This post was co-authored by Megan E. McWaters, a Reed Smith summer associate.

In a unanimous decision, the U.S. Supreme Court overturned a ruling by the U.S. Court of Appeals for the Fifth Circuit which had placed doubt on the continuing efforts by the U.S. Food and Drug Administration (FDA) to regulate the dispensing of mifepristone, one of the drugs used in a medication abortion.

The decision, written by Justice Kavanaugh, held that the doctors and associations who initially brought the challenge in the Northern District of Texas did not have sufficient standing to bring their claims before a federal court. The doctors involved in the suit do not prescribe or dispense mifepristone, and according to Justice Kavanaugh, nor would they be forced to provide even emergency abortion care to patients as a result of the FDA’s approval of the drug.

Because the Court decided that the challengers did not have the requisite standing to bring the claims in the first place, the Court notably did not address any of the arguments about the merits of the FDA’s initial approval of mifepristone or subsequent changes to the drug’s REMS program. Similarly, neither the majority opinion nor Justice Thomas’s concurrence addresses whether the distribution of the pills would violate the Comstock Act, a nineteenth century obscenity law that, among other things, makes it illegal to ship any drug or device designed to cause an abortion.

We have previously written about these cases (here and here), both at the trial and appeals court levels as well as about the Supreme Court’s oral arguments.

Court finds plaintiffs do not have standing

In the opinion, the Court noted that the doctors challenging the FDA’s actions “do not prescribe or use mifepristone” themselves and that the FDA “is not requiring them to do or refrain from doing anything.” Instead, the plaintiffs’ legal theories against the agency were based upon their own moral, ideological, and policy objections to elective abortion. However, as Justice Kavanaugh explained, “[u]nder Article III of the Constitution, a plaintiff ’s desire to make a drug less available for others does not establish standing to sue.” In order to satisfy Article III standing, a plaintiff must demonstrate (i) that they have suffered or likely will suffer an injury in fact, (ii) that the injury likely was caused or will be caused by the defendant, and (iii) that the injury likely would be redressed by the requested relief. In this case, and in most standing disputes, the two key questions involve injury in fact and causation.

Here, the plaintiffs relied on causation theories related to the conscience and economic injuries of the individual doctors, as well as injuries to the larger medical associations who claimed associational standing.

The doctors claimed that FDA’s relaxation of the conditions under which mifepristone can be dispensed to patients have already, and will continue to, lead to an increased prevalence of complications. Plaintiffs argued that additional complications would inevitably require them—against their beliefs—to complete emergency abortions for their pregnant patients. The Court was not persuaded by this argument, citing federal laws that exist to protect such doctors from being forced to perform an abortion contrary to their religious beliefs. The doctors also claimed that they would suffer financial injuries as a result of the relaxed restrictions because they would have to divert time and resources to treating more patients harmed by complications from taking mifepristone and ultimately, they would face increased liability and insurance costs. The Court also rejected this theory, finding that the argument was not supported by the evidence presented and was “highly speculative.” The opinion warned that accepting such an attenuated injury claim would effectively establish a doctrine of “doctor standing” that would allow medical doctors to challenge any and all government regulations, so long as they affected public health in some way.

Court rejects associational standing as well

In addition to the individual doctors, the case was also brought by a group of medical associations on behalf of their members. The Court found that these associations also failed to establish standing to bring suit. The associations argued that, in addition to injuries claimed by their doctor members, they too had suffered injury in fact because of the costs and time spent investigating the safety of mifepristone and presenting their findings while advocating for the drug’s removal.

The Court’s opinion rejected this argument, saying that an association without a concrete injury “cannot spend its way into standing simply by expending money to gather information and advocate against the defendant’s action.”

In his concurrence, Justice Thomas went a step further, stating that he has “serious doubts that an association can have standing to vicariously assert a member’s injury.” The Justice indicated that, while in this case it was not necessary to overturn the Court’s precedents to the contrary, the Court should revisit the topic when the appropriate case presents itself.

So who can challenge the FDA?

During oral arguments, several Justices asked the parties what would happen if they found that the plaintiffs in this case lacked Article III standing. Both sides indicated that there was a distinct possibility that, if these plaintiffs were not found to have standing, then it was possible that no one could challenge FDA’s approval and regulation of mifepristone.

Justice Kavanaugh addressed this in his opinion, noting that even if there were no identifiable alternate plaintiff, the Court had historically refused to allow the “if not us, who?” argument as a basis for standing. He added that some issues are best left up to the political and democratic processes.

What now?

In the wake of the Court’s decision, the FDA program to certify pharmacies for distribution of mifepristone and the relaxation of the in-person requirements will continue unabated. Some pharmacies have already applied for and obtained approval to dispense the drug under the FDA’s current rules in states where pharmacy dispensing is permitted.

However, we foresee a long road ahead for challenges to mifepristone. Comments during oral arguments on the impact of the Comstock Act, as well as claimed shortcomings in FDA’s review processes, left open the possibility that at least some of the Justices might be open to a decision for a proper challenger on the merits.

In other arenas, challenges to various state laws that restrict the dispensing and prescription of mifepristone continue to progress. Additionally, there are other challenges to FDA’s regulation of the drug that have been on hold pending the result in this case. Those lawsuits, brought by states that support abortion access in federal courts in Washington and Virginia, assert that the FDA should not have any heightened restrictions on the dispensing and prescription of mifepristone. Those cases are expected to proceed again now that the Supreme Court has reviewed this case, even in the absence of a decision on the merits.

Reed Smith will continue to follow developments in the post-Dobbs abortion landscape and, particularly, in the regulation of mifepristone. If you have any questions about this, please reach out to the health care lawyers at Reed Smith.