Two Federal Courts Take Contrary Legal Positions on Medication Abortions

UPDATE 4/10/23 at 4:00 PM: The DOJ asked the Fifth Circuit to enter an administrative stay or grant a stay by noon April 13, 2023 to enable the government to seek relief in the Supreme Court if necessary.

On Friday April 7, 2023, Judge Matthew J. Kacsmaryk in Alliance for Hippocratic Medicine et al. v. U.S. Food and Drug Administration et al., case number 2:22-CV-00223, in the U.S. District Court for the Northern District of Texas, issued an unprecedented ruling effectively blocking the U.S. Food and Drug Administration’s (“FDA”) approval of the abortion drug mifepristone, and stayed the applicability of his ruling for seven (7) days to give the Federal government time to appeal the ruling to the Fifth Circuit (the “Texas Ruling”).

Also on Friday, in stark contrast, Judge Thomas O. Rice, in State of Washington et al. v. United States Food and Drug Administration et al., case number 1:23-CV-3026, in the U.S. District Court for the Eastern District of Washington, in a case brought by 18 Attorneys General seeking a preliminary injunction to “affirm the FDA’s original conclusion that mifepristone is safe and effective, preserv[e] the status quo by enjoining any actions by Defendants to remove this critical drug from the market, and enjoin[] the unnecessary and burdensome 2023 restrictions….” issued a preliminary injunction blocking the FDA from limiting access to mifepristone in the Attorneys Generals’ States, but did not prohibit or lift the FDA’s mifepristone restrictions (the “Washington Ruling”).  See Washington Ruling at page 3.

While the U.S. Supreme Court decision in Dobbs ostensibly left the decision regarding a woman’s reproductive rights to the States, it is clear that no ground will be left unturned by the dueling advocates battling the issue of reproductive rights in the United States.  The following sets forth some of the highlights from the respective rulings reflective of the thinking of each of these judges.

The Texas Ruling

Judge Kacsmaryk based his ruling to postpone the effective date of the FDA’s 2000 approval of mifepristone (and all subsequent FDA actions) on the following legal findings:

1. With respect to the timeliness of the Plaintiffs’ claim, Judge Kacsmaryk found that the FDA intentionally “stonewalled the Plaintiffs’ petitions challenging the approval of mifepristone for 16 years, and had the FDA responded sooner to the plaintiffs’ challenges to its approval, the case at issue would have been heard much sooner by the courts. See Texas Ruling at page 1.
2. The FDA’s modifications to the mifepristone approval constituted a reopening of the subject drug’s approval, including in 2016 when certain restrictions with respect to dispensing mifepristone were removed, in 2019 when a generic version of mifepristone was approved, and again in 2021 when the FDA announced that it would allow dispensing of mifepristone through the mail. Given these actions by the FDA, Judge Kacsmaryk, found that the Plaintiff’s claims were not time-barred under the equitable tolling statute.  See Texas Ruling at page 19-23.
3. The FDA improperly approved mifepristone under an accelerated approval process (pursuant to Subpart H), which it should not have done because mifepristone is not a drug that treats “…serious or life-threatening illnesses and provide[s] meaningful therapeutic benefits to patients over existing treatments….” See 21 CFR § 314.500.
4. The Plaintiffs had standing to bring the case by way of “associational standing”, “organizational standing” and “third-party standing” (i.e., on behalf of its member physicians and patients) because of injuries sustained as a consequence of the FDA approval process for mifepristone. See Texas Ruling at page 11.
5. Moreover, the physician members of the Plaintiff organizations suffered injury by “…being forced to end the life of a human being in the womb for no medical reason, including by having to complete an incomplete elective chemical abortion.” See page 8 of the Texas Ruling.  Injury to the Plaintiff associations and organizations are concrete and addressable because the Plaintiffs are (“increased exposure to allegations of malpractice….”) in the “Zone of Interest” with respect to the FDA’s approval action and the Comstock Act (as it relates to the approval and mailing of mifepristone).  See Texas Ruling at page 18.
6. The FDA’s 2021 decision to remove certain restrictions on mifepristone was not within the FDA’s narrow discretionary authority. Defendants cannot shield their decisions from judicial review merely by characterizing the challenged action as exercising “enforcement discretion.” See Texas Ruling at page 25.
7. The Plaintiffs “have a substantial likelihood of prevailing on their claim that the FDA’s decision to allow the dispensing of chemical abortion drugs through mail violates unambiguous federal criminal law.” See Texas Ruling at page 38.
8. The Plaintiffs’ have a substantial likelihood of success on the merits because the FDA erred in approving mifepristone on an expedited basis when the drug is not for treating serious or life-threatening illnesses, and did not have a meaningful therapeutic benefit to patients over existing treatment. See Texas Ruling at page 42-44.
9. The FDA acted in an arbitrary and capricious manner when claiming that it relied upon reported data when it eliminated the requirement to report non-fatal adverse events. Judge Kacsmaryk stated, “[c]ontrary to popular belief and talking points, the evidence shows chemical abortion is not ‘as easy as taking Advil”.  “An agency’s action is ‘arbitrary and capricious’ if it ‘entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.  Defendants fail this test.”  See Texas Ruling at page 47-50.
10. The FDA “entirely failed to consider an important aspect of the problem by omitting any evaluation of the psychological effects of the drug or an evaluation of the long-term medical consequences of the drug…Nor was the drug tested for under-18 girls undergoing reproductive development.” See Texas Ruling at page 51.
11. The FDA acted arbitrarily because it removed the restriction to rule out ectopic pregnancy, and thus, the approval process was improper and the “restrictions were insufficient to ensure safe use.” See Texas Ruling at page 55.
12. According to Judge Kacsmaryk, “[t]he Court does not second-guess FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns – in violation of its statutory duty – based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating that the FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased “access” to chemical abortion – which was the “whole idea of mifepristone.”  See Texas Ruling at page 57.
13. Agreeing with the Plaintiffs that “[t]he physical and emotional trauma that chemical abortion inflicts on women and girls cannot be reversed or erased….” Judge Kacsmaryk issued a stay of the FDA’s initial and subsequent actions relating to mifepristone. See Texas Ruling at page 61.

The Washington Ruling

Judge Rice issued a preliminary injunction ordering the FDA to not prevent access to mifepristone, but refused to order the FDA to lift the FDA’s restrictions on mifepristone because “[i]t is not the Court’s role to review the scientific evidence and decide whether mifepristone’s benefits outweigh its risks without REMS….That is precisely the FDA’s role.”  See Washington Ruling at page 21. 

Judge Rice bases his ruling with respect to his issuance of a partial preliminary injunction on the following legal findings:

1. In September 2000, the FDA approved mifepristone under Subpart H, concluding that mifepristone is safe and effective for medical termination of intrauterine pregnancy through 49 days’ gestation when used in a regimen with the already-approved drug, misoprotol. The FDA imposed restrictions relating to the dispensing of mifepristone whereas, most other drugs do not have such restrictions imposed.  See Washington Ruling at page 4.
2. In 2015, the FDA conducted another review of mifepristone and its restrictions in response to the manufacturer’s proposed modifications to reduce the dosage. As part of the review, the FDA received letters from 40 medical experts, researchers, advocacy groups, and professional associations requesting that the restrictions be removed in their entirety.  See Washington Ruling at page 5.
3. In 2016, the FDA, having found that there were no new safety concerns in recent years, extended the gestational age limit from 49 to 70 days, and reduced the restrictions, continuing to require that mifepristone be administered in a clinical setting. See Washington Ruling at page 5.
4. In 2019, the FDA approved a generic version of mifepristone and established the Mifepristone Risk Evaluation and Mitigation Strategy (“REMS”) Program. See Washington Ruling at page 5 and 19.
5. In 2020, the American College of Obstetricians and Gynecologists challenged the Mifepristone REMS Program requiring the in-person dispensing requirement in light of the COVID-19 pandemic. As a result, the FDA was enjoined from imposing the in-person requirement for six months.  See Washington Ruling at page 6.
6. In April 2021, the FDA suspended the in-person dispensing requirement because during the six-month injunction period there was no increase in serious patient safety concerns.
7. In May 7, 2021, the FDA began its review of the Mifepristone REMS Program, and on January 3, 2023, removed the in-person dispensing requirement, added a pharmacy-certification requirement, and maintained the Prescriber and Patient Agreement Form requirements. See Washington Ruling at page 7.
8. The Plaintiff Attorneys General sought an order enjoining the FDA from: (i) enforcing the 2023 REMS (or any restrictions); and (ii) changing the status quo to make mifepristone less available in the Plaintiff States.[i] See Washington Ruling at page 9.
9. The Plaintiff Attorneys General claimed that they were likely to succeed on the merits of their claim that the 2023 REMS Program violated the APA. See Washington Ruling at page 12.
10. With respect to the 2023 REMS, the Plaintiff Attorneys General claimed injury relating to unrecoverable costs on the States’ Medicaid and State-funded health plans and practice restrictions on providers and pharmacists. Based upon the foregoing, Judge Rice found that the Plaintiffs had demonstrated a probable threat to their economic interests. See Washington Ruling at page 13-14.
11. The Plaintiff Attorneys General alleged that the FDA’s actions were contrary to law, and arbitrary and capricious and a violation of the APA with respect to the 2023 REMS Program. See Washington Ruling at page 17.
12. Judge Rice found that it was “not the Court’s role to review the scientific evidence and decide whether mifepristone’s benefits outweigh its risks without a REMS Program…That is precisely the FDA’s role.” See Washington Ruling at page 21.
13. The Court agreed to issue a status quo preliminary injunction preventing the FDA from removing access to mifepristone for the states of the Plaintiff Attorneys General, but did not issue an injunction prohibiting the FDA from implementation of the January 2023 REMS. See Washington Ruling at page 31.

Commentary on These Two Conflicting Rulings

Regardless of your position on the issue at hand, both rulings raised serious concerns as to whether the legal system can depend on its judges to issue non-politically motivated rulings. While Judge Kacsmaryk states that the FDA’s approval process for mifepristone was politically motivated, his ruling reads much like an advocacy piece to remove mifepristone from the market. Actually, it is difficult to know whether either of the judges issued rulings that were based upon jurisprudence, or motivated by their own personal convictions and or religious beliefs.

Impact of the Texas and Washington Rulings on Medical Abortion

The U.S. Department of Justice and the manufacturer of mifepristone have indicated their intent to appeal the Texas Ruling.  Whether or not this appeal will go the Fifth Circuit or directly to the U.S. Supreme Court is yet to be seen.  In the meantime, the Texas Ruling stay will not go into effect until resolved by the higher courts. Citing Judge Kacsmaryk in his ruling and taken out of context, “One of these things is not like the others, one of these things does not belong. See Sesame Street.”  See Texas Ruling at page 42.

As new developments arise, we will continue to update our Dobbs Decision Resource Center.  In the meantime, please contact one of the lawyers in Shipman’s Health Law practice group if you have questions about this ever-changing legal landscape. 
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[i] Plaintiff States are Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, D.C., Maine, Maryland, Minnesota, Pennsylvania, and Hawaii.