Chapter 2 Legal considerations
Litigation as a result of medical treatment is increasing. This chapter provides guidance on some of the most common issues likely to arise in the labour ward. However, it is only a brief summary of the law in England and Wales, and in cases of any doubt legal advice must be obtained.
A patient has the right under common law to give or withhold consent to medical examination or treatment. The courts have ruled that a mentally competent person has an absolute right to refuse to consent to medical treatment for any reason, rational or irrational, or for no reason at all, even where the decision may lead to the patient’s own death. Until the Mental Capacity Act comes into force in April 2007 (see below), no one else (even next of kin) can consent on behalf of an adult patient (whether competent or not): it is a widely held misconception that a family can consent on behalf of the patient – they can not. The different types of consent are outlined in Box 2.1.
Implied: Consent not discussed but implied by action. An example is offering arm for venepuncture.
Verbal: Consent is sought and verbal permission for procedure is obtained. Documentation of this is advised.
Written: Documentation must be obtained if procedure or treatment carries risks or has side effects.
Patients are entitled to receive sufficient information in the way that they can understand about proposed treatments, possible alternatives and any significant risks (which may be special in kind or magnitude or special to the patient), so that they can make a balanced judgement. Box 2.2 lists the essential features of informed consent.
Box 2.2 Essential for informed consent
A woman who is mentally competent to make a treatment decision may choose not to have medical intervention, notwithstanding the risk to her health, and even though the consequences may be the death or serious handicap of the child she bears or her own death. It is the patient’s right to make such a decision and medical staff have no power to override this. Furthermore, in such cases the court does not have jurisdiction to declare medical intervention lawful.
Those over 16 years can consent to treatment on their own behalf. For those under 16, the person(s) with parental responsibility has the power to make treatment choices for the child, unless the child is ‘Gillick competent’, in which case the child can consent. The wellbeing of the child is paramount. Application may be made to the court (as part of its inherent jurisdiction or under the Children’s Act as a specific issue order) to provide legal sanction for a specific action when doubt or dispute arises.
Patients with mental illness or disability have the same rights as other patients. Mental illness (even detention under the Mental Health Act) does not of itself render them incompetent to make treatment choices unless their illness is so severe so as to mean that they are unable to make a treatment choice and are thus incompetent (see below). However, patients detained under the Mental Health Act can be treated without consent under the direction of their resident medical officer (RMO) if the treatment is for their mental disorder (section 63 Mental Health Act).
Such patients absolutely refuse the transfusion of blood and blood products even where life is put at risk. Alternative treatment should be considered. It is essential to establish the views held by each Jehovah’s Witness patient as some transfusion treatments may be acceptable (such as blood salvage techniques, haemodilution, haemodialysis, cardiopulmonary bypass, albumin, immunoglobulin, clotting factors). To administer blood in the face of refusal may be unlawful. Mentally competent adult patients are entitled to make such a refusal even if others may percieve this to be unwise. This may be by advance directive (which may be oral or written). Treatment of the children of Jehovah’s Witnesses may require application to the court for an order.
In determining if a patient is mentally competent, and therefore whether she has capacity to consent to, or to refuse treatment, the patient must be assessed as being able to:
Only if the patient can do all this is she capable of consenting. This test relates to the patient’s ability to make a decision but is not concerned with the rationality of it – a capable patient is entitled to make a wholly irrational decision.
Advance directives are decisions made while a person has the necessary mental capacity, intended to give effect to wishes as to how treatment or care should be provided in the event they lose capacity.
Advance directives are recognised by English law. They are potentially valid instructions as to which medical treatment that person would or would not be prepared to accept if she should subsequently lose the capacity to decide. However, clinicians are not legally bound to provide treatment if it conflicts with their professional judgement about the most appropriate treatment. Nevertheless the patient’s wishes should be taken into account in deciding the appropriate course of action. An advance directive cannot authorise a doctor to do anything that is illegal. They may express preferences between treatment options or list an individual’s values as a basis for others to reach decisions. They can be in writing or oral.
Healthcare proxies (i.e. the purported delegation to a third party of the right to make a decision to consent to or refuse medical treatment) are not recognised currently in English Law.
Only if the patient is not mentally competent can treatment proceed without consent. In which case the following must also apply:
In 2007 the law relating to adults who lack capacity will be changed and governed by the Mental Capacity Act 2005. It provides a statutory framework for assessing whether a person has capacity and a regime for making decisions on their behalf. It has wide ranging applicability covering both financial affairs and personal welfare (including healthcare decisions).
The Mental Capacity Act is underpinned by five key principles:
The Act defines incapacity as an inability to make a particular decision because of an impairment of, or a disturbance in the functioning of, the mind or the brain. Capacity is issue specific: an individual may have capacity to undertake some decisions but lack capacity in respect of more important ones. Capacity cannot be established merely by reference to a person’s age, appearance or any condition or aspect of a person’s behaviour which might lead to unjustified assumptions about capacity.
Capacity is to be assessed using a statutory test. This specifies that an individual is lacking capacity if they are unable to make decisions due to:
If an individual is assessed as lacking capacity, everything that is done for or on behalf of that person must be in the person’s best interests. The Act defines best interests and provides a checklist of factors that must be considered when deciding when to act in a person’s best interests. An individual may put their wishes and feelings into a written statement in advance, which should be taken into account. The Best Interests Check-List includes the following:
When care or treatment are being provided for an individual who lacks capacity, the healthcare professional will not incur legal liability if this is undertaken in the individual’s best interests. However, restraint2 is only permitted if the person using it reasonably believes it is necessary to prevent harm to the incapacitated person and it is proportionate to the likihood and seriousness of harm.
The Act creates a new role, allowing an individual to appoint an attorney to act on their behalf if they lose capacity in the future. The Lasting Power of Attorney (LPA) replaces the current Enduring Power of Attorney. An LPA can be used to appoint an individual to make decisions for a person who lacks capacity relating to their welfare and finances, as well as healthcare. This therefore permits an individual to appoint a Healthcare Proxy. Where a Healthcare Proxy is appointed under the terms of the LPA, that individual has all the rights to make decisions as to the healthcare of that individual that the incapacitated person would be able to make themselves if they had capacity. Where expressly granted, this can include decisions regarding life sustaining treatment.
The Court of Protection can appoint a deputy. This will replace the current system of receivership. Deputies will be able to make financial decisions as before, but will also be able to make decisions on welfare and healthcare.
Where a person lacks capacity and, amongst other circumstances, serious medical treatment is proposed, an IMCA must be instructed. The IMCA makes representations about the person’s wishes, feelings, beliefs and values and acts as an advocate for that person. They cannot make decisions on behalf of the incapacitated individual.
The Common Law previously recognised Advance Directives (see above). The Act provides statutory rules for Advance Decisions. However, there are no formal requirements, nor does an Advance Decision need to be in writing, unless the Advance Decision relates to life sustaining treatment. Where it does, the Advance Decision must be in writing, signed and witnessed, and must expressly address the issue of life sustaining treatment.
The Act introduces a new Criminal Offence where an individual ill-treats or neglects a person who lacks capacity.
The Act provides a detailed regime where research is undertaken involving individuals who lack capacity.
The Mental Capacity Act is intended to provide a legal framework for all issues relating to those who lack capacity. A Code of Practice is to be published (publication is currently awaited) providing guidance and information on the implementation of the Act and advice on good practice. Unless there is good reason to depart from the provisions of the Code, its guidance should be followed.
If the patient’s competence is unclear, the court can be asked to consider this. If the court finds that the patient is incompetent it can declare that a proposed treatment is lawful, even if the patient does not consent. Such declarations should be sought before treatment and can be obtained urgently at short notice.
Surrogacy is an arrangement made before conception for a woman to hand over her child to another person.
Termination of pregnancy (TOP) may only be undertaken by a registered medical practitioner in accordance with the provisions of section 1 of the Abortion Act 1967. Otherwise any termination will be unlawful. The Abortion Act requires:
Patient information may not be used for a different purpose or passed to anyone else without the consent of the patient. ‘Patient information’ applies to all personal information held in whatever form. It includes medical details and a patient’s name and address, financial and domestic circumstances, etc. A patient should be informed of the uses to which information about them may be put. (Note that the use of personal data is restricted by the Data Protection Act.)
A patient’s healthcare information is held under legal and ethical obligations of confidentiality and should not be used or disclosed without consent. There are however exceptions to this rule that apply in certain specific circumstances.
A patient should be informed of the likely use and disclosure of their information associated with their healthcare. They should also be made aware of the choices that they have (and the implications of those choices) as to how information may be used and shared. Thereafter explicit consent is not usually required for use of the information for the purposes described and within the ambit of the consent given. Even then healthcare information should only be shared among the healthcare team on a ‘need to know’ basis.
There are however uses for information that are not directly associated with healthcare that individuals receive: research, public health, health service management, clinical audit. Specific consent should be obtained from the patient before patient information is used in connection with these.
Disclosure of information is restricted by a wide range of legal obligations including the Common Law of Confidentiality, the Data Protection Act 1998, the Human Rights Act 1998 and a further specific legislation that is beyond the ambit of this chapter (such as the restriction on information related to sexually transmitted diseases including HIV under the NHS Trusts and Primary Care Trusts (Sexually Transmitted Diseases) Directions 2000).
In the absence of consent from the patient, confidential information may only be disclosed:
It is the duty of the father or mother to notify within 42 days the Registrar for the Sub-District in which the birth takes place. If the father or mother are unable to do this the duty falls on the hospital authority in which the child is born.
For stillborn births, the information to be provided to the Registrar is a written certificate that the child was not born alive. The certificate must be signed by the registered practitioner or midwife in attendance at the birth or the person who has examined the body. A stillborn child is one born after 24 weeks of pregnancy who did not breathe after birth.
If an abandoned baby is found, the obligation to notify the Registrar falls on the person finding the child.
For adopted children, the obligation falls on the natural mother and father.
All births (in hospital or at home) must be notified by a doctor or midwife attending at the birth to the district medical officer within 36 hours.
Medical staff owe patients a duty of care. The standard of care is to act in accordance with practice that would be accepted by a responsible body of similar practitioners (Bolam v Friern 1957).
There is no breach of the standard of care if:
Table 2.1 presents some common situations that may lead to litigation with suggestions as to how to avoid them.
Table 2.1 Common situations leading to litigation – and how to avoid them
| Complaint | Prevention |
|---|---|
| Patient did not consent | Ensure a patient has full information and consents to any treatment |
| Shoulder dystocia | Ensure senior staff are involved in delivery and carry out drill procedures |
| Cardiotocograph tracing shows ominous fetal heart rate patterns | Call for prompt medical assistance |
| Delay in proceeding to caesarean section in an emergency | Ensure all staff are aware of warning signs for the need to proceed to operative delivery and put in place necessary protocols to ensure this is achieved quickly (decision to delivery in 30 minutes) |
| Fetus delivered too early ‘by dates’ | Double-check dates at each antenatal appointment |
| Damage to the perineum | Experienced staff to follow established protocols |
Clear and detailed medical records enable communication between members of the clinical team. As such medical records are an important part of ensuring the quality of patient care. They also provide the best defence for staff when matters go wrong. Full and detailed notes should be made in all cases and clearly signed by the member of staff making them. A failure to do so may make a claim for compensation indefensible, or the fact that notes are incomplete can give rise to a breakdown in communication and thus poor patient care.
Therefore, record all important steps and decisions on patient care as contemporaneously and fully as possible, timing the entry and the time the event occurred. Sign, print name and indicate grade.
The European Convention on Human Rights is now part of English Law (Human Rights Act 1998). Public authorities (such as NHS hospitals) must not act in a way that is incompatible with an individual’s rights under the Convention including:
Where issues arise regarding an individual’s human rights, legal advice should be sought.
Clinical governance is the organisations’ concept of total quality management mapped across medical practice. It is defined as a framework of practice where there is continuous improvement in service quality in an environment which encourages excellence in clinical care.
Well-trained staff involved in regular audit and risk assessment form the cornerstones for quality care. Regular appraisal of staff to determine competency, proper supervision and continuing education will maintain high standards of clinical capability. Constant audit of process and procedures ensure improvement of service. Steps which will contribute to minimise clinical risk are listed in Box 2.3.
Box 2.3 Essentials of risk management
Abortion Act. London: HMSO. 1967.
Association of Anaesthetists of Great Britain and Ireland. Information and Consent for Anaesthesia. London: Association of Anaesthetists of Great Britain and Ireland, 1999.
Bolam v Friern Hospital Management Committee 1957 2 All ER 118 1 WLR 582 Judgement of Mr Justice McNair
British Medical Association. Consent Toolkit, 2nd edn., London: BMA, 2003.
Department of Health. Reference Guide to Consent for Examination or Treatment. London: HMSO, 2001.
Department of Health. Confidentiality: NHS Code of Practice November 2003. London: HMSO, 2003.
General Medical Council. Guidance: Intimate Examinations. London: GMC, 2001.
General Medical Council. Ethical Guidance. London: GMC, 2002.
HC(90)22 HC(90)22 A Guide to Consent for Examination or Treatment
HSG(92)32 HSG(92)32 Patient Consent to Examination or Treatment Model Forms
Human Rights Act. London: HMSO. 1998.
Medical Defence Union 1992 Consent to Treatment. Available from the Medical Defence Union (MDU). Tel: 0207 486 6181
Medical Research Council. Human Tissue and Biological Samples for Use in Research. London: MRC, 2001.
Mental Health Act. London: HMSO. 1983.
National Collaborating Centre for Women’s and Children’s Health. Caesarean Section. In: Clinical Guideline. London: RCOG Press; 2004.
Royal College of Obstetricians and Gynaecologists. The Care of Women Requesting Induced Abortion, Guideline. In: Setting standards to improve women’s health. London: RCOG; 2002.