Case Detail

FOIA Project Annotation: Judge Trevor McFadden has granted the Department of Health and Human Services a stay of FOIA litigation brought by Children's Health Defense to allow the Centers for Disease Control to await the completion of two massive discovery orders from a district court judge in Texas requiring FDA to review 5.7 million pages of COVID-19 vaccine-related safety monitoring records in one case and 4.5 million records in the other. After both agencies failed to respond within the statutory time limit, CHD filed suit to speed up the processing of its requests. FDA obtained a stay in the litigation against CHD as well as one in another case involving substantially similar records. Although CHD's FOIA litigation focused on the same 512 records from CDC, its litigation got caught up in the ripple effect resulting from the backlog created at FDA, where the 512 records responsive to CHD's FOIA requests remained caught up in the FDA's voluminous backlog. To provide CDC with the same protection granted to FDA, HHS asked McFadden to grant a similar stay. CHD sent two FOIA requests to the CDC seeking records concerning the CDC's safety-monitoring of COVID-19 injections through the Vaccine Adverse Events Reporting System. Frustrated with the lack of response from CDC, CHD filed suit, settling most of their differences except for 512 potentially responsive records that CDC sent to FDA for consultation. When FDA received the records, it placed them in a first-in, first-out processing queue and they remained there ever since. McFadden noted that "these documents matter to CHD. It wants CDC and FDA records on data mining analyses that trace links between certain 'safety signals' and the COVID-19 vaccine. CDC performed its analysis using a proportional reporting ratio methodology. And FDA used an empirical Bayesian methodology. CHD's FOIA request to CDC seeks information and communication about both forms of analysis." McFadden indicated that "the 512 documents could be responsive to CHD's requests." He noted that "though CDC possessed these records, they originated from FDA. So rather than reviewing and producing the records itself, CDC referred the records to FDA for consultation. This allows FDA to review the documents (redacting and flagging them for withholding as necessary) before CDC produces them." But, McFadden observed, "the consultation process hit a snag when a federal court in Texas ordered the FDA to process 5.7 million pages of COVID-19 vaccine records in a compressed timeframe." He added that "the agency's production efforts in [the Texas cases] have only just begun. It must process roughly 4.5 million records at a minimum rate of 180,000 pages per month until June 2025." To deal with the massive discovery orders, FDA assigned nine full-time employees to process the discovery order records and hired nine full-time contractors and one part-time contractor. It also hired six new full-time employees. As a result, the FDA has been able to spare only a handful of staff to handle all other requests, including the CHD requests. FDA has asked for stays in six other cases, four of which have already been granted, including the litigation CHD had filed directly against the FDA. In the CHD litigation before McFadden, HHS requested an 18-month stay. CHD argued that HHS was a non-party to the suit, which was against CDC, and thus did not have jurisdiction to ask for a stay. McFadden pointed out that "CHD is half right. Typically, only parties may seek relief from a court." HHS argued that it was a party by operation of law, claiming that FOIA automatically makes an executive department a defendant whenever one of its components is sued. Answering the question, McFadden noted that "FOIA's double-layer definition of 'agency' does not â€" as HHS suggests â€" make an 'executive department' a de facto party in every suit against its components." He added that "so based on text and precedent, HHS did not automatically become a party when CHD sued CDC." However, McFadden granted HHS status as an intervenor for the limited purpose of pursuing a stay. He noted that "CDC operates under the HHS umbrella. So from the get-go, HHS has functionally participated here." He observed that "HHS has plainly demonstrated its desire to participate here. So rather than requiring HHS and CHD to engage in 'superfluous motion practice,' the Court will construe HHS's stay motion as a request to intervene on that narrow issue." McFadden explained that "CHD brought two improper withholding claims under FOIA, a statute governing HHS and its components. And critically, HHS is administering FOIA in the context of this litigation by brokering the uniform application of privileges and exemptions across its components, CDC and FDA. So HHS may intervene, but â€" absent a formal intervention motion â€" the Court will limit HHS's participation to this stay motion." McFadden found that Landis v. North American Co., 299 U.S. 248 (1936) provided the best route for granting HHS's request for a stay. He pointed out that a Landis stay "stems 'from the power in every court to control the disposition of the causes on its docket with economy of time and effort itself, for counsel and for litigants.' Time and again, the Supreme Court has recognized that a district court may exercise its 'sound discretion' to 'hold one lawsuit in abeyance to abide the outcome of another, especially when the parties and issues are the same.'" He indicated that "that principle fits these circumstances like a glove. Two courts in this district have required plaintiffs â€" who seek the same documents CHD seeks here â€" to wait their turn. Like a child denied by one parent who decides to ask the other, CHD seeks relief here which was withheld by another judge of this district. Letting CHD skip the line would trigger a host of problems. Most prominently, an order like that would 'interfere with other cases' â€" cases involving the same documents and, for one of the cases, the same plaintiff. The risk of blatant interference alone constitutes a 'strong consideration for a stay.' Greenlighting immediate access would also vitiate CDC's prerogative to consult another agency whose documents happen to be in CDC's possession but are responsive to CHD's FOIA request. And forcing FDA to move 512 documents to the head of the line would encourage every well-heeled FOIA requester to litigate for a fast pass, all to the detriment of every other requester in the queue." CHD claimed that granting a stay violated the requirement of FOIA to respond promptly. However, McFadden noted that "even if the records are being 'withheld,' a 'standard of reasonableness' governs whether the withholding is 'improper.' CDC has taken reasonable measures to process the records. Indeed, FOIA expressly permits 'consultation' 'among two or more components of the agency having substantial subject-matter interest therein.'" He observed that "despite the anticipated length of the delay here, FDA cannot practicably move any quicker unless it is loosed from its [stay] constraints. So a stay will not violate FOIA." He concluded that "the same reason justifying those stays â€" the extraordinary production deadline imposed on FDA by another court â€" applies here too."
Issues: Delay - Stay of proceedings

Date Filed	Doc #	Docket Text
2023-02-16	1	COMPLAINT against CENTERS FOR DISEASE CONTROL AND PREVENTION ( Filing fee $ 402 receipt number ADCDC-9865785) filed by CHILDREN'S HEALTH DEFENSE. (Attachments: # 1 Exhibit, # 2 Civil Cover Sheet, # 3 Summons, # 4 Summons, # 5 Summons)(Flores, Ray) (Entered: 02/16/2023)
2023-02-16		Case Assigned to Judge Trevor N. McFadden. (zcb) (Entered: 02/16/2023)
2023-02-16	2	SUMMONS (3) Issued Electronically as to CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. Attorney and U.S. Attorney General (Attachments: # 1 Notice and Consent)(zcb) (Entered: 02/16/2023)
2023-02-16	3	LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by CHILDREN'S HEALTH DEFENSE (Flores, Ray) (Entered: 02/16/2023)
2023-02-17	4	STANDING ORDER Establishing Procedures for Cases Before Judge Trevor N. McFadden. The parties are hereby ORDERED to read and comply with the directives in the attached standing order. Signed by Judge Trevor N. McFadden on 2/17/2023. (lctnm1) (Entered: 02/17/2023)
2023-02-23	5	RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed on United States Attorney General. Date of Service Upon United States Attorney General February 22, 2023. (Flores, Ray) (Entered: 02/23/2023)
2023-02-23	6	RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the United States Attorney. Date of Service Upon United States Attorney on 2/22/2023. Answer due for ALL FEDERAL DEFENDANTS by 3/24/2023. (Flores, Ray) (Entered: 02/23/2023)
2023-02-23	7	RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. CENTERS FOR DISEASE CONTROL AND PREVENTION served on 2/21/2023 (Flores, Ray) (Entered: 02/23/2023)
2023-03-20	8	NOTICE of Appearance by M. Jared Littman on behalf of CENTERS FOR DISEASE CONTROL AND PREVENTION (Littman, M. Jared) (Entered: 03/20/2023)
2023-03-20	9	Consent MOTION for Extension of Time to Respond by CENTERS FOR DISEASE CONTROL AND PREVENTION. (Littman, M. Jared) (Entered: 03/20/2023)
2023-03-20		MINUTE ORDER: The Government's 9 Consent Motion for Extension of Time is granted. The Government's response to the Complaint is now due by April 24, 2023. SO ORDERED. Signed by Judge Trevor N. McFadden on 3/20/2023. (lctnm1) (Entered: 03/20/2023)
2023-03-21		Set/Reset Deadlines: Answer due by 4/24/2023. (hmc) (Entered: 03/21/2023)
2023-04-17	10	Consent MOTION for Extension of Time to Respond by CENTERS FOR DISEASE CONTROL AND PREVENTION. (Littman, M.) (Entered: 04/17/2023)
2023-04-17		MINUTE ORDER: The Government's 10 Consent Motion for Extension of Time is granted. The Government shall respond to the Complaint by May 24, 2023. SO ORDERED. Signed by Judge Trevor N. McFadden on 4/17/2023. (lctnm1) (Entered: 04/17/2023)
2023-04-18		Set/Reset Deadlines: Government's response due by 5/24/2023. (hmc) (Entered: 04/18/2023)
2023-05-22	11	ANSWER to Complaint by CENTERS FOR DISEASE CONTROL AND PREVENTION.(Littman, M.) (Entered: 05/22/2023)
2023-05-24		MINUTE ORDER: Before the Court are a Complaint and an Answer in this FOIA case. It is hereby ORDERED that the parties shall meet and confer and file a Joint Status Report proposing a schedule for proceeding in this matter. The schedule should address, among other things, the status of Plaintiff's FOIA request, the anticipated number of documents responsive to Plaintiff's FOIA request, the anticipated date(s) for release of the documents requested by Plaintiff, whether a motion for an Open America stay is likely in this case, whether a Vaughn index will be required in this case, and a briefing schedule for dispositive motions, if required. The parties shall file the schedule on or before June 26, 2023. SO ORDERED. Signed by Judge Trevor N. McFadden on 5/24/2023. (lctnm1) (Entered: 05/24/2023)
2023-05-25		Set/Reset Deadlines: Joint Status Report due by 6/26/2023. (hmc) (Entered: 05/25/2023)
2023-06-21	12	Joint STATUS REPORT by CENTERS FOR DISEASE CONTROL AND PREVENTION. (Littman, M.) (Entered: 06/21/2023)
2023-06-22		MINUTE ORDER: The parties shall submit another Joint Status Report by July 24, 2023. SO ORDERED. Signed by Judge Trevor N. McFadden on 6/22/2023. (lctnm1) (Entered: 06/22/2023)
2023-06-22		Set/Reset Deadlines: Joint Status Report due by 7/24/2023. (hmc) (Entered: 06/22/2023)
2023-07-15	13	Joint STATUS REPORT by CENTERS FOR DISEASE CONTROL AND PREVENTION. (Littman, M.) (Entered: 07/15/2023)
2023-07-17		MINUTE ORDER: The parties shall submit another Joint Status Report by September 8, 2023. SO ORDERED. Signed by Judge Trevor N. McFadden on 7/17/2023. (lctnm1) (Entered: 07/17/2023)
2023-07-17		Set/Reset Deadlines: Joint Status Report due by 9/8/2023. (hmc) (Entered: 07/17/2023)
2023-09-07	14	Joint STATUS REPORT by CENTERS FOR DISEASE CONTROL AND PREVENTION. (Littman, M.) (Entered: 09/07/2023)
2023-09-07		MINUTE ORDER: The parties shall file another Joint Status Report by November 7, 2023. SO ORDERED. Signed by Judge Trevor N. McFadden on 9/7/2023. (lctnm1) (Entered: 09/07/2023)
2023-10-20	15	NOTICE of Appearance by Risa Evans on behalf of All Plaintiffs (Evans, Risa) (Entered: 10/20/2023)
2023-11-07	16	Joint MOTION for Extension of Time to File Joint Status Report by CENTERS FOR DISEASE CONTROL AND PREVENTION. (Attachments: # 1 Text of Proposed Order)(Littman, M.) (Entered: 11/07/2023)
2023-11-08		MINUTE ORDER: The Court GRANTS the parties' 16 Joint Motion for an Extension of Time to File a Joint Status Report. The parties' Joint Status Report shall be due by November 14, 2023. And the parties are admonished to follow the Court's four business day rule for requesting extensions of time. See Standing Order § 9(A), ECF No. 4. SO ORDERED. Signed by Judge Trevor N. McFadden on 11/08/2023. (lctnm1) (Entered: 11/08/2023)
2023-11-09		Set/Reset Deadlines: Joint Status Report due by 11/14/2023. (hmc) (Entered: 11/09/2023)
2023-11-13	17	STATUS REPORT by CHILDREN'S HEALTH DEFENSE. (Attachments: # 1 Text of Proposed Order)(Evans, Risa) (Entered: 11/13/2023)
2023-11-15		MINUTE ORDER: The Court ORDERS the parties to appear for an in-person status hearing on December 15, 2023, at 10:00 a.m. in Courtroom 2 before Judge Trevor N. McFadden. SO ORDERED. Signed by Judge Trevor N. McFadden on 11/15/2023. (lctnm1) (Entered: 11/15/2023)
2023-11-15		MINUTE ORDER: The in-person status hearing previously scheduled for December 15, 2023, is hereby RESCHEDULED to January 16, 2024, at 10:30 a.m. in Courtroom 2 before Judge Trevor N. McFadden. SO ORDERED. Signed by Judge Trevor N. McFadden on 11/15/2023. (lctnm1) (Entered: 11/15/2023)
2024-01-18		NOTICE of Rescheduled Hearing: Status Conference rescheduled from 1/16/2024 to 2/8/2024 at 10:00 AM in Courtroom 2- In Person before Judge Trevor N. McFadden. (hmc) (Entered: 01/18/2024)
2024-02-08		Minute Entry for proceedings held before Judge Trevor N. McFadden: Status Conference held on 2/8/2024. The Government shall review 300 pages per month starting in the end of March, unless the Government moves for a stay under Open America . The parties shall also file rolling Joint Status Reports on the 15th of each month, starting on April 15, 2024. (Court Reporter: Lisa Edwards.) (hmc) (Entered: 02/08/2024)
2024-02-12	18	TRANSCRIPT OF STATUS CONFERENCE before Judge Trevor N. McFadden held on February 8, 2024; Page Numbers: 1-13. Date of Issuance: February 12, 2024. Court Reporter/Transcriber Lisa Edwards. Telephone number (202) 354-3269. Transcripts may be ordered by submitting the Transcript Order Form For the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purchased from the court reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter. NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days. The policy, which includes the five personal identifiers specifically covered, is located on our website at www.dcd.uscourts.gov. Redaction Request due 3/4/2024. Redacted Transcript Deadline set for 3/14/2024. Release of Transcript Restriction set for 5/12/2024.(Edwards, Lisa) (Entered: 02/12/2024)
2024-02-27	19	TRANSCRIPT OF STATUS CONFERENCE before Judge Trevor N. McFadden held on February 8, 2024; Page Numbers: 1-13. Date of Issuance: February 27, 2024. Court Reporter/Transcriber Lisa Edwards. Telephone number (202) 354-3269. Transcripts may be ordered by submitting the Transcript Order Form For the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purchased from the court reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter. NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days. The policy, which includes the five personal identifiers specifically covered, is located on our website at www.dcd.uscourts.gov. Redaction Request due 3/19/2024. Redacted Transcript Deadline set for 3/29/2024. Release of Transcript Restriction set for 5/27/2024.(Edwards, Lisa) (Entered: 02/27/2024)
2024-03-27	20	Partial MOTION to Stay by CENTERS FOR DISEASE CONTROL AND PREVENTION. (Attachments: # 1 Declaration Declaration of Suzann Burk)(Littman, M.) (Entered: 03/27/2024)
2024-03-28	21	DECLARATION - Attachment A to Burk Declaration by CENTERS FOR DISEASE CONTROL AND PREVENTION re 20 Partial MOTION to Stay . (Littman, M.) (Entered: 03/28/2024)
2024-03-28	22	Joint MOTION for Extension of Time to File Response/Reply as to 20 Partial MOTION to Stay by CHILDREN'S HEALTH DEFENSE. (Attachments: # 1 Text of Proposed Order)(Flores, Ray) (Entered: 03/28/2024)
2024-03-29		MINUTE ORDER: The Court GRANTS the parties' 22 Joint Motion for Extension of Time. Plaintiff's opposition to the Government's 20 Partial Motion to Stay is due by April 17. And the Government's reply is due by May 3. SO ORDERED. Signed by Judge Trevor N. McFadden on 03/29/2024. (lctnm1) (Entered: 03/29/2024)
2024-04-09	23	Joint STATUS REPORT by CENTERS FOR DISEASE CONTROL AND PREVENTION. (Littman, M.) (Entered: 04/09/2024)
2024-04-09		MINUTE ORDER: Upon consideration of the parties' 23 Joint Status Report, and in light of the Government's pending stay motion, the parties no longer need to file rolling joint status reports on the 15th of each month. Cf. Minute Order (Feb. 8, 2024). SO ORDERED. Signed by Judge Trevor N. McFadden on 04/09/2024. (lctnm1) (Entered: 04/09/2024)
2024-04-17	24	Memorandum in opposition to re 20 Motion to Stay filed by CHILDREN'S HEALTH DEFENSE. (Evans, Risa) (Entered: 04/17/2024)
2024-05-03	25	REPLY to opposition to motion re 20 Partial MOTION to Stay filed by CENTERS FOR DISEASE CONTROL AND PREVENTION. (Attachments: # 1 Exhibit Roger Andoh Declaration, # 2 Exhibit Interim Release)(Littman, M.) (Entered: 05/03/2024)
2024-05-07	26	SURREPLY to re 25 Reply to opposition to Motion REQUEST FOR LEAVE filed by CHILDREN'S HEALTH DEFENSE. (Attachments: # 1 Text of Proposed Order)(Flores, Ray) (Entered: 05/07/2024)
2024-05-07		MINUTE ORDER: The Court GRANTS Plaintiff's 26 Motion for Leave to File a Sur-Reply. The sur-reply is due by May 14, and it must not exceed five double-spaced pages. SO ORDERED. Signed by Judge Trevor N. McFadden on 05/07/2024. (lctnm1) (Entered: 05/07/2024)
2024-05-13	27	SURREPLY to re 25 Reply to opposition to Motion to Stay filed by CHILDREN'S HEALTH DEFENSE. (Attachments: # 1 Declaration)(Flores, Ray) (Entered: 05/13/2024)
2024-07-24	28	MEMORANDUM ORDER resolving Health and Human Services' 20 Partial Motion to Stay and scheduling in-person status conference. See the attached Order for details. Signed by Judge Trevor N. McFadden on 07/24/2024. (lctnm1) (Entered: 07/24/2024)
2024-07-24		MINUTE ORDER: The parties are ordered to file simultaneous submissions addressing whether Children's Health Defense v. FDA, No. 23-cv-220 (RDM) (D.D.C.) qualifies as a related case under Local Civil Rule 40.5(a). The submissions are due on August 7 and may not exceed five double-spaced pages. SO ORDERED. Signed by Judge Trevor N. McFadden on 07/24/2024. (lctnm1) (Entered: 07/24/2024)
2024-07-24		Case Stayed. (hmc) (Entered: 07/24/2024)
2024-08-07	29	MEMORANDUM re Order,, Set Deadlines, by CHILDREN'S HEALTH DEFENSE. (Evans, Risa) (Entered: 08/07/2024)
2024-08-07	30	NOTICE - submission regarding relatedness by CENTERS FOR DISEASE CONTROL AND PREVENTION, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES re Order,, Set Deadlines, (Littman, M.) (Entered: 08/07/2024)
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