Abstract
This chapter offers an overview of the American legal landscape surrounding assisted reproductive technologies (ART). The three basic sources of law are set out, explaining how constitutional law, statutory law and case law regulate the use of assisted conception. Historically, protection of ART as a constitutional right has been questionable, but grows more uncertain in the wake of the U.S. Supreme Court’s decision ending constitutional protection for abortion rights. Congress has paid scant attention to assisted conception as a method of family formation, weighing in only to enact a reporting scheme that collects annual data. Federal legislative efforts have instead been directed at prohibiting the U.S. government from funding any research in which human embryos are created or destroyed, quelling research progress in areas such as germline genome editing and mitochondrial replacement therapy. The bulk of ART regulation is contained in state law that addresses a host of issues, including the parental status of ART offspring, the legality of surrogate parenting arrangements, the division of embryos upon divorce, and the penalties for gametes misdirection and misappropriation. Looking ahead, emerging reproductive technologies may struggle to find solid support in a comprehensive legal regime given the prevailing scattershot approach favored by American lawmakers.
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Notes
- 1.
Henry T. Greely, CRISPR’d Babies: Human Germline Genome Editing in the ‘He Jiankui Affair”, 6 J. Law and the Biosciences 111 (2019). CRISPR stands for clustered regularly interspaced short palindromic repeats. Simply put, CRISPR is a genome editing (also called gene editing) technology that give scientists the ability to change an organism’s DNA by allowing genetic material to be added, removed, or altered at particular locations in the genome. Potentially, this gene editing technology could be used to knock out or replace segments of DNA that are associated with disease, thus promoting the health of the organism. When used in gametes or embryos, CRISPR would make alterations in the resulting offspring and thus potentially pass from one generation to the next. See National Institutes of Health, U.S. National Library of Medicine, Genetics Home Reference, What are Genome Editing and CRISPR-Cas9?, https://ghr.nlm.nih.gov/primer/genomicresearch/genomeediting. Professor Greely observes, “This possibility (though not certainty) of intentionally altering descendants’ genes is what most upsets many people when it comes to editing the genes of early-stage embryos. By changing an early embryo, the method seeks to change every cell in any resulting child.” Greely at 114.
- 2.
See, e.g., Jon Cohen, New Call to Ban Gene-Edited Babies Divides Biologists, Science (Mar. 13, 2019), https://www.sciencemag.org/news/2019/03/new-call-ban-gene-edited-babies-divides-biologists
- 3.
For example, in an early case challenging the legality of a surrogate parenting contract, the New Jersey Supreme Court relied on adoption law to invalidate the agreement as violative of the birth mother’s right to change her mind after birth of the child. In the Matter of Baby M, 109 N.J. 396, 537 A.2d 1227 (1988).
- 4.
An important omitted category is regulation set out by administrative agencies, most notably in the case of reproductive medicine by the Food & Drug Administration and the National Institutes of Health. These governing regulations are discussed under the category of federal legislation.
- 5.
According to the National Council for Adoption, there were 18,395 domestic infant adoptions in the U.S. in 2014, representing 0.5% of all live births for that year. See National Council for Adoption, Adoption: By the Numbers (Feb. 15, 2017), https://www.adoptioncouncil.org/publications/2017/02/adoption-by-the-numbers. According to an annual report published by the Centers for Disease Control and Prevention (CDC), in 2019 there were 83,946 children born in the U.S. who were conceived using some form of assisted reproductive technology (ART), defined essentially by the CDC as IVF. See Ctrs. for Disease Control & Prevention, U.S. Dep’t. of Health and Hum. Servs., 2019 Assisted Reproductive Technology: National Summary Report 25 (2021) (hereafter 2019 ART Report), https://www.cdc.gov/art/reports/2019/pdf/2019-Report-ART-Fertility-Clinic-National-Summary-h.pdf. In addition to IVF births, it is estimated that 60,000 children are born annually via artificial insemination by donor (AID). See. Inst. for Sci., Law & Tech. Working Group, ART Into Science: Regulation of Fertility Techniques, 281 Science 651 (1998) (reporting 60,000 AID births annually). Births via IVF and AID bring the total number of children born through assisted conception to roughly 144,000; the total birth rate for 2019 was nearly four million. See Ctrs. for Disease Control & Prevention, U.S. Dep’t. of Health & Hum. Servs. Births: Provisional Data for 2019, Vital Statistics Rapid Release, May 2020, https://www.cdc.gov/nchs/data/vsrr/vsrr-8-508.pdf (reporting 3,745,540 live births in the U.S. in 2019, down by approximately 1% from 2018). Thus, total ART births in the U.S. in 2019 comprised nearly 4% of all live births.
- 6.
See generally, Erwin Chemerinsky, Constitutional Law: Principles and Policies (6th ed. 2019).
- 7.
Skinner v. Oklahoma, 316 U.S. 535 (1942). For a thorough description and analysis of the events and implications surrounding the Skinner case, see Victoria F. Norse, In Reckless Hands: Skinner v. Oklahoma and the Near-Triumph of American Eugenics (2008).
- 8.
For a fuller discussion of the American eugenics movement and its implications for reproductive freedom, see Judith Daar, The New Eugenics: Selective Breeding in an Era of Reproductive Technologies (2017); Paul A. Lombardo, Three Generations, No Imbeciles: Eugenics, The Supreme Court and Buck v. Bell (2008).
- 9.
316 U.S. at 536.
- 10.
Id. at 541.
- 11.
See, e.g., John A. Robertson, Children of Choice: Freedom and the New Reproductive Technologies (1994) (arguing the right to procreate via ART is constitutionally equal to right attached to natural conception and childbirth); Sonia M. Suter, The “Repugnance” Lens of Gonzales v. Carhart and Other Theories of Reproductive Rights: Evaluating Advanced Reproductive Technologies, 76 Geo. Wash. L. Rev. 1514 (2008) (finding a right to ART potentially supported by theories based on procreative liberty and autonomy, equality and family privacy).
- 12.
See, e.g., Radhika Rao, Constitutional Misconceptions, 93 Mich. L. Rev. 1473 (1995) (rejecting the presumptive primacy of procreative liberty as applied to ART, noting that other constitutional rights may be at issue when donors or surrogates are used and their rights need to be taken into relative account); Ann MacLean Massie, Regulating Choice: A Constitutional Law Response to Professor John A. Robertson’s Children of Choice, 52 Wash. & Lee L. Rev. 135 (1995) (expressing concern that constitutionally equalizing coital and noncoital means of reproduction might suppress the interests of resulting offspring).
- 13.
Lifchez v. Hartigan, 735 F. Supp. 1361 (N.D. Ill. 1990).
- 14.
Id.
- 15.
Kass v. Kass, 1995 WL 110368 (Sup. Ct. of Nassau Co., NY 1995).
- 16.
J.R. v. Utah, 261 F. Supp. 2d 1268 (D. Utah 2002). See also Soos v. Superior Court in and for County of Maricopa, 182 Ariz. 470 (1994) (declaring provision of state law that named surrogate and her husband as legal parents unconstitutional).
- 17.
261 F. Supp. at 1296.
- 18.
Id. at 1294.
- 19.
See, e.g., Johnson v. Calvert, 5 Cal. 4th 87, 98–99 (1993) (finding no constitutional rights of a gestational carrier are implicated by upholding the intended parents’ legal rights because she is not considered a legal mother of any child born).
- 20.
Food & Drug Administration, Guidance for Industry, Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, 69 F.R. 29,786–01 (May 25, 2004).
- 21.
Yaniv Heled, The Regulation of Genetic Aspects of Donated Reproductive Tissue – The Need for Federal Regulation, 11 Col. Science & Tech. L. Rev. 243, 297 (2010). The Commerce Clause of the U.S. Constitution gives Congress the authority “To regulate Commerce… among the several States.” U.S. Const., Art. I, Sec. 8.
- 22.
Id. at 297, citing Gonzales v. Oregon, 546 U.S. 243 (2006), in which the Supreme Court acknowledged the federal government’s authority to set uniform standards in the regulation of health and safety.
- 23.
See National Federation of Independent Business v. Sebelius, 567 U.S. 519 (2012) (a majority of the Court finding that the Affordable Care Act’s individual mandate to purchase health insurance was not a valid exercise of Congress’ power to regulate commerce; the Commerce Clause allows Congress to regulate existing commercial activity, but not to compel individuals to participate in commerce).
- 24.
410 U.S. 113 (1973).
- 25.
505 U.S. 833, 878 (1992).
- 26.
597 U.S. __ (2022).
- 27.
Id. at __.
- 28.
I. Glenn Cohen, Judith Daar, Eli Adashi, What Overturning Roe v. Wade May Mean for Assisted Reproductive Technologies in the U.S., 328(1) JAMA 15–16 (June 6, 2022).
- 29.
See Ethics in Embryo Research Task Force and Ethics Committee of the American Society for Reproductive Medicine, Ethics in Embryo Research, 113 Fertil. Steril 270 (2020).
- 30.
See Fertility Clinic Services: Hearings Before the Subcomm. On Health and the Env’t of the H. Comm. On Energy & Com., 102d Cong. 1–2 (1992) (testimony revealing deception by some fertility clinics to inflate treatment success rates).
- 31.
42 U.S.C. 263a-1 (1992).
- 32.
42 U.S.C. §263a-1 et seq.
- 33.
See Lucy Frith & Eric Blyth, Assisted Reproductive Technology in the USA: Is More Regulation Needed? 29 Reproductive BioMedicine Online 516 (2014).
- 34.
For a history of the FDA’s authority over ART, see Judith Daar, Federalizing Embryo Transfer: Taming the Wild West of Reproductive Medicine?, 23 Col. J. Gender & Law 257, 269 (2012).
- 35.
Human Cells, Tissues, and Cellular and Tissue-Based Products, 21 C.F.R. §1271, https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/donor-eligibility-final-rule-and-guidance-questions-and-answers
- 36.
See supra note 5 (2019 ART Report reporting approximately 27,000 of the 200,000 IVF cycles involved donor eggs).
- 37.
See Frith & Blyth, supra note 33. See also Heled, supra note 21.
- 38.
Practice Committee of the American Society for Reproductive Medicine, Recommendations for Gamete and Embryo Donation: A Committee Opinion, 99 Fertil Steril 47 (2013).
- 39.
See, e.g., R.M. Lim, P. Callum, C. Ruberto, R.E. Zinberg,
Genetic Screening Practices at Ooocyte Donation Programs, 96 Fertil. Steril. S218 (2011) (reporting industry guidelines for genetic testing inconsistently implemented at oocyte donation programs).
- 40.
The Human Fertilisation and Embryology Act (1990, updated 2008) governs ART in the UK, see http://www.legislation.gov.uk/ukpga/2008/22/contents; in Canada, the Assisted Human Reproduction Act (2004) governs. See https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/legislation-guidelines/assisted-human-reproduction.html
- 41.
42 U.S.C. §263a-2(i).
- 42.
U.S. v. Lopez, 514 U.S. 549, 594 (quoting Gibbons v. Ogden, 22 U.S. 1, 203 (1824)).
- 43.
See generally Michelle Bayefsy, Who Should Regulate Preimplantation Genetic Diagnosis in the United States? AMA Journal of Ethics (Dec. 2018), https://journalofethics.ama-assn.org/article/who-should-regulate-preimplantation-genetic-diagnosis-united-states/2018-12;
- 44.
In 2015, Francis Collins, the Director of the National Institutes of Health issued a statement announcing that NIH would not fund any use of gene-editing technologies in human embryos, adding, “The concept of altering the human germline in embryos for clinical purposes has been debated over many years from many different perspectives, and has been viewed almost universally as a line that should not be crossed.” Francis Collins, Statement on NIH Funding of Research Using Gene-Editing Technologies in Human Embryos (Apr. 28, 2015), https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-funding-research-using-gene-editing-technologies-human-embryos
- 45.
See Rosa J. Castro, Mitochondrial Replacement Therapy: The UK and US Regulatory Landscapes, 3 J. Law & Biosciences 726 (2016).
- 46.
Normally, all new drugs and biological products are required to be reviewed by the FDA before they are eligible for clinical use. Occasionally, the FDA will receive requests to allow researchers to administer investigational new drugs (those which have yet been approved) to humans for the purposes of testing the drugs’ safety and effectiveness, Federal law (21 U.S.C. 355(i) and 42 U.S.C. 262(a)(3)) provides the FDA with authority to grant exemptions from review in these situations. See https://scipol.duke.edu/track/consolidated-appropriations-act-2016-public-law-114-113. The IND link to MRT is explained by the National Academies of Science, Engineering and Medicine as follows: “Human genome-editing technologies are considered to be gene therapies with regard to FDA oversight, and the agency regulates human genome editing under the existing framework for biological products, which includes gene therapy products.” National Academies of Sciences, Engineering, and Medicine; National Academy of Medicine; National Academy of Sciences; Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations, Human Genome Editing: Science, Ethics, and Governance (Feb. 2017), https://www.ncbi.nlm.nih.gov/books/NBK447266/
- 47.
21 CFR Part 312.
- 48.
See I. Glenn Cohen & Eli Adashi, The FDA is Prohibited From Going Germline, 353 Science 545 (2016).
- 49.
Pub. Law 113–114, Sec. 749 (2015).
- 50.
Id.
- 51.
See Cohen & Adashi, supra note 48 reviewing congressional hearings on the issue of germline editing. Thus, while germline genome research is not illegal per se, it can only be done using private funding and only at the pre-clinical level. Any attempt to transfer an edited egg, sperm or embryo into a human being would require an IND – unattainable under current law.
- 52.
See Judith Daar, The Prospect of Human Cloning: Improving Nature of Dooming the Species?, 33 Seton Hall L. Rev. 511 (2003) (detailing legislative reactions to cloning, including state bans and the many bills introduced but not passed in Congress).
- 53.
The Balanced Budget Downpayment Act, I, Pub L No 103–99; 128, 110 Stat.34 (1996).
- 54.
See More than 8 Million Babies Born from IVF Since the World’s First in 1978, Science Daily (July 3, 2018), https://www.sciencedaily.com/releases/2018/07/180703084127.htm
- 55.
The latter two topics are not covered in this chapter, but ample commentary is illuminating. See, e.g., Kristine S. Knaplund, Assisted Reproductive Technology: The Legal Issues, 28 Prob. & Prop. 48 (2014) (discussing parentage and inheritance rights of post-mortem conceived children); Dov Fox, Birth Rights and Wrongs: How Medicine and Technology are Remaking Reproduction and the Law (2019) (advancing a theory of reproductive negligence for errors, mishaps and wrongdoing in reproductive medicine).
- 56.
See. e.g., Doornbos v. Doornbos, 139 N.E.2d. 844 (Ill. App. Ct.1956) (use of donor insemination constitutes adultery by wife, child is not legitimate child of marriage); Gursky v. Gursky, 39 Misc. 2d 1083, 242 N.Y.S.2d 406 (1963) (declaring child of sperm donation used during marriage “not the legitimate issue of the husband”).
- 57.
Unif. Parentage Act (Unif. Law Comm’n 2017), §§702–703.
- 58.
See Deborah L. Forman, Exploring the Boundaries of Families Created with Known Sperm Providers: Who’s I and Who’s Out, 19 U. Pa. J.L. & Soc. Change 41 (2016) (cataloging state law regarding parentage of donor-conceived children).
- 59.
Id. at 42–45.
- 60.
For example, in deciding a dispute between two women who used egg donation to birth a child, the California Supreme Court looked to the state’s law on sperm donation as no specific statute addressed the more recently emerged technology. K.M. v. E.G., 37 Cal. 4th 130, 33 Cal. Rptr. 3d 61 (2005).
- 61.
See, e.g., Jason P. v. Danielle S., 171 Cal. Rptr. 3d 789, 796–97 (Cal. Ct. App. 2014) (recharacterization of sperm provider from donor to parent based on post-birth conduct); Ferguson v. McKiernan, 940 A.2d 1236, 1248 (Pa. 2007) (court adopting opt-out system where sperm providers are considered parents, with full parental rights and responsibilities, unless the provider and recipient expressly agree otherwise).
- 62.
See Sonia M. Suter, In Vitro Gametogenesis: Just Another Way to Have a Baby?, 3 J. of Law and the Biosciences, 87 (2015).
- 63.
See generally Judith Daar, Multi-Party Parenting in Genetics and Law: A View From Succession, 49 Family L. Quarterly 71 (2015).
- 64.
Id.at 75–77 (discussing evolving law on multi-party parenthood).
- 65.
According to the CDC national report on ART, embryo transfers using a gestational carrier almost quadrupled from 2010 to 2019, moving from 2649 to 9195. See 2019 ART Report, supra note 5, at 34.
- 66.
See Jenna Casolo, et al., Assisted Reproductive Technologies, 20 Geo. J. Gender & Law 313, 330–42 (2019) (reviewing permissive, restrictive and prohibitive jurisdictions in the U.S.). See also Updated United States Surrogacy Map, https://www.creativefamilyconnections.com/us-surrogacy-law-map/
- 67.
See Cal. Family Code §7962.
- 68.
Andrew E. Kramer, 100 Babies Stranded in Ukraine After Surrogate Births, NY Times (May 16, 2020).
- 69.
Sarah Mervosh, Gay U.S. Couple Sues State Dept. for Denying Their Baby Citizenship, NY Times (July 23, 2019).
- 70.
For example, in Arizona a statute was enacted after a court held that disputed embryos should be awarded to the ex-husband – who wanted to donate them to another couple – based on a written agreement of the parties. The elected official favored a different outcome – one in which the wife would prevail. Thus, the legislature enacted a law effectively abrogating prior agreements and directing courts to award embryos “to the spouse who intends to allow the in vitro human embryos to develop to birth.” Ariz. Rev. Stat. §25–318.03.
- 71.
See I. Glenn Cohen & Eli Adashi, Embryo Dispositions and Disputes: Controversies and Case Law, 46 Hastings Center Rpt. 13 (July–August 2016) (charting the cases according to jurisdiction, result and approach).
- 72.
See Casolo, supra note 66, at 321–23.
- 73.
Reber v. Reiss, 42 A.3d 1131 (Pa. Super. Ct. 2012); Szafranski v. Dunston, 34 N.E.3d 1132 (Ill. App. Ct. 2015). But see Findley v. Lee, No. FDI-13-780539 (Cal. Super. Ct. Jan. 11, 2016) (awarding embryos to ex-husband despite ex-wife’s cancer treatment-induced infertility).
- 74.
Naomi Cahn, Who Gets the Frozen Embryos? Forbes (Feb. 4, 2020).
- 75.
See Practice Committee of the American Society for Reproductive Medicine, Minimum Standards for Practices Offering Assisted Reproductive Technologies: A Committee Opinion, 113 Fertil. Steril. 536 (2020).
- 76.
See, e.g., A.Z. v. B.Z., 725 N.E.2d 1051 (Mass. 2000) (court refused to enforce agreement awarding embryos to wife as against public policy for imposing unwanted parenthood on husband).
- 77.
See Ethics in Embryo Research, supra note 29, at 276 (summarizing state laws that permit and restrict activity and funding on human embryo research).
- 78.
The most generous state-funded program, California’s Prop 71-initiatied California Institute for Regenerative Medicine (CIRM) has largely failed to produce the much-promised revenue streams. The 2004 voter ballot initiative allocated $3 billion over more than 10 years to fund stem cell therapy. A 2018 newspaper article concludes, “Not a single federally approved therapy has resulted from CIRM-funded science. The predicted financial windfall has not materialized. The bulk of CIRM grants have gone to basic research, training programs and building new laboratories, not to clinical trials testing the kinds of potential cures and therapies the billions of dollars were supposed to deliver.” Eric Allday & Joaquin Palomino, Lofty Promises, Limited Results, SF Chron. (Sept 6, 2018), https://projects.sfchronicle.com/2018/stem-cells/politics/
- 79.
In a white paper on oversight of ART issued by the American Society for Reproductive Medicine, the final sentence of the document states in bold type, “ART is already one of the most highly regulated of all medical practices in the United States.” American Society for Reproductive Medicine, Oversight of Assisted Reproductive Technology (2010), https://www.asrm.org/globalassets/asrm/asrm-content/about-us/pdfs/oversiteofart.pdf
- 80.
See generally Federal Policy for the Protection of Human Subjects, 45 CFR 46, https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML
- 81.
See David Cyranoski, Russian ‘CRISPR-Baby’ Scientist Has Started Editing Genes in Human Eggs with Goal of Altering Deaf Gene, Nature (Oct. 18, 2019), https://www.nature.com/articles/d41586-019-03018-0
- 82.
See David Cyranoski, What CRISPR-Baby Prison Sentences Mean for Research, Scientific American, (Jan. 6, 2020), https://www.scientificamerican.com/article/what-crispr-baby-prison-sentences-mean-for-research/
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Daar, J. (2023). Emerging Reproductive Technologies: Regulating Into the Void. In: King, L.P., Band, I.C. (eds) Case Studies in the Ethics of Assisted Reproduction. Springer, Cham. https://doi.org/10.1007/978-3-031-41215-8_2
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