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Standing should not be a political issue.  Ensuring that someone who initiates a lawsuit has enough of a connection to the alleged harm for which they seek redress from a court is a key part of the broader constitutional concept of justiciability.  Because federal courts are courts of limited jurisdiction, they cannot decide just any old dispute.  Imagine how much more clogged federal court civil dockets would be if, in addition to so many dubious product liability claims, there were countless cases pending that fell well outside of the current concept of justiciability.  (Set aside the cost of litigating for this exercise in imagination, as costs do not deter many bogus lawsuits, especially when proceeding pro se is an option.)  Using an implied first person singular unique to this Blog and certain monarchs, imagine if we were litigious, opinionated, and easily offended while otherwise remaining a personal and business resident of the middle Atlantic region.  Should we be allowed to challenge an Alaskan state regulation on the working conditions for salmon fishermen based on our periodic consumption of salmon caught in Alaskan waters?  Should we be allowed to challenge a California state law on animal welfare because it does not comport with our personal religious and ethical precepts?  What about Texas regulation of the cattle industry because of a local environmental impact and/or a suspected detriment to vegans (a group to which we do not belong)?  What about trying to remove a dog food advertisement that appears on billboards in Kansas that depicts our favorite dog breed as not very bright?  Closer to home, what if we wanted to complain about the gaudy color of paint a neighbor chose to repaint their house, which we think might distract drivers into crashing into our car in our driveway or maybe reduce the value of real estate on our block?  There may be other issues with these potential lawsuits, but each one should be dismissed toot sweet for lack of standing, no matter where brought.

For more than a year, we have been following the AHM or Hippo litigation from the Northern District of Texas, through the Fifth Circuit, all the way up to the Supreme Court.  Alliance for Hippocratic Med. v. FDA, 668 F. Supp.3d 507 (N.D. Tex. 2023), stayed in part, 2023 WL 2913725 (5th Cir. Apr. 12, 2023), temporarily stayed, 2023 WL 2942266 (U.S. Apr. 14, 2023), aff’d in part & vacated in part, 78 F.4th 210 (5th Cir. 2023), cert. granted in part and denied in part, 144 S. Ct. 537 (2023).  We documented the many twists and turns along the way here, here, here, here, and here.  Collectively, these posts also give the underlying facts of the case and the details of the prior decisions, which we will not repeat here.  We chose the animalic moniker above primarily because we found the name of the lead plaintiff entity in AHM a bit pretentious if not ironic.  In addition, the humble hippopotamus is actually quite dangerous and is now causing unintended havoc far from its native lands because Pablo Escobar imported some for his Colombian jungle estate.  More substantively, the extremely liberal treatment of established constitutional standards on standing by famously conservative lower courts was a predicate to some really bad and impactful rulings.  The expansion of standing also made us ponder the coming flood of additional litigation should the Supreme Court formally abandon the established standards in an effort to affirm.  The other pachyderm in the room has always been that the underlying issue in Hippo is a limitation on the availability of medication abortion, something that appeals to some people who might otherwise favor federalism and tight standing rules.  Overly simplified, there is a potential conflict—not in the implied preemption sense, although that is clearly an issue in some on-going litigation related to medication abortion (see here, here, here, and here)—between arguably political aims and the larger legal framework.  We saw this conflict when an overlapping panel from the Fifth Circuit applied standard standing principles to decide against the plaintiffs in a case about Sesame Street puppets and vaccination not long after its Hippo decision. We are pleased to report that a unanimous Supreme Court reversed the Fifth Circuit, finding the plaintiffs failed to establish standing for any of their claims.  FDA v. Alliance for Hippocratic Med., — S. Ct. –, 602 U.S. –, 2024 WL 2964140 (Jun. 13, 2024).  In doing so, it reaffirmed the importance of and relatively strict standards for standing.

That is not to say that the Supreme Court’s Hippo decision offers a polemic against federal courts abandoning standing requirements to get to a desired result in a politically charged case.  To the contrary, the reasoning that the district court and Fifth Circuit used to find standing is not discussed, let alone criticized.  In addition, the statement that “[t]he plaintiffs have sincere legal, moral, ideological, and policy objections to elective abortion and to the FDA’s relaxed regulation of mifepristone,” made in the connection with suggesting plaintiffs should raise their concerns in other fora, is one of many in the opinion that seem gratuitous.  Allowing private citizens and ad hoc associations of private citizens to use the Administrative Procedures Act to invalidate, however temporarily, a number of FDA decisions, including approvals of an NDA and ANDA, was unprecedented.  That the plaintiffs were neither users nor prescribers of the drug at issue made the whole Hippo litigation quite threatening to some legal principles previously thought to be untouchable.  The Court’s decision, authored by Justice Kavanaugh, appeared quite conscious in its efforts to link the “bedrock constitutional requirement” of standing to conservative principles.  Early in its analysis, the Court cited to a 1793 letter to President Washington from the Supreme Court (under Chief Justice John Jay, co-author of The Federalist Papers), a 1983 law review article from future Justice Scalia, and a 1993 law review article from future Chief Justice Roberts, each of which emphasized the importance of standing for “Cases and controversies” before Article III courts and, more generally, in the separation of powers.  Id. at *5-6.  (Interestingly, the 1983 article is said to contain a statement from “Justice Scalia” four years before he joined the Court, but the 1993 article is not linked in text to Chief Justice Roberts, who joined the Court twelve years later.)  

After that lead in, the standards for standing, and the cases from which they were derived, were pretty predictable.  The plaintiff must have an injury in fact that is “particularized; the injury must affect the plaintiff in a personal and individual way and not be a generalized grievance.”  Id. at *6 (citation and internal quotation omitted).  “Moreover, the injury must be actual or imminent, not speculative—meaning that the injury must have already occurred or be likely to occur soon.”  Id. (citation omitted).  The injury in fact requirement “screens out plaintiffs who might have only a general legal, moral, ideological, or policy objection to a particular government action.”  Id.  Because the Hippo plaintiffs did not sell, take, or prescribe the medication at issue, their attempt to show an injury in fact that was or likely will be caused by the defendant’s actions—i.e., the FDA’s decisions in connection with exercising its congressional charge to promote public health—relied on a purported cascade of events involving others.  Causation cannot be “too attenuated” and generally cannot “rely on speculation about the unfettered choices made by independent actors not before the courts.”  Id. at *7 (citations omitted).  Instead, “the plaintiff must show a predictable chain of events leading from the government action to the asserted injury—in other words, that the government action has caused or likely will cause injury in fact to the plaintiff.”  Id. at *8.

The plaintiffs did not come close to establishing an injury in fact, causation, and redressability, the third requirement. 

Because the plaintiffs do not prescribe, manufacture, sell, or advertise mifepristone or sponsor a competing drug, the plaintiffs suffer no direct monetary injuries from FDA’s actions relaxing regulation of mifepristone. Nor do they suffer injuries to their property, or to the value of their property, from FDA’s actions. Because the plaintiffs do not use mifepristone, they obviously can suffer no physical injuries from FDA’s actions relaxing regulation of mifepristone.

Id. at *9.  The individual plaintiffs claimed to have suffered “conscience injuries” and both the individual and entity plaintiffs claimed to have suffered economic injuries.  The conscience argument, which was successful below, was that FDA actions increased the risk that the plaintiffs “may be required—against their consciences—to render emergency treatment completing the abortions or providing other abortion-related treatment.”  Although FDA apparently did not contest this as an injury in fact—which the Court said was correct—the full record below made it clear that this was a stretch.  The risk of a specific ER doctor seeing a mifeprestone-related complication requiring surgical intervention was fleetingly small.  Moreover, consistent with the Hippocratic Oath, an ER doctor will surely encounter a wide range of injuries caused by illegal or, from the doctor’s perspective, immoral behavior.  An ER doctor surely would not have standing to challenge a government action that promoted alcohol use and, by extension, the risk of treating a driver injured in a crash that occurred because the driver was affected by alcohol use, albeit had a blood alcohol level below the legal limit.

Even with this concession and the Court’s assumption that the FDA actions that were knocked down by the Fifth Circuit’s ruling had increased the chance that the plaintiffs would encounter women who needed surgical abortions after taking mifepristone, the plaintiffs still could not establish causation.  Federal law allows doctors to refuse to “provide treatment or assistance that would violate the doctors’ religious beliefs or moral convictions,” including abortions.  Id. at *10 (citations omitted).  The plaintiffs could not suffer the harm of which they complained and, indeed, did not identify “any instances where a doctor was required, notwithstanding conscience objections, to perform an abortion or to provide other abortion-related treatment that violated the doctor’s conscience.”  Id.  EMTALA, which is the subject of other litigation, does not override federal conscience law or require individual doctors to do anything.  Id.  Thus, the plaintiffs could not prove causation based on their conscience theory.

The economic theory fared no better.  Again, the doctors had no history of adverse economic consequences or “persuasive evidence or reason to believe that the future will be different.”  Id. at *11.

[T]he 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. Stated otherwise, there is no Article III doctrine of “doctor standing” that allows doctors to challenge general government safety regulations. Nor will this Court now create such a novel standing doctrine out of whole cloth.

Id.  To us, this also runs against the idea of a conscience injury to the individual plaintiffs, not just that they suffered no injury in fact caused by FDA’s actions.  The same goes for the Court’s conclusion that an expansion on standing “would seemingly not end until virtually every citizen had standing to challenge virtually every government action that they do not like.”  Id. at *12.

Going beyond economic injury theories, it appears that the Court closed the door on standing for doctors to challenge FDA actions in almost all instances:

[I]n the FDA drug-approval context, virtually all drugs come with complications, risks, and side effects. Some drugs increase the risk of heart attack, some may cause cancer, some may cause birth defects, and some heighten the possibility of stroke. Approval of a new drug may therefore yield more visits to doctors to treat complications or side effects. So the plaintiffs’ loose approach to causation would also essentially allow any doctor or healthcare provider to challenge any FDA decision approving a new drug. But doctors have never had standing to challenge FDA’s drug approvals simply on the theory that use of the drugs by others may cause more visits to doctors.


The entity plaintiffs—which appear to have been formed largely to bring such lawsuits—offered the novel argument that pursuing the lawsuit itself, along with citizen petitions, studies, and other voluntary activities, created an economic injury that could create standing.  The entity plaintiffs “cannot manufacture” standing by engaging in such activities in the absence of an actual injury in fact to begin with.  Id. at *13.  Judge Thomas wrote his own concurrence to emphasize his previously stated view that associational standing—the entity plaintiffs suing for alleged injuries to their members—and, indeed, all third party standing should not exist.  That is an issue for another day. 

For now, the Hippo case should be gone—sent to the district court for dismissal—because the plaintiffs never had standing in the first place.  Despite the Court’s strong rejection of indirect and speculative standing to challenge FDA actions, we do not expect such challenges to end.  Indeed, we would not be surprised if the same Hippo plaintiffs rejigger and take another shot at challenging the same FDA actions concerning mifepristone.  Nor would we be surprised to see challenges to FDA decisions on drugs or devices for fertility or contraception based on the same playbook.  If the goal is to deter the marketing of certain medical products by increasing the costs and burdens, then injunctions that will only last until stayed or overturned on appeal can still help further the goal.  One possible solution to this problem would be legislation requiring that challenges to FDA actions be brought in particular courts that have particular experience with these recurring issues and may be inclined to take actions that deter frivolous filings by plaintiffs without standing.  Just a thought.