MacNeall and Civil Aviation Safety Authority
[2016] AATA 975
•25 November 2016
MacNeall and Civil Aviation Safety Authority [2016] AATA 975 (25 November 2016)
Division
GENERAL DIVISION
File Numbers
2015/4469 & 2016/3913
Re
Denis MacNeall
APPLICANT
And
Civil Aviation Safety Authority
RESPONDENT
DECISION
Tribunal Senior Member CR Walsh &
Professor J Quinlivan, MemberDate 25 November 2016 Place Perth The Tribunal affirms the decisions under review.
....(Sgd)..........................................................
Senior Member CR Walsh
CATCHWORDS
CIVIL AVIATION – applicant holds a private pilot licence, a commercial pilot licence and an air transport pilot licence – applicant applied to the respondent for a Class 1 medical certificate and a Class 2 medical certificate - whether respondent’s decision not to issue the applicant with a Class 1 medical certificate is the correct and preferable decision – whether the respondent’s decision to issue the applicant with a Class 2 medical certificate, subject to the condition “Holder to fly with safety pilot only”, is the correct and preferable decision – decisions under review affirmed
LEGISLATION
Civil Aviation Act 1988 – s 9A
Civil Aviation Safety Regulations 1998 – reg 11.056 - reg 61.410(1) – reg 61.415(1) – reg 61.415(2) – reg 67.010 – reg 67.015 – reg 67.150 – reg 67.155 – reg 67.180
CASES
Commins and Civil Aviation Safety Authority [2004] AATA 1330
Hall and Civil Aviation Safety Authority [2004] AATA 21
Mulholland and Civil Aviation Safety Authority [2007] AATA 1952
Randazzo and Civil Aviation Safety Authority [2012] AATA 266
White and Civil Aviation Safety Authority [2008] AATA 543Window v Civil Aviation Safety Authority [1999] AATA 525
REASONS FOR DECISION
Senior Member CR Walsh &
Professor J Quinlivan, Member25 November 2016
INTRODUCTION
Mr MacNeall was born in 1945 and is currently 71 years of age.
Mr MacNeall holds a private pilot licence, a commercial pilot licence and an air transport pilot licence.
Broadly, the Civil Aviation Safety Regulations 1998 (the CASR) require the holder of a private pilot licence, a commercial pilot licence or an airport transport licence to also hold a current Class 1 medical certificate or Class 2 medical certificate, issued by the Civil Aviation Safety Authority (CASA), to be authorised to exercise the privileges of the relevant licence: refer to regs 61.410(1) and 61.415(1) and (2) of the CASR.
On 3 December 2014, Mr MacNeall applied to CASA for a Class 1 medical certificate.
On 23 July 2015, CASA wrote to Mr MacNeall notifying him of its decision to refuse to issue him with a Class 1 medical certificate (the Class 1 Medical Certificate Decision). The Class 1 Medical Certificate Decision states:
Medical history and current medical status
On the basis of the available evidence, I have determined that you have an established medical history of multi-vessel coronary artery disease with evidence of moderate reversible ischaemia and post stress left ventricular dysfunction.
Applicable medical standard
The medical standard applicable to your application for a Class 1 Medical Certificate is Medical Standard 1. set out in Table 67.150 of the CASR.
…
Due to this medical condition, I have decided that you do not meet the above sections of Medical Standard.
As you do not meet the Medical Standard, I may only grant you a Class 1 Medical Certificate if it is satisfied that the extent to which you fail to meet the applicable medical standard is not likely to endanger the safety of air navigation.
Risks to air safety
Your condition is associated with the following symptoms which would adversely affect your ability to safely exercise the privileges of your pilot licence:
· Sudden incapacitating chest pain;
· Sudden incapacitating shortness of breath;
· Loss of consciousness;
I have therefore decided that there is a real and substantial risk that these symptoms will interfere with your ability safely to pilot an aircraft and therefore create an unacceptable risk to the safety of air navigation.
Conditional certificate
I have also concluded that no additional conditions imposed upon your medical certificate would adequately ameliorate the risks to air safety posed by your medical condition.
Decision
I have therefore decided to refuse to issue you with a Class 1 Medical Certificate. (Emphasis added.)
On 27 August 2015, Mr MacNeall applied to the Administrative Appeals Tribunal (the Tribunal) for review of the Class 1 Medical Certificate Decision (being application 2015/4469).
On 29 May 2016, Mr MacNeall applied to CASA for a Class 2 medical certificate.
On 7 July 2016, CASA wrote to Mr MacNeall notifying him of its decision to issue him with a Class 2 medical certificate subject to the condition “Holder to fly with safety pilot only” (the Class 2 Medical Certificate Decision). The Class 2 Medical Certificate Decision states:
Medical history and current medical status
On the basis of the available evidence, I have determined that you have an established medical history of obstructive coronary disease with significant residual ischaemia despite CABD and PCI, moderate ischaemic cardiomyopathy with evidence of prior infarction, mild aortic stenosis, and moderate overall LV systolic dysfunction.
Medical Standard
…
The medical standard applicable to your application for a Class 2 Medical Certificate is Medical Standard 2, set out in Table 67.155 of the CASR.
…
Due to your medical condition … I have decided that you do not meet the above sections of the Medical Standard.
As you do not meet the Medical Standard, I may only grant you a … Class 2 Medical Certificate if I am satisfied that the extent to which you fail to meet the applicable medical standards is not likely to endanger the safety of air navigation.
Risks to air safety
Your condition presents an unacceptable risk of inflight incapacitation, because it may cause the following symptoms or side effects which would interfere with your ability to safely exercise the privileges of a pilot’s licence:
· sudden onset of distracting or disabling chest pain;
· sudden onset of distracting or disabling shortness of breath (dyspnoea);
· loss of consciousness (syncope).
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.
Conditional Certificate
While it is acknowledged that the determination of likelihood of risk under Part 67 of the CASR is not a purely statistical or mathematical task, CASA makes use of annual absolute risk percentages of acute incapacitating events in order to assist in determining whether such an event is ‘likely’ for the purposes of regulation 67.180. An acceptable annual risk of 1% for class 1 certificate holders is applied. For Class 2 certificate holders an acceptable risk of 2% is applied. This approach is described in the extract from Ernsting’s Aviation Medicine 4th Edition page 554 to 559 attached.
The evidence available to CASA would indicate that your annual absolute risk percentage of acute incapacitating events is in the range of 3.5 to 5% per annum. This clearly is a magnitude of absolute risk greater than what would be considered for any class of medical certificate.
…
With respect to your Class 2 Medical Certificate, I have concluded that imposing the following operational limitation “with safety pilot only” would adequately ameliorate the risks to air safety posed by your medical condition …
The special condition “Holder to fly with safety pilot only” is associated with a number of requirements that include, among others, that the aircraft flown must be configured with side by side seating in the cockpit, the aircraft being flown must have dual flying controls and that the pilot with the special condition must wear a shoulder restraint harness at all times when occupying a control seat. The Australian Transport Safety Report AO-2008-021 which relates to the collision with terrain of a tandem seat aircraft in 2008 clearly demonstrates why these conditions are required.
Decision
I have therefore decided to …issue you with a Class 2 Medical Certificate subject to the condition “with safety pilot only”.
(Emphasis added.)
On 27 July 2016, Mr MacNeall applied to the Tribunal for review of the Class 2 Medical Certificate Decision (being application 2016/3913).
Application 2015/4469 (being the Class 1 Medical Certificate Decision) and application 2016/3913 (being the Class 2 Medical Certificate Decision) were joined and heard together for convenience.
ISSUES
The relevant issues for determination by the Tribunal are as follows:
(i)Whether Mr MacNeall meets the “relevant medical standard” for the issue of a:
(a)Class 1 medical certificate, as set out in the Table in reg 67.150 of the CASR; and
(b)Class 2 medical certificate, as set out in the Table on reg 67.155 of the CASR, for the purposes of reg 67.180(2)(e)(i) of the CASR;
(ii)If not, whether the extent to which Mr MacNeall fails to meet the relevant medical standards is “likely to endanger the safety of air navigation” for the purpose of r 67.180(2)(e)(ii) of the CASR; and
(iii)If so, whether any conditions could be imposed upon a medical certificate under r 11.056 of the CASR which would ameliorate the threat posed to air safety navigation by Mr MacNeall’s failure to meet the Class 1 or Class 2 relevant medical standards.
Pursuant to s 9A of the Civil Aviation Act 1988 (the CAA), the safety of air navigation is the most important consideration in determining these issues: refer to paragraph 17 below.
CONSIDERATION
Limitations on exercise of privileges of pilot licences – Class 1 or Class 2 medical certificates
Regulation 61.410 of the CASR states:
Limitations on exercise of privileges of pilot licences — medical certificates: private pilot licence holders
(1)The holder of a private pilot licence is authorised to exercise the privileges of the licence only if the holder also holds:
(a) a current class 1 or 2 medical certificate; or
(b)a medical exemption for the exercise of the privileges of the licence.
(Emphasis added.)
Consequently, pursuant to reg 61.140(1) of the CASR, Mr MacNeall is not authorised to exercise the privileges of his private pilot licence unless he also holds a current class 1 or class 2 medical certificate.
Regulation 61.415 of the CASR states:
Limitations on exercise of privileges of pilot licences — medical certificates: commercial, multi-crew and air transport pilot licence holders
(1)The holder of a commercial pilot licence, multi-crew pilot licence or air transport licence is authorised to exercise the privileges of the licence only if the holder also holds:
(a) a current class 1 medical certificate; or
(b)a medical exemption for the exercise of the privileges of the licence.
(2)However, the holder of a commercial pilot licence or air transport licence is authorised to exercise the privileges of the licence in an activity that would be authorised by a private pilot licence if the holder also holds a current class 2 medical certificate.
(Emphasis added.)
Accordingly, pursuant to reg 61.415(1) and (2) of the CASR, Mr MacNeall is not authorised to exercise the privileges of his commercial pilot licence and his air transport pilot licence unless he also holds a current class 1 or class 2 medical certificate.
Issue of medical certificates by CASA
Section 9A of the CAA provides:
Performance of functions
(1)In exercising its powers and performing its functions, CASA must regard the safety of air navigation as the most important consideration.
(Emphasis added.)
Regulation 67.180 of the CASR deals with the issue and refusal of medical certificates by CASA.
In deciding whether to issue or refuse to issue a Class 1 or Class 2 medical certificate to Mr MacNeall under r 67.180 of the CASR, the Tribunal (standing in the shoes of CASA) is required by s 9A of the CAA, to regard the “safety of air navigation as the most important consideration”.
Regulation 67.180 of the CASR provides:
Medical certificates—issue and refusal
(1)Subject to subregulation (7) and regulation 11.055, on receiving an application under regulation 67.175, CASA must issue a medical certificate to the applicant if the applicant meets the requirements of subregulation (2).
(2) For subregulation (1), the requirements are:
(a)the applicant has undergone any relevant examinations that, in the opinion of CASA, are necessary in the particular case; and
(b)each relevant examination has been carried out by an examiner to whom subregulation (4) applies; and
(c)for each relevant examination, the applicant answers every question asked by the examiner that the examiner considers necessary to help CASA to decide whether the applicant meets the relevant medical standard; and
(d)subject to subregulation (5), the applicant authorises the disclosure to CASA and the examiner of any information or documents about the applicant:
(i)that are held by a person, organisation, body or authority mentioned in subregulation (6); and
(ii)that may help CASA to decide whether the applicant meets the relevant medical standard; and
(e) either:
(i)the applicant meets the relevant medical standard; or
(ii)if the applicant does not meet that medical standard—the extent to which he or she does not meet the standard is not likely to endanger the safety of air navigation; and
(f)if, in addition to any relevant examinations that the applicant has undergone under paragraph (a), CASA has directed the applicant to undergo an examination under subregulation 67.165(1):
(i) the applicant has undergone that examination; and
(ii)having taken into account the result of the examination, CASA is satisfied that issuing a medical certificate to the applicant would not endanger the safety of air navigation.
(Emphasis added.)
It is common ground that Mr MacNeall satisfies reg 67.180(2)(a), (b), (c), (d) and (f) of the CASR. What is at issue in this case is whether Mr MacNeall satisfies reg 67.180(2)(e)(i) or (ii) of the CASR, as set out above.
(i) Does Mr MacNeall meet the “relevant medical standard” for the issue of a: (i) Class 1 medical certificate, as set out in the Table in r 67.150 of the CASR; and (ii) Class 2 medical certificate, as set out in the Table in r 67.155 of the CASR, for the purpose of r 67.180(2)(e)(i) of the CASR?
Relevant medical standard
Regulation 67.010 of the CASR defines the expression “relevant medical standard” to mean:
(a) for a class 1 medical certificate—medical standard 1; and
(b) for a class 2 medical certificate—medical standard 2;
(Emphasis added.)
Regulation 67.010 of the CASR further provides:
medical standard 1 means the standard set out in table 67.150.
medical standard 2 means the standard set out in table 67.155
Class 1 medical certificate – medical standard 1
The criteria for “medical standard 1” (i.e. the relevant “medical standard” for a Class 1 medical certificate) is set out in the Table in reg 67.150 of the CASR and includes:
Abnormalities, disabilities and functional capacity
1.1 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
…
Cardiovascular system
1.9Has no safety-relevant heart abnormality
…
1.11Has no significant functional or structural abnormality of the circulatory tree (Emphasis added.)
Class 2 medical certificate – medical standard 2
The criteria for “medical standard 2” (i.e. the relevant “medical standard” for a Class 2 medical certificate) is set out in the Table in reg 67.155 of the CASR and includes:
Abnormalities, disabilities and functional capacity
2.1Has 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
…
Cardiovascular system
2.9 Has no safety-relevant heart abnormality
…
2.11Has no significant functional or structural abnormality of the circulatory tree (Emphasis added.)
Medical evidence
In considering whether there were cardiovascular risk factors and abnormalities present, the Tribunal relies, in particular, on the MRS Online - Medical Examination Report, dated 3 December 2014[1], the myocardial perfusion thallium scans, conducted by Dr Mark Hands (Cardiologist) of Western Cardiology on 3 February 2015[2] and on 28 May 2015[3], the exercise stress echocardiogram, conducted by Dr Hands on 22 May 2015[4], and the expert medical report of Dr Arun Abraham (Cardiologist), dated 15 June 2016[5].
[1] Exhibit 1 at pp161-171.
[2] Exhibit 1 at p186. and p190.
[3] Exhibit 1 at p207.
[4] Exhibit 1 at p206.
[5] Exhibit 2 at pp47-51.
In particular, the Tribunal notes that Dr Abraham concluded the following in his report, dated 15 June 2016[6]:
[6] Exhibit 2 at p50-51.
Conclusion
Mr MacNeall has coronary artery disease with severe triple vessel disease treated by CABG as above with subsequent stenting of proximal LCX and 3rd LV branch. His underlying classical cardiovascular risk factors are age, family history of premature coronary disease, dyslipidaemia and hypertension. More recent (31/3/2015) status of graft / native coronaries though elucidated by angiography (report not sighted) suggests “widely patent grafted LAD and LCX vessels after stenting”. He has obstructed collateralised RCA and a small terminal severely disease OM. Multiple functional test suggest significant residual ischaemia. He has moderate ischaemic cardiomyopathy noted on MRI. He appears to have good functional capacity based on exercise stress and history, and is only limited by dyspnoea at a relatively high workload.
Mr Mac Neall’s (sic.) diagnoses are obstructive coronary disease with significant residual ischaemia despite CABG and PCI, moderate ischaemic cardiomyopathy with evidence of prior infarction, mild aortic stenosis, and moderate overall LV systolic dysfunction with relatively good functional capacity. Mr MacNeall remains at an increased risk for future cardiac events despite near optimal attempts at further revascularisation by PCI and medical therapy.
The above conditions would, in my opinion, constitute failure to meet the medical requirements as set out in items 1.1, 1.9 and 1.11 of the relevant medical standards set out in the CASR. The amelioration of the above is partial and as such the above conditions remain relevant.
Acute coronary syndromes, progressive heart failure, and less likely malignant arrhythmias remain possible complications. I do not have access to a validated instrument to quantify this risk in percentage terms.
As per the Wu et al post CABG (circulation 2012) risk predictor score an annual mortality rate of 3.5% based on a score of 5 for age would apply. Annual likelihood of mortality and cardiovascular events would approach the 5% mark, in my opinion.
Safety relevant impairments such as sudden disturbing chest pains, dyspnoea, or syncope remain a relevant possibility in the context of [Mr MacNeall] operating an aircraft.
…
Although nearly all of his perfusion scans performed before CABG suggests lower burden of ischaemia, these were performed at a low workload resulting in possible systematic under-estimation of ischaemic burden. The perfusion scan from 2015 and the 2 stress echocardiograms after CABG suggest significant ischaemic burden. However, his exercise capacity and symptom status have improved after surgery (through probably not after the subsequent PCI). So we now have a scenario where [Mr MacNeall] was more ischaemic and symptomatic for many years prior to CABG(2013) and was able to fly with a class 1 certificate but now is unable to do so given the above concerns.
Review of records would suggest that [Mr MacNeall] has been symptomatic for coronary disease for many years, with dyspnoea and possibly fatigue being angina equivalents, despite the absence of chest tightness. The evidence that supports this conclusion is the improvement of these symptoms after bypass surgery.
(Emphasis added.)
At the hearing of this application, Mr MacNeall argued that he does not have the risk factor of “family history” as his father lived into his 90s. However, the Tribunal finds that the death of Mr MacNeall’s brother, under the age of 60 years from ischaemic heart disease, is sufficient to find that there is a positive “family history” of heart disease, regardless of the age or cause of death of Mr MacNeall’s other family members.
At the hearing, Mr MacNeall also argued that he does not have the risk factor of “hypertension”. Mr MacNeall conceded that he has had hypertension in the past, but that his blood pressure had been normal for many years. However, noting that the CASA medical examination reports and the reports from Dr Hands of Western Cardiology from 2008 onwards report that Mr MacNeall has been on the antihypertensive medication karvea or irbesartan 300mg daily[7], the Tribunal finds that Mr MacNeall has hypertension that is controlled with karvea or irbesartan.
[7] For example, see Exhibit 1 at p 49, p67, p74, p 83, p99, p102, p117 and p163.
Further, Mr MacNeall argued at the hearing that he does not have the risk factor of “hypercholesterolaemia”. Mr MacNeall acknowledged that he has had high cholesterol levels in the past, but that his levels had been normal for many years. However, noting that the CASA medical examination reports from 2008 and the reports from Dr Hands of Western Cardiology onwards report that Mr MacNeall has been on the prescribed cholesterol lowering medications of rosuvastatin, fenofibrate and ezetimibe (or lipidil), the Tribunal finds that Mr MacNeall has hypercholesterolaemia that is controlled with rosuvastatin, fenofibrate and ezetimibe (or lipidil)[8].
[8] For example, see Exhibit 1 at p 49, p67, p74, p83, p99, p 102, p117 and p163.
At the hearing, Mr MacNeall also argued at the hearing that he does not have the risk factor of “smoking”, as he had only ever smoked a few cigarettes and had not smoked for many years. Based on the medical evidence before it, the Tribunal finds that Mr MacNeall has a distant past history of mild smoking.
It is not in dispute that Mr MacNeall has been diagnosed with left bundle branch block, multivessel coronary artery disease and prior myocardial infarction.
Mr MacNeall further argued at the hearing that he does not have current reversible multi-vessel cardiac ischaemia, and the results of the myocardial perfusion thallium scans conducted on 3 February 2015 and 12 May 2015 could be “false positives”. However, the Tribunal prefers the oral evidence of Dr Abraham (Cardiologist), who stated that the test results were “true positives” as they were consistent across two scans and consistent with other aspects of medical history.
Mr MacNeall conceded, at the hearing, that he has ischaemic cardiomyopathy and a reduced cardiac ejection fraction, but denied it was as great a fraction as stated in some of the reports before the Tribunal. However, the Tribunal prefers the oral evidence of Dr Abraham (Cardiologist), who stated that whilst the absolute value of the reduction in ejection fraction varied between tests, in all cases it was reduced.
Based on the medical evidence before it, the Tribunal finds that Mr MacNeall has the following risk factors and medical conditions:
·Classical risk factors for cardiovascular disease:
oMale gender;
oAge of 71 years;
oA positive “family history” of “ischaemic heart disease”, based on the family history of a brother who died of myocardial infarction in his 50s;
o“Hypertension”, currently controlled with irbesartan 300mg daily;
o“Hypercholesterolaemia” diagnosed on blood lipid profile, with maximum past values of cholesterol of 11.5, low density lipoprotein of 9.7, and risk ratio of 9.2, currently controlled with combination therapy of rosuvastatin, fenofibrate and ezetimibe;
oA “distant past history of mild smoking”;
·“Left bundle branch block”, diagnosed on electrocardiogram;
·“Multi-vessel coronary artery disease”, diagnosed on coronary artery angiogram;
·“Prior myocardial infarction”, diagnosed on the basis of an area of scarring in the myocardium on cardiac imaging;
·Coronary Artery Bypass Graft surgery in 2013;
·Percutaneous Coronary Artery Angioplasty and Stent to the ostium of the third lateral ventricular artery and proximal circumflex coronary artery and balloon angioplasty to a small terminal lateral ventricular artery in 2015;
·“Current reversible multi-vessel cardiac ischaemia”, diagnosed by a perfusion defect in the mid to distal anterior wall and apex and anteriolateral wall on myocardial perfusion thallium scans conducted on 3 February 2015 and 12 May 2015; and
·“Current moderate ischaemic cardiomyopathy”, represented by reduced left ventricular ejection fraction and left ventricular dilation diagnosed on myocardial perfusion thallium scans on 3 February 2015 and 12 May 2015 and moderate global left ventricular impairment post exercise diagnosed on exercise stress echocardiogram on 22 May 2015.
At the hearing, Mr MacNeall argued that the collective impact of his medical conditions carried a risk of a cardiac event of less than 2%. The letter from cardiologist Dr Mark Hands of Western Cardiology, dated 28 May 2015, supported his argument. In that letter, Dr Hands wrote:
I consider his risk of a cardiac event still remains less than 2% a year, particularly now that he has a widely patent major circumflex and obtuse marginal vessel by recent stenting.[9]
[9] Exhibit 1 at p207.
However, the evidence of Senior Medical Officer for CASA, Dr Peter Clem, and of Dr Abraham (Cardiologist) was that Mr MacNeall’s risk of a cardiac event was 5% per annum. Dr Abraham noted the negative prognostic significance of reversible ischaemia, citing the research paper by “Wu et al (circulation 2012)”, which was a clinical risk based estimation of risk. More specifically, in his report dated 15 June 2016, Dr Abraham wrote:
As per the Wu et al post CABG (circulation 2012) risk predictor score an annual mortality rate of 3.5% based on a score of 5 for age would apply. Annual likelihood of mortality and cardiovascular events would approach the 5% mark, in my opinion.[10]
[10] Exhibit 2 at p50.
In oral evidence at the hearing, Dr Abraham elaborated on his report by stating that over and above the 5% risk of a “mortality” related event, was the additional risk of an episode of “disabling morbidity” such as chest pain, shortness of breath or syncope.
The Tribunal prefers the evidence of Dr Clem and Dr Abraham, to that of Dr Hands, and finds that in Mr MacNeall’s case there is a 5% risk of a “mortality” related event, and an additional risk of an episode of “disabling morbidity” such as chest pain, shortness of breath or syncope.
Conclusions – relevant medical standards
Item 1.1 and 2.1 of medical standards 1 and 2
In considering whether Mr MacNeall fails to meet the standard at item 1.1 of the Table in r 67.150 and item 2.1 of the Table in r 67.155 on account of his medical history, there are a number of separate matters which need to be considered:
· Mr MacNeall must suffer a “condition” as defined in paragraphs (a) to (d) of item 1.1 and item 2.1 of the relevant medical standard;
· the condition must be “safety relevant”; and
· the condition must produce a “risk of incapacitation”.
Condition
The Tribunal finds that Mr MacNeall’s medical history of male gender, age, positive family history, hypertension on treatment, hypercholesterolaemia on treatment, left bundle branch block, multi-vessel coronary artery disease, prior myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary artery angioplasty and stent to the ostium of the third lateral ventricular artery and proximal circumflex coronary artery and balloon angioplasty to a small terminal lateral ventricular artery, reversible multi vessel cardiac ischaemia and moderate ischaemic cardiomyopathy, which carry with them an elevated risk of suffering from an acute coronary event or a safety relevant impairment, such as distracting chest pain, shortness of breath or loss of consciousness, is clearly capable of coming within the notion of a “disability or disease (active or latent)” (see item 1.1(b) of the Table in r 67.150 of the CASR and item 2.1(b) in the Table in r 67.155 of the CASR) and is thus a safety relevant “condition” for the purpose of items 1.1 and 2.1 of medical standards 1 and 2: refer to paragraphs 24 and 25 above.
Safety relevant
Regulation 67.015 of the CASR states:
Meaning of safety relevant
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 Tribunal finds that a raised risk of suffering from an acute coronary event or a safety relevant condition such as distracting chest pain, shortness of breath or loss of consciousness, is clearly “safety relevant” within the meaning of the definition of that term in r 67.015 of the CASR because, if Mr MacNeall were to suffer such symptoms whilst at the controls of an aircraft in flight, it would not only reduce, but would potentially be totally destructive of his capacity to exercise the privileges or perform the duties of his pilot’s licences.
Risk of incapacitation
The Tribunal is satisfied that Mr MacNeall’s medical history (as set out at paragraphs 26-38), which carries with it a risk of suffering from an acute coronary event or a safety relevant impairment such as distracting chest pain, shortness of breath or loss of consciousness, is therefore a “risk of incapacitation” for the purpose of item 1.1 and 2.1 of medical standards 1 and 2.
Consequently, the Tribunal finds that, by reason of his medical history, Mr MacNeall fails to meet item 1.1 and item 2.1 of medical standards 1 and 2.
Item 1.9 and 2.9 of medical standards 1 and 2
Items 1.9 and 2.9 of medical standards 1 and 2 provide that a person must not have a “safety relevant heart abnormality”: refer to paragraphs 24 and 25 above.
Mr MacNeall’s medical history of male gender, age, positive family history, hypertension on treatment, hypercholesterolaemia on treatment, left bundle branch block, multi-vessel coronary artery disease, prior myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary artery angioplasty and stent to the ostium of the third lateral ventricular artery and proximal circumflex coronary artery and balloon angioplasty to a small terminal lateral ventricular artery, reversible multi vessel cardiac ischaemia and moderate ischaemic cardiomyopathy, is clearly capable of coming within the definition of “safety relevant heart abnormality” for the reasons explained above for the purpose of items 1.9 and 2.9 of medical standards 1 and 2.
Item 1.11 and 2.11 of medical standards 1 and 2
Items 1.11 and 2.11 of medical standards 1 and 2 provide that a person must not be suffering from any “significant functional or structural abnormality of the circulatory tree”: refer to paragraphs 24 and 25 above.
Mr MacNeall’s medical history of male gender, age, positive family history, hypertension on treatment, hypercholesterolaemia on treatment, left bundle branch block, multi-vessel coronary artery disease, prior myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary artery angioplasty and stent to the ostium of the third lateral ventricular artery and proximal circumflex coronary artery and balloon angioplasty to a small terminal lateral ventricular artery, reversible multi vessel cardiac ischaemia and moderate ischaemic cardiomyopathy, is clearly capable of coming within the definition of “significant functional or structural abnormality of the circulatory tree” for the purpose of items 1.11 and 2.11 of medical standards 1 and 2.
(ii) Is the extent to which Mr MacNeall fails to meet the relevant medical standards “likely to endanger the safety of air navigation” for the purpose of reg 67.180(2)(e)(ii) of the CASR?
Having found that Mr MacNeall fails to meet the relevant medical standards for the issue of a Class 1 and Class 2 medical certificate (being medical standard 1 and medical standard 2, respectively), the Tribunal must next consider whether the extent to which Mr MacNeall fails to meet those standards is “likely to endanger the safety of air navigation” for the purpose of r 67.180(2)(e)(ii) of the CASR.
Meaning of “likely” to endanger the safety of air navigation – reg 67.180(e)(ii)
The meaning of “likely” in the context of the issue of aviation medical certificates by CASA pursuant to Part 67 of the CASR (and, in particular, r 67.180(2)(e)(ii) of the CASR: refer to paragraph 20 above), should be understood as a reference to a substantial or real risk and not to a remote risk of a particular event occurring.
This has been established in a number of decisions of this Tribunal including, for example, Window and Civil Aviation Safety Authority [1999] AATA 525 where the Tribunal said at [60]:
Having regard to the need to protect public safety while having regard to a person’s entitlement to pursue his or her ambitions, we consider that the word “likely” means “a substantial or real and not a remote chance”. That is not a matter which can be assessed on statistical likelihood and certainly does not mean “more likely than not”, “odds on” or “a more than 50% chance of a thing happening”. To adopt those latter three meanings would, in our view, be to place too little weight on the protection of public safety and too much on an individual’s entitlements.
(Emphasis added.)
Similarly, in Hall and Civil Aviation Safety Authority [2004] AATA 21, the Tribunal stated at [45]:
As the Tribunal stated in Re Windows (supra), the assessment of what is “likely” cannot be based on statistical likelihood. In this context, it is a matter of weighing up the requirements of air safety with the applicant’s interest in the safe exercise of the privileges and performance of the duties associated with holding a private pilot’s licence. The Tribunal’s view is that in June 2003, given the medical information available to CASA, a decision to impose a condition on Mr Hall’s Class 2 Medical Certificate was reasonable given the risks associated with his heart condition when considered in the context of air safety. In terms of the medical standard in Schedule 1, Part 1 of the old regulations, and whether his heart condition was likely to interfere with the safe exercise of his privileges or performance of his duties associated with his holding a private pilot’s licence, there was a real risk, albeit a small one. When issues of air safety are under consideration, a small risk may be sufficient to trigger the need to take appropriate action to address the risk. This was the case here.
(Emphasis added.)
In Mulholland and Civil Aviation Safety Authority [2007] AATA 1952, the Tribunal said at [65] to [67]:
Whether Mr Mulholland has a high risk or a low risk of losing consciousness while flying an aircraft is simply irrelevant. The fact is that he has a risk of incapacitation which is significantly different to the remainder of the aviator population who do not suffer from syncope or any other safety-relevant medical condition. In our view the risk of incapacitation is real and not an imaginable or fanciful risk nor is it a remote risk.
Whatever the risk may be of Mr Mulholland suffering a syncopal attack whilst flying, it is not to the point that it can be shown statistically that the risk is small. Dr Nilsson contended that the evidence does not support a finding that the frequency of syncope episodes is increasing. This is not a relevant test under the legislation. What is important is whether Mr Mulholland meets the requirements for the issue of a Class 1 or Class 2 medical certificate. If he does not, the only question remaining is whether CASA should issue to Mr Mulholland medical certificates with conditions in accordance with regulation 67.195 of the CASR. Any conditions imposed on a medical certificate must be necessary in the interests of the safety of air navigation, having regard to the medical condition of the person.
It is also important to understand that CASA must bear in mind the safety of persons other than Mr Mulholland, on the ground and in the air, and also their property. CASA’s principal concern must be the safety of air operations generally and this is clearly set out in s 9A of the Act which, relevantly, provides:
(1)In exercising its powers and performing its functions, CASA must regard the safety of air navigation as the most important consideration.
Further, in White and Civil Aviation Safety Authority [2008] AATA 543 at [80], the Tribunal accepted that the nature of the potential incapacity in question is a relevant consideration to bear in mind in assessing whether the extent to which a person fails the relevant medical standard is likely to endanger the safety of air navigation.
In Commins and Civil Aviation Safety Authority [2004] AATA 1330, the Tribunal accepted that the use to which a person’s licence is put is relevant to assessing the likelihood of a given risk presenting itself. More specifically, the Tribunal said at [23]:
The medical evidence establishes that there is a five per cent risk that Mr Commins will suffer sudden renal colic in the course of the coming year, or a one per cent risk he will do so while actually piloting an aeroplane. It is not entirely clear what a one per cent risk means in this context It might be taken to mean that if he undertakes 100 flights, there is a strong chance that he will suffer renal colic in the course of one of them, or that if he flies 100 hours, it is likely he will experience a bout of sudden renal colic. Or it might have some other statistical meaning. As a practical matter, though, when a person flies an aeroplane as much as Mr Commins does, a one per cent risk cannot be regarded as insignificant. The fact that he flies far afield, sometimes in busy control zones, in a relatively high performance twin-engine aeroplane would tend to make the risk more significant, than for example, if he were a grazier flying a Cessna 152 only for the purpose of cattle operations on a large property. Hand J expressed this correlation well in a famous passage in United States v Carroll Towing Co (1947) 159 F 2d 169 when discussing the duty of a barge owner to take precautions against the risk that the barge will break from its moorings:
the owner's duty; as in other similar situations, to provide against resulting injuries is a function of three variables: (1) The probability that she will break away; (2) the gravity of the resulting injury, if she does; (3) the burden of adequate precautions. Possibly it serves to bring this notion into relief to state it in algebraic terms: if the probability be called P; the injury, L; and the burden, B; liability depends upon whether B is less than L multiplied by P: i.e., whether B < = PL.
In Randazzo and Civil Aviation Safety Authority [2012] AATA 266 the Tribunal considered the term “likely” and also the imposition of a safety pilot condition on the grant of a licence by CASA and said, at [100] to [102], that:
In coming to a decision, we have taken into account the term likely which, when used in the context of aviation Medical Certificates pursuant to Part 67 of the CASR, is understood to be reference to a substantial or real and not remote risk to a particular event occurring. We are mindful of a number of decisions where the term has been considered, Re Window v Civil Aviation Safety Authority [1999] AATA 525: (1999) 56 ALD 316, Re Hall and Civil Aviation Safety Authority [2004] AATA 21, Mulholland and Civil Aviation Safety Authority [2007] AATA 1952 and White and Civil Aviation Safety Authority [2008] AATA 543; (2009) 105 ALD 33.
By way of example, we noted that in Re Window v Civil Aviation Safety Authority, the Tribunal stated:
Having regard to the need to protect public safety while having regard to a person’s entitlement to pursue his or her ambitions, we consider that the word ‘likely’ means ‘a substantial or real and not a remote chance”. That is not a matter which can be assessed on statistical likelihood and certainly does not mean “more likely than not”, “odds on” or “more than 50% chance of a thing happening”. To adopt those latter three meanings would, in our view, be to place too little weight on the protection of public safety and too much on an individual’s entitlements.
We have noted Mr Randazzo’s submissions that it is difficult and inconvenient to negotiate a safety pilot, and for that pilot to provide a report to CASA on each occasion, and that it is potentially expensive to do so. Unfortunately the safety of aviation is the paramount consideration, and whilst we are mindful of potential difficulties, we cannot take that submission into account.
(Emphasis added.)
Based on the medical evidence before the Tribunal (as outlined in paragraphs 26-38 above), the Tribunal is not satisfied that the extent to which Mr MacNeall does not meet the respective relevant criterion of the relevant medical standards would not endanger the safety of air navigation. This risk remains at an unacceptable level.
Mr MacNeall’s history of male gender, age, positive family history, hypertension on treatment, hypercholesterolaemia on treatment, left bundle branch block, multi-vessel coronary artery disease, prior myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary artery angioplasty and stent to the ostium of the third lateral ventricular artery and proximal circumflex coronary artery and balloon angioplasty to a small terminal lateral ventricular artery, reversible multi vessel cardiac ischaemia and moderate ischaemic cardiomyopathy, poses a real and not remote risk that Mr MacNeall may suffer from an acute coronary event, or from a safety-relevant impairment such as distracting chest pain, shortness of breath or loss of consciousness, which if they occurred during flight, would seriously compromise the safety of air navigation.
Based on the medical evidence before the Tribunal (refer to paragraphs 36-39 above), Mr MacNeall’s risk of suffering from a “mortality” related event is 5% per annum, and there is also an additional risk of an episode of “disabling morbidity” such as chest pain, shortness of breath or syncope above this risk of mortality.
The potential that Mr MacNeall is at a risk of an acute coronary event or a safety relevant impairment, such as distracting chest pain, incapacitating chest pain, shortness of breath or loss of consciousness, means that the extent to which Mr MacNeall fails to meet the relevant class 1 and class 2 medical standards on the basis of his medical history is clearly likely to affect his ability to safely exercise the privileges of his pilot’s licences.
The prospect of Mr MacNeall suffering from an incapacitating coronary event at the controls of an aircraft in flight presents as a real and substantial and not remote or fanciful risk that is unacceptable. Such an event would clearly lead to a degree of incapacity which could be totally destructive of the applicant’s ability to control an aircraft in flight. This fact renders intolerable, even slight increases in risk above that which exists in the general population. Even a mild event could produce pain and discomfort which might have the effect of distracting a pilot from the task of flying the aircraft. Sudden unexpected and painful distraction at a critical point during a flight could have catastrophic outcomes in this environment. As pointed out in cases like Hall and Mulholland, the fact that the risk in percentage terms is small does not mean that any such risk is not real or substantial for the purposes of the exercise of CASA’s (and, in its shoes, the Tribunal’s) powers under reg 67.180 of the CASR: refer to paragraphs 53-54 above.
For the above reasons, the Tribunal cannot be satisfied, to the requisite standard, that Mr MacNeall’s failure to meet the relevant medical standards for a Class 1 and Class 2 medical certificate (being medical standards 1 and 2, respectively) is not likely to endanger the safety of air navigation. In reaching this conclusion, the Tribunal is mindful of the requirement in s 9A(1) of the CAA which dictates that a suitably cautious approach must be taken to assessing the risks posed to the safety of air navigation by Mr MacNeall’s medical history: refer to paragraphs 26-38 above.
(iii) Can any conditions be imposed upon a medical certificate under reg 11.056 of the CASR which would ameliorate the threat posed to air safety by Mr MacNeall’s failure to meet the Class 1 or Class 2 relevant medical standards?
Regulation 11.056 of the CASR allows CASA (and, in its shoes, the Tribunal) to grant a medical certificate to the holder of a licence subject to conditions. Regulation 11.056 of the CASR states:
Authorisation may be granted subject to conditions
(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
(ab)for an authorisation to which subregulation 11.055(1B) applies—in the interests of preserving a level of aviation safety that is at least acceptable; or
(ac)for an authorisation that is an experimental certificate—in the interests of the safety of other airspace users or persons on the ground or water; or
(b)to ensure that, as far as practicable, the environment is protected from:
(i) the effects of the operation and use of aircraft; and
(ii)the effects associated with the operation and use of aircraft.
…
(2)A condition imposed under this regulation must be set out in the authorisation.
Thus, in accordance with reg 11.056 of the CASR, CASA can issue Mr MacNeall with a medical certificate which contains conditions, if those conditions can sufficiently ameliorate the risk to air navigation safety posed by his failure to meet the relevant medical standards.
As set out above (in paragraph 5), in the Class 1 Medical Certificate Decision, CASA concluded, having regard to Mr MacNeall’s medical history, that risk to air navigation safety posed by Mr MacNeall’s failure to meet medical standard 1 could not be satisfactorily ameliorated with the imposition of a condition on his Class 1 medical certificate.
The Tribunal agrees with this conclusion. As outlined above (in paragraphs 58-62), the extent to which Mr MacNeall presents as a risk to aviation safety is real and not remote, and for this reason, the Tribunal finds that that there are no conditions which would adequately ameliorate the risk to air navigation safety with respect to Mr MacNeall’s Class 1 Medical Certificate, having regard to his medical history and level of risk.
As set out above (in paragraph 8), in the Class 2 Medical Certificate Decision, CASA concluded, having regard to Mr MacNeall’s medical history, that with respect to a class 2 medical certificate, the risk to air navigation safety posed by Mr MacNeall’s failure to meet medical standard 2 could be satisfactorily ameliorated with the imposition of a condition on his medical certificate which allows Mr MacNeall to fly, but only if accompanied by a safety pilot.
The Tribunal agrees with this conclusion. In Mr MacNeall’s case, the Tribunal finds that conditions can be imposed on the issue of a Class 2 medical certificate which would adequately ameliorate the risks to air navigation safety posed by his condition. More specifically, the Tribunal agrees with CASA’s conclusion that if Mr MacNeall is issued with a Class 2 medical certificate endorsed with a condition that he fly as or with a safety pilot, then any risks to air navigation safety would be adequately managed. This is because if Mr MacNeall were to become incapacitated, or to suffer significant symptoms of his medical conditions, the safety pilot would be able to assume control of the aircraft and ensure a safe landing.
DECISION
For the above reasons, the Tribunal affirms the Class 1 Medical Certificate Decision and the Class 2 Medical Certificate Condition.
I certify that the preceding 70 (seventy) paragraphs are a true copy of the reasons for the decision herein of Senior Member CR Walsh & Professor J Quinlivan, Member .....(Sgd).......................................................
Administrative Assistant
Dated 25 November 2016
Dates of hearing 8 & 9 November 2016 Applicant In person Representative for the
RespondentMs C Swain
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