DR BARRYMORE WALTERS and CIVIL AVIATION SAFETY AUTHORITY
[2009] AATA 330
•11 May 2009
Administrative Appeals Tribunal
DECISION AND REASONS FOR DECISION [2009] AATA 330
ADMINISTRATIVE APPEALS TRIBUNAL )
) No 2007/4576
GENERAL ADMINISTRATIVE DIVISION ) No 2008/6100 Re DR BARRYMORE WALTERS Applicant
And
CIVIL AVIATION SAFETY AUTHORITY
Respondent
DECISION
Tribunal Mr Egon Fice, Member
Miss E.A. Shanahan, Member
Date11 May 2009
PlaceMelbourne
Decision The Tribunal sets aside the decision under review and in substitution decides that Civil Aviation Safety Authority must issue a Class 2 Medical Certificate to Dr Walters without conditions. (sgd) Egon Fice
Member
CIVIL AVIATION – Class 2 Medical Certificate – medical standard – coronary artery disease – ischaemic heart disease – medically significant condition – safety relevant – endanger the safety of air navigation – risk factor control.
Civil Aviation Regulations 1988
Civil Aviation Safety Regulations 1998
Re Terrence Gerald Mulholland and Civil Aviation Safety Authority [2007] AATA 1952
REASONS FOR DECISION
11 May 2009 Mr Egon Fice, Member
Miss E.A. Shanahan, Member1.On 29 August 2007 Dr T.S Sham, a Medical Officer employed by the Civil Aviation Safety Authority (CASA), notified Dr Walters that his Class 2 Medical Certificate would be renewed only with the condition that he fly as, or with, a co-pilot. The Class 2 Medical Certificate was valid for a period of 12 months. CASA issued a conditional medical certificate because, when Dr Walters underwent a thallium myocardial perfusion scan in July 2006, it was reported that he suffered from a moderate area of reversible ischaemia in the distal anterior wall and apex. A subsequent angiogram disclosed localised narrowing in the left anterior descending branch of the left coronary artery (LAD), the right coronary artery and the circumflex arteries.
2.Before CASA would issue the Class 2 Medical Certificate with conditions, Dr Walters was required to agree to the conditions of the endorsement by returning to CASA a signed pro forma document to that effect. He did not do so. Instead, on 18 September 2007, he lodged an application with the Tribunal for a review of the decision of 29 August 2007(matter No 2007/4576).
3.In 2008 Dr Walters underwent a number of other tests and examinations in an attempt to satisfy CASA that he should be granted an unconditional Class 2 Medical Certificate. In October 2008 Dr Walters again submitted to an examination by a Designated Aviation Medical Examiner (DAME), Dr Tunbridge. On 15 October 2008 Dr Walters provided to the Principal Medical Officer of CASA (Dr Sham) further reports and test results relating to his health status. On 25 November 2008 Dr Sham informed Dr Walters that the conditions imposed on his Class 2 Medical Certificate in 2007 would remain until there was further medical information for reconsideration otherwise. On 25 November 2008 CASA issued Dr Walters with a Class 2 Medical Certificate endorsed with the condition that he only fly as or with a co-pilot. That medical certificate was valid for 12 months. Dr Walters remained dissatisfied with CASA’s decision of 25 November 2008 and lodged a review application with the Tribunal on 17 December 2008 (matter No 2008/6100).
4.Although it is not clear from the evidence whether CASA in fact issued Dr Walters with a Class 2 Conditional Medical Certificate in August 2007, it was agreed between the parties that there was no purpose in further pursuing the application in matter No 2007/4576 because, if a certificate did in fact issue, it would nevertheless have expired at the end of August 2008. Even if the Tribunal were to find in favour of Dr Walters, such a decision would be of no practical effect (see ReTerrence Gerald Mulholland and Civil Aviation Safety Authority [2007] AATA 1952 at [35-42]). Accordingly, the application in matter No 2007/4576 is dismissed pursuant to s 42B(1)(a) of the Administrative Appeals Tribunal Act 1975 (AAT Act).
5.The issues which we are required to resolve in matter No 2008/6100 are whether:
(a) Dr Walters has a medically significant condition;
(b) if Dr Walters has a medically significant condition, whether it is safety relevant; and
(c) if Dr Walters has a medically significant condition which is safety relevant, whether the conditions imposed by CASA on his Class 2 Medical Certificate are necessary in the interests of the safety of air navigation.
THE LEGISLATIVE SCHEME
6.Regulation 5.04 of the Civil Aviation Regulations 1988 (CAR) provides that, without the permission of CASA, the holder of a flight crew licence must not perform a duty authorised by the licence if the person does not hold a current medical certificate that is appropriate to the licence.
7.A medical certificate is appropriate to a flight crew licence if, in the case of a private pilot licence, the certificate is a Class 1 or Class 2 Medical Certificate (Reg 5.04(3) (b) of the CAR).
8.Regulation 67.175 of the Civil Aviation Safety Regulations 1998 (CASR) provides that a person may apply to CASA for the issue of a medical certificate. On receiving an application under Reg 67.175, CASA must issue a medical certificate to the applicant only if, relevantly, the applicant meets the requirements of Reg 67.180(2) (Reg 67.180(1)(a)).
9.For the purposes of Reg 67.180(1)(a) of the CASR, the relevant requirements are that 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 (Reg 67.180(2)(e))…
10.A person who satisfies the criteria set out in Table 67.155 of the CASR, meets medical standard 2 (Reg 67.155).
11.Item 2.1 on Table 67.155 of the CASR provides:
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.
12.As far as the cardiovascular system is concerned, Items 2.9-2.11 set out the criteria which must be met for medical standard 2 as follows:
2.9 Has no safety-relevant heart abnormality.
2.10Systolic and diastolic blood pressures are within limits specified by CASA from time to time in the Designated Aviation Medical Examiner’s Handbook (even if approved drugs are used to maintain the blood pressure within those limits).
2.11 Has no significant functional or structural abnormality of the circulatory tree.
13.The expression medically significant condition is defined in Reg 67.010 of the CASR to include:
(a) any of the following (no matter how minor):
(i)any illness or injury;
(ii)any bodily infirmity, defect or incapacity;
(iii)any mental infirmity, defect or incapacity;
(iv)any sequela of an illness, injury, infirmity, defect or incapacity mentioned in subparagraph (i), (ii) or (iii); and
(b) any abnormal psychological state; and
(c) drug addiction and drug dependence; and
(d)for a woman – pregnancy and the physiological and psychological consequences of pregnancy or of termination of pregnancy.
14.The meaning of the expression safety-relevant is set out in Reg 67.015 of the CASR 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.
15.Where an applicant is unable to meet the criteria for medical standard 1, 2 or 3, CASA may, in its discretion, nevertheless issue a conditional medical certificate. Reg 67.195, insofar as it is relevant, provides:
(1)CASA may issue a medical certificate to a person subject to any condition that is necessary in the interests of the safety air navigation, having regard to the medical condition of the person.
DR WALTERS’ MEDICAL CONDITION
16.In accordance with the requirements for a person of his age (75 years) to hold a commercial pilot’s licence, Dr Walters has undergone regular medical examinations by his DAME, Dr Raoul Tunbridge and annual stress electro-cardiographs (ECG’s). On 24 July 2006 his exercise ECG disclosed a mild abnormality. A thallium myocardial perfusion scan on the same day showed a mild to moderate reduction in perfusion in the distal anterior wall of the left ventricle extending to the apex and distal septum. During the exercise ECG atrial ectopic beats were frequent. The left ventricular ejection fraction was 65 per cent, much above the normal level of 45 per cent. His myocardial perfusion returned to normal after rest. Dr Walters did not develop any chest pain during either examination. Nevertheless, he had evidence of ischaemic heart disease (IHD).
17.In view of the myocardial perfusion scan findings, coronary angiography was indicated and this was undertaken on 7 August 2006. The investigation was carried out by Dr Michael Rowe who reported that:
The left main coronary artery was normal. The left anterior descending artery (LAD) had a 70 to 80 per cent stenosis just proximal to the diagonal, with a further 30 per cent stenosis a little more distally and a further 70 per cent stenosis more distally still. The circumflex has a 70 per cent mid-portion stenosis. The right coronary artery had a 70 per cent distal stenosis and left ventricular angiography showed normal function.
18.Based on the combined findings of these investigations, Dr Walters was issued a Class 2 Medical Certificate – As or With Co-pilot – valid for a period of 12 months ending on 29 August 2007.
19.On 8 September 2008 Dr Walters had a further exercise stress ECG followed by a thallium myocardial perfusion scan. In the intervening 12 months Dr Walters had, under the supervision of his treating cardiologist, Dr John Counsell, embarked on a management plan to reduce his IHD risk factors. Dr Walters exercised regularly, maintained his weight at 65 to 69 kilograms, carefully monitored his diet and took the prescribed medication Lipitor (to lower his cholesterol and lipids), the beta blockers Metoprolol and Coversyl which are cardio-protective, and aspirin to reduce platelet clumping and thereby the risk of coronary artery thrombus formation. Dr Walters has never been hypertensive and is not diabetic. On this regime his serum cholesterol and lipid levels fell to well within normal limits; in particular his HDL/cholesterol ratio decreased to 1.3 mmol/per litre (normal is less than 2.2).
20.The exercise ECG and the thallium myocardial perfusion scan performed on 8 September 2008 were conducted while Dr Walters was taking the prescribed beta blockers. Both test results were normal. No ischaemic changes were demonstrated.
21.On receipt of these latest results, CASA declined to reconsider the conditions imposed in August 2006 on the medical advice of Dr Habersberger concerning the negative perfusion scan of September 2008. Dr Habersberger’s concerns related to the fact that the tests had been performed whilst Dr Walters was taking beta blockers.
22.As there was no clinical indication for a repeat coronary angiogram, the Tribunal (a cardiothoracic surgeon (now retired)) suggested during a telephone directions hearing that Dr Walters consider undergoing CT scanning angiography, a far less invasive procedure. CT angiography was undertaken on 8 October 2008 and it showed, in summary;
soft plaque causing occlusion in the LAD and calcific plaque causing borderline stenosis also in the LAD. Heavy calcification within the right coronary artery system but no significant flow limiting stenosis.
23.There was a 75 per cent mixed calcific and soft plaque in the mid circumflex coronary artery. The areas of narrowing in the right coronary artery due to both calcific and soft plaque were all less than 50 per cent and the majority less than 25 per cent.
24.Dr Walters had further stress ECG and myocardial perfusion scanning performed on 6 January 2009 but on this occasion he ceased beta blocker medication 72 hours prior to the testing.
25.The exercise or stress test ECG showed minor non-specific S-T changes; and on exercise, a one millimetre depression in the S-T segment. Two non-sustained salvos of ventricular tachycardia, of six and nine beats respectively, were recorded in the second stage of the test. Dr Walters experienced no chest pain. The myocardial perfusion scan revealed a focal, moderate to severe, perfusion defect in the distal anterior wall extending into the apex. In the delayed study there was no significant change to left ventricular size, this being normal. The left ventricular ejection fraction was 59 per cent. Dr O Pointon, the reporting radiologist, considered the changes in this perfusion scan to be more extensive than those seen in July 2006.
26.Dr Counsell performed an additional exercise stress test on 18 February 2009, after Dr Walters had resumed taking his beta blockers. This was entirely normal and left ventricular function was excellent.
DOES DR WALTERS MEET THE MEDICAL STANDARD FOR THE ISSUE OF A CLASS 2 MEDICAL CERTIFICATE?
27.We have no doubt Dr Walters has a medically significant condition, as that expression is defined in Reg 67.010 of the CASR. His condition can be simply stated as asymptomatic coronary artery disease with evidence of myocardial ischaemia or, IHD. That clearly satisfies the description of a bodily infirmity, defect or incapacity.
28.A medically significant condition is safety relevant if it satisfies the description in Regulation 67.015 of the CASR. The problem with Dr Walters’ medical condition is that, according to Dr Habersberger, patients with triple vessel disease, such as Dr Walters, are at a risk of acute myocardial infarction and/or sudden death. The symptoms of myocardial infarction include prolonged heavy pressure or squeezing pain in the centre of the chest behind the sternum. The pain may spread or be localised to the shoulder, neck, arm and fourth and fifth fingers of the left hand, to the back, to the teeth or to the jaw. The symptoms may be accompanied by nausea and vomiting, sweating, and shortness of breath. A delay in treatment may cause loss of life. Therefore, in the event that Dr Walters were to suffer myocardial infarction, there can be no room for doubt that it would reduce or be likely to reduce his ability to safely fly an aeroplane. It follows that Dr Walters’ medical condition falls within the description of safety relevant for the present purposes.
29.The question is then whether Dr Walters is able to meet the criteria set out in Table 67.155 of the CASR. In order to do so, it must be established that he has no safety relevant condition, including a disease (active or latent), that produces any degree of functional incapacity or a risk of incapacitation. In addition, he must satisfy the criteria relating to the cardiovascular system, and in particular, he must not have a safety relevant heart abnormality. Quite plainly, the medical evidence discloses that Dr Walters does have a safety relevant medical condition which produces a risk of incapacitation and he has a safety relevant heart abnormality. Accordingly, we must find Dr Walters does not satisfy the criteria for medical standard 2. However, that is not the end of the matter. Where an applicant does not meet the medical standard for the issue of a medical certificate, if the applicant is not likely to endanger the safety of air navigation, then a medical certificate must be issued (Reg 67.180 (2)(e)(ii) of the CASR).
IS DR WALTERS’ MEDICAL CONDITION LIKELY TO ENDANGER THE SAFETY OF AIR NAVIGATION?
30.Not surprisingly, the medical practitioners who reviewed Dr Walters’ medical history were significantly divided in their opinions about the risks Dr Walters faces of experiencing myocardial infarction and/or sudden death. Dr Habersberger, who has provided expert consultant cardiological opinions to CASA for many years, expressed a very conservative opinion. Initially, in a report dated 8 December 2007, he concluded that Dr Walters was unfit to fly in any capacity until he had undergone further thallium perfusion scanning and coronary angiographic assessment to determine the state of his coronary arteries. Dr Habersberger’s opinion was based on a coronary angiogram disclosing three vessel disease and a perfusion scan revealing reversible myocardial ischaemia. He estimated Dr Walters’ annual mortality risk at 10 to 12 per cent.
31.In a later report dated 12 November 2008, Dr Habersberger referred to the thallium myocardial perfusion scan performed on 8 September 2008, done while Dr Walters was on medications of Coversyl (2.5 mg daily) and Betaloc (25 mg bd). He noted that the thallium perfusion scan was now negative where as it was positive in July 2006. He suggested that this was due to the development of collaterals which had developed between the LAD and the right coronary artery. However, he noted that this thallium scan was done while Dr Walters was taking a betablocker, which he said may mask the development of myocardial ischaemia. He noted that beta blockers do not necessarily prevent the onset of myocardial infarction and/or sudden death. Dr Habersberger restated his concern that Dr Walters had significant underlying coronary artery disease and although his exercise thallium myocardial perfusion scan was negative, he was not satisfied that Dr Walters could fly solo unless it could be demonstrated that his exercise thallium scan was also negative off beta blockers, or that an invasive coronary angiogram disclosed an acceptable level of disease.
32.Dr Habersberger provided a third report dated 13 March 2009, after he was shown the results of Dr Walters thallium myocardial perfusion scan performed on 6 January 2009. That thallium scan was performed after Dr Walters had ceased taking beta blockers for three days. Dr Habersberger referred to the conclusion of Dr Pointon, who reported the study, that Dr Walters’ myocardial ischaemia at that time was more extensive than was seen in July 2006. Dr Habersberger was particularly worried by two salvos of ventricular tachycardia lasting six and nine beats. He again repeated that Dr Walters was unsuitable to fly alone because of the risk of sudden cardiac incapacitation. In his opinion, ventricular tachycardia is often a precursor of ventricular fibrillation, irrespective of whether the patient has symptoms. He also said that coronary artery disease continues to get progressively worse in the majority of cases, inferring that this was likely to happen to Dr Walters.
33.Dr Counsel provided three reports and gave evidence before the Tribunal. He had first seen Dr Walters in April 2007 on referral from his DAME, Dr Tunbridge. Dr Counsel said that despite the coronary angiogram findings of August 2006 showing a localised narrowing in the LAD and circumflex arteries, a decision was made for conservative therapy. Dr Counsel said this seemed reasonable as there was good evidence that mild to moderate two vessel disease with well preserved underlying heart function does not associate with better outcomes if subjected to angioplasty or bypass surgery. He qualified his opinion by stating that it depended a lot on the follow up with the medications and lifestyle.
34.Dr Counsel also referred to the results of a recent trial in North America, which suggested that angioplasty in a group of lower risk patients, such as Dr Walters, did not produce a better outcome than medical treatment alone. Dr Counsel performed a physical examination of Dr Walters which revealed no abnormal findings. Dr Counsel considered Dr Walters highly likely to remain safe and stable from a cardiovascular view point given his excellent risk factor control.
35.Following performance of the CT angiogram and the further myocardial perfusion scan in the absence of beta blockers, Dr Counsel provided another report dated 11 March 2009. He summarised the results to date, noting that the left anterior descending coronary artery was now totally blocked and as no myocardial infarction had occurred, collateral circulation must have developed between the distal LAD and the right coronary artery. Dr Counsel referred to angiogram evidence collected over many years which disclosed that coronary artery disease did not progress, even over a five to ten year period, when risk factors were well controlled and the current modern cocktail of vascular medications was in place.
36.In his oral evidence, Dr Counsel disagreed with Dr Habersberger’s estimate of the risk of myocardial infarction and/or sudden death in Dr Walters at 10 to 12 per cent per annum. He believed that Dr Walters was behaving clinically as a person with two, rather than three, vessel disease and as such his risk rate was in the order of 5 per cent over a period of five years, which is the same rate as for his normal age group. Dr Counsel was of the opinion that plaques were more stable in older persons and that the risk of developing an arrhythmia in association with ischaemia was slight. In his opinion, Dr Habersberger was pessimistic about Dr Walters’ prognosis and the literature was very controversial on this subject. Dr Counsel said he felt safer in his management of Dr Walters knowing that he had now totally blocked his left anterior descending coronary artery without the occurrence of myocardial infarction, and that CT angiography showed the right coronary artery disease to be of lesser severity and stable.
37.In his oral evidence, Dr Habersberger described CT angiography as the way of the future, as it provided data in the form of differentiation between hard and soft plaques that was not available on ordinary angiography. In Dr Walters’ case, the CT angiogram showed less disease in the right main coronary artery than reported in the coronary angiogram and this could represent regression in the size of the plaques. He agreed with Dr Counsel that Dr Walters’ management was now safer following the total occlusion of the LAD. This, he believed, ruled out the likelihood of myocardial infarct but the occurrence of an arrhythmia was still possible, although the risk was reduced by medication with beta blockers. Dr Habersberger said he had patients under his management who, despite beta blockers, had suffered a myocardial infarction and ventricular fibrillation, but he was unable to recall whether their medical control was that of the more recent regime of beta blockers, statins and aspirin which is now regarded as the treatment of ischaemic heart disease. Figures for mortality of 10 to 12 per cent per annum which he quoted in his report were no longer current as these were the reported figures prior to the introduction of the above stated medical regime. The mortality rates related to three vessel disease was now within the vicinity of 4 per cent with an annual mortality of 1.3 per cent and an incidence of myocardial infarction of 2 to 4 per cent. He agreed with Dr Counsel that Dr Walters’ clinical course had been more like that of two vessel rather than three vessel disease.
38.Under cross-examination by Dr Walters, Dr Habersberger reiterated his concerns regarding the salvos of ventricular tachycardia that occurred during the myocardial perfusion study and exercise testing in January 2009. He did not regard Dr Walters’ risk as being less than 1 per cent, even on beta blockers.
39.In our opinion, Dr Walters’ case appears to be the exception rather than the rule. His stress testing has disclosed excellent effort tolerance for his age and it places him within the top 15 per cent of fitness for age matched healthy individuals. With the use of a beta blocker, resulting in lowering of the heart rate, there was no evidence of ischaemia either in the form of ECG change or the development of angina. As Dr Counsel said, with current medications and his current fitness level, training and heart rate control, there was no evidence of demonstrable ischaemia. Furthermore, as the CT coronary angiogram performed in October 2008 disclosed, his LAD is occluded in mid course. In that sense it is stable. Despite that, Dr Walters did not suffer a myocardial infarct; indicating that he has developed very functional collateral circulation between his right dominant coronary artery and his left anterior descending artery distal to the obstruction. In effect, he has given himself a bypass graft. Furthermore, his collateral blood flow from right and circumflex arteries is sufficient to keep the distal LAD territory and apex adequately supplied under stress to quite high workload. As Dr Counsel said, this has resulted in Dr Walters having effort tolerance clearly above the expected for an age-matched healthy cohort.
40.In addition, Dr Walters’ risk factor control is excellent, with his weight currently at normal levels. He is a non-smoker. He has a very favourable lipid profile with total cholesterol 2.8, HDL 1.3, LDL at 1.2 and triglycerides 0.6. Although Dr Habersberger seemed to have expressed his greatest concern at Dr Walters’ two episodes of ventricular tachycardia, lasting up to nine beats, Dr Counsel was not overly concerned by that; particularly if Dr Walter’s remained on his beta blocker medication. Although Dr Counsel accepted that the potential for non-specific ageing effects remained, in his view this is a slower process particularly where risk factor and blood pressures are well controlled as they are in his case. Although we accept the overall evidence is conflicting in parts, we are persuaded by Dr Counsel’s risk assessment and find that although Dr Walters does not meet the medical standard for the issue of a Class 2 Medical Certificate, the extent to which he does not meet the standard is not likely to endanger the safety of air navigation. Having so found, we need not proceed to examine whether Dr Walters should be issued a conditional medical certificate pursuant to Reg 67.195 of the CASR.
CONCLUSION
41.In our opinion, Dr Walters satisfies the requirements for the issue of a Class 2 Medical Certificate in accordance with Regulation 67.180(2)(e)(ii). Therefore, CASA must issue a Class 2 Medical Certificate to Dr Walters without conditions.
I certify that the fourty one (41) preceding paragraphs are a true copy of the reasons for the decision herein of
Mr Egon Fice, Member
Signed Cassie Renfrew
ClerkDate of Hearing 16 March 2009
Date of Decision 11 May 2009
Applicant Self RepresentedSolicitor for the Respondent Civil Aviation Safety Authority Legal Services Group
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