No Standing For You

FDA v. Alliance for Hippocratic Medicine

In April of 2023, Matthew Kacsmaryk, a federal district judge in Amarillo, Texas, entered a nationwide injunction banning mifepristone, one of two drugs used for medication abortion. He did that despite 20 years of data that established mifepristone as safe and effective, with fewer complications than Tylenol. Judge Kacsmaryk entered a stay for seven days to give DOJ an opportunity to appeal his order. They didn’t need a week, though. They filed within hours.

People who thought it couldn’t get any worse after Dobbs gutted the abortion rights guaranteed in Roe v. Wade were stunned. Medication abortion accounts for more than half of the procedures in the United States, and a significant majority of the public favors letting women use it.

Today, the Supreme Court released its opinion in FDA v. Alliance for Hippocratic Medicine. Here’s a little background—you can be forgiven if you’ve lost track of how this case has evolved since I first wrote about District Judge Matthew Kacsmaryk’s order granting a nationwide injunction banning mifepristone in April of 2023.

Mifepristone was approved by the FDA in 2000. At that time, it had to be prescribed by a doctor, patients were required to have three in-person visits with the doctor, and the drug could only be used to terminate pregnancies up to seven weeks. That changed in 2016, when the FDA relaxed some of those rules, permitting mifepristone to be used up to 10 weeks, allowing healthcare providers like nurse practitioners to prescribe the drug, and permitting just one in-person visit . In the midst of the pandemic in 2021, the FDA did away with the in-person visit requirement altogether.

None of that sat well with the plaintiffs, a group of doctors who were anti-abortion. They challenged everything from the FDA’s approval of the drug in the first place in 2000 forward. At the time, I was deeply concerned that when the case got to the Supreme Court, they might take advantage of the opportunity to all but end access to the most widely used form of abortion left to American women.

But that didn’t happen, at least not today. The Supreme Court didn’t end access to mifepristone; instead, it ducked the substantive issue, leaving it for another day by ruling that the plaintiffs in this case lacked standing and dismissing the proceeding on that basis without considering the merits of their argument. When we first looked at the case, we discussed the fact that that was the correct outcome, that the case should be dismissed due to a lack of standing. The surprise is that this Court, with its uniquely results-oriented jurisprudence when it comes to denying access to abortion, went ahead and did it.

The decision was 9-0, with Justice Brett Kavanaugh writing for a unanimous court. Only Justice Thomas wrote a separate argument, a concurrence.

The sigh of relief here is only temporary. There is nothing to prevent anti-abortion forces from finding better plaintiffs and returning to court. Part of the plaintiffs’ argument in this case involved the Comstock Act, an old law, not used for decades, which bans mailing anything that educates about or can be used to provide an abortion. The law was passed at the behest of a religious fanatic who wanted to define moral purity for the country. Now, conservatives want to bring it back into use, and it’s very unlikely we’ve heard the last of it. We talked about the Comstock Act and its origins in depth here, and it’s worth going back for the refresher—your outrage will keep you from becoming complacent.

If you’re out of time and attention, stop here. But I’ll spend a little time on the details of the case and the standing argument, and what it’s future implications might be, for those who want to be legal nerds tonight.

You can read the full opinion here.

The lawsuit was filed in Texas in 2022 by four pro-life medical associations and several individual doctors with the goal of ending approval for mifepristone. They had a specific judge in mind for their case, Judge Kacsmaryk, who had vigorous anti-abortion views and was the only judge in the Amarillo Division of the Northern District of Texas, which meant they were almost certain to end up with him if they filed the case there. They asked Judge Kacsmaryk to enter a preliminary injunction while the litigation was underway that would either force the FDA to withdraw its initial approval of mifepristone or at least rescind the decisions in 2016 and 2021 that expanded access to it.

Judge Kacsmaryk went all in with the plaintiffs, effectively enjoining the FDA’s approval of mifepristone and ordering its removal from the market. On appeal, the Fifth Circuit granted the stay in part. On the case’s first trip to the Supreme Court, the Justices stayed Judge Kacsmaryk’s order. If you want to refresh your recollection of that “shadow docket” ruling, we discussed it here.

That decision was not unanimous. Thomas and Alito voted against the stay and would have let the ban go into effect while the case was being litigated. It’s possible there could have been additional dissents from granting the stay if Justices chose not to reveal their vote—it only takes five justices to act here. But it was Justice Alito who wrote to explain his decision, provocatively and baselessly claiming that under Biden, the FDA would refuse to follow a lawful court order against it in the case, which drew cries of outrage.

The case went back to the Fifth Circuit. They held that the plaintiffs had standing, so the case could proceed. But they ruled, partially, against the plaintiffs, finding they weren’t likely to successfully challenge the original approval of the mifepristone. They ruled in their favor on the FDA’s expansion of access to the drug in 2016 and 2021, calling it unlawful. That meant that while the Court permitted mifepristone to stay on the market, they limited its use to the original conditions, which only made it available up to seven weeks, so long as it was prescribed by a doctor and used in connection with three in-person visits. The Supreme Court agreed to revisit that decision, which is how the case got to the Court again.

But the Court never got to the question of whether the FDA exceeded its authority, because the case was over once they reached the conclusion the plaintiffs didn’t have standing. Justice Kavanaugh did not mince words, writing, “Under Article III of the Constitution, a plaintiff ’s desire to make a drug less available for others does not establish standing to sue. Nor do the plaintiffs’ other standing theories suffice. Therefore, the plaintiffs lack standing to challenge FDA’s actions.”

What is standing? Justice Kavanaugh references the famous question posited by Justice Scalia, writing in the opinion, “As Justice Scalia memorably said, Article III requires a plaintiff to first answer a basic question: “‘What’s it to you?’” Standing means that “the plaintiff cannot be a mere bystander, but instead must have a “personal stake” in the dispute.”

The test for standing is well established. It requires a plaintiff to show that

1. She has suffered or likely will suffer an injury in fact,

2. The injury likely was caused or will be caused by the defendant, and

3. The relief requested from the court would be sufficient to redress the injury

Justice Kavanaugh wrote that the plaintiffs didn’t meet the test. There are federal conscience laws in place that provide definitive protection for doctors who don’t want to perform abortions or related treatment, and the law protects them from any repercussions due to their refusal. There was no evidence the doctors suffered any economic harms. So, he concluded, there was no injury in fact. “The injury in fact requirement prevents the federal courts from becoming a ‘vehicle for the vindication of the value interests of concerned bystanders.’” A person has to have actual skin in the game to be a plaintiff with standing. Justice Kavanaugh rejected the idea that these plaintiffs suffered injuries caused by the FDA, stating that “the causation requirement screens out plaintiffs who were not injured by the defendant’s action. Without the causation requirement, courts would be ‘virtually continuing monitors of the wisdom and soundness’ of government action.”

There’s a double-edged sword here that also gets fleshed out a bit further in Justice Thomas’ concurrence. It’s the notion of organizational standing. The plaintiffs say they have been harmed and forced to incur costs to oppose the FDA’s policies, listing the following items:

• The FDA “caused” the associations to conduct their own studies on mifepristone so that the associations can better inform their members and the public about mifepristone’s risks.

• The FDA “forced” the associations to “expend considerable time, energy, and resources” drafting citizen petitions to the FDA, as well as engaging in public advocacy and public education.

• All of that has caused the associations to spend “considerable resources” to the detriment of other spending priorities.

Justice Kavanaugh is still not impressed. He writes, “But an organization that has not suffered a concrete injury caused by a defendant’s action cannot spend its way into standing simply by expending money to gather information and advocate against the defendant’s action. An organization cannot manufacture its own standing in that way.” Justice Thomas would go further than that. He writes in his concurrence that, “Our third party standing doctrine is mistaken,”—he would abolish it.

Justice Thomas looks back to an old Alabama case using what’s called associational standing to permit the NAACP to assert claims on behalf of its members. He does not seem to take issue with that case directly because the NAACP arguably faced injuries of its own, but he suggests the Court subsequently did away with that requirement and that associational standing and broad injunctive relief are used to give far too many people remedies for tenuous reasons.

Some civil rights cases and other cases designed to protect rights like abortion rights rely on organizational standing when the proper criteria are met. In some situations, organizations can sue when it is not safe or practical for their members to do so individually. That means there is reason to be concerned that this decision will come back to haunt in future cases. These restrictions on organizational standing already exist in the law, but it is easy to imagine this case being cited back at clinics suing against abortion restrictions or voters who are represented by a civil rights group. Standing is in the eye of the beholder, which means judges have a great deal of discretion to exercise and no definitive answer since the inquiry, as Justice Kavanaugh noted earlier in the opinion, is heavily fact-based. What is needed is the judge as a neutral umpire, calling the balls and the strikes, and not a judge who is seeking to restore what he considers the godliness of America with his every ruling. In other words, this case only underscores our concerns about the Court. And while Justice Thomas is the only one explicitly calling to reject this form of standing today, he was once the only Justice suggesting privacy protections that gave Americans a right to contraception should be overruled. Don’t lose sight of what’s on the ballot in November.

But, at least for today, the Supreme Court has protected the right of American women to access medication abortion in states where abortion is still legal. Justice Kavanaugh concluded: “We recognize that many citizens, including the plaintiff doctors here, have sincere concerns about and objections to others using mifepristone and obtaining abortions. But citizens and doctors do not have standing to sue simply because others are allowed to engage in certain activities—at least without the plaintiffs demonstrating how they would be injured by the government’s alleged underregulation of others.” He also rejected the plaintiff's argument that they had to have standing because if they didn’t, no one did. First, he didn’t accept the idea that there was no one else with standing—perhaps a harbinger of a future legal challenge by states using the Comstock Act—but also, he noted that not all disputes with the government have to be solved with lawsuits and that “some issues may be left to the political and democratic processes.”

Last night I suggested we shouldn’t lose sight of the Court’s ethics issues when the “big cases” started coming down. This case illustrates that proposition. Earlier this week, I mentioned that I was intrigued by a review of how Justice Alito ruled in standing cases. His results-oriented rulings showed he ruled that 100% of the plaintiffs in cases he was ideologically aligned with had standing, but none of the plaintiffs in cases he was opposed to did. That’s remarkable. Here’s a little excerpt from that edition of the newsletter:

What should we now make of Justice Alito’s ruling in the mifepristone case, where he ruled against a party he, until now, has always sided with? It was Justice Brandeis who once said that sunlight is the best disinfectant.

At oral argument in this case, Justice Alito seemed well along to affirming the Fifth Circuit and finding that the plaintiffs’ had standing. But after recent focus on his and other ethical issues on the Court, he apparently backed off.

The test for standing clearly leads to the result in this case, the one that a 9-0 Court reached—no standing. That hasn’t stopped Justice Alito from engaging in results-oriented judging in cases with tenuous standing in the past, but it did here.

Sunlight and lots of it. When we pay attention in a sustained and well-informed fashion, we ourselves may actually be able to restore some of the guardrails at the Court. They used to self-enforce. We don’t know for certain what came into play in this opinion, but Justice Alito’s remarkable shift in view from oral argument and it’s timing lead me to believe we must make sure the Court knows that our eyes are on them and that our expectations for their commitment to the rule of law and the institution they have the honor of being part of are far higher than what we’ve seen recently.

We’re in this together,

Joyce