Abstract
Whilst medical accidents and adverse events clearly have to be the subject of response and redress for individuals who have suffered injury, the current approach to such accidents and events has developed in a piecemeal way. We argue that the various processes involved in such response and redress are outmoded and there is a lack of a clear overview, in particular in terms of promoting better clinical management and less psychological impact on the victim. The current effect of clinical negligence litigation produces adverse outcomes in terms of a patient's safety and the psychological wellbeing of victims. The time has come for an overall approach to be considered, which we suggest should be holistic and which would result in positive outcomes for the NHS and its patients.
Introduction
One of the many ways in which the philosopher Socrates annoyed the Athenian elite was by suggesting that they should learn from humble craftsmen. So he pointed out that a cobbler would never start to make a pair of shoes unless he was completely sure what the shoes would look like when completed. Socrates contrasted this with the approach to many, much more important, affairs of state where actions were taken and decisions made without any clear idea as to what ultimate objective was to be achieved.
No one would suggest that serious medical accidents should not have consequences. The most obvious starting point might be put under the head of patient safety, with consideration being given to the competence of the clinicians involved and the analysis of the causes of the accident; in the United Kingdom, this process is often routinely described as “lesson learning”.
However, the victim is clearly entitled to some redress. In particular, they would reasonably require psychological redress, which would include a full and honest explanation of what has happened; and over a long period, some process of coming to terms with the event and its consequences.
The right to financial redress is comparatively well established and has become an increasingly pressing issue for the modern NHS with significant demand on its resources being made through compensation claims alongside similar demands for improving clinical practice.
In this article, we attempt to explore whether there is some tension between these objectives; in particular, whether the current system of financial redress makes it harder to achieve the important objectives of patient safety and psychological recovery. We suggest that the system for financial redress has followed a seamless track with little consideration as to whether it operates in the best interests of the NHS as a whole. Attempts to achieve the other objectives through a number of initiatives, such as complaints procedures, a duty of candour, patient safety, and mediation are by contrast piecemeal in their development. The time has come to look at the response to medical accidents in a comprehensive way and consider what is, ultimately, the best response – both for the victim and for the NHS as a whole.
The weakness of litigation-led standards – Overly individualistic?
One of the greatest, and indeed most painfully exhausted, clichés to be trotted out when some form of public sector issue or scandal comes to light is that ‘lessons have been learned’. There are a great many reasons why such words ring hollow, not least because we so often feel that we cannot see the results of such. We have no confidence this has happened or will happen. Is it possible that such criticisms also contain an indication as to where we might look to identify the true source of the problem? Perhaps it is because the system we have in place is not one which suits ‘lesson learning’ at all. When you work in or observe a safety-critical industry, safety isn’t an extra. ‘Safety’ or ‘quality’ are rare words because these things are already part of the day-to-day conscious and subconscious thoughts and behaviours of everyone. The system is designed, refined, observed, questioned and challenged to make it easy to do things right.
What can this analysis illuminate about the structural problems from which the NHS suffers? It indicates a number of features which are absent in litigation, being as it is an individualistic enterprise. That is, it deals with individual instances of ‘failure’ and individual people. This leads to three particular difficulties:
Errors are not accepted quickly Estimates from solicitors dealing with high volumes of clinical negligence cases put the time to complete litigation between 12 and 18 months in most circumstances.
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Taken together with the ever worsening figures of shortages and staff turnover
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this creates a serious disconnect between litigation, which may identify an individual failing by an individual person, and that person themselves. In many cases, said individual may be at a different hospital or no longer in the Service, and those with whom they worked are reasonably likely to have moved on also. The effect is that even for individually identifiable errors a considerable time may elapse between the incident itself and sufficient identification and/or acceptance of blame. This is in contrast to Bromiley’s ‘culture of failure’ in which blame is not attached to individuals and thereby problems are freely noted at first instance and attempted to be dealt with immediately.1 Individual error vs. systemic problem In a system where, regardless of the ability to (and logical prevalence of so doing) sue the Trust, the adversarial system pits the victim against their treating clinician/team, it will be immensely difficult to notice where problems are part of or even caused by systemic rather than individual failings. This greatly reduces the scale of issues which are likely to be properly highlighted through this process. Nature of identified issues A somewhat tangential problem, owing to the need for individuals to set out the exact and narrow chain of events which caused their injury, alongside the considerable cost of pursuing such an action, is a narrowing of which injuries (and thereby associated issues) are identified by litigation. Injuries which may be very rare (and thereby more likely to result from individual negligence since they may not be in the experience and typical knowledge of treating clinicians) but cause significant harm are ripe for litigation, whereas relatively low impact but high volume examples are harder to justify litigating (and perhaps to succeed at – if the problem is indeed systemic but cannot be adequately attached to the necessary specific breach of duty). For example with the inevitable resourcing and administrative problems that arise across the NHS, patients likely suffer ‘negligent’ delays the only effect of which is an increased period of pain and suffering. As such, patterns where this may be more frequent can easily be missed. Compare this with Cauda Equina Syndrome - which is relatively rare, somewhere between 1 in 33,000 and 1 in 100,000, yet claims can be in 6 or 7 figures.
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This has led to intense scrutiny of the way in which, and the particular acute timeframes involved in, the development of the condition. Nevertheless it is such a rare occurrence that even the preponderance of high value litigation does little to draw a typical GP or nurse’s attention to the condition given its incidence rate.
As a further consequence of, in particular, the focus on individual failure, even where this may not necessarily attach to specific individuals in fact, the culture which thereby develops is one which conditions doctors to fear litigation. That this is so can be seen in the following analysis: Defensive medicine practice is common among hospital doctors who responded to our survey. Ordering un-necessary tests is the commonest form of the defensive medicine identified in this study. Senior grade is significantly associated with less practice of defensive medicine. Further research is needed on the cost of defensive medicine on the NHS.
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Defensive medicine refers to medical care performed primarily to reduce the risk of litigation. Positive defensive medicine occurs when doctors perform more tests or procedures than are necessary. Negative defensive medicine occurs when doctors avoid high risk procedures or refuse to care for high risk patients … It’s too early to say, although there seems to be a link between higher healthcare spending and lower risk.
These practices are a cause for concern because they can contribute to systemic problems. For example, a recent study based on a global survey of prescribing doctors concluded that defensive medicine was a suggested contributor to antibiotic resistance. 8
Thus, each of these issues contributes to a vicious cycle. The focus on individual failings leads to defensive medicine which can contribute to systemic problems, which are not identified because the focus is on the individual. It is imperative to construct an approach which takes proper account of the overall context in which healthcare is provided, which by its nature litigation will never do.
Psychological issues
There is an inherent irony in a judicial system that individuals who bring a claim may endure injury from the very process through which they seek redress. Strasburger 9
For the majority of individuals and their families, the process of litigation is likely to add to the burden of being harmed by some other’s clinical negligence. It is clear from the accounts of those who are contemplating, undergoing, or have undergone litigation, that the process is disruptive. The experience saps energy and distracts the claimant and their family from their normal day-today functioning.
The litigation process may unwittingly create feelings of abandonment, where the claimant and their family feel alone, isolated and helpless, and are “challenged to confront and manage the emotional burden of the legal process.” 10 It is perhaps, therefore, not surprising that claimants and their families are sometimes hostile to the process of litigation itself, adding to the anger and grief of the original negligence.
Claimants and their families are likely to report a wide range of responses to the litigation process. These responses will depend on the circumstances of the negligence and may include: [1] Anxiety over the process and whether they have the resources to cope with it; [2] Hopelessness over the protracted nature of the process and their inability to have any influence over it, [3] Frustration when they feel that lawyers for either party do not appear to be making any progress; [4] A sense of not being believed, particularly when they opine that the experts examining the case appear hostile; [5] Fear that after all their efforts the claim may fail; [6] A sense of injustice that they even have to go through litigation when it is clear in their minds that negligence has occurred.
The stress of litigation is now being recognised as a process that can result in anxiety, depression, and even post-traumatic stress disorder (PTSD) and physical illness. Lenhart and Shrier in their review of the litigation process note that those claimants who fare best emotionally with litigation are those who (1) set realistic goals; (2) maintain a sense of control of the litigation process: (3) seek out adequate support from at least one significant source (family, therapist, peers, lawyer); (4) appreciate and focus energy on restoring equilibrium in their lives, independent of the litigation process; and (5) adequately acknowledge and grieve the losses inevitably involved even when the litigation has a favourable outcome.
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There is clearly a demand for providing an alternative to existing processes that still allows the claimant and their family to feel that justice has been done and that where clinical negligence was proven, responsibility has been accepted. Any alternative must, however, result in a more transparent programme that makes fewer demands on the claimant and their families.
Piecemeal solutions?
There have been a number of attempts to provide redress to the victims of medical accidents, but these have been sporadic and limited. They have often reflected a political response to a raising of public concern, for example in the wake of the clinical governance scandal affecting the Bristol cardiologists. 12
Patient advice and liason service
First proposed in the 2000 ‘NHS Plan’ put forward by the Blair government, PALS were designed to provide ‘patient advocates’ who would act both as a ‘welcoming point’ and a steer towards the various complain procedures available to families. 13 However, research by one Trust into the use of such systems demonstrates that the vast majority of complaints related to logistical issues around the running of the hospitals; parking, transport, waiting times and the like. 14 This is indicative of the fact that patients do not see this service as a place to go with serious complaints or in the wake of major incidents and accidents.
Hospital complaints procedure
Though all hospitals have to maintain a system for registering, filing and ‘dealing with’ complaints, these too have been scrutinised and found wanting. In a review of NHS hospitals complaints procedures, a number of problems were identified, principally through organisations who work with and within the NHS. These include:
‘Complexity – vulnerable people find the complaints system complicated and hard to navigate. Advocacy – action is needed to make the public more aware of how to access the NHS Complaints Advocacy Service. Leadership and Governance – Chief Executives and Boards must take active responsibility to learn from complaints and to create a culture that is able to take a positive attitude towards complaints. Skills and attitudes – there is a need for quality, trained staff to deal with complaints effectively and appropriately. Lack of engagement – people are reluctant to complain and staff can be defensive and reluctant to listen to or address concerns. Independence – there is a perceived power imbalance in the complaints system. NHS reforms – changes in NHS structures may make it more confusing for patients to know how and where to raise their complaint. Whistle-blowing – requires individuals to recognise errors and speak out, raising many of the same ‘individualistic’ issues described above. Lack of compliance – organisations do not always deliver their legislative responsibilities on complaints handling.’
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Duty of candour
In a 2014/5 initiative, the NMC and GMC issued joint guidance detailing individual’s ‘duty of candour’ which was described as “a professional responsibility to be honest with patients when things go wrong.” 16
Action against Medical Accidents (AvMA) analysed CQC inspection reports from 2017 and found that they ‘did not centrally record alleged breaches of the duty of candour’. It added: The continuing lack of clarity about how the CQC deals with individual allegations or reports of potential breaches of the duty of candour is very worrying. The CQC was unable to provide any information on how many such reports it receives or what had been done about them. Without access to complaints or an ability to realise patterns of breaches, the CQC can’t be relied upon to ensure the duty of candour is adhered to.
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Root cause analyses
One of the most common and seemingly overrated methods for tackling the aftermath of serious incidents is to conduct a ‘root cause analysis’. Whilst it might be thought that the nature of such is rather obvious, it frequently fails to live up to its own epithet. Peerally et al. 18 have identified a number of problems with root cause analyses in general which make them far from fit for purpose:
Attempting to identify a single cause unhelpfully narrows the enquiry.
Political motivations behind the procedures produced ineffective systems.
Time constraints on producing reports. Lack of adequate training for operators of the procedures.
Much as was outlined previously, the focus is often on a confused sense of blameworthiness. This focusses on singular incidents and organisations rather than a wider consideration of the actual root causes on a systemic basis.
Patient safety
The concept of patient safety has been developed in an attempt to influence clinical management and improve outcomes. 19 It is difficult to argue with the concept of patient safety as an objective. However, the impression is that the thinking is utopian rather than practical. It is difficult to see how such an approach could succeed without addressing the structural issues arising from existing processes as identified in this article. Ultimately, patient safety initiatives appear to become small scale or represent easy wins.
Mediation
Since December 2016, the NHSR have been running a mediation scheme designed to encourage more disputes to be settled out of court and at lower cost. The scheme has been judged a success and the use of mediation is increasing. Initial sceptics who questioned whether mediation could offer additional value as opposed to additional cost by comparison with established practices, in particular the joint settlement meeting, appear to have come to appreciate mediation.
However, it is arguable that mediation can only have limited value where, as at present occurs, it is essentially grafted into the ongoing litigation process and therefore cannot address fully all the issues which have arisen through that process.
Whilst there are some anecdotal reports of the imaginative use of mediation, its impact again is going to be limited if the basic outcome remains that seen in litigation; financial compensation.
The piecemeal approach continues?
We suggest that the reason these efforts have not proved to be wholly successful is that they are insufficiently broad and have developed piecemeal in response to perceived problems, rather than prospectively with the desired outcomes in mind. Further, it seems that the number of different measures being attempted results in each of them being underfunded.
This pattern of specific responses to perceived problems continues. The Health Service Safety Investigation Bill was first drafted in 2017 and its intended enactment was announced in the Queen’s Speech in October 2019.
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The explanatory note to the speech makes two key observations: Drawing on the approaches used in other safety-critical sectors… (i)nvestigations would be for the purpose of learning and not attribute blame or find fault.
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Prohibiting the disclosure of information held by the investigations body, except in limited circumstances. This will allow participants to be candid in the information they provide and ensure thorough investigations.
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Contemplating a way forward
If it is accepted that there is some conflict, between achieving the outcomes of patient safety, psychological resolution, and financial redress in response to medical accidents, then it might be useful to speculate as to how the response might operate if the former two outcomes were prioritised.
The essential features of such a response would include swiftness of action, candour, or at least reasonable recognition of what had occurred, and a sense that the shortcomings which led to the incident had been addressed. Against this background, it might be reasonable to contemplate a national body charged with investigating medical accidents and making appropriate recommendations both as to clinical practice and as to regulation of clinicians, after such an investigation. Health Trusts and other health providers could be placed under a statutory duty, equivalent to the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations, 24 to report significant adverse medical incidents to this body. As an alternative, patients or relatives could complain directly to the body. Initial intervention might be by an inspector with the option of escalating to a Tribunal modelled on the previous HC(C) 90 Tribunals used to discipline consultants.
At first blush, the creation and operation of such a body would appear to require major expenditure, but it is expected that this body would supersede most, if not all, of the partial solutions described above: PALS, complaints procedures, duty of candour, root cause analysis, patient safety initiatives, and (at least to an extent) mediation.
Further, such a body could also largely replace the jurisdiction of inquests and regulatory bodies. Whilst at a theoretical level the jurisdiction of coroners and the GMC should have a valuable role in providing a response to medical accidents and promoting patient safety, in practical terms, these jurisdictions have become so afflicted by delay and formality as to provide little real value. Most recently, in the case of R (Chidlow) v HM Senior Coroner for Blackpool and Fylde, 25 the Divisional Court ordered a new inquest because a coroner was found to have misdirected as to law, when the original inquest had taken place nine years after the death of the deceased.
If a composite body was created to address medical accidents, prioritising patient safety and psychological redress, it could then reasonably be asked whether the current system of financial compensation should continue to operate in parallel with such a body. It is difficult to see how this could be done in a way which would not significantly compromise the aims of the new body. Litigation would continue to result in delay, defensiveness and excessive pressure on resources. It is suggested that the statutory body would, in addition to investigating and making recommendations, have power to award fixed sums of compensation in appropriate cases, in a way analogous to the operation of the Criminal Injuries Compensation Authority. These admittedly more modest sums would, however, have the advantage of being provided to patients and families in circumstances in which the expenditure could make a potentially much greater difference to the eventual outcome.
Consideration would have to be given to whether such a system would interfere with individuals’ Article 6 rights. This was considered by the Chief Medical Officer in 2003: In practice, this would potentially mean making provision for a public hearing, with equal rights for each side to present their case. In ensuring that each side could be heard it is likely that the NHS would have to fund the provision of legal advice. In effect this would mean the NHS running and funding a hearing mechanism similar to the courts, but in parallel with the courts.
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Sir Rupert Jackson in a recent presentation to a medico-legal conference “Medical errors: sanctions and compensation – is there another way?” made similar but less radical suggestions. 27 Sir Rupert advocated simplifying and combining a number of disciplinary tribunals and then merging the same with a new forum for clinical negligence claims. In this context, he proposed a new “objective” test for clinical negligence of “reasonably avoidable injury”. Sir Rupert did not elaborate in any detail in relation to this suggested new test and the example that he gave would suggest that it would not operate in a materially different way. It was described that if an injury was reasonably avoidable, then the fact that the doctor had been on a 12-h night-shift and had numerous other patients to treat is neither here nor there. This approach does not appear to be materially different to the current Bolam/Bolitho test. Liability is assessed by the standard of a reasonably competent clinician and cannot be avoided on the basis of understandable human error. Although not explained in Sir Rupert's presentation, the test presumably would have some intellectual content or criteria and it is not clear how and in what way these would differ from the current concepts of breach of duty and causation.
Whilst the proposals do represent some degree of reform and rationalisation of the approach to medical accidents, it is noticeable (perhaps unsurprisingly) that the proposals are largely taken from a perspective of judicial process. The issues relevant to a patient's psychological resolution, such as candour and speed of resolution, are only obliquely referred to. Reference is made to “settlement by negotiation or by mediation should be easier” and “there should be renewed effort to promote early settlement”. Such sentiments have been regularly expressed in the past and it is not clear how Sir Rupert's proposals would meaningfully achieve earlier settlement of claims.
Conclusion
We hope we have demonstrated that there is a conflict between the current system of clinical negligence litigation and the outcome of psychological redress for medical accidents, that such approaches as have been tried have been piecemeal and largely unsatisfactory and that if psychological redress is to be given appropriate emphasis, a radical approach needs to be taken.
Perhaps this represents the type of radical thinking that made Socrates unpopular with the Athenian aristocracy. The authors are conscious that these suggestions may well make them unpopular, certainly amongst those who act for claimants in clinical negligence actions. However, it is hard to argue with the proposition that the stage has been reached whereby a clear overview needs to be taken of the response to medical accidents, in particular if the best outcome in human terms is going to be achieved.
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.