Gocher and Comcare (Compensation)

[2018] AATA 3617

Gocher and Comcare (Compensation) [2018] AATA 3617 (24 September 2018)

Division:GENERAL DIVISION

File Number:           2017/0591

Re:Keva Gocher

APPLICANT

AndComcare

RESPONDENT

DECISION

Tribunal:Deputy President Rayment QC

Date:24 September 2018

Place:Sydney

The reviewable decision is set aside and the matter is remitted to Comcare to reassess the entitlements of Ms Gocher for incapacity under s 19 of the Safety, Rehabilitation and Compensation Act 1988 and to medical treatment under s 16 with effect from the date on which Comcare discontinued payments. The respondent is to pay the costs of the applicant, to be taxed failing agreement as to their amount.

....................................[SGD]....................................

Deputy President Rayment QC

CATCHWORDS

COMPENSATION – workers’ compensation – poisoning by bacterial vaccines – Q fever –applicant held to suffer from chronic fatigue syndrome – whether there is a causal link between chronic fatigue syndrome and Q fever – causal link established – reviewable decision is set aside and remitted to respondent for reassessment of applicant’s entitlements – cost order

LEGISLATION

Safety, Rehabilitation and Compensation Act 1988, ss 16, 19

SECONDARY MATERIALS

World Health Organisation, Causality assessment of an adverse event following immunization (AEFI): User manual for the revised WHO AEFI causality assessment classification (World Health Organisation, Geneva, 2018)

REASONS FOR DECISION

Deputy President Rayment QC

24 September 2018

BACKGROUND

1. Ms Keva Gocher has been employed by the ABC since 1992. As a senior rural reporter, she was stationed in Bega and travelled for the ABC in and around Bega and to a wide part of southern NSW and other parts of NSW and Victoria. As part of her duties, she was exposed to farming regions in the primary industry, including work with animals. She was at risk of exposure to Q fever at sites she visited.

2. The ABC decided to recommend that its staff who attended high risk sites be vaccinated against Q fever at their employer’s expense. Ms Gocher undertook the vaccination procedure in 2012. Vaccination involved a blood test, and later a skin test using a 0.1ml dose of vaccine administered by a syringe to see if there is any adverse reaction. If not, then the full dose of 0.5 ml of vaccine would be administered one week later.

3. In the case of Ms Gocher, the blood test did not indicate that she had Q fever, and the skin test was performed. She had an adverse reaction, and the manufacturer’s instructions suggested that the skin test be re-administered where the blood test had been clear and there had been a reaction to the first skin test. She had a severe reaction to the second skin test, and her case is that she still experiences debilitating symptoms, including chronic fatigue syndrome (CFS), after six years up to the present day. Those symptoms produce incapacity for work. Apart from a short time when she underwent a return to work trial, she has not worked since 2012 and still does not work.

4. Dr Oakley who administered the test dose wrote a report of 28 September 2017 which included the following information:

   1.   Ms Gocher sought Q Fever vaccination in June 2012 and was given an appointment with me on 12^th July 2012. She was employed by the local ABC Radio Station as their rural reporter and, as part of her job, would visit local farms at times. She was a (sic) risk of contracting Q Fever as part of her work activities. She advised me that the ABC now required staff at occupational risk of acquiring Q Fever to be vaccinated.

   Ms Gocher was a regular patient of the practice since 1993 and was normally cared for by Dr John Marshman. I was the only doctor in the practice trained to carry out pre-vaccination screening for Q Fever and so she came to see me for this.

   As you would have noted from the Q-Vax Vaccine and Skin Test Product Information sheet, severe hypersensitivity reactions can happen if people with past exposure to Q Fever (whether by natural infection or immunization) are vaccinated against it. Consequently vaccination is not carried out in these situations and special assessment, to try and determine possible past exposure or sensitivity, is required for everyone prior to vaccination. Current assessment methods are not guaranteed to pick up ail cases of past exposure and so despite negative assessments, some people vaccinated for Q Fever may have significant reactions.

   At the consultation with Ms Gocher on 2nd July 2017, I gave her information about Q Fever infection and possible sequelae and the pre-vaccination assessment. I received from her a history of no know exposure to G Fever. She was given the routine Q Fever prevaccination skin test as an intradermal injection in the forearm of 0.1ml diluted Q-Vax Skin Test solution (16.7ng of antigen) and referred to the Bega Capital Pathology practice for a blood test for Q Fever Antibodies. She signed the usual medical information and consent form (attached).

   On routine review 1 week later, on 9th July 2012, her antibody blood test was negative and her skin test was assessed as borderline (just detectable induration). Vaccination could not proceed immediately as both tests were not negative. In this situation, l referred to my Q Fever clinical handbook, "A guide to Q fever and Q fever vaccination" CSL Biotherapies 2009, Editor Prof, Barrie P Marmion AO. Two possible courses of action were recommended here: either repeat the skin test and have a follow up specific blood test 2 weeks later or give a one fifth dose of Q Fever vaccine and assess for any adverse reaction 48 hours later (page attached). These were discussed with Ms Gocher and in view of the shorter time frame of the latter, it was decided together that she would have the test dose of vaccine.

   She was then given 0.1ml subcutaneous injection left deltoid area of Q-Vax solution, batch 0980-08001, expiry 8/13 (the vaccination dose being 0,5ml of this solution).

   Ms Gocher was reviewed 48 hours later, on 11th July 2012. The vaccination site was examined and appeared normal, with no sign of any reaction at all - no tenderness, induration, heat or redness. She did report symptoms of aching around the vaccination site, starting the previous day. She also reported experiencing some fever, rigors and headache the previous day. These were assessed as being a generalised reaction to the test dose of Q Fever vaccine of moderate severity, indicating past exposure to Q Fever. I advised that full vaccination was contraindicated and gave Ms Gocher a medical certificate to this effect (attached). It was expected that the symptoms experienced would gradually resolved over days and would be managed with symptomatic treatment (eg paracetamol and rest as required).

   Ms Gocher continued under the care of Dr Marshman and l did not see her again in relation to Q Fever

5. Professor Andrew Lloyd, a consultant infectious diseases physician, assessed Ms Gocher as suffering from chronic fatigue and pain syndrome triggered by Q fever vaccination and that her reaction to the vaccination is a rare but well recognised complication of the vaccine. Professor Lloyd has a particular clinical and research interest in the immunological basis of infection outcomes, including post-infective fatigue states. Over several decades, he has led a research program studying the pathogenesis of chronic fatigue syndrome. He was the primary author of the clinical practice guidelines for that syndrome, prepared by an expert group convene by the Royal Australasian College of Physicians and distributed to all Australian medical practitioners in 2002. He provides general practitioners with advice by phone on Q fever immunisation and reviewed Ms Gocher on three occasions at the request of her general practitioner, to whom he had previously provided advice by phone concerning her treatment.

6. There is no dispute in this case between the two expert witnesses, Professor Lloyd and his colleague at the University of New South Wales, Professor Carr, who is a clinical immunologist, that Ms Gocher suffers from chronic fatigue syndrome, nor, I think that she has no capacity for work at the present time or for the foreseeable future. Her history has been one of very slow improvement. Her return to work trial was unsuccessful. I accept Ms Gocher’s evidence to the effect that she attributes her inability to work to the CFS and the various symptoms from which she suffered as a result of the vaccination she had. I reject the suggestion put to her in cross-examination that her failure to go back to work was motivated by her desire to avoid working under a supervisor with whom she had difficulty. She believed that she would no longer be dealing with him. More to the point, her CFS prevented her return to work and still does so. The issue which these reasons resolve is whether the CFS was caused by the vaccination which she received.

7. Mr Gollan of counsel, who appeared for Comcare, challenged the chronic fatigue syndrome diagnosis and referred to the report of Dr Gorman, which had been relied upon by Comcare in making the reviewable decision. Dr Gorman’s report dated 21 June 2016 is within the s 37 documents. He is a consultant general physician, a pain management specialist and a medical oncologist. Dr Gorman expressed doubt about the continuing effect upon Ms Gocher of the Q fever trial vaccination, stating that he could not relate, on the balance of probabilities, her current status to the Q fever vaccination. He thought that the current condition was “more likely a ‘chronic pain condition’ with marked inactivity and deconditioning, a depressed mood and sleep disturbance.” He thought that after rehabilitation, including aerobic exercise, she might return to work, although since the passage of four years, the prognosis was poor. He thought her main problem was one of motivation. He was made aware before his second report of 9 September 2016, of views expressed by Professor Lloyd to the general practitioner, and maintained his opinion that the main problem was lack of motivation.

8. Ms Gocher had been taking OxyContin for her back pain over a number of years. That drug was apparently effective in managing the back pain, as Professor Lloyd observed. That is so even if the dose was increased somewhat because she was able to continue working with the dose she took, even if it was increased somewhat. Ms Gocher recollected that changes to the formulation of the OxyContin produced the increased dose, but the respondent tendered evidence suggesting that Ms Gocher’s recollection is wrong as to the relevant dates.

9. Ms Gocher’s back pain was and continued to be well managed with medication, and even if the dose was increased, that continued to be the case. It was localised and after the vaccination, the pain experienced by Ms Gocher was generalised throughout her body.

   EVIDENCE OF PROFESSOR LLOYD AND PROFESSOR CARR

10. On the question whether Ms Gocher suffers from chronic pain syndrome, I prefer the evidence of Professor Lloyd and Professor Carr, both of whom have extensive experience in treating patients with chronic fatigue syndrome. Both professors had read the reports of Dr Gorman. Professor Lloyd was critical of a number of statements made by Dr Gorman in his reports in support of the view expressed by him that the immunisation probably did not produce her current symptoms. As to the question of causation of the chronic fatigue syndrome, that matter is most reliably resolved, in my opinion, by considering the more detailed evidence given in writing and orally by the professors, including in joint session.

11. When asked by Comcare whether in his opinion, the conditions suffered by Ms Gocher were triggered, caused or contributed to by the Q fever vaccination, Professor Carr said that one cannot be absolute on this issue. He said that for three reasons he did not believe, on balance, that she suffers from a Q-vax-induced illness. The reasons nominated were that her fatigue and pain were present one month before the vaccination, she only received a test dose of the vaccine (and adverse events after Q-vax are not reported in the literature after the one-fifth vaccination dose), and the medical literature does not suggest that the rate of chronic fatigue syndrome (CFS) suffered by those who received Q-vax is higher than those in the general population.

12. As to each of those matters, taking them in the same order, Professor Lloyd says that it should be acknowledged that Ms Gocher did report “stress” associated with workplace issues prior to the immunisation, and did have pre-existing well managed chronic back pain, and did report symptoms of pain and fatigue to her GP in June 2012, but she did not have any significant functional impairment prior to the immunisation evidenced by the lack of repeated or prolonged workplace absences (sick leave) over several years prior to the immunisation.

13. The second and third matters referred to by Professor Carr depend on the rarity of the symptoms suffered by Ms Gocher. Professor Lloyd points out that the confidence levels surrounding the incidence of CFS in the general population and those who have had Q fever vaccination make the comparison meaningless. Secondly, he suggests that the matter is resolved not by considering a comparison of the apparent incidence of CFS in those who have had, and those who have not had Q fever vaccination, but rather by considering this case. In that regard, he had regard to two matters, namely guidelines for the assessment and designation of fatigue states after immunisation, and secondly to guidelines for causality assessment of adverse events following immunisation. As to the first, he said that the evidence in this case indicates that a well-characterised CFS has been diagnosed. The available data makes this designation level 1b – that is, a high level of diagnostic certainty.

14. The World Health Organisation AEFI (adverse events following immunisation) guidelines for causality assessment direct attention to four matters: temporal relationship; populations-based evidence for causality; biological plausibility and consideration of alternative explanations. Professor Lloyd pointed out that those guidelines were promulgated because Q fever vaccine is licensed only in Australia and randomised control groups (cohort groups) were not available for use. The event rate for CFS following Q fever vaccination is very low. Professor Lloyd, who provides an advice service to GPs and information to CSL, the drug manufacturer, has encountered CFS in only three or four cases to date, although he receives calls at the rate of about 10 a year for the last two decades. That does not produce enough data for a numerical estimate to be made, hence the WHO guidelines. Professor Carr does not treat patients with adverse reactions to Q fever, whereas Professor Lloyd does so, and has a reputation as Australia’s Q fever expert.

15. He said in his written report as to these matters:

    With regard to these considerations in this case: firstly, there is a very close temporal relationship demarcating prior essentially good health from the subsequent CFS via the Q fever vaccination, which was followed with onset of symptoms within 24 hours and subsequent persistence without symptom-free interval to the present. Secondly, there is limited but recognised population-level evidence in that such adverse events are recognised to occur (rarely) after Q-Vax immunisation. Thirdly, there is biological plausibility in that CFS is a well-recognised sequel of actual Q fever infection, and that such post Q fever fatigue syndromes are not attributable to ongoing active infection, but are strongly predicted by the severity of the acute illness manifestations, which in turn are immunologically-mediated.^vii,viii In this regard Q-Vax is a killed, whole, Coxeilla burnetii organism (Phase I) vaccine, which provides protection via an immune response closely akin to the natural infection. Fourth, consideration of alternative possibilities is intrinsic to the diagnostic evaluation for CFS. Application of the recommended algorithm indicates that this case meets the criteria for a “consistent causal association to immunisation”. Finally, as a fundamental feature of the human immune system is that immune responses following previous exposure become exquisitely sensitive to even very low dose re­exposure, the notion that the ‘one-fifth’ dosage should not cause the adverse reaction cannot be sustained (if indeed the reaction is immunologically mediated and occurs in those with unsuspected prior exposure).

16. Professor Carr responded to these four matters as follows in his report of 8 February 2018:

    Temporal relationship

    Professor Lloyd notes a temporal relationship between the vaccine and the chronic fatigue, and so concludes that her chronic fatigue is due to the vaccine. Putting aside the fact that her symptoms preceded the vaccine, and that the initial work certificate was for "work stress", it is essential to clarify that a temporal relationship in no way constitutes proof of causality. Let me provide two (somewhat extreme) examples:

    1.Every patient who develops cancer has drunk water and breathed air – that in no way means that the air or water caused the cancer.

    2.A very serious and very real illustration of a mistaken attribution of illness to a vaccine was the "relationship" found between MMR vaccine and autism (Wakefield AJ, et al. ileal-lymphoid-noduiar hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998; 351: 637-41). This false association was a result of people finding what they wanted to find. The paper was subsequently retracted 12 years later, but not before it had resulted in a huge downturn in MMR vaccination rates globally and caused great harm to public health.

    The only way to attribute causality is from a series of prospective, randomized trials showing a consistently greater rate of a given outcome in those who received a given agent (drug, vaccine, etc.) compared to those who did not. Such data do not exist for Q-Vax. This is strongly affirmed in the guidelines for evaluating levels of evidence and subsequent recommendations proposed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) working group. These are now the global standard ( evidence

    The best evidence (albeit fairly imperfect - see above) finds no excess of chronic fatigue in those who have received Q-Vax versus the general population. There are no data for the Q-Vax test dose.

    Biological plausibility

    Given that Chronic Fatigue Syndrome has no proven cause and no objective signs, no one can state at all that the temporal relationship is biologically plausible. Professor Lloyd notes that the vaccine derives from whole, killed organisms, and so might have produced an inflammatory reaction akin to a mild version of true Q fever infection. Indeed, many vaccine reactions are inflammatory in nature, but no local or systemic inflammation was found in Ms Gocher.

    Alternative explanations

    Professor Lloyd states the alternative explanations should be sought. I agree, and there are two alternatives: work stress, which was reported prior to the test dose; and depression, noted a few months after. Whether the depression relates to the work stress or the chronic fatigue or both has not been resolved.

17. The professors went through Ms Gocher’s GP records in joint session at my request. It was explained that “fatigue” referred to in those notes is not to be equated with CFS. I was told that “fatigue” accounts for some 20% of GP visits in Australia. Stress at work is a predictor for an anxiety disorder and the notes include references to panic attacks because of work stress, for which diazepam was prescribed. That was noted in Ms Gocher’s case in and after July 2012, and was the reason nominated for work absences for some months until later in the year, when reaction to the vaccination was the nominated cause. The professors were agreed that work stress did not cause CFS.

1. Professor Lloyd disagrees with Dr Gorman about the likelihood of Ms Gocher being able to return to work and was not supportive of her return to work trial. His planned approach was for her to get better symptom control and try to build her capacity in a structured out of work setting, before attempting such a thing. He recommends cognitive behavioural therapy, graded exercise therapy and cognitive exercise therapy. He said she had previously been exposed to Q fever at some stage in her life. He is confident that her CFS was triggered by the vaccination, while recognising that other possibilities are plausible.

2. Professor Lloyd said that it is not unknown for CFS to last longer than five years in infected persons, although in the majority of cases after infection, recovery takes place earlier. He considered that prior to the vaccination, her fatigue did not amount to CFS.

3. Dr Lloyd gave training to GPs vaccinating for Q fever and GPs are referred to him by the manufacturer, CSL. Professor Carr said that Professor Lloyd is a very well recognised expert in CFS and he himself has referred CFS patients to Professor Lloyd. Moreover, he is Australia’s expert in Q fever, and accordingly the views he expressed in this case are entitled to considerable weight.

4. Professor Lloyd said that persons suffering from Q fever are generally at one end of the spectrum and persons who suffer an adverse reaction to vaccination are generally at the other end, but that the two are reasonable comparators. Those requiring hospitalisation for Q fever had a 200-fold higher risk of having CFS at the 6 month period.

5. Cross-examined carefully by Mr Gollan, Professor Lloyd said that in terms of the fourth matter to which the World health Organisation AEFI guidelines mentioned in [14] above refer, the anxiety and depression from which Ms Gocher suffered can be seen to have fallen away.

6. Professor Lloyd rejected work stress as a cause of CFS and I did not understand Professor Carr to disagree. That removes the need further to consider its significance in the case.

7. As to biological plausibility, Professor Lloyd said that the analogy from that which is known from the more severe Q fever victims (namely a propensity to develop CFS) is plausible because the immune system treats them as similar. Professor Carr doubted whether it could be assumed that the immune system is sufficiently smart to make such an assertion.

8. I would summarise my appreciation of the effect of the evidence from the professors by saying that I prefer the evidence of Professor Lloyd, both because of his evident expertise in both relevant fields, that is CFS and Q fever, and because his chain of reasoning was more persuasive. This does not appear to be a field in which much objective data exists, a matter stressed by Professor Carr, and recognition of a causal link in the particular circumstances of Ms Gocher between the test vaccination and CFS is a matter on which I am satisfied to rely on Professor Lloyd’s evidence.

   DECISION

9. The reviewable decision will therefore be set aside, and the matter will be remitted to Comcare to reassess the entitlements of Ms Gocher for incapacity under s 19 of the Safety Rehabilitation and Compensation Act 1988 and to medical treatment under s 16 of the Act with effect from the date on which Comcare discontinued payments. It is appropriate to make an order for the payment of the applicant’s costs by Comcare, to be taxed failing agreement as to their amount.

I certify that the preceding 26 (twenty-six) paragraphs are a true copy of the reasons for the decision herein of Deputy President Rayment QC

...................................[SGD].....................................

Associate

Dated: 24 September 2018

Dates of hearing:	25-26 June 2018; 19 July 2018; 12 September 2018
Date final submissions received:	10 September 2018
Counsel for the Applicant:	Mr J Mrsic
Solicitors for the Applicant:	Carroll & O'Dea Lawyers
Counsel for the Respondent:	Mr M Gollan
Solicitors for the Respondent:	Lehmann Snell Lawyers