The Fifth Circuit has released its decision in the mifepristone case. In essence (and I read this quickly, so take with a grain of salt), the court did not overturn the initial FDA approval of mifepristone or the approval of generic variants (the former because the claim was time-barred; the latter because the plaintiffs showed no specific evidence that they were additionally injured by generic approvals). However, it upheld the district court's stay on subsequent FDA decisions which made mifepristone more readily accessible (e.g., allowing it to be prescribed by telemedicine). The new FDA regulations were, the court concluded, "arbitrary and capricious" primarily because while the agency did analyze the risks latent in the individual alterations it was making to the regulatory schema and found them to be negligible, the FDA did not specifically analyze how all these changes might interact when aggregated together.
The decision is, as the panel took pains to repeatedly note, stayed until the Supreme Court has an opportunity to act.
In May, I proffered three possibilities of what the Fifth Circuit would do in this case. The first was that they would take the Supreme Court's hint and reverse the district court. The second was that they would largely affirm the district court but try to file off the "rougher edges" to make it more likely the Supreme Court would uphold the ruling. And the third would be to let their freak flag fly and go all in on defending the extremity of the district court ruling.
What we got was mostly in that middle camp. The court didn't accept the most extreme iterations of the district court's ruling which would have completely taken mifepristone off the shelves nationwide. And its analysis, for the most part, styles itself as sober review of the administrative record and standing doctrine. But the end result was still the court stretching the law to force a substantial rollback in its accessibility. The hope, I think it is clear, is to present this ruling as the "reasonable" conservative position that doesn't go as far as the district court and so one that liberals can't really complain about if it is upheld (spoiler: we can and should).
Judge Ho concurred in part and dissented in part because he would have upheld the district court's decision in its entirety, and in contrast to the majority his opinion was squarely in the realm of possibility number three. He went whole hog on every possible avenue for showing his right-wing culture warrior bona fides, including florid discussions of the importance of the doctor's "conscience rights" to be mad that they have to treat patients who are suffering from medical emergencies they disapprove of and a full-scale defense of the applicability of the Comstock Act to block any sort of approval for abortion medication.
There is stiff competition for who is the worst federal appellate judge. But I'm not sure there's any competition for who the most arrogant federal appellate judge is (and it's no surprise, perhaps, that it's a University of Chicago Law alum taking the crown). In that vein, one passage of Judge Ho's opinion especially stood out to me -- his strident defense of the judiciary refusing to accord deference to the scientists at the FDA.
In this appeal, neither the FDA nor Danco is content to simply argue that the district court erred. They disparage the ruling as “an unprecedented judicial assault on a careful regulatory process.” The “non-expert” district court issued an “unprecedented order countermanding the scientific judgment of the Food and Drug Administration.”
Their message is simple: The scientists at the FDA can do no wrong. So courts have no business reviewing their actions.
That’s mistaken on multiple levels.
[....]
Scientists have contributed an enormous amount to improving our lives. But scientists are human beings just like the rest of us. They’re not perfect. See, e.g., Whole Woman’s Health v. Paxton, 10 F.4th 430, 464–70 (5th Cir. 2021) (en banc) (Ho, J., concurring). None of us are. We all make mistakes.
And the FDA has made plenty....
The scientists at the FDA deserve our respect and our gratitude, but not our blind deference. That would defy Congress’s clear directive that courts conduct independent legal review of FDA action under the APA.
Of course it is true that scientists can make mistakes. Judges can make mistakes too (this case is replete with them). And since "we all make mistakes," the actual germane question is who is more likely -- scientific experts or generalist judges -- to make a mistake when it comes to assessing highly technical medical and scientific decisions on drug approval. And the answer there is obvious: judges are far more likely to be mistaken. Hence why the standard of review is "arbitrary and capricious". The agency doesn't get blind deference, but it still gets regular deference. Absent blatant, smack-you-in-the-face mistakes -- the sort that go beyond disputes about best practices or disagreements on matters of judgment and slide all the way into "arbitrary" or "capricious" conduct -- judges defer to the scientists because judges know that in normal circumstances they're more likely to cause a mistake than to correct one.
In this case, the FDA analyzed the risks of its new regulations enhancing public access to mifepristone and found that they were negligible. Would it have been better if it is specifically analyzed how these risks might change when all the regulatory changes were aggregated? I have no idea (since again, I'm not a scientific expert, and I'm modest enough not to venture a guess). But it is hard to argue that the decision to rely on the individual negligibility of the risks is either "arbitrary" or "capricious". That sort of pot-shot second-guessing of scientific judgment is exactly what normal judicial modesty and deference should foreclose.
But Judge Ho's eagerness to emphasize the fallibility of the FDA's scientists is quite predictably paired with a blind refusal to recognize his own parallel status as a mere mortal. In our constitutional system, it seems, scientists aren't gods; only Fifth Circuit judges are.
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