ARTIFICIAL REPRODUCTIVE TECHNOLOGY

ARTIFICIAL REPRODUCTIVE TECHNOLOGY

INTRODUCTION

The rapid advances of artificial reproductive technology^[1] (ART) in the field of medical science provides increasing options to couples and individuals yearning to conceive a genetically related child.^[2] While the number of couples and individuals who may utilize ART to conceive of a child has increased dramatically over the last decade, the law regulating ART has been slow to develop and what law exists oftentimes appears inadequate.

Take for example surrogacy agreements. Although surrogacy has become a widely accepted ART technique, only one state, Florida,^[3] has promulgated legislation which distinguishes between “gestational” and “traditional” surrogacy arrangements, despite the fact that gestational surrogacy is clearly distinguishable in law and in biology.^[4] Arkansas is the only state that has passed legislation providing an unconditional presumption of validity of traditional surrogacy arrangements; their statute concludes that a child born to a surrogate mother is the child of the “intended parents” and not that of the surrogate.^[5]

Other states' laws upholding traditional surrogacy arrangements condition contract validity on the surrogate mother being unpaid and/or the non-gestating “mother” being “infertile”^[6]; as written, such laws may not apply to gestational surrogacy arrangements because the intended mother may be “fertile” to the extent that she can now donate her ovum which, when in vitro fertilized with her husband’s sperm, can be placed into the uterus of a genetically unrelated woman to incubate (gestate) the embryo.^[7] Many states have passed legislation which generally denies the enforcement of surrogacy arrangements.^[8] It is altogether unclear whether such legislation includes the distinguishable gestational surrogacy contracts.

The ever-increasing gap^[9] between ART and the field of medical science, on the one hand, and the lack of any consistent regulation of that science, on the other hand, is also evident in many other techniques of ART besides surrogacy. For example, lawmakers and the courts have struggled to define, with any consistency, the legal rights afforded an embryo; generally that determination turns on whether the embryo is considered merely property,^[10] or afforded rights of a person,^[11] or something in between.^[12] No state legislation has been promulgated concerning rights governing embryo adoption,^[13] and only one state has passed laws regulating embryo destruction.^[14]

This Article will critically examine the current status of the law as applied to the present ART techniques. Part I briefly reviews constitutional cases affecting a person's right to “beget a child”^[15] and the status of ART regulation under Title VII of the Civil Rights Act of 1964 with its pertinent amendments, and the Americans with Disabilities Act of 1990. Part II discusses ART’s biological elements and procedures, defines gametes, zygotes, embryos, the fetus and briefly describes the procedures of artificial insemination and in vitro fertilization. Part III reviews the legal status of gametes and the products of fertilization, zygotes and embryos. Part IV examines the law governing disputes over the control and ownership of cryopreserved embryos. Part V analyzes gender or sex selection of offspring.

Part VI analyzes the regulation of persons conducting in vitro fertilization, ART, embryo research, the use of embryos for clinical research, and the disposition and sale of embryos. Part VII reviews the status of surrogacy contracts and the controversies surrounding the determination of legal parenthood in traditional and non-traditional surrogacy. This Article concludes that it is not the science itself but rather how, if at all, that science should be regulated which poses the greatest challenge associated with ART. As a result, the authors believe that uniform legislation should be developed which, at a minimum, encompasses the scientific advancements made in ART and regulates that science accordingly.

I. PROCREATION AND CONSTITUTIONAL AND FEDERAL STATUTORY RIGHTS

A. Constitutional Protections

Although neither the U.S. Supreme Court nor the federal circuit courts^[16] have yet to decide a case involving a state’s ability to restrict or otherwise regulate ART, and whether such regulation would pass muster under the Constitution, arguably a person’s right to use artificial reproductive technologies to procreate is rooted in the Constitution.^[17] The first U.S. Supreme Court case to judicially recognize a constitutional right to procreate was Skinner v. Oklahoma^[18] in 1942. The Court stated that marriage and procreation are basic civil rights of man.^[19] The Court also declared procreation to be a fundamental right essential to the existence and survival of the race.^[20]

Later, Eisenstadt v. Baird^[21] held that a fundamental right of privacy regarding birth control decisions exists under the penumbra of the Bill of Rights and “liberty” in the Fifth and Fourteenth Amendments. This fundamental right is the “right of the individual to be free from unwarranted governmental intrusion into matters so fundamentally affecting a person as the decision whether to bear or beget a child.”^[22] Writing for the majority, Justice William Brennan’s sagacious use of the word “beget” likely foresaw the oncoming scientific advances in reproductive medicine.

In 1973 the Court’s decision of Row v. Wade^[23] revolutionized women’s privacy rights, holding constitutionally protected a woman’s right to determine whether to terminate her pregnancy. The first trimester strict scrutiny standard of review deflected governmental attempts to restrict women’s freedom of choice until Casey v. Planned Parenthood^[24] in 1992. Justice O’Connor, writing for the majority, held in Casey that the strict scrutiny standard of review applied to the period of non-viability of the fetus. After that time, the government’s interest in protecting the mother and child is not subject to the strict scrutiny standard of review.

Specifically addressing one aspect of artificial reproductive technology, a federal district court in Ohio observed that “the Supreme Court precedent in the field of privacy rights guarantees a woman the right to control her own reproductive functions and thus her desire to become pregnant by artificial insemination.”^[25] Thus, while neither the U.S. Supreme Court nor federal circuit courts have directly ruled on a case involving artificial reproductive technology, it appears that such a right does exist under Constitutional protections afforded an individual to procreate. As such, any attempts of government to intrude or otherwise restrict a person’s access to ART arguably will be limited by the necessity to prove a compelling governmental interest.

B. Statutory Protections Under the Civil Rights and Americans with Disabilities Acts

Congress has promulgated law prohibiting discrimination relating to procreation. The Civil Rights Act of 1964^[26] (CRA) prohibits discrimination in compensation, terms, conditions, or privileges of employment on the basis of race, religion, color, national origin, or sex.^[27] The Pregnancy Discrimination Act (PDA) of 1978,^[28] amending the Civil Rights Act, specifically applied the CRA to women’s employment rights as related to pregnancy. The PDA protects a woman’s choice to become pregnant while maintaining her position in the workforce, thereby ensuring equal opportunity in employment. As a result, any employer’s conduct adversely affecting a woman’s employment status because she chose to undergo possibly time consuming (and expensive) artificial reproductive procedures, including in vitro fertilization, would likely be prohibited under PDA. While the language of the statute appears to limit PDA to women,^[29] it is possible that a court could extend the law to apply to men desiring ART services,^[30] such as men deficient in sperm production (low sperm count) or post-vasectomy (who require a re-anastomosis of their previously ligated vas deferens^[31]).

The Americans with Disabilities Act (ADA) of 1990^[32] prohibits discrimination in employment and at places of public accommodation against a person on the basis of his or her disability. A disability is defined as a physical or mental impairment substantially limiting one or more major life activities.^[33] In Bragdon v. Abbott,^[34] the U.S. Supreme Court found infertility constituted a serious impairment of the “major life activity” of reproduction. Consequently, the Court specifically included infertility as an ADA recognized disability prohibiting discrimination and requiring reasonable accommodation.

Although relatively untested at present, the constitutional and statutory protections applicable to procreation generally will likely also severely limit any attempted governmental regulation aiming to restrict the availability of ART.

II. TERMS AND PROCEDURES OF ART

A. The Biology of ART

Before analyzing the various legal issues related to artificial reproductive techniques, it is important to understand the medical technology associated with ART; indeed, any hope of achieving consistency in the regulation of ART will require, at a minimum, generally accepted definitions of the biology of ART.

A “gamete” is a sex reproduction cell containing one-half (a haploid) of the 46 chromosomes contained in all other human body cells.^[35] Gametes are either a spermatozoa (or sperm^[36], for short) or ova (or eggs).^[37]

One sperm fertilizes one ovum. The result of this cellular fusion is a single cell known as a “zygote.”^[38] The zygote contains 46 chromosomes with half the genetic contents from the genetic female ova and half its genes from the male sperm. The zygote proceeds to multiply by cellular replication. Implantation into the wall of the uterus normally occurs four to six days after fertilization.^[39]

If fertilization is accomplished outside the body (in vitro fertilization), the cellular mass is cultured until it reaches the eight cell stage (about seventy two hours after fertilization).^[40] At this point, the cellular structure (now called a blastomere) may be placed into a uterus or into a fallopian tube in hopes that it will implant into the uterine wall and continue developing.^[41]

Alternatively, at the eight cell stage, the blastomere can be frozen in liquid nitrogen.^[42] The blastomere is also generically referred to as an embryo or pre-embryo. If frozen, the mass is generically termed a frozen embryo. The frozen embryo can later be thawed and placed into a fallopian tube or into a uterus to enable implantation and development into a human fetus. The process of development within the uterus (or womb) is known as gestation.

Medical nomenclature changes from an eight cell blastomere to a cystic blastocoele^[43] (fluid filled area with the cellular mass), and then to an embryo. Biologically the blastocoele becomes an embryo when a condensation of cells, known as the “primitive streak” appears; the primitive streak develops about ten to twelve days after fertilization.^[44]

When the developing embryo reaches a crown-rump length of five centimeters (roughly 2 inches), it weighs approximately eight grams.^[45] This occurs at the end of the eighth week and the embryo has now developed into a fetus.^[46]

B. The Procedures of ART

Procedures include artificial insemination, in vitro fertilization, and pre-implantation surgeries known as GIFT, ZIFT, and TET.^[47] Artificial insemination is the placement of semen (sperm) into the uterus opening (cervix or cervical opening) using a tube conduit (cannula).^[48] This semen may be fresh (ejaculate) or may be from previously frozen and recently thawed semen.^[49] The sperm cells in the semen travel up through the uterus and into the fallopian tubes where fertilization occurs. The fertilized ovum, now a zygote, floats back down the fallopian tube into the uterus, where it implants into the uterine wall.

“In vitro fertilization”^[50] (IVF) literally means “fertilization in a glass.” In vitro fertilization is accomplished by combining sperm and an ovum in a petri dish where fertilization occurs. When the nuclei (actually called pro-nuclei) of the sperm and the ovum have fused, a zygote has formed. This zygote made be placed into the fallopian tube using an abdominal laparoscope, a procedure known as ZIFT.^[51] TET^[52] is a procedure where an embryo, fresh or thawed, is placed into the fallopian tube through an abdominal laparoscope. Most commonly, direct embryo insertion is performed wherein the embryo is inserted through the cervix into the uterus using a cannula, just as is sperm in artificial insemination. The direct procedure does not involve an anesthetic and has almost none of the infection risk which accompany laparoscopic procedures.

III. EMBRYOS AS PROPERTY, PERSONS, OR “SOMETHING IN BETWEEN”

Although federal law appears to recognize an infertile woman’s right to procreate using ART,^[53] it is less than clear what rights, if any, fertilized (combined) gametes, i.e., those potentially capable of developing into human beings, enjoy under the law. On one level, the “building blocks” of an embryo, gametes (e.g., sperm and ova), are treated as mere “property” under the law.^[54] As a consequence, “donated” sperm relieves the male donor of all rights and responsibilities for subsequent use.^[55] However, unless the donation involves a third party intermediary like a sperm bank, a question may arise whether providing the semen specimen included the intent to relinquish all parental rights. For example, a California statute provides that the donor of semen supplied to a licensed physician for use in artificial insemination of a woman other than the donor’s wife is treated in law as if he were not the natural father of a child thereby conceived.^[56] In a case where the semen specimen provided directly to a woman for her self administered artificial insemination, the semen provider was granted paternity rights for the resulting child. The court held that the woman’s failure to utilize a physician intermediary, as provided by statute, precluded her claim for exclusive parental rights.^[57]

A. Liability of a Sperm Bank

A sperm bank exemplifies the classic third party intermediary. Although frozen sperm may be stored by the owner for possible future use, more commonly the sperm bank pays the sperm donor^[58] to provide a specimen which then becomes the property of the sperm bank. The donor signs a contract relinquishing all rights to the sperm. The sperm may be cryopreserved for future commercial sale by the sperm bank.

The sperm bank is liable in negligence for mistakes made in record-keeping when a recipient receives semen which is not that of the purported donor.^[59] In addition, the question of whether the commercial provider of the sperm also is liable for negligent infliction of emotional distress (“NIED”) for mental distress caused by insemination with semen not selected by the recipient was answered in Harnicher v. University of Utah Medical Center.^[60] The court in that case held as a matter of law that, because no physical injury occurred to the wife or child, no cause of action in NIED could lie.

The question of whether cryopreserved semen could be the subject of a devise in a Will was litigated in 1993.^[61] A divorced attorney with two adult children committed suicide and devised his cryopreserved semen to his girlfriend, accompanied by a letter indicating his intention that she produce his posthumous offspring.^[62] The court held the frozen sperm to be the decedent’s “property” and thus, subject to testamentary disposition. In so doing, the probate court specifically recognized that it was “forging new frontiers because science has run ahead of the common law.”^[63] The court went on to add that it needed “some sort of appellate decision telling us what rights are in these uncharted territories.”^[64]

B. Ova “Banks”: Now a Technological Possibility

Until recently, ova extracted from the ovaries required immediate fertilization because storage was not technically possible.^[65] When implanted into the same woman’s uterus (such as might occur in a woman with obstructed fallopian tubes), the woman would necessarily be the genetic mother and the gestational mother (the birth mother). Where the ovum is obtained by a another woman, fertilized by sperm of the intended father, and implanted into wife, the wife is the gestational/birth mother but not the genetic mother.

This latter situation presented itself in McDonald v. McDonald,^[66] a New York divorce and custody dispute. The ovum was obtained from another woman, fertilized with husband’s sperm, and implanted into the wife’s uterus. The husband claimed that, because the wife was not genetically related to the child, she was not the mother and therefore not entitled to custody or visitation rights.^[67] The court held that, because the ovum was “donated,” any rights or claims of the genetic mother were severed.^[68] Because a child can only have one legal mother, the gestational mother (the soon to be former wife) was held to be the natural and legal mother, entitled to custody and visitation rights equal to those of the father.^[69] Essential to the holding was the court’s finding of “donation” of the ovum by the egg provider.

Thus, in the past gamete Cryopreservation had been limited to sperm. Now elective cryopreservation of ova provides the ovulating female the option of cryopreserving her eggs for own future use or of donating the frozen eggs for another’s use. The procedure portends the establishment of ova banks where consumers can select preferred maternal phenotypes,^[70] just as consumers now may choose between desired sperm donor phenotypes.

C. Embryos

While male and female gametes are considered property, zygotes and embryos can be considered property, persons, or something in between property or persons. The classification applied will govern the viability of ART contracts^[71] and the rights of ownership and control of the fate of the embryo.

For example, in one case a California couple went to a Virginia fertility clinic where several of the wife’s ova were fertilized with the husband’s sperm.^[72] Two attempts at implantation were unsuccessful, and the remainder of the embryos were cryopreserved. Later the couple sought to have the frozen embryos transferred to a California fertility clinic for possible future implantation. The Virginia fertility clinic refused to transfer the couple’s frozen embryos. The court held the frozen embryos to be the “property” of the couple.^[73] As their “property,” the court ruled the couple had a right to have the embryos transferred.^[74]

This holding sustains the American Fertility Society’s Ethical Statement on In Vitro Fertilization that embryos are the “property” of the gamete providers.^[75] As such, the property owners had the right to decide, at their sole discretion, the disposition of their property.

The only State to pass legislation attempting to regulate the legal rights provided to embryos is Louisiana.^[76] It declares that embryos are “persons” entitled to all the usual protections of any “juridical person ...unless an IVF fertilized ovum fails to develop over a thirty-six hour period, except when cryopreserved.”^[77] Specifically, the statute states that the fertilized human ovum is deemed to be a biological human being “which is not the property of the physician which acts as an agent of fertilization, or the facility which employs him, or the donors of the sperm and ovum.”^[78] If the IVF gamete providers renounce, “by notarial act,” their parental rights for in utero implantation, the embryo thereby becomes available for adoption.^[79] In this circumstance, the physician becomes the temporary guardian of the embryo “person.” The physician’s responsibility to safeguard the embryo is only relieved by the court appointing a “curator” to guard the interests of the embryo awaiting adoption.^[80]

Rejecting both the property and person characterizations of embryos, many jurisdictions have adopted the “special respect” status accorded embryos by the Tennessee Supreme Court in Davis v. Davis.^[81] The Tennessee Supreme Court concluded that “pre-embryos”^[82] are not, strictly speaking, either “persons” or “property,” but occupy an interim category that entitles them to special respect because of their potential for human life.^[83] The gamete providers have an ownership interest in that they have decision-making authority concerning disposition of the embryos, within the scope of the applicable law. This position appears to give courts of equity maximum flexibility in deciding the difficult issues of, among others, ownership and disposition of embryos.

IV. LIABILITY RESULTING FROM THE CONTROL AND OWNERSHIP OF CRYOPRESERVED EMBRYOS

The potential liability resulting from the control and ownership of embryos may turn on the legal status afforded to an embryo. For example, if an embryo is treated as mere “property,” the gamete providers perhaps may have a cause of action for conversion for the mishandling of the embryo. If, on the other hand, the embryo is deemed a “person,” there may be a cause of action for injury or destruction of the embryo under the same common law theory as damages for mishandling the body of a close relative.

Some courts appear to avoid the issue altogether. In one case, a Virginia couple brought a cause of action for negligent infliction of emotional distress when their newly created embryos were washed an with albumin solution contaminated with the virus of Creutzfeldt-Jakob disease.^[84] An FDA letter directing withdrawal of the albumin had been overlooked by the IVF clinic.^[85] Washing the embryos in the contaminated albumin rendered the embryos unusable. The district court held that, because the Plaintiffs themselves had not sustained physical injury, there was no cause of action for negligent infliction of emotional distress.^[86]

Other courts have recognized a cause of action for emotional distress for the mishandling or destruction of embryos. Indeed, the first purported attempt in America at IVF and embryo freezing occurred in the early 1970s at no less a prestigious institution than Columbia Presbyterian Hospital in New York.^[87] Believing that IVF was unethical and immoral, the department chair unilaterally destroyed the embryo when he learned of the planned implantation. He did this on his own initiative and without notice or consultation with the couple or the doctors involved. A year later, the couple sued the department chair and Columbia Presbyterian for intentional infliction of emotional distress. This ignominious inauguration of frozen embryo IVF in America resulted in the jury awarding the couple $500,000 in damages.^[88]

Oftentimes embryos become the subject of dispute between the two gamete providers. Two state supreme courts have ruled on the ownership and control of cryopreserved human embryos in divorce settings. In 1992, the custody of the frozen embryos of Junior and Mary Sue Davis was decided by the Tennessee Supreme Court.^[89] The court held that, absent prior agreement of the embryos’ disposition, the male gamete provider has equal rights to determine the fate of the couple’s frozen embryos.^[90] The court reasoned that the male gamete provider husband had no right to demand their embryo be implanted into his wife.^[91] Likewise, the female gamete provider had no right to require the male gamete provider to become a father.

While Mary Sue initially had wanted the embryos for her own future use, by the time the court heard the case she had changed her mind and professed a desire to donate the embryos for adoption by another couple. The court weighed Junior Davis’s interest in avoiding parenthood against Mary Sue’s interest in donating the embryos to another couple for adoptive implantation. The Tennessee Supreme Court concluded that disputes involving the disposition of embryos produced by IVF and preserved should first be resolved by the gamete providers.^[92] Absent that resolution, their prior agreement should control. In the event there was no prior agreement, the interests of the parties should be balanced. Assuming the other party has a reasonable possibility of achieving parenthood by means other than by using the disputed embryos, the party wishing to avoid procreation should prevail.^[93] Thus, Junior Davis was granted ownership and control of the frozen embryos.^[94]

In a very recent case, New York’s highest court faced a situation similar to that in Davis. In Kass v. Kass,^[95] the former wife demanded sole custody of five frozen embryos and contended that “these were her only chance for genetic motherhood.”^[96] The former husband objected to the burdens of unwanted fatherhood. A woman’s constitutional autonomy was implicated only upon pregnancy with the implanted embryo. The New York Court of Appeals agreed with the Davis holding that the parties’ pre-IVF agreement controls.^[97] Thus, per this prior written agreement, the embryos were donated to an IVF program where they could be used for legitimate research purposes.

The status of embryos of decedents received notoriety when a California couple died in a plane crash leaving behind several frozen embryos.^[98] The couple died intestate, leaving an estate valued at eight million dollars. The Australian government, having jurisdiction over the embryos, ultimately decided that the embryos could be donated for adoption without any rights of inheritance.^[99]

Inconsistent with this decision is California Probate Code section 6407 which states that “relatives of the decedent conceived before the decedent’s death but born thereafter inherit as if they had been born in the lifetime of the decedent.”^[100] An embryo conceived during the decedent’s life but implanted some months or years later would appear to have the rights of a pretermitted heir. This issue has not yet been litigated, but such child resulting from previous frozen embryos appear to have standing to test the statute.

No state has regulated or proscribed embryo donation for adoption. Indeed, this has been the source of triplets for one New Jersey couple.^[101] The fate of embryos not donated for adoption, but abandoned by their progenitors, is less certain. Some scholars believe that if embryos are considered property, the state laws of abandoned personal property should apply to determine the fate of the embryos.^[102]

Great Britain assumed governmental control over frozen embryos when promulgating a law^[103] providing for the destruction of abandoned embryos. The British government announced that three thousand frozen embryos more than five years old,^[104] unclaimed by August 1, 1996, would be destroyed. Italian doctors offered to purchase and transport these embryos to Italy for implantation into women willing to receive them.^[105] The Catholic Church denounced the planned destruction as “prenatal massacre.”^[106] On August 1, 1996, the British destroyed the three thousand embryos as scheduled. Britain has subsequently amended its law to require ten years of abandonment mandating embryo destruction. However, Britain has not recanted from its position of governmental control of abandoned embryos.^[107]

In contrast, the state of Louisiana has provided the destruction of frozen embryos to be unlawful.^[108] Under Louisiana law, the control over the frozen embryo vests in the IVF physician as the temporary guardian of the embryo, if the parents do not assume that responsibility. This control and stewardship of the frozen embryo continues until either adoptive implantation occurs, or the court appoints a “curator” for the embryo who then controls the fate of the embryo.^[109] Frozen embryos may not be destroyed under the Louisiana statute.^[110]

V. GENDER OR SEX SELECTION OF OFFSPRING

Selective pregnancy reduction, a medical procedure used in multiple pregnancies, has been used to select the gender of the fetus brought to birth. The euphemistic “selective pregnancy reduction” can more honestly and accurately be labeled sex or gender selection abortion.^[111] There is an intuitive disfavor accompanying this mode of gender selection. Fortunately, an advance in ART apparently will render the offensive practice obsolete. Scientists in 1996 published articles on the availability of a technique to separate sperm of mammals into those carrying an X chromosome and those containing a Y chromosome.^[112] In February of 1998, a group of Spanish scientists demonstrated that the fluorescent in-situ hybridization (FISH) technique would produce 80 to 90% purity for X spermatozoa and 60-70% for Y spermatozoa.^[113]

This remarkable advance resulted in the Genetics and IVF Institute, based in Fairfax, Virginia, reporting an 85% success rate in selecting girls (13 of 14 pregnancies) and a slightly lower rate of success in those desiring male fetuses.^[114] One obvious benefit of this procedure is that it enables parents to avoid having children with sex-linked or X-linked diseases, such as common hemophilia and a progressive blindness known as X-linked retinitis pigmentosa, simply by selecting female offspring. Among the troubling aspects of this new technique is a strong preference in some cultures for male offspring and the social disruptions this may engender. The authors foresee a plethora of scholarly articles in the near future regarding the ethical and moral aspects of gender selection using this new ART technology.

V. REGULATION OF IN VITRO FERTILIZATION, EMBRYO RESEARCH, AND THE DISPOSITION AND SALE OF EMBRYOS

A. Federal Regulation

In 1992, the Fertility Clinic Success Rate and Certification Act became effective. The Act requires ART clinic programs to report their success rates to the Centers for Disease Control (CDC) by sending the data through the Department of Health and Human Services. Standards for reporting pregnancy success rates are to be established by the CDC. In the past, voluntary reporting often led to exaggerated claims of success. These success rates are to be made available by the CDC to the general public. Thus, the public desiring ART would have a more accurate prediction of the chances to obtain a live baby.

Another provision required the CDC to develop a model program for the certification of IVF laboratories, which could be adopted by each state. Certification would theoretically maximize the quality of IVF, assure consistent application of established procedures, and guarantee accurate reporting.

Unfortunately, the program lacked implementation funding until 1996, when a mere one million dollars was allocated by HHS to the CDC. While the work has begun, to date there have been no model regulations promulgated or reports of clinic success available from the CDC.

Federal funding for embryo research has run onto a regulatory brick wall. In 1993, the National Institutes of Health Revitalization Act^[115] provided for the elimination of the HHS Ethical Advisory Board. While the Board had specifically concluded that embryo research was theoretically ethical, NIH never allocated any funds for embryo research. Elimination of this Board evidently was a signal to NIH to proceed with funding embryo research experiments. Ever cautious and politically prudent, NIH convened another group of experts, the Human Embryo Research Panel,^[116] consisting of experts in the fields of medicine, law, ethics, and public policy. On the basis of this panels recommendation to fund embryo research, including intentionally creating embryos solely for research purposes, the Advisory Committee to the Director of the NIH advised the NIH Director to begin funding research. In response, President Clinton directed the NIH not to allocate any funds for embryo research. Subsequently, Congress passed Public Law 105-78^[117] statutorily prohibiting the use of federal funds for embryo research of any kind, including destroyed, discarded, or otherwise unusable embryos. Thus, while the law proscribes the use of federal funds for embryo research, there is no federal legislation regulating embryo research in the private sector. As a result, whatever beneficial results are distilled from private sector embryo research are likely to cost the American public a great deal more due to commercial patents.

B. State Regulation

All three of the state statutes criminalizing embryo experimentation which have been challenged in federal court have been held unconstitutional. The Fifth Circuit examined a Louisiana abortion statute criminalizing experimentation on any embryo or fetus unless such experiments were therapeutic.^[118] The Court found the terms “experiment” and “therapeutic” to be unconstitutionally vague.

The Tenth Circuit Court of Appeals reviewed a federal district court decision invalidating a Utah statute criminalizing embryo or fetus experimentation on grounds that the use of the terms “experimentation” and “benefit” were unconstitutionally vague. Finally, the Northern District of Illinois held the failure to define the term “therapeutic” in the Illinois statute criminalizing embryo experimentation rendered it unconstitutionally vague.^[119]

Subsequently, Louisiana^[120] and Pennsylvania^[121] passed laws criminalizing embryo experimentation, all containing more specific definitions of the terms previously declared vague. North Dakota^[122] and Rhode Island^[123] both maintain statutes criminalizing aspects of embryo experimentation. These statutes have not been subject to federal court constitutional challenges.

Florida,^[124] Massachusetts,^[125] Michigan,^[126] and Minnesota^[127] ban non-therapeutic embryo research. New Hampshire explicitly limits the maintenance of non-frozen embryos outside the uterus to fourteen days and prohibits the transfer of research embryos to a uterine cavity.^[128]

Seven states and the District of Columbia specifically prohibit the sale of embryos.^[129] Georgia permits payment for embryos to be used for health services education.^[130] Michigan and Rhode Island prohibit payment for unlawfully used or transferred embryos.^[131] Four other states specifically prohibit the sale of embryos for research purposes.^[132]

The regulation of ART has been lax, consistent with an apparent fundamental procreation “right of access” to ART. The U.S. Supreme Court has not yet ruled whether procreational privacy rights extend to the non-coital procedures of Artificial Reproductive Technologies. Assuming these rights apply to non-coital reproduction, one would expect the Supreme Court to extend the onerous strict scrutiny standard of review to governmental regulation.

Few states have attempted general regulation of ART. The most benign attempt is Pennsylvania’s requirement that ART clinics file reports on the number of personnel employed, and the number of eggs fertilized, implanted, and discarded at any given clinic site.^[133] Virginia and Massachusetts require written informed consents signed by ART patients before ART can be undertaken. These consents must contain information specifying the success rates of the particular clinic.^[134]

C. Industry Self-Regulation

Self-regulation has occurred primarily through the American Society for Reproductive Medicine.^[135] This organization developed laboratory guidelines and clinical standards which members are expected, but not required, to follow. Membership, as well as adherence to the promulgated guidelines, is voluntary. The Director of the CDC, Dr. William Roper, testified^[136] that ninety percent of clinics were voluntarily reporting their success rates as of 1991. However, the system lacks an audit mechanism assuring the accuracy of reported data.^[137]

VII. Surrogacy

A. Traditional Surrogacy Contracts

Traditional surrogacy^[138] involves a contract between an infertile couple (H and W, for example) and a fertile woman (surrogate). In the traditional surrogacy contract, the surrogate agrees to be inseminated with husband’s sperm and to carry the pregnancy to term. After the birth of the baby, the surrogate promises to relinquish all rights to the baby, transfer the baby to H and W, and facilitate the wife’s adoption of the baby.^[139] For this, all the surrogate’s expenses are paid by H and W in addition to a fee for the surrogate’s services. These traditional surrogate contracts have not been well received in the common law courts.

The first case to reach a state supreme court occurred in 1988, in In re Baby M.^[140] The court was asked to determine the validity of a contract providing a new way to bring a child into a family. In addition to expenses, the surrogacy contract provided for a fee of $10,000.00 for the woman’s services. For this consideration, the woman promised to be inseminated with the contracting party husband’s sperm and to carry the conceived child to birth. She promised to then deliver the child to the husband-father, and assist with any formalities of adoption by the wife. However, after the child was born, the gestational mother refused to honor the contract and demanded custody of their child. The husband and wife sued for specific enforcement of the contract.

The trial court held that New Jersey statutes governing adoption, termination of parental rights, and the prohibition of the payment of money in connection with adoption did not apply to surrogacy contracts.^[141] The trial court held the surrogacy contract valid and ordered specific performance of the contract.^[142] The trial court granted the husband sole custody of the child,^[143] severed parental rights of the surrogate, and granted adoption of the child by the wife.^[144]

On appeal, the New Jersey Supreme Court reversed. The Supreme Court invalidated the surrogacy contract, holding that it conflicted with the same laws the trial court found inapplicable. Furthermore, the Supreme Court held that the payment of money to a surrogate mother was illegal, contrary to public policy, and potentially “degrading to women.”^[145] While the Court granted custody to the father, it voided the mother’s parental rights, and the wife’s adoption of the child, and declared the surrogate to be the child’s natural and legal mother.^[146] However, the Court stated that where a woman “voluntarily and without payment agrees to act as a surrogate, provided she is not subject to a binding agreement to surrender her child, no New Jersey law is offended.”^[147]

A few years later, a California Fourth District Court of Appeal ruled on the validity of “traditional surrogacy” contracts in California.^[148] First, the court distinguished traditional surrogacy from an earlier California Supreme Court case addressing “gestational surrogacy.”^[149] The court of appeal relied on the California Family Code requirement that consent for adoption be given in the presence of a licensed social worker.^[150] Because traditional surrogacy contracts necessarily are entered into before the child is born, they could not comply with the California Family Code provision. Consequently, traditional surrogacy contracts are invalid in California.^[151] Of course, a voluntary relinquishment of parental rights by the mother after the child’s birth, in compliance with the Family Code, would be permitted because the elements of a statutory adoption would be satisfied.

The settled common law provides that traditional surrogacy contracts are invalid or unenforceable. Slight unsettling of the common law occurred in the 1998 Connecticut Supreme Court case of Jane Doe v. John Doe.^[152] The couple’s advertisement for a surrogate in their local newspaper resulted in a woman’s agreement to serve as their surrogate.^[153] Of consequence was the fact that the surrogate was also married and living with her husband at the time.

Not a couple to waste perfectly good medical insurance premiums, John frequently accompanied the surrogate to her pre-natal doctor visits where the surrogate assumed Jane’s identity, using Jane’s name and Jane’s social security number. Upon admission to the hospital for delivery, the surrogate identified herself as Jane and the birth certificate indicated Jane’s name as the mother. True to her bargain, the surrogate delivered the baby to John and Jane upon leaving the hospital, never to bother the couple again.

The apparently successful ruse terminated when Jane filed for divorce and requested custody of the now fourteen year old child. John countered with the uncontested fact that Jane was not the genetic mother and that Jane had never adopted the child. The trial court held that the child was not an issue of the marriage and thus it had no subject matter jurisdiction to determine the custody dispute between John and Jane.

To complicate matters, the surrogate was married and living with her husband during the course of the pregnancy and delivery. Connecticut law provides that a child born to a married woman living with her husband is a presumed child of the (surrogate’s) marriage. The trial court concluded that this presumption had not been rebutted by the requisite clear and convincing evidence. At that point, it appeared that neither John nor Jane could be declared the child’s legal parent.

After the trial court’s ruling that the child was not a child of John and Jane’s marriage, John brought a motion in probate court to be declared the child’s father and to sever any (now uncontested) parental rights of the surrogate and her former husband. This motion was granted by the probate court. The trial court subsequently ruled that it, the trial court, did not have jurisdiction to decide custody and thereby accepted the probate court’s action. Thus, the trial court recognized the child’s custody to be with the father by default.

On appeal, the Connecticut Supreme Court reversed and concluded that the trial court did have subject matter jurisdiction over the custody matter. Further, the Court found the statutory presumption of a child’s best interest to be with the natural parent did not apply. The case was remanded back to the trial court for a determination of child custody solely based on the best interests of the child.^[154] While specifying that Connecticut’s equitable parent doctrine did not apply to the facts of this case, the court strongly suggested that the wife should receive custody of the child. This, of course, is exactly the application of the equitable parent doctrine.

This case suggests that the invalidity of traditional surrogacy contracts does not preclude the non-gestational, non-genetically related wife from gaining custody of the child.^[155] This is, indeed, new law. The Court here suggests that the best interests of the child test trump all common law and statutory law. Evidently, the court would vest complete equity power in the trial courts as regards child custody whether or not the child is an issue of the marriage.

The next year, 1998, the Connecticut Supreme Court became the subject of another controversial holding. In Mary Doe v. John Roe,^[156] the Supreme Court ruled on whether the Superior Court (general jurisdiction trial court) had subject matter jurisdiction to render judgment in accordance with a stipulated agreement reached in Probate Court. That post-baby birth settlement agreement included a promise by the traditional surrogate mother to consent to the termination of her parental rights for additional consideration over that provided in the traditional surrogate contract.