Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (N.D. Texas 2023).pdf/29

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Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 29 of 67 PageID 4451

life.” See Bours, 229 F. at 964; ECF No. 28-1 at 206. And twenty-two states filed an amicus brief arguing FDA’s decision to permit mail-in chemical abortion harms the public interest by undermining states’ ability to enforce laws regulating abortion.[1] ECF No. 100 at 17.

b. Individual Injustice and Irreparable Injury

Second, the agency’s actions are “likely to result in individual injustice” or cause “irreparable injury.” Myron, 670 F.2d at 52; Dawson, 504 F.3d at 606. Plaintiffs allege “many intense side effects” and “significant complications requiring medical attention” resulting from Defendants’ actions.[2] ECF No. 7 at 13. Many women also experience intense psychological trauma and post-traumatic stress from excessive bleeding and from seeing the remains of their aborted children. See ECF No. 96 at 25–29; Pauline Slade et al., Termination of pregnancy: Patient’s perception of care, J. of Family Planning & Reproductive Health Care Vol. 27, No. 2, 72–77 (2001) (“Seeing the foetus, in general, appears to be a difficult aspect of the medical termination process which can be distressing, bring home the reality of the event and may influence later emotional adaptation.”). Parenthetically, said “individual justice” and “irreparable injury” analysis also arguably applies to the unborn humans extinguished by mifepristone — especially in


  1. See David S. Cohen et al., Abortion Pills, 76 Stan. L. Rev. 1, 9 (forthcoming 2024) (“Despite state laws, mailed medication abortion can cross borders in ways that undermine state laws … A new organization, Mayday Health, for example, focuses on those who live in states with abortion bans, giving users step-by-step instructions on how to set up temporary addresses in an abortion permissive state and forward the mail into the banned state.”) (internal marks omitted).
  2. At least 4,213 adverse events from chemical abortion drugs have been reported. See ECF No. 96 at 12 n.16. But the actual number is likely far higher because non-fatal adverse events are no longer required to be reported, and because more than 60 percent of women and girls’ emergency room visits after chemical abortions are miscoded as miscarriages. See James Studnicki et al., A Post Hoc Exploratory Analysis: Induced Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization, 9 Health Serv. Rsch. Mgmt. Epidemiology 1, 1 (2022); see also ECF No. 1-8 at 7 (describing Plaintiffs’ difficulty in submitting adverse event reports to mifepristone manufacturer Danco). Other data sources such as the Center for Disease Control and Prevention Abortion Surveillance Reports are “profoundly flawed” because state reporting “is voluntary, with many states reporting intermittently and some not at all.” Studnicki et al., supra note 9, at 2. One Plaintiff physician alleges that when she reported an adverse event to her state’s health department, the “report was rejected because the State said it was not a ‘true’ adverse event because the patient ultimately recovered.” ECF No. 1-10 at 7.

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