Episode Transcript
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Speaker 1 (00:02):
Welcome to scot Discust, a project of the Federalist Society
for Law and Public Policy Studies. Our contributors join us
from around the country to bring you expert commentary on
US Supreme Court cases as they are argued and the
decisions are issued. The Federalist Society takes no position on
particular legal or public policy issues. All expressions are those
(00:23):
of the speaker.
Speaker 2 (00:27):
Hello, and welcome Disco Discust. I'm your host, Kyle hammerniz
On behalf of the Faculty division of the Federalist Society.
Today we have a moderated discussion on Food and Drug
Administration versus Alliance for Hippocratic Medicine in which the Supreme
Court issued a nine zero decision on June thirteenth, twenty
twenty four. It is my honor to introduce our moderator
(00:49):
and our guests today. Our moderator is Professor Teresa Stanton Collette.
Teresa is a professor and the director of the Pro
Life Center at the University of Saint Thomas School Law.
Our first guest is Adam you Nikowski. Adam is a
partner at General Bloc LLP. Our second guest is Megan Wold.
Megan is a partner at Cooper and Kirk, And with that,
(01:12):
I like to turn things over to our moderator to give.
Speaker 3 (01:14):
Us the background of the case.
Speaker 4 (01:21):
Thank you very much.
Speaker 5 (01:23):
I'm delighted to be a part of this program and
excited to hear what our panelists have to say. We're
discussing a case that I believe has been widely in
some ways misreported in the press, in part because it
turns on what some have been calling a legal technicality,
and so rather than take up time with my comments
on it, I will turn to our panelists, who have
(01:44):
some opening statements to sort of explain how they read.
Speaker 3 (01:47):
The case itself. Adam, thank you for that introduction. So
I'll probably just talk for a couple of minutes.
Speaker 6 (01:55):
I'll begin by summarizing what the case was, what the
Supreme Court, and what the implications of the ruling all are,
and then i'll very briefly editorialize a little bit about
what I think about the ruling, which.
Speaker 3 (02:07):
Is maybe the marterest thing part. So most of you
know what the case is about, but for those.
Speaker 6 (02:11):
Who don't, the plaintiffs are organizations of pro life doctors
as well as a few individual pro life doctors. They
filed the lawsuits in the Northern District of Texas, alleging
that the FDA had acted illegally in improving MiFi prostin,
which is a drug that causes abortions, in two thousand
(02:31):
and alternatively arguing that the FDA acted illegally in loosening
certain conditions of use through a series of orders in
twenty sixteen, nineteen, and twenty one. And the plaintiffs, of course,
to establish their entitlement to any relief at all, must
have Article three standing.
Speaker 3 (02:49):
And so the.
Speaker 6 (02:50):
Plaintiffs are doctors that they do not prescribe mifipristone themselves.
Speaker 3 (02:53):
Do not require too, and they never alleged that they
did in fact prescribe it. Their theory of standing was
a little bit different.
Speaker 6 (02:59):
Essentially, of standing turned on injuries that would result if
other doctors prescribing with for pristone.
Speaker 3 (03:04):
The theory was that if other.
Speaker 6 (03:06):
Doctors would do that, then patients would have complications and
then come to emergency rooms and encounter the plaintiff doctors,
whereupon the plant doctors either would experience a conscience violation
or would simply be expanding resources on caring for the patients.
So they'd rather expend in a different way, and the
plane off organizations also alleged that they had to spend
(03:27):
time and money essentially educating people as to the harms
of MiFi pristone, which they wouldn't have had to do
if MEPhI pristone hadn't been approved. So Federal District Court
in Texas agreed with the planiff's arguments on both standing
and the merits and held that the FDA had acted
i legally in approvingly Ford pristone back in two thousand
and essentially granted a complete victory to the plaintiffs. After
(03:51):
some flori of filings both in the Fifth Circuit and
in the Supreme Court, that order was stayed in its entirety,
so it never actually went into effect as a result
of the Supreme It's order. Ultimately, the Fifth Circuit partially
affirmed the District Court as.
Speaker 3 (04:04):
Relevant to the Supreme Court's ruling.
Speaker 6 (04:06):
The court held that the planeffs did have standing, which
is what opened up the door for them to obtain
relief on other issues, and the Fifth Circuit ultimately concluded
that the District Court was correct to hold that the
FDA acty legally with respect to certain decisions in twenty
sixteen and twenty twenty one loosening conditions of use, but
the Fifth Circuit disagreed with the District Court's assessments with
(04:28):
regard to the initial approval in two thousand.
Speaker 3 (04:32):
So in the Supreme Court, the parties litigated.
Speaker 6 (04:35):
Both the standing issue which the plaintiffs had prevailed on
in the Fifth Circuit, as well as the merits issue
that the Planets had prevailed on. The Supreme Court declined
to hear the plaintiff's cross challenge to the issues on
which the plane was lost on in the Fifth Circuit,
and the Supreme Court ultimately ruled that the Planets did
not have Article three standing in a unanimous decision by
Justice Kavanaugh.
Speaker 3 (04:55):
So the Court walked through the three theories of.
Speaker 6 (04:58):
Standing that the Planets had proffered and concluded that each
of them was inadequate. So, first of all, the plaintiffs
alleged a conscience violation that they might experience either if
they had to perform an abortion or perhaps provide medical
care to someone who had complications from a method pristine abortion,
and the Supreme Court rejected this argument both as a
matter of law and fact.
Speaker 3 (05:17):
As a matter of law.
Speaker 6 (05:18):
The court held that there was conscience protections which would
ensure that the doctors didn't personally wouldn't personally have to
face the.
Speaker 3 (05:24):
Situation in the future.
Speaker 6 (05:26):
As a matter of fact, the court walked through the
doctor's declarations and concluded that they didn't have any examples
of situations in the past when they faced these experiences,
and so they hadn't shown a subficient likelihood that they'd
have to face these situations in the future. The planets
also argued that there was a conscience violation that they'd
experienced if they essentially were aware of other doctors performing abortions,
(05:49):
prescribing with a pristone concluding treating complications. The court held
that that type of conscience injury didn't give rise to standing.
In other words, it's one thing to say it's an
injury to my conscience if I have to provide medical care,
but it's another to say my conscience is injured if
I just witness other people doing things that I don't
agree with.
Speaker 3 (06:05):
That's not enough for standing, the court held.
Speaker 6 (06:08):
The second theory of standing was simply that there was
a risk that the plaintiffs would just have to take
care of these patients in the future, and if they
did that, they would spend time on that, they'd rather
spend time on other things, and that was an injury.
And the court held, both as a matter of fact
and law that this this was this didn't establish standing.
As a matter of fact, it was too speculative. There
was no real evidence that this was going to happen.
(06:29):
And as a matter of law, I would really open
the courthouse store for doctors to be able to challenge
essentially any rule eliminating a safety restriction, So the rule
and gun safety were relaxed, or a speed limit were increased,
doctors could sue and say, well, you know, there's many
more people in the emergency room. We'll have to see them,
so we're going to spend time on that. And the
court basically wasn't willing to open up the courthouse.
Speaker 3 (06:49):
Stores in quite that way.
Speaker 6 (06:51):
And the final theory of standing that the plaintiffs proffered
was organizational standing, essentially saying that the organization themselves would
be injured basically because they'd have to spend time educating
people or you know, combating the rule or advocating against it,
and that would expend resources.
Speaker 3 (07:07):
And you know, if the WORL didn't exist, they wouldn't
have to do that.
Speaker 6 (07:10):
As the court pointed out, that would basically obliterate all
limits on standing, because anytime any agency passes a rule
on anything, an organization can say, well, we're spending money
advocating against it, and so that's an injury.
Speaker 3 (07:21):
We'd rather spend the money in other things.
Speaker 6 (07:23):
And you know, that limitless principle would essentially allow, as
I said, any organization to sue any agency over anything,
and the court decided that that expanded standing too far.
So I'll just say one word about you know, about
my views on the decision. I agree that I view
it as a victory for the separation of powers and
judicial restraint. The plaintiff's theories of standing would really broaden
(07:43):
the category of agency actions that would be challenged by
private plaintiffs. I think that the premise of Article three
is that the role of the courts is to address
legitimate grievances by people who have rules that personally affect them.
Speaker 3 (07:55):
But when plaintiffs basically.
Speaker 6 (07:57):
Disagree as citizens as opposed to his individual litigants, the
correct remedies the political process and not litigation, and that
I think is the principle that was indicated by the
court in this case.
Speaker 3 (08:07):
So I'll turn over to my call now.
Speaker 5 (08:11):
Megan, please respond or give us your views of the case.
Speaker 4 (08:17):
Thank you.
Speaker 7 (08:18):
I appreciate that, and I appreciate Adam's discussion of what
the opinion said. I don't really intend to add to that.
He's ably covered everything that it was addressing. In this case,
I filed an amicus brief on behalf of the Catholic
Association along with a doctor, doctor Gracie Poso Christie, who
is a practicing position in diagnostic radiology, so she reads ultrasounds,
(08:43):
which would be the most direct relevance to this case.
And I wanted to say a little bit more about
the purpose of that amicust brief and the information that
it was conveying, in part because I think it's going
to continue to be relevant in potentially the further litigation
of this case, but also another case that exists in
(09:03):
the lower courts in the Ninth Circuit, in which states
are challenging these same mithipristone regulations, and that obviously changes
the standing calculation, something we can talk a little bit
more about, but for purposes of our amicist brief, the
goal of the brief was to convey two different things,
some additional factual background that was echoing and supportive of
(09:23):
what the plaintiffs in this case we're arguing.
Speaker 4 (09:26):
And the first was.
Speaker 7 (09:26):
The medical background about how the deregulation of methi pristone
could lead to and not could but does lead to
more emergency room visits from women who have taken the
drug and are experiencing incomplete abortions. So, miphi PRIs stone
is a drug that a woman takes, usually in my
two drug cocktails, a little bit more complicated than that,
(09:48):
but for simplicity's sake, a woman takes the drug and
it causes the body to expel a pregnancy, and that
process becomes increasingly risky as a pregnancy progresses. So if
a person is supposed to be taken before seventy days
of gestation, so when a woman's been pregnant for roughly
two months, and the best way to date a pregnancy,
(10:12):
in fact, the only effective and accurate way to know
that the date of a pregnancy, to know how far
along a woman is is through an in person ultrasound,
But the FDA's deregulation of mefipristone did away with the
requirement of an in person visit before MiFi pristone could
be administered, and so the result of that is a
(10:33):
greatly increased risk that women are self assessing their pregnancies
incorrectly or with the help of a doctor, their pregnancies
are being assessed incorrectly and improperly dated, quausing them to
take mifipristone much later than seventy days gestation, at which
point the risks increase quite significantly, the risk being that
(10:55):
the abortion might be initiated, but it wouldn't be completed
and that would necessarily require treatment in an emergency room,
and in fact, FDA's packaged insert on mithi pristone says
that emergency room care is the backstop or when these
drugs fail to complete the abortion, which is expected in
a certain percentage of cases. It's also important that women
(11:17):
do experience ec topic pregnancies, which are non viable pregnancies
located in the fallopianco rather than the uterus, and those
can only be diagnosed through an in person ultrasound.
Speaker 4 (11:28):
As well, there are no questions you can ask the woman.
Speaker 7 (11:30):
There are no home pregnancy tests that can tell you
whether pregnancy is a topic and taking mephipristone in the
case of an ectopic pregnancy can be very risky as
well and result in the necessity of emergency room care
and other complications. So for this reason, our brief was
trying to elucidate further some of the factual circumstances at
(11:52):
issue here that the FDA's deregulation of mifipristone, by doing
away with the requirement of an in person diagnostic visit,
would increase the number of emergency room visits and complications
that I'm in face. Then the second portion of the
brief is really focused on Catholic hospitals. First of all,
the very high percentage of hospitals in the United States
(12:14):
that are Catholic hospitals and some of the historical background
for why that is, and these hospitals do have conscience
concerns when it comes to treating women in these emergency circumstances.
To be clear, Catholic hospitals will always treat women who
present in an emergency, regardless of whether they've taken methopristone,
regardless of how they come to be in that emergency
(12:36):
medical situation. The concern though of Catholic hospitals is that
there can be very fraught moral.
Speaker 4 (12:42):
Circumstances at issue.
Speaker 7 (12:44):
For example, a woman may come in wanting to complete
the abortion, but with a living unborn child, and this
would create a serious moral complication for Catholic hospitals. And
also in the heat of an emergency, some of these
details may may not be clear. So this was the
second portion of the brief, was elucidating some of the
(13:05):
conscience problems that would arise for Catholic hospitals. Now, there
were no Catholic hospitals as named plaintiffs in the case,
and as with all amicust briefs, were not able to
actually supplement the factual record. This was just some additional information.
I don't read the court's opinion, and I think they're
pretty explicit and not addressing.
Speaker 4 (13:24):
These kinds of the kind.
Speaker 7 (13:26):
Of medical evidence or weighing that evidence in the case,
which makes perfect sense. You don't have a plaintiff with standing,
so of course you wouldn't engage in the merits of
the dispute.
Speaker 2 (13:36):
But what the.
Speaker 7 (13:36):
Court's opinion focused on was the connection between these plaintiffs
and these alleged injuries, and I think it did a
number of important things. I think affirming that the federal
law provides conscience protections and that doctors can invoke them
simply by refusing to perform medical care that violates their
(13:57):
conscience is a helpful elaboration by the court. It wasn't
entirely clear how those conscience protections would apply, or how
atala another statute at issue in another case before the
court right now would affect conscience protections, and so the
Court did elaborate on those things, and I think very
helpfully for people who have conscious objections to performing abortions.
Speaker 4 (14:23):
But for that reason, these.
Speaker 7 (14:24):
Plaintiffs couldn't assert those conscience objections because they were already
protected by federal law.
Speaker 4 (14:30):
And then these I think the.
Speaker 7 (14:34):
Focus of the Court's opinion was on the attenuation and
the speculative nature of these injuries, of which I was
just discussing about the increase in emergency room visits, the
attenuation between that connection and these plaintiffs that they were
unable to substantiate that they had been seeing these increased
numbers of it, they had been required to perform these
(14:56):
additional procedures in an emergency. I don't think that the
Court's decision is altogether surprising. I think it is an
application of existing standing doctrines, and the Court was confronted
with some very difficult questions. If these plaintiffs had standing,
it would be like giving a blanket doctor created standing
(15:18):
to challenge any public health regulation, for example. And that's
this type of generalized revents that the Court does not
recognize as conveying standing, and instead that the Constitution provides
political avenues for complaints likelis of the plaintiffs that they
can petition Congress and the President to legislatively change things,
that can petition the FDA through the appropriate channels to
(15:42):
reregulate or otherwise change this regulation that for pristone, or
challenge it in the first instance. And those are the
types of relief that these plaintiffs have not through the
courts and through Article three standing.
Speaker 3 (15:55):
Megan.
Speaker 5 (15:56):
Is it also true though, that at least in one
of the declarations filed by one of the physicians that
while she herself had not encountered a woman coming into
the emergency room who still had a live pregnancy, one
(16:16):
of her partners had where the child, they detected the heartbeat,
and the doctor felt in order to stop the hemorrhaging
that was caused by the michipristone that the only way
to do that successfully was to terminate the pregnancy. Could
you explain to the listeners why that wasn't adequate given
(16:38):
to the nature review breath?
Speaker 4 (16:40):
That's right.
Speaker 7 (16:40):
I believe that was doctor Francis who did have her
declaration a description of what had what she had witnessed
or was aware of happening to a partner exactly as
you describe it. And I think had that circumstance happens
to doctor Francis at the court may have reached a
different decision, or doctor Francis her self may have had standing,
(17:02):
But because that hadn't happened to her, it almost in
some ways confirms the fact that in many hospital settings
there are other doctors who can and are willing to
perform these procedures, and so if one doctor has a
conscious objection, there's someone else who can take over. Or
perhaps that these things happened so infrequently that it wasn't
likely that this would happen again. It had never happened
(17:24):
to doctor Francis previously.
Speaker 4 (17:27):
That was this.
Speaker 7 (17:28):
I think that attenuation analysis is what caused that aspect
of doctor Francis's decoration to not be enough to confer.
Speaker 5 (17:36):
Standing and Adam, I had a friend asking me a
question when I was telling them about this program and
encouraging them to watch it, and the question was, how
is it that we have, you know, this plethora of
cases where doctors providing abortion have been granted standing third
(17:57):
party standing based on allegations of their patients, and these
particular doctors don't have third party standing. Why didn't these
doctors fall into a similar exception to the general rule
of third party standing.
Speaker 6 (18:13):
Well, I think the difference is that when it's true
that many laws abortion laws essentially say that if a
doctor performs an abortion, the doctor will face certain criminal
or civil consequences, and so in those cases, the doctors
are directly harmed by the state action in the sense
that their actions are regulated. So the classic situation in
(18:34):
which a plaintiff has standing is when there's a regulation
that's targeting them.
Speaker 3 (18:39):
Like you do something, you go to jail.
Speaker 6 (18:41):
So obviously the going to jail is an injury that
affects the person that's caused by the government if it's
the criminal law that's putting them in jail, and so
they have standing to challenge it.
Speaker 3 (18:49):
They say, I don't want to go to jail, and
so I'm harmed by your law that would put me there.
Speaker 6 (18:55):
Now, the third party standing in those cases stems from
the fact that the constitutional violation is really experienced by
the women. In other words, the argument is I don't
want to go to jail, and my merits claim is
that the constitutional rights of the women who.
Speaker 3 (19:09):
Would be getting the abortion would be violated.
Speaker 6 (19:12):
But standing is just premised on the direct entry of
facing a criminal trial. The doctors in this case were
not targeted by the regulation. The FDA wasn't saying, hey, doctors,
you're going to go to jail unless you do something
you don't want to do.
Speaker 3 (19:23):
The doctors were really.
Speaker 6 (19:24):
Complaining about the collateral effects of other doctors doing things
that were legal under the FDA's rules. And so that's
the difference between those two two fact patterns.
Speaker 5 (19:35):
And I think just of course, in writing the I'm sorry,
Justice Kavanaugh and writing the opinion addressed that directly by
saying that they were not compelled to do anything.
Speaker 3 (19:46):
Although, as Megan.
Speaker 5 (19:47):
Noted, the Idaho case that will be decided, this term
also raises the question about what sorts of treatments might
be required.
Speaker 4 (19:58):
Do you have any predictions on that, either.
Speaker 3 (20:00):
Of you very good.
Speaker 7 (20:05):
It's famously difficult to read the tea leaves and predict
what the court is going to do in any particular case.
Speaker 4 (20:12):
I am on the briefs in that case, so I do.
Speaker 7 (20:15):
Following it very closely, and it obviously makes sense that
it's going to go down to one of the last
days in the term. It was a very important and
significant case argued in the last week of arguments at
the court. So in that sense, I'm not surprised that
we're still waiting, And you know, I think I think
it's just difficult to say.
Speaker 4 (20:35):
It's really difficult to predict.
Speaker 7 (20:37):
I'm optimistic that the court will say that I'm till
it doesn't preempt idahose laws. But because this case was
also arising and sort of an emergency posture, there will
be more factual development in the lower courts, and so
I also think there might be some factual issues that
the Court allows the lower courts.
Speaker 4 (20:55):
To contend with.
Speaker 7 (20:55):
So that's another one of these problems with predicting the
out of decisions. It's not only is it difficult to
predict which way the decision goes, but because of all
the different way that can be written and the complicating factors.
Sometimes there aren't clear wins and losses. So I think
based in oral argument, I am optimistic that Idaho's leave
will not be preempted by MTALA, But I also think
(21:18):
that there might be more life to the case and
so there's going to be continued litigation about it. But
again famously.
Speaker 4 (21:24):
Difficult to protect, and I don't want to be out
on a limb doing that. Maybe Adam Fields.
Speaker 6 (21:28):
Otherwise, I don't feel otherwise a prediction with any educator.
Speaker 3 (21:34):
I mean there's some at oral argument.
Speaker 6 (21:36):
I think there's some back and forth about exactly what
it is that Idaho's band that MTELLA would be legal.
There is like some confusion in the record of exactly
what the gap was between MTEL and Idaho LAT and
maybe that's going to be worked out in the opinions.
Speaker 3 (21:50):
I don't know, but I don't really have any any
educated guests.
Speaker 5 (21:56):
You don't think Justice Kavanaugh gag with sindy hints of
FDA opinion, you know.
Speaker 3 (22:02):
I mean one can infer from that anything.
Speaker 2 (22:05):
I don't know he did with.
Speaker 6 (22:07):
The oral argument transcript from that case, but I find
it very hard to those tea leaves are pretty vague
in my opinion, Yeah.
Speaker 7 (22:16):
I think, you know, just as Kavanaugh noted that TALA
would only apply to the hospitals, so not to individual doctors,
and I think that was a point that he could
make without conveying.
Speaker 4 (22:28):
With the like the outbum of the MTALA cases. So
I agree.
Speaker 7 (22:31):
I don't think it really gives us any better grounds
for predicting than we had before this decision came out.
Speaker 1 (22:38):
Thank you for listening to this episode of SCO Discussed.
Go Discussed is a project of the Federalist Society, not
for profit educational organization of conservative and libertarian law students,
law professors, and lawyers, founded upon the principles that the
state exists to preserve freedom, that the separation of governmental
power is essential to our constitution, and that it is
(22:59):
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(23:19):
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Speaker 4 (23:31):
This has been a FEDSOC audio production