Court filing
Hearing Transcript — Motion to Dismiss — Apter v. HHS (Nov. 1, 2022) (S.D. Tex.)
Filed November 1, 2022 in Apter v. Department of Health and Human Services; one of 66 filings from this case.
Record facts
| Court | U.S. District Court for the Southern District of Texas, Galveston Division |
|---|---|
| Filed | 2022-11-01 |
U.S. District Court for the Southern District of Texas, Galveston Division · No. 3:22-cv-00184 · Doc. 43 · 2022-11-01 · Docket on CourtListener
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Laura Wells, RPR, RMR, CRR, RDR
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UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF TEXAS
GALVESTON DIVISION
ROBERT L. APTER, ET AL
§
3:22-CV-00184
§
V.
§
10:32 A.M. TO 11:39 A.M.
§
DEPARTMENT OF HEALTH AND
HUMAN SERVICES, ET AL
§
§
NOVEMBER 1, 2022
HEARING ON MOTION TO DISMISS
BEFORE THE HONORABLE JEFFREY V. BROWN
Volume 1 of 1 Volume
APPEARANCES:
FOR THE PLAINTIFFS:
Mr. Jared Kelson
Mr. Trent McCotter
Boyden Gray and Associates
801 17th Street NW
Suite 350
Washington, DC 20006
(202) 955-0620
FOR THE DEFENDANTS:
Mr. Isaac Belfer
DOJ-CRT
Civil Division, Consumer Protection Branch
P.O. Box 386
Washington, DC 20044-0386
(202) 305-7134
and
Mr. Oliver McDonald
DOJ-CIV Consumer Protection Branch
450 Fifth Street, NW
Room 6400-South
Washington, DC 20530
(202) 305-0168
Court Reporter:
Laura Wells, RPR, RMR, CRR, RDR
601 Rosenberg, Suite 615
Galveston, Texas 77550
Proceedings recorded by mechanical stenography.
Transcript produced by computer-assisted transcription.
Case 3:22-cv-00184 Document 43 Filed on 11/03/22 in TXSD Page 1 of 59
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Laura Wells, RPR, RMR, CRR, RDR
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VOLUME 1 OF 1 VOLUME
(Hearing on Motion to Dismiss)
Page
November 1, 2022
Announcements...................................
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Argument by Mr. Belfer..........................
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Argument by Mr. Kelson..........................
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Argument by Mr. Belfer..........................
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Argument by Mr. Kelson..........................
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Ruling of Court.................................
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Reporter's Certificate..........................
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10:32:27
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Laura Wells, RPR, RMR, CRR, RDR
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PROCEEDINGS
(Call to order of the Court.)
THE COURT: All right. One case on the Court's
docket this morning. It's in Cause Number 3:22-CV-184,
Robert L. Apter v. United States Department of Health and
Human Services and others -- Robert Apter and others v.
Department of Health and Human Services and others.
Will the attorneys make their appearances, please.
Plaintiff first.
MR. KELSON: Jared Kelson for plaintiffs, Your
Honor.
THE COURT: Good morning.
MR. McCOTTER: Trent McCotter for plaintiffs,
Your Honor.
THE COURT: Good morning. Welcome.
MR. BELFER: Good morning, Your Honor. Isaac
Belfer for the government.
THE COURT: Great. Good to have you.
MR. McDONALD: Good morning. Oliver McDonald for
the government.
THE COURT: Great. And I understand we have some
folks on the phone who are listening in, and I think
George has already asked for you to mute your phones a
couple of times and there are people who have not muted
their phones and we're going to cut the thing off if --
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10:33:30
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10:34:07
10:34:17
10:34:37
Laura Wells, RPR, RMR, CRR, RDR
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we're getting a lot of feedback here in the courtroom.
Please mute your phones if you want to listen in.
All right. I have read the briefing in the case. I
appreciate y'all coming down this morning. Sorry the
weather is not ideal. This is our first time back in our
courtroom since -- in a few months. So it's nice to be
back in our regular courtroom.
I have a series of questions I want to ask you all;
but I would like to get kind of a general argument from
both sides first, recognizing that I am familiar with the
case and the briefing. If there is anything that y'all
want to add to the briefing you have already provided to
the Court, this is your opportunity to do it; and then,
we'll discuss some of the questions that I have for both
sides.
So it's the government's motion, if you would like to
get us started.
MR. BELFER: Can I come up here?
THE COURT: You can argue from there or from
right here in front of the bench, whichever you prefer, as
long as you are speaking into a microphone.
MR. BELFER: I'll try up there.
THE COURT: All right. Come on up. I'm sorry.
Hold on a second.
George, can you just mute them so we don't get --
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
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CASE MANAGER: Yes. I can do that.
THE COURT: Just so we don't -- or just turn the
volume down so we don't hear them.
CASE MANAGER: Yeah. I lowered the volume.
THE COURT: I'm sorry. Go ahead.
MR. BELFER: After receiving multiple reports of
patients requiring medical attention, including
hospitalization, after self-medicating with ivermectin
products intended for livestock, FDA made several public
statements on social media and on its website written in
informal conversational language warning the public about
certain risks of using ivermectin products to treat
COVID-19.
These statements included non-binding recommendations
to consumers who could purchase animal-use ivermectin over
the counter not to take ivermectin to treat COVID-19, but
the statements did not say that doctors could not
prescribe ivermectin to treat COVID-19 or that consumers
could not take ivermectin for that purpose.
Instead, they said that, "If your healthcare provider
writes you an ivermectin prescription, fill it through a
legitimate source such as a pharmacy and take it exactly
as prescribed."
Because the statements simply provided nonbinding
recommendations to consumers, they are not rules and,
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10:35:57
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
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thus, are not agency action as required for waiver of
sovereign immunity. They did not bind the public or FDA,
did not interpret any substantive rules, and did not set
agency policy.
The statements are also not final agency action. They
do not mark the consummation of FDA's decision-making
process because they do not state FDA's final position on
the use of ivermectin to treat COVID-19 but instead
present FDA's tentative recommendations based on currently
available data.
They also do not have legal consequences for anyone
but simply provide nonbinding recommendations to
consumers.
Plaintiffs have also failed to meet their burden to
show standing. The amended complaint alleges five
injuries to plaintiffs and three injuries to their
patients.
Regarding injuries to the plaintiffs, the amended
complaint alleges: First, that there was interference
with their ability to practice medicine; second, that they
were referred to state medical boards; third, that they
were forced to resign from their jobs; fourth, they were
subjected to public ridicule; and fifth, that patients
delayed seeking treatment from plaintiffs.
And then with regard to injuries to their patients,
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Argument by Mr. Belfer
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the amended complaint alleges three injuries: First, that
pharmacists refused to fill patients' ivermectin
prescriptions; second, that insurance companies refused to
pay for those prescriptions; and third, that patients
delayed seeking treatment from plaintiffs or delayed
taking ivermectin.
As discussed in our briefs, many of those injuries are
not an adequate injury in fact. Plaintiffs have also not
shown that any of their claimed injuries are fairly
traceable to defendants' statements because their injuries
were caused by independent third-party conduct that was
not a predictable response to those statements.
For example, it was not predictable that plaintiffs'
employers would punish them for prescribing ivermectin to
treat COVID-19 when the statements themselves acknowledged
doctors' discretion to do just that.
Furthermore, plaintiffs have not shown that the
requested relief would likely redress their claimed
injuries. Many organizations, in addition to FDA, have
recommended against taking ivermectin to treat COVID-19;
and plaintiffs have not shown that removing just the cited
FDA statements would likely cause the third parties that
allegedly injured them to reverse their past decisions.
Finally, plaintiffs have failed to state a claim
because they did not present their issues in the amended
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10:38:15
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
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complaint to FDA. They thereby deprived the agency of the
opportunity to consider their issues in the first instance
and prevented the agency from creating an administrative
record that addressed those issues.
So I would be happy to talk about any further issues
but I think that's a good summary and I'll answer any
questions the Court has.
THE COURT: Okay. All right. First of all, just
a couple of things on -- well, the -- you mentioned the
informational conversational tone of the social media
statements. To me, that seems like part of the problem in
that those statements don't include the qualifier
statements that the article has that was referred to; and
I think those -- I think as far as reputational harm goes,
it's the social media statements are what bother me the
most. And I don't even know where I'm going with the
question here.
But can you understand my concern with that? I mean,
it's like was the purpose of those statements really to
advise patients not to self-medicate with ivermectin? The
social media -- the social media comments in particular.
MR. BELFER: Right. So I don't think the record
shows the FDA's motivation for those statements in
particular. We do know that the article was motivated by
people self-medicating with animal-use ivermectin and
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
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requiring hospitalization. So we do know that that was
part of FDA's motivation.
And so I think with regards to the social media posts,
which are two tweets and an Instagram post, those
statements were clearly aimed at consumers. As we
discussed, they used this conversational language, you
know, "Hold your horses. You are not a horse. You are
not a cow." Information like that.
So clearly this was aimed at consumers. It was not
aimed at medical professionals or hospitals; and it was
not predictable that hospitals or insurance companies or
pharmacies would act based on these statements, let alone
it was not predictable that they would respond to these
statements by firing plaintiffs.
And indeed, the tweets linked to the article. And so
if you look at the tweets, they include the link to the
article. And so it was predictable that if you include
the link to the article, people, you know, will click on
the link and will see the full article, which includes
that disclaimer that if your doctor writes you a
prescription, you should fill it exactly as prescribed.
So in terms of the standing analysis when you are
asking was it predictable that third parties would take
the actions that they took based on the cited statements,
you know -- and it's plaintiffs' burden to show that; and
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
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plaintiffs have not met that burden because, first of all,
the tweets included links to the article and those
statements were clearly -- they were aimed at consumers,
and they were not the sort of statements FDA would make to
influence, for instance, hospitals or, you know,
pharmacies or insurance companies. Right.
So I think for those reasons plaintiffs have not shown
-- certainly have not shown traceability regarding those
statements.
And also, they have not shown redressability regarding
those statements because, as we discussed in our brief,
many organizations, in addition to FDA, have made public
statements advising against the use of ivermectin to treat
COVID-19.
So, you know, even if FDA's tweets and other
statements were taken down, there would still be many
statements by other organizations, like the World Health
Organization and Merck, which makes one of these drugs,
and CDC and NIH, all advising against the use of
ivermectin to treat COVID-19.
And so it would not -- plaintiffs have not shown that
they would -- that the third parties would likely undo
their actions, reverse their past decisions, given that
all those statements by other parties are still out there.
THE COURT: Okay. It's not just common sense
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
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that it would be predictable that state boards would react
to statements by the FDA in ways that they did?
MR. BELFER: So state board -- no state board has
made any discipline against plaintiffs. There is an
allegation that Apter was referred to a state medical
board, but that's all we have. There is no indication
there has been any action whatsoever by that state medical
board and it's speculative, you know, if or when that
medical board will take any action. And as we discussed
in our brief, merely being referred to a state medical
board is not adequate injury in fact. So, you know,
again, it's purely speculative, you know, if or when that
state medical board will act and then what weight it might
give to that -- to that statement.
Importantly, it wasn't the state medical board that
cited the FDA statements. It was some unidentified third
party that included the statement in the referral to the
state medical board.
So, you know, I think to close the loop on that,
essentially, you have this simple allegation after it was
referred for discipline but, you know, we don't know if or
when the state medical board will act on the referral.
And, you know, if and when it does ultimately act, we
don't know to what extent it will give the FDA statements
any -- any weight and the fact that there are all these
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10:43:42
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
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statements by other organizations, like the World Health
Organization and CDC and NIH, indicating that there is not
a showing that simply taking away the FDA statements would
make any difference or would cause them to act any
differently.
THE COURT: Okay. And you are getting into
redressability here. The plaintiffs say that I should
presume redressability at this stage. Are you aware of
any cases in which a motion to dismiss was granted on a
failure to show redressability?
MR. BELFER: Again, off the top of my head, I
can't. I can't think of one right now. But we do cite a
case in our brief. I believe it's the Renal Physicians
case from the, I think, DC Circuit, which says that you
can't presume redressability simply based on traceability.
So even if it's true that the government's statements
caused a third party to make a certain action, you
don't -- you can't presume redressability because it's
possible that some independent factor is holding those
third parties' actions in place.
So here, even if, you know, presuming that the FDA
cited statements influenced some third parties to take
adverse actions against the plaintiffs, you can't presume
redressability because there are these independent third
-- other organization statements, again, like the WHO and
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
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NIH and CDC, that are out there; and those statements are
still in place recommending against the use of COVID-19 --
against the use of ivermectin to treat COVID-19.
Additionally, you know, if the Court were to rule, for
instance, that the FDA does not have authority to make the
cited statements, that wouldn't affect the scientific --
the third-party's scientific understanding of the risks
and benefits of treating COVID-19. It would be a legal
ruling on, essentially, procedural authority grounds. It
wouldn't go to the scientific merits. And so it wouldn't
give the third parties any reason to change their
understanding of whether you should use ivermectin to
treat COVID-19.
And so for all those reasons, even if the Court were
to order that the cited statements be taken down,
plaintiffs haven't shown that that would make any
difference because there are all these other statements
out there; and their requested relief itself wouldn't give
the third parties any reason to change their understanding
of the risks and benefits of taking ivermectin to treat
COVID-19. So, you know, the plaintiffs have failed to
show redressability as well as traceability.
And, of course, that's only part of the jurisdictional
analysis. There is also sovereign immunity. And we think
that's actually an even clearer case why there is no
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
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jurisdiction here.
You know, again, these were -- these were tweets,
social media posts in conversational language. They were
nonbinding recommendations. They did not make -- they
were not binding on anyone. They were not binding on
private parties or the FDA. They did not set agency
policy. They were simply nonbinding recommendations to
the public. And so they were not agency action or final
agency action.
And as discussed in our briefs, an important
requirement for final agency action is that you need to
have a direct effect on the regulated party. So, for
instance, in the Franklin v. Massachusetts case, the
Supreme Court held that the secretary of commerce's report
to the president was not final agency action because it
was simply a nonbinding recommendation. The president's
report to Congress about congressional apportionment did
have a direct effect and was final; but the secretary of
commerce's report to the president was not final agency
action because it had, at most, an indirect effect on
apportionment. It was simply a nonbinding recommendation
to the president.
And similarly, in the Bennett v. Spear case the
Supreme Court upheld this notion that you need a direct
effect to be final agency action. And here, the
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
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plaintiffs have not shown any direct effect of any of the
cited statements on any other party. At most, they show
an indirect theory of causation, whereby the cited
statements influenced third parties, who in turn allegedly
injured plaintiffs. But that indirect line of causation
is not sufficient for final agency action.
THE COURT: And on exhaustion, is a citizen
petition the only way that the plaintiffs could have
challenged the FDA's actions with the agency itself in
this case? What else could they have done?
MR. BELFER: So I am -- I think in this
particular case I'm not -- I'm not aware of another
mechanism that they could have used.
I think, generally, in terms of the issue of
exhaustion, there is not only one mechanism. The focus is
not on which mechanism you use. Instead, the focus is on
just raising your issues somehow to the agency.
So, for instance, if there were, like, a drug
approval, then you could raise the issue in the course of
the back and forth with FDA about the drug approval or you
could raise it, you know, as appropriate, as a citizen
petition.
Here, I think a citizen petition would have been
appropriate. They could have filed a citizen petition
after FDA made its cited statements challenging those
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
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statements and they could have presented all of the issues
in their amended complaints to FDA in that citizen
petition and that would have been beneficial to the agency
by giving the FDA an opportunity to consider the issues,
in the first instance, to apply its expertise and
discretion, and it would have allowed the agency to
compile an administrative record that addressed their
issues.
And so, it would have benefited both the agency and
the Court; but they failed to do that. The plaintiffs ran
straight to court without giving FDA an opportunity to
address their issues in the first instance. And under
kind of core principles of administrative law, that's
unacceptable.
THE COURT: Okay. Let me hear from the
plaintiffs. I may have some more questions for you once I
have heard from them.
MR. BELFER: Thank you, Your Honor.
THE COURT: Thank you.
MR. KELSON: Good morning, Your Honor.
THE COURT: Good morning.
MR. KELSON: As a general matter, the FDA has no
authority to regulate the off-label use of drugs. It
never has. That dates back to the -- to when the FDCA was
first passed in 1938. It's been a repeated consideration
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
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by Congress. They have never given the FDA that
authority. Going so far as to add a provision in
21 USC 396 to expressly prohibit interference, courts
across the entire country have repeatedly relied upon that
provision to show that -- to show that it applies to the
practice of medicine, including the prescription of drugs.
The government is trying to frame this case and its
actions and its response to reports about the use of
animal ivermectin. That doesn't explain why they then
pivoted to talk about human-use ivermectin. There is a
disconnect in what they are claiming the justification for
these actions were and what they actually did.
This is reaffirmed by the internal FDA documents that
talk about this new engagement strategy they had to
promote their recommendations to the public and the United
States. And it belies the fact that what they were trying
to do was stop the use of ivermectin. Their tweets are
explicit on that point.
So when the government says this was purely
informational, conversational, essentially a PR scheme or
a -- excuse me -- a PR endeavor, that doesn't explain
why -- that doesn't explain the language they actually
used, "Stop it. Stop it with the ivermectin."
In the government's brief when it refers to a number
of these statements, including the statements why you
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
18
should not use ivermectin to treat or prevent COVID-19,
the government has to qualify the statements in its own
brief and say "if a doctor prescribes you ivermectin for
the use of COVID-19." The government's briefs, therefore,
implicitly recognize the title of that document; and the
FDA's other actions clearly convey that this is not an
acceptable way to treat these patients. The only reason
the FDA would engage in these actions is because of their
predictable effect, the only explanation.
The Court is right to understand -- recognize that
this is a very much common-sense case. The Supreme Court
recently, within the last year and a half, has made very,
very clear that courts are -- that courts and judges are
not required to exhibit a naivete from which ordinary
citizens are free. That was -- you know, that was --
excuse me. That was in 2019 in Department of Commerce v.
New York. That was Chief Justice Roberts. That applies
directly to this case.
To address some of -- to address upfront some of the
government's arguments and some of the government's
briefing, I want to be very clear to the Court that the
government did not move under 12(b)(6) to challenge any of
these claims on their merits. The government is, thus,
conceding that the plaintiffs have alleged plausible
interference in their practice of medicine, that they have
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alleged plausible claims under the APA. The government
has, instead, challenged them all on standing grounds or
challenged them on administrative exhaustion grounds or
sovereign immunity.
That should inform the Court's position and that
should also -- the Court should also take that into
consideration when the government tries to backdoor merits
considerations into other aspects of this case.
Second, in the government's reply brief the government
replies or the government cites TransUnion and says that
the plaintiffs are only alleging statutory violations.
That is incorrect. We are alleging real harms to real
people that are reinforced by the statute that Congress
passed in 21, Section 396 and, to be honest, the entirety
of the FDCA, which does not give the FDA the authority
that it is trying to assume.
More importantly, if the Court would like to look at
-- if the Court would look at TransUnion, the government
omits the rest of the case, which weighs heavily in favor
of the plaintiffs here. TransUnion is very clear that
there is an injury in fact when there is a harm that is
traditionally recognized as providing the basis for a
lawsuit in America or if there is some sort of common-law
analog. The Court is also very clear that it doesn't have
to be an exact duplicate. That Congress through statute
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or Congress through its own expressions can recognize
harms that might have been too trivial at common law but
were, nonetheless, harms.
In fact, in TransUnion the exact example that the
Court used is various intangible harms, including
reputational harm. That is one of the -- that is one of
the allegations the plaintiffs have made here and, in
fact, provided evidence that they have been maligned on
line and that they constantly suffer reputational harm.
If the government is going to label ivermectin a horse
medicine or a horse dewormer and promulgate the idea that
it is only for animals, then the natural correlation is
that doctors who prescribe it are horse doctors or quack
doctors, which has been -- which has played out. That is
enough of a harm to get into court.
In addition, TransUnion also emphasizes the due
respect that courts should pay to the decisions of
Congress; and Congress has been very clear that the FDA
should not interfere in the practice of medicine. Now the
Court has -- while the Court has recognized that that
cannot completely -- that cannot completely remove the
necessity of showing injury, it should inform the Court's
decision that it is consistent with the Fifth Circuit's
decision that the plaintiffs need only show an
identifiable trifle of an injury. The bar is low. Any
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sort of injury will do, and the plaintiffs have alleged
many here. That injury is sufficient, even if the harm is
difficult to prove or difficult to quantify.
Moving forward, the government places a lot of
emphasis on traceability. The government's arguments in
this regard are flawed.
I'm sorry. I have one more thought I just had about
the injury. When the Court talked about injury in Lujan,
it discussed both a forward and a backward looking
analysis. The exact language in Lujan allows plaintiffs
to present evidence of harms that have accrued.
So even if -- I guess this transitions into the --
sorry. This transitions into traceability. So even if
this wasn't predictable, which is a standard for
traceability, if in retrospect the plaintiffs can show how
these harms were determinative or were caused by the
plaintiffs, de facto causality, that is traceability. The
plaintiffs are not cabined into the predictability test,
even though that is one way of establishing traceability
under the constitution, recognized by both the Fifth
Circuit and by the Supreme Court.
It's unclear what the -- what the government would
have thought their tweets were going to do if -- by saying
"stop it with the ivermectin" or "stop it" except to,
well, stop the use of ivermectin. The government engaged
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in a singularly effective campaign here to malign a common
drug that has been used for a very long time and has been
dispensed in billions of doses. It's one of the most
famously safe drugs in the history of human medicine.
And when people did exactly what the FDA said to "Stop
it. Stop it with the ivermectin," I don't understand how
that would not be traceable back to the FDA.
So if it wasn't -- so it was predictable. It also, in
retrospect, clearly points back to the FDA. When everyone
points to the FDA, there is a pretty good chance that
that's where it is coming from.
The plaintiff -- or the government has repeatedly
stated that people have their own scientific intuitions
about the ivermectin. That's not what is happening here.
People are pointing back and saying, "The FDA said no.
The FDA said no."
That is not a scientific analysis. That is a
deference to the FDA, to an agency that the federal
government set up to be an authoritative voice on the use
of drugs but limited that authority not to practice
medicine and not to make recommendations about medicine.
So in that regard the FDA's actions cannot be excused
simply because they presume that everyone else has these
scientific understanding -- this scientific understanding.
That transitions into redressability. Again, this
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Argument by Mr. Kelson
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is -- there is a common-sense intuition that when everyone
points to these FDA statements if a court were to come out
and say they were made without lawful authority and vacate
them that they would somehow retain their same equal
persuasive force. That seems to brink reality, as well.
In addition, the government points to a number of
other entities that have taken positions on ivermectin.
Each of them are severely flawed. I am not aware of the
FDA ever pointing to a pharmaceutical company and saying
that its statements have the same force and effect or are
of the same persuasive nature as the FDA. That, to me, is
a strange argument I have never heard from the FDA before.
And I don't suspect the FDA plans on deferring to
pharmaceutical companies in the future. In addition, the
FDA regularly disagrees with the World Health
Organization. Remdesivir is a great example of that. And
the FDA seems to think that its -- that its voice on these
drugs is more important than the World Health
Organization's. That's enough to undermine reliance on
the World Health Organization, which also is not an
American body and doesn't have the same effect in the
United States.
The CDC regularly cites to the FDA, and the CDC does
not specialize in the use of drugs in America. And the
NIH for a long period of time took no position on
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ivermectin, a long period of time during which harm was
caused to these plaintiffs. So the FDA can't point to the
NIH and say that it has some sort of -- that it has the
same effect.
In addition, the Fifth Circuit has made very clear
with redressability, especially at this stage of
litigation, that plaintiffs have established their
standing if a favorable ruling could potentially lessen
the plaintiffs' injury. It's a very low bar, and there is
absolutely a potential chance that the injury could be
lessened here. That case is Sanchez v. R.G.L. It's 761
F.3d 495. I believe it's cited in our brief, as well.
But it seems very clear that when everyone is pointing
to the FDA that if this court were to vacate those FDA
statements that there is a potential chance or that it
could potentially lessen the injury that these doctors are
suffering.
In addition, in McClure v. Ashcroft, the Fifth Circuit
as well, says you only need to show an arguable chance
that a third party might consider changing its policy.
The government points out that Dr. Apter is subject to
current investigation or current proceedings against his
medical license. That referral came from the Iowa State
Board of Medicine. It came from another state board.
This was not some random person throwing a document into a
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Laura Wells, RPR, RMR, CRR, RDR
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referral and sending it to a state board.
The FDA's actions here, their statements, their
tweets, they are showing up in court filings. They are
being relied upon by courts as the standard of care in
malpractice proceedings. They are showing up in state
board proceedings, as we have shown here. They are
showing up in public discourse as a way to malign and ruin
the reputations of doctors who have been working their
level best to fight a pandemic.
What the FDA has done is pervasive throughout the
entirety of healthcare and has caused significant injury
to these plaintiffs. And for this court to declare them
unlawful and to vacate them and to enjoin the agency from
engaging in an unlawful practice of medicine in the
future, it undoubtedly would not only address those
injuries it would -- it would undoubtedly redress those
injuries.
More importantly, the practice of medicine is so well
established in this country in the use of off-label drugs.
Up to about 40 percent of off label -- of drugs are used
off label in critical care. The presumption there should
be that if the FDA -- if that has changed somehow for
ivermectin and it started with the FDA, if that -- if that
action by the FDA is vacated that will -- that somehow
that normal will resurface. It's been that way since the
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Argument by Mr. Kelson
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beginning of the practice of medicine in this country and
it's unclear why the FDA has decided in this particular
case to try and interfere with it but that's exactly
what's happened.
On the sovereign immunity points that the government
points out, I would like to respond in a few ways. The
first is that this court should be careful to make sure
that -- to view the ultra vires claim and the APA claim
separately. They are separate claims, and the standards
for them are separate.
First off, under Larson the Supreme Court has been
clear that when you are seeking injunctive relief against
federal officers for exceeding their authority that that's
not barred by sovereign immunity. Larson resolves the
case for the ultra vires -- Larson resolves the sovereign
immunity issue for the ultra vires case.
THE COURT: Wait. Say -- say that again, please,
on Larson.
MR. KELSON: Larson resolves the sovereign
immunity issue for the ultra vires claim. The government
has exceeded its authority; and under Larson, sovereign
immunity does not bar -- sovereign immunity does not bar
injunctive relief against, quote, a federal officer that
acted in excess of his authority or under authority not
validly conferred. That's Larson at 333 -- sorry -- 337
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Laura Wells, RPR, RMR, CRR, RDR
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in the U.S. Reports, Pages 690 to 691. It's also cited in
our brief extensively.
In addition, the government decides -- the government
waited until the reply brief to challenge the plaintiffs'
interpretation of Section 396. Not only have multiple
circuit courts applied that -- the plaintiffs'
interpretation of Section 396 about prohibiting the
interference of the practice of medicine, but this case is
not dependent upon that provision.
Whether or not Section 396 is in effect, the FDCA does
not give the FDA authority to do what it's doing here.
That provision is an emphasis that was added by Congress
to make sure the FDA did not overstep. But if you go back
to the debates leading up to the 1938 Act and all through
the present, Congress has repeatedly expressed that the
FDCA does not have the authority to interfere with the
practice of medicine. This is nothing new.
And so whether or not this court finds that
Section 396 applies here, it doesn't change the outcome of
this case. Section 396 is merely an exclamation point
showing that Congress really did not want the agency doing
what it's doing now.
Moving on to the APA waiver of sovereign immunity, in
5 USC, Section 702, again, the difference between the
ultra vires and the APA claims is important. The ultra
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
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vires claim does not require final agency action. It only
requires agency action. That is very, very clear from the
Fifth Circuit's precedent, for example, the
Alabama-Coushatta case.
The Fifth Circuit has also been clear that pretty much
everything an agency does qualifies as an agency action
under the -- under the APA. There is Fifth Circuit
precedent that is directly on point.
I don't how to pronounce the case, Avoyelles
Sportsmen's League; but that one is very explicit that
anything the agency does is at least an agency action.
The question then becomes if it's final.
In addition, you have the Data Processing [sic] case,
which very clearly says for even informational statements
or agency action the debate will be over whether they are
final.
So to be very clear, as soon as the agency acted they
waived -- Section 702 waived sovereign immunity for an
ultra vires claim. Finality is not a requirement.
For the other APA claims where finality would be a
requirement, it is also clear the agency has acted with
finality here. The agency has maintained this position
for a year and a half. While they say -- while the agency
has said that they might change their position based upon
further factual analysis, the Fifth Circuit expressly
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
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rejected that argument recently in the Data Processing
case -- or the Data Marketing case. If you would like a
citation, that's 45 F.4th at 854.
The Fifth Circuit was very clear and actually
chastising the government that it recycles an argument the
Supreme Court has repeatedly rejected. The action isn't
final because the agency can change its position after
more fact finding. This argument is squarely foreclosed
by numerous Supreme Court decisions.
It would also mean that no agency action is ever final
because the agency can always change its mind after
further fact finding.
Looking at this case then, the agency has maintained
its position for a year and a half. Their statements are
not qualified: "Stop it" and "Stop it with the
ivermectin," "Should I take ivermectin to treat COVID-19"
or "Should I take ivermectin to treat or prevent COVID-19?
No." Those are not qualified statements.
And the fact that they are followed up with "if my
doctor gives me ivermectin, take it exactly as prescribed"
-- whatever that language exactly is -- does not change
the fact that they have just stated unequivocally, "Should
I take ivermectin? No." Period.
And so even if -- in reading those statements
together, it's very clear that the government is either --
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
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it's very clear that the best way to interpret that
statement is that -- the best way to interpret that
statement is that if my doctor prescribes me ivermectin
for something else.
If the government was -- wanted to be clear that if
the government -- that doctors could prescribe ivermectin
for COVID-19 and then should be taken exactly as
prescribed, it could have said that; but it chose not to,
instead, putting all its emphasis and references to
COVID-19 to tell doctors and to tell patients they should
not -- to tell patients they should not take it and to
tell the public that they should not take it either.
I'm sure that this court is aware that doctors and
patients are part of the public and that patients are
consumers. So saying that this document -- saying that
the government's main document why you should not take
ivermectin to treat or prevent COVID-19, by saying that
that was directed to consumers is not a fail proof -- is
not some sort of argument to get out of the real effect
that that document had or the fact that it is directly
talking to people that are in the doctor-patient
relationship.
In addition, on the finality point, the Fifth Circuit
and the Supreme Court have been very clear that finality
is flexible and pragmatic. As part of that flexibility
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and that pragmatic consideration, this court should be
mindful of the fact that Congress in Section 396 said that
the FDA can't interfere in the practice of medicine.
It would be very passing strange if the agency could
do exactly what Congress told them not to and they could
turn around and say, "Our action wasn't final though. So
it's okay." Congress recognized that there was some sort
of real-world effect of the agency interfering in the
practice of medicine; and in so doing, that agency action
would have to -- would be final.
In addition, the Fifth Circuit has said it's a -- the
action only has to be binding as a practical matter, where
private parties might rely on it as the norm. That's the
Texas v. EEOC case. And it's very clear that it's become
a norm. Courts are relying on it as the standard of care.
Like, directly under the Fifth Circuit's precedent in
Texas v. EEOC you would -- as a practical matter the FDA
statements have now become a norm in society. They have
been the norm that is being relied upon by professional
bodies, by advisory bodies and by courts.
In that same case, the Fifth Circuit continued that
private party -- an agency action is final if private
parties are reasonably led to believe that failure to
conform will bring adverse consequences. I think it's
safe to say that failure to conform with the FDA's
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
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position here has brought adverse consequences to these
doctors both reputationally, the fact that Dr. Apter is
now facing board charges.
So viewed in that flexible and pragmatic sense, there
are numerous factors which weigh in favor of finality
here, not to mention the common sense -- not to mention
the common sense view of what the agency has done in
reading its own language.
As an additional point, just in response to the
government, in Bennett the government was acting on a
third party. So there is -- there is some -- there is
other cases where the fact -- the fact of the matter is
there are legal consequences. The government can't
launder its actions by making -- setting up some sort of
standard that can then be relied upon as a third party to
impose those -- by a third party to impose those
consequences.
In addition or finally, in response to the
government's reply brief, I would like to point out to the
Court specifically that on page, I believe it was, 21 the
government makes very clear in its reply brief that it is
not arguing a citizen petition is required. That
concession is incredibly important because the Fifth
Circuit has been very, very clear that unless exhaustion
is required by statute or by regulation, the only time
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Argument by Mr. Kelson
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administrative exhaustion is necessary is when there is
some sort of adversarial proceeding below.
In fact, the government cites repeatedly Palm Valley.
In Footnote 6 of that opinion Judge Costa is explicit that
the administrative exhaustion requirements only apply in
that case because there is a regulation that requires it.
If there is no regulation, you have to have
adversarial proceedings below. You have to have something
tantamount to a judicial proceeding. That is not present
here. That is not in any way present here because the
government gave no process. Instead, it acted
unilaterally to push its -- to push its public campaign.
In fact, the examples that the government gives talk
about when there is, for example, some sort of agency
proceeding over a drug approval, when there is some sort
of existing agency proceeding. There was none here. And
if a citizen petition is not required, which we contend it
is not, based upon the plain language but also based upon
the government's own admission that a citizen petition is
not required, then we are in a separate world of
administrative exhaustion.
And what the government would purport to this court
would be a fundamental change in how administrative
exhaustion has been run in this country and they would
impose a brand new requirement that has never been
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recognized that a party must go to an agency and litigate
its case with an agency before it goes to the government
when the agency gave no process ahead of time.
The whole purpose of administrative exhaustion is to
avoid parties sandbagging an agency and waiting until
court to raise their claims or to give the agency the
opportunity to engage -- to apply its expertise during its
proceedings.
None of that applies here. None of these
considerations are relevant. There were no proceedings.
The government has acted. It's been final. In addition,
this is a legal question. This is not some sort of
factual dispute for the agency. And so the fact that
there is no agency expertise here that the Court would
need to defer to, none of the factors that weigh in favor
of agency exhaustion would otherwise apply.
So agency -- by the government's own admission, agency
exhaustion is not required by the law. It is not required
by a statute. By very clear Fifth Circuit case law and by
-- it is not required as a prudential matter; and even if
it were required as a prudential matter, there are ample
reasons for this court to weigh that exhaustion
requirement because none of the factors that weigh in
favor of exhaustion are present here.
I think that that is -- those are my main responses to
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
35
what the government has said. If you have -- you know, if
the Court has any questions, I would happy to answer them.
THE COURT: Sure. No. I appreciate that. Are
you aware of any cases anywhere else where patients are
the plaintiffs suing over the FDA's comments on
ivermectin?
MR. KELSON: I don't know of any -- I am not
aware of any cases where patients are suing the FDA.
THE COURT: All right. Any idea why there aren't
any -- I guess this is a doctors' case, not a patients'
case is why there aren't any --
MR. KELSON: It's a doctors' case.
THE COURT: -- patients among the plaintiffs in
this case here today.
And another kind of general question.
MR. KELSON: Just as one consideration for the
Court, when it comes to the need for ivermectin, the
plaintiffs see these things every day. They are well
immersed in the science; and they are well immersed,
actually, in the practice of medicine prescribing
ivermectin or trying to prescribe ivermectin and dealing
with the public backlash they get for doing so.
With patients, most patients are only seeking
treatment for COVID; and then once it's over, it's done.
But the benefits of a lawsuit and the motivation for a
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lawsuit are significantly diminished in that regard.
Whereas with these doctors, they have been living in
this world for a year or a year and a half now and they
have suffered significant reputational harm as a result of
it. They see this interference with their practice of
medicine every year -- every day. It takes an extreme
toll on them but also then makes it difficult when they
are constantly battling trying to write prescriptions and
get prescriptions for their patients and then they are
fighting with pharmacists who are saying, "Well, the FDA
says no."
And so, just as a practical matter in that regard, the
explicit answer or the exact answer to your question is I
am not aware of any plaintiffs that are suing the FDA. I
do know some plaintiffs -- I do know of some plaintiffs
who have sued hospitals to try and get ivermectin in the
past. There were a few of them in the news.
But it also is very easy for the Court to see why this
is a particularly problematic issue for doctors, and that
is why the three plaintiffs in this case that I represent
have been willing to undertake the expensive burden of
litigation to try and rectify the injuries that they have
suffered.
THE COURT: I believe the government noted that
it was, like, 26 months or something from the time the FDA
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
37
first started making these statements that the lawsuit was
filed. Is there a reason for that delay?
MR. KELSON: So I think there are -- there are a
number of reasons that could be relevant. I'm not sure
that they are in any way required to bring a lawsuit
within a certain -- they have a four-year statute of
limitations under the APA or six-year statute of
limitations.
When the government first started in 2020 or early
2021, the statements were significantly more benign. They
were problematic, but they were more benign. It really
took off in August when they started with the "You are not
a horse. You are not a cow" campaign and when they
started labeling doctors as essentially horse doctors or
quack doctors. And so that -- that exacerbated the
injury. The government then doubled down recently, I
believe it was in April, with another tweet.
So to say this is anything about animal ivermectin is
even more problematic under the light of the fact that
they are continuing the horse trope many, many months
afterwards.
As a result, because the government has maintained
these documents and has been doubling down on them, like,
the injury has been increasingly severe. And, quite
frankly, sometimes it takes a while to find a lawyer who
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
38
will take your case.
There are a number of considerations and then, you
know, we put an extensive amount of work into trying to
find all the publicly-available examples we could have to
track down what was going on and to make sure that we
could substantiate the plaintiffs' claims.
So for those reasons and the fact that the plaintiffs
have a significantly long runway, six years to bring APA
claims, 26 months isn't actually unreasonable at all.
THE COURT: You argue for a very broad
interpretation of agency -- of what constitutes agency
action. If everything an agency does is agency action
under the APA, then does that mean the APA is kind of a
general waiver of sovereign immunity? That's kind of what
it sounds like.
MR. KELSON: No. No. Because, yes, everything
-- the Fifth Circuit has been explicit that everything an
agency does is going to fall under the definition of
agency action; but to bring a claim under the APA, for
example, and to claim a waiver of sovereign immunity under
the APA, you have to show final agency action. So that is
one distinction.
The ultra vires claim, which is not -- which does not
have a finality requirement to it under the Fifth
Circuit's precedent, yes, if an agency acts then there is
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
39
a waiver of sovereign immunity but it's very limited and
it only applies to injunctive relief, not damages. That
also should not concern the Court because it only becomes
relevant when the agency has acted unlawfully.
All the government's arguments here have nothing to do
about whether or not their actions were lawful. They have
everything to do about setting up barriers for the
plaintiffs to begin a course to seek remedy.
And so to the extent that the agencies act unlawfully,
then, yes, they would be subject to suit. If the agencies
haven't acted unlawfully, it actually becomes immaterial
whether or not agency action is brought because any agency
action that would be -- any challenge to any agency action
-- I'm sorry. I might have been speaking to quickly.
Any challenge to any agency action that is lawful will
be promptly dismissed, and so it's not going to be a
burden on the agency either.
THE COURT: Is any informational statement that
the FDA makes an ultra vires act by the agency?
MR. KELSON: That would be an agency specific
inquiry, Your Honor. The FDA in this particular case
is -- the FDA sits in a very unique spot in the United
States because of the authority that the government has
given it to regulate the approval of drugs to let the
drugs enter into the market and withholding the ability to
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
40
interfere with the practice of medicine.
Most informational statements are not going to be
problematic. The FDA talks about how, well, we've issued
warning letters in the past. That's not -- that might be
an agency action, but it's not unlawful for them to issue
a warning letter to a doctor or to someone who has -- to
someone who is marketing a drug -- who is marketing a drug
contrary to the FDCA.
The statements here go far beyond purely
informational. These are not informational statements.
These are directives to the public. These are directives
to patients or these are strong medical -- these are
medical recommendations. That is the heart of the
practice of medicine.
And so this case needs to be viewed in the
context-specific capacity of the fact that we are dealing
with the FDA which has significant authority in this area,
which has outsized -- which throws around outsized weight
in this area and the fact that Congress has explicitly
recognized the problems that the FDA could cause if it
started meddling in the practice of medicine. It's
relevant throughout the debates. It's relevant in
Section 396 of Title 21.
And so in this particular case we are not talking
about informational statements only. We are talking about
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
41
statements that are making recommendations about medicine.
We're talking about statements that are directing the
public to "stop it" or to "stop it with the ivermectin."
So in that regard, this case is not about whether or
not informational statements are illegal. It's about the
statements here that the FDA has made.
Also, if the government -- the government has
mentioned or has tried to make the argument that it's just
-- that it can speak freely. That's a merits argument,
and that should not be resolved at the motion to dismiss
stage because the government has not raised a 12(b)(6)
motion challenging the merits of the claims.
THE COURT: You mentioned warning letters.
Warning letters seem like they are more than
informational. They can approach being a directive, too,
can't they?
MR. KELSON: The FDCA has the authority to police
how drugs are marketed. That's like -- that is within
their express statutory authority. So it's -- it's
somewhat of a red herring or a straw man where the
government says, "Look, we send out these warning letters
telling a pharmacist we heard that you are promoting this
drug and saying that it is -- it should be used for these
purposes."
That is separate from what is going on here because we
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
42
are not talking about advertising drugs for this -- for
sale and distribution. We're talking about how doctors
deal with their patients and what drugs should be used for
particular treatments off label.
The FDA has authority over what -- over when drugs can
be admitted to the market, what labeling they can use, and
how they can be marketed. If they issue a warning label
on those conditions that is within their authority, then
they are within their authority; but that's not what they
are doing here. They are telling people to stop -- they
are telling consumers, not distributors. They are telling
consumers to stop it. They are telling doctors, the
public, to stop it. That is a totally different thing
that is outside of their authority.
THE COURT: I know that courts have held that
warnings letters are not final agency action. If warning
letters aren't, then how can the statements in this case
be?
MR. KELSON: So, in the first instance, a warning
letter is more tentative than a statement like "Stop it"
or "Stop it with the ivermectin." So there is a
difference in the tone of the letter -- of the statements.
In addition, Section 396 should inform this court's
flexible and pragmatic approach to finality.
In addition, the warning letters -- the warning
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
43
letters are explicitly, by their terms, in preparation for
a potential enforcement action. And so they are very
clearly non-final by their nature. They are issuing a
warning that in the future they may choose to take action;
whereas, these statements about ivermectin have no such
future action attached. They are not -- they are not in
anticipation of something else. They are not a warning.
They are not an initial volley in an ongoing conversation
with a regulated party. These are direct and final
statements to the public, to doctors, to consumers, to
patients. And so, in that regard, they are different.
And in the event the Court feels otherwise, none of
that affects the ultra vires claim which, in any event,
should proceed.
THE COURT: Okay. Well, thank you. I'm going to
see if the government has anything else, but I appreciate
it.
Counsel, you are welcome to -- go ahead. You are
welcome to cover whatever you would like in response to
the plaintiffs' arguments; but I would like you to
specifically address, for one thing, the allegation that
the statements the FDA made that the plaintiffs are
complaining about in this case were not merely
informational but were more like directives.
MR. BELFER: Yes, Your Honor. The cited
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Laura Wells, RPR, RMR, CRR, RDR
44
statements were not directives. They were not mandatory.
They were recommendations. They said what parties should
do. They said, for example, why you should not take
ivermectin to treat COVID-19. They did not say you may
not do it, you must not do it. They did not say it's
prohibited or it's unlawful. They also did not say that
doctors may not prescribe ivermectin.
THE COURT: Well, they very flippantly say "stop
it" in the tweet.
MR. BELFER: Yeah. They use informal language,
that is true; but they did not -- they did not say you may
not do this or it is unlawful. If you look at the
language they used, it is -- yes, it's informal. It's
conversational, but it's not mandatory. It never said
this is unlawful, it's prohibited. And so that contrasts
with, you know, other things that FDA might say where it
is more -- more mandatory.
And if you look at the kind of statements at issue
here, we are not talking about a publication of the CFR or
an official memorandum. We're talking about tweets and
Instagram posts and website posts. These are much more
informal fora.
And so if you look at the informal fora, the fact that
this is informal conversational language, plaintiffs
cannot show that it was predictable that anyone would look
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
45
at these statements and think that they were prohibited
from taking ivermectin to treat COVID-19, especially given
that, you know, the tweets both linked to the article and
the article said that doctors have discretion and that if
your doctor prescribes ivermectin, take it exactly as
prescribed.
So a few general points before we get into the
specific issues that plaintiffs raised. So plaintiffs
argue that -- they tried to frame this case as about the
off-label use of drugs, off-label prescription; but this
is not a case about off-label prescription. This is a
case in particular about the use of ivermectin to treat
COVID-19.
No one is questioning that doctors generally have
authority to prescribe off-label in appropriate
circumstances. Instead, what FDA is saying here is it's
warning consumers about the risks of using ivermectin to
treat COVID-19.
And the fact that FDA generally does not prohibit
doctors from prescribing off-label has never been taken to
be a limitation of FDA's authority to communicate
publicly. FDA communicates publicly about the risks of
drugs all the time. And, in fact, in the amended
complaint the plaintiffs concede that FDA generally has
authority to communicate to the public about the risks of
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
46
drugs. So there is no dispute that FDA generally has
authority to communicate with the public about the risk of
drugs.
Plaintiffs argue that Section 396 is a limitation on
that authority. But tellingly, in their argument, the
plaintiffs don't really defend 396 and for good reason.
Section 396 is directed to medical devices, not drugs.
And even beyond that, 396 is -- does not establish any
general interest in -- against interference with the
practice of medicine, let alone any interest to get into
FDA communications. It's not about that.
Instead, 396 is very specific. It's about doctors'
authority to prescribe or administer medical devices; and
even if you could strike out the word "devices" and
replace it with "drugs," it would still only be about
doctors' authority to prescribe or administer drugs. And
here there is no allegation that doctors' authority to
prescribe or administer drugs was ever impaired.
The plaintiffs, by their own admission, have continued
to prescribe ivermectin. So they always had the
authority. It may be that patients were not able to fill
prescriptions, but the doctors themselves always had the
authority. So Section 396 is not applicable, and there is
-- there is really no general interest against
interference with the practice of medicine at issue here.
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
47
So I would like to respond in particular to a few of
the arguments that have been made on the various issues in
this case. Starting with sovereign immunity, plaintiffs
argue that their ultra vires claim is essentially an
exception to sovereign immunity.
But in the Danos case from the Fifth Circuit, the
court said that it's not enough simply to allege that an
agency action is unlawful or unauthorized. You have to do
more. You have to show that the agency had no colorable
basis for its exercise of authority; and plaintiffs have
not done that here because, again, they concede that FDA
generally has authority to communicate with the public
about the risk of drugs. They argue that 396 is a
limitation on that authority; but as we discussed, 396 is
inapposite here.
And so plaintiffs have not met the standard under
Danos of showing the FDA had no colorable basis for the
exercise of its authority. Right.
And so with regard to agency action, plaintiffs take
the position that essentially any -- any statements by the
agency is agency action. And they say that the Fifth
Circuit has held that essentially everything an agency
does is agency action, but that's simply not true.
If you look at cases like Alabama-Coushatta or
Walmart, both Fifth Circuit cases, those make clear that
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
48
not everything is agency action. In their briefing,
plaintiffs rely specifically on their contention that the
agency -- the cited statements are a rule. That is their
basis for saying there is agency action.
So let's look at the definition of a rule. The
definition of a rule -- I can pull it up right here. So,
essentially, to be a rule you need to be binding on either
the agency or a private party or you need to interpret a
substantive rule or you need to set agency policy. Those
are all the rules. But here the cited statements are none
of those things. They are not binding on anyone. They
don't interpret any rule, and they do not -- they don't
set agency policy.
And so you need to meet -- plaintiffs rely on a rule,
but here the cited statements simply don't meet the
statutory definition of a rule.
And then, with regard to final agency action, I guess
starting with consummation of the agency decision-making
process, we do not argue that the consummation prong is
met simply because the cited statements might be revised
in the future.
Sure. An agency can always take future action, but
that's not what we're arguing. Instead, our argument is
that if you look at the face of the cited statements
themselves, they are expressly tentative. They state that
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
49
they are based on currently available data, that more data
is needed, and that clinical trials are ongoing.
So if you just look at the face of the statements,
they are expressly tentative and based on currently
available data. They do not state FDA's final definitive
position on the use of ivermectin to treat COVID-19.
You know, plaintiffs say that these statements --
going to the legal consequence prong, plaintiffs say that
these statements are unequivocal. They are not
unequivocal. They generally recommend against using
ivermectin but they also say if your doctor prescribes it,
take it exactly as prescribed. And there is no allegation
that anyone read part of the statement but not the entire
statement. And so plaintiffs have not shown that
plaintiffs would not read the entire statement and see
that nuance in the statements.
Plaintiffs cite Texas v. EEOC regarding this notion
that if the agency establishes a norm that that's final
agency action; but the Texas v. EEOC case is plainly
inapposite. In that case, the agency established a norm;
and if private parties did not comply with the norm, they
were subject to legal liability. They could be sued for
failing to comply with the norm. That's a direct effect
on those third parties by changing their legal liability.
Here, there is no effect. The cited statements have
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
50
no effect on anyone's legal liability. There is no direct
legal consequence on anyone.
And, similarly, the plaintiffs cite the Bennett case
but Bennett -- and that's Bennett v. Spear with the
Supreme Court -- is, again, different. In Bennett the
Fish and Wildlife Service issued a biological opinion; and
if other agencies did not comply with that biological
opinion, they could be subject to criminal and civil
liability. So in Bennett there was a direct legal effect
on other agencies. If they did not comply with the Fish
and Wildlife Services statement, they could be subject to
criminal or civil liability.
Again, here there is no similar direct effect. No one
would be subject to criminal or civil liability if they
prescribed ivermectin to treat COVID-19. Instead, the
statement expressly acknowledged that doctors can
prescribe ivermectin for that purpose.
So I would like to say a few words about standing. So
the plaintiffs argue that FDA is trying to stop the use of
ivermectin and that its purpose -- its purpose was to stop
the use of ivermectin; but again, if you look at the
language of the statements, FDA never said that doctors
cannot prescribe ivermectin to treat COVID-19. They said
doctor -- if your doctor writes you a prescription, fill
it and take it exactly as prescribed. So the FDA
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
51
expressly acknowledged that you can use ivermectin for
this purpose if your doctor prescribes it.
And, you know, looking at FDA's intent, FDA was really
focused on consumers. It was advising consumers who could
buy this product over the counter that they shouldn't take
it. They did not say that if your doctor prescribes it,
don't take it. They said follow your doctor's advice. If
your doctor prescribes it, take it exactly as prescribed.
You -- right. So regarding the TransUnion case, you
know, plaintiffs say that essentially that there is injury
in fact here, and they cite that case. So what the
Supreme Court held is that you cannot presume an injury in
fact just because there is an alleged statutory violation.
You still need to look under Article III at whether
plaintiffs have met the requirement for standing.
So, as we discussed, there is no violation of 396.
FDA did not exceed its authority. But even if plaintiffs
had shown a violation of Section 396, that is not itself
alone -- that itself is not alone -- that alone is not
sufficient to show standing. You would still need to show
an injury in fact under Article III.
And because the alleged violation, interference with
the practice of medicine, is a vague conclusory allegation
and plaintiffs were always able to prescribe ivermectin,
they have not shown any injury in fact under Article III.
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
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Regarding traceability, you know, plaintiffs try to
minimize their burden to show traceability; but
importantly, the standard is that -- or, sorry. Under the
Daves case from the Fifth Circuit the Court held that it's
substantially more difficult to show traceability when the
causal chain relies on independent third-party conduct.
And so to meet that much higher burden when, as here,
plaintiffs rely on this indirect causal chain, you need to
show that the third-party conduct would be a predictable
response to the cited statements.
And because FDA statements were directed at consumers,
they were, you know, informal, conversational, and because
they expressly acknowledged doctors' discretion to
prescribe ivermectin, it would not be predictable that,
for example, a hospital would punish a doctor for
prescribing ivermectin when the statements themselves
acknowledged that doctors could prescribe ivermectin to
treat COVID-19.
You know, plaintiffs state that everyone is pointing
to FDA. So, surely, FDA must have caused the third-party
conduct. But if you look at what is alleged in the
complaints in the exhibits, it's clear that third parties
are not just relying on FDA.
For example, Exhibit 12, which is the statement of
Sentara, which is a former employer of Dr. Marik, they did
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Argument by Mr. Belfer
Laura Wells, RPR, RMR, CRR, RDR
53
not simply rely on FDA. Instead, they cited statements
from many organizations -- FDA, CDC and several other
organizations -- and they provided independent medical
analysis. They said there is no randomized control trial
that supports use of ivermectin to treat COVID-19.
So, you know, plaintiffs' employers, pharmacies,
insurance companies, these are sophisticated entities that
make independent -- that exercise independent professional
judgment as shown by Exhibit 12. They did not simply take
what FDA said and accept it at face value. They looked at
FDA statements in combination with the statements made by
many other organizations. They also performed independent
scientific analysis. They looked at the data. And based
on all of that, they concluded that they would not
recommend prescribing ivermectin.
And so, you know, that undermines redressability
because it shows that even if you took away FDA cited
statements, just those statements, you would still have
all those other third-party statements that Sentara and
other organizations relied on.
And I would just give you a few more citations.
Exhibit 25, which is the joint statement by the American
Medical Association and other organizations, also. So
it's not just FDA but many other -- many other statements.
And the DeMarco case the plaintiffs cite, that cites
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
54
not just FDA but many other organizations.
And so simply taking away these particular FDA
statements, plaintiffs have not shown that that would
likely cause third parties to reverse their past conduct;
and again, that's the standard. You have to show -- you
have to -- you have to have allegations that plausibly
allege that it would be likely that third parties would
reverse their past conduct and redress plaintiffs'
injuries, and plaintiffs have not shown that it would be
likely. Right.
So I think, for all those reasons, plaintiffs have not
shown that there is any waiver of sovereign immunity
because they have not shown agency action or final agency
action. And they also have not shown that they have
standing because they have not shown injury in fact for
many of their injuries, and none of their injuries
satisfied the traceability or addressability prongs.
So unless Your Honor has any further questions.
THE COURT: No. I don't think I do right now. I
appreciate it. I'm going to give the plaintiffs the last
word. Thank you, Counsel. Appreciate it.
MR. BELFER: Thank you, Your Honor.
MR. KELSON: I believe the government began by
saying that these were only informal tweets, these were
only informal Instagram posts or LinkedIn posts.
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
55
The government can't launder unlawful action as a good
PR scheme or as a good PR endeavor. The agency acted.
Whether it acted through an informal way with definitive
language or whether it went through the Federal Register
doesn't change the fact that the agency acted here.
The government is trying to -- tries to downplay
TransUnion; but TransUnion explicitly recognizes that
while you can't merely allege statutory harm, other
injuries can be drawn from past precedent, from common-law
analogs. It specifically points out reputational harm,
which we have alleged here.
There is a common-law analog to tortious interference
with a doctor-patient relationship that's recognized in
Texas. If you -- you know, if you want a case for that,
you can look at the Garcia case from the Northern District
of Texas. It's 1999 -- it's an unpublished case; but it
cites a number of other Texas cases -- 1999 Westlaw
362787.
So TransUnion squarely supports the plaintiffs here.
It shows that their injuries are real, that while there is
a statutory violation, which should inform the Court's
interpretation of the injury, and since they only need an
identifiable trifle, there is also plenty of common-law
analogs to show exactly what it is the doctors have
alleged here.
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
56
One of the amicus briefs, the American Association of
Physicians and Surgeons also points out the Tozzi case
where an agency labeling something as dioxin was enough to
cause harm. It was enough to establish standing.
The FDA has labeled this a horse drug. The FDA has
maligned the use of ivermectin and that the agency has
told people to stop it. If there was standing in the
Tozzi case from the DC Circuit, then there is definitely
standing here.
I am not in any way backing away from the plaintiffs'
interpretation of Section 396. That statute has been
repeatedly interpreted by circuits across the entire
United States as applying to the practice of medicine,
including the prescription of drugs.
The government in its briefing says that by using a
"see" statement, a "see" signal to introduce the citation
that the government is -- that the Fifth Circuit was
saying that it was an unrelated -- it was a related but
not directly on point case. That is not what a "see"
signal means. A "see" signal means that the cited -- or
the citation directly supports the proposition stated in
the preceding sentence. That is Bluebook Rule 1.2.
As a result, all these courts have recognized that it
applies. If you look at the -- to the extent there is a
scriveners error in that provision, so be it; but that
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
57
provision was clearly intended to stop the FDA. And even
if it wasn't, the FDA doesn't have this authority. That
has been very clear for 100 years.
I don't -- I don't -- unless the Court would prefer
otherwise, I don't need to walk through all the -- I don't
need to re-walk through all the arguments that we have
already made in response to the government, except I would
-- the only additions I would make is to point the Court
to Avoyelles Sportsmen's League where the Fifth Circuit
was explicit that the APA defines the term "rule" broadly
enough to include virtually every statement an agency may
make. That's a direct quote from a Fifth Circuit case.
In addition, the definition of "rule" in the rule --
in the APA is not exhaustive. It is prefaced by the word
"includes." That means that there -- it is giving
examples of a fall within a rule; and as the Fifth Circuit
has recognized, that includes every statement an agency
may make.
And if the Fifth Circuit's precedent isn't sufficient
to satisfy this case, which we believe it is, there is
also a DC Circuit case on the finality issue called
Ciba-Geigy Corp. It's cited in our briefs. But it talks
about how a hyper-technical approach is not appropriate
and that a series of pronouncements may constitute final
agency action if their cumulative effect causes injury.
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Argument by Mr. Kelson
Laura Wells, RPR, RMR, CRR, RDR
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That case is directly on point.
So to the extent this court wants to look outside the
Fifth Circuit, the DC Circuit has a case that is directly
on point with both Tozzi and Ciba-Geigy, both of which are
cited either in our brief or in the amicus brief.
In sum, the doctors here have been suffering -- have
suffered injuries at the hands of the FDA's public
pressure campaign for a long time now, well over a year.
And this court has the power to stop that or to give them
the possibility of seeking relief. The redressability
standard is low. They just have to show the potential for
some sort of relief.
Especially at this stage of the proceedings, the
standard is plausibility; and the plaintiffs have
unquestionably made plausible arguments, cited numerous --
numerous public statements, numerous public actions by the
agency that establish more than a plausible injury, more
than a plausible traceability back to the FDA, and more
than plausible redressability. That's all that is
required at this stage in the proceeding.
And that just -- that is only the publicly-available
information that we have been able -- that we have seen,
that we have been able to find. Recently, in Biden v.
Missouri it's become very apparent that government
officials have been acting in nonpublic ways to pressure
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Ruling of Court
Laura Wells, RPR, RMR, CRR, RDR
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-- to pressure private parties.
All we can say is that in this case, from the
publicly-available information, it is more than necessary
to satisfy the plausibility standard that is necessary at
this stage of the proceedings.
Unless the Court has any further questions.
THE COURT: No, I don't. I appreciate the -- the
issues are very interesting; and the briefing and the
argument has been very helpful to the Court. And we'll
get a ruling out as quickly as we can for y'all.
MR. KELSON: Thank you, Your Honor.
THE COURT: All right. The Court stands in
recess.
COURT SECURITY OFFICER: All rise.
(Proceedings concluded at 11:39 a.m.)
Date: November 2, 2022
COURT REPORTER'S CERTIFICATE
I, Laura Wells, certify that the foregoing is a
correct transcript from the record of proceedings in the
above-entitled matter.
/s/ L a u r a W e l l s
Laura Wells, CRR, RMR
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