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NEWS: Robert Short UK government to spend £105m to improve stroke services BMJ 2007; 335: 1231-a [Full text]

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Litigation risks with the National Stroke Strategy

Christian O Blyth, Dr Nigel Dudley, Consultant in elderly medicine, St James's hospital, leeds   (19 December 2007)

Litigation risks with the National Stroke Strategy 19 December 2007
Christian O Blyth, ST2 South Yorkshire Northern General hospital, sheffield, S5 7AU, Dr Nigel Dudley, Consultant in elderly medicine, St James's hospital, leeds Send response to journal: Re: Litigation risks with the National Stroke Strategy	The Impact Assessment document accompanying the recently released National Stroke Strategy indicates that the stroke strategy will not have any impact on Legal Aid. [1] This assessment is very likely to prove to be mistaken given firstly the priority of the strategy to expand stroke thrombolysis services to cover 4 – 10% of patients with ischaemic strokes, and secondly the published evidence about litigation claims in US courts relating to the use of tissue plasminogen activator (tPA) in acute stroke. [2] Two areas of possible litigation with thrombolysis are likely to develop, one relating to loss of chance litigation, and the other to consent issues. What should perhaps be of concern to the Department of Health is the way that the recent SITS-MOST “real-life” use of tPA found that there was a 55% chance of recovery to independence if thrombolysis was given and just a 45% chance of being dead or dependent; in other words, having treatment made recovery to independence something that would more likely than not happen if the treatment was given correctly within the three hour time window in line with the protocol. [3] This outcome introduces the possibility of loss of chance claims in relation to a more widespread and routine use of thrombolysis in stroke. This category of litigation in relation to medicine was last tested in the House of Lords in the Gregg v Scott case that was decided in favour of Scott; it was not able to be shown that the failure to treat had caused any damage as even with treatment there would have been less than a 50% chance of survival from the lymphoma. [4,5] Up until SITS-MOST it would have been possible to rely on the pooled tPA study findings or the original NINDS study to defeat any loss of chance claim as both found that the chance of recovery to independence with or without thrombolysis did not exceed 50%.[3,6] This has been borne out by the US case of Ensink v Mecosta County General Hospital that resulted in a success for the hospital as the patient was unable to show that even if thrombolysis had been given within three hours the chance of a better outcome than the one that had occurred would not have exceeded 50%.[2] Consent issues, including an explanation of risks and benefits, will also be important in relation to possible litigation claims. All of the 23 hospitals in the United Kingdom that participated in the SITS-MOST study were contacted and asked to supply under the terms of the Freedom of Information Act 2000 “any information that is given to patients and / or their relatives to consent for thrombolysis for a stroke (e.g a patient information leaflet and consent forms).” Only 18 of the hospitals replied and of those only 3 provided a leaflet as part of the consent process. More reassuringly, 14 gained verbal consent and instructed staff to supply a varying amount of mandatory survival and risk / benefit information. As the aim of the stroke strategy in England is to introduce access to stroke thrombolysis 24 / 7 in specialist centres there is very likely to be an impact on the Legal Aid budget. This impact fortunately could be minimised by ensuring that all hospitals have information leaflets available that provide accurate and understandable risk and benefit information for patients and relatives. In addition, in those cases where patients arrive within three hours but are not given thrombolysis there should be procedures in place to guarantee that there is clear documentation in the medical records about the underlying decision making processes leading to the decision not to treat. Ignoring such simple measures may have previously unforeseen litigation consequences that impact significantly on the Legal Aid budget in England. [1] Department of Health. Impact Assessment. A new ambition for stroke. 2007 www.dh.gov.uk/en/Publcationsandstatistics/Publications/PublicationsLegislation/DH_081057 (accessed 17.12.07) [2] Weintraub MI. Thrombolysis (Tissue Plasminogen Activator) in Stroke. A Medicolegal Quagmire. Stroke 2006;37:1917 – 1922 [3] Wahlgren N, Ahmed N, Davalos A et al. Thrombolysis with Alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke – Monitoring Study (SITS-MOST): an observational study. Lancet 2007;369:275 - 282 [4] Dyer C. Man whose tumour went untreated loses negligence battle. BMJ 2005;330:276 [5] Gregg v Scott [2005] UKHL 2 [6] The National Institute of Neurological Disorders and Stroke rt- PA Stroke Study Group. Tissue plasminogen activator for acute ischaemic stroke. The National Institute for Neurological Disorders in Stroke rt-PA Study Group. N Engl J Med 1995;333:1581 - 7 Competing interests: None declared