Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 47 of 67 PageID 4469
consequences. See ECF No. 96 at 15–17. Contrary to popular belief and talking points, the evidence shows chemical abortion is not “as easy as taking Advil.” Id. at 20.
Compelling evidence suggests the statistics provided by FDA on the adverse effects of chemical abortion understate the negative impact the chemical abortion regimen has on women and girls. When women seek emergency care after receiving the chemical abortion pills, the abortionist that prescribed the drugs is usually not the provider to manage the mother’s complications.[1] Consequently, the treating physician may not know the adverse event is due to mifepristone. Id. at 13. Studies support this conclusion by finding over sixty percent of women and girls’ emergency room visits after chemical abortions are miscoded as “miscarriages” rather than adverse effects to mifepristone.[2] Simply put, FDA’s data are incomplete and potentially misleading, as are the statistics touted by mifepristone advocates.
Lastly, chemical abortion does not “treat patients unresponsive to, or intolerant of, available therapy.” See 21 C.F.R. § 314.500. “To the contrary, because ‘medical abortion failures should be managed with surgical termination’ the option for surgical abortion must be available for any Mifeprex patient.” ECF No. 1-14 at 23 (quoting the Mifeprex “Warnings” label). One study showed that 18.3 percent of women required surgical intervention after the chemical abortion regimen failed. Id. Hence, “any patient who would be intolerant of surgical abortion, if such a class of patients exists, cannot use the Mifeprex Regimen.” Id. at 24. On balance, the data reflect little to no benefit over surgical abortion — much less a “meaningful therapeutic” benefit.
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