US Supreme Court rejects challenge to mifepristone

In a unanimous decision on June 13, 2024, the Supreme Court ruled that the Alliance for Hippocratic Medicine and others lacked standing to challenge the F.D.A.’s 2000 approval of this abortion-inducing drug and the F.D.A.’s 2016, 2019 and 2021 relaxing of some of their restrictions for the drug’s use. Justice Kavanaugh wrote the opinion for the Court.

Food and Drug Administration et. al. v. Alliance for Hippocratic Medicine et al., 602 U.S. ____ (2024).

Mifepristone

Originally, in 2000 the FDA approved mifepristone with restrictions such as using it only in the first seven weeks of the pregnancy. Also, only doctors could prescribe or supervise prescription of the drug. The patient had to appear for three in person visits with the doctor.

In 2015 the manufacturer of the drug petitioned the FDA to relax some of its restrictions. The FDA in 2016 allowed mifepristone to be used up to ten weeks into the pregnancy and allowed nurse practitioners to prescribe it.

In 2016 and 2019 the FDA relaxed its regulatory requirements for mifepristone. This made it easier for doctors to prescribe and for pregnant women to obtain it. [Page 1.] The FDA reduced the in-person visits to one. [Page 2.]

In 2019 the FDA approved the generic mifepristone, which had previously been known only as Mifeprex. In 2021 the FDA no longer required in person visits in view of the pandemic. [Page 3.]]

Article III of the Constitution

Article III confines the jurisdiction of the federal courts to “Cases and Controversies.” The Courts do not issue advisory opinions nor are they an “open forum for citizens to ‘press general complaints about the way in which government goes about its business.’” Allen v. Wright, 468 U.S. 737, 760 (1984). The Court quoted the late Justice Scalia that Article III requires the plaintiff to answer the question, “What’s it to you?” [Page 6.]

Standing

In order to establish standing under Article III a plaintiff must demonstrate 1. that she has suffered or likely will suffer an injury in fact; 2. that the injury likely was caused or will be caused by the defendant; and 3. that the injury will likely be addressed by the requested judicial relief. [Page 8.]

Injury in Fact

The injury must be real and not abstract. It must be “actual or imminent, not speculative.” Article III screens out plaintiffs who might only have a general legal, moral or policy objection to a particular government action. [Page 9.]

Causation

The plaintiff must establish that the injury likely was caused by the defendant’s conduct. [Page 9.] If the plaintiff is not directly impacted, the plaintiff must show that “‘third parties will likely react in predictable ways’ that in turn will injure the plaintiff[s].” [Page 10.]

The plaintiff must show a “predictable chain of events leading from the government action to the asserted injury.” [Page 12.]

Lack of injury

Here the plaintiff doctors and medical associations do not prescribe or use mifepristone. The FDA has not required the plaintiffs to do anything or refrain from doing anything. [Page 13.] The plaintiffs want the FDA to make it more difficult for other doctors to prescribe it and for pregnant women to obtain it. [Pages 1 and 13.]

Lack of causation

The plaintiffs have not shown that they could be forced to participate in an abortion or provide abortion-related medical treatment. [Page 14.] The “Church Amendments” allow doctors and other health care personnel to “refuse to perform or assist” an abortion. 42 USC Section 3000 - 7 (c) (1). [Page 15.] The Emergency Medical Treatment and Labor Act does not require doctors to perform or provide abortion-related medical treatment over their objections of conscience. [Page 16.]

The Court ruled that the “plaintiffs have not shown-and cannot show-that the FDA’s actions will cause them to suffer any conscience injury.” [Page 17.]

The plaintiffs have not offered evidence that the FDA’s actions have caused an increase in women seeking treatment from them causing them to divert time from other patients or causing them to be sued for treating women with mifepristone complications. [Page 18.]

The Court ruled that citizens and doctors do not have standing to sue simply because others are allowed to engage in certain activities. The plaintiffs have not shown the FDA’s actions likely will cause them any injury in fact. The asserted causal link is simply too speculative or too attenuated to support Article III standing. [Pages 20-21.]

No associational standing

The Court ruled further that the plaintiff associations cannot show a “concrete injury” caused by the FDA’s actions simply because they spent money to gather information and advocate against the FDA’s actions. [Page 22.]

Sincere objections

The Court noted the plaintiffs’ “sincere legal, moral, ideological and policy objections to elective abortion and to the FDA’s relaxed regulation of mifepristone. But under Article III of the Constitution, these kinds of objections do not establish a justiciable case or controversy in federal court.” [Page 24.] The Court wrote that the plaintiffs may express their objections to the President, the FDA, the Congress or to their fellow citizens. [Page 24.]

Concurrence

Justice Thomas has written a lengthy Concurrence. He has focused on the issue of “Associational Standing.” He argued at length that this is not supported by Article III. [Page 4 of the Concurrence.]

Comment

The Court has masterfully crafted a position and persuaded all nine justices to agree. The basic issue, abortion, is one of the most contentious issues of our day and possibly of our century. The Court has confined its ruling to the issue of the lack of standing required by Article III and has avoided the need to address the issue of abortion. It has left this to the states in Dobbs v. Jackson Women’s Health Organization, 597 U.S. ____ (June 24, 2022.) Many of the states have since restricted access to abortion.

The issue of reproductive rights will continue to be argued in our faith, legal and political worlds for generations.