The Court’s Analysis: Standing, Causation, and Legal Implications
Today, the U.S. Supreme Court unanimously ruled that the doctors lacked standing in the case regarding Mifepristone, but they did not address the merits of the case. This leaves the possibility for another challenger to demonstrate a direct injury caused by the FDA’s deregulation of the drug.
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The case, U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine, involved the FDA’s deregulation of Mifepristone in 2016 and 2021. These changes allowed near-unfettered access to Mifepristone, a drug used in a two-drug protocol to terminate early pregnancies. The FDA’s changes included extending the permissible usage period from the 7th week to the 10th week of pregnancy, permitting healthcare providers other than physicians to prescribe the drug, and allowing prescriptions via telehealth and mail. Despite Mifepristone’s contentious safety record, these changes were implemented.
Group of doctors contended FDA’s actions were unlawful
The Alliance for Hippocratic Medicine (AHM), a group of pro-life doctors, contended that the FDA’s 2016 and 2021 actions were unlawful. They noted that “all six judges” who considered the case in the district and appeals courts agreed on the merits. The district court labeled the FDA’s actions as “arbitrary and capricious,” blocking the 2000 approval of the drug and subsequent regulatory changes. However, the Appeals Court ruled that it was too late for AHM to challenge the initial approval, allowing the drug to remain available but upholding the injunction against the more recent regulatory changes.
Justice Kavanaugh, writing the majority opinion with a concurring opinion by Justice Thomas, stated: “The plaintiffs do not prescribe or use Mifepristone. And the FDA is not requiring them to do or refrain from doing anything. Rather, the plaintiffs want FDA to make Mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain. Under Article III of the Constitution, a plaintiff’s desire to make a drug less available for others does not establish standing to sue.”
The Court emphasized that standing is necessary to screen out plaintiffs with only general legal, moral, ideological, or policy objections. They clarified that a citizen cannot challenge a government regulation solely because they believe it is illegal. Similarly, moral or ideological objections, no matter how strong, do not suffice to confer standing in federal court.
Proper injury not alleged by plantiff
Further, the Court explained Plaintiffs must show a direct link between the defendant’s action and their injury. The plaintiffs did not allege injuries that typically demonstrate causation, such as direct monetary or physical harm from the FDA’s deregulation of Mifepristone. Instead, their objections were moral and ideological, which do not establish standing.
Justice Thomas, in his concurring opinion, criticized the third-party standing doctrine, stating that plaintiffs cannot establish a case by asserting another person’s rights. He drew parallels with previous cases where abortionists were deemed to lack standing to assert the rights of their clients. “Our third-party standing doctrine is mistaken. As I have previously explained, a plaintiff cannot establish an Article III case or controversy by asserting another person’s rights. So, just as abortionists lack standing to assert the rights of their clients, doctors who oppose abortion cannot vicariously assert the rights of their patients.”
Drug is still dangerous
“We are disappointed that the Supreme Court did not reach the merits of the FDA’s lawless removal of commonsense safety standards for abortion drugs,” said Alliance Defending Freedom Senior Counsel Erin Hawley, vice president of the ADF Center for Life and Regulatory Practice. “Nothing in today’s decision changes the fact that the FDA’s own label says that roughly one in 25 women who take chemical abortion drugs will end up in the emergency room—a dangerous reality the doctors and medical associations we represent in this case know all too well. The FDA recklessly leaves women and girls to take these high-risk drugs all alone in their homes or dorm rooms, without requiring the ongoing, in-person care of a doctor. While we’re disappointed with the court’s decision, we will continue to advocate for women and work to restore commonsense safeguards for abortion drugs—like an initial office visit to screen for ectopic pregnancies. And we are grateful that three states stand ready to hold the FDA accountable for jeopardizing the health and safety of women and girls across this country.”
The Court hinted at future decisions, noting concerns about the Emergency Medical Treatment and Labor Act (EMTALA) potentially being interpreted to require emergency room doctors to perform abortions against their conscience.
“In response to all of that,” the Court’s decision read. “The doctors still express fear that another federal law, the Emergency Medical Treatment and Labor Act or EMTALA, might be interpreted to override those federal conscience laws and to require individual emergency room doctors to participate in emergency abortions in some circumstances. See 42 U. S. C. §1395dd. But the Government has disclaimed that reading of EMTALA. And we agree with the Government’s view of EMTALA on that point. EMTALA does not require doctors to perform abortions or provide abortion-related medical treatment over their conscience objections because EMTALA does not impose obligations on individual doctors.”
This case is far from over
“This case is far from over,” said Liberty Counsel Founder and Chairman Mat Staver. Liberty Counsel, filing an amicus brief for the Frederick Douglass Foundation and the National Hispanic Christian Leadership Conference, argued that Mifepristone is used as a tool for modern-day eugenics. “The same lawsuit can be refiled with different plaintiffs who have standing. The FDA should no longer be allowed to circumvent safety laws to allow a eugenic drug to destroy innocent children and harm women. Chemical abortions are never safe and harm women and kill children.”
