Tabart and Civil Aviation Safety Authority
[2018] AATA 2830
•24 May 2018
Tabart and Civil Aviation Safety Authority [2018] AATA 2830 (24 May 2018)
Division:GENERAL DIVISION
File Number(s): 2016/6660; 2017/5341
Re:Antony Tabart
APPLICANT
AndCivil Aviation Safety Authority
RESPONDENT
DECISION
Tribunal:Egon Fice, Senior Member
Dr A Reddy, MemberDate:24 May 2018
Place:Melbourne
The Tribunal affirms the decisions under review.
........[sgd]................................................................
Egon Fice, Senior Member
CIVIL AVIATION SAFETY AUTHORITY – eligibility for Class 2 medical certificate – one-off intraparenchymal haematoma (stroke) event – safety-relevant condition – percentage per annum risk of stroke recurrence – risk greater than 1% - Class 2 medical certificate issued with condition – decisions affirmed
Legislation
Civil Aviation Safety Regulations1998; Regs 11.015, 11.056, 61.065, 61.410, 67.015, 67.155, 67.180, 67.190, 67.255
Civil Aviation Act 1988; ss. 9A, 20AB
Cases
Boughey v The Queen (1986) 161 CLR 10
Tillmanns Butcheries Pty Ltd v Australasian Meat Industry Employees’ Union (1979) 27 ALR 367
Secondary Materials
Civil Aviation Order 95.4 Instrument 2011
REASONS FOR DECISION
Egon Fice, Senior Member
Dr A Reddy, Member24 May 2018
Mr Tabart holds a Private Pilot Licence. In order to do so, he is also required to hold a Class 2 medical certificate.
On 12 November 2014 Mr Tabart advised CASA, Aviation Medicine, that he had suffered an intraparenchymal haematoma (a stroke) on 7 October 2014. Mr Tabart said he has not experienced any long term deficits as a result of that episode. He has since been prescribed anti-hypertension medication - Amlodipine 10 mg daily.
A CT Scan report dated 8 October 2014 stated:
There is an intraparenchymal bleed noted in the right basal ganglia measuring about 24mm x 14mm and this reveals no interval change in size or extent since the previous scan.
Upon discharge from hospital, the Discharge Summary, dated 10 October 2014, states:
Intraparenchymal Haematoma: presented with symptoms of dysphagia [inability to swallow or difficulty in swallowing], left facial droop, left sided limb weakness and slurred speech. On initial examination he had normal power bilaterally, Normal sensory function to light touch, with downgoing planar reflexes. his [sic] CTB showed right Intraparenchymal Haematoma. He continued to be well on ward with only lingering neurological deficit a mild left facial droop. Serial CTB showed stable features radiologically.
In a letter dated 15 October 2014 addressed to Dr John Menzies (Mr Tabart’s general practitioner), Dr James Gome, a consultant physician and endocrinologist said:
No doubt you have received a copy of a discharge summary regarding Mr Tabart’s presentation to South West Healthcare with acute onset of haemorrhagic stroke affecting the right internal capsule region. This was managed with supportive care and pleasingly he has made a full neurological recovery.… No inpatient rehabilitation was required after comprehensive rehabilitation assessment. He will have an outpatient MRI and review with me to discuss the results in around six weeks time. This will have an impact on his ability to fly and he has been advised he should not be leading flights for the next twelve months and certainly not flying for the next three months. He will take this up further with his CASA physician who he sees in Geelong.
MATTER NUMBER 2016/6660
On 29 November 2014 Dr David Fitzgerald, consultant occupational physician, Aviation Medical Officer with CASA, wrote to Mr Tabart stating:
Having completed the assessment, it is my view that you are not able to be issued with the medical certificate. This is because of your history of stroke and risk of recurrence and adverse sequelae, which are assessed as being an unacceptable aviation safety risk.
Dr Fitzgerald also explained to Mr Tabart that it might be possible that there was some information which CASA had not considered or that had not been provided by his Designated Aviation Medical Examiner (DAME). He informed Mr Tabart that a medical assessment decision would be deferred for 30 days to allow him to make submissions and obtain other reports.
Mr Tabart responded to CASA in a letter dated 20 February 2015. In that letter, Mr Tabart referred to VicRoads guidelines allowing persons to drive a vehicle after one month following a stroke. VicRoads’ commercial standards state that a person should not drive for at least three months following a stroke. Mr Tabart referred to an article, although he did not say where it was published, which indicated cognitive decline represented a much higher accident risk than sudden physical incapacitation. He also referred to the CASA guidelines for DAMEs regarding recurrence of a neurological episode during the 12 month surveillance period. Mr Tabart said that he was taking medication to control his blood pressure; he was driving cars and operating machinery; and he was flying gliders.
In a letter dated 30 March 2015 CASA notified Mr Tabart that his Class 2 medical certificate was suspended until CASA obtained further information. After further consideration, in a letter dated 19 June 2015 CASA informed Mr Tabart that his Class 2 medical certificate was cancelled in accordance with Reg 67.255 of the Civil Aviation Safety Regulations 1988 (CASR). CASA provided detailed reasons for making that decision. Essentially, CASA said that Mr Tabart failed to meet Medical Standard 2 which must be met for the issue of the medical certificate. CASA referred to the following criteria regarding abnormalities, disabilities and functional capacity set out at Table 67.155 of the CASR:
2.1 Has no safety-relevant condition of any of the following kinds that produces any degree of functional incapacity or a risk of incapacitation:
(a)an abnormality;
(b)a disability or disease (active or latent);
(c)an injury;
(d)a sequela of an accident or a surgical operation
2.2 Has no physical conditions or limitations that are safety-relevant
…
2.7 Has no established medical history or clinical diagnosis of:
(a)a safety-relevant disease of the nervous system;
…
The meaning of the expression safety-relevant is set out in reg 67.015 as follows:
For the purposes of this Part, a medically significant condition is safety-relevant if it reduces, or is likely to reduce, the ability of someone who has it to exercise a privilege conferred or to be conferred, or perform a duty imposed or to be imposed, by a licence that he or she holds or has applied for.
The risks to air safety perceived by CASA as a consequence of Mr Tabart’s medical condition was stated to be as follows:
Your medical history of haemorrhagic stroke is of major concern, as any recurrence in the confines of a cockpit is likely to result in incapacitation and unrecoverable loss of control with catastrophic consequences. Your condition is associated with the following symptoms which would adversely affect your ability to safely exercise the privileges of your pilot licence:
· Sudden onset impairment of speech
· Sudden onset impairment of movement
· Sudden loss of consciousness
I have therefore decided that there is a real and substantial risk that these symptoms will interfere with your ability to safely pilot an aircraft and therefore create an unacceptable risk to the safety of air navigation.
CASA also considered the possibility of issuing a medical certificate with conditions but concluded there were no additional conditions which could be imposed which would adequately ameliorate the risks to air safety posed by his medical condition.
Following Mr Tabart’s request to extend time within which to seek review of the decision to cancel his Class 2 medical certificate, on 29 June 2015 CASA granted a 28 day extension from that date for Mr Tabart to either seek reconsideration of the decision by CASA or to make an application to this Tribunal. A further extension of time to seek review was granted by CASA in a letter dated 4 August 2015.
In a letter dated 6 August 2015, Dr Graeme Dennerstein, a DAME, submitted a medical report to CASA regarding Mr Tabart. Dr Dennerstein said:
I believe that the above decision should be reviewed because he was not on anti-hypertensive medication at the time of his stroke and he is now on this medication with a normal to low blood pressure. Furthermore, his general clinic and neurological findings are totally normal.
Attached is a report from his treating physician. I would estimate his 1 year risk of recurrence considerably less than the 5 year risk stated, but would consider a 6 monthly renewal not unreasonable.
This report was provided by Dr Dennerstein along with Mr Tabart’s new application for a Class 2 medical certificate. Where CASA has refused to issue a medical certificate or where CASA has issued a medical certificate subject to a condition not sought by the applicant, that person may seek reconsideration of that decision pursuant to Reg 67.190 of the CASR.
On 28 October 2015 Dr James Gome provided Dr Menzies with a further report and his assessment regarding Mr Tabart’s progress post haemorrhagic stroke. Dr Gome said Mr Tabart was in excellent health and had no complications at all from his stroke, which occurred over a year ago. Dr Gome also said he had performed an exercise stress test which was unremarkable with no evidence of inducible myocardial ischaemia. Dr Gome also commented on Mr Tabart’s risk of future cardiovascular events and post stroke seizure. Dr Gome said that was an extremely difficult task however, he used the most suitable calculator, the Stroke Foundation Risk Calculator, which suggested that Mr Tabart’s risk of either a coronary event or stroke event was around 3% per annum.
On 16 September 2015 CASA informed Mr Tabart that while applications for a medical certificate were normally actioned by a medical assessor (usually the DAME), in his case, given the particular diagnosis as well as other medical conditions, his case was considered complex and had been referred to a team of doctors. This was followed up with a letter from Dr Peter Clem, Senior Medical Officer with CASA, in which Dr Clem stated that CASA conducts a risk assessment for risk of stroke recurrence; acute cardiac event and seizure, at 12 months post first-stroke. Dr Clem said that CASA was proceeding to obtain an independent specialist neurologist opinion. Mr Tabart’s matter was referred to Dr John Cameron, a consultant neurologist, on 24 November 2015.
Dr Cameron provided his report in a letter dated 21 December 2015. Dr Cameron was provided with a number of published studies dealing with the risk of recurrent stroke and post stroke seizures. Regarding those articles, Dr Cameron concluded:
From the journal articles presented, it would appear that Mr Tabart is at risk of subsequent cerebrovascular events, particularly due to his age and his risk is above 1% per year risk required by the various aviation authorities throughout the world.
His risk of further intracerebral haemorrhage has been reduced by treatment of his hypertension but I still believe on the information provided in these documents that he remains above the 1% requirement on the yearly rate of recurrence of cerebrovascular events, coronary events and recurrent haemorrhage.
We were particularly concerned by the findings that are set out in the article entitled Long-term prognosis after recovery from primary cerebral haemorrhage, reported in the journal Neurology in 2002. That study, which involved a mean follow-up period of 5.5 years, examined the annual rates of recurrent primary intracerebral haemorrhage, vascular events and vascular death. The study found that being the age of 65 years or older was the only predictor of a recurrence and vascular death. It found that the age of 65 or older more than doubled the risk of recurrence of vascular event or death. In addition, vascular events in men increased twofold.
Mr Tabart is of course male and at present is 82 years of age. Dr Cameron concluded:
Overall I would conclude that he is at risk of suffering further cerebrovascular events, cerebral haemorrhage and coronary vascular events in view of his age and past history of hypertension.
I would conclude that he is medically unfit on the Guidelines to fly.
In a letter dated 26 January 2016 Dr Clem said that having reviewed all the information received to date, CASA was considering refusing to issue him with a Class 2 medical certificate and it gave him the opportunity to provide further evidence or to make written submissions.
Ms J Pocklington, who appeared on behalf of Mr Tabart at the hearing of this matter, sent an email from Mr Tabart to CASA (Dr Clem) on 3 February 2016 requesting further information and in particular why Mr Tabart was assessed as a flying instructor/Class 1 medical certificate. Mr Tabart also requested the research papers cited in CASA’s letter of 29 January 2016. CASA subsequently admitted that reference to flying instructor/Class 1 medical certificate was an error.
The email also referred to Dr Cameron having been requested to comment on the absolute annual risk of recurrence of post stroke seizure which did not quantify Mr Tabart’s risk, presumably taking into account his personal circumstances.
CASA referred the matter back to Dr Cameron who provided a follow-up report on 7 March 2016. In his report, Dr Cameron referred to what he described as the best article available entitled Seizures after stroke. A prospective multi center study, published by Bladin et al in 2000. The overall conclusion from the study was that seizures were more commonly associated with haemorrhagic stroke rather than ischaemic stroke. The study also noted that [persons with] disabling cortical infarcts or cortical haemorrhage were more likely to have seizures after strokes. Dr Cameron noted that this was his clinical experience as well. He did not believe that Mr Tabart was at particular risk of more than the general population of having a seizure as result of his basal ganglia haemorrhage.
Dr Cameron then expressed the following concerns:
I believe the major concern though here is his risk of recurrent intracerebral haemorrhage and also increased risk of a vascular death, be it coronary or cerebral in nature. I believe he is above that instance of the normal community of his age group in view of his past history of an intracerebral bleed.
Most of the studies I have quoted in my original report suggest that there was a
2-4% increased annual risk of dying of a recurrent cerebral haemorrhage or vascular event in the first two years and this fell to around 2% over the subsequent years to 5 years.
Obviously it is difficult to give a hard figure as to what risk there is here for recurrent cerebral haemorrhage or cerebral vascular event but I would estimate it now at around eighteen months post bleed, his risk is around 2-5% annually. After a two-year period, this annual risk probably drops to around 2-3%.
…
In summary I do not believe that this man’s risk of seizure activity as a consequence of his intracerebral bleed rates him any higher than that expected in the general community on the information provided.
He is however almost triple the risk of further cerebral vascular events including recurrence of a cerebral bleed over the next five years or so.
On 7 June 2016 CASA informed Mr Tabart that it had decided to refuse to issue him with a Class 2 medical certificate.
On 28 June 2016 Mr Tabart sought reconsideration of CASA’s refusal to issue him with a Class 2 medical certificate.
CASA sought and obtained a further medical report from Dr David Fitzgerald, no longer with CASA but as a consultant occupational physician, on 2 November 2016.
Dr Fitzgerald referred in considerable detail to prior reports dealing with Mr Tabart’s condition as well as the numerous academic studies done in this area. He was particularly critical of Dr Gome’s report and his use of the risk assessment tool, which he said was designed for those without pre-existing disease. He referred to Dr Cameron as being more experienced in neurological risk assessment as applied to aviation. He also noted that a physical examination was not required to make assessments as it added little to the assessment.
In his application for the issue of a Class 2 medical certificate, Mr Tabart had referred to flying a minimal number of hours per annum, about 100. It appeared as if Mr Tabart had formed the view that flying fewer hours should result in a decrease in the level of risk. However, as Dr Fitzgerald pointed out, the consideration of hours flown is already taken into account in the derivation of the so-called 1% rule on which CASA bases its acceptable risk profile. Dr Fitzgerald said:
The issue is whether the risk is likely and by this it is held to mean “a substantial or real and not remote chance”.
Respectfully, we agree with that assessment by Dr Fitzgerald. Dr Fitzgerald also noted that Mr Tabart’s recovery, treatment and control had not been ignored. He nevertheless maintained that Mr Tabart carried a significant risk by virtue of his history of a previous event. Dr Fitzgerald also took into account that Mr Tabart was able to fly Recreational Aircraft which are aircraft lighter than his, although by only about 200 kg. He also noted that Mr Tabart was cleared to fly gliders. However, Dr Fitzgerald noted that CASA was required by law to give aviation safety prime consideration. He noted the fitness to drive guidelines are not relevant to aviation fitness.
In conclusion, Dr Fitzgerald said:
In studies of patients post ICH [intracerebral haemorrhage], it is quite reasonable to assume that all are adequately treated in terms of modifiable risk factors, even if not explicitly stated. Indeed it would be negligent for a medical professional not to address neurovascular risk factors to prevent recurrence. The ongoing risks of recurrence are therefore likely to be on top of any modifiable risk factors. This is possibly due to unmeasurable or undetected risk factors. In other words, Mr Tabart due to the history of having one ICH, remains at higher risk than the general population of a further episode of haemorrhagic or ischaemic stroke, which is despite any successful modification of risk by medical treatment, and is likely above the 4% per annum level.
On 16 November 2016 CASA wrote to Mr Tabart indicating it had decided to set aside the decision made by Dr Clem on 7 June 2016 to refuse to issue him with a Class 2 medical certificate. CASA determined that it should issue Mr Tabart with the Class 2 medical certificate subject to the following condition:
Class 2 “Holder to fly with safety pilot only”
On 8 December 2016 Mr Tabart lodged an application with the Tribunal seeking review of CASA’s decision to issue him with a Class 2 medical certificate, valid for one year, with the condition that he was only to fly with a safety pilot. The expiry date on that medical certificate was 6 August 2017. Unfortunately, this application was unable to be heard prior to the expiry date of Mr Tabart’s Class 2 medical certificate with the safety pilot condition.
Following expiry of the first conditional Class 2 medical certificate, on 14 August 2017 CASA issued Mr Tabart with another Class 2 Medical certificate with the condition that he fly only with a safety pilot. That certificate expires on 14 August 2018. As a consequence, Mr Tabart was required to lodge a further application with the Tribunal seeking review of the decision made on 14 August 2017 as a decision in respect of an expired medical certificate would be of no value to Mr Tabart. We have therefore treated the application effectively as if it were a single application regarding a decision made by CASA to issue Mr Tabart with the Class 2 medical certificate with the condition that he only be permitted to fly with a safety pilot. The materials taken into consideration on the first application are equally applicable to the second.
MATTER NUMBER 2017/5341
In addition to the documents and reports which we had in evidence as a consequence of the first application, on this application we also had a report from Professor Peter Gates, a neurologist, dated 23 May 2017 and a document regarding assessment of future stroke using a Stroke Riskometer. We also had two reports from Dr Benjamin Clissold, a neurologist.
Professor Gates referred to an MRI scan dated 25 October 2016 which he said demonstrated: the macro adenoma with super cell extension, chronic deep white-matter ischaemic changes and an abnormality of the side of his previous right external capsule (basal ganglia). He also had reports from Dr Cameron dated 21 December 2015 and
7 March 2016; correspondence from Dr Fitzgerald dated 3 November 2016 and a letter from Dr Mike Seah, Senior Aviation Medical Officer with CASA. He referred to a number of studies which Dr Seah addressed.Professor Gates said that while the incidence of recurrent ischaemic stroke following TIA (transient ischaemic accident) had reduced significantly over the last 10-20 years, the same data was not available for recurrent intracerebral haemorrhage. He noted that as people age, there is an increasing risk of intracerebral haemorrhage related to cerebral amyloid angiography.
He admitted to not being an expert in aviation medicine but did not understand why, if Mr Tabart could fly aeroplanes up to 600 kg, he could not fly his own personal aeroplane. He noted Mr Tabart was permitted to drive a heavy goods vehicle. He was also permitted to fly solo under RAAus (Recreational Aviation Australia). He noted that Mr and Mrs Tabart (Mrs Tabart being Ms Pocklington) were frustrated by the entire process and they were seeking further neurological opinions to advance the cause that Mr Tabart be permitted to resume flying in his own personal aeroplane. Professor Gates pointed out that Mr Tabart had been assessed by others, and reports had been provided by others who were far more experienced in aviation medicine than himself.
Dr Clissold examined Mr Tabart on 5 September 2017 and provided a report of the same date. Dr Clissold noted that his blood pressure on that day was 130/70 and his pulse was 70 and regular. Further, the cranial nerve examination revealed normal visual fields and eye movements closely with no papilloedema on fundoscopy. There were no signs of facial weakness or sensory disturbance and speech pattern was normal with intact lower cranial nerve function. Examination of his limbs revealed normal tone and power with normal coordination and no evidence of sensory inattention.
Dr Clissold stated that it is very difficult to accurately predict the risk of recurrent stroke but that with well-controlled hypertension, he estimated that the risk was around 1-2% per annum. He was of the view that Mr Tabart’s risk of post-stroke seizure was negligible. He also had no residual neurological deficits.
Mr Tabart and Ms Pocklington, who attended with Mr Tabart, referred to the Stroke Riskometer which had been quoted by one of the prior assessed source assessors. Dr Clissold then said:
If we assume that he has had a stroke based on his previous haemorrhage then the 5-year risk score from that tool was 16.18%. This leads to an average of about 3.2% per annum.
Mr Tabart was again examined by Dr Clissold on 20 February 2018. In his brief report,
Dr Clissold said Mr Tabart informed him that his vascular risk factors were well-controlled, including his blood pressure which was sitting around the 120 systolic mark. He had no residual deficits from his prior stroke. Dr Clissold admitted he was not a civil aviation safety authority medical practitioner but was qualified to give an opinion about recurrent stroke risk. Dr Clissold said he did not feel that he would make any changes to his prior statement regarding Mr Tabart’s risk.
Dr Clissold also commented on the MRI scan done in 2016 which disclosed: a haemosiderin deposit in the right basal ganglia/external capsule in keeping with prior hypertensive haemorrhage as well as background moderate small vessel ischaemic changes as evidenced by chronic deep white-matter change on that scan. There was also a single micro-haemorrhage within the right posterior parietal region.
REQUIREMENT TO MEET THE MEDICAL STANDARD FOR A CLASS 2 MEDICAL CERTIFICATE
Part 67 of the CASR deals with medical matters. Medical certificates are dealt with under Subpart 67.C. This is the only legislative framework established for those persons wishing to hold pilot licences. That is not to be confused with pilot certificates which are issued by RAAus. The regulations do not equate with those required to hold a driver’s licence of any kind. A person wishing to fly a glider does not require a flight crew licence, that exemption being found in Civil Aviation Order 95.4. Glider operations are controlled by the Gliding Federation of Australia (GFA). Gliders must be operated in accordance with the rules, orders, directions, standards and operational procedures contained in the GFA Operational Regulations and other applicable manuals and written directives of the GFA.
While Mr Tabart referred to the medical requirements for the operation of gliders and recreational aircraft as well as the driving of motor vehicles, none of those requirements are relevant for the issue of a pilot licence of any class. Obviously, more stringent medical requirements are required in aviation operations which use reasonably heavy and high performance, or at least relatively high performance, aircraft. The dangers associated with such operations would be apparent to a person with an understanding of physics. When asked in the course of the hearing regarding the performance of Mr Tabart’s aircraft, Ms Pocklington said that it had a top speed of around 180 kts and an endurance of 5 hours. It is not a recreational aircraft. Its range would be in the vicinity of 900 nautical miles, depending on wind strength and direction.
Reg 61.410 of the CASR provides:
(1) The holder of a private pilot licence is authorised to exercise the privileges of the license only if the holder holds:
(a)a current class 1 or 2 medical certificate; or
(b)a medical exemption for the exercise the privileges of the licence.
Plainly, holding a recreational aviation medical practitioner’s certificate is insufficient. There is no discretion for anything other than what is set out in the CASR.
Furthermore, Reg 61.065 provides that the holder of a flight crew licence commits an offence if the holder conducts an activity, such as piloting a registered aircraft, while that person is not authorised under Part 61 to do so. Also, s. 20AB(1) of the Civil Aviation Act 1988 (the CA Act) provides:
(1) A person must not perform any duty that is essential to the operation of an Australian aircraft during flight time unless:
(a)the person holds a civil aviation authorisation that is in force and authorises the person to perform that duty; or
(b)the person is authorised by or under the regulations to perform that duty without the civil aviation authorisation concerned.
The essential difficulty faced by Mr Tabart is that he does not satisfy the criteria for the issue of a Class 2 medical certificate. He has a safety-relevant condition because the weight of medical evidence referred to above indicates that Mr Tabart has a risk of experiencing another stroke which would incapacitate him for the purposes of safely operating an aeroplane while airborne. He does not satisfy criterion 2.1, 2.2 or 2.7 on the table under Reg 67.155 of the CASR. If he experienced a stroke while airborne, it would likely reduce his ability to perform a duty imposed on him while flying
Use of the word likely has been the subject of discussion before various courts. Universally, the courts have indicated that the context in which the expression appears will give the more likely meaning that should be used. For example, in criminal cases, likely is inclined to be read as more likely than not (see Boughey v The Queen (1986) 161 CLR 10, 19 – 20). However, in civil cases, for example a case involving the then Trade Practices Act 1974, the Full Court of the Federal Court of Australia (Bowen CJ, Evatt and Deane JJ) in Tillmanns Butcheries Pty Ltd v Australasian Meat Industry Employees’ Union (1979) 27 ALR 367 found it necessary to adopt a different approach. Deane J at 382 said the following:
In the context of s 45 D (1), the preferable view is that the word “likely” is not synonymous with “more likely than not” and that if relevant conduct is engaged in for the purposes of causing loss or damage to the business of the relevant corporation, it will suffice, for the purposes of the sub-section, if that conduct is, in the circumstances, such that there is a real chance or possibility that it will, if pursued, cause loss or damage. Whether or not such conduct is likely (in that sense) to have that effect is a question to be determined by reference to well-established standards of what could reasonably be expected to be the consequence of the relevant conduct in the circumstances.
In our opinion, in the context in which the word likely appears in the definition of the expression safety-relevant, it should be understood as explained by Dean J in Tillmanns’ case. In other words, if there is a real chance or possibility that if Mr Tabart experienced a further intracranial haemorrhage while airborne, there is a real chance that he would lose control of the aircraft entirely which could lead to catastrophic loss of life or damage to property.
That being the case, the issues before us are whether the degree of risk posed by Mr Tabart flying exceeds that of the general population which has not experienced an intracerebral haemorrhage; and if so, whether the risk of the event occurring can be minimised by conditions other than requiring Mr Tabart to fly only with the safety pilot when exercising the privileges of his private pilot licence.
RISK OF FURTHER INTRACEREBRAL HAEMORRHAGE
We had in evidence a number of papers and studies dealing with long-term survival after primary intracerebral haemorrhage (ICH), some of which have been referred to in the reports we have discussed above. The most consistent and prominent findings from those studies were that having had a primary ICH, the risk of recurrence increased. Also, age was a significant predictor, particularly for those persons over the age of 65 years. In addition, the risk of vascular events in men was increased twofold.
Dr Gome on 28 October 2015, using the Stroke Foundation Risk Calculator estimated that Mr Tabart’s risk of either a coronary event or stroke event occurring was around 3% per year. Dr Clissold came to the same conclusion. However, Dr Gome noted that Mr Tabart was at that time medically optimised and at the time of his stroke, his hypertension was uncontrolled. Dr Gome also noted that Mr Tabart’s risk of a seizure post stroke was low as he had no sequelae subsequent to his stroke over one year past the event.
Dr Clissold gave evidence at the hearing of this matter by telephone. At the outset, he commented that he did not do an assessment for the purposes of Mr Tabart’s application to the Tribunal but rather, it was simply a medical opinion. He wanted it noted that he was not a CASA assessor and that Mr Tabart was referred by his local medical practitioner, essentially, to look at his follow-up stroke risk and management in terms of secondary stroke prevention.
Dr Clissold noted that use of the Stroke Riskometer may not have been appropriate in Tabart’s case because that tool was essentially based on the risk of recurrent ischaemic stroke whereas Mr Tabart had had a haemorrhagic stroke. Nevertheless, when asked whether the risk of ischaemic stroke following a haemorrhagic stroke was raised, Dr Clissold agreed it was as there were common risk factors involved and one of those is hypertension. The other common risk factor is age.
Dr Clissold was also asked what evidence he had or whether he used any validated risk calculation tools to reach his conclusion that Mr Tabart’s risk of a haemorrhagic stroke was between 1 and 2% per annum. Dr Clissold referred to a trial called the PROGRESS trial dated 2006 which looked at current ischaemic and haemorrhagic stroke that was followed-up over 3.9 years. He said there were over 6000 patients in that trial and looking at the risk of recurrent haemorrhagic stroke, depending on their blood pressure control, the risk of recurrent haemorrhagic stroke was below 1% per annum in that trial and that was in a very large randomised, controlled trial. The trial was reported in the Journal of Hypertension. When asked whether age was taken into consideration when considering risk factors in the trial, Dr Clissold said there were a range of age groups in the trial. He referred to a graph produced in that paper encompassing all patients at follow-up and it did not discriminate or delineate across age groups. Nevertheless he agreed that age is one of the common factors for both ischaemic and haemorrhagic stroke with increasing age, there was an increase risk.
When it was put to Dr Clissold that averaging out age groups may result in a skewed outcome depending on whether there were more younger or more older people in the study, Dr Clissold said that was a reasonable question and that the mean age in that study was between 60 and 65. Mr Tabart of course is not within that age group.
Dr Clissold was also asked about a cognitive assessment he performed using what was described as the Montréal Cognitive Assessment. In particular, he was asked why he chose to do that assessment. Dr Clissold responded that it was used as a screening tool for dementia but also used for assessing cognitive impairment following a stroke. He noted that Mr Tabart’s score of 26/30 was deemed to be within normal limits, greater than or equal to 26/30 was deemed to be normal. When asked whether this test was adequate for someone undertaking fairly fine motor and cognition skills, Dr Clissold said he was not asked to assess him from a flying perspective. It was about stroke risk factor management and follow-up. Dr Clissold was also asked whether there might be circumstances where Mr Tabart’s blood pressure might spike. While Dr Clissold was of the view that every patient tended to be different, he said it was possible that in an acutely stressful situation, blood pressure may increase.
In his report dated 21 December 2015 Dr Cameron, after reading two reports from
Dr Gome and reviewing the literature which CASA had provided to him regarding the risk of adverse sequelae, concluded that Mr Tabart’s risk of further intracerebral haemorrhage had been reduced by the treatment of his hypertension with medication. Nevertheless, he remained above the 1% yearly rate of risk of recurrence of cerebrovascular events, coronary events and recurrent haemorrhage. However Dr Cameron concluded that
Mr Tabart’s risk of suffering a seizure as a result of the small basal ganglia haemorrhage was probably that associated with the risk of seizure occurring in the general population in a person of his age. Dr Cameron nevertheless concluded that Mr Tabart’s risk of suffering further cerebrovascular events, cerebral haemorrhage and coronary vascular events in view of his age and past history of hypertension remained. He concluded Mr Tabart was not medically fit to fly aeroplanes.Dr Cameron’s second report dated 7 March 2016 reached essentially the same conclusion. He noted that most of the studies he quoted in his original report suggested there was a 2-4% increased annual risk of dying of recurrent cerebral haemorrhage or vascular event in the first two years and this fell to around 2% over the subsequent years to 5 years. After a two-year period, this annual risk probably dropped to around 2-3%.
Dr Cameron also repeated that he did not believe Mr Tabart to be at any higher risk than expected in the general community regarding seizure activity.Dr Cameron also gave oral evidence at the hearing by telephone. When Dr Cameron was asked by Ms Swain, who appeared on behalf CASA, what he considered to be
Mr Tabart’s annual risk of recurrence of cerebral haemorrhage or a cerebral vascular event, Dr Cameron said:On review of the literature [annual risk of recurrence of cerebral haemorrhage or cerebral vascular event] is around two to three percent risk per annum. The older the person the more - there is an increased risk of further events. Now, they don’t all have to be cerebral haemorrhages, they can be other cerebral events like TIAs or cerebral infarction, embolism and there is also a higher risk of coronary artery disease problems.
When asked by Ms Swain whether the symptoms he described resulting from a cerebral bleed could impair a person’s ability to safely operate an aircraft, Dr Cameron said: yes. Dr Cameron was also referred to Dr Clissold’s estimate of 1 to 2% per annum and whether he agreed with that estimate. Dr Cameron said:
Sure. I believe in my assessment on reading the articles, I’ve documented in my first letter that his risk is around one to two per cent, possibly three per cent so I would agree overall with Dr Clissold’s assessment, yes.
[Question from Ms Swain] Closer to which end of the one to two percent would you put that? Or three per cent?--- The articles I’ve quoted tend to suggest it’s at least two per cent. I would put it over more towards the three per cent than the two per cent.
In cross-examination by Ms Pocklington, Dr Cameron was asked whether there was a problem with research literature because it didn’t address a particular person. She said, for instance, it might not be solely restricted to first-ever strokes and it didn’t follow other cardiovascular risk factors, of which Mr Tabart had none, and he had no neurological deficits. He was also on blood pressure medication to control future risk. Dr Cameron responded:
Yes. The studies included – specifically tried to address Mr Tabart’s particular population cohort group in that these people present with a cerebral vascular event, some of which were cerebral haemorrhages, some of which were haemorrhages on the periphery of the brain, some were in the basal ganglia and then they follow these patients through. So I think the studies quoted are quite a good assessment of Mr Tabart’s prognosis. So even though placing one – a particular individual in these groups is always a little difficult at times. I believe the studies that have been quoted are quite fairly representative, if not quite representative of his particular case and prognosis.
In re-examination Ms Swain asked Dr Cameron about the trial referred to by
Ms Pocklington, pointing out that the age of the cohort in that study only went to 71 years. She asked whether that trial would be relevant to an 81-year-old. Dr Cameron said it probably was not totally relevant, although the study quoted by Vermeer went further than 65 years and it found the risk factor of further cerebral vascular events increase the older a person gets.
Dr Cameron was also referred to the MRI done in 2016 which showed moderate ischaemic changes. He was asked whether these were relevant to his risk of recurrent stroke. In particular, he was referred to the single micro haemorrhage within the right posterior parietal region. Dr Cameron responded:
See, that’s a little worrying. Even though his risk factors are all well and truly controlled, from what I gather, again, he has fairly widespread cerebral vascular disease. It may not be causing him any concern at present, nor may it not, but he’s got that small parietal or post-hemisphere small micro bleed and that is a little worry. He’s got generalised cerebral vascular disease vessel changes so that is a little concerning, especially if you’re going to, you know, certify him to use a class 2 licence as a solo pilot.
Dr Michael Seah, a Senior Medical Officer with CASA aviation medicine branch, provided a written statement dated 24 October 2017 which was taken into evidence. He also gave oral evidence at the hearing and was cross-examined.
Dr Seah set out in detail the evidence which we have already stated in the course of our discussion above. It need not be repeated. On the basis of that medical evidence,
Dr Seah was satisfied that Mr Tabart had an established medical history of stroke which constituted a safety-relevant condition as defined in items 2.1, 2.2 and 2.7 of the Table at Reg 67.155 of the CASR.
Dr Seah said that Mr Tabart’s medical condition was associated with a number of potential symptoms and side effects which could adversely affect his ability to safely exercise the privileges of the pilot license, including, most importantly, an increased risk of stroke recurrence leading to acute or subtle in-flight incapacitation. Dr Seah considered that, given Mr Tabart’s condition, there was a real, substantial and not insignificant risk that he may suffer a further stroke or transient ischaemic attack while exercising the privileges of his pilot license. If that were to occur, it would place him, his passengers and the aircraft as well as other airspace users and all persons in the immediate vicinity at serious and potentially grave risk.
Dr Seah was asked about Mr Tabart’s statement that he was only going to fly a very low number of hours per year thereby decreasing his risk. Dr Seah said:
It’s a common assumption that if you fly less that you’re actually at decreased risk. Now, the one per cent rule, as it was derived, actually takes into account the number of hours flown per year. It’s part of the derivation of the actual rule. So if we then extrapolate to the two per cent threshold that CASA accepts, the number of hours flown is irrelevant because the risk remains, regardless of how many hours flown. It’s part of how we look at the absolute risk of someone suffering an event, and that is per annum, not whether they’re in flight or not in flight, it is per annum. So the one per cent per annum, or two per cent per annum is completely independent of the number of hours flown because it has already been taken into consideration.
Mr Tabart had indicated that Dr Dennerstein said a six monthly review would be effective to mitigate the risk. Dr Seah commented on that in the following way:
From the outset there is no actual test that we can administer; sorry, we as the medical profession, and CASA can then rely upon as a regulator that would allow us to predict someone’s risk of stroke in an absolute risk capacity. So in deference to a stress test for cardiovascular disease where there’s very good evidence to say if someone has a negative stress test then their risk of suffering a myocardial event within the 12 months is X per cent. There is no equivalent test for stroke, so we can’t use any objective measure to predict someone’s risk of stroke, and therefore an arbitrary six-monthly review is actually not going to provide CASA any additional reassurance that the applicant is not going to suffer another stroke. So that – that was taken into account, however we are not able to accept that as a mitigation strategy.
Dr Fitzgerald, arguably the best qualified aeromedical practitioner, being a Clinical Senior Lecturer in Aviation and Occupational Medicine, University of Otago, and a former medical officer with a CASA, provided the most fulsome report dated 2 November 2016. He referred to Dr Gome’s report of 6 May 2015 and noted that Dr Gome’s calculation of a 12% five year risk was made assuming he was aged 75 years rather than 79 years, which was the correct age. He accepted that improved blood pressure was lowering Mr Tabart’s risk significantly.
Dr Fitzgerald also noted that in his earlier report dated 28 October 2015, Dr Gome recorded no ongoing deficits and full recovery from the previous stroke. As for risk, Dr Gome again referred to the Stroke Foundation Risk Calculator, quoting a 3% per year risk.
Dr Fitzgerald referred to Dr Cameron’s reports of December 2015 and February 2016 as well as his reply on 7 March 2016, in which Dr Cameron regarded Mr Tabart’s risk as being 2-5% annually dropping to 2-3% after 2 years.
Dr Fitzgerald noted that Dr Gome’s calculation of risk was based on a population data calculator which by its nature did not give weight for the increased risk of previous events. He referred to the evidence relied on by CASA which was consistently quoted upon and no new substantive clinical research evidence was to hand that might negate the previous reliable evidence. He noted that CASA considered absolute risk and that this was conceptualised by the application of the 1% rule and in the case-based risk assessment. Dr Fitzgerald also said:
Mr Tabart’s own neurologist had erroneously applied a risk assessment tool which was designed for those without pre-existing disease. One reason for obtaining an independent risk assessment is that Dr Cameron is more experienced in neurological risk assessment as applied to aviation. CASA medical officers themselves have significant experience in risk assessment as it is their daily work. The assessment undertaken by CASA and Dr Cameron is more appropriate for the circumstances. A physical examination is not required to make such assessments and adds little to the assessment.
Dr Fitzgerald also noted the following:
CASA in my understanding does use Dr Cameron as a consultant due to his qualifications in both neurology and aviation medicine and his experience in risk assessment. In a similar vein Mr Tabart’s neurologist is no more ‘independent’ due to the treating doctor relationship. Dr Cameron has in my experience disagreed with CASA decisions in the past and his learned opinion taken into account by CASA.
Dr Fitzgerald also explained that the consideration of hours flown is already taken into account in the derivation of the 1% rule upon which CASA bases its acceptable risk profile. He also noted that the issue of remote and negligible, and real and substantial risk is a legal question. He correctly stated that the issue is whether the risk is likely and by this it is held to mean “a substantial or real and not remote chance”. He went on to say that medically, the risk of further recurrences was not remote based on Mr Tabart’s medical history and risk profile. He also observed that recovery, treatment and control had not been ignored in the assessment of his risk of recurrence and that despite that, a significant risk remained.
Dr Fitzgerald took into account the studies relied on by Mr Tabart. He noted that being above 73 years of age and male were noted risk factors.
As for the risk of recurrence, Dr Fitzgerald concluded as follows:
It is here where Mr Tabart carries unacceptable risk. As noted by the studies above, the recurrence rates vary widely, but the most comprehensive study in Neurology. 2001 Mar 27;56(6):773-7 gives a recurrent stroke risk of above 4% per annum, which is well outside the accepted parameters under the 1% rule or even going by the NZ CAA slide.
As for Mr Tabart’s submission that he is now being treated for hypertension which was not the case when he had the stroke, Dr Fitzgerald indicated it was reasonable to assume that all of the patients in the studies post ICH were adequately treated in terms of modifiable risk factors even though that may not have been stated in the studies. This was because it would be negligent for a medical professional not to address neurovascular risk factors to prevent recurrence. Therefore, the ongoing risks of recurrence were likely to be on top of any modifiable risk factors. Furthermore, Mr Tabart having had one ICH, remained at a higher risk than the general population of a further episode of ICH or ischaemic stroke despite any successful modification of risk by medical treatment, and is likely to be above the 4% per annum level. He considered Mr Tabart to remain unfit for certification based on his ongoing risk.
In our opinion, the evidence points strongly Mr Tabart having at least a 2% or higher risk of experiencing a further stroke or transient ischaemic attack at some future point in time. We find that Mr Tabart does have a safety-relevant condition which is likely to reduce his ability to exercise a privilege conferred by a private pilot licence. Therefore, he does not meet medical standard 2 which is required for the issue of a Class 2 medical certificate.
ISSUE OF MEDICAL CERTIFICATE WITH CONDITIONS
Reg 11.056 of the CASR provides that an authorisation may be granted subject to conditions. Relevantly, it provides:
(1) CASA may grant an authorisation subject to any condition that CASA is satisfied is necessary:
(a)for an authorisation, other than an authorisation to which subregulation 11.055 (1B) applies or an experimental certificate--in the interests of the safety of air navigation; or
…
An authorisation is relevantly defined in Reg 11.015 as follows:
authorisation means:
(a)…
(b)…
(c)a certificate capable of being granted to a person under these Regulations.
Reg 67.180 at the CASR sets out the requirements for the issue of medical certificates. Reg 67.180(2)(e)(ii) states that where an applicant does not meet the medical standard, a certificate may nevertheless be issued to an applicant to the extent that the level to which they do not meet the standard is not likely to endanger the safety of air navigation.
Section 9A of the CA Act sets out the performance of CASA’s functions. Relevantly, it provides:
(1)In exercising its powers in performing its functions, CASA must regard the safety of air navigation as the most important consideration.
While we have no doubt that CASA may issue a Class 2 medical certificate to Mr Tabart with conditions, in doing so, the safety of air navigation cannot be compromised.
We cannot accept Dr Dennerstein’s proposal that the only condition which ought to be attached to Mr Tabart’s Medical certificate is that he have a six monthly medical examination. In our opinion, that would not reduce the risk that Mr Tabart poses to the safety of air navigation. That is because of the unpredictability of whether and when
Mr Tabart may experience another cerebral bleed. Furthermore, should that occur while he is airborne, we find that the safety of air navigation will be compromised. Despite all that has been said about the risk of persons who have experienced an initial cerebral haemorrhage experiencing recurrence of that event or another cardiovascular event, the studies upon which the various opinions have been based have not considered a man of Mr Tabart’s age (now 82 years). In his statement Dr Seah said:
I also consider that apart from the applicant’s medical condition, it must also be taken into account that by virtue of the applicant’s age this is a risk factor which must also be allowed for. The applicant’s annualised mortality rate from all causes at the time of application (age 79) was 3.94% (Australian Bureau of Statistics, 2015), which has now increased to 5.28% at age 81.
Although Ms Pocklington submitted that the majority of Mr Tabart’s flying would be conducted in country areas and not over built-up areas, we do not consider that is a factor which can alter our opinion. That is because it is inevitable that he will at some stage fly over populated areas, even for only a brief period of time, and will, in doing so, pose a serious risk to persons on the ground.
We find that the only condition which will ensure the safety of air navigation in this case is that Mr Tabart must fly only with a safety pilot.
CONCLUSION
We find that Mr Tabart has a safety-relevant medical condition and accordingly does not satisfy the legislative criteria for the issue of a Class 2 medical certificate. Nevertheless, we have found that Mr Tabart may be issued a Class 2 medical certificate with the condition that he flies only with a safety pilot. That is the only condition which will ensure that the safety of air navigation is not compromised.
Accordingly, we find that the decisions made by CASA on
16 November 2016
(matter no. 2016/6660) and 14 August 2017 (matter no. 2017/5341) to issue to Mr Tabart a Class 2 medical certificate with the condition “Holder to fly with safety pilot only” were the correct decisions. We affirm those decisions.
I certify that the preceding 91 (ninety-one) paragraphs are a true copy of the reasons for the decision herein of Egon Fice, Senior Member and Dr A Reddy, Member
..............[sgd]..........................................................
Associate
Dated: 24 May 2018
Date(s) of hearing: 24 April 2018 Applicant: Jo Pocklington Solicitor for the Respondent: Carol Swain, CASA
Key Legal Topics
Areas of Law
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Administrative Law
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Statutory Interpretation
Legal Concepts
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Judicial Review
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Procedural Fairness
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Standing
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Statutory Construction
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Remedies
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