A Texas lawsuit could soon prohibit nationwide access to the abortion pill. Here's what to know about the case.

A Texas lawsuit brought by conservative groups is seeking to overturn the Food and Drug Administration’s approval of mifepristone, the widely used abortion pill.

The suit, which will be decided by a Trump-appointed judge, Matthew Kacsmaryk, in the coming weeks, was filed by Alliance Defending Freedom, a faith-based organization that has long sought to have abortion outlawed nationwide.

If successful, it could effectively ban mifepristone, even in states where abortion remains legal after the U.S. Supreme Court ruling that overturned Roe v. Wade last year. Mifepristone, which the FDA approved in 2000, is often paired with another drug, misoprostol, and is used to induce abortion without the need for a surgical procedure.

The lawsuit was filed on behalf of four anti-abortion medical organizations and four doctors who have treated patients with the drug, who argue that using mifepristone comes with medical risks.

“Our frontline doctors have firsthand experience in treating and caring for the women and girls harmed by these dangerous drugs,” Erik Baptist, a senior counsel for Alliance Defending Freedom, told Yahoo News in emailed statement, adding, “We hope the court holds the FDA accountable for recklessly approving these harmful drugs without following the law and science.”

Abortion rights advocates dispute those arguments.

“Mifepristone is safe, effective and has been used by more than 5 million people since the FDA approved it more than 20 years ago,” Danika Severino Wynn, vice president of abortion access at Planned Parenthood Federation of America, said in an emailed statement to Yahoo News. “This case is a politically motivated attack to remove mifepristone from the market, which could have far-reaching consequences for patients’ access to abortion nationwide and to other FDA-approved medications.”

In 2020, more than half of abortions in the U.S. (51%) were induced using medication, according to data from the Centers for Disease Control and Prevention.

Rachel Rebouché, dean of Temple University Beasley School of Law, spoke to Yahoo News about the court battle and the shifting landscape for reproductive rights in the United States. Some responses have been edited for length and clarity.

Yahoo News: How common is litigation like this, and what is the significance of the case being filed in Texas?

Rachel Rebouché: This lawsuit has given a lot of people much to talk about, because it is very rare that there is litigation against a federal agency for a decision it made 22 years ago. This is not the first time that there has been a question about whether mifepristone should have been approved. There have been investigations and documentation that the FDA has regulated the drug pretty closely, much more closely than other drugs that have a similar safety profile. So the Government Accountability Office had a report some years ago, almost 60 pages, that went through everything that the FDA had done. The FDA in fact had turned down mifepristone's application twice before approving it.

So this is not a story of hasty approval. It's a story of a pretty long process that was pretty involved and had a lot of moving pieces. The idea that the FDA acted rashly and outside of its powers in weighing the evidence is belied by the evidence. I think that the decision to file in this court is purposeful, and it's before a court that has issued opinions that have not been sympathetic to abortion rights.

If the lawsuit prevails, how would access to mifepristone be affected?

It depends on the nature of the ruling and what type of injunction the judge issues. So if the judge issues a nationwide injunction, essentially the court would have ruled that mifepristone was not appropriately approved by the FDA, so it should be taken off the market. It shouldn't be sold on the market because it's not a drug approved for sale. Now, the FDA could reinstate it, it could use its powers under the current statute and go through the same process of approval and put it back on the market, but that would take time.

So in the meantime, while the case is being litigated and appealed and figured out, it could potentially create a situation — if there's a nationwide injunction where the manufacturers cannot legally sell or distribute mifepristone — because it's an unapproved FDA drug.

What kind of precedent would this set if the judge rules against the FDA?

Other courts could look at its precedent and interpret and apply to try to narrow the FDA's authority to approve drugs, to cut against the FDA's power and to set uniform drug policy.

Personally, I think it's such a funky case, I don't know how applicable it is to other areas of drug policy. But that said, a court deciding until it's reversed, or if there are conflicting decisions in other district courts or circuits, has precedential value that trumps other courts' precedential values within the circuit. And certainly, it could inform the decisions of other federal courts in other places.

What is likely to happen after Judge Kacsmaryk issues his ruling?

There would probably be an appeal either way, and the Fifth Circuit Court of Appeals has had its own track record for decisions that are not necessarily sympathetic to abortion rights. But I don't know what it would do in this particular case.

The last time it heard a case involving medication abortion, it was during the pandemic, when it was considering, for instance, Texas’s S.B. 8 law, which went into effect before Dobbs, and that allowed that law to go into effect. It considered whether Texas could ban abortion during the pandemic as a patient-provider precaution. It allowed the state to do that. So I have no idea what the Fifth Circuit would do, but it's certainly a case that, if the Fifth Circuit affirmed the injunction, that would be appealed, and then that could go before the Supreme Court, too.