Parentage Disputes in the Age of Mitochondrial Replacement Therapy

Home , Adoption, Daughter, Embryo donation, Father, Parent, Parenting

NOTES

AMY B. LEISER*

TABLE OF CONTENTS

INTRODUCTION ...... 414

I. MITOCHONDRIAL REPLACEMENT THERAPY ...... 417

A. WHAT MITOCHONDRIAL REPLACEMENT THERAPY IS AND WHY WE NEED IT ...... 417

B. HOW MITOCHONDRIAL REPLACEMENT THERAPY WORKS ...... 420

II. DETERMINING LEGAL PARENTAGE IN THE CONTEXT OF ASSISTED REPRODUCTIVE TECHNOLOGIES ...... 422

A. RESOLVING PARENTAGE DISPUTES ARISING OUT OF ASSISTED REPRODUCTIVE TECHNOLOGIES ...... 422

B. BENEFITS AND CRITICISMS OF THE INTENT TEST ...... 426

C. APPLYING THE INTENT TEST IN THE CONTEXT OF GAMETE DONATION ...... 428

III. DETERMINATION OF LEGAL PARENTAGE IN THE CONTEXT OF MITOCHONDRIAL REPLACEMENT THERAPY ...... 429

A. APPLYING THE INTENT TEST IN THE CONTEXT OF MITOCHONDRIAL REPLACEMENT THERAPY ...... 430

B. MITOCHONDRIAL REPLACEMENT THERAPY WITH THREE INTENDING PARENTS ...... 431

C. MITOCHONDRIAL REPLACEMENT THERAPY IS NOT THE ONLY “THREE-PARENT” ASSISTED REPRODUCTIVE TECHNOLOGY ...... 433

CONCLUSION ...... 434

* Georgetown Law, J.D. expected 2016; University of Texas, B.S. 2012. © 2016, Amy Leiser. I would like to thank Professor Patricia King and Meagan Gordon for their generous guidance and feedback in developing this Note, and the editors and staff of The Georgetown Law Journal for their thorough comments and advice throughout the publication process. Finally, I would like to thank my family and friends for their continuous support throughout my education.

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INTRODUCTION Mitochondrial replacement therapy (MRT) is an experimental assisted reproductive technology (ART) for women with mitochondrial disease who want to avoid passing that disease on to their children and for women with certain causes of infertility.1 It is unique in that it results in a child with DNA from three different people. Our cells, including egg and sperm cells, contain both nuclei with nuclear DNA—the “instruction manual” for the cell2—and many intracellular organelles that carry on the functions of our cells—the “machin- ery” of the cell.3 One of those organelles, mitochondria, has its own small, independent source of DNA called mitochondrial DNA.4 MRT essentially works by transferring the nucleus (containing nuclear DNA) from one egg cell (the “original egg”) into a different egg cell (the “donor egg”) that has had its nucleus removed but retains its mitochondria and associated mitochondrial DNA.5 Because the fertilized embryo contains mitochondrial DNA from the donor egg that is different from the mitochondrial DNA in the original egg, the resulting embryo has DNA from three different sources: nuclear DNA from the original egg, mitochondrial DNA from the donor egg, and nuclear DNA from the sperm.6 One objection to MRT is that it would be confusing to determine legal parentage when three different people contribute DNA to the embryo.7 Does MRT create new “three-parent babies”? Can we deny the mitochondrial donor parentage rights when the resulting child also carries her DNA? How do we determine legal parentage rights for children conceived using MRT? This Note addresses these questions by analogizing to how state legislatures and courts resolve parentage disputes for children conceived using other ARTs, particularly those involving gamete donation (sperm donation and egg donation). Modern legal parentage disputes are often resolved based on relationships that parents have with their children. Courts have identiﬁed three different relationships that can make someone the parent of a child: (1) An “intended

1. See Paula Amato et al., Three-Parent In Vitro Fertilization: Gene Replacement for the Prevention of Inherited Mitochondrial Diseases, 101 FERTILITY &STERILITY 31, 32 (2014); CELLULAR,TISSUE, AND GENE THERAPIES ADVISORY COMMITTEE,FOOD AND DRUG ADMIN., OOCYTE MODIFICATION IN ASSISTED REPRODUCTION FOR THE PREVENTION OF TRANSMISSION OF MITOCHONDRIAL DISEASE OR TREATMENT OF INFERTILITY 11 (2014) [hereinafter FDA BRIEFING DOCUMENT]. 2. See Deoxyribonucleic Acid (DNA),NAT ’L HUM.GENOME RES.INST., http://www.genome.gov/25520 880 (last visited Dec. 25, 2014). 3. See What Is a Cell?,GENETICS HOME REFERENCE, http://ghr.nlm.nih.gov/handbook/basics/cell (last visited Jan. 7, 2015). 4. FDA BRIEFING DOCUMENT, supra note 1, at 5. 5. See Amato, supra note 1, at 32. There is another method of performing MRT, discussed in Part I.B infra, but the result is the same: an embryo with DNA from three people. 6. See id. 7. Other objections to MRT focus on the risks inherent in a clinical trial. See, e.g., Annelien L. Bredenoord & Peter Braude, Ethics of Mitochondrial Gene Replacement: From Bench to Bedside, 342 BMJ 87, 87, 89 (2011). However, these concerns are beyond the scope of this Note, which focuses on the perceived challenges of recognizing legal parentage rights in the context of MRT. 2016]DISPUTES IN THE AGE OF MITOCHONDRIAL REPLACEMENT 415 parent” is a parent who intended to bring a child into the world to raise as his or her own; (2) a “genetic parent” is a person who shares DNA with the child; and (3) the “biological parent” (also called the “gestational parent” or “birth mother”) is the woman who gave birth to the child.8 Although the same two people used to encompass all three relationships, assisted reproductive technologies have enabled the division of these relationships among multiple people. Using ART to create families is a relatively recent phenomenon,9 and the increasing use of ART has impacted not only couples’ ability to have children, but also which couples can have children, assumptions we make about those couples having children, and whether it is a couple or an individual having children.10 Long before ART, the notion of the “traditional” family, consisting of a husband, a wife, and their biological children, prevailed in American society.11 Therefore, the intending parents and the genetic parents were pre-

8. See SUSAN L. CROCKIN &HOWARD W. J ONES,JR., LEGAL CONCEPTIONS:THE EVOLVING LAW AND POLICY OF ASSISTED REPRODUCTIVE TECHNOLOGIES 11 (2009) (discussing how assisted reproductive technology has changed the definition of motherhood); CHARLES P. K INDREGAN,JR.&MAUREEN MCBRIEN,ASSISTED REPRODUCTIVE TECHNOLOGY:ALAWYER’S GUIDE TO EMERGING LAW AND SCIENCE 2 (2d ed. 2011) (“Thus, traditional notions of the family are qualified by the introduction of entirely new legal parental concepts, such as ‘intended parent,’ ‘gestational carrier,’ and ‘gamete provider.’”). 9. Assisted reproductive technologies include technologies and therapies that allow individuals to achieve “pregnancy through means other than by sexual intercourse.” MODEL ACT GOVERNING ASSISTED REPROD.TECH. § 102-1 (2008). Artificial insemination, the process by which sperm is deliberately introduced into a female’s cervix without sexual intercourse, began in the United States in the 1950s and is the oldest and most common form of assisted reproductive technology. See ROBERT BLANK & JANNA C. MERRICK,HUMAN REPRODUCTION,EMERGING TECHNOLOGIES, AND CONFLICTING RIGHTS 86 (1995). By 1979, estimates indicated that up to 10,000 children conceived by artificial insemination were being born each year. See Mary Patricia Byrn, From Right to Wrong: A Critique of the 2000 Uniform Parentage Act, 16 UCLA WOMEN’S L.J. 163, 174 (2007) (citing Martin Curie-Cohen et al., Current Practice of Artificial Insemination by Donor in the United States, 300 NEW ENG.J.MED. 585, 588 (1979)). And by 1996, approximately 65,000 children conceived by artificial insemination were born each year. Id. (citing Karin Mika & Bonnie Hurst, One Way to Be Born? Legislative Inaction and the Posthumous Child,79MARQ.L.REV. 993, 996 (1996)). In vitro fertilization (IVF), the process by which fertilization of the egg occurs outside the body and the reconstituted embryo is implanted into the female’s uterus, was successfully used in the United States for the first time in 1981. Id. at 174 & n.42. By 2003, nearly 50,000 children conceived from IVF were born in the United States each year. Id. at 175 (citing CTRS. FOR DISEASE CONTROL AND PREVENTION, U.S. DEP’TOFHEALTH &HUMAN SERVS., ASSISTED REPRODUCTIVE TECHNOLOGY SUCCESS RATES:NATIONAL SUMMARY AND FERTILITY CLINIC REPORTS 13 (2005)). As artificial insemination and IVF became more affordable, couples began employing the use of gestational surrogacy, where one woman agrees to gestate the baby intended for another woman, and in 2000 the Centers for Disease Control reported that over 1,200 attempts were made to create gestational surrogacy arrangements. Id. at 176 (citing David P. Hamilton, She’s Having Our Baby: Surrogacy Is on the Rise as In-Vitro Improves,WALL ST. J., Feb. 4, 2003, at D1). 10. See J. Herbie DiFonzo & Ruth C. Stern, Breaking the Mold and Picking Up the Pieces: Rights of Parenthood and Parentage in Nontraditional Families,51FAM.CT.REV. 104, 104–05 (2013) (comment- ing on the transition from the pre-1960s United States, in which families consisted of married couples with children, to the present United States, in which children are born outside of marriage and same-sex couples have children). 11. See KINDREGAN &MCBRIEN, supra note 8, at 5–6 & n.13 (describing the “traditional family” and changing regulation of heterosexual marriage during the 20th century); DiFonzo & Stern, supra note 10, at 104 (“[I]n the pre-1960s United States, ‘marriage and only marriage was one’s ticket of admission to a full family life.’” (quoting Andrew Cherlin, The Deinstitutionalization of American Marriage,66J. 416THE GEORGETOWN LAW JOURNAL [Vol. 104:413 sumed to be the same two people: husband and wife. And unless the couple adopted, the “gestational parent” was also presumed to be the wife. However, as ARTs became more popular, these different parentage relationships were di- vided between different people. For example, a married couple might have used a sperm donor because the husband was infertile. In that case, the intending father (the husband) and the genetic father (the sperm donor) were different people. When disputes arose over who should be recognized as the legal parents of a child, state courts and legislatures resolved them, prioritizing certain relationships over others, depending on the state and the particular facts of the case.12 Most cases have been resolved in favor of the intending parents, though the expressed reasoning of the courts varies.13 In all cases prior to MRT, it has been safe to assume that there are only two genetic parents for every child—a genetic mother who contributed her egg and a genetic father who contributed his sperm—because it was impossible to conceive a child with more than two genetic parents.14 Now, MRT challenges this baseline because children born from MRT have DNA from three different people. This new technology challenges the sufficiency of existing frameworks for settling parentage disputes. For example, relying on intent in the context of MRT could reasonably result in the recognition of three legal parents where all three contributors intended to have the child. This might trigger a knee-jerk reaction in some who do not want to recognize more than two legal parents. Some commentators might urge that greater emphasis should be placed on a child’s genetic relationship to only those parents who contributed nuclear DNA, which accounts for over ninety-nine

MARR.&FAM. 848, 852 (2004))). In the 1700s, the assumption that “traditional” families were the norm was so strong that the marital presumption of paternity—a presumption developed at common law in which the husband is presumed to be the father of any child to which his wife gives birth—was virtually conclusive. The presumption could only be rebutted by proving either that the husband was sterile or that the husband was not present when his wife conceived because he was out of the country for the entire pregnancy. See Debi McRae, Evaluating the Effectiveness of the Best Interests Marital Presumption of Paternity: It Is Actually in the Best Interests of Children to Divorce the Current Application of the Best Interests Marital Presumption of Paternity,5WHITTIER J. CHILD &FAM.ADVOC. 345, 348, 358 (2006). 12. See infra Part III.A discussing different tests applied to resolve parentage disputes in the context of ART. 13. See Mary Patricia Byrn & Lisa Giddings, An Empirical Analysis of the Use of the Intent Test to Determine Parentage in Assisted Reproductive Technology Cases,50HOUS.L.REV. 1295, 1297 (2013); CROCKIN &JONES, supra note 8, at 134 (noting both statutory law providing for rights for intended parents and inconsistent judicial decisions in this area). But see CROCKIN &JONES, supra note 8, at 194 (noting that “[t]he degree to which intended parenthood plays a role in deciding contested parentage disputes continues to be an unpredictable factor” in cases of sperm or embryo mix-ups). 14. See, e.g., Lynda Wray Black, The Birth of a Parent: Deﬁning Parentage for Lenders of Genetic Material,92NEB.L.REV. 799, 812 (2014) (“Notwithstanding the scientiﬁc breakthroughs in reproductive technology and the more inclusive modern understanding of the family unit, every child begins with two (and only two) suppliers of genetic material and one (and only one) gestational carrier.” (emphasis added) (footnote omitted)). 2016]DISPUTES IN THE AGE OF MITOCHONDRIAL REPLACEMENT 417 percent of the DNA in our cells.15 But is that consistent with the rationale for relying on intent? Does the amount of DNA contributed necessarily correlate with a parent’s intent? Over-emphasizing the genetic relationship between parents and children might have negative repercussions for the resolution of parentage disputes in the context of gamete donation, in which one or both intending parents often have no genetic relationship to the child. This Note argues that MRT is analogous to other forms of gamete donation, and that because parentage disputes in the context of gamete donation are commonly resolved using the intent test, parentage disputes in the context of MRT should be resolved using the intent test as well. Part I introduces MRT, why we need it, and how it works. Part II discusses the various methodologies that state courts and legislatures use to resolve parentage disputes in the context of ART as well as the preferred use of the intent test, some strengths and weaknesses of the intent test, and how the intent test is applied in the context of gamete donation. Finally, Part III argues that MRT is analogous to other forms of gamete donation, and explains how the intent test should be applied to resolve parentage disputes in the context of MRT. This Note concludes that parentage disputes in the context of MRT can and should be resolved using the intent test, and therefore the concern over determining legal parentage in the context of MRT is not a persuasive objection to its therapeutic use.

I. MITOCHONDRIAL REPLACEMENT THERAPY This Part describes mitochondrial replacement therapy, a new assisted reproductive technology for use by women with either of two medical indications: mitochondrial disease or infertility. Part I.A explains what MRT is and why we need it. Part I.B explains how MRT actually works and some of the challenges confronting its use and clinical adoption.

A. WHAT MITOCHONDRIAL REPLACEMENT THERAPY IS AND WHY WE NEED IT It is estimated that each year, 1 out of 4,000 children in the United States is born with an inherited mitochondrial disease.16 Although mitochondrial DNA accounts for less than 0.001% of the DNA in our cells and only 0.1%–0.2% of our genes,17 mitochondrial DNA mutations can manifest in diseases of the

15. See infra Part I.A. 16. Amato et al., supra note 1, at 31; see also Masahito Tachibana et al., Towards Germline Gene Therapy of Inherited Mitochondrial Diseases, 493 NATURE 627, 627 (2013) (estimating between 1,000 and 4,000 American children are born with mtDNA diseases every year). 17. See Robert W. Taylor & Doug M. Turnbull, Mitochondrial DNA Mutations in Human Disease,6 NATURE REVIEWS GENETICS 389, 391 (2005). MtDNA contains less than 17,000 base pairs and only 37 genes, whereas nuclear DNA contains about 3.3 billion base pairs and 20,000–30,000 genes. Id. But see Garry Hamilton, The Hidden Risks for ‘Three-Person’ Babies, 525 NATURE 444 (2015) (“Roughly 1,500 nuclear genes are involved in mitochondrial function, including around 76 that encode proteins which bind to mitochondrially derived peptides.”). 418THE GEORGETOWN LAW JOURNAL [Vol. 104:413 brain, muscle, liver, heart, kidney, and the central nervous system,18 and may contribute to the development of common multifactorial disorders such as diabetes mellitus and neurodegenerative disease.19 Clinical expression varies, but symptoms can include deafness, blindness, diabetes, and muscle weakness, as well as fatal heart, kidney, and liver failure.20 There are presently no cures for mitochondrial diseases; available treatments merely “alleviate symptoms and delay disease progression.”21 Because mitochondria are only inherited through the maternal line, mitochondrial diseases are likewise only heritable from the mother.22 Age-related female infertility is also suspected to be associated with reduced quantity and mutation of mitochondria in women’s eggs.23 Egg quality is negatively correlated with maternal age and mitochondrial DNA damage.24 Therefore, few, low-quality mitochondria in a woman’s eggs could contribute to age-related infertility.25 Currently, the only ways to both prevent the transmission of mitochondrial disease between generations and assist infertile women in having children are whole egg donation, embryo donation, and adoption.26 With whole egg donation, the intending parents use only an egg donor, whereas with embryo donation, the intending parents use both an egg donor and a sperm donor.27 However, none of these methods allow both intending parents to be genetic

18. Amato et al., supra note 1, at 31; see also Taylor & Turnbull, supra note 17, at 394. 19. Andrew M. Schaefer et al., The Epidemiology of Mitochondrial Disorders—Past, Present and Future, 1659 BIOCHIMICA ET BIOPHYSICA ACTA 115, 115 (2004). 20. Amato et al., supra note 1, at 31. 21. Tachibana et al., supra note 16. 22. Amato et al., supra note 1, at 31. Although sperm contribute mitochondria to a fertilized egg, those sperm are destroyed shortly after fertilization. See Peter Sutovsky et al., Ubiquitin Tag for Sperm Mitochondria, 402 NATURE 371, 371–72 (1999). 23. See Timothy Wai et al., The Role of Mitochondrial DNA Copy Number in Mammalian Fertility, 83 BIOLOGY OF REPROD. 52, 53 (2010). Although mature oocytes with only 4,000 copies of mtDNA can be fertilized, a threshold of at least 40,000–50,000 copies of mtDNA is required for a mature oocyte to survive post-implantation development. Id; see also FDA BRIEFING DOCUMENT, supra note 1, at 11. 24. Li-ya Wang et al., Mitochondrial Functions on Oocytes and Preimplantation Embryos,10J. ZHEJIANG U. SCI. B 483, 483 (2009). 25. But see FDA BRIEFING DOCUMENT, supra note 1, at 11 (“Neither is there agreement that mitochondrial function is generally compromised in the reproductive system due to advanced age, rather than as the result of other underlying conditions that impact fertility.”). 26. Françoise Baylis, The Ethics of Creating Children with Three Genetic Parents,26REPROD. BIOMEDICINE ONLINE 531, 531 (2013). Cytoplasmic transfer (transfer of a small portion of ooplasm containing healthy mitochondria from one oocyte to another) is reported as banned by the FDA. Masahito Tachibana et al., Mitochondrial Gene Replacement in Primate Offspring and Embryonic Stem Cells, 461 NATURE 367, 371 (2009). However, whether the FDA actually banned the technology is disputed, and others report that the FDA merely asked researchers to apply for permission to test the approach in clinical trials, which no one did. Erika Check Hayden, Regulators Weigh Beneﬁts of ‘Three-Parent’ Fertilization, 502 NATURE 284, 284 (2013). Regardless, cytoplasmic transfer would only dilute the effects of mutant mitochondria passed down from the mother, but it would not eliminate them. Taylor & Turnbull, supra note 17, at 398. 27. See KINDREGAN &MCBRIEN, supra note 8, at 105–07. 2016]DISPUTES IN THE AGE OF MITOCHONDRIAL REPLACEMENT 419 parents: with adoption and embryo donation, neither parent is a genetic parent; with whole egg donation, the intending mother is not a genetic parent. Prenatal testing is also available to inform parents whether the gestational mother is carrying a healthy fetus. Chorionic villus biopsy28 (usually performed between weeks 10 and 13 of pregnancy)29 and amniocentesis30 (usually performed between weeks 15 and 20 of pregnancy)31 are two prenatal tests that can inform parents whether their fetus has inherited a mitochondrial disease.32 However, these tests do not prevent transmission; rather they only inform parents that transmission has already occurred. Nor is preimplantation genetic diagnosis33 guaranteed to result in implantation of a healthy embryo because sampling a single cell is not necessarily representative of the entire embryo’s mitochondrial DNA composition.34

28. “Chorionic villus sampling (CVS) is a prenatal test in which a sample of chorionic villi is removed from the placenta for testing... .Although chorionic villus sampling can provide valuable information about [a] baby’s health,” it is also considered an “invasive” diagnostic test, and thus the decision to use it is serious. Tests and Procedures, Chorionic Villus Sampling, Definition,MAY O CLINIC (Oct. 10, 2012), http://www.mayoclinic.org/tests-procedures/chorionic-villus-sampling/basics/definition/ prc-20013566. Risks of performing chorionic villus sampling include miscarriage, Rh sensitization, and infection. Tests and Procedures, Chorionic Villus Sampling, Risks,MAY O CLINIC (Oct. 17, 2015), http://www.mayoclinic.org/tests-procedures/chorionic-villus-sampling/basics/risks/prc-20013566. 29. Tests and Procedures, Chorionic Villus Sampling, Why It’s Done,MAY O CLINIC (Oct. 17, 2015), http://www.mayoclinic.org/tests-procedures/chorionic-villus-sampling/basics/why-its-done/ prc-20013566. 30. “Amniocentesis is a procedure in which amniotic fluid is removed from the uterus for testing or treatment. Amniotic fluid is the fluid that surrounds and protects a baby during pregnancy.... Although amniocentesis can provide valuable information about [a] baby’s health,” it is important to under the risks. Tests and Procedures, Amniocentesis, Definition,MAY O CLINIC (Oct. 30, 2015), http://www.mayoclinic.org/tests-procedures/amniocentesis/basics/definition/prc-20014529. Risks of performing amniocentesis include miscarriage, needle injury, leaking amniotic fluid, Rh sensitization, and infection. Tests and Procedures, Amniocentesis, Risks,MAY O CLINIC (Oct. 30, 2015), http://www. mayoclinic.org/tests-procedures/amniocentesis/basics/risks/prc-20014529. 31. Tests and Procedures, Amniocentesis, Why It’s Done,MAY O CLINIC (Oct. 10, 2012), http://www. mayoclinic.org/tests-procedures/amniocentesis/basics/why-its-done/prc-20014529. 32. Taylor & Turnbull, supra note 17, at 397. 33. Preimplantation genetic diagnosis (PGD) is a screening test used to determine if genetic or chromosomal disorders are present in embryos produced through in vitro fertilization (IVF). Preimplantation genetic diagnosis screens embryos before they are transferred to the uterus so couples can make informed decisions about their next steps in the IVF process.

Preimplantation Genetic Diagnosis (Embryo Screening),PENN MED., http://www.pennmedicine.org/ fertility/patient/clinical-services/pgd-preimplantation-genetic-diagnosis/ (last visited Nov 8, 2015). How- ever, “preimplantation genetic diagnosis does not replace prenatal testing, such as chorionic villus sampling or amniocentesis,” because PGD “provides diagnostic information based on the analysis of a single cell,” and that cell may not be representative of the embryo as a whole. See id.;see also Amato et al., supra note 1, at 32. Preimplantation genetic diagnosis “is accomplished by performing a biopsy on a single cell that has been taken from the embryo prior to implantation.” KINDREGAN &MCBRIEN, supra note 8, at 95. 34. See Preimplantation Genetic Diagnosis (Embryo Screening), supra note 33. Because mitochondrial DNA replication is not tied to the cell cycle, and mitochondrial segregation is random, mutated and wild-type mitochondrial DNA can replicate at different rates and segregate into daughter cells in 420THE GEORGETOWN LAW JOURNAL [Vol. 104:413

Mitochondrial replacement therapy can prevent transmission of mitochondrial diseases between generations and help infertile women have children while retaining the genetic link between intending parents and offspring.35 This is achieved because MRT transfers the nuclear DNA of the intending mother into a donor egg with healthy mitochondria, ensuring the resulting child will also have healthy mitochondria.36 It is hypothesized that MRT can also be used to treat infertility because the fertilized egg would have more mitochondria, assisting its normal development postimplantation.37 The next section further explains the two proposed methods for conducting MRT.

B. HOW MITOCHONDRIAL REPLACEMENT THERAPY WORKS There are presently two proposed methods for conducting MRT: spindle transfer and pronuclear transfer.38 Spindle transfer works by transferring the nuclear DNA of the unfertilized original egg into an unfertilized donor egg that has had its nuclear DNA removed.39 After the transfer, the donor egg is fertilized and implanted.40 In pronuclear transfer, the nuclear DNA from the fertilized original egg (containing DNA from both the original egg of the genetic mother and the sperm of the genetic father) is transferred into a fertilized donor egg, which has had its nuclear DNA removed.41 Posttransfer, the fertilized donor egg, now containing the nuclear DNA from the fertilized original egg, is implanted.42 The main difference between spindle transfer and pronuclear transfer is that spindle transfer occurs prior to fertilization of the original and donor eggs, whereas pronuclear transfer occurs after fertilization. This has significant impli- different proportions. See Eric A. Shoubridge, Mitochondrial DNA Segregation in the Developing Embryo,15HUM.REPROD. 229, 230 (2000). 35. See Amato et al., supra note 1, at 32–34. 36. Id. There is also a second method for performing MRT, but the ultimate result is the same. See infra Part I.B 37. See FDA BRIEFING DOCUMENT, supra note 1, at 11–12. Cf. Holly Firfer, How Far Will Couples Go to Conceive?, CNN (June 17, 2004, 6:44 AM), http://edition.cnn.com/2004/HEALTH/03/12/infertility. treatment/index.html. In 2004, CNN reported that after ten years of infertility and four failed in vitro fertilization attempts, Sharon and Paul Saarinen conceived using cytoplasmic transfer, a process by which the cytoplasm, which holds the organelles of a cell, including the mitochondria, of a healthy donor egg was implanted into Sharon’s egg, which still contained Sharon’s mitochondria, and fertilized with her husband’s sperm. See id. Cytoplasmic transfer is, in effect, a watered-down version of mitochondrial replacement therapy because it results in a fertilized embryo with a mixture of both women’s mitochondria, whereas in mitochondrial replacement, essentially all the mitochondria (poten- tially less some minimal carryover) comes from the donor egg. See Amato et al., supra note 1, at 32 (Cytoplasmic transfer “adds donor mitochondria, creating a heteroplasmic oocyte with both mitochondrial haplotypes,” whereas with mitochondrial replacement therapy “any resulting child would inherit nuclear genetic material from both parents, whereas the mtDNA would be derived largely or perhaps exclusively from the oocyte provided by the healthy donor.”). 38. Amato et al., supra note 1, at 32–34. 39. Id. 40. Id. 41. Id. 42. Id. at 33 fig.1. 2016]DISPUTES IN THE AGE OF MITOCHONDRIAL REPLACEMENT 421 cations for research funding because pronuclear transfer necessarily requires the creation and destruction of embryos—actions expressly prohibited for research that receives federal funding.43 Because spindle transfer does not require the creation and destruction of embryos, federal funding may be available for research on the spindle transfer technique.44 Unsurprisingly, it appears the spindle transfer technique is more thoroughly researched than the pronuclear transfer technique, and supposedly it “shouldn’t be difficult [for clinics] to master.”45 In 2012, the spindle transfer technique was used successfully to create human embryos in which all of the mitochondria came from a donor egg.46 The technique has also been demonstrated to work with previously frozen eggs, which is critical for clinical application as more women choose to freeze their eggs to delay pregnancy.47 The spindle transfer technique has produced healthy offspring in nonhuman primates, but the long- term safety and efficacy of MRT in humans is unknown.48 These techniques must clear significant regulatory hurdles, for example with the FDA, before either can be clinically used.49 And indeed, there are significant

43. See id. at 34–35; 42 U.S.C. § 289g (2012). 44. See Amato et al., supra note 1, at 34–35. 45. David Cyranoski, DNA-Swap Technology Almost Ready for Fertility Clinic,NATURE (Oct. 24, 2012), http://www.nature.com/news/dna-swap-technology-almost-ready-for-fertility-clinic-1.11651 (quoting Shoukhrat Mitalipov). But see Taylor & Turnbull, supra note 17, at 398 (suggesting that pronuclear transfer is “possibly more feasible” than spindle transfer). 46. Tachibana, supra note 16, at 627–28. Although the researchers could not implant the embryos, they developed the embryos to the blastocyst stage, and then used cells from the blastocyst stage to produce embryonic cell lines on which they performed various tests. Id. However, about 50% of the human eggs underwent abnormal fertilization due to excess maternal DNA from the mitochondrial donor—an indication that the technique is not yet perfected. Id. 47. See Cyranoski, supra note 45; Charlotte Alter, Diane Tsai & Fracesca Trianni, What You Really Need to Know About Egg Freezing,TIME (July 16, 2015), http://time.com/3959487/egg-freezing-need-to- know (citing a study by the Society for Assisted Reproductive Technology, ﬁnding that the number of women freezing their eggs increased from 500 in 2009 to almost 5,000 in 2013, and citing a fertility marketer that estimates that over 70,0000 women will freeze their eggs by 2018); Charlotte Alter, Working Women Are Planning More, Which Is Why Some Are Freezing Their Eggs,TIME (July 23, 2015), http://time.com/3969601/working-women-are-planning-more-which-is-why-some-are-freezing- their-eggs (discussing some of the appeal of egg freezing). 48. Tachibana, supra note 26, at 367. As of October 2012, three years after the birth of the primates, no long-term effects of the procedure were seen. Cyranoski, supra note 45. 49. See 21 C.F.R. § 1271.1, 1271.3(d) (2015) (establishing FDA’s authority to regulate reproductive tissues as human cells, tissues, and cellular and tissue-based products (HCT/Ps)); Federal Food & Drug Administration, What You Should Know—Reproductive Tissue Donation, http://www.fda.gov/Biologics BloodVaccines/SafetyAvailabilit/TissueSafety/ucm232876.htm (describing FDA’s authority to regulate reproductive tissues under 21 C.F.R. § 1271); Cyranoski, supra note 45 (“Before [mitochondrial replacement therapy] can be used in the clinic in the United States, it must be approved by the US Food and Drug Administration, which has asserted its authority over reproductive technologies.”); ERIN NELSON,LAW,POLICY AND REPRODUCTIVE AUTONOMY 241–42 (2013). Federal regulation of reproductive technologies is exceedingly “piece-meal.” Id. at 241. Two statutes govern federal regulation of ART practices: The Clinical Laboratories Improvement Amendments of 1988 (CLIA) and the Fertility Clinic Success Rate and Certiﬁcation Act. Id. However, the Centers for Medicare and Medicaid Services, which administers the CLIA program, has taken the position that certain ARTs are not covered by CLIA and are “therefore within the FDA’s jurisdiction over reproductive tissues and cells.” Id at 242. 422THE GEORGETOWN LAW JOURNAL [Vol. 104:413 concerns about the safety and ethics of MRT that may need to be resolved before gaining regulatory approval.50 Shoukhrat Mitalipov, the scientist leading the spindle transfer experiments in the United States, submitted an application to the FDA in January 2012 for approval to run clinical trials.51 Although the FDA convened in February 2014 to consider the technology’s safety,52 it has not yet issued a decision. Meanwhile, the Institute of Medicine is conducting a series of meetings to discuss related ethical and social policy issues.53 The British Parliament, however, recently voted to allow MRT to be used by specially licensed researchers.54

II. DETERMINING LEGAL PARENTAGE IN THE CONTEXT OF ASSISTED REPRODUCTIVE TECHNOLOGIES As single people and same-sex couples began having children, and as use of ARTs became more popular, state courts and legislatures were forced to redefine legal parentage to consider the relationship between parent and child.55 Prior definitions of legal parentage based on biology, marriage, and adoption56 were no longer practical. This Part addresses how legal parentage is presently determined in the context of ART. Part II.A discusses the different methodologies that states use to determine legal parentage in the context of ART, including the intent test. Part II.B discusses some benefits and limitations of the intent test. Part II.C demonstrates how the intent test has been applied to resolve parentage disputes in the context of children born using ARTs that involve gamete donation.

A. RESOLVING PARENTAGE DISPUTES ARISING OUT OF ASSISTED REPRODUCTIVE TECHNOLOGIES The ﬁfty-one state and district legislatures have been slow to adopt laws that consider legal parentage rights in the context of ART.57 Political branches of

50. See generally NUFFIELD COUNCIL ON BIOETHICS,NOVEL TECHNIQUES FOR THE PREVENTION OF MITOCHONDRIAL DNA DISORDERS:AN ETHICAL REVIEW (2012) (raising safety, efficacy, and ethical issues in the context of mitochondrial replacement therapy); see also Hamilton, supra note 17 (presenting scientists’ differing opinions on the safety and risk-benefit balance of the new technology); Shoukhrat Mitalipov & Don P. Wolf, Clinical and Ethical Implications of Mitochondrial Gene Transfer,25 TRENDS IN ENDOCRINOLOGY &METABOLISM 5, 6–7 (2014) (raising regulatory, legal, and ethical questions in the context of mitochondrial replacement therapy). 51. Cyranoski, supra note 45. 52. See generally FDA BRIEFING DOCUMENT, supra note 1. 53. Activity: Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases,INST. OF MED., http://www.iom.edu/activities/ research/mitoethics.aspx (last visited May 17, 2015). 54. Gretchen Vogel, Mitochondrial Gene Therapy Passes Final U.K. Vote,SCI.INSIDER (Feb. 24, 2015, 5:30 PM), http://news.sciencemag.org/biology/2015/02/mitochondrial-gene-therapy-passes-final- u-k-vote. 55. See DiFonzo & Stern, supra note 10, at 105. 56. Id. at 104. 57. See KINDREGAN &MCBRIEN, supra note 8, at 31 (“[M]ost of the issues that have arisen in the courts involving ART find little solution in statutory law.”); DiFonzo & Stern, supra note 10, at 112 2016]DISPUTES IN THE AGE OF MITOCHONDRIAL REPLACEMENT 423 government find it difficult to pass legislation regulating family law in the context of ART because many of “[t]he issues involved are politically controver- sial and often mixed with religious, moral, medical, political, social, and legal disagreement.”58 This has left state courts59 to adopt various, sometimes conflicting,60 tests of their own to resolve parentage disputes in the context of ART.61 These disputes can arise for a number of reasons, but often do so when the relationship between the parties involved in the arrangement deteriorates. Varia- tion in the law from state to state, and often from case to case, establishes significant uncertainty for intending parents regarding the protection of their legal parentage rights in the face of changing circumstances, such as divorce or remarriage.62 At least four categories of approaches for resolving parentage disputes in the context of ART have been identified: applying state statutes, applying public policy, assigning parentage rights based on the best interests of the child, and assigning legal parentage to the intending parents.63 First, some states have adopted statutes specifically designed to resolve parentage disputes in the context of ART, but these statutes are often only applicable in limited contexts.64 For example, in Minnesota, if, “with the consent of her husband, a wife is inseminated artificially with semen donated by

(“[O]ur laws, and the laws of most other states, have struggled unsuccessfully to keep pace with the complex legal issues that continue to arise as a result of [reproductive] technology.”). Because family law is considered a “police power” reserved to the states, there is no all-encompassing federal law governing family law disputes, although some federal cases have touched on the subject. See, e.g., Troxel v. Granville, 530 U.S. 57 (2000) (holding a visitation order granted to the grandparents over objection of the mother violated the mother’s fundamental right to make decisions concerning custody and care of her children). 58. KINDREGAN &MCBRIEN, supra note 8, at 33. 59. State courts continue to assert that these issues are better resolved in the legislature, joining a chorus of judicial voices pleading for legislative attention to the increasing number of complex legal issues spawned by recent advances in the field of artificial reproduction. Whatever merit there may be to a fact-driven case-by-case resolution of each new issue, some overall legislative guidelines would allow the participants to make informed choices, and the courts to strive for uniformity in their decisions. Id. at 31–32 (quoting Prato-Morrison v. Doe, 103 Cal. App. 4th 222, 232 n.10 (2002)). 60. Id. at 21 (“In a nation where family law issues are mostly resolved by state law rather than federal law, there are bound to be conflicting results regarding parentage issues arising from the use of assisted reproduction by nontraditional families.”). 61. See Byrn & Giddings, supra note 13, at 1301 (recognizing five different court-implemented tests for assigning parentage rights: state statute, public policy, best interests of the child, genetics, and intent). 62. Cf.CROCKIN &JONES, supra note 8, at 212 (discussing the influence of the variable law over the security of surrogacy arrangements). 63. Byrn & Giddings, supra note 13, at 1301. Courts have also assigned parentage rights based on a parent’s genetic relationship with the child, but this method is more common in the context of gestational surrogacies, which are beyond the scope of this Note. See id. at 1306–07 (citing Belsito v. Clark, 644 N.E.2d 760 (Ohio Ct. C.P. 1994)). 64. Id. at 1301 & n.23 (citing MINN.STAT.ANN. § 257.56 (West 2007) and OR.REV.STAT. § 109.243 (West 2011)). 424THE GEORGETOWN LAW JOURNAL [Vol. 104:413 a man not her husband, the husband is treated in law as if he were the biological father of a child thereby conceived.”65 This statute directly addresses determination of legal parentage in the context of a married couple using artificial insemination, but a separate statute may be needed to address determination of legal parentage if the same couple uses egg donation, and yet another statute would almost certainly be needed to address determination of legal parentage if the same couple uses MRT. An entirely different slate of statutes might be needed to address ART children born by unmarried couples or individuals. Some states get around this problem by extending existing statutes to new circumstances for which they were not originally intended.66 For example, in Shineovich v. Kemp, the Oregon Court of Appeals applied its artificial insemination statute (much like the Minnesota statute above) to grant parentage rights to the same-sex domestic partner of a biological mother who used artificial insemination.67 In Shineovich, the Oregon Court of Appeals extended application of the artificial insemination statute to include the children of mothers in same-sex relationships because such extension “advance[d] the legislative objec- tive by providing the same protection [available to children of parents in heterosexual relationships] for a greater number of children.”68 However, there is no guarantee that all courts will construe statutes so broadly, and such a broad reading is premised on states having a statutes addressing ART in the first place.69 Second, state courts have applied their states’ public policies to resolve parentage disputes in the context of ART. For example, in T.F. v. B.L., the Supreme Judicial Court of Massachusetts refused to require a biological mother’s former same-sex partner to pay child support after the couple broke up, notwithstanding the former partner’s prior agreement to co-parent the child.70 The court emphasized that Massachusetts’ policy disfavored “[p]arenthood by contract” and expressed reluctance to “enforce prior agreements that bind individuals to future family relationships.”71 However, public policies, like statutes, vary from state to state, leaving parties at the mercy of the jurisdiction in which they seek relief if and when a dispute arises. For example, contrary to the Massachusetts Supreme Judicial Court, the New York Court of Appeals, in Debra H. v. Janice R., held that a birth mother’s former same-sex partner was a legal parent of a child who was born during their civil union, relying on New York’s public policy of recognizing parentage created by a civil union.72

65. MINN.STAT.ANN. § 257.56. 66. Byrn & Giddings, supra note 13, at 1303. 67. 214 P.3d 29, 39–40 (Or. Ct. App. 2009). 68. Id. at 687. 69. But see Byrn & Giddings, supra note 13, at 1304 (noting rare cases where non-ART statutes, such as second-parent adoption statutes or presumptions of paternity, have been applied to ART cases). 70. See 813 N.E.2d 1244, 1252 (Mass. 2012). 71. Id. at 1246, 1250–51. 72. 930 N.E.2d 184, 196–97 (N.Y. 2010). 2016]DISPUTES IN THE AGE OF MITOCHONDRIAL REPLACEMENT 425

Third, courts have assigned parentage rights based on the best interests of the child. The best-interests approach takes a case-by-case analysis of the facts at the time the dispute arises, not at the time the child was conceived, to determine which party is best suited to care for the child.73 For example, in Rubano v. DiCenzo, the Rhode Island Supreme Court affirmed the family court’s ruling that the best interests of the child were promoted by granting parentage rights to the biological mother’s former same-sex domestic partner, because she had established a de facto parental relationship with the child, and that terminating that relationship went against the child’s best interests.74 The best-interests approach is commonly applied to resolve parentage disputes where both or neither of the parties are the genetic parents, such as in cases of natural conception or adoption, but it is less frequently applied to resolve parentage disputes where one party is a genetic parent and the other is not, as in many disputes arising out of ART.75 Fourth, states rely on the “intent test” to determine legal parentage. The intent test, most notably applied in the California case, Johnson v. Calvert, 76 instructs that “when a child is conceived via ART, the person(s) that intended to bring the child into the world and raise the child should be the child’s legal parent(s).”77 Although Johnson was decided in the context of a gestational surrogacy,78 the intent test is also applied in the context of other ARTs. For example, in Levin v. Levin, the Supreme Court of Indiana held that an ex-husband was the legal father of a child who was born when he and his then-wife knowingly and voluntarily agreed that she would have a child by artificial insemination because he had “induced [his then-wife] to go forward with the artificial insemination” and made a “promise to become the father of the resulting child and to assume his support,” even though he was not the genetic father of the child.79 The Supreme Court of Indiana continued that it would be “unjust” to allow the ex-husband to deny his obligations toward the child.80 Only about twenty percent of parentage disputes in the context of ART explicitly rely on the intent test.81 However, one study determined that regard-

73. See Byrn & Giddings, supra note 13, at 1306. Although this approach has been codified in some states, it is considered separately from the previously mentioned statutory approach. Id. 74. 759 A.2d 959, 961, 976 (R.I. 2000). 75. See Child Custody Prac. & Proc. § 4:1 (“When the custody dispute is between two natural or adoptive parents, married or not, all states mandate that the judge place the physical residency and legal custody of the child according to the ‘best interests’ of the child.”); Byrn & Giddings, supra note 13, at 1306 (finding only approximately 16% of the cases analyzed relied on the best interests of the child approach). 76. 851 P.2d 776, 782 (Cal. 1993). 77. Byrn & Giddings, supra note 13, at 1296 (citing Marjorie Maguire Shultz, Reproductive Technology and Intent-Based Parenthood: An Opportunity for Gender Neutrality, 1990 WIS.L.REV. 297, 322–25). 78. 851 P.2d at 782. 79. 645 N.E.2d 601, 604–05 (Ind. 1994). 80. Id. at 605. 81. See Byrn & Giddings, supra note 13, at 1308. 426THE GEORGETOWN LAW JOURNAL [Vol. 104:413 less of the method used to establish legal parentage, over seventy-four percent of parentage cases resulted in the same outcome as if the intent test had been applied.82 Indeed, since Johnson v. Calvert was decided in 1993, every drafted model act governing the legal parentage of children born as a result of ART incorporates the intent test,83 and the Uniform Parentage Act (UPA), variations of which have been adopted by at least eleven states, essentially codifies the intent test.84 Article 7 of the UPA asserts that a donor of either eggs or sperm who does not intend to become a parent will not be recognized as a legal parent, but a man and woman who use ART because they intend to be the parents of the child are the legal parents of the child.85 It appears that state legislatures and courts generally favor the intent test, either through applying it explicitly, working it into their public policy, or codifying it into statute.

B. BENEFITS AND CRITICISMS OF THE INTENT TEST States favor the intent test because it respects the reliance of the parents and furthers important policy goals. First, the intent test recognizes as parents those individuals who actively plan to become parents.86 It coheres with our need for justice and fairness, giving legal parentage rights and responsibilities to those individuals who sought to bring the child into being.87 Second, the intent test encourages and rewards advance planning for a child, furthering important policy goals such as responsible parenting.88 And third, the intent test respects the intent of “true donors”89 who intended only to provide an egg or sperm, but did not intend to be responsible for raising the resulting child. However, there are several problems with the intent test. First, litigation over parentage rights usually occurs months or years after the arrangement to have a child was made. Therefore, ascertaining intent can require evidence of subjec- tive intent from the distant past, which may be difﬁcult to establish.90 However, this is a foreseeable problem, and ART provides a clear opportunity for unambigu- ous expressions of intent, for example, with a written contract before a conﬂict

82. See id. at 1297. 83. See id. at 1296. 84. UNIF.PARENTAGE ACT § 701–07 (NAT ’L CONFERENCE COMM’RS UNIF.STATE LAWS 2002). The Uniform Law Commission tracks the enactment of the Uniform Parentage Act, and as of 2015 reports that the following states have enacted some version of the Act: Alabama, Delaware, Illinois, Maine, New Mexico, North Dakota, Oklahoma, Texas, Utah, Washington, and Wyoming. Uniform Law Commission, Acts: Parentage Act,UNIFORM L. COMMISSION, http://www.uniformlaws.org/Act.aspx?titleϭ Parentage%20Act (last visited Sep. 23, 2015) (enactment status map). 85. UNIF.PARENTAGE ACT § 701–07 (NAT ’L CONFERENCE COMM’RS UNIF.STATE LAWS 2002). 86. Dara E. Purvis, Intended Parents and the Problem of Perspective,24YALE J.L. & FEMINISM 210, 212 (2012). 87. See, e.g., Levin v. Levin, 645 N.E.2d 601, 605 (Ind. 1994) (“To hold otherwise [than that the intending father is the legal father] would be unjust.”) 88. Purvis, supra note 86, at 227. 89. See infra Part II.C, discussing the difference between a true donor and an intentional lender of procreative genetic material. 90. See, e.g., K.M. v. E.G., 117 P.3d 673 (Cal. 2005); see also infra Part II.C. 2016]DISPUTES IN THE AGE OF MITOCHONDRIAL REPLACEMENT 427 ever arises.91 Additionally, the intent test is not always dispositive in the context of surrogacy arrangements, particularly when the surrogate changes her mind about her intent to parent the child.92 Resolution of parentage disputes in the context of gestational surrogacy arrangements often depends on whether a particular state ﬁnds the gestational surrogacy agreement to be enforceable.93 Finally, the intent test can result in a child’s separation from his or her genetic parents. For example, in the context of gamete donation, a child is conceived with the intent that he or she will not be raised by the gamete donor—a genetic parent.94 However, this does not stop courts from applying the intent test to resolve parentage disputes in the context of gamete donation. For example, in 2007, the Pennsylvania Supreme Court held that a known sperm donor had no parental obligations where he had donated his sperm and agreed not to seek any parental rights in exchange for relief from any parental obligations.95 In 2005, a Pennsylvania Court of Common Pleas also held that an egg donor had no parental rights where she did not originally intend to parent the resulting child, even though the birth mother, who also made a parentage claim, also originally had no intent to parent the child.96 These courts appear to have concluded that the beneﬁts of applying the intent test—placing children in homes that had prepared and planned for them—outweighed whatever drawbacks might be associated with separating a child from a genetic parent.97

91. See Purvis, supra note 86, at 212. 92. See, e.g., In re Baby M, 537 A.2d 1227, 1234 (N.J. 1988) (holding the surrogate mother’s parental rights could not be terminated even though she was not the intended mother); Darra L. Hofman, “Mama’s Baby, Daddy’s Maybe:” A State-by-State Survey of Surrogacy Laws and Their Disparate Gender Impact,35WM.MITCHELL L. REV. 449, 460 (2009) (“In states where surrogacy is banned or legally uncertain, paternity or parentage laws generally place parental rights in the surrogate....Intended mothers are the losers.”). But see, e.g., Johnson v. Calvert, 851 P.2d 776 (Cal. 1993) (granting parental rights to the intended mother in the context of a gestational surrogacy agreement). 93. See Hofman, supra note 92, at 461–67. 94. This is different from adopting an already-born child, who was probably not conceived with the speciﬁc intent to be raised by another family. 95. See Ferguson v. McKiernan, 940 A.2d 1236, 1247–48 (Pa. 2007) (holding enforceable an oral agreement between sperm donor and mother that donor would not seek parental rights over the resulting child and mother would not seek child support from the donor). 96. Flynn v. Bimber, 70 Pa. D. & C.4th 261, 268, 286, 310 (Pa. C.P. 2005) (holding in dispute between intending genetic father, non-originally intending genetic mother who was a previously anonymous egg donor, and birth mother who was originally a gestational surrogate, the intending genetic father and the birth mother were the legal parents of the resulting triplets; the intending genetic father’s paramour lacked legal standing in the case). But see J.F. v. D.B., 879 N.E.2d 740, 741–42 (Ohio 2007) (holding in the same dispute as above that the genetic father and the birth mother had entered into an enforceable surrogacy agreement, and the birth mother was therefore not entitled to legally recognized parental rights); Rice v. Flynn, 9th Dist. No. 22416, 2005-Ohio-4667, 2005 WL 2140576 (holding in the lower court in the same dispute that no ﬁnding had been made determining whether the egg donor had waived her rights as a legal parent). 97. Further, other methods of determining legal parentage can also cause a genetic parent to be separated from his or children. For example, in 2007, the Kansas Supreme Court denied parentage rights to a known sperm donor—the genetic father—who claimed that he had an oral understanding with the gestational mother that he would be the father of their resulting child or children. Under 428THE GEORGETOWN LAW JOURNAL [Vol. 104:413

C. APPLYING THE INTENT TEST IN THE CONTEXT OF GAMETE DONATION As stated earlier, differing state statutes and public policies create signiﬁcant variation in how states resolve parentage disputes.98 However, the policies underlying the intent test are regularly applied, especially in the context of gamete donation,99 where donors can be distinguished as “true donors” and “intentional lenders of procreative genetic material.”100 This section will ex- plain how states have relied on the intent test to resolve parentage disputes between multiple parties in the context of gamete donation. In the context of gamete donation, an egg donor or a sperm donor can be either a “true donor” or an “intentional lender of procreative genetic material.”101 A true donor is someone who contributes his or her gametes to someone else with no intention of parenting the resulting child, whereas an intentional lender of procreative genetic material is someone who contributes his or her gametes for the purpose of having a child whom he or she intends to parent.102 When there is no dispute that the donor was a true donor, courts straightfor- wardly deny the donor parentage rights. Frequently, however, distinguishing between true donors and intentional lenders of procreative genetic material is difﬁcult.103 When disputes arise between a legally recognized parent and a gamete donor, there is usually disagreement as to whether the donor had intended to be a true donor or an intentional lender of procreative genetic material. The parent with

Kansas law, a sperm donor who is not the husband of the gestational mother would not be recognized without a written agreement recognizing his intent to be the father. See In re K.M.H., 169 P.3d 1025, 1029–30, 1043 (Kan. 2007). 98. See supra Part II.B. 99. See supra notes 76–83 and accompanying text; In re K.M.H., 169 P.3d at 1039. Although this case was decided on statutory grounds requiring a written agreement to recognize the parental rights of a sperm donor who is not married to the gestational mother, the court recognized the “legitimate legislative purposes and important governmental objectives” underlying the statute, which are consistent with the intent test. Id. The court writes that the statute encourages men who are able and willing to donate sperm to such women by protecting the men from later unwanted claims for support from the mothers or the children. It protects women recipients as well, preventing potential claims of donors to parental rights and responsibilities, in the absence of an agreement. Its requirement that any such agreement be in writing enhances predictability, clarity, and enforceability.... [T]he design of the statute implicitly encourages early resolution of the elemental question of whether a donor will have parental rights. Id. 100. Black, supra note 14, at 816–17 (urging clarification of the word “donor” to differentiate between “true donors” who have no intention of raising the offspring and “intentional lenders of procreative genetic material” who are lending their gametes for the purpose of creating an offspring which they will take part in parenting). 101. Id. 102. Id. 103. See, e.g., K.M. v. E.G., 117 P.3d 673, 677, 682 (Cal. 2005) (finding in the lower court that K.M. was a true donor and not an intending parent, but finding in the supreme court that K.M. was an intending parent). 2016]DISPUTES IN THE AGE OF MITOCHONDRIAL REPLACEMENT 429 legally recognized parentage rights will insist that the donor had agreed to forfeit any claim to parentage rights when he or she donated the sperm or egg. In response, the donor making a parentage claim will testify that he or she provided the sperm or egg with the intent of parenting the resulting child. A previous relationship between the disputing parties can be strong evidence that both partners had intended to raise the child. For example, in K.M. v. E.G., a same-sex female couple had agreed that one partner, K.M., would provide the egg and that the other partner, E.G., would gestate and give birth.104 After their relationship ended, E.G. claimed that K.M. was a true donor with no parentage rights, but K.M claimed she had intended to parent the child with E.G.105 The California Supreme Court found that K.M. had intended to be a parent, and that her parentage rights should be legally recognized.106 However, a casual relationship between the disputing parties is probably not sufficient evidence in itself to prove that the donor was an intending parent. In Leckie & Voorhies,107 the Oregon Appellate Court denied parentage rights to a known sperm donor who had provided his sperm to a lesbian couple so that the couple could have a child.108 After the child was born, the sperm donor had regular interaction with the child, but after the child turned three years old, the couple limited the child’s interactions with the sperm donor, who filed a claim seeking legal recognition of his parentage rights.109 The court held that the donor had waived his right to assert parentage rights when he donated his sperm, so although he was the genetic father, he was not a legal parent.110 Essentially, the court found that the sperm donor was a true donor, and not an intentional lender of procreative genetic material.111 As one can see, the intent test, though simple in theory, can sometimes be difficult to apply. However, it is laudable in that it provides consistent outcomes and can be applied in new contexts such as mitochondrial replacement therapy, as explained below.

III. DETERMINATION OF LEGAL PARENTAGE IN THE CONTEXT OF MITOCHONDRIAL REPLACEMENT THERAPY As with other assisted reproductive technologies, it is reasonable to anticipate that parentage disputes will arise in the context of MRT. This Part argues that MRT is similar to gamete donation, and therefore that parentage disputes that arise in the context of MRT should be resolved in the same way that parentage disputes in the context of gamete donation are effectively resolved: by applying

104. Id. at 676. 105. Id. at 677. 106. Id. at 682. 107. 875 P.2d 521, 522 (Or. Ct. App. 1994). 108. Id. 109. Id. 110. Id. at 522–23. 111. See id. 430THE GEORGETOWN LAW JOURNAL [Vol. 104:413 the intent test.112 Further, this Part argues that MRT is not the only “three-parent ART” and should not be regarded as such.

A. APPLYING THE INTENT TEST IN THE CONTEXT OF MITOCHONDRIAL REPLACEMENT THERAPY MRT is most like ARTs that use gamete donation. In the context of sperm donation, a man donates his sperm to a woman or couple to help the woman or couple conceive a child. In egg donation, a woman donates her egg to another woman or couple to help the woman or couple conceive a child. In MRT, the mitochondrial donor (the woman whose egg is used to provide mitochondrial DNA) donates her egg to another woman or couple, who uses part of the donor’s egg to conceive a child.113 Although only part of the donor egg is used in MRT, donating the egg and its genetic material to help another person or couple procreate is similar to other forms of gamete donation. Therefore, MRT is analogous to other forms of gamete donation.114 Because MRT is like other ARTs that use gamete donation, parentage disputes arising in the context of MRT can be expected to mirror the disputes that arise in the context of gamete donation. Most likely, the mitochondrial donor or the sperm donor will seek legal recognition of parentage rights for a child based on his or her status as an intending parent. Usually, either one or more of the other parties will dispute this, arguing that the donor was a true donor who had agreed to forfeit his or her rights to parent the child.115 Just as in the context of gamete donation, the dispute centers on whether the donor was a true donor or an intentional lender of procreative genetic material. Because MRT uses donors like other ARTs involving gamete donation, where the intent test is often applied to resolve parentage disputes, the intent test should also be applied to resolve parentage disputes in the context of MRT.116 In MRT, the mitochondrial donor can be considered a true donor or an intentional lender of procreative genetic material depending on the circumstances, and the determination can be made in the same way that it is made for an egg donor or sperm donor. If the mitochondrial donor is a true donor, courts should

112. See supra notes 82–83 and accompanying text, explaining that states have a general tendency toward applying the intent test either explicitly or through statutes and public policy that commonly result in the same outcome. 113. Additionally, a woman may donate her egg to a single man who has arranged for a surrogate to carry the child. However, surrogacy agreements are outside the scope of this Note. 114. It should be noted that use of the word “donor” does not assume that the person is a “true donor” as that term is used in Part II.C above. 115. Because MRT is a therapy directed at helping the original egg donor to have a healthy child, it is unlikely that the original egg donor would have to defend her status as an intentional lender of procreative genetic material, although it is possible. 116. A sperm donor could also be involved in MRT. For simplicity, this section will focus on an example where the mitochondrial donor is making the parentage claim, although the reasoning would extend equally to a sperm donor as well. 2016]DISPUTES IN THE AGE OF MITOCHONDRIAL REPLACEMENT 431 dismiss her claim for legal parentage rights; if she is an intentional lender of procreative genetic material, she should be recognized as a legal parent. The absolute quantity of DNA donated by a mitochondrial donor is irrelevant to her claim. Although a mitochondrial donor contributes less than 0.001% of her DNA,117 her legal claim for parentage rights, if she is an intentional lender of procreative genetic material, should be equally as strong as any other claim by an intentional lender of procreative genetic material because she had the requisite intent and her donation was procreative. If a mitochondrial donor can prove that she intended to raise the child, then she should be recognized as an intending parent. Where the other intending mother is infertile or carries a mitochondrial disease, the mitochondrial donation is procreative because conception of a healthy child is impossible without the donor egg. Therefore, when a mitochondrial donor is actually an intentional lender of procreative genetic material, she should have a claim to legal parentage rights equal to that of any other intending parent.118 However, where the mitochondrial donor did not originally intend to raise the resulting child as her own, she should be recognized as a true donor and her parentage claim should be denied.

B. MITOCHONDRIAL REPLACEMENT THERAPY WITH THREE INTENDING PARENTS What if all three contributors are intentional lenders of procreative genetic material? Historically, this may have presented a problem when American states were not yet ready to recognize three legal parents of a child.119 However, at least ﬁve states and the District of Columbia have recognized more than two legal parents,120 and at least one state court has already recognized more than

117. See Taylor & Turnbull, supra note 17, at 391. 118. For example, if a same-sex female couple decides to have a child together, the woman who was planning to contribute her egg either carries a mitochondrial disease or has decreased fertility, her partner offers to be the mitochondrial donor and has evidence that she intends to parent the child, then the second partner—the mitochondrial donor—is an intentional lender of procreative genetic material and should be recognized as a legal parent. 119. Although courts recognized three parents in certain situations, such as when a de facto parent or stepparent was recognized, the United States did not commonly recognize three legal parents based on natural parentage—parentage based on genetics or birth. See, e.g., Michael H. v. Gerald D., 491 U.S. 110, 118 (1989) (noting that the “law, like nature itself, makes no provision for dual fatherhood,” in the context of a child who already had a legally recognized mother and father); Johnson v. Calvert, 851 P.2d 776, 781 (Cal. 1993) (noting that “for any child California law recognizes only one natural mother, despite advances in reproductive technology rendering a different outcome biologically possible,” in the context of a child who already had one legally recognized father, and recognition of two mothers would lead to three legally recognized parents). 120. See Christopher Cadelago, Jerry Brown Signs California Bill Allowing More Than Two Parents,SACRAMENTO BEE (Oct. 4, 2013, 5:47 PM), http://blogs.sacbee.com/capitolalertlatest/2013/10/ jerry-brown-signs-bill-allowing-more-than-two-parents-in-calif.html; SENATE RULES COMM., BILL ANALY- SIS: SB 274 (2013), available at http://www.leginfo.ca.gov/pub/13-14/bill/sen/sb_0251-0300/sb_274_cfa_ 20130903_224717_sen_ floor.html (discussing situations in Pennsylvania, Maine, Louisiana, Delaware, and the District of Columbia in which a child can have more than two people in his/her life with the rights and responsibilities of parents). 432THE GEORGETOWN LAW JOURNAL [Vol. 104:413 two legal parents in the context of ART.121 First, multiparent families exist when a de facto parent is recognized in addition to two existing parents. For example, Delaware recognizes a third de facto parent when the family court determines that the de facto parent has had “the support and consent of the child’s parent or parents,” among other requirements.122 The District of Columbia’s statutory code also, by definition, recognizes three parents where the third parent is a de facto parent. The code defines “de facto parent” as an individual who “[h]as held himself or herself out as the child’s parent with the agreement of the child’s parent, or if there are 2 parents, both parents” among other requirements.123 Under both statutes, where the de facto parent acts with the consent of two other parents, the de facto parent becomes a third parent. In the context of ART, a Pennsylvania court granted legal parentage rights and obligations to three parties following custody and support claims by a biological mother, the biological mother’s former partner, and a sperm donor.124 Although the trial court originally refused to hold the sperm donor liable for support of the children to avoid an “untenable situation, never having been anticipated by Pennsylvania law,” the appellate court held that such support obligations could be reformulated to include three people.125 Quoting an earlier decision, the court continued:

We recognize this is a matter which is better addressed by the legislature rather than the courts. However, in the absence of legislative mandates, the courts must construct a fair, workable and responsible basis for the protection of children, aside from whatever rights the adults may have vis a vis each other.126

Therefore, courts would not be forced to grapple with an unprecedented situation if they were asked to afford legal parentage rights of a child conceived through MRT to three intending parents.

121. For a discussion of the potential beneﬁts of recognizing multiple parents, see Susan Frelich Appleton, Parents by the Numbers,37HOFSTRA L. REV. 11 (2008). 122. DEL.CODE ANN. tit. 13, § 8-201 (2013) (emphasis added); see also J.W.S. v. E.M.S., Nos. CS11-01557, CS13-01083, 2013 WL 6174814, at *6 (Del. Fam. Ct. May 29, 2013) (consolidating petitions for custody where a child had three legal parents—her biological mother, biological father, and the biological mother’s ex-husband). 123. D.C. CODE § 16-831.01 (2009) (emphasis added). 124. Jacob v. Shultz-Jacob, 923 A.2d 473, 482 (Pa. Super. Ct. 2007). Cf. A.A. v. B.B., (2007) 83 O.R. 3d 561, 574–75 (Can. Ont. C.A.) (holding a child’s genetic father, genetic mother, and the genetic mother’s lesbian partner were all legal parents of the same child). 125. Jacob, 923 A.2d at 482. 126. Id. (quoting L.S.K. v. H.A.N., 813 A.2d 872, 878 (Pa. Super. Ct. 2002)). 2016]DISPUTES IN THE AGE OF MITOCHONDRIAL REPLACEMENT 433

C. MITOCHONDRIAL REPLACEMENT THERAPY IS NOT THE ONLY “THREE-PARENT” ASSISTED REPRODUCTIVE TECHNOLOGY MRT is unique in creating children with three genetic parents, but it is not unique as a “three-parent” ART. Rather, three-parent arrangements are particularly common in the context of ART. With the division of parentage roles into intending parents, genetic parents, and a gestational parent, the law has recognized multiple parties with particular parentage roles for decades.127 Even the Bible contains stories of men seeking surrogates to carry a child for themselves and their wives; as described in the Old Testament Abraham and Sarah were intending parents, and Hagar, a surrogate, was the genetic and gestational parent—three parents in total.128 ARTs have made three-party arrangements even more common. Artificial insemination allows women to have children using foreign-donor sperm.129 In this context, the woman and her husband are intending parents and the donor is a genetic parent—three parents in total. In gestational surrogacy arrangements, a woman and her husband might create an embryo using their own egg and sperm, but a different woman actually carries and gives birth to the child.130 In this context, the husband and wife are both the intending and genetic parents, but the second woman is the gestational parent—three parents in total. Some arrangements could contain up to five different parents. For example, a husband and wife could use a donor egg and donor sperm to create an embryo, which is then carried and birthed by a gestational surrogate. In that case, the resulting child’s intending parents are different from the genetic parents (donors), and they are all different from the gestational parent (surrogate).131 As evidenced by the examples above, many ART arrangements result in a child having three or more parents. Labeling only the children of MRT, and not children of other ARTs, as “three-parent babies” has the unfortunate effect of sensationalizing MRT when, in reality, many ART procedures result in the birth of children with multiple parents. “Three-genetic-parent IVF,” “three-genetic-parent embryos,” “three- genetic-parent babies” would all be more appropriate terms to describe MRT. When “parent” has many potential definitions, it is unfair to describe MRT as

127. See CROCKIN &JONES, supra note 8, at 11 (discussing how assisted reproductive technology has changed definitions of motherhood); KINDREGAN &MCBRIEN, supra note 8, at 2 (“Thus, traditional notions of the family are qualified by the introduction of entirely new legal parental concepts, such as ‘intended parent,’ ‘gestational carrier,’ and ‘gamete provider.’”). 128. Genesis 16:1–10 (explaining that Hagar was a surrogate for Abraham and Sarah). 129. See CROCKIN &JONES, supra note 8, at 133 (“Since artificial insemination and sperm freezing predate virtually all of the ARTs, both legislatures and courts have had decades of experience with many of the family law issues raised by these ‘low-tech’ procedures.”). 130. See, e.g., Belsito v. Clark, 644 N.E.2d 760 (Ohio 1994). 131. See In re Marriage of Buzzanca, 72 Cal. Rptr. 2d 280, 282 (Cal. 1998); John C. Sheldon, Test Tube Babies Meet Stone Age Statutes,27ME. B.J. 140, 140 (2012) (discussing a Maine case where up to eight individuals could qualify as the “parent” of a child). 434THE GEORGETOWN LAW JOURNAL [Vol. 104:413 the only ART that creates three-parent situations, at least without further clarifying the type of parent.

CONCLUSION MRT promises to help women with mitochondrial disease or infertility have healthy children to whom they are genetically related. It is unique in that it results in children with DNA from three different people, and it creates new, unlitigated possibilities for parentage disputes. The emergence of MRT raises an opportunity to reevaluate how parentage rights are recognized when resolving parentage disputes, especially in circumstances where more than two parties are claiming parentage rights. This Note concludes, however, that the existence of more than three parties with a genetic claim to the child does not justify a departure from the general consensus that parentage rights should be granted to intending parents. Concluding that the intent test is the proper method for resolving parentage disputes in MRT contexts has significant consequences. First, it recognizes that the intent test is flexible and adaptable to changing circumstances, a crucial feature of modern doctrine in an era where technology changes at increasingly rapid speeds. States should consider this flexibility when adopting laws that address ARTs because new ARTs are sure to be developed as fast as or faster than states can pass new laws. Second, the intent test is applied without regard for gender or amount of DNA contributed, lessening the opportunities for discrimination based on either of those qualities. Third, adopting the intent test increases the likelihood that multiple-parenting arrangements will become more popular. Although these arrangements already exist in other contexts, they are still infrequent in the context of ART. Although this Note does not address the arguments for or against multiple-parenting arrangements, that is a discussion worth having, as such arrangements may increase in frequency. Fourth, and most immediately significant, it rejects the concern over legal parentage disputes as a valid objection to clinical use of MRT, taking that therapy one step closer to clinical availability for women who need it.