SCOTUS dispatch: in oral arguments, several justices lean against giving mifepristone opponents standing to sue FDA Dispatches
JURIST // Marissa Zupancic
SCOTUS dispatch: in oral arguments, several justices lean against giving mifepristone opponents standing to sue FDA

Marissa Zupancic is JURIST’s Washington DC Correspondent, a JURIST Senior Editor and a 3L at the University of Pittsburgh School of Law. She’s stationed in Washington during her Semester in DC.

Today I attended oral arguments at the US Supreme Court for Food and Drug Administration v. Alliance for Hippocratic Medicine. The case concerns whether the FDA’s actions to amend guidelines in 2016 and 2021 to authorize the drug mifepristone, which is used for abortions, were lawful. I previously published this explainer analyzing the arguments made in the parties’ briefs.

I last attended oral arguments at the Supreme Court in the Trump v. Anderson case, but this experience was a bit different. There was much more security to get into the actual courtroom, with security leafing through each page of each reporter’s notebook. Additionally, there were hundreds of protesters. Not as many reporters were in the press section of the courtroom, either. The court swore in about 20 lawyers to the bar association from multiple states, including Florida and Massachusetts. This time I was able to see the attorneys as they made their arguments to the justices, but I still could not actually see the justices. I was seated right behind the courtroom sketch artist, so I got to see their (drawn) view of the bench.

The court heard arguments from the Food and Drug Administration (FDA), Danco (a drug manufacturer that only makes mifepristone) and the Alliance for Hippocratic Medicine (AHM). The questions focused on whether the AHM had standing to bring the case to court. Article 3 of the US Constitution contains requirements that a party must meet to bring a case. The party must show a concrete injury, that a court decision will remedy that injury and that there is a connection between the injury and the conduct of the other party.

Solicitor General Elizabeth Prelogar represented the FDA. Prelogar gave a brief argument and fielded questions from the justices. First, Justice Clarence Thomas asked Prelogar if the AHM does not have standing to sue the FDA, who would? Prelogar explained that prior lawsuits have been brought by physicians or patients looking to increase access to a drug or even competitors in the drug market. Prelogar noted that because the doctors who AHM represents do not prescribe mifepristone, they do not have standing. Additionally, Prelogar stated that AHM’s claim of injury is too speculative to qualify as a concrete injury. Rather, Prelogar suggested AHM’s claim “rests on a long chain of remote contingencies. Only an exceptionally small number of women suffer the kind of serious complications that could trigger any need for emergency treatment.”

Justice Samuel Alito brought up the changes made by the FDA in its guidance of mifepristone use in 2016 and 2021. Over these years, the FDA no longer required mifepristone to be given in person, allowed it to be prescribed from 7 weeks to up to 10 weeks gestation, and decreased the required number of follow-up visits for a patient taking mifepristone. Alito asked whether, while the FDA claims these three changes are miniscule, the three changes happening together could be dangerous. Prelogar responded that the FDA looked at studies when making these decisions and did not see any serious increase in adverse effects with any of these changes. Alito also brought up the Comstock Act, 18 US Code 1461, which prohibits any item, substance or drug that induces abortion from being sent via the postal system, because mifepristone is now available via the mail with a prescription. Prelogar explained the FDA received legal analysis from the Department of Justice’s Office of Legal Counsel on its interpretation of the Comstock Act to guide it in the regulatory process.

Some justices seemed to be favorable to the FDA’s arguments. Justice Elena Kagan brought up a point in the FDA’s brief that the Fifth Circuit’s decision, which would restrict access to mifepristone, “is the only time any court has restricted access to an FDA-approved drug by second-guessing FDA’s expert judgment about the conditions required to assure that drug’s safe use.” Justice Ketanji Brown Jackson stated she viewed the AHM’s argument as “because we object to having to be forced to participate in this procedure, we’re seeking an order preventing anyone from having access to these drugs at all.” Jackson appeared skeptical that such a sweeping action was necessary by the court.

The attorney for Danco, Jessica Ellsworth, explained that the Comstock Act has “not been enforced for nearly 100 years,” and that this case does not need to consider that statute’s interpretation or reach.

Finally, the attorney for AHM, Erin Hawley, gave the organization’s arguments. She explained that AHM meets the constitutional requirements for standing because the doctors represented by AHM face the choice of “helping a woman with a life-threatening condition or violating their conscience [by assisting in an abortion],” which AHM argued is harmful. Kagan inquired into AHM’s argument concerning conscience objections, which is when a healthcare provider declines to provide abortion care due to a moral or religious objection. The justice asked Hawley to point to where one of the seven doctors who wrote affidavits had their objection denied, but Hawley was unable to give an instance. Instead, Hawley emphasized that because of the often-life-threatening situations in emergency and operating rooms, doctors do not have ample time to object, nor do they have enough information to know whether the patient is suffering from a miscarriage, ectopic pregnancy, adverse effects of mifepristone, or another condition.

Kagan continued to press Hawley when she explained the attorney’s statement was very “probabilistic:”

Let’s say [your theory] is something along the lines of we represent a lot of doctors, and there are a lot of women out there taking mifepristone, and some fraction of them are going to have adverse events, and some fraction of those are going to come to the emergency room, and – so there’s some probability or likelihood that one of our doctors who has a conscience objection is going to come face-to-face with one of these women who has an adverse event.

She then asked Hawley to pick one of the seven who she felt would have the most likelihood of standing, to which Hawley stated it would be Dr. Francis and Dr. Ingrid Skop. Justice Amy Coney Barrett also joined in on this point, questioning if either of the doctors performed an abortion. Barrett explained, “These affidavits do read more like the conscience objection is strictly to actually participating in the abortion to end the life of the embryo or fetus. And I don’t read either Skop or Francis to say that they ever participated in that.” Hawley replied that the conscience objection extends beyond just performing an abortion, but rather being “complicit” in that process.

Thomas asked Hawley about the Comstock Act and how it impacts the FDA’s decision. Hawley stated, “We don’t think that there’s any case of this court that empowers FDA to ignore other federal law. [T]he plain text of [the Act] is clear.”

Finally, Prelogar provided a short rebuttal to Hawley’s arguments for the court. She stressed:

[AHM’s argument] harms the agency, which had the federal courts come in and displace the agency’s scientific judgments. It harms the pharmaceutical industry, which is sounding alarm bells in this case and saying that this would destabilize the system for approving and regulating drugs. And it harms women who need access to medication abortion under the conditions that FDA determined were safe and effective.

After this, arguments were adjourned.

Outside the court, there were hundreds of protesters spanning from pro-choice to anti-abortion. The CEO of Planned Parenthood, Alexis McGill Johnson, gave a speech declaring that she was cautiously optimistic that the justices would reverse the Fifth Circuit’s decision. However, she stressed that this is the same court that overturned Roe v. Wade. She said, “[the AHM] came here with the audacity to try to bring hypothetical arguments and hypothetical cases to challenge the care that we need for our bodies, for our lives, and for our very real futures.”

Pro-choice pro testers held signs that said “Abortion is our right. We won’t stop fighting.” Anti-abortion protesters held banners and signs that read “I don’t call ending a human life healthcare,” “Chemical abortion hurts women,” and “Stop abortion pollution.” One group of individuals had large signs with justices’ faces on fake magazine covers, calling Justice Brett Kavanaugh “People’s sexist man alive,” saying Barrett is “destroying women’s health,” and that Chief Justice John Roberts is “the man who presided over the death of the constitution.”

The court is expected to release a decision by the end of its term in June.