Regulating reproduction

George Washington Law Review

Volumn 76, Issue 6, 2008, Pages 1623-1656

  Garrison, Marsha ^a  

^a BROOKLYN LAW SCHOOL   (United States)

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EID: 59649119200     PISSN: 00168076     EISSN: None     Source Type: Journal    
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References (243)

1. See Marcy Darnovsky, Sex Selection Goes Mainstream, ALTERNET, Sept. 25, 2003, http://www.alternet.org/story/16837.
2. More blatantly, advertisements aimed at Asian immigrants have asked readers, "Desire a Son?" See Susan Sachs, Clinics' Pitch to Indian Émigrés: It's a Boy, N.Y. TIMES, Aug. 15, 2001, at A1 (describing advertisements in India Abroad).
3. See Darnovsky, supra note 1.
4. See infra notes 148, 153, 156-58 and accompanying text.
5. See infra notes 105-06 and accompanying text.
6. See infra notes 108-15 and accompanying text.
7. Karen Wright, Human in the Age of Mechanical Reproduction, DISCOVER, May 1998, at 74, 76.
8. Id.;
9. see also Gina Kolata, Fertility Inc.: Clinics Race to Lure Clients, N.Y. TIMES, Jan. 1, 2002, at F1 (describing marketing and advertising in the infertility business).
10. Human Fertilisation and Embryology Act, 1990, ch. 37 (Eng.).
11. DEREK MORGAN & ROBERT G. LEE, BLACKSTONE'S GUIDE TO THE HUMAN F ERTILISATION & EMBRYOLOGY ACT 1990, at 26 (1990).
12. See id. at 27.
13. See International Federation of Fertility Societies Surveillance 07, 87 FERTILITY & STERILITY S8, S9-12 tbls.2.1, 2.2 (2007) [hereinafter IFFS Report] (showing countries with statutes governing ART practice and those with a licensing body).
14. Coe.int, Council of Europe, http://conventions.coe.int/Treaty/Commun/ ChercheSig.asp?NT=164&CM=1&DF=&CL=ENG (last visited July 15, 2008).
15. See Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine art. 14 (1997), Europ. T.S. No. 164, available at http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm [hereinafter Convention on Human Rights and Biomedicine] (showing ratifications).
16. Both Canada and France ban all payment in connection with ova donation. See Assisted Human Reproduction Act, 2004 S.C., ch. 2, § 7 (Can.), available at http://laws.justice.gc.ca/en/ShowFullDoc/cs/A-13.4///en;
17. Jacques Lansac, French Law Concerning Medically Assisted Reproduction, 11 HUM. REPROD. 1843, 1845 (1996).
18. The U.K. permits modest expense reimbursement. See Human Fertilisation & Embryology Authority, CH(97)01: Payments for Donors (Apr. 1997), http://www.hfea.gov.uk/en/524.html [hereinafter Payments for Donors].
19. See IFFS Report, supra note 11, at S20 tbl.5.1.
20. See AM Archive, IVF Outrage in France, http://www.abc.net.au/am/ stories/s317128.htm (last visited Sept. 26, 2008) (transcribing a June 22, 2001, ABC Local Radio broadcast in Australia).
21. See IFFS Report, supra note 11, at S27 tbl.7.1.
22. JOHN A. ROBERTSON, CHILDREN OF CHOICE: FREEDOM AND THE NEW REPRODUCTIVE TECHNOLOGIES 39, 41 (1994) [hereinafter CHILDREN OF CHOICE].
23. Id. at 126.
24. See John A. Robertson, Preconception Gender Selection, 1 AM. J. BIOETHICS 2, 6-7 (2001).
25. See John A. Robertson, Genetic Selection of Offspring Characteristics, 76 B.U. L. REV. 421, 427-28, 479 (1996) (arguing that trait selection should be protected unless such selection "would cause compelling, tangible harm to others" and that government will only rarely be able to meet this burden).
26. See John A. Robertson, Two Models of Human Cloning, 27 HOFSTRA L. REV. 609, 618-19 (1999).
27. See Marsha Garrison, Law Making for Baby Making: An Interpretive Approach to the Determination of Legal Parentage, 113 HARV. L. REV. 835, 854-59 (2000).
28. For other accounts of procreative liberty rejecting Professor Robertson's view, see JOEL FEINBERG, HARMLESS WRONGDOING 328 (1988);
29. MARY WARNOCK, MAKING BABIES 85 (2002);
30. Dan W. Brock, Procreative Liberty, 74 TEX. L. REV. 187, 205 (1995)
31. (reviewing CHILDREN OF CHOICE, supra note 18);
32. Ronald M. Green, Parental Autonomy and the Obligation Not to Harm One's Child Genetically, 25 J.L. MED. & ETHICS 5,10 (1997);
33. Philip G. Peters, Jr., Harming Future Persons: Obligations to the Children of Reproductive Technology, 8 S. CAL. INTERDISC. L.J. 375, 383-84 (1999);
34. Radhika Rao, Equal Liberty: Assisted Reproductive Technology and Reproductive Equality, 76 GEO. WASH. L. REV. 1457, 1464 (2008).
35. Garrison, supra note 23, at 855.
36. See Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833 (1992).
37. Garrison, supra note 23, at 858.
38. See Roe v. Wade, 410 U.S. 113, 153 (1973) (characterizing abortion rights as involving "a woman's decision whether or not to terminate her pregnancy");
39. see also Casey, 505 U.S. at 872 (reaffirming right of a woman "to choose to terminate or continue her pregnancy before viability");
40. Bellotti v. Baird, 443 U.S. 622, 640 (1979);
41. Whalen v. Roe, 429 U.S. 589, 598-600 (1977).
42. See Roe, 410 U.S. at 153 (concluding that the abortion right "cannot be said to be absolute" and holding that "a State may properly assert important interests in safeguarding health, in maintaining medical standards, and in protecting potential life").
43. Wisconsin v. Yoder, 406 U.S. 205 (1972).
44. Id. at 233-34.
45. See Prince v. Massachusetts, 321 U.S. 158, 168-69 (1944).
46. See Runyon v. McCrary, 427 U.S. 160, 177 (1976) (refusing to recognize parental right to educate children in private segregated academies).
47. See, e.g., C.N. v. Ridgewood Bd. of Educ., 430 F.3d 159, 185 (3d Cir. 2005) (upholding mandatory student participation in survey);
48. Blau v. Fort Thomas Pub. Sch. Dist., 401 F.3d 381, 395-96 (6th Cir. 2005) (upholding a mandatory dress code);
49. Leebaert v. Harrington, 332 F.3d 134, 139 (2d Cir. 2003) (upholding a mandatory health curriculum);
50. Littlefield v. Forney Indep. Sch. Dist., 268 F.3d 275, 291 (5th Cir. 2001) (upholding a mandatory uniform policy);
51. Brown v. Hot, Sexy & Safer Prods., Inc. 68 F.3d 525, 532-34 (1st Cir. 1995) (upholding a public school's curriculum despite parents' free exercise rights);
52. Duro v. Dist. Attorney, Second Judicial Dist. of N.C., 712 F.2d 96, 99 (4th Cir. 1983) (upholding a compulsory education law).
53. See, e.g., Anspach v. City of Phila., 503 F.3d 256, 268-69 (3d Cir. 2007) (finding that a publicly funded program which provided plaintiffs' daughter with the "morning after" pill without parental notification or consent did not violate parental rights);
54. Parents United for Better Schs., Inc. v. Phila. Bd. of Educ., 148 F.3d 260, 275 (3d Cir. 1998) (upholding a voluntary condom-distribution program);
55. Doe v. Irwin, 615 F.2d 1162, 1168-69 (6th Cir. 1980) (finding that a publicly funded program providing sex education to minors did not violate parental rights).
56. For a description of such problems in another context, see U.S. CONG. OFFICE OF TECH. ASSESSMENT, INDUSTRY, TECHNOLOGY, AND THE ENVIRONMENT: COMPETITIVE CHALLENGES AND BUSINESS OPPORTUNITIES 3-6 (1994).
57. See Debora Spar, Reproductive Tourism and the Regulatory Map, 352 NEW ENG. J. MED. 531, 532 (2005) (describing a "patchwork of competing and conflicting regulations" and resulting reproductive tourism).
58. See Payments for Donors, supra note 14.
59. See Helena Echlin, How Much Would You Pay for This?, THE GUARDIAN, July 25, 2005, http://lifeandhealth.guardian.co. uk/health/story/0,1611407,00.html (reporting that 90% of British infertility centers report a shortage of donated ova).
60. See Martyn Halle, This Woman Was Unable to Conceive So She Spent Her GBP 15,000 Savings Buying Eggs from a Mystery Woman in America. But Is This Really the Way to Treat Infertility?, DAILY MAIL, Mar. 7, 2000, at 40.
61. See id.;
62. see also Echlin, supra note 38.
63. See, e.g., Spar, supra note 36, at 531 (identifying examples of reproductive tourism).
64. Reproductive tourism may also occur when services are cheaper in another location. See, e.g., My IVF Alternative, http://www.myivfalternative.com/ ivf-treatment-costs (last visited July 1, 2008) (advertising $6,000 IVF treatments in Czech Republic along with "spa treatments, sight-seeing, dining, movies, wine tasting, brewery tours, day trips, shopping and more").
65. See Garrison, supra note 23, at 878-82.
66. See id. at 872-76.
67. RONALD DWORKIN, LAW'S EMPIRE 176-77 (1986).
68. Id. at 178.
69. Id. at 185.
70. Garrison, supra note 23, at 880.
71. See generally id.
72. Schloendorff v. Soc'y of N.Y. Hosps., 105 N.E. 92, 93 (N.Y. 1914),
73. overruled on other grounds by Bing v. Thunig, 2 N.E.2d 3 (N.Y. 1957).
74. See, e.g., Bang v. Charles T. Miller Hosp., 88 N.W.2d 186, 189-90 (Minn. 1958) (holding that a patient cannot be operated on, absent exigent circumstances, without express or implied consent).
75. See generally Allan H. McCoid, A Reappraisal of Liability for Unauthorized Medical Treatment, 41 MINN. L. REV. 381, 381-87 (1957) (analyzing doctor liability for unauthorized medical treatment).
76. The informed-consent claim was first recognized in Canterbury v. Spence, 454 F.2d 772, 779-81 (D.C. Cir. 1972),
77. and Cobbs v. Grant, 502 P.2d 1, 7-8 (Cal. 1972).
78. For detailed accounts of the history and theory of informed consent, see generally RUTH R. FADEN, TOM L. BEAUCHAMP & NANCY M.P. KING, A HISTORY AND THEORY OF INFORMED CONSENT (1986);
79. Peter H. Schuck, Rethinking Informed Consent, 103 YALE L.J. 899 (1994).
80. See generally Cobbs, 502 P.2d 1;
81. Canterbury, 454 F.2d 772.
82. Food, Drug, and Cosmetics Act of 1938, 21 U.S.C. §§ 301-399 (2000).
83. See id. § 355(d);
84. see also 21 C.F.R. §§ 314.50-314.91 (2006) (drugs);
85. id. §§ 800-898 (medical devices).
86. See F.D.A., The Story of the Laws Behind the Labels: Part II 1938 - The Federal Food, Drug, and Cosmetic Act, FDA CONSUMER, June 1981, available at http://www.cfsan.fda.gov/~lrd/histor1a.html [hereinafter The Laws Behind the Labels].
87. See 45 C.F.R. §§ 46.107-46.111 (2006) (Institutional Review Board requirements);
88. id. §§ 46.116-46.117 (informed consent requirements);
89. id. § 46.115 (recordkeeping).
90. The regulations include special requirements for research involving pregnant women and/or fetuses. See 45 C.F.R. §§ 46.203-46.204 (2007).
91. For a historical account of the development of the regulations, see generally Eric J. Cassell, The Principles of the Belmont Report Revisited: How Have Respect for Persons, Beneficence, and Justice Been Applied to Clinical Medicine, HASTINGS CENTER RPT., July-Aug. 2000, at 12 (Vol. 30, No. 4).
92. See 21 U.S.C. § 355(d).
93. See 45 C.F.R. § 46.111.
94. The regulatory anomalies can be explained by the fact that both the federal Food, Drug and Cosmetics Act and the federal rules governing medical research were passed in response to widely publicized scandals involving the imposition of large risks on unsuspecting individuals. See The Laws Behind the Labels, supra note 55;
95. see also MARSHA GARRISON & CARL E. SCHNEIDER, THE LAW OF BIOETHICS: INDIVIDUAL AUTONOMY AND SOCIAL REGULATION 10 (2003) (medical research regulations).
96. See GARRISON & SCHNEIDER, supra note 59, at 27-70 (describing law of informed consent).
97. See DARTMOUTH ATLAS PROJECT, PREFERENCE-SENSITIVE CARE 1-2 (2007), http://www.dartmouthatlas.org/topics/preference-sensitive.pdf.
98. See Michelle M. Mello & Troyen A. Brennan, The Controversy over High-Dose Chemotherapy with Autologous Bone Marrow Transplant for Breast Cancer, 20 HEALTH AFF. 101, 101 (2001).
99. See id. at 102-03.
100. See Peter D. Jacobson et al., Litigating the Science of Breast Cancer Treatment, 32 J. HEALTH POL. POL'Y & L0. 785, 785 (2007);
101. D.T. Vogl & E.A. Stadtmauer, High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation for Metastatic Breast Cancer: A Therapy Whose Time Has Passed, 37 BONE MARROW TRANSPLANTATION 985, 985-86 (2006).
102. See U.S. DEPT. OF HEALTH & HUMAN SERVS., FACTS ABOUT MENOPAUSAL HORMONE THERAPY 1, 6-11 (2005), available at http://www.nhlbi.nih.gov/health/women/pht-facts.pdf.
103. H. Gilbert Welch & Juliana Mogielnicki, Presumed Benefit: Lessons from the American Experience with Marrow Transplantation for Breast Cancer, 324 BMJ 1088, 1091 (2002).
104. See Jennifer J. Kurinczuk & Carol Bower, Birth Defects in Infants Conceived by Intracytoplasmic Sperm Injection: An Alternative Interpretation, 315 BMJ 1260, 1260 (1997);
105. David M. Nudell & Larry I. Lipshultz, Is Intracytoplasmic Sperm Injection Safe? Current Status and Future Concerns, 2 CURRENT UROLOGY REP. 423, 423 (2001).
106. See, e.g., M. Bonduelle et al., Incidence of Chromosomal Aberrations in Children Born After Assisted Reproduction Through lntracytoplasmic Sperm Injection, 13 HUM. REPROD. 781, 781 (1998);
107. ESHRE Capri Workshop Group, Intracytoplasmic Sperm Injection (ICSI) in 2006: Evidence and Evolution, 13 HUM. REPROD. UPDATE 515, 521 (2007);
108. Kurinczuk & Bower, supra note 67, at 1260-63.
109. See, e.g., F. Belva et al., Medical Outcome of 8-Year-Old Singleton ICSI Children (Born = 32 Weeks' Gestation) and a Spontaneously Conceived Comparison Group, 22 HUM. REPROD. 506, 511 (2007);
110. M. Bonduelle et al, A Multi-Centre Cohort Study of the Physical Health of 5-Year-Old Children Conceived After Intracytoplasmic Sperm Injection, In Vitro Fertilization and Natural Conception, 20 HUM. REPROD. 413, 417 (2005) (reporting that malformation rate for ICSI children was 2.8 times higher than that of control group);
111. I. Sanchez-Albisua et al., Increased Frequency of Severe Major Anomalies in Children Conceived by Intracytoplasmic Sperm Injection, 49 DEVELOPMENTAL MED. & CHILD NEUROLOGY 129, 133-34 (2007) (finding higher frequency of severe congenital anomalies in a small sample of ICSI children);
112. see also Michèle Hansen et al., The Risk of Major Birth Defects After Intracytoplasmic Sperm Injection and In Vitro Fertilization, 346 NEW ENG. J. MED. 725, 729 (2002).
113. See Belva et al., supra note 69, at 511-14.
114. See L. Leunens et al., Cognitive and Motor Development of 8-Year-Old Children Born After ICSI Compared to Spontaneously Conceived Children, 21 HUM. REPROD. 2922, 2927 (2006);
115. L. Leunens et al., Follow-Up of Cognitive and Motor Development of 10-Year-Old Singleton Children Born After ICSI Compared with Spontaneously Conceived Children, 23 HUM. REPROD. 105, 109 (2008);
116. I. Ponjaert-Kristoffersen et al., International Collaborative Study of Intracytoplasmic Sperm Injection-Conceived, In Vitro Fertilization-Conceived, and Naturally Conceived 5-Year-Old Child Outcomes: Cognitive and Motor Assessments, 115 PEDIATRICS e283, e287-88 (2005) (finding, at five years, no significant differences in cognitive and motor development of ICSI children and controls);
117. see also Marjolein Knoester et al., Matched Follow-Up Study of 5-8 Year Old ICSI-Singletons: Comparison of Their Neuromotor Development to IVF and Naturally Conceived Singletons, 22 HUM. REPROD. 1638, 1643-44 (2007) (finding no significant differences after controlling for maternal age and parity);
118. Isabelle Place & Yvon Englert, A Prospective Longitudinal Study of the Physical, Psychomotor, and Intellectual Development of Singleton Children Up to 5 Years Who Were Conceived by Intracytoplasmic Sperm Injection Compared with Children Conceived Spontaneously and by In Vitro Fertilization, 80 FERTILITY & STERILITY 1388, 1395-95 (2003).
119. See Int'l Comm. for Monitoring Assisted Reprod. Tech. (ICMART), World Collaborative Report on In Vitro Fertilization, 2000, 85 FERTILITY & STERILITY 1586, 1606 (2006).
120. Indeed, when a medical decision does have the potential to significantly affect the health of others, numerous restrictions on individual choice apply; if the patient has a communicable disease, he or she may be quarantined, isolated, or subjected to mandatory testing and treatment. See Howard Market et al., Nonpharmaceutical Interventions Implemented by US Cities During the 1918-1919 Influenza Pandemic, 298 JAMA 644, 644, 654 (2007);
121. Wendy E. Parmet, Legal Power and Legal Rights - Isolation and Quarantine in the Case of Drug-Resistant Tuberculosis, 357 NEW ENG. J. MED. 433, 434 (2007).
122. See A. Antsaklis et al., Second-Trimester Amniocentesis vs. Chorionic Villus Sampling for Prenatal Diagnosis in Multiple Gestations, 20 ULTRASOUND OBSTETRICS & GYNECOLOGY 476, 478-79 (2002);
123. Bruno Brambati & Lucia Tului, Chorionic Villus Sampling and Amniocentesis, 17 CURRENT OPINION OBSTETRICS & GYNECOLOGY 197, 197 (2005).
124. See Antsaklis et al., supra note 74, at 480.
125. See Mathias B. Forrester & Ruth D. Mertz, Prenatal Diagnosis and Elective Termination of Down Syndrome in a Racially Mixed Population in Hawaii, 1987-1996, 19 PRENATAL DIAGNOSIS 136, 136-37 (1999) (84%);
126. Caroline Mansfield et al., Termination Rates After Prenatal Diagnosis of Down Syndrome, Spina Bifida, Anencephaly, and Turner and Klinefelter Syndromes: A Systematic Literature Review, 19 PRENATAL DIAGNOSIS 808, 808 (1999) (91-93%).
127. See Mansfield et al., supra note 76, at 810.
128. Illinois and Pennsylvania, however, have outlawed sex-selection abortion. See 720 ILL. COMP. STAT. ANN. 510/6-8 (West 2003);
129. PA. CONS. STAT. ANN. § 3204(c) (West 2008).
130. See Gudrun Schultz, 7,000 Unborn Girls Die from Sex-Selection Abortion Daily in India, LIFESITENEWS.COM, Dec. 14, 2006, http://www.lifesitenews.com/ldn/2006/dec/06121401.html.
131. See Convention on Human Rights and Biomedicine, supra note 13, art. 14. Some countries that have not ratified the treaty, for example the U.K., also have similar regulatory policies.
132. In China, 118 boys were born for every 100 girls in 2005, and some experts project an excess of 30 million males in less than 15 years. Denise Grady, Girl or Boy? As Fertility Technology Advances, so Does an Ethical Debate, N.Y. TIMES, Feb. 6, 2007, at F5.
133. See generally Lisa Belkin, Getting the Girl, N.Y. TIMES MAG., July 25, 1999, at 38;
134. see also Ashley Bumgarner, A Right to Choose? Sex Selection in International Context, 14 DUKE J. GENDER L. & POL'Y 1289, 1290 (2007) (reporting survey data showing that 25% of Americans say they would use sex selection if it were available);
135. BBC, Baby Sex Selection, http://www.bbc.co.uk/dna/h2g2/A939918 (last visited July 1, 2008) (reporting U.S. survey evidence showing that 81% of women and 94% of men wanted their first child to be a boy).
136. Other research finds no such preference. See Ronald Bailey, Sexing Babies: Will Sex Selection Create a Violent World Without Women?, REASON MAG., Oct. 6, 2004, http://www.reason.com/news/show/ 34895.html (summarizing research).
137. Some research suggests that birth order is related to IQ and other advantages. See, e.g., Susan M. Faust, Baby Girl or Baby Boy? Now You Can Choose: A Look at New Biology and No Law, 10 ALB. L.J. SCI. & TECH. 281, 290 (2000) (summarizing research);
138. Human Intelligence: Does Birth Order Affect Intelligence?, http://www.indiana.edu/~intell/birthOrder.shtml (last visited June 10, 2008) (same).
139. Cf. Peter Herissone-Kelly, Parental Love and the Ethics of Sex Selection, 16 CAMBRIDGE Q. HEALTHCARE ETHICS 326, 326, 334 (2007);
140. R. McDougall, Acting Parentally: An Argument Against Sex Selection, 31 J. MED. ETHICS 601, 603-04 (2005).
141. Book-length manuscripts are available. See, e.g., President's Council on Bioethics, Sex Selection Index, http://www.bioethics.gov/topics/sex- index.html (last visited July 1, 2008) (presenting transcripts and papers on sex selection).
142. Cf. U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION, 2005 ASSISTED REPRODUCTIVE TECHNOLOGY (ART) REPORT: SECTION 5 - ART TRENDS, 1996-2005, at fig.50, http://www.cdc.gov/art/ART2005/section5. htm [hereinafter 2005 ART REPORT] (reporting that, in 2005, 34% of pre-embryo transfers using fresh, nondonor eggs resulted in live births).
143. See Genetics & IVF Institute, MicroSort, http://microsort.net/ (last visited July 1, 2008) (describing sperm sorting process).
144. See supra notes 67-72 and accompanying text.
145. See id.
146. See Norbert Gleicher et al., Reducing the Risk of High-Order Multiple Pregnancy After Ovarian Stimulation with Gonadotropins, 343 NEW ENG. J. MED. 2, 6 (2000).
147. For similar views, see, e.g., DEBORAH MATHIEU, PREVENTING PRENATAL HARM: SHOULD THE STATE INTERVENE? 46-51 (2d ed. 1996).
148. Some commentators have also argued that a prospective parent who decides to bear a particular child thereby assumes responsibilities to that future child. See, e.g., id. at 55-57.
149. See infra text accompanying notes 106-15.
150. See generally Sanford N. Katz et al., Child Neglect Laws in America, 9 FAM. L.Q. 1 (1975);
151. Elizabeth J. Sher, Choosing for Children: Adjudicating Medical Care Disputes Between Parents and the State, 58 N.Y.U. L. REV. 157 (1983).
152. See, e.g., MINN. STAT. ANN. § 626.5562 (West 2008);
153. S.D. CODIFIED LAWS § 34-20A-63 (2004);
154. WIS. STAT. ANN. §§ 48.01(1)(am), 48.01(2)(bm), 48.02(1)(am) (West 2008).
155. See Dena M. Marks, Person v. Potential: Judicial Struggles to Decide Claims Arising from the Death of an Embryo or Fetus and Michigan's Struggle to Settle the Question, 37 AKRON L. REV. 41, 45-74 (2004) (reviewing case law by jurisdiction).
156. See Sandra L. Smith, Note, Fetal Homicide: Woman or Fetus as Victim? A Survey of Current State Approaches and Recommendations for Future State Application, 41 WM. & MARY L. REV. 1845, 1872-73 (2000).
157. 45 C.F.R. §§ 46.404-46.406 (2007). "Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
158. C.F.R. § 46.102(i) (2006).
159. Child Abuse Prevention and Treatment Amendments of 1984, Pub. L. No. 98-457, 98 Stat. 1749 (codified at 42 U.S.C. §§ 1501-1515 (2000)).
160. Under CAPTA, [Withholding of medically indicated treatment means the failure to respond to the infant's life-threatening conditions by providing treatment . . . which . . . will be most likely to be effective in ameliorating or correcting all such conditions, except that the term does not include the failure to provide treatment ... to an infant when . . . (A) the infant is chronically and irreversibly comatose; (B) the provision of such treatment would (i) merely prolong dying; (ii) not be effective in ameliorating or correcting all of the infant's life-threatening conditions; or (iii) otherwise be futile in terms of the survival of the infant; or (C) the provision of such treatment would be virtually futile in terms of the survival of the infant and the treatment itself under such circumstances would be inhumane. 42 U.S.C.A. § 5106g(6) (West 2003).
161. 45 C.F.R. § 1340.20 app. (2004).
162. Cf. John A. Robertson, Procreative Liberty and Harm to Offspring in Assisted Reproduction, 30 AM. J.L. & MED. 7, 13 (2004) [hereinafter Robertson, Harm to Offspring] (urging that "[e]nsuring safe and effective use of ARTs should be the goal of ethical practice and sound public policy. Enabling a child to be born when there is a high risk that the child will be born harmed or damaged raises moral concerns of great significance.");
163. John A. Robertson, The Right to Procreate and In Utero Fetal Therapy, 3 J. LEGAL MED. 333, 352 (1982) (urging that "[p]rosecution for child abuse/neglect could ... be predicated on an injury or impairment to the child which proximately results from a parental decision not to have an available in utero procedure performed").
164. For an example, see infra text accompanying notes 106-15.
165. See generally Raymond S. Duff & A.G.M. Campbell, Moral and Ethical Dilemmas in the Special-Care Nursery, 289 NEW ENG. J. MED. 890 (1973) (discussing cases in which parents of handicapped neonates chose not to treat curable medical conditions).
166. Despite CAPTA, survey evidence continues to show substantial support for nontreatment of newborns with genetic disabilities. See Dorothy C. Wertz, Ethical Issues in Pediatric Genetics: Views of Geneticists, Parents and Primary Care Physicians, 6 HEALTH L.J. 3, 18-19 (1998).
167. See GARRISON & SCHNEIDER, supra note 59, at 594-95.
168. Robertson, Harm to Offspring, supra note 100, at 25.
169. See 2005 ART REPORT, supra note 85, at fig.58. The proportion of singleton IVF births, however, also has been increasing. From 1996 through 2005, the percentage of IVF transfers that resulted in singleton live births for fresh nondonor cycles increased 35%.
170. Id. fig.51. Over the same time period, the percentage of transfers resulting in singleton live births increased 79% for frozen nondonor cycles, 36% for fresh donor cycles, and 48% for frozen donor cycles.
171. Id.
172. Between 1980 and 1997, the U.S. experienced a 136.6% increase in triplet and higher-order births. See Ctrs. for Disease Control and Prevention, Contribution of Assisted Reproduction Technology and Ovulation-Inducing Drugs to Triplet and Higher-Order Multiple Births-United States, 1980-1997, 49 MORBIDITY & MORTALITY WKLY. REP. 535, 537 tbl.1 (2000).
173. Some of this increase reflects a higher average maternal age and the impact of ovulation-inducing drugs, but CDC has estimated that IVF was responsible for 38.7% of triplet and higher-order births in 1996 and 43.3% in 1997. Id. at 536 tbl.2.
174. See R.C. Wimalasundera et al., Reducing the Incidence of Twins and Triplets, 17 BEST PRAC. & RES. CLINICAL OBSTETRICS GYNAECOLOGY 309, 309 (2003).
175. ROYAL COMM'N ON NEW REPROD. TECHS., PROCEED WITH CARE: FINAL REPORT OF THE ROYAL COMMISSION ON NEW REPRODUCTION TECHNOLOGIES 528 (1993).
176. See William L. Callaghan et al., The Contribution of Preterm Birth to Infant Mortality Rates in the United States, 118 PEDIATRICS 1566, 1571 (2006).
177. Mario Merialdi & Jeffrey C. Murray, The Changing Face of Preterm Birth, 120 PEDIATRICS 1133, 1133 (2007).
178. See generally PRETERM BIRTH: CAUSES, CONSEQUENCES, AND PREVENTION 311-45 (Richard E. Behrman & Adrienne Stith Butler eds., 2007) [hereinafter PRETERM BIRTH];
179. see also Maureen Hack et al., Long-Term Developmental Outcomes of Low Birth Weight Infants, 5
180. FUTURE CHILD. 176 (1995), available at http://www.futureofchildren.org/information2826/information-show.htm?doc-id= 79895.
181. See Ezekiel J. Emanuel, Eight Is Too Many: The Case Against Octuplets, NEW REPUBLIC, Jan. 25, 1999, at 8;
182. see also Hack et al., supra note 111;
183. Eric S. Shinwell & Isaac Blickstein, The Risks for Very Low Birth Weight Infants from Multiple Pregnancies, 34 CLINICS PERINATOLOGY 587, 587-88 (2007).
184. Emanuel, supra note 112, at 10.
185. See also Aijaz Farooqi et al., Chronic Conditions, Functional Limitations, and Special Health Care Needs in 10- to 12-Year-Old Children Born at 23 to 25 Weeks' Gestation in the 1990s: A Swedish National Prospective Follow-up Study, 118 PEDIATRICS el466, el466-67 (2006) (reporting, [Significantly more extremely immature children than controls had chronic conditions, including functional limitations (64% vs 11%, respectively), compensatory dependency needs (59% vs 25%), and services above those routinely required by children (67% vs 22%). Specific diagnoses or disabilities with higher rates in extremely immature children than in controls included neurosensory impairment (15% vs 2%), asthma (20% vs 6%), poor motor skills ... (26% vs 3%), poor visual perception . . . (21% vs 4%), poor learning skills . . . (27% vs 3%), poor adaptive functioning . . . (42% vs 9%), and poor academic performance . . . (49% vs 7%).).
186. See Robert W. Fogel & Chulhee Lee, Who Gets Health Care?, 131 DAEDALUS 107, 112 (2002).
187. Nicholas M. Fisk & Geoffrey Trew, Two's Company, Three's a Crowd for Embryo Transfer, 354 LANCET 1572, 1572 (1999).
188. See also Wimalasundera et al., supra note 107, at 309 (reporting that cerebral palsy rates are 1-1.5% in twin pregnancies and 7-8% in triplet pregnancies).
189. See, e.g., Georgina M. Chambers et al., Babies Born After ART Treatment Cost More Than Non-ART Babies: A Cost Analysis of Inpatient Birth-Admission Costs of Singleton and Multiple Gestation Pregnancies, 22 HUM. REPROD. 3108, 3111, 3113 (2007) (reporting that the average cost of an ART singleton delivery was €4,818 compared with €13,890 for ART twins and €54,294 for ART higher-order multiples and concluding that the high costs associated with ART multiple births support single embryo transfer).
190. Cf. PRETERM BIRTH, supra note 111, at 398 (estimating that, in 2005, each preterm birth in the United States cost at least $51,600, including immediate medical expenses, the cost of early intervention/special education programs, and lost household and labor market productivity related to some of these disabling conditions).
191. See B.A. Lieberman et al., Presentation of In-Vitro Fertilisation Results, 357 LANCET 397, 397 (2001).
192. P. Donoso et al., Single Embryo Transfer in Preimplantation Genetic Diagnosis Cycles for Women <36 Years Does Not Reduce Delivery Rate, 22 HUM. REPROD. 1021, 1021-22 (2007).
193. See Sarah E. Little et al., Cost of Transferring One Through Five Embryos Per In Vitro Fertilization Cycle from Various Payor Perspectives, 108 OBSTETRICS & GYNECOLOGY 593, 599 (2006) (finding in one recent study that one-embryo transfers for women younger than 35 years reduced preterm birth and cerebral palsy rates by 55% and 41%, respectively).
194. See Viveca Söderström-Anttila & Sirpa Vilska, Five Years of Single Embryo Transfer with Anonymous and Non-Anonymous Oocyte Donation, 15 REPROD. BIOMED. ONLINE 428, 431 tbl.2 (2007) (reporting delivery rate per embryo transfer of 30.4% for SET and 33.3% for DET and twin rates of 0% for SET and 40% for DET).
195. See Zabeena Pandian et al., Number of Embryos for Transfer After IVF and ICSI: A Cochrane Review, 20 HUM. REPROD. 2681, 2682, 2685 (2005);
196. Aafke P.A. van Montfoort et al., In Unselected Patients, Elective Single Embryo Transfer Prevents All Multiples, but Results in Significantly Lower Pregnancy Rates Compared with Double Embryo Transfer: A Randomized Controlled Trial, 21 HUM. REPROD. 338, 341-42 (2006);
197. see also R. Ciriminna et al., Impact of Italian Legislation Regulating Assisted Reproduction Techniques on ICSI Outcomes in Severe Male Factor Infertility: A Multicentric Survey, 22 HUM. REPROD. 2481, 2481 (2007) (reporting that the implantation of a maximum of only three pre-embryos, in ICSI cases, "significantly reduced the number of good-morphology embryos available for transfer" and caused "dramatic reductions in the [clinical] pregnancy rate . . . and the implantation rate," particularly in cases where the male partner was afflicted with non-obstructive azoospermia).
198. Moniek Twisk et al., Preferences of Subfertile Women Regarding Elective Single Embryo Transfer: Additional In Vitro Fertilization Cycles Are Acceptable, Lower Pregnancy Rates Are Not, 88 FERTILITY & STERILITY 1006, 1007 (2007) (reporting also that, if SET lowered pregnancy rates by 3% or 5%, the percentage of women preferring SET dropped to 24% and 15%, respectively).
199. See also Astrid Højgaard et al., Patient Attitudes Towards Twin Pregnancies and Single Embryo Transfer - A Questionnaire Study, 22 HUM. REPROD. 2673, 2677 (2007) (finding that, among patients at a Danish public fertility clinic where DET was typical and the number of reimbursed treatments was limited to three, 58.7% of survey respondents preferred having twins to having one child at a time (37.9%)).
200. See Practice Comm. of the Soc'y for Assisted Reprod. Tech. and Practice Comm. of the Am. Soc'y for Reprod. Med., Guidelines on Number of Embryos Transferred, 86 FERTILITY & STERILITY S51, S51 (2006).
201. id.
202. Id. Cf. 2005 ART REPORT, supra note 85, at fig.54 (reporting, From 1996 to 2005, cycles that involved the transfer of one embryo increased slightly, from 6% to 9%; cycles that involved the transfer of two embryos increased dramatically, from 10% in 1996 to 43% in 2005. Cycles that involved the transfer of three embryos increased from 23% in 1996 to 29% in 2005, and cycles that involved the transfer of four or more embryos decreased from 62% in 1996 to 18% in 2005.).
203. Norbert Gleicher & David Barad, The Relative Myth of Elective Single Embryo Transfer, 121 HUM. REPROD. 1337, 1338 (2006) (internal citations omitted).
204. In Denmark, the public health care system reimburses up to three treatment cycles. See Højgaard et al., supra note 123, at 2673.
205. National Organ Transplant Act of 1984, Pub. L. No. 98-507, 98 Stat. 2339 (1984) (codified as amended at 42 U.S.C. §§ 273-274 (2000)).
206. 42 U.S.C. § 274 (2000).
207. See United Network for Organ Sharing, Who We Are-The OPTN, http://www.unos.org/whoWeAre/theOPTN.asp (last visited July 1, 2008). Since 2000, a competing nonprofit entity, Arbor Research (formerly University Renal Research and Education Association), has assumed responsibility for the Scientific Registry of Transplant Recipients, which assesses and monitors the data collected by the Organ Procurement and Transplantation Network.
208. See Arbor Research Collaborative for Health, The Scientific Registry of Transplant Recipients, http://www.arborresearch.org/srtr.aspx (last visited July 1, 2008).
209. United Network for Organ Sharing, What We Do-Policy Management, http://unos.org/whatWeDo/policyManagement/policyDevelopment.asp (last visited July 1, 2008).
210. See United Network for Organ Sharing, What We Do-Research, http://www.unos.org/whatWeDo/research.asp (last visited July 1, 2008) (indicating UNOS collects all data relevant to transplants, maintains a comprehensive database containing that information, and analyzes it to produce research reports).
211. See Martin A. Strosberg & Ron W. Gimbel, The Public Administration of Organ Allocation: Maintaining the Public-Private Partnership, 7 PUB. ADMIN. & MGMT. 229, 231 (2002).
212. See id.;
213. David L. Weimer, The Puzzle of Private Rulemaking: Expertise, Flexibility, and Blame Avoidance in U.S. Regulation, 66 PUB. ADMIN. REV. 569, 578 (2006).
214. See supra text accompanying notes 101-02, 106-15.
215. See supra notes 92-99 and accompanying text.
216. See Gleicher et al., supra note 89, at 2.
217. Id. at 6.
218. 42 U.S.C. § 274e(c)(1) (2000).
219. S. REP. NO. 98-382, at 17 (1984),
220. as reprinted in 1984 U.S.C.C.A.N. 3975, 3982.
221. See United Network for Organ Sharing, supra note 130.
222. But see Organ Procurement and Transplantation Network, About Data: Data Collection, http://www.optn.org/data/about/collection.asp (last visited July 1, 2008) (indicating that although NOTA defines bone marrow and skin as organs, the UNOS registry system does not include these body parts).
223. See United Network for Organ Sharing, What We Do-Organ Center, http://www.unos.org/whatWeDo/organCenter.asp (last visited July 1, 2008).
224. See H.R. REP. NO. 98-1127, at 16 (1984),
225. as reprinted in 1984 U.S.C.C.A.N. 3989, 3992 (demonstrating that Congress did not intend NOTA to apply to replenishable tissues such as sperm and blood).
226. See Dale D. Chitwood et al., The Donation and Sale of Blood by Intravenous Drug Users, 81 AM. J. PUB. HEALTH 631, 632 (1991).
227. The practice of paying for blood ended due to public health concerns. Id.
228. See 42 U.S.C. § 274e(c)(1) (2000).
229. See Ethics Comm. of the Am. Soc'y for Reprod. Med., Financial Compensation of Oocyte Donors, 88 FERTILITY & STERILITY 305, 308 (2007) [hereinafter Financial Compensation of Oocyte Donors].
230. BBC on This Day, 1978: First "Test Tube Baby" Born, http://news.bbc.co.uk/onthisday/hi/dates/stories/july/25/newsid-2499000/2499411. stm (last visited Sept. 26, 2008).
231. See PRESIDENT'S COUNCIL ON BIOETHICS, REPROD. & RESP., THE REGULATION OF NEW BIOTECHNOLOGIES 149 (2004) [hereinafter PRESIDENT'S COUNCIL ON BIOETHICS] (describing advertisements in college newspapers offering students $25,000 and $50,000 in exchange for ova).
232. Cf. sources cited supra note 14.
233. See Kristian Gravenor, Infertile Ground, MONTREAL MIRROR, Aug. 19-25, 2004, available at http://www. montrealmirror.com/ARCHIVES/2004/081904/cover-news.html.
234. In re Baby M., 537 A.2d 1227, 1250 (N.J. 1988).
235. Id. at 1241.
236. PRESIDENT'S COUNCIL ON BIOETHICS, supra note 148, at 148-49.
237. Id. at 50 (internal citation omitted).
238. Cf. Jennifer Egan, Wanted: A Few Good Sperm, N.Y. TIMES MAG., Mar. 19, 2006, at 44 ("Buying sperm over the Internet ... is not much different from buying shoes.").
239. See Financial Compensation of Oocyte Donors, supra note 146, at 308. The ASRM calculation is based on average sperm-donation fees ($60 to $75 for one hour) multiplied by the typical number of hours required for oocyte donation (fifty-six hours), or $3,360 to $4,200.
240. Id. Because payment in this value range does not fully account for the more onerous nature of oocyte donation, ASRM concludes that "at this time sums of $5,000 or more require justification and sums above $10,000 go beyond what is appropriate."
241. Id.
242. The Egg Donor Program, Becoming an Egg Donor, http://www.eggdonation.com/ becoming-an-egg-donor/BecominganEggDonor.php (last visited July 1, 2008).
243. Reproductive Medicine Associates of New York, Egg Donation New York: Why Donate, http://www.eggdonationny.com/why-donate.aspx (last visited July 1, 2008).