UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
CHILDREN’S HEALTH DEFENSE,
Plaintiff,
v. Case No. 1:23-cv-00431 (TNM)
CENTERS FOR DISEASE CONTROL AND PREVENTION,
Defendant.
MEMORANDUM ORDER
Children’s Health Defense (CHD) wants governmental safety-monitoring records for the
COVID-19 vaccine. So it sent Freedom of Information Act requests to two agencies—the Food
and Drug Administration and Centers for Disease Control and Prevention. The agencies largely
gave CHD what it wanted, except for 512 documents bearing the results of safety analyses
performed by FDA and related communications between FDA and CDC. Those documents,
which are responsive to both FOIA requests, are sitting in an FDA processing queue that has
ballooned because of an unprecedented discovery order from a federal court in Texas.
CHD sued both agencies to speed things up. But FDA obtained a stay in its litigation
with CHD, citing exceptional circumstances and due diligence. See Order at 9, Child.’s Health
Def. v. FDA (CHD I), No. 23-cv-220 (RDM) (D.D.C. Jan. 12, 2024), ECF No. 25. FDA got a
stay in another case involving substantially similar documents. See Orders, Informed Consent
Action Network v. FDA (Informed Consent I), No. 23-cv-219 (RBW) (D.D.C.), ECF Nos. 27 &
29. Now CDC—through its parent agency, the U.S. Department of Health and Human
Services—seeks similar treatment for these same documents. In an exercise of its inherent power, the Court will grant a stay to preserve the integrity of the stay orders in CHD I and
Informed Consent I. CHD may not get fast-track treatment here after it and another plaintiff
were ordered to wait elsewhere.
I.
CHD sent two FOIA requests to CDC “seeking records in connection with the CDC’s
safety-monitoring of COVID-19 injections through the Vaccine Adverse Events Reporting
System (VAERS).” Compl. at 1, ECF No. 1. Frustrated with the pace and substance of CDC’s
responses, CHD sued to move things along. See id. The parties have hashed out most of their
differences, except for 512 potentially responsive records that CDC sent to FDA for
consultation. 1 See HHS Mot. for Partial Stay at 10, 2 ECF No. 20. When FDA received the
records, it placed them in a first-in, first-out processing queue at the Access Litigation and
Freedom of Information Branch within FDA’s Center for Biologics Evaluation and Research.
See id. at 6. The agency slotted the documents into this queue last August, and they have been
sitting there ever since behind hundreds of other, earlier-submitted FOIA requests. See Burk
Decl. ¶¶ 32, 35, ECF No. 20-1.
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. Pl.’s
Opp’n at 12, ECF No. 24. CDC performed its analysis using a proportional reporting ratio
(PRR) methodology. See Burk Decl. ¶ 33. And FDA used an empirical Bayesian (EB)
methodology. See id. CHD’s FOIA request to CDC seeks information and communication
1 CHD also appears unsatisfied with the CDC’s searches and the extent of their redactions. See HHS Mot. at 10–11; Joint Status Report ¶¶ 3, 9, 10, ECF No. 17. But these issues are for another day. 2 The Court’s page citations refer to the pagination automatically generated by CM/ECF. 2 about both forms of analysis. See Compl. ¶ 17. It specifically asks for “[r]ecords of all
communication about PRR results and all follow-up investigation done . . . within CDC, and all
communications about these matters between CDC and FDA.” Id. And it more broadly requests
“[r]ecords of all communications discussing, referencing, or mentioning Proportional Reporting
Ratio, PRR (or PRRs), safety signals (or signals), signal detection, or data mining, . . . within
CDC and between CDC and FDA.” Id.
The 512 documents could be responsive to CHD’s requests. According to a senior FDA
official, they contain “FDA’s EB analyses that FDA shared with CDC, including copies of
FDA’s EB analyses, along with communications between FDA and CDC about the results of
those analyses.” Burk Decl. ¶ 33. 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 a consultation. This allows FDA to review the documents (redacting and flagging them
for withholding as necessary) before CDC produces them. See id. ¶ 32.
But 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. See Order
at 3, Pub. Health & Med. Pros. for Transparency v. FDA (PHMPT I), No. 4:21-cv-1058 (MTP)
(N.D. Tex.), ECF No. 35; Order at 1, Pub. Health & Med. Pros. for Transparency v. FDA
(PHMPT II), No. 4:22-cv-0915 (MTP) (N.D. Tex.), ECF No. 38. Last fall, FDA completed its
production obligations in PHMPT I. See Burk Decl. ¶ 22. But the agency’s production efforts in
PHMPT II have only just begun. It must process roughly 4.5 million records at a minimum rate
of 180,00 pages per month until June 2025. See id. ¶ 24.
The processing burden created by the PHMPT litigation is—without dispute—“many
orders of magnitude greater than anything any agency has ever encountered in a FOIA order.”
3 Id. ¶ 25. FDA responded by “implement[ing] sweeping organizational and work process
changes.” Id. ¶ 23. It assigned nine full-time employees to PHMPT processing and hired nine
full-time contractors (and one part-time contractor) to aid in the effort. Id. It also hired six new
full-time employees since the PHMPT orders came down, although it will take several months of
training for the new hires to become maximally efficient. Id. ¶¶ 25, 27. Because of the intense
production schedule in the PHMPT litigation, FDA has only been able to spare a “handful of
staff” for the rest of the FOIA requests—including the requests here. Id. ¶ 25.
Given these circumstances, FDA “has reviewed every pending FOIA request that is the
subject of litigation to determine whether the case should be stayed to enable [the agency] to
satisfy its production mandates.” Id. ¶ 28. Based on this review, either the FDA or its parent
agency HHS have sought stays in six cases (not counting this one). In one case, the plaintiff
voluntarily dismissed its complaint after the agency asked for a stay. See Stip. of Dismissal,
Informed Consent Action Network v. FDA, No. 23-cv-1508 (CKK) (D.D.C.), ECF No. 15. The
stay motion in another case remains pending. See Defs.’ Mot. to Stay, Informed Consent Action
Network v. FDA, 23-cv-3675 (JMC) (D.D.C.), ECF No. 13. And the stay requests in the other
four cases have all been granted. See Order, Wright v. HHS, No. 22-cv-1378 (RC) (D.D.C.),
ECF No. 28 (18-month stay); Orders, Informed Consent I, No. 23-cv-219, ECF Nos. 27 & 29
(two six-month stays); Minute Order (Dec. 13, 2023), Child.’s Health Def. v. FDA, No. 23-cv-
2316 (LLA) (D.D.C.) (18-month stay); Mem. Op. & Order, CHD I, No. 23-cv-220, ECF No. 25
(six-month stay).
Two of those cases—CHD I and Informed Consent I—directly overlap with this one.
The 512 documents contain FDA’s empirical Bayesian analyses and communications with CDC
about the results of those analyses. See Burk Decl. ¶ 33. That makes the records potentially
4 responsive to the FOIA request here. See Compl. ¶ 17. But they also relate to requests in CHD I
and Informed Consent I. Burk Decl. ¶ 34.
The overlap is hard to miss. In CHD I, CHD asks for “[r]ecords of any Empirical
Bayesian data mining conducted by FDA . . . and any records of any sharing or discussing of
results and signals with the CDC.” Compl. ¶ 16, CHD I, No. 23-cv-220, ECF No. 1. And in
Informed Consent I, the plaintiff seeks “records concerning ‘Empirical Bayesian data mining’
and . . . any communications between FDA and CDC ‘sharing and discussing results of data
mining analyses and signals.’” Compl. ¶ 5, Informed Consent I, No. 23-cv-219, ECF No. 1.
Based on the wording of these requests, a senior FDA official swears under penalty of perjury
that, “[t]o the best of [her] knowledge, the Consult comprises a subset of similar records of
FDA’s EB analysis that [she] believe[s] will be responsive to both of the FOIA requests” in CHD
I and Informed Consent I. Burk Decl. ¶ 34.
Both cases are stayed. In CHD I, the court entered a six-month Open America stay
beginning on January 12, 2024. See Mem. Op. & Order, CHD I, No. 23-cv-220, ECF No. 25.
And the court recently ordered the parties there to file status reports in August addressing
whether the stay should be extended or modified. See Minute Entry (July 9, 2024), CHD I, No.
23-cv-220. Similarly, the Informed Consent I court entered an Open America stay last
November. See Order, Informed Consent I, No. 23-cv-219, ECF No. 27. And in May, the court
extended that stay until November 2024. See Order, Informed Consent I, No. 23-cv-219, ECF
No. 29.
HHS now seeks an 18-month stay here. See HHS Mot. at 6. It says a stay is warranted
under either 5 U.S.C. § 552(a)(6)(C)(i) (which codified the “exceptional circumstances” stay first
recognized in Open America v. Watergate Special Prosecution Force, 547 F.2d 605 (D.C. Cir.
5 1976)), or Landis v. North American Co., 299 U.S. 248 (1936). CHD opposes the Motion, see
Pl.’s Opp’n at 11, which is now ripe for adjudication.
II.
Consider first CHD’s threshold argument that HHS cannot move for a stay because of its
status as a nonparty. See Pl.’s Opp’n at 20–22. CHD says this suit is between CHD and CDC,
and it notes that CDC has not sought a stay. See id. at 20. According to CHD, this means the
Court should either strike or deny HHS’s motion. See id. at 22.
CHD is half right. Typically only parties may seek relief from a court. Cf. Broidy Cap.
Mgmt. LLC v. Muzin, 61 F.4th 984, 990 (D.C. Cir. 2023). But there are various ways an outsider
can become a party: “intervention, substitution, or third-party practice,” to name a few. United
States v. LTV Corp., 746 F.2d 51, 53 (D.C. Cir. 1984) (per curiam). “Movants in trial
proceedings have also historically been considered ‘parties’ by the Supreme Court” in the
context of appealing “collateral orders to which they were parties, even though they were not
named parties to . . . the underlying judgments.” Broidy, 61 F.4th at 990 (cleaned up). No
matter the mechanism, CHD has a point—HHS must become a party to seek relief.
HHS says it is a party by operation of law. Specifically, it says that FOIA automatically
makes an executive department a defendant whenever one of its components is sued. See HHS
Mot. at 1 n.1; HHS Reply at 5–7, ECF No. 25. Not so.
FOIA provides that “each agency . . . shall make [properly requested] records promptly
available to any person.” 5 U.S.C. § 552(a)(3)(A) (emphasis added). Two overlapping
definitions apply to the term “agency” as it appears in that subsection. The term generally
“means each authority of the Government of the United States, whether or not it is within or
subject to review by another agency.” Id. § 551(1) (emphasis added). And for § 552
6 specifically, FOIA says that the term “‘agency’ as defined in section 551(1) . . . includes any
executive department, military department, Government corporation, Government controlled
corporation, or other establishment in the executive branch of the Government (including the
Executive Office of the President), or any independent regulatory agency.” Id. § 552(f)(1)
(emphasis added).
Stitched together, § 551(1) generally defines “agency” and § 552(f)(1) lists some specific
entities that fit that bill. But the word “includes” tees off that list, making its examples
illustrative instead of exclusive. See Antonin Scalia & Bryan A. Garner, Reading Law: The
Interpretation of Legal Texts 132 (2012) (“The verb to include introduces examples, not an
exhaustive list.”). So FOIA’s agency language may refer to an “executive department” (like
HHS). 5 U.S.C. § 552(f)(1). Yet it may also refer to an “authority of the Government of the
United States, whether or not it is within or subject to review by another agency” (like CDC). Id.
§ 551(1). Either way, FOIA’s double-layer definition of “agency” does not—as HHS suggests—
make an “executive department” a de facto party in every suit against its components. Id.
§ 552(f)(1).
Precedent confirms that “subcomponents of federal executive departments may, at least
in some cases, be properly named as FOIA defendants” even if their parent agency is left out of
the action. See Jean-Pierre v. Fed. Bureau of Prisons, 880 F. Supp. 2d 95, 101 (D.D.C. 2012)
(cleaned up). And the D.C. Circuit has said that “agency status [is conferred on] on any
administrative unit with substantial independent authority in the exercise of specific functions.”
Soucie v. David, 448 F.2d 1067, 1073 (D.C. Cir. 1971). So based on text and precedent, HHS
did not automatically become a party when CHD sued CDC.
7 That said, the Court will recognize HHS as an intervenor for the limited purpose of
seeking a stay. Rightly or wrongly, HHS has acted like a party from the beginning of this
litigation. In the Complaint, CHD alleged that CDC was “an agency within the executive branch
of the U.S. Government, . . . is a federal agency within the meaning of 5 U.S.C. § 552(f), and has
possession, custody, and control of records to which Plaintiff seeks access.” Compl. ¶ 3. But
CDC denied the allegation and answered that “CDC is an operating component within [HHS],”
meaning “[HHS] is the proper defendant to this Complaint.” Answer ¶ 3, ECF No. 11. HHS has
also filed joint status reports and joint motions with CHD—all without objection. See, e.g., JSR
at 1, ECF No. 12 (“Plaintiff Children’s Health Defense (“Plaintiff”), and Defendant, the
Department of Health and Human Services (“Defendant” and, together with Plaintiff, “Parties”),
through undersigned counsel respectfully submit the following joint status report[.]”); JSR at 1,
ECF No. 13 (same); Joint Mot. Extension at 1, ECF No. 16 (same). And, of course, CDC
operates under the HHS umbrella. See HHS Mot. at 1. Even CDC’s letterhead in
correspondence with CHD has “Department of Health and Human Services” stamped across the
top. See HHS Reply Ex. 2, at 1, ECF No. 25-2. So from the get-go, HHS has functionally
participated here.
HHS also qualifies for permissive agency intervention under Federal Rule of Civil
Procedure 24(b). That rule says: “On timely motion, the court may permit a federal . . . agency
to intervene if a party’s claim or defense is based on . . . a statute or executive order administered
by the . . . agency.” Fed. R. Civ. P. 24(b)(2)(A). HHS meets that standard.
As for the “timely motion” requirement, the Court recognizes that HHS never filed a
formal motion seeking intervention. But HHS has plainly demonstrated its desire to participate
here. So rather than requiring HHS and CHD to engage in “superfluous motion practice,” HHS
8 Reply at 6, the Court will construe HHS’s stay motion as a request to intervene on that narrow
issue. Cf. In re Sealed Case (Med. Recs.), 381 F.3d 1205, 1211 n.4 (D.C. Cir. 2004) (noting that
several “courts of appeals have construed a district court’s decision to permit a non-party to
participate in a discovery dispute as the equivalent of authorizing intervention” (cleaned up)).
Other circuits have endorsed this practice, which permits a district court to rule on a motion filed
by a nonparty “as if [that nonparty] had filed a formal motion to intervene.” Loyd v. Ala. Dep’t
of Corr., 176 F.3d 1336, 1341 (11th Cir. 1999); accord Carhart v. Carhart-Halaska Int’l, LLC,
788 F.3d 687, 690 (7th Cir. 2015) (affirming decision to permit intervention “without insisting
on the formality of a motion to intervene”); Farina v. Mission Inv. Tr., 615 F.2d 1068, 1074 (5th
Cir. 1980) (rejecting argument “that the FDIC never made a formal petition to intervene”).
As for Rule 24(b)’s substantive requirement, CHD brought two improper withholding
claims under FOIA, Compl. ¶ 4, a statute governing HHS and its components, see 5 U.S.C.
§ 552(a)(3)(A) (requiring covered agencies to make properly requested “records promptly
available to any person”). 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—absent a formal intervention
motion—the Court will limit HHS’s participation to this stay motion. Broidy, 61 F.4th at 995–
96. Finally, the reasons favoring intervention outweigh the risk of “undu[e] delay or prejudice”
to CHD or CDC. Fed. R. Civ. P. 24(b)(3); see also infra Part III (explaining basis for stay). 3
3 HHS need not independently demonstrate Article III standing as a Defendant-Intervenor because it is not “invoking the court’s jurisdiction” or “seeking additional relief” beyond the claims asserted by CHD. Va. House of Delegates v. Bethune-Hill, 139 S. Ct. 1945, 1951 (2019); accord Little Sisters of the Poor Saints Peter & Paul Home v. Pennsylvania, 140 S. Ct. 2367, 2379 n.6 (2020) (stating appellate court “erred by inquiring into [the intervenor’s] independent Article III standing”); Env’t Integrity Project v. Wheeler, No. 20-cv-1734 (KBJ), 2021 WL 9 In sum, the Court treats HHS as a Defendant-Intervenor for the purpose of considering its
stay motion.
III.
Now to address the merits of the stay motion. HHS offers two paths to pausing this case:
one under 5 U.S.C. § 552(a)(6)(C)(i), and another under Landis v. North American Co., 299 U.S.
248 (1936). At this point, with stays issued in both CHD I and Informed Consent I, Landis offers
the better course.
A so-called 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 for itself, for counsel, and for litigants.”
299 U.S. at 254. 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 where the parties and issues are the same.” Am. Life Ins. Co. v. Stewart, 300 U.S. 203,
215 (1937); accord Colo. River Water Conserv. Dist. v. United States, 424 U.S. 800, 817 (1976)
(“As between federal district courts . . . the general principle is to avoid duplicative litigation.”).
That principle fits these circumstances like a glove. Two courts in this district have
required plaintiffs—who seek the same documents CHD seeks here—to wait their turn. See
Mem. Op. & Order, CHD I, No. 23-cv-220, ECF No. 25; Orders, Informed Consent I, No. 23-cv-
219, ECF Nos. 27 & 29. Like a child denied by one parent who decides to ask the other, CHD
seeks relief here that 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 directly
“interfere[] with []other case[s]”—cases involving the same documents and, for one of the cases,
6844257, at *2 (D.D.C. Jan. 27, 2021) (“[T]he D.C. Circuit’s prior holdings” on intervenor standing “predate, and are plainly inconsistent with, the Supreme Court’s recent opinions.”). 10 the same plaintiff. Dellinger v. Mitchell, 442 F.2d 782, 787 (D.C. Cir. 1971). The risk of blatant
interference alone constitutes a “strong consideration for [a] stay.” Id. 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. See 5 U.S.C.
§ 552(a)(6)(B)(iii)(III). 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. Cf. Order at 3, PHMPT I, No. 4:21-cv-1058, ECF No. 35;
Order at 1, PHMPT II, No. 4:22-cv-0915, ECF No. 38.
Of course, the Court must balance its interest in judicial economy and the preservation of
the related stay orders against “any possible hardship to the parties.” Belize Soc. Dev. Ltd. v.
Gov’t of Belize, 668 F.3d 724, 732–33 (D.C. Cir. 2012) (cleaned up). But one party will face
some hardship either way the Court rules. If the Court grants a stay, CHD will not have
immediate access to “crucial information about federal public health agencies’ efforts to
determine whether and to what extent COVID-19 shots are causally linked to” adverse events.
Pl.’s Opp’n at 28–29. If the Court denies a stay, CDC’s counterpart FDA may be forced to
violate a court-mandated processing order given the reality of its limited resources. HHS Mot. at
22–23. And the lack of a stay would impede HHS’s ability to coordinate and uniformly invoke
privileges and exemptions across its components.
CHD counters that a stay of any sort would violate FOIA. It says that CDC has a
statutory obligation to produce the 512 records, and its failure to do so constitutes improper
withholding that cannot continue. See Pl.’s Opp’n at 16–20. While CHD may be right on the
law, see McGehee v. C.I.A., 697 F.2d 1095, 1109 (D.C. Cir. 1983) (noting courts may compel
records “improperly withheld”), it is wrong on its application.
11 Even if the records are being “withheld,” a “standard of reasonableness” governs whether
that withholding is “improper.” Id. at 1110. 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.” 5 U.S.C. § 552(a)(6)(B)(iii)(III). And
this consultation may extend FOIA’s “time limits,” id. § 552(a)(6)(B)(i), as long as the agency
conducts the consult “with all practicable speed,” id. § 552(a)(6)(B)(iii). Despite the anticipated
length of the delay here, FDA cannot practicably move any quicker unless it is loosed from its
PHMPT constraints. So a stay will not violate FOIA.
Nor does FOIA’s statutory scheme undercut the Court’s inherent authority to issue a
Landis stay. See Campaign for Accountability v. U.S. Dep’t of Justice, 280 F. Supp. 3d 112, 115
(D.D.C. 2017). As the D.C. Circuit and Supreme Court recognized decades ago, “FOIA imposes
no limits on courts’ equitable powers in enforcing its terms.” Payne Enters., Inc. v. United
States, 837 F.2d 486, 494 (D.C. Cir. 1988) (citing Renegotiation Bd. v. Bannercraft Clothing
Co., 415 U.S. 1, 20 (1974)).
To recap, several judges in this district have issued stays affecting access to the same
documents CHD seeks here, and one of these cases even involves CHD. See Burk Decl. ¶¶ 33–
34. This alone constitutes a “pressing need” for a stay. Belize Soc. Dev., 668 F.3d at 732. The
same reason justifying those stays—the extraordinary production deadline imposed on FDA by
another court—applies here too.
IV.
Having weighed the equities on both sides of the ledger, the Court will stay this case for
six months from the date of this Order. At the end of this period, the Court will order the parties
to appear for an in-person status conference. And if either of the stays in CHD I or Informed
12 Consent I are lifted, the parties may bring that development to the Court’s attention in a joint
status report. For these reasons, it is hereby
ORDERED that HHS’s [20] Partial Motion to Stay is GRANTED IN PART; and it is
further
ORDERED that this case is STAYED until Friday, January 24, 2025; and it is further
ORDERED that the parties shall appear for an in-person status conference on Friday,
January 24, 2025, at 10:30 a.m. in Courtroom 2 to discuss whether the stay should be extended
or lifted.
SO ORDERED.
The Clerk of Court is requested to add the U.S. Department of Health and Human
Services to the docket as a Defendant-Intervenor.
2024.07.24 10:31:47 -04'00' Dated: July 24, 2024 TREVOR N. McFADDEN, U.S.D.J.