raile, Shapiro [25-10758] (Andrew Michael Grossman ) [Entered: 08/25/2025 04:07 PM] |
| Filing 38 COURT ORDER granting Motion to view and obtain sealed document filed by Appellees FDA, Novo Nordisk, Incorporated, Mr. Marty Makary, Commissioner, U.S. Food and Drug Administration and Appellants Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners [ # 33 ] [25-10758] (MBC) [Entered: 08/07/2025 09:20 AM] |
| Filing 33 UNOPPOSED JOINT STIPULATION filed by Appellants Outsourcing Facilities Association, North American Custom Laboratories, L.L.C. Partners and Appellees Novo Nordisk, Incorporated, Mr. Marty Makary, Commissioner, U.S. Food and Drug Administration and FDA to view and obtain sealed document Date of Service: 08/01/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Hixson, McDonald, Tan, Tenny; Attorney for Appellants: Doyle, Grossman, Kustoff, Raile, Shapiro. [25-10758] (Andrew Michael Grossman ) [Entered: 08/01/2025 09:34 AM] |
| Filing 32 BRIEFING NOTICE ISSUED A/Pet's Brief Due on 08/25/2025 for Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association. [25-10758] (DDL) [Entered: 07/15/2025 07:53 AM] |
| Filing 31 ELECTRONIC RECORD ON APPEAL FILED. Admitted Exhibits on File in District Court? No. Video/Audio Exhibits on File in District Court? No Electronic ROA deadline satisfied. [25-10758] (DDL) [Entered: 07/15/2025 07:52 AM] |
| Filing 29 APPEARANCE FORM FILED by Attorney(s) Daniel Bentele Hahs Tenny for party(s) Appellee Marty Makary, Commissioner, U.S. Food and Drug Administration Appellee FDA, in case 25-10758 [25-10758] (PAC) [Entered: 07/10/2025 03:52 PM] |
| Filing 28 TRANSCRIPT ORDER received from Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association advising transcript unnecessary for appeal purposes - No hearings. [25-10758] (PAC) [Entered: 07/10/2025 11:31 AM] |
| Filing 27 APPEARANCE FORM for the court's review. Lead Counsel? No. [25-10758] (Daniel Bentele Hahs Tenny ) [Entered: 07/09/2025 06:29 PM] |
| Filing 25 APPEARANCE FORM FILED by Attorney(s) Richard Bryan Raile for party(s) Appellant Outsourcing Facilities Association Appellant North American Custom Laboratories, L.L.C. Partners, in case 25-10758 [25-10758] (RSM) [Entered: 07/09/2025 01:52 PM] |
| Filing 23 APPEARANCE FORM FILED by Attorney(s) Kristin Ann Shapiro for party(s) Appellant Outsourcing Facilities Association Appellant North American Custom Laboratories, L.L.C. Partners, in case 25-10758 [25-10758] (RSM) [Entered: 07/09/2025 01:38 PM] |
| Filing 21 APPEARANCE FORM FILED by Attorney Tyler Geoffrey Doyle for Appellant North American Custom Laboratories, L.L.C. Partners in 25-10758, Attorney Tyler Geoffrey Doyle for Appellant Outsourcing Facilities Association in 25-10758 [25-10758] (RSM) [Entered: 07/09/2025 01:29 PM] |
| Filing 19 APPEARANCE FORM FILED by Attorney Andrew Michael Grossman for Appellant North American Custom Laboratories, L.L.C. Partners in 25-10758, Attorney Andrew Michael Grossman for Appellant Outsourcing Facilities Association in 25-10758 [25-10758] (RSM) [Entered: 07/09/2025 01:20 PM] |
| Filing 18 ATTORNEY TRANSCRIPT ORDER form filed by Appellants Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partnersfor the Court to process. Date of service: 07/07/2025 via email - Attorney for Appellees: Block, Brugato, Carolan, Fillmore, Hixson, McDonald, Tan; Attorney for Appellants: Doyle, Grossman, Kustoff. [25-10758] (Andrew Michael Grossman ) [Entered: 07/07/2025 09:53 AM] |
| Filing 17 APPEARANCE FORM for the court's review. Lead Counsel? No. [25-10758] (Richard Bryan Raile ) [Entered: 07/07/2025 09:47 AM] |
| Filing 16 APPEARANCE FORM for the court's review. Lead Counsel? No. [25-10758] (Kristin Ann Shapiro ) [Entered: 07/07/2025 09:46 AM] |
| Filing 15 APPEARANCE FORM received from Mr. Tyler Geoffrey Doyle for North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association for the court's review. Lead Counsel? No. [25-10758] (Tyler Geoffrey Doyle ) [Entered: 07/07/2025 09:45 AM] |
| Filing 14 APPEARANCE FORM received from Mr. Andrew Michael Grossman for North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association for the court's review. Lead Counsel? Yes. [25-10758] (Andrew Michael Grossman ) [Entered: 07/07/2025 09:43 AM] |
| Filing 12 APPEARANCE FORM FILED by Attorney(s) Caroline W. Tan for party(s) Appellee Marty Makary, Commissioner, U.S. Food and Drug Administration Appellee FDA, in case 25-10758 [25-10758] (EMF) [Entered: 07/07/2025 09:12 AM] |
| Filing 11 APPEARANCE FORM for the court's review. Lead Counsel? Yes. [25-10758] (Caroline W. Tan ) [Entered: 07/03/2025 12:43 PM] |
| Filing 10 APPEARANCE FORM FILED by Attorney Benjamin C. Block for Appellee Novo Nordisk, Incorporated in 25-10758 [25-10758] (EMF) [Entered: 07/01/2025 04:19 PM] |
| Filing 9 APPEARANCE FORM received from Mr. Benjamin C. Block for Novo Nordisk, Incorporated for the court's review. Lead Counsel? Yes. [25-10758] (Benjamin C. Block ) [Entered: 07/01/2025 12:41 PM] |
| Filing 8 ELECTRONIC RECORD ON APPEAL REQUESTED from District Court for 4:25-CV-174. Electronic ROA due on 07/15/2025. [25-10758] (RLJ) [Entered: 06/30/2025 03:44 PM] |
| Filing 7 INITIAL CASE CHECK by Attorney Advisor complete. Action: Case OK to Process. [7] Initial AA Check Due satisfied. [25-10758] (RLJ) [Entered: 06/30/2025 03:39 PM] |
| Filing 3 US CIVIL CASE docketed. NOA filed by Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association [25-10758] (RLJ) [Entered: 06/20/2025 01:17 PM] |
| Filing 2 CASE CAPTION updated. Party information modified for Novo Nordisk, Incorporated in 25-10758. [25-10758] (RLJ) [Entered: 06/20/2025 01:13 PM] |
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