Portal de Periódicos da CAPES

Practicing prenatal diagnosis within the law

2004; Wiley; Volume: 24; Issue: 5 Linguagem: Inglês

10.1002/uog.1747

1469-0705

L. de Crespigny, Frank A. Chervenak, Philippe Coquel, Y. Ville, Laurence B. McCullough,

Legal Systems and Judicial Processes

In such a complex environment we usually rely on the law to guide our practice. In the absence of legal clarity, practitioners need to decide between what they believe to be in the patient's best interests and what minimizes the legal risk to the doctor himself or herself. Legal uncertainty can heighten the concern about the activities of anti-abortion groups, which may encourage practitioners not to offer certain procedures. Uncertainty in the law, both criminal and civil, exposes doctors to the risk of legal action, referral to statutory bodies, and being sued by patients not because management is in error or illegal, but because of uncertain legal guidelines. Yet it is often the controversial cases that ultimately establish the laws in our different countries. We present three exemplary cases that have resulted in new laws or have affected prenatal practice. The cases graphically illustrate the legal vulnerability of those in our speciality and how the lives of those in prenatal diagnosis are impacted by local laws, or by the absence of clear laws. Decided by the US Supreme Court in 1973 Citation: Roe v. Wade, 410 US 113 (1973) This case originated in the State of Texas, which required pregnant women to attend a hearing before physicians to establish that termination of pregnancy was necessary to save the woman's life. Justice Harry Blackmun (appointed by President Nixon) wrote the majority opinion that held that the Constitutional right of privacy protected reproductive decisions within the doctor-patient relationship from intrusion by the state unless the state had compelling reasons for such intrusion. This right of privacy and its application to reproductive decisions had been established earlier by the Supreme Court in a case concerning contraception (Griswold v. Connecticut, 381 US 479 (1965)). One such reason for intrusion would be that the fetus was a person in the meaning of the United States (US) Constitution, which the Court held was not the case. The Court also declined to take a position on ‘when human life begins’ (i.e. when there exist enforceable obligations to protect fetal life), because of long-standing disagreement among scientists, philosophers, and theologians about the moral status of the fetus. The Court presented a ‘trimester’ approach, holding that for the first two trimesters the only relevant issue was the health of the pregnant woman and that therefore the state could, on the basis of reliable evidence, regulate where abortions are provided. The Court also held that the state could protect viable fetuses, except when the life or health of the pregnant woman was at stake. Subsequent rulings clarified that this exception included the mental health of the woman. Roe v. Wade did not establish the right to ‘abortion on demand’ (i.e. the right of a pregnant woman to compel a physician to perform abortion). This is a common misconception. In a subsequent case, Planned Parenthood of Southeastern Pennsylvania v. Casey (60 US 4795 (1992)) the US Supreme Court reaffirmed the right of a pregnant woman to make decisions with her physician about termination of pregnancy, but changed the basis from privacy to a ‘liberty interest’ founded in the 14th Amendment to the US Constitution (which provides that no person shall be deprived of ‘life, liberty, or property without the due process of law’). Casey at the same time put the woman's reproductive rights on firmer Constitutional grounds, but also weakened those rights, because a liberty interest allows more state-imposed restrictions (e.g. mandated waiting period, parental notification in the case of minors) than does a privacy-based right. We chose this case because it is the most important case in reproductive health law in the US during the 20th century. Prior to Roe, some states, such as New York, had legalized access to abortion in some circumstances, but most states (especially Southern states) had laws like that in Texas. The latter were invalidated by Roe, making abortion before the end of the second trimester legally allowed in all states and US territories. Unwanted pregnancy continues to be a major public health problem in the US, especially among teenage women. It is well recognized that physicians are legally free to refuse to perform abortion for any reason, including matters of religious beliefs and other sources of individual conviction and conscience. Since Roe was decided there has been a ‘right to life’ response to it that has strongly influenced American politics and health policy, especially legislation that has tested the boundaries of acceptable restrictions under the Casey ruling, such as attempts to outlaw ‘partial-birth abortion’ (all of which, to date, have been struck down by federal courts under the Roe and Casey frameworks). The ethical justification for the abortion policy that has emerged from Roe and subsequent cases can be established on the basis of the concept of the fetus as a patient. We have argued that, prior to fetal viability, the fetus is a patient solely as a function of the pregnant woman's autonomy and she should have the freedom to confer, withhold, or having once conferred withdraw, the moral status of being a patient on or from her fetus(es). After viability, the fetus is a patient. However, in all cases, the physician's obligations to a fetal patient must be balanced against obligations to the pregnant woman. A major advantage of this approach is that it dispenses with the concept and language of fetal rights, which is an intellectual and clinical quagmire1. F. A. Chervenak and L. B. McCullough The Roe v. Wade decision has had an impact far outside the borders of the US. Would ‘viability’ be considered such a milestone around the world today if it were not for Roe v. Wade? The trimester framework of Roe v. Wade was partly because in 1973 the risks of abortion in the second trimester were higher than they are today and risks were considered substantial in the third trimester. The impact of the case continues today despite the introduction of new techniques that make safe abortion available at any gestational age and the dramatic lowering of the age of ‘viability’. The patients of those of us practicing prenatal diagnosis sometimes choose abortion following the diagnosis of abnormality, particularly when the abnormality is severe. Often too little note has been taken of the impact of the abnormality on ‘viability’. In some cases fetuses with a major abnormality, such as a major heart abnormality, may not be ‘viable’ until well into the third trimester. While we do not support viability as a critical milestone, we argue that those who do so should define viability (i.e. what proportion of fetuses need to survive to make it ‘viable’) and individualize for particular fetuses. The fact that a non-anomalous sibling might survive at 23 or 24 weeks may have little relevance to whether a fetus with anomalies can survive. L. de Crespigny and Y. Ville In February 2000 an acutely suicidal woman was referred to a major teaching hospital in Australia. The fetus was diagnosed with skeletal dysplasia, most likely achondroplasia. The patient, who was 31 weeks' pregnant, requested pregnancy termination and rejected all other options. A geneticist, genetic counselor, obstetrician, obstetric sonologist and psychiatrist all saw her and agreed she was acutely suicidal. It was clear that her ongoing risks would not be solved by short-term psychiatric treatment. Consent for the abortion was obtained from the responsible medical administrator. Intracardiac potassium chloride (KCl) was administered and labor was induced. Autopsy was refused although a photograph of the baby showed features suggestive of achondroplasia. The abortion was performed for psychiatric reasons, not because of fetal abnormality. The likelihood is high that the woman would not be alive today if abortion had been refused. Without prior discussion, 4 months later the Chief Executive Officer of the hospital rang the staff involved, sacked the obstetric sonologist who administered the KCl and suspended the other staff. He indicated that he would report the matter to all of the following: the coroner, the police, a hospital internal inquiry and the Medical Practitioners Board. Over the subsequent week the hospital withdrew the sacking and suspensions while running an intensive media campaign. The Interim Internal Hospital Inquiry concluded that the clinicians acted in good faith; the coroner subsequently resolved that she did not have jurisdiction to investigate the case; the police have indicated that the actions of the medical staff were lawful. The Medical Practitioners Board of Victoria plans to hold an enquiry and now, nearly 4 years later, is still going through the courts attempting to obtain the medical record from the hospital to assess whether there are grounds for suspension or cancelation of registration of the doctors involved. There is no gestational age limit to Victoria's abortion law. There is a second law, the Law of Child Destruction, that applies to a child capable of being liveborn; while there is no case law to indicate when this law might apply, late abortion is said not to be unlawful if done in good faith solely to preserve the pregnant woman's life2. Australian politicians are reluctant to clarify abortion laws—this lack of clarity is the underlying cause of the disastrous sequelae of this case. on the lives of the patient, her family and the staff involved in the case; on the hospital itself—they have been at least part of the reason for the resignation of many doctors from the hospital, including the five staff managing the case; on other institutions, including a call for the Medical Board to be sacked because of their slow response to a complaint about the case, and newspaper headlines criticizing the state coroner's handing over of the patient's private medical records to a politician. Termination review committees have become popular in Australia. This is an unfortunate development as many share some of the problems of the hospital committee that was established immediately following the reporting of this case3. Members of the committee, who include hospital administrators, are anonymous. They decide on the lives of women, the grounds on which they base their decisions is unknown, there is no right of appeal, and there is no ability of the patient to represent herself, or to know how others have represented her. Finally, the case has been divisive in the community. It has been prominent in the press. It has been widely misrepresented as a late abortion for dwarfism, rather than the real reason—because of the high chance of the woman committing suicide. It has become the focus for politicians and others who wish to pursue an anti-abortion line. Whether it will impact on law remains to be seen. This case shows how vulnerable those of us practicing prenatal diagnosis are to a single complaint. This applies particularly in countries where abortion laws are unclear. We care for women who request a potent mix of potentially controversial procedures including abortion, late abortion and feticide, for often similarly controversial indications. A complaint by either the patient or a third party can result in aggressive headline press coverage, enquiries by statutory bodies and even possible criminal charges. We have an ethical responsibility to put the best interest of our patients first, but the fallout can have devastating consequences for both medical staff and patients. If the doctors in this case had refused the patient's request for an abortion there is a high chance that she would have died. The doctors might have again faced the prospect of a coroner's inquest and Medical Board enquiry. They could also have been charged with manslaughter by negligence4, which is punishable by up to 20 years' imprisonment. Abortion law reform is needed—whatever the doctors did they faced the possibility of multiple enquiries, a conviction and a custodial sentence. If a patient is likely to die without an abortion because of a physical illness, abortion is usually legal and most would consider it ethical. If a patient were likely to die without an abortion because of a psychiatric illness, it would be discriminatory to apply different rules. We in prenatal diagnosis have a responsibility on behalf of our patients to demand clear laws in our area of practice, in this case the abortion law. Clear laws will not remove the controversy that is part and parcel of our specialty, but it will allow both patients and doctors to reduce the risk of third-party complainants. Laws in four Australian jurisdictions are still based on an 1861 English law, although the UK Abortion Act 1967 repealed and replaced its antiquated legal statutes5. Many Australian laws relating to abortion are unclear. This exposes Australian women and their doctors to unacceptable legal risks and doctors to unacceptable professional risks. A series of cases and controversies have resulted in recent changes in law in three of Australia's states and territories. The late abortion case illustrates that politicians must introduce clear and consistent laws across the country to replace Australia's current antiquated, inconsistent and often unclear laws6. Those of us in prenatal diagnosis need to be more vocal so that the community can better understand the awful dilemmas facing some of our patients. People empathize with patients facing health problems—a poll in the US showed that while 80% of people say they do not support partial-birth abortions being legal, more than half of this same group would support the procedure to prevent a serious threat to the woman's health7. It is ironic that although the case has added clarity to interpretation of the law and should allow doctors more confidence in offering abortion, in reality it has resulted in an increase in the fears of doctors and it has encouraged development of abortion committees, making it harder for some women to obtain an abortion. Women and their doctors deserve a single clear national law on abortion, both early and late in pregnancy. L. de Crespigny This case documents how a conscientious obstetrician, who is ethically motivated and mindful of legitimate organizational concerns and legal issues, can seek and obtain administrative approval for a controversial procedure and yet not be supported subsequently by the administration. When a doctor seeks and obtains administrative approval in such a case, it is unconscionable for the administrators who provided the approval to later abandon, rather than vigorously support, that doctor. Failure to provide such support violates the administrator's obligation to protect and promote the professional integrity of doctors8. In the US the law regarding patients who are an imminent danger to themselves as a consequence of mental disorder or illness is clear. The law permits an emergency, short-term admission so long as the doctor promptly initiates legal proceedings to commit the patient involuntarily. This legal approach applies independent of whether the patient also happens to be pregnant. Invoking protection of the fetus is not necessary and might not be legally successful. The requirements for involuntary commitment to protect patients who are an imminent danger to themselves are stringent, in order to protect the constitutional and civil rights of people. The law in this area differs from country to country and may also differ from jurisdiction to jurisdiction. The individual facts of each case determine the ethical appropriateness of seeking involuntary commitment. In our view, a critical dimension of this case is that the feticide was not performed for fetal achondroplasia but rather to address a difficult, acute psychiatric problem. Local authorities would be much more likely to respect such a distinction if we had clear and applicable professional guidelines concerning the inappropriateness of third-trimester feticide for fetal achondroplasia. Such guidelines are crucial for maintaining professional integrity, justifying exceptions, and securing the support of administrators whose steadfastness may waiver under the force of external political and other pressures. F. A. Chervenak and L. B. McCullough Nicolas Perruche was born deaf, almost blind and severely intellectually handicapped after his mother contracted rubella in the early stages of pregnancy. Mr and Mrs Perruche brought a wrongful birth claim and were successful. In wrongful birth, damages are recovered by the parents where the physician has breached a duty to practice or impart medical information about potential fetal defects with due care. Damages recovered include the expenses of the child's medical treatment as well as custodial and educational care9. The medical laboratory and her doctor were found to be negligent in failing to diagnose and properly advise Mrs Perruche of her rubella infection. The court found that they had a duty of care to advise Mrs Perruche of the foreseeable risks of giving birth to a child with disabilities due to rubella infection. She would have terminated the pregnancy had her doctor advised her properly. The abortion would have been medically indicated and lawful. Their disabled child then brought a wrongful life claim. Wrongful life is brought by a child to cover anticipated extraordinary expenses as a result of being born with a defect that was either not discovered by the physician or not acted upon9. The breach of duty caused precisely the damage that medical care was intended to prevent: the birth of a child with disabilities due to rubella. The disability afflicting the child was destined to occur with the birth since it was caused by Mrs Perruche's intrauterine rubella infection. All that can be said of the doctor is that his negligence caused the birth; his management was not the cause of the disability. Refusal to accept damage to the child while accepting damage to the parents presents an incoherent, internal contradiction because the damage to the parents is, ultimately, based on exactly the same error as that causing damage to the child. Compensating the parents involves accepting the idea of disregarding the life which, without the error which was committed, would not have existed. The child coming to court asserts that the doctor had a duty to kill him in utero by terminating the pregnancy. The law could not countenance such a duty. The Court of Cassation eventually made the following ruling on the 17 November 2000: ‘Since mistakes committed by the doctor and the laboratory while carrying out their contract with Mrs Perruche prevented her from exercising her choice to end the pregnancy to avoid the birth of a handicapped child, the latter can ask for compensation for damages resulting from this handicap and caused by the retained mistakes.’ The decision generated a great deal of attention in the media. A number of academic writers have argued that wrongful life claims satisfy the basic elements of a traditional negligence action and should therefore be recognized as such. Wrongful life claims have been strongly supported by the judicial community and some philosophers but have been opposed by spokespeople for the disabled, the Catholic Church and the medical community. French people were divided in the ensuing emotional debate about the ethics of abortion, disability and the sanctity of life. Doctors, in particular prenatal ultrasound specialists, believed they had been unfairly penalized for failing to have an unrealistic 100% success rate in detecting fetal anomalies. They feared that it would open the gates to a flood of compensation claims for minor disabilities. This could either result in doctors recommending more abortions or alternatively prevent them from practising. Doctors also saw their insurance premiums increase ten-fold while government fixed fees for patients were too low and had not been increased for 7 years. Pressure by doctors and insurers in particular, but also from an often ill-informed public, ultimately forced the government to act. Some doctors had even ceased carrying out prenatal scans. A new law was passed essentially stating that: ‘Nobody can claim to have been harmed simply by being born’. In a very limited number of cases, and only if the error is ‘obvious’, wrongful life laws allow parents to seek compensation for their direct costs of providing facilities for a severely handicapped child because of a negligent doctor; the award does not include indirect costs (such as alterations of life style and employment) incurred in looking after a severely handicapped child. The costs are theoretically paid by the nation's social security system and by national solidarity—a national health service that provides a minimum amount of vital support. A bill was passed rapidly by an overwhelming majority in an emergency session of Parliament, but it is far from ideal. To be successful the new law would have needed to be based on a more dispassionate debate. Many academics have strongly criticized the new law. Even opponents of the Perruche ruling were critical of the law as it was badly written and vague. It has in fact limited parents' access to damages. The first judgments following the new law have shown that financial compensation awarded by judges has soared. This is paid for by a doctor's insurance. For medical practice, the consequences have been immense. Many insurance companies have left the market and it is becoming very difficult to find a medical insurer. Insurance premiums have soared and show no sign of coming down, forcing many doctors to stop performing fetal sonography altogether. There are a rising number of malpractice suits and insurers are concerned about the increasing size of payouts. A key fact is that the social security system is not able to recover the amount paid for the disabled person's medical care from the doctor's insurer because the compensation is not given to the child. The French discovered wrong-life actions with the Perruche case. Elsewhere in the world9, most jurisdictions reject these claims (e.g. McKay v. Essex, AHA 1982 GB). Three states in the US have allowed wrongful life: California (Turpin v. Sortini, 1982), Washington (Harbeson v. Parke-Davis Inc, 1983) and New Jersey (Procanik v. Cillo, 1984). Claims have been universally rejected when they were related to complications of birth. Life cannot be a damage for which one can be compensated. Wrongful birth and wrongful life cases raise complex moral, religious and policy arguments. The debate continues about the ethics of abortion for medical indications. French law allows abortion to be performed until the last day of pregnancy if the pregnant woman has a severe medical reason or a ‘severe and incurable disease’ affects the fetus. When a disabled child is born, the real issues become economic, not ethical. Nicolas Perruche was forced to turn to the courts so that he could obtain money for his education, and for special equipment necessary for his physical independence. The whole debate has shown the inability of the law to resolve the hurdles that prevent the pregnant woman from exercising her choice to have an abortion in order to avoid the birth of a handicapped child. The only good news to arise from the Perruche ruling is that patients are better informed about the limitations of prenatal sonography. Yet 2 years later, nobody is satisfied. Many think that the problem that first led to the Perruche affair has still to be addressed—there remains a lack of resources to support the parents of handicapped children, in particular those with congenital anomalies. Although the French Parliament has voted for generous laws in favor of disabled people in the past, unfortunately these laws were never put into practice. There has been no improvement in living conditions for the disabled and they can no longer get money from doctors' insurance. Their disability has become a greater burden to them because they are left feeling rejected by society and they receive inadequate support from the state. Some disabled adults, in particular, believe they have been deceived and let down. P. Coquel and Y. Ville The rejection of the concept of wrongful life is, in our judgment, sound public policy. This is because non-existence cannot reasonably be conceived of as a benefit to someone; one must at least be alive in order to derive benefit. This is in contradistinction to a tort injury for wrongful birth, which is understood to be harm to the parents for which they should be reasonably compensated. Parents should be compensated for (or protected by social programs from) the differential costs of medical care, education, support services and, for example, changes in home architecture to remove barriers. There is variation in social support from country to country, resulting in a mix of compensation and protection from costs from both public and private sources. Any decent society has an ethical obligation to effectively look after the disabled and handicapped. This is because these individuals are among the most vulnerable and are therefore entitled to higher levels of support than are individuals without disability or handicap; the healthy individuals do not experience vulnerability. In the US, the American with Disabilities Act outlaws discrimination in employment and housing and federal law also mandates the mainstreaming of handicapped children in local public schools. Wrongful birth is an accepted concept in American tort law. The response to the Perruche case by French physicians underscores the importance of the professional virtues of integrity and self-sacrifice1. Integrity requires that physicians practice medicine and conduct research to standards of intellectual and moral excellence. These standards do not include perfection, i.e., error-free medicine. However, these standards do not tolerate negligence. Integrity should not be compromised. It follows that physicians should not alter the standard of care in response to highly publicized cases such as the Perruche case. There are, however, reasonable limits on self-sacrifice. Physicians have a legitimate interest in recovering the necessary costs of their medical practices, including professional liability premiums10. When, as a direct result of public policy—in the Perruche case, both a court ruling and a new statute—physicians' professional liability premiums increase, public payment systems need to be rapidly adjusted to compensate physicians for a cost, over the increase in which they have no control. Otherwise, public policy makes demands for financial self-sacrifice that physicians rightly judge to be unreasonable public policy and financially very burdensome, if not ruinous. F. A. Chervenak, L. B. McCullough and L. de Crespigny The law, particularly the abortion law, is altered only slowly in response to medical developments. We hope that this Editorial, by highlighting these pivotal cases and discussing the issues arising from them, might lead others to consider the risks and uncertainties in their own countries. It behoves all physicians in prenatal diagnosis to consider the legal limits of practice in their country, to understand any legal uncertainties, and to consider the legal status of new techniques.