Speaker 1: This is Bloomberg Law with June Grossel from Bloomberg Radio.
Speaker 2: Just think of law as these cases as a series
Speaker 2: of kate of cars on a long train, and you
Speaker 2: just accept the train, and you just add another car.
Speaker 2: We just follow wherever it's going. We never go to
Speaker 2: the front see who's driving the train. Where's it going?
Speaker 2: And you could go up there in the engine room
Speaker 2: and find us an orangutang drive in the train. Would
Speaker 2: you want to follow that just because it's a train.
Speaker 1: Justice Clarence Thomas used that train metaphor last week to
Speaker 1: describe the import of settled law or precedent in deciding
Speaker 1: new cases. Thomas downplayed the importance of prior Supreme Court
Speaker 1: cases and said he wouldn't follow them if it doesn't
Speaker 1: make sense to him.
Speaker 2: And I don't think that any of these cases that
Speaker 2: have been decided are the gospel. And I do give
Speaker 2: respect to precedent, but it should to precedent should be
Speaker 2: respectful of our legal tradition and our country and our laws,
Speaker 2: and be based on something not just something that somebody
Speaker 2: dreamt up and others went along with.
Speaker 1: In the new term, beginning on Monday, the Supreme Court
Speaker 1: will be considering several cases with long standing precedents, including
Speaker 1: a ninety year old precedent that limits a president's ability
Speaker 1: to remove members of some independent federal agencies without cause
Speaker 1: and a landmark nineteen eighty six decision about the use
Speaker 1: of race in redistricting under the Voting Rights Act. So
Speaker 1: Thomas's comments dissing the importance of prior case law might
Speaker 1: lead some to question whether those precedents will be overruled,
Speaker 1: much as the Court has overrule precedents like the constitutional
Speaker 1: right to a book and race and college admissions decisions.
Speaker 1: My guest is Supreme Court expert David Super, a professor
Speaker 1: at Georgetown Law. David, what was your reaction to Thomas's comments.
Speaker 3: Justice Thomas's remarks were quite remarkable. He said that adherence
Speaker 3: to precedent is perhaps overrated. He compared it to a
Speaker 3: situation where people are riding a train without knowing who's
Speaker 3: in the cabin driving the engine and suggested that that
Speaker 3: might well be an orangutan, and we should not take
Speaker 3: directions from an orangutan. I've never compared the US Supreme
Speaker 3: Court to an orangutan, but he has apparently, And he
Speaker 3: said that precedent may be something that one person just
Speaker 3: bought up and everyone else said, yeah, let's go along.
Speaker 3: And on that basis, he thinks that the court needs
Speaker 3: to be more willing to overrule precedent unless deferential. President.
Speaker 1: When the Supreme Court justices have their confirmation hearings, they
Speaker 1: all say, oh, you know, we're going to follow precedent. Yes, yes, yes,
Speaker 1: And of course they don't in many cases. So tell
Speaker 1: us about the importance of precedents in the law.
Speaker 3: Well, precedent is what makes the courts distinctive. Anybody can
Speaker 3: decide however they want at the moment. Why we listen
Speaker 3: to the courts is because they are bound by the law,
Speaker 3: and in the Anglo American system, the law is precedent.
Speaker 3: We even have a fancy term for it, starry decisives,
Speaker 3: and it is supposed to be what keeps unelected judges
Speaker 3: from acting willfully and just pursuing their personal agendas.
Speaker 1: He also said, it's not the gospel, which I always
Speaker 1: thought precedent was the gospel. But as you mentioned, he
Speaker 1: in a backhanded way, made fun of prior Supreme Court justices.
Speaker 1: He said, the President and if it's totally stupid, and
Speaker 1: that's what they've decided. You don't go along with it
Speaker 1: just because it's decided. Does it show just a lack
Speaker 1: of respect for prior justices.
Speaker 3: Well, it certainly does. It suggests that the current court
Speaker 3: is smart and its predecessors are foolish, which is a
Speaker 3: remarkably condescending approach. It's also an ahistorical approach. We've had
Speaker 3: many brilliant justices on the court. We've had many court
Speaker 3: that historians regard as all star courts, packed with brilliant
Speaker 3: legal minds, and to suggest that they can be compared
Speaker 3: to orangutans, it's disappointing.
Speaker 1: Thomas is a believer in originalism looking at history, but
Speaker 1: yet when the justices look at history, they often come
Speaker 1: up with totally different conclusions about the historical origins of
Speaker 1: the law. Why does he think that that's so much
Speaker 1: better better than following precedent, I don't know.
Speaker 3: And I find it exceedingly strange that perhaps the court's
Speaker 3: most vociferous originalist is taking this view, Because if there
Speaker 3: is one core principle of the original understanding of the
Speaker 3: courts is that they were bound by precedent. That's the
Speaker 3: essence of the common law system that England had for
Speaker 3: many centuries before the founding of this country, and that originalists,
Speaker 3: like Justice Thomas say, should control how we decide things now.
Speaker 3: There are important decisions that were handed down five six
Speaker 3: hundred years ago that decided difficult questions and that no
Speaker 3: court since then has ever disputed. Just as Thomas seems
Speaker 3: to suggest that that core original aspect of Anglo American
Speaker 3: jurisprudence is irrelevant, this is not.
Speaker 1: Really anything new for Justice Thomas. The late Justice Antonin
Speaker 1: Scalia told one of Thomas's biographers quote, he doesn't believe
Speaker 1: in starry decisive period and Thomas has also frequently suggested
Speaker 1: overturning landmark opinions in cases that are not before the court.
Speaker 3: Well, and it's important that Justice Cleia was Justice Thomas's
Speaker 3: best friend on the court and most frequent ally, but
Speaker 3: unlike Justice Thomas, Justice Cleia generally decided the cases that
Speaker 3: were brought for him, whereas Justice Thomas for a long
Speaker 3: time has written concurring or descending opinions inviting parties to
Speaker 3: bring cases to the court. That departs from another important
Speaker 3: aspect of originalism, which is that the courts are passive.
Speaker 3: They take the cases that come to them, but they
Speaker 3: don't go out trying to do affirmative policy making. Again,
Speaker 3: that goes back hundreds and hundreds of years, and an
Speaker 3: originalist like Justice Thomas should be particularly anxious to follow
Speaker 3: the traditional role of the courts as passive deciders rather
Speaker 3: than as policy makers with an agenda.
Speaker 1: The Roberts Court has overturned I read twenty one precedents,
Speaker 1: but it includes significant precedents, of course, the constitutional right
Speaker 1: to abortion in Roe v. Wade, race conscious admissions and
Speaker 1: higher education and the Harvard case, the power of executive agencies,
Speaker 1: and the Chevron doctrine, a forty year old precedent on
Speaker 1: unions in the Janice case. And seventeen of those cases
Speaker 1: that they overturned were split five to four decisions, with
Speaker 1: the conservative justices on one side and the liberal justices
Speaker 1: on the other. I mean, does that tell you anything
Speaker 1: about what was going on there? Well?
Speaker 3: Does suggest that this is a court with an agenda,
Speaker 3: That they are not calling balls and strikes, as justices
Speaker 3: like to say when they're seeking confirmation, but rather that
Speaker 3: they're pursuing a particular agenda, that they are more conservative
Speaker 3: than their four bears, and they're trying to move the
Speaker 3: law in that direction. I should note that one of
Speaker 3: those five four decisions you mentioned actually had five justices
Speaker 3: voting to overturn president, and the Chief Justice, a very
Speaker 3: conservative justice in his own right, joining with the pree
Speaker 3: moderate to liberal justices in disagreeing that being bobbed.
Speaker 1: Roberts recently has talked about how you know, the Roberts Court,
Speaker 1: His court overturned precedence at the lowest rate of any
Speaker 1: of the recent courts, and the New York Times study
Speaker 1: said that it was one point six per term averaged out.
Speaker 1: But does that ignore the significance or the importance of
Speaker 1: the precedents that they're overturning.
Speaker 3: Well, it does, and it also is subject to a
Speaker 3: lot of counting. There have been many, many, many cases
Speaker 3: about abortion rights after Roe v. Wade. Do you say
Speaker 3: that Bob's only overturned Row. No, it made a whole
Speaker 3: bunch of other cases irrelevant and wrong as well when
Speaker 3: they said this or that restriction on abortion was unconstitutional.
Speaker 3: So you have to make some very arbitrary choices in
Speaker 3: doing account like that. There are going to be some
Speaker 3: very very technical cases in admulti law that may get
Speaker 3: overturned because of new technology, and no one really knows
Speaker 3: or cares, and then they're going to be sweeping decisions
Speaker 3: about the Fourteenth Amendment about the separation of powers, and
Speaker 3: that kind of counting game blurs all of them together.
Speaker 1: We look at the upcoming term that starts on Monday,
Speaker 1: there seem to be a few precedents that may get overturned,
Speaker 1: and one involves that nearly century old ruling called Humphrey's
Speaker 1: Executor that protects the heads of independent agencies. Justice Elena Kagan,
Speaker 1: in a dissent when the majority allowed Trump to fire
Speaker 1: for now, the last Democratic member of the FTC, said
Speaker 1: that her colleagues are quote raring to overturn Humphrey's Executor.
Speaker 1: Do you think that'll be the next precedent to go?
Speaker 3: It will be unless they overturned something else first. Humphrey's
Speaker 3: Executor is clearly on its way out. There's a real
Speaker 3: irony here because Justices Gorsuch and Capitol have criticized lower
Speaker 3: courts for not showing in our prospect or Supreme Court president,
Speaker 3: even when that president is handed down through the shadow docket,
Speaker 3: without full briefing, without oral argument, without much of an opinion.
Speaker 3: And here Justice Thomas, their partner, is turning around and
Speaker 3: saying that he would disrespect Supreme Court decisions even that
Speaker 3: were fully argued, fully briefed, and the result of painstaking opinions.
Speaker 3: I think the Justices need to decide whether the work
Speaker 3: of the Supreme Court is or is not entitled to
Speaker 3: great deference.
Speaker 1: The Trump administration is asking the justices to take his
Speaker 1: challenge to birthright citizenship, and they did use the birthright
Speaker 1: citizenship clash to make it harder for federal judges to
Speaker 1: block government policies nationwide. If they take this case, does
Speaker 1: that say, yes, we're going to overturn the precedent from
Speaker 1: eighteen ninety eight that supported birthright.
Speaker 3: Citizenship and as the president handed down by arguably the
Speaker 3: most conservative Supreme Court in the nation's history, So it
Speaker 3: would be quite remarkable to overturn that case. I think
Speaker 3: the Justices will take this simply because it's a high
Speaker 3: profile and very important matter that the President has been emphasizing.
Speaker 3: I would have trouble imagining how they could overturn it.
Speaker 3: The original opinion is based on analysis of historical uses
Speaker 3: of terms going back hundreds of years. It's a very
Speaker 3: model of originalism, and the Trump administration's complaint is largely
Speaker 3: a political one responding to their base and their opposition
Speaker 3: to immigrants. Any serious originalist approach would affirm the plain
Speaker 3: language of the fourteenth Amendment and the decision from the
Speaker 3: nineteenth century.
Speaker 1: In a concurring opinion in the Dodds case, which overturned
Speaker 1: Row Thomas suggested revisiting cases concerning the rights to conception,
Speaker 1: same sex intimacy, and marriage quality. And the Court is
Speaker 1: being asked to overturn the Obergefell decision, the landmark twenty
Speaker 1: fifteen decision that legalized same sex marriage nationwide in a
Speaker 1: case involving Kim Davis, the former Kentucky cleric who became
Speaker 1: famous when she was jailed for refusing to issue marriage
Speaker 1: licenses to a gay couple on religious grounds. Do you
Speaker 1: think that same sex marriage is in jeopardy.
Speaker 3: It certainly is in jeopardy. It's hard to know what
Speaker 3: the Court will do. The Chief Justice Roberts has been
Speaker 3: insisting that the judges look at cases on their merits
Speaker 3: and are not pursuing a political agenda. If the Court
Speaker 3: turns over a decision handed down barely a decade ago
Speaker 3: that has had this profounded impact on the nation's fabric,
Speaker 3: I think his effort to persuade people that this court
Speaker 3: is anything other than the super legislature will fail.
Speaker 1: I mean, do you think Thomas with these statements as
Speaker 1: an outlier that the other justices are sort of cringing
Speaker 1: when they hear them.
Speaker 3: I imagine the Chief Justice was cringing all the way
Speaker 3: through reading accounts of this, because Justice Thomas is so
Speaker 3: overtly politicizing the court. But Justice Thomas is winning a
Speaker 3: lot more cases than he's losing these days, So it
Speaker 3: would seem that a number of other justices are pretty
Speaker 3: comfortable with this approach.
Speaker 1: So you think it's just the Chief that's uncomfortable with
Speaker 1: these sort of brazen statements from Thomas.
Speaker 3: I think a lot of the others, first and foremost
Speaker 3: the Chief, but certainly also Justice Barrett, would rather we
Speaker 3: not be this explicit about the Court pursuing its own agenda.
Speaker 3: But Justice Thomas, I guess it's feels like he's reached
Speaker 3: the point where he sees no reason to be secret
Speaker 3: to about it. He's got a super majority, he can
Speaker 3: lose a very conservative justice and still win a case,
Speaker 3: and so he's prepared to dispense with pretemps.
Speaker 1: And why do you say Justice Barrett in particular.
Speaker 3: Well, she's given a couple of interviews lately in which
Speaker 3: she said that we're not at a constitutional crisis and
Speaker 3: things are working more or less ordinarily, and they sort
Speaker 3: of downplaying the importance of what's happening and seems to
Speaker 3: suggest that what we're doing is simply a technical act
Speaker 3: of judging, and Justice Thomas is saying, no, I'm not
Speaker 3: doing technical judging. I'm getting rid of the stupid stuff.
Speaker 1: Well, we're off to a new start on Monday. We'll
Speaker 1: see whether this new term brings any more reversals of precedent.
Speaker 1: Thanks so much, David. That's Professor David Super of Georgetown Law.
Speaker 1: Last week, President Trump warned about the unproven link between
Speaker 1: women's use of thailanol during pregnancy and autism in children
Speaker 1: and advise women to tough it out.
Speaker 4: For this reason, they are strongly recommending that women limit
Speaker 4: iler and all use during pregnancy unless medically necessary, that's,
Speaker 4: for instance, in cases of extremely high fever.
Speaker 1: Medical experts and organizations immediately slam the remarks as irresponsible
Speaker 1: and dangerous advice not backed by science, and thailan al's
Speaker 1: manufacturers said there is no proven link between taking acidaminifin
Speaker 1: and autism. Still, the FDA has initiated the process for
Speaker 1: a labeled change to products containing a set ofminifin. Joining
Speaker 1: me is healthcare attorney Harry Nelson, a partner at leech
Speaker 1: Tishman Nelson Hardiman. So let's start with the elephant in
Speaker 1: the room, so to speak, President Trump and of course
Speaker 1: RFK Junior's claim that there is a link between the
Speaker 1: use of thailanol during pregnancy and autism in children.
Speaker 5: So President Trump and the FDA were citing two US studies.
Speaker 5: In both studies there was some heightened rate of autism
Speaker 5: in the population of moms who took seamnifin thailanl during pregnancy.
Speaker 5: So the FAA was rolling on these two studies. What
Speaker 5: many people are pointing out is that there was a
Speaker 5: very large Swedish study of the same issue with two
Speaker 5: point five million people participating, substantially a bigger cohort, which
Speaker 5: found absolutely no link. So first, there's really competing data
Speaker 5: on the point, and second, there's nothing here to suggest
Speaker 5: causation that thailandal causes autism if taken by a mother
Speaker 5: and pregnancy, rather some correlation which needs to be studied further.
Speaker 5: So it's an interesting case again of a major divide
Speaker 5: about what good science looks like.
Speaker 1: Well, also in the FDA news release itself, it said,
Speaker 1: it's important to note that while in association between a
Speaker 1: set of MINIFIT and neurological conditions has been described in
Speaker 1: many studies, a causal relationship has not been established, and
Speaker 1: there are contrary studies in the scientific literature. So why
Speaker 1: are they doing this if they're saying in their own
Speaker 1: statement that it hasn't been established.
Speaker 5: My sense is that this president and this administration is
Speaker 5: really trying to make sure that it maintains an activist
Speaker 5: kind of footing with people who are looking for change
Speaker 5: in its base of supporters, and that this was a
Speaker 5: very aggressive style of announcement that was made before there
Speaker 5: was any kind of conclusive process here, but that this
Speaker 5: was done really as a kind of political driver, with
Speaker 5: the president wanting an opportunity to stand at the podium
Speaker 5: and make the claim that he's doing something to protect
Speaker 5: public health and fighting back against the scientific establishment, you know,
Speaker 5: and yet another way. So that's at least my sense
Speaker 5: of why this happened the way it did.
Speaker 1: When does the law allow the FDA to change a
Speaker 1: drug label.
Speaker 5: So the FDA can at any point initiate an administrative
Speaker 5: process of looking at how a drug both a prescription
Speaker 5: druger and over the counter drug and tailanol interestingly is
Speaker 5: both has both forms. You know, there's a whole administrative
Speaker 5: process by which a change can be proposed, the public
Speaker 5: has a chance to comment on it, and then it's
Speaker 5: finally ordered. And then only after that process do prescription
Speaker 5: drug manufacturers like the company can view here that makes
Speaker 5: tilanol have the right to challenge it. So there's a
Speaker 5: long process that's still ahead, and it's not unusual for
Speaker 5: the FDA to undertake that process. It's just that here
Speaker 5: the sequence of events of really that evidence, review, the decision,
Speaker 5: and a process that happening came second. Normally that process
Speaker 5: comes first. Here the political announcement came ahead of everything.
Speaker 1: Is it normal to do this without negotiating with the
Speaker 1: company first.
Speaker 5: I do think that it is more typical to allow
Speaker 5: prescription drug manufacturers to be part of a process and
Speaker 5: make sure that all of the evidence, all of the
Speaker 5: research is considered. So I don't know exactly how much
Speaker 5: can view, how much opportunity had. It seems clear from
Speaker 5: everything that the company is saying that it intends fully
Speaker 5: to challenge this action and to argue that the FDA
Speaker 5: is acting without sufficient scientific justification and that process. Certainly,
Speaker 5: if there was an unquestionable issue here, the FDA normally
Speaker 5: could have started in dialogue with the company to make
Speaker 5: sure that this action was sound. You know, the thing
Speaker 5: that worries me the most here is that TAILERML is
Speaker 5: one of the most widely used and trusted medications out
Speaker 5: there during pregnancy as well as for many other conditions,
Speaker 5: and this creates a risk of confusion of fear, and
Speaker 5: you know that's a process is not great for public health.
Speaker 1: Yeah, I mean, there are so many stories about doctors
Speaker 1: obgyns receiving tons of calls from pregnant women who don't
Speaker 1: know what to do. They're very confused about this new
Speaker 1: allegation I guess from the FDA.
Speaker 5: Yeah. And it's by the way, globally, we're seeing with
Speaker 5: World Health Organization and European drug regulatory systems that around
Speaker 5: the rest of the world, the message is going out
Speaker 5: that that has seen a minifit is perfectly safe for
Speaker 5: pregnant mothers. And so this is like a creating a
Speaker 5: real contrast between the public health word in the rest
Speaker 5: of the world and apparently in the United States that
Speaker 5: this goes all the way through.
Speaker 1: And do we know how the FDA intends to change
Speaker 1: the label. Is it going to be like a tobacco
Speaker 1: warning on cigarette packs.
Speaker 5: Well, it's a big question. Again, it's a question whether
Speaker 5: this is only going to apply to the prescription drug
Speaker 5: form or also to the over the counter form. There's
Speaker 5: a lot of generic cinematics and out there on sales,
Speaker 5: and it's not clear exactly who this is going to
Speaker 5: apply to or what the labels going to look like.
Speaker 5: That's something that will have to be resolved by the
Speaker 5: FDA as we go through the administrative process ahead.
Speaker 1: So the drugmaker can only challenge in the administrative process
Speaker 1: after the review is complete.
Speaker 5: Yeah, exactly. There needs to be a final order. So
Speaker 5: so first the agency has to make the final proposed action,
Speaker 5: as it's called, and then there has to be an
Speaker 5: opportunity for the public to comment, and only when the
Speaker 5: action is actually finalized and is an agency decision by
Speaker 5: the FDA. At that point, you know the issue is
Speaker 5: ripe to be challenged by the drug manufacturer.
Speaker 1: Harry, does anyone in the healthcare community doubt that no
Speaker 1: matter what the public comments are and what the manufacturer says,
Speaker 1: that the FDA is going to go ahead to try
Speaker 1: to relabel a cineminefin.
Speaker 5: I think it's fairly safe to say this administration has
Speaker 5: a strong grip on the FDA. No one is expecting
Speaker 5: a kind of independence or for the FDA leadership to
Speaker 5: buck the announcements, particularly after it's made by the President.
Speaker 5: So you know, and by the way, I should say
Speaker 5: that manufacturer will have initially it has a challenge in
Speaker 5: the FDA, but eventually we'll get to a federal court
Speaker 5: and be before a federal judge to make the argument
Speaker 5: that this action is arbitrary and capricious and not grounded
Speaker 5: in solid science. So there's no question in my mind
Speaker 5: that the FDA is going to move forward here, but
Speaker 5: the question of whether this actually stands is a very
Speaker 5: big one.
Speaker 1: Coming up next on the Bloomberg Law Show, I'll continue
Speaker 1: this conversation with healthcare attorney Harry Nelson. Can the manufacturer
Speaker 1: ignore the administrative process and go straight to court? I'm
Speaker 1: June Grosso. When you're listening to Bloomberg, the Food and
Speaker 1: Drug Administration said it initiated the process for a labeled
Speaker 1: change to products containing a sit of minifin after President
Speaker 1: Trump's announcement last week that warned about the unproven link
Speaker 1: between women use of tail and all during pregnancy and
Speaker 1: autism in children. Trump's announcement on the medication, which has
Speaker 1: long been recommended during pregnancy to treat pain, fever, and aches,
Speaker 1: has spurred confusion for patients and pushback from medical organizations.
Speaker 1: I've been talking to healthcare attorney Harry Nelson, a partner
Speaker 1: at Leech Tishman Nelson Hardiman. Since the manufacturer basically knows
Speaker 1: what's going to happen down the road, can they jump
Speaker 1: the administrative process and just go to court.
Speaker 5: No, It's a fundamental principle and administrative law that you
Speaker 5: have to wait for a final action. Judges don't want
Speaker 5: to be making decisions about things that are still influx
Speaker 5: in the regulatory process. So since there has been no
Speaker 5: action taken yet by the FDA, just a warning that's
Speaker 5: going to happen, the company doesn't have great recourse. It
Speaker 5: essentially is sort of fighting. Has to really fight this
Speaker 5: issue for the time being in the media and try
Speaker 5: to hold on to public trust, you know, fight for
Speaker 5: its stock price and build confidence, But judges do not
Speaker 5: want to be addressing this issue until the FDA has
Speaker 5: actually done something.
Speaker 1: This is sort of wild, but could the company sue
Speaker 1: Trump and Kennedy for defamation?
Speaker 5: The principle of sovereign immunity here limits the action. We
Speaker 5: already have the Supreme Court, by the way, broadening substantially
Speaker 5: the things that the president is immune for actions taken
Speaker 5: in executive office. But this is classically something where there's
Speaker 5: a mixed case. So it's not like President Trump acted
Speaker 5: without any scientific basis. It's just that there's evidence on
Speaker 5: both sides of this issue. So I think it's going
Speaker 5: to be very difficult for the company to think about
Speaker 5: actually having a case against Trump or against RFK.
Speaker 1: This is just, I mean, a chip of the iceberg.
Speaker 1: The Trump administration or RFK his department is continuing to
Speaker 1: put out information and guidance that contradicts medical organizations and
Speaker 1: scientists and state health departments on vaccines and antidepressants. Is
Speaker 1: anything being done about that?
Speaker 5: I think you're right, by the way. A lot of
Speaker 5: how I view this is this issue is in many
Speaker 5: ways adjacent to this broader effort, whether it's around vaccines
Speaker 5: or otherwise on public health to really undermine confidence and
Speaker 5: agencies and to express more skepticism and to validate people
Speaker 5: who are already incredibly skeptical of our public health agencies.
Speaker 5: So I think a massive kind of political persuasive effort
Speaker 5: has been underway kind of underpins all of these issues
Speaker 5: around RFK and around our public health system. I think
Speaker 5: that's an issue that's going to be decided in many
Speaker 5: ways at the ballot box and by courts, which are
Speaker 5: going to be called upon to decide what is arbitrary
Speaker 5: and frecious and when government agencies are justified. So I
Speaker 5: don't know that there's any recourse other than voting for
Speaker 5: administrations that take positions on public health and science that
Speaker 5: people support, or judges standing in.
Speaker 1: Let's say the FDA approves the final rule and then
Speaker 1: they're sued by the manufacturer. I mean, what kind of
Speaker 1: decisions would the judges be making that this was arbitrary
Speaker 1: and capricious, or would they be making decisions about the science.
Speaker 5: I think the fundamental issue that judges have to confront
Speaker 5: is the administrative prestide erect. That is the federal law
Speaker 5: by which all federal agencies make rules, whether it's the
Speaker 5: environmental protection agency, whether it's the Food and Drug Administration,
Speaker 5: the Center for Disease Control. So it is a decision
Speaker 5: about arbitrary and capriciousness, and whether the procedure by which
Speaker 5: the decision was made was handled in a fair way.
Speaker 5: In that process, inherently part of figuring out what's arbitrary
Speaker 5: and capricious is assigning if the findings are supported by
Speaker 5: the evidence, and if the conclusions are supported by the finding.
Speaker 5: So I don't think it's possible for judges to completely escape,
Speaker 5: you know, having opinions about science. That's really the tricky
Speaker 5: part here is that the administration did operate on the
Speaker 5: basis of some studies. It's just that we also see contrary,
Speaker 5: much larger studies that totally contradict what they did.
Speaker 1: And where does RFK Junior and the Health Department stand
Speaker 1: on vaccines?
Speaker 5: At this point, the administration has moved forward on a
Speaker 5: complete policy shift on vaccine distribution, and I think like
Speaker 5: a substantial amount has already happened to cut funding, cut distribution,
Speaker 5: and change policy in a way that also is going
Speaker 5: to drive lack of coverage in the insurance industry. There
Speaker 5: are multiple lawsuits going forward. State attorneys general have brought
Speaker 5: lawsuits to challenge vaccine policy. It's just that we have
Speaker 5: not seen any legal action yet that is really undercutting
Speaker 5: anything that the administration is doing.
Speaker 1: And in some states, I know New York State, the
Speaker 1: governor declared that, you know, vaccines would be paid for.
Speaker 5: Right. So there's two different levels. One is a challenge
Speaker 5: to the actions of Department Health, um Services and RFK
Speaker 5: in terms of changing vaccine recommendations and access from government programs.
Speaker 5: And the second issue is all of the commercial health
Speaker 5: plans that are affecting their changing coverage. By the way,
Speaker 5: a number of private organizations, the American Academy Pediatrics, the
Speaker 5: American Public Health Association, and a number of other groups
Speaker 5: have also filed suit claiming the actions are unlawful. We
Speaker 5: have since nineteen eighty six, we've had the National Childhood
Speaker 5: Vaccine Injury Act. There's been the arguments made that the
Speaker 5: existing federal law preempts the actions that are being taken,
Speaker 5: and that we already have a substantial amount of process
Speaker 5: also here too under the Administrative Proceedure Act for how
Speaker 5: this has to happen. So I do think there is
Speaker 5: going to be a reckoning with the vaccine policy. The
Speaker 5: question is how much will have already happened on the
Speaker 5: ground based on narrower eligibility, based on the ending of
Speaker 5: emergency use authorsations for COVID vaccines, and changes on all
Speaker 5: these advisory and recommendation bodies that are adjusting vaccine schedules.
Speaker 5: So there's a lot of change on the ground, but
Speaker 5: there will be a reckoning at court at some point.
Speaker 1: Has there been another administration where there was so much
Speaker 1: change at the Health Department in such a short period
Speaker 1: of time, sort of upending the norms.
Speaker 5: I think it's safe to say that this administration has
Speaker 5: set a new bar for activism and for lawsuits and
Speaker 5: for controversy around federal health posse. It's not like we
Speaker 5: never had these issues before. It's just that we've never
Speaker 5: seen an administration that had such an ideologically aggressive position
Speaker 5: on hostility to the pharmaceutical industry and to vaccines themselves,
Speaker 5: and so many questions about science. It's you can go
Speaker 5: back and you can cherry pick examples from the Obama
Speaker 5: administration or from the Reagan administration where we had narrow
Speaker 5: issues come up on particular public health points. But there's
Speaker 5: never been an administration with the breadth and depth of
Speaker 5: public health changes, really significant changes that we're seeing this year.
Speaker 1: Thanks so much, Harry. That's healthcare attorney Harry Nelson of
Speaker 1: Leech Tishman Nelson Hardiman. And that's it for this edition
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