CNN
—
The Supreme Court on Thursday dismissed a lawsuit challenging the Food and Drug Administration’s efforts to regulate the abortion drug mifepristone, ruling that will allow the drug to continue to be mailed to patients without an in-person doctor’s examination.
The decision is the Supreme Court’s first major case on reproductive rights since the court’s conservative majority overturned Roe v. Wade in 2022 and represents a major setback for the anti-abortion movement.
Justice Brett Kavanaugh wrote the unanimous decision.
The court ruled that doctors and anti-abortion groups who challenged access to the drug had no right to sue. The court’s decision, while technical, is important because it could encourage other lawsuits against mifepristone in the future.
“We recognize that many members of the public, including the plaintiff physicians, have genuine concerns and objections to the use of mifepristone and to people obtaining abortions,” Kavanaugh wrote, “but members of the public and their physicians have no right to sue simply because others are permitted to conduct certain activities — at least not unless the plaintiffs can show how they are harmed by the government’s lack of regulation of others.”
Litigation against the drug has been fiercely opposed by the pharmaceutical industry, which has warned that a ruling questioning the regulation of mifepristone could open the door to lawsuits targeting all kinds of medicines.
Kavanaugh wrote that under the Constitution, “a plaintiff’s desire to make it harder for others to obtain a drug does not establish standing to litigate.”
“Citizens or physicians who disagree with what the law allows others to do can always raise their concerns with the executive or legislative branches and seek increased regulation or legislative limits on certain activities,” he wrote.
Most of Justice Kavanaugh’s opinion dealt with the various legal standards that plaintiffs must reach for the Court to be appropriate to intervene in a dispute. Regarding anti-abortion doctors and medical groups who sued the federal government over the current drug regulatory regime, Justice Kavanaugh wrote that the plaintiffs had suffered neither financial nor physical harm to be party to the litigation. Federal law already protects individual medical professionals who oppose the performance of abortions on moral grounds, he noted.
“In sum, given the broad and comprehensive conscience protections guaranteed by federal law, plaintiffs have not demonstrated, and cannot demonstrate, that FDA’s actions caused an injury to their conscience,” Kavanaugh wrote.
Justice Clarence Thomas wrote a concurring opinion that raised other issues he had with the anti-abortion groups’ standing argument.
Initially, the litigation had led to anti-abortion doctors and medical groups challenging the FDA’s rules, arguing that mifepristone was unsafe and seeking to have it removed from the market entirely, but this argument has been refuted by mainstream medical groups.
The effort came against a backdrop of conservative state laws that severely restrict abortion access in many parts of the country. These bans have fueled demand for medication abortions, which by one estimate account for nearly two-thirds of all abortions in the United States.
Matthew Kacsmarik, a federal judge in Texas appointed by former President Donald Trump, sided with anti-abortion groups, but the ruling did not go into effect.
The 5th Circuit Court of Appeals overturned part of that ruling, finding that the drug’s 20-year-old approval was valid, but sided with doctors who challenged the agency’s subsequent decisions that expanded access to the drug, including dispensing it by mail.
None of the lower court rulings have taken effect since the Supreme Court stepped in last year and ordered the status quo on mifepristone to be maintained until justices could reconsider the case. The Supreme Court heard the case in March.
The FDA approved mifepristone in 2000 as part of a two-drug combination therapy for abortion. Over the past two decades, the FDA has relaxed the restrictions it initially imposed on the drug’s use. In 2016, it allowed the drug to be taken later in pregnancy, from the seventh to the 10th week of pregnancy. It also allowed non-physicians, such as nurse practitioners, to prescribe it. During the COVID-19 pandemic, the FDA announced that it would no longer enforce in-person dispensing requirements.
After doctors filed a lawsuit last year, the FDA formalized its decision and allowed the drug to be distributed by mail.
Several medical groups, including the FDA and the American Medical Association, told the Supreme Court that mifepristone is safe.
But doctors, many of whom have long been involved in the anti-abortion movement, said they faced the risk of being forced to treat patients with complications from the drugs, such as bleeding more than expected, and that triaging these women had a huge impact on their practice. Some said they had been asked to perform abortions after people took the drugs, which went against their beliefs.
During a Supreme Court hearing earlier this year, several justices, including conservatives, expressed doubts about whether the doctors had overcome a procedural standard called standing to sue, which requires plaintiffs to prove they were harmed by government action.
None of the doctors who submitted statements to the lower court had actually prescribed mifepristone, and none could point to cases where they had been asked to perform abortions for patients who had experienced complications after taking mifepristone.
The lead medical group in the lawsuit, the Hippocratic Medical Union, was formed in Amarillo, Texas, months before filing the lawsuit, allowing it to pick a court that would ensure it was assigned to Kacsmalik, who was appointed by former President Donald Trump.
The Biden administration, along with mifepristone manufacturers, which intervened to defend the FDA, argued that it was not appropriate to challenge the regulation because anti-abortion doctors don’t prescribe the drug.
“Today’s decision does not close the door on future challenges to mifepristone, including from the handful of Republican-leaning states that have already been allowed to intervene in district court in this case,” said Steve Vladeck, a CNN Supreme Court analyst and professor at the University of Texas Law School.
“But the rationale for this litigation makes such a challenge unlikely to succeed because it would make it harder for them (and other plaintiffs) to prove they were harmed by FDA’s actions,” he added.
The ruling comes in the midst of a presidential election that has already hinged heavily on the Supreme Court’s abortion doctrine. The 2022 ruling in Dobbs v. Jackson Women’s Health Organization ended the constitutional right to abortion that Roe established in 1973. The ruling prompted conservative states to impose severe restrictions on abortion access, spurred further litigation and helped rally Democrats. President Joe Biden has repeatedly denounced the ruling on the campaign trail this year.
The mifepristone appeal is one of two abortion cases the Supreme Court will hear this month. The other is a case challenging a strict ban on abortions in Idaho. The Biden administration sued the state over the ban, arguing that federal law requires Medicare-funded hospitals to provide stabilizing care in emergency rooms, including abortions, when a pregnant woman’s health is at risk.
This story has been updated with additional details.
