Supreme Court Reverses Injunction of FDA Abortion Drug Approval on Standing Grounds

On June 13, 2024, the U.S. Supreme Court issued a 9-0 decision delivered by Justice Brett Kavanaugh that reversed a decision of the Fifth Circuit upholding an injunction of the U.S. Food and Drug Administration's (FDA) approval of the abortion drug mifepristone. Food and Drug Administration v. Alliance for Hippocratic Medicine, No. 23–235 (U.S. June 13, 2024). As previously reported, those lower court orders were stayed pending appeals by the government and Danco Laboratories (Danco), which distributes the drug. Although both the district court and Fifth Circuit Court of Appeals held that the plaintiff doctors and medical associations had Article III standing to pursue their claims, a unanimous Supreme Court held those "unregulated parties who seek to challenge the FDA's regulation of others" did not.

The Court's analysis of standing focused on whether the plaintiffs had alleged an injury in fact caused by the FDA's challenged actions. Off the bat, the Court stated that the plaintiffs did not allege the kinds of injuries that unregulated parties sometimes assert to demonstrate causation under the standing test. Noting that the plaintiff doctors and medical associations do not prescribe or use mifepristone, the Court stated that the FDA's challenged conduct has not required them to do anything or refrain from doing anything. The Court further noted that the plaintiffs did not allege monetary or physical injuries from the FDA's actions.

The Court considered and rejected each of the three "complicated causation theories" the plaintiffs presented for how the FDA's actions caused them harm. First, the plaintiffs claimed that the FDA's actions caused them conscience injuries, consisting of their being required to perform more emergency abortions against their conscience after pregnant women who take mifepristone suffer complications. The Court dismissed this argument, stating that state and federal law "fully protects doctors against being required to provide abortions or other medical treatment against their consciences—and therefore breaks any chain of causation between FDA's relaxed regulation of mifepristone and any asserted conscience injuries to the doctors."

Next, the Court considered the plaintiffs' argument that the FDA's action will cause them monetary and related injuries related to their having to divert resources and time from other patients to treat patients with mifepristone complications, resulting in increases to their liability risks and potential increases in their insurance costs. The Court found that "[t]he causal link between FDA's regulatory actions and those alleged injuries is too speculative or otherwise too attenuated to establish standing."

The Court then addressed the plaintiff medical associations' argument that they had organizational standing because the FDA's actions impaired their ability to provide services and perform their organizational missions. The Court rejected the assertions that the associations had sustained injuries from the FDA's conduct because they expended time, energy, and resources in drafting citizen petitions to the FDA and incurred costs to perform studies on mifepristone and its risks. This argument failed, according to the Court, because an organization "cannot spend its way into standing simply by expending money to gather information and advocate against the defendant's action."

In addition to reaching its holding that "the plaintiffs have failed to demonstrate that FDA's relaxed regulatory requirements likely would cause them to suffer an injury in fact," the Court opined that the federal courts are the wrong forum for addressing the plaintiffs' concerns about the FDA's actions. According to the Court, "[t]he 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." 

Justice Clarence Thomas wrote a concurring opinion highly critical of the associational standing doctrine, whereby an association is permitted to pursue it members' claims without joining those members as parties to the lawsuit. Although the doctrine was not challenged in this case, Justice Thomas stated that in the appropriate case the Court should address whether associational standing "can be squared with Article III's requirement that courts respect the bounds of their judicial power."

The Court did not address the merits arguments related to the FDA's mifepristone approval process. The case was remanded for further proceeding consistent with the opinion. 

Amici Urge Supreme Court to Review Tenth Circuit's Decision Holding Oklahoma PBM Law Preempted

One month ago, Oklahoma's insurance commissioner asked the U.S. Supreme Court to review the Tenth Circuit Court of Appeals' decision in PCMA v. Mulready, 78 F.4th 1183 (10th Cir. 2023), which held that parts of an Oklahoma law regulating pharmacy benefit managers (PBMs) were preempted by ERISA and by Medicare Part D. Since the state filed its petition on May 10, 2024, five amicus briefs have been filed in support of Oklahoma's request.

As previously reported, a unanimous three-judge panel of the Tenth Circuit issued a decision agreeing with the Pharmaceutical Care Management Association (PCMA) that the challenged provisions of Oklahoma's Patient's Right to Pharmacy Choice Act (the Act) are preempted by ERISA because they interfere with central matters of plan administration by restricting ERISA plans from structuring their pharmacy networks in a particular manner. The Tenth Circuit also concluded that the Act's "Any Willing Provider Provision" is preempted by Medicare Part D and its "field preemption" clause. In its petition to the Supreme Court, Oklahoma argues that Mulready" is irreconcilable with [the Supreme Court's] unanimous decision in Rutledge [v. Pharmaceutical Care Management Association, 592 U.S. 80 (2020)]" and that the decision created a "textbook" circuit split with the Eighth Circuit regarding preemption by ERISA and by Medicare Part D.

On June 10, 2024, a bipartisan group of attorneys general (AGs) from 31 states and the District of Columbia filed a brief requesting that the Supreme Court accept Oklahoma's request for review to address the issue of federal preemption of state regulation of PBMs. They argue that the Supreme Court should take up the issue because the Tenth Circuit's decision has resulted in "nationwide uncertainty for regulators, a corresponding increase in consumer harms, and a substantial likelihood of continued litigation on the topic in light of the deep circuit split." Further, the state AGs explain that state regulation is necessary to protect consumers from abuses by PBMs and is part of "states' well-established police powers to protect the health and safety of their constituents." The AGs who filed the brief represent Arizona, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Indiana, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Texas, Utah, Virginia, Washington, and the District of Columbia.

On June 14, 2024, five pharmacy industry groups filed a brief similarly supporting Oklahoma's request for review to the Supreme Court. Like the AGs' brief, the pharmacy industry group's brief focused on purported confusion and uncertainty created by the Mulready decision and resulting "regulatory gap over PBM practices." In addition, the brief by industry groups addressed ways in which PBMs harm consumers and smaller pharmacies. According to the brief, PBMs "distort the healthcare market, favoring abusive practices with serious consequences (for both pocketbooks and well-being) for the very patients and plans these systems were designed to serve." In addition, the brief asserts that the Tenth Circuit's decision "expands ERISA preemption into areas where ERISA has nothing to say, and leaves PBMs free to exert staggering market power in ways that distort and impair a functioning healthcare system." The pharmacy industry groups who filed the brief are American Pharmacies Inc., the American Pharmacists Association, the National Association of Chain Drug Stores, Inc., the National Community Pharmacists Association, and the Oklahoma Pharmacists Association.

Additional amicus briefs in support of Oklahoma's request have been filed by the American Dental Association and Eight Health-Care Provider Associations (June 12, 2024); PatientRightsAdvocate.Org, Inc. (June 14, 2024); and the National Association of Specialty Pharmacy (June 14, 2024).

The state's petition was docketed as Case No. 23-1213. PCMA's deadline to file its brief in opposition is July 15, 2024.

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