Abortion Medication Lawsuit Explainer

By Grace Haley, Researcher

As Jessica discussed on MSNBC last week, we are waiting any day now to hear the ruling on the abortion medication lawsuit in Texas aiming to undo FDA approval of mifepristone — the first pill in the 2-step medication abortion procedure. There’s a hearing today for the case in Amarillo, Texas. 

Background

National anti-abortion groups have viewed medication abortion as “the new frontier of abortion” that requires a “new approach,” and this case is the first major step in uncharted territory. Mifepristone is the pill in the 2-step regime that blocks the hormone progesterone before misoprostol is administered to prompt contractions that expel the embryo. The lawsuit argues that the FDA wrongfully approved mifepristone in 2000, that the medication is unsafe, and that providers sending mifepristone in the mail violate federal criminal law through the 1873 Comstock Act. 

This is a historic case not only in how it will determine abortion access to mifepristone nationally, but it is also unprecedented in how it could undermine the legitimacy of the FDA approval process for all drugs. Healthcare experts are concerned about how this ruling could change how the FDA approves medicine, and the implications this has for access to PreP and hormone therapies for gender-affirming care.

What is the anti-abortion strategy here?

The anti-abortion organizations leading the lawsuit targeted Amarillo, Texas through a practice known as “forum shopping.” Amarillo is a district in Texas with only one federal judge, so any conservative interest group targeting federal policies (like the federal approval of abortion pills, in this case) can file a legal complaint in the Amarillo federal courthouse and be guaranteed a Trump-appointed, right-wing, religiously conservative judge followed by a like-minded appellate review in the 5th Circuit Court of Appeals—the most conservative Circuit Court in the nation.

Through using a legal strategy that targets the federal process that put mifepristone on the market, anti-abortion groups not only can further limit access in states where abortion is severely restricted, but in abortion-safe states across the country, as well. By attempting to minimize the FDA’s authority, it could also pave the way for other lawsuits concerning pro-abortion, contraceptive, LGBTQ, and gender-affirming health care. (In fact, that is part of the point.)

Who is District Judge Matthew Kacsmaryk?

The lone federal judge in Amarillo, District Judge Matthew Kacsmaryk was appointed in 2019 during the Trump presidency and has been outspoken in his opposition to abortion throughout his career. The Washington Post described Kacsmaryk as “a religious conservative who is widely regarded as a thorough and analytical legal thinker but who also comes to his judicial work with a long history of activism rooted in his religious beliefs.” During his Senate confirmation hearing in 2019, many of the Senators’ questions focused on his activist approach to the judicial system. 

His career as a federal judge has shown a commitment to deep conservative views. In a decision he wrote in 2022 (Deanda v. Becerra), he attacked the grant system designed to provide birth control to low-income and uninsured families by arguing the system did not adequately protect parental rights over the health decisions of their teenage daughters. And in Neese v. Becerra, his decision held that a federal law prohibiting discrimination by health providers did not cover anti-LGBTQ discrimination and declared Biden administration protections for transgender workers unlawful. 

Before his career as a federal judge, he had long been candid about his anti-abortion, anti-woman, and anti-LGBTQ views. In an article he wrote in 2015 for the Journal of the Witherspoon Institute, he said that the sexual revolution sought “public affirmation of the lie that the human person is an autonomous blob of Silly Putty unconstrained by nature or biology, and that marriage, sexuality, gender identity, and even the unborn child must yield to the erotic desires of liberated adults.”

Who are the anti-abortion groups in this lawsuit?

The Alliance for Hippocratic Medicine filed the lawsuit in November on behalf of five out-of-state organizations: the American Association of Pro-life Obstetricians and Gynecologists (AAPLOG), the American College of Pediatricians, the Christian Medical & Dental Associations, the Catholic Medical Association and the Coptic Medical Association of North America. The individual doctors listed in the lawsuit, Shaun Jester, Regina Frost-Clark, and George Delgado, are represented by the Alliance Defending Freedom. As reported in the Intercept, the Alliance for Hippocratic Medicine was newly created in Amarillo in August 2022 and “presumably incorporated to bolster the pending lawsuit” to help establish jurisdiction as part of the conservative forum-shopping strategy.

These are the same organizations pushing state bills banning transgender health care, who drafted the Mississippi abortion ban in the Dobbs case, were at the forefront of the school bathroom and sports team bans for trans children, and are outspoken in their opposition to adoptions through gay partnership. Many of the key players have a history going back to Roe: AAPLOG was formed in 1973 as part of a shadow medical community pushing the narrative that abortion was immoral and dangerous. Doctor George Delgado is known for his attempt to develop an “abortion pill reversal” study. The studied procedure administered a large dose of progesterone to “reestablish the pregnancy” and was consequently suspended after a fourth of his patients hemorrhaged and were hospitalized.

What will happen with the ruling?

It is unclear what exactly Judge Kacsmaryk’s ruling will be, but it is expected he will do everything in his power to limit access to abortion medication. But what exactly is in his power? We’ve drawn out a few potential scenarios, including arguments made by law professors David S. Cohen, Greer Donley, and Rachel Rebouché, who are leaders in the repro legal conversation. They argue that several legal principles should limit his power at this moment.

Scenario 1: Given the politics and conservative strategy of this lawsuit, the scenario written in the draft order of the lawsuit lends us a strong indication of how the judge will rule. The anti-abortion groups call for a national injunction and request that the court “[i]ssue a preliminary and permanent injunction ordering Defendants to withdraw mifepristone and misoprostol as FDA-approved chemical abortion drugs and to withdraw Defendants’ actions to deregulate these chemical abortion drugs.” They also ask for the court to “hold unlawful, set aside, and vacate” the FDA mifepristone approval decisions for the past 2 decades, “declare that the chemical abortion drugs mifepristone and misoprostol fall outside the scope of the FDA’s regulation,” prohibit the FDA’s use of certain studies, among other recommendations.

Scenario 2: The pill would stay on the market until the ruling is resolved in the 5th Circuit Court of Appeals. Pro-abortion groups will most likely appeal Kacsmaryk’s decision and motion to stay the injunction pending in the 5th Circuit Court of Appeals, which is usually granted. Pro-abortion groups would likely argue the merits of maintaining the status quo until the appellate court can weigh into this. This keeps the pill on the market. However, the appellate courts’ decisions will likely have greater importance in the coming months. 

Scenario 3: Judge Kacsmaryk may order the FDA to start the congressional procedures required to remove mifepristone from the market. Cohen, Donley, and Rebouché argue:

“Congress crafted procedures by statute for the FDA to use to withdraw approval of a drug. Judge Kacsmaryk cannot force the FDA to adopt another process to do the same—doing so would violate federal law. At best, he should only be able to order the agency to start the congressionally mandated process, which involves public hearings and new agency deliberations. This could take months or years, with no guarantee of the result.”

Scenario 4: Judge Kacsmaryk may bypass the congressionally-mandated process, but could be blocked by legal precedent:

“[If Judge Kacsmaryk forgoes this process and rules that the FDA’s approval was unlawful and that mifepristone is now deemed a drug without approval, he cannot force the FDA to enforce the decision. Because the FDA does not have the capacity to enforce its statute against every non-approved product on the market, it has long been settled law, decided in a unanimous 1985 Supreme Court decision, that the agency has broad enforcement discretion, meaning the agency, not courts, gets to decide if and when to enforce the statute.”

Scenario 5: Federal law around civil procedure could only apply to the FDA and the manufacturer of mifepristone listed in the lawsuit at this point in time. According to Cohen, Donley, and Rebouché:

“Judge Kacsmaryk’s order, no matter what it says, will only apply to the parties in the case. The FDA is one of the parties that would be bound by the order. The other is Danco, the brand-name manufacturer of mifepristone, which intervened in the case and is now also a party. But no other person or entity would be bound by what he orders, even if Judge Kacsmaryk tries something extreme, like ordering all distributors of mifepristone to cease distribution and all medical care providers to stop prescribing for patients. Doing so would violate basic federal rules of civil procedure as well as constitutional guarantees of due process that require someone to have notice and an opportunity to be heard before a court binds them with a ruling.”

Scenario 6: The question over the validity of FDA’s approval of mifepristone could end up in the Supreme Court. Twelve Democratic states are countering the Texas mifepristone lawsuit with one of their own in Washington state: they are “asking a federal court in Washington State to find the FDA’s approval of mifepristone valid and prevent its removal from market.” Depending on the results of the conflicting orders in Texas and Washington federal court, the future of mifepristone could land in the docket of our highest court. 

What does this mean for access?

As we’ve mentioned in the newsletter before, doctors are prepared to pivot to a misoprostol-only protocol if access to mifepristone is restricted. Advocates have underscored the importance of knowing that medication abortions will still be possible using only misoprostol, which is safe and studies show is nearly as effective as the two-drug regimen. However, there is concern because the miso-only protocol is more painful—and doctors worry that because patients need to take additional doses of miso, that discomfort may stop them from doing so.

Dr. Rebecca Gomperts, founder of Aid Access—which ships abortion medication to the U.S. and other abortion-restrictive countries—told The Guardian, “You cannot just say it’s OK. It’s not.” She continues, “As a doctor, you have to give the best treatment that’s available. And we know that the best treatment possible is the two drugs combined.”

Access to mifepristone will likely still be somewhat available through organizations like Aid Access regardless of which scenario unfolds following Kacsmaryk’s ruling—but the lawsuit and potential bans could create supply issues of the medication in the U.S.

For more information on the lawsuit and today’s hearing, make sure to look out for tonight’s issue of Abortion, Every Day.

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