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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 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.” The 1 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 frozen 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) .

*

A.B. 1989, University of Michigan; J.D. 1998, Cornell Law School.

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Background on Cryogenic Technology A. Embryo Cryopreservation 2

Cryogenics is the science of “low temperature phenomena,” involving “the freezing . . . 3 [,] subsequent thawing and 4regeneration of bodies and body parts.” Infertility clinics in the United States and elsewhere are drawing upon advances 5 6 in cryogenics to explant human eggs (ovum), fertilize them through assisted reproduction and store these embryos at the in vitro 7 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 permit. 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 [hereinafter 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) ; Ovary Cryopreservation (Ovarian Freezing, Egg Banking) (visited Nov. 11, 1997) [hereinafter 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. Schulman, 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 Couples, PR NEWSWIRE, Mar. 5, 1987 [hereinafter Einstein]. One day after the sperm is mixed with the egg, fertilization 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: Panacea 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 (IVFET), 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, Posthumous Conception: A Private or Public Matter?, 11 B.Y.U. J. PUB. L. 1, 4 (1986); Judith F. Daar, Selective Reproduction 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.

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8

the time it reaches the two-cell or eight-cell stage. These frozen embryos 10 are later thawed and 9 implanted in the gestational mother’s uterus during her menstrual cycle. Although there is substantial 11 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 develop12at the same rate and have the same potential for defects as do naturally occurring embryos. These studies also show that women 13 implanted with these embryos can have successful pregnancies and give normal, live births. 14

Though still cost-prohibitive for many people, frozen embryo technology is now avail15 able to the public. In fact, embryo cryopreservation has become so refined 16 that facilities no longer need to discard unused embryos for lack of ability to preserve them. Given the favorable endorsement cryogenics and IVF treatment have received worldwide over the last 17 decade, public interest in these technologies foreshadows increased demand for them in the 18 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 Survive 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 Otherwise 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 Phoenix, 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.

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B. Ovary Cryopreservation Similar to the process of embryo cryopreservation, 19 the process of preserving human female ovaries through cryopreservation is now also possible. The cryopreservation process allows ovarian ovarian 20 tissue to be removed, cryogenically frozen and later implanted in the female’s 21 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. In fact, of the frozen embryos GIVF alone has stored, approximately 250 of them have been re-implanted and have resulted in full-term pregnancies. Human Embryo Cryopreservation: Embryo Freezing and Frozen Embryo Transfer Cycles, Genetics & IVF Web page, http://www.givf.com/embryo_cryo1.html, (visited Sept. 11, 1997) [hereinafter Human Embryo Cryopreservation]; see also Christi D. Ahnen, Disputes Over Frozen Embryos: Who Wins, Who Loses, and How Do We Decide? An Analysis of Davis v. Davis, York v. Jones, and State Statutes Affecting Reproductive Choices, 24 CREIGHTON L. REV. 1299, 1301 (1991).

14.

Tony Thomas, USA: IVF Research Shows Seeds of Success, BUS. REV. WKLY., Apr. 10, 1992. In 1992, couples paid approximately $6,000 for each IVF treatment cycle necessary for this process. In most cases, approximately six treatment cycles per couple are necessary. Id. Statistics in Britain indicate that as of September 1997, IVF treatment in the United Kingdom cost approximately 3,000 pounds per treatment. Roger Highfield, Science: The Options When the Biological Clock Runs Down, DAILY TELEGRAPH, Sept. 17, 1997, at 16; see also John A. Robertson, Decisional Authority Over Embryos and Control of IVF Technology, 28 JURIMETRICS J. 285, 299 (1988).

15.

Cryopreservation for human embryos only became possible in 1984. See Schulman, supra note 4. One of the first hospitals to offer cryogenics and IVF treatment to its patients was the Albert Einstein Medical Center in Philadelphia, Pennsylvania, which began offering these services to patients in 1985. Einstein, supra note 5. In early 1987, several other U.S. hospitals began offering such services to their patients as well. Id.

16.

Although between five and twelve embryos result from a single treatment cycle, couples usually only have three or four of them implanted simultaneously to reduce the possibility of multiple births. With cryopreservation, the remaining embryos may be frozen, rather than discarded. This, in turn, reduces the number of times the donor female must undergo egg harvesting, thereby reducing the female’s burden. Human Embryo Cryopreservation, supra note 13; see also Thomas, supra note 4, at 257; Debbie R. Lerner, New Productive Technology and Wisconsin Law: Fertility Clinics Making Law, 75 MARQ. L. REV. 206, 211 (1991).

17.

For instance, in 1988, GIVF assisted in the birth of the first twins in the U.S. to be born from frozen embryos. Schulman, supra note 4; Ovary Cryopreservation, supra note 4; Human Embryo Cryopreservation, supra note 13. In 1990 in Hong Kong, a woman in her 30s gave birth to twins as a result of IVF treatment, after trying to conceive naturally for ten years. Mary Ann Benitez, Hong Kong: Test Tube Twins Find Debut a Big Yawn, S. CHINA MORNING POST, May 31, 1990. Additionally, in August of this year, a couple in Singapore gave birth to their second set of twins that originated from the same group of frozen embryos as did their first set of twins, born approximately six years earlier. Lim, supra note 7, at 2.

18.

While storing a viable frozen embryo for more than a period of five years is still a rare occurrence, some doctors believe that frozen embryos may remain viable for “an indefinite period.” Ovary Cryopreservation, supra note 4; Human Embryo Cryopreservation, supra note 13. In fact, one “common practice” now is that frozen embryos may be transported in liquid nitrogen tanks from their place of origination to another facility. This gives the donor parents additional freedom to move to new locations, and either have their embryos moved to a site near them, or keep them in long-term storage. Ovary Cryopreservation, supra note 4. GIVF alone uses cryopreservation for an average of between 2,000 and 2,300 human embryos each year. Id.

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Both in regard to ovary cryopreservation and embryo cryopreservation, there are two groups of women who will likely be the more prevalent users of these technologies: women who are undergoing chemotherapy or radiation treatments, and women who are in their mid22 30s through mid-40s —ages when becoming pregnant naturally carries with it a higher likelihood of fetal defects—or who could no longer engage in the reproductive process without assis23 tance from IVF technology. Woman who prefer to pursue their careers and delay childbearing 24 now may do so, thereby redefining what society views as the “normal” time for childbearing. As such, these women who were traditionally considered too old to conceive children, 25 may now have children without exposing the fetus to an increased risk of birth defects. C. Defining the Status of Frozen Embryos in the United States A fundamental difficulty in cryogenic technology today 26 is the disagreement as to whether a frozen embryo is a person, property or something else. Because U.S. lawmakers seemingly want to tiptoe quietly away from resolving this issue, the development of cryogenic regulations in the United States has been stunted. To avoid the controversial debate a federal circuit or U.S. 19.

The first facility in the U.S. to offer this technology to the public was GIVF. Schulman, supra note 4; see also Human Embryo Cryopreservation, supra note 13.

20.

For a more complete description of the exact process involved in ovarian cryopreservation, see Ovary Cryopreservation, supra note 4. Professor Roger Gosden of Leeds University in the United Kingdom was the first person to develop this technique. Currently, GIVF is working in conjunction with him in its ovarian slice cryopreservation efforts. Id.; Highfield, supra note 14, at 16. According to Gosden, cryogenic freezing of ovarian tissue may be a more opportune means for women to become pregnant in their later years, as tissue preserved in this manner “does not suffer some of the technical problems we have seen with freezing eggs.” Ovary Cryopreservation, supra note 4.

21.

See Ovary Cryopreservation, supra note 4.

22.

As sources throughout the world have noted, in developed nations, birthrates have declined due to many women pursuing careers and deciding not to have children. Newborns Hit Record Low as Couples Marry Later, NIKKEI WKLY., July 15, 1996, Economy section, at 2. In fact, there are estimates that in the future, only one in four or five women will have children. David Fletcher, Thirtysomething is Most Popular Age to Have Babies, DAILY TELEGRAPH, June 25, 1997, at 5. Moreover, during the last few years, there has been a substantial increase in the number of women who are giving birth in their early 30s, as compared to women in their 20s. Id.; see also Carow, supra note 10, at 529.

23.

Women who undergo chemotherapy or other treatments involving radiation run the risk of causing destruction to their ovaries. Schulman, supra note 4. Indeed, although an average woman is born with approximately one million eggs, this number falls to approximately 250,000 by the time she reaches puberty. However, even healthy women who do not undergo radiation treatments only have the potentiality of releasing a maximum of between 400 and 500 eggs over the course of her lifetime. For this reason, by the time a woman is in her mid-40s, her chances of becoming pregnant naturally through her own menstrual cycle become very slim. Highfield, supra note 14.

24.

Ovary Cryopreservation, supra note 4; see also Thomas, supra note 4, at 269.

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Supreme Court decision in this area would spawn, U.S. lower courts remain content to resolve cryogenics issues by defaulting to contract principles—principles that govern the informed consent agreements from IVF clinics that frozen embryos’ biological parents sign. This phe27 nomenon was first illustrated in the case York v. Jones. Consequently, it is important to focus on why U.S. courts rely on contract principles, rather than on property principles, to resolve frozen embryo cases.

25.

See id.; see also Thomas, supra note 4, at 269-70; Shirley J. Paire et al., Ethical Dilemmas in Reproductive Medicine, 18 WHITTIER L. REV. 51, 56 (1996).

26.

See BARRY R. FURROW ET AL., BIOETHICS: HEALTH CARE LAW AND ETHICS 36 (1991), reprinted in FURROW, ET AL., HEALTH LAW: CASES, MATERIALS AND PROBLEMS (2d ed. 1991); see also Barry Brown, Reconciling Property Law with Advances in Reproductive Science, 6 STAN. L. & POL’Y REV. 73, 76 (1995) (discussing some of the problems present when we do not acknowledge the extent to which property rights are involved); Alise R. Punitch, The Davis Dilemma: How to Prevent Battles over Frozen Preembryos, 41 CASE W. RES. L. REV. 543, 544 (1991) (noting that the law is presently unclear on how to treat frozen pre-embryos); Tony Hartsoe, Person or Thing—In Search of the Legal Status of a Fetus: A Survey of North Carolina Law, 17 CAMPBELL L. REV. 169, 175 (1995) (stating the inconsistent rulings that are being given from various state courts).

27.

In 1989, the Eastern District of Virginia in York v. Jones, 717 F. Supp. 421 (E.D. Va. 1989), confined its analysis to the breach of contract aspect of the case. The husband-and-wife gamete donors alleged that their consultant doctor at the Jones Institute in Norfolk, Virginia, breached his duties under the Cryopreservation Agreement by his refusal to approve the airline transportation of their frozen embryo to a facility in California. Id. at 424. Notably, though, in the Cryopreservation Agreement, Jones and the other defendants classified the frozen embryo as the plaintiffs’ “property.” Id. at 425. York v. Jones was the first reported U.S. case dealing with cryogenics in the frozen embryos context. There were, however, other earlier unreported cases dealing with this area. See, e.g., Del Zio v. Presbyterian Hosp., No. 74 Civ. 3588 (S.D.N.Y. Apr. 12, 1978) (memorandum decision) (awarding tort damages in the amount of $50,000 to a couple for emotional distress suffered when a doctor terminated an experiment involving their gametes); Otto Wolff Handelsgesellschaft v. Sheridan Transp. Co., 800 F. Supp. 1359, 1366 (E.D. Va. 1992) (discussing the ingredients necessary to create a bailment).

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1. Is It a Person? The hesitancy of U.S. courts to define rights for frozen embryos may be attributed to the debate regarding what status to accord these embryos. In the United States, there is widespread disagreement as to what constitutes a person and when an entity achieves “personhood” 28

29

status. For instance, under the “human stock” theory, a person is “the reproductive product 30 of other human beings,” and thereby attains the status of personhood upon conception. In contrast, 31 under the “ensoulment” theory, a being becomes human several weeks after conception. Still 32 yet another theory defines personhood according to criteria incorporating brain function. One way to maneuver this debate is to hypothesize that the frozen embryos have occurred naturally in the mother’s womb, rather than outside of it. It may then be argued that, under a Roe v. Wade analysis, a frozen embryo is fetus-like and should possess the legal protections that fetuses currently enjoy, such as a compelling state interest in protecting these frozen embryos 33 that outweighs the rights of others. This argument, however,34fails for several reasons. First, a frozen embryo is developmentally not the equivalent of a fetus. Under a Roe v. Wade analysis, the embryo could be aborted, due to its early developmental stage. Likewise, disposing of fro28.

FURROW, supra note 26, at 36-37; see also Brenda L. Henderson, Achieving Consistent Dispositions of Frozen Embryos in Marital Dissolution Under Florida Law, 17 NOVA L. REV. 549, 561 (1992) (stating that a frozen embryo in and of itself is not a person but is a potential for human life); Stephanie J. Owen, Davis v. Davis: Establishing Guidelines for Resolving Disputes over Frozen Embryos, 10 J. CONTEMP. HEALTH L. & POL’Y 493, 507 (1993) (discussing the person versus property debate of frozen embryos); Michelle F. Sublett, Frozen Embryos: What Are They and How Should the Law Treat Them?, 38 CLEV. ST. L. REV. 585, 590 (1990) (acknowledging the school of thought that the “entity” known as a frozen embryo may be a human life).

29.

FURROW, supra note 26, at 37; see also Stanley v. Illinois, 405 U.S. 645, 651 (1972) (the conception of a child brings adoption and custody issues into play); Wendy Dullea Bowie, Multiplication and Division—New Math for the Courts: New Reproductive Technologies Create Potential Legal Time Bombs, 95 DICK. L. REV. 155, 168 (1990) (stating that an embryo should have rights independent of its parents).

30.

FURROW, supra note 26, at 37, 41. Leading geneticists, such as Dr. Jerome Lejeune of France, have called the small collection of cells following conception as “early human beings” and “tiny persons,” equating the destruction of a frozen embryo with death from a “concentration can.” Davis v. Davis, 842 S.W.2d 588, 593 (Tenn. 1992), cert. denied, 113 S. Ct. 1259 (1993); see also Webster v. Reproductive Health Services, 109 S. Ct. 3040 (1989) (holding that certain aspects of the Roe holding should be overruled concerning when a person is created); Jed Rubenfeld, On the Legal Status of the Proposition that “Life Begins at Conception,” 43 STAN. L. REV. 599, 602 (1991) (questioning the Supreme Court’s view that this “entity” becomes a person upon viability).

31.

FURROW, supra note 26, at 37; Rogaly, supra note 8. This paper does not seek to explore the timing of ensoulment in detail. For this reason, it suffices to note that Catholics believe ensoulment occurs at the time of conception, whereas Jews believe it occurs when the soul enters the fetus. See also Louise Harmon, Fragments on the Deathwatch, 77 MINN. L. REV. 1, 7 (1992) (noting that the theory of ensoulment has tremendous legal, constitutional and medical effects); Mark S. Scott, Quickening In the Common Law: The Legal Precedent Roe Attempted and Failed to Use, 1 MICH. L. & POL’Y REV. 199, 206 (1996) (acknowledging that in common law, an ensoulment theory of life was adopted). But see Sarah A. Rumage, Resisting the West: The Clinton Administration’s Promotion of Abortion at the 1994 Cairo Conference and the Strength of the Islamic Response, 27 CAL. W. INT’L L.J. 1, 8 (1996) (arguing that ensoulment theory supporters have various disagreements amongst them as to when ensoulment begins).

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zen embryos is effectively the equivalent of a pregnant woman having an abortion at an extremely early stage of her pregnancy. Moreover, courts have previously noted that the state’s 35 interest in maintaining the life of frozen embryos is “at best slight.” Frozen embryos, under this analysis, are not persons because they do not even meet the threshold requirement of attaining fetal status. Second, a fetus is a being that has already attached itself to its gestational mother’s uterine wall. This physical attachment to the mother constitutes the fetus’s presumptive right to a

32.

See FURROW, supra note 26, at 38-39. Bioethicists advocate this position. For example, Joseph Fletcher lists the following 15 items as the criteria that should be used in determining whether a being is human: minimal intelligence; self-awareness; self-control; a sense of time; a sense of futurity; a sense of the past; the capability to relate to others; concern for others; communication; control of existence; curiosity; chance and changeability; balance of rationality and feeling; idiosyncrasy; and neocortical function. Joseph Fletcher, Humanness, in HUMANHOOD: ESSAYS IN BIOMEDICAL ETHICS, 12-16 (1979), reprinted in FURROW, supra note 26, at 38-40; see also Jay A. Friedman, Taking the Camel by the Nose: The Anencephalic as a Source for Pediatric Organ Transplants, 90 COLUM. L. REV. 917, 928 (1990) (stating that many still consider an individual dead if the brain is dead but they can breathe on their own); Julie Koenig, The Anencephalic Baby Theresa: A Prognosticator of Future Bioethics, 17 NOVA L. REV. 445, 457 (1992) (questioning the wisdom of determining life strictly by brain waves).

33.

See Elizabeth G. Patterson, Human Rights and Human Life: An Uneven Fit, 68 TUL. L. REV. 1527, 1543 (1994); also Roe v. Wade, 410 U.S. 113 (1973). In Roe v. Wade, the U.S. Supreme Court determined that in various places throughout the text of the U.S. Constitution, the word “person” was only intended to have postnatal applications. A fetus, under this decision, did not itself possess constitutional rights. Noting that the state possessed a compelling interest in protecting the fetus at the point of viability, however, the Court held that the Fourteenth Amendment protected a fetus by proscribing its gestational mother’s ability to have an abortion to a point prior to the fetus’s viability. Id. at 163-64. See

34.

In Roe v. Wade, the U.S. Supreme Court held: With respect to the State’s important and legitimate interest in potential life, the “compelling point” is at viability. This is so because the fetus then presumably has the capability of meaningful life outside the mother’s womb. State regulation protective of fetal life after viability thus has both logical and biological justifications. Id. at 163. As one author states, “[A] human who has not yet been born, reached viability, or satisfied some other criterion for the beginning of life, is not considered a person in whom human rights inhere. . . . Traditionally, the law has not treated the fetus as a person.” Patterson, supra note 33, at 1550; see also Rosen v. Louisiana Board of Medical Examiners, 318 F. Supp. 1217, 1219 (D. La. 1970) (recognizing that the words “embryo” and “fetus” refer to different stages in prenatal development); Doe v. Shalala, 862 F. Supp. 1421, 1430 (D. Md. 1994) (noting that differences do exist between embryo and fetus).

35.

Patterson, supra note 33, at 1551 (quoting Davis v. Davis, 842 S.W.2d 588, 602 (Tenn. 1992), cert. denied, 113 S. Ct. 1259 (1993)). Indeed, Justice Stevens voiced this sentiment in Webster v. Reproductive Health Servs., 492 U.S. 490, 569 (1989), noting that there is an “obvious difference between the state interest in protecting the freshly fertilized egg and the state interest in protecting a 9-month-gestated, fully sentient fetus on the eve of birth.” See also Litchez v. Harrigan, 735 F. Supp. 1361, 1366 (1990) (outlining some of the difficulty courts have had when it comes to the destruction of frozen embryos).

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uterus. A frozen embryo, however, does not possess a presumptive right to a human uterus, having never asserted a “claim” to a human uterus; it never possessed an umbilical cord and, therefore, never physically attached itself to a uterine wall. Consequently, the frozen embryo necessarily has less of a claim to “in utero development rights” than does an embryo that occurs naturally. Finally, a frozen embryo is the product of IVF and, as such, occurs outside the zone of a woman’s privacy. Notably, there is nothing specifically enumerated in the U.S. Constitution regarding birth, contraception or abortion. It is for this reason that the U.S. Supreme 36 Court was able to extrapolate a right of privacy from several amendments to the Constitution. For 37 example, in Griswold v. Connecticut, the Court recognized a zone of marital privacy to insulate abortion from legislative control. In essence, the holding of Griswold was that it is not the state’s place to regulate a natural process, such as becoming pregnant, because38 this process traditionally occurs in a “zone of privacy” immune from governmental regulation. Here, the “zone of privacy” in question is synonymous with the mother’s womb. IVF occurs, however, with medical assistance, in an arena outside the womb. Once outside the “zone of privacy,” fertilization and the reproductive process no longer occur naturally. Rather, medical technicians and institutions become involved in the interim. To function properly, these groups require legal controls regarding how best to manage, govern and protect genetic materials associated with human reproduction. Therefore, prior to the time a frozen embryo is re-introduced into the “zone of privacy” of a woman’s womb, the state should be free to regulate both the frozen embryo and the members of society responsible for its safekeeping. 2. Is It Quasi-property? Despite the above analysis, the view that has met with the greatest degree of acceptance in the United States is that a frozen embryo enjoys a higher39status than that of other human tissue, but a lesser status than that accorded to actual persons. This view grew out of case law precedent defining ownership rights in body parts, notably Moore v. Regents of the University of Cali40 fornia. Moore was one of the first U.S. cases to address whether a person maintains a property interest in his or her cells once they are removed from his or her body. The Supreme Court of 36.

See Corkey v. Edwards, 322 F. Supp. 1248, 1251 (W.D.N.C. 1971) (holding that a statute was overbroad in prohibiting use of drugs by a pregnant woman to destroy an unborn child); see also Barucki v. Ryan, 827 F.2d 836, 844 (1st Cir. 1987) (stating that a right of privacy is found to exist in the Eighth and Fourteenth Amendments); Plante v. Gonzalez, 575 F.2d 1119, 1223 (5th Cir. 1978) (noting that while privacy does exist, it is limited and does not include financial privacy); Young Women’s Christian Assoc. v. Kugler, 342 F. Supp. 1048, 1052 (D.N.J. 1972) (recognizing that a right of privacy exists in the Constitution and is derived from the penumbras and emanations).

37.

381 U.S. 479 (1965) (holding unconstitutional a Connecticut law prohibiting the giving of information to a married couple regarding contraceptive measures).

38.

Id. at 485; see also Planned Parenthood of Southeastern Pa. v. Casey, 505 U.S. 833 (1992) (right to reproductive freedom); San Antonio School Dist. v. Rodriguez, 411 U.S. 1 (1973) (right to procreate); Roe v. Wade, 410 U.S. 113 (1973) (right to reproductive freedom); Eisenstadt v. Baird, 405 U.S. 438 (1972) (right to use contraception).

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California determined that because people do not retain “any continuing interest in excised 41 cells,” these cells cannot remain a person’s property. The court equated these cells to blood and transplantable organs, holding that a person’s cells are “objects sui generis,” and should be “regulat[ed] . . . to achieve 42 policy goals rather than abandoning [their regulation] to the general law of personal property.” The court further 43 answered the question of “how could one not have a right in one’s own genetic material” by holding that because other people produced the same category of cells, 44 these cells were “no more unique to [one person] than the number of vertebrae in the spine.” The Moore decision may have laid the foundation for the rationales other U.S. courts applied in the handful of reported frozen embryo cases. The first case to gain widespread 45 acclaim in this area was Davis v. Davis. This case involved a divorcing husband and 46 wife, and focused on which genetic parent should retain “custody” of seven frozen embryos. In regard to the embryos’ disposition, the Tennessee Supreme Court concluded these entities were “not, strictly speaking, either ‘persons’ or ‘property,’ but occup[ied] an 47 interim category that entitles them to special respect because of their potential for human life.” Thus born was the concept of “quasi-property,” which largely remains the U.S. standard regarding frozen embryos’ sta48 tus.

39.

The use of frozen embryos opens the door to a frontier of property rights issues. See Barry Brown, International Symposium on Law and Science at the Crossroads: Biomedical Technology, Ethics, Public Policy, and the Law: Preface, 27 SUFFOLK U. L. REV. 1169 (1993); see also Hecht v. Superior Court of Los Angeles County, 16 Cal. App. 4th 836, 849 (2d App. Dist. 1993) (citing Davis when setting aside trial court’s order directing the personal representative of decedent’s estate to destroy all of decedent’s sperm contrary to decedent’s wish to release his sperm to his girlfriend); York v. Jones, 717 F. Supp. 421, 424 (D. Va. 1989) (recognizing the confused state that courts are in trying to define an embryo).

40.

51 Cal. 3d 120 (1990). In this case, the plaintiff, Moore, suffered from hairy-cell leukemia. Doctors treating Moore as a patient began to use samples of Moore’s leukemia cells for research and biomedical development purposes, prior to obtaining his consent. Id. at 135; Arato v. Avedon, 5 Cal. 4th 1172, 1184 (1993) (distinguishing Moore).

41.

Moore, 51 Cal. 3d at 137; see also Perry v. St. Francis Hosp., 886 F. Supp. 1551 (1995); James Boyle, A Theory of Law and Information: Copyright, Spleens, Blackmail and Insider Trading, 80 CAL. L. REV. 1413, 1422 (1992).

42.

Moore, 51 Cal. 3d at 137; see also Jean de Vellis, Symposium on Biomedical Technology and Health Care: Social and Conceptual Transformations, 65 S. CAL. L. REV. 697 (1991).

43.

Moore, 51 Cal. 3d at 138.

44.

Id. at 139.

45.

842 S.W.2d 588 (Tenn. 1992), cert. denied, 113 S. Ct. 1259 (1993). Other cases include Doe v. Sundquist, 106 F.3d 702 (6th Cir. 1997); Broadwell v. Holmes, 871 S.W.2d 471 (Tenn. 1994); and Hawk v. Hawk, 855 S.W.2d 573 (Tenn. 1993).

46.

Davis, 842 S.W.2d at 589. The Tennessee Supreme Court noted that at the time it heard this case, over 20,000 frozen embryos were in storage at various facilities throughout the country. Id. at 590.

47.

Id. at 597.

48.

Foreign publications still acknowledge the standard the United States follows for frozen embryo classification as one where the frozen embryos maintain the status of something between pure property and personhood. Rogaly, supra note 8; see also Lifchez v. Hortigan, 735 F. Supp. 1361 (D. Ill. 1990).

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3. Is It Property? As the years progress, U.S. courts are moving closer to classifying human embryos as prop49 erty, or are at least willing to return to this position once again. This progression is best illus50 trated through the case of Hecht v. Superior Court of Los Angeles County. In this case, the California Court of Appeals was faced51with deciding whether the frozen sperm of a deceased man constituted property of his estate. In its analysis, the court admitted that, in the United 52 States, “[t]he present legal position toward property rights in the human body is unsettled.” Notably, though, the court acknowledged the American Fertility Society’s finding in its ethical statement53on IVF that “it is understood that the gametes and concepti are the property of the donors.” Relying on these and other findings of the American Fertility Society, the court concluded that frozen54sperm “is a unique type of ‘property’” that should be considered as part of a decedent’s estate. The court was not willing, however, to draw a further line than this and outrightly call sperm pure property. Instead, the court noted that “[i]t is not the role of the judiciary 55 to inhibit the use of reproductive technology when the Legislature has not seen fit to do so.” Since the time of this decision, the guidelines the United States currently follows are the ones that govern legal ownership of 56 human sperm and ova; frozen embryos are considered the property of the husband and wife.

49.

Arguably, the United States has already classified frozen embryos as property in York v. Jones, 717 F. Supp. 421 (E.D. Va. 1989). In this case, the court determined that the Cryopreservation Agreement between the IVF clinic and the Yorks established a bailor-bailee relationship. As such the clinic, as bailee, had a duty to return to the Yorks their property when the purpose of the bailment terminated. Id. at 425. The decision in Davis v. Davis, 842 S.W.2d 588, 593 (Tenn. 1992), cert. denied, 113 S. Ct. 1259 (1993), however, temporarily moved the direction courts were taking in this area backward a step.

50.

16 Cal. App. 4th 836 (2d App. Dist. 1993).

51.

The situation arose after the long-time girlfriend of the deceased, Ms. Hecht, alleged that this sperm had been “gifted” to her and, therefore, during a will contest, did not mention a claim to it as property she wanted from the decedent’s estate. Id. at 841-42; see also Archer-Daniels-Midland Co. v. United States, 32 Cust. Ct. 305 (1954) (noting a property right for whale sperm).

52.

Hecht, 16 Cal. App. 4th at 847 (quoting Personalizing Personalty: Toward a Property Right in Human Bodies, 69 TEX. L. REV. 209, 220 (1990)).

53.

Id. at 848 (emphasis added).

54.

Id. at 850.

55.

Id. at 861.

56.

If the frozen embryo is the result of gametes donated from unmarried parties, then the female gamete donor/ genetic parent retains sole ownership. The ultimate disposition of the embryo, however, may be subject to a court order or directive from another governmental organization. IVF Phoenix, supra note 1.

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Implicit in the Hecht decision was the court’s acknowledgment that frozen sperm, like any other collection of human cells, should be treated as property. The next logical step would be for courts to use the Hecht decision as a springboard, analogizing that, similar to frozen sperm, frozen embryos should be treated as pure property. This would put an end to the debate regarding the status of frozen embryos and would allow appropriate regulation to be more readily enacted. Therefore, for public policy reasons, designating frozen embryos as pure property seems to be the best approach. Judicial hesitancy to become the branch of government that takes the first step in defining the status of human embryos, however, contributes to the apparent stalemate in the United States regarding how to regulate this technology.

II. Cryogenics in Other Countries A. British Model as a Basis for Comparison 1. Formation of a Special Committee This dilemma regarding how to classify frozen embryos has manifested itself through the varying characterizations of these objects across international borders. This is possibly because scientists, lawmakers and ethicists impaneled to draft regulations in this area have arrived at differing solutions, most likely as a result of their respective countries’ legal framework. The United Kingdom, for example, began its inquiry into frozen embryo regulation in the mid-1980s with the formation of a special committee, the Committee of Inquiry into Human 57 Fertilisation and Embryology (the “Committee”). The findings of this committee were 58 contained in a report that would shape the direction British policy would take on this issue. The report urged 59 that legislation regarding frozen embryos “must be foreseen and must be enacted quickly.” The Committee faced the dilemma of how to classify the status of frozen embryos. Ultimately, the Committee agreed upon utilitarian recommendations, determining that law governing frozen embryos “must be generally seen to be beneficial, . . .60intelligible, and . . . enforceable,” and “must not outrage the feelings of too many people.” Consequently, the 57.

See Mary Warnock, Letter from Mary Warnock to the Government, June 26, 1984, reprinted in MARY WARNOCK, A QUESTION OF LIFE: THE WARNOCK REPORT ON HUMAN FERTILISATION & EMBRYOLOGY vi-vii (1985). This Committee, formed in July 1982, was composed of representatives from many professions and religious denominations. The thought behind the composition of the Committee’s members was that numerous viewpoints would be heard in consideration of the difficult moral issues inherent to frozen embryo regulation. Id. The aim of the Committee was “to examine the social, ethical and legal implications of recent, and potential developments in the field of human assisted reproduction.” Id.; see also Tamara L. Davis, Protecting the Cryopreserved Embryo, 57 TENN. L. REV. 507, 515 (1990) (discussing some U.K. policies concerning frozen embryos); Barbara Gregoratos, Tempest in the Laboratory: Medical Research on Spare Embryos From In Vitro Fetilization, 37 HASTINGS L.J. 977 (1986) (briefing the views of many international nations as they pertain to frozen embryos); Bartha Knoppers, Recent Advances in Medically Assisted Conception: Legal, Ethical & Social Issues, 17 AM. J.L. & MED. 329 (1991) (stating different views of many of the world’s nations concerning frozen embryos).

58.

See WARNOCK, supra note 57, at vi-vii.

59.

Id. at xiii.

60.

Id. at xvi.

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Committee adopted the “actual mode of61existence” theory, one that assigned to frozen embryos a status closely akin to that of property. 2. Consequences of Incorporating Committee Recommendations into Legislation Acting upon the Committee’s recommendations, Britain passed the Human Fertilisation 62 and Embryology Act of 1990 (the “British Act”).63 However, some would argue that this law does not clearly define frozen embryos’ status. It is the opinion of the chair of Britain’s Human Fertilisation and Embryology Authority (the “Authority”), Ruth Deech, that frozen 64 embryos “are not ‘little babies in the freezer.’” This view, echoing the sentiments of the Committee from more than ten years earlier, possibly provides an explanation for why the British Act mandates that human embryos may only be stored up to a maximum of five years, and 65 must be destroyed thereafter. In contrast with the aims of the Committee, though, the British Act was met with a great deal of controversy and public outcry last year when it was announced 66 that approximately 3,300 frozen embryos were to be destroyed within a one week period. Because the British Act currently appears to thwart the underlying purpose behind the law 67 itself, this law is, perhaps, in need of revisiting and revision at this time.

61.

Id. at xii. The “actual mode of existence” theory, which the majority of the Committee embraced, focused on the embryo’s appearance at the stage in time immediately following fertilization. In contrast, the “potentiality” theory that the minority of the Committee advocated focused on whether, if certain conditions were met, the embryo would ultimately develop into a human. Id. at xv; see also Maria Durant, Cryopreservation of Human Embryos: A Scientific Advance, a Judicial Dilemma, 24 SUFFOLK U. L. REV. 707, 711 (1990) (outlining the Ethics Board of Fertility’s position); John A. Robertson, In the Beginning: The Legal Status of Early Embryos, 76 VA. L. REV. 437 (1990) (discussing various theories that people take when discussing embryos).

62.

The British Act governs IVF measures in Britain. Victor Sebestyen, You Can’t Give a Group of Cells Legal Rights, EVENING STANDARD (LONDON), at 17; see Janet J. Berry, Life After Death: Preservation of the Immortal Seed, 72 TUL. L. REV. 231 (1997) (summarizing some of the challenges against the Human Fertilisation and Emryology Act); Kuo, supra note 9, at 1035 (discussing the Catholic Church’s feelings about the Human Fertilisation and Embryology Act).

63.

See Rogaly, supra note 8, at 1; see also Gregoratos, supra note 57, at 978.

64.

Joe Rogaly, Discarding the Frozen Embryos, PLAIN DEALER, Aug. 3, 1996, at B11. The British Act officially created the Authority. R. v. Human Fertilisation and Embryology Auth., ex parte Blood, [1997] 2 W.L.R. 806, available in LEXIS, Intlaw Library, Engcas file, at *17.

65.

Under the Act, criminal sanctions are imposed on those who fail to dispose of these frozen embryos at the end of this period. Rogaly, supra note 8, at 1. Exceptions to this rule, though, have been made in cases of “special need,” based on the sperm and egg donors’ request. Id. The five-year maximum storage period was extended to ten years for couples who provided the in vitro storage clinics with their consent. Sebestyen, supra note 62, at 17; see Todd M. Krim, Beyond Baby M: International Perspectives on Gestational Surrogacy and the Demise of the Unitary Biological Mother, 5 ANNALS HEALTH L. 193, 197 (1996) (discussing aspects of the mandate); Elizabeth Ann Pitrolo, The Birds, the Bees and the Deep Freeze: Is There International Consensus in the Debate Over Assisted Reproductive Technologies, 19 HOUS. J. INT’L L. 147, 160 (1996) (analyzing international norms concerning reproductive technology); see also supra note 18 and accompanying text.

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B. Case Law Ramifications from Imprecise Law: Regina v. Human Fertilisation and Embryology Authority, ex parte Blood in Britain The difficulties of imprecise regulations regarding frozen embryos is evidenced through the outcomes of court decisions which use these regulations as their guidelines. This point was illustrated recently in England, where the Court of Appeal (Civil Division) was faced with setting precedent in cryogenic jurisprudence through a case on appeal from the Queen’s Bench 68 Division, Regina v. Human Fertilisation and Embryology Authority, ex parte Blood. In this case, Mr. Blood lapsed into a coma and had two 69 sperm samples taken from him without his prior consent by means of electro-ejaculation. 70 The sperm was then entrusted to the Infertility Research Trust, where it 71 remains currently. Mr. Blood died several hours after the second sperm sample was taken. Mrs. Blood, his wife, wished to have the cryogenically 72 preserved sperm transported to Belgium so that she could be inseminated with them there. As the court aptly pointed out, Mrs. Blood’s case “raises problems for which there are no clear precedents and in relation to which the law is only clarified by the passage through the 73 courts.” The court met with great difficulty in resolving the issue of how to regulate Mr. Blood’s existing frozen sperm for IVF purposes, given the apparent conflict of law between the provisions 74 of the British Act and provisions of the European Community Treaty (the “EC Treaty”). Specifically, under Articles 59 and 60 of the EC Treaty, a75 Community citizen possesses a right to “receive medical treatment in another member state.” Because EC Treaty law is deemed to be a part of English law, the court held that the British Act infringed upon a person’s ability to export gametes to other EC member states (such as Belgium). To define the 66.

Originally, there were approximately 10,000 frozen embryos that the British Act affected. The in vitro clinics storing these embryos successfully contacted numerous couples whose frozen embryos were members of this collection. However, these clinics were unsuccessful in contacting approximately 900 couples—650 of whom who could not be located—and failed to receive word from these couples regarding the destiny of their frozen embryos. The approximately 3,300 embryos that were destroyed are the ones originating from these 900 couples. Sebestyen, supra note 62, at 17. These frozen embryos were disintegrated first through their removal from the liquid nitrogen in which they were stored, and next from their immersion in a warm solution. Embryos Dissolved After Warming from Brit Cryo-Storage (CNN television broadcast, Aug. 1, 1996) [hereinafter Embryos Dissolved]. L’Osservatore Romano, the newspaper of the Vatican, characterized this mass discarding of frozen embryos as a “pre-natal massacre.” Rogaly, supra note 8, at 1. In fact, several anti-abortion groups in Britain and nuns in Italy demanded that these frozen embryos be put up for adoption, rather than being destroyed. Embryos Dissolved, supra.

67.

Notably, though, Singapore’s Health Ministry possesses guidelines similar to the British Act. These guidelines state that frozen embryos may be stored for more than a period of five years. Lim, supra note 7, at 2. Therefore, if British law is in need of revision, arguably, so are similar laws in other nations. See generally Jennifer Brown, Laws Prohibiting Preembryo Discard Violate the Constitutional Right to Privacy, 28 U.S.F. L. REV. 183 (1993) (criticizing Britain’s Act).

68.

[1997] 2 W.L.R. 806, available in LEXIS, Intlaw Library, Engcas file, at *1; see also Berry, supra note 62, at 25455 (discussing Ex parte Blood).

69.

See Ex parte Blood, [1997] 2 W.L.R. 806, at *6.

70.

See id.

71.

See id.

72.

See id. at *15.

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extent of Mrs. Blood’s cross-border rights, the court stated that there was no need to resort to the Court of Justice, but that “the decision [of this court] must be . . . justified by some imperative requirement in the general interest, it must be suitable for securing the attainments of the objects 76 which it pursues and it must not go beyond what is necessary to attain that objective.” The court, nonetheless, resisted the opportunity to take a firm stance and define the extent of Mrs. Blood’s cross-border rights, deciding instead to defer to the judgment of the 77 Authority. C. The Australian Commission and Resulting Case Law: In re Estate of the Late K; ex parte: The Public Trustee in Australia Similar to the English Court of Appeal, Australian courts have also struggled with how to regulate cryogenic technology. The widely publicized cases with which Australian courts have 78 dealt, however, concern frozen embryos, rather than frozen sperm. In one case, In re Estate of the Late K; ex parte: The Public Trustee, the Supreme Court of 79 Tasmania was faced with determining what, if any, inheritance rights frozen embryos possess. Similar to the situation in Ex parte Blood, the deceased’s80sperm was used with his spouse’s egg to produce embryos which were cryogenically stored. Citing rationales from the British case Paton v. Trustees of the British

73.

Id. at *20; see also Sperm Was Taken and Preserved Unlawfully, TIMES, Feb. 7, 1997, (reprint of the court of appeals’ decision in Regina v. Human Fertilisation and Embryology Authority). There were two main issues in this case, one involving the husband’s informed consent, and the other involving a conflicts of laws issue discussed infra. In regard to the issue of the husband’s consent, the court determined that although the sperm samples were taken to aid Mrs. Blood in fulfilling the couple’s desire to have children, the manner in which Mr. Blood’s sperm was taken violated several provisions of the British Act governing consent of the parties. This violation occurred because the now deceased husband had not provided prior to his death his “effective consent” to contributing his sperm, as Schedule 3, Paragraph 5 of the British Act requires. The husband also did not receive the appropriate counseling and information regarding cryogenic preservation of his sperm, as Schedule 3, Paragraphs 1(a) and 1(b) require. Absent this counseling and informed consent from a gamete-contributing party, Schedule 3, Paragraph 5(2) of the British Act prohibits use of gametes from this party for purposes of gamete donation and use. Ex parte Blood, [1997] 2 W.L.R. 806, at *10. However, another provision of the British Act indicated that if the couple were “receiving treatment services,” then an exception to these other sections would arise. The exception would have arisen under Section 4(1)(b) of the Act, which provides an exemption from the requirement of a license to obtain sperm, when sperm is obtained for “treatment services.” Id. Determining that Mr. Blood’s sperm should not have been preserved in the first instance, the court held that in future cases, written consent from the gamete donor would be necessary prior to the cryogenic preservation of the donor’s gametes. Id. at *14, 21. This part of the decision resolved the issue of under what circumstances gametes may be taken from a party.

74.

See Ex parte Blood, [1997] 2 W.L.R. 806 at *14.

75.

Id.

76.

Id. at *17.

77.

Id. at *9.

78.

See In the Marriage of: A Husband and B Wife, No. 100096, slip op. at 1 (Fam. Ct. Austl. Dec. 22, 1989) (holding that legal representation of a gamete donor is important in matters of determining the best interest of frozen embryos resulting from the donor’s gametes); In re Late K, ex parte: The Public Trustee, 1996 TAS LEXIS 479, at *1, *18 (Sup. Ct. Tasmania Apr. 22, 1996) (holding that inheritance rights attach to a child developed from a frozen embryo upon that child’s birth); see also Pitrolo, supra note 65, at 149 (Australia began its IVF program in 1980 and by 1989 there were 3,125 births).

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Pregnancy Advisory Service, and from the U.S. case Roe v. Wade, the court determined that a frozen embryo possessed a contingent interest in the estates of its deceased progenitors, but that 83 interest did not actualize until the child developing from the embryo was born. Strikingly, and in contrast to the English Court of Appeal, the Supreme Court of Tasmania was able to take a firm, decisive stance in regard to setting precedent on a matter concerning human cryogenic technology. Possibly, a reason for this is that, in addition to precedent from other courts internationally, the Supreme Court of Tasmania possessed clear, non-self-contradictory guidance from a report of the New South Wales Law Reform Commission (the “Com84 mission”) entitled In Vitro Fertilization Law Reform Commission 58 1988. This contrasts with the situation in Ex parte Blood because, in that case, the recommendations of the British Act 85 were unclear as to Mrs. Blood’s situation, and were in contradiction to other existing laws. Therefore, Late K and Ex Parte Blood together emphasize the need for courts to have precise guidance from special committees whose focus is on cryogenic technology, as well as from clear

79.

See Late K, 1996 TAS LEXIS 479, at *1-*2; see also Pitrolo, supra note 65, at 178 (noting that the Waller Committee ruled that parents’ rights over the embryo are limited by similar constraints applied to coital-birth parents). The United Kingdom has been an historic leader in the field of assisted reproduction. Id. at 173. The Warnock Committee took the position that the embryo had no legal entitlements. They did say, however, that it was endowed with a special status which, pursuant to some regulatory guidelines, could not be researched upon unless the progenitors gave their consent. Id.

80.

See Late K, 1996 TAS LEXIS 479, at *2. The first Australian birth was at Royal Women’s Hospital in Melbourne, Victoria. See Pitrolo, supra note 65, at 150 n.3. Louise Brown was born in England on July 25, 1978—the first child conceived using the process of in vitro fertilization. Id. at 149.

81.

[1978] 2 All ER 987, [1979] QB 276. In this case, Sir George Baker, writing for the court, noted the following: The fetus cannot in English law . . . have any right of its own, at least until it is born and has a separate existence from the mother. That permeates the whole of the civil law of this country . . . and is indeed, the basis for the decisions in those countries where law is founded on the common law, that is to say, in America, Canada, Australia and, I have no doubt, in others. Late K, 1996 TAS LEXIS 479, at *9; see also Kathleen R. Guzman, Property, Progeny, Body Part: Assisted Reproduction and the Transfer of Wealth, 31 U.C. DAVIS L. REV. 193 (1997) (concerning the misapplication of an outmoded model of epistemology in a context that is driven by the new developments in reproductive assistance and assertion that the embryo is property that can pass through succession).

82.

410 U.S. 113, 163 (1973); see also Guzman, supra note 81, at 214 (Anglo-American jurisprudence has it that a testator may leave property to whomever he or she pleases, however it restricts transfers primarily to persons).

83.

See Late K, 1996 TAS LEXIS 479 at *16; see also Guzman, supra note 81, at 206 (noting that if the embryo is to be considered property the legal owners would have to lay their claim through a combination of labor and occupation theories).

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legislative measures. Only then, it seems, will courts feel comfortable in taking firm stances and drawing lines in this area.

III. U.S. Response to the Laws of Other Countries A. The U.S. Courts’ Response Remains Unchanged The decisions in recent cryogenics cases in England and Australia provide U.S. courts with an opportunity to contemplate the rationales foreign courts used in their decisions. They also provide U.S. courts with time to reflect on the wisdom of rationales used in prior U.S. decisions involving frozen embryos, frozen sperm and other human cells. Despite this opportunity for introspection, U.S. courts still remain hesitant to advance the state of the law in the area of property law and to break the status quo of primarily using contract law in cryogenics cases. The New York Appellate Division demonstrated this hesitancy when it decided Kass v. 86 Kass. This case involved a divorcing husband and wife who 87 entered into a cryopreservation contract regarding the disposition of their frozen embryos. Ultimately, the court determined that despite the female gamete donor’s desire to preserve the five frozen embryos for the maximum five-year period, the contract 88 allowing these embryos to be donated for research purposes was determined to be controlling. Absent from this opinion, though, was any 89 attempt to define the status of these frozen embryos as persons, quasi-property or property. Once again, a U.S. court was content to default to the use of contract law—rather than property law—as the basis for its decision.

84.

See Late K, 1996 TAS LEXIS 479 at *15. In Recommendation 39(i) of its report, the Commission stated that “the law should allow, and should not preclude, a specific testamentary gift in favour of a posthumously conceived child or a child born from a stored embryo.” Id. The Commission noted, however, that where an ovum of a widow is fertilised in an IVF procedure, by the posthumous use of her deceased husband’s semen and transferred to her by embryo transfer, the resulting child should be recognised as the lawful child of the dead husband except for the purposes of inheritance and succession. Id. (emphasis added). Australia has been a leader in the IVF debate on parental property rights over cryogenic progeny. Pitrolo, supra note 65, at 179-80. Assisted reproduction, although now a nearly worldwide phenomenon, nonetheless encounters opposition from traditional bastions of moral preserve such as the Catholic Church, especially in places such as Argentina where the church is widely influential. Id. at 181.

85.

See R. v. Human Fertilisation and Embryology Authority, ex parte Blood, [1997] 2 W.L.R. 806, available in LEXIS, Intlaw Library, Engcas file, at *29-30.

86.

235 A.D.2d 150 (2d Dep’t 1997).

87.

The parties, pursuant to the consent agreement they signed, agreed to allow their cryopreserved zygote to be used for future genetic and biological research. Id. at 161. The parties underwent ten unsuccessful attempts to have a child through IVF between March 1990 and June 1993, at a total cost in excess of $75,000. Id. at 151.

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B. Probable Reasons for Maintaining the Status Quo One possible reason why U.S. courts may be hesitant to depart from contract-based rules for frozen embryos is that the United States is, in fact, cognizant of the public condemnation the British Act received following the Ex parte Blood decision, and does not want to experience similar adverse public reaction to a congressional act. Enforcement of contract law, as private law between the gamete donors and the IVF facility, does not raise the ethical dilemmas that would arise under public law such as a statutory scheme. Parties to a contract may define for themselves the rights they wish to recognize or waive. For these reasons, U.S. courts may view contract law as a safe harbor mechanism, and as a way to prevent as best as possible adverse public reaction to their decisions. Alternatively, U.S. courts may be waiting for legislative guidance before taking a firm stance in the cryogenics regulatory debate. These possibilities will be addressed below regarding steps the United States should now take for cryogenics regulation.

IV. Steps the United States Should Take A. Private Law of Contract Is Not the Optimal Approach 1. Potential for Contracts of Adhesion There are several reasons why allowing contract law to continue as the primary basis for U.S. courts’ decisions in cryogenics cases is not the best approach. First, a contract law framework allows doctors and medical technicians involved in the IVF process the opportunity to exert their unregulated influence over the gamete donors, who in most cases may not be very scientifically literate 90 or well-versed in their ability to bargain for the elements in IVF contracts they truly desire. This inequality of bargaining power among parties may lead to IVF agreements containing terms that were arrived at through procedurally unconscionable means. For this reason, IVF contracts, like insurance contracts, may be viewed as contracts of adhesion, wherein the gamete donors may be forced to accept the unfavorable contract 91 terms the IVF facility offers, or be left with the alternative of having no IVF treatment at all. Indeed, in the 88.

The Kass court specifically noted: “We are in full agreement with the decision in Davis to the extent it requires that where a manifestation of mutual intent exists between the parties, that intent must be given effect by the court.” Id. at 157. The plaintiff, prior to this court’s ruling, had been awarded “unfettered discretion” over the pre-zygotes in accordance with coital post-fertilization principles, but the court herein, relying on the mutual intent agreement signed by the parties, held that the agreement should be given effect. Id. at *9; see also Davis v. Davis, 42 S.W.2d 588, 601 (1992) (stating that a woman’s established right to exercise virtually exclusive control over her own body is not implicated in the IVF scenario until such time as implantation actually occurs, for it is only then that her body integrity is at issue).

89.

At one point in the opinion, the court referred to the respective parties’ control over the frozen embryos as “custody or possession,” thereby implying that these frozen embryos were either human or were property. Kass, 235 A.D.2d at 154.

90.

For a sample of terms a cryopreservation agreement may contain, see York v. Jones, 717 F. Supp. 421, 424 (E.D. Va. 1989).

91.

See RESTATEMENT (SECOND) OF CONTRACTS § 3 (1979) (stating that “an agreement is a manifestation of mutual assent on the part of two or more persons”).

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unlikely case that other IVF facilities offer gamete donors more favorable IVF contract terms, these gamete donors may not know how to seek out these other facilities that offer more favorable IVF contract terms, if such facilities exist. Therefore, to prevent physicians and health care providers from potentially taking advantage of gamete donors’ positions, there should remain an unbroken link between these professionals and 92 government regulation which mandates the type of terms IVF agreements should contain. Enactment of a national statutory scheme would provide limitations and minimum requirements for contract terms, and would act as a protective shield against procedural unconscionability for people who seek IVF treatment involving frozen embryos. 2. Potential for Social Irresponsibility Requires Setting an Age Limit Under a contract approach, almost anyone of requisite mental capacity may enter into an 93 IVF contract. There is no upper age limit imposed on women who wish to become a party to this type of contract. Absence of this control encourages bad social policy. Specifically, there is a very real risk that older females may disregard the principle of parental responsibility; they may focus less on the future welfare of the frozen embryo, and may instead focus on their94more immediate desire to act in a self-gratifying manner by fulfilling their desire to give birth. For example, it is now possible for post-menopausal 95 women between the ages of 50 and 60 to gestate and give birth to children as a result of IVF. Our society must consider from the potential child’s perspective whether it is good social policy for women of this age to begin raising children. Perhaps a child will be her only living relative in ten years. Upon her death, the child will need to be given up for adoption. Moreover, an elderly mother may no longer be physically or emotionally suited to caring for the everyday needs of an infant child. Allowing 92.

Indeed, it has been argued that there must be “watchful governmental control of science,” and that breaking the link, or, in fact, failing to forge this link at all, may be a mistake. YVONNE M. CRIPPS, CONTROLLING TECHNOLOGY: GENETIC ENGINEERING AND THE LAW 10 (1980).

93.

Assuming that having children at an older age is synonymous with acting in a socially irresponsible manner, this author believes that men who father children at older ages also act in a socially irresponsible manner. Prior to advances in cryogenics, one of the two biological parents (i.e., the woman), due to biological constraints, was necessarily forced to have children at a younger age. This caused the female gestational parent to act in a socially responsible manner. With cryogenics, neither biological parents nor the gestational parent need act in a socially responsible manner. See Lisa Belkin, Pregnant with Complications, N.Y. TIMES, Oct. 26, 1997, § 6, at 34 (discussing the increasing incidence of older women seeking to conceive well beyond medically approved child-bearing years).

94.

As one author has noted, in the United States, “social responsibility has taken a back seat to individual rights. . . . Americans have perfect rights but no perfect duties to their communities. Their duties are imperfect because they are derived from their rights; the community exists only to protect those rights. Moral obligation is therefore entirely contractual.” Ronald Chester, Freezing the Heir Apparent: A Dialogue on Postmortem Conception, Parental Responsibility, and Inheritance, 33 HOUS. L. REV. 967, 970 (1996).

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these older women freedom to contract in regard to IVF contracts demonstrates disregard for the parens patriae doctrine, wherein the best interest of the child should be considered. Failure to prohibit such contracts flies in the face of steps U.S. courts have taken to protect children’s 96 best interests, particularly when these children originally began from cryopreserved embryos. Implementation of a congressional measure setting a maximum age limit at which a female should be allowed to gestate a frozen embryo would protect against this scenario. Setting such an age limit for IVF treatment has already met with favorable endorsement from scientific experts in Europe. In the summer of 1997, IVF experts in Britain were in agreement that due to the “possible adverse social effects on a child97growing up with elderly parents,” women past age 50 should not be afforded IVF treatment. Also, only several weeks ago at a recent European fertility conference, experts voted against allowing post-menopausal women to participate 98 in IVF programs. 99 While it true that the Authority currently has no age limit for women seeking IVF treatment, in light of the current sentiments among the European fertility expert community, this may likely change in the near future. Notably, a spokesperson from this body stated that doctors are currently required “to bear 100 in mind the parents’ ages and their future ability to look after or provide for a child’s needs.” The shared sentiment among experts in Europe should be instructive to lawmakers in the United States. By looking to its European peers, U.S. lawmakers will have a foundation for legislation prohibiting post-menopausal women over age 50 from gestating their own frozen embryos. 3. Refutation of Other Reasons for a Purely Contractual Framework Several arguments may be made against those supporting a purely contractual framework for cryogenic regulation. First, there are those who argue that the government should not be 95.

These women are more frequently found in Italy and in America, where people are more liberal-minded regarding who may take advantage of IVF. Highfield, supra note 14; Woman of 54 Has Test Tube Twins, HERALD (GLASGOW), June 5, 1997, at 3. In fact, Italy has almost no legal controls as to requirements necessary to be eligible for IVF treatment, an anomaly among nations. Celestine Bohlen, Almost Anything Goes in Birth Science in Italy, N.Y. TIMES, Apr. 4, 1995, at A14. Indeed, a 59-year-old British woman last June received IVF treatment in Italy, returned to Britain to give birth, and became the oldest woman in the world to give birth to twins. Woman of 54 Has Test Tube Twins, supra, at 3. Though there is no upper age limit for IVF treatment of women in Hong Kong, women are required to attend counseling sessions regarding complications if over the age of 40. Alice Cairns, Breaking Taboos, SO. CHINA MORNING POST, Mar. 10, 1996, Magazine, at 10. In the United States, Arceli Keh, a 63 year-old California woman, lied to the doctors at the fertility clinic and became the first sexagenarian to give birth to a child using the IVF method. Belkin, supra note 93, at 34. Keh’s actions created a firestorm of controversy as ethicists, feminists and scientists found themselves defending multiple fronts of the IVF debate simultaneously. Id.

96.

See Tamara L. Davis, Protecting the Cryopreserved Embryo, 57 TENN. L. REV. 507, 530 (1990).

97.

Woman of 54 Has Test Tube Twins, supra note 95, at 3.

98.

See Highfield, supra note 14, at 16.

99.

See Woman of 54 Has Test Tube Twins, supra note 95, at 3. Although IVF is currently available to women of all ages, as the Human Fertilisation and Embryology Authority has noted, “less than a fifth of one percent of all women [who receive IVF treatment] are in their fifties.” Highfield, supra note 14, at 16.

100. Highfield, supra note 14, at 16.

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involved 101in a female’s decision to become a parent, as this is a highly intimate and personal choice. However, as John Stuart Mill stated in his essay On Liberty: “[T]he only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is102 to prevent harm to others. His own good, either physical or moral, is not a sufficient warrant.” Second, prominent legal scholars, such as John A. Robertson, argue that the directives contained103in IVF contracts are similar to those of marriage contracts and of advance directives at death. As such, the contract framework encourages courts to merely focus on104the rights of the parties to the contract, rather than on rights the frozen embryos may possess. This position enables courts to skirt around the debate over the status to accord frozen 105 embryos, including resolution of the constitutional law issues surrounding this debate.106 This pure contract approach focuses on the future disposition of the frozen embryos only, instead of the social consequences that may arise thereafter. Because this analysis only looks selectively at a 107 fragment of the picture regarding frozen embryos, this “general principles of contract” approach is not as comprehensive a remedy as is necessary for adequate regulation in this area. Third, an argument can be made that there are older women who may, in fact, be perfectly capable of gestating, giving birth to and raising a child. As in adoption proceedings, a judge could evaluate on a case-by-case basis whether the female biological parent possesses the lifestyle, mental capacity and physical capacity appropriate for becoming the gestational and actual parent of her own frozen embryo. A counter-argument to this, however, is that a line must be drawn at some point. Just as the United States saw fit to impose a minimum age at which people are determined competent to vote in national elections, the United States should also possess a maximum age at which women are determined to lack certain capacities related 108 to responsible participation in cryogenic advances. Consequently, a national law placing an age limit appears to be a necessity for controlling women’s freedom to contract in the frozen embryo arena.

101. Indeed, studies have shown that Americans believe risk-taking to be a private affair and one in which the government and quasi-government entities should not be involved. See, e.g., Peter Huber, Safety and the Second Best: The Hazards of Public Risk Management in the Courts, 85 COLUM. L. REV. 277, 280 (1985). 102. John Stuart Mill, On Liberty, reprinted in AREEN (emphasis added).

ET AL.,

LAW, SCIENCE

AND

MEDICINE 237 (2d. ed. 1996)

103. See John A. Robertson, Prior Agreements for Disposition of Frozen Embryos, 51 OHIO ST. L.J. 407, 414 (1990). Professor Robertson has published several articles regarding the status and regulation of frozen embryos. For additional discussion regarding Robertson’s pure contract framework theory, see John A. Robertson, In the Beginning: The Legal Status of Early Embryos, 76 VA. L. REV. 437 (1990). 104. See Mario J. Trespalacios, Frozen Embryos: Towards an Equitable Solution, 46 U. MIAMI L. REV. 803, 826 (1992). 105. See id. at 826, 833. 106. See Robertson, supra note 103, at 418. 107. Id. at 424.

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B. Move from a Private Law Framework Toward a Public Law Framework Given the difficulties involved in regulating cryogenics through a purely contractual framework, implementation of comprehensive legislation establishing a uniform 109 system of regulation is the most plausible means of filling the void for guidance in this area. Currently, 110 only a handful of states possess statutes that attempt to regulate cryogenics. The difficulty with each state possessing its own unique cryogenics statutes is that potential IVF participants will be induced to forum shop for the state that possesses laws most favorable to their interests, the frozen embryos’ interests, or both. By implementing a federal regulatory scheme in place of state regulation, lawmakers would be helping to reduce the need for forum shopping, and therefore 111would be assisting, rather than interfering with, the development of cryogenic technology.

Conclusion Cryogenic technology offers attractive new options in the area of human reproduction. As the use of frozen embryos becomes more widespread, society must have the foresight to extensively regulate cryogenic technology. The deficiency in the United States of comprehensive regulations to address the potential difficulties arising from cryogenic preservation of human embryos carries with it adverse social ramifications that need to be addressed proactively at this time. The contract-based approach U.S. courts are currently taking to resolve frozen embryo cases is an inadequate solution. At this time, the United States would not be remiss in following the measures other countries have taken. Indeed, Congress has recognized the need for the United States to consider the actions of other countries, as it considers recent developments in scientific technology to be an 112 international, rather than merely an American, issue. Similar to the Committee in Britain, the United States could form a committee composed of legal scholars, scientists, ethicists, theologians and the like to formulate legislative recommendations specifically tailored to U.S. citi108. For a further discussion regarding why and how the minimum age of majority and the minimum drinking age were reached, see Patterson, supra note 33, at 1534. The approach of prohibiting reproduction in certain instances is not a novel concept, either in the United States or elsewhere. In China, for instance, the government instituted limits on the number of offspring families were entitled to have, as a measure to control the country’s exploding population. FURROW, supra note 26, at 63-64; see also Buck v. Bell, 274 U.S. 200 (1927) (holding that in certain circumstances, the Fourteenth Amendment allows for certain people who are unfit to care for and raise their own children to be prevented from having children). 109. See CRIPPS, supra note 92, at 81 (endorsing the notion of “establishment of a unified system of regulation that would, to the fullest extent possible, govern every facet of the technology”); Chester, supra note 94, at 998 (noting that in regard to cryogenic technology, “a uniform law might be the only realistic way to create the needed law”). 110. The states that currently possess the most comprehensive regulations regarding cryogenics include Virginia, Louisiana and California. See CAL. FAM. CODE § 7613(b) (West supp. 1996); CAL. PROB. CODE § 6407 (West 1991); LA. CIV. CODE ANN. 1474; VA. CODE ANN. § 20-156 (1997). Of these states, Virginia’s statute seems the most comprehensive. For example, chapter 9 of Virginia’s Domestic Relations statutes is devoted entirely to addressing the status of children of assisted conception. See id. 111. See Brown, supra note 39, at 1169-70.

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zenry. Congress could then enact appropriate legislation in conformance with these recommendations. If this legislation contained language defining frozen embryos as pure property, U.S. courts would then possess guidance for how to leave the safe harbor of contract law, and would be more readily able to start moving the law forward in the area of property law. Similar to the utilitarian ideals behind the British Act, a congressional mandate would enable all states to possess uniform guidelines in various areas of concern. For example, the law could require IVF facilities to apprise the frozen embryos’ biological parents of the rate of deterioration their frozen embryo(s) may experience over the course of a fixed number of years, given the current state of technology in this area. This way, the parent-owners of the frozen embryos could make well-informed, individual choices regarding when, or if, to discard them. Moreover, similar to how Britain should react in the aftermath of Ex Parte Blood, and after U.S. courts have been presented with ample opportunity to tailor their decisions in conformance with the congressional mandate, Congress could amend the statute if the courts’ pronouncements meet with waves of public discontent, or the Supreme Court could affirm the constitutionality of the existing statutes, prior to its amendment. There is no easy answer for how the United States can regulate cryogenic technology without incurring some public discontent. By attempting to regulate frozen embryos as property within a national regulatory framework, however, the United States would put itself on at least equal footing with other countries that have sought to set forward-looking guidelines for developments in this area. By shaping social policy in this manner, American society and other countries that look to the United States for guidance will indeed benefit.

112. In regard to the closely related issue of regulating the area of cloning embryos, Vice-Chairman of the Technology Subcommittee of the House Science Committee, Rep. Gutknecht of Minnesota, stated the following: [T]he one question I wanted to ask was what other countries are doing currently. . . . I hope that as this 90-day commission goes forward, that those important issues will be addressed, because this is not just an American issue. Obviously, it’s an international issue, and . . . in the end, it may well have to be addressed by some international group, whether it’s the United Nations or some special panel that’s put together. Ethics of Cloning: Hearing of the Technology Subcommittee of the House Science Committee, 105th Cong., 1st Sess. (1997) (statement of Rep. Gutknecht of Minnesota, Vice-Chairman, Technology Subcommittee of the House Science Committee). 113. As noted in the Warnock Report, “different countries are at different stages in the development . . . of a policy response. They have different cultural, moral and legal traditions, influencing the way in which a problem is tackled and the ways in which it might be resolved.” WARNOCK, supra note 57, at 6. Recognizing these differences, the Warnock Report urges that countries adopt individual remedies appropriate for their own culture. Id. Reprinted with permission from the New York International Law Review, Summer 1998, published by the New York State Bar Association, one Elk Street, Albany, New York 12207.

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