Don't blame me
Date: 11 April 2008
Authors: Andrew Harris
Issue: Vol 158, Issue 7316
Categories: Features, Employment, Personal injury, Community care
A short while after childbirth in an NHS hospital, Mayra Cabrera died of a heart attack, caused by mistakenly being given the drug Bupivacaine intravenously, instead of the similarly styled saline drip. The two infusion bags looked identical and were stored in the same unlocked drawer; similar incidents have occurred in other hospitals. The coroner‘s inquest ruled that Mrs Cabrera was unlawfully killed after gross negligence by the trust; the widower called for a prosecution against the midwife. What should the test of negligence be in such cases? Do we apply the Bolam test, ie “not acting in accordance with a practice accepted as proper by a responsible body of medical men, skilled in that particular art” (Bolam v Friern Hospital Management Committee [1957] 2 All ER 118), to the hapless midwife, who put up the infusion, or a test of primary liability of the trust?
CONTROLLING MINDS
Currently for such an error to amount to a criminal offence by the trust, there is the need to surmount the exceptionally high hurdle of requiring an employee to have a “controlling mind”. The new offence of corporate manslaughter, which came into effect on 6 April this year, will become available as a coroner’s verdict and apply to NHS organisations, as Crown immunity will no longer be a defence (Corporate Manslaughter and Corporate Homicide Act 2007 (CMCHA 2007), s 11). The duty of care owed in negligence is breached if the death is caused by the way in which activities are managed and organised or amount to a gross breach of a relevant duty of care (s 1(1)).
The organisational failing needs to be a substantial element of the breach and fall at senior management level. There must be a temptation in any fatal case to prosecute the doctor, the organisation and the manager, to secure at least one conviction, with the risk that all will blame each other, although the permission of the director of public prosecutions is required before mounting a prosecution (s 17). But the temptation will be all the greater since the organisation will not be judged on the high threshold of Bolam. Ministry of Justice guidance on CMCHA 2007 suggests that factors that might be considered include: the systems of work used by employees; their level of training and adequacy of equipment; supervision of middle management; arrangements for assessing and monitoring risk and auditing its management; and broader attitudes within the organisation to health and safety. Further, it is for the court to decide if there has been a gross breach of duty on its objective assessment of the facts and technical and professional advice. Is there a non Bolam alternative to criminal prosecution of corporate liability in the civil law, especially for less gross breaches, and on what could it be based?
SYSTEM FAILURES
The mischief upon which CMCHA 2007 is focused is organisational system failures. We know quite a bit about health system failures. The Harvard Medical Practice Study suggested that one in 25 admissions is harmed, two-thirds have errors in care, but in only about 1% of admissions is actual negligence is found. Extrapolated to the
STATUTORY DUTY OF QUALITY
NHS organisations are bound by a statutory duty of quality (SDQ). The Health Act 1999, s 18(1) states:
“It is the duty of each [NHS provider] to put and keep in place arrangements for the purpose of monitoring and improving the quality of health care which it provides for individuals.”
These arrangements are defined by the Department of Health as clinical governance, which is:
“A framework through which NHS organizations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish.” (A First Class Service, Department of Health 1988)
In law, clinical governance is a legal duty on organisations, not upon professionals. The SDQ, according to health service circular, HSC 1999/065: Clinical Governance in the New NHS, should underpin clinical governance, requiring arrangements to be in place to prevent incidents and lines of responsibility for serious failures in standards of care. Chief executives gained accountability for establishing and maintaining systems to ensure clinical quality. Failure to store and manage drugs in a way that meets guidance to reduce risks of error is an organisational liability. But the general rule is that breach of statutory duty is not actionable.
HUMAN RIGHTS ACT
However, the Human Rights Act 1998 has come to the rescue of potential litigants of NHS organisations by a recent preliminary decision of the Court of Appeal on the duty of health authorities to prevent suicide in Savage v South Essex Partnership NHSFT [2007] EWCA Civ 1375, [2007] All ER (D) 316 (Dec). In order to establish an Art 2 breach (right to life), the standard of organisational negligence does not have to be gross negligence: knowledge of a real and immediate risk to life, which judged reasonably, might have been expected to be avoided by taking measures within the scope of the trust, is sufficient.
The common law had already established primary liability that does not require use of the Bolam test, but the two lines of cases are not often followed. The first are where care, but not duty, is delegated to a non employee or other organisation. Actions have been brought successfully in Cassidy v Ministry of Health [1951] 2 KB 343, [1951] 1 All ER 574; M v Calderdale & Kirklees HA [1998] Lloyds Rep Med 157, and unsuccessfully in Roe v Ministry of Health and others [1954] 2 All ER 131. In Cassidy, primary liability allowed the negligence of the professional to not even be examined: res ipsa loquitur was accepted. In Roe, the ampoules of local anaesthetic were stored in phenol, which percolated minute cracks in the glass, and the contamination caused the spastic paraplegia, when injected into the spine. The Court of Appeal exonerated the doctor.
In Calderdale, the NHS trust, and not its referring doctor, was held negligent for an incompetently conducted abortion it organised in an uninsured private German hospital. The extension of liability beyond the control of the hospital, as in Calderdale, has been considered as not current law, by the Court of Appeal in Re A v MoD and Guys & St Thomas’ NHST [2004] EWCA Civ 641, [2004] All ER (D) 96 (May), although it approved liability for a non-delegable duty of care in Watson v British Boxing Board of Control Ltd and another, (2001) QB 1134, [2000] All ER (D) 2352.
ORGANISATIONAL LIABILITY
The second line of cases specifically deals with system failure and has more authority. The most graphic description of organisational liability, can be found in a successful action for allowing water to be contaminated in Read v Croydon Corporation [1938] 4 All ER 631:
“(p 644)... all these officers were men who were qualified for their work, and I find no trace anywhere of that degree of negligence… ” (p 646) “...the corporation failed in its duty. …no evidence was adduced that any member of the committee made any inquiry, or took any step whatever, to formulate any established policy in connection with chlorination, or… to put that policy into effect, or to provide a proper system of supervision and inspection to secure that any policy that was adopted was being efficiently, regularly and systematically carried out. In these circumstances, where the responsibility prima facie rests, there I propose to let it lie.”
Thus organisational liability may be found for the non-establishment of a safe system. Its poor implementation might also attract liability in the absence of logistical constraints, but the case law seems to be confined to delays causing birth asphyxia (Robertson v Nottingham HA (1997) 8 Med LR 1 CA, Mercer v Royal Surrey NHST QBD 2000, [2000] All ER (D) 2404; Richards v Swansea NHST [2007] EWHC 487, [2007] All ER (D) 202 (Mar)). There are cases where system failure and primary organisational liability seem relevant but are not argued. An example is Hardaker v Newcastle HA, CC Northumbria, MLC 0395, QBD Medical Litigation 2001, [2001] All ER (D) 157 (Jun), a post SDQ case: no negligence was found for disability from inexpert initial treatment by a first-year registrar and delays after transfer to the police decompression chamber, which the NHS had commissioned, but where the oxygen facility was out of use and staff unavailable.
As stated above, the majority of errors in healthcare are multifactorial and involve organisational failures. It is of interest that there are so few reported cases of primary liability, when organisational error is so common, and the test of negligence is not clear. The NHS Litigation Authority confirms that primary organisational failure is argued in settlements, but there are no published records.
It has been argued (Malik S, AvMA MLJ, Vol 11, 1, 2005) that the use of “material increase in risk” is a more appropriate test than the “but for test” for MRSA infections, based on breach of statutory Control of Substances Hazardous to Health Regulations 2002. Should a similar approach be used, based on SDQ—perhaps using evidence of compliance with Healthcare Commission core standards, as a test of organisational system competence? If the injury is death, a criminal prosecution and an Art 2 claim is possible, but for those with injury from organisational failures, can we be sure that the hurdle of Bolam does not inhibit the law justly reflecting the science?
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