US Supreme Court rules to reinstate in-person attendance requirements for abortion pill during Covid-19 pandemic

Food and Drug Administration v American College of Obstetricians and Gynaecologists 592 U.S.__ (2021)

Summary

A majority of the Supreme Court of the United States stayed an order by the District Court which suspended the requirement that people attend a hospital or clinic in-person in order to obtain mifepristone, a prescription drug used for medical abortions.

In July 2020, the District Court found that the in-person requirement posed an “undue burden”[1] on people seeking an abortion in light of the COVID-19 pandemic.[2] The Supreme Court’s decision reinstates the Food and Drug Administration’s (FDA) requirement that patients attend a hospital, clinic, or medical office to pick up mifepristone and sign a disclosure form.

Facts

Mifepristone is a prescription medication which, if taken in conjunction with misoprostol, induces a medical abortion. The medication is available to people during the first 10 weeks of pregnancy.

The FDA allows patients to receive doctor consults virtually, and take the medication at home without medical supervision, but requires people to attend a hospital, clinic, or medical office to obtain mifepristone. Mifepristone is the only FDA-approved medication to be taken at home that requires in-person pick-up.

This case concerns a decision of Judge Theodore Chuang of the Maryland Federal District Court to prevent the FDA from enforcing the in-person pick-up requirement during the COVID-19 pandemic. Judge Chuang stated that the restrictions were an undue burden and a “substantial obstacle” on people’s access to abortion services.[3]

The District Court decision is being appealed to the US Court of Appeals for the 4th Circuit. In the interim, the Department of Justice applied to the Supreme Court to reinstate the requirement pending the outcome of the appeal. The Supreme Court granted a stay of the District Court order. This had the effect of reinstating the requirement for patients to attend in-person to obtain mifepristone.

Majority Decision

The majority failed to provide any reasoning for its decision to grant the stay. Chief Justice Roberts, who concurred in the grant of application for stay, found that the case did not turn on whether the “requirements for dispensing mifepristone impose an undue burden on a woman’s right to an abortion.”[4] Rather, the question is whether the District Court properly ordered the FDA to lift the imposition of such requirements because of their assessment of the impact of the pandemic. Chief Justice Roberts held that “the courts owe significant deference to the politically accountable entities with the background, competence and expertise to assess public health.”[5] Therefore, there was not a sufficient basis for the District Court to compel the FDA to alter their requirements.

Dissenting judgment

The dissenting judgment of Justices Sotomayor and Kagan considered two questions:

1.      whether the decision was correct on the merits and the requirements did impose a “substantial obstacle”; and

2.      whether the US Government succeeded in showing “irreparable harm” from the injunction.

1.      Substantial Obstacle

The dissenting Justices considered the severity and impacts of the COVID-19 pandemic, including both the health risks and the impact on the availability of medical appointments. They cited the Centers for Disease Control advice that medical providers should use telemedicine “whenever possible.”[6] Justices Sotomayor and Kagan also noted that during the COVID-19 pandemic, the FDA waived in-person requirements for several other medications, including some opioids. Considering these factors, “the Government has thus recognized that in-person healthcare during the COVID-19 pandemic poses a significant risk to patients’ health.”[7]

Justices Sotomayor and Kagan cited the proposition in Whole Woman’s Health v Hellerstedt that health regulations that present a “substantial obstacle” to people seeking an abortion are constitutionally invalid.[8] Taking into account the health risks and the “dramatically reduced availability” of clinics during the COVID-19 pandemic,[9] as well as the 10-week window for obtaining the medication, the dissenting Justices held that the in-person requirement posed a “substantial obstacle”. The judgment also considered that people of colour and those on low incomes face greater risks as a result of COVID-19 which causes “significant deterrents” for people seeking a medical abortion.[10]

The dissenting Justices rejected the US Government’s argument that there was no “substantial obstacle” as people could still seek out a surgical abortion, finding that restricting access to common and safe abortion procedures could be constitutionally invalid. Overall, these reasons led their Honours to find the District Court was correct on the merits.

2.      Irreparable Harm

Justices Sotomayor and Kagan went on to consider that, even if the District Court was not correct on the merits, a stay is “extraordinary relief”, meaning an applicant must also show that they will suffer
“irreparable harm” if the order is not granted.[11]

The dissenting Justices rejected the US Government’s arguments that all injunctions against a government inherently cause “irreparable harm’ and that the in-person requirements mitigate health risks by allowing for in-person counselling. Justices Sotomayor and Kagan held that patients may receive counselling remotely and that, overall, the US Government failed to show “irreparable harm”.

Commentary

The US Supreme Court ruling demonstrates that the bench was willing to exercise significant deference to the executive branch of government, and was made in in circumstances where the request to reinstate restrictions for patients seeking to obtain mifepristone was instigated by the Trump administration.

It is promising to see a powerful dissent that demonstrates the potential that courts have to protect the right to abortion against legislative or administrative action, and hopefully this framework will be adopted in future judgments.

In welcome news, in April 2021, the FDA decided to suspend enforcement of the policy, effectively rendering the Supreme Court decision redundant. Advocates hope that this will be a starting point for the FDA to reconsider the need for the in-person dispensing requirement beyond the pandemic.

The full case can be read here.

Britt Mashado is a Law Graduate at King & Wood Mallesons.


[1] American College of Obstetricians and Gynaecologists v United States Food and Drug Administration 472 F.Supp.3d 183, 206.

[2] Ibid, 211-217.

[3] Ibid, 216-217.

[4] Food and Drug Administration v American College of Obstetricians and Gynaecologists 592 U.S.__ (2021) (‘FDA v American College’), 1.

[5] Ibid, 1-2.

[6] Ibid, 3.

[7] Ibid.

[8] 579 US __ (2016), 1.

[9] FDA v American College, 7.

[10] Ibid.

[11] Ibid, 5.