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

(a)(6)(C)(i) (which codified the “exceptional circumstances” stay first

recognized in Open America v. Watergate Special Prosecution Force,

(D.C. Cir.

5 1976)), or Landis v. North American Co.,

(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,

(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.,

(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,

(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.”

(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.”

§ 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).

(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).

§ 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,

(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,

(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

(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.),

, 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.,

(11th Cir. 1999); accord Carhart v. Carhart-Halaska Int’l, LLC,

(7th Cir. 2015) (affirming decision to permit intervention “without insisting

on the formality of a motion to intervene”); Farina v. Mission Inv. Tr.,

(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

(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,

(2019); accord Little Sisters of the Poor Saints Peter & Paul Home v. Pennsylvania,

, 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),

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

(a)(6)(C)(i), and another under Landis v. North American Co.,

(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.”

. 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,

(1937); accord Colo. River Water Conserv. Dist. v. United States,

(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,

(D.C. Cir. 1971). 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. See

(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,

, 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.,

(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.”

. 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.”

(a)(6)(B)(iii)(III). And

this consultation may extend FOIA’s “time limits,”

§ 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,

(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,

(D.C. Cir. 1988) (citing Renegotiation Bd. v. Bannercraft Clothing

Co.,

(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.,

. 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.

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