Doctors challenging mifepristone face scrutiny over their limited experience with the abortion drug

By John Fritze and Tierney Sneed, CNN

(CNN) — The blockbuster case at the Supreme Court that could make it harder for millions of Americans to access the abortion pill mifepristone has turned almost entirely on 11 anti-abortion doctors and advocates who say their work has been upended by patients experiencing complications from the drug.

One of those doctors is also a Republican state senator in Indiana. Another claims to be an expert in an “abortion pill reversal” procedure that a leading medical group described as “unproven and unethical.” A third hasn’t been licensed to practice medicine for years.

Most of the doctors directly involved in the case, which will be heard by the Supreme Court on Tuesday, have long records advocating against abortion. None of the doctors who submitted declarations prescribe mifepristone and none have pointed to an instance when they personally were required to perform an abortion for a patient who had complications after taking the drug.

In what has emerged as the most important abortion case since the overturning of Roe v. Wade in 2022, the Supreme Court is being asked whether the Food and Drug Administration overstepped its authority by making it easier to obtain mifepristone, such as by expanding who may prescribe the drug and allowing it to be dispensed through the mail.

But before the court reaches that issue, it must first decide whether the doctors and medical groups who filed the lawsuit have been harmed by the drug in a way that gives them a right to sue, a concept known as “standing.” Adam Unikowsky, a well-known Supreme Court litigator, has questioned whether the groups are even close to meeting that standard.

Much of the evidence the doctors have put forward for how mifepristone’s availability is harming them is vague, at best, and has put the case on flimsy legal footing.

“They’re not forced to prescribe it,” said Unikowsky, a former clerk to the late conservative Justice Antonin Scalia. “Their theory of standing is based on other people being prescribed the drug by other doctors.”

In a series of declarations filed at an earlier stage in the case, the doctors say that on some occasions they must treat patients dealing with complications from the drug, such as heavier-than-expected bleeding, and that triaging those women has had a substantial impact on their practices and other patients. Others say they or their colleagues have been forced to perform post-medication procedures that violate their beliefs.

Dr. Christina Francis, an Indiana OB-GYN and CEO of one of the anti-abortion groups involved in the case, hasn’t personally been forced to perform an “emergency abortion” because of mifepristone but told the court about a patient who arrived at an emergency room in such an unstable condition in 2022 that a colleague had to perform an emergency abortion despite feeling as though she was “forced to participate in something that she did not want to be a part of.”

Leading medical groups such as the American Medical Association have told the Supreme Court that mifepristone is “extremely safe.” The FDA first approved the drug more than 20 years ago, though at that time pregnant women were required to schedule multiple in-person visits at a doctor’s office. The FDA later eliminated that requirement.

Removing that requirement, Francis claimed, “has led to a significant increase in women coming into our emergency rooms.” Francis described that assertion as anecdotal, claiming that it can take years for such trends to appear in published research.

“Where the problem comes in for us is that we have women showing up to our emergency rooms with incomplete abortions,” Francis said. “We are being asked … to then complete a process that we have a moral opposition to.”

A study published recently looking at whether medication abortion via telehealth was as safe and effective as medication abortion provided in clinics.

Questions about the anti-abortion doctors and advocates at the heart of the mifepristone case will almost certainly feature prominently in the arguments. Those inquiries could open a path for some justices to sidestep the more politically fraught issues raised by the litigation.

A lawyer for the doctors and groups, Erik Baptist, dismissed the criticism over standing, noting that two lower courts have allowed the case to proceed. Baptist is a senior counsel at the conservative legal advocacy group Alliance Defending Freedom, which has spearheaded several successful Supreme Court cases in recent years.

“I’m not aware of any other agency action across the federal government that has openly and expressly conscripted doctors to violate their conscience rights to divert their resources and to suffer emotional harm,” Baptist said.

When women arrive at hospitals, he said, “our doctors are more than happy to help them,” but, “that’s creating a concrete harm for them and they have every right to sue the federal government for that.”

Medication abortions account for nearly two-thirds of all abortions in the US, and any move by the high court that makes mifepristone abortion pills harder to obtain could have downstream effects on abortion access more broadly. If more women must turn to in-person abortions, that could extend wait times at brick-and-mortar clinics, which have already seen a surge in demand from patients who live in states where abortion is prohibited.

Defenders of the FDA argue that the looser rules make abortion more accessible for rural patients, and that the ability to dispense mifepristone via telemedicine protects the safety and privacy of people seeking an abortion.

Considering ‘the messenger’

The case challenging the government’s regulation of mifepristone began five months after the Supreme Court’s explosive Roe v. Wade reversal.

The lawsuit was filed by several anti-abortion medical groups and four individual doctors who allege the FDA broke the law when it approved the drug in 2000 and subsequently took steps to expand access to the medication.

For those who have followed the decades-old legal battles around abortion, some of the doctors’ names are familiar. Dr. Ingrid Skop, a Texas OB-GYN who is also vice president at the anti-abortion advocacy group Charlotte Lozier Institute, regularly testifies on abortion and has been involved in multiple lawsuits involving the procedure.

“I have cared for at least a dozen women who have required surgery to remove retained pregnancy tissue after a chemical abortion,” Skop told the district court in the current case in a declaration submitted on behalf of one of the anti-abortion groups.

In a blistering brief submitted in the case earlier this year, the American Civil Liberties Union noted that other courts have previously rejected the expert witness testimony offered by some of the doctors in other cases.

A trial court in Florida in 2022, for instance, found Skop’s testimony on abortion safety “inaccurate and overstated.”

In a statement to CNN, Skop said she has “delivered over 5,000 babies in over 30 years” of practice.

“As someone who has treated many women harmed by these abortion drugs, I stick to facts and research, not ad hominem attacks,” she said. “Any data that doesn’t confirm their abortion on demand bias is ignored by mainstream medical organizations who lobby for abortion through all nine months for any reason.”

Another doctor who filed a statement in the case, Dr. Jeffrey Barrows, has not been licensed to practice medicine for more than a decade, the ACLU said. Barrows, who is a senior vice president at the Christian Medical & Dental Associations, did not respond to a request for comment.

“The lower courts should have considered who the messenger is,” said Julia Kaye, senior staff attorney with the ACLU Reproductive Freedom Project, which is supporting the FDA.

“The Constitution,” Kaye added, “does not allow people to bring lawsuits just because they dislike a government policy that does not actually affect them.”

Dr. Tyler Johnson, one of the individual plaintiffs in the case, is also a Republican state senator in Indiana, where he pushed for the legislature to adopt the strict abortion ban that went into there effect last year.

Dr. George Delgado of California, also an individual plaintiff, has for years advocated for a process of reversing the effects of abortion medication that the American College of Obstetricians and Gynecologists has described as “not based on science.” They are among the doctors who submitted roughly 80 pages of statements that lower courts heavily relied on to establish that the plaintiffs had standing to challenge the drug.

Johnson and Delgado did not respond to requests for comment.

Lower courts based decisions on doctors’ statements

The lead medical group in the suit, the Alliance for Hippocratic Medicine, was incorporated in Amarillo, Texas, months before it filed the lawsuit – allowing it to choose a court where it was guaranteed to be assigned to conservative US District Judge Matthew Kacsmaryk.

Kacsmaryk invalidated the FDA’s decades-old approval of mifepristone in a 67-page decision last year. The judge found that the doctors and groups who filed the suit had standing, in part because of the “enormous pressure and stress” dealing with the drug’s complications placed on their practices.

His ruling was pared back by the 5th US Circuit Court of Appeals, which said the statute of limitations to challenge the FDA’s underlying approval of mifepristone had likely run out but that other moves by the agency to ease access to the drug should be blocked. The 5th Circuit’s decision would have made it much harder to obtain mifepristone.

The original lawsuit leaned on declarations submitted by the doctors and advocates – and so did the lower courts. The 5th Circuit included lengthy quotes from both Skop and Francis.

But in some instances, those courts glossed over key points. The 5th Circuit, for instance, noted Francis saw a patient who had obtained mifepristone from a website. It left out a part of her statement that noted the patient was told the drugs came from India, suggesting they might have been obtainable regardless of whether the FDA had approved them.

The Supreme Court  placed the appeals court decision on hold while it considered the case.

Can doctors show a ‘concrete harm’?

To justify its second-guessing of the FDA’s approach, the appeals court said there was a “statistical certainty” that the challengers would be required in the future to treat more patients with complications because the FDA had eased access to mifepristone.

“The fact that women are not being seen in person before getting these drugs, which the FDA acknowledged were high-risk drugs, is ridiculous,” Francis said, claiming that patients are not being sufficiently screened by a doctor for potential complications.

Skeptics of the anti-abortion doctors warn that their theories would toss open the doors to a flood of new lawsuits – from both liberal and conservative groups – over countless other decisions made by the federal government.

“The theories of standing in this case really suggest that any rule that theoretically has some impact of safety can be challenged by activists,” Unikowsky told CNN. That would “dramatically expand the ability of ideological organizations to challenge almost anything” the government does.

The approach the Supreme Court’s conservative majority has taken on standing has been a flashpoint in recent cases, including a successful challenge to Biden’s student loan forgiveness program and to efforts to weaken protections for LGBTQ Americans. Liberal dissenters have accused their conservative colleagues of accepting standing theories that are far afield from the typical legal rules for who can bring lawsuits.

But in other cases, the court has permitted the Biden administration’s policies because challengers lacked standing, including in an important immigration case last year in which Texas and Louisiana tried to block the federal government from prioritizing certain immigrants for deportation over others.

Three Republican-led states attempted to jump into the mifepristone case to challenge the FDA alongside the doctors. They were successful at the district court level, but the Supreme Court declined to allow them to intervene. The gambit was seen by some outside observers as an effort by the abortion pill opponents to shore up the standing weaknesses in their lawsuit.

Baptist noted that Alliance Defending Freedom consented to the states taking part and said, “they have every right and every interest to participate in this litigation.”

In their Supreme Court filings, the states all but promised that they would quickly file a similar challenge over mifepristone access if the court ultimately finds that the doctors can’t sue. That means that if the Supreme Court decides the current case on standing the justices may wind up confronting the same questions in short order, only with a different set of parties.

Such a ruling, the states said, would “would nearly guarantee this case comes before this court again … within months.”

CORRECTION: This story has been updated to correctly reflect Unikowsky’s position on standing and lawsuits.

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