Supreme Court justices are concerned that their ruling on unprecedented cases challenging the availability of mail-order abortion medication, and the federal agency that regulates it, could have consequences that extend well beyond potential damages to its plaintiff clinicians.
During oral arguments heard Tuesday morning, questions from the nation’s top judges began and frequently returned to the plaintiffs’ standing as well as whether a nationwide injunction on mail-order prescriptions of the drug mifepristone would be an appropriate remedy or a “profound mismatch.”
Justice Ketanji Brown Jackson, Justice Neil Gorsuch and Chief Justice John Roberts all seemed dissatisfied with the arguments from Erin Hawley, who represented physicians from the Alliance for Hippocratic Medicine with conscientious objections to providing abortion care.
After hearing from Solicitor General Elizabeth Prelogar, who represents the federal government, tell Justice Brett Kavanaugh and Justice Amy Coney Barrett that individual physicians are not currently required to set aside their personal beliefs to provide emergency care stemming from adverse events related to the medication, others questioned Hawley on why more action was needed from the judiciary.
“Isn’t that enough to remedy their issue?” Jackson asked. “Do we have to also entertain your argument that no one else in … America should have this drug in order to protect your clients?”
Gorsuch said the current case that only involves “a handful of individuals ... seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on FDA rule or other federal government action.”
He noted that such “universal injunctions” have been historically rare to nonexistent, but that he has seen, in the past four years, “something like 60 and maybe more than that” ordered by lower courts. Gorsuch, along with Roberts, appeared resistant to allowing the top court to impose its first such injunction under the presented circumstances.
"You're asking us to extend and pursue this relatively new remedial course, which this court has never adopted itself," he said.
Hawley argued that a broad reversal of the Food and Drug Administration's (FDA's) regulatory decisions is necessary to protect her clients, saying that patients with access to the drugs will inevitably reach emergency rooms and that it is “impractical” for practitioners to voice their objections in such a situation.
Multiple justices appeared skeptical of the claims and criticized Hawley for largely speaking of hypothetical scenarios of injury as opposed to those stated by the physicians for the court. Prelogar seized upon the opening in her closing rebuttal.
“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,” the solicitor general said. “Instead, the respondents have pointed to generalized assertions and declarations that never come out and specifically say … ‘Here’s the care I provided, here’s how it violated my conscience and here’s why conscience protections were unavailable to me.’ … It is so speculative and turns on so many links in the chain that would have to occur, and in the end would be backstopped by having the federal conscience protections in play.”
Judges question whether FDA is "infallible," role of courts in drug safety decisions
Tuesday’s hearing is the latest in a monthslong legal battle that, in August 2023, saw the Fifth Circuit Court of Appeals permit mifepristone to stay on the market in recognition of a 2000 FDA approval. However, the appellate court struck later regulatory action related to mail-order prescriptions and, in its written decision, questioned the decisions and authority of the regulatory agency’s experts.
Lawyers from the federal government, mifepristone manufacturer Danco Laboratories and trade groups from the pharmaceutical and healthcare industries have warned the courts that judiciary intervention could have disastrous impacts on the FDA’s authority to regulate drugs.
Those concerns surfaced during the oral arguments. Conservative justices questioned Prelogar as to whether the FDA should be immune to pushback should its regulatory decisions unlawfully lead to harm, to which the solicitor general suggested that the agency could be subject to court authority in certain circumstances with clear evidence of harm.
They, along with Justice Sonya Sotomayor, also sought to understand the agency’s line of thinking around updating mifepristone’s availability after it had stopped requiring reports of nonfatal adverse events.
Prelogar and Jessica L. Ellsworth, who represented Danco, broadly asserted that the FDA had strong enough evidence and the statutory authority to make the adjustments.
Ellsworth went on to warn that, though the FDA should not be viewed as infallible, it is much better equipped to gauge drug safety than the courts. Here, she pointed to the decisions on the case made in recent months by the lower courts that cited unreliable, and later withdrawn, data to justify their injunctions.
“Those sorts of errors can infect judicial analysis precisely because judges are not experts in statistics, they are not experts in the methodology used for scientific studies for clinical trials,” she said. “That is why FDA has many hundreds of pages of analysis on the record of what the scientific data showed, and the courts are just not in a position to parse through and second guess that.”
Two of the court's prominent originalists, Justice Samuel Alito and Justice Clarence Thomas, floated questions regarding the Comstock Act, an 1873 anti-vice law that bans sending “obscene” materials through the mail and has recently been cited by abortion opponents and lower court judges.
Hawley told the judges that the act “is relevant here” and that the plain text of the law “is pretty clear.” Ellsworth, who noted that the statute has not been enforced for nearly a century, pushed back by noting that the FDA “routinely” approves drugs that have restrictions under other laws and that “this court should think hard about the mischief it would invite if it allowed agencies to start taking action based on statutory responsibilities that Congress has assigned to other agencies.”
The Supreme Court’s final decision in the consolidated cases is expected by early summer.