WEBVTT - Justice Thomas Cautions Against Following Precedent 0:00:02.759 --> 0:00:07.520 This is Bloomberg Law with June Grossel from Bloomberg Radio. 0:00:09.080 --> 0:00:12.879 Just think of law as these cases as a series 0:00:12.920 --> 0:00:16.560 of kate of cars on a long train, and you 0:00:16.720 --> 0:00:20.599 just accept the train, and you just add another car. 0:00:21.120 --> 0:00:23.479 We just follow wherever it's going. We never go to 0:00:23.560 --> 0:00:26.920 the front see who's driving the train. Where's it going? 0:00:28.320 --> 0:00:31.680 And you could go up there in the engine room 0:00:31.680 --> 0:00:34.320 and find us an orangutang drive in the train. Would 0:00:34.360 --> 0:00:37.000 you want to follow that just because it's a train. 0:00:37.840 --> 0:00:42.080 Justice Clarence Thomas used that train metaphor last week to 0:00:42.159 --> 0:00:46.640 describe the import of settled law or precedent in deciding 0:00:46.720 --> 0:00:51.560 new cases. Thomas downplayed the importance of prior Supreme Court 0:00:51.680 --> 0:00:55.320 cases and said he wouldn't follow them if it doesn't 0:00:55.320 --> 0:00:56.560 make sense to him. 0:00:56.880 --> 0:00:58.760 And I don't think that any of these cases that 0:00:58.800 --> 0:01:02.080 have been decided are the gospel. And I do give 0:01:02.120 --> 0:01:07.440 respect to precedent, but it should to precedent should be 0:01:07.520 --> 0:01:11.800 respectful of our legal tradition and our country and our laws, 0:01:12.160 --> 0:01:16.280 and be based on something not just something that somebody 0:01:16.400 --> 0:01:18.240 dreamt up and others went along with. 0:01:19.440 --> 0:01:22.760 In the new term, beginning on Monday, the Supreme Court 0:01:22.840 --> 0:01:28.120 will be considering several cases with long standing precedents, including 0:01:28.120 --> 0:01:31.880 a ninety year old precedent that limits a president's ability 0:01:32.120 --> 0:01:36.720 to remove members of some independent federal agencies without cause 0:01:37.240 --> 0:01:41.040 and a landmark nineteen eighty six decision about the use 0:01:41.080 --> 0:01:45.080 of race in redistricting under the Voting Rights Act. So 0:01:45.160 --> 0:01:50.120 Thomas's comments dissing the importance of prior case law might 0:01:50.240 --> 0:01:54.680 lead some to question whether those precedents will be overruled, 0:01:55.160 --> 0:01:59.200 much as the Court has overrule precedents like the constitutional 0:01:59.280 --> 0:02:03.360 right to a book and race and college admissions decisions. 0:02:03.880 --> 0:02:07.840 My guest is Supreme Court expert David Super, a professor 0:02:07.880 --> 0:02:13.000 at Georgetown Law. David, what was your reaction to Thomas's comments. 0:02:14.080 --> 0:02:19.880 Justice Thomas's remarks were quite remarkable. He said that adherence 0:02:19.919 --> 0:02:24.000 to precedent is perhaps overrated. He compared it to a 0:02:24.040 --> 0:02:29.280 situation where people are riding a train without knowing who's 0:02:29.360 --> 0:02:33.760 in the cabin driving the engine and suggested that that 0:02:33.960 --> 0:02:37.040 might well be an orangutan, and we should not take 0:02:37.080 --> 0:02:41.360 directions from an orangutan. I've never compared the US Supreme 0:02:41.360 --> 0:02:44.760 Court to an orangutan, but he has apparently, And he 0:02:44.919 --> 0:02:49.600 said that precedent may be something that one person just 0:02:49.760 --> 0:02:52.800 bought up and everyone else said, yeah, let's go along. 0:02:53.000 --> 0:02:55.919 And on that basis, he thinks that the court needs 0:02:56.000 --> 0:03:00.760 to be more willing to overrule precedent unless deferential. President. 0:03:01.440 --> 0:03:04.800 When the Supreme Court justices have their confirmation hearings, they 0:03:04.800 --> 0:03:09.160 all say, oh, you know, we're going to follow precedent. Yes, yes, yes, 0:03:09.240 --> 0:03:13.079 And of course they don't in many cases. So tell 0:03:13.160 --> 0:03:16.560 us about the importance of precedents in the law. 0:03:16.960 --> 0:03:22.639 Well, precedent is what makes the courts distinctive. Anybody can 0:03:22.680 --> 0:03:27.160 decide however they want at the moment. Why we listen 0:03:27.240 --> 0:03:30.519 to the courts is because they are bound by the law, 0:03:31.120 --> 0:03:35.040 and in the Anglo American system, the law is precedent. 0:03:35.120 --> 0:03:38.240 We even have a fancy term for it, starry decisives, 0:03:38.560 --> 0:03:43.640 and it is supposed to be what keeps unelected judges 0:03:44.040 --> 0:03:48.040 from acting willfully and just pursuing their personal agendas. 0:03:48.160 --> 0:03:50.640 He also said, it's not the gospel, which I always 0:03:50.640 --> 0:03:53.520 thought precedent was the gospel. But as you mentioned, he 0:03:53.880 --> 0:03:58.520 in a backhanded way, made fun of prior Supreme Court justices. 0:03:58.600 --> 0:04:02.160 He said, the President and if it's totally stupid, and 0:04:02.160 --> 0:04:04.600 that's what they've decided. You don't go along with it 0:04:04.760 --> 0:04:07.680 just because it's decided. Does it show just a lack 0:04:07.720 --> 0:04:10.960 of respect for prior justices. 0:04:11.080 --> 0:04:14.560 Well, it certainly does. It suggests that the current court 0:04:14.680 --> 0:04:18.760 is smart and its predecessors are foolish, which is a 0:04:18.800 --> 0:04:25.080 remarkably condescending approach. It's also an ahistorical approach. We've had 0:04:25.160 --> 0:04:30.000 many brilliant justices on the court. We've had many court 0:04:30.279 --> 0:04:35.400 that historians regard as all star courts, packed with brilliant 0:04:35.480 --> 0:04:39.120 legal minds, and to suggest that they can be compared 0:04:39.120 --> 0:04:41.040 to orangutans, it's disappointing. 0:04:41.960 --> 0:04:47.440 Thomas is a believer in originalism looking at history, but 0:04:47.560 --> 0:04:51.120 yet when the justices look at history, they often come 0:04:51.200 --> 0:04:56.560 up with totally different conclusions about the historical origins of 0:04:56.640 --> 0:04:59.760 the law. Why does he think that that's so much 0:04:59.760 --> 0:05:03.160 better better than following precedent, I don't know. 0:05:03.560 --> 0:05:09.479 And I find it exceedingly strange that perhaps the court's 0:05:09.560 --> 0:05:14.000 most vociferous originalist is taking this view, Because if there 0:05:14.080 --> 0:05:18.880 is one core principle of the original understanding of the 0:05:18.920 --> 0:05:22.000 courts is that they were bound by precedent. That's the 0:05:22.320 --> 0:05:26.560 essence of the common law system that England had for 0:05:26.720 --> 0:05:31.760 many centuries before the founding of this country, and that originalists, 0:05:31.880 --> 0:05:36.400 like Justice Thomas say, should control how we decide things now. 0:05:37.040 --> 0:05:41.920 There are important decisions that were handed down five six 0:05:42.040 --> 0:05:46.200 hundred years ago that decided difficult questions and that no 0:05:46.360 --> 0:05:51.200 court since then has ever disputed. Just as Thomas seems 0:05:51.240 --> 0:05:55.640 to suggest that that core original aspect of Anglo American 0:05:55.800 --> 0:05:59.279 jurisprudence is irrelevant, this is not. 0:05:59.200 --> 0:06:04.039 Really anything new for Justice Thomas. The late Justice Antonin 0:06:04.160 --> 0:06:09.040 Scalia told one of Thomas's biographers quote, he doesn't believe 0:06:09.080 --> 0:06:14.200 in starry decisive period and Thomas has also frequently suggested 0:06:14.320 --> 0:06:19.080 overturning landmark opinions in cases that are not before the court. 0:06:20.080 --> 0:06:23.479 Well, and it's important that Justice Cleia was Justice Thomas's 0:06:23.480 --> 0:06:28.359 best friend on the court and most frequent ally, but 0:06:29.360 --> 0:06:35.800 unlike Justice Thomas, Justice Cleia generally decided the cases that 0:06:35.839 --> 0:06:39.640 were brought for him, whereas Justice Thomas for a long 0:06:39.720 --> 0:06:46.039 time has written concurring or descending opinions inviting parties to 0:06:46.200 --> 0:06:50.760 bring cases to the court. That departs from another important 0:06:50.800 --> 0:06:55.840 aspect of originalism, which is that the courts are passive. 0:06:55.960 --> 0:06:58.520 They take the cases that come to them, but they 0:06:58.560 --> 0:07:02.560 don't go out trying to do affirmative policy making. Again, 0:07:02.640 --> 0:07:06.600 that goes back hundreds and hundreds of years, and an 0:07:06.680 --> 0:07:11.480 originalist like Justice Thomas should be particularly anxious to follow 0:07:11.960 --> 0:07:16.160 the traditional role of the courts as passive deciders rather 0:07:16.280 --> 0:07:18.920 than as policy makers with an agenda. 0:07:19.280 --> 0:07:22.920 The Roberts Court has overturned I read twenty one precedents, 0:07:23.040 --> 0:07:26.920 but it includes significant precedents, of course, the constitutional right 0:07:27.000 --> 0:07:31.040 to abortion in Roe v. Wade, race conscious admissions and 0:07:31.120 --> 0:07:35.840 higher education and the Harvard case, the power of executive agencies, 0:07:35.880 --> 0:07:39.640 and the Chevron doctrine, a forty year old precedent on 0:07:39.960 --> 0:07:44.160 unions in the Janice case. And seventeen of those cases 0:07:44.200 --> 0:07:48.720 that they overturned were split five to four decisions, with 0:07:48.800 --> 0:07:52.680 the conservative justices on one side and the liberal justices 0:07:52.920 --> 0:07:56.120 on the other. I mean, does that tell you anything 0:07:56.400 --> 0:07:59.760 about what was going on there? Well? 0:08:00.120 --> 0:08:04.000 Does suggest that this is a court with an agenda, 0:08:04.240 --> 0:08:08.800 That they are not calling balls and strikes, as justices 0:08:09.320 --> 0:08:13.880 like to say when they're seeking confirmation, but rather that 0:08:13.960 --> 0:08:19.040 they're pursuing a particular agenda, that they are more conservative 0:08:19.320 --> 0:08:21.800 than their four bears, and they're trying to move the 0:08:21.880 --> 0:08:24.800 law in that direction. I should note that one of 0:08:24.800 --> 0:08:29.960 those five four decisions you mentioned actually had five justices 0:08:30.240 --> 0:08:34.320 voting to overturn president, and the Chief Justice, a very 0:08:34.360 --> 0:08:38.600 conservative justice in his own right, joining with the pree 0:08:38.679 --> 0:08:42.320 moderate to liberal justices in disagreeing that being bobbed. 0:08:43.120 --> 0:08:47.400 Roberts recently has talked about how you know, the Roberts Court, 0:08:47.480 --> 0:08:51.679 His court overturned precedence at the lowest rate of any 0:08:51.720 --> 0:08:54.240 of the recent courts, and the New York Times study 0:08:54.440 --> 0:08:57.760 said that it was one point six per term averaged out. 0:08:58.360 --> 0:09:02.280 But does that ignore the significance or the importance of 0:09:02.360 --> 0:09:04.760 the precedents that they're overturning. 0:09:05.600 --> 0:09:10.520 Well, it does, and it also is subject to a 0:09:10.559 --> 0:09:14.800 lot of counting. There have been many, many, many cases 0:09:14.840 --> 0:09:18.840 about abortion rights after Roe v. Wade. Do you say 0:09:18.840 --> 0:09:22.080 that Bob's only overturned Row. No, it made a whole 0:09:22.120 --> 0:09:25.880 bunch of other cases irrelevant and wrong as well when 0:09:25.920 --> 0:09:30.000 they said this or that restriction on abortion was unconstitutional. 0:09:30.120 --> 0:09:34.280 So you have to make some very arbitrary choices in 0:09:34.360 --> 0:09:37.600 doing account like that. There are going to be some 0:09:38.400 --> 0:09:43.360 very very technical cases in admulti law that may get 0:09:43.400 --> 0:09:46.880 overturned because of new technology, and no one really knows 0:09:47.000 --> 0:09:50.920 or cares, and then they're going to be sweeping decisions 0:09:51.040 --> 0:09:55.040 about the Fourteenth Amendment about the separation of powers, and 0:09:55.280 --> 0:09:58.679 that kind of counting game blurs all of them together. 0:10:00.280 --> 0:10:03.840 We look at the upcoming term that starts on Monday, 0:10:04.480 --> 0:10:07.520 there seem to be a few precedents that may get overturned, 0:10:07.520 --> 0:10:12.559 and one involves that nearly century old ruling called Humphrey's 0:10:12.600 --> 0:10:18.319 Executor that protects the heads of independent agencies. Justice Elena Kagan, 0:10:18.800 --> 0:10:23.240 in a dissent when the majority allowed Trump to fire 0:10:23.679 --> 0:10:27.400 for now, the last Democratic member of the FTC, said 0:10:27.440 --> 0:10:32.199 that her colleagues are quote raring to overturn Humphrey's Executor. 0:10:32.840 --> 0:10:35.280 Do you think that'll be the next precedent to go? 0:10:35.920 --> 0:10:39.880 It will be unless they overturned something else first. Humphrey's 0:10:39.920 --> 0:10:43.160 Executor is clearly on its way out. There's a real 0:10:43.200 --> 0:10:49.000 irony here because Justices Gorsuch and Capitol have criticized lower 0:10:49.080 --> 0:10:52.880 courts for not showing in our prospect or Supreme Court president, 0:10:53.360 --> 0:10:57.600 even when that president is handed down through the shadow docket, 0:10:57.960 --> 0:11:01.840 without full briefing, without oral argument, without much of an opinion. 0:11:02.360 --> 0:11:07.360 And here Justice Thomas, their partner, is turning around and 0:11:07.559 --> 0:11:12.000 saying that he would disrespect Supreme Court decisions even that 0:11:12.160 --> 0:11:17.319 were fully argued, fully briefed, and the result of painstaking opinions. 0:11:17.480 --> 0:11:20.360 I think the Justices need to decide whether the work 0:11:20.400 --> 0:11:23.000 of the Supreme Court is or is not entitled to 0:11:23.120 --> 0:11:23.920 great deference. 0:11:24.520 --> 0:11:29.240 The Trump administration is asking the justices to take his 0:11:29.480 --> 0:11:34.400 challenge to birthright citizenship, and they did use the birthright 0:11:34.440 --> 0:11:38.760 citizenship clash to make it harder for federal judges to 0:11:38.880 --> 0:11:44.000 block government policies nationwide. If they take this case, does 0:11:44.040 --> 0:11:47.360 that say, yes, we're going to overturn the precedent from 0:11:47.640 --> 0:11:51.599 eighteen ninety eight that supported birthright. 0:11:51.160 --> 0:11:55.480 Citizenship and as the president handed down by arguably the 0:11:55.520 --> 0:11:59.640 most conservative Supreme Court in the nation's history, So it 0:11:59.640 --> 0:12:04.360 would be quite remarkable to overturn that case. I think 0:12:04.440 --> 0:12:08.439 the Justices will take this simply because it's a high 0:12:08.440 --> 0:12:13.960 profile and very important matter that the President has been emphasizing. 0:12:14.240 --> 0:12:17.200 I would have trouble imagining how they could overturn it. 0:12:17.760 --> 0:12:23.600 The original opinion is based on analysis of historical uses 0:12:23.640 --> 0:12:26.319 of terms going back hundreds of years. It's a very 0:12:26.400 --> 0:12:32.679 model of originalism, and the Trump administration's complaint is largely 0:12:32.720 --> 0:12:36.559 a political one responding to their base and their opposition 0:12:36.640 --> 0:12:42.959 to immigrants. Any serious originalist approach would affirm the plain 0:12:43.120 --> 0:12:46.959 language of the fourteenth Amendment and the decision from the 0:12:47.040 --> 0:12:47.959 nineteenth century. 0:12:48.559 --> 0:12:52.000 In a concurring opinion in the Dodds case, which overturned 0:12:52.160 --> 0:12:57.520 Row Thomas suggested revisiting cases concerning the rights to conception, 0:12:57.840 --> 0:13:01.840 same sex intimacy, and marriage quality. And the Court is 0:13:01.880 --> 0:13:07.720 being asked to overturn the Obergefell decision, the landmark twenty 0:13:08.120 --> 0:13:13.040 fifteen decision that legalized same sex marriage nationwide in a 0:13:13.120 --> 0:13:18.200 case involving Kim Davis, the former Kentucky cleric who became 0:13:18.320 --> 0:13:21.960 famous when she was jailed for refusing to issue marriage 0:13:22.000 --> 0:13:25.960 licenses to a gay couple on religious grounds. Do you 0:13:25.960 --> 0:13:28.880 think that same sex marriage is in jeopardy. 0:13:29.760 --> 0:13:32.719 It certainly is in jeopardy. It's hard to know what 0:13:32.760 --> 0:13:35.640 the Court will do. The Chief Justice Roberts has been 0:13:35.679 --> 0:13:40.480 insisting that the judges look at cases on their merits 0:13:40.480 --> 0:13:44.079 and are not pursuing a political agenda. If the Court 0:13:44.200 --> 0:13:50.679 turns over a decision handed down barely a decade ago 0:13:51.160 --> 0:13:56.000 that has had this profounded impact on the nation's fabric, 0:13:56.600 --> 0:14:00.280 I think his effort to persuade people that this court 0:14:00.360 --> 0:14:03.040 is anything other than the super legislature will fail. 0:14:03.320 --> 0:14:05.840 I mean, do you think Thomas with these statements as 0:14:05.880 --> 0:14:09.280 an outlier that the other justices are sort of cringing 0:14:09.480 --> 0:14:10.600 when they hear them. 0:14:11.040 --> 0:14:14.480 I imagine the Chief Justice was cringing all the way 0:14:14.559 --> 0:14:19.640 through reading accounts of this, because Justice Thomas is so 0:14:19.800 --> 0:14:24.640 overtly politicizing the court. But Justice Thomas is winning a 0:14:24.680 --> 0:14:28.760 lot more cases than he's losing these days, So it 0:14:28.800 --> 0:14:32.000 would seem that a number of other justices are pretty 0:14:32.000 --> 0:14:33.520 comfortable with this approach. 0:14:34.320 --> 0:14:37.680 So you think it's just the Chief that's uncomfortable with 0:14:37.760 --> 0:14:41.720 these sort of brazen statements from Thomas. 0:14:42.600 --> 0:14:45.280 I think a lot of the others, first and foremost 0:14:45.280 --> 0:14:48.800 the Chief, but certainly also Justice Barrett, would rather we 0:14:48.960 --> 0:14:54.600 not be this explicit about the Court pursuing its own agenda. 0:14:54.760 --> 0:14:57.560 But Justice Thomas, I guess it's feels like he's reached 0:14:57.600 --> 0:14:59.840 the point where he sees no reason to be secret 0:14:59.840 --> 0:15:02.520 to about it. He's got a super majority, he can 0:15:02.560 --> 0:15:06.080 lose a very conservative justice and still win a case, 0:15:06.320 --> 0:15:10.120 and so he's prepared to dispense with pretemps. 0:15:10.720 --> 0:15:13.560 And why do you say Justice Barrett in particular. 0:15:14.200 --> 0:15:18.520 Well, she's given a couple of interviews lately in which 0:15:18.680 --> 0:15:22.360 she said that we're not at a constitutional crisis and 0:15:22.440 --> 0:15:26.440 things are working more or less ordinarily, and they sort 0:15:26.440 --> 0:15:31.640 of downplaying the importance of what's happening and seems to 0:15:31.680 --> 0:15:35.880 suggest that what we're doing is simply a technical act 0:15:35.920 --> 0:15:38.880 of judging, and Justice Thomas is saying, no, I'm not 0:15:38.960 --> 0:15:41.720 doing technical judging. I'm getting rid of the stupid stuff. 0:15:42.120 --> 0:15:45.880 Well, we're off to a new start on Monday. We'll 0:15:45.920 --> 0:15:49.680 see whether this new term brings any more reversals of precedent. 0:15:50.160 --> 0:15:54.360 Thanks so much, David. That's Professor David Super of Georgetown Law. 0:15:54.960 --> 0:15:59.200 Last week, President Trump warned about the unproven link between 0:15:59.280 --> 0:16:04.360 women's use of thailanol during pregnancy and autism in children 0:16:04.720 --> 0:16:06.800 and advise women to tough it out. 0:16:07.480 --> 0:16:11.320 For this reason, they are strongly recommending that women limit 0:16:11.440 --> 0:16:18.000 iler and all use during pregnancy unless medically necessary, that's, 0:16:18.040 --> 0:16:20.880 for instance, in cases of extremely high fever. 0:16:22.080 --> 0:16:28.120 Medical experts and organizations immediately slam the remarks as irresponsible 0:16:28.200 --> 0:16:32.480 and dangerous advice not backed by science, and thailan al's 0:16:32.520 --> 0:16:37.160 manufacturers said there is no proven link between taking acidaminifin 0:16:37.480 --> 0:16:42.280 and autism. Still, the FDA has initiated the process for 0:16:42.360 --> 0:16:47.080 a labeled change to products containing a set ofminifin. Joining 0:16:47.080 --> 0:16:50.520 me is healthcare attorney Harry Nelson, a partner at leech 0:16:50.600 --> 0:16:54.840 Tishman Nelson Hardiman. So let's start with the elephant in 0:16:54.880 --> 0:16:58.120 the room, so to speak, President Trump and of course 0:16:58.400 --> 0:17:02.000 RFK Junior's claim that there is a link between the 0:17:02.120 --> 0:17:06.480 use of thailanol during pregnancy and autism in children. 0:17:07.000 --> 0:17:12.840 So President Trump and the FDA were citing two US studies. 0:17:13.359 --> 0:17:18.560 In both studies there was some heightened rate of autism 0:17:19.040 --> 0:17:26.240 in the population of moms who took seamnifin thailanl during pregnancy. 0:17:26.040 --> 0:17:28.359 So the FAA was rolling on these two studies. What 0:17:28.640 --> 0:17:31.000 many people are pointing out is that there was a 0:17:31.119 --> 0:17:35.680 very large Swedish study of the same issue with two 0:17:35.760 --> 0:17:40.600 point five million people participating, substantially a bigger cohort, which 0:17:40.600 --> 0:17:44.320 found absolutely no link. So first, there's really competing data 0:17:44.520 --> 0:17:47.960 on the point, and second, there's nothing here to suggest 0:17:48.160 --> 0:17:52.800 causation that thailandal causes autism if taken by a mother 0:17:52.840 --> 0:17:57.720 and pregnancy, rather some correlation which needs to be studied further. 0:17:57.800 --> 0:18:02.320 So it's an interesting case again of a major divide 0:18:02.320 --> 0:18:04.240 about what good science looks like. 0:18:04.840 --> 0:18:08.640 Well, also in the FDA news release itself, it said, 0:18:09.000 --> 0:18:11.840 it's important to note that while in association between a 0:18:11.920 --> 0:18:15.159 set of MINIFIT and neurological conditions has been described in 0:18:15.240 --> 0:18:19.879 many studies, a causal relationship has not been established, and 0:18:19.920 --> 0:18:25.080 there are contrary studies in the scientific literature. So why 0:18:25.080 --> 0:18:27.480 are they doing this if they're saying in their own 0:18:27.560 --> 0:18:30.360 statement that it hasn't been established. 0:18:31.040 --> 0:18:36.520 My sense is that this president and this administration is 0:18:36.560 --> 0:18:41.160 really trying to make sure that it maintains an activist 0:18:41.760 --> 0:18:45.480 kind of footing with people who are looking for change 0:18:45.520 --> 0:18:49.800 in its base of supporters, and that this was a 0:18:49.920 --> 0:18:54.480 very aggressive style of announcement that was made before there 0:18:54.560 --> 0:18:57.760 was any kind of conclusive process here, but that this 0:18:58.040 --> 0:19:01.679 was done really as a kind of political driver, with 0:19:01.800 --> 0:19:05.160 the president wanting an opportunity to stand at the podium 0:19:05.200 --> 0:19:07.840 and make the claim that he's doing something to protect 0:19:07.920 --> 0:19:12.320 public health and fighting back against the scientific establishment, you know, 0:19:12.400 --> 0:19:14.880 and yet another way. So that's at least my sense 0:19:14.920 --> 0:19:16.560 of why this happened the way it did. 0:19:17.280 --> 0:19:21.639 When does the law allow the FDA to change a 0:19:21.720 --> 0:19:22.479 drug label. 0:19:22.760 --> 0:19:26.080 So the FDA can at any point initiate an administrative 0:19:26.080 --> 0:19:29.000 process of looking at how a drug both a prescription 0:19:29.119 --> 0:19:31.800 druger and over the counter drug and tailanol interestingly is 0:19:31.840 --> 0:19:35.159 both has both forms. You know, there's a whole administrative 0:19:35.200 --> 0:19:38.840 process by which a change can be proposed, the public 0:19:38.840 --> 0:19:40.560 has a chance to comment on it, and then it's 0:19:40.600 --> 0:19:44.000 finally ordered. And then only after that process do prescription 0:19:44.119 --> 0:19:47.360 drug manufacturers like the company can view here that makes 0:19:47.440 --> 0:19:49.960 tilanol have the right to challenge it. So there's a 0:19:50.000 --> 0:19:53.919 long process that's still ahead, and it's not unusual for 0:19:53.960 --> 0:19:56.960 the FDA to undertake that process. It's just that here 0:19:57.240 --> 0:20:00.600 the sequence of events of really that evidence, review, the decision, 0:20:00.800 --> 0:20:03.560 and a process that happening came second. Normally that process 0:20:03.600 --> 0:20:06.840 comes first. Here the political announcement came ahead of everything. 0:20:07.240 --> 0:20:10.919 Is it normal to do this without negotiating with the 0:20:10.960 --> 0:20:11.920 company first. 0:20:12.600 --> 0:20:15.600 I do think that it is more typical to allow 0:20:15.760 --> 0:20:19.760 prescription drug manufacturers to be part of a process and 0:20:20.040 --> 0:20:22.240 make sure that all of the evidence, all of the 0:20:22.280 --> 0:20:25.720 research is considered. So I don't know exactly how much 0:20:25.880 --> 0:20:29.440 can view, how much opportunity had. It seems clear from 0:20:29.440 --> 0:20:31.920 everything that the company is saying that it intends fully 0:20:31.960 --> 0:20:34.480 to challenge this action and to argue that the FDA 0:20:34.520 --> 0:20:38.520 is acting without sufficient scientific justification and that process. Certainly, 0:20:38.560 --> 0:20:42.679 if there was an unquestionable issue here, the FDA normally 0:20:42.720 --> 0:20:45.280 could have started in dialogue with the company to make 0:20:45.320 --> 0:20:47.880 sure that this action was sound. You know, the thing 0:20:47.920 --> 0:20:49.879 that worries me the most here is that TAILERML is 0:20:49.880 --> 0:20:53.040 one of the most widely used and trusted medications out 0:20:53.040 --> 0:20:56.040 there during pregnancy as well as for many other conditions, 0:20:56.400 --> 0:21:00.360 and this creates a risk of confusion of fear, and 0:21:00.680 --> 0:21:03.520 you know that's a process is not great for public health. 0:21:04.280 --> 0:21:08.040 Yeah, I mean, there are so many stories about doctors 0:21:08.280 --> 0:21:13.720 obgyns receiving tons of calls from pregnant women who don't 0:21:13.720 --> 0:21:16.880 know what to do. They're very confused about this new 0:21:17.280 --> 0:21:19.480 allegation I guess from the FDA. 0:21:19.640 --> 0:21:21.480 Yeah. And it's by the way, globally, we're seeing with 0:21:21.520 --> 0:21:26.680 World Health Organization and European drug regulatory systems that around 0:21:26.720 --> 0:21:28.480 the rest of the world, the message is going out 0:21:28.480 --> 0:21:31.359 that that has seen a minifit is perfectly safe for 0:21:31.440 --> 0:21:34.600 pregnant mothers. And so this is like a creating a 0:21:34.640 --> 0:21:39.440 real contrast between the public health word in the rest 0:21:39.480 --> 0:21:41.280 of the world and apparently in the United States that 0:21:41.400 --> 0:21:42.600 this goes all the way through. 0:21:43.000 --> 0:21:46.000 And do we know how the FDA intends to change 0:21:46.040 --> 0:21:48.720 the label. Is it going to be like a tobacco 0:21:48.800 --> 0:21:50.320 warning on cigarette packs. 0:21:50.720 --> 0:21:53.320 Well, it's a big question. Again, it's a question whether 0:21:53.359 --> 0:21:55.320 this is only going to apply to the prescription drug 0:21:55.359 --> 0:21:58.040 form or also to the over the counter form. There's 0:21:58.080 --> 0:22:01.760 a lot of generic cinematics and out there on sales, 0:22:01.800 --> 0:22:03.320 and it's not clear exactly who this is going to 0:22:03.359 --> 0:22:05.119 apply to or what the labels going to look like. 0:22:05.200 --> 0:22:06.919 That's something that will have to be resolved by the 0:22:06.960 --> 0:22:10.280 FDA as we go through the administrative process ahead. 0:22:10.840 --> 0:22:14.879 So the drugmaker can only challenge in the administrative process 0:22:15.680 --> 0:22:17.800 after the review is complete. 0:22:18.040 --> 0:22:21.120 Yeah, exactly. There needs to be a final order. So 0:22:21.119 --> 0:22:24.960 so first the agency has to make the final proposed action, 0:22:25.080 --> 0:22:26.919 as it's called, and then there has to be an 0:22:26.920 --> 0:22:30.160 opportunity for the public to comment, and only when the 0:22:30.240 --> 0:22:33.239 action is actually finalized and is an agency decision by 0:22:33.280 --> 0:22:35.800 the FDA. At that point, you know the issue is 0:22:36.200 --> 0:22:38.320 ripe to be challenged by the drug manufacturer. 0:22:38.720 --> 0:22:42.920 Harry, does anyone in the healthcare community doubt that no 0:22:42.960 --> 0:22:48.320 matter what the public comments are and what the manufacturer says, 0:22:48.680 --> 0:22:51.280 that the FDA is going to go ahead to try 0:22:51.280 --> 0:22:54.200 to relabel a cineminefin. 0:22:54.000 --> 0:22:56.680 I think it's fairly safe to say this administration has 0:22:56.720 --> 0:23:00.000 a strong grip on the FDA. No one is expecting 0:22:59.720 --> 0:23:02.919 a kind of independence or for the FDA leadership to 0:23:03.000 --> 0:23:06.480 buck the announcements, particularly after it's made by the President. 0:23:06.640 --> 0:23:08.360 So you know, and by the way, I should say 0:23:08.359 --> 0:23:11.760 that manufacturer will have initially it has a challenge in 0:23:11.800 --> 0:23:14.280 the FDA, but eventually we'll get to a federal court 0:23:14.680 --> 0:23:18.119 and be before a federal judge to make the argument 0:23:18.160 --> 0:23:21.520 that this action is arbitrary and capricious and not grounded 0:23:21.560 --> 0:23:24.640 in solid science. So there's no question in my mind 0:23:24.640 --> 0:23:26.600 that the FDA is going to move forward here, but 0:23:27.000 --> 0:23:29.400 the question of whether this actually stands is a very 0:23:29.400 --> 0:23:30.040 big one. 0:23:30.400 --> 0:23:32.840 Coming up next on the Bloomberg Law Show, I'll continue 0:23:32.880 --> 0:23:37.600 this conversation with healthcare attorney Harry Nelson. Can the manufacturer 0:23:37.720 --> 0:23:41.760 ignore the administrative process and go straight to court? I'm 0:23:41.840 --> 0:23:46.199 June Grosso. When you're listening to Bloomberg, the Food and 0:23:46.240 --> 0:23:50.800 Drug Administration said it initiated the process for a labeled 0:23:50.880 --> 0:23:55.000 change to products containing a sit of minifin after President 0:23:55.000 --> 0:23:59.200 Trump's announcement last week that warned about the unproven link 0:23:59.280 --> 0:24:02.840 between women use of tail and all during pregnancy and 0:24:02.960 --> 0:24:07.040 autism in children. Trump's announcement on the medication, which has 0:24:07.119 --> 0:24:11.040 long been recommended during pregnancy to treat pain, fever, and aches, 0:24:11.359 --> 0:24:16.360 has spurred confusion for patients and pushback from medical organizations. 0:24:16.640 --> 0:24:20.119 I've been talking to healthcare attorney Harry Nelson, a partner 0:24:20.160 --> 0:24:25.040 at Leech Tishman Nelson Hardiman. Since the manufacturer basically knows 0:24:25.080 --> 0:24:28.119 what's going to happen down the road, can they jump 0:24:28.320 --> 0:24:31.160 the administrative process and just go to court. 0:24:31.840 --> 0:24:35.320 No, It's a fundamental principle and administrative law that you 0:24:35.480 --> 0:24:38.640 have to wait for a final action. Judges don't want 0:24:38.640 --> 0:24:41.959 to be making decisions about things that are still influx 0:24:42.080 --> 0:24:44.840 in the regulatory process. So since there has been no 0:24:45.400 --> 0:24:48.440 action taken yet by the FDA, just a warning that's 0:24:48.480 --> 0:24:51.679 going to happen, the company doesn't have great recourse. It 0:24:51.800 --> 0:24:54.439 essentially is sort of fighting. Has to really fight this 0:24:54.520 --> 0:24:57.600 issue for the time being in the media and try 0:24:57.640 --> 0:25:01.119 to hold on to public trust, you know, fight for 0:25:01.160 --> 0:25:04.440 its stock price and build confidence, But judges do not 0:25:04.560 --> 0:25:07.600 want to be addressing this issue until the FDA has 0:25:07.640 --> 0:25:08.600 actually done something. 0:25:09.200 --> 0:25:12.560 This is sort of wild, but could the company sue 0:25:12.720 --> 0:25:14.679 Trump and Kennedy for defamation? 0:25:15.280 --> 0:25:18.119 The principle of sovereign immunity here limits the action. We 0:25:18.160 --> 0:25:21.280 already have the Supreme Court, by the way, broadening substantially 0:25:21.920 --> 0:25:25.200 the things that the president is immune for actions taken 0:25:25.240 --> 0:25:29.880 in executive office. But this is classically something where there's 0:25:29.920 --> 0:25:32.359 a mixed case. So it's not like President Trump acted 0:25:32.400 --> 0:25:35.919 without any scientific basis. It's just that there's evidence on 0:25:36.000 --> 0:25:38.600 both sides of this issue. So I think it's going 0:25:38.640 --> 0:25:40.600 to be very difficult for the company to think about 0:25:40.600 --> 0:25:42.960 actually having a case against Trump or against RFK. 0:25:43.640 --> 0:25:46.359 This is just, I mean, a chip of the iceberg. 0:25:46.800 --> 0:25:52.399 The Trump administration or RFK his department is continuing to 0:25:52.440 --> 0:25:58.840 put out information and guidance that contradicts medical organizations and 0:25:59.119 --> 0:26:06.320 scientists and state health departments on vaccines and antidepressants. Is 0:26:06.400 --> 0:26:07.760