Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 52 of 67 PageID 4474
provider’s decision to decide which method — if any — is used to make this determination. FDA has never denied that an ultrasound is the most accurate method to determine gestational age and identify ectopic pregnancies. See ECF No. 1-14 at 62. And the fact that other clinical methods can be used does not mean that all such methods are equal in their accuracy and reliability.[1] FDA did rely on a study showing that clinicians rarely underestimate gestational age. ECF No. 1-28 at 19 n.49. But this study does nothing to support FDA’s view that a transvaginal ultrasound is not necessary to diagnose ectopic pregnancies. To this point, FDA merely argues that even transvaginal ultrasounds do not guarantee an existing ectopic pregnancy will be identified. Id. at 19. If that is the case, it does not follow that it should be left to the provider’s discretion to employ less reliable methods — or no methods at all.
Correct diagnosis of gestational age and ectopic pregnancies is vital. The error in FDA’s judgment is borne out by myriad stories and studies brought to the Court’s attention. One woman alleged she did not receive an ultrasound or any other physical examination before receiving chemical abortion drugs from Planned Parenthood. ECF No. 1 at 22. “The abortionist misdated the baby’s gestational age as six weeks, resulting in the at-home delivery of a ‘lifeless, fully-formed baby in the toilet,’ later determined to be around 30-36 weeks old.” Id.; see also Patel v. State, 60 N.E.3d 1041, 1043 (Ind. Ct. App. 2016) (woman who used chemical abortion drugs “delivered a live baby of approximately twenty-five to thirty weeks gestation who died shortly after birth”). Another woman was given chemical abortion drugs during an ectopic pregnancy because her ultrasound “was not even that of a uterus but was of a bladder.”[2] ECF No. 31 at 5.
- ↑ Studies reflect that women recurrently miscalculate their unborn child’s gestational age. See P. Taipale & V. Hiilesmaa, Predicting delivery date by ultrasound and last menstrual period in early gestation, 97 Obstetrics Gyn. 189 (2001); David A. Savitz et al., Comparison of pregnancy dating by last menstrual period, ultrasound scanning, and their combination, 187 Am. J. Obstetrics Gyn. 1660 (2002).
- ↑ This incident also demonstrates that even where ultrasounds are used, only a qualified provider can assure they are done properly.
52
