Supreme Court hears oral arguments on major abortion pill case

Steve Vladeck, CNN Supreme Court analyst and professor at the University of Texas School of Law, has this to say about the injunction discussion:

"One of the issues lurking in this case, and several other before the Court this term, is the uptick in what Justice Neil Gorsuch calls 'universal' injunctions—court orders that block state or federal policies as applied to anyone based solely on a claimed injury to a small handful of individuals.

At the very least, the question of when policies should be blocked on a statewide or nationwide basis because a handful of citizens object to them is an issue that should get more discussion—not just from the courts, but from Congress, which has, to this point, been unwilling to provide more guidance for when these kinds of orders should and should not be allowed."​​

Oral arguments have concluded in a major Supreme Court case over access to the commonly used abortion drug mifepristone.

The nine justices heard arguments from three separate attorneys for more than an hour Tuesday morning. A decision in the case is expected by the end of June or early July.

Chief Justice John Roberts and Justice Neil Gorsuch have peppered the attorney for the abortion pill challengers why her clients were seeking a nationwide relief in the case as opposed to a narrower remedy that would apply only to the plaintiff doctors.

“Why can't the court specify that this relief runs to precisely the parties before the court as opposed to looking to the agency in general and saying agency you can't do this anywhere?” Roberts asked the attorney, Erin Hawley.

For his part, Gorsuch told Hawley that he went back “and looked and there are exactly zero universal injunctions that were issued during Franklin Delano Roosevelt's 12 years in office.”

“And over the last four years or so, the number is something like 60 and maybe more than that,” he continued.

Justice Ketanji Brown Jackson flipped a question from Justice Samuel Alito on its head to give the US Food and Drug Administration's defenders an opportunity to argue that the agency is better suited to make calls on medical science than the courts.

Alito had suggested that, according to the arguments of the administration and mifepristone manufacturer, the FDA would be “infallible” to any skepticism of its approach.

Jackson returned to the question while Danco’s attorney, Jessica Ellsworth, was arguing, and asked Ellsworth her concerns about judges “parsing” medical and scientific studies.

Ellsworth pointed to some of the questionable types of “misleading” assertions the lower courts used to justify their second guessing of the agency, including a blog post analyzing anonymous anecdotes and studies that have since been retractions.

Congress gave the US Food and Drug Administration the authority to regulate drugs more than 60 years ago, and in 1962 it was also given the authority to require that drug companies prove that the drugs are effective. Mifepristone, one of the drugs used in medication abortion in the US, was initially approved in 2000, but regulations around its use have shifted since then.

For a medicine to be approved by the the FDA, drugmakers needs to meet rigorous standards that show that the drug is safe and effective. They do this through data from lab, pre-clinical and clinical studies.

Here's a timeline of FDA's regulations around mifepristone:

2000: Initially, mifepristone was approved for medical termination of pregnancy with several restrictions. It could only be prescribed through seven weeks of gestation and only doctors could prescribe it in-person.

2016: The FDA expanded the use of mifepristone after Danco Laboratories, the drug’s sponsor, submitted additional materials to change the way the drug could be used. The FDA took a closer look at 16 years of data on mifepristone use and took into account the way it was prescribed in other countries, as well as professional organization guidelines. Using data from 20 additional studies that looked at the safety and effectiveness of the drug, the FDA allowed clinicians to prescribe the medicine up to 10 weeks of pregnancy.

2021: Due to the Covid-19 pandemic along with studies looking at the effectiveness and safety of telehealth, the FDA eliminated the in-person dispensing requirement. After additional review of the available safety and effectiveness data, and based on the experience of millions of people who used the drug, the FDA made that change permanent in 2023 and eliminated the in-person dispensing requirement.

Erin Hawley, an attorney representing the abortion pill’s challengers, told the justices that they should undo the the US Food and Drug Administration's moves in recent years to ease restrictions around the drug, arguing those decisions ran afoul of federal law.

“FDA’s outsourcing of abortion drug harm to respondent doctors forces them to choose between helping a woman with a life-threatening condition and violating their conscience,” she added later.

Hawley is a senior counsel at Alliance Defending Freedom, a conservative advocacy group. She was a law clerk to Chief Justice John Roberts during the same term as her now-husband, Republican Sen. Josh Hawley from Missouri. An experienced advocate who has specialized in anti-abortion litigation, the mifepristone case will mark Hawley’s first appearance at the Supreme Court lectern.

Jessica Ellsworth, an attorney representing Danco, which makes mifepristone, has just begun delivering her arguments in defense of the abortion pill the company manufactures.

Ellsworth is a partner at the Hogan Lovells law firm and has specialized in administrative law disputes. She is a regular practitioner in federal appellate courts, and this case will be her second time at the lectern before the justices.

Justice Samuel Alito said that a long unenforced law banning the mailing of drugs used for illegal abortions was not “obscure” but rather a “prominent” law.

Alito’s reference to the Comstock Act, a 19th century statue outlawing the use of the mail to send various “lewd” materials, is notable. Some anti-abortion activists see the law as an avenue to end medication abortion, and perhaps all kinds of abortion.

The Comstock Act has not been a central part of this case, but the challengers have gotten a little bit of traction at the lower court level with their argument that the FDA acted unlawfully in its approach to mifepristone because it did not take into account to Comstock Act’s criminal prohibitions on mailing drugs used for illegal abortions.

Solicitor General Elizabeth Prelogar countered on Tuesday that it is not the Food and Drug Administration's job to enforce criminal law, and that the FDA did get advice at the time that from the Justice Department about its interpretation of the law. 

Defenders of the FDA have also argued that the Comstock Act’s prohibitions are geared towards “illegal” abortions, and this case is attempting to limit the access of mifepristone even in places where abortion is legal. 

Justice Clarence Thomas also brought up the Comstock Act in questions for Danco, a mifepristone manufacturer that has intervened to defend the FDA’s regulation. Danco’s attorney said that this case was not an appropriate venue for the court to weigh the reach of the Comstock Act.

The discussion has turned to a key question — if the doctors challenging the nationwide approval of mifepristone can simply have a "conscientious objection" that doesn't require them to assist in an abortion rather than force a nationwide ban on the drug.

Conservative Justice Brett Kavanaugh asked whether federal law provides some protections for doctors who object to providing an abortion on moral and religious grounds – a sign that he may not be convinced that the plaintiff doctors had the legal right to bring their suit against the FDA.

“Just to confirm on the standing issue: under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct?” Kavanaugh – who is sometimes a swing vote on the high court — asked Solicitor General Elizabeth Prelogar.

Prelogar pressed that point to Justices Amy Coney Barrett and Ketanji Brown Jackson as well.