Opinion and Order denying FDA's motion to alter judgment — Phmpt v. FDA (N.D. Tex.)

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UNITED STATES DISTRICT COURT · No. 4:21-cv-01058-P · Doc. 108 · 2025-01-10 · Docket on CourtListener

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UNITED STATES DISTRICT COURT 
FOR THE NORTHERN DISTRICT OF TEXAS 
FORT WORTH DIVISION 
 
PUBLIC HEALTH AND MEDICAL 
PROFESSIONALS FOR 
TRANSPARENCY,  
Plaintiff,  
 
v. 
No. 4:21-cv-01058-P
FOOD AND DRUG ADMINISTRATION, 
Defendant. 
 
 
OPINION AND ORDER 
 
      Before the Court is the Motion to Alter Judgment filed by  Defendant 
Food and Drug Administration (the “FDA”). ECF No. 103. In its Motion, 
the FDA asks the Court to impede and suspend the release of documents 
related to the emergency-approval of the Pfizer COVID-19 vaccine for 
an indefinite and unspecified amount of time. These documents should 
have been produced months ago under the Court’s previous orders and 
the undersigned is exhausted by the FDA’s continued attempts to pause 
the production of information related to one of the preeminent events of 
our time—the COVID-19 pandemic.  
      The Court has previously emphasized that the basic purpose of the 
Freedom of Information Act (“FOIA”) is to ensure an informed citizenry 
and to pierce the veil of administrative secrecy. A fellow Texan, 
President Lyndon B. Johnson, upon signing FOIA into law, stated: “A 
democracy works best when the people have all the information that the 
security of the Nation permits. No one should be able to pull curtains of 
secrecy around decisions which can be revealed without injury to the 
public interest.” President Lyndon B. Johnson, Statement by the 
President Upon Signing the ”Freedom of Information Act,” July 4, 1966, 
https://www.presidency.ucsb.edu/documents/statement-the-president-
upon-signing-the-freedom-information-act. 
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      Information is the currency of democracy—and information is useful 
only if it is timely. Thus, unless instructed to do so from a higher court, 
this Court cannot allow the FDA to continue its devaluation of this 
essential information through its delay and obfuscation. Env’t Texas 
Citizen Lobby, Inc. v. ExxonMobil Corp., 123 F.4th 309, 311 (5th Cir. 
2024) (“Justice delayed is justice denied.”). Consequently, having 
considered the briefing and applicable legal authorities, the Court will 
DENY the FDA’s request for an indefinite stay of production for the 
reasons stated herein. 
BACKGROUND 
      This case was filed on September 16, 2021, and it is the oldest active 
case on the undersigned’s docket. On January 6, 2022, the Court entered 
an order setting a production schedule, which was partially modified on 
February 2, 2022. The production schedule required the FDA to 
“produce 80,000 pages on or before May 2, June 1, and July 1, 2022; 
70,000 pages on or before August 1, 2022; and then 55,000 pages on or 
before the first business day of each month thereafter.” Additionally, the 
Parties were ordered to file a Joint Status Report every ninety days, 
apprising the Court of the production’s progress.  
      On December 19, 2023, in a Joint Status Report, the FDA notified 
the Court that it had completed its production of responsive documents. 
However, on April 23, 2024, in a related case also before the 
undersigned, Plaintiff learned that the FDA may have identified but not 
produced an Emergency Use Authorization (“EUA”) file. Thereafter, on 
July 17, 2024, in its response to Plaintiff’s adequacy-of-search letter, the 
FDA disclosed that it had in fact identified but not produced an EUA file 
for the Pfizer Vaccine. Id. Because the Parties were unable to resolve 
this issue without court intervention, the matter was briefed. And on 
December 6, 2024, the Court entered an order finding that the EUA file 
was responsive to Plaintiff’s FOIA request and must be produced. The 
Court ordered the FDA to produce the EUA file on or before June 30, 
2025. The FDA now requests that the Court not only delay the 
production of the EUA file, but indefinitely stay it.  
 
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LEGAL STANDARD 
      A motion to alter judgment under Federal Rule of Civil Procedure 
(“Rule”) 59(e) is appropriate: (1) where there has been an intervening 
change in the controlling law; (2) where the movant presents newly 
discovered evidence that was previously unavailable; or (3) to correct a 
manifest error of law or fact. Schiller v. Physicians Res. Grp. Inc., 342 
F.3d 563, 567 (5th Cir. 2003) (internal citations omitted). But a motion 
under Rule 59 cannot be used to raise arguments or claims “that could, 
and should, have been made before the judgment issued.” Marseilles 
Homeowners Condo. Ass’n v. Fidelity Nat. Ins. Co., 542 F.3d 1053, 1058 
(5th Cir. 2008) (per curiam) (internal citation omitted). District courts 
enjoy discretion in deciding whether to reopen a case under Rule 59(e). 
Weber v. Roadway Exp., Inc., 199 F.3d 270, 276 (5th Cir. 2000) (citing 
Edward H. Bohlin Co. v. Banning Co., 6 F.3d 350, 353 (5th Cir. 1993)). 
“Reconsideration of a judgment after its entry is an extraordinary 
remedy that should be used sparingly.” Templet v. Hydrochem Inc., 367 
F.3d 473, 479 (5th Cir. 2004). In striving to strike a balance between the 
need for finality and the need to render just decisions on the basis of all 
the facts, “the Fifth Circuit has observed that Rule 59(e) favor[s] the 
denial of [these motions.]” Greenidge v. Carter, No. 3:21-cv-1868-L, 2024 
WL 4183523, at *1 (N.D. Tex. May 21, 2024) (Lindsay, J.) (cleaned up) 
(citing S. Constructors Grp., Inc. v. Dynalectric Co., 2 F.3d 606, 611 (5th 
Cir. 1993)). 
ANALYSIS 
      The FDA argues that the Court should alter or amend its order for 
the FDA to produce the EUA file on or before June 30, 2025, because: (1) 
the Court committed a manifest error by “never consider[ing] the timing 
necessary to search for and process further records, the availability of 
agency resources, or the agency’s other processing obligations and 
responsibilities under FOIA;” (2) “exceptional circumstances exist given 
this Court’s production order in PHMPT II1 and the agency’s other 
essential FOIA obligations;” and (3) the FDA is “exercising due diligence 
 
      1PHMPT II refers to a sister-case that is also on the undersigned’s docket. 
See PHMPT v. FDA, No. 4:22-cv-915-P. 
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and has made, and continues to make, extraordinary efforts to hire, 
train, and otherwise maximize efficiencies to comply with this Court’s 
Orders.” ECF No. 104 (cleaned up).  
      As a preliminary matter, in its Cross-Motion for Summary 
Judgment, Plaintiff specifically requested that the Court order the FDA 
to produce the EUA file on or before February 20, 2025. ECF No. 94 
at 22 (emphasis added). The FDA had the opportunity, in its Response, 
to explain why it should not be ordered to produce the documents so 
expeditiously, but it wholly failed to do so. See generally ECF Nos. 97, 
98. Consequently, because the FDA’s Motion does not present an 
intervening change in the controlling law or newly discovered evidence 
that was previously unavailable, the Court would be justified in denying 
this Motion because it presents numerous arguments and claims “that 
could, and should, have been made before the judgment issued.” Fidelity 
Nat. Ins. Co., 542 F.3d at 1058. Nevertheless, the Court finds it prudent 
to address each argument in turn.  
A. Clear Error and/or Manifest Injustice 
      First, the FDA argues that the Court committed clear error “in 
imposing the . . . deadline . . . [without] considering the timing necessary 
to search for and process further records, the availability of agency 
resources, []or the agency’s other processing obligations and 
responsibilities under FOIA” because “[n]either party briefed the 
feasibility of meeting a June 30, 2025 production deadline.”2 ECF No. 
104 at 22–23 (cleaned up). The FDA’s argument falls flat.  
 
      2In support of its assertion that the Court did not consider the agency’s 
other processing obligations, the FDA claims that there are 135 requests that 
“were received [] before Plaintiff’s FOIA request in this case.” ECF No. 104 at 
23. However, having reviewed the examples presented in the brief, as well as 
the appendix, the Court notes that these requests were filed in 2023 and 
2024—years after the request in this case. If the FDA’s contention is that the 
Court’s order for it to produce the responsive EUA file is a new request, that 
gets placed at the bottom of the list, it is plainly mistaken. The request for the 
EUA file—along with the other responsive documents—was made back in 
2021. Therefore, the Court’s order evidences the FDA’s continued obligation to 
produce responsive documents for a 2021 request, which far predates the 
examples provided by the FDA.  
 
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      “[C]lairvoyance is not a power vested in the judiciary under Article 
III of the Constitution. . . .” Gipson v. Weatherford Coll., No. 4:22-CV-
0730-P, 2023 WL 8539847, at *1 (N.D. Tex. Dec. 11, 2023) (Pittman, J.). 
As discussed above, Plaintiff raised the issue of a production schedule, 
and the FDA chose not to respond. Despite the FDA’s failure to respond, 
the Court—after considering the history of this case3 and the challenges 
that may be presented in accomplishing the production—sua sponte 
gave the FDA an extension of over four months. Specifically, the Court 
considered that: (1) the Court’s original order setting a production 
schedule was entered over three years ago; (2) the FDA knew about the 
EUA file well before its existence was disclosed to Plaintiff or the Court; 
(3) the EUA file was undoubtedly responsive to Plaintiff’s FOIA request 
and should have been produced along with the other responsive 
documents; (4) the EUA file purportedly contained just over one-million 
pages; (5) the FDA last produced a document in this case on November 
1, 2023—over fourteen months ago; and (6) the FDA would have 
produced the EUA file in roughly eighteen months had it continued 
production according to the Court’s schedule.4  
      After considering the aforementioned, the Court determined that it 
was appropriate to set the production deadline for a few months after 
the date that the production would have been completed if the FDA had 
not ceased its production in this case. To be clear, the Court’s order 
granting summary judgment was not in response to a new FOIA request 
and did not create a new production burden. Rather, it simply required 
the FDA to finish its production of responsive documents based on the 
original schedule and FOIA request. The FDA has had ample 
 
      3In this case, the Court has repeatedly recognized the “unduly burdensome” 
challenges that this FOIA request has presented to the FDA. See generally 
ECF Nos. 23, 30, 34. But, as the Court has also previously expressed, there 
may not be a “more important issue at the Food and Drug Administration . . . 
than the pandemic, the Pfizer vaccine, getting every American vaccinated, 
[and] making sure that the American public is assured that this was not 
[rushed] on behalf of the United States. . . .” ECF No. 34 at 46. In other words, 
the Court has placed a burden on the FDA that it feels is appropriate in light 
of the unique significance of the request.   
 
        41,000,000 pages/55,000 pages per month=18.2 months.  
 
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opportunity and time to process and produce the EUA file. If the FDA 
was truly worried about efficiency—at any point during its twenty-two-
month production effort, and not twelve months after its completion—it 
should have disclosed the existence of the EUA file to Plaintiff and asked 
the Court to determine its responsiveness. Instead, the FDA attempted 
to hide the file’s existence until roughly eight months after it had 
“completed production.” Consequently, the undersigned finds that the 
FDA has failed to show that the Court committed a manifest error in 
law or fact by setting the June 30, 2025 deadline.5 
 
      5The FDA’s brief is riddled with quotations from cases before the United 
States District Court for the District of Columbia. These quotes make clear 
that the FDA has consistently grumbled about this Court and its orders in this 
case and PHMPT II. The Court, however, was most disturbed by Judge 
Randolph D. Moss’s statement alleging that this Court is somehow “jumping 
the queue.” See ECF No. 104 at 23. The undersigned was not disturbed because 
it evidences the FDA’s criticism, but because it demonstrates that the FDA has 
presented this Court’s production orders as inconsiderate and disrespectful to 
other judges and their dockets. If true, this is false and inflammatory. See 
Dondi Properties Corp. v. Com. Sav. & Loan Ass’n, 121 F.R.D. 284, 295 (N.D. 
Tex. 1988) (“To the office of judge, a lawyer owes respect, diligence, candor and 
punctuality, the maintenance of the dignity and independence of the judiciary, 
and protection against unjust and improper criticism and attack. . . .”). 
 
     Seemingly, the FDA is presenting the circumstances of this case in such a 
manner that it appears this Court is jumping the queue with its orders. The 
undersigned is sympathetic to Judge Moss’s frustration regarding another 
court usurping his inherent authority to control his docket. See, e.g.,  Chamber 
of Com. of U.S. v. Consumer Fin. Prot. Bureau, 733 F. Supp. 3d 558 (N.D. Tex. 
2024). But that is not the case here. The Court assures Judge Moss, and all 
other concerned judges, that the Court means no disrespect, nor does it wish 
to manifestly affect any judge’s ability to control their docket. The undersigned 
simply wishes to bring about the resolution of this ancient case, which came 
first in temporal proximity with regard to the FOIA request, filing of the case, 
and the Court’s order.  
 
      As discussed above, the June 30, 2025 production deadline is not based 
upon a new production obligation or new FOIA request. Rather, it is a deadline 
imposed on a production of documents that stalled for fourteen months and, as 
a consequence, is well past its sell-by date. The undersigned agrees that 
“comity runs both ways,” and if the undersigned is ever presented with the 
opportunity to show deference to Judge Moss, or any other judge, and wait in 
“the queue,” he will happily do so. However, because this case is almost four 
years old and the production should have already occurred, the FDA’s new 
arguments do not change the Court’s analysis here. The FDA cannot refuse to 
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B. Exceptional Circumstances  
      Second, the FDA essentially argues that exceptional circumstances 
exist because—in an age where the length of rules and regulations 
number not in the hundreds but the hundreds of thousands6—the 
agency tasked with processing and producing responsive documents for 
the Nation’s FOIA requests is staffed by ten people. See ECF No. 104 at 
13 (“ALFOI7 was able to keep its FOIA queues relatively low and stable 
with nine regular staff and one branch chief.”). While the agency has 
hired fourteen new employees since this case began, the FDA contends 
that it takes two years8 for each of those employees to be fully trained 
and capable of doing their jobs. See id. at 14–15. In support of its 
argument, the FDA cites to multiple cases out of the United States 
District Court for the District of Columbia. See id. at 14–16. The FDA 
offers these cases to show that the Court’s production orders are 
exceptional and onerous because they far exceed the “normal” 
production rate of only 500-pages per month. Id.  
 
produce responsive documents and then further delay because new cases have 
since arisen. 
 
      6See, e.g., Clyde Wayne Crews Jr., 2024 Federal Register Page Count is 
Highest Ever, FORBES, https://www.forbes.com/sites/waynecrews/2024/12/31/
bidens-2024-federal-register-page-count-is-highest-ever/ (the 2024 register 
contains 107,262 pages and 3,248 final rules and regulations).   
   
       7Access Litigation and Freedom of Information, a branch of the FDA’s 
Center for Biologics Evaluation and Research. 
 
      8To say that the Court was astounded by the length of time new-ALFOI 
employees must be trained before they are allowed to do their jobs is an 
understatement. After being appointed, the undersigned was given one week 
of training at what is affectionately referred to as “baby judge school.” In fact, 
the entire COVID-19 pandemic itself lasted around two years. See President 
Joe Biden, 60 Minutes (@60Minutes), X (Sept. 18, 2022, 7:09 PM), 
https://tinyurl.com/2s35maau (declaring the COVID-19 pandemic over).  You 
can also walk across the continental United States in less than two years. See 
https://texags.com/s/17847/john-ball-the-walking-aggie-completes-his-cross-
country-trek.  And, most notably, becoming a Navy Seal, a Green Beret, or an 
Astronaut takes less than two years. See https://special-ops.org/time-to-fully-
qualified-navy-seal-or-green-beret/; 
https://www.nasa.gov/humans-in 
space/astronauts/astronaut-selection-program/. 
 
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      The Court has previously noted the importance of the public’s ability 
to have access to the information derived from Plaintiff’s FOIA request 
in an expedited manner and not in the 75 years the FDA originally 
requested—when most of those who took the Pfizer vaccine are long 
passed. See ECF No. 35. Americans are capable of doing great things in 
times of crisis, from thirteen colonies uniting to defeat the British 
Empire, to executing the Berlin Airlift, to putting a man on the moon, 
the citizens and government of the United States have consistently 
shown the ability to overcome difficult and seemingly impossible 
circumstances. In fact, despite representing that doing so would be 
unduly burdensome or impossible, the FDA has shown some of that 
same resiliency and thus far has risen to the challenge of complying with 
the Court’s orders. The Court is confident that it will do so again here.9 
Therefore, the Court finds that the FDA has failed to show exceptional 
circumstances that warrant indefinitely staying the production 
schedule.  
C. Due Diligence  
      Third, and finally, the FDA argues that it has demonstrated due 
diligence through its efforts to comply with the Court’s prior orders 
while handling other FOIA requests. ECF No. 104 at 16–19.  Here, the 
FDA reasserts and rehashes most of its exceptional-circumstances 
argument. The Court agrees that the FDA has demonstrated due 
diligence in complying with the Court’s prior orders. And, as discussed 
above, the Court is confident that it can continue to do so. Consequently, 
the Court finds that the FDA’s due diligence does not warrant an 
indefinite stay of production in this case.  
 
 
9The FDA reviewed and approved the Pfizer vaccine for emergency use in 
an unprecedented amount of time. Every American was urged or forced to take 
a COVID-19 vaccine. Surely, documents supporting the approval can be 
released to the public in seven months. Unprecedented times call for 
unprecedented actions. As Abraham Lincoln stated: “I am a firm believer in 
the people and, if given the truth, they can be depended on to meet any national 
crisis. The point is to bring before them the real facts.” Carl Jenson, STORIES 
THAT CHANGED AMERICA: MUCKRAKERS OF THE 20TH CENTURY, at 23, (2002). 
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CONCLUSION 
      From the beginning of this case, the undersigned—without much, if 
any, precedent from the Fifth Circuit—has been tasked with 
determining what the appropriate rate of production is for arguably the 
most important FOIA request in American history. Plaintiff filed this 
case seeking an expedited production schedule for documents and 
information related to a vaccine that was developed in response to a 
once-in-a-hundred-year pandemic. See Sambrano, et al. v. United 
Airlines, Inc., 707 F. Supp. 3d 652, 664 (N.D. Tex. 2023) (Pittman, J.) 
(“The COVID-19 pandemic was a once in a century event, unprecedented 
in the modern era . . . .”). Hundreds of millions of Americans were 
urged—and some coerced—into taking a vaccine that was developed, 
and approved for emergency use, at an unprecedented rate. The FDA 
wanted 75 years to produce the responsive documents.10 It is axiomatic 
that information which directly effects every American could not be 
produced at such a snail’s pace. Thus, the Court, noting that “stale 
information is of little value,” ordered production at what has been 
described as an extraordinary rate. See ECF No. 35 (internal citation 
omitted); see generally ECF No. 104.  
      While it is evident that the FDA has spilled much ink in the United 
States District Court for the District of Columbia about the unfairness 
of the Court’s production orders in this case and PHMPT II, the FDA 
has not challenged any of the Court’s orders on appeal and has largely 
complied with them. The undersigned has suffered from a lack of  
guidance from the Fifth Circuit on what is appropriate and what is 
“unfair” in this case.  The Court has made its decision, but it encourages 
the FDA to seek whatever appellate remedy is appropriate—up to and 
including mandamus—from the Fifth Circuit. But, as far as this Court 
is concerned, to quote the undersigned’s predecessor, the late Judge 
Eldon B. Mahon: “Let the chips fall where they may.” Sony Music Ent. 
 
      10The Court notes that the FDA’s seventy-five-year request did not include 
the production of the EUA file which essentially doubled the number of 
responsive pages. So, presumably, the FDA would have needed an additional 
seventy-five years to produce the EUA file. In that case, the FDA would finish 
its production in the year 2171.  
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Inc. v. Clark-Rainbolt, No. 4:23-CV-0275-P, 2023 WL 3993191, at *2 
(N.D. Tex. June 14, 2023) (Pittman, J.); see also Galyean v. Guinn, No. 
4:21-CV-1287-BJ, 2023 WL 8006412, at *12 (N.D. Tex. Nov. 17, 2023) 
(Cureton, M.J.).  
“Truth will ultimately prevail where pains [are] taken to bring it to 
light.”11 Because the arguments presented in the FDA’s Motion are 
arguments and claims that could, and should, have been made before 
the judgment was issued, and for the other reasons set out above, the 
FDA’s Motion to Alter Judgment (ECF No. 103) is DENIED. The FDA 
shall produce the responsive EUA file on or before June 30, 2025.  
SO ORDERED on this 10th day of January 2025. 
 
 
11George Washington, LETTER TO CHARLES M. THURSTON (August 10, 
1794),  available at https://founders.archives.gov/documents/Washington/05-
16-02-0376.  
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