The Supreme Court’s reversal of Roe v. Wade last June was decades in the making, culminating in a dramatic evisceration of women’s constitutional privacy rights and ability to obtain an abortion.
Yet it is a different kind of case and, ultimately, could bring a different resolution.
The challenge by anti-abortion physicians and medical groups tests the US Food and Drug Administration’s 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.
US District Judge Matthew Kacsmaryk in his Friday ruling put himself in the shoes of agency experts, declaring that they had failed to evaluate sufficiently the harms of the drug mifepristone, the first of a two-drug abortion regimen that has become the most common among women trying to end a pregnancy.
“The Court,” he wrote of his determination, “does not second-guess FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns – in violation of its statutory duty – based on plainly unsound reasoning and studies that did not support its conclusions.”
The US Department of Justice, on behalf of the FDA, forcefully rejected Kacsmaryk’s stance in a filing Monday as it seeks to postpone the effect of his ruling beyond this Friday as appeals are underway. If the ruling took effect, the drug could be unavailable nationwide by the end of the week.
Since 2000, when the FDA determined that mifepristone was safe and effective to terminate early pregnancies, government lawyers say, the agency “has consistently adhered to that judgment across five presidential administrations. During that time, more than five million Americans have chosen to end their pregnancies using mifepristone…. When mifepristone is used as FDA directs, serious adverse events are exceedingly rare, just as they are for many common drugs like ibuprofen.”
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.”
It’s not just the availability of this abortion pill that’s at stake. If those defenders of the FDA lose and Kacsmaryk’s decision is affirmed by a lower appellate court and then a majority of the nine Supreme Court justices, it would transform the rules for FDA determinations, far beyond the abortion realm, to other existing or new drugs.
Equally important in the continuing battle over abortion rights, if the decision stands, it would diminish access to abortion even in states that currently allow it. When the Supreme Court ruled in the case of Dobbs v. Jackson Women’s Health Organization last summer, the narrow majority emphasized that they were removing judges from the business of abortion regulation and returning the issue to the individual states.
Justice Brett Kavanaugh, the apparent key fifth vote in favor of that decision, wrote a separate statement, declaring that judges would no longer decide “difficult moral and policy questions” related to abortion.
“To be clear, then,” Kavanaugh added, “the Court’s decision today does not outlaw abortion throughout the United States. On the contrary, the Court’s decision properly leaves the question of abortion for the people and their elected representatives in the democratic process.”
To try to preserve abortion in their states and ensure no retrenchment on current FDA protocols for medication abortion, Washington state and 16 other Democratic-run states, along with the District of Columbia, had separately sued the FDA to prevent it from adding new restrictions to the dispensing of mifepristone.
Acting last Friday soon after Kacsmaryk in the Texas-based FDA challenge, US District Judge Thomas Rice issued an order that would prevent the FDA from changing rules that would affect the availability of mifepristone in the 18 jurisdictions that were part of the litigation.
Issues of standing amid a passionate debate
The decision from Kacsmaryk’s Amarillo courtroom more urgently drew the attention of Biden administration lawyers, drug manufacturers and abortion rights advocates.
Abortion opponents, too, view the case as a prime battleground for further reducing women’s opportunities to end a pregnancy. The challengers, a group of anti-abortion physicians and medical groups, had specifically sought out Kacsmaryk’s court for their lawsuit. A 2019 appointee of former President Donald Trump, the judge previously worked as a deputy general counsel at the First Liberty Institute, a conservative Christian legal advocacy group.
In his 67-page decision Friday, Kacsmaryk demonstrated frustration, bordering on contempt, for the FDA process. He also revealed his abhorrence for abortion. In describing how mifepristone works, he said it “blocks the hormone progesterone, halts nutrition, and ultimately starves the unborn human until death.”
He observed in a footnote that jurists often use the word “fetus” in opinions – as in fact the Supreme Court did in its Dobbs decision – but that he was favoring “unborn human” or “unborn child.”
Any abortion-rights dilemma is bound to incite religious and cultural passions, along with profound questions about a woman’s right to make the deeply personal decisions related to a pregnancy.
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.
DOJ lawyers have argued that the medical groups challenging the FDA lack standing to sue because they have no actual injury and offer baseless speculation regarding harms to women and the medical profession from mifepristone.
Denying that contention, Kacsmaryk found that the groups had standing based on numerous grounds, including that they allege “adverse events from chemical abortion drugs can overwhelm the medical system and place enormous pressure and stress on doctors during emergencies and complications.”
The heart of his decision was a full-scale rejection of the safety of medication abortion to a woman, physically and psychologically.
Data analyzed by CNN shows mifepristone is even safer than some common, low-risk prescription drugs, including penicillin and Viagra. The risk of death by penicillin, for example, is four times greater than it is for mifepristone, according to a study on life-threatening allergic reactions.
Kacsmaryk contended, however, the FDA had failed to consider “the intense psychological trauma and post-traumatic stress women often experience from chemical abortion.” He maintained that use of the drug had caused many more deaths and severe adverse reactions than the FDA had acknowledged.
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.
Dr. Courtney Schreiber, a professor in the Department of Obstetrics and Gynecology at the University of Pennsylvania, warned about the consequences of restricting access to mifepristone in a declaration attached to the drug manufacturer’s motion to suspend Kacsmaryk’s decision during appeals.
If access to mifepristone disappears, she said, some facilities may offer just misoprostol – a second medication drug that usually works in concert with mifepristone. That would, she contended, “surely result in more unscheduled visits and emergency room visits for pain, incomplete abortion, and side-effect concerns.”