Informed Consent Action Network v. Centers for Disease Control and Prevention

District Court, District of Columbia·Decided September 24, 2025·No. Civil Action No. 2023-0747·Published

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

)

INFORMED CONSENT ACTION ) NETWORK, )

)

Plaintiff, )

v. ) No. 1:23-cv-747 (GMH)

)

CENTERS FOR DISEASE CONTROL AND ) PREVENTION, et al., )

)

Defendants. )

__________________________________________)

MEMORANDUM OPINION AND ORDER Plaintiff Informed Consent Action Network has sued the Centers for Disease Control and Prevention (the “CDC” or the “Agency”) and the Department of Health and Human Services (to- gether, “Defendants”) under the Freedom of Information Act (“FOIA”), 5 U.S.C. § 552. The dis- pute centers on Defendants’ withholding of records pursuant to FOIA’s Exemption 5, which pro- tects against disclosure of “inter-agency or intra-agency memorandums or letters that would not be available by law to a party other than an agency in litigation with the agency,” id. § 552(b)(5), an exception that has been interpreted to include documents shielded by the so-called deliberative process privilege, which Defendants claim here. The parties’ cross-motions for summary judg- ment are currently pending. 1 For the reasons that follow, both motions are denied without preju- dice.

1 The documents most relevant to this Memorandum Opinion and order are: (1) Defendants’ motion for summary judgment and its exhibits, ECF Nos. 31 through 31-4; (2) Plaintiff’s cross-motion for summary judgment and opposition to Defendants’ motion for summary judgment and its exhibits, ECF Nos. 32 through 32-2; (3) Defendants’ reply in further support of their motion for summary judgment and opposition to Plaintiff’s motion for summary judgment and its exhibit, ECF Nos. 35 through 35-1; and (4) Plaintiff’s reply in further support of its cross-motion for summary judgment, ECF No. 37. After the motions were fully briefed, the parties consented to magistrate judge jurisdiction for all purposes and the case was randomly assigned to the undersigned. See ECF No. 38; Minute Order (Apr. 22, 2025); Minute Entry (Apr. 22, 2025). The page numbers cited herein are those assigned by the Court’s CM/ECF system.

I. BACKGROUND

On June 30, 2022, Plaintiff submitted a FOIA request to the CDC seeking

[a]ll records related to the Proportional Reporting Ratio (PRR) analyses performed “to identify [adverse events, or ‘AEs,’] that are disproportionately reported relative to other [adverse events]” pursuant to Sections 2.0, 2.3, and 2.3.1 of the [Vaccine Adverse Events Reporting System, or ‘VAERS,’] Standard Operating Procedures for COVID-19. This should include, but not be limited to, all communications concerning PRR analyses including communications concerning any decision not to conduct PRR analyses.[2]

ECF No. 1-1 at 2. The request suggested that such records would likely be found in the CDC’s Immunization Safety Office. See id. On July 6, 2022, the CDC National Center for Emerging and Zoonotic Infectious Diseases (known as NCEZID) informed the CDC’s FOIA office that no search had been conducted in response to Plaintiff’s request. 3 See ECF No. 35-1, ¶ 4. On July 29, 2022, Roger Andoh, the CDC’s FOIA Officer, sent the Agency’s final response letter to Plaintiff, which attempted to explain why no search had been conducted for the PRR analyses. Id.; ECF No. 1-1 at 16–17. In it, the Agency relayed that NCEZID had reported that

[t]here are no written communications regarding the use of [Empirical Bayesian data mining, also known as EB,] over PRR for purposes of signal detection.

The VAERS Standard Operating Procedures (SOP) is a planning document for internal use by CDC with collaborating partners. It is a dynamic document this is used, revised, and implemented based on the current science of the COVID-19 pandemic . Please see the “Disclaimer” excerpt from the SOP below.

“Disclaimer: This document is a draft planning document for internal use by the Centers for Disease Control and Prevention, with collaborating contractors. Numerous aspects (including but not limited to specific adverse events to be monitored, timeframes for

2 Defendants explain (and Plaintiff does not dispute) that the VAERS is a “passive reporting system to which medical professionals, pharmaceutical companies and others can report an adverse event occurring after administration of a vaccine, and [Proportional Reporting Ratio] measures how common an adverse event for a particular vaccine is compared to how common the event is in the overall VAERS database.” ECF No. 32-1 at 4, ¶ 5. 3 The Immunization Safety Office was apparently housed within the CDC’s National Center for Emerging and Zoonotic Infectious Diseases. See Organizational Structure, National Center for Emerging and Zoonotic Infectious Diseases , CDC (Jan. 26, 2024), https://www.cdc.gov/about/divisions-offices/ncezid.html [https://perma.cc/CY47- 62YB].

report processing, data elements to be reported, and data analysis)

are dynamic and subject to change without notice.”

Therefore, it was determined that the Proportional Reporting Ratio (PRR) analyses would not be performed. Instead, the U.S. Food and Drug Administration (FDA)

performs Empirical Bayesian (EB) data mining with VAERS data. EB data mining is a statistical method of detecting disproportionate reporting and is considered the “gold standard” for disproportionality analysis.

There are no written communications regarding the use of EB over PRR for purposes of signal detection. EB has been used for years for this purpose. It is widely accepted as the choice method for detecting potential safety signals (with passive pharmacovigilance data, at least), and thus was assumed to be the preferred method of detecting safety signals among COVID-19 vaccines. PRR is included in the [VAERS Standard Operating Procedures] as a potential alternative or adjunct method, but EB was always understood to be the superior method.

ECF No. 1-1 at 16–17. That same department later explained that “no search was conducted for any communications concerning PRR analyses including communications concerning any deci- sion to not conduct PRR analyses” because Empirical Bayesian data mining “has been the acknowledged ‘gold standard’ of detecting disproportionality for pharmacovigilance, which pre- dates COVID-19.” ECF No. 31-3, ¶ 9. Accordingly, “[n]o formal decision-making process was involved to use EB data mining for COVID-19 vaccines.” Id. PRR was used not “as the primary means of detecting disproportionality in VAERS,” but as “a quick, crude means of detecting dis- proportionality . . . to corroborate EB data mining findings.” Id.

Plaintiff appealed the CDC’s final response on October 7, 2022, asserting that the Agency had failed to conduct an adequate search for the requested records. ECF No. 1-1 at 2, 4. The appeal characterized the relevant request as contain[ing], at least, three major elements:

(1) All records related to Proportional Reporting Ratio (PRR) analysis performed to identify AEs that are disproportionately reported relative to other AEs[] pursuant to Sections 2.0, 2.3., and 2.3.1 of the VAERS Standard Operating Procedures for COVID-19;

(2) All communications concerning PRR analyses; and

(3) Communications concerning any decision to not conduct PRR analyses.

Id. at 4. Among other things, Plaintiff contended that the CDC’s response failed to sufficiently address Plaintiff’s request for “records related to PRR analysis performed to identify ‘AEs that are disproportionately reported relative to other AEs’ . . . for COVID-19” without reference to the VAERS Standard Operating Procedure and failed to address at all the second element, which sought production of “any communications concerning PRR analysis.” Id. at 4–5 (alteration in original).

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