Case: 23-10362 Document: 543-1 Page: 15 Date Filed: 08/16/2023
heightened risk of liability and increased insurance costs.
The Organizations reason that, given the millions of women who take mifepristone, the number of women who experience complications from taking the drug, and the high number of the Organizations’ members who treat such women, their members are likely to continue to treat women suffering complications as a result of mifepristone. For the reasons listed above, providing that treatment will injure the Doctors. Thus, the Medical Organizations (via their members) are likely to be injured by FDA’s actions. We first examine the evidence supporting those contentions.
a. Adverse Effects
FDA and Danco do not dispute that a significant percentage of women who take mifepristone experience adverse effects. From Mifeprex’s initial approval to subsequent amendments to the REMS, FDA has acknowledged that a certain fraction of patients would require surgery due to miscellaneous complications. Approval Memorandum at 1; see also 2011 Mifepristone REMS at 5 (“[A]bout 5-8 out of 100 women taking Mifeprex will need a surgical procedure to end the pregnancy or to stop too much bleeding.”). Similarly, as explained by the motions panel, the required patient agreement discloses that “the treatment will not work” in “about 2 to 7 out of 100 women” who use mifepristone. All. for Hippocratic Med., 2023 WL 2913725, at *5.
To be sure, not every woman who experiences complications will present to the emergency room or require surgery and/or some other form of urgent care. But many will. According to the most updated REMS medication guide, in studies conducted in the United States, between 2.9% and 4.6% of women visited the emergency room after taking mifepristone. Mifeprex Prescribing Information at 8 tbl.2 (Jan. 2023). Some women experience especially severe conditions, such as sepsis (.02%) or hospitalization relating to abortion (.04% to .06%), and some women require a blood transfusion because
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