Abstract
The combination of the introduction of a statutory duty of candour and the Supreme Court decision in Montgomery v Lanarkshire Health Board emphasises the profound change in the doctor–patient relationship that has occurred over the last few decades. As a society, we have moved a long way from the paternalistic doctor deciding what is best for his (and it was usually a his) patient.
This article considers the changes and how they may be used in a clinical negligence claim.
Statutory duty
This has had a long gestation, but finally came into force on 1 October 2014 through the Health and Social Care Act 2008 (Duty of Candour) Regulations 2014. The principles are:
A registered person must act in an open and transparent way in relation to care and treatment. At present, the “registered persons” are limited (and would, for example, exclude a private Hospital), but will be expanded in the near future Where a “notifiable safety incident” has occurred, the registered person must:
Provide a truthful account of all the facts known about the incident Advise on further enquiries (and the outcome of such enquiries) Apologise A notifiable safety incident is an incident which appears to have resulted in death, severe or moderate harm to the service user. Severe harm is defined as a permanent lessening of bodily, sensory, motor, physiological or intellectual functions. Moderate harm is defined as a moderate increase in treatment, significant, but not permanent harm. Prolonged psychological harm or prolonged pain.
It is not clear how often this statutory duty has been met. The recent Select Committee report, “Investigating clinical incidents in the NHS”, HC 886 published on 27 March 2015 reported 12,000 avoidable deaths, 10,000 serious incidents and a total of 1.4 million “incidents”. There were 174,872 written complaints. These figures would suggest a huge number of letters of apology being sent out each week. That seems extraordinarily unlikely to have happened. I have yet to meet a client who has received such a letter.
Background
It is worth recalling the observations of Lord Denning in Hatcher v Black 1954 in which he held that, whilst not telling the truth to a patient might be ethically wrong, it was not necessarily a breach of the doctor’s duty of care, if it conformed with a professional practice:
[The doctor] told a lie, but he did it because he thought that in the circumstances it was justifiable … The law does not condemn the doctor when he only does that which many a wise and good doctor would do”
And, in William and Anita Powell v UK ECHR 4 May 2000 45305/99:
Doctors have no duty to give parents of a child who died as a result of their negligence a truthful account of the circumstances of the death, nor even to refrain from deliberately falsifying records
Thank goodness. This could not be said now. How did this change come about?
On 3 July 2009, the House of Commons Health Committee published its report “Patient Safety” (HC 151-1).
At paragraph 9 of the report, the Committee concluded:
Harmed patients and their families or carers must receive honest information, a full explanation, an unequivocal apology and an undertaking that the harm done will not be repeated.
In practice, this did not happen. A National Audit Office report in 2005 revealed that only 24% of NHS Trusts routinely informed patients of a patient safety incident and, astonishingly, 6% admitted to never informing patients.
A number of specific recommendations were made by the Health Committee, including:
Implementation of the NHSLA guidance on giving apologies and explanations Wider investigation by coroners to investigate underlying causes rather than a narrow focus of immediate cause of injury Improvements in the complaints process Improvements in the Patient Advice and Liaison Services Implementation of the Redress Scheme (the committee were “appalled” that this had not been done, and found the explanation “wholly unsatisfactory”.
The Committee also recommended that:
further consideration be given to the CMO’s proposal for a statutory duty of candour in respect of harm to patients
This referred back to the CMO’s report “Making Amends”, published in 2003, which included the following statement:
Statutory provisions would be introduced to encourage openness in the reporting of adverse events. This would encompass
∼ A duty of candour requiring clinicians and health service managers to inform patients about actions which have resulted in harm
The final straw was the Francis Inquiry into the Mid Staffordshire Trust, and the long and sustained campaign by AVMA for what they called “Robbie’s Law” following the arguments in Powell v United Kingdom.
The advantages of candour are obvious:
Most people who have suffered bad treatment want an explanation and an apology. Litigation is an unusual outcome in a system such as the NHS. In May 2009, the NRLS report some 850,000 incidents in the NHS annually. In 2014, that number had increased to 1.4 million incidents (not necessarily involving harm). And yet there are “only” 174,872 complaints. Studies put the rate of adverse event in acute care at between 2.7% and 16.6%. Many patients admitted to hospital suffer some harm, much of which is avoidable, yet a small minority bring actions against the Trusts responsible. Research supports the view that injured patients who take legal action are seeking information and an apology, rather than damages or disciplinary sanctions (see “Why do people sue their doctors?” The Lancet 1994; 343: 1069–1613) Organisations that have adopted policies that support open disclosure and apology have found that such candour about medical error may actually reduce the likelihood of litigation (see “Risk Management: extreme honesty may be the best policy” Annals of Internal Medicine 131(12): 970–972). The University of Michigan found that an apology and disclosure programme led to reduction in damages of 47% and faster resolution of cases, down from an average of 20 months to six months The defensive “closed shop” apparently engendered by the fear of litigation is misplaced. It discourages staff from reporting and discussing adverse incidents, and denies the opportunity to learn from such incidents. Evidence suggests that events can be avoided if lessons are learned. Unless and until trusts are open about mistakes, change in practices will not occur. As Dietrich Bonhoeffer observed: Action springs not from thought, but from a readiness for responsibility The power of an apology should not be understated. Apologies have the power to heal humiliations and grudges, remove the desire for vengeance, and generate forgiveness. For the offender, they can diminish the fear of retaliation and relieve the guilt and shame that can grip the mind with a persistence and tenacity that are hard to ignore. The result of the apology process, ideally, is the reconciliation and restoration of broken relationships (S Kellog, The art and power of apology, June 2007)
A common law duty of candour?
As ever, the development of the law has displayed the English preference for pragmatism over principle. So, for example, unlike courts in the United States, the English courts have not categorised the relationship between the doctor and patient as fiduciary in nature, or explored the idea of a vulnerable patient giving rise to a special relationship akin to a parent–child or teacher–pupil.
Similarly, the analysis of the duty to volunteer information before treatment, or to answer questions, has in some cases been answered by reference to the Bolam principle.
In Blyth v Bloomsbury HA, 1993 4 Med LR 151, the Court of Appeal held that a doctor was not under a duty to respond truthfully when asked a question: rather, the duty was as laid down in Bolam.
Blyth might be seen as an aberration and, perhaps not surprisingly, the courts have retreated from this position. In Pearce v United Bristol Healthcare NHS Trust 1999 PIQR P53, Lord Woolf stated that:
if a patient asks about the risk, then the doctor is required to a give an honest answer
Most cases have concerned the duty to provide information before treatment – the “informed consent” line of cases. Some have dealt with the duty to answer questions. Very few have considered the duty to volunteer information after treatment. However, there are cases in which the courts have recognised a “legal” duty of candour.
In Naylor v Preston HA 1987 2 ALL ER 353, the Master of the Rolls Sir John Donaldson held: I personally think that in professional negligence cases, and in particular in medical negligence cases, there is a duty of candour resting upon the professional man. This is recognised by the legal profession in their ethical rules requiring their members to refer the client to other advisers, if it appears that the client has a valid claim for negligence. This also appears to be recognised by the Medical Defence Union, whose view is that “the patient is entitled to a prompt, sympathetic and above all truthful account of what has occurred
In what he acknowledged to be an obiter remark, he went on:
It is but one aspect of the general duty of care, arising out of the patient–medical practitioner or hospital authority relationship and gives rise to right s both in contract and in tort
Although with Sir John Donaldson in spirit, neither Glidewell LJ nor Sir Frederick Lawton was explicit in their support for such a duty.
For a majority Court of Appeal (Sir John Donaldson and Mustill LJ) view one has to go back a year to Lee v South West Thames RHA 1985 1 WLR 845
It should never be forgotten that we are here concerned with a hospital–patient relationship. The recent decision of the House of Lords in
In Sidaway, Lord Bridge stated (with the agreement of Lords Templeman and Diplock):
When questioned specifically by a patient … about risks involved in a particular treatment proposed, the doctor’s duty must, in my opinion, be to answer truthfully and as fully as the questioner required
What is surprising is that these remarks had not developed into clear, non-obiter, unequivocal statements of a duty of candour (which might obviate the need for a statutory duty). Far from it. In paragraph 3.141 of the excellent First Edition of Kennedy & Grubb’s Principles of Medical Law, the concept of a duty of candour in post treatment disclosure is summarised as:
It may be ethically appealing, but in the context of the trench warfare of medical negligence, it would not be regarded by those who advise doctors as a duty but rather an act of folly
Then, through cases such as Chester v Afshar, Pearce v United Bristol Heathcare 1999 and Birch v University College Hospital 2008 EWHC 2237, which “laid the ground”, we had the Supreme Court decision in Mongomery v Lanarkshire Health Board 2015 UKSC 11.
The Montgomery principles may be summarised as follows:
Courts are increasingly conscious of fundamental values such as self-determination. Societal and legal changes – in particular, the advent of the Human Rights Act 1998 – point towards an approach to the law which treats patients, so far as possible, as adults capable of under-standing that medical treatment is uncertain of success and may involve risks, of accepting responsibility for risks affecting their lives, and of living with the consequences of their choices. Patients are “persons holding rights”. They have access to a wealth of information not available in previous times, particularly via the internet Self-determination is a fundamental value which underlies Article 8 and patients are rights-holding and often internet-informed consumers. Disclosure of information to a patient is no longer to be regarded merely as an aspect of medical care. It follows that the appropriate extent of disclosure should not be treated as a matter of clinical judgment. Therefore, a doctor’s role, when advising a patient of risk, is not of the kind with which the Bolam test is concerned. Responsibility for determining the nature and extent of a person’s rights rests with the courts, not the medical professions. Doctors must take reasonable care to ensure that patients are made aware of any material risks involved in a recommended treatment and of any reasonable alternatives. Materiality of risk cannot be reduced to percentages: risk significance reflects other factors besides magnitude, e.g. the nature of the risk, effect of its occurrence on the patient’s life and the importance to the patient of the beneficial aim of the treatment. The test of materiality is fact and patient sensitive. The test is whether, in the circumstances of the particular case, either:
• a reasonable person in the patient’s position would be likely to attach significance to the risk; or * the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it. To advise properly, the doctor must engage in dialogue with the patient. Whilst there is a “therapeutic exception” to this general rule (for example, a doctor can withhold information from a patient when he considers disclosure to be seriously detrimental to the patient’s health or in a case of necessity where the patient is unconscious), the exception is limited and should not be abused The heart of the decision is at Paragraph 87: An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it (per Lord Kerr and Lord Reed)
Practical uses
“A sword”
Following the decision in Montgomery, many Claimants rushed to amend Particulars of Claim to add a new allegation of failing to obtain the patient’s informed consent.
It was widely thought that Montgomery changed the goalposts in relation to what have always been seen as “consent cases”. In a recent article in the AVMA June 2015 newsletter, Jim Duffy suggested: Those who act for defendants might see Montgomery as the death knell to any consent defence. Equally, Claimant lawyers might welcome it as a something of a panpharmacon for any consent case
He proposed 10 questions he felt should be asked:
Has the clinician taken full notes documenting the consent process? Have reasonable alternatives been discussed? From the notes, does it appear that adequate time has been set aside for a meaningful consent process? What steps has the clinician taken to understand the particular concerns and wider circumstances of the individual patient before imparting his or her advice? For example, does he or she have other medical conditions that might affect the risk–benefit analysis? Are his or her family circumstances relevant? Is there evidence of a genuine dialogue between the doctor and patient around consent? Has the clinician done any more than simply express magnitude of risk by reference to percentages? Have the risks of possible distressing, painful or dangerous intervening events been explained to the patient, in addition to the risks of adverse final outcomes? If the clinician has consciously decided not to share certain information with the patient in a purported exercise of the therapeutic exception, do the circumstances justify that approach in the light of the respect to be accorded to patient autonomy? Is it clear that the patient fully understood the advice given? Is there any impression of lip service having been paid to the consent process? For example, does it appear that it consisted of the provision of a leaflet and not much more? It seems probable that analysing cases in this way will greatly strengthen a “consent case” for the Claimant
Cases applying Montgomery
The subsequent (still limited) case law suggests that the courts are drawing back from the more radical interpretation of Montgomery.
The importance of expert evidence as to what is reasonable medical care remains persuasive. In Grimstone v Epsom & St Helier Hospitals 2015 EWHC 3756, Mrs Justice McGowan attached considerable weight to the view of the Trust’s expert that a reasonable body of doctors in the same position would not have given such information to a patient In Tasmin v Barts NHS Trust 2015 EWHC 3135, Mr Justice Jay attached weight to the NICE Guidelines in considering whether the parents should have bene offered a Caesarean Section, as well as a foetal blood sample (FBS). The NICE Guidelines only advised an FBS It is also not every risk that needs to be mentioned. In both A v East Kent Hospitals NHS Foundation Trust 2015 EWHC 1038 and Tasmin, the courts concluded that a small risk of 1–1000 was a “theoretical, negligible or background” risk that did not represent a “material risk” in Montgomery terms. In A, Mr Justice Dingemans accepted that a 1–3% risk should have been discussed. He went on to decide that a patient would not attach much weight to a risk of 1–1000 (despite the Claimant saying that she would). In all four cases (Montgomery, A, Tasmin and Grimstone), the trial judge held that the patient would not have made the choice they said that they should have been offered. More anecdotally, the NHSLA point to Pearce v United Bristol Heathcare 1999 and Birch v University College Hospital 2008 EWHC 2237 to say that the law has not really changed.
“A shield”
In Miller v Imperial College NHS Trust, the Claimant presented at hospital with increasing pain in her leg, a cold leg with a white/blue appearance and a lack of pulses in the ankle and foot.
This required urgent vascular review, heparin and surgery In fact, the Claimant was discharged.
By the time she returned to the hospital a few days later, the window of opportunity for successful treatment had passed. She suffered an above-knee amputation.
The Claimant complained to the hospital about her treatment (ac complaint triggered by the refusal to fund an Orion leg), which led to an internal e-mail that the claim was medico-legally indefensible
When she asked, at a meeting with the Trust, whether her leg would have been saved with competent management, the Trust failed to give any reply. They said that they would need expert evidence. It was only when proceedings were issued that it was admitted, in the Defence, that her above knee amputation and the catastrophic consequences could have been avoided had they offered competent care.
Somewhat surprisingly, the Trust argued the claim was barred by the Limitation Act. This was, superficially correct. The claim was brought five years after the amputation. But, the Claimant argued:
The common law (see above) recognized a duty of candour Section 14 Section 32.
N relation to the statutory provisions of the Limitation Act, we intended to argue as follows:
Section 14
of the Act requires that she must know that the injury was attributable in whole or in part to the act or omission which is alleged to constitute negligence. In considering whether the Claimant has knowledge. Brooke LK in North Essex District HA v Spargo 1997 PIQR 235, 242, considered that a Claimant would not have the requisite knowledge:
If her knowledge of what the defendant did or did not do is so vague or general that she cannot fairly be expected to know what she should investigate
In many cases, and this was one such case, the relevant information requires expert evidence that something could (rather than should) have been done. Where, for example, the negligence consists of an omission to treat, the Claimant must know more than the mere fact that he has not been treated. In Smith v West Lancashire HA 1995 PIQR 514, the Claimant was told that the original procedure had not worked, and that there was nothing further that could be done. He did not know that the operation had not been performed promptly enough, or that there had been a failure to diagnose his condition properly, and only had such knowledge when he received his report from his expert witness. None of the treating doctors volunteered the information. The hospital failed to give the information when asked. They claimed that they needed expert evidence. If they had the information, they concealed it (see below). If they did not have it, and still did not know whether her leg could have been saved, how could a lay patient be deemed to have knowledge which the hospital itself said they lacked?
Section 32 of the Limitation Act provides that where:
Any fact relevant to the plaintiff’s right of action has been concealed from him by the defendant … the period of limitation shall not begin to run until the plaintiff has discovered the concealment
This has been interpreted as deliberate concealment of any fact relevant to the Claimant’s cause of action, regardless of whether such concealment was contemporaneous with or subsequent to the accrual of the cause of action Sheldon v RHM Outhwaite 1996 1AC 102 Deliberate concealment by the defendant of the fact that he has been negligent satisfies the test in section 32 Williams v Fanshaw Parker & Hazlehurst 2004 Inwitness. None of the treating doctors volunteered the information. The Hospital failed to give the information when asked. They claimed that they needed expert evidence. How could a lay patient be deemed to have knowledge which the Hospital itself said they lacked?
A preliminary hearing on limitation was ordered by the Master. A few days before the hearing date, limitation was conceded.
Interest
The NHSLA often argue that interest should not run for the full period in some of the older cases, even where the Claimant is a child/patient and has brought the claim within the primary Limitation Act period.
Non-disclosure of material facts would act as a powerful riposte to such argument.
Summary
There are significant changes which strengthen the Claimant’s hand. The post Montgomery case law suggests that it is not the “game-changer” some thought, and it will have to be used with judgment. It seems clear that judges will still attach weight to clinicians’ evidence of reasonable practice, and be sceptical of patients who say that they would not follow a doctor’s recommendation. The duty is to obtain informed consent, and does not give the patient a “right to choose” any available treatment.
Footnotes
Declaration of conflicting interests
The author declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author received no financial support for the research, authorship, and/or publication of this article.