Food and Drug Administration v. Alliance for Hippocratic Medicine

STANDING FOR RESPONDENTS – PHYSICIANS PERFORMING ABORTION

Petitioner, the FDA, argues that judicial standing is a fundamental constitutional necessity for any legal case in the United States to ensure that federal courts address only actual, concrete disputes and maintain their designated role within the government's separation of powers framework. Brief of Petitioner, Food and Drug Administration, at 15. The FDA contends that the standing doctrine demands that a plaintiff prove a direct, personal injury that is attributable to the defendant’s conduct and can be alleviated by the Court’s intervention. Id. at 15-16. The FDA further asserts that, in cases where an association represents its members, it must establish that at least one member has experienced or is imminently at risk of specific, tangible harm. Id. at 16. The FDA maintains that allegedly causing or potentially causing harm to members—who are medical professionals openly opposed to abortion—does not confer standing. Id.

The FDA claims that the Alliance's arguments for associational standing hinge on speculative and indirect harm based on the actions of unrelated third parties. Id. at 16-18. According to the FDA, the Alliance speculates a scenario where the loosened restrictions would allow other doctors to prescribe mifepristone and more women to seek emergency care due to the side effects of mifepristone, potentially forcing physicians to perform abortions against their conscience. Id. at 17-18. The FDA contends that this argument relies on a series of conjectural events and does not demonstrate that any member faces a concrete and imminent injury directly traceable to the FDA's 2016 and 2021 actions regarding mifepristone. Id. at 18-20, 28-32. The FDA maintains that the Alliance’s approach mirrors hypothetical or statistical theories that lack specific, identifiable harm to establish standing, thus previously rejected by the lower court. Id. at 19-21.

The FDA also argues that the Alliance’s organizational standing claims are equally tenuous. Id. at 32. In response to the Alliance’s claims that the FDA's actions have forced the doctors to divert resources and hindered their ability to counsel against chemical abortions, the FDA asserts that these impacts do not constitute direct legal injuries. Id. at 32-33. The FDA further contends that the Alliance’s claims stem from their opposition to the FDA's decisions rather than from any actions by the FDA that directly affect their legal rights or operational capacities. Id. at 33-34. Thus, the FDA concludes that the speculative nature of the claimed injuries, the indirect causal chain connecting the injuries to the FDA's actions, and the absence of any direct, personal harm to the respondents or their members undermine the standing claims. Id. at 15 - 16.

The Alliance counters that they have standing to challenge the FDA’s actions. Brief of Respondent, Alliance for Hippocratic Medicine, at 17. The Alliance notes that standing requires “(1) an injury in fact, (2) a sufficient causal connection, and (3) a likelihood at the injury will be redressed” (internal quotation marks excluded). Id.

Specifically, AHM claims it can show an injury in fact because its doctors would have to violate their conscience to meet the relevant FDA standards. Id. at 18. The Alliance argues that the FDA requirements would demand that doctors participate in elective abortions that they find to be unethical. Id. The Alliance contends that the doctors would also have to treat complications from abortion drugs in emergencies which often require prioritizing the mother’s life over that of the fetus. Id. at 20-21. The Alliance also alleges an injury in fact because it must use its limited time and resources to facilitate elective abortions rather than doing other tasks required of obstetrician gynecologists (“OB/GYNs”). Id. at 21. The Alliance argues that doctors must deal with emergency complications from abortion drugs, pulling them away from their other patients and that OB/GYNs are not well-suited to do emergency medicine. Id. at 22.The Alliance also contends that it faces an injury in fact in the form of emotional and spiritual distress to doctors as a result of having to participate in abortions. Id. at 22-23. The Alliance asserts that it would also face increased insurance costs. Id. at 23. Additionally, the Alliance argues that its risks of malpractice would increase since its doctors would spend an increased amount of timedealing with more emergency and high-risk situations. Id. At 24.

The Alliance highlights that there is a substantial risk these injuries would occur, and the harm is not speculative because the existence of abortion drugs virtually guarantees that those drugs will have complications that OB/GYNs must deal with. Id. The Alliance argues that the FDA has repeatedly stated that emergency room care is necessary to deal with abortion drug complications. Id. at 15. Additionally, the Alliance contends that over half of the women who have gotten abortions have used abortion drugs like mifepristone, and of those, about 3-5 percent go to the emergency room. Id. at 26.

The Alliance argues that the injuries are traceable to the FDA’s actions because the deregulation of the abortion drugs led to an increased usage of those drugs. Id. at 33-34. In other words, the Alliance claims, the increase usage of those drugs are the “predictable effect of government action” sufficient to generate standing. Id. The Alliance also states that its claims can be redressed by simply restoring the original safety standards for the drugs, which the Alliance claims would result in fewer emergency room visits and reduce the strain on doctors and lower the overall risks they face. Id. at 41-42.

MERITS – DEFERENCE TO THE FDA’S SCIENTIFIC EXPERTISE

The FDA argues that, by overlooking the deferential standard that should be applied in such regulatory contexts, the Fifth Circuit erroneously deemed as arbitrary and capricious the FDA's actions concerning mifepristone adjustments in 2016 and the removal of in-person dispensing requirements in 2021. Brief of Petitioner, Food and Drug Administration, at 34. The FDA claims that in 2016, it judiciously expanded mifepristone's use window and reduced unnecessary clinical visits by allowing non-physician healthcare providers to prescribe the drug. Id. at 34-35. The FDA states that these modifications are supported by extensive scientific studies conducted over two decades demonstrating safety and efficacy compared to the original protocols, reinforcing its commitment to evidence-based decision-making. Id. at 36-41.

The FDA argues that the lower court also misunderstood the rationale behind the 2021 decision to remove the in-person dispensing requirement for mifepristone. Id. at 42. This decision, according to the FDA, is backed by thorough reviews and evidence from its use during the pandemic, demonstrating that patient safety was not compromised. Id. The FDA contends that their rigorous evaluation process and reasoned explanations, respecting the complex and dynamic nature of healthcare and pharmaceuticals, underscore the lawfulness of their decision. Id. at 42-44. The FDA concludes that deference to the FDA's expertise is essential, particularly when the agency navigates the nuanced terrain of medical and pharmaceutical regulations to protect and advance public health objectives. Id.

The Alliance counters that the FDA’s removal of safeguards for mifepristone was arbitrary and capricious. Id. at 47. The Alliance asserts that the FDA changed a longstanding policy with no justification provided. Id. at 47-49. Additionally, the Alliance argues that the FDA relied on reports that it knew were inaccurate and incomplete when making its decision. Id. at 50. The Alliance further contendsthat the FDA is also responsible for insufficient or weakdata on the use of the drug since it removed reporting requirements on abortion drug providers. Id. at 51. The Alliance contends that the FDA also relied on studies that it agreed could not be generalized to the U.S. population because of the studies’s small sample sizes and inclusion of other kinds of pre-abortion safeguards. Id. at 52. The Alliance finally emphasizes that the FDA ignored studies suggesting an increased risk to people as a result of reducing safeguards. Id. at 53.

Finaly, the Alliance claims that the FDA’s removal of the requirement of people seeking abortion drugs to attend an in-person visit violates the Comstock Act. Id. at 56. The Alliance argues that the text of the Comstock Act prohibits the mailing of any abortion drugs even if the abortions are lawful (and additionally, Congress considered and rejected an amendment limiting the law to illegal abortions). Id. at 56-57.