Some of the Republican-appointed members of the Supreme Court on Tuesday expressed doubts about the standing of plaintiffs seeking to restrict access to the abortion pill, an encouraging sign for the Biden administration as it seeks to maintain broad access to the medication.
Justices appointed from both parties questioned the legal basis for the doctors in the case to sue the Food and Drug Administration regarding the approval of the drug. The question about standing played a central role in the oral arguments over whether the FDA violated the Administrative Procedures Act when it incrementally loosened restrictions on the abortion pill in 2016 and 2021.
The case came before the Supreme Court after the Biden administration appealed a lower court’s ruling that would limit how the medication, known as mifepristone, is prescribed and distributed, such as by mail or online orders. Four medical associations and four physicians who oppose abortion brought the challenge to the drug in Texas.
Two cases were weighed in a consolidated format, Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine. The arguments took place less than two years after the high court ruled 6-3 in Dobbs v. Jackson Women’s Health Organization to overturn the landmark Roe v. Wade decision, allowing states to impose laws restricting access to abortion procedures.
Abortion is illegal in 14 states, but abortion pills have remained widely available across the nation.
Mifepristone was approved by the FDA in 2000 and has been defended by the agency as safe and effective. But anti-abortion advocates have said the drug is not safe and that the FDA didn’t sufficiently study it before approval.
The plaintiffs who sued are seeking a high court decision that would roll back actions the FDA has taken since 2016 to make the pills more accessible, including regulations on allowing mail delivery, pharmacy dispensing, and online ordering of the drug.
Danco Laboratories, the maker of mifepristone, is arguing alongside the FDA to keep these accessibility changes in place.
Roberts tees up question on ‘standing’ theory
Chief Justice John Roberts asked Justice Department Solicitor General Elizabeth Prelogar about the theory of legal “standing,” which would allow some people to bring a lawsuit like the one at the center of the case if there is a statistical likelihood that they would face the requisite injury to bring the suit.
“Is there a number of which your argument would change the significant number of consequences — a higher likelihood of an emergency room visit? Doctors who spend more time in the emergency room at some point. Does this analysis lead to the other result?” Roberts asked Prelogar.
Prelogar argued that the government does not agree with the theory.
“Obviously the FDA is not requiring them to do or refrain from doing anything,” Prelogar said, referring to doctors who may have a conscience objection to assisting in the completion of an abortion. “They aren’t required to treat women who take mifepristone. FDA is not directing the women who take the drug to go seek out care from these specific doctors, and so they stand at a far distance from the upstream regulatory action they’re challenging.”
Justice Clarence Thomas also raised the question of whether an association or organization could bring a suit against the FDA for conscience harms. Prelogar argued that this case does not invalidate other precedent on associational standing but rather that the specific argument from AHM rests on too many hypotheticals.
“The problem with their associational standing theories is that they rest on this chain of remote possibilities, so many different steps in the process that would have to occur, each one layering one speculative remote odds of a chance of injury on top of another to get to the ultimate harm,” Prelogar said.
Alito and Thomas invoke Comstock Act, ask who can sue the FDA
Justice Samuel Alito, the author of the Dobbs decision, raised concerns that the mail ordering of mifepristone may be linked to higher instances of emergency room visits, as prior studies have indicated.
Alito also questioned whether the government is arguing that no one can sue the FDA if it were to have violated the law.
“So your argument is that it doesn’t matter if the FDA flagrantly violated the law and didn’t do what it should have done, endangering the health of women? It’s just too bad — nobody can sue in court,” Alito suggested.
Prelogar responded that “drug sponsors themselves remain responsible at all times.”
“We have a tort system in this country, and that can help ensure that if there are safety problems that come to pass, the sponsors will take action in reaction to that,” Prelogar said. “So if the premise here is that unsafe drugs could somehow remain on the market, I think that that’s incorrect.”
Thomas, who also formed the Dobbs majority, bought up the Comstock Act of 1873, which disallows sending contraceptives through the mail, in questions for Danco: “How do you respond to an argument that mailing medication abortion is a crime under the Comstock Act?”
“We agree very much with the government that FDA’s charge under the Food, Drug, and Cosmetic Act is limited to looking at safety and efficacy considerations. That’s true for new drug approvals,” said Jessica Ellsworth, an attorney for Danco.
Jackson: Are there ‘concerns’ with judges parsing scientific studies?
Justice Ketanji Brown Jackson, the newest justice appointed by President Joe Biden, asked Danco’s attorney if judges should be parsing medical and scientific studies.
Ellsworth responded that the pharmaceutical industry has expressed “significant concerns” over this sort of judicial review as it may threaten the FDA’s gold standard drug approval process.
Judges are “not experts in statistics,” Ellsworth added. “They are not experts in the methodology used for scientific studies for clinical trials.”
Justice Sonia Sotomayor asked Prelogar whether it is in the FDA’s authority to determine if the marginal rise in emergency room visits following the removal of in-person screening requirements rose “to a sufficient safety risk.”
Determining the level of complications that would mean the drug should not be in use “is a very difficult question,” Sotomayor said.
“That’s a question that Congress has entrusted to FDA,” Prelogar said.
Gorsuch cautions turning suit into ‘nationwide legislative assembly’
Justice Neil Gorsuch, who also was part of the 6-3 decision in Dobbs, raised a line of questioning from Jackson toward Erin Hawley, who represents groups claiming harm by the FDA’s expansion of abortion pill access.
Gorsuch pondered why relief in this case could not be limited to the doctors claiming conscience injury, rather than a broad change to the entire nation’s access to medication.
“And this case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule or any other government actions,” Gorsuch said. “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’?”
Thomas has doubts about injury to plaintiff doctors
Hawley, who is married to Sen. Josh Hawley (R-MO), later faced some doubts from Thomas over claims that the group she representing actually experienced harm, asking her how the “diverted time and resources” by the Alliance for Hippocratic Medicine “isn’t just the cost of litigating and pursuing this litigation.”
Hawley said there is also “noneconomic” harm, but Thomas still appeared skeptical of the stated harms, saying that claims of injury from pursuing litigation are “easy to manufacture.”
Justices Amy Coney Barrett and Jackson also asked Hawley about the harms done to doctors by requiring that they participate in emergency abortion care.
As Hawley described, physicians in emergency situations often only learn that they are treating a self-managed abortion patient after they have “scrubbed up” or prepared for a surgical procedure. At this point, Hawley argued, the physician faces the ethical dilemma of either providing lifesaving emergency care to the patient, thereby connecting themselves to the abortion procedure, or risking fatal consequences for the patient by failing to find another available physician.
Jackson and Justice Elana Kagan, however, were not convinced that this theoretical harm directly affected the physicians represented by Hawley’s legal advocacy organization, the Alliance Defending Freedom.
Gorsuch cautions turning suit into ‘nationwide legislative assembly’
Arguments concluded at approximately 11:45 a.m. Protesters were gathered outside of the high court on Tuesday, some opposing limiting access to mifepristone and others encouraging the plaintiffs in their pursuit of a favorable ruling.
New York Attorney General Letitia James, a Democrat, joined Planned Parenthood Federation of America President Alexis McGill Johnson outside of the Supreme Court stressing to protesters the importance of voting for abortion access in the 2024 elections.
Meanwhile, parties in the cases offered their final remarks in statements to the Washington Examiner following oral arguments.
“The FDA has shown a callous disregard for what women and girls experience when taking these high-risk drugs all alone—without the in-person care of a doctor,” Hawley said in a statement. “Every American should be deeply concerned that the FDA chose to put women at greater risk of serious complications. Women deserve better.”
Ellsworth countered in a follow-up statement that the plaintiffs’ theory for the case could put in “jeopardy” drugs approved by the FDA for millions of U.S. residents.
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
“And the ability of the American pharmaceutical industry to develop and get approval for new drugs would be severely harmed, slamming the door on promising research into medicines for everything from Alzheimer’s to cancer,” Ellsworth added.
A decision by the Supreme Court is expected by the end of June.
