District Court: Enforcing FDA Rules on Abortion Drugs During Pandemic Violates Constitution

On Monday, federal district judge Theodore D. Chuang granted a preliminary injunction (in American College of Obstetricians & Gynecologists v. FDA) that bars the Food and Drug Administration from enforcing during the coronavirus pandemic two of its rules governing the drug regimen used in medication (i.e., non-surgical) abortions—rules, I’ll note, that were adopted during the Obama administration.

Specifically, Judge Chuang barred the FDA from enforcing (1) its requirement that mifepristone may be dispensed only in a hospital, clinic, or medical office, by or under the supervision of a certified health-care provider, and (2) its requirement that the health-care provider give a copy of a Patient Agreement Form disclosing certain information about mifepristone and its risks to the patient, that the health-care provider review it with the patient and counsel her about the risk of serious complications, and that the patient sign the form acknowledging that she had read and received the form and received the counseling.

These requirements, Chuang ruled, are likely to amount to an unconstitutional “undue burden” under the standard set forth in Whole Woman’s Health v. Hellerstedt (2016) and supposedly “reaffirmed” in the Supreme Court’s ruling just last month in June Medical Services v. Russo.

The plaintiffs in the case are four organizations of OB-GYNs and medical providers, along with one doctor who prescribes medication abortions.

Here are some key parts of Chuang’s analysis on undue burden, together with some quick comments of mine:

1. Whole Woman’s Health clarified that the substantial-obstacle requirement of Planned Parenthood v. Casey calls for courts to consider the burdens a law imposes on abortion access together with the benefits the law confers. “The plurality in June Medical Services reaffirmed that general approach.” The Chief Justice’s concurrence in June Medical didn’t have the effect of limiting or overruling the balancing test of Whole Woman’s Health. (Pp. 36-38.)

Comment: How can a mere “plurality” re-affirm anything? The Chief Justice sure seemed to think that he was repudiating a reading of Whole Woman’s Health that would allow a balancing test. Indeed, as Amy Howe observed at SCOTUSblog, the Court’s decision to GVR (grant, vacate, and remand) two abortion cases in the aftermath of June Medical “suggests that the Supreme Court wants the 7th Circuit to apply the more lenient test outlined in the concurring opinion filed by Chief Justice John Roberts.”

2. Patients are heavily burdened by the FDA rules during the pandemic:

(a) The pandemic has caused the closure of some facilities that provide medication abortion services, and even when those facilities re-open, their capacity to offer medication abortion service might be limited. (Pp. 45-46.)

(b) Abortion patients, who are disproportionately people of color and poor, face more significant health risks than other people do in traveling to a medical facility during the pandemic. (Pp. 46-47.)

(c) They are also more likely to face transportation and child-care challenges. (Pp. 47-48.)

(d) The severe economic crisis exacerbates these challenges. (P. 49.)

Comment: Chuang sure seems determined to make an everything-plus-the-kitchen-sink argument, just as you’d expect of someone who was appointed by President Obama and served in the Obama administration. (His early reference to the human embryo as “the pregnancy tissue” (p. 2) is telling.) It’s quite a trick for these plaintiffs to be able to invoke the third-party standing of abortion patients and obtain an injunction that applies nationwide, not just where facilities have closed in a way that has an actual impact. And since when are ordinary transportation and child-care challenges a meaningful part of the calculus?

3. The rules provide no significant health-related benefit. All the necessary counseling can be done by telemedicine. The rules don’t prevent delays in the initiation of the regimen. (Pp. 51-59.)

Comment: Chuang purports to give “appropriate deference” to the expertise of the Obama administration’s FDA, but his opinion reflects no deference at all. One might also have thought that the poverty that abortion patients disproportionately suffer from would correlate with a lower level of education and thus make in-person counseling all the more valuable. But Chuang shows himself very eager to defer to plaintiffs’ experts.