Last week, a federal judge in Texas finally made a highly anticipated ruling that could block access to mifepristone — one of the two drugs used in the recommended medication abortion regimen — as soon as this Friday. Yet a separate ruling made by a federal judge in Washington state could protect access to the drug. The conflicting messages from two separate federal judges could lead to a confusing situation regarding the accessibility of medication abortions.
"They're incredibly in conflict with each other," David S. Cohen, a professor of law at Drexel Kline's School of Law, told Salon.
Statistically, medication abortions are a common procedure: According to data from the Centers for Disease Control and Prevention, medication abortions account for an estimated 42 percent of all abortions in the United States where the method was reported to the CDC. In 2019, the CDC logged 247,000 medication abortion procedures.
While the Department of Justice asked a federal appeals court on Monday to put the Texas ruling on hold, healthcare law experts say the way in which both rulings are in conflict with each other is unprecedented, as a legal standoff is expected to ensue that may go to the Supreme Court. And together, legal experts worry about the precedent both cases set in regards to the relationship U.S. courts have over the independent federal agency.
"They're incredibly in conflict with each other," David S. Cohen, a professor of law at Drexel Kline's School of Law, told Salon. "One basically says we're going to trust the FDA to make decisions based on science, and the other one says, 'I'm going to second guess the FDA with anti-abortion propaganda.' One says because of judicial fiat, the FDA approval of the drug is in question, and the other says FDA has to keep the status quo."
As explained by Cohen, the Texas ruling made by U.S. District Court Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, is based on the misinformed argument that the FDA did not have the authority to approve mifepristone 23 years ago — and that the agency's approval of the drug has put women in danger ever since and was unlawful. Though this is not true, much of Kacsmaryk's brief includes anti-abortion rhetoric and pseudoscience to that effect.
"It's a more favorable circuit for the position of the FDA and the DOJ in Washington than the circuit where Texas sits."
The American College of Obstetricians and Gynecologists, the American Medical Association and the Society for Maternal-Fetal Medicine, and nine other prominent medical organizations previously submitted an amicus brief including a list of evidence showing that mifepristone is safe and effective, and that the argument presented by the anti-abortion organization Alliance for Hippocratic Medicine is scientifically inaccurate.
In Washington, a lawsuit was filed against the Food and Drug Administration by 18 Democratic attorneys general; that lawsuit challenges the agency's authority to regulate mifepristone. Those attorneys general argue that because it is as safe as over-the-counter drugs like Tylenol, it should be treated as such.
In the case of the Washington lawsuit, Judge Thomas O. Rice, who was appointed by former President Barack Obama, blocked the FDA from taking "any action to remove mifepristone from the market or otherwise cause the drug to become less available." Though this suit similarly questioned the FDA's authority to regulate the drug, if the attorneys general prevail it would protect access to mifepristone and likely make it more accessible.
"It could certainly be an important part of continuing the access to the pill," Cohen said. "This Washington ruling is certainly important."
Seema Mohapatra, a professor of law at Southern Methodist University Dedman School of Law, agreed.
"It's definitely possible," Mohapatra said. "In terms of the circuit, it's a more favorable circuit for the position of the FDA and the DOJ in Washington than the circuit where Texas sits."
Mohapatra said that technically both lawsuits are questionable for what they say about the court's ability to affect the decisions of a purportedly independent government agency.
"We now have two federal judges who have both ruled, kind of directing the FDA to do something — which in both cases is not really appropriate because the FDA is its own independent agency," Mohapatra told Salon. "And what I mean about critiquing the Washington decision is that it's a kind of a misunderstanding of how federal agencies work and what the roles of the courts are and what the roles of independent agencies are."
In other words, Mohapatra said courts are not in the best position to be deciding whether a drug is safe or unsafe — that's not their role.
As far as what the final impact of both ruling will be and how this will play out, both legal experts said it's difficult to predict.
At the moment, mifepristone is still legally accessible in states where medication abortions are allowed. Under Kacsmaryk's ruling, there will be a nationwide injunction on Friday unless a higher court issues a stay.
"If no action is taken by a higher court by Friday night at midnight, then we're going to start seeing what happens next," Cohen said. "Is the FDA going to announce what it does? Is it just going to sit with its appeal process and say nothing? Then what are the drug companies going to do in response to the ruling?"
Cohen emphasized that lawmakers aren't "handcuffed by this order from a Texas judge" and it is "important that they take action consistent with their political views, which is that abortion should be accessible."
Medication abortions typically occur by taking the brand name drug Mifeprex, which contains mifepristone. In the two-step process, a pregnant person first takes a mifepristone pill, which is the drug at the center of the lawsuit. Then 24 to 48 hours later, a second pill containing misoprostol is taken.
Medication abortion works up to 70 days after the first day of a person's last period, which corresponds to week 10 of a pregnancy. As Salon previously reported, without the mifepristone pill, the first step in the process, the only drug that will be available for medication abortions is misoprostol. Yet Cohen predicts a lot can happen before it gets to that point.
"The first chapter has been written but there's a lot more coming, there are going to be other filings or court decisions, probably within the next five days, and there's going to be a lot of whiplash," Cohen said. "I don't know how it will play out, the Texas case is legally frivolous, but I have no confidence in the appeals court or the Supreme Court to agree with that."
