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Courts Give Opposing Rulings on Mifepristone

Friday was an interesting day on the abortion front, and a vivid demonstration that two judges presented with the same facts and the same law can come to diametrically opposed decisions (presumably based largely on their personal politics).

In Texas, U.S. District Judge Matthew Kacsmaryk decided that mifepristone is not safe and banned it nationally. In Washington State, U.S. District Judge Thomas Rice decided that mifepristone is safe and ordered the FDA to continue allowing it to be prescribed in 17 states (and D.C.). The FDA cannot follow both court orders at the same time. The next step in this kabuki drama is that the U.S. Court of Appeals for the Fifth Circuit will uphold Kacsmaryk's ruling and the U.S. Court of Appeals for the Ninth Circuit will uphold Rice's verdict. When two appeals courts come to contradictory conclusions on an important matter, the U.S. Supreme Court almost always takes the case. The only question here is the timing. It could consider this an emergency and take the case immediately or it could let the process play out in the appeals courts and take it after each one has ruled.

The case is somewhat different than the run-of-the-mill abortion case. Usually some state legislature has banned abortions after [X] weeks. State legislatures probably have the authority to do that, at least after Dobbs. But in this case, there is a legal question of whether judges should be making decisions about medical matters about which they know nothing. The drug approval process is very detailed and involves many doctors, scientists, and drug experts, not to mention the FDA staff and the FDA administrator. Mifepristone has been in use for 23 years with very few complications or unwanted side effects. Can a single judge who never studied biology or medicine tell a whole host of doctors and scientists that he knows drug safety better than they do? And do this despite the drug being out there for almost a quarter of a century with almost no problems? We cannot imagine any judge even attempting to overrule the FDA on a cancer drug or a diabetes drug or any other any drug not closely tied to the culture wars.

It should be noted that the folks who brought the case to Kacsmaryk knew exactly what they were doing. He went to a Christian university (specifically, Abilene Christian University) before going to law school. He later worked for a Christian legal group and submitted an amicus brief to the Supreme Court arguing against contraceptives. He was well known in legal circles as a conservative Christian activist. He was appointed to the bench by Donald Trump. He is the only judge in the Northern District of Texas, so the group that decided to sue there knew in advance they would get him as the judge and they also knew with 99.999% certainty how he would rule. One wonders if he deliberately released his ruling on Good Friday.

Rice also went to a religious college (specifically, Gonzaga in Spokane). It is a Catholic school, so he is probably a man of faith. So the dueling opinions are not due to one judge being deeply religious and the other being an atheist. Rice was an assistant U.S. attorney in Spokane for 25 years before Barack Obama appointed him to the district court.

Rice's ruling was a bit of a surprise, but Kacsmaryk's ruling was long expected, starting on the day the lawsuit was filed. Washington State was so sure Kacsmaryk would ban mifepristone even before the hearings started that it ordered and stockpiled 30,000 doses of mifepristone (a 3-year supply for the state), in advance. Other states may have done something similar, but given the cost ($1,275,000), not every blue state may have funds available for a large purchase.

What happens next on the legal front isn't clear, although the Biden administration immediately filed an appeal to the Fifth Circuit. Some Democrats are claiming Kacsmaryk has no authority over the FDA and Biden should just ignore him. But Biden is afraid that could influence the appeals process in a negative way. He is also worried that openly defying the courts would give a future Republican president a precedent for doing the same thing. On the other hand, he has Rice's simultaneous decision as a cover. If he obeys Kacsmaryk's order, then he is disobeying Rice's.

Some abortion clinics are already switching to surgical abortions or medical abortions using misoprostol, which is less effective and less safe than the two-drug regime of mifepristone followed by misoprostol. Misoprostol has been around forever and is used to treat stomach ulcers and other conditions. Its use is not controversial. It would be ironic if the main effect of Kacsmaryk's ruling were to cause women seeking an abortion to end up using a drug that was less effective and had more complications than the preferred one.

A lot of the media coverage features outrage at Kacsmaryk's decision because it relates to the hot-button issue of abortion. It really should be directed to the fact that apparently a single federal judge who knows nothing about medicine or drug testing gets to overrule the hundreds of doctors, scientists, statisticians, and researchers at the FDA and drug companies who spent years and millions of dollars vetting and approving mifepristone. Who gave him this authority, if anyone? Judicial review isn't a power the Constitution specifically grants to even the Supreme Court, let alone to all 670 district judges. What's next? Can a devout Christian district judge ban Viagra because it encourages sexual activity not related to reproduction? Can a health-conscious district judge ban weight-loss pills because dieting and exercise are better ways to lose weight? Can a Christian Scientist judge ban all medicines because prayer has demonstrably fewer side effects and would save Medicare billions of dollars per year? What about an antivax judge who bans all vaccines nationwide because somebody somewhere had an allergic reaction to one vaccine once? The list goes on and on. The real danger here is that if this stands, every district judge will think that he or she is the Supreme Court and make national rulings. Once she opened the box, Pandora couldn't get it shut again and we may soon be in for a repeat performance. Or many repeat performances.

This is not just our view. HHS Secretary Xavier Becerra said essentially the same thing yesterday on CNN's "State of the Union": "When you turn upside down the entire FDA approval process, you're not talking about just mifepristone, You're talking about every kind of drug. You're talking about our vaccines. You're talking about insulin." Then he added: "If a judge decides to substitute his preference, his personal opinion for that of scientists and medical professionals, what drug isn't subject to some kind of legal challenge?" But even he didn't raise the question of what law grants every one of the 670 district judges the power to ban any medicine he or she doesn't happen to like. What is needed to get the discussion rolling is some national ruling from a district judge that conservatives really, really don't like. For example, some random district judge ruling that the federal, state, and local governments are forbidden from providing any funding for any purpose to any school run by a religious organization because that violate's the Constitution's "establishment" clause. It would even mean college students with Pell grants couldn't use them at religious schools. The reaction to this would come within 50 nanoseconds and start the discussion about whether a single district judge can make national rulings.

Mark Joseph Stern at Slate has an interesting analysis of the two cases from a legal point of view. For example, by law, after a drug is approved, there is a 6-year window in which people can file suits about the decision. Mifepristone was approved 23 years ago. Maybe the judge is not good at math, but if so, he could have appointed a special master to help him decide whether 23 is greater or less than 6. At the start of the case, Kacsmaryk also ruled that doctors who may some day treat patients who were prescribed mifepristone by other doctors have suffered sufficient injury have standing to sue. The ideal person to sue would be a woman who used mifepristone and said it injured her somehow. No such woman is a party to the suit. Much of Kacsmaryk's 67-page ruling was directly copied and pasted from the plaintiff's brief.

When the case makes it to the Supreme Court, which is inevitable, the justices will be in a bind. In the Dobbs decision, they said that the decision to allow or prohibit abortions should be up to the democratic process, meaning Congress and the state legislatures. If they take the case and sustain Kacsmaryk they will in fact be saying that the decision to allow or prohibit it is not up to the democratic process. It is up to one unelected activist judge. Chief Justice John Roberts knows that sustaining Kacsmaryk will completely destroy the authority of the Supreme Court, but even if he joins the three Democratic appointees, that is only four votes. He will have to get one of the other five to join him. It is our guess that Samuel Alito, Clarence Thomas, and Amy Coney Barrett won't join him, so he will have to work hard on Neil Gorsuch and Brett Kavanaugh to get at least one of them. Republicans should be careful what they wish for here. If they thought that Dobbs was a problem in 2022, they ain't seen nothin' yet. Next year could be 10x worse if Kacsmaryk is sustained. (V)

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