Some justices on the U.S. Supreme Court may have thought—or hoped—that overturning the abortion rights landmark decision, Roe v. Wade, and leaving the issue to the states would free them from the controversial issue. It’s not likely. The most important abortion case since their June 2022 decision could be before them as early as next term.
Abortion rights advocates and anti-abortion organizations are anxiously awaiting a Texas federal judge’s decision in a challenge to the U.S. Food and Drug Administration’s approval more than two decades ago of the drug mifepristone. That drug is the first of the two-drug regimen for medication abortions.
Medication abortions accounted for 54 percent of abortions in this country in 2022, according to the Guttmacher Institute. The stakes for women seeking this type of medical care are obviously high, especially as they face a tsunami of anti-abortion bills and restrictions in a number of states following the Supreme Court’s decision.
The loser in the FDA challenge will inevitably take the next step of appeals to the federal appellate court and the Supreme Court.
Technical Issues in the Case
But before looking at the challengers’ claims, there are two “technical” reasons to be concerned about this case, reasons that go to the operation of our justice system.
First, the challengers to the FDA policy are asking the judge for a temporary and permanent injunction. The judge could issue an injunction, known as a nationwide or universal injunction, that blocks access to medication abortion even in states where it is legal.
Nationwide injunctions stop litigation in other jurisdictions in their tracks. They have been the target of much recent criticism, including by Justices Clarence Thomas and Neil Gorsuch. Thomas has argued that there is no historical basis for them. There also is no statute that permits courts to issue them or forbids them from doing so.
Critics argue that those injunctions raise constitutional questions about judicial power, short-circuit the discussion of legal issues in the lower courts, and undermine public confidence in the judiciary, among other problems. Defenders, however, counter that they promote efficiency in litigation by eliminating the need for everyone affected by a government policy to bring a separate lawsuit, and they provide a critical check on executive power.
The second reason to be concerned about the FDA case is the more recent phenomenon of “judge shopping,” which is different from the more common practice of “forum shopping,” where lawyers seek the most hospitable location in which to file a lawsuit.
“Judge shopping,” which we have written about earlier, is a practice that law professor Stephen Vladeck of the University of Texas Law School has examined and written about in articles and legal briefs. Texas Republican officials have been particularly adept at filing challenges to Biden administration policies in districts with single judges appointed by former President Donald Trump.
In the FDA medication abortion case, the challengers—a coalition of anti-abortion medical associations acting under the recently created umbrella of the Alliance for Hippocratic Medicine—filed their lawsuit in the federal court in Amarillo, Texas.
More than 95 percent of the civil cases filed in that court go to Judge Matthew Kacsmaryk, appointed by former President Donald Trump. One news organization has said the judge has made Texas a “legal graveyard” for policies of the Biden Administration. Kacsmaryk’s nomination was vigorously opposed by liberal groups. Before joining the bench, he was deputy general counsel at the First Liberty Institute, a conservative religious liberty legal organization. The challengers are represented by Alliance Defending Freedom, a conservative religious legal organization.
The Lawsuit and Response
So what do the challengers claim in their lawsuit and what is the government’s response?
The challengers argue that the FDA in 2000 never had the authority to approve mifepristone and the second drug in the regimen, misoprostol. The agency, they contend, acted under a regulation allowing accelerated approval of certain new drug products for treatment of serious or life threatening illnesses. Pregnancy is neither, they say.
They also argue the agency eliminated certain safeguards over the years for those who use medication abortion by, for example, changing the dosage and reducing the number of required in-person office visits from three to one. And they contend that agency has violated a longstanding federal law by allowing the drugs to be dispensed by mail or mail order pharmacies.
The U.S. Justice Department, representing the FDA, counters that these challengers don’t meet the requirements for an injunction and don’t even have standing—the right to bring this lawsuit. The Justice Department claims the challengers rely on speculative, novel claims of injury not recognized by Article III of the Constitution; they offer no evidence to support their claims; they challenge agency actions long after the time allotted for those challenges has expired; and they raise claims that they failed to exhaust, as required by law, before the FDA itself.
Congress authorized the FDA to make decisions about new drugs and the agency approved mifepristone in 2000 based on scientific evidence about its safety and efficacy. An injunction removing access to the drug, the government adds, “would upend the status quo and the reliance interests of patients and doctors who depend on mifepristone, as well as businesses involved with mifepristone distribution.”
The briefs by the challengers and the government are much more detailed than space here allows. Not surprisingly, competing briefs have been filed by coalitions of Republican and Democratic state attorneys general.
Twenty-two Republican state attorneys general argue that the FDA exceeded its authority in approving the drug and interfered with state authority and laws in this area. And 22 Democratic attorneys general support the FDA and warn that eliminating access to medication abortion would result in more abortions occurring in later pregnancies, increasing health risks to patients and costs to the health care system.
The judge in the Texas case could rule at any moment on the challengers’ request for an injunction. But this will only be the beginning of this battle.
Twelve Democratic state attorneys general also recently filed a lawsuit in the state of Washington in an effort to get the FDA to loosen restrictions on the distribution of mifepristone. The suit against the FDA states: “The extremely limited availability of abortion in other states, and the growing threat to abortion access nationwide, makes patients’ access to medication abortion paramount. Medication abortion through a combination of mifepristone and misoprostol is the ‘gold standard’ for early termination of pregnancy, used by the majority of people in the U.S. who choose to have an abortion.”
The Supreme Court generally can do whatever it chooses, but it will become increasingly difficult for it to close its doors when abortion-related challenges come knocking.
Marcia Coyle is a regular contributor to Constitution Daily and PBS NewsHour. She was the Chief Washington Correspondent for The National Law Journal, covering the Supreme Court for more than 30 years.
