Case: 23-10362 Document: 543-1 Page: 32 Date Filed: 08/16/2023
Frost-Clark Declaration ¶ 18; Dr. Jester Declaration ¶ 13. Given the already-substantial risk of harm, the evidence of increased risk is sufficient to confer standing to challenge the 2016 Amendments. See Nat. Res. Def. Council, Inc. v. EPA, 464 F.3d 1, 6–7 (D.C. Cir. 2006) (holding that plaintiffs had standing based on “increased risk” of developing skin cancer); Sutton v. St. Jude Med. S.C., Inc., 419 F.3d 568, 570–75 (6th Cir. 2005) (holding that plaintiffs had standing based on an “increased risk” of harm from a medical device).
ii. 2021 Non-Enforcement Decision
The Medical Organizations and Doctors have also shown that the 2021 Non-Enforcement Decision contributes to their injury. That decision effectively removes the in-person dispensing requirement, allowing women to request and take mifepristone without ever going to the doctor’s office. Evidence was introduced that this change will cause additional severe complications. Among other things, several doctors testified that supervision is necessary to ensure patients’ safety:
The FDA’s actions harm women, including my patients, because clinics and physicians prescribing or dispensing chemical abortion drugs, or websites that provide these drugs through mail order delivery without any physician involvement, often underprepare women for the severity and risks of chemical abortion, and they often provide insufficient or no follow-up care to those women.
Dr. Skop Declaration ¶ 27; see also Dr. Harrison Declaration ¶ 25 (“Mifepristone and misoprostol are serious drugs that should not be administered without medical supervision. The FDA’s actions to eliminate the necessary supervision of these drugs harms women and obstetrics professionals….”); cf. Dickerson Declaration ¶ 12 (“[Mifepristone] can now be administered and dispensed with no in-person examination or oversight by a physician.”).
Doctors also testified that, without in-person examination, the pre-
32
