Section 1: The legal structure of negligence

A few words about error

If our aim is to reduce the number of clinical errors, then we must explain what we mean by ‘error’. The Oxford English Dictionary defines ‘an error’ as a mistake. This is self-evident and does not really help us, the authors, to define our goal.

We could define our aim by looking at the end-result of errors and say that we want to prevent poor patient outcomes. That must be our primary concern, but our aim is broader; many mistakes can be rectified before any serious harm is done.

We could look at the seriousness of the error, how ‘bad’ the mistake actually was. Some errors could be so crass and the consequences so serious that they can be labelled ‘criminal’ by one and all and in fact some cases are investigated by the police and come before the criminal courts, as we shall see later. Other errors are the sort that only become obvious with the benefit of hindsight and could be made by anyone, even the best of doctors. In short, we want to look at all errors across the spectrum. What we hope to achieve is to raise the standard of care provided to patients, so that mistakes of all kinds are reduced.

But as soon as we mention error, the word negligence also springs to mind. The law has defined negligence in specific terms and not all errors will be considered negligent. But since the law looms large in any discussion of clinical error, we will now provide a brief explanation of what negligence in a legal context actually means and on how the compensation that we mentioned in our Introduction is calculated, when negligence occurs.

Medical negligence

If a doctor makes a mistake in the treatment of a patient, then he or in the case of a child, his family, may decide to pursue the doctor for compensation. Generally speaking, in order to win compensation, the family will have to prove that the doctor (or the collectively the practice, or Trust) were negligent.

Negligence

Before looking in detail at what is relevant to this book, medical negligence, we need to know the basics that lie behind what is called the tort of negligence (tort is simply the old French word for wrong; in modern legal terms, it forms a branch of legal study).

In principle, a person is liable in negligence if he breaches a duty owed to another in such a way as to cause damage to that person. What does this mean? In practical terms, in order to decide whether an act is negligent, a lawyer will break this formula down, looking at each of its constituent parts, phrase by phrase, word by word. For example, he will ask himself whether a duty of care exists between the injured person and the alleged defendant.

It may not always be clear whether a duty exists in a given set of circumstances, but as far as medical treatment is concerned, it is assumed that a doctor owes such a duty to his patient. The key questions in any medical negligence case are whether that duty to take care has been breached and then if it has, whether any damage has been caused as a result of that breach.

Has there been a breach of duty?

When the treatment of a patient comes under scrutiny in a potential negligence claim, the first question that will be asked is: was that treatment in accordance with the standards of a body of reasonable or responsible general practitioners? If it was, then the general practitioner will not have breached their duty of care; but if the treatment does not accord with the standards of a reasonable body of general practitioners, then they will have breached that duty.

This test was first formulated by the House of Lords in the case of Bolam v Friern Hospital Management Committee in 1957. Hence the Bolam test.

Over the years, a body of cases has built up that indicates how this Bolam test should be applied. How, for instance, should we look on a case, where in a given set of circumstances, one set of general practitioners may treat a patient in a certain fashion, while others would adopt a different approach? Answer: it is enshrined in case law that so long as both bodies of general practitioners are reasonable/responsible, then it would not matter which of the two approaches the doctor adopted. In other words, it is possible to have more than one correct approach to treatment.

But this begs the question: who determines whether you have breached your duty of care?

If a general practitioner has received a letter of claim from the solicitors representing the family concerning the treatment of a patient, this should indicate that the family have investigated the case and gone to medical experts who have written reports critical of the care provided. At first blush, there is a case for the doctor to answer.

In response, the defence organization of the general practitioner, or the lawyers for the Trust, will instruct experts to look at the allegations made against it. The experts will be asked to consider both breach of duty and causation. So in the first instance, the answer to the question is that the opinions of the experts, as interpreted by the lawyers, will determine the progress of the case. If both experts, the expert for the family and the expert for the defendant believe that the care was substandard (it did not accord with the standards of a reasonable body of general practitioners), then it is likely that the defence organization will concede that the treating doctor has breached their duty of care. But what happens, if the expert for the defendant general practitioner concludes that the treating clinicians have not breached their duty of care?

At this point one may say that the difference in the two opinions, that of the family’s expert and that of the defendant’s expert, simply reflects two different approaches. Have we not just said that a doctor will not breach his duty of care, so long as he acts in accordance with a reasonable body of opinion? Has not the general practitioner’s expert supported the clinicians’ care? Is this not enough?

The short answer is that it may be, but not necessarily. The Bolam test has been qualified or rather refined by the case of Bolitho v City and Hackney Health Authority. The judges in this 1993 case stated that although one group of so called reasonable practitioners may adopt a certain approach to treatment, if that approach does not stand up to logical analysis, then a doctor cannot expect his treatment of the patient to be endorsed, if he adopted that apparently ‘reasonable’, but illogical approach to treatment. This is just one way in which the competing views of experts may be resolved. But it may come down to something less tangible: merely that one expert is more believable than another.

At the end of the day, if the case cannot be determined by other means, it will come before a judge, who will hear all the evidence, listen to the experts and decide which of them he prefers. It is, of course, he who will be the final arbiter. But before then, depending upon where in the United Kingdom the case is brought (the procedural rules differ from jurisdiction to jurisdiction), evidence will have been disclosed, meetings will be held and views will crystallize. The experts for the opposing sides will have met and their opinions may shift one way or the other. The reality is that few cases will go before a judge. They will either be settled out of court or the patient or family will decide to drop the case.

Causation

But let us assume that the patient proves that the general practitioner has breached their duty of care to him or her. This does not automatically mean that they will be awarded any money. In order to obtain compensation, they must clear the causation hurdle. They must demonstrate that the breach of duty caused some injury or damage to them, that it changed the outcome for the worse.

In some cases, causation is uncomplicated and straightforward. In others, it can be fiendishly complex. In the context of this book, we shall not delve too deeply into its intricacies, but hope to give you some idea of its basic concepts.

As an example of straightforward causation, take the case of a general practitioner who misdiagnoses acute angle closure glaucoma as migraine and the patient loses the use of one eye. It will be relatively easy to prove causation because if the condition was suspected and diagnosed while the patient had a painful eye but good sight, swift treatment would have saved the sight.

Causation will be far less easy to prove in a case of delayed diagnosis of colorectal cancer. At diagnosis the patient had inoperable disease with distant metastases. Would the metastases still have been there if the general practitioner had referred the patient 9 months earlier? The patient died of his disease, but would he have lived but for the delay?

Damages

The purpose of a claim in negligence is to provide the patient or family with compensation for any harm done to him through substandard care. Once it is established that the doctor has breached his duty of care to the patient and that that breach has caused injury, the court will move on to determine how much the claimant should be awarded in damages.

Clearly, it is impossible to adequately compensate someone in monetary terms for the physical disabilities they may suffer as a result of negligence, but the idea behind compensation is to put the patient or family in the same position as they would have been, if the error had not been made.

The patient will be given a sum of money which is designed to compensate him for his pain and suffering. He will also receive a sum to compensate him for any monetary expense arising from the negligence which he has incurred in the past: for example, the costs of physiotherapy.

Finally, he will be compensated for the future losses that he will incur as a result of the negligence. The sorts of loss will depend on the severity of the injury. In the most severe cases of brain damage, the compensation for future loss could include sums for loss of earnings, the cost of buying and adapting a suitable home, the costs of nursing care, physiotherapy, occupational therapy, speech therapy and computer technology to aid in communication. Over the lifetime of a brain-damaged child, for example, the loss that he will suffer as a result of negligence could easily be several million pounds, depending on his life expectancy.

The claimant may receive the damages as a one-off lump sum payment. Alternatively, he may receive periodical payments spread over his lifetime.

If, however, the patient dies as a result of negligence, then the damages will be very limited. His estate will be awarded a sum for his pain and suffering and his funeral expenses. The family will also receive a statutory sum for bereavement damages that is currently set at £11 800.

The limitation period

An adult injured through medical negligence has three years to start his claim formally in the courts. (This three year period runs essentially from the time when the negligence occurred, but is more accurately defined by when the person harmed knew of the negligence.) Although the court can extend this limitation period in certain circumstances, if he fails to start court proceedings within these three years, he can no longer pursue his claim.

The rules concerning children are different. Children are not considered to have legal capacity until they are 18. Before then, a child’s case will be brought on his behalf by his parents, standing in the child’s legal shoes. The ‘limitation clock’ does not start to tick until the 18th birthday. Therefore, a child who has suffered injury has until he is 21 to bring a claim.

However, if a person lacks mental capacity beyond the age of 18, the limitation clock may never start to run. He can then bring a case at any point in his life. ‘Mental capacity’ in this context means the ability to run one’s own financial affairs; it is different from the test for capacity in consent cases (see below).

The most expensive cases, the ones that cost millions of pounds, are often those that concern brain-damaged infants from the most severe cases to those suffering some form of developmental delay (e.g. through an alleged delay in diagnosing and treating meningitis). It is not unusual for these cases to be litigated 20, 30 or more years after the date of the alleged negligence. This may seem strange. There are several reasons why this may be so. But the family often only discover the true difficulties of looking after a brain-damaged child when the child grows older and his lack of mobility becomes a problem and it may be only then that their thoughts turn to suing the clinical team that treated their child. Or it may be that the family’s lawyer will advise them to delay the claim until the impact of the injury on the child and family can be fully assessed.

When a patient dies, whether a child or an adult, his personal representatives will have three years to start proceedings. This three years runs from the date of death or when it was known that there had been a mistake, if this is later.

Jurisdictions

The United Kingdom is divided into a number of different legal jurisdictions. In certain areas of law, England and Wales, Scotland and Northern Ireland have their own, different set of rules, as do also the Channel Islands and the Isle of Man. However, what we have said above about medical negligence applies to all jurisdictions. (The Scottish word for tort is delict, but the principles are the same.) However, these jurisdictions do have their own rules for procedure, that affect how a case is litigated.

The defence of the NHS trusts in medical negligence cases is also organized in different ways. Thus the NHSLA is responsible for cases in England, whereas Welsh Health Legal services is responsible in Wales. In essence, however, defence of such cases is financed out of central funds, no matter where in the United Kingdom NHS hospital cases are litigated. General practitioners are generally represented by one or other of the Medical Defence Organisations (MDOs): either the MDU, MPS or the MDDUS.

Learning from system failures – the vincristine example

The way that the courts look at negligence is to focus on the acts of individuals and to ascribe fault to particular doctors, if their treatment of the patient fell below the standard of the Bolam test. But as mentioned in our Introduction, there is another way of looking at errors and that is to consider system failures.

In order to illustrate the difference between system failures and individual fault, the authors of An Organisation with a Memory examined a case concerning the maladministration of the drug vincristine. The mistake cost the patient, a child, his life. A number of shortcomings occurred during the child’s stay in the hospital. The events obviously occurred in hospital but the detailed analysis in the report shows well the generic mix of system and personal errors that lead to medical tragedies. We believe that it would be useful to set out what happened in the lead up to this child’s death, pointing out at each stage, the failings that occurred. We will then provide a more detailed discussion of the general lessons that can be learnt from the case, and its applicability to medical mistakes in general.

The following is taken with minor amendment from An Organisation with a Memory. It is a classic example of how a number of small mistakes can add up to a massive error and end with a fatality. The comments in italics provide a brief analysis of the faults that occurred:

A child was being treated in a district general hospital (DGH). He was due to receive chemotherapy under a general anaesthetic at a specialist centre. He should have been fasted for 6 hours prior to the anaesthetic, but was allowed to eat and drink before leaving the DGH.

Fasting error. Poor communication between the DGH and the specialist centre.

When he arrived at the specialist centre, there were no beds available on the oncology ward, so he was admitted to a mixed-specialty ‘outlier’ ward.

Lack of organizational resources; there were no beds available for specialized treatment. The patient was placed in an environment where the staff had no specialist oncology expertise.

The patient’s notes were lost and were not available to the ward staff on admission.

Loss of patient information.

The patient was due to receive intravenous vincristine, to be administered by a specialist oncology nurse on the ward, and intrathecal (spinal) methotrexate, to be administered in the operating theatre by an oncology Specialist Registrar. No oncology nurse specialist was available on the ward.

Communication failure between the oncology department and the outlier ward. Absence of policy and resources to deal with the demands placed on the system by outlier wards, including shortage of specialist staff.

Vincristine and methotrexate were transported together to the ward by a housekeeper instead of being kept separate at all times.

Drug delivery error due to noncompliance with hospital policy, which was that the drugs must be kept separate at all times. Communication error: the outlier ward was not aware of this policy.

The housekeeper who took the drugs to the ward informed staff that both drugs were to go to theatre with the patient.

Communication error. Incorrect information communicated. Poor delivery practice, allowing drugs to be delivered to outlier wards by inexperienced staff.

The patient was consented by a junior doctor. He was consented only for intrathecal (IT) methotrexate and not for intravenous vincristine.

Poor consenting practice. Junior doctor allowed to take consent. Consenting error.

A junior doctor abbreviated the route of administration to IV and IT, instead of using the full term in capital letters.

Poor prescribing practice.

When the fasting error was discovered, the chemotherapy procedure was postponed from the morning to the afternoon list. The doctor who had been due to administer the intrathecal drug had booked the afternoon off and assumed that another doctor in charge of the wards that day would take over. No formal face-to-face handover was carried out between the two doctors.

Communication failure. Poor handover of task responsibilities. Inappropriate task delegation.

The patient arrived in the anaesthetic room and the oncology Senior Registrar was called to administer the chemotherapy. However the doctor was unable to leave his ward and assured the anaesthetist that he should go ahead as this was a straight-forward procedure.

Inadequate protocols regulating the administration of high toxicity drugs. Goal conflict between ward and theatre duties. Poor practice expecting the doctor to be in two places at the same time.

The oncology Senior Registrar was not aware that both drugs had been delivered to theatre. The anaesthetist had the expertise to administer drugs intrathecally but had never administered chemotherapy. He injected the methotrexate intravenously and the vincristine into the patient’s spine. Intrathecal injection of vincristine is almost invariably fatal, and the patient died 5 days later.

Situational awareness error. Inappropriate task delegation and lack of training. Poor practice to allow chemotherapy drugs to be administered by someone with no oncology experience. Drug administration error.

Although the authors of An Organisation with a Memory analyze this sorry tale in the context of system failures, rather than individual fault, it is clear that many of the failings represent a mixture of the two. Many of the actions undertaken by an individual member of the hospital staff could be analyzed in terms of the Bolam reasonableness test and be found wanting, i.e. the individual would be found to be in breach of his duty of care to the child. But that is not the point. The systems approach suggests that we should not automatically assume that we should look for an individual to blame for an adverse outcome. What we are asking is that when an error is made, the finger should not necessarily be pointed at the doctor who made the final error. We are asking that a more considered approach be taken that looks at matters in the round, that digs a little deeper and tests the role of management and the systems that operate in the hospital.

In a case such as this, a judge in the civil courts will most generally look at the act that immediately caused the death, the intrathecal administration of vincristine. It was the anaesthetist who did this and so a judge will focus his attention on him. In terms of strict legal causation, most of the other failings cannot be said to have caused the death. For example, the fact that the child’s notes went missing is clearly substandard and forms part of the background circumstances that led to the fatal error. But the causal link between the loss of the notes and the death is not strong.

As we approach in time the moment when the fatal dose was administered, matters become less clear in terms of causation. The actions of the oncology Senior Registrar – who, in having the afternoon off, failed to do a proper handover – may not have directly caused the death. However, it is clear that partly as a result of his omission, an inexperienced anaesthetist was put in a situation in which he should not have found himself.

A poor handover is a systems error as well as an individual fault. It is clear that the individual doctor had a lax attitude towards handover; he was dealing with a child requiring specialist oncology treatment on an outlier ward. But it is probably also representative of a systemic problem in the hospital. It could be indicative of a lax attitude to this important element of patient care among the hospital staff at large. Such statements are difficult to substantiate without direct knowledge of how hospital was organized more than 10 years ago. But what we do know is that the hospital failed in its treatment of this child. The patient was placed on an outlier ward with no cover from a specialist oncology nurse. There should have been a protocol in place to deal with this situation.

Whether a civil court recognizes such errors or not, system failures do play their part in most cases of negligence; they produce the circumstances in which the final error is made.

Although the errors committed in this maladministration of vincristine are, of course, specific to the case, they also illustrate general issues and a number of themes emerge that warrant further discussion.

Failure to follow protocols or guidelines

A number of errors that occurred in the management of this child arose from either a failure to follow protocols or the absence of policy on key issues. Thus the housekeeper transported the vincristine and the methotrexate to the ward together; hospital policy was that the two drugs should have been kept separate at all times. When the patient was admitted to the outlier ward, there was no specialist oncology nurse to attend to his needs; there was no policy in place to deal with the demands of outlier wards, especially in relation to the availability of specialist staff.

The decade since the writing of An Organisation with a Memory has seen the introduction of numerous guidelines to try to improve the service offered by the hospitals and general practitioners to its patients. In hospital they will often be protocols. In general practice they will often be management or referral guidelines. These can only be for the good, setting in place good working practices and, therefore, improving patient care.

A general practitioner can take some comfort that by adhering to a guideline he may well be protected from criticism. In principle, a guideline issued by a respectable source can be regarded as a statement by a responsible body of medical opinion on what to do in a particular set of circumstances. But adherence may not always provide protection to a doctor. There may be some circumstance relevant to the individual patient that renders a particular guideline inappropriate. A guideline or protocol should not replace good judgement.

Whether a failure to follow a guideline is negligent or amounts to professional misconduct, is a question that should be answered by reference to the Bolam test. What we can say, though, is that a general practitioner should be very careful before departing from a guideline. He should have clearly thought out the reasons for doing this, and ideally, have discussed it with his colleagues. He should also note the reasons for his actions within the general practice record.

Inadequate communication

Several of the errors in the vincristine case can be categorised as communication errors. This is not surprising. Many errors in diagnosis and treatment can be traced back to inadequate communication. This may be between sequential general practitioners seeing the patient in the community, the Out of Hours service, the Accident & Emergency (A&E) department or poor liaison after hospital discharge. In general practice it often comes down to the standard of the clinical notes (for the next clinician), the standard of the discharge summary or the communication between the general practitioner and, say, the district nurses or physiotherapists. In many cases of alleged delay in diagnosis the patient (with, for example, the subarachnoid haemorrhage, pulmonary embolism or cervical cord compression) will have been seen by different general practitioners over a period of time, in A&E or by physiotherapists.

Communication can be achieved through the written or the spoken word. In the vincristine example, the doctor who was to administer the drugs and who took the afternoon off, should have done a formal face-to-face verbal handover with the doctor who was in charge of the ward that afternoon. Similarly, the loss of the child’s medical records prevented the staff from comprehensively assessing the child’s needs. Both these failings, one entailing verbal, the other written communication, denied others important information.

Reference

Department of Health (2000) An Organisation with a Memory, the report of an expert group on learning from adverse events in the NHS, chaired by the ChiefMedical Officer (2000). http://www.dh.gov.uk/en/Publication sandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4065083.