Important Court Cases Will Determine Whether Moms and Babies Can be Protected From Dangerous Abortion Pills

In addition, there was a decision in West Virginia challenging that state’s ability to ban sales of the abortion pill decided late last year that could be revisited on appeal.

Bryant v. Stein

In January of 2023, abortionist Amy Bryant filed suit in federal district court challenging North Carolina’s chemical (or “medication”) abortion law. Her argument was that the state regulations were more restrictive than those the federal government, through the U.S. Food and Drug Administration (FDA) had determined were necessary for safe use of the drugs.

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Bryant and her legal team argued that the FDA was the entity authorized to make such safety decisions and that it had explicitly already considered and rejected the safeguards the state wished to impose. Catherine C. Eagles, the federal judge for the Middle District of North Carolina appointed by Barack Obama in 2010, essentially agreed in her April 30, 2024, decision, but with a caveat.

Judge Eagles concluded that rules that were part of North Carolina’s informed consent or general abortion laws could stand, so long as they weren’t particularly connected to chemical abortion or based on safety claims that the FDA had already dismissed.

Historical Background

As most people are aware, mifepristone, or RU-486, was originally considered under a special provision of the federal drug code called “Subpart H.” This allowed for accelerated approval but also allowed the agency to impose certain restrictions on distribution and prescription of the drug.

When the FDA approved mifepristone in September of 2000, it limited prescription to physicians who could certify that they could appropriately assess gestational age and identify ectopic pregnancy. This was because the drug’s effectiveness dropped off after a certain number of weeks and did not work at all in circumstances of ectopic pregnancy, when the child implants outside the womb.

The doctor or his or her designated agent had to meet with the prospective patient in person to do these assessments, screen the patient for conditions that might make the drugs dangerous or deadly for her, to give her the pills, and follow up to determine if the abortion was complete or further intervention was necessary.

This was in addition to whatever paperwork the FDA wanted doctor and patient to sign indicating the process and its risks had been fully explained and promises made by doctors that they had equipment on hand for potential emergencies and could surgically handle complications or had plans in place for someone else to do so if needed.

It is critical to note that during Democrat administrations, the FDA, under pressure from the abortion industry, rolled back many of these restrictions in 2016, 2021, and 2023.  Prescribers no longer had to be doctors after 2016 but could simply be a “certified health care provider.” The number of required in-person visits shrunk from three to one in 2016 and then to none in 2021.  Mandatory reporting of all serious complications or “adverse events” to the FDA, was reduced in 2016 to just reporting of any deaths.

North Carolina’s Laws Being Challenged

When North Carolina updated its own abortion law in 2023, it added back in many of the FDA’s original restrictions.  North Carolina limited prescription to physicians. It required that women be examined and receive their drugs in-person and return for a follow-up assessment.  All significant adverse events, not simply deaths, were to be reported to the FDA’s MedWatch monitoring system.

These are general safety regulations Judge Eagles struck down. Note that these were indeed requirements the FDA itself had in place in the drug’s early years. The changes were ostensibly an indication that the FDA no longer considered them necessary to safe use of the drug. An objection that this was not a thorough or objective assessment was a key part of the challenge by pro-life doctors in FDA v. AHM.  But the judge ruled that the agency had since reconsidered and jettisoned those original requirements.   Judge Eagles said Congress had given the FDA the responsibility and authority to make such determinations made theirs the final word on the issue.

In her decision, Judge Eagles granted that states, rather than the federal government, generally have the primary responsibility for public health and safety and the corresponding authority to regulate the practice of medicine. However, she goes on to cite various case law and the Constitution’s “Supremacy Clause” to support her contention that federal law preempts state law whenever that state law poses an obstacle to the purpose or function of the federal law.

This could be a matter of dispute in possible future appeals, but it is the ruling for now.

Practical Consequences

This means North Carolina cannot require that abortion pill prescribers be physicians or require that patients pick up their pills in person. They can’t require follow-up visits for abortion pill patients and cannot mandate the reporting of all adverse events to the FDA’s national Medwatch system.

Yet at the same time, the judge allowed other regulations that the state imposed on abortion generally, or put in place for purposes of informed consent, to stand.  Regulations related to drug safety were the purview of the FDA, whatever their experts thought best, but abortion policy, patients’ rights, particularly after Dobbs, remained the state’s prerogative.

So while North Carolina could not require that the patient pick up her pills in person, it could require that any patient seeking a chemical or surgical abortion, have an in-person consultation with the clinician at least 72 hours before her scheduled procedure or receipt of pills. It could require, as part of its state informed consent procedures, that the woman have an ultrasound to determine the gestational age of her child (to give data for state reports and presumably for the mother to be aware of her child’s development).

Blood tests could be required to determine whether or not the woman has Rh negative blood and thus might require immunoglobulin shots if she wishes to bear a healthy child in the future.

North Carolina generally requires that all complications, from either surgical or chemical abortions, be reported to the state. While the FDA no longer requires that data for its own federal safety profile of mifepristone, Judge Eagles said there is no problem with the state requiring and collecting this data for its own statistical purposes.

The consequence of all this seems to be that a woman in North Carolina can legally get abortion pills shipped through the mail. However, she will still have to visit the clinic at least three days before to have an ultrasound and blood testing and receive whatever counseling or information materials the state thinks she needs to be able to make an informed decision.

Prescribers are still responsible for tracking her and reporting any complications back to the state.

It’s up to the federal government–the FDA– to decide the rules that are needed to ensure the drug is used safely, the judge held. But it’s up to the state, North Carolina, to set the state’s abortion policy.

GenBioPro v. Sorsaia

A similar case from West Virginia was decided in much the same way.  In GenBioPro v. Sorsaia, the generic manufacturer of mifepristone sued the state of West Virginia after that state passed a law generally protecting unborn children, allowing for exceptions in the case of ectopic pregnancy, a medically nonviable unborn child, or other medical emergency.

The state also allowed abortion for survivors of rape or incest up to 14 weeks gestation so long as they filed a police report or sought medical treatment for the assault.

GenBioPro sued West Virginia, asserting that the state could not ban the sale of a drug that had been approved for use for women throughout the whole country.

Like the judge in the North Carolina case, Judge Robert C. Chambers or the U.S. District Court for the Southern District of West Virginia, Huntington Division offered somewhat of a split decision. He upheld West Viriginia’s right to limit abortion within its borders, chemical or surgical, but declared that when and where it allowed abortion (e.g., for those rape or incest survivors less than 14 weeks pregnant), it could not dictate which abortion method was used.

Mifepristone could be used, if doctor and patient decided, in those emergency or exceptional cases of sexual assault. But the state was within its rights prohibit its general use or sale in the state.

GenBioPro has appealed the case to the 4^th Circuit, the next highest federal court. It is now identified as GenBioPro v. Raynes.

Future Prospects

Both Bryant v. Stein and GenBioPro v. Raynes may eventually be appealed and higher courts could come up with similar or different rationales and results.

But for now, the pattern post Dobbs seems to be that states can pass and enforce laws limiting abortion generally, but not laws singling out a particular form of abortion that the federal government has elsewhere officially declared “safe” and “effective.”