PI Brief Update

Clinical Consent: Where Are We Now? - Ruwena Khan, Park Square Barristers

1. 30/09/20. Clinical negligence litigation continues apace; the doctor-patient relationship ever-evolving, medical professional guidance adapting and incremental changes to the common law running in tandem. Who knows how the law will change, if at all, following what we hope will eventually be a swift and safe conclusion to the current global pandemic. Will there be significant numbers of cases brought in relation Covid-19 medical treatment: inadequate facilities and staff being made available; insufficient PPE being utilised whilst treating patients; consent not being lawfully obtained? Will there be claims which allege that the knock-on effect on other areas of medical care, such as reduced cancer screening, resulted in delays in diagnosis and consequent treatment?

2. Estimates published last year put the total cost of outstanding compensation claims at £83 billion, although that figure includes both pre- and post-issue cases. NHS England’s total budget in 2018-19 was £129 billion. These figures seem startling. Clearly, in general terms, as society develops there is an increase in social media usage, awareness of rights and advertising and the numbers of those seeking to make claims increase. However, the figures reflect the unfortunate reality that the area of clinical negligence law most often involves significant compensation sums being sought due to the impact of the alleged negligence that has taken place, most often in birth injury claims which require life-long monetary assistance. Moreover, the area of clinical negligence does not just involve money as the central focus - far from it - patients and families most often seek responses to unanswered questions and often they see the claims process as the best way forward.

3. This article reviews how ‘consent’ has changed in clinical negligence litigation over the years and provides an update on relevant recent case law, particularly in light of Montgomery v Lanarkshire Health Board [2015] UKSC 11 and the increasing importance of patient autonomy.

From Bolam to Montgomery

4. Every clinical negligence practitioner will be more than familiar with Bolam v Friern Hospital Management Committee [1957] 1 WLR 582. McNair J set the basic test as to whether a medical professional has met the required standard of reasonable care and skill:

“The test is the standard of the ordinary skilled man exercising and professing to have that special skill…[A doctor] is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art…Putting it the other way round, a man is not negligent if he is acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view.”

5. The claim was brought by a patient who was suffering from mental illness and during the course of electro-convulsive therapy, sustained acetabular fracture injuries. Although he had signed a consent form, he had not been warned of the risk of fracture, nor had he been given relaxant drugs. McNair J directed the jury to utilise the above test in relation to both the issue of the relaxant drugs and the issue of consent. This emphasises that at that time, and for many decades thereafter, the patient’s right to be informed of the risks of their own treatment, and how far that right extended, was to be determined by the medical profession.

6. In Sidaway v Board of Governors of the Bethlem Royal Hospital & Maudsley Hospital & Others [1985] AC 871, in an appeal by the patient from a decision of the Court of Appeal, the issue was whether a neurosurgeon failed to exercise due care in the advice he gave his patient when recommending an operation as he failed to warn her of the risk of damage to her spinal cord which in fact occurred. The difficulties with the Bolam test in the context of informed consent were highlighted, although ultimately the majority of the House of Lords held that the doctor had to decide what ought to be said and how it should be said. Lord Scarman’s dissenting judgment, however, asserted that the Bolam test was inappropriate when dealing with issues of informed consent;

“…is it right that medical judgment should determine whether there exists a duty to warn of risk and its scope? It would be a strange conclusion if the courts should be led to conclude that our law, which undoubtedly recognises a right in the patient to decide whether he will accept or reject the treatment proposed, should permit the doctors to determine whether and in what circumstances a duty arises requiring the doctor to warn his patient of the risks inherent in the treatment which he proposes.”

7. Although not a case concerning informed consent, in Bolitho v City and Hackney Health Authority [1998] AC 232, steps were taken to move away from enabling medical opinion to dictate the standard of care. The House of Lords accepted that when determining whether a medical professional had acted in accordance with a reasonable body of opinion, the court had to consider whether such opinion had a logical basis. Lord Brown-Wilkinson opined:

“The use of these adjectives – responsible, reasonable and respectable – all show that the court has to be satisfied that the exponents of the body of opinion relied upon can demonstrate that such opinion has a logical basis.”

8. Via a number of other subsequent cases (e.g. Pearce v United Bristol Healthcare NHS Trust [1998] 5 WLUK 361 and Chester v Afshar [2004] UKHL 41) which had tacitly attempted to move away from the Bolam test over the years since Sidaway, the Supreme Court in Montgomery finally took Lord Scarman’s dissenting judgment as the starting point. In Montgomery, M was not informed by her treating consultant obstetrician that there was a 9-10% risk of shoulder dystocia occurring during the birthing process. During the delivery, shoulder dystocia occurred and the baby was deprived of oxygen due to occlusion of the umbilical cord and he was born with severe disabilities.

9. The Supreme Court held that an adult person of sound mind was entitled to decide which, if any, of the available forms of treatment to undergo, and their consent had to be obtained before treatment interfering with their bodily integrity was undertaken. Doctors were under a duty to take reasonable care to ensure that patients were 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 be reasonably aware that the particular patient would be likely to attach significance to it.”

10. Exceptions were noted at paragraph 88 of Montgomery, however. A doctor is entitled to withhold from the patient information as to a risk if they reasonably consider that its disclosure would be seriously detrimental to the patient’s health. The doctor is also excused from conferring with the patient in circumstances of necessity. Furthermore, as is noted in the case of Duce below, a clinician is not required to warn of a risk of which they could not reasonably be taken to be aware, therefore still taking into consideration the Bolam test.

11. Nonetheless, after nearly six decades, the Supreme Court allowed the law to catch up with the turning tides of society to assert that it was the patient’s basic human right to make their own decision.

Informed Consent – Case Law since Montgomery

Spencer v Hillingdon Hospital NHS Trust [2015] EWHC 1058 (QB)

12. The patient had suffered a deep vein thrombosis, followed by a pulmonary embolism on each lung, after surgery for an inguinal hernia. He clamed that hospital staff had not advised him of the risk of a thrombosis or embolism and that he had not been made aware of the signs and symptoms or the importance of seeking medical help. In applying Montgomery, Judge Collender QC held that members of the medical profession had a duty of care to advise and inform patients of anything which the ordinary sensible patient would be justifiably aggrieved not to have been told when fully appraised of its significance. In this particular instance, the duty of care had been breached as modern, safe and responsible medical practice should have warranted the giving of that advice to patients undergoing general anaesthetic.

13. The focus espoused by the Deputy High Court Judge was on the “ordinary sensible patient” and whether they would feel “justifiably aggrieved”.

Thefaut v Johnston [2017] EWHC 497 (QB)

14. The patient underwent surgery to try and alleviate the severe pain in her back and the numbness in her left leg. However, the surgery exacerbated her left leg pain and did not resolve her back pain. She alleged that had she been properly advised she would have known that the chances of a full recovery (approximately 50%) from her back pain in particular were nowhere near as optimistic as portrayed (not far off 90%) and she would not have consented to surgery at all. Mr Justice Green held that the doctor had not met the test in Montgomery.

15. Reference was made to the modus operandi of communication as espoused in Montgomery at paragraph 90. Firstly, “dialogue” was central and as Green J noted, in modern times that could include dialogue via skype or over the phone (more so in the Age of Covid-19). Secondly, there was a need to de-jargonise communications to ensure that the message is conveyed in a comprehensible manner.

16. Mr Justice Green disagreed with the view put forward in Spencer. The test was not just that of the ‘ordinary sensible patient’, relating to objectivity alone, as the Montgomery test required consideration of a subjective element. Furthermore, Montgomery did not require consideration of whether a patient was left feeling ‘justifiably aggrieved’ but rather the test was what a “…reasonable person in the patient’s position would be likely to attach significance to…” ‘Materiality’ depends, of course, on context.

Gallardo v Imperial College Healthcare NHS Trust [2017] EWHC 3147 (QB)

17. The patient underwent major abdominal surgery in 2001 immediately following a CT scan which had showed a mass on his stomach and a malignant tumour was removed. In 2006 he began suffering abdominal pain again which he sought to be investigated. In November 2010 his previous consultant explained that the first operation in 2001 was for a malignant tumour. The patient alleged that he had never been informed that the tumour was malignant and that there was a risk of recurrence which required him to have regular check-ups and CT scans. He underwent major complex surgery in 2011. Experts agreed that the consultant should have advised regular CT scans were necessary. Had that been done then it was likely that the tumour would have been diagnosed in 2006 and further surgery would have taken place four years earlier when the tumour would have been smaller.

18. The Judge held that it was a patient’s right to be informed of the outcome of any treatment, the prognosis, and the options for follow-up care and treatment. Information should only be withheld in exceptional circumstances, and for clear and persuasive therapeutic reasons. Discussion should occur as soon as the patient was well enough to participate fully. Furthermore, significant criticism was placed on the absence of any note or record of discussions with the patient as to his treatment and prognosis, including the need for regular scans and check-ups. The omission to set it out in writing was a “glaring failure” (paragraph 62).

Duce v Worcestershire Acute Hospitals NHS Trust [2018] EWCA Civ 1307

19. The appellant patient alleged that the Trust had negligently failed to warn her of the risk of developing chronic post-surgical pain following a total abdominal hysterectomy and bilateral salpingo-oophorectomy in 2008. The Court of Appeal upheld the decision of the lower court that the claim failed at the first hurdle as the state of medical knowledge had to be considered at the time that the alleged negligence occurred. As of 2008 the existence of a risk of such post-operative pain was insufficient to justify the imposition of a duty to warn of such a risk. Therefore, Montgomery was still followed as a clinician was not required to warn of a risk of which they could not reasonably be taken to be aware.

20. Additionally, when considering the issue of causation, the Court of Appeal accepted that the Judge had considered in detail the appellant’s long history of symptoms from which she hoped to gain relief by undergoing surgery and the fact that she had been made aware of a number of other quite serious risks but, still sought to undergo surgery. That history was justifiably rightly considered to weigh in favour of her choosing to undergo surgery when she did, even if a different warning as to the risk of pain had been given.

Diamond v Royal Devon & Exeter NHS Foundation Trust [2019] EWCA Civ 585

21. The patient had not been properly informed of her options before consenting to a hernia repair procedure – this breach of duty was upheld by the Court of Appeal. However, she was unable to establish that a freestanding claim in damages arose from the NHS Trust’s failure to warn her that a mesh-based procedure might risk future pregnancies. The facts established that she would still have opted for the mesh-based, rather than suture based, procedure had she been properly advised.

NKX (By his L/F NMK) v Barts Health NHS Trust [2020] EWHC 828 (QB)

22. A claim was brought for alleged birth injury, namely severe neuro-disability consequent upon an acute near total hypoxic-ischaemic insult. The Deputy High Court Judge held that there was no breach of duty in relation to the antenatal counselling that had been provided to the claimant’s mother as she had been given sufficient warning of the risk of undergoing monitoring by intermittent auscultation as opposed to continuous foetal monitoring and the correspondence and birth plan had made it clear that the Consultant Midwife’s preference was for continuous rather than intermittent monitoring.

23. However, when the claimant’s mother went into labour at 41 weeks’ gestation, the Judge was critical of the absence of counselling and re-assessment of risks which was necessary as there was a very real possibility that the mother would change her mind if provided with a sober re-assessment of the risks and benefits at that particular juncture, including that the maternity unit was very busy and the Midwife was not capable of managing the mother’s specific labour plan with intermittent auscultation. It was established that with further counselling and re-assessment on the night of labour, continuous foetal monitoring would have been accepted by the claimant’s parents and ultimately foetal heart abnormalities would have been noted sooner.

24. Although the case also dealt with issues concerning delivery, namely the delay in seeking obstetric assistance, the High Court emphasised that the patient’s right to make their own decisions with all material risks and information being disclosed was of central importance and that the need for a patient’s decision to be an informed one is continuous as risks and circumstances can change and evolve, particularly during the labour process.

ABC v St George’s Healthcare NHS Trust and Others [2020] EWHC 455 (QB)

25. What of a duty to provide information and details of risks to those not ordinarily considered a patient? The claimant’s father had killed her mother and had been detained under the Mental Health Act 1983 at a hospital run by the second defendant. He received care from a multi-disciplinary team led by a consultant forensic psychiatrist, which included family therapy sessions also attended by the claimant. It was suspected that the father might be suffering from Huntington’s disease, a genetic condition, but initially he refused to undergo any tests and further was adamant that neither of his daughters, including the claimant, should be informed of the suspected diagnosis as it could impact their decision to have children. The issue was whether the patient’s confidentiality should be breached in the public interest as per the guidelines for psychiatrists at the time. The decision was made not to breach his confidentiality. The father’s diagnosis was confirmed when the claimant was 20 weeks pregnant but, the claimant was not aware of the diagnosis until accidentally informed of the same after her baby had been born. The claimant submitted that the defendants owed her a duty of care to balance her interest in being alerted to the genetic risk against the interest of her father in having his confidentiality preserved and the public interest in maintaining confidentiality.

26. Whilst it was accepted that the claimant was a patient of the family therapy team, the information about her father’s diagnosis was acquired in the context of her father’s treatment and management, rather than the family therapy. She was not in a doctor-patient relationship with the forensic psychiatrist. However, in the unique factual circumstances of the case, which Mrs Justice Yip DBE was very clear to underscore, it was held that a close proximal relationship arose with the second defendant as the clinicians had significant information about the claimant’s circumstances and direct communication with her. They had foreseen the possibility of psychological harm to her and the loss of opportunity to terminate the pregnancy. It was fair, just and reasonable to impose a legal duty on them to balance her interest in being alerted to the genetic risk against the interest of her father and the public interest in confidentiality.

27. Nonetheless, there was no breach of the duty of care as a proper exercise of judgment had been made by the forensic psychiatrist. He had balanced the patient’s safety, taken advice from a geneticist and heard competing arguments. There was room for reasonable disagreement as to the exercise of that judgement, as demonstrated by the lack of consensus between the many expert witnesses. The decision was supported by a responsible body of medical opinion. In any event, the claimant had not proven on the balance of probabilities that she would have undergone a termination if notified of the diagnosis during pregnancy.

28. Mrs Justice Yip DBE did note (paragraph 180) that following Montgomery“the old paternalistic view that a doctor might withhold information about risks because it is the doctor’s assessment that it is better for the patient not to know is no longer good law. Had the information about the genetic risk come to the defendants in the context of a patient relationship with the claimant, they would have been bound to disclose it.”

Informed Consent in Practice

29. There may well have previously been no legal doctrine of informed consent but, that does not mean the medical and healthcare professions had not already been highlighting and reinforcing the importance of patient autonomy in their own guidance for many years.

30. Wider, national guidance has been obtainable at length from bodies such as the General Medical Council (‘Consent: patients and doctors making decisions together’, 2008 onwards), the Department of Health (‘Better information, better choices, better health: Putting information at the centre of health’ 2004; ‘NHS Toolkit for producing patient information’ 2003) and the National Institute for Health and Care Excellence. The NHS Wales Governance e-manual has a section on ‘Patient Consent’ which notes:

“It is a general legal and ethical principle that valid consent must be obtained before starting treatment or physical investigation or providing personal care for a patient. All NHS organisations are therefore required to have robust policies and procedures in place to ensure patient consent is obtained appropriately”

It highlights that the taking of consent is not a single event (as was held in the case of NKX (By his L/F NMK)). It further emphasises the need to review local policies to ensure consistency with the new Guide to Consent for Examination or Treatment 2017, itself revised following Montgomery. Indeed, local/individual NHS Trusts ordinarily have their own practices as to obtaining informed consent reflected in policy and procedural documents.

31. Further, different clinical areas usually have their own specific guidance related to the taking of informed consent. By way of example, Pubic Health (England) has guidance related to obtaining informed consent for cancer screening, last updated in December 2018: “For participants to make an informed decision and therefore give valid consent, they should be provided with sufficient information and support about the screening process.” The Royal College of Anaesthetists, back in February 2003, produced ‘Raising the Standard: Information for Patients’.

32. In conjunction with the above, medical professionals have been able to find assistance by way of pro forma documentation in obtaining consent, although invariably each case differs and some cases may require further matters to be discussed, additional notes to be made and risks to be considered than contained within such documents. For example, the NHS in Wales produced a revised NHS Wales Model Policy together with consent forms to support the practical application of the consent guidance. Public Health (England) has provided sample letters to be utilised in cancer screening cases where patients wish to refuse screening to ensure that they understand the implications of what they are doing.

33. Information leaflets together with written correspondence and verbal communication all lead to the patient having a clearer understanding of the benefits and disadvantages of treatment and care and to ensure that consent is validly obtained. As repeated in Thefaut, the importance of open and clear dialogue in the doctor-patient relationship, whether via electronic means or otherwise, cannot be overstated. The importance of contemporaneous medical notes, ideally with written consent, goes hand in hand with this. If oral consent is given, it can be useful to have a permitted family member or friend with the patient to ensure that information is relayed understandably, and cynically, to have a witness present.

Conclusion

34. With the backdrop of fundamental rights being recognised by the European Convention on Human Rights and the Human Rights Act 1998, society’s continual move towards individual autonomy and the freedom to make one’s own life choices, it was inevitable that the Bolam test could not stand to remain the deciding factor in clinical negligence litigation involving issues of patient consent. Montgomery finally gave legal scope to the notion that the patient’s right to make an informed decision based on known material medical risks is of central importance, a right that has long been recognised by medical and healthcare professionals and bodies alike.

35. Cases since Montgomery confirm that taking consent is not a single event but a process of discussion, of weighing up the options and providing support to patients to enable them to make the right decision for them as individuals. It requires an ability to communicate clearly through open dialogue. Effectively, individual patient autonomy is guided and promoted through collaborative teamwork with their medical and healthcare professionals.

36. Clinical consent – where are we now? A much better place.

RUWENA KHAN

PARK SQUARE BARRISTERS

Image: public domain from https://pixabay.com/en/hospital-ward-hospital-medical-room-1338585/