WASHINGTON — The U.S. Supreme Court ruled in a much-anticipated decision Thursday that mifepristone, one of two pharmaceuticals used in medication abortion, can remain available under current prescribing guidelines.
The high court unanimously rejected attempts by anti-abortion groups to roll back access to what was in place more than eight years ago, writing that they lacked standing to bring the case.
Those limits would have made it more difficult for patients to get a prescription for mifepristone, which the Food and Drug Administration has approved for up to 10 weeks gestation and is used in about 63% of U.S. abortions.
Erin Morrow Hawley, senior counsel at Alliance Defending Freedom, who argued the case in front of the court on behalf of the legal organization, doesn’t believe this is the end of efforts to challenge access to mifepristone.
She said on a call shortly after the ruling was released the three states that intervened in a lower court — Idaho, Kansas and Missouri — could still advance their arguments against mifepristone and potentially hold standing, the legal right to bring a case.
“I would expect the litigation to continue with those three states,” Hawley said.
Kavanaugh writes opinion
Justice Brett Kavanaugh wrote the opinion in the united ruling from the Supreme Court, with Justice Clarence Thomas writing a concurring opinion.
“Plaintiffs are pro-life, oppose elective abortion, and have sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others,” Kavanaugh wrote.
The four anti-abortion medical organizations and four anti-abortion doctors who originally brought the lawsuit against mifepristone have protections in place to guard against being forced to participate in abortions against their moral objections, he noted.
“Not only as a matter of law but also as a matter of fact, the federal conscience laws have protected pro-life doctors ever since FDA approved mifepristone in 2000,” Kavanaugh wrote. “The plaintiffs have not identified any instances where a doctor was required, notwithstanding conscience objections, to perform an abortion or to provide other abortion-related treatment that violated the doctor’s conscience.”
“Nor is there any evidence in the record here of hospitals overriding or failing to accommodate doctors’ conscience objections,” he added.
Alliance Defending Freedom has not “identified any instances where a doctor was required, notwithstanding conscience objections, to perform an abortion or to provide other abortion-related treatment that violated the doctor’s conscience since mifepristone’s 2000 approval,” the opinion said.
Kavanaugh might have also included hints on how the court will rule later this session on a separate abortion access case that addresses the Emergency Medical Treatment & Labor Act, known as EMTALA.
“EMTALA does not require doctors to perform abortions or provide abortion-related medical treatment over their conscience objections because EMTALA does not impose obligations on individual doctors,” Kavanaugh wrote.
Thomas agrees but questions who can sue
Thomas wrote a concurring opinion in the case, saying that he agreed with the court’s unanimous decision, which he did join, but brought up concerns with how a certain type of standing is used by the Court.
“Applying these precedents, the Court explains that the doctors cannot establish third-party standing to sue for violations of their patients’ rights without showing an injury of their own,” Thomas wrote.
“But, there is a far simpler reason to reject this theory: Our third-party standing doctrine is mistaken,” Thomas added. “As I have previously explained, a plaintiff cannot establish an Article III case or controversy by asserting another person’s rights.”
Reaction pours in
Politicians, anti-abortion groups and reproductive rights organizations all reacted to the ruling within hours of its release, often pointing to November’s elections as a potential next step.
President Joe Biden released a written statement saying the “decision does not change the fact that the fight for reproductive freedom continues.”
“It does not change the fact that the Supreme Court overturned Roe v. Wade two years ago, and women lost a fundamental freedom,” Biden added. “It does not change the fact that the right for a woman to get the treatment she needs is imperiled if not impossible in many states.”
Former President Donald Trump, the Republican Party’s presumptive nominee, was in meetings most of Thursday with U.S. House Republicans and then separately with Republican U.S. Senators.
Neither Trump nor his campaign released a statement by early Thursday afternoon addressing the Supreme Court’s ruling.
Louisiana Republican Sen. Bill Cassidy, ranking member on the Health, Education, Labor and Pensions Committee, wrote in a statement that the justice didn’t actually address the merits of the case.
“The Court did not weigh in on the merits of the case, but the fact remains this is a high risk drug that ends the life of an unborn child,” Cassidy wrote. “I urge FDA to follow the law and reinstate important safeguards.”
President of the American College of Obstetricians and Gynecologists Stella Dantas related a statement saying the ruling “provides us with long-awaited relief.”
“We now know that patients and clinicians across the country will continue to have access to mifepristone for medication abortion and miscarriage management,” Dantas wrote. “Decades of clinical research have proven mifepristone to be safe and effective, and its strong track record of millions of patient uses confirms that data.”
Hawley from Alliance Defending Freedom wrote in a written statement the organization was “disappointed that the Supreme Court did not reach the merits of the FDA’s lawless removal of commonsense safety standards for abortion drugs.”
“While we’re disappointed with the court’s decision, we will continue to advocate for women and work to restore commonsense safeguards for abortion drugs—like an initial office visit to screen for ectopic pregnancies,” Hawley wrote. “And we are grateful that three states stand ready to hold the FDA accountable for jeopardizing the health and safety of women and girls across this country.”
Nancy Northup, president and CEO of the Center for Reproductive Rights, wrote in a statement she had “both relief and anger about this decision.”
“Thank goodness the Supreme Court unanimously rejected this unwarranted attempt to curtail access to medication abortion, but the fact remains that this meritless case should never have gotten this far,” Northup wrote.
“The FDA’s rulings on medication abortion have been based on irrefutable science,” Northup wrote. “Unfortunately, the attacks on abortion pills will not stop here — the anti-abortion movement sees how critical abortion pills are in this post-Roe world, and they are hell bent on cutting off access.”
Scientific evidence argued
The Supreme Court heard oral arguments in the case in March, during which Solicitor General Elizabeth Prelogar argued the FDA’s guidelines for prescribing mifepristone were based on reputable scientific evidence and years of real-world use.
“Only an exceptionally small number of women suffer the kinds of serious complications that could trigger any need for emergency treatment,” Prelogar said. “It’s speculative that any of those women would seek care from the two specific doctors who asserted conscience injuries. And even if that happened, federal conscience protections would guard against the injury the doctors face.”
Hawley of ADF told the court that conscience protections in federal law didn’t do enough to protect anti-abortion doctors from having to possibly treat patients experiencing complications from medication abortion.
“These are emergency situations,” Hawley said. “Respondent doctors don’t necessarily know until they scrub into that operating room whether this may or may not be abortion drug harm — it could be a miscarriage, it could be an ectopic pregnancy, or it could be an elective abortion.”
The case reached the Supreme Court within two years of ADF originally filing the lawsuit in the District Court for the Northern District of Texas, where ADF wrote the FDA “exceeded its regulatory authority” when it originally approved mifepristone in 2000.
ADF filed the case on behalf of Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, American College of Pediatricians and Christian Medical & Dental Associations, as well as four doctors from California, Indiana, Michigan and Texas.
Kacsmaryk ruling started journey to high court
Judge Matthew Joseph Kacsmaryk essentially agreed with the anti-abortion groups, in a ruling in April 2023, where he wrote he did “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,” Kacsmaryk wrote.
The U.S. Supreme Court issued a stay at the request of the Justice Department, which put the district court’s ruling on hold until the appeal process could work itself out.
The Justice Department also appealed the district court’s ruling to the 5th Circuit Court of Appeals in Louisiana, where a three-judge panel heard the case in May 2023.
The panel — composed of Jennifer Walker Elrod, who was appointed by former President George W. Bush, as well as James C. Ho and Cory T. Wilson, who were both appointed by former President Donald Trump — issued its ruling in August 2023.
The appeals court disagreed with the district court’s ruling that mifepristone’s original approval should be overturned, though it said that the FDA erred in making changes to prescribing guidelines in 2016 and 2021.
“It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events,” the appeals judges wrote. “And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”
That ruling didn’t take effect under the Supreme Court’s earlier stay.
The Department of Justice wrote to the high court weeks later in September, urging the justices to take up an appeal of the 5th Circuit’s decision.
“The loss of access to mifepristone would be damaging for women and healthcare providers around the Nation,” the DOJ wrote in the 42-page document. “For many patients, mifepristone is the best method to lawfully terminate their early pregnancies. They may choose mifepristone over surgical abortion because of medical necessity, a desire for privacy, or past trauma.”
Briefs filed with court
Dozens of abortion rights organizations and lawmakers filed so-called amicus curiae or friend of the court briefs to the Supreme Court calling on the justices to keep access to mifepristone in line with the FDA guidelines.
A group of more than 16 medical organizations, including the American College of Obstetricians and Gynecologists and the American Medical Association, wrote that “restricting access to mifepristone will not only jeopardize health, but worsen racial and economic inequities and deprive women of the choices that are at the very core of individual autonomy and wellbeing.”
Anti-abortion groups and lawmakers opposed to mifepristone wrote numerous briefs as well.
Attorneys general from Alabama, Alaska, Arkansas, Florida, Georgia, Indiana, Iowa, Kentucky, Louisiana, Mississippi, Montana, Nebraska, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, West Virginia and Wyoming sent in a 28-page brief.
They wrote that the availability of mifepristone undermined states’ rights, since some of their states had sought to restrict abortion below the 10 weeks approved for mifepristone use or had sought to bar access to medication abortion.
“The FDA’s actions undermine these laws, undercut States’ efforts to enforce them, and thus erode the federalism the Constitution deems vital,” the attorneys general wrote. “Given these harms to federalism, this Court should view the FDA’s actions with skepticism.”
During oral arguments in March, several Supreme Court justices brought up conscience protections that insulate health care workers from having to assist with or perform procedures they have a religious objection to, like abortion.
Associate Justice Ketanji Brown Jackson said she was “worried that there is a significant mismatch in this case between the claimed injury and the remedy that’s being sought.”
“The obvious, common-sense remedy would be to provide them with an exemption that they don’t have to participate in this procedure,” Jackson said.
Associate Justice Neil Gorsuch said the case seemed “like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule, or any other federal government action.”
Forty-nine percent of resident women who obtained abortions and for whom race was reported were White; 44% were African American; 4% were Asian/ Pacific Islander; and 4% reported more than one race (Figure 2). Five percent of women with known ethnicity who obtained abortions were of Hispanic origin.