Case: 23-10362 Document: 543-1 Page: 34 Date Filed: 08/16/2023
Francis Declaration ¶ 11 (“The frequency of these complications has increased since a federal district court first enjoined and set aside the FDA’s in-person dispensing requirement of mifepristone in 2020.”); see generally Am. Coll. of Obstetricians & Gynecologists v. FDA, 472 F. Supp. 3d 183 (D. Md. 2020) (district court opinion enjoining the in-person requirements).[1]
Based on that evidence, the Medical Organizations and Doctors have made a clear showing that the 2021 Non-Enforcement Decision causes an increased risk of injury. FDA and Danco resist this conclusion, arguing that any increase to the Medical Organizations and Doctors injury is speculative because the number of women who experience ectopic pregnancies is so small. FDA Reply Br. at 24; Danco Reply Br. at 11–12. But that understates the bases of the alleged injury. The Medical Organizations and Doctors argue that ectopic pregnancy (and the possible failure to diagnose it) is one of the reasons why removing the in-person dispensing requirement will lead to more complications—not the only reason. As explained above, the declarants offer several other grounds for their contention, including the need for in-person supervision when a patient takes mifepristone, the need to accurately assess gestational age, and the need for in-person follow-up. We conclude that the Medical Organizations and Doctors have shown a substantial risk of injury due to the 2021 Non-Enforcement Decision. As such, they have associational standing to challenge this action. ***
Because we hold that the Medical Organizations and Doctors have associational standing, we need not consider whether they also have organiza-
- ↑ FDA initially appealed that ruling, but the parties dismissed the appeal after FDA announced that it would decline to enforce the in-person dispensing and prescription requirements. See Am. Coll. of Obstetricians & Gynecologists v. Indiana, No. 20-1784, 2021 WL 3276054 (4th Cir. May 19, 2021).
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