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Home Court filings Public Health and Medical Professionals for Transparency v. Food and Drug Administration Appendix to FDA Rule 59(e) Motion to Alter or Amend Judgment — PHMPT v. FDA

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Appendix to FDA Rule 59(e) Motion to Alter or Amend Judgment — PHMPT v. FDA

Record facts

CourtU.S. District Court for the Northern District of Texas
Filed2025-01-03

U.S. District Court for the Northern District of Texas · No. 4:21-cv-01058-P · Doc. 105 · 2025-01-03 · Docket on CourtListener

Summary

An appendix in support of the defendant's motion to alter or amend judgment under Federal Rule of Civil Procedure 59(e), filed January 3, 2025 as Document 105 in Public Health and Medical Professionals for Transparency v. United States Food and Drug Administration, Civil Action No. 4:21-cv-01058-P, in the U.S. District Court for the Northern District of Texas. Its table of contents lists a declaration of Suzann Burk and the transcript of an October 4, 2024 status hearing in Children's Health Defense v. FDA, Civ. A. No. 23-0220 (RDM). In that transcript, before Judge Randolph D. Moss, government counsel states that the FDA is processing 230,000 pages per month though required to process 180,000, and that the requester stood 301st in the queue as of September 6, 2024. Plaintiff's counsel disputes the staff time the FDA says it needs for 150 pages of records. The appendix is 47 pages.

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Full text

1 
 
IN THE UNITED STATES DISTRICT COURT 
FOR THE NORTHERN DISTRICT OF TEXAS 
___________________________________ 
 
 
 
 
 
 
) 
PUBLIC HEALTH AND MEDICAL 
)    
PROFESSIONALS FOR  
 
 
) 
TRANSPARENCY 
 
 
 
) 
 
 
 
 
Plaintiff, 
) 
 
 
 
 
 
 
) 
v. 
 
 
 
 
)    Civil Action No. 4:21-cv-01058-P 
 
 
 
 
 
 
) 
UNITED STATES FOOD AND DRUG 
) 
ADMINISTRATION, 
 
 
) 
 
 
 
 
 
 
) 
 
 
 
 
Defendant. 
) 
___________________________________  ) 
 
APPENDIX IN SUPPORT OF DEFENDANT’S MOTION TO ALTER OR AMEND 
JUDGMENT PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 59(e) 
Table of Contents 
 
 
 
 
 
 
 
 
 
 
 
Page Numbers 
Declaration of Suzann Burk………………………………………………………...App’x 001-021 
October 4, 2024 Hearing Transcript in Children’s Health Defense v. FDA,  
Civ. A. No. 23-0220 (RDM) (D.D.C.)……………………………………………....App’x 022-044 
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Dated: January 3, 2025 
 
 
Respectfully submitted, 
 
BRIAN M. BOYNTON 
Principal Deputy Assistant Attorney General 
 
ELIZABETH J. SHAPIRO 
Deputy Director, Federal Programs Branch 
 
  /s/ Andrew F. Freidah 
     
 
 
ANDREW F. FREIDAH 
Trial Attorney 
United States Department of Justice  
 
Civil Division, Federal Programs Branch 
1100 L Street, N.W. 
Washington, DC 20005 
Tel.: (202) 305-0879 
Email: andrew.f.freidah@usdoj.gov 
 
Attorneys for Defendant 
 
OF COUNSEL: 
 
PATRICIA ZETTLER 
Deputy General Counsel 
U.S. Department of Health and Human Services 
 
MARK RAZA 
Chief Counsel 
U.S. Food and Drug Administration 
 
WENDY S. VICENTE 
Deputy Chief Counsel, Litigation 
U.S. Food and Drug Administration 
 
JACLYN E. MARTINEZ RESLY 
MAGGIE R. REDDEN 
Associate Chief Counsel 
Office of the Chief Counsel 
U.S. Food and Drug Administration 
10903 New Hampshire Ave. 
White Oak 31 
Silver Spring, MD 20993-0002 
 
 
 
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3 
 
CERTIFICATE OF SERVICE 
 
I hereby certify that on January 3, 2025, I electronically filed this document with the 
Clerk of the Court for the United States District Court for the Northern District of Texas by using 
the CM/ECF system.  Counsel in the case are registered CM/ECF users and service will be 
accomplished by the CM/ECF system. 
 
  /s/ Andrew F. Freidah 
ANDREW F. FREIDAH 
Trial Attorney 
United States Department of Justice 
 
 
 
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App'x 001
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App'x 002
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IN THE UNITED STATES DISTRICT COURT 
FOR THE DISTRICT OF COLUMBIA 
 
 
CHILDREN'S HEALTH DEFENSE, 
                                           Civil Action 
            Plaintiff,                     No. 1: 23-220 
                                            
       vs.                                 Washington, DC 
                                           October 4, 2024 
UNITED STATES FOOD AND DRUG 
ADMINISTRATION,                            9:12 a.m. 
 
            Defendant.
 
__________________________/ 
 
 
TRANSCRIPT OF STATUS HEARING 
BEFORE THE HONORABLE RANDOLPH D. MOSS 
UNITED STATES DISTRICT JUDGE 
 
 
APPEARANCES: 
 
For the Plaintiff:      Risa Evans 
RISA EVANS LAW 
PO Box 273 
Contoocook, NH 03229 
 
Ray L. Flores 
LAW OFFICES OF RAY L. FLORES II 
11622 El Camino Real 
Suite 100 
San Diego, CA 92130 
 
 
For the Defendant:
Dimitar Georgiev-Remmel 
U.S. ATTORNEY'S OFFICE  
FOR THE DISTRICT OF COLUMBIA 
Civil Division 
601 D Street NW 
Washington, DC 20530 
 
Court Reporter:     
SHERRY LINDSAY 
                       Official Court Reporter 
                       U.S. District & Bankruptcy Courts  
                       333 Constitution Avenue, NW  
                       Room 6710 
                       Washington, DC 20001 
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P R O C E E D I N G S 
THE COURTROOM DEPUTY:  We are here on civil case
number 23-220, Children's Health Defense versus United States
Food and Drug Administration.  
Counsel, please state your name for the record,
starting with plaintiff's counsel.
MS. EVANS:  Good morning, Your Honor.  This is Risa
Evans for Children's Health Defense.  And my cocounsel.
MR. FLORES:  Ray Flores for Children's Health
Defense.  Good morning, Your Honor.
THE COURT:  Good morning.
MR. GEORGIEV-REMMEL:  Good morning, Your Honor.
Dimitar Georgiev-Remmel for the Food and Drug Administration.
I am also joined on the phone by Elizabeth Bonomo.  She is a
law clerk at the FDA.
THE COURT:  All right.  Why don't we go ahead and
start with you if you can give us any update on where things
stand, both with respect to the PHMPT 2 litigation as well as
the request in this case.
MR. GEORGIEV-REMMEL:  Of course, Your Honor.  The FDA
continues to comply with the production order.  It is making
regular production in that case.  My understanding is that to
meet the June 2025 deadline, it needs to process 230,000 pages
per month, which it is only required to process 180,000 per
month.  It is meeting those obligations.  
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App'x 023
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In terms of this request, I have some updated
numbers, Your Honor.  I am told that as of September 6, 2024
which is the latest update for which we have an update, the
request has moved two spaces.  And it now is 301st in the
queue.  That is an update from our August submission.
Moreover, I am told that FDA has now hired six new FTEs since
our report.  Three of those, once trained, will be dedicated to
processing (inaudible) FOIA requests.
THE COURT:  I'm sorry.  Three will be dedicated to -- 
MR. GEORGIEV-REMMEL:  These are the updates, Your
Honor, since our (Inaudible) --
Three will be dedicated generally to processing non
(inaudible) -- 
THE COURT:  I have lost you.
MR. GEORGIEV-REMMEL:  I didn't hear your question.
THE COURT:  You are cutting in and out.  So dedicated
to processing what?
MR. GEORGIEV-REMMEL:  I apologize.  Non-PHMPT pages.
THE COURT:  I see.  Okay.  All right.  Anything more
from the plaintiffs?
MS. EVANS:  Your Honor, I guess it is hard to sort of
know what the significance is of the new information without
additional information about, you know, how long it is going to
take for the new FTEs to be trained, et cetera, et cetera.  So
I think that we are still in a situation where, you know, what
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App'x 024
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we last heard is that it was going to be at least 24 to 36
months until our FOIA request is reached.  We are still in a
situation I think where the FDA's lack of diligence in
processing our request, in particular, and requests in the
complex queue in general is really still an issue.  I don't
think that this sort of vitiates that.  I think -- just a
couple of more points.
THE COURT:  I'm sorry.  Just on that point here, I
think that sort of kind of blanks reality here a little bit.
They have hired numerous additional people to do this.  The
problem here is the Texas litigation.  That is the problem.
There is a completely unreasonable demand being placed on the
FDA in the Texas litigation.  And that is the problem here.  I
mean, they have done their best.  They have hired a number of
additional people.  And so it is a little hard for me to know
what else I can do with the FDA.  They don't have an unlimited
budget.  I can't tell them to go hire a thousand people because
they don't have a budget to do that.
MS. EVANS:  A couple of points, Your Honor.  First, I
think it was clear from a number of the FDA's pleadings that
until now all of the new personnel that were hired were
channeled to the Texas litigation.  And, in fact, up until this
latest report the number of personnel who were processing
requests that were not part of the Texas litigation was reduced
from 2022, not increased.  It went down.  It was six in 2022
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and it was five up until this new information that just came
in.  So for a couple of years while the backlog was growing,
nothing happened in terms of the processing of the non-PHMPT
requests.  The second thing is that the -- you know, the FDA
has now I think 169 FOIA personnel.  And, again, it seems that
there is this real bottleneck that has been created within
ALFOI specifically for the vaccine-related request that are
channeled to the complex queue.  And the FDA is really the only
entity in a position to do anything about that.  In terms of
the unfairness of the PHMPT orders, the FDA was the only entity
in a position to challenge those orders.  Instead of doing
that, it is shifting the costs to all other FOIA requestors.  
THE COURT:  I am not sure it is fair to say they
didn't challenge it.  I am confident they opposed those
requests.  
Let me ask you -- I was actually wondering just about
that topic though.  Why haven't you and all of the other FOIA
requestors gone down to Texas and either moved to intervene in
that case and at least filed an amicus brief in that case and
said, Judge, do you realize you are shutting down everyone else
in the country because of what you are doing here?  
Why haven't you done that?  
MS. EVANS:  I don't think we have standing to do
that.  That is a very interesting thought.
THE COURT:  You can file an amicus brief letting the
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App'x 026
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judge down there know the consequences of what he is doing is
he is shutting down everyone else's FOIA requests in the
country.
MS. EVANS:  Again, the burden on us as FOIA
requestors is to make a request that is well formulated, which
we did over two years ago.  We also at the time sought
expedited processing.  And although the FDA continues to deny
that there is any urgency for these records, again, it was very
clear -- Your Honor asked them after the last status conference
whether these records had been disclosed anywhere else.  And
those are records that are specifically addressed to whether
any of the massive number of adverse events reported to VAERS
are actually causally linked to the COVID shots.  It is the
only records that are out there about this.
The FDA and the CDC continue to rely on the
monitoring of VAERS that underlies our FOIA request.  And yet
still this information has not been made public.  And that is
very clear from the FDA's last filing.
So, you know, with the continued kind of promotion of
the shots and the continued statements about their safety and
efficacy, we, the American people -- we are sort of on behalf
of the American people saying, just show us the safety data.
And the 150 pages of records that are really most at issue in
this case, which have been sought by three other requestors --
and I think Your Honor is aware of that.  This 150 pages of
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records, I mean, would take to produce these -- the FDA didn't
actually answer the question in their pleading.  But it would
probably take less than a half hour of processing time.  
And another note just on that --
THE COURT:  I am not sure that is true.  I thought
they addressed it.  I thought they said it would take them 30
days.  There was something in there.
MS. EVANS:  What they said is they would have to free
up approximately one month of staff time to process 150 pages
of records, because of how the requests are assigned to FOIA
personnel.
THE COURT:  Right.
MS. EVANS:  But it is very obvious, I mean, it can't
possibly take a full month of staff time.  That is 40 hours --
160 hours to process 150 pages of records.  I mean, that is
just not possible.  You think about this speed with which they
are processing the PHMPT -- I did the math.  It is in the
footnote of our pleading.  It should take an hour at most of
actual time to process these records.  So I am not sure -- I
don't really understand, except if there is something very,
very wrong with how the requests are processed there that it
could take a full month of staff time to process 150 pages of
records.  It just doesn't make any sense.  
And the other thing is we know that these records are
basically statistical analyses, which are not -- which don't
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fall into any FOIA exemptions and cover emails.  So at a very
minimum, I think producing these records, which have been
sought, like I said, by at least three other requestors
including a sitting US senator, ICAN in another state lawsuit
and a journalist, at least producing these records, would
certainly be within the realm of possibility, putting aside the
need for other searches, you know, just at a minimum these
records.  But to make us wait for another two to three years
for records that are really going to be so stale by then, they
are just -- there is no value to them.
THE COURT:  I agree completely with everything you
are saying.  And I think the problem is that there is an
unreasonable request or demand on the FDA in the Texas
litigation, in which they have to comply with that on pain of
contempt.  And there are other people who are in the queue.
And what is bothering me here is I am open to the notion of
saying, just produce it and do it.  But when I am doing that, I
think what I am saying is someone else is not going to get
their records who is ahead of you in the queue.  That is what
troubles me is why, you know, given the limited resources and
the unreasonable demands from the Texas litigation, why do you
get to jump the queue over the person whose records would
otherwise be processed right now?
MS. EVANS:  Your Honor, a couple of things.  First of
all, the FDA in a number of places in their pleadings sort of
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make that argument, that somehow that requiring the FDA to
respond to us in a -- I won't say a timely fashion since it has
already been two years, but before another three years elapse,
that would be unfair.  The unfairness doesn't come from
responding to us.  The unfairness comes from how the queues
have been managed and how the FDA has addressed the situation.
It is not --
THE COURT:  That is not -- I am not sure that is --
that gets to my point.  I appreciate your concerns.  And I
think they are entirely legitimate concerns.  But I think we
all have to be sort of realistic about what is going on.  The
FDA has hired additional people.  And you say, well, they are
using more people to do the Texas litigation.  That is so they
are not held in contempt of court down there that they are
doing that.  It is not their choice.  It is not they are
saying, well, all of the new people we are going to devote to
Texas.  They are saying, we have to do that because the judge
has ordered us to do it down there.  So they have limited
resources.  There are other people who are in the queue.  It
doesn't strike me as an incorrect argument for the FDA to make
or it doesn't seem to me that they are positioning themselves
in any way to simply say, we have got this unreasonable request
demanded on us in Texas.  We have to comply on that with pain
of contempt.  We can only obtain so many additional resources.
We have done everything we can.  But with that, we have to
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process things in order, because that is the only fair way to
do it.
MS. EVANS:  I think that Open America and the other
cases and the FOIA statute itself recognize that when a party,
you know, is interested enough in records to put the effort
into litigation, that that means something.  Otherwise, the
statute wouldn't require a quicker turnaround time on responses
to lawsuits when they are filed.  I mean, I think that, you
know, the fact that a lawsuit has been filed, the fact --
THE COURT:  Excuse me.  Where in the statute does it
say there is a quicker turnaround time when you file a lawsuit?
MS. EVANS:  I will have to look at that.  I'm sorry.
I don't have the -- I think it is 30-day response time instead
of a 60-day response time for the defendant.  I don't have the
citation in front of me, but I am happy to provide that to Your
Honor.  And if I misspoke, I will let you know that as well,
but that is my understanding.
THE COURT:  Okay.
MS. EVANS:  We routinely in the lawsuits that we have
filed, we have agreed to extensions to 60 days.  But I think
that the Open America, the case itself sort of talks about
that, particularly in the concurrence.  And, again, we have
argued, you know, that the FDA does not -- I think it granted
one out of, you know, 300 requests for expedited processing in
the last year or something like that.  It does not tend to
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grant requests for expedited processing.  But, again, I would
argue the Open America case made it very clear that Open
America stays are appropriate only when there is no urgency for
the records.  And we have made a case for urgency from the
outset here.  This is not something where we sort of sought
records on a casual basis and got tired of waiting and, you
know, filed a lawsuit.  So I think that is another way this is
really different from Open America.
THE COURT:  But still, what do I do though?  I mean,
because I think what you are asking me to do means to say to
them, either push somebody else back in the queue or
potentially violate the order in Texas.  Those are -- they are
hiring people already.  So I am not sure what their other
options are.
MS. EVANS:  Well, Your Honor, I guess what I would
suggest is that, you know, if the FDA adds the resources that
it would take to process our request and to move the expedited
processing queue along, then the other requestors in that queue
really get the benefit of our having litigated this.  And so,
you know, so we move to the front of the queue, but the queue
actually starts moving instead of sort of sitting as a holding
tank.
THE COURT:  I am not sure I understand that either.
I mean, the queue is moving at whatever rate it is moving at.
And only -- it would mean someone whose request would be
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processed tomorrow is not going to be requested until a month
later, however long it takes to process your request and they
get pushed back by that period of time.  
MS. EVANS:  Well, I think if the Court ordered
production of the 150 pages of records, it would push requests
back about an hour.  Again, because that is how much time it
will actually take to process the records.  It just doesn't
take, you know, a month of staff time to review 150 pages of
statistical analysis to decide whether it is exempt or not.  So
I think that that argument really just doesn't go anywhere.
And then, again, in terms of the other requests, you
know, I suspect that if the FDA is working to move the queue
along, part of the reason for that is the pressure from
litigators like ourselves and the few other plaintiffs who have
been seeking requests that have been languishing in that queue.
So I would submit in truth, you know, putting our requests at
the front of the queue where we have invested the effort to
really, you know -- 
THE COURT:  But a bunch of my colleagues have issued
stays in cases where people have gone to the trouble of
litigating, so you would be bumping ahead of them because they
have got stays in place.
MS. EVANS:  Well, we are two of those.  Two of the
other cases are ours.  And then another case I think is the
Informed Consent Action Network's case, which is also seeking
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the EB mining records.  They are a little bit ahead of us in
the queue.  I am not sure who the last case is.  We would be
sort of bumping ourselves in the queues, because several of
those are --
MR. GEORGIEV-REMMEL:  Judge, may I respond briefly to
a couple of points from counsel.
THE COURT:  Yes.  But before you do, so I actually
had a question for you.  If you could address the 150 pages and
how long it is going to take to process.  
MR. GEORGIEV-REMMEL:  Of course, Your Honor.  We have
provided a written submission on that in our August report.
That is on pages 9 through 12.  It is the Agency has determined
it would take about a month of staff time.  It is not --
THE COURT:  Why is that?  Why isn't Ms. Evans correct
about that?  How can it possibly take a month to review 150
pages, even assuming that there have to be two or three levels
of review of those pages.  It does seem like a month of staff
time or 160 hours it is a little bit implausible to say that it
would take that much time to review 150 pages.
MS. EVANS:  My understanding, Your Honor, is it is
not just looking at the documents.  As you said, it might take
a couple of levels of review.  But those are -- a lot of these
documents involve Excel spreadsheets.  So it is not just 150
pages.  There is data there that needs to be reviewed.  There
are emails that need to be reviewed.  The production needs to
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be prepared so that it can be produced.  So it is not just
looking at the documents.  There are a number of steps that
need to happen, between identifying those documents, processing
them and actually producing them.
THE COURT:  Is there anyone who is higher up in the
queue who has requested the same 150 pages?  Ms. Evans said
there were three other requestors.  Are any of those requestors
higher up in the queue, so if you processed that request it
would get Ms. Evans what she is looking for?
MR. GEORGIEV-REMMEL:  I believe so.  Just looking at
our submission, I think that was the first question that we had
addressed in the overlap that the Court asked us last time.
That is on pages 3 through 5 in our written submission.
MS. EVANS:  Your Honor, if I might, just to be a
little bit more specific, one of the litigations that is stayed
which is the ICAN, Informed Consent Action Network litigation
in this District, they are ahead of us in the queue.  And that
is exactly what they are seeking is those 150 pages.  The other
two requesters that I mentioned did not file suit.  One was
Senator Johnson and other one was The Epoch Times.  And neither
one of them, as far as I know, filed suit.  And Senator Johnson
wasn't in any queue because he made the request through a
different channel.  And The Epoch Times, you know, I think
because they -- the request was denied as ours was initially.
The FDA said, without having actually located the records that
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they were all exempt from disclosure under the deliberative
process exemption.  So they are not in the queue as far as I
know, unless they are in an administrative appeal queue.
THE COURT:  So the Informed case, is that the one
that is in front of Judge Walton?
MS. EVANS:  Correct.
MR. GEORGIEV-REMMEL:  Yes.
THE COURT:  Is the Informed Consent Action Network
involved in the Texas litigation?
MS. EVANS:  Yes, they are.  Well, no, not Informed
Consent Action Network is not, no.  That is a different group.
It is Physicians for Public Health and Medical Transparency.
It is a different organization, I believe.
MR. FLORES:  Same attorney, Your Honor, but a
different organization.
THE COURT:  I'm sorry?
MR. FLORES:  It is the same attorney, Your Honor,
just a different organization.
THE COURT:  I see.  I see.  Okay.  Thank you.
All right.  Mr. Georgiev, you can continue.
MR. GEORGIEV-REMMEL:  I just wanted to address one
point that my colleague on the other side made regarding taking
the time to litigate and that somehow pushes the FOIA request
ahead of ours.  If that is the position that -- we disagree
with that, because that would reward requestors who are able to
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obtain counsel, who are able to have the funds to obtain
counsel and to litigate to the detriment of other requestors
who might not be able to do so.  
The way that the FDA is processing these requests is
on first in, first out basis.  That is the most equitable way
of doing so.  That is what Open America has said is the
appropriate way of doing the request, not whether a party is
represented or not.
THE COURT:  So do you know where the Informed Consent
Network's request is in the queue, for the 150 pages?
MR. GEORGIEV-REMMEL:  I do not.  I can follow up.
THE COURT:  Because the stay in that case ought
not -- consistent with what you are saying, the stay is of the
litigation.  The stay is not of our obligation to process.
MR. GEORGIEV-REMMEL:  Correct.
THE COURT:  And so --
MR. GEORGIEV-REMMEL:  Correct.  Those people --
THE COURT:  If they are higher up, maybe you are
going to get to those sooner and that is going to resolve the
issue on the 150 pages, at least.
MR. GEORGIEV-REMMEL:  I will follow up with -- I will
find out and follow up with you, Judge.
THE COURT:  Ms. Evans, did you want to say something
about that?
MS. EVANS:  I just looked at the latest pleading in
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that case which was filed in June and they are still -- they
were as of June somewhere in the 300s, I believe.  So it is
still several years away from processing.  It is not like they
are up close to the front of queue.  I think their request was
filed about a month before ours was.  So it is sooner, but not
meaningfully sooner.
THE COURT:  And, Mr. Georgiev, come June of 2025 what
happens with respect to the Texas litigation?  Is there another
tranche of documents that are materials that are going to have
to be reviewed and produced there or is the FDA done come June
of '25 with the Texas case?
MR. GEORGIEV-REMMEL:  Honestly, Judge, I don't want
to try and predict what happens there.  We thought after PHMPT
1 that the FDA was done.  But then we got PHMPT 2.  Certainly,
the FDA's hope is we will be done with that case and producing
in that case.  And the resources that were dedicated to PHMPT 2
could be dedicated to clearing out the backlog.  And that is
the anticipation from FDA.  But who knows what the Court in
Texas does.
THE COURT:  Where do the requests in the PHMPT case
stand in relation to the requests here, for example?  So were
there multiple requests there?  And were they all before the
Children's Health Defense request or were some of those after
that request?
MR. GEORGIEV-REMMEL:  I am not sure I understand your
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question, Your Honor.
THE COURT:  So the FDA is responding in the Texas
litigation's request it received from PHMPT; correct?
MR. GEORGIEV-REMMEL:  Yes.
THE COURT:  And I assume that there are multiple
requests in this case or maybe there is just one request.  I
don't know.
MR. GEORGIEV-REMMEL:  The Court's indulgence.
THE COURT:  I will tell you why I am asking the
question.  Which is, if there are other requests that have been
made that are potentially subject to the litigation in Texas,
that came in after Children's Health Defense's request here, I
may well want to put an order on the books to make clear that.
FDA's next obligation is to respond to Children's Health
Defense request, because I have been deferential to the judge
in Texas, because he has an existing order in place.  But if we
are lining up in making a queue here, I want my order in place
before his next one, if there is one coming, if it relates to
FOIA requests that came before whatever FOIA requests he -- I
don't want this to be a process that goes on forever down
there, where people keep just adding and adding to their
requests, even with requests that came in later so they are all
jumping the queue.  And then all of the other judges in the
country are deferring to one judge in Texas who is doing this
out of a matter of comity.  Because comity runs two ways.  And
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if that is what is going on, I want to make sure I have an
order on the list in place that that judge in Texas has to show
some comity too and says that that order comes before his
order -- next order of priorities.  That is the reason for my
question.
MR. GEORGIEV-REMMEL:  I understand your question.
No, Judge.  I think I would need to go back and get authority
to articulate its position on what Your Honor thinks.
THE COURT:  Okay.  All right.  I don't know enough
about what is going on in the litigation down there.  But if it
was just one request that was a gigantic request that came in
years ago that is still being processed, that is one thing.  If
it is a series of requests including ones that came in after
the request at issue here, that is a different thing.  
Ms. Evans, do you know the answer to that question?
MS. EVANS:  I do not, Your Honor.
THE COURT:  Okay.  Well, I have to say, I am still
somewhat at a loss as to what to do here, because I do think
the FDA is making good faith efforts.  They are hiring
additional people.  They are doing their best.  They are under
some unreasonable demands.  And I need to be cognizant of the
demands of others in the queue and need to make sure that I am
not treating anyone else unfairly in this process by allowing
someone to improperly jump the queue.
So I guess what I would like to do is two things:
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One is, Mr. Georgiev, if you can get back to me and maybe if
you can just do this in a week and tell me how long literally
it is going to really take to process the 150 pages.  I am
dubious that it really is 160 hours of time.  And say, if we
were to process those pages, how long would it take?  How long
would the review take?  How long would the secondary review
take?  I mean, Bates stamping and putting in the system isn't
going to take any time at all.  So I would like to know with
more specificity and certainty how long it is going to take to
process those 150 pages.  Because I am skeptical that it really
would require 160 hours of time to do that.  
I would also like to know where the first requestor
is in the queue, the first requestor on those materials in the
queue, even if that requestor hasn't filed litigation.  And
then I would like to know the answer to my question about what
is going on in the Texas litigation and whether -- where the
requests at issue in that litigation stack up as compared to
the requests in this case and whether there are other requests
in that case that -- or potentially in that case that came in
later where I need to make sure I am putting down a marker by
entering an order that these come next.  And we are not waiting
forever for everything that gets filed in another jurisdiction
to get processed, even where those are requests that came in
months or years after the requests at issue in this case,
because that would be unfair.
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MR. GEORGIEV-REMMEL:  Understood, Your Honor.  And I
think I heard you ask for a report within a week?
THE COURT:  Is that possible?
MR. GEORGIEV-REMMEL:  If you Your Honor orders us,
we'll make it possible.
THE COURT:  No.  I don't want to be -- I am trying
not to be unreasonable with you.  I want to make sure you also
have time to accurately answer those questions.  They don't
sound to me like terribly complicated questions.  But if you
needed a little bit more time than a week, that would be okay
with me, so tell me what do you need to be --
MR. GEORGIEV-REMMEL:  Two weeks.  But if we have the
answer (inaudible ) can we get two weeks as an order?
THE COURT:  That is fine.  So today is the 4th.  So I
will order by the 18th you file a status report if you can
provide me with that information.
I would like to find some way to move forward with
the 150 pages, if there is a way to do that.  I don't want to
do it in a way that is unfair to others that have been waiting
to have their requests processed.  If it is just a few hours,
maybe that is not material anyway.
MR. GEORGIEV-REMMEL:  Understood, Your Honor.
THE COURT:  All right.  Anything else?
MR. FLORES:  One more thing to add, Your Honor, if we
do locate any information, case law that says those who file
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suit have priority, may we submit that to the Court as well?
THE COURT:  I would appreciate that if you did, yes.
MR. FLORES:  Thank you.
THE COURT:  All right.  Anything else from you,
Mr. Flores or Ms. Evans?
MS. EVANS:  No.  Thank you, Your Honor.
THE COURT:  All right.  This is a very frustrating
circumstance for everybody involved and we have to do our best
with it.  Thank you.
MR. FLORES:  Thank you, Your Honor.
MS. EVANS:  Thank you, Your Honor.
MR. GEORGIEV-REMMEL:  Thank you, Judge.
(Proceedings concluded at 9:42 a.m.)
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C E R T I F I C A T E 
 
       I, Sherry Lindsay, Official Court Reporter, certify that 
the foregoing is a true and correct transcript of the remotely 
reported proceedings in the above-entitled matter. 
       PLEASE NOTE:  This hearing occurred by videoconference 
and is therefore subject to the technological limitations of 
court reporting remotely. 
 
 
                        Dated this 13th day of October, 2024. 
 
 
                   ________________________ 
                        Sherry Lindsay, RPR             
                   Official Court Reporter 
 
 
 
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