Case Detail

FOIA Project Annotation: A federal court in Connecticut has ruled that the FDA is not entitled to an Open America stay because the Center for Drug Evaluation and Research has been able to manage its backlog of FOIA requests despite an increase in the number of requests. The Treatment Action Group, an AIDS research and policy think tank, and the Global Health Justice Partnership, a non-profit connected to Yale Law School and Yale School of Public Health, requested records on the drug applications for Sovaldi and Harvoni, two drugs approved for treating Hepatitis C. The organizations also requested expedited processing. The FDA denied the request for expedited processing, but did not indicate how long it would take to process their request. TAG and GHJP appealed the denial of expedited processing, but the agency upheld its initial decision on appeal, explaining that the organizations had not shown a compelling need. The organizations filed suit and the FDA filed a motion requesting a 14-month stay. Addressing the denial of the organizations' request for expedited processing, the court observed that there was no case law regarding the imminent threat to life or safety for purposes of showing a compelling need for disclosure. The court examined whether TAG or GHJP were primarily involved in disseminating information, concluding that neither organization qualified. The court also rejected the organizations' claims of an urgency to inform the public, pointing out that the two drugs were approved in December 2013 and October 2014 and that "by the time the Plaintiffs made their initial request for expedited processing, in December 2014, there was no longer any sense of urgency or urgent need to information the public regarding the FDA's actions from two months to a year before the Plaintiffs made their initial request." Turning to the FDA's request for a stay, the court noted that stays could be granted where an agency was deluged by an unanticipated volume of requests, existing resources were inadequate to met the deluge, and the agency had exercised due diligence in processing the requests. However, the court found the FDA did not qualify under the circumstances. Instead, the court observed that the Center for Drug Evaluation and Research had gained seven full-time employees while its number of requests remained more or less consistent. Further, the FDA's statistics showed the Center had been able to respond to more requests than it received. The court found that "the FDA is unable to show that its existing resources are inadequate. . ." The agency had begun processing the organizations' request during the pendency of the litigation. As a result, the court ordered the FDA "to immediately produce all responsive records gathered so far and report back to the Court. . .as to the responsive records yet to be produced and when the Plaintiffs could expect to receive any documents outstanding. . ."
Issues: Delay - Stay of proceedings

Date Filed	Doc #	Docket Text
2015-06-25	1	COMPLAINT against Food and Drug Administration of the United States, Department of Health and Human Services ( Filing fee $400 receipt number 0205-3646919.), filed by Treatment Action Group, Global Health Justice Partnership. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Civil Cover Sheet)(Manes, Jonathan) (Entered: 06/25/2015)
2015-06-25		Request for Clerk to issue summons as to Food and Drug Administration of the United States, Department of Health and Human Services. (Manes, Jonathan) (Entered: 06/25/2015)
2015-06-25		Judge Victor A. Bolden added. (Malone, P.) (Entered: 06/25/2015)
2015-06-25	2	STANDING PROTECTIVE ORDER Signed by Judge Victor A. Bolden on 6/25/2015.(Fazekas, J.) (Entered: 06/25/2015)
2015-06-25	3	ELECTRONIC FILING ORDER - PLEASE ENSURE COMPLIANCE WITH COURTESY COPY REQUIREMENTS IN THIS ORDER Signed by Judge Victor A. Bolden on 6/25/2015.(Fazekas, J.) (Entered: 06/25/2015)
2015-06-25	4	NOTICE TO COUNSEL: Counsel initiating or removing this action is responsible for serving all parties with attached documents and copies of 3 Electronic Filing Order, 2 Standing Protective Order, 1 Complaint, filed by Treatment Action Group, Global Health Justice Partnership Signed by Clerk on 6/25/2015.(Fazekas, J.) (Entered: 06/25/2015)
2015-06-25	5	ELECTRONIC SUMMONS ISSUED in accordance with Fed. R. Civ. P. 4 and LR 4 as to *Food and Drug Administration, Department of Health and Human Services* with answer to complaint due within *30* days. Attorney *Jonathan Matthew Manes* *Yale Law School* *127 Wall St., PO Box 208215* *New Haven, CT 06520*. (Fazekas, J.) (Entered: 06/25/2015)
2015-07-02	6	Corporate Disclosure Statement by Treatment Action Group. (Manes, Jonathan) (Entered: 07/02/2015)
2015-07-02	7	Corporate Disclosure Statement by Global Health Justice Partnership. (Manes, Jonathan) (Entered: 07/02/2015)
2015-08-03	8	CERTIFICATE OF SERVICE by Global Health Justice Partnership, Treatment Action Group (Manes, Jonathan) (Entered: 08/03/2015)
2015-08-12	9	NOTICE of Appearance by Alan M. Soloway on behalf of Food and Drug Administration, Department of Health and Human Services (Soloway, Alan) (Entered: 08/12/2015)
2015-08-12	10	MOTION for Extension of Time until Sept 30, 2015 Answer/Dsipositive Motion by Food and Drug Administration, Department of Health and Human Services. (Soloway, Alan) (Entered: 08/12/2015)
2015-08-14	11	ORDER granting 10 Motion for Extension of Time. Signed by Judge Victor A. Bolden on 8/14/2015. (Shin, D.) (Entered: 08/14/2015)
2015-08-14		Answer deadline updated for All Defendants. (Shin, D.) (Entered: 08/14/2015)
2015-08-14	12	NOTICE of Appearance by Jonathan Matthew Manes on behalf of Global Health Justice Partnership, Treatment Action Group (Manes, Jonathan) (Entered: 08/14/2015)
2015-09-29	13	ANSWER to 1 Complaint, with Affirmative Defenses by Food and Drug Administration, Department of Health and Human Services.(Soloway, Alan) (Entered: 09/29/2015)
2015-10-27	14	MOTION for Leave to Appear for Law Student Interns Yurij Melnyk, Ben Picozzi, and Ethan Wong by Global Health Justice Partnership, Treatment Action Group. (Attachments: # 1 Exhibit A)(Manes, Jonathan) (Entered: 10/27/2015)
2015-10-28	15	ORDER granting 14 Motion for Leave for Law Student Interns YURIJMELNYK, BEN PICOZZI, and ETHAN WONG to Appear. Signed by Judge Victor A. Bolden on 10/28/2015. (Shin, D.) (Entered: 10/28/2015)
2015-11-12	16	MOTION to Stay by Food and Drug Administration, Department of Health and Human Services.Responses due by 12/3/2015 (Attachments: # 1 Exhibit Exhibit in Support, # 2 Exhibit Exhibit in Support)(Soloway, Alan) (Entered: 11/12/2015)
2015-11-24	17	MOTION for Extension of Time to File Response/Reply as to 16 MOTION to Stay until December 7, 2015 by Global Health Justice Partnership, Treatment Action Group. (Manes, Jonathan) (Entered: 11/24/2015)
2015-11-24	18	ORDER granting 17 Motion for Extension of Time to File Response re 16 MOTION to Stay. Responses due by 12/7/2015. Signed by Judge Victor A. Bolden on 11/24/2015. (Shin, D.) (Entered: 11/24/2015)
2015-12-07	19	Cross MOTION for Summary Judgment on Plaintiffs' Claim for Expedited Processing and Opposition to Defendants' Motion to Stay by Global Health Justice Partnership, Treatment Action Group.Responses due by 12/28/2015 (Attachments: # 1 Memorandum in Support, # 2 Exhibit A, # 3 Exhibit B, # 4 Exhibit C, # 5 Exhibit D, # 6 Exhibit E, # 7 Exhibit F, # 8 Exhibit G, # 9 Exhibit H, # 10 Exhibit I, # 11 Exhibit J, # 12 Exhibit K, # 13 Exhibit L, # 14 Exhibit M, # 15 Exhibit N, # 16 Exhibit O, # 17 Exhibit P, # 18 Exhibit Q, # 19 Exhibit R, # 20 Exhibit S, # 21 Exhibit T, # 22 Exhibit U, # 23 Exhibit V, # 24 Exhibit W, # 25 Exhibit X, # 26 Exhibit Y, # 27 Exhibit Z, # 28 Exhibit AA, # 29 Exhibit BB, # 30 Statement of Material Facts)(Manes, Jonathan) (Entered: 12/07/2015)
2015-12-08	20	MOTION for Extension of Time until Jan. 8, 2016 To Answer Motion for Partial Summary Judgment 19 Cross MOTION for Summary Judgment on Plaintiffs' Claim for Expedited Processing and Opposition to Defendants' Motion to Stay by Food and Drug Administration, Department of Health and Human Services. (Soloway, Alan) (Entered: 12/08/2015)
2015-12-08	21	ORDER granting 20 Motion for Extension of Time. Signed by Judge Victor A. Bolden on 12/8/2015. (Shin, D.) (Entered: 12/08/2015)
2015-12-08		Set Deadlines as to 19 Cross MOTION for Summary Judgment on Plaintiffs' Claim for Expedited Processing and Opposition to Defendants' Motion to Stay . Responses due by 1/8/2016 (Ghilardi, K.) (Entered: 12/08/2015)
2016-01-04	22	MOTION for Extension of Time until January 29, 2016 Answer to Motion for Partial Summary Judgment by Food and Drug Administration, Department of Health and Human Services. (Soloway, Alan) (Entered: 01/04/2016)
2016-01-04		Set/Reset Deadlines as to 19 Cross MOTION for Summary Judgment on Plaintiffs' Claim for Expedited Processing and Opposition to Defendants' Motion to Stay . Responses due by 1/29/2016 (Fazekas, J.) (Entered: 01/05/2016)
2016-01-05	23	ORDER granting 22 Motion for Extension of Time. Signed by Judge Victor A. Bolden on 1/5/2016. (Shin, D.) (Entered: 01/05/2016)
2016-01-25	24	NOTICE of Appearance by James T. Cowdery on behalf of Gilead Sciences, Inc. (Cowdery, James) (Entered: 01/25/2016)
2016-01-25	25	NOTICE of Appearance by John P D'Ambrosio on behalf of Gilead Sciences, Inc. (D'Ambrosio, John) (Entered: 01/25/2016)
2016-01-25	26	MOTION for Attorney(s) Benjamin C. Block, Esq. to be Admitted Pro Hac Vice (paid $75 PHV fee; receipt number 0205-3871829) by Gilead Sciences, Inc.. (Attachments: # 1 Exhibit A)(Cowdery, James) (Entered: 01/25/2016)
2016-01-25	27	MOTION for Attorney(s) Jennifer Zachary, Esq. to be Admitted Pro Hac Vice (paid $75 PHV fee; receipt number 0205-3871840) by Gilead Sciences, Inc.. (Attachments: # 1 Exhibit A)(Cowdery, James) (Entered: 01/25/2016)
2016-01-25	28	MOTION for Attorney(s) Mingham Ji, Esq. to be Admitted Pro Hac Vice (paid $75 PHV fee; receipt number 0205-3871849) by Gilead Sciences, Inc.. (Attachments: # 1 Exhibit A)(Cowdery, James) (Entered: 01/25/2016)
2016-01-25	29	Consent MOTION to Intervene by Gilead Sciences, Inc..Responses due by 2/15/2016 (Attachments: # 1 Memorandum in Support, # 2 Exhibit 1, # 3 Exhibit 2)(Cowdery, James) (Entered: 01/25/2016)
2016-01-26	30	ORDER granting 26 Motion to Appear Pro Hac Vice for Benjamin C. Block. Certificate of Good Standing due by 3/26/2016. Signed by Clerk on 1/26/2016. (Fazekas, J.) (Entered: 01/26/2016)
2016-01-26	31	ORDER granting 27 Motion to Appear Pro Hac Vice for Jennifer Zachary. Certificate of Good Standing due by 3/26/2016. Signed by Clerk on 1/26/2016. (Fazekas, J.) (Entered: 01/26/2016)
2016-01-26	32	ORDER granting 28 Motion to Appear Pro Hac Vice for Mingham Ji. Certificate of Good Standing due by 3/26/2016. Signed by Clerk on 1/26/2016. (Fazekas, J.) (Entered: 01/26/2016)
2016-01-26	33	CERTIFICATE OF GOOD STANDING re 26 MOTION for Attorney(s) Benjamin C. Block, Esq. to be Admitted Pro Hac Vice (paid $75 PHV fee; receipt number 0205-3871829) by Gilead Sciences, Inc.. (Cowdery, James) (Entered: 01/26/2016)
2016-01-26	34	CERTIFICATE OF GOOD STANDING re 27 MOTION for Attorney(s) Jennifer Zachary, Esq. to be Admitted Pro Hac Vice (paid $75 PHV fee; receipt number 0205-3871840) by Gilead Sciences, Inc.. (Cowdery, James) (Entered: 01/26/2016)
2016-01-26	35	CERTIFICATE OF GOOD STANDING re 28 MOTION for Attorney(s) Mingham Ji, Esq. to be Admitted Pro Hac Vice (paid $75 PHV fee; receipt number 0205-3871849) by Gilead Sciences, Inc.. (Cowdery, James) (Entered: 01/26/2016)
2016-01-26	36	MOTION to Amend/Correct by Food and Drug Administration, Department of Health and Human Services.Responses due by 2/16/2016 (Attachments: # 1 Exhibit Amended Answer)(Soloway, Alan) (Entered: 01/26/2016)
2016-01-29	37	MOTION for Summary Judgment by Food and Drug Administration, Department of Health and Human Services.Responses due by 2/19/2016 (Attachments: # 1 Memorandum in Support Memorandum in Support and in Opposition, # 2 Exhibit 56a1 Statement, # 3 Exhibit 56a2 Statement, # 4 Exhibit Kotler Declaration, # 5 Exhibit Himebaugh Declaration, # 6 Exhibit Birnkrant Declaration, # 7 Exhibit Sager Supplemental Declaration)(Soloway, Alan) (Entered: 01/29/2016)
2016-02-02	38	ORDER granting 36 Motion to Amend/Correct. Signed by Judge Victor A. Bolden on 1/27/2016. (Shin, D.) (Entered: 02/02/2016)
2016-02-02	39	ORDER granting 29 Motion to Intervene. Signed by Judge Victor A. Bolden on 2/2/2016. (Shin, D.) (Entered: 02/02/2016)
2016-02-02	40	First MOTION for Leave for Law Student Intern Steven Lance to Appear, MOTION for Leave for Law Student Intern Amanda Lynch to Appear, MOTION for Leave for Law Student Intern Nora Niedzielski-Eichner to Appear by Attorney Jonathan Manes. On behalf of Global Health Justice Partnership, Treatment Action Group. (Attachments: # 1 Exhibit Exhibit A: Intern Certifications, # 2 Exhibit Exhibit B: Client Consents, # 3 Exhibit Exhibit C: Supervising Attorney Consent)(Manes, Jonathan). Added MOTIONS for Leave to Appear on 2/10/2016 (Blough, B.). (Entered: 02/02/2016)
2016-02-10	41	ORDER granting in part 40 Motion to Appear Law Student Intern. The motion for leave to appear is granted as to Amanda Lynch. As to Steven Lance and Nora Niedzielski-Eichner, the Court orders movant to submit a memorandum of law in support of the motion for leave to appear addressing: (1) whether the requirements of Local Rule 83.9(c) have been waived previously in the District of Connecticut and, if so, under what circumstances; and (2) if the requirements have not been waived previously and/or the movant cannot find any indication of whether they previously have been waived, the basis for why such waiver should be permitted now. Signed by Judge Victor A. Bolden on 2/10/2016. (Shin, D.) (Entered: 02/10/2016)
2016-02-19	42	Memorandum in Opposition to Defendants' Cross-Motion for Summary Judgment on Expedited Processing, Reply in Further Support of Plaintiffs' Motion for Summary Judgment on Expedited Processing, and Sur-Reply in Opposition to Defendants' Motion for a Stay re 37 MOTION for Summary Judgment filed by Global Health Justice Partnership, Treatment Action Group. (Attachments: # 1 Exhibit Senate Finance Committee Report, # 2 Exhibit Kowdley Study, # 3 Exhibit Rule 56(a)2 Statement)(Manes, Jonathan) (Entered: 02/19/2016)
2016-02-19	43	MOTION for Leave to File Sur-Reply in Opposition to Defendants' Motion for a Stay by Global Health Justice Partnership, Treatment Action Group. (Manes, Jonathan) (Entered: 02/19/2016)
2016-02-22	44	ORDER granting 43 Motion for Leave to File. Signed by Judge Victor A. Bolden on 2/22/2016. (Shin, D.) (Entered: 02/22/2016)
2016-03-04	45	REPLY to Response to 16 MOTION to Stay , 37 MOTION for Summary Judgment , 19 Cross MOTION for Summary Judgment on Plaintiffs' Claim for Expedited Processing and Opposition to Defendants' Motion to Stay filed by Food and Drug Administration, Department of Health and Human Services. (Soloway, Alan) (Entered: 03/04/2016)
2016-04-18	46	ORDER denying without prejudice 40 Motion to Appear, as to Law Student Interns Steven Lance and Nora Niedzielski-Eichner. In the absence of the information requested by the Court, see Doc. No. 41, the Court finds no basis for deviating from the requirements of the Local Rules at this time. Signed by Judge Victor A. Bolden on 4/18/2016. (Shin, D.) (Entered: 04/18/2016)
2016-05-11	47	ORDER Setting Hearing on Motions 16 MOTION to Stay, 19 Cross MOTION for Summary Judgment on Plaintiffs' Claim for Expedited Processing and Opposition to Defendants' Motion to Stay , 37 MOTION for Summary Judgment: Motion Hearing set for 9/9/2016 02:00 PM in Courtroom Two, 915 Lafayette Blvd., Bridgeport, CT before Judge Victor A. Bolden. Signed by Judge Victor A. Bolden on 5/11/2016.(Shin, D.) (Entered: 05/11/2016)
2016-07-21	48	MOTION for Attorney(s) Cortelyou C. Kenney to be Admitted Pro Hac Vice (paid $75 PHV fee; receipt number 0205-4075704) by Global Health Justice Partnership, Treatment Action Group. (Attachments: # 1 Affidavit Declaration in Support of Cortelyou C. Kenney's Admission as a Visiting Attorney)(Manes, Jonathan) (Entered: 07/21/2016)
2016-07-22	49	ORDER granting 48 Motion to Appear Pro Hac Vice for Cortelyou C. Kenney Certificate of Good Standing due by 9/20/2016. Signed by Clerk on 7/22/2016. (Fazekas, J.) (Entered: 07/22/2016)
2016-07-22	50	MOTION for Attorney(s) Margaret E. McCarthy to be Admitted Pro Hac Vice (paid $75 PHV fee; receipt number 0205-4077408) by Global Health Justice Partnership. (Attachments: # 1 Affidavit)(Manes, Jonathan) (Entered: 07/22/2016)
2016-07-25	51	ORDER granting 50 Motion to Appear Pro Hac Vice for Margaret E. McCarthy. Certificate of Good Standing due by 9/23/2016. Signed by Clerk on 7/25/2016. (Fazekas, J.) (Entered: 07/25/2016)
2016-07-26	52	NOTICE of Appearance by Cortelyou C. Kenney on behalf of Treatment Action Group, Global Health Justice Partnership (Payton, R.) Modified on 7/26/2016 TO ADD ADDITIONAL FILER (Oliver, T.). (Entered: 07/26/2016)
2016-07-26		Docket Entry Correction re 52 Notice of Appearance Modified on 7/26/2016 TO ADD Global Health Justice Partnership AS AN ADDITIONAL FILER (Oliver, T.) (Entered: 07/26/2016)
2016-07-26	53	NOTICE of Appearance by Margaret E. McCarthy on behalf of Treatment Action Group , Global Health Justice Partnership (McCarthy, Margaret) Modified on 7/27/2016, added additional filer (Fazekas, J.). (Entered: 07/26/2016)
2016-07-27		Docket Entry Correction re 53 Notice of Appearance, ADDED Global Health Justice Partnership AS AN ADDITIONAL FILER. (Fazekas, J.) (Entered: 07/27/2016)
2016-08-02	54	MOTION for Attorney(s) Shannon M. Singleton to be Admitted Pro Hac Vice (includes a request to waive the fee) by Food and Drug Administration, Department of Health and Human Services. (Attachments: # 1 Exhibit Declaration)(Soloway, Alan) (Entered: 08/02/2016)
2016-08-04	55	ORDER finding as moot 54 Motion to Appear. Signed by Judge Victor A. Bolden on 8/4/2016. (Chen, C.) (Entered: 08/04/2016)
2016-08-12	56	MOTION for Leave to File Supplemental Materials by Global Health Justice Partnership, Treatment Action Group. (Attachments: # 1 Memorandum in Support Memorandum in Support of Plaintiffs' Motion to Supplement the Summary Judgment Record, # 2 Affidavit Declaration of Mark Harrington, # 3 Exhibit A, # 4 Exhibit B, # 5 Exhibit C, # 6 Exhibit D, # 7 Exhibit E, # 8 Exhibit F, # 9 Exhibit G)(Kenney, Cortelyou) (Entered: 08/12/2016)
2016-08-12	57	Amended EXHIBIT E re: 56 MOTION for Leave to File Supplemental Materials by Global Health Justice Partnership, Treatment Action Group. (Kenney, Cortelyou) Modified on 8/15/2016 (Payton, R.). (Entered: 08/12/2016)
2016-08-12	58	CERTIFICATE OF GOOD STANDING re 50 MOTION for Attorney(s) Margaret E. McCarthy to be Admitted Pro Hac Vice (paid $75 PHV fee; receipt number 0205-4077408) by Global Health Justice Partnership, Treatment Action Group. (Fazekas, J.) (Entered: 08/16/2016)
2016-08-26	59	ORDER Setting Hearing on 16 MOTION to Stay, 19 Cross MOTION for Summary Judgment, 37 MOTION for Summary Judgment: Motion Hearing is RESET for 9/9/2016 03:30 PM in Courtroom Two, 915 Lafayette Blvd., Bridgeport, CT before Judge Victor A. Bolden. Signed by Judge Victor A. Bolden on 8/26/2016.(Chen, C.) (Entered: 08/26/2016)
2016-08-26	60	NOTICE OF E-FILED CALENDAR: THIS IS THE ONLY NOTICE COUNSEL/THE PARTIES WILL RECEIVE. ALL PERSONS ENTERING THE COURTHOUSE MUST PRESENT PHOTO IDENTIFICATION. Hearing on MOTION to Stay, Cross MOTION for Summary Judgment, MOTION for Summary Judgment is set for 9/9/2016 03:30 PM in Courtroom Two, 915 Lafayette Blvd., Bridgeport, CT before Judge Victor A. Bolden. Please note the time change from the original Order dated 5/11/2016. (Chen, C.) (Entered: 08/26/2016)
2016-08-28	61	RESPONSE filed by Food and Drug Administration, Department of Health and Human Services. (Attachments: # 1 Affidavit)(Soloway, Alan) (Entered: 08/28/2016)
2016-08-30	62	REPLY to Response to 56 MOTION for Leave to File Supplemental Materials filed by Global Health Justice Partnership, Treatment Action Group. (Kenney, Cortelyou) (Entered: 08/30/2016)
2016-09-09	63	Minute Entry for proceedings held before Judge Victor A. Bolden: Motion Hearing held on 9/9/2016 re 56 MOTION for Leave to File Supplemental Materials filed by Treatment Action Group, Global Health Justice Partnership, 16 MOTION to Stay filed by Food and Drug Administration, Department of Health and Human Services, 37 MOTION for Summary Judgment filed by Food and Drug Administration, Department of Health and Human Services, 19 Cross MOTION for Summary Judgment on Plaintiffs' Claim for Expedited Processing and Opposition to Defendants' Motion to Stay filed by Treatment Action Group, Global Health Justice Partnership. Total Time: 1 hours and 2 minutes. (Court Reporter S. Montini.) (Chen, C.) (Entered: 09/09/2016)
2016-09-09	64	NOTICE OF E-FILED CALENDAR: THIS IS THE ONLY NOTICE COUNSEL/THE PARTIES WILL RECEIVE. Telephonic Status Conference set for 10/21/2016 10:00 AM before Judge Victor A. Bolden to discuss the status of ongoing document production in response to Plaintiffs' FOIA request. Dial-in Information: 888-808-6929, Participant Code: 9284309. (Chen, C.) (Entered: 09/09/2016)
2016-09-20	65	ORDER granting Defendants' 37 Cross-Motion for Partial Summary Judgment regarding Expedited Processing; denying Defendants' 16 Motion to Stay; denying Plaintiffs' 19 Motion for Partial Summary Judgment. Signed by Judge Victor A. Bolden on 9/20/2016. (Chen, C.) (Entered: 09/20/2016)
2016-09-20	66	ORDER denying 56 Motion for Leave to File Supplemental Materials, consistent with the Court's reasoning in the 65 Ruling on Defendants' Motion to Stay and the Parties' Motions for Summary Judgment Regarding Expedited Processing. Signed by Judge Victor A. Bolden on 9/20/2016. (Chen, C.) (Entered: 09/20/2016)
2016-10-07	67	NOTICE by Food and Drug Administration, Department of Health and Human Services (Attachments: # 1 Exhibit FDA Safety Warning)(Soloway, Alan) (Entered: 10/07/2016)
2016-10-07	68	CERTIFICATE OF SERVICE by Food and Drug Administration, Department of Health and Human Services (Soloway, Alan) (Entered: 10/07/2016)
2016-10-21	69	Minute Entry for proceedings held before Judge Victor A. Bolden: Telephonic Status Conference held on 10/21/2016. 15 minutes. (Court Reporter S. Montini.) (Chen, C.) (Entered: 10/21/2016)
2016-10-21	70	NOTICE OF E-FILED CALENDAR: THIS IS THE ONLY NOTICE COUNSEL/THE PARTIES WILL RECEIVE. Telephonic Status Conference set for 11/10/2016 02:00 PM before Judge Victor A. Bolden to discuss the status of document production. Dial-in Information: 888-808-6929, Participant Code: 9284309. (Chen, C.) (Entered: 10/21/2016)
2016-11-02	71	Amended ANSWER to 1 Complaint, with Affirmative Defenses by Food and Drug Administration, Department of Health and Human Services.(Soloway, Alan) (Entered: 11/02/2016)
2016-11-10	72	Minute Entry for proceedings held before Judge Victor A. Bolden: Telephonic Status Conference held on 11/10/2016. 10 minutes. (Court Reporter S. Montini.) (Chen, C.) (Entered: 11/10/2016)
2016-11-10	73	NOTICE OF E-FILED CALENDAR: THIS IS THE ONLY NOTICE COUNSEL/THE PARTIES WILL RECEIVE. Telephonic Status Conference set for 11/18/2016 03:30 PM before Judge Victor A. Bolden to discuss the status of document production. Dial-in Information: 888-808-6929, Participant Code: 9284309. (Chen, C.) (Entered: 11/10/2016)
2016-11-18	74	NOTICE OF E-FILED CALENDAR: THIS IS THE ONLY NOTICE COUNSEL/THE PARTIES WILL RECEIVE.ALL PERSONS ENTERING THE COURTHOUSE MUST PRESENT PHOTO IDENTIFICATION. Telephonic Status Conference is RESET FROM 11/18/2016 03:30 PM and is now set for 11/30/2016 11:00 AM before Judge Victor A. Bolden. Dial-in information is the same as for previous calls. (Chen, C.) (Entered: 11/18/2016)
2016-11-29	75	Joint STATUS REPORT by Food and Drug Administration, Department of Health and Human Services. (Singleton, Shannon) (Entered: 11/29/2016)
2016-11-30	76	Minute Entry for proceedings held before Judge Victor A. Bolden: Telephonic Status Conference held on 11/30/2016. 3 minutes. (Court Reporter S. Montini.) (Chen, C.) (Entered: 11/30/2016)
2017-05-03	77	ORDER. The Parties shall file a Joint Status Report by 5/12/2017 to update the Court regarding the status of this case. Signed by Judge Victor A. Bolden on 5/3/2017. (Chen, C.) (Entered: 05/03/2017)
2017-05-12	78	STATUS REPORT Joint Status Report by Food and Drug Administration, Department of Health and Human Services. (Soloway, Alan) (Entered: 05/12/2017)
2017-05-15	79	ORDER. As the parties requested in the 78 Joint STATUS REPORT, the parties shall submit another Joint Status Report by 6/19/2017. Signed by Judge Victor A. Bolden on 5/15/2017. (Chen, C.) (Entered: 05/15/2017)
2017-06-19	80	STATUS REPORT by Food and Drug Administration, Department of Health and Human Services. (Soloway, Alan) (Entered: 06/19/2017)
2017-06-20	81	ORDER. As the parties indicated in the 80 Status Report filed by Food and Drug Administration, Department of Health and Human Services, the parties shall submit another Joint Status Report by 8/18/2017. Signed by Judge Victor A. Bolden on 6/20/2017. (Chen, C.) (Entered: 06/20/2017)
2017-08-17	82	STATUS REPORT by Food and Drug Administration, Department of Health and Human Services. (Soloway, Alan) (Entered: 08/17/2017)
2017-08-18	83	ORDER. As the parties indicate in the 82 Status Report filed by Food and Drug Administration, Department of Health and Human Services, the parties shall submit another Joint Status Report by 9/1/2017. Signed by Judge Victor A. Bolden on 8/18/2017. (Chen, C.) (Entered: 08/18/2017)
2017-08-23		Set Deadlines/Hearings: Joint Status Report due by 9/1/2017 (Perez, J.) (Entered: 08/23/2017)
2017-09-01	84	STATUS REPORT by Food and Drug Administration, Department of Health and Human Services. (Soloway, Alan) (Entered: 09/01/2017)
2017-09-01	85	STIPULATION Of Judgment and Proposed Briefing Schedule by Food and Drug Administration, Department of Health and Human Services. (Soloway, Alan) (Entered: 09/01/2017)
2017-09-06	86	STIPULATED JUDGMENT. For Appeal Forms please go to the following website: http://www.ctd.uscourts.gov/forms/all-forms/appeals_forms Signed by Judge Victor A. Bolden on 9/6/2017.(Perez, J.) (Entered: 09/11/2017)
2017-09-11		JUDICIAL PROCEEDINGS SURVEY: The following link to the confidential survey requires you to log into CM/ECF for SECURITY purposes. Once in CM/ECF you will be prompted for the case number. Although you are receiving this survey through CM/ECF, it is hosted on an independent website called SurveyMonkey. Once in SurveyMonkey, the survey is located in a secure account. The survey is not docketed and it is not sent directly to the judge. To ensure anonymity, completed surveys are held up to 90 days before they are sent to the judge for review. We hope you will take this opportunity to participate, please click on this link: https://ecf.ctd.uscourts.gov/cgi-bin/Dispatch.pl?survey (Perez, J.) (Entered: 09/11/2017)
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