Outsourcing Facilities v. FDA
| Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners, doing business as Farmakeio Custom Compounding |
| Food & Drug Administration, Dr. Robert M. Califf and Dr. Marty Makary, Commissioner, U.S. Food and Drug Administration |
| Eli Lilly and Company |
| 25-10600 |
| May 12, 2025 |
| U.S. Court of Appeals, Fifth Circuit |
| Other Statutes |
Docket Report
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| Filing 85 COURT ORDER granting 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 [ # 77 ] E/Res's Brief deadline canceled [25-10600] (LEF) [Entered: 10/03/2025 04:12 PM] |
| Filing 77 UNOPPOSED MOTION to suspend briefing notice dated 06/20/2025 [77]. [25-10600] REVIEWED AND/OR EDITED - The original text prior to review appeared as follows: UNOPPOSED MOTION filed by Appellees Mr. Marty Makary, Commissioner, U.S. Food and Drug Administration and FDA to extend time to file brief of appellee [77]. Date of service: 10/01/2025 via email - Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; Attorney for Appellees: Eiswald, Kelly, Murphy, Rowen, Tan, Tenny; US mail - Attorney for Appellee: Stephens [25-10600] (Caroline W. Tan ) [Entered: 10/01/2025 02:38 PM] |
| Filing 75 REDACTED RECORD EXCERPTS FILED. # of Copies Provided: 0 [25-10600] 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: 08/22/2025 via email - Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; Attorney for Appellees: Eiswald, Kelly, Murphy, Rowen, Tan, Tenny; US mail - Attorney for Appellee: Stephens [25-10600] (Andrew Michael Grossman ) [Entered: 08/22/2025 04:08 PM] |
| Filing 73 REDACTED APPELLANT'S BRIEF FILED Additionally the Brief requires INSUFFICIENT FOR: REDACTED RECORD EXCERPTS MUST BE FILED AS A SEPARATE DOCKET EVENT. Instructions to Attorney: PLEASE READ THE ATTACHED NOTICE FOR INSTRUCTIONS ON HOW TO REMEDY THE DEFAULT. # of Copies Provided: 0 [25-10600] 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: 08/21/2025 via email - Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; Attorney for Appellees: Eiswald, Kelly, Murphy, Rowen, Stephens, Tan, Tenny [25-10600] (Andrew Michael Grossman ) [Entered: 08/21/2025 08:34 AM] |
| Filing 72 CLERK ORDER granting Motion to extend time to file appellee's brief filed by Appellee Eli Lilly and Company [ # 68 ] Appellee's Brief due on 10/03/2025 for Appellee Eli Lilly and Company [25-10600] (RLJ) [Entered: 08/13/2025 10:59 AM] |
| Filing 68 UNOPPOSED MOTION filed by Appellee Eli Lilly and Company to extend time to file brief of appellee until 10/03/2025 [68]. Date of service: 08/12/2025 via email - Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; Attorney for Appellees: Eiswald, Kelly, Murphy, Rowen, Stephens, Tan, Tenny [25-10600] (Erin Murphy ) [Entered: 08/12/2025 08:51 AM] |
| Filing 67 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 [ # 63 ] Appellee's Brief due on 10/03/2025 for Appellees Food & Drug Administration and Marty Makary, Commissioner, U.S. Food and Drug Administration. No action is being taken on the request for an extension for Appellee Eli Lilly and Company because counsel cannot request an extension on behalf of a party she does not represent. A separate request for an extension must be filed by their counsel. [25-10600] (LEF) [Entered: 08/11/2025 02:46 PM] |
| Filing 63 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 10/03/2025 [63]. Date of service: 08/08/2025 via email - Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; Attorney for Appellees: Eiswald, Kelly, Murphy, Rowen, Tan, Tenny; US mail - Attorney for Appellee: Stephens [25-10600] (Caroline W. Tan ) [Entered: 08/08/2025 12:10 PM] |
| Filing 62 COURT ORDER granting Motion to place brief under seal filed by Appellants Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners [ # 55 ]; granting Motion to place record excerpts under seal filed by Appellants Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners [ # 55 ] Miscellaneous due on 08/21/2025 for Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association (redacted brief and redacted record excerpts to be filed) [25-10600] (LEF) [Entered: 08/07/2025 12:32 PM] |
| Filing 57 RECORD EXCERPTS FILED by Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association. # of Copies Provided: 0 [25-10600] (LEF) [Entered: 08/05/2025 01:48 PM] |
| Filing 56 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 08/29/2025 for Appellees Eli Lilly and Company, Food & Drug Administration and Marty Makary, Commissioner, U.S. Food and Drug Administration [25-10600] (LEF) [Entered: 08/05/2025 01:43 PM] |
| Filing 55 UNOPPOSED MOTION filed by Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association to place brief under seal [55], to place record excerpts under seal [55]. Date of service: 07/30/2025 [25-10600] (LEF) [Entered: 08/05/2025 01:37 PM] |
| Filing 54 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: 07/30/2025 via email - Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; Attorney for Appellees: Eiswald, Kelly, Murphy, Rowen, Stephens, Tan, Tenny [25-10600] (Andrew Michael Grossman ) [Entered: 07/30/2025 05:47 PM] |
| Filing 53 COURT ORDER granting joint stipulation of the parties to view and obtain sealed documents filed by Appellees FDA, Eli Lilly and Company, Mr. Marty Makary, Commissioner, U.S. Food and Drug Administration and Appellants Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners [ # 48 ] [25-10600] (LEF) [Entered: 07/17/2025 09:04 AM] |
| Filing 48 JOINT STIPULATION filed by Appellants North American Custom Laboratories, L.L.C. and Outsourcing Facilities Association and Appellees Eli Lilly and Company, FDA and Mr. Marty Makary, Commissioner, U.S. Food and Drug Administration to view and obtain sealed document [25-10600] REVIEWED AND/OR EDITED - The original text prior to review appeared as follows: UNOPPOSED MOTION filed by Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association to view and obtain sealed document. Date of service: 07/16/2025 via email - Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; Attorney for Appellees: Eiswald, Kelly, Murphy, Rowen, Stephens, Tan, Tenny [25-10600] (Andrew Michael Grossman ) [Entered: 07/16/2025 08:19 AM] |
| Filing 47 BRIEFING NOTICE ISSUED. A/Pet's Brief Due on 07/30/2025 for Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association. [25-10600] (SEP) [Entered: 06/20/2025 10:07 AM] |
| Filing 46 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. [25-10600] (SEP) [Entered: 06/20/2025 10:06 AM] |
| Filing 45 FEE PAID by Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association. [25-10600] (SEP) [Entered: 06/20/2025 10:05 AM] |
| Filing 44 ELECTRONIC RECORD ON APPEAL REQUESTED from District Court for 4:24-CV-953. Electronic ROA due on 06/24/2025. [25-10600] (LEF) [Entered: 06/09/2025 04:16 PM] |
| Filing 41 LETTER filed advising that the fee was paid in the district court. [25-10600] REVIEWED AND/OR EDITED - The original text prior to review appeared as follows: LETTER filed by Appellants Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners Date of Service: 06/06/2025 via email - Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; Attorney for Appellees: Eiswald, Kelly, Murphy, Rowen, Stephens, Tan, Tenny [25-10600] (Andrew Michael Grossman ) [Entered: 06/06/2025 10:14 AM] |
| Filing 40 UPDATED CASE PROCESSING NOTICE sent. [25-10600] (LEF) [Entered: 06/06/2025 08:07 AM] |
| Filing 37 TRANSCRIPT ORDER received advising transcript unnecessary as it is already filed. Transcript Order ddl satisfied [25-10600] (LEF) [Entered: 06/05/2025 04:55 PM] |
| Filing 35 APPEARANCE FORM FILED [25-10600] (RLJ) [Entered: 06/04/2025 02:57 PM] |
| Filing 33 APPEARANCE FORM FILED by Attorney Tyler Geoffrey Doyle for Appellant Outsourcing Facilities Association in 25-10600, Attorney Tyler Geoffrey Doyle for Appellant North American Custom Laboratories, L.L.C. Partners in 25-10600 [25-10600] (RLJ) [Entered: 06/04/2025 02:56 PM] |
| Filing 31 APPEARANCE FORM FILED by Attorney Richard Bryan Raile for Appellant North American Custom Laboratories, L.L.C. Partners in 25-10600, Attorney Richard Bryan Raile for Appellant Outsourcing Facilities Association in 25-10600 [25-10600] (RLJ) [Entered: 06/04/2025 02:54 PM] |
| Filing 29 APPEARANCE FORM FILED by Attorney Andrew Michael Grossman for Appellant North American Custom Laboratories, L.L.C. Partners in 25-10600, Attorney Andrew Michael Grossman for Appellant Outsourcing Facilities Association in 25-10600 [25-10600] (RLJ) [Entered: 06/04/2025 02:42 PM] |
| Filing 28 ATTORNEY TRANSCRIPT ORDER form filed by Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Associationfor the Court to process. Date of service: 06/04/2025 via email - Attorney for Appellants: Doyle, Grossman, Raile, Shapiro; Attorney for Appellees: Eiswald, Kelly, Murphy, Rowen, Stephens, Tan, Tenny. [25-10600] (Andrew Michael Grossman ) [Entered: 06/04/2025 09:15 AM] |
| Filing 27 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. [25-10600] (Tyler Geoffrey Doyle ) [Entered: 06/03/2025 12:13 PM] |
| Filing 26 APPEARANCE FORM received from Ms. Kristin Ann Shapiro for North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association for the court's review. Lead Counsel? No. [25-10600] (Kristin Ann Shapiro ) [Entered: 06/03/2025 12:12 PM] |
| Filing 25 APPEARANCE FORM received from Mr. Richard Bryan Raile for North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association for the court's review. Lead Counsel? No. [25-10600] (Richard Bryan Raile ) [Entered: 06/03/2025 12:11 PM] |
| Filing 24 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. [25-10600] (Andrew Michael Grossman ) [Entered: 06/03/2025 12:08 PM] |
| Filing 22 APPEARANCE FORM FILED by Attorney(s) Kyle Raymond Eiswald for party(s) Appellee Eli Lilly and Company, in case 25-10600 [25-10600] (EMF) [Entered: 06/03/2025 11:04 AM] |
| Filing 20 APPEARANCE FORM FILED by Attorney(s) Matthew Rowen for party(s) Appellee Eli Lilly and Company, in case 25-10600 [25-10600] (EMF) [Entered: 06/03/2025 11:01 AM] |
| Filing 18 APPEARANCE FORM FILED by Attorney(s) Erin Murphy for party(s) Appellee Eli Lilly and Company, in case 25-10600 [25-10600] (EMF) [Entered: 06/03/2025 10:59 AM] |
| Filing 17 APPEARANCE FORM for the court's review. Lead Counsel? No. [25-10600] (Kyle Raymond Eiswald ) [Entered: 06/02/2025 01:15 PM] |
| Filing 16 APPEARANCE FORM for the court's review. Lead Counsel? No. [25-10600] (Matthew Rowen ) [Entered: 06/02/2025 01:14 PM] |
| Filing 15 APPEARANCE FORM for the court's review. Lead Counsel? Yes. [25-10600] (Erin Murphy ) [Entered: 06/02/2025 01:13 PM] |
| Filing 13 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 25-10600 [25-10600] (RLJ) [Entered: 05/23/2025 02:04 PM] |
| Filing 11 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 25-10600 [25-10600] (RLJ) [Entered: 05/23/2025 02:03 PM] |
| Filing 8 CASE CAPTION updated. Appellee Robert M. Califf in 25-10600 substituted by Appellee Marty Makary, Commissioner, U.S. Food and Drug Administration in 25-10600 [25-10600] (RLJ) [Entered: 05/23/2025 01:41 PM] |
| Filing 7 APPEARANCE FORM for the court's review. Lead Counsel? Yes. [25-10600] (Caroline W. Tan ) [Entered: 05/21/2025 03:02 PM] |
| Filing 6 APPEARANCE FORM for the court's review. Lead Counsel? No. [25-10600] (Daniel Bentele Hahs Tenny ) [Entered: 05/21/2025 02:52 PM] |
| Filing 5 INITIAL CASE CHECK by Attorney Advisor complete. Action: Case OK to Process. [5] Initial AA Check Due satisfied.. Transcript order due on 06/04/2025 for Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association [25-10600] (RSM) [Entered: 05/20/2025 02:30 PM] |
| Filing 1 US CIVIL CASE docketed. NOA filed by Appellants North American Custom Laboratories, L.L.C. Partners and Outsourcing Facilities Association [25-10600] (MBC) [Entered: 05/12/2025 04:10 PM] |
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