One of the plots of the Canadian science fiction thriller Orphan Black involves a scheme to create dozens of siblings by harvesting the eggs of one woman, fertilizing them with the sperm of a single man, and implanting them for gestation in dozens of apparently willing surrogates. (1) The casualness of the procedure speaks to how comfortable we have all become with reproduction by technology. Yet there are still aspects of this process that remain outside the normative boundaries of most of our worldviews. This article considers recent advances in assisted reproductive technology (ART) that can result in a viable, fertilized embryo even when the mother is herself either permanently unconscious from a severe injury or has actually lost all brain function and therefore meets the legal criteria for brain death. It reviews these advances and applies them to four scenarios, or vignettes, that represent different concerns about the prospective mother's intent to reproduce before losing her ability to give consent.
INTRODUCTION I. BACKGROUND ON ARTIFICIAL REPRODUCTIVE TECHNOLOGY A. History of the Regulation of Reproductive Technology B. History of Organ Donation C. The Law of Posthumous Conception D. Legal Obligations to Maintain a Pregnancy II. POSTHUMOUS RETRIEVAL OF REPRODUCTIVE MATERIAL A. Why Extraction of Eggs is Different from Extraction of Sperm B. Recently Reported Case of PAR Involving a Woman C. Reproductive Exceptionalism D. Financial Considerations: Who Pays? E. Transplantation of Reproductive Organs F. Separating the Dead from the Almost Dead III. SCENARIO ANALYSIS A. Scenario 1: ART Interrupted 1. Medical Analysis 2. Legal Analysis 3. Ethical Analysis B. Scenario 2: Just Starting Out Together 1. Medical Analysis 2. Legal Analysis 3. Ethical Analysis C. Scenario 3: The Single Teenager 1. Medical Analysis 2. Legal Analysis 3. Ethical Analysis CONCLUSION INTRODUCTION
Assisted reproductive technology (ART) has become what Harvard Business School Professor Clayton Christensen would describe as a "disruptive technology" because it has transformed "the way we live and work, enable[d] new business models, and provide[d] an opening for new players to upset the established order." (2) Christensen's examples are of companies that survived sweeping changes like the automobile or the personal computer--changes that destroyed other companies. (3) But these developments in reproductive medicine that make it possible for doctors and scientists to successfully extract reproductive material from women who have been declared dead or who are in a permanent vegetative state threaten to have the same kind of disruptive effect on our current understanding of human reproduction. The particular disruptive technologies here are ones that make it possible to harvest and freeze unfertilized human oocytes so that they can indefinitely be preserved for later fertilization. The extraction and freezing process can occur while the ovaries are still functioning within the body of a woman or after they are extracted and transplanted into the body of another woman.
The legal and ethical implications of this new technology make it important for lawyers, ethicists, doctors, and scientists to pause and consider creating a framework or taxonomy about how to respond to requests by family or other surrogates to retrieve unfertilized eggs from women in permanent vegetative states (in other words, women who are still alive) or women who meet the legal criteria for brain death yet remain sustained through medical equipment and technology. Although there is substantial literature about requests to harvest sperm from men who are dead, the issue is far different with women because the process is far less direct. (4) In general, men produce sperm on a continuous basis with a ready supply always available in the testicles. To retrieve the number of oocytes necessary for fertilization outside of the body, however, it is necessary to start a course of hormone therapy that induces the ovaries to make multiple eggs available for harvest.
This article considers the process of extracting, implanting, and requesting genetic material and in the context of four scenarios, outlines how medical personnel who receive these requests, and the lawyers and ethicists that medical personnel may consult for advice, should respond in the context of the current laws and norms in the United States. It develops and analyzes three scenarios involving female posthumous reproduction (PAR) that exemplify the extent to which current advances in science have outstripped any form of legal regulation and are in need, at least, of ethical guidelines. Although this state of lawlessness is in general true of many topics in ART, so far none of these cases have reached the legal system or have motivated practitioners or scholars to develop guidelines. By failing to develop legislation in anticipation of, or even in response to change, the United States has essentially ceded control of important decisions affecting fundamental constitutional rights to the doctors who must make rapid decisions about how to use these powerful innovations. This is in contrast to the decisions made by many other countries with similar access to these reproductive technologies that control their use through central regulatory bodies. (5)
This article will consider the legal, ethical, medical, and scientific issues relevant to the use of these technologies in clinical care. The intent is not to supersede medical judgment in areas of clinical care, but rather to introduce transparent guidelines so that all involved know the perimeters of what interventions are and are not legal.
Because this article is authored by a law professor who teaches and writes in the area of bioethics--Professor Jennifer S. Bard--and a research scientist who works in the area of fertility and infertility-- Lindsay Penrose, Ph.D.--this article presents a multi-disciplinary approach to what is likely to become an increasingly common dilemma as medical science becomes better able to collect and preserve unfertilized ovum for future reproduction. It will include not just a review of reported cases, but also the review of hypothetical scenarios in which a clinic might be asked to facilitate assisted reproduction with patients who are already dead and hypothetical scenarios developed based upon Dr. Penrose's experience in assisted reproduction utilizing currently available techniques in the ART laboratory.
BACKGROUND ON ARTIFICIAL REPRODUCTIVE TECHNOLOGY
History of the Regulation of Reproductive Technology
We in the United States do not, of course, live in the dystopian world of fantasy novels where women have obligations to maximize their fertility. (6) The U.S. Supreme Court has recognized that the rights of both women and men not to reproduce are as strong as those protecting the right to procreate without government interference. (7) However, the landmark cases involving childbearing occurred well before the advent of technology that permitted first the extraction of oocytes and then their fertilization outside the body. (8) The only U.S. Supreme Court case directly addressing reproductive technology is one interpreting the rights of posthumously conceived children to inherit under pension benefits. (9) The law has always lagged behind scientific and medical advances in reproductive technology. Reproductive technology today depends on advances in cryopreservation to both freeze and safely thaw reproductive material. The first successful cryopreservation was of human sperm in 1953 (10) and the next was of fertilized embryos. (11) As discussed below, the freezing of unfertilized oocytes was a considerable technological barrier that has only recently been breached. (12)
Looking at the issue as two ends of a spectrum, the gestation period required for a viable birth has been steadily decreasing with the development of medicines and machines that can sustain the life and growth of a fetus that has only experienced half of the typical gestation time in its mother's womb. Emerging as a third lane in the race to disruption are advances in transplanting ovaries from one human to another and transplanting the uterus from one animal to another. (13) At this pace, it would be irresponsible to deny that these technologies will not at some point merge into the development of a safe method of transferring an embryo at the very earliest stages of development from one womb to another. How that transfer occurs we cannot yet know, but the ability to interrupt a pregnancy at any point without harm to the developing embryo is a certainty.
History of Organ Donation
The first successful human organ transplant occurred in 1960. (14) The need for legal regulation of the process soon became clear. Individual states began passing laws to standardize both organ donation and organ distribution. These processes became standardized as states adopted the Uniform Anatomical Gift Act. (15) The National Organ Transplant Act of 1984 (NOTA) defines the term "human organ" to "mean the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation." (16) While each state has its own definition of death, all have been amended to allow a person being sustained on machines to be declared dead for the purpose of organ donations. It is also illegal anywhere in the United States to sell organs. (17)
The legal regulation of reproductive material depends on how it is classified. Sperm is not considered a tissue under these regulations because like blood (but not kidneys or hearts), sperm is replenished by the body. (18) Oocytes, on the other hand, although renewable, are regulated as tissue that can be donated. (19)
One of the legal...