Who Can Sue the Food and Drug Administration?

If doctors who believe the Food & Drug Administration mistakenly approved or deregulated a drug cannot sue the FDA, can anyone else? This was the very first question asked at oral argument in FDA v. Alliance for Hippocratic Medicine last week. Though initially raised by Justice Thomas, other justices picked up on the question, and it remains an interesting question. If AHM lacks standing here (as I have argued), can anyone sue the FDA? Maybe. Maybe not (at least at the moment). And if not, that might be okay.

It is quite common in standing cases for a judge or justice to ask “if not this plaintiff, then who would have standing?” While it is often the case that a different plaintiff, who is differently situated or has a more concrete stake in the underlying question may be more likely to have standing, that is not always the case. In some cases, no one has standing, at least not under current law. Not every governmental wrong may be remedied in federal court. As Justice Alito wrote for the Court in Clapper v. Amnesty International (quoting prior decisions of the Court going back fifty years), “the assumption that if respondents have no standing to sue, no one would have standing, is not a reason to find standing.” In a standing case, the question is always whether the plaintiffs have standing, as this is what Article III (as currently interpreted) requires, not whether there is a hypothetical plaintiff that might have standing.

As a general matter, it is always more difficult to demonstrate standing when a plaintiff is seeking to influence how the government treats a third party than when a plaintiff is seeking to vindicate his or her own rights as against the government. So, for instance, a taxpayer may be able to sue if she believes the government unlawfully denied her a tax break, but is unlikely to have standing to challenge a governmental decision granting an illegal tax break to someone else.

In the regulatory context, it is always easier for a regulated firm to challenge how it is regulated than it is for third parties to challenge regulatory decisions. So a regulated firm has standing to challenge an Environmental Protection Agency regulation restricting that firm’s activities, but an individual who wants to see more stringent regulation may or many not have standing to sue the EPA for failing to regulate that firm more aggressively. In some cases (environmental law in particular), Congress has created citizen suit provisions to address this asymmetry and make it easier for the beneficiaries of government regulation to meet the requirements of standing, and the Supreme Court has recognized that such provisions can make it easier to satisfy some of Article III’s requirements. Congress has also enacted qui tam laws that facilitate suits by whistleblowers or others who discover government malfeasance or misfeasance, and these statutory provisions have enabled plaintiffs to clear the standing hurdle. Congress has not enacted such a provision that applies to FDA drug approval, however.

Even though Congress has never enacted an FDA-specific cause-of-action to make it easier for non-regulated parties to sue the FDA, that does not mean groups haven’t tried. AHM is not the first ideological-oriented organization that sought to challenge the FDA’s  product-approval or regulatory decisions in court, and it is not the first such plaintiff to confront a serious standing hurdle. Courts have turned away several such suits, including cases filed by activist groups seeking to challenge FDA approval of vaccines (and not just for COVID-19), dental groups seeking greater regulation of mercury in dental amalgam, and suits by environmental organizations seeking greater regulation of hair-straightening products. The U.S. Court of Appeals for the Sixth Circuit also turned away a suit filed by a medical group challenging the FDA’s revocation of an emergency use authorization for hydroxychloroquine, concluding it could not meet the test for associational standing.

While most activist suits challenging FDA policies have foundered on standing grounds, one that succeeded (at least in a district court) involved an effort by various medical organizations to force greater regulation of vaping products. In American Association of Pediatrics v. FDA, 379 F.Supp.3d 461 (D. Md. 2019), a district court in Maryland accepted claims of associational standing that mirror those asserted by AHM. According to the plaintiffs, if the FDA did not force vaping product manufacturers to submit their product marketing applications more rapidly, the plaintiff organizations would have more difficulty pursuing their public health mission because they would not have access to the information generated by the application review process. The district court bought this argument based upon an aggressive reading of Havens Realty, and the FDA ultimately acquiesced (leading to a crush of vaping product applications that the agency had no ability to properly review on a timely basis, arguably contributing to the FDA’s vaping problem). As readers might expect, I think this decision had some of the same problems as did the lower court opinions in the AHM litigation (perhaps more, as the AAP case also implicated the FDA’s enforcement discretion). [Note: Another activist group filed suit against the FDA for failing to ban menthol cigarettes this week, and standing should be an issue here too.]

There are also cases in which competitors have been able to assert standing to sue the FDA. As Michael Dorf notes in this post, there are cases in which the maker of a brand-name pharmaceutical challenged the approval of a generic, but this avenue will not always be available.

Another possibility that Dorf suggests might result from an FDA drug approval decision that will increase the costs for health care providers, there might be an argument for standing. Of note, this was the theory upon which several blue states sued the FDA arguing that it had not done enough to reregulate mifepristone (a suit, as I noted here, clearly intended to create a conflict in case AHM’s claims succeeded). Specifically the states argued that the FDA’s failure to make mifepristone more widely available increased the costs borne by state Medicaid programs, both because there are costs to comply with the FDA’s restrictions and because restrictions on mifepristone result in more surgical abortions. I was skeptical of these arguments here, but it does indicate the sort of standing theory that might work. So, for instance, insofar as health insurers are required to provide cost-free coverage of certain classes of FDA-approved medications, an insurer might be able to assert standing when a new such drug is approved and that approval will increase the insurers’ costs.

It is certainly true that it is difficult for those who are not regulated by the FDA to sue the agency for its regulatory and drug-approval decisions, but this is not mean those who are harmed by FDA drug-approval decisions have no means of redress. The FDA regularly reconsiders drug-approval decisions when new information reveals risks or problems about which the agency had been aware. More importantly, when the FDA approves a medication, this does not immunize the manufacturer against tort liability, as cases such as Wyeth v. Levine make clear. As FDA drug approval decisions are largely based upon the manufacturer’s submissions, such liability may actually more to protect the public than would making it easier to sue the agency.

Regular readers know that I am hardly an FDA apologist. The agency has made mistakes and bad policy decisions, and likely will again. And, like any agency, the FDA’s decisions should be subject to hard-look review when a party with Article III standing brings a suit in court. It may be difficult for non-regulated entities and individuals to bring such claims, but that does not mean plaintiffs such as AHM should get special treatment by the courts. Rather, if it is too difficult for associations and others to sue the FDA, it is up to Congress to create causes of action that facilitate standing as it has done in other areas. But unless and until Congress takes such a step, plaintiffs such as AHM should be told they lack standing to bring these sorts of claims in federal court.

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For those interested, here are my prior blog posts about the AHM mifepristone litigation and the issues it raises:

  • “The Next Abortion Battlegrounds,” June 22, 2022;
  • “Assessing the Legal Claims in Alliance for Hippocratic Medicine v. FDA,” March 8, 2023;
  • AHM v. FDA: A Contrary View and a Rejoinder,” March 28, 2023;
  • “Blue-State AGs Have A Mifepristone Lawsuit of Their Own,” March 29, 2023;
  • “Two (Wrong) Mifepristone Court Rulings in One Day,” April 8, 2023;
  • “The Good and Bad of the Fifth Circuit’s Abortion Pill Ruling,” April 13, 2023.
  • “BREAKING: Supreme Court to Consider Fifth Circuit’s Abortion Pill Decision,” Dec. 13, 2023.
  • Supreme Court Denies Red State Effort to Intervene in Mifepristone Case, Feb. 20, 2024.
  • Can Emergency Room Doctors Sue the FDA for Failing to Regulate Mifepristone More Aggressively?, Mar. 26, 2024.
  • Mifepristone in the Supreme Court—Comments on Oral Argument (Updated), March 26, 2024