The Suleman Octuplet Case: An Analysis of Multiple Ethical Issues

Women’s Health Issues 20 (2010) 260–265

www.whijournal.com

Policy matters

The Suleman Octuplet Case: An Analysis of Multiple Ethical Issues M. Sara Rosenthal, PhD * Program for Bioethics, Department, Internal Medicine, University of Kentucky, Lexington, Kentucky Article history: Received 14 October 2009; Received in revised form 6 April 2010; Accepted 6 April 2010

a b s t r a c t The Suleman octuplet case is the first reported case in which surviving octuplets were born as a result of in vitro fertilization and embryo transfer. In this case, the octuplets were born to an American single mother of six children, who was on public assistance, and who used a sperm donor. This has raised multiple ethical questions, which include the ethical obligations of the health care providers involved, the informed consent process, as well as moral obligations of the mother to her existing children and unborn children. This case analysis provides a clinical ethics and prenatal ethics framework, based on relevant American media and public documents available from January 26, 2009, to January 26, 2010, the period of time in which media scrutiny of this case was most relevant. Although this analysis introduces broader ethical implications, it is not intended as a philosophical discourse regarding the rights of patients to reproduce or the rights of society to place limits on who can and who cannot reproduce; neither is it intended as an in-depth policy review of reproductive technologies. Rather, this analysis focuses on clinical ethics breaches in this particular case, which led to an unintended outcome. The relevant clinical ethical principles, duties, and obligations are identified, with recommendations for a preventative ethics approach in the absence of clear policies that regulate embryo transfer. Copyright Ó 2010 by the Jacobs Institute of Women’s Health. Published by Elsevier Inc.

Introduction The Suleman octuplet case demonstrates breaches of ethical duties on the part of the fertility specialist, which is the focus of this analysis. Such ethical breaches eventually led to the fertility specialist involved to be charged by the California Medical Board with ‘‘gross negligence’’ (Mohajer, 2010). The ethical principles discussed in this case center on autonomy, beneficence and nonmaleficence. Autonomy obligates the physician to respect patients’ rights to self-determination, guided by their stated wishes, preferences, and values. Beneficence refers to a physician’s obligation to maximize clinical goods and minimize clinical harms. Beneficent-based obligations recognize limits to patient autonomy when patients ask for medically inappropriate procedures. The doctrine of informed consent supports both autonomy and beneficence. When patients cannot provide genuine informed consent, they require special protections; in these cases, medical decisions should be made using a beneficence framework. * Correspondence to: M.S. Rosenthal, PhD, Program for Bioethics, Department, Internal Medicine, Suite K522, University of Kentucky, 740 South Limestone Street, Lexington, Kentucky 40536-0284. Phone: 859-257-9474; fax: 859-2572605. E-mail address: [email protected]

Nonmaleficence refers to a physician’s obligation not to intentionally, or negligently, cause harm. The Suleman case also raises several issues that relate to the principle of Justice, such as access to in vitro fertilization (IVF), the societal burden of highorder multiple (HOM) pregnancies, and resource allocation. These issues are beyond the scope of this particular analysis, which focuses on the physician–patient relationship. To explore this case, a prenatal clinical ethics framework is used. The facts of the case were collected through a review of relevant media (Tables 1 and 2) and public documents from January 26, 2009, to January 26, 2010. This analysis is limited to the facts from the public record; no live interviews were conducted with any party connected to this case. This analysis concludes with preventive ethics recommendations in the absence of policy. Background The medical risks involved with HOM pregnancies and births have been well documented in the prenatal and pediatric literature (Ahner et al., 2001; American Society for Reproductive Medicine [ASRM], 2008; Hack et al., 2002; Schieve et al., 2002; Schieve et al., 1999). For these reasons, most countries with government-sponsored IVF have developed legislation reflective

1049-3867/$ – see front matter Copyright Ó 2010 by the Jacobs Institute of Women’s Health. Published by Elsevier Inc. doi:10.1016/j.whi.2010.04.001

M.S. Rosenthal / Women’s Health Issues 20 (2010) 260–265 Table 1 Broadcast Media Reviewed (Listed Alphabetically) Program

Air Date

Dateline, NBC. (2009). Interview with Nadya Suleman. Dr. Phil, Paramount Pictures. (2009). Octuplet Debate. Dr. Phil, Paramount Pictures. (2009). Octuplet Scandal. Dr. Phil, Paramount Pictures. (2009). Octuplets’ Mom Talks to Dr. Phil. Dr. Phil, Paramount Pictures. (2009). Octuplets’ Mom Talks to Dr. Phil, Part 2. Larry King Live, CNN. (2009). Dr. Phil on Octuplets. Oprah, Harpo Productions. (2009). Interview with Ed Doud. The Today Show, NBC. (2009). Interview with Gloria Allred.

February February February February

10, 11, 12, 25,

2009. 2009 2009 2009

February 26, 2009 February 27, 2009 February 19, 2009 March 25, 2009

of a ‘‘preventative ethics’’ model that encourages a beneficent approach to IVF therapies. There is wide consensus that the best outcome for an IVF patient is the birth of a single baby through single embryo transfer (ET; Veleva, Karinen, Tomas, Tapanainen, & Martikainen, 2009); the birth of healthy twins is considered a reasonable outcome; however, the risks of prematurity or other complications with twins are still considerable (Campbell & Templeton, 2004; Hamersley, Coleman, Bergauer, Bartholomew, & Pinckert, 2002; Khan, Indrees, Palamarchuk, & Dawlatly, 2008; Skupski, Chervenak, & McCullough, 2007). Pregnancy with triplets or more is considered by many fertility specialists to be an undesirable consequence, given the gravity of risks and harms to both the mother and the developing fetuses (ASRM, 2008). There is general consensus that creating a pregnancy in which selective reduction (Chervenak & McCullough, 1992; Wapner et al., 1990) needs to be considered is an unfortunate consequence of IVF that should not be encouraged (Assisted Human Reproduction Canada, 2009; ASRM, 2008; Human Fertilisation and Embryology Authority, 2009). The first country to regulate fertility treatment was the United Kingdom. The Human Fertilisation and Embryology Authority were formed in 1990, and regulates IVF treatment, including ET. In Canada, Assisted Human Reproduction Canada is the federal regulatory agency responsible for controlling ET, and ensuring compliance with the 2004 Canadian legislation known as the Assisted Human Reproduction Act (Assisted Human Reproduction Canada, 2009). Several European countries have similar regulatory agencies (Sorenson, 2006). The United States, however, does not have regulation regarding this issue. Although the ASRM publishes clinical practice guidelines, it states: ‘‘Strict

261

limitations on the number of embryos transferred, as required by law in some countries, do not allow treatment plans to be individualized . . . accordingly, these guidelines may be modified, according to individual clinical conditions’’ (*ASRM, 2008). Thus, American fertility clinics utilize an ‘‘innovative therapy’’ model for managing infertility patients, and are not legally obligated to follow a mandated standard of care. Despite regulations and guidelines, the ethical obligations of physicians to their infertile patients remain unchanged. Regardless of the number of embryos any particular practitioner judges appropriate to transfer, the doctrine of informed consent and the ethical principles of autonomy and beneficence require a clear duty of care to both the mother and her potential children, when the mother presents her potential children as patients (Chervenak & McCullough, 1995, 1996, 1997, 2001, 2003; Chervenak et al., 2003; McCullough & Chervenak, 1994, 2008). The first publicized case of a natural HOM birth was the Dionne quintuplet case (Canada, 1934). In this case, the quintuplets essentially became the property of the Canadian government, which made them wards of the state, and exploited the five girls, using them as tourist attractions (Dionne, Dionne, & Dionne, 1997; DePalma, 1998; Soucy, Dionne, & Dionne, 1997). Louise Brown (England, 1978) was the first child born through IVF technologies, and thereafter, multiple births have increased precipitously due to superovulation with fertility drugs for IVF (Klotzko, 1998). The first publicized octuplet pregnancy was the Mandy Allwood case (England, 1996). Allwood became pregnant with an HOM as a result of fertility drugs, and was offered $1 million dollars to carry the fetuses to term by a British tabloid (Caplan, 1997). Allwood ignored her doctor’s advice to undergo selective reduction, and attempted to carry all eight fetuses to term; the pregnancy ended traumatically in the third trimester with all eight dying over a period of consecutive days (Adams, 2002). Successful HOM births include the McCaughey septuplets (United States, 1997), two of whom have cerebral palsy (Klotzko, 1998; Lemonick, 1997); and the Chukwu octuplets (United States, 1998), which resulted in one neonatal death (Lyman, 1998). The most common health problem with HOM births is extremely low birth weight, defined by a birth weight of less than 1,500 grams. In both the McCaughey and Chukwu cases, each infant had extremely low birth weight. Consequently, the ASRM revised its guidelines in 2008 on ET with the explicit purpose of reducing the number of HOM pregnancies (ASRM, 2008). Ultimately, the trend toward regulating IVF and ET recognize there are wider ethical issues at stake, including the welfare of children (European Society of Human Reproduction and Embryology Task Force, 2007; Purdy, 1996, 2007).

Table 2 Web-Based Media Reviewed URL

Accessed

Grandma: Octuplet http://www.radaronline.com/ February 16, 2009 Doc Promised He exclusives/2009/02/grandmaWouldn’t Do In octuplet-docpromised-heVitro. wouldnt-do-in-vitro.php. Grandma Blasts http://www.radaronline.com/ February 16, 2009 Octuplet Mom: exclusives/2009/02/grandma‘‘Nadya’s Not blasts-octupletmom-nadyasCapable’’. not-capable.php. ‘‘I screwed up my http://www.radaronline.com/ June 4, 2009 life.’’ exclusives/2009/06/worldwideexclusive-octo-momsanguishi-screwed-myself-i-screwedmy-life-my-kids

Facts of the Case On January 26, 2009, Nadya Suleman (the mother), a 33-year old, single mother of six children (all born through IVF provided by the same physician), gave birth prematurely to the first surviving set of octuplets, the consequence of an ET of six embryos created from the mother’s eggs and donor sperm. The existing children were all under 7 years of age; one has autism and two have been diagnosed with attention deficit hyperactivity disorder. The single mother lived with her parents, relied on her parents’ income, and received public assistance. The hospital would not release any of the octuplet newborns into the mother’s custody unless a more suitable home could be found.

262

M.S. Rosenthal / Women’s Health Issues 20 (2010) 260–265

The mother stated she refused to have selective reduction, despite knowing the risks of significant morbidity associated with preterm delivery. At 23 weeks gestation, severe pain prompted a call to emergency services that resulted in an admission to Kaiser Permanente Bellflower Medical Center in California; it is not clear whether the mother had sufficient health insurance to cover the hospital medical bills. According to statements made by the hospital, the efforts of the health care team stabilized her pregnancy until 31 weeks, when a group of 46 doctors, nurses, and surgical assistants attended to the birth. The birth was announced through a press conference, with the permission of the mother. Shortly after the birth, the fertility specialist involved was revealed to be Michael Kamrava, an ASRM member. After an investigation into his clinical practice, the ASRM’s disciplinary committee expelled Kamrava from its membership (Yoshino, 2009). The California Medical Board charged Kamrava with ‘‘gross negligence’’ in 2010 (Mohajer, 2010). Ethical Analysis Using the prenatal clinical ethics framework developed by McCullough and Chervenak (2008; Chervenak & McCullough, 1995, 2001; Chervenak et al., 2003), the mother’s values and preferences establish whether the embryo or fetus is a ‘‘patient’’ in which dependent (rather than independent) moral status is granted. Within this clinical ethics framework, when the mother presents the embryo or fetus for moral consideration as a ‘‘patient,’’ it is a ‘‘patient’’ requiring a beneficent approach, where clinical harms are minimized and clinical benefits are maximized. Although the concept of embryonic/fetal ‘‘patienthood’’ has been misread by critics for implying moral equivalency between the autonomous mother and the unborn child (Brown, 2008; Lyerly, Little, & Faden, 2008; Strong, 2008), McCullough and Chervenak correct their critics (McCullough & Chervenak, 2008) and reassert that in any discussion of embryo/fetal patienthood, we are first dealing with ‘‘dependent’’ moral status granted by the mother. This not the same as independent moral status granted by society irrespective of the mother. In the ‘‘patienthood’’ framework, the mother decides whether the embryo/fetus is to be presented as a patient, and thus morally considered. ‘‘Patienthood’’ status is thus an extension of the mother’s autonomous wishes, and merely clarifies in a perinatal setting whether the physician has an obligation of beneficence to the embryo(s)/fetus or not. When the fetus/embryo is a patient, this does not mean granting independent moral status or moral equivalence to the embryo/fetus, where the embryo/fetus’s interests are equal to the mother’s. Rather, patienthood status respects the mother’s wish for the doctor to maximize benefits and minimize harms to her embryo/fetus, and not automatically assume the embryo/fetus is morally inconsequential. The concept of embryo/fetal patienthood ‘‘responds to and deals practically with the full spectrum of clinical reality in perinatal medicine’’ when no other frameworks ‘‘come anywhere close to accomplishing this important clinical reality’’ (McCullough & Chervenak, 2008). When the mother does not grant ‘‘patienthood’’ status, as in cases where she wishes to terminate pregnancy, the embryo/fetus is not morally considered until viability. In this case, because the mother stated that she regarded the frozen embryos as ‘‘[her] children’’, the embryos are clearly presented to the physician as ‘‘patients,’’ which obligates the health care provider to treat the embryos as ‘‘patients’’ from the

outset. This establishes the clinical parameters for offering beneficent care, while upholding the principles of nonmaleficence. The mother’s values thus guide clinical management, but beneficence-based obligations restrict the practitioner from operating outside an accepted standard of care that would introduce unnecessary risks to the mother or embryos. Aggressive ET and Refusing Inappropriate Patient Requests The mother stated she had wanted all six embryos transferred; it remains unclear whether the mother specifically made this request or selected this option only after it was offered to her. In either scenario, under a beneficent framework, the transfer of six embryos into this particular patient was medically unsound and inappropriate, and even ‘‘egregious’’ (Chervenak & McCullough, 2009). If the mother made the request, the fertility specialist ought to have refused the request on beneficencebased grounds. Other grounds for refusing fertility patients’ risky requests include professional integrity (Chervenak & McCullough, 2009), extreme barriers to parental fitness (Minkoff & Ecker, 2009), and conscientious objection (Strong, 1999). Moreover, ET can be refused on autonomy-based grounds because such requests run counter to the presumed preferences of the mother: To have a healthy child and to remain healthy herself. If the fertility specialist made the offer to the patient, he violated the principle of nonmaleficence by greatly increasing the chance for a multiple pregnancy, which poses risks to the mother and fetuses, even for twins (Campbell & Templeton, 2004; Hamersley et al., 2002; Khan et al., 2008; Skupski et al., 2007). The California Medical Board’s ‘‘gross negligence’’ charge indeed relates to violations of this principle (Mohajer, 2010). The Absence of Informed Consent Using clinical ethics criteria to evaluate informed consent in this case (Etchells , Sharpe, Walsh, Williams, and Singer, 1996c), the request to be made pregnant a seventh time must start with a thorough informed consent process, which cannot ignore psychosocial factors given that the patient has obligations to her existing children. Notwithstanding a libertarian approach, the argument that a patient’s financial and psychosocial circumstances are completely irrelevant to the therapeutic relationship involved with fertility treatment is flawed, because the clear ethical duty of beneficent care in this situation requires the fertility doctor to assess financial and psychosocial fitness of the patient and her ability to care for her existing six, and potentially seven or more children. Assuming the public record is correct, there are only two likely scenarios. In the first scenario, the patient requests all six embryos be transferred; in the second, physician gives the option. In either scenario 1 or 2, the physician must assess whether this patient can both physically and psychosocially endure a potentially high-risk, HOM pregnancy and related consequences (ASRM, 2008; Schieve et al, 2002; European Society of Human Reproduction and Embryology Task Force, 2007). Because the physician has a dual obligation to both the mother and the developing offspring (Chervenak & McCullough, 2003; Fleischman, Chervenak, & McCullough, 1998), this information informs and guides clinical management.

M.S. Rosenthal / Women’s Health Issues 20 (2010) 260–265

Any definition of ‘‘informed consent’’ provides that all risks be disclosed (Etchells, Sharpe, Burgess, & Singer, 1996a; Etchells Sharpe, Walsh, Williams, & Singer, 1996c), which would include the risk of terrible hardship and financial disruption should there be a HOM birth, even if this was presumed to be a small risk. Any appropriate informed consent also means that the consequences and options available must be discussed, should a HOM pregnancy result. This means that the discussion of selective reduction must be included in the informed consent process. A prospective mother’s attitude about selective reduction is critical for the physician to assess whether to take an aggressive or more conservative approach regarding the number of embryos used for ET (Chervenak, McCullough, & Rosenwaks, 2001). Given that the mother has stated opposition to abortion and selective reduction, the only two possibilities here are that it was never discussed until the HOM pregnancy was discovered or the mother initially agreed she would do it in the unlikely event of HOM, and changed her mind. In the only other possibilitydthat it was discussed and the mother refusedd considering the expressed opposition to this procedure by the mother, it would be difficult to ethically defend the transfer of a great numbers of embryos. However, even with a proper consent process, there is always the possibility that once pregnant, a patient may change her mind, which should be considered a risk of HOM pregnancies in general, and why avoidance of HOM pregnancies is a critical concept in ethical management of IVF patients. Strong (1999) states that physicians should refuse a patient’s request for aggressive ET if the mother refuses to agree to selective reduction in advance. Decision-making capacity (Etchells, Sharpe, Elliott, & Singer, 1996b) is another crucial component of the doctrine of informed consent, which is designed to protect patient autonomy, and, in particular, protect patients from making decisions that could lead to undesirable, harmful, or catastrophic outcomes to them or others. Appropriate decision-making capacity means that the patient demonstrates understanding and appreciation of her circumstances, as well as evidence of rationality in arriving at her decision (Dickens & Cook, 2004; Etchells et al., 1996b; Hull, 2002; Jones, McCullough, & Richman, 2005; Loewy, 2005; Meyers, 2004; Tauber, 2003; Veatch, 1995). In this case, there are serious questions about the mother’s decision-making capacity (Tables 1 and 2), with documented complaints by mandated reporters that this mother is unfit to look after her children (Table 1; Scruby, 2009). The mother states that she regrets having made the decision to have aggressive ET, and indicated she did not understand or appreciate that this outcome was a possibility. Decision-making capacity operates on a sliding scale that permits lesser standards of capacity for less consequential medical decisions (such as getting a flu shot), and requires higher standards of capacity for greater consequential decisions such as creating a high-risk pregnancy (Etchells et al., 1996b). Thus, the mother’s decision to risk a HOM pregnancy without sufficient care giving and financial resources when she already had six children to care for as a sole parent (three with disabilities) seriously challenges her capacity. When a patient cannot demonstrate genuine decision-making capacity for important medical decisions, particularly for elective, high-risk, nontherapeutic medical procedures, the physician has a beneficencebased duty to protect her from pointless harm, and in this case, prevent unnecessary risks to the mother, her existing children, and potential children. There are limits to patient autonomy that

263

physicians must recognize to satisfy beneficence (Loewy, 2005; Tauber, 2003); however, decision-making capacity also protects patient autonomy in that autonomy cannot be expressed without adequate capacity to do so. Discussion and Recommendations This case is an example of what happens when ET is not strictly regulated and when professional societies ‘‘lack the resources, statutory empowerment, training and experience to regulate clinical practice’’ (Ory, 2010). The Suleman case illustrates the appropriateness of ET regulation in countries that practice it. The absence of legislation regarding ET in the United States makes future such cases likely. The only explanation for this outcome is the clinician’s belief that there are no limits to patient autonomy, even when capacity is in question. It seems plausible, too, that the embryos were merely regarded as a ‘‘reagent’’ to produce the pregnancy; in a laboratory, a reagent is a substance used to produce a chemical reaction. It is doubtful that a preemptive discussion regarding embryo storage, embryo disposal, or selective reduction took place, given the facts of this case. In an IVF context, the clinician must particularly place limits on patient autonomy when the patient’s risky requests concern others and can harm others. John S. Mill’s ‘‘The Harm Principle’’ (Collini, 1989) considers the interests of other people affected by the autonomous person’s choices. The ‘‘other people’’ are not limited to the mother’s existing six children, but involve potential children, extended family, and the role of society in caring for multiple children born to a mother with limited financial resources. Although it can be complex to determine whose interests should prevail, children should be protected from preventable harms when possible; in this case, Suleman’s existing children would have an interest in not being harmed by the risky pregnancy. Protecting patient autonomy also obligates the clinician to assess decision-making capacity along with therapeutic options. For IVF patients with impaired capacity, elective procedures should be delayed; surrogate decision makers are only necessary for medical decisions that are emergent. Lifeboat Ethics and Selective Reduction The prenatal ethics literature clearly establishes that in circumstances where the mother is placing the viable fetus(es) in certain harm’s way, the physician has a beneficence-based duty to intervene and protect the fetus(es) (Bessner, 1994; Chervenak & McCullough, 1991; Mahowald, 2006; Strong, 1997). In this case, the mother refused selective reduction, optimally recommended by 11 weeks (Wapner et al., 1990), which placed her and her fetuses at great risk. Selective reduction is ethical (Chervenak, McCullough, & Wapner, 1992, 1995), but coerced selective reduction violates both autonomy and nonmaleficence to the extent that it could not be defended as a beneficent act that trumps other ethical principles, because the fetuses do not have independent moral status and rights (McCullough & Chervenak, 2008; Strong, 2008). Coerced selective reduction could only be defended as a beneficent act if the mother’s life is at risk. Ultimately, selective reduction is a ‘‘lifeboat ethics’’ dilemma because competing ethical principles cannot be satisfied. However, the refusal of selective reduction is a preventable ethical dilemma when it is discussed at the appropriate time (in

264

M.S. Rosenthal / Women’s Health Issues 20 (2010) 260–265

advance of IVF), because a mother’s hesitance to undergo this procedure is a clear indication for single ET. Proponents of regulated ET argue that even the consideration of selective reduction means that the contemplated number of embryos for transfer is medically inappropriate, which is why the ethical position supports regulated and single ET. Opponents of regulated ET argue that there are cases where aggressive ET is appropriate (in older women with low fecundity and limited insurance or funds for IVF cycles). Yet even when patients are properly consented about the risks associated with aggressive ET, informed consent is not a justification for abandoning beneficent obligations to adhere to a quality of standard care, which is why preventive ethics guidelines (Table 3) are useful. Preventive Ethics Guidelines In countries such as the United States, which do not strictly regulate ET, a preventive ethics approach can remedy HOM problems in the absence of regulated ET (Rosenthal, 2010). The informed consent process should guide clinical management; patients should be asked about their preferences regarding embryo storage and disposal. In older patients who are appropriate for more aggressive ET, selective reduction must be discussed. In IVF patients unwilling to have their unused embryos frozen or discarded, fewer embryos should be created and used in the first place. In patients opposed to abortion or selective reduction, single ET should be the only option, regardless of their age or insurance coverage (Strong, 1999). During the consent process, patients who cannot demonstrate decision-making capacity should be referred for capacity assessment by an appropriate mental health professional. A controversial but necessary ethical guideline involves the assessment of psychosocial fitness to parent (European Society of Human Reproduction and Embryology Task Force, 2007). Because fertility specialists are not competent to judge parental fitness (Chervenak & McCullough, 2009; Minkoff & Ecker, 2009), IVF candidates should be referred for outside assessment by qualified professionals. The California Medical Board’s complaint against Kamrava included his failure to refer Suleman for a mental health evaluation (Mohajer, 2010). In IVF cases in which aggressive ET is appropriate (because of a patient’s age), the case should be subject to an ethics review, which could ensure that proper informed consent occurs. Such a review could be available through hospital ethics committees

Table 3 Proposed Preventive Ethics Guidelines for IVF Patients in the U.S. 1. Informed consent must precede the IVF process, and include discussion of embryo storage, disposal, selective reduction, and psychosocial issues.* This information guides clinical management. 2. Patients who cannot demonstrate understanding, appreciation and rationality have impaired decision-making capacity, which should prompt a capacity assessment. Procedures should be delayed until decisionmaking capacity can be demonstrated. 3. In IVF patients who are unwilling to have their unused embryos frozen or discarded, fewer embryos should be created and used. 4. In patients opposed to abortion or selective reduction, single ET should be the only option. 5. Cases where patients request aggressive ET should be subject to an ethics review prior to the IVF process by either a hospital ethics committee (if available) or by an independent ad hoc committee of two outside peers, and one bioethicist (may be contacted through the American Society for Bioethics and Humanities.) * Psychosocial assessments should be done to gauge fitness to parent by appropriate mental health practitioners.

(if available), appropriate professional societies, which could form small committees through professional peers, bioethicists, and mental health professionals. Alternatively, the ethics review could be done by an independent ad hoc committee of two outside peers and one bioethicist. Preventive ethics recommendations work within the prenatal ethics framework of embryo/fetal ‘‘patienthood.’’ Here, beneficence-based obligations of care to the mother and her developing fetus recognize that creation of a HOM pregnancy fails to adequately maximize clinical benefits and minimize clinical harms. In the Suleman case, this outcome would not have occurred if a preventive ethics framework had been applied. References Adams, T. (2002). When the Story’s Over, The Guardian, January 27. Available: http://wwwguardiancouk/theobserver/2002/jan/27/featuresmagazine57. Accessed February 16, 2009. Ahner, R., Bikas, D., Rabl, M., Al-Kouatly, H. B., Krauss, A. N., McCullough, L. B., et al. (2001). Ethical implications of aggressive obstetric management at less than 28 weeks of gestation. Acta Obstetricia et Gynecologica Scandinavica, 80, 120– 125. American Society for Reproductive Medicine (ASRM). (2008). Guidelines on number of embryos transferred. Fertility and Sterility, 90, S163–S164. Assisted Human Reproduction Canada. (2009). Available: www.ahrc-pac.gc.ca. Accessed February 16, 2009. Bessner, R. (1994). State intervention in pregnancy. In G. E. M. Basen, & A. Lippman (Eds.), Misconceptions: The social construction of choice and the new reproductive technologies, volume 2. Hull, Quebec: Sean Fordyce. Brown, S. D. (2008). The "fetus as Patient": A critique. The American Journal of Bioethics, 8, 47–49. Campbell, D. M., & Templeton, A. (2004). Maternal complications of twin pregnancy. International Journal of Gynaecology and Obstetrics: The Official Organ of the International Federation of Gynaecology and Obstetrics, 84, 71–73. Caplan, A. L. (1997). And baby makes moral muddles. In A. L. Caplan (Ed.), Am I my brother’s keeper? The ethical frontiers of biomedicine. Bloomington: Indiana University Press. Chervenak, F. A., & McCullough, L. B. (1991). Legal intervention during pregnancy. JAMA, 265, 1953. Chervenak, F. A., & McCullough, L. B. (1992). Selective termination down to a singleton pregnancy. Ultrasound in Obstetrics & Gynecology, 2, 231. Chervenak, F. A., & McCullough, L. B. (1995). Ethical implications for early pregnancy of the fetus as patient: A basic ethical concept in fetal medicine. Early Pregnancy, 1, 253–257. Chervenak, F. A., & McCullough, L. B. (1996). The fetus as a patient: an essential ethical concept for maternal-fetal medicine. The Journal of Maternal-Fetal Medicine, 5, 115–119. Chervenak, F. A., & McCullough, L. B. (1997). Ethics in obstetrics and gynecology. An overview. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 75, 91–94. Chervenak, F. A., & McCullough, L. (2001). Ethical implications of the embryo as a patient. In C. F. Kurjak (Ed.), The embryo as a patient. New York: Parthenon. Publishing. Chervenak, F. A., & McCullough, L. B. (2003). The fetus as a patient: An essential concept for the ethics of perinatal medicine. American Journal of Perinatology, 20, 399–404. Chervenak, F. A., & McCullough, L. B. (2009). Professional integrity, respect for autonomy, and the self-regulation of reproductive endocrinology. American Journal of Obstetrics and Gynecology, 201, 3. Chervenak, F. A., McCullough, L. B., & Wapner, R. J. (1992). Selective termination to a singleton pregnancy is ethically justified. Ultrasound in Obstetrics & Gynecology, 2, 84–87. Chervenak, F. A., McCullough, L. B., & Wapner, R. (1995). Three ethically justified indications for selective termination in multifetal pregnancy: A practical and comprehensive management strategy. Journal of Assisted Reproduction and Genetics, 12, 531–536. Chervenak, F. A., McCullough, L. B., & Rosenwaks, Z. (2001). Ethical dimensions of the number of embryos to be transferred in in vitro fertilization. Journal of Assisted Reproduction and Genetics, 18, 583–587. Chervenak, F. A., McCullough, L. B., & Rosenwaks, Z. (2003). Ethical considerations in newer reproductive technologies. Seminars in Perinatology, 27, 427–434. Collini, S. (1989). On Liberty and Other Writings. In J. S. Mill (Ed.). New York City: Cambridge University Press. DePalma, A. (1998, March 4). The babies of quintland now: Broke and bitter. The New York Times.

M.S. Rosenthal / Women’s Health Issues 20 (2010) 260–265 Dickens, B. M., & Cook, R. J. (2004). Dimensions of informed consent to treatment. International Journal of Gynaecology and Obstetrics: The Official Organ of the International Federation of Gynaecology and Obstetrics, 85, 309–314. Dionne, A., Dionne, C. D., & Dionne, Y. (1997). Advice from the Dionne quintuplets. Time. Etchells, E., Sharpe, G., Burgess, M. M., & Singer, P. A. (1996a). Bioethics for clinicians: 2. Disclosure. CMAJ, 155, 387–391. Etchells, E., Sharpe, G., Elliott, C., & Singer, P. A. (1996b). Bioethics for clinicians: 3. Capacity. CMAJ, 155, 657–661. Etchells, E., Sharpe, G., Walsh, P., Williams, J. R., & Singer, P. A. (1996c). Bioethics for clinicians: 1. Consent. CMAJ, 155, 177–180. European Society of Human Reproduction and Embryology Task Force; Pennings, G., de Wert, F., Shenfield, J., Cohen, B., Tarlatzis, P., & Devroey, P.. (2007). ESGRE Task Force on Ethics and Law 13: The welfare of the child in medically assisted reproduction. Human Reproduction, 22, 2585–2588. Fleischman, A. R., Chervenak, F. A., & McCullough, L. B. (1998). The physician’s moral obligations to the pregnant woman, the fetus, and the child. Seminars in Perinatology, 22, 184–188. Hack, M., Flannery, D. J., Schluchter, M., Cartar, L., Borawski, E., & Klein, N. (2002). Outcomes in young adulthood for very-low-birth-weight infants. New England Journal of Medicine, 346, 149–157. Hamersley, S. L., Coleman, S. K., Bergauer, N. K., Bartholomew, L. M., & Pinckert, T. L. (2002). Delayed-interval delivery in twin pregnancies. The Journal of Reproductive Medicine, 47, 125–130. Hull, R. T. (2002). The alchemy of informed consent. The Journal of Clinical Ethics, 13, 63–66. Human Fertilisation and Embryology Authority. Available: www.hfea.gov.uk. Accessed February 16, 2009. Jones, J. W., McCullough, L. B., & Richman, B. W. (2005). Informed consent: it’s not just signing a form. Thoracic Surgery Clinics, 15, 451–460. Khan, R., Indrees, M., Palamarchuk, T., & Dawlatly, B. (2008). Successful term delivery of the second twin after rescue cervical cerclage at 21 weeks with the placenta of the first twin in situ. Journal of Obstetrics and Gynaecology, 28, 346–347. Klotzko, A. J. (1998). Medical miracle or medical mischief? The saga of the McCaughey septuplets. Hastings Center Report, 28, 5–8. Lemonick, M. D. (1997). It’s a miracle. Time. Loewy, E. H. (2005). In defense of paternalism. Theoretical Medicine and Bioethics, 26, 445–468. Lyerly, A. D., Little, M. O., & Faden, R. R. (2008). A critique of the ‘fetus as patient’. The American Journal of Bioethics, 8, 42–44. Lyman, R. (1998). Mother of the octuplets goes home to recover. The New York Times. Mahowald, M. B. (2006). Noncompliance during pregnancy. In M. B. Mahowald (Ed.), Bioethics and women across the lifespan. New York: Oxford University Press. McCullough, L. B., & Chervenak, F. A. (1994). Ethics in obstetrics and gynecology. New York: Oxford University Press. McCullough, L. B., & Chervenak, F. A. (2008). Response to commentaries on "A critical analysis of the concept and discourse of "unborn child". The American Journal of Bioethics, 8, W4–W6. Meyers, C. (2004). Cruel choices: Autonomy and critical care decision-making. Bioethics, 18, 104–119. Minkoff, H., & Ecker, J. (2009). The California octuplets and the duties of reproductive endocrinologists. American Journal of Obstetrics and Gynecology, 201, 15.e1–e3.

265

Mohajer, S.T. (2010, January 5). Michael Kamrava charged with gross negligence. Associated Press. Purdy, L. M. (1996). Genetics and reproductive risk: Can having children be immoral? In L. M. Purdy (Ed.), Reproducing persons: Issues in feminist bioethics. Ithaca, NY: Cornell University Press. Purdy, L. M. (2007). Could there be a right not to be born an octuplet? In S. B. Noggle (Ed.), Taking responsibility for children, Waterloo, Ontario: Wilfred Laurier Press. Ory, S. (2010). The American octuplet experience: A transformative event. Fertility and Sterility, 93, 337–338. Rosenthal, M. S. (2010). A preventive ethics approach to IVF in the age of octuplets. Fertility and Sterility, 93, 339–340. Schieve, L. A., Meikle, S. F., Ferre, C., Peterson, H. B., Jeng, G., & Wilcox, L. S. (2002). Low and very low birth weight in infants conceived with use of assisted reproductive technology. New England Journal of Medicine, 346, 731–737. Schieve, L. A., Peterson, H. B., Meikle, S. F., Jeng, G., Danel, I., Burnett, N. M., et al. (1999). Live-birth rates and multiple-birth risk using in vitro fertilization. JAMA, 282, 1832–1838. Scruby, A. (2009, February 17). Radio psychiatrist files complaint against octuplet mom. Whittier Daily News. Skupski, D., Chervenak, F. A., & McCullough, L. (2007). An ethically justified decision-making pathway for the management of pregnancies complicated by twin-to-twin transfusion syndrome. Fetal Diagnosis and Therapy, 22, 339–342. Sorenson, C. (2006). ART In the European Union. Euro Observer: The Health Policy Bulletin of the European Observatory on Health Systems and Policies, 8, 1–8. Soucy, J., Dionne, Y., & Dionne, C. (1997). Family secrets: The Dionne quintuplets’ autobiography. New York: Berkley. Strong, C. (1997). Ethics in reproductive and perinatal medicine: A new framework. New Haven: Yale University Press. Strong, C. (1999). Octuplets and Ethics. Fertility and Sterility, 72, 970–972. Strong, C. (2008). Do Embryonic "patients" have moral interests? The American Journal of Bioethics, 8, 40–52. Tauber, A. I. (2003). Sick autonomy. Perspectives in Biology and Medicine, 46, 484–495. Veatch, R. M. (1995). Abandoning informed consent. Hastings Center Report, 25, 5–12. Veleva, Z., Karinen, P., Tomas, C., Tapanainen, J. S., & Martikainen, H. (2009). Elective single embryo transfer with cryopreservation improves the outcome and diminishes the costs of IVF/ICSI. Human Reproduction (Oxford, England). Wapner, R. J., Davis, G. H., Johnson, A., Weinblatt, V. J., Fischer, R. L., Jackson, L. G., et al. (1990). Selective reduction of multifetal pregnancies. Lancet, 335, 90–93. Yoshino, K. (2009, October 20). Doctor who treated octuplets mom ejected from Society of Reproductive Medicine. Los Angeles Times.

Author Descriptions M. Sara Rosenthal, PhD, is Associate Professor, Bioethics and Director, Program for Bioethics at the University of Kentucky College of Medicine. She is Chair of the University of Kentucky Medical Center’s Hospital Ethics Committee and directs the clinical ethics consult service.