The Volokh Conspiracy
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BREAKING: Supreme Court to Consider Fifth Circuit's Abortion Pill Decision
The Court granted two petitions for certiorari seeking review of a controversial lower court decision limiting federal approval of mifepristone.
Today the Supreme Court granted certiorari in several cases to be heard later this term. Among the petitions granted were two seeking review of the U.S. Court of Appeals for the Fifth Circuit's decision in Alliance for Hippocratic Medicine v. Food & Drug Administration, which challenged the FDA's approval and subsequent regulation of mifepristone, a drug that is widely prescribed to terminate pregnancies (i.e. to perform a "medication abortions").
Specifically, the Court granted petitions filed by the Solicitor General and Danco Laboratories (the maker of Mifeprex, a brand of mifepristone). Interestingly enough, the Court did not grant the cross-petition for certiorari filed by AHM.
Based upon the questions presented in the two granted petitions, here is what will be before the Court.
First, and quite significantly, is the threshold question of standing. As I have blogged repeatedly (see posts below), I do not believe that the plaintiffs can satisfy the requirements of Article III standing under current doctrine. Both granted petitions ask the Court to consider standing--and even if they hadn't, because standing presents a threshold jurisdictional question, it would be a part of the case. The centrality of standing to this litigation is particularly interesting because (as happened in the California v. Texas ACA litigation) traditional Article III standing arguments cut strongly against litigants seeking a conservative policy outcome.
The petitions also ask the Court to consider whether the Fifth Circuit was correct to uphold the district court's injunction against the FDA's 2016 and 2021 decisions to revise and relax the conditions placed on the prescription of mifepristone. As framed in the petitions, the questions encompass both the conclusions reached on the merits (that the FDA's actions were arbitrary and capricious) and the relief ordered (a preliminary injunction).
What is not included in the cert grant is whether the Fifth Circuit was correct to reject AHM's attempts to challenge the FDA's initial approval of mifepristone in 2000 as untimely. As I have noted previously, I think this part of the Fifth Circuit's decision was definitely correct, as AHM's arguments relied upon an unduly aggressive reinterpretation of the "reopener" doctrine. The Supreme Court will also not review AHM's substantive argument that the FDA improperly approved mifepristone in 2000.
The bottom line is that the Supreme Court will consider whether the plaintiffs had standing to bring this case and, if so, whether the FDA properly relaxed its regulation of mifepristone in 2016 and 2021. The decision here will undoubtedly affect the availability of mifepristone, but the case no longer includes the question of whether the FDA should have approved mifepristone for the purpose of terminating pregnancies in the first place.
I have blogged a fair amount about the issues in this litigation, and plan to do more. Accordingly, I am indexing my posts here, and will update this list as I blog additional posts.
- "The Next Abortion Battlegrounds," June 22, 2022;
- "Assessing the Legal Claims in Alliance for Hippocratic Medicine v. FDA," March 8, 2023;
- "AHM v. FDA: A Contrary View and a Rejoinder," March 28, 2023;
- "Blue-State AGs Have A Mifepristone Lawsuit of Their Own," March 29, 2023;
- "Two (Wrong) Mifepristone Court Rulings in One Day," April 8, 2023;
- "The Good and Bad of the Fifth Circuit's Abortion Pill Ruling," April 13, 2023.
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"According to the Doctors, when they treat women who are experiencing complications after taking mifepristone, they are required to perform or complete an abortion, or otherwise required to participate in a process that facilitates abortion. They maintain that personally conducting those procedures violates their sincerely held moral beliefs. The Doctors also contend that treatment of mifepristone patients diverts time and resources away from their ordinary patients, causes substantial mental and emotional distress, and exposes them to heightened malpractice risk and increased insurance costs."
What a joke.
Lawnmowers cause injuries; should we ban them?
Can we ban weapons now too since injuries from gun shots can, ". . . divert() time and resources away from their ordinary patients, causes substantial mental and emotional distress, and exposes them to heightened malpractice risk and increased insurance costs."
The relevant question is whether the plaintiffs were injured by the FDA’s action. Standing requires the existence of an injury in fact. This makes a claim that the plaintiff has been injured highly relevant. And products that cause injuries get banned all the time. Numerous products are banned for this reason. Moreover the FDA has a statutory obligation to ensure medical products are safe. If it approved a dangerous one, it would have acted illegally. It’s not a joke at all.
I think someone who has been personally injured by a product an agency had approved had injury-in-fact standing to challenge the approval, although whether there’s a meritorious legal theory is a separate question.
In this case, I think there are two fundamental problems with AHM’s arguments. The first problem is standing. The possibility that they might, some day in the future, treat a patient injured by mifepristone isn’t enough to establish that THEY have been injured. There is no injury in fact and hence no standing. And on the merits, the evidence AHM presented to support its claims that mifepristone is dangerous to women who use it for abortion purposes is just very poor. It’s pretty much junk science. The 5th Circuit erred both by finding standing and by finding this evidence persuasive even in part.
.
You miss a more fundamental point: even if they could establish with 100% certainty that they will in the future treat a patient injured by mifepristone, that isn't an injury. (I mean the patient is injured in that scenario; the doctor isn't.)
Note that if it were, then doctors would have standing to challenge auto safety regulations, gun laws, food stamp benefits, Ukraine policy, and anything else; if the government adopted a different set of policies with respect to any of those, then fewer people might be injured and doctors wouldn't have to treat them. Needless to say: no.
Tobacco, red meat, processed foods, natural gas stoves, automobiles, horse riding, football, etc
The doctors are essentially saying that a patient showing up needing care is an injury to them.
Funny. McDonald's likes it when someone shows up to buy a hamburger.
The sentence you put in parentheses (“I mean the patient is injured in that scenario; the doctor isn’t”) seems a simple paraphrase of the sentence from me that you quoted.
So I must confess I don’t understand the “fundamental point” that I’m missing.
I mean, I said “there is no injury in fact.” Isn’t your statement “that isn’t an injury” just a paraphrase of that? I don’t see how what you said is meaningfully different from what I said.
You said that the possibility that they'll have to treat a patient injured by mifepristone isn't enough to establish injury. I'm saying that even an absolute certainty that they'll have to treat a patient injured by mifepristone isn't an injury.
The injury is a 13th amendment one -- forced labor.
Or can the doctors simply refuse to treat and let the woman bleed to death? That WOULD be effective in banning the pill...
Professional responsibility isn't a violation of the 13th amendment.
1. It's never RICO.
2. It's never the 13th Amendment.
If, on the internet, someone says it has to be one of these, then you know they are just making stuff up.
Sorry, some of us didn't go into medicine to kill babies (some did, go to them if you want to kill babies)
I know, it's an unviable tissue mass, a blastula, morula, drackula (made that one up) would have a horrible life, die a horrible early death (you could have said the same about Floyd George)
Frank
Medicine is a very broad area of practices and performing abortion or even post abortion care can be easily avoid by selecting a different area of practice. I can only think of two areas where a doctor could expect they might be called on to perform an abortion or abortion related procedures. Those are OBGYN for obvious reasons and ER physicians, where a patient might present and require an abortion.
Any ER physician that would complain about having to treat a woman that was experiencing complications after taking mifepristone shouldn't be working in an ER, where they would be ethically bound to treat a serial killer that needed medical care.
WHOSE ethics, Jason? There are conflicting ethics here.
And as to a serial killer, there HAVE been ethical issues about treating one so that he could be executed. Likewise with treating someone who is currently insane so that he can be executed.
"Sorry, some of us didn’t go into medicine "
Should have stopped there.
Look at it a different way -- Narcan is not cheap and must a state supply it, free of charge, to every druggie that overdoses? Former Maine Governor Paul LePage proposed that the state would only administer it ONCE -- and unless the druggie reimbursed the state, there wouldn't be a second dose.
That was challenged on ethical grounds, and because it was Paul LePage proposing it, but does the state have to provide recourse for misadventure using a product banned under state law?
So if the abortion pill is banned in the state, can the state say "sucks to be you" to those suffering complications from using an illegal product? And that may be what it comes to -- doctors suing for the right to let someone bleed to death.
What the fuck? States aren't going to let people bleed out just because...I d...
what the fuck?
Oh come on; you're making it too easy:
What you've just said is one of the most insanely idiotic things I have ever heard. At no point in your rambling, incoherent response were you even close to anything that could be considered a rational thought. Everyone in this room is now dumber for having listened to it. I award you no points, and may God have mercy on your soul.
"traditional Article III standing arguments cut strongly against litigants seeking a conservative policy outcome."
This is an interesting idea put forth in the argument and one that clearly deserves more consideration. I doubt the framers of the Constitution were prejudiced against conservatives so why do conservatives have so much trouble with standing. As a non lawyer observer, it appears to me that the so-called conservative have trouble because they are not able to show direct injury but rather are attempting to show that they are injured by the freedom of others. Instead of arguing that their voting rights are impeded, they cannot marry the person they love, or that they cannot make their own medical decisions, the argument is that other people's voting rights dilute my vote, my marriage is lessened if gays can marry, or my values are bruised if women can make health care decisions. I think that the writer of the Constitution valued freedom and did want to promote people taking other's freedoms.
Yup. Here's a Bible verse that every Christian conservative should memorize:
"But let none of you suffer as a . . . busybody in other men's matters." I Peter 4:15.
Nice, you should heed it.
Please give an example of when I've meddled in other men's matters.
What you do in your bedroom is your own business.
Right, tell that to Christian conservatives too.
How are politicians gonna block business so as to get kickbacks unless they suffer to be busibidies, sorry, busibodies in other mens' affairs?
Fundamental Theorem of Government: Corruption is not an unfortunate side effect of the wielding of power. It is the purpose of it from day one.
In the west, with a free press, they just have to hide it better. But rest assured, this is why every single one of them goes into government. Proof? All human history and the entire surface of the Earth.
A favourite argument when defending a corrupt politician.
You keep calling it a fundamental theorem when it's just inchoate hostility coming from your ass.
We call that a "posterior postulate" .
I'm pretty sure there are also Biblical edicts about not killing. Insofar as conservatives believe that abortion is killing, it seems those passages outweigh your busybody invective.
There are plenty of biblical passages that promote killing: Capital punishment, going to war, self defense. So the issue isn't whether it's killing; the issue is whether it's murder.
Conservatives are entitled to their opinion that abortion is murder. They are not entitled to have everyone else agree with them. I'm quite certain the anti-murder passages are all limited to situations in which there's no real dispute that a murder is being committed, though if you're aware of an exception feel free to cite it.
However, there is no biblical text that supports the position that abortion is killing a human, and a few that support the opposite view.
Lots of context there pal. Lots.
re: "why do conservatives have so much trouble with standing"
As a general rule, they don't. Or more precisely, they have no more nor less problem than any opposition party. At times past (including recent past), liberals had the same trouble with standing.
For a very recent example, look at the latest 'children's climate lawsuit' which will get bounced on standing issues just like the last several have.
One could argue the children's climate lawsuit is a publicity stunt and isn't a serious attempt to litigate. Whereas, using the legal system to limit other people's access to safe abortifacients is intended to succeed, especially given the current Supreme Court's balance of right-to-life Catholics in the majority.
Over the medium to long term, most or all of conservatives' current red meat issues -- gun nuttery; support for Israel's violent right-wing belligerence; anti-abortion absolutism -- seem doomed to fail as the American culture war resolves.
Those who hitched their political aspirations to the culture war's losing side -- especially if their views are animated by old-timey superstition, vestigial bigotry, or obsolete right-wing thinking -- are destined to sustain the consequences of choosing the wrong side of history.
The most it seems reasonable for conservatives to hope for is that better Americans might be somewhat magnanimous toward the culture war's casualties.
Rossami - While I question how the kids got standing in the various climate lawsuits,( perhaps the standards for standing are less rigorous in state courts), It does beg the question of how Mass got standing in Mass v EPA given the speculative nature of the injury / an injury which might or might not occur in the future. I will defer to others on how standing in that case. Standing in the Montana kids climate lawsuit - was standing from " pre traumatic stress "?
That's an odd stance in the case of marriagr. To a religious person, only God can marry people, as directed by a priest. A judge's marriage, or a state license, carries no weight.
So how could other people sinning reduce your marriage?
If it carries no weight, then what do you care if the state marries a gay couple?
'To a religious person, only God can marry people,'
I'm sure there are religious people who think this, but most recognise civil marriages.
Especially after their first divorce.
Bah-dump chhhhhh!
Krayt : "So how could other people sinning reduce your marriage?"
Moderation4ever didn't claim to find that persuasive; he said it's an argument conservatives make. And he's right. I've seen it made just-so on multiple occasions. As for the justification, it seems to be that gay marriage damages the "brand".
Yeah, I know that makes no sense (doubly so coming from sel-professed religious people), but it seems to be the rationale.
(edit function still doesn't work)
"Our marriage doesn't affect you, so bake that cake or suffer severe legal consequences!"
The Margrave of Azilia : “Our marriage doesn’t affect you ..... "
“Our marriage doesn’t affect you, so why not show some Christian humility and common human brotherhood and please bake us a cake."
See, it's kinda how you word it. That appeal would work for most people. Hell, it would even work for most Christians. It would probably even work for Jesus himself, though he was more in the carpentry line I hear. It's only with certain pinched & sour pharisees where it comes up short.
(Damn it, I was going to switch to a capital "H" Himself but the edit function still doesn't work. If I end up in Hell it'll all be that damn Volokh person's fault)
I'm not sure the First Amendment permits the government to enforce "Christian humility."
How would that work - a Humility Police? Sounds pretty arrogant.
Anyway, the "my marriage doesn't affect you" line doesn't work if the government can punish the anti-Christian heretics who disagree with gay marriage. In fact, it shows that gay marriage *does* affect them quite directly.
But I'm interested in seeing you elaborate on your idea of the government punishing heretical Christians. Does this mean all non-Chalcedonians?
And what if a Jewish baker rejects Christian humility? Wouldn't there be an *extra* problem enforcing Christian humility on him?
Again, I would think it would violate Christian humility for the government to use civil and maybe criminal penalties on those whose Christian humility they deem deficient.
The Margrave of Azilia : "your idea of the government punishing"
Try rereading. I didn't say the slightest thing about governments. I was talking about basic human decency. Maybe that's what threw you....
Apparently you thought these dissenters should comply with the law for non-legal reasons. I didn't pick up on that.
But the law is always there to threaten bankruptcy against those who don't show the "human decency" of complying with compulsory cakes.
The Margrave of Azilia : Apparently you thought these dissenters should comply with the law for non-legal reasons. I didn’t pick up on that.
Close, but more accurately put thus: With basic human decency the law wouldn't even be a factor. Even for someting so traumatizing as (your words) "compulsory cakes".
"Disagree" is being stretched all out of meaning here. John Williams King "disagreed" with James Byrd Jr's homosexuality and was punished in April 2019 when he was put to death by the state of Texas. Does that mean "disagreeing" gives you standing? Or maybe it was the murder he committed that the government was objecting to.
You can't seem to distinguish one atrocity from another. Perhaps you typed your illogical screed in haste?
'My thirst doesn't affect you, so let me drink from that water fountain or suffer the legal consequences!'
Of course enforcing antidiscrimination laws affects the violators.
So the "doesn't affect you" talking point doesn't even work with *any* antidiscrimination policies, even if we let you steal a base and assume that compelling gay cakes is like fighting Jim Crow.
A black person drinking from public water fountain doesnt affect anyone except the person drinking, a gay couple getting married doesn't affect anyone but them and their friends and families. Doesn't stop them being discriminated against.
Enforcing antidiscrimination laws affects the discriminators.
Even if we swallow your premise that compulsory gay cakes are like banning Jim Crow.
They wouldn't be much good if they didn't.
Cakes aren't gay or straight or even bi.
Apparently Jim Crow is an example of brutally oppressive tyranny you *don't* want to learn any lessons from.
"brutally oppressive tyranny"
To go to the baker next door for your cake?
That's the same as lynching, segregated businesses, separate and unequal schools, and all the rest?
'The same?' No. In part because of antidiscrimination laws being enforced.
You still haven't explained the rationale of compulsory cake-baking, except for thought-stopping, emotional appeals to Jim Crow.
Does Jim Crow stop your thinking? No wonder you don't get it.
Sorry, cheap shot. Damn the broken edit function.
OK, I appreciate it.
"Enforcing [X] laws affects the [law breakers]"
So you're opposed to gay marriage because you don't understand that non-discrimination law is a legally and philosophically distinct concept?
Simply put, most of the (in)famous "bake the cake" cases don't involve legal marriages at all: Elane Photogrpahy got started in 2006, 6 years before the state had any legal recognition of gay unions at all, and Colorado only had Civil Unions when Masterpiece Cakeshop got sued, Ocean Grove refused the lesbian couple in 2007, and New Jersey wouldn't have same-sex marriage until 2013, and so-on.
And you see the same on the other side: same-sex marriage has been legal in every state of the union for almost a decade now, and there *still* isn't any lawsuit about refusing services to a gay couple in Texas because Texas doesn't have a non-discrimination law that includes sexual orientation.
So simply put, you can have non-discrimination law that protects gay people without marriage, and you can have marriage without non-discrimination law. So arguing that we can't have marriage because non-discrimination law also exists in some places reveals that either you're an idiot, or you're hoping your readers are.
The right long-term answer is that the FDA should be stripped of its ability to make these regulatory decisions in the first place. Turn them into a research/advisory organization akin to the UL Seal of Approval and let patients and their doctors make the final decision about what drugs or treatments to try.
But that, like abortion policy, is something that only Congress can fix.
'and let patients and their doctors make the final decision about what drugs or treatments to try.'
Good luck, early adopters.
You should maybe look at why the FDA was created in the first place.
Because dangerously shoddy food and drugs were being sold, duh!
But that doesn't give any insight into Rossami's point. If poor quality widgets are a problem, you can address that by requiring approval by a government agency, or by private certification, or hybrid systems. We currently use all three methods:
Govt: FDA, FAA, ... - all vendors must meet government mandated standards
Private: SAAMI puts out standards for guns and ammunition (n.b. that much of Europe does this via gov't proof houses). UIAA tests climbing equipment. These are voluntary for consumers, i.e. dumb climbers can use clothesline for rope if they want, and you can buy non-SAAMI spec ammunition (and in some cases, that's reasonable). Snell rates helmets, etc, etc.
Hybrid: Private entities promulgate most of the building and fire codes, but you may be legally mandated to follow them in many cases. Or not; your new subpanel will usually have to be UL rated, but your new toaster won't be.
Each method has advantages and disadvantages; any given problem may best be solved by one method or another. Just saying 'the FDA was created because people were selling bad things' doesn't mean the FDA is the best method.
(I don't really have an opinion about the FDA vs other methods, but I think your argument is weak)
The contrast between regulating food and drugs (and even plumbing and electrical work) and private standards for climbing gear and ammunition is that the latter affects fewer people who should be expected to be better informed about the kind of products and what risks they are taking, and can usually see the outcomes of shoddy products quickly (but perhaps catastrophically). Snake oil sellers and other quacks have long been a thing; sellers of substandard climbing equipment and ammunition undoubtedly exist, but not so much that we have any common idioms for them or their products (OK, I guess "Saturday night special" might qualify).
Public health measures taken proactively are far more efficient than trying to unwind widespread damage after the fact. They do impede some innovation; allowing terminally ill patients access to experimental treatments would be a good thing, but I don't see an obvious bright line between that sort of case and quacks/snake oil.
Another point is that a lot of the private certification you discuss does not require a ton of technical expertise, nor need it take a long time. I suspect that someone can do a good job of testing rope in a hell of a lot less time than it takes to do a clinical trial.
Can you expand on how that might affect a private/govt choice?
Clinical trials are indeed hard and expensive, but why is it more efficient to get 'FDA approved' vs 'AMA approved'?
Sort of related, if you are unlucky enough to get cancer, your oncologist will decide on your treatment based on large, expensive clinical trials done under private auspices (I used to work for one of the big name cancer research center, supporting the biostatisticians who designed and analyzed the clinical trials). Why is, say, deciding on antibiotic therapy so different?
(and, again, I don't really have a problem with the FDA, I just don't see how your argument is compelling)
Drug research is largely funded by the federal government, even if pharmaceutical companies want all the credit (and profit). I suspect that for any other federal expenditure you would prefer the government to verify what they spent their money on. "AMA approved" would either outsource the same work (if every drug had to have AMA approval instead of FDA approval) or create inefficiency, potential gaps and consumer uncertainty if there were competing private approvals (or the FDA would spend its time approving the private approvals).
Your non-governmental approvals would also be more likely to fall prey to regulatory capture.
We only have to look back a couple years to see good examples (and probably a few people here still believe in them...)
Hydroxychloroquine & Ivermectin
Even with the FDA and CDC coming out against these drugs for treatment of COVID-19, people took them.
I don't necessarily expect patients to be super-informed about drugs (though I think you're underestimating most of them) but I very much do expect doctors to be well informed and capable of making good decisions about what certifications to trust.
Yes.
Additionally, it's not like we don't let people make dumb medical decisions today. We know a few people who go to naturopaths, homeopaths, take essential oils, and so on. If we let someone treat there cancer with essential oils, you might as well let them treat it with some experimental drug.
Supplements and such are careful to avoid making claims that would require them to get FDA approval; a lot of them are harmless and not widely used. But as it is, antibiotics are abused to the point of diminishing effectiveness. Opiates are a terrible scourge but the country would probably not survive making them available over-the-counter. Thalidomide did actually treat morning sickness, but the FDA was obviously correct to block it in the US.
The FDA has provisions for "compassionate use", which I mentioned in an earlier post.
"a lot of them are harmless"
The harm comes, to cite the example of one of my wife's yoga buddies, when you say 'I'm going to treat that lump that showed up on my mammogram with the herbal concoctions my naturopath recommends'. It's not that the herbal tea that harms you, it's the advice that using the tea is a reasonable substitute for for the FDA approved big pharma medical-industrial complex types of therapy, like surgery and chemo, that are pretty nasty to go through but do actually reduce your chance of dying by quite a bit.
My point is just that we allow individuals to make those decisions, and if we let you follow your naturopath's advice on essential oils, it's not a stretch to let you follow some, shall we say, off the beaten path remedy from an M.D.
The herbal tea might actually harm you. I have a relative, who got COVID but not a severe case, who resolved to nebulize hydrogen peroxide on the advice of some alternate health guru.
People are able to make many of the decisions you call for; deciding to end one's life is not a decision generally permitted, but maybe should be for patients who are terminal and in extreme pain but who can do no more than refuse heroic measures. You haven't demonstrated that private regulation would better filter out things like thalidomide and over-the-counter opiates from harmless (probably) herbal supplements.
It looks like you're arguing there are other ways to put safety-based guardrails on a market than via administrative agency.
I'd have to dive into the costs-benefits, but would your example have caught thalidomide?
The incentive to cut corners on safety and efficacy studies is not small, especially for edge use-cases or dire but rare side effects that might be hard to trace absent a dedicated study.
At first blush, an industry-policed seal of approval doesn't seem right for this industry.
The bottom line is that Rossami's comment was another dumb answer to a complicated problem; it was driven by hostility to the administrative state. My evidence for this is that he put it as what the Supreme Court should do, not just a general opinion about the FDA.
The FDA didn't catch thalidomide. If anything, that works against your argument. Private guardrails don't have to be perfect. They just have to be less-bad than the government's approach. And given the many unintended consequences (some of them evident in the article above), that's not that high a bar.
You also need to work on your reading. I explicitly said that it is something only Congress (that is, not SCOTUS) can fix.
https://en.wikipedia.org/wiki/Thalidomide_scandal#United_States
In the U.S., the FDA refused approval to market thalidomide, saying further studies were needed. This reduced the impact of thalidomide in U.S. patients. The refusal was largely due to pharmacologist Frances Oldham Kelsey who withstood pressure from the Richardson-Merrell Pharmaceuticals Co.
I stand corrected on my reading.
And I stand corrected on my history of thalidomide. I think I was confusing it with Canada's FDD (which did approve it, only to pull the approval 2 years later).
FDA never approved thalidomide. That's why there were only around 20 victims in USA, while there were thousands in Germany.
Actually, in the case of motorcycle helmets there are government and Snell certifications, and some other ratings that I didn't know about until I looked it up.
I know that for bicycle helmets, most riders don't care about the DOT certification, and only respect the Snell certification.
-dk
Indeed, there is Snell, DOT, and others.
And, having been a long time motorcycle rider, it's not obvious which certification is best. I sold my last motorcycle a decade ago, so I haven't been keeping up, but IIRC Snell provided the best protection for the most severe impacts, but at the cost of transmitting more force in lesser impacts. If you knew in advance the precise impact you want to survive you could pick the best certification. But given that you face a range of impacts, it wasn't at all obvious which cert was best.
I completely agree that AHM has no standing and the correct legal outcome for this case is to dismiss it in its entirety for lack of standing. I think it likely a large majority of the Court will agree, although given the dissents from the interlocutory orders so far it is probably not going to be unanimous.
If the Court does reach the merits, I think the matter in general is well within the FDA’s statutory grant of authority, and the 5th Circuit was insufficiently deferential to the FDA’s authority to adjudicate the scientific merits of approval.
The one exception I’d make, again only if the merits get reached, is the approval of supply by mail order. At the time the FDA decided this issue, it was completely within the FDA’s authority, as Roe v. Wade had rendered all federal statutes restricting abortion and abortifacients unenforceable. However, Dobbs’ reversal of Roe resurrected the Comstock Act provision prohibiting mailing abortifacients. Like all federal agencies, the FDA’s authority is governed by all federal laws pertaining to its subject matter, not just the law authorizing it. Accordingly, Roe’s resurrection of the Comstock Act removed the FDA’s authority to approve abortifacients by mail.
Sorry, Dobbs’ resurrection of the Comstock Act. The edit function no longer works.
The Comstock Act is not going to be decided here, because SCOTUS denied cert on the petition to broaden the Fifth Circuit's prohibition.
The 5th circuit struck down the FDA’s more recent decidion decision to expand the approval relax conditions on prescribing, and specifically to permit prescribing remotely and by mail order, which wasn’t permitted in the original approval. The Suoreme Court accepted the FDA’s appeal from that decision.
So it seems to me that the subquestion of whether the FDA legally expanded the original approval to permit teleprescription and delivery by mail is potentially within the FDA’s cert petition and the question presented. For it to be legal, the 5th Circuit’s decision otherwise would have to be overturned. If AHM has standing (which I doubt), they could potentially use the Comstock Act as an alternative ground for upholding the 5th Circuit’s decision on this particular point.
The Comstock Act is the only plausible reason for mifepristone to be banned over the mail. It's also an example of what a terrible decision Dobbs was.
Comstock has been basically unenforceable for over 50 years, was it really the will of Congress that the court resurrect a long dead law?
Or the dozens of old abortion laws or aspirational trigger laws. Those are all suddenly now in effect?
Dobbs is an utter disaster of judicial activism. If anything, it shows that once a law has been unconstitutional and unenforceable for a significant period it should remain that way, and that trigger laws themselves should be unconstitutional. Legislative bodies need to pass laws for the legal landscape as it is, not some imagined counterfactual.
Like the yellow-dog-contract laws, and the laws against excessive working hours for bakers, etc?
I'm not sure the references you're making. It looks like yellow-dog contracts were outlawed in 1932 and the law remains in effect so I don't see the relationship there. And I don't get the baker reference either.
https://www.oyez.org/cases/1900-1940/208us161
https://www.oyez.org/cases/1900-1940/198us45
Ok, so what does that have to do with Dobbs resurrecting laws that had been considered unconstitutional for decades, including laws that were deliberately unconstitutional (and unenforceable) when passed?
I wonder if the Supreme Court will use this case to cabin, perhaos even overrule, Havens Realty. The 5th Circuit used an extremely expansive, “stretch” interpretation of Havens Realty to find that AHM had organizational standing. I’m pretty confident the Supreme Court will reject this interpretation. But where will they leave the doctrine of organizational standing? Will they decide only enough to dispose of this case, which could be done without removing Havens Realty’s core? Or will they use this case to narrow or abolish Havens Realty?
I personally think Havens Realty makes it too easy for activist groups of all stripes to claim they have been injured without having to show that they or their members ever experienced any injury directly. The intent of Article III standing is to limit judicial intervention to cases where plaintiffs have a direct personal as distinct from an ideological interest in the outcome. I think Havens Realty has become an end run around standing and should be cabinned.
Remember when Milfeprestone came out (I know it's "Mifepristone", I just love the chance to type "Milf") it was called "RU-486"(I preferred the sleep med, "RU-16-Yet?") which sounded more like a Computer model...
Originally developed as an Ulcer/Heartburn med, found to have umm, this certain "Side Effect", and Whammo!!!!
There were certain OB/GYNs (they were all White Men back then) who would joke about putting it in Malt Liquor...
That's what's so great about the Ike Turner Abortion Procedure (I'd tell you but then I'd have to kill you ) no Doctors, "Ethics Committees" and nearly 100% effective
Frank
Not quite kinder and gentler, but true.
Edit is still not working.
Just want to post some appreciation for Prof. Adler's post.
A good mix of some analysis and thought but quick enough to still be breaking.
Most (all?) of Jonathan's posts are thought-through and insightful. I don't always agree with him, but it's always non-trivial to formulate an argument disagreeing with what he says. One of the few contributors I'm here to read, not to mock, any more.
Maybe if Blackman took some classes from Pof. Adler .....?
I think what makes his posts so worth reading is how he focuses so strongly on the facts and legal analysis. His purpose is obviously to inform and stimulate discussion of legal issues, with little emphasis on political and policy questions. Not that he's apolitical, but he takes his position as a law professor seriously. That's his job, not political advocacy.
I also think he's got some good raw processing power going on.
At some point, continuing to associate with this blog's partisan professorial hacks, bigots, cowards, hypocrites, etc. reflects badly on the less objectionable contributors.
+1
A percentage of women who have had abortions later regret them. Given this, I wouldn’t think it all that hard for activist groups opposing abortion to find a woman who has used mifepristone, regretted it, and claims to have been injured by it, to join them as a co-plaintiff.
I find myself wondering why this AHM group has undertaken all this trouble without bothering to take this basic step that would have shored up their standing. It would seem something basic, something very simple to do.
Of course, if it’s hard to find such a person, that would speak volumes about the evidence underlying their merits claims.
And I would think that’s true for activist groups in general. If it’s hard to find somenody who’s actually been injured, then how meritorious are the claims of harm that activist group is making?
.
Even assuming "regret" is a cognizable injury, how would such regret give such a woman standing to overturn the approval of mifepristone (or related regulations)? One of the requisite elements of standing is redressability. Blocking these rules would prevent future women from suffering regret, but obviously not her.
I don't see the injury. Presumably if she used mifepristone she wanted an abortion. If the drug hadn't been available she very probably would have gotten one some other way.
The injury, such as it is, stemmed from the decision to have an abortion, not from the method.
This group is claiming lots of women have been injured by mifepristone to the point of needing to be treated by emergency room doctors. That’s an essential part of their standing claim.
If they’re right on that point, then it shouldn’t be so hard to find an actual real live one. And if they can’t find one, maybe that says something about the quality of their investigation and evidence.
That’s all I’m saying.
I'm quite certain that if they want they can find a woman who took mifepristone and suffered complications requiring ER treatment. I just don't understand how you think that would help this group's case, legally.
If they found had such a woman, and she had been joined as a plaintiff from the beginning, then the case would have cleared the injury-in-fact hurdle. It still wouldn’t have cleared all hurdles, but it would have cleared that one.
CNN headline: Supreme Court agrees to hear its biggest abortion case since Roe v. Wade.
Did they forget about Dobbs?
Well, it is CNN.
With the majority of abortions being via pills, this case could affect more abortion seekers. (Is there some way that the Supreme Court could make a narrower ruling limited to some states, or is this all or nothing for this drug in the whole country?) Dobbs as presented was potentially much narrower (the way John Roberts appears to have wanted to go, ever mindful of Republican election prospects) even though the ruling was very broad.
Still, the CNN front page showing "Supreme Court agrees to hear its biggest abortion case since Roe v. Wade" does have strong Greenspan "with notably rare exceptions" energy. They should have followed Vox: "The Supreme Court will hear its biggest abortion case since it overruled Roe v. Wade". The actual CNN story if you click through is more reasonably headlined "Supreme Court to decide whether to restrict abortion drug nationwide".
For abortion policy the difference between affirming and reversing the Fifth Circuit is not that big. Do we go back to the Obama-era rules where the two drug procedure requires an extra doctor's office visit? The Supreme Court court already refused to take the drug off the market entirely.
The implications for standing doctrine and the Administrative Procedure Act are more important. Those don't get the same clicks as predicting the end of easy abortion.
The difference is a lot of women in states where doctors are prohibited from assisting with abortion would lose local access. It would dramatically increase the costs such that only wealthier women could afford the procedure.
That's a big change for a lot of women.
"CNN headline: Supreme Court agrees to hear its biggest abortion case since Roe v. Wade.
Did they forget about Dobbs?"
Q. How is CNN like the GOP?
A. They both are trying really hard to forget about Dobbs.
This is a chemical that is used to kill unborn humans via chemical abortion. And the FDA allows it because their mission is to promote health and safety or something, right? Nice.
But setting that aside, it sounds like this is a risky drug with serious side effects including cases of life-threatening (to the mother) sepsis, and there is a necessity to confirm it is not used beyond 7 weeks pregnancy, or with various contraindications, and therefore should be administered by doctors. What's so controversial about that? Having the drug administered by doctors also helps to ensure that women aren't being forced or tricked into taking the drug and killing their baby unwillfully. Of course, it'd be better to get rid of the FDA and let states regulate things or at least have Congress make these decisions or simply not regulate drugs generally. But that's not what we have.
And it can turn your child into a drag queen, force them to learn CRT in kindergarten, and there's a risk they may end up playing for the Dallas Cowboys.
The Comstock Act ain't what it used to be. Congress repealed the part about birth control, and courts and juries considerably watered down the obscenity part.
That won't stop people from calling it the Comstock Act, of course, trying to evoke negative feelings based on past applications of the Act which are no longer applicable today.
The part which remains is the ban on sending abortifacients through the mail or by private express companies. I don't know how that will get enforced, since the administration says it won't enforce it according to the literal language. How to make them do it? Darned if I know.
since the CURRENT administration says it won’t enforce it
TMofA asks:
The current administration might not enforce it, but that's not really enough for Danco and others to know what the legal ramifications are in the longer term.
However, since mifepristone has more uses than only as an abortificant, there is no Comstock Act based rationale to totally ban mifepristone shipments via US Mail/common carrier. For example, it is used for miscarriage management and treatment of Cushing's Syndrome. As these are not "abortificant" uses, shipment for these purposes is not precluded by the Comstock Act. Going from memory, there was case law saying people the Comstock Act prevented shipping condoms that were intended for "birth control" ... but shipments intended for "disease prevention" were not covered.
But even if one assumes the Comstock Act applies to mifepristone across the board, then distribution via "US Mail" and "common carriers" is banned (see 18 U.S. Code §§ 1461 & 1462). Private carriers and/or distribution by Danco itself are not within the ambit of the Comstock Act - while Danco's costs to distribute would undoubtedly go up, legal distribution methods would remain. So again, handwaving about the Comstock Act doesn't provide a sufficient hook for AHM to obtain the relief they want - completely revoking FDA approval of the drug itself.
The 5th Circuit would disagree, in all likelihood, but that's because they're results-oriented hacks who - if the denial of AHM's cross-appeal for cert on the original FDA approval is any guide - are going to get bench slapped (more) by the S.Ct.
This is based on a bogus legal analysis that focused on a case distinguishing a different statute that prohibited only for otherwise illegal uses from the Comstock Act. The Justice Department misrepresented a case that actually distinguished the Comstock Act from a law with a textual exception the Comstock Act doesn’t have - a case explaining what the Comstock Act doesn’t say - as a case pronouncing what the Comstock Act says.
The idea that if the thing has some legal use it isn’t covered is just nonsense. Under the actual Comstock Act cases, if the drug was intended to induce an abortion in the specific case, or is primarily used for abortion, its interstate shipping is illegal.
Nothing about current statute law lets courts force a prosecution.
Thus, this is one area in which if the executive disagrees with the judiciary on legal interpretation, the executive wins, essentially. It takes two to tango.
Yes - for all the talk of judicial supremacy there are so many ways for executive to impose its own legal interpretations independent of the courts.
Not entirely. It might be relevant to this case. One of the COVID-related changes the FDA made in 2021 was to permit prescription by telemedicine and mail order. If the Supreme Court finds AHM has standing (I don’t think it will), it might uphold the 5th Circuit’s order striking down this particular portion of the approval changes, on grounds the Comstock Act prohibits mailing an abortifacient directly to a patient for the specific purpose of abortion.
Even in the absence of prosecution, laws have collateral effects that come up every now and then.
For example, in the late 20th century, North Carolina courts refused to apply victim restitution laws to unmarried couples wjo were burglarized, even though the fornication statute had gone largely unenforced, on grounds that fornication was still a crime in the state, and the restitution statute specifically prohibited restitution to people who were in the process of committing a crime at the time of the victimization.
The danger here is that SCOTUS will opine in substance: conservative "Christians" have Article III standing; no one else does. The justices would of course couch that in flowery language, but substance matters.
The AHM plaintiffs' theory of standing appears to be that if mifepristone stays on the market, other doctors will prescribe mifepristone to their pregnant patients, the pregnant patients will suffer side effects, and then the patients will switch doctors and come to the plaintiff-doctors. This, in turn, will injure the plaintiff-doctors because it will divert their attention from their other patients, potentially force them to complete “unfinished abortions,” and possibly expose them to malpractice lawsuits. By contrast, if mifepristone is off the market, these women will elect to carry their babies to term (as opposed to seeking surgical abortions), thus preventing the plaintiff-doctors from facing these risks. (H/t to Adam Unikowsky for his cogent summary of the theory.)
This theory completely fails to address how a ruling removing mifepristone from the market of limiting its availability will redress the plaintiffs' claimed injury. A pregnant woman who is unable to obtain mifepristone has three options: she can undergo a medication abortion using misopristol only, she can obtain a surgical abortion, or she can carry her pregnancy to term.
Any of these options -- each of which is riskier than a mifepristone/misoprsitol abortion -- is at least as likely to injure the plaintiff-doctors because it will divert their attention from their other patients, potentially force them to complete “unfinished abortions” or deliver babies, and possibly expose them to malpractice lawsuits.
What am I missing?
I think you’re missing the fact that this is not the first time this case has gone to the Supreme Court. The Supreme Court previously stayed preliminary injunction orders issued by the District Court and the 5th Circuit, with Alito and Thomas dissenting. This suggests that the majority of the court is not so inclined to by AHM’s arguments as you are assuming.
I think this case will be decided on standing. The Court will reject AHM’s standing claim, rule AHM doesn’t have standing, and dismiss the entire case without going any further.
If there was no standing, doesn't that deprive a court of jurisdiction?
Yes. The courts below had issued orders striking down portions of the mifepristone approval; the FDA had expanded the approval during Covid to make the drug easier to get. If the Supreme Court finds there was no standing, it will vacate the lower-court orders striking down the approval expanison, on grounds that there was no jurisdiction, and when federal courts have no jurisdiction, they can’t issue any orders to anyone. This means that the full expanded approval will go back into effect as before. Both the FDA and the companies making mifepristone will win, since this is the result they had been seeking.
Three things to know about Mifeprisone:
1. The right-to-lifers are, strictly speaking, right on the legal history. Mifepristone was approved in an unusual way: FDA used a fast-track approval protocol which had originally been established for anti-HIV drugs - a sort of "right-to-try" for AIDS patients. They did this because President George HW Bush had been refusing to fund clinical trials in USA and directing FDA to delay, in order to court the religious right, so approval was far overdue when Clinton became President, and the GYNs didn't want to wait any longer.
2. But right-to-lifers are wrong on the science. The experience in other countries, and the experience here in USA in the past years since approval, show that the Mifepristone-followed-by-misoprostol regimen is sufficiently safe and effective to justify approval. There is no medical justification for reconsidering it now.
3. Even if Mifepristone becomes unavailable, the doctor can substitute methotrexate for Mifepristone, and use a methotrexate-followed-by-misoprostol regimen instead of the no-longer-available Mifepristone-followed-by-misoprostol regimen. This was demonsterated in the 1990s by Dr. Richard U. Hausknecht and Dr. Eric Schaff. So the actual effect of yanking Mifepristone (if it gets yanked) won't prevent any significant number of non-surgical abortions.