EXTRA DIVISION, INNER HOUSE, COURT OF SESSION
Lord Osborne Lord Wheatley Lord Emslie	[2010] CSIH 40 A762/04 OPINION OF THE COURT delivered by LORD OSBORNE in causa by ELIZABETH MILLER Pursuer and Respondent; against GREATER GLASGOW NHS BOARD Defenders and Reclaimers: _______

Pursuer and Respondent: McEachran, Q.C., Barne; Drummond Miller, LLP

Defenders and Reclaimers: Murphy, Q.C., Davie; The Central Legal Office

14 May 2010

The background circumstances

[1] On 18 October 2001, the respondent was admitted to Glasgow Royal Infirmary, "the hospital", for an aortic valve replacement. The operation took place on the following day. On 28 October 2001, she was diagnosed as having a suspected post-operative wound infection. Antibiotic treatment involving cefuroxime was prescribed. A sample of the discharge from the pursuer's wound was sent for culture. On 29 October 2001, the pursuer was transferred to Monklands District General Hospital, for recuperation before being sent home. Subsequently, on or about 30 October 2001, the Department of Microbiology at the hospital identified the infection as being methicillin-resistent staphylococcus aureus, "MRSA". It is averred by the respondent that her wound infection was not caused by an organism that she was carrying herself. She claims that the timing of the infection and its relatively superficial location indicated that the infection was not contracted during the operation. She avers that it was probably caused by the transfer of the organism to her by the hands of a staff member, who had not followed the hospital's hand hygiene policy.

[2] Against that general background, the respondent has pled two common law cases. The first of these, to be found in Condescendence 5, is based upon an alleged breach of the reclaimers' duty, directly incumbent upon them, to exercise reasonable care to look after the safety and welfare of patients, while being treated in the hospital. It is said that it was their duty to take reasonable care to ensure that adequate hygiene measures were instituted and enforced in the hospital by various detailed means, which have been specified. The second of the respondent's common law cases, set out in Condescendence 7, is based upon the claim that her injury was caused by the fault of the hospital staff, for whose acts and omissions in the course of their employment the defenders are vicariously liable. Several particular failures upon the part of members of the hospital staff are specified. In addition to these cases, the respondent alleges that her injury was caused by breaches of statutory duty on the part of the reclaimers. In particular, she alleges that breaches of regulations 6(1), 7(1), 8(1) and 9(1) of and schedule 3 to the Control of Substances Hazardous to Health Regulations 1999, "the 1999 Regulations". Condescendence 6 contains averments of a number of respects in which it is claimed that the 1999 Regulations were breached.

[3] Both parties tabled preliminary pleas. The case came before the Lord Ordinary on 24 January 2008 at a procedure roll diet when it was indicated that the respondent was prepared to see the case dealt with by way of proof before answer. However, the reclaimers insisted upon their preliminary pleas. In the course of the debate, leave was given to counsel for the respondent to delete certain of her averments. Subsequently, further amendment of the respondent's pleadings was allowed. On 11 July 2008, the Lord Ordinary allowed further amendment of the pleadings, sustained the first plea-in-law for the reclaimers to the extent of excluding certain averments from probation, and thereafter allowed a proof before answer, all remaining pleas being left standing. Against that interlocutor the present reclaiming motion has been brought. On 14 October 2009 this Court, on the opposed motion of the respondent, allowed further amendment of the pleadings.

[4] The factual averments in respect of the common law cases pled by the respondent are set out in Condescendence 4. Having averred that, after her operation, she suffered an infection which was subsequently identified as MRSA, and that this was not caused by an organism she herself was carrying, or by the operation itself, she avers that she was infected, after the operation, whilst in a ward in the hospital. Her averments continue as follows:

"From the time of the surgery until the pursuer was transferred back to Ward 65 of the hospital at 2.30pm 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 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."

[5] In the pleadings, the respondent makes reference to the relevant parts of the hospital's Infection Control Policy Manual. It is specifically stated that "the hand washing requirement" contained in the hygiene policy was a standard requirement in hospitals in Scotland at the material time for hospital staff having direct contact with patients. It is said that "the hospital's Infection Control Policy was defective due to the absence of managing systems to ensure effective implementation of inter alia the hospital's hand hygiene policy". There are then averments made of an assessment of Ward 65 which was undertaken on 1 November 2001, a few days after the respondent's infection was diagnosed, and a number of defects are there reported. Further, references are made to the minutes of an outbreak committee, which was established in response to the outbreak of infection of the MRSA in the hospital, which refer to criticisms of staff and working practices in the ward. Finally, there are averments about a report by Audit Scotland in 2003, some two years after the infection, a follow up to a review published in April 2000, which is said to have uncovered defects in the cleaning regime, and, in particular, the hand hygiene policy supposedly in place in the hospital. It is further averred that, in the overwhelming majority of cases, MRSA is only spread within hospitals and the infection is not a community organism. The reclaimers' position is that the MRSA infection could be acquired in a number of ways which would import no negligence on their part. It is said that the infection can be transferred in different ways and that it is not possible to achieve total compliance with hand hygiene policies.

[6] At the debate before the Lord Ordinary, counsel for the reclaimers submitted that the respondent had attempted to develop a novel and far-reaching duty of care, and the court had to consider whether it was fair, just and reasonable to impose such a new duty on them. Reference was made to Caparo Industries plc v Dickman [1990] 2 AC 605. The statutory scheme under which the reclaimers operated was described. In particular, it was pointed out that bodies such as the reclaimers could make provision in relation to liabilities arising out of negligence in the carrying out of their functions. Counsel submitted that any common law duty of care had to be understood and interpreted in the context of those statutory provisions, which were designed to ensure that the statutory duties incumbent on the reclaimers were carried out; they were separate from delictual liability. In considering whether averments of negligence were relevant, regard had to be had to them in the context of the statutory framework. Reference was made to X v Bedfordshire County Council [1995] 2 AC 633. Junior counsel for the reclaimers before the Lord Ordinary submitted that the tripartite test in Caparo Industries plc v Dickman had not been met in the present case. It was argued that the first two parts of the test, namely proximity and foreseeability, were not relevantly averred by the respondent. Further, it was maintained that the third test had not been met by averments that were relevantly stated. A number of factors had to be considered in this regard. Firstly, it was said that, if the case were to go to proof, any patient who had contracted MRSA would similarly be entitled, without further justification, to an enquiry into their claims; this would have enormous implications for the Health Service. Secondly, it was maintained that MRSA was a micro organism which occurred naturally in the environment and it was therefore not possible to eradicate it completely from hospitals. The mere fact of infection occurring did not connote negligence. Thirdly, it was contended that matters such as the frequency of cleaning and general hand hygiene were not properly justiciable. The adequacy or otherwise of the facilities available for cleanliness within the hospitals depended upon policy decisions about the allocation of resources; the court ought not to intervene in what was a discretionary process on the part of the reclaimers. Fourthly, it was said that the National Health Service had been set up for the benefit of the public as a whole and that any proliferation of cases would lead to resources being diverted from the provision of health services to the conduct of litigation. Fifthly, reference was made to other available remedies, such as claims for professional negligence. Finally, it was suggested that the reclaimers should not be forced into making defensive policy decisions, in order to prevent potential claims.

[7] The next issue which the Lord Ordinary had been asked to consider was the matter of causation. Counsel for the reclaimers had submitted that the respondent had failed to aver a sufficient causative link between the transmission of MRSA to her and a source of that infection which would import negligence on the part of the reclaimers. The respondent had averred different sources of possible transmission, but not all of these implied that the reclaimers had been negligent. Accordingly, the respondent had not made relevant averments of causation.

[8] In reply counsel for the respondent had maintained that the case was important and ought not to be dismissed without enquiry, unless it could be shown that the pleadings were manifestly irrelevant. It was well-recognised that there was a general duty on the reclaimers to take reasonable care for the safety and welfare of patients, while they were being treated in hospital. The respondent was not seeking to derive duties of care from the reclaimers' Infection Control Policy, nor did either of the respondent's common law cases attempt to found upon a breach of a public law duty, or some novel duty of care; the respondent sought to found upon a particular example of a recognised general duty of care in the hospital context. The issue of causation was straightforward; the respondent was offering to prove that the probable cause of her MRSA infection was by way of the hands of a staff member, who had not followed the hospital's hand hygiene policy. The respondent maintained that she had become infected because members of the hospital staff were involved in "hands-on" treatment of her; this increased the risk of transmission of infection. The probable cause of her infection therefore was via the hands of a staff member who had not followed the hospital's hand hygiene policy. The hospital's Infection Control Manual emphasised that MRSA was spread mainly on the hands of staff and that this was easily prevented by effective and frequent hand washing. The reclaimers had given no notice of why it was not fair, just and reasonable to impose a duty of care; in any event, that issue should be decided after enquiry into the facts.

[9] The Lord Ordinary had concluded that there was a well-recognised direct duty of care on the reclaimers to exercise reasonable care for the health and welfare of patients and also that there could be a corresponding vicarious duty on their part for the actions of their employees in this regard. The question was whether there should be, as the reclaimers suggested, some limitation on these duties in the circumstances of the present case. She had concluded that the reclaimers had failed to establish that the direct common law case pled by the respondent was irrelevant and that there was any justification for concluding that the principles of Caparo Industries plc v Dickman operated against the respondent's claim. She concluded that there might be room for controversy as to whether, in the circumstances of this case, a particular duty of care existed, but that was different from saying that the duty averred was irrelevant. The only justification apparently offered by the reclaimers for their submission was that a case based on the contraction of MRSA infection was a novelty in the Scottish Courts.

[10] The Lord Ordinary had gone on to consider the detailed criticism of the respondent's averments by the reclaimers. In relation to Condescendence 4, she had found that the averments in the closed record at pages 11B-C to 12A-B, 12C-D to 14B-C were irrelevant. The averments at page 11B-C were concerned with the minutes of a meeting of the Outbreak Committee on 8 November 2001, which described some of the steps taken to deal with the MRSA outbreak, and that the recorded deficiencies were not confined to Ward 65 as regards the hospital's hand hygiene policy. The averments described the conditions in Ward 65 and suggested that effective cleaning ought to be an important aspect of any hospital's Infection Control Policy. There were averments made that extra cleaning of the ward had been organised and that long standing problems in the level of cleaning in Ward 65 had been identified. The Lord Ordinary considered these averments to be irrelevant because they related to events after the discovery of the respondent's infection. The averments between pages 12C-D and 14B-C were concerned principally with the publication of a review of domestic services in Scottish hospitals published in April 2000 by Audit Scotland which made a number of recommendations about cleanliness in hospitals and referred to the Scottish Infection Manual, which was produced in 1998 by the Scottish Executive. The review also made a number of recommendations about the control and prevention of infection. The averments went on to describe the findings in a follow-up review by Audit Scotland in April 2003, which had been very critical of the hospital's performance. The Lord Ordinary had decided to exclude these averments from probation, because she considered that they dealt with matters which post-dated the contraction of the infection by the respondent and therefore were unconnected with the grounds of fault. In Condescendence 5 she decided to exclude averments referring to the principle of res ipsa loquitur; there appeared to be no suggestion that she had been wrong to do so. As regards the remainder of the respondent's case, the Lord Ordinary had been satisfied that it would not necessarily fail if all of the averments made were proved. In that connection she referred to Jamieson v Jamieson 1952 S.C. (H.L.) 44.

[11] The Lord Ordinary went on to reject the respondent's case of vicarious liability for the negligence of employees, pled in Condescendence 7. She rejected the idea that this was a simple case relating to an employee or employees, who had failed to obey instructions on hygiene policy. She concluded that this case was truly one of professional negligence, although it did not appear that that was submitted to her in argument by either party. She observed that there was no averment that a member of the staff failed to carry out the reclaimers' hand washing requirement, or failed in their duties. She concluded that whether staff failure amounted to a breach of the legal standard of care depended on the requirement that a claimant had to aver that the course of action that the health professional had adopted was one which no professional person of ordinary skill and exercising ordinary care would have taken. That was the settled law as explained in Hunter v Hanley 1955 SC 200. She was satisfied that, properly analysed, the respondent's case against hospital staff members raised issues of professional practice and that, as pled, it was irrelevant for the reasons stated. The case pled in Condescendence 7, she considered, would necessarily fail. In summary, the effect of the Lord Ordinary's decision was that certain averments were deleted from Condescendence 4, as were also the averments in respect of the principle of res ipsa loquitur in Condescendence 5; the whole of Condescendence 7 was excluded from probation.

[12] In connection with this reclaiming motion, the reclaimers have lodged grounds of appeal and the respondent has lodged grounds of cross-appeal. In their grounds of appeal, the reclaimers advance several contentions. First, it is said that the Lord Ordinary erred by her failure to properly distinguish between a general common law duty of care and a particularised duty of care, in the absence of any averments of the practice of other public authorities, or of a basic standard of care below which no public authority could lawfully fall. There was no notice of the content of the duty upon which the respondent relied. If such notice were given, that would result in the respondent seeking to establish a duty which would impinge on non-justiciable issues which Parliament had reserved to health authorities. No such particular duty of care was incumbent on the reclaimers; it would not be fair, just and reasonable to impose it. Second, it is contended that the Lord Ordinary had erred by misconstruing the respondent's averments. Properly construed the respondent's factual averments did not disclose an inferential case of negligence, but only an offer to prove causation by reference to the failure to comply with a written policy. It is contended that such a policy was not to be equiparated with a legal standard of care. The Lord Ordinary ought to have held that there were no relevant averments of causation. In the third place, it is contended that the Lord Ordinary erred in holding, in paragraph [65] of her Opinion, that there was a general objective standard of reasonable care implied by law, in the absence of averment by the respondent as to what a pursuer undertakes to prove and rely upon in respect of such a standard. Finally, it is contended that the Lord Ordinary erred in holding that the Control of Substances Hazardous to Health Regulations 1999 applied to the averred facts of the present case.

[13] In her grounds of cross appeal, the respondent advances two contentions. First, it is said that the Lord Ordinary erred in sustaining the reclaimers' first plea-in-law by deleting the averments identified in paragraph [63] of her Opinion. Those averments indicate that the hospital's hand hygiene policy was not being complied with at around the time the respondent's infection occurred. They also refer to conditions in the hospital at around that time. They also related to the survival of MRSA in dust, the cleaning regime being inadequate and the need for implementation of the hand hygiene policy with particular diligence. These averments were relevant to the common law cases and the statutory defence which might be available to the reclaimers under the 1999 Regulations. Secondly, it is contended that the Lord Ordinary erred in sustaining the reclaimers' first plea-in-law in relation to Condescendence 7, the part of the respondent's case based on vicarious liability. She had assessed averments of compliance with the hand hygiene policy as relating to an issue of professional negligence. In particular she had come to the view, without hearing evidence on the subject, that compliance with the hospital's hand hygiene policy involved the exercise of professional skill and care, as a result of which, the test set out in Hunter v Hanley applied. The reality was that that case did not apply to the circumstances set out in the respondent's pleadings. Furthermore, since the Lord Ordinary's decision, the respondent had introduced by an amendment an esto case to the effect that, if compliance with the hand hygiene policy did involve the exercise of professional skill and care, then there were failures in such exercise. On any view, that alternative position ought to be the subject of investigation.

Submissions of the reclaimers

[14] Junior counsel's submissions to us fell into three categories relating to: (1) the averments of the common law duty of care; (2) the issue of causation; and (3) the case under the 1999 Regulations. As regards the first, the submission would be that there was no particularisation of the duty; no fair notice had been given of it. In Condescendence 5 there was nothing to say what the reclaimers ought to have done. The vicarious liability case, excluded by the Lord Ordinary, lacked specification. There was no content to the duty of care averred. It would be illegitimate for the case to stray into areas of policy discretion. As regards the matter of causation, insufficient had been averred to entitle the respondent to prove that essential ingredient. There were averred several possible sources for the infection, only one of which imported negligence. Thirdly, as regards the 1999 Regulations the reclaimers continued to contend that they did not apply in the circumstances of this case. They only covered cases where the risk of exposure occurred in connection with the work being undertaken. That was not addressed. The regulations were primarily intended to protect employees and did not extend to third parties present in the workplace, for example patients in a hospital. The regulations could not be interpreted widely enough to confer a remedy upon the respondent. The reclaimers would seek to persuade the court that the Lord Ordinary's interlocutor of 11 July 2008 should be recalled and that the action should be dismissed.

[15] It had to be mentioned that, so far as the reclaimers understood, while there had been cases concerning allegedly negligent treatment of patients infected with MRSA, for example McColm v Borders General Hospital NHS Trust 2007 G.W.D. 672, this was the first case in which it was alleged that, through negligence, a patient had become infected with MRSA.

[16] Counsel accepted that a claim for damages for personal injuries could not be dismissed unless, on the averments made, the court could say that it was bound to fail, as appeared from Jamieson v Jamieson. If particular duties of care were to be relied upon, they had to be the subject of specific averment; Morrisons Associated Companies Limited v James Rome & Sons Limited 1964 S.C. 160 at page 182. In the present case, no adequate averments had been made of the duties relied upon. Condescendence 4 contained a number of contradictions. It was to be inferred that the infection was contracted after the operation, yet there were averments concerning the conditions in operating theatres. It was not clear what the respondent was contending concerning the number of "hands-on" staff. In the crucial averments at page 8D-E of the reclaiming print there was dubiety concerning the origin of the source of infection, whether it was another patient, or from dust or dirt in the hospital environment. It was not clear what was meant by the latter expression. There were no averments that any particular staff members failed to follow the hand hygiene policy. What was lacking were any averments providing a factual basis for infection, which were related to the grounds of fault stated. It appeared to be suggested that the obligation of staff was to wash their hands before and after any patient contact, yet there remained the possibility of bacteria being transmitted by the touching of bed sheets, etc. Hand hygiene was important but might not be completely effective. There were averments at page 10 of the reclaiming print that related to an assessment dated 1 November 2001, yet the swab which showed that the respondent had become infected was taken on 27 October 2001. It was difficult to see what relevance the report had. This was not a case comparable with McGhee v The National Coal Board 1973 SC (HL) 37, since the respondent was not founding upon a material increase of risk. More particularly, what was lacking was any statement of the criterion that, it was said, the reclaimers had to meet. Furthermore, the averments contained no attempt to exclude sources of infection other than the hands of staff. It was acknowledged that the case was not one of res ipsa loquitur; accordingly there had to be specific averments of fact and of fault. The mere occurrence of infection did not import negligence. That was evident from Hajgato v London Health Association 1982 Ont. Rep. Lexis 243.

[17] At pages 11 to 14 of the reclaiming print there were averments relating to the investigation carried out by the outbreak committee, which had, in part, been deleted, although that decision was subject to the cross reclaiming motion. These averments were properly deleted. There was nothing to relate what was said there with Ward 65. There was nothing to show that the required standards were not in fact implemented in the relevant locus. Reliance on post-infection findings were irrelevant. In Condescendence 5 where the respondent's direct common law case was made, there were references to "adequate hygiene measures", which were not explained or further specified. Those averments were not properly related to what had gone before. Later in Condescendence 5, the respondent attempted to elevate the hand hygiene policy into a basis for a legal duty. The adoption of a particular policy did not result in the creation of a legal duty. The existence of the reclaimers' discretion in relation to how they ran a hospital was important. In connection with this submission, reliance was placed on X v Bedfordshire County Council [1995] 2 AC 633. Much of what was averred in Condescendence 4 was irrelevant. The reclaimers sought deletion from the words "in November 2001" at page 8A to C on the same page. The averment concerning the hospital's Infection Control Policy at page 10A was unspecific and unrelated to anything else. It ought to be deleted. The averments relating to the infection control environmental assessment should also be deleted. The deletions effected by the Lord Ordinary should be maintained. Those parts of Condescendence 5 that related to "adequate hygiene measures", which themselves were not specified, were irrelevant.

[18] Since the Lord Ordinary's decision was made, dismissing the case of vicarious liability, the averments in Condescendence 7 had been amended by the addition of the averments commencing at page 28D of the reclaiming print. These averments were irrelevant because there was no factual material to which they related in Condescendence 4. The averments at page 28C-D and 29C relating to the failure to observe the hand hygiene policy were irrelevant.

[19] Turning to the matter of causation, there was a bald averment relating to the cause of the respondent's infection at page 8D-E of the reclaiming print. However, where there were several different factors possibly at work, the occurrence of the actual infection gave rise to no inference as to which factor had caused it. Causation was usually a matter for proof, however the present case raised the issue in the light of the averments made. In this connection reliance was placed on Wilsher v Essex Area Health Authority [1988] 1 AC 1074, at 1090. The respondent's averments were of a chance or possibility of infection from a particular source. That was an inadequate basis for her case. That might be sufficient in some cases, for example Fairchild v Glenhaven Funeral Services Limited [2003] 1 AC 32, but not in this one. Reference was also made to Clerk & Lindsell on Torts 19^th Ed., paragraphs 2.42 and 2.44. The Lord Ordinary's observations in paragraph [62] of her Opinion were erroneous. The importance of making a proper averment concerning causation was highlighted in Kyle v P & J Stormonth Darling 1992 S.C. 57 at pages 64, 67, 68 and 69. It was accepted that causation might be inferred, as appeared from Brown v Redpath Brown & Company Limited 1963 S.L.T. 219, but if that were to be done, the recognised form of pleading involving the use of the words "believed and averred" should be adopted. That had not been done here. There were not even any averments of failures by staff at the hospital to wash their hands. That they had not done so was apparently a matter of inference from the outcome.

[20] Counsel turned next to consider the statutory case in Condescendence 6. At the outset counsel moved for leave, which was granted, to delete the averment at page 26D-E of the reclaiming print that MRSA was not hazardous to health. Thereafter, she embarked upon a detailed examination of the terms of the regulations founded upon. The proper approach to the interpretation, particularly of Regulation 7(1) could be seen from Dugmore v Swansea NHS Trust [2003] ICR 574 at page 580. The regulations were widely drafted and imposed onerous duties. Caution had to be exercised as to reaching a conclusion about their applicability. Regulation 7(10) and Schedule 3 were crucial in relation to the issue of applicability. Paragraph 2(1) of Schedule 3 made reference to "exposure to biological agents". Yet, there was no "deliberate intention to work with or use" a biological agent in this case, which was important having regard to the terms of paragraph 2(1)(a) of Schedule 3. The nub of the reclaimers' argument was that the regulations did not apply in the circumstances of the present case. Regulation 2(2) referred to exposure arising out of or in connection with work which was under the control of an employer. Those provisions were ill-adapted to apply to the situation here, where a person who was not an employee had not deliberately been exposed to a substance hazardous to health. The Lord Ordinary's conclusion in paragraph [90] of her Opinion was erroneous. There was a fundamental difficulty in the application of the regulations to the circumstances averred here. The wording of Regulation 3(1) which extended the application of the regulations to persons other than employees, did not sit happily with the possibility of applications in relation to a patient in a hospital.

Submissions on behalf of the respondent

[21] Counsel for the respondent moved the Court, in terms of the cross reclaiming motion, to recall the interlocutor of the Lord Ordinary, but only in so far as identified and to restore the excluded averments save for those relating to the case of res ipsa loquitur. Counsel said that he would address the Court in relation to six topics: (1) the 1999 Regulations; (2) the common law case; (3) the pleadings; (4) the respondent's case of direct liability at common law; (5) the respondent's case of vicarious liability; and (6) the issue of causation.

[22] Turning then to the case under the 1999 Regulations, it was accepted that MRSA was a biological agent and a substance hazardous to health. There was no controversy about that. The issues in the case related to "control" and "reasonable practicability. It was submitted that there was no requirement that a "substance hazardous to health" had to be in the "control" of an employer. No issue of foreseeability arose in relation to the statutory case. Regulation 2(2) was important. It contained a reference to exposure to a substance hazardous to health "arising out of or in connection with work which is under the control" of an employer. These words were very broad. They made clear that what was to be under the control of an employer was the work and nothing else. The Court should take a purposive approach in relation to the interpretation of this regulation in association with Regulation 3(1). Regulation 5(1)(c) contained an exception to applicability, but there was no question of the hazardous substance here being "administered in the course of ... medical treatment", so that exception did not operate. However, it was important in showing that the regulations were designed to cover a health care situation. Regulation 7(1) was of fundamental importance. It created a direct duty. Paragraph 6(1)(k) was important. It related to the "accidental transfer" of a biological agent, in relation to the prevention of which the institution of hygiene measures might be appropriate. Paragraph 7 of Schedule 3 was also significant, since its wording contemplated the kind of situation involved in the present case. As regards the application of the regulations to persons other than employees, Regulation 3(1) had effect. The Lord Ordinary had dealt with all of these matters in paragraphs [85] to [90] of her Opinion. While there were certain obscurities in relation to the application of the regulations, it could not be said that a case based upon them was bound to fail. The Lord Ordinary's decision in relation to the statutory case should not be interfered with.

[23] Counsel next proceeded to consider in association the respondent's common law cases and her pleadings. The guiding principles could be found in the cases of Jamieson v Jamieson and Miller v South of Scotland Electricity Board 1958 S.C. (H.L.) 20. Before an action for damages for personal injuries could be dismissed, it had to be shown that, if all the averments made were proved the action was bound to fail. That could not be said in this case. It was, of course, recognised that fair notice had to be given to the defenders in the action, but that had been done. In short, it was appropriate that a proof before answer should be allowed.

[24] The clear issue in the present case was how MRSA infection entered the respondent's operative wound. In her averments at page 7C-D of the reclaiming print averments were made as to how the infection had not occurred. The important issue was how the infection entered the respondent's body, not the original source of it. Some of the averments at page 8A-B of the reclaiming print were vestiges of a previous form of the pleadings. However, the case now made was that the respondent contracted MRSA post-operatively in Ward 61 or, latterly Ward 65. At page 8D it was clearly averred that the probable cause of the respondent's infection was the transmission of the organism to her from a source elsewhere in the wards via the hands of a staff member who had not followed the hospital's hand hygiene policy. That averment was clear and unequivocal. It was clear from the averments at page 10A-B that the hospital's Infection Control Policy required effective implementation of the hospital's hand hygiene policy. The core of the respondent's case was a management failure to ensure such implementation. As regards the averments concerning the Infection Control Safe Patient Environmental Assessment of Ward 65, undertaken on 1 November 2001, the inference to be drawn was that the state of affairs revealed at that time had not changed since mid-October 2001. Certain of the averments excluded from probation by the Lord Ordinary were habile to demonstrate such a management failure. The Lord Ordinary had also excluded averments between page 12C-D to page 14B-C, which sought to demonstrate that MRSA was an "issue" in the hospital.

[25] Counsel then turned to deal with the respondent's direct case of negligence against the reclaimers. There was no controversy that the reclaimers owed a general duty of care to patients in the hospital, such as the respondent. It appeared that the difficulties arose in relation to the particularisation of that duty. The respondent's approach was simple; the reclaimers had assumed responsibility for her as a patient. That was well-recognised, as appeared from Medical Negligence by Michael Jones 2003, paragraphs 7.017 and 7.018. The reclaimers were under a duty to implement appropriate measures in the conduct of the hospital for which they were responsible. The matter of hand hygiene was recognised as important; the reclaimers had a duty to enforce the policy in relation to that matter, in the implement of reasonable care. It was quite wrong to say that this issue was non-justiciable. There was a reasonable foreseeability of injury to patients if such a policy was not properly implemented. An early example of the implementation of this kind of duty was to be found in Lindsey County Council v Marshall [1937] A.C. 97. The observations of Lord McMillan at pages 118 to 119 were cogent.

[26] Counsel next dealt with the respondent's case based on vicarious liability. The Lord Ordinary had rejected this case upon the view that professional negligence was involved and that the requirements of the law, as explained in Hunter v Hanley, had not been observed in the respondent's pleadings. That decision was erroneous and misconceived. There was no issue of professional negligence involved in the respondent's case; what was claimed was negligence on the part of employees in failing to comply with hospital standing orders and procedures in relation to hand hygiene. This point was clearly made in the respondent's ground of appeal 2. It was not a case of professional practice of any kind, whether of a nurse or medical practitioner, that was criticised in the respondent's case. What was said was that ordinary precautions against the transmission of infection by the implementation of rules relating to hygiene had not been observed by staff members who came into contact with a patient, whoever they might be. The Lord Ordinary's decision to exclude this part of the respondent's case should be reversed.

[27] Counsel for the respondent dealt finally with issues related to causation. His submission was that sufficient had been pled by the respondent to enable the case to be sent to a proof. The case of Wilsher v Essex Area Health Authority had been relied upon by the reclaimers. That reliance was misplaced, since the respondent's case was not comparable to that involved in that decision. Here, the respondent offered to prove that her contraction of infection by MRSA was caused by fault. In Wilsher v Essex Area Health Authority, there were no relevant findings in fact on causation; the case had been remitted back for further enquiry on that matter. It had been argued that because there were potentially multiple sources of MRSA infection the case was comparable. That involved a confusion. It was not the source of the infection that mattered but the mechanism of infection of the wound. What the respondent offered to prove was that the infection occurred because of the fault averred. It was not necessary for her to exclude every possible non-negligent mechanism of infection, because the case that she had pled was now not one of res ipsa loquitur. The fact that on page 8D of the reclaiming print the respondent had used the expression "probable cause" was not significant. That simply demonstrated a recognition that the standard of proof so far as the respondent was concerned was on a balance of probabilities. It had been suggested that the formula of pleading involving the expression "believed and averred" should have been employed. That was misconceived. The pursuer was not inviting an inference in the circumstances of this case; there was expert evidence to be led which supported the averment at page 8D. In support of his submissions, counsel relied on Burnett v Menzies McDougall 2006 S.C. 93, which clarified the decision in Brown v Redpath Brown & Company Limited. In all the circumstances, the cross reclaiming motion should be allowed.

Submissions of senior counsel for the reclaimers

[28] Senior counsel submitted that, since Condescendence 4 did not contain relevant averments of an act or omission, nor, in consequence, relevant averments of statutory exposure, both the common law cases and the statutory cases were irrelevant. Accordingly the action should be dismissed. Since the respondent's case was based upon an act or omission, if that were not relevantly averred, the case was bound to fail. At the outset, senior counsel emphasised that the decision in this case was of importance to the reclaimers. There would be wide implications for them were the case to be sent to a proof. If infection occurred in a hospital, issues relating to the management of the infection had to be resolved by the reclaimers. They might require to take decisions as to the closure of a hospital unit, which would affect the treatment of other patients. These were matters within the discretion of the reclaimers and their counterparts in other hospitals.

[29] The respondent's averments at page 8D-E of the reclaiming print were crucial. If it was a direct case one had to ask why the word "probable" was used. If it was an inferential case, there were no averments of fact from which the inference required could be drawn; furthermore the recognised manner of pleading and inferential case had not been followed. The test of relevance in Jamieson v Jamieson was well known and existed in order to protect defenders from ill-conceived cases and lengthy proofs with no prospects of success. It was in the interests of the justice system that such protection should be afforded.

[30] Turning to the respondent's common law case, senior counsel relied on Kyle v P & J Stormonth Darling, particularly the observations of Lord McCluskey at page 67. There it was observed that in claims for damages in the law of negligence in Scotland the pursuer had to aver and establish (a) the negligent act, (b) loss, injury and damage, and (c) that the act caused the loss, injury and damage complained of. These principles were trite, yet they had not been observed by the respondent. Looking at Condescendence 4, what appeared at page 8D-E of the reclaiming print appeared like an inference to be drawn from primary facts, but the question was whether that was a legitimate inference. The inference appeared to be that the bacteria were transmitted to the respondent on the hands of a health worker who had not followed hygiene procedures. However, it was necessary to find averments of fact from which that could properly be inferred. What one found on examining the pleadings was averments of certain facts that did not lead to the inference sought to be relied upon. The averments at page 10 concerned a post-infection situation and were therefore irrelevant. Quite simply the averments of primary fact in Condescendence 4(4) could not give rise to the inference sought to be drawn.

[31] Furthermore the critical averment at page 8D-E was couched in inappropriate language. The use of the word "probable" was inappropriate. There was no averment of guilt on the part of staff members. The averment at page 29B-C was in the wrong place. It ought to have been in Condescendence 4. Altogether the respondent's averments were so defective as not to merit enquiry.

[32] Senior counsel next turned to consider the respondent's statutory case. Dealing with that case, he said that the same criticisms regarding the averments at page 8D-E of the reclaiming print could be addressed in relation to the statutory case as had been addressed in relation to the common law case. Turning to the 1999 Regulations themselves, he made the point that, in Regulation 2(2) it was the work that had to be under the control of the employer. Regulation 2(2) had no relationship with Regulation 3(1). The latter dealt with the employer's duty towards "any other person who may be affected by the work carried on by the employer". It had to be acknowledged that there was some level of uncertainty concerning the operation of the regulations, Regulation 3(1) in particular. There were no averments by the respondent regarding how the regulations imposed a duty upon employers in favour of "any other person", within which description the respondent had to put herself. There was no attempt to apply Regulation 3(1) in a comprehensible manner. In these circumstances the respondent's statutory case was irrelevant.

[33] In completing his submissions, senior counsel observed that in paragraph [66] of her Opinion, the Lord Ordinary had indulged in a frolic of her own. The reclaimers had not relied upon Hunter v Hanley in their submissions to her. On the issue of causation, senior counsel said that he did not take issue with what junior counsel for the respondent had said on the matter. The present case was not one concerned with issues relating to a material increase of risk.

Submissions for senior counsel for the respondent

[34] Senior counsel began by regretting the very considerable delay that had taken place in this action since its inception. The Court ought to consider the introduction of a more effective system of case management. The present action was an example of what ought not to happen. The arguments of the reclaimers had strayed beyond the stated grounds of appeal. Effect should not be given to anything other than the contentions enshrined in them. Having made these general observations, senior counsel then sought leave to amend the respondent's pleadings in certain respects. He proposed that at page 29 of the reclaiming print in Condescendence 7 between letters D-E after the reference to the defenders the word "staff" should be inserted in those two places. Further, at page 8D-E the word "ward" should be deleted and, in its place, the word "wards" should be inserted. Senior counsel for the reclaimers stated that he had no objection to this course, although this was the eighth amendment that that respondent had made to her pleadings. Accordingly, leave to amend was granted.

[35] Senior counsel for the respondent noted that, during the course of the submissions, there had been little reference to the Opinion of the Lord Ordinary, although her Opinion dealt in detail with matters discussed at the procedure roll diet, which extended over a period of six days. The Lord Ordinary had allowed the respondent's statutory case to go to a proof; that decision should not be disturbed. The starting point in an appreciation of the respondent's statutory case was Regulation 7, which required that every employer should ensure that the exposure of his employees to substances hazardous to health was either prevented or, where that was not reasonably practicable, adequately controlled. Regulation 2(2) was supplementary to that. Thereafter one had to look at Regulation 3(1) which extended the employer's obligation in respect of hazardous substances to "any other person ... who may be affected by the work carried on ...". The Lord Ordinary had considered the implications of these provisions in that part of her Opinion dealing with the statutory case and in paragraph 87 had reached an appropriate conclusion. In Dugmore v Swansea NHS Trust [2003] ICR 574, in paragraph 27, Hale L.J. had given a general explanation of the purpose of the regulations. There was no real difficulty in following the approach adopted in the respondent's pleadings to her statutory case. The terms of Regulation 5(1) and 6(1) were important in the context of the present action. What the respondent had to show was that she had been infected in the hospital with MRSA. It was a substance hazardous to health. The work carried on in the hospital was under the control of the reclaimers as employers. There was exposure to the substance hazardous to health arising out of or in connection with work which was under the control of the employer.

[36] Turning to the exclusions from probation adopted by the Lord Ordinary, senior counsel submitted that the averments excluded at page 11B-D, should remain for proof. The same was true of the averments at page 11D-12A. The passage between pages 12C-14C should not be excluded from probation. Much of that material related to the issue of reasonable practicability, intended to refute the reclaimers' statutory defence.

[37] Turning to the Lord Ordinary's treatment of the respondent's case based on vicarious liability, it was submitted that she had misdirected herself. That appeared to be acknowledged by the reclaimers themselves. The case of Hunter v Hanley had no application to the circumstances of this case, since what was alleged was not professional negligence but a straightforward failure on the part of staff at the hospital, whoever they might be, to adhere to the appropriate hygiene regime.

[38] Senior counsel said that he had little to add to the submissions of junior counsel on the issue of causation. In Condescendence 4 there was sufficient to enable a proof to be allowed. It was made clear that contact with a staff member who had not followed the hand hygiene policy was averred to be the cause of the respondent's infection. She was entitled to an opportunity to prove that.

The decision

[39] In our view, the averments of the respondent, particularly those in Condescendence 4, cannot be said to be lucid and well-ordered. There have been numerous amendments to the pleadings in this case, which itself reflects, at least, an initial failure to focus the real issues in controversy, as well as being a cause of some of the delay that has unfortunately occurred in this case. Indeed, there was a further amendment during the course of the hearing before us. Such procedure is to be deplored, since it is productive of unnecessary expense and delays progress. However, it has to be recognised that the test of the adequacy of pleadings in an action such as this is not whether elegance and lucidity have been achieved; as appears from Miller v South of Scotland Electricity Board, the issue which must be addressed is whether, if all of a pursuer's averments were proved, the action is nevertheless bound to fail. Looked at in that way, we are persuaded that a proof before answer must be allowed.

[40] In our opinion, the general outline of the respondent's case is, in fact, reasonably clear. In Condescendence 4 averments concerning the state of matters in the hospital are made. References are to be found concerning dust and dirt in the hospital environment. The risk of MRSA bacteria being present on other patients is mentioned. Against that background emphasis is placed upon the hospital's hand-hygiene policy. Averments are made concerning the situation that was identified as at 1 November 2001 concerning hygiene facilities. At that time, it is said that there existed defects in the washing facilities, both as regards the plumbing system and the availability of soap. Towels were missing in some areas. Various hygiene preparations such as antiseptic soap and alcohol gel were not available where they might have been appropriate. Against that background it is claimed that there were management deficiencies. The hospital's Infection Control Policy Manual, which contained a section on MRSA control was said not to be available to staff, who did not know where to locate it. In the circumstances outlined in Condescendence 5, a case is made against the reclaimers themselves which, in our view is relatively simple and straightforward. It is to the effect that, in the exercise of their duty to take reasonable care for patients in the hospital, the reclaimers had a duty to take reasonable care to ensure that adequate hygiene measures were instituted and enforced. There then follows a particularisation of that alleged duty. Principally it involves responsibility for the issuing of instructions to staff and monitoring their compliance with them. In association with that, there are averments of duty to take reasonable care to ensure that adequate facilities were available, so that they might follow those instructions, in the form of washing facilities and the provision of appropriate cleaning materials. Since as early as the case of Lindsey County Council v Marshall it has been recognised that the operators of a hospital might owe a duty of care to patients in respect of infection which might be contracted within a hospital. In these circumstances, as a matter of principle, we see no insuperable obstacle to a claimant making a case against a hospital authority of the kind which has been undertaken in this action.

[41] In the course of the submissions before us, the point was made on behalf of the reclaimers that to affirm that a claim such as that advanced here was appropriate for enquiry would bring the court into consideration of a matter that was, as it was put, non-justiciable. As we understood it, the argument was to the effect that, in the operation of a hospital, the hospital authority had to exercise its discretion in relation to the allocation of resources and the fixing of priorities, which matters might affect the extent to which protection might be available against the spread of infection. We reject that contention. It is quite plain from the pleadings in this action that what is the focus of the respondent's criticism is not the exercise of a discretion, but specifically the management of a particular area of hospital activity, namely the Infection Control Policy and, more specifically, the hospital's hand-hygiene policy. The present claim seems to us to involve a case against the reclaimers, set out in Condescendence 5, which is specifically related to the institution and enforcement in the hospital of adequate hygiene measures in a context in which MRSA infection was a foreseeable risk. In our view, the making of such a case cannot be seen as an attack upon a discretionary decision relating to priorities on the part of the reclaimers. However, having said that, if the reclaimers were of the view that the implementation of some precaution desiderated by the respondent would be disproportionately expensive, as compared with any benefit that it might confer, no doubt averments to that effect might have been made by the reclaimers.

[42] Counsel for the reclaimers directed criticism against the language used in Condescendence 4 in the respondent's pleadings. In particular, it was said that the use of the word "probable" in the averment that the probable cause of the pursuer's MRSA's infection was the transmission of the organism to her from a source elsewhere in the ward via the hands of a staff member who had not followed the hospital's hand-hygiene policy. While the use of that word might suggest that what was involved in the respondent's case was the making of an inference as to the cause of her infection from a range of other primary facts, we do not think that that is necessarily so. While there might have been other ways of averring the cause of the respondent's infection, we are not persuaded that the use of the language selected is productive of serious difficulty or confusion. Accordingly we reject the contention advanced by the reclaimers.

[43] Further criticism was focused upon the respondent's averments in Condescendence 4, appearing on page 10 of the reclaiming print relating to an Infection Control Safe Patient Environmental Assessment of Ward 65, which was undertaken on 1 November 2001. Averments are made concerning the findings of that assessment which are critical of the facilities existing, particularly concerning washing. It was argued that, having regard to the date of the respondent's contraction of the infection, these averments were irrelevant. We reject that contention. The respondent's post-operative wound infection was first suspected on 28 October 2001, when a sample of the discharge from the wound was sent for culture. The MRSA infection was reported on 30 October 2001. In our view the averments made concerning the Assessment may be taken as giving an indication of the facilities and circumstances existing at the time of it and within, at least, a short time before it. Bearing in mind the date of the respondent's contraction of the infection, we consider that the averments in question are relevant for enquiry, since they must relate to a time when the infection was actually contracted. There is no suggestion anywhere in the case that there was any material change in relation to those circumstances between the date of the assessment and the date of the respondent's contraction of the infection a few days earlier.

[44] As was made clear in Kyle v P & J Stormonth Darling, in an action of the present nature it is essential that a pursuer must aver and establish, among other things, that the negligent act complained of caused the loss, injury and damage in respect of which the action is brought. It was argued that, in the present case, there were no relevant averments of causation. We reject this contention. The respondent's loss, injury and damage arises from her contraction of the MRSA infection. The negligent acts founded upon are described in Condescendences 5 and 7; essentially they comprise, in the case of the former, failure to ensure that adequate hygiene measures were instituted and enforced in the hospital and, in the case of the latter, failures on the part of the staff to comply with the hand-washing requirement. In Condescendence 4, in the passage at page 8D-E, it is averred that the probable cause of the infection was the transmission of the organism concerned via the hands of a staff member who had not followed the hospital's hand hygiene policy. It appears to us that these averments are sufficient to entitle the respondent to an enquiry in relation to these matters and, in particular, the matter of causation.

[45] In paragraph [66] of her Opinion, the Lord Ordinary considered the case of vicarious liability made against the reclaimers in Condescendence 7. For the reasons which she sets out in that paragraph she concluded that that case of vicarious liability must necessarily fail, essentially because the respondent's case had not been formulated according to the settled principles set out in the case of Hunter v Hanley, which of course relates to the formulation of a case based on alleged professional negligence. In our view, the Lord Ordinary has erred in reaching that conclusion. The respondent's case of vicarious liability is set out in Condescendence 7. The allegation is that members of the hospital staff providing hands-on treatment to the respondent had a duty to take reasonable care to ensure that they complied with the hand washing requirement operating in the hospital. That averment is followed by more specific averments relating to the same matter. It appears to us perfectly clear that no issue of professional negligence, as such, arises in connection with this part of the case. It is directed against unnamed members of hospital staff, who might, or might not, have been professionals, in any sense of the word. The case is not based on an alleged departure from any professional practice of any kind; rather it is focused upon the responsibility of persons, whoever they might have been, having personal contract with patients and, in particular, the respondent to observe hygiene requirements in the form of hand washing. It appears to us that the Lord Ordinary's categorisation of this part of the case as one involving potentially an issue of professional negligence is misconceived. It is worth observing that, in the course of the submissions of senior counsel for the reclaimers, it was made clear that no argument supporting the Lord Ordinary's approach to this matter had been addressed to her.

[46] We should also say that, at page 86 of the reclaiming print in paragraph [66] of her Opinion, the Lord Ordinary observes that there are no averments that staff members failed to carry out the hand washing requirement or failed in their duties. It appears to us that that statement is erroneous. The averments made in Condescendence 4 at page 8E involve the allegation that the staff members who, it is claimed, transmitted the infection to the respondent "had not followed the hospital's hand hygiene policy". Furthermore, in Condescendence 7 at page 29 of the reclaiming print, it is said that one or more hospital staff members failed 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 requirements. In all these circumstances we consider that the respondent's case at common law of vicarious liability is appropriate for enquiry.

[47] During the course of the debate before us consideration was given to the issue

of whether certain particular averments ought to be excluded from any enquiry that might be ordered. To that we now turn. It was said that the averments of the respondent at page 11C-12A of the reclaiming print which had been excluded from probation ought to be restored as part of the respondent's case. In our view, with one qualification which we shall mention, these averments seem to us to relate to matters which occurred so close in time to the diagnosis of the respondent's infection that the circumstances to which they relate may have a bearing upon the matters in issue in the case. Accordingly we consider that they should be the subject of enquiry. Our qualification is that the passage at pages 11E to 12A contains what amounts to an unspecific general assertion, which goes far beyond the legitimate scope of the respondent's hand-hygiene case. We do not consider that that averment should go to enquiry. Its terms are: "Effective cleaning should be an important aspect of any hospital's infection control policy"; our opinion is that, at any proof, this might be relied on as justifying an extensive investigation into the cleanliness of premises, vehicles, equipment, furnishings, clothing and other items throughout the hospital environment.

[48] The next chapter of the respondent's averments in controversy is that to be found between page 12D to page 14A of the reclaiming print. While we have some misgivings concerning the scope of these averments, it is evident that, while they deal with reviews of hospital hygiene both before and after the respondent's contraction of the infection, they may contain material which has a bearing on the issues relating to that contraction. However, we regard two particular averments within the passage concerned as inappropriate for inquiry. The first of these is the averment at page 12D:

"The defenders' failure to take adequate steps to protect hospital patients from hospital acquired infection has also been identified in relation to its cleaning regime".

The second is the quite general and unspecific averment at page 14A of the reclaiming print:

"The cleaning regime instituted by the defenders for the hospital was inadequate".

In our view, these passages must also be excluded from probation on the ground that they stray far beyond the legitimate scope of the respondent's hand-hygiene case.

[49] Turning now to the statutory case pled in Condescendence 6, we would at once observe that the intended scope and application of the 1999 Regulations are far from obvious, in the context of a case like this, where the position of a non-employee, such as the pursuer, is in issue. It is perhaps on this account that those Regulations were soon replaced by rather differently framed Regulations in 2002. The 1999 Regulations were promulgated in implementation of a European Directive which related to the protection of employees in the workplace. However, as well as making provision along such lines, they incorporated a significant addition in the form of Regulation 3. So far as relevant for present purposes, that Regulation was in the following terms:

"3(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....".

The opening clause of that Regulation directs attention to duties arising towards employees and, by reference to these, provides for a "like duty" to arise in favour of third parties affected by the employer's work. Whether Regulation 3(1) can be thought to apply in a given case thus depends on (i) an examination of the scope and content of duties concerning employees; (ii) an evaluation of like duties regarding third parties, although the former may be of an employment-specific nature; and (iii) consideration of the question whether an individual is "affected" by the employer's work.

[50] Under the 1999 Regulations a "substance hazardous to health" is widely defined in inter alia these terms:

" 'substance hazardous to health' means any substance (including any preparation) which is -

....

(c) a biological agent;

....

(e) a substance, not being a substance mentioned in sub-paragraphs (a) to (d) above, which creates a hazard to the health of any person which is comparable with the hazards created by substances mentioned in those sub-paragraphs;

....

'biological agent' means a micro-organism....which may cause any infection, allergy, toxicity or otherwise create a hazard to human health;

....

'micro-organism' means a micro-biological entity, cellular or non-cellular, which is capable of replication or of transferring genetic material; .....".

Importantly, however, Regulation 2(2) bears to restrict the concept of exposure as follows:

"(2) In these Regulations, any reference to 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 5 further defines a range of exceptions to duties arising under Regulations 6 to 12, notably, for present purposes, in circumstances where a risk to health arises from the administration of a substance in the course of medical treatment or research.

[51] In this case the respondent relies on Regulation 3, allied to Regulations 6 to 9 inclusive. Regulation 6 provides inter alia for an assessment to be carried out where there is a risk of exposure to a substance hazardous to health "...created by (the employer's) work". Where a risk is not so created, and a harmful or infective agent is merely present in the workplace, no such assessment appears to be required. Supported by provisions regarding control measures in Regulations 8 and 9, Regulation 7 provides inter alia as follows:

"7(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.

....

(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".

[52] As recognised by the Court of Appeal in Dugmore v Swansea NHS Trust, the apparently absolute duty to control what cannot reasonably practicably be prevented is tempered by considerations of adequacy. However, the factors deemed relevant in that context are significantly restricted under Regulation 7(11) and as regards biological agents Schedule 3 makes additional provision for special assessments (paragraph 4); for a bias towards the adoption of less hazardous agents (paragraph 5); and for a range of means by which exposure to biological agents may be controlled. These latter means include inter alia (a) reduction in the number of exposed persons; (b) the design of processes and control of measures so as to prevent or minimise the release of biological agents into the place of work; and (k) the institution of 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 the provision of appropriate and adequate washing and toilet facilities.

[53] As in the context of the cases of fault pled at common law, there are several respects in which we find the respondent's pleadings in Condescendence 4 confusing and unsatisfactory. This is a source of concern where, in our view, it is not easy to see how the 1999 Regulations were supposed to apply to a non-employee in the respondent's position. Nevertheless, with some hesitation, we have reached the conclusion that to exclude her statutory case from probation would not be justified, and that that case should go forward to proof along with the common law cases pled in Condescendences 5 and 7.

[54] Formally or otherwise, this is said to be a lead or test case on the subject of MRSA infection in a hospital context, and, to our minds it would be wrong to exclude any part of it on technical grounds and without proof, unless that course were plainly warranted. Where the common law cases are already going forward to inquiry, there is perhaps even less reason to deny a parallel inquiry in relation to the statutory case.

[55] Beyond that, applying the standard test for relevancy, as affirmed in Jamieson v Jamieson, we are not persuaded that the respondent "must necessarily fail" on this branch of her case. If, as we have held, the primary averments of causation at page 8D-E in the reclaiming print are sufficiently relevant and specific to go to proof, we do not think that the possibility of success under the 1999 Regulations can be ruled out at this stage. Post-operative treatment with unwashed hands, if proved, might arguably be "work" for the purposes of Regulations 2(2) and 3(1); the respondent's exposure to MRSA might then arguably arise out of or in connection with such work; and, as the patient being treated, the respondent might arguably be "affected" by the work in question. On that basis, as it seems to us, the respondent might be thought to have at least some prospect of bringing herself within the protection of the Regulations. More accurately, perhaps, we are at this stage unable to hold that she has no prospect of doing so.

[56] Since these matters are now to be the subject of proof, we are reluctant to say much more on the disputed issues which arise in the context of the 1999 Regulations. Suffice it to say, at this juncture, that we would have had great difficulty with any interpretation whereby liability might flow from the mere presence of an infective agent within the hospital workplace. We would also have had difficulty, although perhaps less acute, with any interpretation whereby hospital work in general, irrespective of location or period, might per se satisfy the requirements of Regulations 2(2) and 3(1). In our judgment such an interpretation might again bring about a result which cannot seriously have been intended, namely liability arising from the mere presence, somewhere within the hospital environment, of the MRSA organism or other infective agent. For these reasons, we are unable to sustain the argument presented by the reclaimers in support of their fourth ground of appeal. The Lord Ordinary's allowance of proof on the respondent's statutory case is therefore affirmed.

[57] Finally, it is right to make clear that all members of the court have contributed to the preparation of this Opinion.