1 Ralph Waldo Emerson, May Day (1867).

2 Hereinafter also referred to as “mothers.”

3 See, e.g., Lo, Y. M. et al., Presence of Fetal DNA in Maternal Plasma and Serum, 350 Lancet 485, 485–487 (1997)Google Scholar; Shulman, Lee P., Fetal Cells in Maternal Blood, 3 Current Women's Health Reps. 47, 47 (2003)Google Scholar.

4 Chiu, Rossa W. K. & Lo, Y. M., The Biology and Diagnostic Applications of Fetal DNA and RNA in Maternal Plasma, 61 Current Topics in Developmental Biology 81, 84 (2004)Google Scholar (noting that fetal genetic material can be “reliably detected” as early as 5 weeks’ gestation).

5 Jorde, Lynn B. et al., Medical Genetics 282 (2d ed. 1999)Google Scholar.

6 I use the terms “prenatal genetic diagnosis” and “prenatal genetic testing” to distinguish from other prenatal procedures that do not directly analyze the fetus's genetic material.

7 Jorde et al., supra note 5, at 275; Telephone Interview with Dr. Jane Chueh, Clinical Associate Professor, Obstetrics & Gynecology, Stanford Univ. Sch. of Med. (May 9, 2005).

8 See Am. C. of Obstetricians & Gynecologists, ACOG Practice Bulletin No. 27: Prenatal Diagnosis of Fetal Chromosomal Abnormalities, at 2 (May 2001) [hereinafter ACOG Practice Bulletin No. 27].

9 See id. at 2-3; U.S. Preventative Services Task Force, U.S. Dep't of Health and Human Services, Guide to Clinical Preventative Services, Section 1: Screening: Congenital Disorders: Screening for Down Syndrome (2d ed. 1996), available at http://www.ahrq.gov/clinic/2ndcps/downsyn.pdf.

10 See ACOG Practice Bulletin No. 27, supra note 8, at 3-4 (describing ultrasound screening for anatomic indicators of aneuploidy, i.e. an abnormal number of chromosomes).

11 Jorde et al., supra note 5, at 275.

12 ACOG Practice Bulletin No. 27, supra note 8, at 5.

13 See Jorde et al., supra note 5, at 275-78.

14 Id. at 275-76.

15 Id. at 276.

16 Id. Karyotyping is especially time-intensive, taking as many as three weeks to complete. Thus, researchers are investigating a switch to molecular methods of analysis, like FISH and PCR. See G.M. Grimshaw et al., Nat’l Coordinating Center for Health Tech. Assessment, U.K., Evaluation of Molecular Tests for Prenatal Diagnosis of Chromosome Abnormalities, at iii (2003), available at http://www.hta.nhsweb.nhs.uk/fullmono/mon710.pdf.

17 See Hahn, Sinuhe & Holzgreve, Wolfgang, Prenatal Diagnosis Using Fetal Cells and Cell-Free Fetal DNA in Maternal Blood: What is Currently Feasible?, 45 Clinical Obstetrics & Gynecology 649, 649 (2002)Google Scholar.

18 Karyotype Test (May 26, 2005), http://my.webmd.com/hw/being_pregnant/hw6392.asp.

19 See Fluorescent IN SITU Hybridization (FISH) (Aug. 21, 2004), http://members.aol.com/chrominfo/fishinfo.htm.

20 Single-gene disorders are conditions arising from a mutation on a particular gene on one particular chromosome. They may be distinguished from chromosomal abnormalities, which arise when the fetus inherits too many or too few full chromosomes. Although amniocentesis and CVS are most frequently used to diagnose chromosomal abnormalities like trisomy-21 (Down Syndrome), trisomy-18, trisomy-13, Turner Syndrome (XO), and related conditions, they can be also used to detect a much wider array of conditions, for which scientists have developed relatively reliable genetic tests. Jorde et al., supra note 5, at 277. Examples include sickle cell disease, hemophilia, cystic fibrosis, and Tay-Sachs disease. Id.

21 See, e.g., Hahn & Holzgreve, supra note 16, at 652 (“[T]he metaphase karyotype has remained the gold standard for cytogenic analysis, which can of course be achieved only by the examination of a large number of rapidly dividing cells.”).

22 See Lab VI Cytogenics: Human Karyotyping (Sept. 25, 2001), http://academic.bowdoin.edu/courses/f01/bio212/dissemination/labIVkaryotyping.pdf; Medical Encyclopedia: Karyotyping (Jan. 11, 2007), http://www.nlm.nih.gov/medlineplus/ency/article/003935.htm.

23 See Karyotype Test, supra note 18; Lab VI Cytogenics: Human Karyotyping, supra note 22.

24 See Grimshaw et al., supra note 16, at 1.

25 Jorde et al., supra note 7; Grimshaw et al., supra note 16, at iii.

26 Grimshaw et al., supra note 16, at iii.

27 Fluorescent probes specifically bind to target molecules and emit a bright, fluorescent glow under certain lighting and chemical conditions. See generally Jameson, David M., Gregorio Weber, 1916–1997: A Fluorescent Lifetime 75 Biophysical J. 419, 419 (1998)Google Scholar, available at http://www.biophysj.org/cgi/reprint/75/1/419.pdf.

28 FISH Analysis—definition from Biology-Online.org (Oct. 3, 2005), http://www.biology-online.org/dictionary/Fish_analysis; see also Hahn, S. et al., Fetal Cells in Maternal Blood: Current and Future Perspectives, 4 Molecular Hum. Reproduction 515, 517-18 (1998)Google Scholar; Roderiguez de Alba, M. et al., Prenatal Diagnosis on Fetal Cells Obtained from Maternal Peripheral Blood: Report of 66 Cases, 19 Prenatal Diagnosis 934 (1999)Google Scholar.

29 See, e.g., Vaidehi Jobanputra et al., Prenatal Detection of Aneuploidies using Fluorescence In Situ Hybridization: A Preliminary Experience in an Indian Set Up, 27 J. Biosciences 155, 159, 159 fig. 1(a) (2002), available at http://www.ias.ac.in/jbiosci/mar2002/155.pdf.

30 See, e.g., Sekizawa, A. et al., Prenatal Diagnosis of Duchenne Muscular Dystrophy Using a Single Fetal Nucleated Erythrocyte in Maternal Blood, 46 Neurology 1350 (1996)Google Scholar.

31 See U.S. Patent 4,683,202, at [57] (filed Oct. 25, 1985).

32 See id. at col.1, ll.23-32.

33 See, e.g., Hahn et al., supra note 28, at 518.

34 Jorde et al., supra note 7, at 276.

35 Id.; ACOG Practice Bulletin No. 27, supra note 10, at 5; Deutchman, Mark & Sakornbut, Ellen L., Diagnostic Ultrasound in Labor and Delivery, 51 Am. Fam. Physician 145, 151 (1995)Google Scholar.

36 Deutchman & Sakornbut, supra note 35, at 151.

37 Centers for Disease Control & Prevention, Draft Genetic Test Review: Cystic Fibrosis: Clinical Utility, at 4-26 (2002) [hereinafter Draft Genetic Test Review], available at http://www.cdc.gov/genomics/gtesting/file/print/FBR/CFClilUti.pdf; see also Sangalli, Michel et al., Pregnancy Loss Rate Following Routine Genetic Amniocentesis at Wellington Hospital, 117 N.Z. Med. J. U818 (Apr. 2, 2004)Google Scholar, available at http://www.nzma.org.nz/journal/117-1191/818/ (citing earlier studies that demonstrated a background miscarriage rate of about 0.5-1.7%).

38 Jorde et al., supra note 7, at 276-77.

39 Deutchman & Sakornbut, supra note 35, at 151.

40 See, e.g., Squier, M. et al., Five Cases of Brain Injury Following Amniocentesis in Mid-Term Pregnancy, 42 Developmental Med. & Child Neurology 554, 554 (2000)Google Scholar.

41 See Jorde et al., supra note 7, at 277.

42 See id.; Chorionic Villus Sampling, http://www.healthatoz.com/healthatoz/Atoz/ency/chorionic_villus_sampling.jsp (Dec. 2002).

43 See, e.g., id.

44 Jauniaux, Eric, Fetal Testing in the First Trimester of Pregnancy, 22 The Female Patient 15 (1997)Google Scholar (listing a background miscarriage rate of 3% for weeks 9-12 of pregnancy), available at http://www.obgyn.net/femalepatient/default.asp?page=jauniaux.

45 See Jorde et al., supra note 7, at 277.

46 Id.; see also ACOG Practice Bulletin No. 27, supra note 10, at 6; Olney, Richard S. et al., Chorionic Villus Sampling and Amniocentesis: Recommendations for Prenatal Counseling, 44 Recommendations and Reps. 1 (Centers for Disease Control & Prevention, ed. 1995)Google Scholar, available at http://www.cdc.gov/mmwr/PDF/RR/RR4409.pdf.

47 It is generally acknowledged that when a woman reaches age 35, the risk of bearing a fetus with a chromosomal abnormality or other defect (which increases with age) outweighs the risk of miscarriage, thus warranting invasive prenatal genetic testing. See Jorde et al., supra note 7, at 276.

48 See id. at 276-77.

49 See, e.g., Harris, Ryan A. et al., Cost Utility of Prenatal Diagnosis and the Risk-Based Threshold, 363 Lancet 276, 278 tbl.1 (2004)Google Scholar.

50 See discussion infra Part IV.C.1.

51 Joyce A. Martin et al., Births: Final Data for 2001, 51 Nat’l. Vital Stats. Reps. 70 (Centers for Disease Control & Prevention, Atlanta, GA), Dec. 18, 2002 [hereinafter Martin et al., Births: 2001].

52 Joyce A. Martin et al., Births: Final Data for 2002, 52 Nat’l. Vital Stats. Reps. 79 (Centers for Disease Control & Prevention, Atlanta, GA), Dec. 17, 2003 [hereinafter Martin et al., Births: 2002].

53 Joyce A. Martin et al., Births: Final Data for 2003, 54 Nat’l. Vital Stats. Reps. 79 (Centers for Disease Control & Prevention, Atlanta, GA), Sept. 8, 2005 [hereinafter Martin et al., Births: 2003].

54 The 5,000,000 figure for annual pregnancies is derived from the CDC's most recent statistics on live births (indicating about 4,000,000 each year) and legal abortions [indicating a number between 854,000 (the CDC's 49-state survey—excluding Alaska, California, and New Hampshire) and 1,293,000 (the Alan Guttmacher Institute's estimate—based on interpolation from previous surveys) in 2002]. See Nat’l Center for Health Statistics, Centers for Disease Control & Prevention, Health, United States, 2005, at 149 (2005) [hereinafter Health, United States, 2005]. More generally, the CDC suggests a link between the decline in the number of amniocentesis procedures performed and the increased use of certain non-invasive screening measures like MSAFP testing and ultrasound. See, e.g., Martin et al., Births: 2003, supra note 53, at 14. This is evidence of medical professionals’ unwillingness to subject women to invasive testing (with its risks to fetal and maternal health) where other alternatives are available, and it illustrates the current push toward non-invasive testing.

55 Peter A.|Benn et al., Changes in Utilization of Prenatal Diagnosis, 103 Obstetrics & Gynecology 1255, 1257 (2004)Google Scholar.

56 Email from Louanne Hudgins, Director of Perinatal Genetics, Stanford Univ. Med. Center, to Henry T. Greely, Deane F. and Kate Edelman Johnson Professor of Law, Stanford Law Sch. (Feb. 22, 2006).

57 See Martin et al., supra notes 51-53.

58 See Jorde et al., supra note 7, at 282.

59 See infra notes 83, 124 and accompanying text.

60 See infra note 83 and accompanying text.

61 Note that the terms and abbreviations for these procedures are my own. The scientific literature has not yet settled on a consistent term for either procedure.

62 Hahn & Holzgreve, supra note 32, at 649.

63 Id.

64 Id.

65 See Bianchi, Diana W. et al., PCR Quantification of Fetal Cells in Maternal Blood in Normal and Aneuploid Pregnancies, 61 Am. J. Hum. Genetics 822 (1997)Google Scholar.

66 See, e.g., Hahn, S. et al., Fetal Cells in Maternal Blood: Current and Future Perspectives, 4 Molecular Hum. Reprod. 515, 516 (1998)Google Scholar.

67 Id.

68 Id.

69 Id.

70 See id. at 515; Shulman, Lee P., Fetal Cells in Maternal Blood, 3 Current Women's Health Rep. 47, 47 (2003)Google Scholar.

71 One seminal study involving leukocytes is Herzenberg, L. A. et al., Fetal Cells in the Blood of Pregnant Women: Detection and Enrichment by Fluorescence-Activated Cell Sorting, 76 Proc. Nat’l. Acad. Sci. USA 1453 (1979)Google Scholar.

72 Shulman, supra note 70, at 48.

73 See, e.g., Ciaranfi, A. et al., [Post-Partum Survival of Fetal Lymphocytes in Maternal Blood], 107 Schweiz Med. Wochenschr 134 (1977)Google Scholar; Schroder, J. et al., Fetal Leukocytes in the Maternal Circulation After Delivery, 17 Transplantation 346 (1974)Google Scholar.

74 See Hahn et al., supra note 66, at 516; Hahn & Holzgreve, supra note 32, at 650; Shulman, supra note 70, at 48.

75 Hahn et al., supra note 66, at 516.

76 See, e.g., Bianchi, Diana W. et al., Isolation of Fetal DNA From Nucleated Erythrocytes in Maternal Blood, 87 Proc. Nat’l Acad. Sci. 3279 (1990)Google Scholar.

77 Two typical markers that are utilized in both the FACS and MACS contexts are anti-CD71 (transferring receptor), see e.g., id., and anti-glycophorin-A (anti-GPA), which was preferred over anti-CD71 in Troeger, C. et al., A Comparison of Different Density Gradients and Antibodies for Enrichment of Fetal Erythroblasts by MACS, 19 Prenatal Diagnosis 521, 523-24 (1999)Google Scholar.

78 Hahn & Holzgreve, supra note 32, at 650.

79 See id.; Troeger, et al., A Comparison of Different Density Gradients and Antibodies for Enrichment of Fetal Erythroblasts by MACS, 19 Prenatal Diagnosis 521, 522 (1999)Google Scholar.

80 See Shulman, supra note 70, at 49.

81 See Hahn & Holzgreve, supra note 32, at 650.

82 Hahn et al., supra note 66, at 516 (noting the pioneering research of Takayabashi et al., Development of Non-Invasive Fetal DNA Diagnosis From Maternal Blood, 15 Prenatal Diagnosis 74 (1995)).

83 See Hahn et al., supra note 66, at 518.

84 Id.

85 Note that MSFCS, like amniocentesis and CVS, would likely be used to target only the more common abnormalities in order to conserve medical resources and keep the price of the test down. Nevertheless, the technique may be used (likely manually, rather than in an automated manner) to diagnose less common conditions, for which the fetus is known to be at particular risk.

86 See, e.g., Lo, Y. M. et al., Prenatal Sex Determination by DNA Amplification from Maternal Peripheral Blood, 334 Lancet 1363 (1989)Google Scholar.

87 See, e.g., Sekizawa et al., supra note 30, at 1350.

88 See, e.g., Lo, Y. M. et al., Prenatal Diagnosis of Fetal RhD Status by Molecular Analysis of Maternal Plasma, 339 New Eng. J. Med. 1734 (1998)Google Scholar.

89 See, e.g., Roderiguez de Alba et al., supra note 28, at 936.

90 Telephone Interview with Dr. Jane Chueh, supra note 7.

91 Shulman, supra note 70, at 49.

92 Id.

93 See Hahn et al., supra note 66, at 517; Hahn & Holzgreve, supra note 32, at 651.

94 For information on one lab's successful use of five-color FISH analysis, see Bischoff, F. Z. et al., Prenatal Diagnosis With Use of Fetal Cells Isolated From Maternal Blood: Five-Color FISH Analysis on Flow Sorted Cells for Chromosomes X, Y, 13, 18, and 21, 179 Am. J. Obstetrics & Gynecology 203 (1998)Google Scholar.

95 See Schroder et al., supra note 73.

96 See Ciaranfi et al., supra note 73.

97 It is not known whether fetal cells can, in fact, persist in maternal blood for 27 years, as the 27-year figure noted above may have been the result of a failed male pregnancy that occurred subsequent to the birth of the woman's last child. Nevertheless, researchers have consistently demonstrated that certain types of fetal cells persist in maternal serum for many years after birth or pregnancy termination. See, e.g., Bianchi, Diana W. et al., Male Fetal Progenitor Cells Persist in Maternal Blood for as Long as 27 Years Postpartum, 93 Proc. Nat’l. Acad. Sci. USA 705 (1996)Google Scholar; Ciaranfi et al., supra note 73.

98 Shulman, supra note 70, at 50.

99 Hahn & Holzgreve, supra note 32, at 650.

100 Bianchi et al., supra note 97, at 707.

101 Telephone interview with Dr. Jane Chueh, supra note 7.

102 Lo, Y. M. et al., Presence of Fetal DNA in Maternal Plasma and Serum, 350 Lancet 485 (1997)Google Scholar.

103 Chiu, Rossa W. K. & Lo, Y. M., The Biology and Diagnostic Applications of Fetal DNA and RNA in Maternal Plasma, 61 Current Topics in Developmental Biology 81, 84 (2004)Google Scholar.

104 Id. at 86-87. See also Bianchi, Diana W., Circulating Fetal DNA: Its Origin and Diagnostic Potential—A Review, 18 Placenta S93, S94–S96 (2004)Google Scholar.

105 Lo, Y. M. et al., Quantitative Analysis of Fetal DNA in Maternal Plasma and Serum: Implications for Non-Invasive Prenatal Diagnosis, 62 Am. Hum. Genetics 768 (1998)Google Scholar.

106 One pair of researchers notes that “[a]s a result of the relative abundance of fetal DNA in maternal plasma, its presence can be detected by a number of molecular techniques without special enrichment protocols.” Chiu & Lo, supra note 103, at 99.

107 See, e.g., Dhallan, R. et al., Methods to Increase the Percentage of Free Fetal DNA Recovered From the Maternal Circulation, 291 J. Am. Med. Ass’n 1114 (2004)Google Scholar.

108 Chung, Grace T. Y. et al., Lack of Dramatic Enrichment of Fetal DNA in Maternal Plasma by Formaldehyde Treatment, 51 Clinical Chemistry 655, 655 (2005)Google Scholar.

109 See, e.g., Li, Ying et al., Detection of Paternally Inherited Fetal Point Mutations for β-Thalassemia Using Size-Fractionated Cell-Free DNA in Maternal Plasma, 293 J. Am. Med. Ass’n 843, 844 (2005)Google Scholar.

110 See, e.g., id. See also Chan, K.C.A. et al., Size Distributions of Maternal and Fetal DNA in Maternal Plasma, 50 J. Clinical Chemistry 88, 91 (2004)Google Scholar (reporting that 86% of cell-free fetal DNA fragments recovered contained fewer than 201 base pairs).

111 In addition, simple quantitative analysis of cell-free fetal DNA may be used as a noninvasive screening measure for chromosomal abnormalities, see Lo, Y. M. et al., Increased Fetal DNA Concentrations in the Plasma of Pregnant Women Carrying Fetuses With Trisomy-21, 45 J. Clinical Chemistry 1747 (1999)Google Scholar (finding an average of twice as much fetal DNA in the blood of mothers carrying fetuses with Down Syndrome than in the blood of mothers carrying unaffected fetuses); and for pre-eclampsia, a condition of high blood pressure during pregnancy, see Bianchi, supra note 104, at S93, S98. The ultimate goal of MPFDR, however, is not to merely screen for, but accurately to diagnose, genetic conditions.

112 See, e.g., Chiu & Lo, supra note 4, at 86 (discussing the “size distribution of fetal DNA fragments in maternal plasma”) (emphasis added).

113 Id.

114 Chiu & Lo, supra note 103, at 84.

115 “[A]utomated platforms for fetal DNA extraction have been evaluated and adopted by some groups.” Id. at 100 (citing Costa, J. M. & Ernault, P., Automated Assay for Fetal DNA Analysis in Maternal Serum, 48 J. Clinical Chemistry 679 (2002)Google Scholar and Dee, R. et al., Validation of Automated Fetal DNA Extraction With the MagNA Pure for Large Scale RHD Typing on Maternal Plasma, 49 J. Clinical Chemistry S11 (2003))Google Scholar.

116 E.g, paternally inherited genetic mutations. See discussion infra p.22-23.

117 See, e.g., Lo, Y. M. et al., Rapid Clearance of Fetal DNA From Maternal Plasma, 64 Am. J. Hum. Genetics 218 (1999)Google Scholar.

118 See, e.g., id. (reporting that fetal DNA was undetectable in 7 out of 8 women just two hours postpartum).

119 See Chiu & Lo, supra note 103, at 89.

120 An individual's “Rhesus D status” refers to the presence or absence, in that individual's red blood cells, of Rhesus (Rh) factor, a protein substance that can cause a strong immune response. “Rh incompatibility” results when an Rh-negative mother (whose blood does not contain Rh factor) is carrying an Rh-positive fetus. In such situations, the presence of Rh-positive fetal cells in the mother's blood induces the formation of antibodies. These antibodies are usually harmless to the first fetus. However, a subsequent fetus is at serious risk if the mother's antibodies enter the later fetus's bloodstream and begin attacking and destroying fetal red blood cells. For this reason, it is important to learn the Rh D status of a fetus carried by an Rh-negative woman, particularly where the father is Rh-positive. Rh Factor, Encyclopedia, http://www.answers.com/Rh%20factor (last visited Jan. 21, 2007).

121 Chiu & Lo, supra note 103, at 101.

122 Bianchi, Diana W. et al., Noninvasive Prenatal Diagnosis of Fetal Rhesus D: Ready for Prime(r) Time, 106 Obstetrics & Gynecology 841, 842 (2005)Google Scholar.

123 Id. at 841.

124 Id.

125 See González-González, Cristina et al., Application of Fetal DNA Detection in Maternal Plasma: A Prenatal Diagnosis Unit Experience, 53 J. Histochemistry & Cytochemistry 307 (2005)Google Scholar.

126 Li et al., supra note 109, at 843.

127 See Chiu & Lo, supra note 103, at 90.

128 One possibility is the use of epigenetic markers, where each member of a pair of fetal chromosomes (called an “allele”) differs, depending upon who supplied it. Using a particular locus where the maternally inherited allele is unmethylated and the paternally inherited allele is methylated, one group of scientists was able to amplify the maternally inherited fetal allele separately from the background maternal DNA. Id. (citing Poon, L. L. M. et al., Differential DNA Methylation Between Fetus and Mother as a Strategy for Detecting Fetal DNA in Maternal Plasma, 48 Clinical Chemistry 35 (2002))Google Scholar. Another potential strategy employs messenger RNA molecules found only in the fetus and not in the mother. See An Earlier Look at Baby's Genes, Science, Sept. 2, 2005, at 1476, 1478.

129 See, e.g., Chiu & Lo, supra note 4, at 86 (discussing the “size distribution of fetal DNA fragments in maternal plasma”) (emphasis added).

130 Lo et al., Quantitative Analysis, supra note 105, at 768 (1998).

131 See, e.g., Chiu & Lo, supra note 103 (containing a detailed, 21-page summary of the current technology and its limitations, with no mention of potential “gaps” in the fetal genome).

132 See infra note 135.

133 Also note that scientists are currently investigating other, analogous prenatal diagnostics that are less invasive than amniocentesis and CVS, including recovery of fetal RNA from maternal plasma, see Chiu & Lo, supra note 103, at 92-94; and, most recently, isolation of intact fetal cells from cervical mucus, see Katz-Jaffe, Mandy G. et al., DNA Identification of Fetal Cells Isolated From Cervical Mucus: Potential for Early Non-Invasive Prenatal Diagnosis, 112 British J. Obstetrics & Gynecology 595 (2005)Google Scholar.

134 Telephone Interview with Dr. Jane Chueh, supra note 7. However, the prospect of using MSFCS or MPFDR as a screening measure is significant in itself. Although they would not reach the level of accuracy required to positively diagnose the fetus's condition, these technologies could identify at-risk fetuses for further testing. Moreover, because MSFCS and MPFDR could identify virtually any genetic abnormality for which scientists have a reliable test, the screening would not be limited to detecting chromosomal and anatomical abnormalities, as current screening measures are. See description of current screening measures at supra Part II. A full discussion of the use of MSFCS or MPFDR as screening tests is beyond the scope of this Article.

135 Particularly with respect to MPFDR, scientists are very optimistic. See, e.g., Bianchi, Circulating Fetal DNA, supra note 104, at S99 (“With the microarray technology that is already available it is not difficult to imagine that amplified fetal nucleic acids will ultimately permit a non-invasive fetal genome scan as part of routine prenatal screening.”); González- González et al., supra note 125, at 307 (“The detection of fetal DNA sequences is a reality and could reduce the risk of invasive techniques for certain fetal disorders in the near future.”); An Earlier Look at Baby's Genes, supra note 128, at 1476 (“Ready or not, noninvasive fetal diagnosis is here. Tests based on fetal DNA circulating in a woman's blood are expected to replace invasive prenatal tests … .”). The technology is even beginning to receive mainstream hype, as evidenced by a recent “Today Show” story, which highlighted a Massachusetts company's introduction of the “Baby Gender Mentor,” a $275 home test that apparently uses MPFDR to determine fetal sex from a maternal blood sample. Id. (citing Today Show (NBC television broadcast Jun. 17, 2005)).

136 While nationwide use of physical and chemical screening tests like ultrasound, MSAFP analysis, and the triple screen are already relatively high, current usage of genetic testing (i.e. through amniocentesis and CVS) is relatively low.

137 The 150,000 figure is an estimate, which uses the most recent CDC figures and assumes that approximately equal numbers of amniocentesis and CVS procedures are performed each year. Martin et al., supra notes 51-53 (indicating about 78,000 amniocentesis procedures performed each year in 2001, 2002, and 2003). In reality, however, the number of CVS tests (which pose slightly more risk to the developing fetus) is likely much lower than the number of amniocentesis tests. See text at supra pp. 14-15; Benn et al., supra note 55. On the other hand, the CDC's amniocentesis statistics likely underestimate the number of tests performed each year, because they record such procedures based on the number of live births each year. Presumably, a number of women who receive a positive test result opt to terminate their pregnancies, and these uses would not be counted toward the CDC's total.

138 As indicated earlier, this approximate number of pregnancies is derived from the CDC's most recent statistics on live births (about 4,000,000 each year) and abortions (between 854,000 and 1,293,000 in 2002). See Health, United States, 2005, supra note 54, at 149.

139 See Martin et al., supra notes 51-53.

140 While not officially considered “standard of care,” ultrasound is widely recommended by OB/GYNs, as evidenced by the fact that about 2/3 of all pregnancies in 2001, 2002, and 2003 were screened via ultrasound. Id. For a discussion of standard of care with respect to ultrasound and other procedures, see text at infra Part IV.B.3.

141 Chiu & Lo, supra note 103, at 81.

142 See Am. College of Obstetricians and Gynecologists, ACOG Practice Bulletin No. 58: Ultrasonography in Pregnancy, at 6 (December 2004) [hereinafter ACOG Practice Bulletin No. 58] (concluding that “ultrasound energy delivered to the fetus cannot be assumed to be completely innocuous” because it can “produce physical effects, such as mechanical vibrations … or an increase in tissue temperature” that may harm the fetus in unknown ways).

143 As noted above, the term “non-invasive,” as used in the context of prenatal genetic testing, means non-invasive to the uterus. Clearly, taking a blood sample involves puncturing the skin and is “invasive” to the pregnant woman in that sense. However, the invasiveness of concern to researchers is that which jeopardizes the integrity of the uterus.

144 Jorde et al., supra note 7, at 282.

145 Id. at 524.

146 Genetics & Pub. Pol’y Ctr., Reproductive Genetic Testing: What America Thinks 46 (2004), http://www.dnapolicy.org/images/reportpdfs/ReproGenTestAmericaThinks.pdf.

147 See, e.g., Martin et al., Births: 2002, supra note 52, at 31 (indicating that about 86.2% of live births in 2002 were women under the age of 35); Lilo T. Strauss et al., Abortion Surveillance – United States, 2002, 54 Morbidity & Mortality Weekly Rep., Nov. 25, 2005, at tbl.4, http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5407a1.htm (last visited Jan. 20, 2007) (indicating that, in 2002, about 87.7% of legal abortions in 46 states were obtained by women under the age of 35).

148 An unlikely prospect, as explained at infra Part IV.A.5.

149 Univ. of Penn. Health Sys., Amniocentesis, http://www.pennhealth.com/health_info/pregnancy/000207.htm (last visited Jan. 20, 2007); What is Amniocentesis?, http://www.babycenter.com/refcap/327.html (last visited Jan. 20, 2007).

150 See, e.g., CVS Test, Berkeley Parents Network, CVS Test, http://parents.berkeley.edu/advice/pregnancy/cvs.html (last visited Jan. 20, 2007); Chorionic Villi Sampling (CVS), http://www.answers.com/topic/chorionic-villi-sampling-cvs (last visited Jan. 20, 2007).

151 See, e.g., St. John's Mercy Health Care, Tests and Procedures: Chorionic Villus Sampling, http://www.stjohnsmercy.org/healthinfo/test/gyn/TP108.asp (last visited Jan. 20, 2007) (instructing women to “rest at home and avoid strenuous activities for at least 24 hours”); Univ. of Penn. Health Sys., Amniocentesis, supra note 149 (noting that “most physicians recommend several hours of rest”).

152 Deutchman & Sakornbut, supra note 35, at 151.

153 Genetics & Pub. Pol’y Ctr., supra note 146, at 45.

154 Id.

155 Cunniff, Christopher, Prenatal Screening and Diagnosis for Pediatricians, 114 Pediatrics 889, 892 (Sept. 2004)Google Scholar; see also ACOG Practice Bulletin No. 27, supra note 10, at 2 (estimating detection at approximately 60% for women under 35, and approximately 75% for women over 35).

156 U.S. Preventive Servs Task Force, U.S. Dep't of Health & Human Servs, Guide to Clinical Preventive Services, Section 1: Screening: Congenital Disorders: Screening for Down Syndrome (2d ed. 1996), http://odphp.osophs.dhhs.gov/pubs/guidecps/PDF/CH41.PDF (last visited Mar. 5. 2007). The variances also depended upon which fetal structures were examined (nuchal lucency, shortened femur length, etc.). More recent tests have found overall ultrasound sensitivities of about 80%, when screening for Down Syndrome. See Vintzelios, et al., Indication-Specific Accuracy of Second-Trimester Genetic Ultrasonography for the Detection of Trisomy-21, 181 Am. J. Obstetrics & Gynecology 1045 (1999)Google Scholar.

157 Suter, Sonia Mateu, The Routinization of Prenatal Testing, 28 Am. J. L. & Med. 233, 258 n.155 (2002)Google Scholar.

158 Id.

159 Id.

160 See Planned Parenthood of Southeastern Pa. v. Casey, 505 U.S. 833, 873 (1992).

161 See, e.g., Palo Alto Medical Foundation, Your Second Trimester Testing and Exams, http://www.pamf.org/pregnancy/second/prenatal.html (last visited Jan. 20, 2007) (noting that ultrasound is often used for a “routine anatomy scan of the fetus at 18 to 20 weeks”). The American College of Obstetricians and Gynecologists (ACOG) has recently issued a committee opinion noting that first trimester screening may be an option for some women, but only if strict criteria are met (such as maintaining high standards of ultrasound training and quality control, and ensuring availability of diagnostic tests following positive diagnoses). See News Release, ACOG, ACOG Issues Position on First Trimester Screening Methods (June 30, 2004), available at http://www.acog.org/from_home/publications/press_releases/nr06-30-04.cfm (last visited Jan. 20, 2007).

162 See Jorde et al., supra note 7, at 282; Hahn et al., supra note 66, at 516.

163 Chiu & Lo, supra note 103, at 84.

164 Draft Genetic Test Review, supra note 37, at 4-38.

165 See id. at 4-45 to 4-46 (listing several researchers’ calculations of costs, including: $200 in 1994 dollars [or $255 in 2005 dollars], $315 in 1996 dollars [or $382 in 2005 dollars], and $332 in 1996 dollars [or $403 in 2005 dollars]).

166 See Chiu & Lo, supra note 4, at 100 (noting and citing the research of scientists who have “evaluated and adopted” “automated platforms for fetal DNA extraction”).

167 Hahn & Holzgreve, supra note 17, at 651.

168 See, e.g., Grizzly Analytical Biotech Lab Equipment, Used/reconditioned/rebuilt Biotech Lab Equipment, Jan. 18, 2007, http://www.grizzlyanalytical.com/ (last visited Jan. 20, 2007) ($153,500 for a used 2001 FACSVantage™ system); Pacific Laboratory Medicine Services, Clinical Immunology Fees Policy, http://www.palmslab.com.au/research/ flowcyto.pdf (about $180,000 U.S. dollars for a FACSVantage™ SE system, in 2000); RE: FACScanto, http://www.cyto.purdue.edu/hmarchiv/2004/1666.htm (last visited Jan. 20, 2007) (about $215,000 U.S. dollars for a FACSCanto™ system, one of BD Biosciences's most state-of-the art models).

169 See, e.g., BD Biosciences, Magnetic Cell Separation, hhttp://www.bdbiosciences.com (listing the BD iMagnet™ at $495) (last visited Jan. 20, 2007). Compare this with the $50,000 to $200,000 outlay for clinic-quality ultrasound equipment currently used in prenatal testing. See, e.g., Heidi Evans, Doctors Who Perform Fetal Sonograms Often Lack Sufficient Training and Skill, Wall St. J., June 20, 1995, at B1 (“most sophisticated equipment” can cost up to $200,000); Prod. Eng’g – Med. Equip. Div., http://www.pemed.com/ultrasnd/ultrasnd.htm (“list” prices range from $38,000 to $165,000 for clinical ultrasound equipment) (last visited Jan. 20, 2007).

170 The FACSCanto™ by BD Biosciences boasts speeds of up to 10,000 events per second. See BD Biosciences Releases BD FACSCanto™ Flow Cytometry System for Clinical Diagnostics, Sept. 21, 2004, http://www.bd.com/contentmanager/b_article.asp?Item_ID=21690&ContentType_ID=1&BusinessCode=20001&d=&s=&dTitle=&d c=&dcTitle= (last visited Jan. 20, 2007).

171 See University of Massachusetts, Amherst, Introduction to the Flow Cytometry Facility: Cost & Availability, http://www.bio.umass.edu/mcbfacs/intro.htm#cost (last visited Jan. 20, 2007).

172 Li et al., supra note 109, at 849.

173 See Bruno Verhasselt, Comparison of the Different Real-Time PCR Machines 1, 24, http://72.14.207.104/search?q=cache:UgO4UoIMzJQJ:www.cytometry.be/RTPCR2004/Verhasselt.pdf+cost+of+a+PCR+machine+Rotor+Gene&hl=en&start=10 (last visited Jan. 20, 2007) (showing prices from about 35,000 to about 120,000 Euros).

174 See Quantitative Real Time PCR: Blake's Cost Benefit Analysis, http://www.uttyler.edu/biology/Bextine/bextineQRTPCR.htm (last updated Jun. 19, 2006).

175 See Draft Genetic Test Review, supra note 37, at 4-39 (“This estimate includes the costs of reagents, supplies, licenses, royalties, technician time, administrative time and overhead. In the future, it is likely that automation and competition will reduce these costs.”).

176 Li et al., supra note 109, at 849.

177 Most fetuses with major chromosomal abnormalities are spontaneously aborted.

178 Draft Genetic Test Review, supra note 37, at 4-45 (estimating the lab costs of amniocentesis to be between $400 and $600, depending on whether karyotyping is performed).

179 See, e.g., Bette Van Metter, Ultrasound, http://parenting.ivillage.com/pregnancy/psecondtri/0,,43hx-p,00.html (last visited Jan. 20, 2007) ($200 to $300); Ultrasound for Screening During Pregnancy, http://www.tennesseehealth.com/main-before-you-buy/MedicalTechnologies/Medical_Value_Index/ULTRASOUND_FOR_SCREENING_DURING_PREGNANCY.HTM (last visited Apr. 20, 2006) (average cost of $250.42, but range of $126 to $350).

180 Marcia Mobilia Boumil et al., Medical Liability in a Nutshell 25 (2d ed. 2003).

181 Id. at 25-26.

182 Barry R. Furrow et al., Health Law 174 (4th ed. 2001).

183 See, e.g., Cayton v. English, 23 F.2d 745, 748-49 (D.C. Cir. 1927) (noting that the lower court correctly instructed the jury that an osteopathic physician was to be held to the standard of an ordinary skillful practitioner of the osteopathic school); Force v. Gregory, 27 A. 1116, 1116-17 (Conn. 1893) (holding, in a malpractice action against a homeopathic physician, that defendant was to be judged by the tenets and practices of his own school).

184 See, e.g., SeaRiver Maritime, Inc. v. Indus. Med. Serv., Inc., 983 F. Supp. 1287, 1296 (N.D. Cal. 1997) (“physician must exercise the degree of skill or care possessed by doctors in good standing practicing in the same locality under similar circumstances”); Taylor v. Wilmington Med. Ctr., Inc., 577 F. Supp. 309 (D. Del. 1983) (neurosurgeon in Wilmington must conform to the standards of comparable specialists practicing in that city); Swan v. Lamb, 584 P.2d 814, 817 (Utah 1978) (professed expert surgeons in Salt Lake City should be held to the standard of care exercised by experts in the same field in cities of comparable size).

185 Robbins v. Footer, 553 F.2d 123, 128-29 (D.C. Cir. 1977); see also Rojas-Ithier v. Sociedad Espanola de Auxilio Mutuo y Beneficiencia de Puerto Rico, 394 F.3d 40, 43 (1st Cir. 2005) (“Puerto Rico law holds physicians to a national standard of care.”); Nalder v. West Park Hosp., 254 F.3d 1168, 1175-76 (10th Cir. 2001) (for purposes of medical malpractice claims, Wyoming requires nationally board certified physicians to conform to a standard of care adhered to by that national board, not a local standard of care).

186 Furrow et al., supra note 182, at 266 (“Neither the Food and Drug Administration, the National Institutes of Health, the Department of Health and Human Services nor state licensing boards have had much to do with shaping medical practice.”).

187 Id.

188 ACOG, for example, organizes conferences and seminars on important professional topics and sponsors “online discussions” from its website. See The American College of Obstetricians and Gynecologists, http://www.acog.org (last visited Jan. 20, 2007).

189 The number of “clinical research articles based on randomized clinical trials jumped from about 100 per year to 10,000 annually” between 1966 and 1995. Furrow et al., supra note 182, at 270.

190 Some include the American Journal of Obstetrics and Gynecology; the British Journal of Obstetrics and Gynecology; Clinical Obstetrics and Gynecology; International Journal of Obstetric Anesthesia; Journal of Obstetric, Gynecologic, and Neonatal Nursing; Obstetrical and Gynecological Survey; Journal of Maternal-Fetal Investigation; and Maternal and Child Health Journal. Many OB/GYN articles are also published in general—rather than practice-specific—medical journals such as the Journal of the American Medical Association or The Lancet.

191 The publication features “original articles and research studies on: scientific advances, new medical and surgical techniques, obstetric management, and clinical evaluation of drugs and instruments.” See American College of Obstetricians and Gynecologists, http://www.acog.org/navbar/current/greenJournalLeader.cfm (last visited Jan. 20, 2007).

192 See NGC - National Guideline Clearinghouse, www.guideline.gov (last visited Jan. 20, 2007).

193 Furrow et al., supra note 182, at 267.

194 Id. at 268.

195 See Inst. of Med., Clinical Guidelines: Directions for a New Program 38 (M. Field & K. Lohr, eds. 1990), available at http://books.nap.edu/books/0309043468/html/index.html

196 Furrow et al., supra note 182, at 269.

197 See, e.g., Green v. Goldberg, 630 So.2d 606, 609 (Fla. Dist. Ct. App. 1993) (ACOG bulletin on breast cancer treatment could be used to cross-examine expert witness); Miles v. Edward O. Tabor, M.D., Inc., 443 N.E.2d 1302, 1303 (Mass. 1982) (obstetrician violated ACOG guidelines by failing to resuscitate infant immediately following delivery).

198 Suter, supra note 157, at 252.

199 Id.; see also Basten v. United States, 848 F. Supp. 962, 967 (M.D. Ala. 1994).

200 Suter, supra note 157, at 252-53.

201 See, e.g., Basten, 848 F. Supp. at 967-68.

202 Olney et al., supra note 46, at 2.

203 Such Practice Bulletins are considered “Clinical Management Guidelines for Obstetrician-Gynecologists,” but, as with all recent ACOG recommendations, each bulletin is careful to include a disclaimer that “[t]hese guidelines should not be construed as dictating an exclusive course of treatment or procedure … .” See, e.g., ACOG Practice Bulletin No. 27, supra note 10, at 1.

204 Id. at 8.

205 See citations at infra notes 206-07.

206 Nat’l Insts. of Health, Prenatal Diagnosis: First and Second Trimester Evaluation of Aneuploidy Risk (Faster), 43 (May 2004), available at http://www.nichd.nih.gov/publications/pubs/upload/Council_MRDD_2001.pdf (describing a multi-center prospective study to compare first- and second-trimester noninvasive screening methods for fetal aneuploidy).

207 ACOG Practice Bulletin No. 27, supra note 10, at 2; see also Am. Coll. of Obstetricians & Gynecologists, ACOG Committee Opinion No. 296: First-Trimester Screening for Fetal Aneuploidy, 1 (July 2004) [hereinafter ACOG Committee Opinion No. 296] (second-trimester maternal serum screening is “commonly offered” to test for (fetal aneuploidy and) neural tube defects and other fetal malformations); Am. Acad. of Pediatrics & Am. Coll. of Obstetricians & Gynecologists, Guidelines for Perinatal Care 95 (5th ed. 2002) (“Women who are younger than 35 years as of the estimated delivery date should be offered multiple marker serum screening to assess the risk of trisomy 21, ideally between 16 and 18 weeks of gestation… . MSAFP testing also should be offered to all pregnant women not undergoing amniocentesis … ideally between 16 and 18 weeks of gestation.”).

208 ACOG Practice Bulletin No. 27, supra note 10, at 2.

209 See, e.g., Dr. Joseph Woo, A Short History of Amniocentesis, Fetoscopy and Chorionic Villus Sampling, available at http://www.ob-ultrasound.net/amniocentesis.html.

210 ACOG Practice Bulletin No. 27, supra note 10, at 2; ACOG Committee Opinion No. 296, supra note 207, at 1.

211 ACOG Practice Bulletin No. 27, supra note 10, at 4.

212 Id.

213 ACOG Committee Opinion No. 296, supra note 207, at 2.

214 Id. at 2. The criteria included: appropriate ultrasound training and quality control, sufficient resources for comprehensive genetic counseling, and access to the appropriate diagnostic test in the event of a positive diagnosis. Id. at 2-3.

215 Martin et al., Births: 2002, supra note 52, at 79.

216 See Rubenstein, James B., What is Ultrasound and How is it Used?, N.Y. Daily News Health, Mar. 14, 2002Google Scholar, http://nydailynews.healthology.com/nydailynews/16236.htm (last visited Apr. 22, 2006). The National Collaborating Centre for Women's and Children's Health, based at the Royal College of Obstetricians and Gynecologists in the U.K., lists, as a “Class A” recommendation, that women should be offered an early ultrasound (prior to 12 weeks), and notes the routine offering of a later ultrasound (at 18-20 weeks) to test for structural abnormalities. Nat’l Collaborating Ctr. for Women's & Children's Health, Antenatal Care: Routine Care for the Healthy Pregnant Woman (2003), available at http://www.guideline.gov/summary/summary.aspx?doc_id=4808&nbr=3470&string=routine+AND+ultrasound.

217 ACOG Practice Bulletin No. 58, supra note 142, at 8-9.

218 Id. at 6.

219 Id. at 6, 9.

220 An Earlier Look at Baby's Genes, supra note 128, at 1476 (citing U.S. National Institute of Child Health and Human Development Fetal Cell Study, or NIFTY trial).

221 Rodriguez de Alba et al., supra note 28, at 937-40.

222 Bianchi et al., Noninvasive Prenatal Diagnosis, supra note 122, at 842.

223 Wrongful life lawsuits, which are more controversial than wrongful birth lawsuits, have nonetheless been recognized in several states. See, e.g., Turpin v. Sortini, 643 P.2d 954 (Cal. 1982); Procanik v. Cillo, 478 A.2d 755 (N.J. 1984); Harbeson v. Parke-Davis, Inc., 656 P.2d 483 (Wash. 1983).

224 See, e.g., Phillips v. United States, 566 F.Supp. 1 (D.C.S.C. 1981) (failure to perform amniocentesis that would have diagnosed Down Syndrome in fetus); Berman v. Allan, 404 A.2d 8 (N.J. 1979) (failure to inform patient about availability of amniocentesis that would have disclosed Down Syndrome in fetus).

225 See, e.g., Smith v. Saraf, 148 F. Supp. 2d 504 (D.N.J. 2001.) (failure to perform either a “triple screen” or an alpha-fetoprotein test that would have revealed severe neural tube defects); Basten v. United States, 848 F. Supp. 962 (M.D. Ala. 1994) (failure to offer MSAFP screening that would have disclosed neural tube defects in fetus).

226 Furrow et al., supra note 182, at 466.

227 Id. at 468.

228 See Sang, Jeffrey R., First-Party Insurance Coverage for Medically Necessary Treatment, 15 Am. Jur. 3d Proof of Facts 355, § 2 (1991)Google Scholar (“definitions of medical necessity are almost as numerous and diverse as the cases in which they are found”).

229 75 A.L.R. 4th 763 (1990 & Supp. 1998).

230 E.g. medical necessity exists when, in the insurer's own “interpretation of accepted medical standards, it cannot be omitted without adversely affecting the patient's condition.” Jacob v. Blue Cross & Blue Shield of Oregon, 758 P.2d 382, 383 (Or. Ct. App. 1988).

231 E.g. medical necessity exists only if a procedure: (a) is ordered by one's physician and (b) is “commonly and customarily recognized throughout the doctor's profession as appropriate in the treatment of the sickness or injury and (c) is neither experimental nor educational and (d) “is not allocable to scholastic education or vocational training of the patient” in the case of hospital confinement.” Dozsa v. Crum & Forster Ins. Co., 716 F. Supp. 131, 134 (D.N.J. 1989).

232 Id.

233 For a discussion of standard of care in prenatal genetic diagnosis, see text at supra Part IV.B.

234 Furrow et al., supra note 182, at 470.

235 Some states consider a viable fetus a “person” for the purposes of certain statutes. See, e.g., Commonwealth v. Morris, 142 S.W.3d 654 (Ky. 2004) (unborn child is a “person” for purposes of homicide statute) and Whitner v. State, 492 S.E.2d 777 (S.C. 1997) (viable fetus is a “child” under child abuse and endangerment statute). However, it is unquestionable that a 15-17 week old fetus could not survive outside the womb, even with the most advanced technological assistance. See Pro-Life America, Facts of Fetal Development, http://www.prolife.com/FETALDEV.html (last visited May 5, 2006) (citing Allen, M. et al., The Limits of Viability, 329 New Eng. J. Med. 1597 (1993)Google Scholar) (at 23 weeks, the fetus has a 15% chance of viability outside the womb; at 24 weeks, the chance rises to 56%). Even if the fetus could be considered a “person” requiring “treatment,” however, medical necessity provisions likely apply only to the individual listed on the policy, not to any unborn children of the insured. And mere diagnosis of another “person’s” health is unlikely to constitute “treatment,” even if the natural and voluntary state of pregnancy could be considered a “condition” requiring such treatment.

236 I am not aware of any such situations, as Rh incompatibility (discoverable by prenatal genetic testing) poses no risk to maternal health. Indeed, it is typically the mother's health conditions (i.e. diabetes, seizures, infections, asthma, or family history of genetic disease) that pose a risk for the developing fetus, not the other way around. However, I cannot rule such circumstances out completely. It is possible, for example, that certain genetic disorders of the fetus could increase the possibility of pre-eclampsia during delivery, thus endangering both mother and fetus.

237 See, e.g., U.S. Dep't of Health & Hum. Srvcs., Coverage and Reimbursement of Genetic Tests and Services: Report of the Secretary's Advisory Committee on Genetics, Health, and Society 17-18 (Feb. 2006) [hereinafter Coverage and Reimbursement of Genetic Tests], available at http://www4.od.nih.gov/oba/sacghs/reports/CR_report.pdf (“Of the few [private] coverage policies that are publicly available, most cover genetic testing for … prenatal and neonatal diagnosis … in certain situations (e.g. advanced maternal age, suspected fetal anomaly, or history of miscarriage or developmental problems in prior pregnancies).”); Univ. of California, San Francisco, Children's Hospital, Prenatal Diagnosis: Amniocentesis, http://www.ucsfhealth.org/childrens/medical_services/preg/prenatal/amniocentesis.html (last visited Jan. 20, 2007) (“Most insurance plans cover amniocentesis …, especially for women over 35 years of age”).

238 Harvard Univ. Health Srvc., Harvard Student Health Insurance Handbook 24 (2005-06).

239 Aetna, Inc., Clinical Policy Bulletin No. 0140: Genetic Testing (reviewed Apr. 22, 2005), available at http://www.aetna.com/cpb/medical/data/100_199/0140.html.

240 Around 80% of all babies with Down Syndrome are born to women under 35. See Nat’l Down Syndrome Soc’y, Down Syndrome: Myths and Truths, http://www.ndss.org/index.php?option=com_content&task=category&sectionid=23&id=58&Itemid=234 (last visited Jan. 20, 2007) [hereinafter Down Syndrome: Myths and Truths].

241 See Lieu, Tracy A. et al., The Cost of Medical Care for Patients with Cystic Fibrosis in a Health Maintenance Organization, 103 Pediatrics 72 (1999)Google Scholar.

242 See Beazoglou, Tryfon et al., Economic Evaluation of Prenatal Screening for Down Syndrome in the U.S.A., 18 Prenatal Diagnosis 1241, 1242 (1998)Google Scholar (estimating lifetime incremental costs of Down Syndrome, in 1996, to be about $504,000).

243 See Krauth, C. et al., Cystic Fibrosis: Cost of Illness and Considerations for the Economic Evaluation of Potential Therapies, 21 Pharmacoeconomics 1001 (2003)Google Scholar (estimating lifetime costs of CF, in 2003, to be $200,000 to $300,000). These numbers, however, may be much higher, depending upon the severity of the disease. One study estimated average annual costs of $13,300 for each CF patient, in 1996. With a 30-year lifespan, this results in over $399,000 in lifetime costs in 1996 dollars, or nearly $485,000 in 2005 dollars. See Lieu et al., supra note 241, at 72.

244 Down Syndrome: Myths and Truths, supra note 240 (“Down syndrome occurs in 1 in 800 to 1,000 births.”); Anthony J. F. Griffiths et al., Modern Genetic Analysis, at tbl.11-1 (7th ed. 1999) (citing CF incidence as “1/1600 Caucasians”); Martin et al., Births: 2003, supra note 53, at 37 (noting an estimated 2,300,000 yearly “non-Hispanic White” births); Part V at tbl.1.

245 In this sub-section, the term “catch” refers to any fetus that is both positively diagnosed and aborted.

246 Note that the following exercise is meant as a rudimentary estimation to illustrate a point. In reality, the calculations get trickier, because seriously disabled children become eligible for Medicaid rather quickly.

247 This figure assumes that MSFCS and MPFDR are, or are beginning to become, the standard of care. Of course, this may not occur until several years after the tests’ introduction.

248 Nat’l Inst. of Health, Down Syndrome, Genetics Home Reference (Sept. 2005), http://ghr.nlm.nih.gov/condition=downsyndrome.

249 See U.S. Envtl. Prot. Agency, The Cost of Illness Handbook, at III.8-8, tbl.III.8-2, (1991 & Supp. 2004), available at http://www.epa.gov/oppt/coi (assuming a 5% discount rate and converting from 1996 dollars to 2005 dollars by using an inflation calculator).

250 Four million women is an estimate, based on the number of live births each year. However, a certain percentage of these births are multiple births, so the actual number of pregnant U.S. women each year is lower than 4 million. However, this merely makes my estimate more conservative.

251 This assumes that there is no correlation between the status of carrying a fetus with Down Syndrome and a woman's desire or ability to obtain prenatal genetic testing.

252 Note that this is a conservative figure. In fact, amniocentesis and CVS are both at least 99% accurate, according to ACOG. See ACOG Practice Bulletin No. 27, supra note 8, at 5.

253 Note that this is a conservative figure, as studies show that termination rates range from 85-95% upon positive diagnosis. See, e.g., Kramer, Ralph L. et al., Determinants of Parental Decisions After the Prenatal Diagnosis of Down Syndrome, 79 Am. J. Med. Genetics 172, 172-73 (1998)Google Scholar (finding an elective termination rate of 86.9%, regardless of race, religion, or insurance); Vincent, V.A. et al., Pregnancy Termination Because of Chromosomal Abnormalities: A Study of 26,950 Amniocenteses in the Southeast, 84 South Med. J. 1210 (1991)Google Scholar (finding termination rates of 92% to 95% for autosomal trisomies, at 14 centers in the southeastern U.S.).

254 Nat’l Governors Ass’n, Ctr. for Best Practices, MCH Update: States Protect Health Care Coverage during Recent Fiscal Downturn, at tbl.1 (Aug. 11, 2005) (Draft), available at http://www.nga.org/Files/pdf/0508MCHUPDATE.PDF (noting that Medicaid births comprised 37.24% of nationwide births in 2001, and 36.07% of nationwide births in 2000).

255 See, e.g., 42 U.S.C. § 1396 (1984).

256 See Furrow et al., supra note 182, at 728; 42 U.S.C. § 1396a(a)(10)(A)(i)(III-IV) (2005); 42 U.S.C. § 1396d(n) (2004).

257 Furrow et al., supra note 182, at 586.

258 42 C.F.R. § 441.200 (1987).

259 42 U.S.C. § 1397ee(c)(1) (2003).

260 See Guttmacher Inst., State Policies in Brief: State Funding of Abortion Under Medicaid, 1-2 (March 1, 2007), available at http://www.guttmacher.org/statecenter/spibs/spib_SFAM.pdf.

261 See Henry J. Kaiser Family Foundation, Medicaid Coverage of Perinatal Services: Results of a National Survey 14 & 16 tbl.II-5 (2001), available at http://www.kff.org/womenshealth/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=13738 [hereinafter Medicaid Coverage of Perinatal Services].

262 Indeed, a plain language reading of the Hyde Amendment and state constitutional equivalents almost certainly precludes the argument that public funding of prenatal genetic testing constitutes public funding of abortion. The Arkansas Supreme Court faced this question when abortion rights opponents filed suit against the University of Arkansas School of Medical Science, alleging that the University's genetics program violated a state constitutional amendment. See Knowlton v. Ward, 889 S.W.2d 721 (Ark. 1994). A Hyde analog, the Arkansas amendment provided that “[n]o public funds will be used to pay for any abortion, except to save the mother's life.” Ark. Const. amend. 68, § 1. Consistent with the language of the amendment, the Arkansas high court limited the funding ban to actual payment for abortions. Knowlton, 889 S.W.2d 721. It held that “the plain and unambiguous meaning of this provision does not prohibit the [genetic] testing, diagnosis, and counseling to families during the preconceptional, prenatal and postnatal periods that is performed at [the University].” Id. at 726.

263 See, e.g., Ark. Const. amend. 68, § 2 (“The policy of Arkansas is to protect the life of every unborn child from conception until birth, to the extent permitted by the Federal Constitution.”).

264 As noted by the Secretary of Health and Human Services’ Advisory Committee on Genetics, Health, and Society, “Coverage decisions in some States also may be affected by the fact that genetic tests are used for reproductive decisionmaking or family planning, which are viewed by some as tests that can lead to pregnancy termination.” Coverage and Reimbursement of Genetic Tests, supra note 237, at 32.

265 Medicaid Coverage of Perinatal Services, supra note 261, at 14 & 16 tbl.II-5. This national survey, conducted in 2000, found that all states surveyed except one (Colorado) provided state Medicaid funding for amniocentesis, and all states surveyed except five (California, Colorado, Missouri, Oklahoma, and West Virginia) provided state Medicaid funding for CVS. Mississippi, New Mexico, and Wyoming did not respond to the survey. Id. at 16 tbl.II-5. More recent information seems to confirm this trend. See, e.g., Alabama Medicaid Agency, FY 2004 Annual Report 27, available at http://www.medicaid.alabama.gov/documents/Resources/4J-4_Annual%20Reports/4J-Medicaid.AR2004.pdf (“Medically indicated procedures such as ultrasound, non-stress tests, and amniocentesis are examples of other services covered by Medicaid.”).

266 They are equivalents in that genetic material is used to make diagnoses that could lead to abortion.

267 Coverage and Reimbursement of Genetic Tests, supra note 237, at 5.

268 Henry J. Kaiser Family Foundation, Medicaid Facts: Medicaid's Role for the Disabled Population Under Age 65, at 1-2 (Apr. 2001) (“Medicaid's disabled population has a wide range of physical and mental conditions including … cystic fibrosis, Downs Syndrome, mental retardation, autism, [and] spina bifida … .”).

269 Calculations are based upon an estimated 4 million total live births and an estimated 49% female live births each year in the United States. See, e.g., Martin et al., Births: 2003, supra note 53, at 8, 48. Incidence data is derived from the following sources: Anthony J. F. Griffiths et al., Modern Genetic Analysis, at tbl.11-1 (7th ed. 1999) (cystic fibrosis, Tay- Sachs disease, hemophilia, and sickle cell disease); Huntington's Disease Soc’y of America, Fast Facts About HD, (2006) http://huntingtondisease.tripod.com/usfhdcenterofexcellence/id14.html; Nat’l Inst. of Health, supra note 247; Nat’l Inst. of Health, Turner Syndrome, Genetics Home Reference, Sept. 2005, http://ghr.nlm.nih.gov/condition=turnersyndrome; Statistics By Country for Klinefelter Syndrome, http://www.wrongdiagnosis.com/k/klinefelter_syndrome/stats-country.htm (last visited Apr. 29, 2006).

270 The basic formula is: Estimated Births if MSFCS/MPFDR Become Widespread = (Current Incidence) – [(Current Incidence) * 0.675 * 0.98 * (Disorder-Specific Rate of Pregnancy Termination)]. The estimates that I use are relatively conservative. I assume MSFCS/MPFDR usage by approximately 2,700,000 women out of 4,000,000 live births each year in the U.S. (67.5%), and an accuracy rate of only 98%. For simplicity's sake, I assume the full 2% of testing errors are false negatives, and thus, do not count toward the number of “catches.” In addition, I include totals at both the lower and upper estimates for “approx. rate of pregnancy termination.” Note also that while I use the same fractional approximation (67.5%) for sub-populations, it is likely that this is not fully accurate. For example, it is possible that, due to varying socioeconomic conditions, the Ashkenazi Jewish population would obtain prenatal genetic testing for Tay-Sachs at greater rates than 67.5%, and the African American population would obtain prenatal genetic testing for sickle cell disease at lower rates than 67.5%.

271 Such rates will obviously vary region-by-region. The figures cited in Table 1 are estimates, based upon scientific studies that recorded rates of pregnancy termination. Where possible, I focused on U.S. studies.

272 Multiple testing of this nature is currently too costly and time-consuming; thus, a fetus is usually tested only for conditions for it is at heightened risk. See Telephone Interview with Dr. Jane Chueh, supra note 7. However, the introduction of automation could make multiple testing a routine part of clinical practice.

273 See, e.g., Ralph L. Kramer et al., supra note 253, at 172-173 (finding an elective termination rate of 86.9%, regardless of race, religion, or insurance); V.A. Vincent et al., supra note 253 (finding termination rates of 92% to 95% for autosomal trisomies, at 14 centers in the southeastern U.S.).

274 See, e.g., Tex. Dep't of State Health Srvcs., Birth Defects Risk Factor Series: Turner Syndrome (2002) http://www.dshs.state.tx.us/birthdefects/risk/risk25-turner.shtm (citing termination rates from 11 different studies in several nations, which range from 64% to 100%). As U.S. studies are scarce, my (conservative) estimate is at the lower end.

275 See Forrester, M. B. & Merz, Ruth D., Pregnancy Outcome and Prenatal Diagnosis of Sex Chromosome Abnormalities in Hawaii, 1986-1999, 119 Am J. Med. Genetics 305 (2003)Google Scholar (46% termination rate); see also Mansfield, Caroline et al., Termination Rates After Prenatal Diagnosis of Down Syndrome, Spina Bifida, Anencephaly, and Turner and Klinefelter Syndromes, 19 Prenatal Diagnosis 808 (1999)Google Scholar (58% termination rate); Marteau, Theresa M. et al., Outcomes of Pregnancies Diagnosed with Klinefelter Syndrome: The Possible Influence of Health Professionals, 22 Prenatal Diagnosis 562 (2002)Google Scholar (44% termination rate across 5 European nations and 11 years).

276 This is based upon an estimated 600,000 yearly African American births. See Martin et al., Births: 2003, supra note 53, at 29.

277 See, e.g., Wang, X. et al., Experience With 500 Prenatal Diagnoses of Sickle Cell diseases: The Effect of Gestational Age on Affected Pregnancy Outcome, 14 Prenatal Diagnosis 851 (1994)Google Scholar (finding, in New York, a 51% termination rate).

278 Study results are based on questionnaire responses, rather than actual terminations. See, e.g., Karimi, M. et al., Comparison of Attitudes Towards Prenatal Diagnosis and Termination of Pregnancy for Haemophilia in Iran and Italy, 10 Haemophilia 367, 367 (2004)Google Scholar (16.7% of Italian respondents accepted pregnancy termination for hemophilia); Kraus, E. M. & Brettler, D. B., Assessment of Reproductive Risks and Intentions by Mothers of Children With Hemaphilia, 31 Am. J. Med. Genetics 259 (1988)Google Scholar (17% would terminate); Ranta, S. et al., Hemophilia A: Experiences and Attitudes of Mothers, Sisters, and Daughters, 11 J. Pediatric Hematology/Oncology 387 (1994)Google Scholar (16% of women would definitely terminate).

279 Bloch, M. et al., Predictive Testing for Huntington Disease: Demographic Characteristics, Life-style Patterns, Attitudes, and Psychosocial Assessments of the First Fifty-One Test Candidates, 32 Am. J. Med. Genetics 217 (1989)Google Scholar (29.4% would obtain prenatal testing and terminate a high-risk fetus); Maat-Kievit, A. et al., Experience in Prenatal Testing for Huntington's Disease in The Netherlands: Procedures, Results and Guidelines (1987-1997), 19 Prenatal Diagnosis 450, 450 & 452 (1999)Google Scholar (39% of fetuses at increased risk were terminated); Markel, D. S. et al., At-risk Persons’ Attitudes Toward Presymptomatic and Prenatal Testing of Huntington Disease in Michigan, 26 Am. J. Med. Genetics 295 (1987)Google Scholar (21% would undergo prenatal testing and terminate an affected fetus).

280 This is based upon an estimated 2,300,000 yearly “non-Hispanic White” births. Martin et al., Births: 2003, supra note 53, at 37.

281 U.S. studies are scarce. But see, e.g., Henneman, L. et al., Attitudes Towards Reproductive Issues and Carrier Testing Among Adult Patients and Parents of Children With Cystic Fibrosis (CF), 21 Prenatal Diagnosis 1, 5 tbl.4 (2001)Google Scholar (45% of parents would abort); Simpson, Neil et al., The Cost-Effectiveness of Neonatal Screening for Cystic Fibrosis: An Analysis of Alternative Scenarios Using a Decision Model, 3 Cost-Effectiveness & Resource Allocation 10 (2005)Google Scholar, available at http://www.resource-allocation.com/content/pdf/1478-7547-3-8.pdf (surveys suggest about 50% of affected individuals and their family would terminate).

282 This figure is estimated based upon Tay Sach's severity, its extremely shortened life span (affected children rarely live beyond age five), and its classification as a disease of the central nervous system. See Schechtman, Kenneth B. et al., Decision-Making for Termination of Pregnancies with Fetal Anomalies: Analysis of 53,000 Pregnancies, 99 Obstetrics & Gynecology 216 (2002)Google Scholar (finding that termination rates are higher for diseases of greater severity, and in particular, for diseases of the central nervous system).

283 See Gillott, John, Screening for Disability: A Eugenic Pursuit?, 27 J. Med. Ethics ii21, ii22 (Supp. II 2001)CrossRefGoogle Scholar (“We cannot avoid the fact that the primary choice offered by these services is the choice to avoid having a child with a genetic condition … .”).

284 Roop, Wendy E., Not in My Womb: Compelled Prenatal Genetic Testing, 27 Hastings Const. L.Q. 397, 409 (2000)Google Scholar.

285 See, e.g., Andrews, Lori B., Prenatal Screening and the Culture of Motherhood, 47 Hastings L.J. 967, 981-82 (1996)Google Scholar (“Society may make women feel guilty for continuing the pregnancy of a fetus with even a slight disability.”).

286 Amy Harmon, Burden of Knowledge: Tracking Prenatal Health; In New Tests for Fetal Defects, Agonizing Choices for Parents, N.Y. Times, June 20, 2004, available at http://query.nytimes.com/gst/fullpage.html?sec=health&res=9402EED91539F933A15755C0A9629C8B63. This article mentions the pressure on many women in anti-abortion regions, quoting the manager of an Internet support group for people who have terminated pregnancies because of their fetus's health: “‘I cannot turn on the computer any day without getting an e-mail from someone who needs help[.]’ … ‘But nobody's talking about it. Certainly not here in southeastern Virgina[.]’” Id. The decision can be even harder where, as in numerous cases, a woman's decision “contradict[s] [her] previously held beliefs.” Id. (“‘People will come into my office in tears and say they’ve been against abortion their whole lives,’ [Dr. John Larsen] said, ‘but they’ll make an exception for themselves.’”).

287 See, e.g., Andrews, supra note 285, at 972; Roop, supra note 284 (considering, but rejecting, the possibility that states could compel women to undergo prenatal genetic diagnosis).

288 See Suter, supra note 157, at 233 (titling her article The Routinization of Prenatal Testing).

289 Id. at 234.

290 Id. at 253 (noting that, following California's legal mandate that healthcare providers offer MSAFP screening to all pregnant patients, some doctors “tried to make it difficult for women to refuse by telling them to take the test”). Indeed, such efforts may also have the consequence of bestowing de facto standard-of-care status on MSFCS or MPFDR before they have obtained the support of the medical community.

291 Id. at 253-54 (describing how California's mandate to offer MSAFP screening to all pregnant women “profoundly influenced the way in which providers offered, described and discussed MSAFP screening,” including: calling it a “simple blood test,” spending no more than two minutes discussing the procedure, failing to explain that it was voluntary, or failing to explain the purpose of the test).

292 For example, if a fetus is found to have a dominant genetic disease like Huntington's disease, for which the mother or father is known to be at risk (e.g. because one of their parents has the disorder), a positive diagnosis for the fetus is a positive diagnosis for the at-risk parent as well. See Andrews, supra note 285, at 976. Such revelations could also raise paternity issues if, for example, the fetus is found to have Huntington's disease, but neither the mother nor her husband are at risk of developing the disease; in that case, a positive diagnosis of the fetus means that the husband is not the fetus's true father.

293 See Planned Parenthood of Southeastern Pa. v. Casey, 505 U.S. 833, 857 (1992) (noting that constitutional developments since Roe v. Wade have not disturbed or diminished “the recognized protection accorded to the liberty relating to intimate relationships, the family, and decisions about whether or not to beget or bear a child” and that Roe may also be seen as supporting “a rule … of personal autonomy and bodily integrity”).

294 I.e. through the initial anxiety of the test, the decision to terminate, or the additional genetic information obtained (e.g. a parent's diagnosis, a parent's carrier status, a husband's non-paternity).

295 See Baptists for Life, Inc., What About Prenatal Testing?, http://www.bfl.org/Prenatal+Testing.aspx?Page=c0467858-5234-4ede-9c1b-952668abf113 (last visited Mar. 9, 2007). Indeed, a Harvard Medical School study found that mothers who received a diagnosis of Down Syndrome prenatally were “generally happier over the birth of their infant with DS than their counterparts who had received the diagnosis postnatally.” Skotko, Brian G., Prenatally Diagnosed Down Syndrome: Mothers Who Continued Their Pregnancies Evaluate Their Health Care Providers, 192 Am. J. Obstetrics & Gynecology 670, 676 (2005)Google Scholar.

296 See, e.g., Harmon, supra note 286 (citing the example of a woman who “knew her marriage would not survive having a severely ill child”).

297 See discussion at supra Part V.A.

298 See, e.g., Beazoglou et al., supra note 242.

299 Id. at 1242.

300 Asch, Adrienne, Disability Equality and Prenatal Testing: Contradictory or Compatible?, 30 Fla. St. U. L. Rev. 315, 316 (2003)Google Scholar.

301 See March of Dimes, Quick References and Fact Sheets: Birth Defects, http://www.marchofdimes.com/pnhec/4439_1206.asp (last visited Jan. 20, 2007). Birth defects may result from non-genetic factors, such as environmental factors (e.g. alcohol abuse, drug abuse, exposure to certain medications or chemicals) or infections (e.g. rubella, syphilis), or from a combination of genetic and other factors. Moreover, “the causes of about 70 percent of birth defects are unknown.” Id.

302 Suter, supra note 157, at 269. But see Gillott, supra note 283 (arguing against the notion that genetic screening programs or individual parents are pursuing “eugenics”).

303 Roop, supra note 284, at 421.

304 Moreover, to the extent that entrepreneurs may try to capitalize on this technology by offering commercial versions, the public should be encouraged to obtain tests from trained healthcare providers, who are held to far more stringent professional and institutional standards. See Bianchi, Diana W., At-Home Fetal DNA Gender Testing: Caveat Emptor, 107 Obstetrics & Gynecology 216 (2006)Google Scholar (warning about use of unregulated products like the “Baby Gender Mentor,” see Today Show, supra note 135).

305 See Harmon, supra note 286.

306 See id.