IJG-08241; No of Pages 5 International Journal of Gynecology and Obstetrics xxx (2015) xxx–xxx
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
SPECIAL ARTICLE
Medical, legal, and ethical challenges associated with pregnancy and catastrophic brain injury Christopher M. Burkle a,⁎, Jennifer Tessmer-Tuck b, Eelco F. Wijdicks c a b c
Department of Anesthesiology, Mayo Clinic, Rochester, MN, USA Department of Obstetrics/Gynecology, North Memorial Medical Center, Robbinsdale, MN, USA Department of Neurology, Mayo Clinic, Rochester, MN, USA
a r t i c l e
i n f o
Article history: Received 11 September 2014 Received in revised form 9 December 2014 Accepted 13 February 2015 Keywords: Brain death Brain injury Ethics Legal issues Patient autonomy
a b s t r a c t In late 2013, two women from North America gained attention after sustaining catastrophic brain injuries while pregnant. After Marlise Muñoz—who was at 14 weeks of pregnancy when she developed a pulmonary embolism—was pronounced brain dead, hospital officials initially refused to withdraw support, citing a Texas state law requiring them to maintain life-sustaining treatment for a pregnant patient to help to save the fetus. By contrast, when Robyn Benson was pronounced brain dead after a brain hemorrhage at 22 weeks of pregnancy, both her husband and the physicians agreed to continue support until a viable child could be delivered. The Muñoz and Benson cases offer an opportunity to explore the medical, legal, and ethical issues surrounding catastrophic brain injury in pregnant women. It is hoped that the present article will enable clinicians to better appreciate the history and present state of issues involving advance directives for pregnant women, maternal versus fetal interests, and the impact of fetal viability on medical decision making, as well as offer a practical assessment of the various US state laws concerning the rare, yet catastrophic event of brain injury in a pregnant woman. © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction On November 26, 2013, Marlise Muñoz, a 33-year-old woman who had been pregnant for 14 weeks, was found unconscious in her home in Texas, USA, after a pulmonary embolism [1–3]. After being rushed to hospital, she was pronounced brain dead, at which point her family (including her husband and her parents) requested that life support measures be discontinued [1]. Although Muñoz had not left any written directives regarding end-of-life care, her husband stated that she had previously verbalized to him that she did not want to be kept alive by machines [3]. However, officials at the hospital refused to withdraw life support, citing a state law requiring them to maintain lifesustaining treatment for a pregnant patient. Almost 2 months after her fatal event, and following a judge’s order, the hospital acknowledged that Muñoz had been brain dead since November 28, 2013, and that her fetus was not viable; life support was then removed [2–4]. While deliberations were continuing in the Muñoz case, a similar tragic fate had occurred to Robyn Benson of Victoria, BC, Canada. On December 28, 2013, Benson was found collapsed on her bathroom floor after having had a cerebral hemorrhage [5]. At 22 weeks of pregnancy, she was declared brain dead, after which both doctors and ⁎ Corresponding author at: Department of Anesthesiology, Mayo Clinic, 200 1st St SW, Rochester, MN 55905, USA. Tel.: +1 507 284 9695; fax: +1 507 284 0120. E-mail address: [email protected] (C.M. Burkle).
her husband agreed to maintain support until the fetus could be delivered by cesarean [6]. According to reports, a healthy child was delivered on February 8, 2014 [6]. Despite differences in the goals and wishes of both the families and hospitals, these two recent cases offer the opportunity to explore the medical, legal, and ethical issues surrounding catastrophic brain injury in pregnant women. It is hoped that a review will provide practicing clinicians with information that will enable them to better understand the history and present state of issues involving advance directives for pregnant women, maternal versus fetal rights, and the impact of fetal viability on medical decision making, as well as offer a practical assessment of where varying US state laws stand on catastrophic brain injury in pregnant women. 2. Incidence and previous reports Catastrophic neurological injury leads to coma. Patients can progress to brain death or remain in a prolonged coma such as persistent vegetative state (PVS) [7]. The structural abnormalities in PVS fundamentally consist of extensive damage to the subcortical structures of the brain, including the white matter of the cerebral hemispheres and/or the thalamus, irrespective of the cause of injury [7]. The brainstem can also be damaged [7]. By contrast, brain death is caused by a bilateral hemispheric injury that has secondarily resulted in loss of all brainstem function, including breathing [7]. Thus, brain death is defined as loss of
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Please cite this article as: Burkle CM, et al, Medical, legal, and ethical challenges associated with pregnancy and catastrophic brain injury, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.12.011
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all brainstem function, resulting in breathing abnormalities and often hypotension requiring vasopressors [7]. Unlike brain death, PVS is not equivalent to death. The incidence of PVS during pregnancy is unknown but is probably low. Several case reports [8–10] have provided some general insight into PVS and pregnancy relating to the type of insulting injury, gestational age at time of initial insult, gestational age at delivery, and maternal and fetal outcomes. Chiossi et al. [9] reported on two cases of successful delivery of neonates from mothers who were in a PVS after motor vehicle accidents. The initial insults occurred when the fetuses had gestational ages of 80 and 168 days, with successful delivery occurring at 31 and 34 weeks, respectively. Both children were reported to be faring well at age 1 year. One of the earliest gestational period insults was reported by Sim et al. [10]. After a maternal insult after only 4 weeks of pregnancy, a child was delivered at 33 weeks and was reported to be leading a normal life 12 months later. By contrast, Bush et al. [8] reported on a case of a woman who was in a PVS as a result of multiple sclerosis: a neonate was delivered after 24 weeks, but unfortunately did not survive past 24 hours. The mother died 1 year after delivery [8]. Brain death itself is uncommon (b10% of all major acute brain injuries) and therefore is an exceedingly rare event during pregnancy [11–13]. The most common reported causes of brain death in pregnancy include ruptured intracranial aneurysm or ruptured arteriovenous malformation, spontaneous ganglionic hypertensive hemorrhage, or anoxic-ischemic encephalopathy associated with cardiac arrest (including arrest associated with saddle pulmonary emboli) [14]. In most instances, there will be a concomitant fetal demise [13]. In some patients, however, a living fetus remains after maternal resuscitative efforts. Cases of prolonged support of a mother deemed brain dead with the goal of sustaining the fetus are reported in the literature and, since 1982, there have been over 25 reported cases of successful deliveries after prolonged support. A 2010 review of 30 pregnant women who were declared brain dead [15] found that the mean maternal age at the time of brain death was 26.5 years, the mean gestational age at the time of brain death was 22 weeks, and the mean gestational age at time of delivery was 29.5 weeks. Twelve viable neonates were born and survived the neonatal period [15]. However, none of these reported cases were within the last 15 years in the USA. It is possible that many of the reported cases of brain death during pregnancy could have been misdiagnosed and therefore misclassified. Pregnant women are not candidates for organ donation, and organ procurement agencies will not proceed with any pregnant woman with a live fetus. This issue is important because full brain death determination is generally performed in anticipation of organ donation. When donation is out of the question, the incentive to perform a full examination—including the critical apnea test that documents loss of respiratory drive and so is definitive evidence of loss of brainstem function—is reduced. In several case reports [15,16], apnea testing was not performed, perhaps because of an unsubstantiated fear of causing hypoxemic injury to the fetus during the procedure. Furthermore, many of the case reports [16,17] failed to document neurology or neurosurgery physician involvement, or provide full descriptions of brain death testing. It is therefore possible that some of these patients might still have retained function of the medulla oblongata, making long-term hemodynamic support more feasible and affecting neonatal outcomes. 3. Fetal viability and gestational age A consensus statement from the National Institute of Child Health and Development, the National Institutes of Health, the Society for Maternal Fetal Medicine, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists (ACOG) [18] defines periviability broadly as a gestational age of 20 weeks exactly to
25 weeks and 6 days, but acknowledges that neonates born after 20 and 21 weeks of pregnancy do not survive irrespective of resuscitative efforts and that at 22 and 23 weeks survival is uncommon [18]. Although the consensus guidelines recommend aggressive newborn resuscitative efforts begin at a gestational age of 23 weeks exactly, decisions about neonatal resuscitative efforts at birth and ongoing interventions for periviable newborns are complex and personal, and involve many parties, including parents, obstetricians, neonatologists, and individuals who support parents (e.g. family members and religious leaders). Given these challenges, any decision to proceed with prolonged medical support of a mother with the intention to deliver a viable neonate should (at a minimum) consider the gestational age of the fetus.
4. Fetal and maternal legal interests One area that inevitably arises when confronted with clinical situations that could mean that a woman is denied healthcare decision-making rights in exchange for benefits to her fetus is the legal balance between these potential opposing interests. Legal controversies involving the fetus date as far back as the mid-1880s [19]. In Dietrich v Inhabitants of Northampton, a woman brought a claim after slipping on a bridge and a subsequent spontaneous abortion, but the court ruled that the construction company was not liable for the death of the fetus because the woman herself had no injuries [19–21]. This case developed what was ultimately termed the “single entity rule”: a pregnant woman and her fetus were legally considered to be one being [19,21]. However, in 1949, the case of Verkennes v Corniea was the first to separate care of the fetus from care of the pregnant woman with the ruling that a hospital and physician could be held liable for the negligent medical care of the viable fetus irrespective of maternal outcomes [19,21,22]. The Dietrich and Verkennes cases involved third-party injuries to a fetus and not those caused by a mother’s decision or action. Courts have since struggled to strike a balance between the potential interests of the fetus and the mother when they oppose one another [19,21,22]. Specific state legislation in the USA has been enacted to protect the interests of pregnant women even when such actions could result in the harm or death of her fetus [23,24]. Additionally, ACOG and the ACOG Ethics Committee support the right of a woman to decide her care irrespective of the consequences to the fetus [21,25]: “In the absence of extraordinary circumstances, circumstances that, in fact, the Committee on Ethics cannot currently imagine, judicial authority should not be used to implement treatment regimens aimed at protecting the fetus, for such actions violate the pregnant woman’s autonomy.” However, despite court precedent, legislative measures, and input from professional medical societies, the legal interests of pregnant women and the fetus remain unsettled to date [26,27].
5. The right to terminate support of medical treatment measures Several landmark legal battles have been fought over the right of a patient to refuse medical treatment [28,29]. The case of In re AC [29] provided criteria to be used when the patient is unable to provide clear and convincing guidance at the time [29]. The case itself surrounded a lower court’s decision requiring an unconscious woman with cancer to undergo a cesarean delivery in an attempt to save the life of her fetus. It was determined that the patient’s written or oral directions concerning treatment should be followed first. When no such directions exist, the person’s past decisions concerning medical treatment should be sought. If unknown, her values should be respected. When uncertainty still remains, a process of substituted judgment should follow. This process considers how most people would proceed when confronted with a similar medical situation [29,30].
Please cite this article as: Burkle CM, et al, Medical, legal, and ethical challenges associated with pregnancy and catastrophic brain injury, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.12.011
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6. US laws affecting maternal–fetal rights, living wills, and medical proxy statutes Despite a general trend in the law allowing for maternal autonomy surrounding decisions about their health along with precedence providing step-by-step guidance as to how to decide on termination of medical treatment, many states continue to maintain pregnancy exclusions within their advance directive statutes [31]. Currently, states in the USA are categorized into five classifications depending on their approach to the impact of pregnancy on life-sustaining treatment (Table 1) [31]. Twelve states have the most restrictive legislation, with automatic invalidation of a woman’s advance directive during pregnancy (Tables 1 and 2) [31,32]. Fourteen states have enacted legislation in line with the Uniform Rights of the Terminally Ill Act (Table 1), which means that a pregnant woman will be maintained on cardiopulmonary support if it is “probable” that the fetus will develop to the stage of “live birth” [31]. Four of these states (New Hampshire, North Dakota, Pennsylvania, and South Dakota) allow for exceptions when continued treatment could be physically harmful or cause severe pain to the woman. Four states employ a viability standard when deciding whether to respect a woman’s advance directive (Table 1). These jurisdictions modify the language used by states following the Uniform Rights of the Terminally Ill Act standards by including terms defining fetal viability. For example, Delaware’s statute states that a decision about whether to continue treatment will be based on whether “the fetus will develop to be viable outside the uterus with the continued life-sustaining procedure” [31]. Five states allow women to write instructions into their advance directives concerning treatments specific to pregnancy (Table 1). Fourteen other states, plus the District of Columbia, remain silent on the impact that pregnancy has on a patient’s advance directive (Table 1), leaving the final decision up to the courts if a dispute surfaces. In these states, certain unintended consequences could occur while the courts determine how to proceed, including continued treatment measures that might be against the wishes of the woman [31]. There remains concern in legal circles regarding the application of different standards to women who are pregnant and those who are not. Questions include whether a well-established constitutional right to individual autonomy should change given a state of pregnancy. Some argue that treating a pregnant woman’s rights differently could violate constitutional standards of equal protection by transforming her into an incubator for the sole purpose of delivering a child [26]. In addition to conflicts under equal protection, continuing supportive measures against a woman’s wishes could cross over the line into involuntary servitude [26,33,34]. Although these constitutional concerns have been raised before the courts in both North Dakota and Washington, they were dismissed for procedural reasons [34]. To date, the constitutionality of pregnancy-dependent advance directives has not been decided by the courts [34]. It is important to appreciate that the state statutes discussed here are specific to patients who are considered alive (in a condition of PVS or an otherwise incapacitated state, and terminally or irreversibly ill patients) and do not apply to brain death [33]. This clarification played an
Table 2 US state statutes for advance directives during pregnancy. State/district
Statute
Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming
Ala. Code § 22–8A–4 Alaska Stat. § 13.52.055 Ariz. Rev. Stat. Ann. § 36–3262 Ark. Code Ann. § 20–17–206 Cal. Prob. Code §§ 4670 to 4701 Colo. Rev. Stat. §§ 15–18–101 to 15–18–113 (2010) Conn. Gen. Stat. Ann. §§ 19a–570 to 19a–580g (West 2010) Del. Code Ann. tit. 16, § 2503 D.C. Code §§ 7–601 to 7–630 Fla. Stat. Ann. § 765.113 Ga. Code Ann. § 31–32–4 Haw. Rev. Stat. §§ 327E–1 to 327E–16 Idaho Code Ann. § 39–4510 (2011) 755 Ill. Comp. Stat. 35/3(c) Ind. Code Ann. § 16–36–4–8 Iowa Code Ann. § 144A.6 Kan. Stat. Ann. § 65–28,103 Ky. Rev. Stat. Ann. § 311.625 La. Rev. Stat. Ann. §§ 40:1299.58.1 to 40:1299.58.10 Me. Rev. Stat. Ann. tit. 18–A, §§ 5–802 to 5–817 Md. Code Ann., Health–Gen. § 5–603 Mass. Gen. Laws Ann. ch. 201D, §§ 1 to 17 Mich. Comp. Laws Ann. § 700.5512 Minn. Stat. Ann. § 145C.10 Miss. Code Ann. §§ 41–41–201 to 41–41–229 Mo. Ann. Stat. § 459.025 Mont. Code Ann. § 50–9–202 Neb. Rev. Stat. § 20–408 Nev. Rev. Stat. § 449.624 N.H. Rev. Stat. Ann. 137–J:10 N.J. Stat. Ann. § 26:2H–56 N.M. Stat. Ann. §§ 24–7A–1 to 24–7A–17 N.Y. Pub. Health Law §§ 2980 to 2994 N.C. Gen. Stat. §§ 90–320 to 90–323 N.D. Cent. Code § 23–06.5–09 Ohio Rev. Code Ann. § 2133.06 Okla. Stat. Ann. tit. 63, § 3101.4 Or. Rev. Stat. §§ 127.505 to 127.660, 127.995 20 Pa. Cons. Stat. Ann. § 5471 R.I. Gen. Laws § 23–4.11–6(c) S.C. Code Ann. § 44–77–70 S.D. Codified Laws § 34–12D–10 Tenn. Code Ann. §§ 32–11–101 to 32–11–113 Tex. Health & Safety Code Ann. § 166.049 Utah Code Ann. § 75–2a–123 Vt. Stat. Ann. tit.18, § 9702 Va. Code Ann. §§ 54.1–2981 to 54.1–2993 Wash. Rev. Code § 70.122.030 W. Va. Code Ann. §§ 16–30–1 to 16–30–13 Wis. Stat. Ann. § 154.03 Wyo. Stat. Ann. §§ 35–22–401 to 35–22–416
important part in the Muñoz case because the Texas statute reads that “[a] person may not withdraw or withhold life-sustaining treatment from a pregnant patient” [35]. Although not specifically tested in cases involving pregnancy, both New Jersey and New York allow for families to argue on religious grounds against a diagnosis of death on the basis of neurological criteria alone [36,37].
Table 1 Advance directives statutes during pregnancy in the USA.a Classification
States/districts
Automatic invalidation of a pregnant woman’s advance directive
Alabama, Connecticut, Idaho, Indiana, Kansas, Kentucky, Michigan, Missouri, South Carolina, Texas, Utah, Washington, Wisconsin Alaska, Arizona, Arkansas, Illinois, Iowa, Montana, Nebraska, Nevada, New Hampshire, North Dakota, Ohio, Pennsylvania, Rhode Island, South Dakota Colorado, Delaware, Florida, Georgia California, Hawaii, Louisiana, Maine, Massachusetts, Mississippi, New Mexico, New York, North Carolina, Oregon, Tennessee, Virginia, West Virginia, Wyoming, District of Columbia Maryland, Minnesota, New Jersey, Oklahoma, Vermont
Enacted the Uniform Rights of the Terminally Ill Act (URTIA) Viability standard to determine enforceability of declaration Statutes that are silent in regard to pregnancy Statutes that offer a clear option regarding pregnancy a
3
Information obtained from Greene and Wolfe [31].
Please cite this article as: Burkle CM, et al, Medical, legal, and ethical challenges associated with pregnancy and catastrophic brain injury, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.12.011
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7. Ethical arguments during pregnancy
surrounding
advance
directives
The American Medical Association clarifies that although ethical and legal principals can be closely related, “ethical obligations typically exceed legal duties” [38]. They go on to suggest that when met with such conflict, physicians should work to amend laws they find unjust and that in exceptional circumstances, “ethical responsibilities should supersede legal obligations” [38]. ACOG and the ACOG Ethics Committees specifically state that “[s]tatutes that prohibit pregnant women from exercising their right to determine or refuse current or future medical treatment are unethical” [39]. Additionally, the FIGO Committee for the Study of Ethical Aspects of Human Reproduction and Women’s Health has specifically addressed the topic of brain death and pregnancy [40]. Their 2012 recommendations state that “fetal rescue does not exonerate health care givers from the duty to respect [the] right of the primary patient, the woman” [40]. Several academic commentaries have highlighted the challenges surrounding decisions to continue support in hopes of delivering a healthy child [41,42]. Colb suggested that when a woman initially communicates her end-of-life wishes (via an advance directive or other means), she might not envision being pregnant and on life support at that time [41]. This could complicate decision making for healthcare providers and family members who are serving as surrogate decision makers for their loved one. The right of any person to refuse medical treatment—male or female, pregnant or not—is one that is sacrosanct in the USA both legally and ethically. By delivering unwanted support to a person declared brain dead, an abuse of liberty interests could occur by “using [the] body as an instrument to house a fetus” [41]. However, others point out that interests and obligations typically present while a patient is alive might no longer exist upon death. Sperling suggested that there are certain moral and ethical responsibilities that must be maintained in addition to obligations to individual relationships [42]. Among these are responsibilities to society including family, religion, and communities. Sperling argued that although a pregnant woman might need to consider these added responsibilities while alive, death releases such obligations because she is no longer a social and moral component of the family [42]. In a previous article, Nelson raised questions about a physician’s responsibility to support pregnant women who have been declared brain dead [42]. The queries included were whether there is a continuation of the duty of a physician to respect a woman’s wishes, the duty of the state to protect the wellbeing of a fetus, beneficence to the fetus, and lastly a duty driven by the “special relationship” between mother and fetus [42]. Nelson ultimately concluded that no legal duty on the part of the physician exists on the woman’s death. The academic commentaries have been provided for completeness of any discussion involving the legal and ethical challenges confronted. It is not the suggestion of the authors that physicians ignore existing laws. Instead, if there is concern for the unjustness nature of any standing law, only appropriate avenues available for amending such laws should be undertaken. 8. Conclusion The cases of Marlise Muñoz and Robyn Benson highlight the difficult and multidimensional issues associated with catastrophic brain injury during pregnancy. Because of the unique situation confronted by families of a pregnant woman diagnosed with PVS or brain death, and variations in US state laws regarding applicability of advance directives to pregnant women, obstetricians should add this topic to the discussion during an early prenatal visit. These recent cases—which had completely different outcomes—should serve as a warning cry that catastrophe can happen to anyone and at any time, and that patients and families rely on physicians to help to guide them through decision making. To optimize this discussion, an appreciation by the obstetrician
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Please cite this article as: Burkle CM, et al, Medical, legal, and ethical challenges associated with pregnancy and catastrophic brain injury, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.12.011
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
SPECIAL ARTICLE
Medical, legal, and ethical challenges associated with pregnancy and catastrophic brain injury Christopher M. Burkle a,⁎, Jennifer Tessmer-Tuck b, Eelco F. Wijdicks c a b c
Department of Anesthesiology, Mayo Clinic, Rochester, MN, USA Department of Obstetrics/Gynecology, North Memorial Medical Center, Robbinsdale, MN, USA Department of Neurology, Mayo Clinic, Rochester, MN, USA
a r t i c l e
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Article history: Received 11 September 2014 Received in revised form 9 December 2014 Accepted 13 February 2015 Keywords: Brain death Brain injury Ethics Legal issues Patient autonomy
a b s t r a c t In late 2013, two women from North America gained attention after sustaining catastrophic brain injuries while pregnant. After Marlise Muñoz—who was at 14 weeks of pregnancy when she developed a pulmonary embolism—was pronounced brain dead, hospital officials initially refused to withdraw support, citing a Texas state law requiring them to maintain life-sustaining treatment for a pregnant patient to help to save the fetus. By contrast, when Robyn Benson was pronounced brain dead after a brain hemorrhage at 22 weeks of pregnancy, both her husband and the physicians agreed to continue support until a viable child could be delivered. The Muñoz and Benson cases offer an opportunity to explore the medical, legal, and ethical issues surrounding catastrophic brain injury in pregnant women. It is hoped that the present article will enable clinicians to better appreciate the history and present state of issues involving advance directives for pregnant women, maternal versus fetal interests, and the impact of fetal viability on medical decision making, as well as offer a practical assessment of the various US state laws concerning the rare, yet catastrophic event of brain injury in a pregnant woman. © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction On November 26, 2013, Marlise Muñoz, a 33-year-old woman who had been pregnant for 14 weeks, was found unconscious in her home in Texas, USA, after a pulmonary embolism [1–3]. After being rushed to hospital, she was pronounced brain dead, at which point her family (including her husband and her parents) requested that life support measures be discontinued [1]. Although Muñoz had not left any written directives regarding end-of-life care, her husband stated that she had previously verbalized to him that she did not want to be kept alive by machines [3]. However, officials at the hospital refused to withdraw life support, citing a state law requiring them to maintain lifesustaining treatment for a pregnant patient. Almost 2 months after her fatal event, and following a judge’s order, the hospital acknowledged that Muñoz had been brain dead since November 28, 2013, and that her fetus was not viable; life support was then removed [2–4]. While deliberations were continuing in the Muñoz case, a similar tragic fate had occurred to Robyn Benson of Victoria, BC, Canada. On December 28, 2013, Benson was found collapsed on her bathroom floor after having had a cerebral hemorrhage [5]. At 22 weeks of pregnancy, she was declared brain dead, after which both doctors and ⁎ Corresponding author at: Department of Anesthesiology, Mayo Clinic, 200 1st St SW, Rochester, MN 55905, USA. Tel.: +1 507 284 9695; fax: +1 507 284 0120. E-mail address: [email protected] (C.M. Burkle).
her husband agreed to maintain support until the fetus could be delivered by cesarean [6]. According to reports, a healthy child was delivered on February 8, 2014 [6]. Despite differences in the goals and wishes of both the families and hospitals, these two recent cases offer the opportunity to explore the medical, legal, and ethical issues surrounding catastrophic brain injury in pregnant women. It is hoped that a review will provide practicing clinicians with information that will enable them to better understand the history and present state of issues involving advance directives for pregnant women, maternal versus fetal rights, and the impact of fetal viability on medical decision making, as well as offer a practical assessment of where varying US state laws stand on catastrophic brain injury in pregnant women. 2. Incidence and previous reports Catastrophic neurological injury leads to coma. Patients can progress to brain death or remain in a prolonged coma such as persistent vegetative state (PVS) [7]. The structural abnormalities in PVS fundamentally consist of extensive damage to the subcortical structures of the brain, including the white matter of the cerebral hemispheres and/or the thalamus, irrespective of the cause of injury [7]. The brainstem can also be damaged [7]. By contrast, brain death is caused by a bilateral hemispheric injury that has secondarily resulted in loss of all brainstem function, including breathing [7]. Thus, brain death is defined as loss of
http://dx.doi.org/10.1016/j.ijgo.2014.12.011 0020-7292/© 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
Please cite this article as: Burkle CM, et al, Medical, legal, and ethical challenges associated with pregnancy and catastrophic brain injury, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.12.011
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all brainstem function, resulting in breathing abnormalities and often hypotension requiring vasopressors [7]. Unlike brain death, PVS is not equivalent to death. The incidence of PVS during pregnancy is unknown but is probably low. Several case reports [8–10] have provided some general insight into PVS and pregnancy relating to the type of insulting injury, gestational age at time of initial insult, gestational age at delivery, and maternal and fetal outcomes. Chiossi et al. [9] reported on two cases of successful delivery of neonates from mothers who were in a PVS after motor vehicle accidents. The initial insults occurred when the fetuses had gestational ages of 80 and 168 days, with successful delivery occurring at 31 and 34 weeks, respectively. Both children were reported to be faring well at age 1 year. One of the earliest gestational period insults was reported by Sim et al. [10]. After a maternal insult after only 4 weeks of pregnancy, a child was delivered at 33 weeks and was reported to be leading a normal life 12 months later. By contrast, Bush et al. [8] reported on a case of a woman who was in a PVS as a result of multiple sclerosis: a neonate was delivered after 24 weeks, but unfortunately did not survive past 24 hours. The mother died 1 year after delivery [8]. Brain death itself is uncommon (b10% of all major acute brain injuries) and therefore is an exceedingly rare event during pregnancy [11–13]. The most common reported causes of brain death in pregnancy include ruptured intracranial aneurysm or ruptured arteriovenous malformation, spontaneous ganglionic hypertensive hemorrhage, or anoxic-ischemic encephalopathy associated with cardiac arrest (including arrest associated with saddle pulmonary emboli) [14]. In most instances, there will be a concomitant fetal demise [13]. In some patients, however, a living fetus remains after maternal resuscitative efforts. Cases of prolonged support of a mother deemed brain dead with the goal of sustaining the fetus are reported in the literature and, since 1982, there have been over 25 reported cases of successful deliveries after prolonged support. A 2010 review of 30 pregnant women who were declared brain dead [15] found that the mean maternal age at the time of brain death was 26.5 years, the mean gestational age at the time of brain death was 22 weeks, and the mean gestational age at time of delivery was 29.5 weeks. Twelve viable neonates were born and survived the neonatal period [15]. However, none of these reported cases were within the last 15 years in the USA. It is possible that many of the reported cases of brain death during pregnancy could have been misdiagnosed and therefore misclassified. Pregnant women are not candidates for organ donation, and organ procurement agencies will not proceed with any pregnant woman with a live fetus. This issue is important because full brain death determination is generally performed in anticipation of organ donation. When donation is out of the question, the incentive to perform a full examination—including the critical apnea test that documents loss of respiratory drive and so is definitive evidence of loss of brainstem function—is reduced. In several case reports [15,16], apnea testing was not performed, perhaps because of an unsubstantiated fear of causing hypoxemic injury to the fetus during the procedure. Furthermore, many of the case reports [16,17] failed to document neurology or neurosurgery physician involvement, or provide full descriptions of brain death testing. It is therefore possible that some of these patients might still have retained function of the medulla oblongata, making long-term hemodynamic support more feasible and affecting neonatal outcomes. 3. Fetal viability and gestational age A consensus statement from the National Institute of Child Health and Development, the National Institutes of Health, the Society for Maternal Fetal Medicine, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists (ACOG) [18] defines periviability broadly as a gestational age of 20 weeks exactly to
25 weeks and 6 days, but acknowledges that neonates born after 20 and 21 weeks of pregnancy do not survive irrespective of resuscitative efforts and that at 22 and 23 weeks survival is uncommon [18]. Although the consensus guidelines recommend aggressive newborn resuscitative efforts begin at a gestational age of 23 weeks exactly, decisions about neonatal resuscitative efforts at birth and ongoing interventions for periviable newborns are complex and personal, and involve many parties, including parents, obstetricians, neonatologists, and individuals who support parents (e.g. family members and religious leaders). Given these challenges, any decision to proceed with prolonged medical support of a mother with the intention to deliver a viable neonate should (at a minimum) consider the gestational age of the fetus.
4. Fetal and maternal legal interests One area that inevitably arises when confronted with clinical situations that could mean that a woman is denied healthcare decision-making rights in exchange for benefits to her fetus is the legal balance between these potential opposing interests. Legal controversies involving the fetus date as far back as the mid-1880s [19]. In Dietrich v Inhabitants of Northampton, a woman brought a claim after slipping on a bridge and a subsequent spontaneous abortion, but the court ruled that the construction company was not liable for the death of the fetus because the woman herself had no injuries [19–21]. This case developed what was ultimately termed the “single entity rule”: a pregnant woman and her fetus were legally considered to be one being [19,21]. However, in 1949, the case of Verkennes v Corniea was the first to separate care of the fetus from care of the pregnant woman with the ruling that a hospital and physician could be held liable for the negligent medical care of the viable fetus irrespective of maternal outcomes [19,21,22]. The Dietrich and Verkennes cases involved third-party injuries to a fetus and not those caused by a mother’s decision or action. Courts have since struggled to strike a balance between the potential interests of the fetus and the mother when they oppose one another [19,21,22]. Specific state legislation in the USA has been enacted to protect the interests of pregnant women even when such actions could result in the harm or death of her fetus [23,24]. Additionally, ACOG and the ACOG Ethics Committee support the right of a woman to decide her care irrespective of the consequences to the fetus [21,25]: “In the absence of extraordinary circumstances, circumstances that, in fact, the Committee on Ethics cannot currently imagine, judicial authority should not be used to implement treatment regimens aimed at protecting the fetus, for such actions violate the pregnant woman’s autonomy.” However, despite court precedent, legislative measures, and input from professional medical societies, the legal interests of pregnant women and the fetus remain unsettled to date [26,27].
5. The right to terminate support of medical treatment measures Several landmark legal battles have been fought over the right of a patient to refuse medical treatment [28,29]. The case of In re AC [29] provided criteria to be used when the patient is unable to provide clear and convincing guidance at the time [29]. The case itself surrounded a lower court’s decision requiring an unconscious woman with cancer to undergo a cesarean delivery in an attempt to save the life of her fetus. It was determined that the patient’s written or oral directions concerning treatment should be followed first. When no such directions exist, the person’s past decisions concerning medical treatment should be sought. If unknown, her values should be respected. When uncertainty still remains, a process of substituted judgment should follow. This process considers how most people would proceed when confronted with a similar medical situation [29,30].
Please cite this article as: Burkle CM, et al, Medical, legal, and ethical challenges associated with pregnancy and catastrophic brain injury, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.12.011
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6. US laws affecting maternal–fetal rights, living wills, and medical proxy statutes Despite a general trend in the law allowing for maternal autonomy surrounding decisions about their health along with precedence providing step-by-step guidance as to how to decide on termination of medical treatment, many states continue to maintain pregnancy exclusions within their advance directive statutes [31]. Currently, states in the USA are categorized into five classifications depending on their approach to the impact of pregnancy on life-sustaining treatment (Table 1) [31]. Twelve states have the most restrictive legislation, with automatic invalidation of a woman’s advance directive during pregnancy (Tables 1 and 2) [31,32]. Fourteen states have enacted legislation in line with the Uniform Rights of the Terminally Ill Act (Table 1), which means that a pregnant woman will be maintained on cardiopulmonary support if it is “probable” that the fetus will develop to the stage of “live birth” [31]. Four of these states (New Hampshire, North Dakota, Pennsylvania, and South Dakota) allow for exceptions when continued treatment could be physically harmful or cause severe pain to the woman. Four states employ a viability standard when deciding whether to respect a woman’s advance directive (Table 1). These jurisdictions modify the language used by states following the Uniform Rights of the Terminally Ill Act standards by including terms defining fetal viability. For example, Delaware’s statute states that a decision about whether to continue treatment will be based on whether “the fetus will develop to be viable outside the uterus with the continued life-sustaining procedure” [31]. Five states allow women to write instructions into their advance directives concerning treatments specific to pregnancy (Table 1). Fourteen other states, plus the District of Columbia, remain silent on the impact that pregnancy has on a patient’s advance directive (Table 1), leaving the final decision up to the courts if a dispute surfaces. In these states, certain unintended consequences could occur while the courts determine how to proceed, including continued treatment measures that might be against the wishes of the woman [31]. There remains concern in legal circles regarding the application of different standards to women who are pregnant and those who are not. Questions include whether a well-established constitutional right to individual autonomy should change given a state of pregnancy. Some argue that treating a pregnant woman’s rights differently could violate constitutional standards of equal protection by transforming her into an incubator for the sole purpose of delivering a child [26]. In addition to conflicts under equal protection, continuing supportive measures against a woman’s wishes could cross over the line into involuntary servitude [26,33,34]. Although these constitutional concerns have been raised before the courts in both North Dakota and Washington, they were dismissed for procedural reasons [34]. To date, the constitutionality of pregnancy-dependent advance directives has not been decided by the courts [34]. It is important to appreciate that the state statutes discussed here are specific to patients who are considered alive (in a condition of PVS or an otherwise incapacitated state, and terminally or irreversibly ill patients) and do not apply to brain death [33]. This clarification played an
Table 2 US state statutes for advance directives during pregnancy. State/district
Statute
Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming
Ala. Code § 22–8A–4 Alaska Stat. § 13.52.055 Ariz. Rev. Stat. Ann. § 36–3262 Ark. Code Ann. § 20–17–206 Cal. Prob. Code §§ 4670 to 4701 Colo. Rev. Stat. §§ 15–18–101 to 15–18–113 (2010) Conn. Gen. Stat. Ann. §§ 19a–570 to 19a–580g (West 2010) Del. Code Ann. tit. 16, § 2503 D.C. Code §§ 7–601 to 7–630 Fla. Stat. Ann. § 765.113 Ga. Code Ann. § 31–32–4 Haw. Rev. Stat. §§ 327E–1 to 327E–16 Idaho Code Ann. § 39–4510 (2011) 755 Ill. Comp. Stat. 35/3(c) Ind. Code Ann. § 16–36–4–8 Iowa Code Ann. § 144A.6 Kan. Stat. Ann. § 65–28,103 Ky. Rev. Stat. Ann. § 311.625 La. Rev. Stat. Ann. §§ 40:1299.58.1 to 40:1299.58.10 Me. Rev. Stat. Ann. tit. 18–A, §§ 5–802 to 5–817 Md. Code Ann., Health–Gen. § 5–603 Mass. Gen. Laws Ann. ch. 201D, §§ 1 to 17 Mich. Comp. Laws Ann. § 700.5512 Minn. Stat. Ann. § 145C.10 Miss. Code Ann. §§ 41–41–201 to 41–41–229 Mo. Ann. Stat. § 459.025 Mont. Code Ann. § 50–9–202 Neb. Rev. Stat. § 20–408 Nev. Rev. Stat. § 449.624 N.H. Rev. Stat. Ann. 137–J:10 N.J. Stat. Ann. § 26:2H–56 N.M. Stat. Ann. §§ 24–7A–1 to 24–7A–17 N.Y. Pub. Health Law §§ 2980 to 2994 N.C. Gen. Stat. §§ 90–320 to 90–323 N.D. Cent. Code § 23–06.5–09 Ohio Rev. Code Ann. § 2133.06 Okla. Stat. Ann. tit. 63, § 3101.4 Or. Rev. Stat. §§ 127.505 to 127.660, 127.995 20 Pa. Cons. Stat. Ann. § 5471 R.I. Gen. Laws § 23–4.11–6(c) S.C. Code Ann. § 44–77–70 S.D. Codified Laws § 34–12D–10 Tenn. Code Ann. §§ 32–11–101 to 32–11–113 Tex. Health & Safety Code Ann. § 166.049 Utah Code Ann. § 75–2a–123 Vt. Stat. Ann. tit.18, § 9702 Va. Code Ann. §§ 54.1–2981 to 54.1–2993 Wash. Rev. Code § 70.122.030 W. Va. Code Ann. §§ 16–30–1 to 16–30–13 Wis. Stat. Ann. § 154.03 Wyo. Stat. Ann. §§ 35–22–401 to 35–22–416
important part in the Muñoz case because the Texas statute reads that “[a] person may not withdraw or withhold life-sustaining treatment from a pregnant patient” [35]. Although not specifically tested in cases involving pregnancy, both New Jersey and New York allow for families to argue on religious grounds against a diagnosis of death on the basis of neurological criteria alone [36,37].
Table 1 Advance directives statutes during pregnancy in the USA.a Classification
States/districts
Automatic invalidation of a pregnant woman’s advance directive
Alabama, Connecticut, Idaho, Indiana, Kansas, Kentucky, Michigan, Missouri, South Carolina, Texas, Utah, Washington, Wisconsin Alaska, Arizona, Arkansas, Illinois, Iowa, Montana, Nebraska, Nevada, New Hampshire, North Dakota, Ohio, Pennsylvania, Rhode Island, South Dakota Colorado, Delaware, Florida, Georgia California, Hawaii, Louisiana, Maine, Massachusetts, Mississippi, New Mexico, New York, North Carolina, Oregon, Tennessee, Virginia, West Virginia, Wyoming, District of Columbia Maryland, Minnesota, New Jersey, Oklahoma, Vermont
Enacted the Uniform Rights of the Terminally Ill Act (URTIA) Viability standard to determine enforceability of declaration Statutes that are silent in regard to pregnancy Statutes that offer a clear option regarding pregnancy a
3
Information obtained from Greene and Wolfe [31].
Please cite this article as: Burkle CM, et al, Medical, legal, and ethical challenges associated with pregnancy and catastrophic brain injury, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.12.011
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7. Ethical arguments during pregnancy
surrounding
advance
directives
The American Medical Association clarifies that although ethical and legal principals can be closely related, “ethical obligations typically exceed legal duties” [38]. They go on to suggest that when met with such conflict, physicians should work to amend laws they find unjust and that in exceptional circumstances, “ethical responsibilities should supersede legal obligations” [38]. ACOG and the ACOG Ethics Committees specifically state that “[s]tatutes that prohibit pregnant women from exercising their right to determine or refuse current or future medical treatment are unethical” [39]. Additionally, the FIGO Committee for the Study of Ethical Aspects of Human Reproduction and Women’s Health has specifically addressed the topic of brain death and pregnancy [40]. Their 2012 recommendations state that “fetal rescue does not exonerate health care givers from the duty to respect [the] right of the primary patient, the woman” [40]. Several academic commentaries have highlighted the challenges surrounding decisions to continue support in hopes of delivering a healthy child [41,42]. Colb suggested that when a woman initially communicates her end-of-life wishes (via an advance directive or other means), she might not envision being pregnant and on life support at that time [41]. This could complicate decision making for healthcare providers and family members who are serving as surrogate decision makers for their loved one. The right of any person to refuse medical treatment—male or female, pregnant or not—is one that is sacrosanct in the USA both legally and ethically. By delivering unwanted support to a person declared brain dead, an abuse of liberty interests could occur by “using [the] body as an instrument to house a fetus” [41]. However, others point out that interests and obligations typically present while a patient is alive might no longer exist upon death. Sperling suggested that there are certain moral and ethical responsibilities that must be maintained in addition to obligations to individual relationships [42]. Among these are responsibilities to society including family, religion, and communities. Sperling argued that although a pregnant woman might need to consider these added responsibilities while alive, death releases such obligations because she is no longer a social and moral component of the family [42]. In a previous article, Nelson raised questions about a physician’s responsibility to support pregnant women who have been declared brain dead [42]. The queries included were whether there is a continuation of the duty of a physician to respect a woman’s wishes, the duty of the state to protect the wellbeing of a fetus, beneficence to the fetus, and lastly a duty driven by the “special relationship” between mother and fetus [42]. Nelson ultimately concluded that no legal duty on the part of the physician exists on the woman’s death. The academic commentaries have been provided for completeness of any discussion involving the legal and ethical challenges confronted. It is not the suggestion of the authors that physicians ignore existing laws. Instead, if there is concern for the unjustness nature of any standing law, only appropriate avenues available for amending such laws should be undertaken. 8. Conclusion The cases of Marlise Muñoz and Robyn Benson highlight the difficult and multidimensional issues associated with catastrophic brain injury during pregnancy. Because of the unique situation confronted by families of a pregnant woman diagnosed with PVS or brain death, and variations in US state laws regarding applicability of advance directives to pregnant women, obstetricians should add this topic to the discussion during an early prenatal visit. These recent cases—which had completely different outcomes—should serve as a warning cry that catastrophe can happen to anyone and at any time, and that patients and families rely on physicians to help to guide them through decision making. To optimize this discussion, an appreciation by the obstetrician
for the unique emotional and practical environment associated with these catastrophic events is imperative. Conflict of interest The authors have no conflicts of interest. References [1] Plaintiff's original petition for declaratory judgment and application for unopposed expedited relief cause No. 017-270080-14. http://thaddeuspope.com/images/ Munoz_v._JPS_Jan_2014_.pdf. Accessed February 6, 2015. [2] Chappell B. Judge tells hospital to take pregnant woman off life support. http:// www.npr.org/blogs/thetwo-way/2014/01/24/265785603/judge-tells-hospital-totake-pregnant-woman-off-life-support. Published January 24, 2014. Accessed February 6, 2015. [3] Hellerman C, Morris J, Smith M. Brain-dead Texas woman taken off ventilator. http://www.cnn.com/2014/01/26/health/texas-pregnant-brain-dead-woman/ index.html?iphoneemail. Published January 27, 2014. Accessed February 6, 2015. [4] Tarrant County. 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Please cite this article as: Burkle CM, et al, Medical, legal, and ethical challenges associated with pregnancy and catastrophic brain injury, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.12.011
