200 mg mifepristone and 800 μg misoprostol, the typical regimen for early medical abortion. Photograph Source: VAlaSiurua – CC BY-SA 4.0
How a single federal judge could upend twenty years of science.
Texas Federal District Judge Matthew J. Kacsmaryk recently banned prescribing and distributing the abortion pill mifepristone as unsafe. However, after a four-year review, the Food and Drug Administration (FDA) certified the pill safe in 2000. Its status as a safe drug was maintained across five presidential administrations until this one Judge wouldn’t accept that decision.
Judge Kacsmaryk’s heart rather than science seems to lead him to ban mifepristone. In his ruling, he refers to the fetus as an “unborn human” or “unborn child.” These are not medical terms but moral statements.
Language reinforces our beliefs into reality. Kacsmaryk used terms to define abortion as a violation of a moral code. However, he and similar moralist judges are careful not to morally condemn aborting a fetus. If they did so, they would pierce their veil of claiming that they pursue secular justice.
Six years before his ruling banned the abortion pill, we could see him as an advocate for a Christian morality code. Washington Post reported that Kacsmaryk had submitted an article to a Texas law review criticizing Obama-era protections for those seeking abortions.
He argued that the Obama administration had discounted religious physicians who “cannot use their pens to prescribe or dispense abortifacient drugs designed to kill unborn children.” In other words, the doctors’ religious freedom would be violated if a woman asked them not to give birth even if they were rapped. The doctors were the victims, not the pregnant woman.
Kacsmaryk must have realized that his logic might not fly at his Congressional confirmation hearings. So, although he had initially been listed as the article’s sole author, he removed his name and replaced it with two other attorneys from the First Liberty Institute, where he was the deputy general counsel.
First Liberty claims to be the nation’s largest legal organization focused exclusively on defending the religious freedom of individuals and businesses. Their attorneys sue the government to stop regulations that force their doctor clients to violate their religious beliefs, like allowing women control over their bodies. However, Kacsmaryk, ignoring his years working to overthrow abortion procedures, said before his Senate confirmation hearing in 2017, “As a judge, I’m no longer in the advocate role.”
He is seen as fair by conservative moralist groups because his decisions have been against sustaining liberal civil rights laws. That reputation attracted the Christian legal firm Alliance Defending Freedom to have their client, The Alliance for Hippocratic Medicine (AHM), file a lawsuit against the FDA in Texas’s North District Court.
They did so because Kacsmaryk was the only judge in that sector to try their case. Like any federal judge, his rulings could have nationwide implications. However, Defending Freedom would not say whether they filed their suit against FDA in Amarillo, TX, because Kacsmaryk was the judge.
It appears that way since (AHM), was a Tennessee-based organization until it moved to Amarillo three months after the Dobbs decision. Shortly after relocating, AHM filed its lawsuit against FDA.
Since Kacsmaryk’s ruling lacked a verified scientific justification, FDA appealed his decision to a three-judge Fifth Circuit panel covering Texas, Louisiana, and Mississippi.
The Defending Freedom law firm also understood that an appeal to Kacsmaryk’s ruling would go to the Fifth Circuit Court, which has Trump-appointed judges. Two of them were on the circuit courts’ three-judge panel that heard FDA’s appeal. They backed Kacsmaryk’s decision that mifepristone is unsafe to use.
Although the Circuit Court’s decision was unsigned, the record indicates that only two of the three judges favored a total ban on mifepristone. However, their unanimous decision reintroduced three medically unnecessary measures: 1) requiring in-person visits with doctors, 2) rolling back the availability of the pills from the first ten weeks of pregnancy to seven weeks, and 3) barring dispensing them by mail.
The DOJ accused the Circuit Court’s ruling of ignoring the large body of research showing that mifepristone is safe and effective. For example, the American College of Obstetricians and Gynecologists analyzed hundreds of published studies and found that “serious side effects occur in less than 1% of patients, and major adverse events — significant infection, blood loss, or hospitalization — occur in less than 0.3%.”
Consequently, the Department of Justice (DOJ) filed an emergency request to preserve the F.D.A.’s prior approved use of mifepristone with the Supreme Court. Their appeal to SCOTUS notes that to “the government’s knowledge, this is the first time any court has abrogated FDA’s conditions on a drug’s approval based on a disagreement with the agency’s judgment about safety.”
Without dismissing this case, by banning or restricting a prior FDA-approved drug, future challenges could be made to any FDA-approved drug in court. For example, businesses could easily sue to delay the distribution or deny a competitor’s medication based on minimal data. In addition, the development time for releasing new drugs would likely be significantly extended to gather additional clinical trials to reply to pending lawsuits.
Since the Supreme Court’s Roe vs. Wade decision to legalize abortion, one of the largest groups in our nation, devout Christians, has worked toward establishing their moral code of opposing abortion as the nation’s moral code, regardless of religious affiliation.
The tension between justifying our laws within a secular or moralistic framework is at the core of determining how our legal system shapes our culture. The temporal and moral worlds see reality differently, but they do overlap. Secularism is not amoral, nor is morality irrational. Although both could go down those roads if not constrained by the norms of a democratic society seeking to establish rational decisions.
The Supreme Court punts but remains in the game
The Supreme Court, in replying to DOJ’s motion to toss out the lower courts’ rulings, choose to reject the lower-court restrictions to suspend mifepristone from the market and impose significant accessibility barriers to allow the lawsuit to continue.
Their decision came in a one-paragraph order, with two dissenting justices: Clarence Thomas and Samuel A. Alito Jr. However, up to two other judges could have disagreed with the order without public disclosure since the order was unsigned. Thomas did not explain his dissent, but Alito provided a detailed three-page analysis that attacks FDA strictly on procedural grounds.
Alito’s dissent is required reading to understand how morality will never be discussed in any decision to support eliminating access to this abortion pill. He also avoids attacking the validity of FDA’s science and settles for merely noting that there is no real threat of harm from an expected short appeal period.
If Alito’s dissent foreshadows the arguments that the Circuit Court will apply to sustain Kacsmaryk’s decision, the final decision comes down to who will be on their panel to hear the FDA’s case. It may not be the same judges that heard FDA’s initial motion.
However, if the panel has a majority of Trump appointees, they would be expected to reach a similar conclusion. If they overreach and base their decision on FDA’s science, they could be on shakier ground for winning a Superior Court ruling if it decides to hear an appeal.
Circuit panels generally consist of three judges, supposedly selected at random. A Cornell Law Review article by a professor found that rarely are the judges chosen randomly. Since the Fifth Circuit Court has four Democrat-appointed to twelve Republican-appointed judges, it is the most conservative appeals court.
It turned even further right with Trump appointing six of the judges. If a three-judge panel is used to hear the FDA case, two of the three will likely be Trump appointees, having the same makeup as the original panel that heard FDA’s appeal.
If the Circuit Court denies FDA’s appeal or overrules Kacsmaryk’s decision, one of the parties will undoubtedly appeal to the Supreme Court. But, again, Trump-appointed judges may hold sway; half of the six Republican-appointed justices are moralists selected by Trump.
The Supreme Court conservative Justices’ would be headed toward a strict moralistic application of the law. Following Alioto’s logic, they would prefer to define their ruling around procedural issues, not morality. If the Circuit Court’s decision questions the science used as a basis for their ruling, the SCOTUS justices could be split on how they rule on the appeal of that court’s finding.
Whatever the outcome, the conservative Supreme Court Justices’ decision to deny this pill to women would reflect their unwavering Christian beliefs. Acknowledging that the US can harbor a mixture of religious thoughts and practices without one faith being morally superior will not be present in their decision.
No government cannot decree that a democratic society must make a perfect moral world; it can only make a world that regulates harmful behavior toward other citizens. That is why Congress must remove this issue from the judicial system and codify women’s rights to control their bodies.
