There are 5 things the Supreme Court will consider in the medication abortion case
The Kacsmaryk Injunction in the New Abortion Medication Case to the U.S. Court of Appeals
The FDA has the authority to review and approve drugs for use. It brings to federal courts nuts-and-bolts questions of agency protocols and judicial deference, including when and under what situations courts may jettison longstanding scientific determinations.
The new abortion medication dispute now moving up through appellate courts, however, centers on important but dry issues of legal standing, the deadline for filing a lawsuit against the FDA and whether, if the merits of the case are reached, the agency’s actions were arbitrary and capricious.
Kacsmaryk said on Friday he was suspending the FDA’s approval of the drug and giving its defenders time to appeal the case. The Justice Department wants Kacsmaryk’s ruling to be paused so that they can request intervention from the Supreme Court. The 5th Circuit is not obligated to meet that deadline.
The Supreme Court might also take issue with the relief that Kacsmaryk ordered. He decided he could go ahead and ignore the agency and not have to get approval again. Had he, instead, issued an injunction against the FDA, the move could have allowed the agency to work in a more timely manner to implement the decision.
The new filing by the Justice Department states that Kacsmaryk acted in a restrained manner, but blocking access to a safe and effective drug is what they want to do.
Separately, the pill-manufacturer Danco, backing the FDA, said in a Monday filing that Kacsmaryk’s “relentlessly one-sided narrative … never mentions the millions of women who have benefitted from the availability of medication abortion or the harms an injunction would wreak on Danco, a one-product company.”
Abortion opponents, too, view the case as a prime battleground for further reducing women’s opportunities to end a pregnancy. A group of anti-abortion physicians sought Kacsmaryk’s court for their lawsuit. A judge who was appointed by former President Donald Trump worked as a deputy general counsel at the First Liberty Institute.
The states had argued that the FDA should lift some of the restrictions on mifepristone access, which they argued were unnecessary and unsupported by science. The FDA was ordered by Rice to preserve access in the states that brought the suit.
The decision from Kacsmaryk’s Amarillo courtroom more quickly drew attention to the Biden administration lawyers, drug makers and abortion rights advocates.
The Supreme Court used the word “fetus” in its decision in the Dobbs case, but he was against abortion and favoring un born child.
Mifepristone: A Simple Alternative to Prescription Medicines? The DOJ argues a No-Go Theorem
DOJ lawyers argued that the medical groups challenging the FDA have no standing to file a lawsuit since they don’t have any actual injury or harms to women or the medical profession.
Mifepristone is one of the safest prescription drugs, with data showing it’s even safer than some prescription drugs. The risk of death by penicillin was four times greater than the risk of death by Mifepristone in a study.
The DOJ lawyers said Kacsmaryk cherry-picked dubious materials to support his position, and some doctors were quick to try to refute the judge’s medical conclusions.
Reproductive health providers and experts say that medication abortion, which is typically used in the first 12 weeks of pregnancy, would still be available in some form. Mifepristone might be sent from overseas, or the F.D.A. could decide not to take action against providers prescribing it. And some providers would switch to prescribing only the second abortion medication, misoprostol. But more patients would probably need to seek surgical abortions, and the ruling would create uncertainty and likely chaos throughout the country.
There have been years of studies indicating that the requirement to obtain the drug in person from a provider is safe. The drug needs to be prescribed by a certified health provider rather than by a physician. The only drug that was required to be obtained in person from a medical provider was Mifepristone, and it could be taken at home or anywhere the patient wanted. As a result, the F.D.A. and medical experts would dispute the judge’s contention that the 2021 rule change would create greater safety risks, especially since serious complications with mifepristone are rare.
The Science of Abortion: A State-Dependent Case of F.D.A. and its Attorney, Scott Carhart,
Since 2022, voters have sent a clear message when the question is what abortion law ought to look like: They have sided with supporters of abortion rights in six out of six ballot initiatives, boosted Democratic candidates and, just last week, transformed the Wisconsin Supreme Court. A recent Ipsos poll found that nearly two-thirds of Americans want medication abortion to be kept legal.
Many anti abortion groups tried to undermine abortion by claiming that it harms girls and women, and that abortion opponents were seeking to protect pregnant people from the “abortion industry.”
This strategy underwrote targeted regulations of abortion providers (TRAP laws), onerous clinic regulations and statutes forcing women to receive medically unnecessary and invasive vaginal ultrasounds. State legislatures enacted burdensome laws requiring waiting periods before a woman can legally terminate a pregnancy. This all despite the fact that a woman is about 14 times more likely to die by carrying a pregnancy to term than having an abortion.
The Supreme Court upheld the federal Partial-Birth Abortion Ban Act in 2007, which made dubious scientific arguments more central to antiabortion advocacy. The court decided in the case of Carhart that legislators had more latitude in regulating abortion if the science wasn’t certain. It made antiabortion groups more likely to find uncertainty by creating their own data and witnesses.
Scientific claims can be visible on social media and in congressional hearings. In a separate fight, for example, the antiabortion group Students for Life of America has asked the FDA to reconsider its mifepristone approval by making claims about the ill effects of abortion on wastewater.
Women who have aborted a child — especially through chemical abortion drugs that necessitate the woman seeing her aborted child once it passes — often experience shame, regret, anxiety, depression, drug abuse and suicidal thoughts because of the abortion.
Defendants contend that plaintiffs’ theories of standing “depend upon layer after layer of speculation.” The suit alleges that F.D.A. had a chemical abortion regimen that caused problems for patients requiring medical intervention and attention.
F.D.A.s original approval for the abortion regimen was not retained when they changed their approach in 2016 and 2021. F.D.A. repeatedly altered its original decision by removing safeguards and changing the regulatory scheme for chemical abortion drugs.
Judge Kacsmaryk relies in part upon the Comstock Act, an 1873 anti-vice law that barred the mailing of contraceptives and “lewd” materials, along with drugs that could be used in an abortion. The Office of Legal Counsel concluded in December that abortion-causing drugs can be sent by mail if the sender does not intend for the recipient to misuse them.
Reducing incentives for investment will likely be adversely affected by the addition of regulatory uncertainty to the already inherently risky work of discovering and developing new medicines. Among them are top executives from several drug companies.
The Pharmaceutical Research and Manufacturers of America does not party to the litigation, but it is important that the policy environment supports the agency’s ability to regulate and provide access to FDA-approved medicines.
The lead counsel for Danco is hopeful that the appeals court or supreme court will put the decision on hold until after the Passover holidays.
The Case of a Supreme Court Judge in a Case Concerning Mifepristone: A Critique of the Public Health Impact on Prenatal and Child Abuse
“Vague speculation that someday, somewhere, some unspecified doctor will be overwhelmed by an onslaught of patients coming into the ER after taking mifepristone does not establish that these particular doctors face an imminent risk of a concrete and particularized harm,” Adam Unikowsky, a lawyer and former clerk of conservative Justice Antonin Scalia, wrote in his newsletter.
“These questions of whether the plaintiffs have the kind of real-world injury that is necessary to get into court, and whether their claim was timely or filed too late apply across the board in federal lawsuits,” said Supreme Court litigator Andrew Pincus.
“There are serious questions on whether the Supreme Court is willing to endorse the district’s court’s very broad approach to those questions,” he said.
Some of the Supreme Court members may view this case differently because of it being less about abortion and more about authority a federal agency has in assessing public health.
“The current conservative majority has generally been very skeptical of how much authority various agencies exercise,” said CNN Supreme Court analyst Steve Vladeck who is a professor at the University of Texas School of Law. The agency’s authority was the one place where they have been less suspicious of, because it was predicated on long settled and well developed technical and scientific expertise.
Kacsmaryk chooses, instead, to use the word “unborn human.” He also refers to medication abortion as “chemical abortion” – a term favored by opponents of abortion rights.
At other times his language is graphic. The writer Kacsmaryk says that the effects of mifepristone starve the unborn human until death.
She wrote that restricted access to this safe therapeutic threatens the health of people who are mothers, sisters, daughters, wives and friends.
“Okay, so to recap the judge asserts that ‘fourteen percent of women and girls report having received insufficient information’ without revealing the entire sample consists of anonymous blog posts on pro-life website designed for women who regret their abortions,” Unikowsky wrote.
For that reason, even some conservatives criticized the decision. My colleague Adam Liptak wrote that the legal scholars who interviewed him described the decision as being of poor quality and breathtaking sweep.
The implementation of Kacsmaryk’s decision was put on hold to allow for an appeals court in New Orleans to review it. The outcome of the appeal may depend on whether the three judges randomly assigned to it happen to be conservative or liberal, but the New Orleans court isn’t likely to have the final word. The Supreme Court is.
The Justice Department and a manufacturer of abortion pills have submitted the final round of court briefs in the emergency dispute over whether an appeals court should freeze a judge’s ruling that would suspend the Food and Drug Administration’s approval of medication abortion drugs.
The Justice Department filing pushed back on the claims of the challengers that the 5th Circuit did not have authority to hear the appeal of Kacsmaryk’s ruling. The Justice Department said that Kacsmaryk and the challengers should not have relied on anonymous posts to claim that Mifepristone is unsafe.
