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Case TitleInformed Consent Action Network v. United States Food and Drug Administration
DistrictSouthern District of New York
CityFoley Square
Case Number1:2019cv10235
Date Filed2019-11-04
Date Closed2021-04-30
JudgeJudge John G. Koeltl
PlaintiffInformed Consent Action Network
Case DescriptionInformed Consent Network submitted a FOIA request to the FDA for records concerning clinical study reports for all clinical trials relied upon by the agency when it approved Varicella in 1995. The agency acknowledged receipt of the request. After hearing nothing from the agency, Informed Consent Network filed an administrative appeal. After hearing nothing more, Informed Consent Network filed suit.
Complaint issues: Failure to respond within statutory time limit, Litigation - Attorney's fees

DefendantUnited States Food and Drug Administration
Documents
Docket
Complaint
Opinion/Order [9]
User-contributed Documents
 
Docket Events (Hide)
Date FiledDoc #Docket Text

2019-11-041COMPLAINT against United States Food and Drug Administration. (Filing Fee $ 400.00, Receipt Number ANYSDC-17890803)Document filed by Informed Consent Action Network.(Siri, Aaron) (Entered: 11/04/2019)
2019-11-042CIVIL COVER SHEET filed. (Siri, Aaron) (Entered: 11/04/2019)
2019-11-043FILING ERROR - DEFICIENT PLEADING - SUMMONS REQUEST PDF ERROR - REQUEST FOR ISSUANCE OF SUMMONS as to United States Food and Drug Administration, re: 1 Complaint. Document filed by Informed Consent Action Network. (Siri, Aaron) Modified on 11/5/2019 (pc). (Entered: 11/04/2019)
2019-11-05CASE OPENING INITIAL ASSIGNMENT NOTICE: The above-entitled action is assigned to Judge John G. Koeltl. Please download and review the Individual Practices of the assigned District Judge, located at http://nysd.uscourts.gov/judges/District . Attorneys are responsible for providing courtesy copies to judges where their Individual Practices require such. Please download and review the ECF Rules and Instructions, located at http://nysd.uscourts.gov/ecf_filing.php . (pc) (Entered: 11/05/2019)
2019-11-05Magistrate Judge Sarah L. Cave is so designated. Pursuant to 28 U.S.C. Section 636(c) and Fed. R. Civ. P. 73(b)(1) parties are notified that they may consent to proceed before a United States Magistrate Judge. Parties who wish to consent may access the necessary form at the following link: http://nysd.uscourts.gov/forms.php . (pc) (Entered: 11/05/2019)
2019-11-05Case Designated ECF. (pc) (Entered: 11/05/2019)
2019-11-05***NOTICE TO ATTORNEY REGARDING DEFICIENT REQUEST FOR ISSUANCE OF SUMMONS. Notice to Attorney Aaron Siri to RE-FILE Document No. 3 Request for Issuance of Summons. The filing is deficient for the following reason(s): the PDF attached to the docket entry for the issuance of summons is not correct; Attorney address field is blank;. Re-file the document using the event type Request for Issuance of Summons found under the event list Service of Process - select the correct filer/filers - and attach the correct summons form PDF. (pc) (Entered: 11/05/2019)
2019-11-054REQUEST FOR ISSUANCE OF SUMMONS as to United States Food and Drug Administration, re: 1 Complaint. Document filed by Informed Consent Action Network. (Siri, Aaron) (Entered: 11/05/2019)
2019-11-065ELECTRONIC SUMMONS ISSUED as to United States Food and Drug Administration. (dnh) (Entered: 11/06/2019)
2019-12-06Minute Entry for proceedings held before Judge John G. Koeltl: Initial Conference set for 2/3/2020 at 04:30 PM in Courtroom 14A, 500 Pearl Street, New York, NY 10007 before Judge John G. Koeltl. (Fletcher, Donnie) (Entered: 12/06/2019)
2019-12-096AFFIDAVIT OF SERVICE of Summons and Complaint. Document filed by Informed Consent Action Network. (Siri, Aaron) (Entered: 12/09/2019)
2019-12-137ANSWER to 1 Complaint. Document filed by United States Food and Drug Administration.(Bretz, Emily) (Entered: 12/13/2019)
2020-01-288LETTER MOTION to Adjourn Conference addressed to Judge John G. Koeltl from Emily Bretz dated 1/28/2020. Document filed by United States Food and Drug Administration.(Bretz, Emily) (Entered: 01/28/2020)
2020-01-289ORDER granting 8 Letter Motion to Adjourn Conference. 1. The 2/3/20 Conference is adjourned sine die. 2. Status reports every 3 months is sufficient unless a problem arises. SO ORDERED. (Signed by Judge John G. Koeltl on 1/28/2020) (ks) (Entered: 01/28/2020)
2020-04-2810STATUS REPORT. Document filed by United States Food and Drug Administration..(Bretz, Emily) (Entered: 04/28/2020)
2020-07-2711STATUS REPORT. Document filed by United States Food and Drug Administration..(Bretz, Emily) (Entered: 07/27/2020)
2020-07-2812MEMO ENDORSEMENT on re: 11 Status Report filed by United States Food and Drug Administration. ENDORSEMENT: The parties should provide a status report by September 30, 2020. SO ORDERED. (Signed by Judge John G. Koeltl on 7/28/2020) (ks) (Entered: 07/28/2020)
2020-09-3013STATUS REPORT. and proposal for further status report by December 2, 2020 Document filed by United States Food and Drug Administration..(Aronoff, Peter) (Entered: 09/30/2020)
2020-10-0114MEMO ENDORSEMENT on re: 13 Status Report filed by United States Food and Drug Administration. ENDORSEMENT: APPLICATION GRANTED SO ORDERED. (Signed by Judge John G. Koeltl on 10/1/2020) (jca) (Entered: 10/01/2020)
2020-12-0215STATUS REPORT. (joint) and proposal for further status report by January 8, 2021 Document filed by United States Food and Drug Administration..(Aronoff, Peter) (Entered: 12/02/2020)
2020-12-0316MEMO ENDORSEMENT on re: 15 Status Report filed by United States Food and Drug Administration. ENDORSEMENT: Application granted. SO ORDERED. (Signed by Judge John G. Koeltl on 12/3/2020) (ks) (Entered: 12/03/2020)
2021-01-1117STATUS REPORT. (joint) for further status report by February 8, 2021 Document filed by Informed Consent Action Network..(Brehm, Elizabeth) (Entered: 01/11/2021)
2021-01-1218MEMO ENDORSEMENT on re: 17 Status Report filed by Informed Consent Action Network. ENDORSEMENT: Application granted. SO ORDERED. (Signed by Judge John G. Koeltl on 1/12/2021) (ks) (Entered: 01/12/2021)
2021-02-0819STATUS REPORT. (joint) and proposal for further status report by April 30, 2021 Document filed by United States Food and Drug Administration. (Attachments: # 1 summary of challenged records).(Aronoff, Peter) (Entered: 02/08/2021)
2021-02-0920MEMO ENDORSEMENT on re: 19 Status Report filed by United States Food and Drug Administration. ENDORSEMENT: Application granted. SO ORDERED. (Signed by Judge John G. Koeltl on 2/9/2021) (kv) (Entered: 02/09/2021)
2021-04-2921PROPOSED STIPULATION AND ORDER. Document filed by United States Food and Drug Administration..(Aronoff, Peter) (Entered: 04/29/2021)
2021-04-3022STIPULATION AND ORDER: IT IS HEREBY STIPULATED AND AGREED, by and between the parties by and through their respective counsel that: 1. Pursuant to the FDA's representations that (a) the FDA has completed processing (and re-processing, as applicable) all records identified in the parties' letters to the Court, dated January 28, 2020 (Dkt. No. 8) and dated February 8, 2021 (Dkt. No. 19), and that (b) the FDA engaged in an adequate search, the above-captioned action is voluntarily dismissed, with prejudice pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(ii), each side to bear its own costs, attorneys' fees, and expenses; 2. ICAN reserves all rights to seek additional documents, whether or not related to this Request, through pending or future FOIA requests to the FDA or any other governmental agency as appropriate and nothing herein shall restrict such right; and 3. This stipulation may be signed in counterparts and electronic (PDF) or fax signatures may be deemed originals for all purposes. The Clerk is directed to close this case. SO ORDERED. (Signed by Judge John G. Koeltl on 4/30/2021) (ks) (Entered: 04/30/2021)
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