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Health care practitioners’ priority is the provision of the highest standard of care within the constraints of the resources available to them: no obstetrician or gynaecologist goes to work with the intention of providing substandard care and causing harm to one’s patients.
The nature of the practice of medicine, and obstetrics in particular, involves uncertainty. The majority of pregnancies are in healthy women who remain healthy and give birth to healthy babies at term. However, the course and outcome of any pregnancy is unpredictable such that physiology can evolve into pathology within a very short time frame.
Therefore, it is not surprising that when an adverse pregnancy outcome occurs, questions are asked as to how such a situation could have arisen and why it was not anticipated and prevented: expectations of a happy outcome are high. With this in mind, obstetrics is sometimes referred to as a ‘low-risk, high-stakes’ specialty, in which the ‘low risk’ refers to the naturally favourable likelihood of a happy outcome (healthy mother and healthy child) and the ‘high stakes’ refers to the devastating consequences of the loss or permanent injury to a mother or child.
The practice of gynaecology is more predictable than obstetrics. However, complications arising from planned surgical intervention not uncommonly result in patient dissatisfaction. Careful and thorough discussion of all relevant treatment options forms the cornerstone of shared decision-making, which is a key component of obtaining informed consent prior to any surgical intervention.
Against such a background, there is inevitably a low threshold to investigate and intervene during pregnancy, with some practitioners making recommendations based on personal experience and anecdotal practice. Herein lies the potential to generate large variations in practice, resulting in inconsistent care, inconsistent advice and poor service. In an effort to improve the consistency of care, evidence-based guidelines have developed over the past 3 decades and have become the principal determinant of the standard of care to be expected by a patient attending an obstetrician or gynaecologist. Such national and international guidance is adopted by regional service providers (groups of hospitals) in the form of local protocols which are to be adhered to, reflecting as they do the resource constraints of the local service and the local patient demographics. Guidelines and protocols have naturally evolved to often become the standard against which the standard of care in an individual case is judged.
For the purposes of civil justice, the United Kingdom has three separate legal jurisdictions: England and Wales, Scotland and Northern Ireland. UK law in each jurisdiction encompasses primary legislation (Acts of Parliament), secondary legislation (regulations made under or by virtue of primary legislation) and case law. Case law, also known as common law, is based on previous judgements (judicial rulings), which have set precedents for the interpretation and application of the law in similar cases. Case law from other similar jurisdictions – for instance, other UK and Commonwealth countries – is often considered if relevant.
Judgements of the UK Supreme Court on identical or very similar primary legislation will be taken as binding in all jurisdictions. Legislation – primary or secondary – supersedes case law but applies only in the jurisdiction in which it was passed.
An expression of dissatisfaction or a written complaint is addressed by the complaints department of an institution. This is a process which usually results in an apology. Beyond this, each hospital has a process whereby adverse outcomes such as stillbirth or an injury sustained by a child during birth are investigated and a detailed report is generated. The findings of such a report are shared with the parents, an explanation provided, an apology when appropriate, and changes to practice via education and reallocation of resources are made if required. Individual hospitals are not in a position to provide financial compensation for loss, harm or injury. If a patient is not satisfied with the explanation provided or questions the independence of the process, the patient can seek an independent review via the relevant health ombudsman.
When a patient is seeking financial compensation in connection with a complaint, litigation is the mechanism whereby this is pursued. There is no other mechanism whereby a patient can receive compensation for loss of earnings, psychological harm, loss of society and so on. In order for litigation to be successful, the patient (pursuer) must demonstrate that they have sustained harm as a consequence of substandard care. A time limit of 3 years from the event or from when the patient becomes aware of the event is generally applied. However, when a child is involved, the time limit is from when the child become an adult, that is, up to 21 years after birth. Hence, some obstetric cases commence many years after the event.
Medical negligence has a precise meaning, which is encompassed by ‘substandard care provided by a medical professional which has directly caused injury or caused an existing condition to worsen’. Substandard care is often referred to as a ‘breach of duty of care’, in which a breach of duty represents actions which fall below the standard of care likely to be expected by a reasonable person.
In medical negligence, the standard of care is defined by case law. In England, the test is that set out in the case of Bolam v Friern Hospital Management Committee [1957] 1 WLR 582, 587. Mr Bolam underwent electro-convulsive therapy and, as a consequence, experienced serious physical injuries. The ruling in this matter can be summarised as ‘…if a doctor reaches the standard of a responsible body of medical opinion, they are not negligent’ and has become known as the ‘Bolam test’. This was refined in Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] AC 871, a case focussed purely on consent, in which Mrs Sidaway alleged that her surgeon was negligent in omitting to warn her of the risk of paralysis as a complication of spinal surgery. She lost the case (on appeal), as the majority ruling supported application of a qualified Bolam test to the consent process. In essence, Sidaway held that failure to warn of risks would not breach a doctor’s duty of care if a body of medical opinion accepted this ‘failure to warn’ as proper.
In Scotland, the ruling in the case of Hunter v Hanley [1955] SC 200, 206 is referred to. This case relates to injury sustained by the breakage of a hypodermic needle. The ruling in this matter can be summarised as ‘…the true test for establishing negligence on the part of the doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of, acting with ordinary care’. It also required persons alleging negligence to show that if they had been warned of a risk they would have declined treatment, placing the onus on patients rather than doctors.
Within the context of medical negligence, broadly speaking, the standard of care that must be provided is not the highest standard but must not fall below the standard of care that a proportion of other competent clinicians would provide. This presents a high bar which has to be reached in order to prove medical negligence.
The burden of proof in medical negligence cases, however, is relatively low. Medical negligence cases are civil and not criminal cases. In civil cases, the level of proof required is ‘on a balance of probabilities’, i.e., 51% or more chance to have been responsible for an adverse outcome or consequence, whereas in criminal cases the level of proof is ‘beyond reasonable doubt’. What this translates to is that if, for example, a doctor did not request an investigation when necessary, resulting in delayed diagnosis and injury, then it only has to be probable rather than certain that an earlier diagnosis would have been made and only probable rather than certain that subsequent injury would have been avoided or minimised.
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