Mifepristone challenge fails; SCOTUS rules anti-abortion doctors, groups lack standing

“[T]he federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions," Justice Kavanaugh wrote for the unanimous court.

The U.S. Supreme Court unanimously rejected a high-profile effort by an anti-abortion doctors and medical associations to restrict the use of the medication abortion drug mifepristone beyond the standards set by the U.S. Food and Drug Administration.

The drug remains available — as it has throughout the litigation — on the FDA’s current terms.

After garnering national attention for more than a year, the challenge was ultimately rejected without the justices addressing the underlying questions about the FDA’s actions. Instead, Justice Brett Kavanaugh wrote for the unanimous court, the doctors and associations could not show that they had legal standing to bring their lawsuits. Specifically, Kavanaugh detailed, they failed to show that the FDA’s decisions were the cause of the injuries they claimed.

“[T]he plaintiffs do not prescribe or use mifepristone. And FDA is not requiring them to do or refrain from doing anything. Rather, the plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain,” Kavanaugh wrote. “Under Article III of the Constitution, a plaintiff’s desire to make a drug less available for others does not establish standing to sue.”

The doctors and associations, led by the “Alliance for Hippocratic Medicine,” initially sought to reverse the FDA’s 2000 approval of mifepristone altogether. While U.S. District Judge Matthew Kacsmaryk went along with that, that request was a step too far even for the conservative U.S. Court of Appeals for the Fifth Circuit.

The appeals court, however, did uphold two of Kacsmaryk’s other rulings, which would have tossed out the FDA decisions in 2016 and 2021 loosening the restrictions on the use of mifepristone. The FDA’s changes extended the time in pregnancy during which mifepristone could be prescribed, reduced the number of medical visits, and eventually ended the in-person dispensing requirement — allowing mifepristone to be mailed.

The Supreme Court put Kacsmaryk’s order on hold throughout the appeals, however, keeping the drug available on its current terms during the litigation.

The FDA appealed the Fifth Circuit’s ruling to the Supreme Court, as did Danco Laboratories, the maker of Mifeprex, and the court agreed to hear both cases. Notably, the court rejected the plaintiffs’ request for the Supreme Court to hear their appeal of the Fifth Circuit’s rejection of their request to block the 2000 approval.

As such, the case was already limited by time it got to the court, but the questions raised by the Fifth Circuit’s decision were significant and the consequences of accepting the Fifth Circuit ruling, effectively returning the prescription of mifepristone to the pre-2016 rules, would have been significant — especially in a post-Roe v. Wade landscape.

More than 14 months after Kacsmaryk issued his order that would have sought to end approval of mifepristone altogether and nationwide, though, Kavanaugh wrote, bluntly, that “the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”

There are three points from Kavanaugh’s opinion — which, again, is unanimous and solely about standing — that I think are noteworthy:

• Conscience protections for individual doctors — and Solicitor General Elizabeth Prelogar’s discussion of them at oral arguments — were important to the court’s unanimity on Thursday. Kavanaugh cites repeatedly to Prelogar’s responses supportive of conscience protections in his opinion for the court.

  

• Kavanaugh and the court strongly reject the idea that “highly speculative” claims that the doctors will face “monetary and related injuries” because of “general public safety requirements” are sufficient to justify standing.

  

• Finally, Kavanaugh — again, for a unanimous court — notes that “if not us, who?” is not a sufficient standing argument.

It is important to remember that this is a Supreme Court decision, and any decision aggressively applying limits to standing — the opinion’s discussion of the limits of organizational standing in particular — could have fallout in other cases where organizations on the left would like a more robust theory of standing.

But, in front of this court and in this legal environment, I’m not sure that many on the left are going to be fighting rulings that restrict standing in the ways Kavanuagh’s opinion for the court on Thursday does.

Which leads to a brief mention of Justice Clarence Thomas’s concurring opinion. He joined Kavanaugh’s opinion in full, so there’s no disagreement voiced with any of the above. He wrote, however, to address associational standing — and question whether it should be a thing at all. His brief, 9-page concurrence questioned whether there is any constitutional underpinning for the court’s rulings that allow associations, in certain instances, to sue on behalf of their members. He suggested, as he often does in solo concurrences or in writings when the court denies certiorari, that the court “should address” the issue “in an appropriate case.”

The bottom line: Mifepristone is safe, on current terms, for now.

Why the caveat?

First, a trio of conservative states have intervened in this challenge at the district court before Kacsmaryk, something that I have written about previously. Adam Unikowsky, though, has written about how a ruling that the original plaintiffs lack standing — i.e., what we got on Thursday — should be sufficient to end the case altogether because that would mean the court never had jurisdiction to hear the case. It is Kacsmaryk, however, so whether that’s what happens remains to be seen.

Additionally, because it was a standing decision, as stated above, there was no discussion of the merits of the challenges raised by the doctors and associations. So, there was no Supreme Court ruling on Thursday that the FDA’s rules are proper — and no ruling about the status and interpretation of the 1873 anti-vice law known as the Comstock Act. And, regardless, a later administration could change FDA’s rules and interpretation of the Comstock Act — especially in the absence of Roe’s protections.

It also should be noted that many conservative states’ anti-abortion laws include restrictions on medication abortion, and this ruling does nothing the reject or impair them.

But, again, for now, mifepristone remains accessible on current terms in the wake of Thursday’s decision.

This is a breaking news post. It was updated after initial publication, with the final update at 2:45 p.m. Please check back at Law Dork for the latest.