Screening for abdominal aortic aneurysms: some legal implications

Clin Risk 2008;14:211-214
doi:10.1258/cr.2008.080089
© 2008 Royal Society of Medicine Press

 

This Article
Screening for abdominal aortic aneurysms: some legal implications

Abstract

Full Text (PDF)


Alert me when this article is cited

Alert me if a correction is posted
Screening for abdominal aortic aneurysms: some legal implications
Services
Screening for abdominal aortic aneurysms: some legal implications

Email this article to a friend

Similar articles in this journal


Alert me to new issues of the journal

Download to citation manager

Screening for abdominal aortic aneurysms: some legal implications
Citing Articles
Screening for abdominal aortic aneurysms: some legal implications
Citing Articles via Google Scholar
Screening for abdominal aortic aneurysms: some legal implications
Google Scholar
Screening for abdominal aortic aneurysms: some legal implications

Articles by Elliott, T.
Search for Related Content
Screening for abdominal aortic aneurysms: some legal implications
Social Bookmarking
Screening for abdominal aortic aneurysms: some legal implications
Screening for abdominal aortic aneurysms: some legal implications

What’s this?


Patient safety


Tracey Elliott

Email: t.a.elliott{at}qmul.ac.uk




Abstract

Top

Abstract
Introduction

Errors in relation to…

Issues in relation to…

Failure to monitor, re-call…

Conclusion

References

 

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-typeclaims are to be avoided.





Introduction

Top

Abstract

Introduction
Errors in relation to…

Issues in relation to…

Failure to monitor, re-call…

Conclusion

References

 

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 medicalprocedures and technologies inevitably raises legal issues,particularly in the event of misjudgment or mishap, or if themedical 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:

  1. errors in relation to diagnosis;
  2. issues in relation to consent, particularly with regard to the provision of information to the patient;
  3. failure to monitor, re-call and/or re-scan the patient;
  4. problems arising from the conduct of the surgery.3

In this short article I propose to focusupon the first three of these and to highlight some of the mainlegal implications of AAA scanning.





Errors in relation to diagnosis

Top

Abstract

Introduction

Errors in relation to…
Issues in relation to…

Failure to monitor, re-call…

Conclusion

References

 

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.4One potential area for complaint is in relation to the scanningprocess, particularly in relation to the interpretation of whatthe 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 theClaimant failed to establish a breach of duty because, on thefacts of the case, it was unlikely that the abnormality in questionwould have been observable at the time of the scan and, evenif it had been visible, a sonographer exercising reasonablecare 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:

  1. whether a sonographer exercising reasonable care could have failed to see what was on the ultrasound scan;
  2. 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, ifthe judge is not to conclude that the sonologist failed to actwith reasonable care and skill.





Issues in relation to consent

Top

Abstract

Introduction

Errors in relation to…

Issues in relation to…
Failure to monitor, re-call…

Conclusion

References

 

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 duringsurgery, their family may leap to the conclusion that ‘somethingmust 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.33In such a case, the patient faces the ‘double whammy’of knowing that they have a condition which may suddenly causetheir death and that it cannot be treated. In the event thatthey had not been warned that this was a possible outcome andif, faced with this bleak outcome, they were to develop clinicaldepression, one could envisage them seeking to bring a claimon the basis that, had they been informed that the scan mightreveal a potentially fatal, but untreatable AAA, they wouldhave decided not to have the scan and would have preferred toremain 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





Failure to monitor, re-call and/or re-scan the patient

Top

Abstract

Introduction

Errors in relation to…

Issues in relation to…

Failure to monitor, re-call…
Conclusion

References

 

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 heldthat a decision made without the patient’s knowledge or consentto abandon the preferred course of following up a mammogramand biopsy with a repeat biopsy to confirm or exclude malignantbreast cancer (from which the patient subsequently died) wasnegligent.





Conclusion

Top

Abstract

Introduction

Errors in relation to…

Issues in relation to…

Failure to monitor, re-call…

Conclusion
References

 

It is somewhat paradoxical that medical advances which bringsignificant health benefits to patients nevertheless commonlylead to a surge in legal claims. In this brief article I amunable to explore all of the legal ramifications of AAA scanningand treatment, but have sought to highlight some of the mainlegal implications of the AAA screening programme. If cliniciansare aware of the legal pitfalls, particularly in relation tothe provision of sufficient information to patients about theirtreatment, it is to be hoped that avoidable claims in relationto this area of medicine can be minimized.




Footnotes


Tracey Elliott LLM LLB, Barrister, 9–12 Bell Yard; andLecturer, Queen Mary, University of London, UK




References

Top

Abstract

Introduction

Errors in relation to…

Issues in relation to…

Failure to monitor, re-call…

Conclusion

References


  • 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

Screening for abdominal aortic aneurysms: some legal implications
CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What’s this?






This Article
Screening for abdominal aortic aneurysms: some legal implications

Abstract

Full Text (PDF)


Alert me when this article is cited

Alert me if a correction is posted
Screening for abdominal aortic aneurysms: some legal implications
Services
Screening for abdominal aortic aneurysms: some legal implications

Email this article to a friend

Similar articles in this journal


Alert me to new issues of the journal

Download to citation manager

Screening for abdominal aortic aneurysms: some legal implications
Citing Articles
Screening for abdominal aortic aneurysms: some legal implications
Citing Articles via Google Scholar
Screening for abdominal aortic aneurysms: some legal implications
Google Scholar
Screening for abdominal aortic aneurysms: some legal implications

Articles by Elliott, T.
Search for Related Content
Screening for abdominal aortic aneurysms: some legal implications
Social Bookmarking
Screening for abdominal aortic aneurysms: some legal implications
Screening for abdominal aortic aneurysms: some legal implications

What’s this?