Supreme Court Seems Skeptical of Challenge to Abortion Pill Access

By Catherine Yang

Mar 26

The Supreme Court appeared skeptical that the doctors group who challenged the Food and Drug Administration's (FDA) loosening of regulations of the abortion pill mifepristone had the right to bring the case.

Justice Neil Gorsuch pointed out that the universal injunction the group was requesting is a relatively new form of court order that the high court itself has "never adopted." He said this case was a prime example of a small case turning into a "nationwide legislative assembly."

The pro-life doctors argued that they've suffered harm from having to conduct emergency procedures for women who've taken the abortion pill and experience complications. The government counters this by contending that complications from the abortion pill are rare, and the objecting doctors can themselves opt out of the procedure under federal conscience laws.

Oral arguments have concluded after about 1 hour and 45 minutes.

By Samantha Flom

Mar 26

In her rebuttal, Solicitor General Elizabeth Prelogar reiterated her assertion that the respondent doctors did not have standing to challenge the FDA’s approval of mifepristone.

“What is so telling is that respondents don’t have a specific example of any doctor ever having to violate this care in violation of their conscience,” Ms. Prelogar said. “Instead, respondents pointed to generalized assertions and the declarations that never come out and specifically say, by one of their identified members, ‘Here’s the care I provided, here’s how it violated my conscience, and here’s why conscience protections were unavailable to me.’”

That lack of testimony, she said, indicated to her that “the past harm hasn’t happened.”

By Catherine Yang

Mar 26

Ms. Hawley argued that the FDA rule effectively turns emergency rooms into "follow-up visits."

Justice Barrett pointed out that first visits did not require ultrasound and would not be able to give an "accurate gestational read on age or detect an ectopic pregnancy."

"So why would the elimination of the visit necessarily increase the risks?" she asked.

By Savannah Hulsey Pointer

Mar 26

Justices Ketanji Brown Jackson and Elena Kegan questioned attorney Erin Hawley, who is representing Alliance Hippocratic Medicine (AHM), about whether the doctors represented in her case suffered conscience harm, and whether this was a broad or narrow application of the alleged harm.

The justices asked the attorney to clarify the broader conscience harm, according to AHM's case.

Ms. Hawley asserted that the broader harm "is being complicit in the process that unnecessarily leads a takes an unborn life, such as performing DNC and abortion."

By Samantha Flom

Mar 26

Justice Sonia Sotomayor pressed Erin Hawley, attorney for the Alliance of Hippocratic Medicine, on whether there was sufficient basis for the organization’s argument that its doctors were being forced to violate their consciences by treating women injured by mifepristone.

Ms. Hawley pointed to the cases of two doctors who claimed to have been in that situation.

One, Dr. Francis Scott, said she was required to perform a dilation and curettage, or D&C, procedure because she did not have an opportunity to state her objection.

By Catherine Yang

Mar 26

Justice Neil Gorsuch interrupted a back-and-forth between Justice Ketanji Brown Jackson and attorney Erin Hawley on the topic of conscience injuries.

Normally, courts issue relief that addresses the plaintiff's injuries "and go no further," he said. Here there were a "handful" of individuals with conscience objections.

"Normally, we would allow equitable relief to address them. Recently, I think what Justice Jackson's alluding to, we've had what one might call a rash of universal injunctions of vacatures. And this case seems like a prime example of turning a small lawsuit into a nationwide legislative assembly on an FDA rule or any other federal action," he said, asking for Ms. Hawley's thoughts.

By Savannah Hulsey Pointer

Mar 26

In her opening argument before the Supreme Court, Erin Hawley, representing Alliance Hippocratic Medicine (AHM), asserted that the FDA's approval of abortion drugs without adequate data violates the Administrative Procedure Act (APA).

Ms. Hawley emphasized that the lower court's decision simply restored protections for women who use abortion drugs, highlighting the need to safeguard their well-being: "The lower court's decision merely restored long-standing and crucial protections under which millions of women used abortion drugs."

Addressing the issue of standing, Ms. Hawley presented evidence to satisfy Article III requirements, saying, "Article III is satisfied here because one, the FDA relies on OB hospitalists to care for women harmed by abortion drugs.

By Samantha Flom

Mar 26

Jessica Ellsworth, representing mifepristone manufacturer Danco Laboratories, asserted that judges should not question the FDA’s decision-making, holding that they are not qualified to make those determinations.

“You have a district court that, among other things, relied on one study that was an analysis of anonymous blog posts. You have another set of studies that he relied on that were not in the administrative record and would never be because they post-date the FDA decisions here. They have since been retracted for lack of scientific rigor, and for misleading presentations of data,” Ms. Ellsworth said, referencing the emergency room visit studies Justice Alito raised earlier.

“Those sorts of errors can infect judicial analyses precisely because judges … are not experts in statistics. They are not experts in the methodology used for scientific studies for clinical trials,” she continued. “That is why FDA has many hundreds of pages of analysis in the record of what the scientific data showed, and courts are just not in a position to parse through and second-guess that.”

By Catherine Yang

Mar 26

Justice Samuel Alito asked Jessica Ellsworth, attorney for drug company Danco Laboratories, who her company thought would be "aggrieved" by the case.

Mifepristone is the only drug the company is currently marketing, and the lower court decision did not prohibit the company from continuing to do so.

"So I gather your injury is that you're going to sell more if the restrictions that were previously in place were lifted," Justice Alito said.

By Savannah Hulsey Pointer

Mar 26

Justice Ketanji Brown Jackson questioned Solicitor General Elizabeth Prelogar about the concern that there is a "mismatch" in the case before the court, saying there could be dissonance between the claimed injury and the remedy sought.

"I don't know that our doctrines sort of capture this, but I guess I see it that the injuries that the respondents allege … are conscience induced injury, that they are being forced to participate in a medical procedure that they object to," Justice Jackson said. "And so the obvious common sense remedy would be to provide them with an exemption … and you say, and you've said here several times that federal law already gives them that."

Ms. Prelogar echoed Justice Jackson's concerns, likening the situation to a "zone of interest" analysis, suggesting that the respondents were seeking relief under a statute that did not regulate them.

By Catherine Yang

Mar 26

Ms. Prelogar said that only two of the seven doctors had argued conscience objections, but protections are in place.

"Federal conscience protections are specifically designed to deal with this issue," she said, adding that they provide "broad coverage here."

In the 1970s, the "Church Amendments" were added to conscience laws to protect the rights of those who object to performing abortion or sterilization procedures.

By Samantha Flom

Mar 26

Justice Samuel Alito questioned whether the FDA had adequately assessed studies showing an increased frequency in emergency room visits among women who took mifepristone.

The studies in question, first referenced in an amicus brief filed by the Charlotte Lozier Institute, were cited by U.S. District Judge Matthew Kacsmaryk in his initial injunction blocking mifepristone’s approval last year. The studies were recently retracted by Sage Journals after a review.

Justice Alito noted that, in its response, the FDA acknowledged the studies’ implications but simply stated that there are “no apparent increases in other serious adverse events related to mifepristone use.”

By Catherine Yang

Mar 26

Justice Samuel Alito asked Ms. Prelogar if the FDA should have "at least considered" a statute prohibiting the mailing of "obscene or crime-inciting matter."

Ms. Prelogar said those statutes, known as the "Comstock laws," don't "fall within the FDA's lane."

She argued it was not the FDA's responsibility to consider that, "nor could it have considered that."

By Catherine Yang

Mar 26

Supreme Court Chief Justice John Roberts said Ms. Prelogar emphasized that adverse effects were a remote possibility and asked if there was a number at which that assessment would change.

"The significant number of consequences? A higher likelihood of an emergency room visit? Doctors who spend more time in the emergency room?" he asked. "At some time does this lead to the other result?"

Ms. Prelogar said it was hard for her to imagine that it could.

By Savannah Hulsey Pointer

Mar 26

Justice Samuel Alito pressed Solicitor General Elizabeth Prelogar about who would have the standing to bring a case for a drug like mifepristone because of the government's argument that the respondent, Alliance for Hippocratic Medicine (AHM), has no standing.

Justice Alito asked Ms. Prelogar if "there anybody who could challenge in court" on the lawfulness of the FDA's decision on the use of mifepristone, due to her previous answer to Justice Clarence Thomas's similar question, starting with whether states had the right to bring a suit.

Ms. Prelogar responded that she did not believe there was standing to bring the case, saying, "No, we think the state's lack standing there asserting indirect injuries," and went on to cite the case United States v. Texas.

By Samantha Flom

Mar 26

The government has argued that the medical professionals and organizations challenging the FDA’s approval of mifepristone have no standing to bring a lawsuit.

Supreme Court Justice Clarence Thomas asked Solicitor General Elizabeth Prelogar who would have standing in the case.

“We’ve seen lawsuits in the past that are brought by, for example, prescribing physicians or patients who want greater access to a drug,” he noted. “Sometimes, we’ve seen theories of competitor standing where a competing drug manufacturer might sue and claim that FDA approval of a drug creates a competitive harm or injury in that sense.”

By Catherine Yang

Mar 26

Solicitor General Elizabeth Prelogar argued the doctors had no standing.

"FDA approved mifepristone based on the agency's scientific judgment that the drug is safe and effective. Its maintained that judgment through five presidential administrations and millions of Americans have used mifepristone to safely end their pregnancies," Ms. Prelogar said.

"Respondents may not agree with that choice but that doesn't give them Article 3 standing or a legal basis to upend the regulatory scheme.

By Savannah Hulsey Pointer

Mar 26

Erin Hawley, the wife of Sen. Josh Hawley (R-Missouri) is representing Alliance for Hippocratic Medicine. Ms. Hawley is Senior Counsel and Vice President at Alliance  for Defending Freedom and has an extensive background in litigation, including before the Supreme Court.

She taught constitutional law at the University of Missouri and is a constitutional law as senior fellow at the Kinder Institute for Constitutional Democracy, and was part of the legal team that argued the Dobbs decision from 2022 that overturned Roe v. Wade.

Ms. Hawley previously worked at the Department of Justice, serving as counsel to Attorney General Michael Mukasey. She holds a law degree from Yale Law School and a bachelor's degree in Animal Science from Texas A&M University, and is admitted to practice before the U.S. Supreme Court and various federal courts of appeals.

By Samantha Flom

Mar 26

As the justices hear oral arguments in the case, letters will be making their way around the country to the CEOs of some of the nation’s leading retail pharmacies.

Written by Students for Life of America (SFLA) President Kristan Hawkins, the letters urge the companies to reject efforts to “coerce medical professionals into the business of abortion” through the sale and distribution of abortion pills.

“However this case turns out, the Pro-Life Generation is looking for pharmacies offering life-affirming care,” Ms. Hawkins said in a March 25 statement.

By Samantha Flom

Mar 26

The question at the core of the lawsuit is whether the FDA followed the appropriate protocols when it approved mifepristone in 2000 and subsequently removed certain safeguards in 2016 and 2021.

March for Life President Jeanne Mancini said she believed the agency ignored its own standards with its decisions surrounding the drug, putting the health of women and girls at risk.

“Despite the FDA’s own label showing that roughly 1 in 25 women end up in the emergency room after ingesting these pills, the agency does not require prescribers to report resultant medical emergencies like severe bleeding and sepsis,” Ms. Mancini noted in a statement.

Ahead of the hearing, CatholicVote, a Catholic advocacy organization, called out the FDA in a statement for its “reckless removal of basic safeguards” to protect women from the potentially harmful side effects of the abortion drug mifepristone.

The agency’s decision, CatholicVote President Brian Burch said, “endangers women every single day—leaving them to suffer horrific, sometimes life-threatening, complications completely alone, without the oversight of a qualified medical provider.

“The FDA’s own data shows that about 1 in 25 women end up in the emergency room after taking chemical abortion pills and may require attention for serious, even life-threatening complications,” Mr. Burch continued. “This is unacceptable. It’s long past time to hold the FDA accountable for endangering and abandoning women and downplaying their sufferings for the sake of abortion politics.”

By Sam Dorman

Mar 26

The abortion pill case brought a chaotic scene of dueling protests outside the Supreme Court on March 26. Before the justices entered the courtroom, fake magazine covers with the conservative justices’ faces could be seen with derogatory messages near the steps of the building.

To the right was a rally hosted by Alliance Defending Freedom, which is representing the group of doctors who sued the FDA.

In the street, a group of pro-life protesters participated in a “die-in” and pro-abortion protesters chanted messages like, “If we don’t get it, shut it down.”

By Sam Dorman and Matthew Vadum

Mar 26

The case today on a challenge to the Biden administration’s decision to relax certain regulations around how women receive the abortion pill mifepristone.

Oral argument will likely focus on whether the Food and Drug Administration (FDA) failed to abide by its standards for protecting women’s safety and health, as well as whether the individuals challenging the FDA regulations have standing—the idea that they suffered harm that allows them to sue in court.

A group of doctors is challenging the FDA’s 2016 and 2021 decisions, which collectively altered the dosage of the medication known as mifepristone, as well as how much women had to interact with doctors in person and receive the pill in person. The FDA’s rules, they argue, should receive scrutiny under the Administrative Procedures Act, which allows for judicial review of certain types of agency action.