Skip to content

Case Detail

[Subscribe to updates]
Case TitleExela Pharma Sciences, LLC v. Food and Drug Administration
DistrictDistrict of Maryland
CityGreenbelt
Case Number8:2023cv00951
Date Filed2023-04-10
Date ClosedOpen
JudgeJudge Paula Xinis
PlaintiffExela Pharma Sciences, LLC
Case DescriptionExela Pharma Sciences submitted three FOIA requests to the FDA for records concerning the FDA's proposed decision to increase the aluminum content limits applicable to PN products. Excela Pharma Sciences also requested expedited processing. The agency acknowledged receipt of the requests. The agency denied Exela Pharma Sciences' requests for expedited processing. However, after hearing nothing further from the agency, Exela Pharma Sciences filed suit.
Complaint issues: Litigation - Attorney's fees, Adequacy - Search, Failure to respond within statutory time limit, Litigation - Vaughn index

DefendantFood and Drug Administration
Documents
Docket
Complaint
Complaint attachment 1
Complaint attachment 2
Complaint attachment 3
Complaint attachment 4
Complaint attachment 5
Complaint attachment 6
Complaint attachment 7
Complaint attachment 8
Complaint attachment 9
Complaint attachment 10
Complaint attachment 11
Complaint attachment 12
Complaint attachment 13
Complaint attachment 14
Complaint attachment 15
Complaint attachment 16
Complaint attachment 17
Complaint attachment 18
Complaint attachment 19
Complaint attachment 20
Complaint attachment 21
Complaint attachment 22
Complaint attachment 23
Complaint attachment 24
Complaint attachment 25
User-contributed Documents
 
Docket Events (Hide)
Date FiledDoc #Docket Text

2023-04-101COMPLAINT against FOOD AND DRUG ADMINISTRATION ( Filing fee $ 402 receipt number AMDDC-10534825.), filed by EXELA PHARMA SCIENCES, LLC. (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4, # 5 Exhibit 5, # 6 Exhibit 6, # 7 Exhibit 7, # 8 Exhibit 8, # 9 Exhibit 9, # 10 Exhibit 10, # 11 Exhibit 11, # 12 Exhibit 12, # 13 Exhibit 13, # 14 Exhibit 14, # 15 Exhibit 15, # 16 Exhibit 16, # 17 Exhibit 17, # 18 Exhibit 18, # 19 Exhibit 19, # 20 Exhibit 20, # 21 Exhibit 21, # 22 Civil Cover Sheet Civil Cover Sheet, # 23 Summons Summons, # 24 Summons Summons, # 25 Summons Summons)(Lienhard, Jonathan) (Entered: 04/10/2023)
2023-04-102[FILED IN ERROR] Local Rule 103.3 Disclosure Statement by Exela Pharma Sciences, LLC (Lienhard, Jonathan) Modified on 4/11/2023 (mg3s, Deputy Clerk). (Entered: 04/10/2023)
2023-04-113Summons Issued 30 days as to Food and Drug Administration, U.S. Attorney and U.S. Attorney General(mg3s, Deputy Clerk) Modified on 5/5/2023 (mg3s, Deputy Clerk). (Entered: 04/11/2023)
2023-04-114QC NOTICE: 2 Local Rule 103.3 Disclosure Statement filed by Exela Pharma Sciences, LLC was filed incorrectly. **Please refile the Local Rule 103.3 Disclosure Statement. Everyone designated on your disclosure statement as having financial interest in the outcome of the case needs to be added as a corporate parent or other affiliate when the system prompts you. It has been noted as FILED IN ERROR, and the document link has been disabled. (mg3s, Deputy Clerk). (Entered: 04/11/2023)
2023-04-115Local Rule 103.3 Disclosure Statement by Exela Pharma Sciences, LLC identifying Corporate Parent Exela Pharm Sci, Inc., Other Affiliate Exela Holdings, Inc. for Exela Pharma Sciences, LLC.(Lienhard, Jonathan) (Entered: 04/11/2023)
2023-04-196MOTION to Appear Pro Hac Vice for Jason Torchinsky (Filing fee $100, receipt number AMDDC-10551981.) by Exela Pharma Sciences, LLC (Attachments: # 1 Rider A - List of Court Admissions)(Lienhard, Jonathan) (Entered: 04/19/2023)
2023-04-197MOTION to Appear Pro Hac Vice for Edward M. Wenger (Filing fee $100, receipt number AMDDC-10552048.) by Exela Pharma Sciences, LLC (Attachments: # 1 Rider A - List of Court Admissions)(Lienhard, Jonathan) (Entered: 04/19/2023)
2023-04-198PAPERLESS ORDER granting 6 Motion to Appear Pro Hac Vice on behalf of Jason Brett Torchinsky. Directing attorney Jason Brett Torchinsky to register for pro hac vice filing in the District of Maryland through PACER at https://pacer.uscourts.gov/ if attorney has not already done so. The Pro Hac Vice option must be selected when registering. Signed by Clerk on 4/19/2023. (mh4s, Deputy Clerk) (Entered: 04/19/2023)
2023-04-199PAPERLESS ORDER granting 7 Motion to Appear Pro Hac Vice on behalf of Edward Wenger. Directing attorney Edward Wenger to register for pro hac vice filing in the District of Maryland through PACER at https://pacer.uscourts.gov/ if attorney has not already done so. The Pro Hac Vice option must be selected when registering. Signed by Clerk on 4/19/2023. (mh4s, Deputy Clerk) (Entered: 04/19/2023)
2023-04-2510SUMMONS Returned Executed by Exela Pharma Sciences, LLC. Food and Drug Administration served on 4/11/2023, answer due 5/11/2023. (Attachments: # 1 Exhibit A)(Lienhard, Jonathan) Modified on 5/5/2023 (mg3s, Deputy Clerk). (Entered: 04/25/2023)
2023-05-2611ANSWER to 1 Complaint,, by Food and Drug Administration.(Wilson, Michael) (Entered: 05/26/2023)
2023-06-2012SCHEDULING ORDER: Status Report due by 11/2/2023. Signed by Judge Paula Xinis on 6/20/2023. (mg3s, Deputy Clerk). (Entered: 06/21/2023)
2023-06-2013LETTER ORDER regarding the Filing of Discovery Motions. Signed by Judge Paula Xinis on 6/20/2023. (mg3s, Deputy Clerk). (Entered: 06/21/2023)
2023-07-0514STATUS REPORT (Joint) by Food and Drug Administration(Wilson, Michael) (Entered: 07/05/2023)
2023-07-0615PAPERLESS NOTICE: The Rule 16 conference call set for July 7, 2023 has been RESCHEDULED to July 14, 2023 at 10:15 a.m. Plaintiff should initiate call to Chambers, (301) 344-0653. (tb2s, Chambers) (Entered: 07/06/2023)
2023-07-1216PAPERLESS ORDER: The Rule 16 conference call scheduled for July 14, 2023 is CANCELLED. Parties should submit a Joint Status Report by August 9, 2023. Signed by Judge Paula Xinis on 7/12/2023. (tb2s, Chambers) (Entered: 07/12/2023)
2023-08-0917STATUS REPORT (Joint) by Food and Drug Administration(Wilson, Michael) (Entered: 08/09/2023)
2023-08-1018PAPERLESS ORDER STRIKING 12 Scheduling Order. Parties are DIRECTED to file Joint Status Report no later than February 9, 2024. Signed by Judge Paula Xinis on 8/10/2023. (dg3s, Deputy Clerk) (Entered: 08/10/2023)
2024-02-0919STATUS REPORT (Joint) by Food and Drug Administration(Wilson, Michael) (Entered: 02/09/2024)
2024-02-1320PAPERLESS ORDER staying the case for 60 days and directing parties to file a joint status report by no later than April 9, 2024. Signed by Judge Paula Xinis on 2/13/2024. (mg3s, Deputy Clerk) (Entered: 02/13/2024)
Hide Docket Events
by FOIA Project Staff
Skip to toolbar