Sarah McKay and Civil Aviation Safety Authority

[2012] AATA 607

[2012] AATA 607 

Division	GENERAL ADMINISTRATIVE DIVISION
File Number	2011/2374
Re	Sarah McKay
APPLICANT
And	Civil Aviation Safety Authority
RESPONDENT

DECISION

Tribunal	Mr Egon Fice, Senior Member Dr Kerry Breen, Member
Date	10 September 2012
Place	Melbourne

The Tribunal affirms the decision of the Civil Aviation Safety Authority made on
5 January 2011 to refuse to issue to Ms Sarah McKay a Class 2 medical certificate.

......[sgd Egon Fice]..................................................................

Mr Egon Fice, Senior Member

AVIATION – Class 2 Medical Certificate – the safety of air navigation – medical standard for the issue of a Class 2 Medical Certificate – safety-relevant condition – epilepsy – seizures – epilepsy surgery – student pilot licence

Civil Aviation Act 1988 (Cth) ss 9A, 20AB

Civil Aviation Regulations 1988 (Cth) regs 5.04, 5.08

Civil Aviation Safety Regulations 1998 (Cth) regs 11.055, 67.010, 67.015, 67.145, 67.155, 67.175, 67.180

Re Lachlan Window and Civil Aviation Safety Authority [1999] AATA 525

Dorland’s Illustrated Medical Dictionary (27th ed, 1988)

REASONS FOR DECISION

Mr Egon Fice, Senior Member
Dr Kerry Breen, Member

1. Ms Sarah McKay wished to undertake flying instruction and on 8 April 2009 she applied for a Class 2 medical certificate.  She was examined by Dr IMD Davis who is a Designated Aviation Medical Examiner (DAME).  Because Ms McKay has a medical history of seizures, she was required to provide a report from her neurologist, Professor M Cook.

2. After reviewing the report prepared by Prof Cook and a further report from Professor RG Beran, also a neurologist, on 9 September 2010 the Civil Aviation Safety Authority (CASA) informed Ms McKay that her application for a Class 2 medical certificate had been refused.  That was because she failed to meet the medical standard for a Class 2 medical certificate.  Ms McKay was informed that the Aviation Medicine Section of CASA was prepared to look at further medical reports which may demonstrate that she met the medical standard, or why the issue of a medical certificate would not be likely to affect the safety of air navigation.

3. After obtaining a further report on 5 January 2011 from a neurologist, Dr EB Tomlinson, CASA notified Ms McKay that it had completed its assessment of the further medical information provided and had decided to refuse to issue her with a Class 2 medical certificate in accordance with the Civil Aviation Safety Regulations 1998 (CASR).

4. Ms McKay applied for reconsideration of the decision to refuse her application for a Class 2 medical certificate.  Following reconsideration, on 2 June 2011 CASA informed Ms McKay that it affirmed its original decision.  On 17 June 2011 Ms McKay lodged an application with the Tribunal seeking review of CASA's decision to refuse to grant her a Class 2 medical certificate.

5. The issues which we are required to determine are:

   (a)whether Ms McKay meets the medical standard for the issue of a Class 2 medical certificate;

   (b)if Ms McKay does not meet the medical standard for the issue of a Class 2 medical certificate, whether a medical certificate should be issued because her medical condition is not likely to affect the safety of air navigation; and

   (c)if Ms McKay does not meet the medical standard for the issue of a Class 2 medical certificate, whether a medical certificate should be issued subject to conditions.

   QUALIFICATIONS OF FLIGHT CREW

6. A person cannot perform the duties of a pilot without holding an appropriate licence. Section 20AB(1) of the Civil Aviation Act 1988 (CA Act) provides:

   20AB  Flying aircraft without licence etc.

   (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.

   Penalty:  Imprisonment for 2 years.

7. The expression civil aviation authorisation is defined in s 3 of the CA Act as follows:

   civil aviation authorisation means an authorisation under this Act or the regulations to undertake a particular activity (whether the authorisation is called an AOC, permission, authority, licence, certificate, rating or endorsement or is known by some other name).

8. Part 5 of Division 2 of the Civil Aviation Regulations 1988 (CAR) sets out the general requirements that apply to flight crew licences.  Reg 5.04 deals with medical certificates.  In so far as it is relevant, it provides:

   5.04    Medical certificate: flight crew licence

   (1)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.

   Penalty:   50 penalty units.

   (1A)An offence against subregulation (1) is an offence of strict liability.

   Note For strict liability, see section 6.1 of the Criminal Code.

   (2)CASA may, on the written or oral application of the holder of a flight crew licence, permit the holder to perform a duty essential to the operation of an Australian aircraft during flight time without holding a current appropriate medical certificate if:

   (a)in all the circumstances it is reasonable to allow the holder to perform the duty without holding the certificate; and

   (b)the performance of the duty by the holder without holding the certificate will not adversely affect the safety of air navigation.

   (3)For the purposes of this regulation, a medical certificate is appropriate to a flight crew licence if:

   (a)in the case of an air transport pilot licence, a commercial pilot licence (other than a commercial pilot (balloon) licence), a multi‑crew pilot (aeroplane) licence, a flight engineer licence or a student flight engineer licence — the medical certificate is a class 1 medical certificate; and

   (b)in the case of a commercial pilot (balloon) licence, a private pilot licence, a student pilot licence or a flight radiotelephone licence — the medical certificate is a class 1 or class 2 medical certificate.

   Note 1   Class 1 and class 2 medical certificates are issued under Part 67 of CASR.

   Note 2The medical standards for obtaining each class of medical certificate are set out in Part 67 of CASR.

9. Clearly, for Ms McKay to undertake flying instruction, she must hold a student pilot licence for which she must hold a Class 1 or Class 2 medical certificate.  The expression flight crew licence is defined in Reg 5.08 and it includes not only a variety of pilot licences, but also other licences such as a radiotelephone operator licence and flight engineer licence.  We have no doubt that it is correct to say that it would not be reasonable to allow a student pilot to perform flying duties without holding a Class 2 medical certificate either with or without conditions.  She is unlikely to fall within the exceptions set out in Reg 5.04(2).

   MEDICAL CERTIFICATES

10. Part 67 of the CASR deals generally with medical requirements.  Reg 67.145 provides for three classes of medical certificate.  Reg 67.155 provides that a person who satisfies the criteria in table 67.155 meets medical standard 2.  The criteria relevant to Ms McKay's application are as follows:

    Table 67.155    Criteria for medical standard 2

    Item     Criterion

    Abnormalities, disabilities and functional capacity

    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

    …

    Nervous system

    2.7 Has no established medical history or clinical diagnosis of:

    (a)  a safety‑relevant disease of the nervous system; or

    (b) epilepsy; or

    (c)a disturbance of consciousness for which there is no satisfactory medical explanation and which may recur

    2.8 Is not suffering from safety‑relevant effects of a head injury or neurosurgical procedure

11. The expression safety-relevant is defined in Reg 67.015 as follows:

    67.015    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.

12. Reg 67.175 provides that a person may apply to CASA for the issue of the medical certificate.

13. Reg 67.180(1) provides that 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).

14. The expression relevant medical standard is defined in Reg 67.010 as:

    relevant medical standard means:

    (a)for a class 1 medical certificate — medical standard 1; and

    (b)a class 2 medical certificate — medical standard 2; and

    (c)for a class 3 medical certificate — medical standard 3.

15. The relevant requirements as far as Ms McKay is concerned are those referred to in Reg 67.180(2)(e) which provides:

    (2)   For subregulation (1), the requirements are:

    …

    (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

    …

16. Reg 67.180(7) provides:

    (7)  CASA must not issue a medical certificate to an applicant if it is satisfied that the applicant:

    (a)has knowingly or recklessly made a false or misleading statement in relation to the application for the medical certificate; or

    (b)does not satisfy the requirements of this regulation; or

    (c)has not, in the course of undergoing a relevant examination for the medical certificate, complied with a request made under subregulation 67.170 (1).

    CLASS 2 MEDICAL STANDARD

17. Ms G Bennett, a Principal Lawyer with the Legal Branch of CASA, who appeared on behalf of CASA, submitted that the available medical evidence disclosed:

    (a)Ms McKay had a history of epilepsy and had experienced partial seizures;

    (b)she had epilepsy surgery (right temporal lobectomy) in 2005;

    (c)Ms McKay discontinued taking epilepsy medication in late 2005 or early 2006; and

    (d)Ms McKay's medical history disclosed an ongoing future risk of seizure events, despite the surgery, in excess of the general population.

18. In her witness statement dated 3 February 2012 Ms McKay said that she had no history of seizures prior to contracting a recurrence of measles associated with fever when she was 17 years old.  She was subsequently diagnosed as suffering from encephalitis and a couple of weeks later, she began suffering seizures.

19. Ms McKay was initially treated with Tegretol but later the seizures returned.  After undergoing scans, she was advised by Prof Cook that the scans revealed very clear abnormalities in her right temporal area.  She elected to have surgery to correct the abnormalities and to stop the episodes of seizure.  Her right temporal lobe was removed in September 2005.

20. Ms McKay stopped taking her medication after surgery and has been free from any seizures since that surgery, some seven years ago.  She has since been issued with a Victorian Driver's Licence and according to her specialist doctors, the prognosis is good.

21. CASA contended that Ms McKay failed to meet Item 2.1 of Table 67.155.  That is because she had a safety-relevant condition which produces functional incapacity or risk of incapacitation.  Ms Bennett submitted that Ms McKay had an abnormality or a disease in the form of epilepsy which fell within Item 2.1.  Although Mr P Baume of counsel, who appeared on behalf of Ms McKay, submitted that she had not been diagnosed with epilepsy, we cannot agree.  The word epilepsy is derived from the Greek epilepsia which means seizure.  It is defined in Dorland’s Illustrated Medical Dictionary, 27th edition, in the following way:

    epilepsy – paroxysmal transient disturbances of brain function that may be manifested as episodic impairment or loss of consciousness, abnormal motor phenomena, psychic or sensory disturbances, or perturbation of the autonomic nervous system.

22. It appears that because the description epilepsy carries with it a negative connotation, medical practitioners usually refer to the condition as seizure. Viral encephalitis is a known cause of seizures.

23. CASA also contended that Ms McKay failed to meet Item 2.7(b) of Table 67.155.  That is because she had a medical history and clinical diagnosis of epilepsy.  Prof Cook, a prominent neurologist and epileptologist with the Department of Clinical Neuroscience at St Vincent's Hospital in Melbourne, provided three witness statements which were taken into evidence and he also gave oral evidence at the hearing.

24. Prof Cook said he first saw Ms McKay with post-encephalitic epilepsy in 2002.  He explained that Ms McKay's seizures were stereotype, consisting of a scared feeling which was very intense, during which she was seen to go blank and perhaps weak down one side.  He said that confused behaviour might be a feature of these but the attacks seem to have been brief.  Otherwise, he regarded her health as excellent.  He said there were no other medical complaints and there was no history of seizures in infancy or childhood.  There were no convulsions with fever.  There was no family history of relevance and she has had no serious head injuries.  A neurological examination was unremarkable.

25. Although a later MRI (magnetic resonance imaging) scan was normal, a PET (positron emission tomography) scan showed very clear right temporal abnormalities.  Video EEG (electroencephalogram) monitoring confirmed seizures of right temporal origin.  Surgery was performed by Dr M Murphy in September 2005.  The surgical procedure was uncomplicated and Ms McKay made an excellent recovery.  Histological examination of the resected tissue did not demonstrate any definite abnormality.  12 months after the surgery, her medication was completely discontinued.  She has had no therapy of any kind since 2007 and has remained seizure free.

    DOES MS MCKAY HAVE A SAFETY-RELEVANT CONDITION?

26. The first question which we need to address is whether the condition as described by Ms McKay and Prof Cook can be considered to be safety-relevant.  To answer that question we need to determine whether it is likely that Ms McKay's condition will reduce her ability to exercise the privileges of a student pilot licence.

27. The meaning of the word likely in the context of the medical standards set out as they were then in the CAR was fully explored by Deputy President Forgie in Re Lachlan Window and Civil Aviation Safety Authority [1999] AATA 525. The expression considered by DP Forgie was: is likely to interfere with the safe exercise of privileges….  After considering the use of the word likely in a range of different contexts she concluded, 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 remote chance".  That is not a matter which can be assessed on a statistical likelihood and certainly does not mean "more likely than not", "odds-on" or "a more then 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.

28. In his witness statement dated 25 January 2012 Prof Cook said that he had obtained an opinion from Prof R Beran who suggested that she undergo what was described as a long video EEG with sleep deprivation.  This procedure was performed between 19 and 22 October 2010 and, according to Prof Cook, demonstrated no abnormalities and certainly no seizure activity or focal change.

29. In Prof Cook's opinion, Ms McKay, having gone so long without seizures particularly off medication, had an extremely low likelihood of seizure recurrence.  He said that the risk remained at approximately 1 to 2% after surgery even after long periods of seizure freedom.  He said the risk was believed to extend into the very long term although there were no statistical analyses of studies that described her specific circumstances.

30. In the course of cross-examination, Prof Cook was asked whether it was possible to determine whether Ms McKay would have future seizures.  He answered: no.

31. Professor SF Berkovic, who is at the Department of Medicine (Neurology) University of Melbourne and a Director of the Comprehensive Epilepsy Program and Epilepsy Research Centre at Austin Health, provided a written report dated 10 October 2011.  He agreed that Ms McKay had done very well since her right temporal lobectomy.  He said that approximately 80% of subjects selected for temporal surgery have a good outcome.  He said that group of subjects encompasses patients who never have another attack and those who are markedly improved from a previous life of very frequent seizures.  However, he noted that the success rate in achieving total seizure freedom over the long term is more difficult and there is a gradual attrition of patients previously seizure free who have at least one seizure many years after temporal lobectomy.

32. Prof Berkovic also said that even after five or six years seizure free, there was a seizure risk of between 1 and 2% per year.  He said that the risk of new onset seizures in the general community for a young adult in industrialised countries is approximately 50 per 100,000 per year, or 0.05% per annum.  He said that Ms McKay's risk of seizures was therefore at least 20 times higher than that of the general community.  Prof Cook was asked if he agreed with that figure and he said he did.  Prof Berkovic also said that although epilepsy surgery was popularly viewed as curative, analysis of the outcome data suggests otherwise.  He said that while many individuals who have had epilepsy surgery have subsequently had in excess of 20 years free of seizures, sometimes without medication, the overall data shows a continual attrition of seizure free cases even after 15 years or more following epilepsy surgery.

33. Prof Berkovic also gave oral evidence at the hearing.  He was asked to comment on whether the fact that Ms McKay had successful EEG monitoring over a 72 hour period with sleep deprivation indicated that she was now free of the risk of seizures.  Prof Berkovic said that it did not rule out the possibility of further seizures.  He said that there was no good data that the risk was reduced and in any event, he relied on his experience.  While Prof Berkovic agreed Ms McKay was lucky to have had a good outcome from this surgery, and her pathology was negative, he did not know whether it remained a problem.  He said it remained a concern.  He was of the view that Ms McKay's risk of seizure was not down to the same level as a healthy person of her age.  He said the risk was considerably higher.  Prof Berkovic also said that PET scans subsequent to surgery were not good to determine post-operative risk.  He said while it may be a good prognostic sign, it was not absolute.  Prof Berkovic described Ms McKay's seizures as complex partial seizures.  They resulted in Ms McKay experiencing loss of awareness, understanding and ability to respond.  She would not respond to instruction and subsequently would be in a confused state, taking some time to recover.

1. Ms McKay gave evidence about the nature of the seizures.  She said she had some warning of a seizure coming on although the warning was possibly only a few minutes prior to the onset.  Generally, the seizures seemed to be of a passive nature which she described as being in a trancelike state.  Dr D Fitzgerald, a medical officer with CASA, described Ms Kay's seizures as being passive and unresponsive.  There was no evidence that she suffered from convulsive seizures.  Although he said that was safer to a degree, sometimes there was no warning and, ordinarily, less warning.

2. There seems to be no dispute between the experts who gave evidence regarding Ms McKay's epilepsy.  The fact that she has been seizure free without medication since she had surgery does not permit a finding that she is no longer at risk of having a seizure in the future.  Furthermore, the evidence discloses that she remains at a significantly higher level of risk of having a seizure in the future than a person of her age who has never had a seizure.  Although her seizures apparently are not of a convulsive nature, there seems to be no doubt about the fact that she has had brief attacks of altered consciousness.  There can be no doubt that a person in command of an aircraft who has a passive seizure would have a reduction in the ability to exercise privileges conferred by a student pilot licence.

3. Accordingly, we must find that Ms McKay does not meet medical standard 2 because she has an abnormality or disease in the form of epilepsy which is safety-relevant.  That is because her condition is likely to reduce her ability to exercise privileges of holding a student pilot licence.  There is a real and not remote chance of Ms McKay becoming incapacitated while flying.  It is a chance which is significantly higher than that expected from a person who does not suffer from epilepsy.

   ISSUE AND REFUSAL OF MEDICAL CERTIFICATES

4. While Ms McKay does not meet the relevant medical standard for the issue of a Class 2 medical certificate, that does not mean that a medical certificate must not issue. As Reg 67.180(2)(e)(ii) provides, CASA may nevertheless issue a medical certificate if the extent to which the applicant does not meet the standard is not likely to endanger the safety of air navigation. Section 9A of the CA Act provides:

   9A  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.

5. Ms McKay contended that if she were to be issued with a Class 2 medical certificate, it would not adversely affect the safety of air navigation nor endanger the safety of the general public.  She has now been seizure free for almost 7 years since her surgery, six of those years being without medication.  Mr Baume contended on her behalf that the risk of recurrence of any seizures was now very low, much the same as the general population.  In fact he contended that she did not fall within the statistical data for recurrence of seizures in a number of studies referred to by CASA.  She was in a unique category.

6. Mr Baume also referred to the evidence of Prof Cook who indicated that the studies referred to by CASA did not provide a guide in Ms McKay's case.  While it is correct to say that Prof Cook said there were no specific statistical analyses of studies that described her circumstances, he nevertheless agreed that her risk of seizure remained at approximately 1 to 2% after even very long periods of seizure freedom.  That is consistent with what was said by Prof Berkovic.  He said that although epilepsy surgery was popularly viewed as curative, analysis of the outcome data suggested otherwise.  He explained that the overall data disclosed continual attrition of seizure free cases even after 15 years or more following epilepsy surgery.  He also said that to his knowledge, there was no robust data with longer follow-up than this.

7. We have also considered a letter provided by Prof Cook dated 9 September 2011 in which he said: Given the time that has elapsed, and her normal prolonged EEG recording, it [sic] think she is fit to fly.  It is an exceptional and unique situation, but she has my full support.  With respect to Prof Cook, the question is not one regarding the fitness of Ms McKay to fly.  The question is whether Ms McKay, at the present time, if she were in control of an aircraft, posed a danger to safe air navigation.

8. The problem with Ms McKay's condition is that the aviation environment is totally unforgiving.  A loss of normal conscious functioning, even for very brief periods of time, can have catastrophic consequences.  The cockpits of all aircraft, including helicopters which are the kind of aircraft Ms McKay wishes to fly have very restricted working space.  Even if she were to have a passive seizure, the likelihood of interference with controls is high and would most likely create serious problems whether she is flying on her own or with another pilot.  Furthermore, as Prof Berkovic said, she would be unresponsive to instruction and would lose awareness and understanding.  It would take some time for her to fully recover from such an event.  For these reasons we find that Ms McKay, were she granted a Class 2 medical certificate, would be likely to endanger the safety of air navigation.

9. The only remaining issue is whether Ms McKay should be issued a Class 2 medical certificate with conditions.  In our opinion, there remains a significant risk to the safety of air navigation even if Ms McKay were permitted to fly only with a qualified pilot.  That is because the form of incapacitation is one which, in the very restrictive space of the cockpit, carries with it a real risk of interference with flight controls and the inability of the safety-pilot to properly control the aircraft following a seizure episode.  Furthermore, the consequences of such a problem would almost certainly be loss of life to more than one person.  Given CASA's mandated primary duty to consider the safety of air navigation, it would fail to perform its function were Ms McKay permitted to fly with a safety-pilot.

   CONCLUSION

10. In our opinion, Ms McKay does not meet the standard for the issue of a Class 2 medical certificate.  She has a safety-relevant condition because she has an established medical history and clinical diagnosis of epilepsy.  Despite the fact that she has not suffered a seizure in the past seven years, six of those years without the support of medication, her risk of seizure remains significantly in excess of that of the normal population.

11. Were Ms McKay to suffer a seizure while at the controls of an aircraft, it cannot be reasonably said that she is not likely to endanger the safety of air navigation.  Furthermore, given the very serious consequences which are likely to result should she suffer a seizure while at the controls of an aircraft, it is reasonable that CASA exercises a high degree of caution before considering that Ms McKay's condition would not endanger the safety of any navigation. 

12. The very limited statistical material available regarding the risk of seizure following surgery suggests that if an epilepsy sufferer remains seizure free for a number of years following surgery, the risk of suffering a further seizure is reduced.  However, the length of time after surgery where the risk is significantly reduced is unclear.  The evidence was that there is no such thing as a cure for epilepsy.  However, as CASA has indicated, if there is a 10 year seizure free period following surgery, it would consider the issue of a medical certificate in an appropriate case.  In our opinion, Ms McKay is likely to be a candidate following a 10 year seizure free period.

13. We find that CASA's decision made on 5 January 2011 to refuse to issue to Ms McKay a Class 2 medical certificate was correct.  We affirm the decision.

I certify that the preceding 46 (forty -six) paragraphs are a true copy of the reasons for the decision herein of
Mr Egon Fice, Senior Member
Dr Kerry Breen, Member

...[sgd].....................................................................

Associate

Dated  10 September 2012

Dates of hearing	21-22 June 2012
Counsel for the Applicant	Mr P J M Baume
Solicitors for the Applicant	Maitland Lawyers
Advocate for the Respondent	Ms G Bennett, Civil Aviation Safety Authority
Solicitors for the Respondent	Civil Aviation Safety Authority