Today, the U.S. Supreme Court ruled unanimously that the doctors did not have standing but did not rule on the merits. This decision leaves the door open for another challenger who can show a direct injury from Mifepristone traceable to the FDA’s deregulation.
The case of U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine centered around the FDA’s sweeping deregulation of Mifepristone in 2016 and 2021 allowing near-unfettered access to the drug. Mifepristone, half of a two-drug protocol used to end pregnancies in early stages, effectively starves an unborn baby to death and has the potential for many significant adverse events harmful to women and girls. The FDA’s deregulation changes included allowing the drug to be used through the 10th week of pregnancy, rather than only through the 7th week, allowing healthcare providers who are not physicians to prescribe the drugs, and allowing the drug to be prescribed through telehealth appointments and sent through the mail. The FDA made these changes despite the drug’s questionable safety record.
The Alliance for Hippocratic Medicine (AHM), a group of pro-life doctors, argued the FDA’s actions in 2016 and 2021 were “unlawful” and state that “all six judges that have opined on the merits of this case” in the district court and in the appeals court “have agreed.” The district court ruled the FDA’s actions were “arbitrary and capricious” and blocked the FDA’s 2000 approval of the drug and all its regulatory changes. However, the Appeals Court ruled that it was too late for AHM to challenge the FDA’s approval and kept the drug on the market but upheld the injunction against the FDA’s more recent changes.
The majority opinion is written by Justice Kavanaugh with a concurring opinion by Justice Thomas.
“But 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. Nor do the plaintiffs’ other standing theories suffice. Therefore, the plaintiffs lack standing to challenge FDA’s actions,” wrote Justice Kavanaugh.
“Under Article III of the Constitution, a plaintiff’s desire to make a drug less available for others does not establish standing to sue. Nor do the plaintiffs’ other standing theories suffice…Under Article III of the Constitution, a plaintiff ’s desire to make a drug less available for others does not establish standing to sue. Nor do the plaintiffs’ other standing theories suffice. Therefore, the plaintiffs lack standing to challenge FDA’s actions,” wrote Justice Kavanaugh.
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The High Court further wrote, “Standing screens out plaintiffs who might have only a general legal, moral, ideological, or policy objection to a particular government action. For example, a citizen does not have standing to challenge a government regulation simply because the plaintiff believes that the government is acting illegally. A citizen may not sue based only on an “asserted right to have the Government act in accordance with law. Nor may citizens sue merely because their legal objection is accompanied by a strong moral, ideological, or policy objection to a government action.”
“The causation requirement is central to Article III standing. Like the injury in fact requirement, the causation requirement screens out plaintiffs who were not injured by the defendant’s action. Without the causation requirement, courts would be ‘virtually continuing monitors of the wisdom and soundness’ of government action. “
“The plaintiffs do not allege the kinds of injuries described above that unregulated parties sometimes can assert to demonstrate causation. Because the plaintiffs do not prescribe, manufacture, sell, or advertise mifepristone or sponsor a competing drug, the plaintiffs suffer no direct monetary injuries from FDA’s actions relaxing regulation of mifepristone. Nor do they suffer injuries to their property, or to the value of their property, from FDA’s actions. Because the plaintiffs do not use mifepristone, they obviously can suffer no physical injuries from FDA’s actions relaxing regulation of mifepristone. Rather, the plaintiffs say that they are pro-life, oppose elective abortion, and have sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others. The plaintiffs appear to recognize that those general legal, moral, ideological, and policy concerns do not suffice on their own to confer Article III standing to sue in federal court. So to try to establish standing, the plaintiffs advance several complicated causation theories to connect FDA’s actions to the plaintiffs’ alleged injuries in fact.”
“In sum, the doctors in this case have failed to establish Article III standing. The doctors have not shown that 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.”
“The plaintiffs have sincere legal, moral, ideological, and policy objections to elective abortion and to FDA’s relaxed regulation of mifepristone. But under Article III of the Constitution, those kinds of objections alone do not establish a justiciable case or controversy in federal court. Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact. For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions. The plaintiffs may present their concerns and objections to the President and FDA in the regulatory process, or to Congress and the President in the legislative process. And they may also express their views about abortion and mifepristone to fellow citizens, including in the political and electoral processes.”
In his concurring opinion, Justice Thomas wrote, “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.”
Today’s opinion by the High Court drops a hint regarding a forthcoming decision:
“In response to all of that, 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.” (emphasis added).
Liberty Counsel filed an amicus brief to the U.S. Supreme Court in the case on behalf of the Frederick Douglass Foundation and the National Hispanic Christian Leadership Conference, arguing how Mifepristone has become a “tool of modern-day eugenics” to inexpensively abort millions of unborn lives through widespread abortion.
Liberty Counsel Founder and Chairman Mat Staver said, “This case is far from over. 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.”
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