No, the Fifth Circuit Didn’t Restrict Access to the Abortion Pill

No, the Fifth Circuit Didn’t Restrict Access to the Abortion Pill

The U.S. Court of Appeals for the 5th Circuit vacated part of a lower district’s ruling regarding the abortion pill. They agreed the FDA didn’t do its job when it expanded access to the abortion pill and think some restrictions should stand.

However, the decision means the pill can stay on the market until the Supreme Court takes it up again, likely in 2024.

That’s because, in April, SCOTUS ordered that access to the pill remains the same “while litigation proceeds.”

SCOTUS wrote in April:

The April 7, 2023 order of the United States District Court for the Northern District of Texas, case No. 2:22–cv–223, is stayed pending disposition of the appeal in the United States Court of Appeals for the Fifth Circuit and disposition of a petition for a writ of certiorari, if such a writ is timely sought. Should certiorari be denied, this stay shall terminate automatically. In the event certiorari is granted, the stay shall terminate upon the sending down of the judgment of this Court.

So despite what the headlines across the media say, there has NOT been a change to abortion pill access.

Certiorari “is a ‘writ’ by which a higher court (such as an appellate court) reviews some lower court’s decision (such as a district court).”

The Fifth Circuit judges concluded its ruling: “Accordingly, those actions will be stayed pending final judgment. But to repeat, all of this relief is subject to the Supreme Court’s prior order, which stays the district court’s order until the disposition of any petition for certiorari.”

Those who do not agree with the Fifth Circuit decision can petition for a writ of certiorari. The Supreme Court usually only accepts these cases if it has “national significance.”

So, onto the opinion!

The Alliance for Hippocratic Medicine, organizations, and other doctors challenged the regulation of mifepristone, also known as the abortion pill.

The judges affirmed that when the FDA loosened the pill’s safety restrictions, “it failed to address several important concerns about whether the drug would be safe for the women who use it.”

Many of the doctors associated with the organizations in the lawsuit represent OB/GYNs in emergency rooms:

Many women face severe complications as a result of taking mifepristone. The Doctors allege that they are harmed when they treat those kinds of patients.

According to the Doctors, when they treat women who are experiencing complications after taking mifepristone, they are required to perform or complete an abortion, or otherwise required to participate in a process that facilitates abortion. They maintain that personally conducting those procedures violates their sincerely held moral beliefs. The Doctors also contend that treatment of mifepristone patients diverts time and resources away from their ordinary patients, causes substantial mental and emotional distress, and exposes them to heightened malpractice risk and increased insurance costs.

Seeking to prevent those alleged injuries, the Medical Organizations and Doctors moved for preliminary injunctive relief. The district court granted the motion, but rather than entering a traditional injunction, the court stayed the effective date of each of the challenged actions under 5 U.S.C. § 705. FDA appealed, as did Intervenor Danco Laboratories, LLC, the pharmaceutical company that distributes Mifeprex.

The court vacated the portion concerning the 2019 Generic Approval because the judges did not find the doctors proved “they are injured by that particular action.”

The court affirmed the stay orders regarding the 2016 Amendments and the 2021 Non-Enforcement Decision.

The plaintiffs listed three reasons why the 2016 Amendments will lead to an increase of women taking mifepristone in emergency rooms. The first is older women taking the pill. The second is that “the Amendments remove the requirement for a second and third in-person visit.”

Then there’s the third reason:

Third, and relatedly, the percentage of women who present to the emergency room will increase because the Amendments allow non-physicians to prescribe mifepristone. As the motions panel explained, women who receive the drug from someone other than a doctor “cannot possibly go back to their non doctor-prescribers for surgical abortions.” All. for Hippocratic Med., 2023 WL 2913725, at *5. And multiple doctors testified that they have seen or expect to see more women with serious complications resulting from mifepristone. Given the already substantial risk of harm, the evidence of increased risk is sufficient to confer standing to challenge the 2016 Amendments. See Nat. Res. Def. Council, Inc. v. EPA, 464 F.3d 1, 6–7 (D.C. Cir. 2006) (holding that plaintiffs had standing based on “increased risk” of developing skin cancer); Sutton v. St. Jude Med. S.C., Inc., 419 F.3d 568, 570–75 (6th Cir. 2005) (holding that plaintiffs had standing based on an “increased risk” of harm from a medical device).

The 2021 Non-Enforcement Decision fits with the above third reason:

Finally, many doctors offered testimony that, as a result of the 2021 Non Enforcement Decision, more women will suffer serious adverse events. Dr. Wozniak Declaration ¶ 14 (“The increasing number of chemical abortions through mail-order or telemedicine methods means that more women will suffer complications from unsupervised use of mifepristone and misoprostol.”); Dr. Frost-Clark Declaration ¶ 12 (“The FDA’s suspension of the in-person dispensing requirement of mifepristone and misoprostol harms women and doctors because it has resulted in an increase in complications.”); see also Dr. Skop Declaration ¶¶ 20–21; Dr. Johnson Declaration ¶ 18; Dr. Jester Declaration ¶ 13. One doctor personally witnessed an increase in complications after a district court temporarily enjoined the in-person dispensing requirement in the midst of the COVID-19 pandemic. Dr. Francis Declaration ¶ 11 (“The frequency of these complications has increased since a federal district court first enjoined and set aside the FDA’s in-person dispensing requirement of mifepristone in 2020.”); see generally Am. Coll. of Obstetricians & Gynecologists v. FDA, 472 F. Supp. 3d 183 (D. Md. 2020) (district court opinion enjoining the in-person requirements).

The judges concluded the plaintiffs made a “clear showing” of imminent injury:

FDA’s own data shows that a definite percentage of women who take mifepristone will require emergency room care, be it a blood transfusion, a surgery to complete a failed abortion or ongoing pregnancy, or some other complication. The data further shows that millions of women take mifepristone. And the Medical Organizations testified that hundreds of their members are OB/Gyns and emergency-room doctors who care for women in these circumstances. The Medical Organizations and Doctors therefore face a “substantial risk” of future injury.

The plaintiffs also proved their case because of the evidence of real cases they encountered while performing their duties.

But as I said, nothing has changed because of the April order from SCOTUS.

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