If doctors who believe the Food & Drug Administration wrongly approved or deregulated a drug can’t sue the FDA, can anyone else? This was the first question asked during the oral discussion FDA v. Hippocratic Medicine Alliance last week. Although initially raised by Justice Thomas, other justices have taken up the issue, and it remains an interesting question. Self AHM fails to stay here (as I argued), can anyone sue the FDA? Perhaps. Maybe not (at least at the moment). And if not, that might be fine.
It is quite common in ongoing cases for a judge or judge to ask “if not this plaintiff, then who would be standing?” Although it is often the case that a different actor, who is in a different situation or has a more concrete interest in the underlying issue, is more likely to be legitimized, this is not always the case. In some cases, no one is legitimized, at least not under current law. Not all government errors can be resolved in federal court. As Justice Alito wrote for the Court in Clapper against Amnesty International (citing previous Court decisions dating back fifty years), “the assumption that if the respondents did not have standing to sue, no one would have standing, is not a reason to stand.” In an ongoing case, the question is always whether plaintiffs have standing, since that is what Article III (as currently interpreted) requires, not whether there is a hypothetical plaintiff who might have standing.
In general, it is always more difficult to demonstrate legitimacy when an actor tries to influence how the government treats a third party than when an actor tries to assert his or her rights against the government. So, for example, a taxpayer may be able to sue if he believes the government has illegally denied him a tax break, but he is unlikely to have standing to challenge a government decision granting an illegal tax break to somebody else.
In the regulatory environment, it is always easier for a regulated business to challenge how it is regulated than for third parties to challenge regulatory decisions. So a regulated company has standing to challenge an Environmental Protection Agency regulation that limits that company’s activities, but an individual who wants to see stricter regulation may or may not have standing to sue the EPA to not having regulated that company more aggressively. In some cases (environmental law in particular), Congress has created citizen action provisions to address this asymmetry and make it easier for beneficiaries of government regulation to meet standing requirements, and the Supreme Court has recognized that such provisions can make it easier to meet some of the requirements of Article III. Congress also passed legislation here tam laws that facilitate lawsuits by whistleblowers or others who uncover government misconduct or wrongdoing, and these statutory provisions have allowed plaintiffs to overcome the permanent hurdle. Congress, however, has not adopted such a provision to apply to FDA drug approvals.
While Congress has never enacted an FDA-specific cause of action to make it easier for unregulated parties to sue the FDA, that doesn’t mean groups haven’t tried. AHM is not the first ideologically-minded organization that has sought to challenge the FDA’s product approvals or regulatory decisions in court, and it is not the first such plaintiff to face a serious permanent obstacle. Courts have rejected several such suits, including cases brought by activist groups seeking to challenge the FDA’s approval of vaccines (and not just for COVID-19), dental groups seeking greater regulation of mercury in dental amalgam and lawsuits brought by environmental organizations seeking greater regulation. of hair straightening products. The U.S. Court of Appeals for the Sixth Circuit also rejected a lawsuit brought by a medical group challenging the FDA’s revocation of an emergency use authorization for hydroxychloroquine, concluding that it could not meet the test of associative legitimation.
While most activist lawsuits challenging FDA policies have failed, the one that has succeeded (at least in a district court) involved an effort by various medical organizations to impose greater regulation of vaping products. In American Pediatric Association v. FDA, 379 F.Supp.3d 461 (D. Md. 2019), a Maryland district court accepted membership status claims 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 quickly, the plaintiff organizations would have greater difficulty pursuing their public health mission because they would not have access to the information generated by the application review process. . The district court accepted this argument based on an aggressive reading of Real estate paradises, and the FDA ultimately agreed (leading to an avalanche of vaping product requests that the agency lacked the ability to adequately review in a timely manner, likely contributing to the FDA’s vaping problem). As readers might expect, I think this decision had some of the same problems as lower court opinions in the AHM litigation (maybe more, like the AAP case also involved FDA 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 where competitors have succeeded in asserting standing to sue the FDA. As Michael Dorf notes in this post, there are cases where the manufacturer of a brand-name drug has challenged the approval of a generic, but this avenue will not always be available.
Another possibility that Dorf suggests could result from an FDA drug approval decision that will increase costs for healthcare providers could be an argument in favor. Of note, this has been the theory under which several blue states sued the FDA claiming it hadn’t done enough to reregulate mifepristone (a lawsuit, as I’ve noted here, clearly intended to create a conflict in case AHM’s claims were successful). Specifically, states argued that the FDA’s failure to make mifepristone more widely available has increased the costs incurred by state Medicaid programs, both because there are costs to comply with FDA restrictions and because restrictions on mifepristone result in plus surgical abortions. I was skeptical of these arguments here, but they point to the kind of standing theory that might work. So, for example, to the extent that health insurers are required to provide free coverage for certain classes of FDA-approved drugs, an insurer may be able to enforce its position when a new drug of this type is approved and such approval will increase insurers’ costs. .
It is certainly true that it is difficult for those who are not regulated by the FDA to sue the agency over its regulatory and drug approval decisions, but that does not mean that those who are harmed by the FDA’s drug approval decisions do not have remedies. . The FDA regularly reconsiders drug approval decisions when new information reveals risks or problems that the agency was aware of. More importantly, when the FDA approves a drug, this does not immunize the manufacturer from tort liability, as cases such as Wyeth vs. Levine clarify. Given that the FDA’s drug approval decisions rely largely on manufacturer claims, such liability may actually serve more to protect the public than to make it easier to sue the agency.
Regular readers know that I am hardly an FDA apologist. The agency has made mistakes and made poor policy decisions, and likely will again. And, like any agency, FDA decisions should be subject to rigorous review when an Article III party brings a case to court. It may be difficult for unregulated entities and individuals to bring such lawsuits, but that does not mean that plaintiffs like AHM should receive special treatment by the courts. Rather, if it is too difficult for associations and others to bring suit against the FDA, it is up to Congress to create causes of action that make it easier to take a stand, as it has done in other areas. But unless and until Congress takes such a step, plaintiffs like AHM should be told they have no standing to bring these types of claims in federal court.
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For those interested, here are my previous blog posts on the AHM litigation over mifepristone and the issues it raises:
- “Abortion Battlefields Coming,” June 22, 2022;
- “Evaluation of legal claims in Hippocratic Medicine Alliance vs. FDA,” March 8, 2023;
- “AHM v. FDA: A Contrary View and a Rejoinder,” March 28, 2023;
- “Blue-State AGs Have Lawsuit of Their Own Against Mifepristone,” March 29, 2023;
- “Two (wrong) court rulings on mifepristone in one day,” April 8, 2023;
- “The Good and the Bad of the Fifth Circuit’s Abortion Pill Ruling,” April 13, 2023.
- “BREAKING: Supreme Court to Consider Fifth Circuit Abortion Pill Decision,” December 13, 2023.
- Supreme Court Denies Red State Attempt to Intervene in Mifepristone Case, February 20, 2024.
- Can emergency room doctors sue FDA for not regulating mifepristone more aggressively?, March 26, 2024.
- Mifepristone to the Supreme Court: Comments on Oral Argument (updated), March 26, 2024