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Cryogenics, Frozen Embryos and the Need for New Means of Regulation: Why the U.S. Is Frozen in Its Current Approach

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Cryogenics, Frozen Embryos and the Need for New Means of Regulation: Why the U.S. Is Frozen in Its Current Approach Summer 1998] Cryogenics and Frozen Embryo Regulation 77 CRYOGENICS, FROZEN EMBRYOS AND THE NEED FOR NEW MEANS OF REGULATION: WHY THE U.S. IS FROZEN IN ITS CURRENT APPROACH Kimberly E. Diamond* Introduction Due to advances in scientific technology, a growing number of facilities in the United States can cryogenically store human fertilized eggs, more commonly known as “frozen embryos.” The1 United States, however, currently possesses a very limited amount of regulation in this area. As a result, U.S. law is not in step with cryogenics law in other countries, where management of this technology is being confronted head-on. For these reasons, the United States needs to enact appropriate measures to proactively address the social consequences of this technology. This article explores cryogenic technology and suggests theories for its regulation. Part I provides background regarding scientific advances in cryogenics, and describes the difficulty the United States is facing in defining the status of frozen embryos. Part II explores legal approaches other countries have taken, and assesses their effectiveness. Next, Part III analyzes steps the United States has taken in response to this guidance from other countries. Finally, Part IV recommends steps the United States should follow to regulate cryogenics most effectively and promote good social policy. This paper concludes that the United States should equate fro- zen embryos with pure property and enact national regulations to guide American society as use of this technology becomes more widespread. 1. See IVF Phoenix, Infertility Treatments and Procedures (visited Nov. 11, 1997) <http://www.ihr.com/ivfphoenix/ fertbook/treatment.htm#cryo>. * A.B. 1989, University of Michigan; J.D. 1998, Cornell Law School. 78 New York International Law Review [Vol. 11 No. 2 I. Background on Cryogenic Technology A. Embryo Cryopreservation 2 Cryogenics is the science of “low temperature phenomena,” involving3 “the freezing . [,] subsequent thawing and 4regeneration of bodies and body parts.” Infertility clinics in the United States5 and elsewhere are drawing upon advances6 in cryogenics to explant human eggs (ovum), fertilize them through assisted reproduction7 and store these embryos at the in vitro fertilization (IVF) clinic for future implantation. Cryogenics is involved in the IVF process when a human zygote is placed in a glass pipette and is immersed in liquid nitrogen between 2. WEBSTER’S II NEW RIVERSIDE UNIVERSITY DICTIONARY 333 (1984). Cryogenics differs from cryonics in that cryonics involves freezing and storing dead bodies with the intent to revive them when scientific advances per- mit. Id.; see also David A. Baker, Cryonic Preservation of Human Bodies—A Call for Legislative Action, 98 DICK. L. REV. 677 (1994). 3. Steve Connor, Sci-fi Pipe Dreams Rush into Reality, SUNDAY TIMES, Dec. 22, 1996; see also Steven I. Freidland, The Health Care Proxy and the Narrative of Death, 10 J.L. & HEALTH 95, 98 (1995-96) (citing JOHN BOWLER, THE MEANINGS OF DEATH 3 (1991)); Baker, supra note 2, at 269-70. 4. At the forefront of cryogenics technology is the Genetics & IVF Institute, located in Fairfax, Virginia [hereinaf- ter GIVF]. This facility is “the largest integrated provider of infertility and genetic services in the world,” and has the international reputation of being a leader in cryopreservation technology. Joseph D. Schulman, GIVF: A Decade of Achievement and Service (visited Nov. 11, 1997) <http://www.givf.com/decade.html>; Ovary Cryo- preservation (Ovarian Freezing, Egg Banking) (visited Nov. 11, 1997) <http://www.givf.com/ovar1.html> [herein- after Ovary Cryopreservation]; see also Lynne M. Thomas, Abandoned Frozen Embryos and Texas Law of Abandoned Personal Property—Should There Be a Connection?, 29 ST. MARY’S L.J. 255, 312 (1997). 5. In 1985, GIVF performed the first nonsurgical ultra-sound transvaginal human egg retrieval in the world. Schul- man, supra note 4. The IVF process begins with stimulating a woman’s egg production, extracting available eggs and mixing each with sperm outside the woman’s body. Einstein Announces New Procedure to Help Infertile Cou- ples, PR NEWSWIRE, Mar. 5, 1987 [hereinafter Einstein]. One day after the sperm is mixed with the egg, fertiliza- tion normally occurs. Freezing and Thawing of Embryos, NEW STRAITS TIMES (MALAYSIA), May 25, 1997, at 14 [hereinafter Freezing and Thawing of Embryos]; see also Judith F. Daar, Regulating Reproductive Technologies: Pana- cea or Paper Tiger?, 34 HOUS. L. REV. 609, 621 (1997). 6. Several techniques that are now used in reproductive fertilization technology include IVF-embryo transfer (IVF- ET), gamete intra-fallopian transfer (GIFT), zygote intra-fallopian transfer (ZIFT) and intra-cytoplasmic sperm injection (ICSI). For additional information regarding each of these techniques, see Laurence C. Nolan, Posthu- mous Conception: A Private or Public Matter?, 11 B.Y.U. J. PUB. L. 1, 4 (1986); Judith F. Daar, Selective Reproduc- tion of Multiple Pregnancy: Lifeboat Ethics in the Womb, 25 U.C. DAVIS L. REV. 773, 791-91 (1992) (discussing methods of assisted reproduction); IVF Phoenix, supra note 1. 7. See IVF Phoenix, supra note 1. Effectively, cryopreservation holds the embryos in a state of suspended animation. Allison Lim, Second Set of Twins from Frozen Embryos, SING. STRAITS TIMES, Aug. 14, 1997, at 2; see also Helene S. Shapo, Matters of Life & Death: Inheritance Consequences of Reproductive Technologies, 25 HOFSTRA L. REV. 1091, 1141 (1997); Gina Kolata, Medicine’s Troubling Bonus: Surplus of Human Embryos is the Fruit of Doctor’s Labor, N.Y. TIMES, Mar. 16, 1997, at A1. Summer 1998] Cryogenics and Frozen Embryo Regulation 79 8 the time it reaches the two-cell or eight-cell9 stage. These frozen embryos 10are later thawed and implanted in the gestational mother’s uterus during her menstrual cycle. Although there is substantial11 risk to the embryo during the freeze-thaw process prior to its re-implantation in the uterus, studies have shown that embryos surviving this process develop12 at the same rate and have the same potential for defects as do naturally occurring embryos. These studies also show that women13 implanted with these embryos can have successful pregnancies and give nor- mal, live births. 14 Though still cost-prohibi15 tive for many people, frozen embryo technology is now avail- able to the public. In fact, embryo cryopreservation has become so refined16 that facilities no longer need to discard unused embryos for lack of ability to preserve them. Given the favor- able endorsement17 cryogenics and IVF treatment have received worldwide over the last decade, public18 interest in these technologies foreshadows increased demand for them in the near future. 8. For a more explicit description of the timing involved in zygote cell division and cryopreservation, see In re Estate of the Late K, ex parte: The Public Trustee, 1996 TAS LEXIS 479, at *2 (Sup. Ct. Tasmania Apr. 22, 1996). For further estimations regarding the timing of zygote cell division, see Einstein, supra note 5; Freezing and Thawing of Embryos, supra note 5, at 14; Joe Rogaly, Cost of Mastering Nature: Man May be Too Clever to Sur- vive with His Humanity Intact, FIN. TIMES-LONDON, July 27, 1996, Weekend, at 1; see also Davis v. Davis, 842 S.W.2d 588, 593 (Tenn. 1992), cert. denied, 113 S. Ct. 1259 (1993) (noting that frozen embryos are merely “four- to eight-cell entities”). 9. For purposes of this analysis, it is important to visualize the individual female gamete donor according to three categories of parenthood as follows: (1) Genetic or Biological Parenthood—The person (male or female) provides the biological material (gamete) necessary for reproduction. (2) Gestational Parenthood—The person (female) acts in an incubator-like capacity, providing a facility for the development of a fertilized embryo into a child. This person physically gives birth to the child. (3) Legal Parenthood—The person (male or female) does not necessarily possess a biological link to the child, but nonetheless becomes the parent of the child through the legal process, such as through an adoption proceeding. See also Lee Kuo, Lessons Learned From Great Britain’s Human Fertilization and Embryology Act: Should the United States Regulate the Fate of Unused Frozen Embryos?, 19 LOY. L.A. INT’L & COMP. L.J. 1027, 1030 (1997); Nolan, supra note 6, at 1. 10. See Technique Gives Hope to Infertile, S. CHINA MORNING POST, Apr. 23, 1994, supp. at 3; see also Samuel A. Gunsburg, Frozen Life’s Dominion: Extending Reproductive Autonomy Rights to In Vitro Fertilization, 65 FORDHAM L. REV. 2205, 2211 (1997); Jennifer L. Carow, Davis v. Davis: An Inconsistent Exception to an Other- wise Sound Rule Advancing Procreational Freedom and Reproductive Technology, 43 DEPAUL L. REV. 523, 530 (1994). 11. Statistically, an embryo that undergoes the cryopreservation process has a 50% chance of survival. See IVF Phoe- nix, supra note 1; Schulman, supra note 4; see also Rogaly, supra note 8. Also, some embryos that are frozen are later disposed of, due to their poor quality. Id.; see also Ethics Commission of the American Fertility Society, Ethical Considerations of the New Reproductive Technologies: The Moral and Legal Issues of the Pre-embryo, 53 FERTILITY & STERILITY 58S, 59S (supp. 11 1990); John A. Robertson, Embryos, Families, and Reproductive Liberty: The Legal Structure of the New Reproduction, 59 S. CAL. L. REV. 939, 992 (1986). 12. IVF Phoenix, supra note 1. 80 New York International Law Review [Vol. 11 No. 2 B. Ovary Cryopreservation Similar to the process of embryo cryopreservation, 19the process of preserving human female ovaries through cryopreservation is now also possible. The cryopreservation process allows ovarian20 tissue to be removed, cryogenically frozen and later implanted in the female’s 21ovarian bed. The result is that the female’s reproductive and endocrine functions are restored. 13. Id. Worldwide, several thousand children have been born from frozen embryos.
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