Case Detail

FOIA Project Annotation: A federal court in New York has ruled that the FDA properly rejected a request from the Informed Consent Action Network for records concerning clinical trials for Engerix-B for babies and children in 1989 that had a safety review period longer than seven days following administration of the vaccine. In response, the FDA told ICAN that it could not search its database for information about the length of each review unless it looked at each file separately, which was too burdensome. The FDA told ICAN that if it would amend its request to ask for all the 1989 clinical trials for Engerix-B, the agency could provide all 3,000 pages of records and let ICAN decide for itself what trials may have satisfied its time criteria. ICAN refused to amend its request and filed suit instead. The FDA argued that ICAN had failed to reasonably describe the records it was seeking while ICAN claimed its description was sufficient. District Court Judge Alison Nathan explained that "the phrase 'safety review period' has a seemingly plain meaning. It 'refers to the period of time safety was reviewed after administering the vaccine.' And here ICAN specified the period of time is seven days measured from the date the vaccine was administered." The FDA pointed out that the 1989 trials reflect a multiple-dose approach, meaning that the reviewer would need to decide when the seven-day period began. ICAN emphasized that its request specifically indicated that the seven-day period began on the date of administration. But Nathan noted that "but this response elides the question, which is when to start counting that seven-day period for a multi-dose vaccine. Indeed, ICAN's repeated use of a definite article to describe the starting point of the safety review period â€" i.e., following the administration of the vaccine â€" overlooks that there is not just one administration and not just one dose of the vaccine. And because the 'safety review period' is not a term of art with an authoritative definition to which FDA employees or the Court can refer, the ambiguity remains." Nathan concluded that "ICAN's request did not reasonably describe the records sought in such a way that an FDA employee could determine which trials were responsive to ICAN's request and which were not. That conclusion is further supported by the Court's finding that the sworn declarations submitted by the FDA, which explain its process and these issues in detail, are properly 'accorded a presumption of good faith.'" She explained that once the FDA determined it could not search for the records it was required to work with ICAN to construct a workable request. Nathan noted that "the FDA did just that," by providing ICAN with an opportunity to review all the records and make its own decision. Nathan indicated that when an agency could not respond to an overly specific request, it could resolve the dispute by providing "a broader search" and production of documents. She noted that the Court finds this is one such circumstance. And while this may have resulted in ICAN receiving a larger volume of documents than it would prefer, the Court does not find that the maximum possible production of approximately 3,000 pages is likely to overwhelm ICAN's ability to review them."
Issues: Adequacy - Search, Request - Specificity

Date Filed	Doc #	Docket Text
2020-01-24	1	COMPLAINT against United States Food and Drug Administration. (Filing Fee $ 400.00, Receipt Number ANYSDC-18594662)Document filed by Informed Consent Action Network.(Siri, Aaron) (Entered: 01/24/2020)
2020-01-24	2	CIVIL COVER SHEET filed. (Siri, Aaron) (Entered: 01/24/2020)
2020-01-24	3	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) (Entered: 01/24/2020)
2020-01-27		CASE OPENING INITIAL ASSIGNMENT NOTICE: The above-entitled action is assigned to Judge Alison J. Nathan. Please download and review the Individual Practices of the assigned District Judge, located at https://nysd.uscourts.gov/judges/district-judges . 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 https://nysd.uscourts.gov/rules/ecf-related-instructions . (pne) (Entered: 01/27/2020)
2020-01-27		Magistrate Judge Stewart D. Aaron 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: https://nysd.uscourts.gov/sites/default/files/2018-06/AO-3.pdf . (pne) (Entered: 01/27/2020)
2020-01-27		Case Designated ECF. (pne) (Entered: 01/27/2020)
2020-01-27	4	ELECTRONIC SUMMONS ISSUED as to United States Food and Drug Administration. (pne) (Entered: 01/27/2020)
2020-02-03	5	NOTICE OF INITIAL PRETRIAL CONFERENCE: It is hereby ORDERED that counsel for all parties appear for an initial pretrial conference with the Court on Friday, June 5, 2020 at 3:00pm in Courtroom 906 of the United States District Court for the Southern District of New York, Thurgood Marshall U.S. Courthouse at 40 Foley Square, New York, New York. The parties are hereby ORDERED to ECF file a Proposed Civil Case Management Plan and Scheduling Order no later than seven days prior to the Initial Pretrial Conference. The parties shall use this Court's form Proposed Case Management Plan and Scheduling Order available at the Court's website (http://nysd.uscourts.gov/judge/Nathan). IT IS FURTHER ORDERED that included with the Proposed Civil Case Management Plan, the parties jointly submit a letter, not to exceed five (5) pages, providing the following information in separate paragraphs as further set forth in this Order. Counsel who have noticed an appearance as of the issuance of this order are directed to notify all other parties attorneys in this action by serving upon each of them a copy of this order and the Court's Individual Rules (available at the Court's website, http://nysd.uscourts.gov/judge/Nathan) forthwith. If unaware of the identity of counsel for any of the parties, counsel receiving this order must forthwith send a copy of this order and Individual Rules to that party personally. (Initial Conference set for 6/5/2020 at 03:00 PM in Courtroom 906, 40 Centre Street, New York, NY 10007 before Judge Alison J. Nathan.) (Signed by Judge Alison J. Nathan on 2/3/20) (yv) (Entered: 02/03/2020)
2020-02-04	6	NOTICE OF APPEARANCE by Samuel Hilliard Dolinger on behalf of United States Food and Drug Administration..(Dolinger, Samuel) (Entered: 02/04/2020)
2020-02-10	7	AFFIDAVIT OF SERVICE of Summons and Complaint. Document filed by Informed Consent Action Network..(Siri, Aaron) (Entered: 02/10/2020)
2020-02-28	8	ANSWER to 1 Complaint. Document filed by United States Food and Drug Administration..(Dolinger, Samuel) (Entered: 02/28/2020)
2020-03-17	9	AMENDED COMPLAINT amending 1 Complaint against United States Food and Drug Administration.Document filed by Informed Consent Action Network. Related document: 1 Complaint..(Siri, Aaron) (Entered: 03/17/2020)
2020-03-24	10	ANSWER to 9 Amended Complaint. Document filed by United States Food and Drug Administration..(Dolinger, Samuel) (Entered: 03/24/2020)
2020-05-28	11	LETTER addressed to Judge Alison J. Nathan from Samuel Dolinger dated 5/28/2020 re: parties' joint letter in advance of initial conference scheduled for June 5, 2020. Document filed by United States Food and Drug Administration..(Dolinger, Samuel) (Entered: 05/28/2020)
2020-06-04	12	NOTICE OF APPEARANCE by Elizabeth Ann Brehm on behalf of Informed Consent Action Network..(Brehm, Elizabeth) (Entered: 06/04/2020)
2020-06-05	13	MEMO ENDORSEMENT on re: 11 LETTER addressed to Judge Alison J. Nathan from Samuel Dolinger dated 5/28/2020 re: parties' joint letter in advance of initial conference scheduled for June 5, 2020. Document filed by United States Food and Drug Administration. ENDORSEMENT: The Court adopts the parties' proposed summary-judgment briefing schedule. Following submission of the Government's brief, Plaintiff may seek discovery. The initial pretrial conference in this matter is hereby canceled. So ordered. The following hearing(s) was terminated: Initial Conference. (Motions due by 7/10/2020.) (Signed by Judge Alison J. Nathan on 6/3/2020) (rjm) Modified on 6/9/2020 (rjm). (Entered: 06/05/2020)
2020-06-05		Set/Reset Deadlines: Cross Motions due by 8/14/2020. Responses due by 9/4/2020. Replies due by 9/25/2020. (rjm) (Entered: 06/09/2020)
2020-07-10	14	MOTION for Summary Judgment . Document filed by United States Food and Drug Administration. Responses due by 8/14/2020.(Dolinger, Samuel) (Entered: 07/10/2020)
2020-07-10	15	MEMORANDUM OF LAW in Support re: 14 MOTION for Summary Judgment . . Document filed by United States Food and Drug Administration..(Dolinger, Samuel) (Entered: 07/10/2020)
2020-07-10	16	DECLARATION of Suzann Burk in Support re: 14 MOTION for Summary Judgment .. Document filed by United States Food and Drug Administration. (Attachments: # 1 Exhibit A - 6/21/2019 FOIA request, # 2 Exhibit B-1 - 7/9/2019 email, # 3 Exhibit B-2 - 7/12/2019 email, # 4 Exhibit B-3 - 7/26/2019 email, # 5 Exhibit B-4 - 7/30/2019 email, # 6 Exhibit C - 8/13/2019 FDA letter, # 7 Exhibit D - 9/9/2019 FDA letter).(Dolinger, Samuel) (Entered: 07/10/2020)
2020-08-14	17	CROSS MOTION for Summary Judgment and Opposition to Defendant's Motion for Summary Judgment . Document filed by Informed Consent Action Network. Responses due by 9/4/2020.(Siri, Aaron) (Entered: 08/14/2020)
2020-08-14	18	MEMORANDUM OF LAW in Support re: 17 CROSS MOTION for Summary Judgment and Opposition to Defendant's Motion for Summary Judgment . . Document filed by Informed Consent Action Network. (Attachments: # 1 Exhibit A - Document Request).(Siri, Aaron) (Entered: 08/14/2020)
2020-09-04	19	REPLY MEMORANDUM OF LAW in Support re: 14 MOTION for Summary Judgment . and in Opposition to Plaintiff's Cross-Motion for Summary Judgment . Document filed by United States Food and Drug Administration..(Dolinger, Samuel) (Entered: 09/04/2020)
2020-09-04	20	DECLARATION of Suzann Burk (Supplemental) in Support re: 14 MOTION for Summary Judgment .. Document filed by United States Food and Drug Administration. (Attachments: # 1 Exhibit 1 - Recombivax 00659-00686, # 2 Exhibit 2 - Recombivax 00657-00658).(Dolinger, Samuel) (Entered: 09/04/2020)
2020-09-09	21	LETTER MOTION for Local Rule 37.2 Conference regarding Plaintiff's improper service of discovery demands in this FOIA matter addressed to Judge Alison J. Nathan from Samuel Dolinger dated 9/9/2020. Document filed by United States Food and Drug Administration..(Dolinger, Samuel) (Entered: 09/09/2020)
2020-09-11	22	LETTER RESPONSE in Opposition to Motion addressed to Judge Alison J. Nathan from Aaron Siri dated 09/11/2020 re: 21 LETTER MOTION for Local Rule 37.2 Conference regarding Plaintiff's improper service of discovery demands in this FOIA matter addressed to Judge Alison J. Nathan from Samuel Dolinger dated 9/9/2020. . Document filed by Informed Consent Action Network..(Siri, Aaron) (Entered: 09/11/2020)
2020-09-16	23	ORDER OF REFERENCE TO A MAGISTRATE JUDGE: Order that case be referred to the Clerk of Court for assignment to a Magistrate Judge for General Pretrial (includes scheduling, discovery, non-dispositive pretrial motions, and settlement). Referred to Magistrate Judge Stewart D. Aaron. SO ORDERED. Motions referred to Stewart D. Aaron. (Signed by Judge Alison J. Nathan on 9/15/2020) (ama) (Entered: 09/16/2020)
2020-09-17	24	ORDER FOR TELEPHONE CONFERENCE: The parties shall appear via Telephone for a conference in the above-captioned matter on Thursday, September 24, 2020, at 3:00 p.m. EST. During the conference, the parties should be prepared to discuss Defendants Letter Motion. (See ECF No. 21.) At the scheduled time, the parties shall each separately call (888) 278-0296 (or (214) 765-0479) and enter access code 6489745. So Ordered. (Telephone Conference set for 9/24/2020 at 03:00 PM before Magistrate Judge Stewart D. Aaron.) (Signed by Magistrate Judge Stewart D. Aaron on 9/17/2020) (js) (Entered: 09/17/2020)
2020-09-24	25	ORDER granting 21 Letter Motion of Defendant: On the record before this Court, I find, in my discretion, that Plaintiff has not made a sufficient showing to warrant discovery at this time. (Signed by Magistrate Judge Stewart D. Aaron on 9/24/20) (Aaron, Stewart) (Entered: 09/24/2020)
2020-09-24		Minute Entry for proceedings held before Magistrate Judge Stewart D. Aaron: Telephone Conference held on 9/24/2020. (kl) (Entered: 09/28/2020)
2020-09-25	26	REPLY MEMORANDUM OF LAW in Support re: 17 CROSS MOTION for Summary Judgment and Opposition to Defendant's Motion for Summary Judgment . . Document filed by Informed Consent Action Network. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E).(Siri, Aaron) (Entered: 09/25/2020)
2020-10-08	27	APPEAL OF MAGISTRATE JUDGE DECISION to District Court from 25 Order on Motion for Local Rule 37.2 Conference,. Document filed by Informed Consent Action Network. Copies of Appeal of Magistrate Judge Decision to District Court served on Attorney(s) of Record: Samuel Dolinger..(Siri, Aaron) (Entered: 10/08/2020)
2020-10-09		***NOTICE TO ATTORNEY TO RE-FILE DOCUMENT - EVENT TYPE ERROR. Notice to Attorney Siri, Aaron to RE-FILE Document 27 Appeal of Magistrate Judge Decision to District Court. Use the event type Objection (non-motion) found under the event list Other Answers. (tp) (Entered: 10/09/2020)
2020-10-09	28	Objection re: 25 Order on Motion for Local Rule 37.2 Conference, / Plaintiff's Objection to Magistrate Judge Aaron's September 24, 2020 Order Regarding Discovery . Document filed by Informed Consent Action Network..(Siri, Aaron) (Entered: 10/09/2020)
2020-10-22	29	RESPONSE re: 28 Objection (non-motion), . Document filed by United States Food and Drug Administration. (Attachments: # 1 Exhibit A - Judge Aaron's oral ruling dated 9/24/2020).(Dolinger, Samuel) (Entered: 10/22/2020)
2020-10-26	30	ORDER: On September 24, 2020 Magistrate Judge Aaron issued an order granting Defendant's motion to quash Plaintiff's unauthorized discovery requests. See Dkt 25. Plaintiff objected, pursuant to the Federal Rules of Civil Procedure Rule 72(a), which allows a party to "file objections to the order within 14 days after being served with a copy," after which the "district judge in the case must consider timely objections and modify or set aside any part of the order that is clearly erroneous or is contrary to law." Fed. R. Civ. P. 72(a). See Dkt. 28. Magistrate Judge Aaron's order is not clearly erroneous or contrary to law. Judge Aaron correctly interpreted the Court's June 3, 2020 order as permitting Plaintiffs to seek discovery, not that Plaintiff had a right to any particular form of discovery. Dkt. 13. Moreover, because this case was filed under the FOIA, Plaintiff "cannot serve discovery demands before a holding by the Court that the plaintiff has shown agency bad faith or that the agency has not met its burden under FOIA." See Grand Cent. Pship, Inc. v. Cuomo, 166 F.3d 473, 489 (2d Cir. 1999). Judge Aaron did not err in determining that Plaintiff had not made the requisite showing here. SO ORDERED. (Signed by Judge Alison J. Nathan on 10/26/2020) (ks) (Entered: 10/26/2020)
2020-12-28	31	LETTER addressed to Judge Alison J. Nathan from Samuel Dolinger dated 12/28/2020 re: notice of undecided motions pursuant to Your Honor's Individual Practices. Document filed by United States Food and Drug Administration..(Dolinger, Samuel) (Entered: 12/28/2020)
2021-09-13	32	ORDER: By September 24, 2021, the parties shall meet and confer and jointly write the Court providing a status update, if any, that they wish to bring to the Court's attention before resolution of the pending motion, docket number 17. SO ORDERED. (Signed by Judge Alison J. Nathan on 9/13/2021) (vfr) (Entered: 09/13/2021)
2021-09-22	33	LETTER addressed to Judge Alison J. Nathan from Samuel Dolinger dated 9/22/2021 re: parties' response to order dated September 13, 2021. Document filed by United States Food and Drug Administration..(Dolinger, Samuel) (Entered: 09/22/2021)
2022-03-28	34	MEMORANDUM OPINION & ORDER re: 14 MOTION for Summary Judgment filed by United States Food and Drug Administration, 17 CROSS MOTION for Summary Judgment and Opposition to Defendant's Motion for Summary Judgment filed by Informed Consent Action Network. For the reasons above, the Court GRANTS the FDA's motion for summary judgment and DENIES ICAN's motion for summary judgment. This resolves docket numbers 14 and 17. The Clerk of Court is respectfully directed to enter judgment and close the case. SO ORDERED. (Signed by Judge Alison J. Nathan on 3/28/2022) (vfr) Transmission to Orders and Judgments Clerk for processing. (Entered: 03/28/2022)
2022-03-28	35	CLERK'S JUDGMENT re: 34 Memorandum & Opinion in favor of United States Food and Drug Administration against Informed Consent Action Network. It is hereby ORDERED, ADJUDGED AND DECREED: That for the reasons stated in the Court's Memorandum Opinion and Order dated March 28, 2022, the FDA's motion for summary judgment is GRANTED and ICAN's motion for summary judgment is DENIED; accordingly, the case is closed. (Signed by Clerk of Court Ruby Krajick on 3/28/2022) (Attachments: # 1 Right to Appeal) (km) (Entered: 03/28/2022)
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