QUEEN'S BENCH DIVISION
ON APPEAL FROM CENTRAL LONDON COUNTY COURT
HER HONOUR JUDGE BAUCHER
Strand, London, WC2A 2LL |
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B e f o r e :
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Mr Wayne Bass |
Appellant/ Claimant |
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- and – |
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Ministry of Defence |
Respondent/ Defendant |
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(instructed by Hilary Meredith Solicitors) for the Appellant
Mr Ben Collins QC and Mr Robert Dickason
(instructed by Government Legal Department) for the Respondent
Hearing dates: 5 and 6 December 2019
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Crown Copyright ©
Mr Justice Martin Spencer:
Introduction
CDSG Communicable Diseases Steering Group CQPG Chloroquine and Proguanil DIN Defence Instruction & Notice DNBI Disease & Non-Battle Injury FOB Forward Operating Base Medint Medical Intelligence MHSWR Management of Health & Safety at Work Regulations 1999 MIA Medical Intelligence Assessment QF Q-Fever QFCFS Q-Fever Chronic Fatigue Syndrome The 2001 Order
The Health and Safety at Work etc Act 1974 (Application Outside Great Britain) Order 2001
Background facts
Knowledge of Q fever
"These reports undoubtedly show that Q fever is a disease of military significance for which preventative measures need to be taken. In epidemics where numbers were recorded, the loss of manpower ranged from 23% to 77% and the operational efficiency of some units must have been seriously impaired."
"The disease in man responds promptly to early Oxytetracycline administration and has not been observed to relapse in the 29 clinical cases studied.
Oxytetracycline, given prophylactically late in the incubation period, prevents clinical disease but similar amounts given soon after exposure do not prevent disease, merely delaying the time of onset.
Pneumonia detectable only by x-ray studies was present in one half of the cases. Individuals who did not have pulmonary lesions at the time antibiotic therapy was begun did not develop such lesions subsequently."
"Tigertt and Benenson showed that tetracycline, in a dose of three grams daily for six days, taken late in the incubation period, prevented the appearance of symptoms in a group of volunteer soldiers experimentally infected with Coxiella Burnetii. There is only one account of chemoprophylaxis in a military epidemic and as the report is incomplete in several respects the outcome must be considered inconclusive. Chemoprophylaxis for individuals or groups at short-term risk of developing Q fever, particularly if they perform essential roles, may be of value. Long-term prophylaxis with the dosage of tetracycline used by Tigertt and Benenson cannot be recommended and no study appears to have been undertaken with tetracycline at lower dosage levels."
"On the available evidence, Q fever is simply and largely preventable as a significant military disease by implementation of the following measures:
i) Education on the source and methods of infection.
ii) Banning the use of hay and straw for bedding, and the clearing and burning of hay and straw from farm buildings prior to occupation.
iii) The exclusion of sheep and goats from military areas.
iv) Regular serological surveillance of flocks adjoining military areas for evidence of heavy infection by Coxiella Burnetii.
v) Vigilance for an unusually high incidence of abortion in flocks adjoining military areas which should initiate an immediate serological survey to determine the possibility of gross environmental contamination by the Q fever organism.
vi) The possible use of short-term prophylaxis with tetracycline for limited exposures to Q fever."
Q Fever and the British army in Afghanistan
i) Topography and climate;
ii) Demographics, population displacement and NGO status;
iii) Economy and public health infrastructure;
iv) High risk infectious diseases;
v) Environmental and industrial hazards;
vi) Hazardous plants and animals;
vii) Civilian and military medical capability overview.
Among the high-risk infectious diseases identified in section iv) were food and waterborne diseases (bacterial diarrhoea, hepatitis A and E, protozoal diarrhoea and typhoid), vector-borne diseases (malaria, cutaneous leishmaniasis), animal contact diseases (rabies) and contact diseases (hepatitis B). Among the animals identified were various species of viper. At Appendix D, intermediate risk diseases were identified: foodborne and waterborne diseases (diarrhoea-cholera, hepatitis E), vector-borne diseases (Crimean-Congo haemorrhagic fever, leishmaniasis-visceral, sandfly fever, mite-borne typhus, West Nile fever), animal-borne diseases (anthrax, Q fever, brucellosis), sexually transmitted infections (HIV/AIDS), water-contact diseases (leptospirosis) and respiratory (tuberculosis).
"High: the main force health protection emphasis should be on these diseases which are the most likely to degrade operations by affecting a large percentage of personnel or by causing severe illness in a smaller percentage.
Intermediate: these diseases also warrant force protection emphasis. They are less likely to degrade operations because they generally affect smaller numbers of personnel or cause mild symptoms. Other intermediate risk diseases are those assessed to be present at unknown levels that, under conditions favourable for transmission, could degrade operations.
Low: other militarily significant diseases that are likely to have a minimal impact on operational readiness."
It is to be noted that the grading of these risks was by reference to their possible impact on operational capability rather than by reference to the risk to any particular individual, although Mr Collins QC, for the Defendant, argued that the two are inextricably linked: see paragraph 51 below. Hepatitis A, Hepatitis B, typhoid, malaria, leishmaniasis and rabies were graded as high risk, but Q fever was designated as an intermediate risk along with, for example, anthrax, HIV and gonorrhoea and chlamydia.
"As expected, numerous observations were made on health protection, and considerable detailed input was obtained. In particular, reviews of current threat assessments for malaria and hepatitis B are recommended. Detailed guidance and further work on the management of diarrhoea and vomiting and outbreak control are required. Improved information should also inform the level of risk associated with current practices for managing relief in place."
The audit contained a number of recommendations including the following:
"82. Health protection risk assessment – malaria and hepatitis B. Evidence suggests that the current assessment may not be correct for these two diseases and an urgent review of both should take place to ensure that personnel are optimally protected from these important diseases."
In his witness statement, Col Ross explained:
"Q Fever did not feature in this audit as it was not identified as a significant health threat to deployed forces due to it being rare. There were many other more serious health threats and risks to the health of those in theatre, including, but not limited to, the diseases I have set out above"
[this being a reference to malaria, hepatitis B, rabies and Leishmaniasis].
"Overall I've had 86 medical inpatients over the three weeks I've been here and most are from the Bastion area which I suspect is the tip of the iceberg compared to what is going on in the FOBs [Forward Operating Bases]! I think I've been a bit busier than my predecessor (Andy Johnston) but then I did volunteer to come at this time because I knew it coincided with a roulement and the seasonal increase in Helmand fever cases."
Having then reported on various types of illness including gastroenteritis and scarlet fever, he said at paragraph 7:
"That's about it really – except to say I remain convinced there is no malaria in Helmand and that if we're going to take prophylaxis then it should be Doxycycline … but I know we've discussed this before."
"6.6 The malaria policy for Op. Herrick should be reviewed including assessment of risk for personnel based in different locations, and choice of chemoprophylaxis. This should be undertaken at the end of the current season."
This led to Permanent Joint Headquarters being requested by Medical Command to consider a switch to Doxycycline chemoprophylaxis for malaria in view of the presentations with Helmand fever, and the Communicable Disease Steering Group ("CDSG") was requested to advise.
"It was felt that the present regimen should continue unchanged for the present, since there was no evidence that it was failing to protect against malaria. This decision will be reviewed in light of the HPA's final report and PH's finished paper."
This decision was reflected in a notice sent by Lt Col Hennessey on 10 February 2011 which stated, among other things, as follows:
"4. Each nation follows national guidelines and national licensing laws. The UK advice concerning seasonal risk and chemoprophylaxis is provided by Advisory Committee on Malaria Prophylaxis and their current advice is to use Chloroquine and Proguanil with no alternative regime recommended. There remains no problem with Chloroquine resistance in P.Vivax in Afghanistan. The season is somewhat arbitrarily determined based on incidence of reported malaria cases and has previously been set as 1 March – 1 November. …
5. Little is known about the epidemiology of Rickettsial[1] disease in Afghanistan, and there is ongoing work to try and determine if significant numbers of UK service personnel are being exposed. The seroprevalence study which is a collaborative project between MOD and HPA has only reported interim findings which are not sufficiently robust yet to make definitive decisions. This project will be monitored closely and results reviewed in time to inform the next malaria season.
6. The Med FP Audit demonstrated that compliance with chemoprophylaxis is poor due to a combination of factors including individuals not believing the threat and mistrusting the advice due to differences in policies between deployed nations. This review, however, did not find compelling evidence to go against UK national guidelines just to align with another nation. There is a clear need to make yet more effort to reinforce the need for anti-malarials and the emphasis on bite avoidance measures which is being actioned as part of in-theatre health protection and through the CoC.
Summary
7. A review of malaria and malaria chemoprophylaxis was conducted following recommendations in the 2010 Medical Force Protection Audit. The results of the review were presented to the CDSG who has found no justification to change the current chemoprophylaxis regime at this time."
Clearly, this notice from Lt Col Hennessey and the decision taken not to substitute Doxycycline chemoprophylaxis for Chloroquine and Proguanil is at the heart of this case as a change in 2011 would have potentially benefitted the Claimant who was deployed to Afghanistan in October 2011.
"The HPA/MOD study results … suggest up to 20% of deployed personnel studied … had seroconverted for Q fever by the end of their deployment. Clearly not all of these had been ill. Mark Bailey's research and analysis suggest that of those seroconverted 50% would be symptomatic (to a greater or lesser extent) of which 25% could develop Q fatigue and 1-5% could go on to have chronic Q [fatigue]. If the HPA results are accurate (and Andy Green is yet to have a close look at them) this could represent a significant number of cases that arguably we should be following up. There is very little data or research that tells us what the long-term health implications of asymptomatic seroconversion are."
This email, sent to Air Cdre Wilcock, among others, was met with the following response on 1 April 2011 from Air Cdre Wilcock:
"This needs some discussion. It is not clear whether the science behind the concerns is yet robust enough to generate policy, or whether in fact we need a broader research project or some sort of cohort follow-up. Recognising the timescales for continuing involvement in Herrick, this may be difficult to achieve. I haven't read the full report, but no doubt the clinical experts will give a view in due course. Whilst I hesitate to say it, it would be useful to know what the US experience has been, given their greater numbers and longer length of deployment."
"I question whether the current recommendation of Chloroquine and Proguanil could be re-evaluated and Doxycycline considered. This would have the following advantages:
(a) Prevent daily drugs being taken weekly and vice-versa. There is a significant risk of toxicity if this occurs;
(b) Treatment of Q fever and rickettsial typhus;
(c) Treatment of acne and folliculitis;
(d) Treatment of chlamydia;
(e) Better tolerance."
In the course of summer 2011, there appears to have been a continuing groundswell of support for Doxycycline as chemoprophylaxis for malaria. On 5 June 2011, Lt Col Bailey published his Helmand fever paper and recommended that Doxycycline chemoprophylaxis be considered. On the same day, he referred, in an email which was widely distributed, to having diagnosed four new cases of Q fever in British troops over the previous few weeks and seeing about one case a week when he was deployed in Helmand and suggesting that Q fever remained a 'significant problem' in Helmand. This resonated with Gp Capt. Steven Kilbey who, on 9 June 2011, referred to comments he had made in 2010 on whether malaria prophylaxis should be in line with the US, "as we would cover more diseases and potentially improve compliance". On 10 June 2011, Col Martin Nadin wrote that he strongly supported Gp Capt. Kilbey's comment and that:
"We should consider switching to Doxycycline as our primary anti-malaria in South Afghanistan given its wider prophylactic properties".
This was responded to in an email (the author of which is not apparent) as follows:
"This matter is indeed due to be reviewed at the next meeting of the CDSG. Like you I think Mark's points move us towards a Doxy [Doxycycline] default but I would be very interested in Andy Green's take on this."
On 2 July 2011, Col Ross wrote:
"I think you all know my view because I made it clear in the last Med FP report that there would be significant benefits in changing to Doxycycline, which Mark has reiterated in his comments."
"There has only been one reported case of Helmand fever in the US Forces – this patient had not been taking his anti-malarial prophylaxis (Doxycycline)."
The trial before, and judgment of, HHJ Baucher
"In the light of this material, the Defendant had to give careful consideration to any change of policy. Given those factors and the complete lack of evidence that Doxycycline worked as a prophylaxis for Q fever, coupled with the attendant problems of tolerability of the drug I find that the Defendant was entitled to keep to its existing regime. It was not required to change its chemoprophylaxis and did not fail in its duty of care to the Claimant."
The arguments on this appeal
i) The territorial application of the MHSWR;
ii) The learned judge's approach to risk assessment and whether she should have found breach of duty;
iii) The approach of the judge to tolerability;
iv) Whether the Claimant would have been compliant with a regimen of Doxycycline chemoprophylaxis;
v) Whether Doxycycline would have been effective to prevent contraction of Q fever;
vi) Whether Doxycycline would have been effective to prevent chronic fatigue syndrome.
Permission to Appeal
Issue 1: The territorial application of the MHSWR
(1) The prescribed provisions of the 1974 Act shall, to the extent specified in the following articles of this Order, apply to and in relation to the premises and activities outside Great Britain which are so specified as those provisions apply within Great Britain.
(2) The reference in paragraph 1 of this article to premises and activities includes a reference to any person, article or substance on those premises or engaged in, or, as the case may be, used or for use in connection with any such activity, but does not include a reference to an aircraft which is airborne."
None of the articles then referred to could be treated as extending the application of the Regulations to the Claimant's work in Afghanistan. Regulation 23 of the MHSWR provides that the MHSWR:
"shall, subject to Regulation 2, apply to and in relation to the premises and activities outside Great Britain to which sections 1 – 59 and 80 – 82 of the Health and Safety at Work Act 1974 apply by virtue of the [2001] Order."
"It is important to recognise that we are being asked to authorise an extension of the law of negligence (as indeed of Article 2) into a new field. We have not been referred to any authority in the higher courts in this country or any comparable jurisdiction, in which the State has been held liable for any injuries sustained by its own soldiers in the course of active hostilities. Further we are concerned only with duties at common law rather than under statute. As the Court of Appeal recognised, para. 38, statutory regulations governing the responsibilities of the Ministry as employers do not apply outside the United Kingdom."
The reference by Lord Carnwath to paragraph 38 is to the judgment of Moses LJ in the court below where he had said:
"38. It is beyond dispute, and the MOD did not purport to dispute, that it owed a duty of care at common law to members of the armed forces as their employer. Nor was it disputed that health and safety provisions contained in sections 2–4 and 6–7 of the Health and Safety Act at Work 1974 and in regulations made under section 15 imposed statutory duties on the MOD. For example, it is required to secure suitable personal protective clothing and adequate information, instruction and training about such equipment under the Personal Protective Equipment at Work Regulations 1992 (SI 1992/2966) to construct or adapt work equipment so that it is fit for purpose under the Provision and Use of Work Equipment Regulations 1998 (SI 1998/2306), to make a suitable and sufficient assessment of risks to health and safety, and to secure adequate health and safety training on recruitment, or when exposed to new or increased risks, under the Management of Health and Safety at Work Regulations 1999 (SI 1999/3242). The territorial scope of those regulations is limited to Great Britain: section 84(1), extended to Northern Ireland by Order in Council under section 84(3) of the 1974 Act."
Mr Collins submits that the force of the dictum by Lord Carnwath is not detracted from by the fact that, in relation to the duty under common law, his was a dissenting judgment. Clearly, it is only obiter dictum though: it was no necessary part of the decision of the Supreme Court to determine whether the Regulations did or did not apply.
"24. … The effect of Regulation 23 and the 2001 Order is to exclude work activities outside the UK. I do not consider that the Regulations have any application to this case. I'm satisfied the duty I have to consider is the common law duty of care."
I agree with the learned judge. In my judgment were it otherwise the courts would be faced with the impossible task of distinguishing between decisions concerning the activities of soldiers serving abroad which, although equally affecting their health and safety, might be made in this country or in the theatre of deployment. It seems to me that, as submitted by Mr Collins QC, the clue lies in the word "activities". Where soldiers are deployed abroad, those activities are extra-territorial and this provides an umbrella of protection from the applicability of the Regulations relating to those activities and to decisions taken by the employer in relation to those activities, wherever those decisions are made. In the circumstances I agree with Judge Baucher that we are concerned only with the Defendant's duty at common law and I am comforted by the thought that this appears to be consistent with the view of Lord Carnwath.
Issue 2: The learned judge's approach to risk assessment and whether she should have found breach of duty
"Both experts agreed it was foreseeable and RHB [Professor Behrens] pointed out that the Medical Intelligence Assessment for Afghanistan carried out in 2005 described the risk of infection with Q fever."
This was also a concession made by the Defendant at paragraph 10 of the opening skeleton argument for the trial below.
"From these authorities I deduce the principles, that the overall test is still the conduct of the reasonable and prudent employer, taking positive thought for the safety of his workers in the light of what he knows or ought to know; where there is a recognised and general practice which has been followed for a substantial period in similar circumstances without mishap, he is entitled to follow it, unless in the light of common sense or newer knowledge it is clearly bad; but, where there is developing knowledge, he must keep reasonably abreast of it and not be too slow to apply it; and where he has in fact greater than average knowledge of the risks, he may thereby obliged to take more than the average or standard precautions. He must weigh up the risk in terms of the likelihood of injury occurring and the potential consequences if it does; he must balance against this the probable effectiveness of the precautions that can be taken to meet it and the expense and inconvenience they involve. If he is found to have fallen below the standard to be properly expected of a reasonable and prudent employer in these respects, he is negligent."
The Claimant's arguments in the court below
"an obvious and reasonable step for the Defendant to prescribe Doxycycline prophylactically upon deployment and warn/advise/instruct the Claimant and colleagues to adhere to the prescription in precisely the way done to combat the risk of malaria infection, but in fact with far better prospect of general compliance."
The Defendant's arguments in the court below
"It was a challenging job. There was a significant amount of uncertainty as to some of the hazards that were being assessed. There wasn't a lot of information … it was a new deployment. This was a difficult process. We used baseline assessments from previous countries. Intelligence and information, medical information from either a war-torn country or a developing country is very hard to get hold of, particularly around disease."
It was submitted that other diseases were rightly categorised as presenting a higher level of risk, and in particular malaria. The Helmand fever study had not estimated the prevalence of the disease stating only that "a sero-epidemiological study is required to estimate the true burden of the diseases": the study had identified only six cases of Q fever over a six-month period. It was submitted that: "It was wholly impossible for the Defendants to do more, when assessing the risk of Q fever, than recognise that troops were at risk but that the risk of infection was relatively low, and the risk that any such infection would lead to serious consequences was itself relatively low."
It was submitted that the emphasis by Gp Capt. Green on malaria prophylaxis was wholly appropriate: this disease being a significant threat, there having been over 600 cases of malaria in NATO forces by 2011. Gp Capt. Green said in evidence:
"The primary role or the reason for giving malaria prophylaxis is to prevent malaria as a disease, and I think, as this attached paper from Lt Col Hennessey also describes, it was clearly a policy which was working because there had been zero cases in British troops the year before, in contrast to, as we've already said, a large number of other NATO forces who had significant numbers of malaria cases."
Gp Capt. Green also noted that malaria was more common in US troops who were taking Doxycycline prophylaxis.
The Judgment of HHJ Baucher
"I consider that when the MIA is considered in the context of other diseases that the risk was indeed 'low' and Professor Behrens' identification of it as such was therefore a fair assessment. Indeed it is reflected by the evidence."
"He was certainly not suggesting, as Dr Healy asserted, that it was his opinion that a change should be made."
"111. If the Defendant had been ignoring risks or not giving proper credence to such then I consider it could have ignored the Helmand study. However, I find rather than simply doing nothing, as Mr Huckle contends, the Defendant gave due consideration to the paper and reflected upon the risk. In my view that reflection was shown in the Medical Force Protection Audits of 2009 and 2010."
"There can be no doubt that the CDSG did so in the knowledge that the alternative regime may provide some protection against Rickettsial disease."
She rejected the suggestion that the CDSG had considered matters in a vacuum on the basis that it knew the ambit of the research and the discussion which had preceded the referral to it. The conclusion of the CDSG had been that the present regimen should continue unchanged for the present, "Since there was no evidence that it was failing to protect against malaria". Gp Capt. Green had said that the Defendant was following national policy in relation to malaria prophylaxis and took the view that, "to change away from national policy would require compelling evidence".
"However Col Ross was at pains to point out he specifically referred to the Kenya study because albeit that was looking at another chemoprophylaxis regime for malaria the question of side effects was a significant matter. His evidence confirmed that the Defendant was weighing up and considering the risks."
The learned judge referred to the meeting of the Infectious Disease Working Group in August 2011 and the decision that the consultant physician would approach Gp Capt. Green with reference to anti-malaria prophylaxis being changed to Doxycycline. She referred to Gp Capt. Green's evidence that all the personnel who were part of the working group were deployed in Afghanistan and based at Camp Bastion. Whilst the implication might well have been that Doxycycline was working in the US forces, he said they only had a small perspective based on their observations at the camp and had little understanding of the wider picture and whilst there was a reference to no reported cases in US troops he did not know if the US was even examining for Q fever at the time. This was evidence which the learned judge accepted and she considered that the Defendant was entitled to consider such in the context of the wider picture which included the further sub issues of size, nature of the risk, effectiveness and tolerability.
"147. I am satisfied the Defendant was required to identify the potential risk of Q fever. A review of the entirety of the documents and the evidence shows it did so albeit that the focus was principally on malaria. The risk of Q fever was low. I refute the contention there was sufficient data upon which the Defendant could have taken an alternative view. There was no evidence that suggests the risk changed by the time of the Claimant's deployment. I accept there will always be a time when more data could assist but even in 2014 when the Newman study was published there was a recommendation for the need for further research."
She concluded that she was satisfied that the Defendant considered the risk of Q fever, that it appropriately assessed the level of the risk and its consequences. On that basis she identified the crucial issue as being whether the Defendant's response to that risk was reasonable.
"Given the reference to the prevalence of malaria in Afghanistan in the Wallis and Hennessey papers and its incidence in other forces I consider the Defendant was right to have regard to the risk. Professor Bailey considered that the risk was overstated in the Helmand Province, but he did not advocate a change of chemoprophylaxis policy but just that change be considered. The Defendant was aware that when the US was in Iraq, they had seen cases of malaria when using Doxycycline. Gp Capt. Green referred in his evidence to 50 reported cases of malaria in 2010 amongst NATO personnel in Afghanistan most of whom were Americans taking Doxycycline prophylaxis. Professor Bailey said that he thought the US had seen few, if any, cases in Afghanistan but that they still have a significant rate of seroconversion suggesting exposure or infection that did not present as symptoms or did not present for treatment. In the light of this material the Defendant had to give careful consideration to any change of policy. Given those factors and the complete lack of evidence that Doxycycline worked as a prophylaxis for Q fever, coupled with the attendant problems of tolerability of the drug I find that the Defendant was entitled to keep to its existing regime. It was not required to change its chemoprophylaxis and did not fail in its duty of care to the Claimant."
The Claimant's arguments on this appeal
The Defendant's arguments on this appeal
"But I do not say 'would', and I remember writing this sentence and pondering on that word and I did not [write] 'would', and I wanted to create the impression that it could work, that it might be a possibility, but I knew the evidence for it was limited and I did not want to overstate what I was saying so I put 'could'. This was then reviewed by senior authors and this is what we submitted."
Mr Collins referred to the evidence of Gp Capt. Green where he gave similar evidence in re-examination:
"There was no conclusion as to its efficacy at all. The 'could' implies a suggestion of a possibility, rather than a recommended course of action."
Referred to the conclusions of the study he said that what was being stated was that prophylaxis with Doxycycline and possibly Q fever vaccine should be considered, no more than that. Mr Collins also referred to the evidence of Lt Col Bailey where he referred to the small quantity of data relied on. Asked by Mr Collins whether it is an unusual situation for clinicians and advisors to be working on small amounts of data he said:
"Your Honour, I think that's correct for when you're making decisions that affect one or two patients, and certainly I think the small amount of data I generated was enough to change our clinical policy for the number of patients coming through. But then to take those findings and apply them to 10,000 troops deploying twice a year to Afghanistan is an extrapolation that experts in public health need to look at … my perspective is of seeing the patients and of being aware of some quite severe cases and more frequent cases. So obviously I'm particularly interested in trying to prevent these cases but I have different perspective, a restricted view of the overall situation."
Thus, Mr Collins submitted that the evidence of Lt Col Bailey and in particular what he was saying in the various documents and emails in 2010 and 2011 needs to be looked at in that context: the decision of risk assessment and prophylaxis for 20,000 troops a year was more of a wider public health decision, whilst taking into account Lt Col Bailey's more limited perspective from treating those patients who contracted the disease.
"Yes, he was certainly suggesting that it was his opinion that the change should be made, but also eager to point out that it wasn't his ultimate decision. That's how I read the evidence."
Mr Collins submitted that it was simply impossible to understand how Dr Healy could have continued to insist on this view of Lt Col Bailey's position when Lt Col Bailey had made it crystal clear, time and again, that this was not in fact his position. He submitted, as he submitted to the court below, that this was an example of Dr Healy being unable to acknowledge that his approach had been shown to be wrong, compromising his position as an independent witness.
"So in public health, clearly when you introduce an intervention, you have to weigh up whether it is going to cause more harm than good and the benefit of that intervention, and in some of the discussions, whilst I've been an advocate, shall we say, for thinking of using Doxycycline as the alternative to Chloroquine and Proguanil, I then considered the significant side effects may be more significant with Doxycycline, which we heard about from Lt Col Bailey in terms of the different Doxycycline preparations which were available, and the one we had available in the UK to us was the one that was more likely to cause gastro or intestinal side effects and other side effects."
She said that this was referred to by her when she referred to the malaria study in Kenya which was addressing the issue of side effects. Mr Huckle put to her that it was always a trade-off in considering the prescription of any drug whether its prophylactic benefits outweighed the potential side effects and non-tolerance with which she agreed. He put that her expression of view in the email of 2 July 2011 was pretty clear to which she responded:
"… as a public health physician, I have to then go and look for the evidence, and I may try to advocate, whether it be for the clinician or the patient, to see whether we ought to introduce a new, different intervention. At the time I was taken, following my first audit and discussion whilst I was in theatre, that there might be benefits from using Doxycycline to perhaps prevent other Rickettsial type illnesses and sandfly fever. What I didn't have at that time which is why I asked for a review certainly in the second audit, was the evidence to support my own personal opinion as opposed to the scientific evidence which was in the community."
Relying on this and the other evidence, Mr Collins submitted that what this revealed was in fact a good process of risk assessment whereby concerns were listened to, were considered and eventually were rejected for good reasons.
Discussion
"89. The importance of a suitable and sufficient risk assessment was explained by the Court of Appeal in Allison v London Underground Ltd [2008] ICR 719. Smith LJ observed at para. 58 that insufficient judicial attention has been given to risk assessments in the years since the duty to conduct them was first introduced. She suggested that was because judges recognised that a failure to carry out a sufficient and suitable risk assessment was never the direct cause of an injury: the inadequacy of a risk assessment could only ever be an indirect cause. Judicial decisions had tended to focus on the breach of duty which led directly to the injury. But to focus on the adequacy of the precautions actually taken without first considering the adequacy of the risk assessment was, she suggested, putting the cart before the horse. Risk assessments were meant to be an exercise by which the employer examined and evaluated all the risks entailed in his operations and took steps to remove or minimise those risks. They should, she said, be a blueprint for action. She added at para. 59, cited by the Lord Ordinary in the present case, that the most logical way to approach a question as to the adequacy of the precautions taken by the employer was through a consideration of the suitability and sufficiency of the risk assessment. We respectfully agree."
Thus far, the parties and the judge below were in full agreement, as am I.
"My Lord, I think my answer to that is I can see how one might think there would be a danger, but the danger should be dealt with in the process of risk assessment and the steps appropriate to take to meet such risks that are identified and assessed.
Mr Justice Martin Spencer: But you can't assess one particular disease in isolation can you?
Mr Huckle: I don't think you can, no, and in fact it is part of our very case, of course, as my learned friend relies upon this, that Dr Healy was prepared to concede that if one was only looking at the question of Q fever, would one start Doxycycline prophylaxis just to deal with that? His conclusion was that no-one would have on the information that was then available. But the point here was that bearing in the mind that there was already a regime, if you like, of anti-malaria prophylaxis, and bearing in mind that a relatively small and cost-effective change of that regime would also have dealt with the risk of the Rickettsials, as we say was the case with other Allied Forces, then it was a reasonable step to take."
The effect of this was that it was conceded that it was not incumbent on the Defendant to consider the risk of Q fever in isolation and that Doxycycline would not be independently prescribed as chemoprophylaxis for Q fever, without reference to the other risks. In my judgment, this concession is highly significant. In the end, the Defendant was principally concerned with malarial prophylaxis and the issue was whether it should have changed its malarial prophylaxis to take account of the risk of the Helmand fevers including Q fever. But given that the priority for the Defendant was malaria prophylaxis, and it is conceded that the Defendant was entitled to prioritise malaria prophylaxis, in my judgment the Defendant was entitled to take as its starting point the fact that the existing regime of prophylaxis for malaria was apparently effective. The burden was thus on anyone advocating change of regime to justify that change principally in terms of malaria prevention. The Defendant was, in my judgment, fully entitled to take a cautious approach and wait for the evidence to be much more complete than it was in 2011 before taking such a significant step. The approach of Gp Capt. Green (and Air Cdre Walton) was just such a cautious one from a public health standpoint and in my judgment HHJ Baucher was correct to conclude that firstly there had been an appropriate risk assessment (the MIA of 2005), secondly that this assessment had been kept under review, and thirdly, that the Defendant was not in breach of duty in failing to carry out a full reassessment and change the regime of prophylaxis to Doxycycline. Instead, in keeping with its duty as an employer, the Defendant, through its medically qualified staff, left the position open for more evidence to emerge before taking such a radical step as to change the chemoprophylaxis regime for malaria for 20,000 troops every year.
Issue 3: The approach of the judge to tolerability
"When assessing the appropriateness of a change of chemoprophylaxis to Doxycycline, tolerability was inevitably an appropriate matter for the Respondent to have regard, because a soldier who does not tolerate the drug may either become ill as a consequence of it, or may choose not to take it, hence becoming at risk of infection."
For the Appellant, Mr Huckle submitted that, in relation to breach of duty, tolerability was rightly characterised in the court below as a, "red herring". He submits that the judge's review of this question from paragraph 172 of her judgment is a, "flawed attempt to justify a decision that the Respondent never took". The learned judge is criticised for asking herself the wrong question, namely would it have been reasonable decision for the MOD to choose the existing regime of Chloroquine and Proguanil ("CQPG") as its malarial chemoprophylaxis over Doxycycline on grounds of tolerability. He submitted, "In this the judge makes the same error as did the Respondent, namely approaching the matter as primarily one of anti-malaria chemoprophylaxis it being an assumed given (despite the contentions of Lt Col Bailey and others to the contrary) that malaria required to be guarded against in the Herrick 15 deployment. The correct question was: Would it have been a reasonable step to protect the men against the identified risk of contraction/development of QF/QFCFS to prescribe them Doxycycline as chemoprophylaxis? The correct question allows a proper appreciation of the absolute risks of non-tolerance of Doxycycline."
"When considering a change of regime Col Ross said that in public health 'When you introduce an intervention you have to weigh up whether it is going to do more harm than good and the benefit of that intervention and in some of the discussions whilst I had been an advocate for thinking of using Doxycycline as the alternative to Chloroquine and Proguanil I then considered the significant side effects may be more significant with Doxycycline … the one we had available in the UK was the one that was more likely to cause gastro-intestinal side effects and other side effects.' He said that as a public health physician he needed to consider the evidence. I do not accept Mr Huckle's assertion that, 'tolerability is a red herring'. I consider the Defendant was entitled to have regard to the tolerability of Doxycycline."
On this basis, it would appear that tolerability did form part of the Defendant's decision.
"177. I consider the paper by Saunders published in 2015 provides the most assistance when considering the question of tolerability."
However, this was not a paper which was available to the Defendant at the relevant time. It would certainly be relevant to questions of causation, namely, had the Defendant changed its chemoprophylaxis to Doxycycline, whether the new regime would have been effective but that was not the context in which the expert evidence and the various studies and papers referred to by the experts was being considered. In that regard, to a certain extent, I agree with Mr Huckle that in relation to breach of duty, much of the evidence on tolerability was indeed something of a red herring. In my judgment, though, questions of tolerability were ones which the Defendant was entitled to take into account in considering any change of regime and appear to have formed part of the reasoning for not changing the regime as reflected in the evidence of Col Ross referred to by the learned judge. It is enough that there was material in existence at the relevant time, 2011, for questions of tolerability to play at least some part in the decision made by the Defendant. At paragraph 181 the learned judge said:
"In the light of this material the Defendant had to give careful consideration to any change of policy. Given those factors and the complete lack of evidence that Doxycycline worked as a prophylaxis for Q fever, coupled with the attendant problems of tolerability of the drug I find the Defendant was entitled to keep to its existing regime. It was not required to change its chemoprophylaxis and did not fail in its duty of care to the Claimant."
Issue 4: Whether the Claimant would have been compliant with a regimen of Doxycycline chemoprophylaxis
"However there is all the difference in the world between taking something that you are prescribed when you are ill and taking something as a preventative measure."
The learned judge said that the only objective evidence gainsays the Claimant's evidence, the objective evidence being the medical record for 2012 and the audit of the Claimant's own tour which showed that 71% did not take the malaria prophylaxis prescribed for them.
i) The Claimant did not take CQPG as instructed but only 50% of the time;
ii) He complained of no side effects with CQPG so this was not the reason for his failure to take his medication. When he took Doxycycline (as treatment for Q fever) his reaction was worse not better than CQPG so side effects would have made him less compliant not more compliant in the case of Doxycycline;
iii) The Claimant's understanding of the risk of malaria was that it was at least as serious as he now knows Q fever to be – he recognised it to be potentially fatal; and
iv) In fact he understood little of the risks but simply accepted he had been told to take the medication.
In the light of those matters, Mr Collins submitted that the judge's conclusion was all but inevitable and it is now impossible for the Appellant to show that it was "wrong". He submits that the submissions on behalf of the Appellant amount to "an attempt to circumvent the Appellant's own evidence."
Issues (v) and (vi): Whether Doxycycline would have been effective to prevent contraction of Q fever and/or QFCFS;
Note 1 Rickettsial disease appears to be used as a generic term to cover all the Helmand fevers, including Q Fever. [Back]