Supreme Court "Shadow Docket" Order Preserves Mifepristone Via Telemedicine--For Now
The Court stayed a lower court order that would have blocked FDA rules allowing the prescription of mifepristone to terminate pregnancies via telemedicine.
Yesterday evening, as expected, the Supreme Court granted mifepristone manufacturers' requests for a stay of an order of the U.S. Court of Appeals for the Fifth Circuit blocking a 2023 Food and Drug Administration regulation allowing doctors to prescribe mifepristone as an abortifacient via telemedicine. The order was issued shortly after the expiration of an administrative stay entered, and then extended, by Justice Alito. Justices Thomas and Alito each dissented. There are no other recorded votes.
As is common in such situations, the order in Danco Laboratories v. Louisiana stays that of the lower court pending the disposition of the appeal and any subsequent petition for certiorari. This means the case will find its way back to the Court, perhaps even later next term.
The order was unsurprising because, as I noted here, the Fifth Circuit's order blocked the implementation of a federal regulation on questionable grounds. Louisiana's suit is based upon an aggressive and somewhat speculative theory of standing and the Fifth Circuit's order relies upon faulty reasoning from a prior, since-vacated, opinion from the prior round of mifepristone litigation. Thus there were at least two stay considerations weighing strongly in the manufacturers' favor: The Fifth Circuit had blocked a federal regulation and the manufacturers have a strong argument they are likely to prevail on the merits.
That said, Justices Thomas and Alito make some weighty points in their defense, and the issuance of a stay here was never certain. As I noted last week, while an army of amici filed briefs with the Court, the federal government did not. The federal government neither sought a stay from the Court nor filed a brief supporting the manufacturers' defense of the FDA's rule. So while blocking a regulation may presumptively constitute irreparable harm to the federal government, it is not clear that such concerns should carry much weight if the federal government does not raise them. The federal government is not obligated to defend every agency regulation at every turn, even against questionable judgments. (And, for what is worth, this is not the first time this has happened with the FDA. For example, the agency dropped its appeal to American Association of Pediatrics v. FDA, in which a district court accepted a questionable standing claim and forced the agency to regulate vaping products more aggressively.)
Absent an FDA filing, the manufacturers had to establish irreparable harm on their own, and this is where Justices Thomas and Alito found their stay requests wanting. Neither found the manufacturers' concerns about reduced mifepristone sales particularly compelling. Nor was either moved by concerns that the Fifth Circuit order would make it more difficult to obtain mifepristone in jurisdictions that (unlike Louisiana) allow its use.
As Justice Thomas noted, federal law (the Comstock Act) already prohibits the distribution of abortifacients via the mail. Therefore, he reasoned, the manufacturers were effectively complaining that the Fifth Circuit order would deprive them of "lost profits from their criminal enterprise." I take Justice Thomas' point in the Comstock Act, which remains on the books even if it is never enforced, but the FDA order at issue is not limited to mail-order prescriptions.
Justice Alito made some similar points, while also stressing that mifepristone manufacturers are well aware that the FDA's 2023 order facilitates the provision of mifepristone in jurisdictions where its use to terminate pregnancies is illegal, that the FDA has acknowledged concerns about the analyses upon which the 2023 regulation was based, and that the manufacturers' claim of irreparable harm is undermined by the fact that the FDA has given no indication it would take any enforcement action against manufacturers were the 2023 rule stayed, and it could not be forced to take such actions by federal courts. Prescribing doctors and potential users of mifepristone may be affected, but neither were parties to the case.
Justice Alito's dissent validates Louisiana's concern that it's post-Dobbs ability to enforce its own abortion laws has been undermined by "certain medical providers, private organizations, and States that abhor" its laws. No doubt this is true. If other states and the federal government allow the distribution of something, whether mifepristone or marijuana, other states may have a more difficult time enforcing their own prohibitions. The federal government has the unquestioned power to limit the distribution of mifepristone into states where its use is barred, but it has chosen not to, and the FDA is not required to base its regulations on such concerns. [As for what other states can or cannot do, I recommend Professor Steve Sachs' comments at this Federalist Society panel on abortion law post-Dobbs]
Justice Alito also paused to note that the Court's issuance of an "unreasoned order" granting stays of a lower court action, no doubt to tweak those (both on and off the Court) who routinely complain about "shadow docket" orders issued without explanation (and, in this case, on behalf of private corporations too). He can be forgiven for thinking that many complaints about "shadow docket" orders are driven as much or more by disagreements on the merits as they are concerns about process.