Prenatal Screening: Undue Influence?

Dr. James B. Robins MB ChB MPhil MRCOG

Consultant Obstetrician & Gynaecologist

Inverclyde Royal Hospital,

GREENOCK PA16 0XN

Tel: 01475 633777 Ext. 4512

Fax: 01475 656188

Email:

Introduction

Prenatal screening for fetal abnormality, and in particular Down syndrome, has become in the eyes of the Government, the public, the media and health service professionals alike an acceptable part of antenatal care. Yet there are harms that may arise from the offering of these tests. Whilst concerns regarding quality, effectiveness and reliability are regularly debated in the press and medical journals, other issues surrounding prenatal screening such as discrimination, coercion, loss of individual autonomy, and interference with reproductive choice have often been neglected.

Over deference to the scientific aspects of screening and the legitimising of technological innovation, have eroded individual rights to self-determination and autonomy. Of some concern has been the recent introduction of a series of initiatives to modernise antenatal screening that include moves to introduce routine first trimester screening for Down syndrome. The customary offering of this service within the antenatal care package reinforces compliant behaviour and presumes acceptance.

A presumption of acceptance…

Prenatal screening for Down syndrome is unusual as a medical service in that its value does not lie in managing or curing illness but instead in producing information that generates difficult choices for the patient. The information required to make these decisions is complex and technical, contrasting relative risks and involving terms and ideas that are not part of the everyday experience of the woman. Despite an intended neutrality the very act of offering Down syndrome screening, (be it serum screening, nuchal translucency measurement or both), intrinsically puts forth the assertion that possession of this knowledge will be beneficial and empowering.(1) In other words the potential damage of mandatory offering is that women can experience the process of receiving the offer of a test as compulsion. Women come to perceive screening for Down syndrome as an integral part of antenatal care and feel a responsibility to have it.(2)

…and an expectation of compliant behaviour

Recently a group of midwives from Sheffield have described ‘compliant behaviour’ in the antenatal setting.(3,4) Their studies suggest that inequalities in power and status in the maternity services have a greater influence on what happens to women giving birth than either their hopes and dreams or the choices that they feel informed to make. An offer that is made under conditions that take advantage of a woman’s vulnerabilities, when she is hoping for good care and attention and does not want to be seen to disappoint her obstetrician, midwife or general practitioner, does not respect her voluntariness. The woman may fear covertly expressed suggestions of rejection by the professional staff when she wants to be seen to be doing the best for her baby; her resistance is weakened by her desire for the complete antenatal care package, (which is after all almost entirely organized around the provision of prenatal screening tests – in itself a presumption of acceptance).

The woman’s participation in the decision-making process and ultimate choice regarding the administration of a screening test must be voluntary. The decision as to whether or not to be screened should rest on knowledge of potential benefits but remain free from social pressures and coercions. Yet how many simply acquiesce to meet the terms of the service provided?

Provision of information is only one of the necessary conditions – and not a sufficient condition – for informed choice in the context of health care. Competence, (of patients to understand choices), voluntariness (freedom from constraints and coercion), and decision-making ability are also necessary. (5)

Most antenatal patients are competent but in the context of pregnancy care in the United Kingdom it is doubtful whether all decisions are truly voluntary.(5) The real issue in this situation is whether the ‘informed’ choice is freely made. (6)

Consent and the requirement for voluntariness

In traditional medical practice patients ask doctors for advice and treatment for their complaints. The doctor’s duty is to do only that for which the patient has given consent. Screening for asymptomatic or occult disease differs from this: the contact is initiated by health care providers who seek out people who believe themselves to be well with an offer to optimise their future health. By offering to screen, however, the doctor assumes the same duty of care as if the patient had initiated the contact.(7)

Failure to obtain consent for a screening procedure is not only ethically unacceptable but also exposes the provider to the risk of litigation. A subject who has suffered unpleasant or hazardous procedures as a result of a screening test, or who was wrongly reassured by a false negative result, might bring a successful action if she can show that the nature and limitations of the screening process had not been adequately explained or that the test had not been correctly performed.(7)

To give a valid consent subjects must understand the nature of the screening process. In the context of antenatal screening the consequences of a positive screening result must be explained. These can be serious, entailing invasive investigations and possibly culminating in the loss of a normal infant because of a false positive result or a complication of the diagnostic procedure. In addition there is the possibility that a false negative result may be followed by the birth of a severely handicapped child with disastrous emotional and legal consequences. In this regard the Scottish case of McLelland v Greater Glasgow Health Board provides a recent example of a successful claim.(8)

There are three criteria that fall to be determined for legally valid consent to exist and all must be present. Firstly we have to consider whether the patient had both the competence and capacity to give consent. Then we have to ensure that the person giving consent was appropriately informed prior to making a decision. Lastly, the question of whether the consent was voluntarily given arises.

What is voluntariness?

In the context of consent, "voluntariness" refers to a patient's right to make treatment decisions free of any undue influence. A patient's freedom to decide can be impinged upon by internal factors, such as anxiety, or by external factors. External factors include the ability of others to exert control over a patient by force, coercion or manipulation.

Typically, force requires the use of physical restraint or sedation to enable a treatment to be given whereas coercion involves the use of explicit or implicit threats to ensure that a treatment is accepted. Manipulation, however, involves the deliberate distortion or omission of information in an attempt to induce the patient to accept a treatment.(9) Issues of coercion and informational manipulation can arise in prenatal screening and in these circumstances voluntariness may be compromised.

Obviously, the requirement for voluntariness does not imply that clinicians should refrain from persuading patients to accept advice. Persuasion involves appealing to the patient’s reason in an attempt to convince her of the merits of a recommendation. Reasoned argument is never an unjustified form of influence. The goal in this situation is simply to avoid overwhelming the person with frightening information. In attempting to persuade the patient to follow a particular course of action, the clinician still leaves her free to accept or reject this advice.

Voluntariness is grounded in several related concepts, including freedom, autonomy and independence. Legally and ethically the principle of autonomy of the individual is central to any consideration of voluntariness.(9)

Autonomy & voluntariness

There are three primary concepts in the theory of autonomy: competence, freedom and respect. (10) A woman is autonomous if she is competent to make decisions about how she ought to live her life, is free to do so and is respected as an individual within society.

Autonomy involves competence or ability to rule one’s self. (11) Yet, although necessary, competence alone is not sufficient for an individual to be deemed autonomous. In addition to having the ability to formulate a life-plan an individual must also have the freedom to carry out that plan. A fully autonomous individual is free from both the controlling interferences of others and any personal limitations that may prevent meaningful choice.

It is this ability to act free from controlling influence that has been termed voluntariness. As already considered, freedom from external influence is a matter of degree.(12) However, in addition to freedom from control of others there is also the concept of internal freedom. A woman lacks autonomy if she allows intrinsic forces to subjugate her ability to reason. Thus a free individual is one who is free from both extrinsic forces such as deception and intrinsic forces such as fear, pain or discomfort. Autonomous persons typically consider the freedom to act as no less important than adequate understanding.

The final component of autonomy theory is respect. In order for a particular individual’s autonomy to flourish, other individuals and society as a whole must respect that autonomy. Respect for autonomy obligates professionals to disclose information to probe for and ensure understanding and voluntariness and to foster adequate decision-making.

Thus, when considered within the principle of autonomy, voluntariness may be better expressed in the statement “that a person acts voluntarily to the degree she wills the action without being under the control of another influence”.(12)

The legal significance of voluntariness

The ethical principle that each person has a right to autonomy finds its expression in law through the legal concept of consent,

“The fundamental principle underlying consent is said to be a right of self determination; the principle or value of choice of autonomy of the person… It is an ethical principle which is simply reflected in legal rules because our law has been developed by judges sensitive to the practical application of generally held community ethical principles”.(13)

The law has long recognized that a consent or refusal coerced by threats or manipulated by misrepresentations is invalid and seeks to protect autonomy by ensuring that a person’s decision is the product of her freely self-chosen and informed plan.

The terms “voluntariness” and “voluntary choice” are used in connection with matters relating to criminal proceedings – typically, and as in R v Gregory,(14)in relation to the defence of duress. Fortunately, duress, compulsion, force and deception are not usually features of medical practice. However, it would be wrong to forget that there are situations in which coercion may at least hover, typically when medical care is given in prison institutions.(15)

For example, an element of coercion is implicit in the prison doctor-patient relationship. In Freeman v Home Office (No.2),(16) an argument was advanced on behalf of the plaintiff, a prisoner serving a life sentence, who claimed that he had received medical treatment against his will. Freeman claimed that not only had he not consented but also that there were certain contexts in which consent could never be voluntary. It was agreed that whatever the circumstances the issue of voluntariness is a fact but, in the absence of overt coercion, the restricted circumstances in which a prisoner’s consent to treatment is given would be unlikely to affect the validity of that consent in law. However;

‘a court must be alive to the risk that what may appear on the face of it to be real consent is not so’.(16)

But when voluntariness is defined in such a way as to take account of the more subtle pressures to which patients may be exposed, there may be a role for the law in drawing a line between the permissible and the impermissible.(15) In drawing the line it is helpful to note that there are two contexts in which a claim of lack of voluntariness could arise. Firstly the patient may claim that she was treated after a consent that was improperly gained. Alternatively it may be alleged that the patient’s refusal or provision of consent was the consequence of improper pressure.

The English case of Re T (adult: refusal of medical treatment) has established the legal context in which voluntariness should be analysed in relation to medical practice.(17) In Re T the Court of Appeal recognised that for the most part claims of lack of voluntariness do not involve brute force or duress, instead the pressure may be more insidious.

The Court of Appeal in Re T applied a well-recognised and understood doctrine from contract law, that of ‘undue influence’. In applying this doctrine the Court widened the scope of the influences or circumstances that could render a patient’s consent invalid. This is because ‘undue influence’ is a more devious and subtle process than overt pressure and therefore calls for closer examination of the facts.

Re T concerned a young woman’s refusal of consent and whether it was voluntary in view of the influence exercised over her by her mother. The case stands as clear authority that involuntariness can be proved by evidence of undue influence as well as the more obvious examples of circumstances that might overbear the will of the patient. As such the case should be explored in more depth. However, it is first appropriate to briefly outline the concept of ‘undue influence’ that arises in contract law. The standard of ‘undue influence’ is a further example of how law flows from the theory of autonomy.

Vitiating Factors in Contract Law

There are a number of factors that may affect the validity of a contract even though the contract appears legitimate. These are known as ‘vitiating’ factors and normally arise from the circumstances in which the contract was made or from its purpose. Vitiating factors include error, misrepresentation and illegality. However, particularly relevant are the issues of force and fear, facility and circumvention and most importantly ‘undue influence’. They can be considered within the structure applied earlier to external factors affecting voluntariness – force, coercion and manipulation.

Obviously consent obtained by threats of, or actual, physical violence is in the eyes of the law, no consent at all and any contract obtained by such means will be void. The rule of force and fear extends to threats to close relatives and even threatened loss of employment.

The subtler concept of facility refers to frailty or weakness of mind that falls short of insanity but makes a person vulnerable to manipulation and as such would normally be considered an internal factor. Illness, old age, stress or bereavement might bring about this state of mind. It may be temporary or permanent but because it does not amount to insanity it does not remove capacity to contract. It is always considered in association with circumvention. Circumvention is misleading behaviour that falls short of actual fraud.(18) The combination of facility and circumvention can render any contract voidable at the instigation of the victim but there are few decided cases with MacGilvray v Gilmartin a rare modern example. (19)

Undue influence

Influence that prevents someone from exercising an independent judgment with respect to any transaction is considered undue influence. A contract or gift procured by the exercise of undue influence is liable to be set aside by the courts. The exercise of undue influence must normally be proved affirmatively – it must be shown that there is a dealing or transaction in which an unfair advantage has been taken of another person. Undue influence may, therefore, be difficult to prove directly.

However, a presumption of undue influence is made as a judicial tool when certain characteristics are present. Typically, and as established in Gray v Binny,(20) a confidential relationship exists in which one party is in a position of superiority over the other. When the relationship between the parties is such the contract may be voidable at the instance of the weaker party. Typically there will be some element of trust or confidence between the parties but no fraud or deceit, merely influence. Paradigmatic examples include the doctor-patient, lawyer-client and trustee-beneficiary relationships. These are confidential relationships where one person is dependent on another. In these circumstances it is argued that the vulnerable party may be susceptible to the influence of the dominant party. The dependent person may not be free from the control of the influencer because of her dependency. Undue influence does not require that the victim has facility, only that she has been improperly influenced.(18)

A classification of cases of undue influence was adopted by the Court of Appeal in Bank of Credit and Commerce International SA v Aboody, (21) and was quoted with approval by Lord-Browne-Wilkinson in Barclays Bank plc. v O’Brien.(22)

Class 1: Actual undue influence. In these cases it is necessary for the claimant to prove that the wrongdoer exerted undue influence on the complainant to enter into the particular transaction that is impugned.

Class 2: Presumed undue influence. In these cases the complainant only has to show that there was a relationship of trust and confidence between the complainant and the wrongdoer of such a nature that it would be fair to presume that the wrongdoer abused that relationship in procuring the complainant to enter into the impugned transaction. Once a confidential relationship has been proved, the burden then shifts to the wrongdoer to prove that the complainant entered into the impugned transaction freely. Such a confidential relationship can be established in two ways;