US Supreme Court decision on mifepristone ‘not a victory, but a punt’
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On June 13, the U.S. Supreme Court rejected a lawsuit that challenged the FDA’s approach to regulating the abortion pill mifepristone.
Although some viewed it as a win for reproductive rights and the larger medical community — including rheumatologists and their patients — some experts believe further legal challenges await.
According to Greer Donley, JD, associate dean for research and faculty development, an associate professor of law and John E. Murray Faculty Scholar at the University of Pittsburgh Law School, there are critical details that make the ruling a positive step but not an outright win for reproductive rights.
“The Supreme Court did not uphold the approval of mifepristone,” she said in an interview. “Rather, it found that the plaintiffs who brought the lawsuit lacked standing to sue. By dismissing the lawsuit on standing, the court never reached the merits of the plaintiffs’ claims, and a future litigant could raise the claim again.”
Despite those concerns, experts in the rheumatology community are encouraged by the decision.
“The court’s decision ensured that patients in states without abortion bans maintain access to mifepristone, thereby respecting the democratic process,” Ashira D. Blazer, MD, assistant professor of medicine in the division of rheumatology at the University of Maryland, told Healio.
Blazer added that the ruling also upholds the FDA’s authority to regulate medications in the United States.
According to Catherine A. Sims, MD, a clinical associate in the department of medicine, rheumatology and immunology at Duke University, the impact of the ruling on mifepristone could be felt in rheumatology clinics across the country.
“As a rheumatologist who manages high risk pregnancies every week, I observe firsthand the need for medications like mifepristone,” Sims told Healio. “Amongst myself and my colleagues within reproductive health, there was a collective relief when the Supreme Court made this ruling.”
However, she added that there is still work to be done.
“I am very concerned about women’s health care and health care for pregnant patients in the United States, given many recent and ongoing political rulings,” Sims said.
Understanding the particulars of the ruling and how future litigation could impact access to mifepristone is essential information for every rheumatologist.
No ‘moral harm’
In Food and Drug Administration v. Alliance for Hippocratic Medicine, the Supreme Court unanimously preserved access to mifepristone in every U.S. state, including those where abortion is restricted. However, the ruling has less to do with mifepristone itself and more to do with the nature of the suit, according to Donley.
“Every litigant must show that they were harmed by the defendant’s conduct and that a court can provide a remedy,” she said. “In the Alliance case, the plaintiffs claimed they had been harmed because they might theoretically be forced to treat in an emergency room a patient who had consumed mifepristone and experienced a rare complication. They claimed this was a moral harm equivalent to providing an abortion.”
Sims described this theory of harm as “incredibly weak.”
Donley, meanwhile, underscored the legal basis for this description.
“Perhaps most important to the court’s analysis was that federal law allows people to conscientiously object to abortion care without facing any retribution, so in fact, no plaintiff would be forced to provide the care they found immoral,” she said. “Moreover, the plaintiffs were unable to prove that the FDA’s conduct caused them harm or that reversing the FDA’s regulation would remedy it.”
However, because the case was dismissed on procedural grounds for a lack of standing, Donley noted that the court never reached the question of whether the FDA’s regulation of mifepristone was lawful.
“I expect the issue to be raised again in future lawsuits with different plaintiffs,” she said. “The ruling was not a victory, but a punt.”
In the meantime, it is worthwhile to consider that the pharmaceutical industry uniformly opposed this lawsuit, according to Donley.
“They went so far as to file amicus briefs about how an antiabortion victory here would have devastating impacts for pharmaceutical innovation,” she said. “As physicians are acutely aware, obtaining FDA approval is a long, expensive and highly rigorous process. If plaintiffs could overturn the FDA’s expert judgment on ideological grounds, then access to many drugs could become threatened.”
Vaccines, COVID-19 treatments and drug rehabilitation treatments could all be under attack, Donley added.
“It is possible and likely that a similar case will be brought in the future,” Blazer said, noting cases in Florida and Idaho have been brought to court due to hospital systems’ refusal to provide abortions in emergency situations. “In several of these cases, mothers have suffered life-threatening bleeding and have had to be emergently flown to states with more permissive abortion laws.”
According to Blazer, the Biden administration has moved to penalize these hospitals under the Federal Emergency Medical Treatment and Labor Act (EMTALA), which requires hospitals that receive federal dollars to stabilize or transfer all patients requiring emergency care.
“That includes those needing emergency abortions,” she said. “The Supreme Court will soon decide whether EMTALA protects emergency abortion access and will further shape reproductive health in this country.”
As legal and medical experts alike await these decisions from the court, rheumatologists may continue to use mifepristone in the clinic legally.
‘A matter of public health’
“Myself and my colleagues simply want to provide comprehensive reproductive health care to the women of the United States,” Sims said. “We have legitimate concerns about our ability to provide this care due to the conversations and subsequent legal rulings that are occurring outside of our clinic rooms, and without the input of knowledgeable medical professionals.”
Blazer stressed that these issues stretch far beyond the theoretical legal arguments found in the court room — there are real-world, often dire consequences to treating patients without mifepristone.
“Given that miscarriages occur in about 20% of lupus pregnancies, this drug protects our patients from infections and future fertility loss,” she said. “Mifepristone can be lifesaving for lupus patients with complications such as preeclampsia, blood clots, or lupus kidney disease.”
Access to mifepristone is also essential in helping to minimize the likelihood of such outcomes in certain marginalized populations, according to Blazer.
“Considering that women and ethnic minorities are disproportionately affected by autoimmune disease, access to mifepristone is at the intersection between medical necessity and health disparities,” she said.
Ultimately, the availability of the drug is an important component of not just rheumatology care, but the overall U.S. health care system.
“Provision of safe and effective pregnancy terminations is a matter of public health,” Blazer said.
The data bear this out. In one example, a study published in June in JAMA Pediatrics, Gemmill and colleagues found a 12% increase in infant deaths in Texas since the passage of a state law there in 2021 that banned abortion after embryonic cardiac activity, and did not allow exemptions for congenital anomalies.
“Ensuring that this medication is available and accessible helps our most vulnerable patients receive the reproductive care that they need,” Blazer said.
According to Sims, the issue is a matter of individual autonomy.
“Like any other medical decision, patients are capable of assessing the risks and benefits of their clinical situation and making an informed decision to either continue or terminate their pregnancy,” she said.
Sims added that providers should have the latitude to allow patients to make those decisions using the best and safest tools.
“Mifepristone is not only a safe and effective method to facilitate the patient’s decision, but can be mailed and administered at home, which may mitigate any potential trauma experienced by the patient,” she said.
It is also important to consider that women with autoimmune disease who undergo pregnancy termination are not commonly at increased risk for complications or flares of their disease, according to Sims.
“Access to mifepristone to perform safe and effective pregnancy terminations has the potential to improve maternal health for some patients in this higher risk population,” she said.
Health care ‘under continuous assault’
As future cases arise, it may be important for the Supreme Court — or any court — to understand that medication abortion is the cheapest and least invasive way to terminate an early pregnancy, according to Donley.
“It would be significantly harmful for a court to remove such a safe, effective and well-studied drug that benefits many patients for ideological reasons,” she said.
In light of this, Sims encouraged rheumatologists to continue the fight for reproductive health care access in whatever ways they can.
“This demonstrates the critical need to have knowledgeable medical professionals informing the decisions of the Supreme Court and other legislative bodies,” she said. “Medical professionals who practice in women’s health and reproductive health gain their knowledge and expertise through daily conversations and shared decision making with patients. Medical professionals have a unique platform to collectively represent the medical needs and priorities of their patient population.”
That platform is essential, as access to mifepristone and other reproductive health medications and procedures are continuously endangered by legal cases presented at the local, state and national levels, according to Sims.
“Medical professionals are becoming advocates in their own communities to inform elected officials of the life-threatening consequences for patients if mifepristone is no longer available,” she said.
Blazer similarly called on the rheumatology community to advocate wherever and whenever possible.
“In the post-Roe era, reproductive health is under continuous assault,” she said. “Codifying abortion access into law is the only solution to protect abortion rights, and access to abortifacient medications.”
References:
Gemmill A, et al. JAMA Pediatr. 2024;doi:10.1001/jamapediatrics.2024.0885.
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