Clin Risk 2008;14:211-214
doi:10.1258/cr.2008.080089
© 2008 Royal Society of Medicine Press
Screening for abdominal aortic aneurysms: some legal implications
Tracey Elliott
Email: t.a.elliott{at}qmul.ac.uk
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Abstract
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This article explores some of the main legal implications of
abdominal aortic aneurysm (AAA) scanning and treatment, particularly
in relation to the interpretation of AAA scans, the provision
of patients with adequate information about their options and
the risks involved, and issues in relation to monitoring, re-scanning
and re-calling the patient for further assessment and treatment.
It is suggested that the introduction of national AAA scanning
programme is likely to lead to an increase in litigation claims
in this field, and that, given the complex nature of the risk–benefit
assessment in relation to AAA treatment, particular care needs
to be taken to ensure that patients are properly informed about
their condition and its treatment, if
Chester v Afshar-type
claims are to be avoided.
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Introduction
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As Mr Hafez has demonstrated in the preceding article, the introduction
of a national abdominal aortic aneurysm (AAA) disease screening
programme in England and Wales is likely to offer considerable
health benefits for those men aged 65 years suffering from AAA
disease, enabling them to have what might otherwise have remained
an undetected condition monitored and/or to receive timely surgical
intervention and dramatically reducing their risk of mortality
from AAA rupture.
1 However, the introduction of new medical
procedures and technologies inevitably raises legal issues,
particularly in the event of misjudgment or mishap, or if the
medical outcome fails to meet the patient's expectations.
To give some idea of the extent of litigation claims in relation to vascular surgery, including AAA surgery, in England and Wales, a recent study by Markides et al.2 identified 395 claims submitted to the NHSLA between 1995–2007. Of these claims, 160 Claimants were successful and received compensation (ranging from minimal damages to in excess of £650,000) in 160 cases. Of the successful cases, 10 (less than one case per year) involved AAA surgery. The introduction of a national AAA scanning programme and an increase in the number of elective surgical procedures for the condition is likely to lead to an increase in litigation claims. In particular, I suggest that there are four broad ‘problem areas’, which are likely to lead to patient complaints and/or litigation:
- errors in relation to diagnosis;
- issues in relation to consent, particularly with regard to the provision of information to the patient;
- failure to monitor, re-call and/or re-scan the patient;
- problems arising from the conduct of the surgery.3
In this short article I propose to focus
upon the first three of these and to highlight some of the main
legal implications of AAA scanning.
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Errors in relation to diagnosis
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Errors of diagnosis in relation to AAA disease have led to litigation
in the past: Markides
et al. found that failure or delay of
diagnosis and/or treatment, which led to serious complications,
was the subject of complaint in seven of the 10 successful cases.
4 One potential area for complaint is in relation to the scanning
process, particularly in relation to the interpretation of what
the scan reveals.
Specialist doctors are expected to exercise the ordinary skill of their specialty: ‘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’,5 a well-known and established principle known as the Bolam test. So, in the context of routine ultrasound scanning, the standard is that of a reasonably competent sonologist exercising reasonable care at the time when the scan was being conducted.6 For example, in B v South Tyneside Health Care NHS Trust,7 the Claimant failed to establish a breach of duty because, on the facts of the case, it was unlikely that the abnormality in question would have been observable at the time of the scan and, even if it had been visible, a sonographer exercising reasonable care could have failed to see an apparent abnormality.
The task of a court considering a clinical negligence claim, however, goes beyond merely relying on the Bolam test.8 First, if a judge considering expert evidence as to whether the practice of the Defendant acted in accordance with responsible professional practice concludes that ‘the professional opinion is is not capable of withstanding logical analysis’,9 then the judge ‘is entitled to hold that the body of opinion is not reasonable or responsible’.10 Second, it is clear from the Court of Appeal decision of Penney v East Kent Health Authority,11 a decision concerning the negligent classification of cervical smear tests as negative, that a judge must distinguish between matters of professional judgment, to which the Bolam test applies, and issues of fact, to which the Bolam test does not apply, and which are for the judge to determine. Following Penney, it appears that, in the event of a claim being made in respect of an alleged failure to spot an AAA during a scan, the quesion of what was apparent from the scan would be a question of fact for the judge who, having determined the answer to that issue, would then have to go on to consider:
- whether a sonographer exercising reasonable care could have failed to see what was on the ultrasound scan;
- whether a reasonably competent sonographer, aware of what a sonographer exercising reasonable care would observe on the scan, have treated the appearance of the scan as normal.12
Furthermore, it has recently been made clear
by the Court of Appeal in
Lillywhite v University College London Hospitals' NHS Trust,
13 a case involving antenatal ultrasound
scanning, that the context in which the treatment takes place
may be relevant to the determination of the standard of care
and skill required. Following a routine abnormality scan of
Mrs Lillywhite, during which the radiographer had been unable
to see the normal anatomy in the front part of the fetal brain,
she had been referred to a distinguished consultant at the respondent
hospital, who conducted a further scan and concluded after a
long examination that the fetus was normal. In due course, Mrs
Lillywhite gave birth to a severely disabled daughter who suffered
from holoprosencephaly, a severe malformation of the brain.
Mr and Mrs Lillywhite subsequently brought an action in negligence
against the respondent Trust, claiming that their consultant
had, when conducting the scan, negligently failed to appreciate
that it showed fetal brain abnormalities indicative of holoprosencephaly.
The trial judge dismissed the claim, concluding that negligence
had not been established. However, the majority of the Court
of Appeal disagreed and concluded that, given that this was
a scan in a tertiary referral centre by a consultant sonologist
following a referral because an initial scan had failed to detect
normal fetal brain structures, this was a ‘scan with a
focus’,
14 and that the duty of care owed by the respondent's
consultant ‘demanded a high standard of care and skill’.
15 Although this was not a case in which the principle
res ipsa loquitur16 applied, given that the consultant concerned had
‘purported to identify structures which were simply not
there’,
17 he was ‘under a heavy burden... to reconcile
his incorrect conclusions with the exercise of all reasonable
care and skill’.
18 Since the House of Lords refused leave
to appeal, the approach of the Court of Appeal in
Lillywhite must be taken to be authoritative on this point, although the
scope and effect of the decision may be further developed by
the courts. The significance of the decision so far as AAA scanning
is concerned, is that a higher standard of care is required
from consultant sonologists dealing with referrals at tertiary
centres than from sonologists conducting routine scans. If a
claim is brought in respect of a ‘scan with a focus’
at a tertiary centre, where relevant structures have been misidentified,
it is likely that the Defendant will need to provide ‘a
plausible expanation’
19 for the misidentification, if
the judge is not to conclude that the sonologist failed to act
with reasonable care and skill.
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Issues in relation to consent
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There are a number of difficulties in relation to the obtaining
of informed consent to AAA scanning and treatment, particularly
with regard to providing the patient with adequate information
about to their options and the risks involved. Some of the main
difficulties are highlighted in a recent American study of patients
by Berman
et al.20 which investigated communication between
surgeons and patients, and the issue of informed consent in
relation to AAA repair. The study found that patients who had
been informed that they had AAA disease tended to see surgery
as their only option, lacked a balanced appreciation of the
likely progression of their condition, the risks and causes
of rupture and the risks of surgery,
21 and felt that they were
‘walking on eggshells for fear the thing would burst’.
22
The risk is that if patients are confused or harbour misapprehensions about the relative risks of regular monitoring of their condition and surgery, they may have excessively high expectations which, if not met, may lead to litigation. Such speculation is not without foundation: screening programmes for breast and cervical cancer, have led to what has been termed ‘a wave of litigation’,23 and it has been suggested that this may be due to a failure to appreciate the limitations of screening,24 and to unrealistic expectations on the part of patients and their families.25 Patients who are scanned for AAA disease may incorrectly assume that they are ‘safe’, and if, prior to the next scheduled scan, an aneurysm grows unexpectedly quickly and ruptures, with fatal results, their family may assume that the death was caused by a failure of diagnosis. Alternatively, patients and their families, faced with a diagnosis of AAA disease, may focus upon the benefits of scanning and early treatment, without comprehending the very real risks of surgery.26 If the patient then dies during surgery, their family may leap to the conclusion that ‘something must have gone wrong’ and blame the surgeon.
So far as the law of negligence is concerned, a doctor is under a duty to advise his patient about his options and the significant risks involved in treatment,27 and to take ‘reasonable and appropriate steps to satisfy themselves that the patient has understood the information which has been provided’,28 although he is not under an obligation to make sure that the patient understands this information.29 Given that the risk-benefit assessment in relation to AAA treatment is not straightforward,30 care needs to be taken to ensure that patients are properly informed about their condition and its treatment,31 if Chester v Afshar-type32 claims, made upon the basis that there was a failure to warn of significant risks and that, had he been properly informed, he would not have undergone that treatment, are to be avoided. I would suggest that it would be prudent to extend care in relation to the provision of information not merely to the aftermath of scanning, but to the scan itself. Scanning is generally seen (by patients, at least) as a beneficial, or at least a benign process. However, this may not always be the case. For a small number of patients, a scan may show that the patient has an AAA, but that repair is impossible, or tests following the scan may reveal that the patient is too unwell for repair surgery or other surgical treatment to be conducted.33 In such a case, the patient faces the ‘double whammy’ of knowing that they have a condition which may suddenly cause their death and that it cannot be treated. In the event that they had not been warned that this was a possible outcome and if, faced with this bleak outcome, they were to develop clinical depression, one could envisage them seeking to bring a claim on the basis that, had they been informed that the scan might reveal a potentially fatal, but untreatable AAA, they would have decided not to have the scan and would have preferred to remain ignorant of their condition.
Having said that there is a legal duty to warn the patient of significant risks, may a doctor treating an anxious or vulnerable patient, who does not give such a warning, rely on ‘therapeutic privilege’, upon the basis that the provision of such information was not in the patient's interests? In Chester v Afshar,34 Lord Steyn considered this, and suggested that there might be ‘wholly exceptional cases objectively in the best interests of the patient the surgeon from giving a warning’.35 However, he then proceeded to emphasize that ‘[i]n modern law medical paternalism no longer rules and a patient has a prima facie to be informed by a surgeon of a small, but well established, risk of serious injury as a result of surgery’,36 suggesting that such ‘exceptional cases’ are likely to be very rare indeed.37
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Failure to monitor, re-call and/or re-scan the patient
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If a patient is diagnosed as suffering from a small AAA,
38 they
will have to be re-called at regular periods for repeat surveillance
scans to see if the AAA has grown and surgery is required. Even
patients who undergo surgical treatment will require lifelong
periodic monitoring to check that no problems have arisen in
relation to the graft. Erroneously discharging an AAA patient
is likely to be found to amount to a breach of the duty of care
in the event of an untreated AAA rupturing. An illustration
of a consultant being found to be negligent for incorrectly
discharging a patient may be found in the case of
Mellor v Sheffield Teaching Hospitals NHS Trust,
39 where a consultant cardiologist
had discharged a patient who had multiple risk factors for coronary
heart disease (CHD), and who subsequently died from the disease,
without ruling out that condition. Given the seriousness of
the risk should CHD materialize, it was held that the consultant
ought to have carried out further investigations, which would
then have led to treatment. Similarly, a failure properly to
monitor or to re-call the patient for a further surveillance
scan, or the abandoning of preferred options in relation to
scanning or other tests without obtaining the informed consent
of the patient may be held to be negligent. For example, in
Cooper v Royal United Hospital Bath NHS Trust40 it was held
that a decision made without the patient's knowledge or consent
to abandon the preferred course of following up a mammogram
and biopsy with a repeat biopsy to confirm or exclude malignant
breast cancer (from which the patient subsequently died) was
negligent.
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Conclusion
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It is somewhat paradoxical that medical advances which bring
significant health benefits to patients nevertheless commonly
lead to a surge in legal claims. In this brief article I am
unable to explore all of the legal ramifications of AAA scanning
and treatment, but have sought to highlight some of the main
legal implications of the AAA screening programme. If clinicians
are aware of the legal pitfalls, particularly in relation to
the provision of sufficient information to patients about their
treatment, it is to be hoped that avoidable claims in relation
to this area of medicine can be minimized.
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Footnotes
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Tracey Elliott LLM LLB, Barrister, 9–12 Bell Yard; and
Lecturer, Queen Mary, University of London, UK
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References
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- See for example Scott RAP. The place of screening in the management of abdominal aortic aneurysm. Scanda J Surg 2008; 97: 136–8, which suggests a 58% reduction in mortality
- Markides G, Subar D, Al-Khaffaf H. Litigation claims in vascular surgery in the United Kingdom's NHS. Eur J Endovasc Surg 2008; 36: 452–7
- For example, Markides et al. identified two successful claims relating to AAA surgery. In one claim nerve damage had been caused, the other related to suturing of the bowel wall: ibid. Unsurprisingly, it appears that the lowest mortality and morbidity rates for AAA repair are achieved by specialist vascular surgeons who perform the highest numbers of such repairs in hospitals in which the largets numbers of such operations are conducted: see for example Holt PJ, Poloniecki JD, Loftus IM, Michaels JA, Thompson MM. Epidemiological study of the relationship between volume and outcome after abdominal aortic aneurysm surgery in the UK from 2000 to 2005. Br J Surg 2007; 94: 441–8; Rosenthal R, von Kanel O, Eugster T, Stierli P, Gurke L. Does specialization improve outcome in abdominal aortic anuerysm surgery? Vascular 2005; 13: 107–13
- Ibid.
- Bolam v Maynard v. West Midlands Regional Health Authority [1984] 1 WLR 634, Lord Scarman, 648
- Cf Penney & Ors v East Kent Health Authority [2000] PNLR 323, 329
- [2004] EWHC 1169 (QB)
- See Smith v Southampton University Hospitals NHS Trust [2007] EWCA Civ 387, in which the trial judge was criticized by the Court of Appeal for appearing to ‘rely exclusively on the Bolam test’, and indicated that ‘where there is a clear conflict of medical opinion, the court's duty is not merely to say which view it prefers, but to explain why it prefers one to the other’: Wall LJ [44]. An appeal to the House of Lords is pending
- Bolitho v City and Hackney Health Authority [1998] AC 232, Lord Browne-Wilkinson, 243
- Ibid.
- [2000] PNLR 323
- Ibid., Lord Woolf MR, 331; B v South Tyneside Health Care NHS Trust [2004] EWHC 1169 (QB), Simon J [13]
- [2005] EWCA Civ 1466
- Pithers v Leeds Teaching Hospitals NHS Trust [2004] EWHC 1392 (QB), Holland J [14]. The approach in Pithers was endorsed and followed by the majority of the Court of Appeal in Lillywhite: [2005] EWCA Civ 1466, Latham LJ [30]–[33]
- Ibid., Latham LJ [31]
- See Delaney v Southmead Health Authority [1995] 6 Med LR 355, Stuart Smith LJ, 359; Ratcliffe v Plymouth and Torbay Health Authority [1998] Lloyds LR Med 162, Hobhouse LJ at 177
- [2005] EWCA Civ 1466, Latham LJ [33]
- Ibid., Latham LJ, [34]; cf Buxton LJ [86]–[87]
- Ibid., Latham LJ [34], [39]; Buxton LJ [86]–[87]
- Berman L, Curry L, Gusberg R, Dardik A, Fraenkel L. Informed consent for abdominal aortic aneurysm repair: The patient's perspective. J Vasc Surg 2008; 48: 296–302. The study was small-scale (20 patients were interviewed), but nevertheless highlights some significant difficulties in relation to obtaining informed consent to AAA surgery. Cf Vohra HA, Ledsham J, Vohra H, Patel RL. Issues concerning consent in patients undergoing cardiac surgery – the need for patient-directed improvements: a UK perspective. Cardiovasc Surg 2003; 11: 64–9
- Berman et al., ibid., 298–9
- Berman et al., ibid., 299 Following the decision of the House of Lords in Johnson v NEI Combustion Ltd. [2008] 1 AC 281, ‘fear of the future’ claims are not tenable in English law, at least where no physical damage is caused, and the sole basis for the claim is a fear of developing an illness in the future
- Benson JR, Purushotham AD, Warren R. Screening and litigation. BMJ 2000; 321: 760
- Ibid.
- Wilson RM. Screening for breast and cervical cancer as a common cause for litigation. A false negative result may be one of an irreducible minimum of errors. BMJ 2000; 320: 1352–3[Free Full Text]
- See Hafez H [ante], 4–5
- See Pearce v United Bristol Healthcare NHS Trust [1999] PIQR P53, Lord Woolf MR, 59; Chester v Afshar [2005] 1 AC 134, Lord Steyn [15]–[16]
- Al Hamwi v Johnston [2005] EWHC 206 (QB), Simon J [69]
- Ibid.
- Hafez H, above, n26
- A number of organizations provide clear, patient-friendly information about AAAs, including NHS Direct (www.nhsdirect.nhs.uk), the British Heart Foundation (Factfile No. 7, 2008), the Circulation Foundation (www.circulationfoundation.org.uk), www.patient.co.uk and NICE (‘Keyhole surgery to repair abdominal aortic aneurysm’, Information about NICE interventional procedural guidance 229, London: NICE, 2007. See http://www.nice.org.uk/)
- [2005] 1 AC 134
- See for example Johnson JN. Should we screen for aortic aneurysm? No. BMJ 2008; 336: 863[Free Full Text]
- [2005] 1 AC 134, [16]
- Ibid.
- Ibid.
- But see for example the Australian case of Battersby v Tottman (1985) 37 SASR 524 where the defence of therapeutic privilege succeeded
- Less than 5.5 cm: Hafez, above, n26, 7
- [2004] EWHC 780 (QB), Gross J. The claim ultimately failed because causation could not be established
- [2004] EWHC 3381 (QB), Butterfield J
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Abstract
Introduction
