Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 54 of 67 PageID 4476
to February 2019.[1] That study noted 20 deaths, 529 life-threatening events, and 1,957 severe adverse events before concluding that a pre-abortion ultrasound “should be required to rule out ectopic pregnancy and confirm gestational age.”[2]
The record confirms FDA once shared these concerns. After all, many tragedies could be avoided by auditing physician qualifications and requiring ultrasounds. In 1996, the FDA Advisory Committee expressed to the Population Council “serious reservations” on how the drugs were described “in terms of assuring safe and adequate credentialing of providers.” ECF No. 1-14 at 51. Population Council initially committed to conducting post-approval studies in 1996, and FDA reiterated these requirements mere months before the September 2000 approval. See ECF No. 1-24 at 6 (“We remind you of your commitments dated September 16, 1996, to perform the … Phase 4 studies.”). Those protocols would have required, inter alia, that the Population Council: (1) assess the long-term effects of multiple uses of mifepristone; (2) ascertain the frequency with which women follow the regimen and outcomes of those that do not; (3) study the safety and efficacy of chemical abortion in girls under the age of eighteen; and (4) ascertain the regimen’s effects on children born after treatment failure.[3] ECF No. 1-28 at 32.
- ↑ Aultman et al., supra note 44.
- ↑ Id.
- ↑ See 153 Cong. Rec. S5765 (daily ed. May 9, 2007) (statement of Sen. Coburn) (“I recently learned of a woman who was given RU-486 after she had a seizure. Her physicians assumed that the seizure was life-threatening to the baby she was carrying and gave her RU-486 for a therapeutic abortion. RU–486 was not effective in her case and the woman carried the baby to term. When the baby was born at a low birth weight, it also suffered from failure to thrive. That baby has had three subsequent brain surgeries due to hydrocephalus. The baby also suffers from [idiopathic lymphocytic colitis] — an inflammatory disease of the colon, which is extremely rare in children. It is clear that RU-486 not only is unsafe in women, but it is also not completely effective. And when it is not effective, the results are devastating.”).
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