Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 45 of 67 PageID 4467
therapeutic benefit over surgical abortion. See 21 C.F.R. § 314.500 (examples include where the benefit is the “ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy”). To the extent surgical abortion can be considered a “therapy,” the clinical trials did not compare chemical abortion with surgical abortion to find such a benefit. ECF No. 1 at 44.
Defendants argue just one “meaningful therapeutic benefit”: chemical abortion drugs avoided “an invasive surgical procedure and anesthesia in 92 percent of” patients in the trial. ECF No. 28 at 37. But “[b]y defining the ‘therapeutic benefit’ solely as the avoidance of the current standard of care’s delivery mechanism, FDA effectively guarantees that a drug will satisfy this second prong of Subpart H as long as it represents a different method of therapy.” ECF No. 1-14 at 22. And even if that were a benefit, chemical abortions are over fifty percent more likely than surgical abortion to result in an emergency room visit within thirty days. ECF No. 7 at 21.[1] Consequently, the number of chemical abortion-related emergency room visits increased by over five hundred percent between 2002 and 2015. ECF No. 1 at 19.
One study revealed the overall incidence of adverse events is “fourfold higher” in chemical abortions when compared to surgical abortions.[2] Women who underwent chemical abortions also experienced far higher rates of hemorrhaging, incomplete abortion, and unplanned surgical evacuation.[3] Chemical abortion patients “reported significantly higher levels of pain, nausea,
- ↑ Some studies report that the exact number is fifty-three percent. See Studnicki et al., supra note 22.
- ↑ See Maarit Niinimäki et al., Immediate Complications After Medical Compared with Surgical Termination of Pregnancy, 114 Obstetrics & Gynecology 795 (2009). FDA agrees with this study but finds it “not surprising” given that chemical abortion “is associated with longer uterine bleeding.” ECF No. 1-44 at 38. See also ECF No 113 at 15, n.68–72 (collecting studies demonstrating the far higher rates of adverse events in chemical abortion over surgical abortion).
- ↑ Id.
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