Miller (AP) v Greater Glasgow NHS Board [2008] ScotCS CSOH

OUTER HOUSE, COURT OF SESSION

[2008] CSOH 71

OPINION OF LADY CLARK OF CALTON

in the cause

ELIZABETH MILLER (A.P.)

Pursuer;

against

GREATER GLASGOW NHS BOARD

Defenders:

________________

Pursuers: McEachran QC; Barne; Drummond Miller LLP

Defenders: Murphy QC; Davie; Central Legal Office

14 May 2008

Summary

[1] In this case the pleadings narrate that on 18 October 2001, the pursuer was admitted to Glasgow Royal Infirmary for an operation. On about 30 October 2001 an infection sample was identified as methicillin-resistant staphylococcus aureus (hereinafter referred to as MRSA). It is averred that the pursuer was infected post-operatively and that the probable cause of the pursuer's MRSA infection was the transmission of the organism to her via the hands of a staff member. From these initial averments, the pursuer develops two common law cases based on alleged negligence of the defenders. The first case is based on a breach of the defenders' duty to take reasonable care of the pursuer. The second case is a vicarious case based on a failure to take reasonable care of the pursuer by hospital staff employed by the defenders. In addition the purser avers that her loss, injury and damage was caused by the defenders' breach of statutory duties under and in terms of the Control of Substances Hazardous to Health Regulations 1999 (hereinafter referred to as the 1999 Regulations). Counsel for the defenders sought absolvitor or dismissal, which failing deletion of certain averments, on the basis that as pled neither the common law duties or the 1999 Regulations were relevantly averred.

Procedural History

[2] I noted that both parties had preliminary pleas. I referred counsel to the interlocutor of Lord Macphail dated 13 March 2007 which ordained the parties to lodge notes of argument. I was informed that parties had prepared their cases on the basis that the defenders alone wished to debate the preliminary pleas-in-law. Senior counsel for the pursuer explained that the pursuer was offering and had always been prepared to offer a proof before answer. He was not seeking at this stage to have the first preliminary plea-in-law for the pursuer upheld. Counsel for the defenders did not invite a procedural roll discussion which included the preliminary pleas of both parties. In these circumstances, the hearing proceeded on the basis that the pursuer offered a proof before answer. The defenders continued to insist on their preliminary pleas in accordance with their note of argument (14 of process). At the commencement of the hearing, senior counsel for the pursuer deleted without opposition certain averments of fault relating to the "outbreak committee". I also permitted further amendment by senior counsel for the pursuer during the hearing. The final state of the pleadings are to be found in the amended Closed Record (18 of process). The preliminary pleas-in-law for the defenders on which the procedural discussion took place were pleas one, four and five. Plea-in-law one is a standard plea to relevancy seeking dismissal. Plea-in-law four states "The defenders having discretion in the exercise of their statutory duty owing no duty of care to persons such as the pursuer in the exercise of such discretion, decree of absolvitor should be pronounced". Plea-in-law five states "The pursuer's averments regarding breach of duty by the defenders, being irrelevant et separatim lacking in specification, should be excluded from probation." The procedure roll discussion took place over 6 days.

The Pursuer's Pleadings in relation to the common law cases

[3] Article 4 of condescendence sets out the factual averments which underpin the various grounds of legal liability founded upon in subsequent articles of the pleadings. It is averred that on 18 October 2001 the pursuer was admitted to Glasgow Royal Infirmary (hereafter referred to as "the Hospital") for an operation. Post operation, the pursuer suffered a discharge from her wound which was identified on about 30 October 2001 as MRSA. It is averred that the pursuer's wound infection was not caused by an organism she was carrying herself and was not contracted during the operation for reasons averred at pages 7D to 8B. It is averred that the pursuer was infected post operatively and that:

"from the time of surgery until the pursuer was transferred back to ward 65 of the Hospital at 2.30 pm on the second post operative day, at least thirteen members of Hospital staff were involved in "hands-on" treatment of the pursuer. After the pursuer was transferred back to ward 65, she continued to be attended to by various different members of the Hospital staff. The greater the number of staff which has "hands-on" contact with the patient, especially when there are wounds present, the higher the risk of transmitting infection. The probable cause of the pursuer's MRSA infection was the transmission of the organism to her from a source elsewhere in the ward (probably another infected patient or directly from dust or dirt located in the Hospital environment) via the hands of a staff member who had not followed the Hospital's hand hygiene policy. If the Hospital's hand hygiene policy had been implemented, enforced and adhered to, the pursuer would not have become infected with MRSA" (8C-9A)

Thereafter at page 9A to 10A the pursuer makes reference to parts of the Hospital's infection control policy manual. At page 9D (in averments added by amendment during the hearing) it is stated that "This hand washing requirement contained in the said hand hygiene policy ("the hand washing requirement") was a standard requirement in hospitals in Scotland at the material time for Hospital staff having direct contact with patients. Then reverting to the original pleadings it is averred that "the Hospital's infection control policy is defective due to the absence of management systems to ensure effective implementation of inter alia the Hospital's hand hygiene policy" (10A). It is averred that an assessment of ward 65 was undertaken on 1 November 2001 and a detailed list of findings of alleged defects are averred (10B- 10E). Averments are made about the minutes of an outbreak committee on 8 November 2001. These relate to criticisms of staff and working practices not only in relation to ward 65 but also the operating theatre. Reference is also made to the minutes about high dust levels on ward 65, dusty and dirty equipment and long standing problems with the cleaning of ward 65. At page 12A, it is further averred that the risks associated with the presence of MRSA on hospital premises was well known since the 1960's. Averments are made about the importance of cleaning, the recommendations following a review by Audit Scotland in April 2000 and reference is made to an Audit Scotland report in 2003. (12D-13E). It is then averred:

"the cleaning regime instituted by the defenders for the Hospital was inadequate. In such circumstances the Hospital's hand hygiene policy should have been implemented and enforced with particular diligence by the defender to protect patients, such as the pursuer, from MRSA infection.

The implementation of the infection control policy within the Hospital should have been monitored and controlled by the Hospital's infection control committee" (14A-14B).

[4] In answer to the defenders averments, the pursuer avers that:

"Epidemic MRSA strains, such as that contracted by the pursuer, emerge in hospitals. They spread from hospital to hospital. In an overwhelming majority of cases, MRSA is only spread within hospitals. They are not community organisms. ... The emergence and continuing presence in hospitals is explained by what takes place in hospitals. The main source of MRSA in hospitals is the infected patient. Such patients are being treated in hospital. The work processes they undergo (for example wound dressing), can cause the spread of MRSA to other patients. MRSA is generated as a by-product of work processes in hospital." (15D-16B).

[5] It may be helpful to put the submissions on behalf of the parties into context to refer at this point to the defenders pleadings. The defenders aver that MRSA infection could be acquired in a number of ways which would import no negligence on the part of the defenders. They aver that the infection can be transferred in different ways including hands, air or via mites on bed clothes or in the environment (18D-19A). The defenders aver that total compliance with hand hygiene policies in hospital is not possible and set out various ways in which they attempt to achieve implementation and compliance. This includes statistical process monitoring (19B- 20B). It is averred that the precise role of cleaning in the control of infectious organisms is unknown and that there could be improved hospital hygiene regimes in relation to environmental cleaning with an increase in the incidence of MRSA (20C- 20D).

[6] Following the factual averments made by the pursuer, the pursuer avers in article 5 of condescendence that:

"It was the defenders' duty to take reasonable care to look after the safety and welfare of patients, such as the pursuer, while being treated in the Hospital. Res ipsa loquitur. Esto said maxim does not apply, it was the defenders' duty to take reasonable care to ensure that adequate hygiene measures were instituted and enforced in the Hospital. It was their duty to take reasonable care by way of instructions to staff and monitoring to ensure that hospital staff complied and were able to comply with the hand washing requirement. It was their duty to take reasonable care to ensure that there was available to hospital staff adequate facilities by making available liquid soap, paper towels, antiseptic soap and alcohol gel together with accessible basins with a sufficient flow of water to allow them to comply effectively with the hand hygiene policy. The defenders knew or ought to have known that if the hand washing requirement was not complied with, a patient within the Hospital, such as the pursuer would probably become infected with an organism such as MRSA." (22C-23C).

The reference in article 5 to the hand washing requirement and the specification of the means by which that was to be achieved were averments added by amendment during the hearing.

[7] Article 6 pleads a statutory case and I deal with that in paragraphs [67] - [89].

[8] Article 7 sets out a vicarious liability case averring that:

"It was the duty of those members of the Hospital staff attending the pursuer to take reasonable care to look after the safety and welfare of the pursuer while she was being treated in hospital. In exercise of that duty it was those staff members' duty to take reasonable care to ensure that they complied with the hand washing requirement. It was their duty to take reasonable care to wash and dry their hands before and after each direct contact with a patient in accordance with the hand washing requirement. The said Hospital staff knew or ought to have known of the hand washing requirement and knew or ought to have known that if the Hospital's hand hygiene policy was not complied with, a patient within the Hospital, such as the pursuer, would probably become infected with an organism such as MRSA. In all these duties, the defenders failed and thereby caused the pursuers' loss, injury and damage. But for the defenders' failure in duty, the pursuer's loss, injury and damage would not have occurred." (30A-30E).

[9] Article 8 of condescendence sets out the loss, injury and damage suffered by the pursuer.

[10] The first plea-in-law for the pursuer is directed to the relevancy and specification of the defenders averments. The second plea-in-law states "The pursuer having suffered loss, injury and damage as a result of the defenders' fault et separatim breach of statutory duty et separatim as a result of fault on part of the defenders employees, for his acts and omissions in the course of his employment the defenders are liable, is entitled to reparation therefore". The third plea-in-law is a standard plea in relation to the reasonableness of the sum sued for.

The note of argument for the defenders

[11] The note of argument for the defenders (14 of process) is brief and gives no notice of the many authorities on which the defenders sought to rely. It is unfortunate that the general criticisms of the pleadings which counsel for the defenders sought to develop over some four days were not set out in more detail. That might have shortened the discussion.

[12] Paragraph 1 of the note of argument stated that the defenders are a statutory body and perform their duties and functions within a statutory framework. The provision and management of hospital accommodation and facilities constitute a practical implementation of these statutory duties in which the defenders have a discretion at operational level. In these circumstances, the defenders submit that an issue arises as to whether in carrying out those functions, the defenders owe the pursuer a common law duty of care. The defenders do not accept that the pursuer has averred sufficient to meet the proximity test and the foreseeability test, but in any event the defenders state that an issue arises as to whether it is fair, just and reasonable to impose a duty of care on the defenders in the circumstances averred by the pursuer. Properly characterised the pursuer's case (according to the defenders) is that a microbe of unknown source has infected the pursuer. The defenders state infection per se does not import negligence. Accordingly, and particularly in the absence of proof of causation, the defenders contend that it is not fair, just and reasonable to impose such a duty on a public authority. In the light of the statutory scheme, the defenders submit such a duty is unnecessary and would result in the defenders being a guarantor that no patient admitted to hospital will succumb to infection. This would be an intolerable burden. Such a duty would be novel and would not represent an incremental development by analogy with well established common law principles.

[13] Paragraph 2 of the note of argument is superseded because senior counsel for the pursuer amended Article 5 of condescendence to delete certain averments.

[14] In paragraph 3 of the note of argument there is criticism of the pursuer's statutory case in Article 6 of condescendence. I deal with this in paragraph [69].

[15] In paragraph 4 of the note of argument, there is specific criticism of parts of Article 4 of condescendence to this effect. At page 8D, the pursuer avers that "If the Hospital's hand hygiene policy had been adhered to, the pursuer would not have become infected with MRSA". The defenders state that these averments are unsupported. In particular there are no averments identifying a breach of a duty of care on the part of the defenders or those for whom the defenders are vicariously liable. There are insufficient averments of fact to establish causation.

[16] In paragraph 5 of the note of argument the specific criticism is that "the pursuer includes averments regarding the cleanliness of the Hospital at Article 4 of condescendence (pages 11D-14A) but there are no averments regarding any duty of care on the defenders relating to cleanliness or any alleged breach of such duty.

Submissions by counsel for the defenders
[17] The primary position adopted by junior counsel for the defenders was that she sought absolvitor. She made elaborate and lengthy submissions in support of the first paragraph of the defenders' note of argument. She argued that the pursuer was attempting to develop a novel and far reaching duty of care. I was invited to conclude that there was no common law duty of care previously found against a health board of the type averred by the pursuer and that the duty founded upon by the pursuer was not merely an incremental extension of the law but a new duty. In such circumstances, the defenders submitted that I must apply the approach explained in Caparo Industries Plc v Dickman [1990] 2 AC 605 and consider whether it was fair, just and reasonable to impose such a new duty. I was invited to conclude that it was not fair, just and reasonable and to conclude that no duty of care existed.

[18] I was referred to the common law position prior to and after 1947 when the National Health Service was created. To illustrate the pre 1947 legislation, Reidford v Magistrates of Aberdeen 1933 S.C.276 was cited. In this case it was held that the defenders, the governing body of a public hospital, were not responsible for negligent discharge of professional duties by competent doctors and nurses engaged by the defenders. After the National Health Service (Scotland) Act 1947, a different result was reached in MacDonald v Glasgow Western Hospital 1954 S.C.453. It was held that the board of management, particularly in view of the duties imposed on them by the National Health Service (Scotland) Act 1947, were responsible for any negligence established on the part of their resident medical officers. The Court concluded that the action against the defenders was accordingly relevant.

[19] I was referred to the legislation in force at the time of the alleged events involving the pursuer in 2001. This involved consideration of the National Health Service (Scotland) Act 1978, in particular sections 1, 1A, 2, 2A and 12H. These provisions relate to the general duty of the Secretary of State and the duty of Scottish Ministers to promote health. The provisions also cover the setting up of health boards and their functions and duties. I was referred to Part III of the Act, in particular section 36 which sets out a duty to provide throughout Scotland, to such extent as the Minister considers necessary to meet all reasonable requirements, accommodation and services which includes medical nursing and other services. I was referred to the Functions of Health boards (Scotland) Order 1991 (1991/570) in particular section 2(1)(a), section 3(1), and section 4(d) and (j). This Order makes specific provision for the duties and functions of the health boards. I was referred to the National Health Service (Clinical Negligence and Other Risks Indemnities Scheme) (Scotland) Regulations 2000 (2000/54). Under these Regulations, NHS Trusts and certain other bodies may make provision in relation to liabilities arising out of negligence in the carrying out of their functions. Junior counsel provided certain factual information about how this scheme worked in practice. She explained that the scheme did not at present cover lower value claims which I understood to be claims under £20,000. Junior counsel submitted that any common law duty of care must be understood and interpreted in the context of the particular statutory scheme which she had set out and explained. She pointed out that within the statutory scheme there were provisions for sanctions and procedures which were separate from damages for delictual liability to ensure that statutory duties were carried out.

[20] Junior counsel explained that she was not submitting that there is no common law duty merely because there exists a statutory framework which involves discretionary duties. Her submission was that in assessing whether averments are relevant, it is important to bear in mind the statutory framework and background. I was referred to X v Bedfordshire County Council [1995] 2 A.C.633 in particular to Lord Browne-Wilkinson at page 730B-731B. Lord Browne-Wilkinson considered circumstances where a plaintiff suffered damage in consequence of an authority's performance or non performance of a particular function imposed by statute. He pointed out the need to distinguish actions to recover damages based on a private cause of action from an action in public law to enforce a statutory duty by way of judicial review. Counsel also referred to passages at pages 735-740. At page 735B Lord Browne-Wilkinson discussed four categories of private law claims for damages. In the third category he explained,

"....the claim alleges either that a statutory duty gives rise to a common law duty of care owed to the plaintiff by the defendant to do or refrain from doing a particular act or (more often) that in the course of carrying out a statutory duty the defendant has brought about such a relationship between himself and the plaintiff as to give rise to a duty of care at common law. A further variant is a claim by the plaintiff that, whether or not the authority is itself under a duty of care to the plaintiff, its servant in the course of performing the statutory function was under a common law duty of care for breach of which the authority is vicariously liable."

Lord Browne-Wilkinson expressed the opinion that it is not possible to lay down general principles to determine the circumstances in which the law would impose a common law duty of care arising from the exercise of statutory powers or duties. He stated that it is quite impossible to detect such a principle in the wide range of authorities and academic writings or to devise any such principle de novo. His conclusion was that:

"statutory duties now exist over such a wide range of diverse activities and take so many different forms that no one principle is capable of being formulated applicable to all cases."

In the context of the appeals under consideration, Lord Browne Wilkinson identified certain points of significance. At page 739A-E, he considered the situation where the plaintiff complained of alleged carelessness, not in the taking of a discretionary decision to do some act but in the practical manner in which that act has been performed, for example the running of a school. He concluded that the question whether there is such a common law duty and if so its ambit must be influenced by the statutory framework. He discussed the distinction between direct and vicarious liability at page 739H-740C under reference to various hospital cases. He stated that those conducting a hospital are under a direct duty of care to patients. They are liable for the negligent acts of a member of staff which constitute a breach of that duty, whether or not the member of staff himself is in breach of a separate duty of care owed to the plaintiff. The defenders' junior counsel then referred to Stovin v Wise [1996] A.C.923 particularly Lord Hoffmann at page 952E who quoted with approval Lord Browne-Wilkinson in the previous case. I was then referred to Burnett v Grampian Fire and Rescue Service 2007 S.L.T.61. She sought to distinguish this case and submitted that specific averments had been made in the pleadings about competence to the effect that "no firefighter of ordinary competence exercising reasonable skill and care and attending the fire would have failed to carry out various tasks specified". She contrasted that with the present case and submitted that the pursuer's pleadings were in novel form.

[21] Junior counsel for the defenders then considered whether in the present case, the Caparo tripartite test was satisfied under reference to the Opinion of Lord Bridge at page 617. She did not concede that the first two elements of the test, proximity and foreseeability, were relevantly averred by the pursuer. She submitted that before the Court could be satisfied that the pursuer's averments could set out a common law duty of care, the Court required to consider whether the third element in the Caparo test was satisfied. She submitted that it is plain from Gibson v Orr 1999 S.C.420 page 430D-431D that the Caparo approach is adopted in Scots law.

[22] In assessing the relevance of the pursuer's averments, I was therefore invited to apply Caparo and consider a number of factors, first mentioned in oral submission, which junior counsel stated bore upon the application of "the fair, just and reasonable" test. She referred to six main factors in support of her main submission that the test was not satisfied in the present case. She accepted that some of the factors or issues were interconnected. She referred firstly to what may be called the "floodgates" problem. She submitted that there would be no limit to the number of actions which might result and which would require to go to proof. This would result in very substantial resources being diverted from health care to damages, legal and other expenses. She stated that the case concerned MRSA for which there was an environmental source. MRSA could be transferred to a patient, even if staff members washed their hands. Thus she claimed any patient infected in hospital by MRSA would be entitled to a proof as to the cause of that particular infection. She submitted that the pleadings were so wide and therefore resulted in so many potential cases it was proper to take the numbers of potential cases into account. She prayed-in-aid Lord Browne Wilkinson at page 749D-763H. She appeared to concede that this policy statement might be too wide in the light of two later cases. She referred firstly to Barrett v Enfield London Borough Council [2001] 2 AC 550, Lord Steyn at page 568A-B. Lord Steyn considered the policy approach in X v Bedfordshire County Council [1995] 2 AC 633 but considered that the issues in Barrett were different and led to different policy conclusions. The second case referred to was Phelps v Hillington London Borough Council [2001] 2 A.C.619. This case dealt with a number of plaintiffs referred to local education authorities' school psychological services. The Court held that a person exercising a particular skill as a professional might owe a duty of care in its performance to those who might forseeably be injured, if due care and skill were not exercised; that an educational psychologist was a person owing such duty of care and the fact that she owed a duty to the local education authority did not mean that she did not also owe a duty to the child. It was also held that a local education authority might be vicariously liable for breach of such duty. Lord Slyn at 654H-655B, considered whether there are reasons of public policy why the Court could not recognise such liability. He stated that there was a need to be cautious in recognising such a duty of care where so much is discretionary in such areas of social policy but he did not consider that the imposition of such vicarious liability hampered the carrying out of the services. He concluded that the recognition of a duty of care did not impose unreasonably high standards under reference to the well accepted test for professional negligence set out in Bolan v Friem Hospital Management Committee [1957] 1 WLR 582 per McNair at 587

"Any fear of a flood of claims may be countered by the consideration that in order to get off the ground the claimant must be able to demonstrate that the standard of care fell short of that set by the Bolan test: that is deliberately and properly a high standard in recognition of the difficult nature of some decisions which those to whom the test applies require to make and for the room for genuine differences of view on the propriety of one course of action as against another".

In summarising the first factor, junior counsel emphasised that in the absence of any reference in the pleadings to the Bolan test, there was the potential for a multitude of claims which would require to be dealt with from the limited health service budget. The front line health services would therefore be adversely affected. She submitted that as no analogous claim had previously been accepted by the Courts, there is a need for caution, to proceed incrementally and by analogy from decided cases.

[23] The second factor relied on by junior counsel was her assertion of fact that MRSA is a microbe naturally occurring in the environment and that it is not possible to eradicate it completely from hospitals. Reference was made to Hajgato v London Health Association (1982) 36 OR (2d) 669. She submitted that the mere fact that infection invades the site of a surgical incision is not as a matter of common experience evidence of negligence. She contended that the Hospital should not be put in the position of being a guarantor for patients against the acquiring of MRSA.

[24] Thirdly, she submitted, that issues such as cleaning frequency and general hand hygiene were not matters which ought to be justiciable. She prayed in aid Barrett v Enfield London Borough Council [2001] 2 A.C.550. She submitted this was a discretionary area which was not appropriate for the Court to determine. The same point was made in relation to the pursuer's averments at page 23B in relation to lack of adequate facilities. It was submitted that the adequacy or otherwise of facilities depends upon policy decisions about allocation of resources. The Court should not intervene to substitute its decision making for that of the discretionary decision making of the health board about these matters.

[25] Fourthly, she submitted that the health service was set up for the benefit of the public as a whole. Payment of damages, multiple claims and multiple proofs would lead to resources being diverted from provision of health service care.

[26] Fifthly, she pointed to the adequacy of other remedies. It was submitted that there were various public law remedies available. In addition at common law there was an adequate remedy available in circumstances where averments of professional negligence were appropriate or where departure from an appropriate standard could be averred. If these common law remedies were to be extended, it was more appropriate that an extension should be made by Parliament.

[27] Lastly it was submitted that health board decision makers making decisions about infection control should be free to exercise their judgement and not engage in defensive decision making to prevent potential claims. Health boards require to make a range of decisions in relation to health care and this can be affected if defensive decision making about reduction of infection became necessary. She submitted that there are many issues surrounding infection control. Hand washing and facilities are part of a more complex issue. These are matters which are in essence policy decisions. These should be made by the appropriate health board not by the Court.

[28] Junior counsel for the defenders then dealt with the res ipsa loquitur averments in Article 5 of Condescendence. She referred to the classic exposition in Scott v London & St Katherine Docks (1865) 3 H & C 596 and O'Hara v Central SMT Co 1941 SC 363. It was submitted that the maxim was not a legal principle but merely a presumption of fact depending on the circumstances of each case. Whether res ipsa applies or not depends upon whether the circumstances of the occurrence are enough to infer negligence. Reference was also made to Ballard v North British Railway Company 1923 SC (HL) 43. Having set out the general principles, junior counsel developed the submission by referring to McQueen v Ballater Golf Club 1975 SLT 160. In that case Lord Wylie reviewed the case law and expressed caution about the application of the maxim. Junior counsel submitted that as the facts relied upon by the pursuer are susceptible to more than one explanation, the maxim does not come into play at all. In the present case the pursuer is not averring facts and circumstances to eliminate all possible other sources of infection. This is a case in which it is averred or accepted by the pursuer that MRSA is a naturally occurring microbe. There are no averments that the microbe is under the control and management of the health board to the extent that would be required for the application of this maxim or alternatively that the occurrence of MRSA infection in a hospital environment is not something which can happen if the management had used proper care. She drew a parallel with the situation in Morton v West Lothian Council [2005] CSOH 142 and referred in particular to the opinion of Lord Glennie in paragraphs 70-71. She also referred to Cassidy v Ministry of Health [1951] 2 KB 343 which she sought to distinguish on its facts. She founded on the passage in the opinion of Singleton LG at page 353-354 in which he made reference to the dicta in Scott v London & St Katherine Docks (1865) 3 H & C 596 and submitted that the pursuer in the present case did not aver relevant facts and averments for the maxim to apply. She accepted that in some circumstances res ipsa loquitur liability could arise in a hospital situation. In the present case the circumstances averred fell outwith the well recognised categories.

[29] The issue of causation was then addressed. Junior counsel for the defenders submitted that to be relevant, the pursuer must aver and offer to prove facts to establish causation. She submitted that the pursuer averred different sources of possible transmission of MRSA but these included "guilty" and "innocent" sources. She submitted that the pursuer's case is faced with the difficulties highlighted in Wilsher v Essex AHA [1988] AC 1074. The pursuer's case is not pled as a material increase in risk on the basis of McGhee v NCB 1973 SC (HL) 37 nor on the basis of Fairchild v Glenhaven Funeral Services Limited [2003] 1 AC 32. In these circumstances, junior counsel submitted that the pursuer did not have relevant averments of causation.

[30] Senior counsel for the defenders adopted the submissions made by junior counsel but his emphasis was very different. His submissions were firstly directed to the question of dismissal rather than absolvitor. In concentrating on the issues of relevancy and specification, he identified more clearly and in more detail the pleading difficulties which he submitted lay at the heart of the pursuer's case.

[31] I was invited to consider relevancy and specification in relation to, firstly articles 5 and 7, secondly the res ipsa loquitur case in article 5 and lastly the statutory case in article 6. He submitted that the defenders were entitled as a minimum to deletion of one of more of the various cases pled. If his cumulative submissions were accepted, he submitted that the action should be dismissed by sustaining the defenders' first plea-in-law. Senior counsel for the defenders accepted that this would be sufficient to dispose of the action and that any further opinion expressed would be obiter. He acknowledged that the issues raised by junior counsel invited a decision of absolvitor on the basis that there was no common law duty of care of the type averred by the pursuer. This was on the basis that either the particular duty averred would impinge on discretionary non-justiciable issues or because of legal policy it would not be fair, just and reasonable to impose such a duty. That last issue would also arise if the Court was against the submissions on behalf of the defender about the relevancy and specification of article 5 but agreed with the submissions in relation to article 7 of condescendence. If the submissions of the defenders were accepted, the defenders should be assoilzied from the conclusions of the summons in so far as founded on such a duty of care. If the decision could not properly be made without proof, a proof before answer should be allowed. Senior counsel for the defenders conceded that, if none of the defenders' submissions were accepted, a proof before answer should be allowed.

[32] Turning to the averments in article 5, senior counsel submitted that the averments are irrelevant. The pursuer seeks to equate a policy or requirement with a legal duty of care and that is erroneous. The correct approach would involve a reference to the practice of other health boards or an approach based upon the defenders actings being such as no other health board, acting with reasonable care, would or could follow. Turning to article 7 of condescendence, he submitted that the vicarious liability of the defenders for the acts and omissions of "health professionals" is dependent on averring that those professionals are at fault. If one assumes this relates to a nursing care case, one requires averments about an averred act or omission or a practice case. No such case is averred. In any event, senior counsel submitted that if the logic of the averments in article 5 are followed this brought the pursuer into the area which impinged on discretionary non-justiciable issues and appeared to result in a novel duty of care. In such a situation, the Court should consider whether it would be fair just and reasonable to impose such a duty and he submitted that it would not for the reasons explained by junior counsel.

[33] In making these submissions, senior counsel took into account the amendments made by the pursuer during the hearing. He submitted that in the absence of any averments that the policy requirement represented ordinary practice for a particular profession or a minimum level of care which no health board acting reasonably would fall below, the amendments did not cure the defect in the pleadings. He submitted that this defect in the pleadings ran throughout the pursuer's case including the averments about hand washing and also the averments about the facilities. He pointed out, for example, that the averments about facilities at page 30C are tied in with "the requirement" in the policy document rather than ordinary professional practice or reference to the standards of a reasonable health board.

[34] Turning to causation, senior counsel submitted that the pursuer's averments at 8D-E should be interpreted as a "believed and averred" inference. The pursuer has not excluded all non negligent causes in the averments. The pursuer does not aver that proper hand washing will result in no infection.

[35] In summary, he submitted the error in the pursuer's pleadings is that the pursuer relies on the defenders' policies (in the amended version the "requirement") as the measure of the common law duty. The pursuer baldly avers that failure to properly implement a policy or requirement amounts to a breach of a duty of care. This is a non-sequitor. A policy or written requirement may be an aspiration but that is not to be confused with a standard at common law. Senior counsel submitted that an averment of failure to properly implement a policy or requirement, even one applicable to all hospitals (as now averred by the pursuer) does not give particularised content to a duty of care at common law. This was important because if the pursuer had followed the correct and necessary approach to averring particular duties, the pursuer would specify what other similar hospitals or units do. It was submitted that this would reveal a range of possible responses to infection control, hygiene, cleaning and adequacy of facilities. Individual hospitals may react differently to a given problem because there is a discretionary spectrum at policy level. It would be odd if the pursuer could argue that she was owed a duty for some universal "standard" of cleaning or hygiene or a clean hospital. Under statute, the Hospital has a discretion at policy level in which judgments, based on limited resources and priorities, are made by professionals. Senior counsel submitted that the Hospital owes no duty of care in respect of its policy choices. Senior counsel submitted that such a finding of a duty of care cutting across such policy discretion would amount to a new development and incremental increase in the law of delict. He then re-emphasised and expanded the various factors which had been set out by junior counsel in relation to the legal policy considerations for or against the imposition of a duty of care in such circumstances.

[36] Turning to the averments about res ipsa loquitur, he submitted that the pursuer's pleadings at page 22D aver that the mere fact MRSA infection is suffered results in an onus shifting to the defender. This is averred as a separate esto case from that based on a particular duty to take reasonable care. He submitted that the facts averred do not fall within a recognised category involving a general duty and the averments do not exclude all negligent causes. He submitted that the seven lines up to the words "in exercise" in article 5 should be deleted.

Submissions by counsel for the pursuer

[37] In opening his case, junior counsel for the pursuer emphasised the importance of the case, and the need for evidence before a decision is reached. He submitted that the Court should dismiss a personal injury case only if it is "manifestly irrelevant". Turning to the broader issues in the common law case, he pointed out that the pursuer avers that "it was the defenders' duty to take reasonable care to look after the safety and welfare of patients, such as the pursuer, while being treated in the Hospital" (page 22D). He pointed out that in Answer 5 there was a general denial by the defenders of that duty. He submitted that it was well settled that such a general duty existed. The pursuer avers specific duties in the context of that well recognised general duty. He referred to Lindsey County Council v Marshall [1937] AC 97. In that case a patient in a maternity home administered by committee of a county council was found to be suffering from puerpal fever after she was removed to hospital. The matron and medical advisers of the home were so informed and certain steps were taken to disinfect the home and the staff. Thereafter the plaintiff was admitted to the home and she developed puerpal fever. The plaintiff sued the county council for damages for negligence. Counsel prayed in aid Lord McMillan at page 118-119 and Lord Wright at page 121. Lord Wright M.R. stated "..it might at first sight seem that on general principles there was a duty on those that operate a home..to exercise due care and skill by themselves and their servants to avoid receiving patients into their home so long as there was danger, of which they knew or ought to have known, of infection of puerpal fever, a serious disease which is extremely infectious and liable to be attended with grave and perhaps fatal consequences. I do not put the obligation as high as that of a warranty; but the gravity of the risk must emphasise the gravity of the precautions proper to be taken to guard against it." Junior counsel stated that this was merely an example to show that there is nothing unusual about a claim by a patient for the transmission of infection in a hospital situation. He referred to Medical Negligence, Michael Jones (2003), pp 605 to 619 in particular paragraphs 7-016 to

7-017 where it is stated:

"The notion that a hospital authority may be directly liable for negligence in the organisation of its services is not new. Actions have in the past been formulated in this way in order to overcome the argument that the Hospital were not vicariously liable for the negligence of their professional staff."

This statement by the author is made under reference to Vancouver General Hospital v McDaniel [1934] 152 L.T. 56. At paragraph 7-018, the author states: "A hospital also owes a duty to establish adequate procedures to safeguard patients from cross-infection". Under reference to the two cases cited, junior counsel for the pursuer submitted that counsel for the defenders misrepresented or misunderstood the pleadings. He explained that the pursuer is not seeking to derive duties of care from the infection control policy. The hand hygiene policy is simply a list of requirements set out by the defenders in order to protect patients from inter alia the foreseeable risk of cross-infection. The use of the word "policy" should not be given the significance which the defenders seek to place on it.

[38] Counsel submitted that the defenders' submissions in so far as relying on authorities about the enforcement of a public law duty were ill founded in the context of this case. This is a case in which the pursuer is a patient in hospital and clearly there has been an assumption of responsibility for the patient by the defenders. The common law clearly recognises that this gives rise to a general duty of care by the defenders. The averments are based on "hands-on" contact with the pursuer and this clearly relates to the realm of operations not policy decision making. He submitted that both the direct case against the Health board in article 5 and the vicarious liability case in article 7, did not attempt to found a case upon a breach of some public law duty. The averments of the pursuer were the expression of longstanding recognised and accepted common law duties.

[39] Junior counsel submitted that the present case is not a novel case. He stated that Caparo Industries Plc v Dickman [1990] 2AC 605 and the later authorities founded upon by the defenders are not applicable. In this case the pursuer is not trying to set up a novel duty of care but merely particularising a recognised general duty in the Hospital context. He did not wish to engage with the fair, just and reasonable factors which were specified by the defenders for the first time at the hearing. Junior counsel submitted that it would be for the defenders to aver these matters and focus them in the pleadings in order to give fair notice. To the extent that factual matters inherent in the submissions on behalf of the defenders were not agreed, proof would be necessary. He referred to Gorringe v Calderdale Metropolitan Borough Council [2004] 1 WLR 1057 at paragraphs 38-40.

[40] Dealing with the res ipsa loquitur case, junior counsel for the pursuer submitted that this maxim can fulfil different functions in different contexts. He accepted that in some cases the pursuer may have to rely on the maxim to bridge an evidential gap. He explained that was not the pursuer's intention in this case. He submitted that the reference to res ipsa loquitur in article 5 of condescendence was to give notice that the pursuer was offering to prove on the basis of evidence a prima facie case of negligence causing the loss, injury and damage. But thereafter the pursuer would contend that a prima facie case having been established, the evidential onus or burden transferred to the defender. Counsel then carried out an exercise, collecting from the pleadings in article 4, a number of circumstances to set up such a prima facie case. These circumstances were:

1. The pursuer did not have MRSA when she entered hospital.

2. MRSA is an organism associated with hospitals.

3. It was in hospital that the MRSA infection began.

4. MRSA is located within the wound suggesting that it was not contracted during surgery.

5. MRSA was contracted during post-operative care.

6. Numerous members of the hospital staff were involved in hands-on care post-operatively.

7. MRSA is most likely to be passed by contact with contaminated hands rather than by other means.

8. The defenders' Infection Control manual acknowledges that the spread of MRSA is mainly on the hands of staff and easily prevented by effective and frequent hand washing.

9. Before and after direct contact with patients, staff are required to wash their hands.

10. Washing hands is effective in preventing MRSA.

Junior counsel for the pursuer then made reference to Ratcliffe v Plymouth and Torbay Health Authority [1998] PIQR 170 in which there is a review of res ipsa loquitur in relation to medical negligence cases.

[41] In summarising the position about causation, junior counsel for the pursuer stated that the pursuer was not seeking any relaxation in the test of causation. It was plain from the averments that the pursuer was offering to prove that the probable cause of the pursuer's MRSA infection was via the hands of a staff member who had not followed the Hospital's hand hygiene policy.

[42] Senior counsel for the pursuer adopted the submissions made by junior counsel and submitted that a proof before answer should be allowed. He submitted that this was a simple straightforward case. The defenders' employees did not follow the instructions for hand washing. It is not a professional negligence case. Counsel for the defenders were making submissions about complexity and novelty where none such existed. He submitted that the present case was plainly a test case. There were many other cases with similar potential causes. The Court should not be concerned with pleading quibbles. He submitted that there had been minimal criticism of detailed points of specification in the note of argument and in the submission of junior counsel for the defenders. The defenders had sought to build their case upon submissions about Caparo Industries plc v Dickman [1990] 2 AC 605. He submitted the whole approach of the defenders was ill founded in that respect.

[43] He accepted that although it might be possible at procedure roll to reach a concluded opinion as to whether the statutory case in principle applied to a hospital patient, the common law cases have many difficult scientific, medical and legal issues and an enquiry was essential.

[44] Senior counsel for the pursuer gave an overview of the case and explained that the primary case at common law was a case of vicarious liability on the part of hospital staff. It was "a cleaning hands case". No more complicated than a case based on a failure to clean a floor. The case directed in article 5 of condescendence against the defenders is inserted almost as a precaution in case the staff maintained that there was a lack of adequate facilities which explained any failure by them in hand washing. Senior counsel submitted that the pursuer built up her case by narrating the history, averring that the pursuer was infected post-operatively that thirteen members of the Hospital staff were involved in "hands-on" treatment of the pursuer, that this increased the risk of transmitting infection and that the probable cause of her infection was via the hands of a staff member who had not followed the Hospital's hand hygiene policy. The defenders' manual states "MRSA may spread from person to person mainly on the hands of staff. This contact is the most important means of spread and is easily prevented by effective and frequent hand washing and the use of antiseptic hand rub." The defenders manual further provides that "Before and after any situation which involves direct patient contact, hospital staff are required to wash their hands using either soap and water or an alcohol hand-rub or antiseptic detergent or a combination of these defending on the circumstances". Senior counsel said that this amounted to a clear instruction to staff to carry out hand washing.

[45] Senior counsel for the pursuer submitted that the type of case pled is no different to that made against any employer whose employee does not follow instructions and injury occurs. He gave the example of a contractor doing work on a house who instructs his employees to remove all work equipment from the scaffolding. An employee fails to do so and the wind causes equipment to fall on the head of the householder. In that situation, senior counsel for the pursuer submitted that the employer is liable on a vicarious basis for the failure of his employee to follow instructions. In summarising the case in article 5 of condescendence, he pointed out that following the last amendment, the case now averred in article 5 of condescendence specifies the particular equipment which the defenders ought to have provided. Based on the authorities referred to by junior counsel for the pursuer, he submitted that it was plain that the Courts had long accepted general direct duties on the defenders in the hospital context. The averments were a particularisation of that general duty.

[46] Senior counsel for the pursuer relied on the well accepted common law duty of care and emphasised that Cassidy v Ministry of Health [1951] 2 KB 343 was a case which favoured the pursuer. He submitted that despite the defenders' pleadings, it was clear that counsel for the defenders accepted in oral submissions that there was a general duty of care owed by the defenders to the pursuer as a patient in the Hospital run by the defenders. Senior counsel stated that he could not understand the attempt on behalf of the defenders to argue that somehow public law duties were involved. He emphasised that there were no novel questions and that the type of issue which arose in Morton v West Lothian Council [2005] CSOH 142, did not arise in the present case. As a matter of law, the mere fact that there was a statutory framework, whatever it might be, did not prevent a common law duty existing. He referred as an example to MacDonald v Glasgow Western Hospital's 1954 SC 453, Burnett v Grampian Fire and Rescue Service 2007 SLT 61, X v Bedfordshire County Council [1995], Lord Browne Wilkinson at page 735 and Gorringe v Calderdale Metropolitan Borough Council [2004] 1 WLR 1057, Lord Hoffman paragraph 38.

[47] The Caparo test was irrelevant. Even if it was relevant to consider the fair, just and reasonable test, he pointed out that the defenders had given no prior notice of the points on which they relied to underpin their submission that it would not be fair, just and reasonable to impose a duty of care. He submitted that notice should be given and issues, if not admitted, should be explored at proof. He submitted that, in any event, the question of whether it was fair, just and reasonable to impose a duty of care was not to be decided in the abstract but on the basis of what had been proved. He prayed in aid Barrett v Enfield London Borough Council [2001] 2 AC 550, Lord Slyn at 574E and Lord Browne Wilkinson at 557F. Even if the defenders were correct in their analysis, it was plain that such difficult matters should be determined only after an examination of the facts at proof. Senior counsel for the pursuer said that his fundamental position was that the defenders counsel had failed to understand that the Caparo approach only applied when a novel ground of negligence is claimed. The questions which exercised the Courts in Caparo and Barrett and Phelps and other similar cases were all examples of situations where there was an issue as to whether or not the law recognised or should impose a duty of care in particular types of circumstances. These included difficult cases such as whether auditors should be liable to shareholders in negligence, whether a local authority should be liable for a child taken into care or whether an education authority should be liable for the diagnosis of a psychologist. In the present case there are clear averments sufficient to justify proof in relation to proximity and foreseeability and there are no further issues to be considered about whether it is fair, just and reasonable to impose a duty of care. The pursuer has averred a well recognised general duty of care both in respect of article 5 and article 7. The question for the Court will be whether there is a breach of reasonable care in the circumstances averred and that can only be determined after evidence. He emphasised that the test is reasonable care. Reasonableness in the sense of the test of reasonable care could be regarded as akin to fair, just and reasonable in a different context. Reasonableness is still at the heart of this. But that is not to say that the Court should be entering into the type of analysis which arose in Caparo.

[48] In relation to causation, senior counsel for the pursuer submitted that the pursuer avers on the balance of probabilities that the infection was transferred by the hands of staff. That is all that is required for a relevant case. He prayed in aid Clerk & Lindsell on Torts, 19^th Edition, para 2-07. He submitted that the cases relied on by the defenders, Wilsher v Essex AHA [1988] AC 1074, McGhee v NCB 1973 SC (HL) 37 and Fairchild v Glenhaven Funeral Services Limited [2003] 1 AC 32 all dealt with completely different situations.

Common Law Cases pled by the Pursuer: Discussion
Caparo Industries Plc v Dickman

[49] The pursuer's pleadings have undergone a number of amendments. The pleadings cannot be considered an example of model pleadings. Nevertheless, it is apparent from the pleadings that there is an attempt in Article 5 of condescendence to set out a case in negligence based on direct and primary liability of the defenders. The averments in Article 7 of condescendence are an attempt to set up a case of vicarious liability on the part of the defenders based upon the alleged breach of duty of a member of the hospital staff attending the pursuer. It was plain from the submissions on behalf of the defenders, that they did not seek to deny that in principle, if properly pled, both direct and vicarious liability on the part of a health board has been recognised in law. Junior counsel for the defenders founded upon the opinion of Lord President Cooper in MacDonald v Glasgow Western Hospitals at page 478:

"I find it quite impossible to read the statutory provisions of the new health service's scheme as if the only duty imposed upon the hospital board was an administrative one, involving merely that the board should introduce the patient to the hospital medical personnel and to leave them to do their best, however negligently, without further responsibility on the board, other than the responsibility 'to provide an efficient, heated, clean and wholesome sick house, equipped with the necessary furniture and fittings ... and to employ competent staff'".

Having considered the situation after the enactment of the National Health Service Act 1947, the Lord President concluded that

"persons in the position of the resident medical officers charged with negligence in these cases, are persons for whose negligence in the discharge of their professional work, the board must now accept responsibility".

I consider that in the first part of the opinion quoted in which reference is made to the responsibility on the board "to provide an efficient, heated, clean and wholesome sick house, equipped with the necessary furniture and fittings", it is recognised and accepted that there is a direct duty of care on a board. I note that direct duty encompasses a "clean and wholesome sick house". The Lord President also clearly accepted that the board is vicariously liable for negligence of staff in the discharge of their professional work. The defenders' counsel accepted that in certain circumstances the defenders might be directly liable for failure to institute precautions against the transfer of infection and also that a failure in duty of the Hunter v Hanley 1995 SLT 212 type might give rise to vicarious liability on the part of the defenders. Unfortunately, despite my attempts to obtain clarification, the defenders counsel never explained how, or on the basis of what principles, the defenders sought to define the limits of the duty of care. I was referred to none of the many authorities in which a duty of care has been accepted without question in circumstances where a patient was receiving treatment in hospital post Macdonald. Even the discussion about Hunter v Hanley was implicit not explicit as the case was not cited formally to me.

[50] I consider that it is fair to describe the defenders' approach as founded on a bare assertion that the common law cases pled by the pursuer were novel in that few cases of MRSA infection had been considered by the Courts and none hitherto by the Courts in Scotland. Counsel for the defenders submitted that as there is no similar case pled in the Courts which has been upheld and because the way in which the duties were pled were unusual and novel, a detailed consideration of Caparo and subsequent authorities was essential. I was asked by counsel for the defenders to apply the approach developed in Caparo. I was somewhat surprised at this submission as the pleadings did not suggest to me that novel issues arose about whether the defenders owed a duty of care to a patient in their care in hospital. That issue is distinct and different from issues as to whether the form of the pleadings are relevant. In my opinion, the approach of counsel for the defenders to Caparo and the later authorities referred to is ill founded in the context of this case. I consider that the confusion in the analysis of the defenders arises from a failure to acknowledge the implications of well settled law. If it is accepted that a general duty of care is recognised by the law there may be room for dispute about whether in the particular factual circumstances of the case a particularised duty existed but that is not what the Court in Caparo is considering.

[51] The issue of whether a general duty of care exists in particular circumstances is one of law and may involve policy determinations by the Court. This is the type of issue classically illustrated in Donoghue v Stevenson 1932 A.C. 502. The policy decisions made by the Court in that case have been more formally recognised, explained and defined in Caparo and in a Scottish context in Gibson v Orr. In my opinion in making these policy decisions the Courts are considering to what extent, if at all, the law should give a remedy for the negligent causing of harm. In my opinion, it has been long settled in Scotland that a health board in principle may be liable both for their own negligence and vicariously for negligence of staff if they cause physical injury to a patient in their care by failure to take reasonable care of the patient. I do not consider that there is an area of uncertainty in the law which would involve new policy decisions as to whether or not to provide a remedy. The mere existence of a particular novel factual matrix does not in my opinion change that. In any event, I do not regard this case as novel merely because it happens to involve MRSA. It is a case involving alleged physical injury to a patient as a result of the transfer of infection and there is nothing novel in that. In Donaghue v Stevenson, Caparo and the post Caparo cases cited, the Courts were trying to reach a view about the limits to which a remedy should be provided for various novel and complex relationships. There is no doubt that the Court were involved in making policy decisions. That is made plain by the approach of the Courts in articulating the fair, just and reasonable issues which they consider in the context of these cases.

[52] The conceptual issue of whether a duty of care is recognised in law is different from an issue about the content of the duty, the legal standard to be applied and the question whether the duty was breached in the particular circumstances of the case. In the context of a case involving professional decision making in medical matters, the standard of duty has some specialities as a matter of law. The methods and circumstances in which duties may be breached are infinite depending on the factual circumstance. In my opinion, the criticisms which the defenders' counsel level at the pursuer's pleadings in respect of the absence of a duty of care are misconceived in that context. I consider however that the criticisms may be relevant in relation to the standard of care and breach thereof and the way in which the case is pled. That has nothing to do with Caparo but it may bear upon issues about the relevancy of the pleadings.

[53] In the present case I consider that there is relevantly averred the existence of a general duty owed by the defenders to the pursuer which is recognised in law in both Articles 5 and 7 of Condescendence. This is pled in the usual way by reference both to foreseeability and the concept of proximity. As counsel for defenders do not accept that the pursuer has relevant averments in relation to these tests I now address that. As to foreseeability, I am satisfied that the pursuer has relevant and sufficient averments about foreseeability based on the averments at page 12A-12C. As to proximity, Lord Oliver of Aylmarton in Caparo at page 632F commenting on the opinion of Lord Atkin in Donaghue v Stevenson states that:

"It must be remembered, however, that Lord Atkin was using these words in the context of loss caused by physical damage where the existence of the nexus between the careless defendant and the injured plaintiff can rarely give rise to any difficulty."

In the present case, the allegations are about physical injury directly caused to the pursuer while a patient in hospital administered and controlled by the defenders and while under the care of the defenders' staff. In my opinion, proximity is sufficiently averred in this case.

[54] As the main focus of the discussion initiated by counsel for the defenders related to Caparo and its implications, I have set out the submissions in some detail. I disagree with the merits of the defenders submission in relation to Caparo but, even if the submission is well founded, I am of the opinion that any determination of the fair, just and reasonable test is premature. I consider that this is a type of case where evidence would assist the Court in reaching a view about whether it was fair, just and reasonable to recognise a duty of care. It should be borne in mind that in the present case, the first intimation of any factors prayed in aid in relation to "fair, just and reasonable" test were made in oral submission by junior counsel for the defenders. That may explain in part the lack of detailed response on behalf of the pursuers. Some of the factors were dependent upon facts which might be disputed. I would be reluctant to conclude, before proof and without evidence, that on policy grounds a pursuer should be denied a remedy for direct physical harm caused by negligence. I consider that the approach of Lord Browne-Wilkinson in X v Bedfordshire County Council has much to recommend it for the reasons he gives. If I am wrong about that and it is considered that my view should be expressed on the merits of submissions by the defenders about "the fair, just and reasonable" test, I am prepared to do that for whatever assistance it might be. The matters relied on by counsel for the defenders, are summarised at paragraphs [22] - [27].

[55] I was unpersuaded by the "floodgates" summarised in paragraph [22]. This seemed to ignore the realities of litigation and the duties on professional legal advisers to obtain evidence of fault and causation before making averments. It would be insufficient for the purposes of a common law case for a pursuer merely to aver that he or she has contracted MRSA in hospital. Even if there were numerous claims in which sufficient evidence existed to enable the pursuer to make relevant averments, I do not consider that the number of claims would be a reason for denying a remedy. If numerous claims existed, there may be merit in enabling litigation to be pursued to encourage hospitals to take reasonable care for patients to prevent infection with MRSA.

[56] Counsel for the defenders' submitted that the NHS service is for the benefit of the public and funded by public resources and this pointed away from an individual damages remedy. In my opinion the public funding makes it difficult to conclude that the law should allow the burden and costs to fall solely on an individual where there has been a negligent act or omission causing physical damage to an individual in the care of a hospital. The existence of remedies other than damages does not provide a remedy of compensation for the individual.

[57] I also found the submission about defensive decision making unpersuasive. I would respectfully agree with the approach adopted by Lord Slyn of Hadley in Barrett v Enfield London Borough Council at page 568E-H and Lord Hamilton in Gibson v Orr at 436D.

[58] In relation to the matter summarised in paragraph [23], this involves unresolved questions of fact and I cannot comment further.

[59] In relation to the matters summarised in paragraph [24] and [27], prima facie this appears to be related to the type of operational matters about which Courts regularly reach a view after evidence. I am not persuaded that this is an area of policy into which the Courts should be reluctant to intervene.

Relevancy and specification of the common law case
[60] Because of the way in which the submissions on behalf of the defenders were presented, there was in my opinion insufficient focus and examination of authorities in relation to the general criticisms about relevancy and specification which were developed by counsel for the defenders. I had sympathy with senior counsel for the pursuer who was plainly prepared to give serious consideration to general criticisms of relevancy and attempt to meet them. If the submissions on the relevancy points which were imbedded in the defenders' submission had not been obscured by the Caparo submissions it might have been possible to reduce some of the areas of controversy.

[61] In turning to the pleadings, I propose to deal firstly, with the specific criticisms made on behalf of the defenders in paragraphs 4 and 5 of the note of argument which I have summarised in paragraphs [15] and [16].

[62] In relation to the criticisms of the pleadings about causation, I am satisfied that the pleadings of the pursuer at 8D-8E are relevant. The pursuer has set out what she is seeking to prove as the probable cause. In my opinion, this is a matter about which the pursuer is entitled to lead evidence. The criticisms of counsel for the defenders appear to be based partly on their interpretation of the facts about how MRSA infection can be transmitted. They obviously have a view about the difficulties which the pursuer may face in proving causation, standing the history narrated by the pursuer in the pleadings. Nevertheless, in my opinion, this is a matter for evidence and prima facie the pursuer sets out averments which, in my opinion, are relevant.

[63] In relation to the criticisms flowing from the fifth paragraph of the note of argument, I consider that there is merit in these criticisms. Starting at page 11C, there are averments about the minutes of the outbreak meeting for 15 November 2001. This makes reference to conditions in the operating theatre leading into averments about dust levels, and problems about effective cleaning of ward 65. There then follows averments about the defenders' failure to take adequate steps to protect hospital patients from a hospital acquired infection in relation to its cleaning regime. There are then averments about various deficiencies in hospital cleaning set out by Audit Scotland and various reviews about cleaning etc. These averments, which post-date the acquiring of the infection by the pursuer in ward 65, appear unconnected with the grounds of fault in Articles 5 and 7 of condescendence. It was not suggested by the pursuer's counsel that these averments had any bearing on the statutory case. There is an averment at 14A-14B to the effect that, where there was an inadequate cleaning regime, the hospital's hand hygiene policy should have been implemented with particular diligence. In my opinion, that does not save these averments. I consider that it might be relevant to have factual averments, to the effect that prior to the pursuer contracting the infection, ward 65 was dusty and dirty along with averments indicating why this increased the risk of MRSA. The averments as they stand however, seem to involve a general and unfocused reference to events post-infection. In my opinion, this would unnecessarily extend the proof into areas which are not fundamental to the cases pled. I would therefore delete as irrelevant, the averments beginning at 11B-C "at around the time of the outbreak" to "improvement at 12A-B and at 12C-D" beginning "the defenders' failure to take adequate steps" to 14B-C "infection control".

[64] I now turn to Article 5 of condescendence to deal with the averments about res ipsa loquitur. There is no dispute by the parties that in appropriate circumstances, it might be relevant to plead a case making reference to the principle of res ipsa loquitur even in a case involving a patient in hospital. This is well illustrated in Ratcliffe v Plymouth and Torbay Health Authority. Nevertheless, I consider that the submissions by counsel for the defenders are well founded for the reasons they give and which I summarise at paragraph [28] and [36]. Junior counsel for the pursuer made a valiant effort to explain the use which the pursuer wished to make of the principle in the context of the present case. In my opinion, however, that explanation underlined the difficulties for the pursuer in pleading the case on the basis of res ipsa loquitur. This is a case in which the pursuer claims to know the reason for the transmission of infection and offers to prove that cause. Senior counsel for the pursuer conceded that the reference to the principle was not perhaps helpful. I agree with him. I consider that the averments of res ipsa loquitur have merely added to the difficulties in this case. I therefore delete from the pleadings at 22D-22E the words "res ipsa loquitur. Esto said maxim does not apply, then."

[65] I now turn to consider the remaining averments in Article 5 of condescendence in which the pursuer attempts to set out a direct case against the defenders. As I have explained, I do not accept the defenders' submissions that the pursuer's averments takes the case into policy areas where Courts are unwilling or reluctant to make decisions. I have no difficulty in accepting that the defenders owe a direct duty to take reasonable care for the safety of patients in their care, at least in respect of operational matters which include the provision of proper facilities, equipment and systems. In my opinion, the pursuer is plainly trying to plead a case within this area which I consider to be a relevant area. I do not accept that the pursuer is trying to aver and establish at proof some groundbreaking basis of liability by way of novel averments. My understanding of the submission of the defenders' counsel is that in such a case it is not sufficient for the pursuer to merely aver that the breach about which they complained was a standard requirement in hospitals in Scotland at the material time. Senior counsel submitted that it was necessary for the pursuer to aver that the defaults complained of fell below a minimum level of care which no health board acting reasonably would fall below. They did not argue that the approach taken by their Lordships in Lindsey County Council v Marshall was inconsistent with the law of Scotland. I have some difficulty in resolving this matter because despite the many authorities cited to me, very few were directly concerned with negligence arising in the context of a patient in hospital and none were focused on pleading practice. In the absence of any detailed submission about relevant case law, I can only deal with matter broadly. I accept that the averments may involve matters of professional judgement on the part of the health board but this is not a case where the pursuer avers that the health board was out of step with the general, accepted and standard practice of other health boards. The case is that the health board adopted a policy which was in line with standard practice of health boards but failed to instruct, implement and provide facilities in respect thereof. I note that the defenders make it plain in the pleadings in Answer 5 that they are raising the discretionary nature of the implementation of their policy, but I do not consider that alters the nature of the defenders' liability in law or the way in which the pursuer must plead the case. Essentially, the pursuer's case is based on the failure to instruct and maintain a proper system of care with proper equipment. It would be for the Court on the basis of the evidence to reach a view in all the circumstances whether or not the defenders did take reasonable care. In assessing reasonableness, the Court would be entitled to take into account in the usual way, such considerations as the nature and severity of the danger, the facilities available, the costs of changes and practical difficulties of implementation in so far as these matters are raised at the proof. In my opinion the standard in such cases where a health board is exercising specialist functions is the general objective standard which the law would expect of a health board responsible for a hospital of the type involved in all the circumstances. It is a matter for the Court to judge, after proof, whether the standard is met. There is no specific averment about the standard but as the standard is implied by law I do not consider the absence of such an averment is necessarily fatal to the relevancy of the pleadings. The issue to be determined by the Court is not what the particular health board considered reasonable in provision or indeed what all or most health boards considered reasonable. These facts may inform the Court in reaching its conclusion about whether the health board's provision was reasonable in a particular case but are not definitive of the objective standard. The standard of reasonable care is founded upon by the pursuer in the pleadings. I consider that I am not in a position at this procedural stage to form a concluded opinion that the pursuer's case pled in article 5 of condescendence "will necessarily fail" even if the pursuer's averments are proved. That is the well recognised test set out in Jamieson v Jamieson 1952 SC (H.L.) 44 which was not cited to me but I consider to be the test to be applied. In these circumstances, I do not accept the submissions by counsel for the defenders that the case pled in article 5 is irrelevant.

[66] I now turn to consider Article 7 of condescendence. Senior counsel for the pursuer submitted that this was not a medical negligence case, but akin to a case where an employee fails to obey an instruction of his employer. I cannot accept that analysis. It is plain from the averments that this case involves "hands-on" care of a patient in hospital. That, in my opinion involves professional skill and judgement on the part of the staff. The complaint of the pursuer relates to transmission of the MRSA infection during staff contact by a staff member who failed to follow the defenders' hand hygiene policy (or requirement). The failure by a doctor or a nurse to follow an instruction or policy or requirement of the health board employer may incur consequences for that employee in the employment context, for example, disciplinary consequences. But, that is not the recognised legal standard of care in delict. The pursuer has averred that there is only one recognised professional practice (policy or requirement) in relation to hand washing. The pursuer avers that the defenders failed in the duties. There are no averments that staff members failed to carry out the hand washing requirement or failed in their duties. This should be averred. Whether staff failure amounts to a breach of the legal standard of care, depends in law on a further requirement that the pursuer must aver that the course the health professional adopted, (that is failure to follow the hand washing requirement) was one which no such professional person of ordinary skill would have taken if he had been acting with ordinary care. This is the settled law and is the third part of the criteria set out by Lord President Clyde in Hunter v Hanley 1955 S.C. 200. Counsel for the defenders criticised the pleadings in general terms in relation to this, albeit the case law was not put before me. I am satisfied that properly analysed, the pursuer's case against the hospital staff members does raise issues of professional practice and that as pled it is not therefore relevant. It is not clear from the pleadings whether the reference to staff members relates to nursing staff and/or a combination of medical staff and perhaps other staff. If that is the case, averments would be required about the professional standards in relation to the different health professionals. It may be that in such a case, for reasons which may appear obvious, the standards are standardised but it is a matter which in my opinion requires to be addressed and pled. As I have rejected the analysis founded upon by the pursuer, I consider that as pled the case in Article 7 "must necessarily fail".

Article 6 and the COSH 1999 Regulations
The Pleadings and the Defenders' Note of Argument
[67] In Article 6 of condescendence, it is averred that the pursuer's loss injury and damage were caused by the defenders' breaches of statutory duty. At page 25A-B, the pleadings state that MRSA is a substance hazardous to health in terms of the 1999 Regulations. It is further averred that it was the defenders' duty to comply with Regulations 6(1), 7(1), 8(1) and 9(1) of the 1999 Regulations and schedule 3 thereof. Having quoted parts of said regulations, the pursuer then makes further averments at page 27A - 28B in these terms:

"It is reasonably practicable that the defenders be under these duties in respect of patients admitted to the Hospital, such as the pursuer, as they are under in respect of Hospital staff. In these duties the defenders failed and thereby caused the pursuer to suffer loss, injury and damage. No adequate and sufficient assessment of the risks associated with MRSA infection was made. As hereinbefore condescended upon, the Hospital's Infection Control Policy was defective. The defenders did not adequately control the risk of patients becoming infected with MRSA. The defenders did not implement and enforce an adequate hand hygiene policy amongst hospital staff. The defenders did not take reasonable steps to ensure that the hand hygiene policy was properly complied with. The defenders did not ensure that the equipment with which hospital staff was supplied in order to comply with the hand hygiene policy was maintained in an efficient state, in efficient working order and in good repair. The equipment provided by the defenders to enable Hospital staff to wash their hands was inadequate and defective."

It is then averred that had the defenders fulfilled the said duties incumbent upon them the pursuer would not have become infected with MRSA.

[68] In order to put the defenders' criticism of these averments into context, it may be of assistance to refer to the defenders' averments in Answer 6. The defenders admit the terms of the 1999 Regulations and thereafter make a general denial of the pursuer's averments. They specifically aver that the 1999 Regulations do not apply to the acquisition of MRSA by a patient in the circumstances condescended upon by the pursuer. They aver that MRSA is not a substance hazardous to health in terms of the 1999 Regulations. On an esto basis they aver that if MRSA is a substance hazardous to health, the 1999 Regulations apply where the exposure to a substance hazardous to the health of an employee is under the control of his employer. They make averments of fact about the colonisation process and aver that MRSA is not present in hospitals as part of a work process or generated as a by product of a work process within the Hospital. On a further esto basis they plead that the pursuer is not a person affected by the work carried on by the employer and it is not reasonably practicable to extend any duty imposed by the 1999 Regulations to a patient such as the pursuer in terms of regulation 3(1). They then make separate averments to the effect that if any duty was owed, the defenders complied with all duties so far as reasonably practicable and they deny that any breach of duty caused the pursuer's injury.

[69] These lines of defence are reflected in paragraph 3 of the Note of Argument for the defenders (14 of process). The defenders there contend that the 1999 Regulations are not intended to apply to a hospital patient in the circumstances averred by the pursuer listing particular reasons (1) that MRSA is not a substance hazardous to health as defined in the Regulations; (2) that MRSA occurs naturally and is not generated as part of or as a by-product of a work process. Any exposure to MRSA is not therefore under the control of the defenders as employer within the terms of the Regulations; (3) that a patient in hospital is not a person "affected by the work carried on" in the sense envisaged by the Regulations nor is it "reasonably practicable for the defenders to be under a like duty to patients as that owed to employees in this regard. It is further stated that the whole structure of the 1999 Regulations, in particular Regulation 5(1)(e) suggests that an absolute duty in terms of these statutory provisions was not intended to apply to patients in a hospital.

Submissions by Counsel for the Defenders

[70] Despite the terms of the defences, junior counsel, on behalf of the defenders, conceded that MRSA is a "substance hazardous to health" in terms of the 1999 Regulations as it is a biological agent which may cause infection or otherwise create a hazard to human health. It is a "micro-organism" which in terms of Regulation 2(b)(ii) "means a micro biological entity, cellular or non-cellular, which is capable of replication or of transferring genetic material." That concession was supported by senior counsel for the defenders. It follows thereafter that the first line of defence narrated in the note of argument and reflected in the pleadings was not supported in submission. For reasons which were not explained, the defenders counsel did not seek to amend the pleadings to reflect the position adopted. In any event if this issue is disputed it raises matters of fact which can only be resolved by proof.

[71] The defenders maintained in oral submission that the pursuer had not relevantly pled a case under the 1999 Regulations. Junior counsel for the defenders made reference to paragraph 2 of the Regulations which sets out the definition of "substance hazardous to health" in particular Regulation 2(2). She submitted that this Regulation is critical to the defenders' submission. She submitted that the Regulations were not intended to cover the circumstances averred in the present case under reference to Fytche v Wincanton Logistics plc [2004] 1 ICR 975, Lord Hoffman at 979 E-H. She submitted that the Regulations were intended to cover situations where the substance hazardous to health was generated in the workplace and over which the employer had control. She deduced this from paragraph 2(2) of the 1999 Regulations. She prayed-in-aid Andrew Sayers v Loganair Limited, unreported 29^th February 2004. She drew attention in particular to paragraphs 17 to 24. The pursuer in that case had contended under reference to Fulton v Fastnet Highlands Limited [1988] S.L.T 1323, and Williams v Farne Salmon and Trout Limited 1998 S.L.T 1329 that under the Regulations the duty was absolute and that it was enough for the pursuer to aver exposure, leaving it to the defenders to aver reasonable practicability. Mr Coutts QC sitting as a part time judge agreed with Lord Nimmo Smith's Opinion in Williams v Farne Salmon and Trout Limited that foreseeability is not essential when pleading a case under the then Regulations. He concluded that exposure by itself would be enough. He questioned whether it was helpful to describe the duty under the Regulations as an absolute duty, qualified as it is by "reasonable practicability" and by other indefinite words such as suitable and sufficient. Counsel then drew attention to the structure of the Regulations in particular Regulations 3, 6 and 7. She also referred to Regulation 7(10) which provides that schedule 3 of the Regulations shall have effect in relation to biological agents. She submitted that the types of provisions envisaged in Schedule 3 were clearly intended to cover substances over which an employer has control and not substances which are naturally occurring in the environment. Her primary contention was that the pursuer's averments about the Regulations were irrelevant as the Regulations did not apply to a patient such as the pursuer who has contracted MRSA as a result of alleged "hand on" care by hospital staff.

[72] As a secondary and alternative submission junior counsel for the defenders submitted that if the Regulations were applicable, the defenders had a complete defence under Regulation 5(1). The pursuer averred that MRSA was caused by transmission via the hands of a staff member (page 8D-E). She submitted that the circumstances averred by the pursuer fell within the exception in paragraph 5(1). She prayed in aid Ndri v Moorfields Eye Hospital NHS Trust [2006] EWHC 3652. Accordingly she concluded no relevant case was averred.

[73] Senior counsel for the defenders adopted the approach and submissions made by junior counsel. He accepted that the Directives might assist with interpretation but pointed out that the Regulations had gone further than the Directives by extending protection to persons other than workers. Albeit the makers of the Regulations were entitled to extend protection, he submitted that the Directives could be of little assistance in interpreting the Regulations in the present case. Senior counsel drew attention to the fact that in two particular respects, significant for present purposes, the Regulations went further than the Directive. He referred to Article 4(2) of Council Directive 90/679/EEC and pointed out that it was notable that Article 6 of the Directive was not thereby applied to the situation where the activity does not involve a deliberate intention to work with or use a biological agent but may result in the workers being exposed to a biological agent. In extending the protection afforded by the Directive, the Regulations apply the equivalent of Article 6 not only to workers but to persons who may be affected by the work carried on by the employer in terms of Regulation 3(1). The equivalent protection to Article 6 of the Directive is to be found in Regulation 7. Senior counsel submitted that if the Regulations applied and, in particular, if Regulation 7 applied to a patient in a hospital there would be a duty on the employer, in this case the NHS Board, involving an absolute duty to adequately control MRSA. He submitted that in certain parts of the Hospital such as Bacteriology/Haematology departments such a duty is intelligible. As in these circumstances the employer has established the presence of a biological agent or is testing for the presence of such an agent, for example in a suspect patient. He submitted that in such circumstances there was implied a degree of control of the biological agent. He submitted that it is apparent from the terms of Schedule 3 of the Regulations, which by virtue of paragraph 7(10) makes special provisions relating to biological agents, that the Schedule has in mind special facilities and procedures.

[74] Turning to the averments of the pursuer, senior counsel criticised the pleadings and said that there are no averments to found a case that the MRSA has arisen from work under the control of the Health board. He submitted that the Regulations, which impose a duty of adequate control do so in circumstances which imply an ability to control on the part of the employer. He submitted that paragraph 2(2) of the Regulations was critical. Properly construed "the exposure" of the employee (in this case extended to the patient) to the substance must arise out of or in connection with "work which is under the control of the employer". He conceded that in certain circumstances, for example if a suspect sample of MRSA was left lying on the ward, or if a nurse knowingly treated a carrier of MRSA and then treated an uninfected patient without precautions, the Regulation could apply. Such situations were covered as the exposure to the substance would arise out of or in connection with "work" under the control of the Health board. Nevertheless senior counsel contended that the pursuer in the pleadings was not offering to prove that the exposure to the substance arose out of or in connection with work under the control of the Health board. The pursuer was offering to prove merely that infection took place. He submitted that there are no averments linking exposure with relevant work. Finally he submitted that even if there were prima facia averments, there was still a problem for the pursuer because of the terms of the exceptions in Regulation 5(1)(c). He submitted that this exception would protect a doctor or nurse who for example gives morphine to a patient. Such an act would plainly be "administration" for the purposes of the regulations. He conceded that the Ndri v Moorfields Eye Hospital NHS Trust [2006] EWHC 3652 case seemed to go further. He accepted that in the absence of any persuasive reasoning in that case, the ambit of the exception under Regulation 5 was unclear and might be difficult to apply to the circumstances averred in the present case.

Submissions by Counsel for the Pursuers
[75] Junior counsel for the pursuer submitted that the pursuer was entitled to rely on the 1999 Regulations. He pointed to Regulation 3(1) which clearly extended the 1999 Regulations beyond the employer/employee relationship. It was plain from Regulation 5(1) that the 1999 Regulations envisaged circumstances involving patients in hospital otherwise an exception would not be required. He submitted that counsel for the defenders misinterpreted Regulation 2(2). He submitted that it is the work that has to be controlled in terms of the Regulations not the exposure to the substance. He pointed to examples in Regulations 5 and 6 and Schedule 3, which plainly envisage situations where the employer does not have control over the substance. He submitted that none of the cases cited on behalf of the defenders supported their submission. The case of Ndri v Moorfields Eye Hospital NHS Trust provided no reasoning or analysis of the relevant legislation and was not therefor of any assistance.

[76] Senior counsel for the pursuer adopted the submissions of junior counsel. He submitted that there were three relevant questions to consider. Firstly, the question whether MRSA is a substance hazardous to health within the definition of the Regulations. He pointed out that the defenders' counsel had conceded in the course of their submissions that it is a micro-organism and is covered by the Regulations in terms of the definition in Regulation 2. The second question is whether the Hospital is covered by the Regulations. He submitted this was also conceded by the defenders as plainly it must be. A hospital is a workplace where numerous staff work. There is a specific exemption in paragraph 5, albeit in narrow terms. The third question is whether the Regulations cover patients as well as hospital staff. He submitted that contrary to the defenders' position, the answer to this question should be in the affirmative. In this case the pursuer as a patient was "affected by the work carried out by the employer".

[77] Senior counsel submitted that it was important to note that the extension of protection to persons such as the pursuer is not co-extensive with the protection to employees. A duty is placed in terms of paragraph 3(1) of the 1999 regulations only "so far as is reasonably practicable" in respect of persons "who may be affected by the work carried on by the employer" He prayed-in-aid Munkman Employers Liability, 14^th Edition paragraph 22.13 and Anderson v Trump 1996 CLY 5657. Senior counsel drew attention to the pursuer's pleadings at page 16 B where it is averred that "the work processes (patients) undergo (for example wound dressing) can cause the spread of MRSA to other patients. MRSA is generated as a bi-product of work processes in a hospital" He submitted that there is a factual dispute requiring proof and this is not an issue which can be resolved on the basis of consideration of the pleadings. The wording of Regulation 2(2) is very wide. The Regulation applies to exposure to a substance "arising out of or in connection with work which is under the control of his employer" These words "arising out of or in connection with" are wide enough, when read with Regulation 3, to cover patients, such as the pursuer, being treated in hospital. The Regulations are designed to control the exposure of employees to substances. By extension, the protection is extended to some extent to other persons. In conclusion, senior counsel for the pursuer submitted that properly construed the Regulations, as extended by Regulation 3 to the pursuer, do not provide for absolute liability on the part of the employer but fall into the type of case such as Nimmo v Alexander Cowan & Sons Limited [1968] AC 107 where the onus is transferred to the defenders. As an example of this approach, he prayed-in-aid Bilton v Fastnet Highlands Limited and Williams v Farne Salmon and Trout Limited. He submitted that the averments at 25 A to 27 B were relevant and sufficient to go to proof. He explained that the averments at 27 B to 27 E commencing "no adequate and sufficient assessment of the risk associated with MRSA infection" were merely responding to the defenders' answers and were not an essential part of the pursuers case in Article 6.

Discussion
[78] I was informed that there was no prior case law which addressed directly the issues in the present case. In these circumstances, I asked to be addressed not only about the Regulations but about any relevant Directives. I am grateful to senior counsel for the defenders for extending his submission in response to my request. The 1999 Regulations were an enactment of earlier Regulations to similar effect and were in large part intended to implement various Council Directives. The Directive which I consider to be most relevant to the issues underlying the present case is Council Directive 90/679/EEC. Reference in submissions was also made to Council Directive 80/1107/EEC. Both these Directives deal with the protection of workers from risks related to exposure to biological agents at work. It may be helpful to set out the terms of the relevant Directives and Regulations to put the discussion into context.

Council Directive 90/679/EEC and Council Directive 80/1107/EEC
[79] Council Directive 90/679/EEC deals with the protection of workers from risks related to exposure to biological agents at work. Section 1, Article 1 sets out the objective:

"The Directive, ... has as its aim the protection of workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to biological agents at work....."

Article 2 is a definition section. Article 3 provides:

"Scope - Determination and assessment of risks

1. This Directive shall apply to activities in which workers are or are potentially exposed to biological agents as a result of their work.

2.(a) In the case of any activity likely to involve a risk of exposure to biological agents, the nature, degree and duration of workers' exposure must be determined in order to make it possible to assess any risk to the workers' health or safety and to lay down the measures to be taken......"

Article 4 provides:

"Application of the various Articles in relation to the assessment of risks

1. If the results of the assessment referred to in Article 3 show that the exposure and/or potential exposure is to a group 1 biological agent, with no identifiable health risk to workers, Articles 5 to 17 and Article 19 shall not apply.

However, point 1 of Annex VI should be observed.

2. If the results of the assessment referred to in Article 3 show that the activity does not involve a deliberate intention to work with or use a biological agent but may result in the workers being exposed to a biological agent, as in the course of the activities for which an indicative list is given in Annex I, Articles 5, 7, 8, 10, 11, 12 13 and 14 shall apply unless the results of the assessment referred to in Article 3 show them to be unnecessary

In Section II there is set out employers' obligations and Article 5 provides:

"Replacement

The employer shall avoid the use of a harmful biological agent if the nature of the activity so permits, by replacing it with a biological agent which, under its conditions of use, is not dangerous or is less dangerous to workers' health, as the case may be, in the present state of knowledge."

Article 6 deals with the reduction of risk and provides:

"Reduction of risks

1.Where the results of the assessment referred to in Article 3 reveal a risk to workers' health or safety, workers' exposure must be prevented.

2.Where this is not technically practicable, having regard to the activity and the risk assessment referred to in Article 3, the risk of exposure must be reduced to as low a level as necessary in order to protect adequately the health and safety of the workers concerned, in particular by the following measures which are to be applied in the light of the results of the assessment referred to in Article 3."

The remainder of the Article provides various detailed measures.

Article 7 makes provision for certain information to be provided to the competent authority where the Article 3 assessment reveals the risk to workers' health or safety.

Article 8 makes detailed provision in relation to hygiene and individual protection. Article 8(1) provides:

"Hygiene and individual protection

Employers shall be obliged, in the case of all activities for which there is a risk to health or safety of workers due to work with biological agents, to take appropriate measures to ensure that....."

Thereafter detailed provisions are made, including in Article 8(c) that workers are provided with appropriate and adequate washing facilities. Article 9 makes provision about the information and training of workers. Article 10 makes provision about worker information in particular cases. Articles 11, 12 and 13 deal respectively with the duties on employers in certain circumstances to keep a list of exposed workers, consultation and participation of workers and notification to the competent authority in certain circumstances. Thereafter in Section III there are miscellaneous provisions. Article 14 makes provision about health surveillance. Article 15 deals with health and veterinary care facilities other than diagnostic laboratories. Article 16 provides for special measures for industrial processes, laboratories and animal rooms. Article 17 deals with the use of data. Article 18 deals with classification of biological agents. Articles 19-21 deal with implementation and updating. Annex 1 which is referred to in Article 4(2) provides an indicative list of activities which includes in paragraph 4:"work and health care, including isolation and post-mortem units." Thereafter Annex 2 to Annex 7 deals with a variety of detailed matters.

[80] I was referred briefly to Council Directive 80/1107/EEC which deals with the protection of workers from the risks related to exposure to chemical, physical and biological agents at work. Article 1 emphasises that the aim of the Directive is the protection of workers against risk to their health and safety, including the prevention of such risks arising or likely to arise at work from exposure to biological agents considered harmful. In Article 2(b) "worker" means any employed person exposed or likely to be exposed to such agents at work. The Regulations provide for various protective measures but Council Directive 90/679/EEC makes more detailed provisions which are reflected in the 1999 Regulations.

The Control of Substances Hazardous to Health Regulations 1999 (S.I.1999/437)
[81] The 1999 Regulations were made inter alia under section 2(2) of the European Communities Act 1972 and under various provisions including section 15 of the Health and Safety at Work Etc Act 1974. The Regulations came into force on 25 March 1999.

[82] Regulation 2, the interpretation section, includes the definition of "biological agent". MRSA falls within the definition. This was accepted by the defenders, as I explained in paragraph [70]. Regulation 2 provides:

"(2) In these Regulations, any reference to an employee being exposed to a substance hazardous to health is a reference to the exposure of that employee to a substance hazardous to health arising out of or in connection with work which is under the control of his employer".

Regulation 3 provides:

"(1) Where any duty is placed by these Regulations on an employer in respect of his employees, he shall, so far as is 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 on by the employer except that the duties of the employer -

(a) under regulation 11 (health surveillance) shall not extend to persons who are not his employees; and

(b) under regulations 10 and 12(1) and (2) (which relate respectively to monitoring and information, training etc) shall not extend to persons who are not his employees, unless those persons are on the premises where the work is being carried on".

Regulation 5 provides:

"(1) Regulations 6 to 12 shall have effect with a view to protecting persons against risks to their health, whether immediate or delayed, arising from exposure to substances hazardous to health except - .....

'(1)(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 his medical treatment;...

'(2) In paragraph (1)(c) 'medical treatment' means medical or dental examination or treatment which is conducted by, or under the direction of, a registered medical practitioner or registered dentist and includes any such examination, treatment or administration of any substance conducted for the purpose of research".

Regulation 6 makes provision about the assessment of health risks created by work involving substances hazardous to health and provides:

"6.(1) An employer shall not carry on any work which is liable to expose any employees to any substance hazardous to health unless he has made a suitable and sufficient assessment of the risks created by that work to the health of those employees and of the steps that need to be taken to meet the requirements of these Regulations".

Regulation 7 provides:

"(1) Every employer shall ensure that the exposure of his employees to substances hazardous to health is either prevented or, where this is not reasonably practicable, adequately controlled.

(2) So far as is reasonably practicable, the prevention or adequate control of exposure of employees to a substance hazardous to health, except to a carcinogen or a biological agent, shall be secured by measures other than the provision of personal protective equipment".

(10) Schedule 3 of these Regulations shall have effect in relation to biological agents....

(11) In this Regulation, 'adequate' means adequate having regard only to the nature of the substance and the nature and degree of exposure to substances hazardous to health and 'adequately' shall be construed accordingly".

[83] The Regulations make further detailed provision. Provision is made in Regulation 8 about the use of control measures, in Regulation 9 about the maintenance, examination and test of control measures and, in Regulation 10 about monitoring exposure in the workplace. Regulation 11 makes provision about health surveillance. Regulation 12 makes provision in relation to information, instruction and training for persons who may be exposed to substances hazardous to health. Regulation 13 makes provision in relation to certain fumigations. Regulation 14 provides for exemption certificates. Regulation 15 provides for extension outside Great Britain in certain circumstances. Regulation 16 provides for a defence in criminal proceedings in certain circumstances. Regulation 17 provides exemptions particularly in relation to visiting forces and the Ministry of Defence.

[84] It was not suggested that the remaining provisions in Regulations 18 to 20 or the Schedules, except for Schedule 3, were of any assistance in relation to the issues in the case. Schedule 3 of the Regulations makes special provision relating to biological agents. Paragraph 2 provides:

"(1) This Schedule shall have effect with a view to protecting employees against risks to their health, whether immediate or delayed, arising from exposure to biological agents except that paragraph 11 shall not apply in relation to a particular biological agent where the results of the assessment made under regulation 6 indicate that -

(a) the activity does not involve a deliberate intention to work with or use that biological agent; and

(b) there is no significant risk to the health of employees associated with that biological agent.

(2) Unless otherwise expressly provided, the provisions of this Schedule shall have effect in addition to and not in substitution for other provisions of these Regulations".

Paragraph 3 relates to classification of biological agents. According to senior counsel for the defenders, MRSA was not classified until after 2001 but it was not submitted that this was relevant to the issues in the case. Paragraph 4 makes consequential provision. Paragraph 5 provides:

"Without prejudice to the generality of regulation 7(1), if the nature of the activity so permits, every employer shall ensure that the exposure of his employees to a particular biological agent is prevented by substituting a biological agent which is less hazardous".

Paragraph 6 provides:

"(1) Where there is a risk of exposure to a biological agent and it is not otherwise reasonably practicable to prevent that exposure then it shall be adequately controlled, in particular by the following measures which are to be applied in the light of the results of the assessment".

The remainder of paragraph 6 makes detailed provisions which include:

"(k) instituting hygiene measures compatible with the aim of preventing or reducing the accidental transfer or release of a biological agent from the workplace, including, in particular -

(i) the provision of appropriate and adequate washing and toilet facilities; and...."

There then follows in paragraphs 7 and 8 provision for special control measures for health and veterinary care isolation facilities, laboratories, animal rooms and industrial processes. Paragraph 9 makes provision in relation to examination and maintenance of personal protective equipment. Paragraph 10 provides for information to be given to employees in certain circumstances. Paragraph 11 makes provision for employers to keep a list of employees exposed to Group 3 or Group 4 biological agents in certain circumstances. Paragraph 12 makes provision for the storing or use in certain circumstances of biological agents. Paragraph 13 makes provision for the consignment of biological agents specified in Part V. Paragraph 14 makes further provisions about notification in relation to biological agents specified in Part V. Part II makes detailed provisions relating to containment measures for health and veterinary care facilities, laboratories and animal rooms. Part III makes provision for containment measures for industrial processes. Part IV specifies details about the biohazard sign. Part V lists certain biological agents referred to in paragraphs 12, 13 and 14.

Interpretation of the Regulations

[85] The Council Directives to which I have referred, deal only with the protection of workers. Regulation 3 of the Regulations extends some protection to other persons "who may be affected by the work carried on by the employer". That plainly extends the scope of the Regulations beyond the protection contained in the Directives. It is important to note however that the duty under the Regulations is imposed in respect of non employees only so far "as is reasonably practicable". In my opinion 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.

[86] The Regulations are intended to implement the Directives in so far as the Directives apply to the protection of workers. In my opinion, 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. In the latter case an indicative list is given in Annex 1. In paragraph 4 of Annex 1, a specific reference is made to "healthcare". The Directive makes this distinction and in certain situations provides that additional rules may apply to certain activities which involve a deliberate intention to work with or use a biological agent. In my opinion, the Directive is intended to extend to activities which have the result that workers are exposed to a biological agent and that includes workers in healthcare. I do not read into the terms of the Directive any qualification that the biological agent must be under the control in some way of the employer.

[87] Turning to the 1999 Regulations, I am not persuaded by the submissions of counsel for the defenders that there is a test or criterion within the Regulations limiting the application thereof to situations where the biological agent is under the control of the defenders. I accept that Regulation 2(2) is critical in determining the scope of the Regulations. I consider that the words "which is under the control of his employer" are intended to qualify the word "work" in Regulation 2(2). I cannot read the Regulations in the way submitted on behalf of the defenders to the effect that the qualifying words refer to "substance hazardous to health". I do not consider that to be the natural meaning and construction of the wording. I also consider that the words used "arising out of or in connection with work" are intended to be words of wide application. Further, in my opinion, the interpretation put forward by the defenders' counsel does not fit with the purpose of the Directive or the Regulations. Throughout the Regulations there is reference to the purpose of protecting persons against risks to their health arising from exposure to substances hazardous to health. See for example Regulation 5(1), 6(1), 7(1). The Regulations do make specific provision in certain parts of the Regulations for situations where a biological agent may be under the control of the employer. In my opinion these are specific provisions to deal with specific types of circumstances. The Regulations are not limited by these specific circumstances. Examples of such specific provision may be found in Schedule 3, Part 1, paragraph 6(1)(h), paragraph 12 and paragraph 13. Similar detailed provisions are found, for example, in Schedule 3, part 2 and part 3.

[88] I turn now to the submission made on behalf of the defenders that a patient in hospital is not a person "affected by the work carried on" in the sense envisaged by the Regulations. The extension of the Regulations to persons other than employees is to be found in Regulation 3. I did not understand the defenders' counsel in oral submission to suggest that a patient in hospital could never be covered by the Regulations. My understanding of the submission was that on the averments in the case, it was submitted that the pursuer was not so covered. I have some difficulties with this analysis. The analysis appears to involve both fact and law. I am not in a position to determine factual matters at this stage. The assertion by the defenders' counsel that MRSA is naturally occurring in the environment, that the infection suffered by the pursuer is not related to work by the defenders employees and the pursuer was not affected by the work carried on by the defenders, involve disputed factual assertions. The pursuer has averments at page 16 B which in my opinion are sufficient in relation to this issue to allow the pursuer a proof. After proof, the Court will be better placed to determine whether the pursuer falls within the protection of the Regulations. I am not persuaded by the submissions of the defenders' counsel to conclude that the pursuer, in the circumstances averred in this case, is outwith the protection of the Regulations. I consider that the general approach of senior counsel for the pursuer is well founded for the reasons which he gave and which I have summarised in paragraph [77].

[89] Counsel for the defenders also made submissions that if prima facie the Regulations were apt to cover the pursuer in the circumstances averred, the defenders had a complete defence under Regulation 5(1). There is an exception in Regulation 5(1)(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 his medical treatment". Medical treatment means "medical or dental examination or treatment which is conducted by, or under the direction of, a registered medical practitioner or registered dentist and includes any such examination, treatment or administration of any substance conducted for the purpose of research". I read this exception as being wide enough to cover a situation where the risk to health is a risk to the health of a person to whom the substance is administered in the course of examination or treatment by a health care professional. That is on the assumption for present purposes that the health care professional is acting under the direction of a registered medical practitioner. I find it difficult to envisage that this exception is intended to cover a situation where infection is transferred unintentionally and negligently by hands on treatment. In fairness to senior counsel for the defenders, he accepted that such a construction might be a strained construction. He did not seek to place much reliance on Ndri v Moorfields Eye Hospital NHS Trust in which there was no analysis or reasoning given. I consider that the Regulations envisage circumstances in which biological agents may be administered in the course of medical treatment and specific exception is provided for that. There may be medical treatments which involve in some way the use of biological agents or exposure thereto. I find it more difficult to construe this exception to 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. Looking to the intention of the Regulations, which are designed for the protection of employees and others for whom the protection of the Regulations is extended, I conclude 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. I do not go so far as to conclude that the defence cannot apply in the circumstances averred by the pursuer. It may be that the facts will shed some light on the application of the exception. I consider that unlikely but not impossible. It is for the defenders' counsel to persuade me that the pursuer's case is irrelevant because of the exception in Regulation 5 but at this stage I am not so persuaded.

[90] In conclusion, I consider that the general approach of the defenders seeking dismissal or absolvitor in relation to the statutory case is ill founded. There are some factual matters to be determined which may shed light on the construction of Regulation 3 and possibly Regulation 5. A fuller understanding of the factual matters underpinning the case may assist with the interpretation and application of the Regulations to the circumstances of the present case. I consider that a proof before answer in relation to the statutory case should be allowed.

[90] As it may be helpful to parties to consider my Opinion before I deal with the pleas in law, I have instructed a By Order hearing.

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	Scottish Court of Session Decisions
You are here: BAILII >> Databases >> Scottish Court of Session Decisions >> Miller (AP) v Greater Glasgow NHS Board [2008] ScotCS CSOH_71 (14 May 2008) URL: http://www.bailii.org/scot/cases/ScotCS/2008/CSOH_71.html Cite as: [2008] ScotCS CSOH_71, 2008 SLT 567, [2008] CSOH 71, 2008 GWD 20-341

Scottish Court of Session Decisions