In unanimous decision, Supreme Court solves FDA’s ‘standing’ issue

Background: What is standing, and why is it important to the FDA?

• While it’s true that anyone can sue anyone (including a federal agency), tosuccessfullysue someone is more challenging. Courts may dismiss an issue for any number of reasons, including finding that a case is frivolous or that a person lacks “standing” to file a lawsuit.
• UnderArticle III of the Constitution, a party must have “standing” to challenge a rule or law. The test to determine whether a party has standing to challenge a particular action hasthree parts: first, the party must have suffered (or will suffer) a “concrete and particularized injury”; second, the injury is traceable to the challenged action; and third, that the courts can adequately remedy the injury. The Supreme Court has consistently ruled that this injury cannot be speculative and must affect the party in “a personal and individual way,” including physical, monetary, and property injuries or an injury to a party’s constitutional rights.
• For federal agencies,standingis an important principle which serves to defend against all manner of legal challenges to otherwise lawful policymaking.Federal policymakers have long benefited from legal precedent thatrequiresthat a person must have been harmed by a policy to have standing to file a lawsuit challenging that same policy in federal court. This is beneficial to the FDA, for example, by protecting it from lawsuits from persons who merelydon’t likean FDA policy action; rather, persons or groups wishing to sue the FDA must also find persons with standing to sue. This is intended to stop the federal courts from becoming “a vehicle for the vindication of the value interests of concerned bystanders,” or those who have nopersonalstake in a case. The courts are also heavily focused on the requirement of a causal link between a challenged action and the specific harm to a party, and will dismiss cases if the chain of causation between the events is too vague or attenuated.
• However, a recent court case had called into question the extent of FDA’s defense against lawsuits for which “standing” had a less-than-direct connection.In the case ofAlliance for Hippocratic Medicine v. FDA, the Alliance for Hippocratic Medicine sued the FDA, charging that the agency had violated federal law when it approved the abortion drug mifepristone and, later, amended conditions intended to assure its safe use. The first court to hear the case, the District Court for the Northern District of Texas, ruled in favor of the plaintiffs in the case. [Read AgencyIQ’s analysis of that case here.] The case was thenappealedto the Fifth Circuit Court of Appeals in New Orleans, which then largelyruled in favorof the plaintiffs.
• Asreported by POLITICO, “The decision — if allowed by the Supreme Court to take effect — would roll back actions the federal government has taken since 2016 to make the pills more accessible, including rules allowing online ordering, mail delivery, and pharmacy dispensing of the drugs. It also would roll back access from the current 10 weeks of pregnancy to seven and would reimpose a requirement that only physicians can prescribe the pills.” However, the ruling found that the lower court’s decision that the original approval of the drug should be overturned was improper, and that the Alliance for Hippocratic Medicine’s legal action had not been filed in a timely manner.
• For both courts, however, the issue of “standing” was a central argument.The plaintiffs – a group of physicians and medical organizations – had argued that they were harmed by FDA’s policies by way of a sort of Rube Goldberg-esque series of associated harms.
• As the Fifth Circuit’s opinionexplained(Page 14): “The Doctors are allegedly injured when they treat mifepristone patients.They offer four reasons why that is so.First, when a doctor treats a woman suffering from a mifepristone complication, he or she will often be required to perform or complete an abortion. And even if not, the doctor must participate in the medical treatment that facilitates an abortion. The Doctors allege that being made to provide this treatment conflicts with their sincerely held moral beliefs and violates their rights of conscience.Second, treating mifepristone patients imposes mental and emotional strain above what is ordinarily experienced in an emergency-room setting.Third, providing emergency treatment forces the Doctors to divert time and resources away from their ordinary patients, hampering their normal practice. Andfourth, the Doctors allege that mifepristone patients involve more risk of complication than the average patient, and so expose the Doctors to heightened risk of liability and increased insurance costs.”(Emphasis added)
• This argument for standing was strained.The doctors were not prescribing mifepristone. They were not manufacturing mifepristone. They were not dispensing mifepristone. They were not complying with mifepristone’s Risk Evaluation and Mitigation Strategy (REMS) plan. They were not purchasing mifepristone. They were not subject to any direct regulation by the FDA related to mifepristone. And in many cases, they had what the FDA had characterized as a “diametrically opposed” or “antagonistic” relationship with patients who have taken mifepristone at the direction of another medical provider.
• And yet, according to the Fifth Circuit Court of Appeals’ decision, they were an injured party with standing to sue the FDA on the basis of these indirect (“associational”) harms– that becausesomephysiciansmaytreat patients who have consented to medical treatment involving mifepristone, and that such care is unconscionable to them, the FDA’s decision to approve mifepristone and associated risk-control schemes have injured them.

The Supreme Court today provided a unanimous rebuke to this theory of standing.

• “Plaintiffs lack Article III standing to challenge FDA’s actionsregarding the regulation of mifepristone,”the court wrote. “Plaintiffs advance several complicated causation theories to connect FDA’s actions to the plaintiffs’ alleged injuries in fact. None of these theories suffices to establish Article III standing,” the court added.
• The court’s decision is notable for how thoroughly it dismantles the arguments the lower courts relied upon to establish standing for the case.The doctors, they found, “have not shown that they could be forced to participate in an abortion or provide abortion-related medical treatment over their conscience objections,” which protect doctors from being required to provide conscience-violating care. With respect to the economic arguments related to liability and increased insurance costs, the court found the link between FDA’s actions and financial costs to providers to be “too speculative” and “too attenuated to establish standing.”
• Or, as the court succinctly put it: “the law has never permitted doctors to challenge the government’s loosening of general public safety requirements simply because more individuals might then show up at emergency rooms or in doctors’ offices with follow-on injuries. Citizens and doctors who object to what the law allows others to do may always take their concerns to the Executive and Legislative Branches and seek greater regulatory or legislative restrictions.”
• The court also recognized limits on the ability of the Alliance for Hippocratic Medicine to have standing on its own, reasoning that there is no “expansive theory that standing exists when an organization diverts its resources in response to a defendant’s actions.” The alliance had argued that FDA “forced” it “expend considerable time, energy, and resources drafting citizen petitions to FDA, as well as engaging in public advocacy and public education, all to the detriment of other spending priorities.”

While other parties may still sue the FDA over its regulation of mifepristone, the Court’s decision is important for the FDA.

• Had the court ruled that the partiesdidhave standing, it likely would have opened FDA – and other regulatory agencies – up to a whirlwind of litigation.To put it bluntly: If standing to sue could be demonstrated by a physician who merelypotentiallytreats a patient whomayexperience side effects, then presumably there would be little to protect the FDA from lawsuits filed by any physician against any drug or product the FDA approves.
• In fact, bythe logicof the Fifth Circuit Court of Appeals,the existence ofanyside effects alone would have been sufficient to allow nearly any doctor to claim they were “injured” and therefore have standing to sue the FDA. (“Finally, many doctors offered testimony that, as a result of the 2021 Non-Enforcement Decision, more women will suffer serious adverse events,” the court wrote. And based on associated evidence and testimony that the court found convincing, “the Medical Organizations and Doctors have made a clear showing that the 2021 Non-Enforcement Decision causes an increased risk of injury. […] We conclude that the Medical Organizations and Doctors have shown a substantial risk of injury due to the 2021 Non-Enforcement Decision. As such, they have associational standing to challenge this action.”)
• That the Supreme Court struck down this argument offers FDA a potential respite from endless lawsuits and maintains the bar for plaintiffs to show demonstrable harms to establish standing.Had they not, FDA’s authority to regulate would likely have been strained considerably. It doesn’t take much effort to imagine lawsuits against the FDA intended to suppress access to vaccines, painkillers, birth control products, products used in the provision of care to transgendered persons, and even products for which there are standing safety concerns or for which residual uncertainties exist, such as drugs granted accelerated approval. According to the court’s opinion, if there exists a side effect, and an FDA action serves to increase access to the product (and therefore the side effect), and a doctor would have reason to treat that side effect as a condition of their employment, then they have standing to sue.

To contact the author of this piece, please email Alec Gaffney (agaffney@agencyiq.com)
To contact the editor of this piece, please email Walker Livingston, Esq. (wlivingston@agencyiq.com)

Key Documents and Dates

• FOOD AND DRUG ADMINISTRATION ET AL. v. ALLIANCE FOR HIPPOCRATIC MEDICINE ET AL.