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IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS
FORT WORTH DIVISION
PUBLIC HEALTH AND MEDICAL ) CASE NO. 4:21-CV-01058-P
PROFESSIONALS FOR ) TRANSPARENCY )
) FORT WORTH, TEXAS
vs. )
) DECEMBER 14, 2021
FOOD AND DRUG ADMINISTRATION ) 9:05 A.M.
VOLUME 1
TRANSCRIPT OF SCHEDULING CONFERENCE
BEFORE THE HONORABLE MARK T. PITTMAN
UNITED STATES DISTRICT COURT JUDGE
A P P E A R A N C E S:
FOR THE PLAINTIFF: AARON SIRI
Siri & Glimstad, LLP 200 Park Avenue
New York, New York 10166
Telephone: 212.532.1091
JOHN HOWIE
Howie Law, PC 2608 Hibernia Street
Dallas, Texas 75204
Telephone: 214.622.6340
FOR THE DEFENDANT: ANTONIA KONKOLY
U.S. Department of Justice Civil Division
Federal Programs Branch
1100 L. Street NW Washington, DC 20005
Telephone: 202.514.2395
COURT REPORTER: MONICA WILLENBURG GUZMAN, CSR, RPR
501 W. 10th Street, Room 310
Fort Worth, Texas 76102 Telephone: 817.850.6681
E-Mail: [email protected]
Proceedings reported by mechanical stenography, transcript
produced by computer. 1
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INDEX
PAGE VOL.
Appearances 3 1 .................................
Comments by the Court 4 1 .......................
Argument by Mr. Siri 10 1 .......................
Response by the Government .................32 1
Rebuttal by Mr. Siri 49 1 .......................
Proceedings Adjourned 55 1 ......................
Reporter's Certificate 56 1 ..................... 1
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P R O C E E D I N G S
(December 14, 2021, 9:05 a.m.)
THE COURT: We're here in Cause Number
4:21-CV-1058-P, the matter of Public Health and Medical
Professionals for Transparency vs. Food and Drug
Administration.
At this time I will call upon the -- I think for
lack of a better term I'll call it the doctors group, unless
you-all have a better term for me to call you-all. But I'llturn it over to the plaintiffs, if you could identify
yourselves for the record, each of the attorneys, please.
MR. SIRI: Good morning, Your Honor. Aaron Siri on
behalf of the plaintiff.
THE COURT: Thank you, Mr. Siri.
MR. HOWIE: Good morning, Judge. John Howie here on
behalf of plaintiff.
THE COURT: Good morning, Mr. Howie. How are you?
MR. HOWIE: Just fine. How are you, sir?
THE COURT: Doing well.
And you, sir? Are you a client rep?
MR. ARMER: No, Your Honor. I'm just here to assist
in an administrative capacity.
THE COURT: What's your name?
MR. ARMER: Nicholas Armer.
THE COURT: All right. Thank you. Thank you, 1
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gentlemen, for flying down today.
Who do I have for the -- representing the Department
of Justice?
MS. KONKOLY: Good morning, Your Honor. Antonia
Konkoly from the U.S. Department of Justice. I'm here on
behalf of the U.S. Food and Drug Administration.
THE COURT: Tell me -- pronounce your name for me
one more time.
MS. KONKOLY: I'm sorry, what?
THE COURT: Pronounce your name for me once more.
MS. KONKOLY: Oh, Antonia Konkoly.
THE COURT: Konkoly?
MS. KONKOLY: Konkoly.
THE COURT: Okay. If I mispronounce it, just
forgive me.
MS. KONKOLY: No worries. You won't be the first.
THE COURT: Let me make a few comments about what's
going to be helpful for me on this and what's not.
You know, in today's hotly contested political
environment, it goes without saying we're deeply divided. I
mean, I think that we are probably closer in this country thanwe have been at any time since the civil war to right versus
left, political fights, et cetera, et cetera. I am afraid
that we are getting to the point that Abraham Lincoln warnedus about, the house divided against itself won't stand. And I 1
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hope that we're not there.
But none of that stuff is really helpful to me when
it comes to the case before us. I mean, in my mind let's keepthe politics out of it. Of course we see a lot of that stuff,
and, you know, no matter what you do, when the Twitter world
comes out or the media world comes out, you're always going tobe accused of doing something that's political. Believe me, I
strive not to, and I do try to follow the law.
So, none of the political arguments, arguing against
the administration for some -- there being some big conspiracy
when it comes to the vaccine, whether there is or there isn't,
for the purposes of my hearing here today, and when and howthe FDA can turn over the documents, is a different matter.
So, that's just not very helpful.
I think that we have two administrations here, both
Republican and Democrat, that are encouraging people to take
the vaccine. And it's just not helpful to point fingers and
make political arguments, that's not going to work with me.So, that's number one.
Number two, with all due respect, ma'am, I think
it's safe to say that 55 years is a heck of a long time tohave to make a request to turn this stuff over. And I'm
hoping we can come together and try to reason.
And I look back in my own time and think about 55
years ago, what was going on here in this courthouse. My two 1
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predecessors, one served to be 87, he was the Judge that I
clerked for, he was a Nixon appointee; and the Judge that I
replaced, the Honorable Judge McBryde, is 90, and he came onthe bench in 1988 or '89.
So, I think back, who would have been here in 1966,
55 years ago? It would have been a judge who's probably beendead for about 30 years, okay? President Lyndon Johnson was
in office. My parents -- and I'm no young man -- but my
parents were in junior high school in 1966.
I'm not saying this flippantly. But if you're
really going to tell me it's going to take 55 years to do
this, I think it would be easier for me to get the Kennedyassassination files produced, okay? And I only say that in
half-gist. So that's not going to work either.
And I told you a little bit about some of my
background this morning. I've either had the privilege or, I
guess, perhaps, the torture of being a Government attorney in
various agencies where I've had to turn over and reviewvarious requests for information throughout my career.
Indeed, as I told you, I used to office in your
office. And when I was at 1100 L Street, I dealt with failedbank cases related to the Winstar line of cases dealing with
failed savings and loans. And in those cases, it would not be
unusual for us to turn over, in one case, two- tothree-million pages worth of documents. 1
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The other stages of my career at the FDIC and the
SEC, it's not unusual for me to have to review several
terabytes of information. Much more so than the 300,000 pagesthat we have before us that are being requested in the FOIA
request. And I can assure you that they had all kinds of
customer information, social security numbers, bankinginformation, the most private-type information, I would argue,
even more important than trade-secret-types of information;
that, indeed, I'm in agreement with the Government, that itneeds to be protected. But I can assure you, we were able to
do that in a manner in which we didn't need 55 years, nor even
a year or, safe to say, even a half a year to do so.
I tried a health-care fraud case in this Court a few
weeks ago, and in that case the Government turned over,
related to a long-term scheme at a local hospital that hadbeen going on for at least a decade, three to four terabytes
worth of information. And they were able to do that and give
all the information, including patient identifyinginformation, the most private medical records on folks, in
less than six months. And that's at a local U.S. Attorney's
office with a paralegal and one attorney going through it, andmaybe a case agent.
We're talking about the Federal Food and Drug
Administration with 19,000 employees, possibly the biggest, atleast the most controversial, matter that the FDA has ever 1
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approved, and that would be the vaccine on the most important
issue of our time, that being the COVID-19 pandemic. And if
we truly and really want to encourage the public to continuetaking the vaccine and the efficacy of the vaccine, to me, and
I want you to persuade me otherwise, when we're saying it
takes this long to produce the information, isn't that justplaying into the conspiracies that the vaccine is not safe,
that it was produced in a manner that wasn't given thorough
peer review and it was a rush to get it approved?
I'm not here to make policy decisions, but I think
that if I were the United States of America, I would want to
produce this information as soon as possible, even if it meanthiring as many contractors as possible. I don't know, perhaps
under the Build Back Better program, we could dedicate
$100,000 to hiring some contractors to produce thisinformation. But if we truly want to reach a situation where
100% of Americans receive the vaccine, we ought to be able to
show them what goes in the vaccine.
Those are my preliminary comments. I'll turn it
over to Mr. Siri.
MR. SIRI: Thank you, Your Honor.
THE COURT: You'll need to use the podium.
One more warning about this old courthouse, you have
to speak into the microphone, and you almost have to eat themicrophone. It's very hard to hear. The courtroom was built 1
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in the days when you used your church voices here in the
courtroom and you didn't use microphones. So, just be sure
you speak into the mic.
Go ahead, sir.
MR. SIRI: Yes, Your Honor.
THE COURT: And you heard my comments.
MR. SIRI: I did. I'm going to, Your Honor, try
to -- I will avoid -- if there's something specific Your Honor
would like me to address.
THE COURT: Let's keep it to why we're here. No
dispute from the Government that these documents that you've
requested -- you have a valid request, perhaps they wouldargue a little bit overbroad. There's no argument that you're
entitled to these documents.
I think she's going to make some arguments with
regards to the expedited request. Whether this is expedited
and how you can treat it, it's fine to address that. But the
real thing I want to consider, let's figure out the best,quickest way to get these documents. And rather than arguing
that the Government is trying to hide something or there's
some big conspiracy here, that the green alien people want toinject us with something, is not going to be helpful, okay?
Let's figure out how do we resolve this, and save the other
argument for outside of the courtroom.
MR. SIRI: Yes, Your Honor. 1
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THE COURT: Does it make sense what I'm asking?
MR. SIRI: Absolutely. And I can speak for my
client, and completely agree that I don't think that there'sanybody in the doctors group that believes there's a
conspiracy here. I think it's precisely what Your Honor said,
which is transparency is important to give confidence to theAmerican people that the medical product that they're being
mandated to receive, the medical product that the Federal
Government has said is the only thing that will be able to endthis pandemic has, in fact, been properly reviewed, licensed
and approved. That will increase confidence. That should, as
Your Honor pointed out, increase uptake of the product.
In terms of turning to the more substantive
components, as Your Honor would like me to do. In terms of
actually reviewing the documents at issue here, in terms ofthe scope of what's being requested, I don't know if there's
really much contest with regards to the scope that it's
overbroad. That's because the scope of what's being requestedhere is precisely what's provided for in the FDA's own
regulations, 21 C.F.R. 601 --
(Court Reporter interrupts)
MR. SIRI: 21 C.F.R. 601.51(e). And in that
regulation promulgated by the FDA, it says that there are
certain categories of information that are to be, "immediatelyavailable for public disclosure unless extraordinary 1
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circumstances are shown."
The categories of information requested by this FOIA
request are exactly what's delineated in that list. So, it'snot like they're asking for anything that the FDA is not
already aware of and didn't already itself make the policy
choice, should be immediately available to the public directlyupon licensure.
In terms of the review of the documents itself, Your
Honor, they are claiming they need to review for two things.One would be personally identifiable information. Now, again,
the FDA's own regulations, and we cited in our papers, 21
C.F.R. 20.63(b), already provides that Pfizer was to provideredacted, de-identified versions of the documents to the FDA.
And I don't think there's a lot of contest with regards to
those.
In fact, in their response papers --
THE COURT: So, in other words, if I am one of the
patients that was used as a -- I can't think of the word thismorning. If I was --
MR. SIRI: Clinical trial participant?
THE COURT: One of the trial participants, their
information has already been redacted, so the FDA would not
know that it's John Doe living at 1212 Mockingbird Lane in New
York, New York; is that correct? So that's already beenredacted? 1
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MR. SIRI: I misspoke, de-identified. So, the
information provided wouldn't have included names, it wouldn't
have included home addresses already. In the clinical trials,they use identifier numbers including -- because there's
blinding in the trials and so forth. So when the information
is provided to the FDA, it is provided in de-identified formso that you can't identify specific individuals.
The FDA's only retort to that in their papers was,
Well, we need to just make sure that Pfizer didn't missanything. I would say that the -- that the interest to the
American people in having transparency far outweighs any
potential mistake and inadvertent disclosure. You know, theydon't need to do a detailed word-by-word review in that
regard. I mean, I think that that undercuts the whole purpose
of FOIA in expedited treatment.
Separately, with regards to trade secrets, Your
Honor, similarly there is a provision in the FDA's own
regulations, and that is 21 C.F.R. 20.61(d), and that's alsocited in our papers. And what it provides is that -- it
provides that a sponsor, in this case Pfizer, has an
opportunity, before submitting their documents for licensure,to, again, identify what information is trade secrets when
they submit the documents or, as provided in the regulations,
shortly thereafter. Pfizer has had an opportunity to identifythat information. 1
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But with that said, most of the information at issue
here is not going to include trade secrets. Most of it is
patient-level data. What the doctors group is most interestedin, Your Honor, is doing an analysis of the primary data that
the FDA analyzed when licensing this product. That data,
which is mostly contained in data files of patient-level data,is not trade -- is not -- wouldn't have trade secret
information. Those would be --
THE COURT: They're all that of the health condition
of the participants, correct?
MR. SIRI: That's right, Your Honor. It would be
the patient-level data.
THE COURT: Did you have any discussions with the
Government as far as -- I know that they offered to do the big
production by the end of -- 12,000 pages by the end ofJanuary.
I mean, I think, given the modern era, okay -- and
I'm not so old that I -- before I went on the state courtbench, this is something we frequently did. We had all
types -- when I worked for the United States, all types of
programs to be able to cull out certain documents. You know,you were able to contact contractors, you had the software.
I just cannot imagine the Food and Drug
Administration does not have the same capability of at leastthree to four agencies that I worked for, including the 1
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Department of Justice, where you're able to cull out certain
information and do almost like a rolling production. So, if
this is the most pertinent information, would that have beensomething that's in the first production that's proposed by
the 31st of January 2020 (sic)?
MR. SIRI: That information is not there,
unfortunately. We had an initial meet and confer, per Your
Honor's order, in Washington, D.C.
And at that -- and during that in-person meet and
confer, I expressed to the DOJ attorney who appeared for the
meet and confer that the doctors group would like to get that
data. And, you know, and the -- and the counsel for the FDAsaid they would revert on that.
We provided the FDA, through their counsel, an
initial list, what they're calling the priority list, andwe -- of certain information to be provided by November 17th.
The purpose of that list was so that the doctors group can get
an initial understanding of what was in the overall file.
THE COURT: Right.
MR. SIRI: It was not because it intended to have
anything actually useful or valuable from it.
Instead, the DOJ has decided to use that and call it
our -- the doctors' priority list and treat it as if they're
providing something of value, when they're not providinganything of it. That's not what really is of value. The idea 1
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of what was asked for by November 17th, what they're calling
the priority list, was to understand, generally, what's in the
data files.
For example, one of the things the doctors group
wants to know is, what are the column headers in most of these
data files? You know, there was a partial index that the FDAprovided, and in that index it shows over 100 data files.
Now, they all seem to be -- each file appears to be from
various clinical trial sites. Presumably, Your Honor, theheader across each of those files is the same, even the same
column headers.
Well, my hope was, if I could see those column
headers, we could quickly discuss and identify which columns
might or might not contain any type of personally identifiable
information.
I had an exchange just yesterday asking again for
those column headers, and I was advised that since that wasn't
something, apparently I didn't -- we didn't ask for it in ourinitial, what they're calling our priority list, they're not
going to provide just the headers until after January 31. And
in terms of when they would provide that, they won't even giveus a date.
So, to your point, Your Honor, yes, there are these
data files. They are supposed to be de-identified already.They probably are de-identified already. The one data file 1
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they did provide had no redactions on it. We would like to
get copies of all of them, but I can't even get the column
headers from the Department of Justice.
I'm not saying that to -- I'm just saying that we're
not able to obtain that. I would like to work constructively
to obtain those. I suspect that those data files can beturned over without virtually any review. You'll have to ask,
you know, obviously, counsel why that --
THE COURT: Let's -- let's go off the record. I'd
like to see you-all back in my conference room.
(Short recess taken)
THE COURT: Back on the record at this time in the
matter of Public Health and Medical Professionals for
Transparencies vs. the Food and Drug Administration.
I took a brief break to go off the record and
discuss some logistical issues in this case, and got I
Mr. Siri interrupted in the middle of his argument. I'd like
for you to go ahead and continue. And you can put anythingyou'd like to on the record. I'll try not to interrupt you.
MR. SIRI: Thank you, Your Honor.
THE COURT: Go ahead.
MR. SIRI: The doctors group certainly appreciates,
Your Honor, that the FDA has said that they're going to
proceed and produce in good faith and that they should trustthe FDA that they will produce as expeditiously as they can. 1
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But it has been more than 108 days since the FOIA request has
been submitted.
One-hundred-and-eight days is the amount of time
that the FDA took to license -- to review all of the documents
that are being requested here and license this product in a
process that the FDA says was the most rigorous, robust,detailed review they've ever conducted. That process took
them 108 days. But yet, despite over 108 days passing, they
have only produced, on average, a few pages per day to thedoctors group of those 400,000 documents to date.
And I would point out in the declaration submitted
yesterday by the -- by the FDA, their declarant says that,"Two of the subpoenas have yielded over hundreds of thousands
of pages each." So it does appear that the FDA does have a
precedent of responding to subpoenas and producing,apparently, hundreds of thousands of pages, and this, they
were referring to since 2018. So, the FDA can, and it is
practicable for the FDA to produce, apparently, hundreds ofthousands of pages by their own admission, by their own
declarant, in their papers.
Now, we all have to follow the law. That's -- you
know, Americans don't get to say they don't want to follow the
FDA's regulations nor the statutes passed by Congress. And
the Congress here has passed a statute that the whole purposeof which is transparency, for the American people to have 1
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transparency about Government conduct. And it's provided that
in situations where there's an urgent need for the public to
know about Government activities, there should be expeditedtreatment, or as the statute calls it, not just promptly --
yes, Your Honor?
THE COURT: The Government has made an argument that
you haven't correctly made a request for expedited review.
And, indeed, even if you had, that point is moot now because
you're, essentially, getting expedited treatment.
What's your response to their argument?
MR. SIRI: I'm not sure -- the doctors group has
certainly made an appropriate request for expedited treatment.A request for expedited treatment was followed -- excuse me --
it was filed with the FDA, and a copy of it is in our papers.
It clearly lays out the grounds for why expedited treatment isappropriate here for two reasons.
First, as provided in FOIA, you get expedited
treatment where there's an urgent need to review Governmentconduct. I can't think, Your Honor, frankly, of something
more urgent right now than to review the FDA's licensure of
the product that the Federal Government says is the only thingthat's going to save us from this pandemic, that Americans are
mandated to receive, that the Federal Government's provided
immunity to liability for --
(Court reporter interrupts) 1
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MR. SIRI: The Federal Government has provided
Pfizer over $17 billion dollars from American taxpayers, where
the review that the FDA conducted was done under significanttime constraints, and where we -- what we're seeing -- and
with political pressures. And what we're seeing is that the
licensed vaccine, as we've seen on the news, there's waningimmunity, there are variants that are evading immunity, and
the CDC has said it doesn't prevent transmission.
We need independent scientists to review this data.
We need all hands on deck. The FDA shouldn't be hoarding this
data. If there was ever a need for immediate transparency,
for urgent review of the public for Government conduct, thisis it.
We need all -- we need the scientists from across
this country who comprise the plaintiff's group here, some ofthe prestigious -- most prestigious universities in this
country, who are independent of all these influences who don't
have to work under severe time constraints, for our -- toreview this data.
Yes, Your Honor? I'm sorry.
THE COURT: And assuming that I agree with you. I
mean, even if you did represent a group of scientists and
physicians, the American people are entitled to this
information. I mean, they -- we are the Government. TheGovernment is not some big ominous group here. We're a 1
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republic, and the American people are entitled to this
information. I think we can all assume that, including
counsel for the United States.
What bothers me -- and if you did any research on me
before you came before me, one of my big issues that I think
is really -- and it's not just a product of the last couple ofadministrations, I think that this has been something that
we've seen over the years, is that the Federal Government --
rather the Federal Judiciary continues being involved inthings that it does not need to be involved in. One of the
things that Thomas Jefferson warned us about 200 years ago is
that the Federal Judiciary -- within the judiciary lies theseed and the dissolution of our republic, because we keep
assuming jurisdiction and going into areas that we're really
not supposed to be going into. That's not a new phenomenon,that's been going on for at least 75 years.
And me being the guy in the black robe that's a
lawyer, not a scientist, has some hesitancy just saying, Bygolly, FDA, you have to produce that in 30 days.
What are the limits as far as what I can do?
Assuming that we have this -- I have to balance this need forthe information, but at the same time, obviously, I want to
protect trade secrets, I want to protect personal information.
What are you asking for?
And other than just producing in the most 1
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expeditious way possible, what would be the dream order from
the physicians group from me? That they must produce all of
the information no later than January 31st or --
MR. SIRI: Yes, Your Honor.
That -- I think the dream request from the doctors
group, and I think that large swaths of the American public,would be that Your Honor would order the FDA to comply with
what FOIA requires, which is to produce it as soon as
practicable. And what's practicable for the FDA here is thatthey can produce this in 30 days if they want to. They could
muster the resources to do so.
Certainly if this were a request by Pfizer that
related to getting the vaccine license, I would imagine they
would get it done. Over the course of the last year, the FDA,
the Federal health authorities, have given Pfizer millions ofdollars per day of taxpayer money.
THE COURT: I think you bring up a good point. And
I do apologize for interrupting.
MR. SIRI: I'm sorry.
THE COURT: No, I interrupted you.
In a case of this magnitude where the Government's
basic defense is -- everybody agrees that the private
information of these participants isn't something that the
American public needs, and that's something that needs to beprotected. 1
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But when it comes to a large amount of these
documents containing Pfizer and trade secrets, for example, I
was a little bit surprised that Pfizer wasn't an interveningparty here. I would think as much money as they have been
given in this, and as highly confidential that some of their
trade secrets are, that they would have intervened.
Is that something that's unusual in these types of
cases? And do you know why Pfizer isn't here?
MR. SIRI: I can't speak for Pfizer. But I can say
this -- I can say two things. One is, they may not be
surprised because Pfizer, at this time, is used to the Federal
Government working on their behalf. The Federal Government isthe one that has funded them with over a billion dollars to
help develop the product. The Federal Government is the one
that's given them immunity liability. The FederalGovernment's mandated -- the Federal Government spent over
$18 million marketing their product. They've gotten maybe
used to the Federal Government, through the Department ofJustice, defending them, promoting their --
THE COURT: I guess I would, at least, have thought
they would have filed some sort of amicus brief consideringthis is their secrets. You're basically having the United
States Government determining what's a trade secret and what's
not for a private company.
Do you understand? 1
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MR. SIRI: I do. And if I'm Pfizer looking at this
from outside -- and, again, Your Honor, I can only speculate.
THE COURT: I mean, I would think if I did a FOIA
request to the DOT -- DOD for the ingredients for a
thermonuclear weapon that Morton-Thiokol would be an
interested party.
Do you understand my point?
MR. SIRI: I do, Your Honor.
But where the FDA is taking the position that they
are willing to commit to 500 pages per month, which, by the
way, based on the total number of documents that are not
disclosed, that would come out to over 75 years. I hope thatthat's not taken as hyperbolic, that's just math.
If they commit -- if that's what they actually
do --
THE COURT: All right. If I enter an order --
MR. SIRI: If I'm Pfizer, maybe I'm not so worried
today. Maybe I'm waiting --
THE COURT: Because we'll all be dead by the time it
all comes out?
MR. SIRI: You know, that's possible. The other
thing --
THE COURT: I'm 46, I don't think I'll make it 55
years or 75 certainly.
MR. SIRI: And the FDA is saying they want to do a 1
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word-by-word, line-by-line review to assure Pfizer trade
secrets. I mean, if you read their papers, there's not a
sentence in there that makes any -- any recognition of theimportance of this to the American people to do an independent
scientific review.
Frankly, I found it incredible that the FDA, at
least, will not give a recognition to that. I mean, their
duty is to the American public, not to Pfizer's trade secrets.
At least they can recognize the interest of the Americanpeople and approach it in a more balanced manner. But if you
read their papers, that is what they focus on is Pfizer's
trade secrets. And if I'm Pfizer looking at that, I'mthinking the Federal Government is there to protect me.
The other piece of this is, too, is this, who's the
one that's there -- with most drugs, Your Honor, whether it'sHepatitis C or any drug, the FDA is not out there promoting
those products. They're not telling Americans to get it.
Janet Woodcock and Peter Marks, the acting
Commissioner of the FDA and the head of the CBER, the
biologics division, they have been promoting this vaccine
before it was even licensed. That's -- there's no conspiracythere, Your Honor. It's just a basic, you know, when somebody
goes out and promotes a product, it makes them probably a
little less reluctant to admit there was a mistake, that'sall, no conspiracy there. 1
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And that's -- that's part of the reason why we have
independent review. That's why --
THE COURT: And I get that, counsel.
MR. SIRI: Yes.
THE COURT: What I'm concerned about -- I'm not
arguing you don't deserve this information, that it doesn'tneed to be produced posthaste.
Where does my authority go as the Judge?
MR. SIRI: Yes.
THE COURT: Do I -- is it going to be an order that
stands up to review of the colleagues that grade my papers on
the next two courts up if I enter your dream order?
MR. SIRI: Let me answer that directly this time.
THE COURT: And where does my authority go? Can I
order the FDA to hire 100 contractors to help review thisinformation? At what point does it become draconian what I --
the burden that I place on the Government?
MR. SIRI: Yes. Your powers, Your Honor, by the
statutes passed by Congress, Congress has empowered you to
enforce the FOIA statute that says the FDA, in this instance,
must produce these documents as soon as practicable.
What that is -- what that means, certainly in this
instance, it could certainly be done in 30 days; that is
practicable. It happens all the time in commerciallitigation, in other Government requests. By the very 1
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admission by the FDA, in their own declaration, that they've
responded with hundreds of thousands of pages to subpoenas.
It is practicable for the FDA to do this. Your Honor isempowered to require them to do that.
To the point of what expedited treatment means.
There's two pieces to it. One is, that you get to the frontof the line, right? You jump ahead of all the other requests,
the FOIA requests. And there's a second piece to it, and
second piece to it -- and we've cited numerous cases in ourpapers that say that stale information, the information not
timely produced is stale, it's of no value.
The whole point of why Congress put in expedited
treatment in the '90s, was for precisely this situation where
there's a unique need for the public to have access. And the
Government should argue -- of course the Government doesn'twant to do it, you're reviewing the Executive Department's
conduct. Of course they're not going to want to provide it to
you quickly. They're going to want to delay it as long aspossible. Nobody likes having their own homework reviewed and
double checked. They're not going to want that, of course.
That's why courts always have -- often have intervened in theadministration and forced them to do it in timely manner.
THE COURT: No, I understand.
Certainly that authority has limits and I can't
order it to be produced tomorrow or the Fifth Circuit is going 1
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to tell me that's being too tough on the agency. If the
agency only has ten folks that they have employed to do this,
and I enter an order saying it has to be done in 30 days, Ijust leave it for them to work out the details.
MR. SIRI: They can, number one, they can hire
independent contractors to review these documents -- orprofessional contract document reviewers, excuse me, who
conduct document review all the time, that they can hire.
They could allocate reviewers from the Department of
Justice. Attorneys review documents all the time. They can
bring in from other agencies. There are all types of
individuals they can bring in from within or from without.They can also put the burden on Pfizer.
They've already given Pfizer $17 billion of the
American's money. Why not make Pfizer do it in 30 days;certainly they can pull it off. I'm sure they've got a lot of
large fancy law firms that they have on -- you know, that they
have on retainer that they can review this pretty quickly,Your Honor, and provide, you know, what it is they think
should be redacted for trade secrets and personal information
and let the FDA know.
THE COURT: I think the United States is going to
tell me that the cases you cited in your briefs are extreme
outlier cases. Even if I take those cases at face value, whatyou're requesting and the timeline you're requesting still 1
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goes far and beyond that.
How do you respond to that?
MR. SIRI: This is an unprecedented request.
THE COURT: This is a one of a kind?
MR. SIRI: I would say, Your Honor, this is one of a
kind. And I don't agree with their characterization of thecase law.
I pointed out two different cases, and we cite in
our papers, in which the FDA was -- produced over 10,000 pagesper month for products. One was a Hep C drug, and one was a
very rare neuromuscular disorder. And in those cases the FDA
warned them -- the FDA produced over 80,000 pages at a clip ofover 10,000 pages a month, plus there were over a thousand
electronic files in that case.
And we've cited in our paper -- the case name, Your
Honor, is Treatment Action Group vs. FDA, 15-CV-00976. It was
82,000 pages, over 1,000 electronic files. They've identified
here 126 data files. They said there might be more, butthey're not telling us how many. And there the FDA produced
it in seven months. Over 11,800 pages per month, plus
electronic files.
And that was for something that was not what they
said could be the only thing that could end the most important
issue addressing America today. The pandemic has resulted inincredible economic disruption. It has resulted in 1
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impingements, if I may, on individual rights we've never seen
in the history of this country. Just the ability to leave
your home, to go to work, to walk in the street. It hasdisrupted, virtually, every single aspect of American life.
There is no product, that I'm aware of, where the
Federal Government mandates you to get it, can't -- gives thecompany that sells it immunity from liability, you can't sue
for injuring anybody, gave the company the billions to develop
it; and then, when they licensed it in 108 days, doesn't wantto expeditiously produce the product. That's unprecedented.
It truly is unprecedented.
There is no other product of this nature. There is
no other situation that I can think of that's even comparable.
If they can do 11,800 pages plus electronic documents in the
Hepatitis C case, and that was in 2016, over a seven-monthperiod, this case calls for, at least, ten times that rate.
And we cited another case called Seife vs. FDA , and
that was from 2020, and it's 492 F.Supp.3d 269. And over afour-month period was over 10,000 pages a month, where a rare
neuromuscular disease, which I will point out, just like the
Hep C, was not in the news, had not been the focus of themedia's attention every single day and is not urgently needing
review, because that is not -- there's no claims that there's
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preventing effective transmission.
I mean, we need -- this doctors group, they want
something very simple, Your Honor. And it's -- and it's -- itcouldn't be more practicable. We just want to independently
review the documents submitted by Pfizer and that the FDA
reviewed to license this product. That is criticallyimportant for every American. And I do think that, unlike the
precedent that the FDA is citing, this calls for unprecedented
speed. They did operations warp speed to get the productlicensed.
THE COURT: You don't need to harp on it. I'm in
agreement.
I think that this is -- in my mind I couldn't think
of a more important FOIA case in the entire country or a more
important forefront issue that the American people areentitled to know.
When you're being asked or, indeed, mandated to take
something and insert a foreign substance in your body, I wouldthink, first and foremost, that the Government ought to have
to -- in our system of Government, we're not in communist
Russia or China or in Nazi Germany -- when the Government hasmandated something, I would think the American people are
entitled to know the underlying efficacy of what they're being
asked to do.
I think it's no doubt in my mind that this is 1
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something that needs to be produced posthaste. The only
question I have in my mind is when and how it can be done in a
manner in which I'm not shutting down the entire FDA. I mean,what if there's a pending request for a drug that's going to
cure cancer, and I have to enter an order that 19,000 people
at the FDA have to go and review information for privilege andwe don't get a cure for cancer. And in the meantime, we're
fighting over the documents underlying COVID-19, which as bad
as it is, certainly -- what is the survival rate of COVID-19,99.5%?
Do you understand my point?
MR. SIRI: I do, Your Honor.
And that's why we went out and we tried to provide
as many metrics as we can. We were not able to obtain them
from the FDA, unfortunately. But we did provide, in ourpapers, Your Honor, number one, we got a quote from a
professional document review company, that's all they do.
We explained to them that the review here requires
for personally identifiable information and for trade secrets.
We've got a quote from that company, we provided it in our
papers. They say they can conduct that entire review withabout a hundred-grand budget, ten reviewers and a few weeks.
Also, we've taken a look, and we provided in our
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those two bases, but you have to review for privileged, for
attorneys-eyes-only documents, confidentiality, a whole host
of other things. Most law review articles, ABA journals andtrade publications, they average about 50 hours -- 50 pages
per hour for those reviews.
THE COURT: And I think it's safe to say, everyone
in the room that's been out in practice for awhile that's been
involved in modern-day commercial litigation, indeed, you can
even see this in tort litigation, 400,000 documents inmodern-day litigation is really not a lot.
In fact, some of the prosecutors out here are
frequently involved in health-care fraud claims. We had onerecently where the Government had to review four terabytes of
information for the same exact thing we're looking at here
now, private information, trade-secret-type information. Fourterabytes, that's a lot of information, and they had to do
that in about two weeks.
So, it's not something that's unusual in the grand
scheme of things. Certainly in the litigation context,
400,000 documents just ain't a lot of documents in this day
and age.
All right. I'd like to hear from the United States.
MS. KONKOLY: Thank you, Your Honor.
I'd like to begin by, again, emphasizing that the 55
years being cited by the plaintiff is not a number that the 1
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FDA has ever cited. It's very much a hyperbolic calculation
that rests on, at least, two faulty assumptions. One that
goes to the FDA, and one that is within plaintiff's owncontrol.
The faulty assumption that pertains to the FDA, is
that it is not acting in good faith; when it is repeatedlyrepresenting to this Court that it's making every effort to
move forward as quickly as possible, and if it can process the
documents faster, it will. That commitment is demonstrated bythe efforts that it has already made to date. It's released
3,000 documents, as of yesterday, and the proposal that its
making to release close to 9,000 more by the end of January,which is a matter of six weeks from now.
So, in those other FDA cases, they are outliers. I
can't speak to the particular circumstances of them. Butevery FOIA case is different. Some are easy, some are hard.
The point is that where we're standing right now, at this very
early juncture in this FOIA case, the FDA simply has not hadan adequate opportunity to get its arms around these 400,000
documents at issue here.
THE COURT: How long is that going to take, ma'am?
How long -- and I'd like to note, I'm very, very disappointed
that no one from the FDA bothered showing up for this. I
understand that we're living in a time of COVID and it'sprobably more difficult to travel. 1
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But I, particularly, did not put this hearing for an
immediate hearing after I issued the order, because I wanted
enough time, having been a Government attorney, knowing howlong it takes to travel, to get it authorized, so I would have
someone from the FDA here, so I'd have firsthand information
with regards to how long this is going to take. I'm verydisappointed that we don't have anyone here. I hope you
communicate that with your client agency.
MS. KONKOLY: Your Honor, I will -- you can rest
assured I will convey that in no uncertain terms to the FDA.
The message will be received.
THE COURT: Go ahead. I've been really bad about
interrupting.
MS. KONKOLY: And let me reiterate on the record,
that no disrespect was intended by that. It was simply afunction of the FDA's travel policies, which are restricted in
this time of the pandemic.
THE COURT: I guess the reason I'm disappointed, I
would think that this would be in the -- at least in the top
five of the most important pieces of litigation they have at
the moment.
MS. KONKOLY: Your Honor, this case very much has
the FDA's attention. They started processing documents even
before we got to this point, that's not how it normally worksin a FOIA case. 1
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As we noted in our reply brief, even though, you
know, formal expedition was denied, it's really a moot point
because the FDA, is, in effect, expediting this case. It isprocessing documents and is making a full-court press in
putting every available resource that exists in the real world
that they are operating in into moving this forward as quicklyas they can.
They've made -- we've made extensive efforts to
confer with plaintiffs. The FDA has bent over backwards totry to get them the information that they wanted. We heard
from plaintiff's counsel that they wanted the raw data from
the clinical trials, and so we identified that as Section 5.2and 5.3 in the product file.
We went through and tried to create a detailed index
for them to help them identify where the FDA can start mostproductively for them. The parties agreed on a priority list.
I understand that plaintiff's counsel is taking some issue
with that term. The plaintiffs have been using that termthemselves. It's right there in some of the correspondence
the plaintiff introduced in his appendix, I believe it was
appendix 637. He, himself, uses priority list.
The idea wasn't -- the initial priority list is the
things they want first. We understand that this is, in a
certain sense, the tip of the iceberg. The FDA took theplaintiff's priority request to heart. It is starting with 1
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that set. It is making every effort to get through that
initial set as quickly as possible. It's proposing to produce
close to 9,000 more documents, bringing the total, I believe,close to 13,000 documents six weeks from now.
So, these outlier cases -- to return to the point I
was making a few moments ago, that plaintiff's counsel hascited, the FDA is moving at a pace, you know, roughly akin to
that. And it is committing that if it can maintain that pace
or even pick it up, it's going to do so. At this moment,however, it just has not had sufficient time to get its arms
around the entire corpus of the 400,000 documents at issue,
especially to make a firm commitment as to how quickly it canget through that.
The FDA certainly hopes, and I don't know if I can
use the word expects, but we are very much hoping that thereare going to be efficiencies and there are going to be certain
portions of this that can be gone through very quickly. It
just depends on what's on the data. Some portions of it aregoing to be slow going, some are going to be fast. We can
work with plaintiff's counsel to identify the parts that we
can get out quickly.
I assure you that this has the FDA's attention and
that they are putting every available resource into moving
forward, even --
THE COURT: One of the things that I had hoped -- 1
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and I do hope that the parties are able to talk. I mean, this
is -- this should not be World War III, this is a FOIA case.
And as counsel has pointed out, and I think the
Government agrees, this is something that should be at the
forefront of the agency's attention, particularly when we're
in an environment where we're encouraging all U.S. citizens totake the vaccine. I think transparency and forthrightness on
behalf of the United States is more important here, possibly,
than any other case in recent times. So, it's disappointingfor me no one here is from the FDA to tell me exactly what's
going on.
Can you tell me the extent of the discussions
between the parties? I mean, is it the parties that can't
discuss this? Do -- have y'all sat down and actually talked
about, This is what it incurs, this is what we're able to do,this is what we're not able to do?
MS. KONKOLY: Yes, Your Honor.
THE COURT: And again, the original request was sent
back in November. We are beyond that now. I would expect at
least one, maybe two meetings, between the parties.
Do you communicate, is what I'm trying to ask?MS. KONKOLY: The FDA has been bending over
backwards to try to give plaintiff the information that it
needs to make an effective priority list and to move thisforward as quickly as possible. 1
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When plaintiffs said that they wanted the raw data,
the FDA went ahead and identified for them the parts of the
file where that would be likely to be located. They made thetime investment to make a 90-page -- they had to go manually,
take screen shots of those 90 pages and break out the folder
to create that index. That's in our first appendix filed withour first brief.
Plaintiff's counsel --
THE COURT: Does the FDA not have all this on an
electronic database? I mean, that's -- I'm an old guy. And
so when I was working and representing Federal agencies, even
15 years ago, Federal agencies had databases of informationthat were searchable, via FOIA searches, via certain
categories and types of information.
I would be shocked that an agency as advanced and
scientifically oriented as the FDA did not have some sort of a
program to organize these documents. They had to have known
the FOIA request was coming.
MS. KONKOLY: Your Honor, I think -- I don't want
to, you know, speak beyond what I, you know, have confidence I
can represent here. But I can say that the seed documents,the point I was trying to get to eventually, that plaintiffs
have made the argument that this really shouldn't take that
long because all of the information has already been redacted,and this is just not so. 1
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There is a regulation that does ask the
manufacturers to redact identifying information, but whether
it's because by either read differently or some stuff got pastthem, in the production that went out yesterday of 3,000
pages, the FDA found several dozen instances of PII that
needed to be redacted. And that was the product of aline-by-line review that needed to be done to protect the
privacy interests of the child participants, which as I noted
in conference, is I think a very important interest thateveryone here can recognize.
THE COURT: And certainly I agree.
Let me ask you another question with regards to
document production. In the world of litigation, where we
have big productions, we have what's called a claw-back
mechanism. I would assume that the parties can enter anagreement that says before the plaintiffs take any of this
information and do what it is with it, if they come across
something that has personally identifiable information and/orsomething that is clearly a trade secret that was
inadvertently produced, isn't there something akin to like a
claw-back agreement that the parties can make amongstthemselves?
MS. KONKOLY: Your Honor, that's a --
THE COURT: Is that ever done in FOIA litigation?
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why you would have that question. But the answer is, no, that
does not apply to FOIA litigation. Once the release is made,
it's made to the public. There's no such thing as a protectedorder or a claw back in the FOIA context.
THE COURT: So, in other words, the parties couldn't
enter -- the Government couldn't enter into an agreement withplaintiffs in a case like this?
MS. KONKOLY: No. That's not -- that's for civil
discovery, it's not a FOIA concept.
THE COURT: All right. Go ahead.
MS. KONKOLY: I would also like to note that one of
the things that is a very substantial factor in the amount oftime this is going to take on the ground is the breadth of the
plaintiff's request. They're certainly entitled to the full
400,000 documents under the scope -- you know, under the FOIAstatute, the FDA doesn't dispute that. But it is a choice
that the plaintiffs are making to ask -- I should clarify,
that's somewhere in the ballpark of 400,000, once we added inthe two additional categories of documents that I think
plaintiffs are saying, if I understand them correctly, they
want FBI to -- I'm sorry, FDA to expand its construction ofits request to encompass. That will bring in an additional
several tens of thousands of documents and pushes that
somewhere close to around 400,000.
That is their choice to make, and there are 1
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consequences on the ground, just like anything else in the
world, work takes time and the more work you need to do the
longer it's going to take. So, there is very much aresponsibility on the plaintiff for having brought such a
broad request. It just can't be the case that you asked for
400,000 documents and get them overnight, which is,essentially, what they are asking for.
THE COURT: It would seem the vast tranche of the
documents are something that would not contain informationthat's clearly personally identifiable-type stuff.
The mere underlying data, why is that not something
that couldn't be produced in, let's say, even 90 days?
MS. KONKOLY: Well, Your Honor, the documents do
need to be reviewed line by line for that PII. There is also
exemption for the commercial trade secrets.
The Government cannot simply outsource that, despite
their -- I very strongly doubt that plaintiffs would actually
like that world. If the drug company had the final say onwhat was, you know, protected under the exemption, formal or
confidential, there would be absolutely nothing stopping them
from just drawing a big black box over the entire set ofrecords.
The FDA has an independent obligation under FOIA to
make that --
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asking. My question was more towards the cases like this. Is
the party that's effectively the most concerned with the
production, in this case that would be Pfizer, I don't thinkanybody can argue that, the party that would be most affected
by this information being produced, taking out the individual
patients or participants in the study, would be Pfizer itself.
Are there any instances where that party appears as
either an intervenor or an interested third-party or, heck,
even an amicus-type situation?
MS. KONKOLY: I'm not aware of any in the FOIA
context, Your Honor. I can't speak definitively to that.
THE COURT: And I'm not a FOIA lawyer.
MS. KONKOLY: Well, we do a lot of FOIA work in my
office, but I haven't seen that come up. I can't say
definitively whether it's ever done. It would certainly bevery unusual, I would think.
There is a process, and part of the reason that time
will be required just necessarily to work through this, weexplained this in a couple of places, but most recently in our
reply brief on page 20. There's something called informally
reverse FOIA, which here, if the FDA determines not towithhold information that might be confidential pursuant to
its regulations that, you know, as plaintiff's counsel has
hastened to point out, is required to comply with its ownregulations, which in this instance would require the FDA to 1
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notify Pfizer and give Pfizer an opportunity to object.
That is certainly just a process that, you know,
takes time, like anything else, to happen. And I think it canbe reasonably anticipated to happen in various instances if
the FDA works its way through this massive set of documents.
Again, I would note that the order that plaintiffs
have asked for, they want apparently everything produced by
March 3rd, that is 80 days from today, folding in these new
documents, under an expanded construction of their request,that works out to 5,000 pages per day or 150,000 pages per
month.
I will, again, just emphasize that, you know,
plaintiff's counsel clearly did his research, he found a
handful of extreme outlier cases in which the courts have
ordered a pretty extreme processing schedule, that I know, inat least one instance, it was a case I was monitoring. The
Open Society case in New York, it threw the State Department
into absolute turmoil for a great deal of time. It really didshut down some things for them in order to comply with that
order, and that was 5,000 pages a month.
THE COURT: But --
MS. KONKOLY: The plaintiff is asking for 5,000
pages a day.
THE COURT: But why is this not an unusual outlier
case? It's not like they're making a request for the studies 1
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that were done behind the MHMR vaccine that was approved in
1972. We're asking for -- this is the most -- I cannot stress
this, I don't think anybody in the entire courtroomdisagrees -- this is the most important issue of our time.
MS. KONKOLY: The FDA --
THE COURT: No doubt about it. This is as important
as World War II. This is -- this is the most important issue
of our day. This is -- in many ways I think it would trump
September 11th. We are asking every single American to inserta foreign substance into their body. And the response from
the Government is that, Well, this is too much trouble for us
to get the underlying data out.
Do you see how this looks very, very bad?
MS. KONKOLY: Your Honor, the FDA -- I would just
like to state on the record, again, absolutely understands thevery substantial public interest in this, it's effectively
expediting it. It went immediately into production.
Three-thousand pages have already gone out. It is movingfull-steam ahead to get $9,000 -- 9,000 pages out the door by
the end of January.
And if it can maintain that pace or increase it, it
will. It has repeatedly said that. We are just not in a
position, as I stand here today, to make a commitment about
this very large universe of documents that the FDA has not hadan opportunity, given all the work that it's doing to process 1
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those documents as quickly as we can, to get a handle on
what's in there, and, you know, how quickly they think they
might be able to get through it.
Which is why the FDA has said, If you would please
enter our proposed order, we're moving full-steam ahead, give
us a little more time to confer with the plaintiff, try to getthem some more information, give the plaintiffs an opportunity
to narrow their request, because there is a very large degree,
in which, things are in their control, if they reasonablynarrowed the less documents at issue, it stands to reason that
it will take less time.
THE COURT: Just to be quite frank with you, that
was part of the reason that I scheduled the hearing today. I
had hoped that someone -- a client rep would have been here so
I can let you-all go back and talk. It's always good to talkface to face.
I have the luxury of having two jury rooms that are
very spacious and comfortable, and you guys could have spentthe day here talking this out and perhaps reasoning together
and coming up with something that everyone could have agreed
with or, at least, could have narrowed the issues for me.But, apparently, that's not possible.
Go ahead and conclude your argument.
MS. KONKOLY: Can I --
THE COURT: Ma'am, I have a full criminal docket -- 1
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MS. KONKOLY: Okay.
THE COURT: -- that I have to get done.
MS. KONKOLY: I will conclude. But let me -- I just
note that if Your Honor would like --
THE COURT: But the answer "no" or "it's too much
work" is just not going to get you there.
MS. KONKOLY: The FDA agrees that it would be
productive for the parties to have more time to try to work
together to come to an agreement on this.
THE COURT: But if they agreed, why didn't they
bother sending somebody up? And don't give me the
bureaucratic answer.
MS. KONKOLY: Your Honor, again, I apologize. I
explained that I can't --
THE COURT: I have not -- I cannot think of a more
important issue at the Food and Drug Administration right now
than the pandemic, the Pfizer vaccine, getting every American
vaccinated, making sure that the American public is assuredthat this was not a rush on behalf of the United States, that
they really had the safety of the American people in mind to
try to quash the pandemic.
We're hearing an omicron variant, we're probably
going to get shut down again. By golly, we ought to be able
to get all hands on deck, get this information out, okay?
MS. KONKOLY: Your Honor, can I -- 1
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THE COURT: This ought to be as important in getting
the information out as it was in approving the vaccine in the
first place.
MS. KONKOLY: I absolutely take that point. Can I
say one thing in response? Which is just that I would, again,
note that the FDA agrees that more conferral would beproductive. The FDA will receive, I assure you, in no
uncertain terms, the Judge's message they should have been
here today.
THE COURT: You know --
MS. KONKOLY: I'm sure we can get the FDA to come
back down here, I can come back down here. I'm not sure ifthere's a magistrate judge who you can, potentially, refer,
you know, to mediation session to where the parties can sit at
the table with agency counsel here to try come to an agreementthat is practicable, and as you said, will not, you know,
require FDA's very important public health operations in
areas, like, cancer research and approval of lifesaving drugsin other contexts to come to a halt in order to agree to a
production schedule that is 15-times larger than anything
that's ever been entered in the history of FOIA, as far as I'maware.
THE COURT: Yeah. And I figured this is 15-times
larger than anything that the FDA has ever had to approve insuch a short amount of time, too. 1
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Let me make a point. I think that Mr. Howie, and
certainly some of my AUSAs that are out there can attest, the
previous occupant of this courtroom is a guy named JohnMcBryde. John McBryde is still alive and still hearing cases.
And you can do some Google searching for him, if you'd like to
know what he was like as a judge.
But he was known during his tenure, when he would
get answers like this -- one time he went so far as to order
the Secretary of the Treasury to be present for settlementnegotiations to try to talk it out because no one from the IRS
showed up for negotiations like we have now.
I am not prepared to do that. But if I do have
another hearing, I am going to order someone from the FDA with
the appropriate authority to come and discuss exactly what
this entails. Because, quite frankly, I've been in your shoesbefore, I've been a main justice attorney, I know you're
limited on what you can say. But this is not summary judgment
in a typical case.
This is a FOIA case involving the Pfizer vaccine,
something we all agree that the American people are entitled
to know and they're entitled to get to as quickly as possible.Making all the legal arguments, frankly, are just not that
helpful, all right?
I get the main point that that is an overbearing
case and the entire FDA is going to go over the mountain if I 1
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order this to be expedited too quickly. The burden is too
heavy, I get it, that sums it.
Brief reply, and then I need deal with my criminal
docket.
MS. KONKOLY: We can make a mediation conference
happen.
THE COURT: All right. Thank you.
And again, I'm not saying this to be rude, these are
just my concerns. I wouldn't be doing my job if I didn't tellyou.
MS. KONKOLY: Understood.
THE COURT: Go ahead .
MR. SIRI: Thank you, Your Honor. I'll be very
brief.
In terms of the scope of documents. As the doctors
have made very clear, unless they have all the data, the
entire production, they can't do a proper review. If even one
data set is missing, they don't know if their analysis iscorrect.
In terms of the actual scope that was requested. As
I pointed out, I believe earlier, this FOIA request is for theprecise scope of documents that the Code of Federal
Regulations, that the FDA's own regulations say, should be
made immediately available after licensure.
And then in terms of -- and this is really 1
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important, Your Honor. While the cases that we cite, the two
that I pointed out earlier, have a rate of about 10, 11,000
pages per month, and that's, you know, I think 50-timesgreater rate than any other case, I think that's a bit
hyperbolic, but there is something consistent through all the
cases. And that is, when there's expedited treatment, thedocuments must be produced in a timely manner to make them
useful. Meaning, it's the end date that the courts have
consistently found needs to be done within a timely manner,not the rate, that's typically been focused upon.
And I quote the Fifth Circuit, which says, you know,
FOIA was to "pierce the veil of administrative secrecy and toopen agency action to the light of public scrutiny." And that
"stale information produced pursuant to FOIA requests is of
little value." The quotes go on and on and we have them all inour papers, in our initial brief and second brief, where
courts repeatedly affirmed the principle that when there's
expedition warranted -- there couldn't be a more clear case ofexpedited treatment here -- that it's the end date that's
critical, and the agency has to come and do what's needed to
meet that deadline. And that is what Your Honor is empoweredto do.
They would like to tell us, Trust us, we're going to
act expeditiously, but it's now been 108 days since the FOIArequest and the doctors group has received about an average of 1
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a few pages per day, essentially, if you average out all the
documents they've provided, that doesn't provide a lot of
confidence.
And in terms of bending over backwards in
negotiations, I respectfully say -- and I do always hope to
work with opposing counsel on every case. But here we've notbeen able to get an accurate number of the pages. We can't
get an index. Literally, an index of the file that they have,
they won't provide a full index to us. We can't get theheaders of the Excel spreadsheets that are repeated over and
over again. We don't know the total number of data files,
that won't be provided to us.
And as I mentioned when we met to confer in person,
I'm sure there's a universe of pages that don't require a lot
of review. And if they can identify those we can have thatdiscussion, but that's never happened.
In terms of the PII, the personal information
redactions, there were a few made the other day, but they werevery limited and many of them did not seem necessarily,
particularly, I would say, they looked a bit like they're
looking for redactions, given that there's no names, there'sno -- it's almost impossible to identify the information by,
you know, some of the stuff that was redacted.
In any event, one last point I'll make, Your Honor,
and it's this, is that in terms of licensing this product, 1
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Pfizer actually directly paid the FDA over $2 million to
actually do the licensure process. It's, you know, it's part
of the way the FDA operates. And, you know, in this instance,we actually even offered, the doctors group, to provide money
to the FDA, we directly offered to provide them funds but they
rejected that.
THE COURT: Here's the problem with that, and I'll
say that, because -- again, I've been interrupting counsel way
too much. This has been my own experience, both as aGovernment employee and as a judge, and counsel for the United
States may say this, do you see how the table that you're at,
that the glass is broken in front of you.
MS. KONKOLY: Oh, it's fine.
THE COURT: Well, let me tell you a story. I was
trying a case in here a couple of weeks ago involving aproducts liability matter where the product at issue, the
counsel dropped it and cracked my glass, and he graciously
offered to pay. Here's the issue, and I've run into this inthe courthouse, the Government has a lot of other regulations
where they are unable to take private money to pay for things
such as that, in the same way the attorney couldn't pay for myglass, okay?
It's an important point, and I get the point you're
trying to make. But, at least, my understanding -- and I'mjust a poor country judge from Fort Worth -- is that the 1
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Government can't accept private funds for things like that, as
much as we would like to.
MR. SIRI: You know what, I completely understand
it, because it corrupts and can create conflicts.
THE COURT: Let me give you an example.
MR. SIRI: Yes.
THE COURT: One of the things that we would like to
do here in Fort Worth is to be able to create an exhibit on
the Constitution downstairs for school kids to come through.I told you-all in chambers about some of the historic things
that happened in this courthouse, everything from school
integration, to civil rights cases, to Lyndon Johnson runningin the Senate.
I had several private foundations that wanted to
give money, the Government could use carte blanche to dowhatever it wanted, I could not take the money. I am familiar
with this.
That's a good point, but it doesn't get you there.MR. SIRI: Well, then it certainly does, even
further, bring into focus why these documents should be
public, because the FDA did take over $2 million directly fromPfizer to pay for the licensure process.
THE COURT: Okay. This has been -- I won't say it's
been helpful. What I expect to accomplish, you guys haven'ttold me anything that we didn't agree upon when we came in 1
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here.
I really wanted somebody from the FDA here that I
could talk to, that you-all could go back and talk to, to workout an agreement, work out a schedule. And I'm sorry, ma'am,
but the excuse they couldn't get down here because of
constraints under COVID in a case like this. Perhaps I shouldhave made my order clear that said client reps have to be
here, too.
I just assumed, from all my years at the Government,
that you would have been required to bring somebody from the
FDA with you. All these legal arguments, they're important,
but the real issue here is what's the burden on the FDA to getthis information out? Do I want to kill that agency where
they can't get the cancer drug treated? Of course not. The
American people have a right to know. And I'm disappointedthat you-all haven't come to any more agreement than we have
today.
I'm planning on getting an order out over the next
couple of weeks. And it may be that I bring you back, and I
just have to order, whoever at the FDA is working on this, to
show up and spend a couple of days here out west in thehinterlands of Fort Worth talking about these issues. But I
do plan on getting an order out with the scheduling soon.
I don't think that 30 days is feasible, but I don't
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feasible, particularly given the magnitude of what we're here
on. I don't think anybody can disagree that this is the
number-one issue in the entire world at the moment. We oughtto be able to get out the information posthaste underlying the
vaccine that we're trying to force everyone to take, whether
right or wrong.
And I say that, I've been double vaccinated, I fully
anticipate getting the booster. And I think many of us in
this courtroom that have had the Pfizer vaccine would like toknow exactly what we're being told to take.
All right. We will issue an order, and maybe that
you're brought back and maybe we just issue the order pursuantto what's in front of us. I think the briefing is very good.
If I would have known that no one was here to visit,
I wouldn't have made everybody come down here. You guyscoming from New York as well, I'm sure they had better things
to do this time of year.
Thank you all. You may be dismissed.
(Proceedings Adjourned) 1
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REPORTER'S CERTIFICATE
I, Monica Willenburg Guzman, CSR, RPR, certify
that the foregoing is a true and correct transcript from
the record of proceedings in the foregoing entitled matter.
Further, the proceedings were held during the COVID-19 Pandemic and some parties, including witnesses,
were speaking while wearing masks.
I further certify that the transcript fees format
comply with those prescribed by the Court and the Judicial
Conference of the United States.
Signed this 16th day of December, 2021.
/s/Monica Willenburg Guzman
Monica Willenburg Guzman, CSR, RPR
Texas CSR No. 3386 Official Court Reporter
The Northern District of Texas
Fort Worth Division
CSR Expires: 7/31/2023
Business Address: 501 W. 10th Street, Room 310
Fort Worth, Texas 76102
Telephone: 817.850.6681
E-Mail Address: [email protected] 1
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2425Case 4:21-cv-01058-P Document 34 Filed 12/16/21 Page 56 of 56 PageID 1714Case 4:21-cv-01058-P Document 34 Filed 12/16/21 Page 56 of 56 PageID 1714