Abstract
Introduction
Public and government concern in nosocomial (hospital-acquired) infection has recently increased. Relentless media interest and an increasing Department of Health and government policy reflect the fact public awareness of the dangers is set to continue.
MRSA (Methicillin-resistant Staphylococcus aureus) is the most commonly known ‘superbug’. Others have more recently followed. The latest, Clostridium difficile (C. difficile), although a wealth apart from MRSA in acquisition and symptoms, is being highlighted in the same category. This article highlights the issues which set nosocomial infection cases apart from other clinical negligence claims.
Cases nearly always start where would-be Claimants consult solicitors as a result of information they have gleaned from the media. There is certainly plenty of information available. Some new legal arguments are presently being tested in the courts.
Public interest – is it warranted?
Public interest in infection control in hospitals is at an all-time high. Media attention focused on ‘superbugs’ has been continuing for some time. Most would agree that much of the media attention has been sensationalized and sometimes misleading. This may not be so easy to suggest with the newcomers to the media's superbug category. When there are high mortality rates, the media spotlight may be more justified. Further still, the government are committed to the reduction of nosocomial infection.
Cases awaited with interest
Currently, a 71-year-old lady is taking a case through the Scottish courts claiming her negligent acquisition of MRSA at Glasgow Royal Infirmary. Mrs Miller is bringing a claim for £30,000 concerning her acquisition of MRSA in 2001 when she underwent heart valve replacement surgery. It is reported that her solicitor has, waiting in the wings, some 160 clients in similar positions awaiting the outcome of her case. These include some large claims.
At the preliminary hearing (where the Greater Glasgow NHS Board sought dismissal or absolvitor in relation to the statutory case of Mrs Miller and that the pleaded common law duties were not relevantly averred), Lady Clark of Calton, presiding over the Outer House, Court of Session 1 found that averments about res ipsa loquitor could not be adjudicated upon without a full hearing of the facts. She found, in being unpersuaded by arguments in relation to ‘floodgates’, that she was reluctant to conclude, before proof and without evidence, that on policy grounds Mrs Miller should be denied a remedy for direct physical harm caused by negligence.
The NHS Board was unsuccessful in that the Court of Session has allowed the case to continue to a proof before answer in relation to the statutory case. Lady Clark commented that a fuller understanding of the factual matters underpinning the case would assist with the interpretation and application of the Control of Substances Hazardous to Health Regulations 1999, to the circumstances of the present case. Further discussion of this is outlined below.
In relation to a different organism, in England, between October 2005 and September 2006 there were two outbreaks of C. difficile at Maidstone & Tunbridge Wells NHS Trust resulting in approximately 60 linked deaths. A report by the Healthcare Commission in October 2007 found in total 90 patients who definitely or probably died of C. difficile infection. Criticism over the strength of leadership in infection control, poor surveillance, outbreak policy, equipment cleaning and the low level of staffing all featured in the report.
C. difficile infection is caused by a toxin which is associated with the use of antibiotics. The number of deaths from infection appears to be rising. Of probable relevance (but the evidence is conflicting) is that there is some evidence that C. difficile toxin 027 is linked to an increase in disease severity and/or mortality and responds to a different treating antibiotic. Similar to the usual strains of toxin, this strain is associated with antibiotic use, but different antibiotics than from those usually expected. 2
Proving negligence and causation
While most of the reported cases involving MRSA relate to a delay in either diagnosis or treatment, as opposed to negligent acquisition, there are probably better chances of supportive expert evidence for a Claimant relating to acquisition with organisms such as C. difficile which now is associated with higher mortality rates. Unlike MRSA, patients are unlikely to be aware of the presence of the organism without suffering symptoms, the main symptom being diarrhoea.
Outbreak management of these organisms would be a particular focus of medical experts. Of relevance is at what point, if any, an expert would judge that a hospital has failed to take reasonable measures to limit spread. With some nosocomial infection, this could primarily come from a change in antibiotic policy (e.g. C. difficile) but in others changes in isolation procedures/accommodation and cleaning/disinfection.
Of relevance to disclosure, it is important that experts are provided with specific documents in nosocomial infection cases. Such documents include Infection Control Committee minutes, Infection Control policies (outbreak, specific policies relating to the organism), the Infection Control team's records, bed occupancy, the number of ward rounds on the relevant wards, staff–patient ratios, level of staff absenteeism, level of nursing and care assistant bank usage, surveillance policies and statistics. Therefore, medical experts should expect to have to peruse a great deal more information than just patient medical notes.
A recurring theme in cases involving nosocomial infection is the high level of bed occupancy and transfer between wards and indeed hospitals. In cases involving (negligent) contact with the offending bacterium in a number of institutions, the Fairchild case 3 will assist Claimants in arguing that a difficulty in conclusively identifying the source of infection need not be fatal to a case. Similar to mesothelioma, infection is not acquired in a cumulative way.
A new legal argument – health and safety legislation
An argument presently being raised, and used in some legal statements of case now for Claimants, is whether some organisms which cause nosocomial infection, such as MRSA, should be regarded as a hazard under the Control of Substances Hazardous to Health Regulations 2002 (‘the COSHH Regulations’).
The COSHH Regulations ostensibly only cover employees. If patients were also to be covered, there need not necessarily be the requirement for reasonable foresight. 4 Trusts would have implemented reasonably practicable measures in order to avoid liability.
While organisms such as MRSA appear to fall within the definition of a substance hazardous to health as a biological agent, 5 the Health and Safety Executive have expressly said that it does not generally deal with clinical matters as these are more appropriately dealt with elsewhere 6 save in cases where there are management failures or failures of systems of work.
The argument is based upon the fact that MRSA, being a biological agent, falls within the definition of 2(1) COSHH regulations. However, Schedule 3 concentrates on the Regulations which relate to work with biological agents, especially in laboratories, animal rooms and industrial processes. There is reference in 2(2) to the organism being connected with work and not arising out of it. Regulation 3(1) states that ‘where a duty is placed… on an employer in respect of his employees, he shall, so far as it reasonably practicable, be under a like duty in respect of any other person, whether at work or not, who may be affected by the work carried out by the employer…’.
Regulation 5(1) states that ‘Regulations 6-13 shall have effect with a view to protecting persons against a risk to their health, whether immediate or delayed, arising from exposure to substances hazardous to health except (c) where the risk to health is a risk to the health of a person to whom the substance is administered in the course of medical treatment’.
The author believes the drafter's intention was only to protect employees and thus far, the courts have sensibly refused to afford Claimants this added argument. 7–9
In the above-mentioned case of Miller v Greater Glasgow NHS Board, 1 in which the Control of Substances Hazardous to Health Regulations 1999 were pleaded, Lady Clark's opinion was that ‘it is open to an employer to plead lack of reasonable practicability in defence of an alleged breach of the Regulations founded upon by a person who is not an employee. The Regulations in my opinion do not seek to impose in all circumstances an identical duty in respect of employees and non-employees who may be affected by the employer's work… The terms of Council Directive 90/679/EEC acknowledge a distinction between activities which involve a deliberate intention to work with or use a biological agent and activities that result in workers being exposed to a biological agent.’ 1 She said of the intention of the Regulations, and in respect of whether the Regulations cover a situation where there is no intention to administer the substance and the substance is not intended to be any part of the medical treatment, the Regulations ‘are designed for the protection of employees and others for whom the protection of the Regulations is extended’. However, she concluded that ‘the Regulations are not intended to provide an exception where the biological agent is unknowingly and negligently transferred to a patient and forms no part of the medical treatment’. She stated that ‘I do not go so far as to conclude that the defence cannot apply in the circumstances… It may be that the facts will shed some light on the application of the exception. I consider that unlikely but not impossible.’ 1
Of note, with C. difficile the diarrhoea is caused by a toxin, not the organism itself and therefore there is probably a further argument against relevance should COSSH regulations be raised in these cases.
New legislation and guidelines
Legislation is now in place dealing with superbugs. The Government and the Department of Health have been busy. The Health Act 2006 has been in force since 2 April 2007. Part 2 relates to prevention and control of healthcare associated infections, Code of Practice, commission for healthcare Audit and Improvement notices. The Health Protection Agency is due to publish Clostridium difficile: How to deal with the problem: A board to ward approach. It was out for consultation until 23 April 2008 and is due to publication shortly.
Conclusion
This rather interesting and important area of clinical negligence is poised to receive more debate and deliberation in the near future. There is a potential for many more cases to be brought, but there is some doubt as to whether some allegations of statutory breach will be successful. The media and government attention will, no doubt, cause would-be Claimants to continue to seek legal advice and the landscape may possibly change in relation to the cases taken on in the future.