Latest / Bloomberg Law / Justice Thomas Cautions Against Following Precedent
Transcript
- 0:02Speaker 1: This is Bloomberg Law with June Grossel from Bloomberg Radio.
- 0:09Speaker 2: Just think of law as these cases as a series
- 0:12Speaker 2: of kate of cars on a long train, and you
- 0:16Speaker 2: just accept the train, and you just add another car.
- 0:21Speaker 2: We just follow wherever it's going. We never go to
- 0:23Speaker 2: the front see who's driving the train. Where's it going?
- 0:28Speaker 2: And you could go up there in the engine room
- 0:31Speaker 2: and find us an orangutang drive in the train. Would
- 0:34Speaker 2: you want to follow that just because it's a train.
- 0:37Speaker 1: Justice Clarence Thomas used that train metaphor last week to
- 0:42Speaker 1: describe the import of settled law or precedent in deciding
- 0:46Speaker 1: new cases. Thomas downplayed the importance of prior Supreme Court
- 0:51Speaker 1: cases and said he wouldn't follow them if it doesn't
- 0:55Speaker 1: make sense to him.
- 0:56Speaker 2: And I don't think that any of these cases that
- 0:58Speaker 2: have been decided are the gospel. And I do give
- 1:02Speaker 2: respect to precedent, but it should to precedent should be
- 1:07Speaker 2: respectful of our legal tradition and our country and our laws,
- 1:12Speaker 2: and be based on something not just something that somebody
- 1:16Speaker 2: dreamt up and others went along with.
- 1:19Speaker 1: In the new term, beginning on Monday, the Supreme Court
- 1:22Speaker 1: will be considering several cases with long standing precedents, including
- 1:28Speaker 1: a ninety year old precedent that limits a president's ability
- 1:32Speaker 1: to remove members of some independent federal agencies without cause
- 1:37Speaker 1: and a landmark nineteen eighty six decision about the use
- 1:41Speaker 1: of race in redistricting under the Voting Rights Act. So
- 1:45Speaker 1: Thomas's comments dissing the importance of prior case law might
- 1:50Speaker 1: lead some to question whether those precedents will be overruled,
- 1:55Speaker 1: much as the Court has overrule precedents like the constitutional
- 1:59Speaker 1: right to a book and race and college admissions decisions.
- 2:03Speaker 1: My guest is Supreme Court expert David Super, a professor
- 2:07Speaker 1: at Georgetown Law. David, what was your reaction to Thomas's comments.
- 2:14Speaker 3: Justice Thomas's remarks were quite remarkable. He said that adherence
- 2:19Speaker 3: to precedent is perhaps overrated. He compared it to a
- 2:24Speaker 3: situation where people are riding a train without knowing who's
- 2:29Speaker 3: in the cabin driving the engine and suggested that that
- 2:33Speaker 3: might well be an orangutan, and we should not take
- 2:37Speaker 3: directions from an orangutan. I've never compared the US Supreme
- 2:41Speaker 3: Court to an orangutan, but he has apparently, And he
- 2:44Speaker 3: said that precedent may be something that one person just
- 2:49Speaker 3: bought up and everyone else said, yeah, let's go along.
- 2:53Speaker 3: And on that basis, he thinks that the court needs
- 2:56Speaker 3: to be more willing to overrule precedent unless deferential. President.
- 3:01Speaker 1: When the Supreme Court justices have their confirmation hearings, they
- 3:04Speaker 1: all say, oh, you know, we're going to follow precedent. Yes, yes, yes,
- 3:09Speaker 1: And of course they don't in many cases. So tell
- 3:13Speaker 1: us about the importance of precedents in the law.
- 3:16Speaker 3: Well, precedent is what makes the courts distinctive. Anybody can
- 3:22Speaker 3: decide however they want at the moment. Why we listen
- 3:27Speaker 3: to the courts is because they are bound by the law,
- 3:31Speaker 3: and in the Anglo American system, the law is precedent.
- 3:35Speaker 3: We even have a fancy term for it, starry decisives,
- 3:38Speaker 3: and it is supposed to be what keeps unelected judges
- 3:44Speaker 3: from acting willfully and just pursuing their personal agendas.
- 3:48Speaker 1: He also said, it's not the gospel, which I always
- 3:50Speaker 1: thought precedent was the gospel. But as you mentioned, he
- 3:53Speaker 1: in a backhanded way, made fun of prior Supreme Court justices.
- 3:58Speaker 1: He said, the President and if it's totally stupid, and
- 4:02Speaker 1: that's what they've decided. You don't go along with it
- 4:04Speaker 1: just because it's decided. Does it show just a lack
- 4:07Speaker 1: of respect for prior justices.
- 4:11Speaker 3: Well, it certainly does. It suggests that the current court
- 4:14Speaker 3: is smart and its predecessors are foolish, which is a
- 4:18Speaker 3: remarkably condescending approach. It's also an ahistorical approach. We've had
- 4:25Speaker 3: many brilliant justices on the court. We've had many court
- 4:30Speaker 3: that historians regard as all star courts, packed with brilliant
- 4:35Speaker 3: legal minds, and to suggest that they can be compared
- 4:39Speaker 3: to orangutans, it's disappointing.
- 4:41Speaker 1: Thomas is a believer in originalism looking at history, but
- 4:47Speaker 1: yet when the justices look at history, they often come
- 4:51Speaker 1: up with totally different conclusions about the historical origins of
- 4:56Speaker 1: the law. Why does he think that that's so much
- 4:59Speaker 1: better better than following precedent, I don't know.
- 5:03Speaker 3: And I find it exceedingly strange that perhaps the court's
- 5:09Speaker 3: most vociferous originalist is taking this view, Because if there
- 5:14Speaker 3: is one core principle of the original understanding of the
- 5:18Speaker 3: courts is that they were bound by precedent. That's the
- 5:22Speaker 3: essence of the common law system that England had for
- 5:26Speaker 3: many centuries before the founding of this country, and that originalists,
- 5:31Speaker 3: like Justice Thomas say, should control how we decide things now.
- 5:37Speaker 3: There are important decisions that were handed down five six
- 5:42Speaker 3: hundred years ago that decided difficult questions and that no
- 5:46Speaker 3: court since then has ever disputed. Just as Thomas seems
- 5:51Speaker 3: to suggest that that core original aspect of Anglo American
- 5:55Speaker 3: jurisprudence is irrelevant, this is not.
- 5:59Speaker 1: Really anything new for Justice Thomas. The late Justice Antonin
- 6:04Speaker 1: Scalia told one of Thomas's biographers quote, he doesn't believe
- 6:09Speaker 1: in starry decisive period and Thomas has also frequently suggested
- 6:14Speaker 1: overturning landmark opinions in cases that are not before the court.
- 6:20Speaker 3: Well, and it's important that Justice Cleia was Justice Thomas's
- 6:23Speaker 3: best friend on the court and most frequent ally, but
- 6:29Speaker 3: unlike Justice Thomas, Justice Cleia generally decided the cases that
- 6:35Speaker 3: were brought for him, whereas Justice Thomas for a long
- 6:39Speaker 3: time has written concurring or descending opinions inviting parties to
- 6:46Speaker 3: bring cases to the court. That departs from another important
- 6:50Speaker 3: aspect of originalism, which is that the courts are passive.
- 6:55Speaker 3: They take the cases that come to them, but they
- 6:58Speaker 3: don't go out trying to do affirmative policy making. Again,
- 7:02Speaker 3: that goes back hundreds and hundreds of years, and an
- 7:06Speaker 3: originalist like Justice Thomas should be particularly anxious to follow
- 7:11Speaker 3: the traditional role of the courts as passive deciders rather
- 7:16Speaker 3: than as policy makers with an agenda.
- 7:19Speaker 1: The Roberts Court has overturned I read twenty one precedents,
- 7:23Speaker 1: but it includes significant precedents, of course, the constitutional right
- 7:27Speaker 1: to abortion in Roe v. Wade, race conscious admissions and
- 7:31Speaker 1: higher education and the Harvard case, the power of executive agencies,
- 7:35Speaker 1: and the Chevron doctrine, a forty year old precedent on
- 7:39Speaker 1: unions in the Janice case. And seventeen of those cases
- 7:44Speaker 1: that they overturned were split five to four decisions, with
- 7:48Speaker 1: the conservative justices on one side and the liberal justices
- 7:52Speaker 1: on the other. I mean, does that tell you anything
- 7:56Speaker 1: about what was going on there? Well?
- 8:00Speaker 3: Does suggest that this is a court with an agenda,
- 8:04Speaker 3: That they are not calling balls and strikes, as justices
- 8:09Speaker 3: like to say when they're seeking confirmation, but rather that
- 8:13Speaker 3: they're pursuing a particular agenda, that they are more conservative
- 8:19Speaker 3: than their four bears, and they're trying to move the
- 8:21Speaker 3: law in that direction. I should note that one of
- 8:24Speaker 3: those five four decisions you mentioned actually had five justices
- 8:30Speaker 3: voting to overturn president, and the Chief Justice, a very
- 8:34Speaker 3: conservative justice in his own right, joining with the pree
- 8:38Speaker 3: moderate to liberal justices in disagreeing that being bobbed.
- 8:43Speaker 1: Roberts recently has talked about how you know, the Roberts Court,
- 8:47Speaker 1: His court overturned precedence at the lowest rate of any
- 8:51Speaker 1: of the recent courts, and the New York Times study
- 8:54Speaker 1: said that it was one point six per term averaged out.
- 8:58Speaker 1: But does that ignore the significance or the importance of
- 9:02Speaker 1: the precedents that they're overturning.
- 9:05Speaker 3: Well, it does, and it also is subject to a
- 9:10Speaker 3: lot of counting. There have been many, many, many cases
- 9:14Speaker 3: about abortion rights after Roe v. Wade. Do you say
- 9:18Speaker 3: that Bob's only overturned Row. No, it made a whole
- 9:22Speaker 3: bunch of other cases irrelevant and wrong as well when
- 9:25Speaker 3: they said this or that restriction on abortion was unconstitutional.
- 9:30Speaker 3: So you have to make some very arbitrary choices in
- 9:34Speaker 3: doing account like that. There are going to be some
- 9:38Speaker 3: very very technical cases in admulti law that may get
- 9:43Speaker 3: overturned because of new technology, and no one really knows
- 9:47Speaker 3: or cares, and then they're going to be sweeping decisions
- 9:51Speaker 3: about the Fourteenth Amendment about the separation of powers, and
- 9:55Speaker 3: that kind of counting game blurs all of them together.
- 10:00Speaker 1: We look at the upcoming term that starts on Monday,
- 10:04Speaker 1: there seem to be a few precedents that may get overturned,
- 10:07Speaker 1: and one involves that nearly century old ruling called Humphrey's
- 10:12Speaker 1: Executor that protects the heads of independent agencies. Justice Elena Kagan,
- 10:18Speaker 1: in a dissent when the majority allowed Trump to fire
- 10:23Speaker 1: for now, the last Democratic member of the FTC, said
- 10:27Speaker 1: that her colleagues are quote raring to overturn Humphrey's Executor.
- 10:32Speaker 1: Do you think that'll be the next precedent to go?
- 10:35Speaker 3: It will be unless they overturned something else first. Humphrey's
- 10:39Speaker 3: Executor is clearly on its way out. There's a real
- 10:43Speaker 3: irony here because Justices Gorsuch and Capitol have criticized lower
- 10:49Speaker 3: courts for not showing in our prospect or Supreme Court president,
- 10:53Speaker 3: even when that president is handed down through the shadow docket,
- 10:57Speaker 3: without full briefing, without oral argument, without much of an opinion.
- 11:02Speaker 3: And here Justice Thomas, their partner, is turning around and
- 11:07Speaker 3: saying that he would disrespect Supreme Court decisions even that
- 11:12Speaker 3: were fully argued, fully briefed, and the result of painstaking opinions.
- 11:17Speaker 3: I think the Justices need to decide whether the work
- 11:20Speaker 3: of the Supreme Court is or is not entitled to
- 11:23Speaker 3: great deference.
- 11:24Speaker 1: The Trump administration is asking the justices to take his
- 11:29Speaker 1: challenge to birthright citizenship, and they did use the birthright
- 11:34Speaker 1: citizenship clash to make it harder for federal judges to
- 11:38Speaker 1: block government policies nationwide. If they take this case, does
- 11:44Speaker 1: that say, yes, we're going to overturn the precedent from
- 11:47Speaker 1: eighteen ninety eight that supported birthright.
- 11:51Speaker 3: Citizenship and as the president handed down by arguably the
- 11:55Speaker 3: most conservative Supreme Court in the nation's history, So it
- 11:59Speaker 3: would be quite remarkable to overturn that case. I think
- 12:04Speaker 3: the Justices will take this simply because it's a high
- 12:08Speaker 3: profile and very important matter that the President has been emphasizing.
- 12:14Speaker 3: I would have trouble imagining how they could overturn it.
- 12:17Speaker 3: The original opinion is based on analysis of historical uses
- 12:23Speaker 3: of terms going back hundreds of years. It's a very
- 12:26Speaker 3: model of originalism, and the Trump administration's complaint is largely
- 12:32Speaker 3: a political one responding to their base and their opposition
- 12:36Speaker 3: to immigrants. Any serious originalist approach would affirm the plain
- 12:43Speaker 3: language of the fourteenth Amendment and the decision from the
- 12:47Speaker 3: nineteenth century.
- 12:48Speaker 1: In a concurring opinion in the Dodds case, which overturned
- 12:52Speaker 1: Row Thomas suggested revisiting cases concerning the rights to conception,
- 12:57Speaker 1: same sex intimacy, and marriage quality. And the Court is
- 13:01Speaker 1: being asked to overturn the Obergefell decision, the landmark twenty
- 13:08Speaker 1: fifteen decision that legalized same sex marriage nationwide in a
- 13:13Speaker 1: case involving Kim Davis, the former Kentucky cleric who became
- 13:18Speaker 1: famous when she was jailed for refusing to issue marriage
- 13:22Speaker 1: licenses to a gay couple on religious grounds. Do you
- 13:25Speaker 1: think that same sex marriage is in jeopardy.
- 13:29Speaker 3: It certainly is in jeopardy. It's hard to know what
- 13:32Speaker 3: the Court will do. The Chief Justice Roberts has been
- 13:35Speaker 3: insisting that the judges look at cases on their merits
- 13:40Speaker 3: and are not pursuing a political agenda. If the Court
- 13:44Speaker 3: turns over a decision handed down barely a decade ago
- 13:51Speaker 3: that has had this profounded impact on the nation's fabric,
- 13:56Speaker 3: I think his effort to persuade people that this court
- 14:00Speaker 3: is anything other than the super legislature will fail.
- 14:03Speaker 1: I mean, do you think Thomas with these statements as
- 14:05Speaker 1: an outlier that the other justices are sort of cringing
- 14:09Speaker 1: when they hear them.
- 14:11Speaker 3: I imagine the Chief Justice was cringing all the way
- 14:14Speaker 3: through reading accounts of this, because Justice Thomas is so
- 14:19Speaker 3: overtly politicizing the court. But Justice Thomas is winning a
- 14:24Speaker 3: lot more cases than he's losing these days, So it
- 14:28Speaker 3: would seem that a number of other justices are pretty
- 14:32Speaker 3: comfortable with this approach.
- 14:34Speaker 1: So you think it's just the Chief that's uncomfortable with
- 14:37Speaker 1: these sort of brazen statements from Thomas.
- 14:42Speaker 3: I think a lot of the others, first and foremost
- 14:45Speaker 3: the Chief, but certainly also Justice Barrett, would rather we
- 14:48Speaker 3: not be this explicit about the Court pursuing its own agenda.
- 14:54Speaker 3: But Justice Thomas, I guess it's feels like he's reached
- 14:57Speaker 3: the point where he sees no reason to be secret
- 14:59Speaker 3: to about it. He's got a super majority, he can
- 15:02Speaker 3: lose a very conservative justice and still win a case,
- 15:06Speaker 3: and so he's prepared to dispense with pretemps.
- 15:10Speaker 1: And why do you say Justice Barrett in particular.
- 15:14Speaker 3: Well, she's given a couple of interviews lately in which
- 15:18Speaker 3: she said that we're not at a constitutional crisis and
- 15:22Speaker 3: things are working more or less ordinarily, and they sort
- 15:26Speaker 3: of downplaying the importance of what's happening and seems to
- 15:31Speaker 3: suggest that what we're doing is simply a technical act
- 15:35Speaker 3: of judging, and Justice Thomas is saying, no, I'm not
- 15:38Speaker 3: doing technical judging. I'm getting rid of the stupid stuff.
- 15:42Speaker 1: Well, we're off to a new start on Monday. We'll
- 15:45Speaker 1: see whether this new term brings any more reversals of precedent.
- 15:50Speaker 1: Thanks so much, David. That's Professor David Super of Georgetown Law.
- 15:54Speaker 1: Last week, President Trump warned about the unproven link between
- 15:59Speaker 1: women's use of thailanol during pregnancy and autism in children
- 16:04Speaker 1: and advise women to tough it out.
- 16:07Speaker 4: For this reason, they are strongly recommending that women limit
- 16:11Speaker 4: iler and all use during pregnancy unless medically necessary, that's,
- 16:18Speaker 4: for instance, in cases of extremely high fever.
- 16:22Speaker 1: Medical experts and organizations immediately slam the remarks as irresponsible
- 16:28Speaker 1: and dangerous advice not backed by science, and thailan al's
- 16:32Speaker 1: manufacturers said there is no proven link between taking acidaminifin
- 16:37Speaker 1: and autism. Still, the FDA has initiated the process for
- 16:42Speaker 1: a labeled change to products containing a set ofminifin. Joining
- 16:47Speaker 1: me is healthcare attorney Harry Nelson, a partner at leech
- 16:50Speaker 1: Tishman Nelson Hardiman. So let's start with the elephant in
- 16:54Speaker 1: the room, so to speak, President Trump and of course
- 16:58Speaker 1: RFK Junior's claim that there is a link between the
- 17:02Speaker 1: use of thailanol during pregnancy and autism in children.
- 17:07Speaker 5: So President Trump and the FDA were citing two US studies.
- 17:13Speaker 5: In both studies there was some heightened rate of autism
- 17:19Speaker 5: in the population of moms who took seamnifin thailanl during pregnancy.
- 17:26Speaker 5: So the FAA was rolling on these two studies. What
- 17:28Speaker 5: many people are pointing out is that there was a
- 17:31Speaker 5: very large Swedish study of the same issue with two
- 17:35Speaker 5: point five million people participating, substantially a bigger cohort, which
- 17:40Speaker 5: found absolutely no link. So first, there's really competing data
- 17:44Speaker 5: on the point, and second, there's nothing here to suggest
- 17:48Speaker 5: causation that thailandal causes autism if taken by a mother
- 17:52Speaker 5: and pregnancy, rather some correlation which needs to be studied further.
- 17:57Speaker 5: So it's an interesting case again of a major divide
- 18:02Speaker 5: about what good science looks like.
- 18:04Speaker 1: Well, also in the FDA news release itself, it said,
- 18:09Speaker 1: it's important to note that while in association between a
- 18:11Speaker 1: set of MINIFIT and neurological conditions has been described in
- 18:15Speaker 1: many studies, a causal relationship has not been established, and
- 18:19Speaker 1: there are contrary studies in the scientific literature. So why
- 18:25Speaker 1: are they doing this if they're saying in their own
- 18:27Speaker 1: statement that it hasn't been established.
- 18:31Speaker 5: My sense is that this president and this administration is
- 18:36Speaker 5: really trying to make sure that it maintains an activist
- 18:41Speaker 5: kind of footing with people who are looking for change
- 18:45Speaker 5: in its base of supporters, and that this was a
- 18:49Speaker 5: very aggressive style of announcement that was made before there
- 18:54Speaker 5: was any kind of conclusive process here, but that this
- 18:58Speaker 5: was done really as a kind of political driver, with
- 19:01Speaker 5: the president wanting an opportunity to stand at the podium
- 19:05Speaker 5: and make the claim that he's doing something to protect
- 19:07Speaker 5: public health and fighting back against the scientific establishment, you know,
- 19:12Speaker 5: and yet another way. So that's at least my sense
- 19:14Speaker 5: of why this happened the way it did.
- 19:17Speaker 1: When does the law allow the FDA to change a
- 19:21Speaker 1: drug label.
- 19:22Speaker 5: So the FDA can at any point initiate an administrative
- 19:26Speaker 5: process of looking at how a drug both a prescription
- 19:29Speaker 5: druger and over the counter drug and tailanol interestingly is
- 19:31Speaker 5: both has both forms. You know, there's a whole administrative
- 19:35Speaker 5: process by which a change can be proposed, the public
- 19:38Speaker 5: has a chance to comment on it, and then it's
- 19:40Speaker 5: finally ordered. And then only after that process do prescription
- 19:44Speaker 5: drug manufacturers like the company can view here that makes
- 19:47Speaker 5: tilanol have the right to challenge it. So there's a
- 19:50Speaker 5: long process that's still ahead, and it's not unusual for
- 19:53Speaker 5: the FDA to undertake that process. It's just that here
- 19:57Speaker 5: the sequence of events of really that evidence, review, the decision,
- 20:00Speaker 5: and a process that happening came second. Normally that process
- 20:03Speaker 5: comes first. Here the political announcement came ahead of everything.
- 20:07Speaker 1: Is it normal to do this without negotiating with the
- 20:10Speaker 1: company first.
- 20:12Speaker 5: I do think that it is more typical to allow
- 20:15Speaker 5: prescription drug manufacturers to be part of a process and
- 20:20Speaker 5: make sure that all of the evidence, all of the
- 20:22Speaker 5: research is considered. So I don't know exactly how much
- 20:25Speaker 5: can view, how much opportunity had. It seems clear from
- 20:29Speaker 5: everything that the company is saying that it intends fully
- 20:31Speaker 5: to challenge this action and to argue that the FDA
- 20:34Speaker 5: is acting without sufficient scientific justification and that process. Certainly,
- 20:38Speaker 5: if there was an unquestionable issue here, the FDA normally
- 20:42Speaker 5: could have started in dialogue with the company to make
- 20:45Speaker 5: sure that this action was sound. You know, the thing
- 20:47Speaker 5: that worries me the most here is that TAILERML is
- 20:49Speaker 5: one of the most widely used and trusted medications out
- 20:53Speaker 5: there during pregnancy as well as for many other conditions,
- 20:56Speaker 5: and this creates a risk of confusion of fear, and
- 21:00Speaker 5: you know that's a process is not great for public health.
- 21:04Speaker 1: Yeah, I mean, there are so many stories about doctors
- 21:08Speaker 1: obgyns receiving tons of calls from pregnant women who don't
- 21:13Speaker 1: know what to do. They're very confused about this new
- 21:17Speaker 1: allegation I guess from the FDA.
- 21:19Speaker 5: Yeah. And it's by the way, globally, we're seeing with
- 21:21Speaker 5: World Health Organization and European drug regulatory systems that around
- 21:26Speaker 5: the rest of the world, the message is going out
- 21:28Speaker 5: that that has seen a minifit is perfectly safe for
- 21:31Speaker 5: pregnant mothers. And so this is like a creating a
- 21:34Speaker 5: real contrast between the public health word in the rest
- 21:39Speaker 5: of the world and apparently in the United States that
- 21:41Speaker 5: this goes all the way through.
- 21:43Speaker 1: And do we know how the FDA intends to change
- 21:46Speaker 1: the label. Is it going to be like a tobacco
- 21:48Speaker 1: warning on cigarette packs.
- 21:50Speaker 5: Well, it's a big question. Again, it's a question whether
- 21:53Speaker 5: this is only going to apply to the prescription drug
- 21:55Speaker 5: form or also to the over the counter form. There's
- 21:58Speaker 5: a lot of generic cinematics and out there on sales,
- 22:01Speaker 5: and it's not clear exactly who this is going to
- 22:03Speaker 5: apply to or what the labels going to look like.
- 22:05Speaker 5: That's something that will have to be resolved by the
- 22:06Speaker 5: FDA as we go through the administrative process ahead.
- 22:10Speaker 1: So the drugmaker can only challenge in the administrative process
- 22:15Speaker 1: after the review is complete.
- 22:18Speaker 5: Yeah, exactly. There needs to be a final order. So
- 22:21Speaker 5: so first the agency has to make the final proposed action,
- 22:25Speaker 5: as it's called, and then there has to be an
- 22:26Speaker 5: opportunity for the public to comment, and only when the
- 22:30Speaker 5: action is actually finalized and is an agency decision by
- 22:33Speaker 5: the FDA. At that point, you know the issue is
- 22:36Speaker 5: ripe to be challenged by the drug manufacturer.
- 22:38Speaker 1: Harry, does anyone in the healthcare community doubt that no
- 22:42Speaker 1: matter what the public comments are and what the manufacturer says,
- 22:48Speaker 1: that the FDA is going to go ahead to try
- 22:51Speaker 1: to relabel a cineminefin.
- 22:54Speaker 5: I think it's fairly safe to say this administration has
- 22:56Speaker 5: a strong grip on the FDA. No one is expecting
- 22:59Speaker 5: a kind of independence or for the FDA leadership to
- 23:03Speaker 5: buck the announcements, particularly after it's made by the President.
- 23:06Speaker 5: So you know, and by the way, I should say
- 23:08Speaker 5: that manufacturer will have initially it has a challenge in
- 23:11Speaker 5: the FDA, but eventually we'll get to a federal court
- 23:14Speaker 5: and be before a federal judge to make the argument
- 23:18Speaker 5: that this action is arbitrary and capricious and not grounded
- 23:21Speaker 5: in solid science. So there's no question in my mind
- 23:24Speaker 5: that the FDA is going to move forward here, but
- 23:27Speaker 5: the question of whether this actually stands is a very
- 23:29Speaker 5: big one.
- 23:30Speaker 1: Coming up next on the Bloomberg Law Show, I'll continue
- 23:32Speaker 1: this conversation with healthcare attorney Harry Nelson. Can the manufacturer
- 23:37Speaker 1: ignore the administrative process and go straight to court? I'm
- 23:41Speaker 1: June Grosso. When you're listening to Bloomberg, the Food and
- 23:46Speaker 1: Drug Administration said it initiated the process for a labeled
- 23:50Speaker 1: change to products containing a sit of minifin after President
- 23:55Speaker 1: Trump's announcement last week that warned about the unproven link
- 23:59Speaker 1: between women use of tail and all during pregnancy and
- 24:02Speaker 1: autism in children. Trump's announcement on the medication, which has
- 24:07Speaker 1: long been recommended during pregnancy to treat pain, fever, and aches,
- 24:11Speaker 1: has spurred confusion for patients and pushback from medical organizations.
- 24:16Speaker 1: I've been talking to healthcare attorney Harry Nelson, a partner
- 24:20Speaker 1: at Leech Tishman Nelson Hardiman. Since the manufacturer basically knows
- 24:25Speaker 1: what's going to happen down the road, can they jump
- 24:28Speaker 1: the administrative process and just go to court.
- 24:31Speaker 5: No, It's a fundamental principle and administrative law that you
- 24:35Speaker 5: have to wait for a final action. Judges don't want
- 24:38Speaker 5: to be making decisions about things that are still influx
- 24:42Speaker 5: in the regulatory process. So since there has been no
- 24:45Speaker 5: action taken yet by the FDA, just a warning that's
- 24:48Speaker 5: going to happen, the company doesn't have great recourse. It
- 24:51Speaker 5: essentially is sort of fighting. Has to really fight this
- 24:54Speaker 5: issue for the time being in the media and try
- 24:57Speaker 5: to hold on to public trust, you know, fight for
- 25:01Speaker 5: its stock price and build confidence, But judges do not
- 25:04Speaker 5: want to be addressing this issue until the FDA has
- 25:07Speaker 5: actually done something.
- 25:09Speaker 1: This is sort of wild, but could the company sue
- 25:12Speaker 1: Trump and Kennedy for defamation?
- 25:15Speaker 5: The principle of sovereign immunity here limits the action. We
- 25:18Speaker 5: already have the Supreme Court, by the way, broadening substantially
- 25:21Speaker 5: the things that the president is immune for actions taken
- 25:25Speaker 5: in executive office. But this is classically something where there's
- 25:29Speaker 5: a mixed case. So it's not like President Trump acted
- 25:32Speaker 5: without any scientific basis. It's just that there's evidence on
- 25:36Speaker 5: both sides of this issue. So I think it's going
- 25:38Speaker 5: to be very difficult for the company to think about
- 25:40Speaker 5: actually having a case against Trump or against RFK.
- 25:43Speaker 1: This is just, I mean, a chip of the iceberg.
- 25:46Speaker 1: The Trump administration or RFK his department is continuing to
- 25:52Speaker 1: put out information and guidance that contradicts medical organizations and
- 25:59Speaker 1: scientists and state health departments on vaccines and antidepressants. Is
- 26:06Speaker 1: anything being done about that?
- 26:08Speaker 5: I think you're right, by the way. A lot of
- 26:09Speaker 5: how I view this is this issue is in many
- 26:12Speaker 5: ways adjacent to this broader effort, whether it's around vaccines
- 26:16Speaker 5: or otherwise on public health to really undermine confidence and
- 26:21Speaker 5: agencies and to express more skepticism and to validate people
- 26:26Speaker 5: who are already incredibly skeptical of our public health agencies.
- 26:29Speaker 5: So I think a massive kind of political persuasive effort
- 26:35Speaker 5: has been underway kind of underpins all of these issues
- 26:39Speaker 5: around RFK and around our public health system. I think
- 26:43Speaker 5: that's an issue that's going to be decided in many
- 26:46Speaker 5: ways at the ballot box and by courts, which are
- 26:48Speaker 5: going to be called upon to decide what is arbitrary
- 26:52Speaker 5: and frecious and when government agencies are justified. So I
- 26:56Speaker 5: don't know that there's any recourse other than voting for
- 27:00Speaker 5: administrations that take positions on public health and science that
- 27:05Speaker 5: people support, or judges standing in.
- 27:07Speaker 1: Let's say the FDA approves the final rule and then
- 27:11Speaker 1: they're sued by the manufacturer. I mean, what kind of
- 27:14Speaker 1: decisions would the judges be making that this was arbitrary
- 27:18Speaker 1: and capricious, or would they be making decisions about the science.
- 27:22Speaker 5: I think the fundamental issue that judges have to confront
- 27:25Speaker 5: is the administrative prestide erect. That is the federal law
- 27:28Speaker 5: by which all federal agencies make rules, whether it's the
- 27:32Speaker 5: environmental protection agency, whether it's the Food and Drug Administration,
- 27:37Speaker 5: the Center for Disease Control. So it is a decision
- 27:39Speaker 5: about arbitrary and capriciousness, and whether the procedure by which
- 27:44Speaker 5: the decision was made was handled in a fair way.
- 27:47Speaker 5: In that process, inherently part of figuring out what's arbitrary
- 27:50Speaker 5: and capricious is assigning if the findings are supported by
- 27:54Speaker 5: the evidence, and if the conclusions are supported by the finding.
- 27:56Speaker 5: So I don't think it's possible for judges to completely escape,
- 28:00Speaker 5: you know, having opinions about science. That's really the tricky
- 28:03Speaker 5: part here is that the administration did operate on the
- 28:07Speaker 5: basis of some studies. It's just that we also see contrary,
- 28:10Speaker 5: much larger studies that totally contradict what they did.
- 28:13Speaker 1: And where does RFK Junior and the Health Department stand
- 28:17Speaker 1: on vaccines?
- 28:19Speaker 5: At this point, the administration has moved forward on a
- 28:22Speaker 5: complete policy shift on vaccine distribution, and I think like
- 28:26Speaker 5: a substantial amount has already happened to cut funding, cut distribution,
- 28:31Speaker 5: and change policy in a way that also is going
- 28:34Speaker 5: to drive lack of coverage in the insurance industry. There
- 28:37Speaker 5: are multiple lawsuits going forward. State attorneys general have brought
- 28:41Speaker 5: lawsuits to challenge vaccine policy. It's just that we have
- 28:45Speaker 5: not seen any legal action yet that is really undercutting
- 28:49Speaker 5: anything that the administration is doing.
- 28:52Speaker 1: And in some states, I know New York State, the
- 28:54Speaker 1: governor declared that, you know, vaccines would be paid for.
- 29:00Speaker 5: Right. So there's two different levels. One is a challenge
- 29:02Speaker 5: to the actions of Department Health, um Services and RFK
- 29:06Speaker 5: in terms of changing vaccine recommendations and access from government programs.
- 29:11Speaker 5: And the second issue is all of the commercial health
- 29:15Speaker 5: plans that are affecting their changing coverage. By the way,
- 29:19Speaker 5: a number of private organizations, the American Academy Pediatrics, the
- 29:23Speaker 5: American Public Health Association, and a number of other groups
- 29:26Speaker 5: have also filed suit claiming the actions are unlawful. We
- 29:30Speaker 5: have since nineteen eighty six, we've had the National Childhood
- 29:33Speaker 5: Vaccine Injury Act. There's been the arguments made that the
- 29:36Speaker 5: existing federal law preempts the actions that are being taken,
- 29:39Speaker 5: and that we already have a substantial amount of process
- 29:42Speaker 5: also here too under the Administrative Proceedure Act for how
- 29:45Speaker 5: this has to happen. So I do think there is
- 29:48Speaker 5: going to be a reckoning with the vaccine policy. The
- 29:51Speaker 5: question is how much will have already happened on the
- 29:53Speaker 5: ground based on narrower eligibility, based on the ending of
- 29:58Speaker 5: emergency use authorsations for COVID vaccines, and changes on all
- 30:02Speaker 5: these advisory and recommendation bodies that are adjusting vaccine schedules.
- 30:08Speaker 5: So there's a lot of change on the ground, but
- 30:10Speaker 5: there will be a reckoning at court at some point.
- 30:13Speaker 1: Has there been another administration where there was so much
- 30:16Speaker 1: change at the Health Department in such a short period
- 30:21Speaker 1: of time, sort of upending the norms.
- 30:24Speaker 5: I think it's safe to say that this administration has
- 30:27Speaker 5: set a new bar for activism and for lawsuits and
- 30:32Speaker 5: for controversy around federal health posse. It's not like we
- 30:36Speaker 5: never had these issues before. It's just that we've never
- 30:39Speaker 5: seen an administration that had such an ideologically aggressive position
- 30:46Speaker 5: on hostility to the pharmaceutical industry and to vaccines themselves,
- 30:52Speaker 5: and so many questions about science. It's you can go
- 30:54Speaker 5: back and you can cherry pick examples from the Obama
- 30:57Speaker 5: administration or from the Reagan administration where we had narrow
- 31:01Speaker 5: issues come up on particular public health points. But there's
- 31:05Speaker 5: never been an administration with the breadth and depth of
- 31:08Speaker 5: public health changes, really significant changes that we're seeing this year.
- 31:13Speaker 1: Thanks so much, Harry. That's healthcare attorney Harry Nelson of
- 31:16Speaker 1: Leech Tishman Nelson Hardiman. And that's it for this edition
- 31:20Speaker 1: of The Bloomberg Law Show. Remember you can always get
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