[2015] AATA 170  

Division	GENERAL ADMINISTRATIVE DIVISION	
File Number(s)	2014/1792	
Re	Victor Caplikas	
	APPLICANT	
And	Comcare	
	RESPONDENT	
Decision

Tribunal	Senior Member J F Toohey
Dr Isles, Member
	
Date	25 March 2015  	
Place	Sydney	
The Tribunal affirms the decision under review.
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Senior Member J F Toohey

CATCHWORDS – compensation – knee injury – liability accepted – stem cell assisted arthroscopy – whether proposed surgery was reasonable medical treatment – evidence of promising results – decision under review affirmed 

Legislation
Safety Rehabilitation and Compensation Act 1988 ss 4, 14, 16(1)

Cases
Comcare v Rope (2004) 80 ALD 99 
Re Jorgensen and Commonwealth (1991) 23 ALD 321
Re King and Comcare (1998) 53 ALD 791
Re Kentish and Telstra Corporation Limited [1999] AATA 661
Stroud and Comcare [2002] AATA 350
Doan and Australian Postal Corporation [2014] AATA 66

REASONS FOR DECISION

Senior Member J F Toohey
Dr Isles, Member

Background
1.	In August 2000, Mr Victor Caplikas injured his left knee at work.  The respondent accepted liability under s 14 of the Safety Rehabilitation and Compensation Act 1988 (the Act) to compensate him for “strain of medial collateral ligament of knee (left)”.  
2.	In December 2010, Mr Caplikas injured his right knee while at work.  The respondent accepted liability to compensate him for a “tear of medial cartilage or meniscus of knee (right)”. 
3.	Mr Caplikas has undergone a range of treatment for both knees over the years, with varying success.  He is 49 years old and wants to avoid knee replacements for as long as possible.  His treating orthopaedic surgeon, Dr Samiul Sorrenti, recommends he undergo bilateral knee stem cell assisted arthroscopy.  
4.	Where an employee suffers an injury, Comcare is liable to compensate him or her in respect of the cost of medical treatment obtained in relation to the injury where it is treatment that is reasonable for the employee to obtain in the circumstances: s 16(1).
5.	It is not in dispute that bilateral knee stem cell assisted arthroscopy is medical treatment within the meaning of s 4 of the Act.  The only question that arises in these proceedings is whether the treatment recommended by Dr Sorrenti is treatment that is reasonable for Mr Caplikas to obtain in the circumstances.
What is reasonable treatment? 
6.	The Act offers no guidance as to the meaning of reasonable medical treatment other than that it must be reasonable in the circumstances.
7.	For Mr Caplikas it is submitted that the Act, being beneficial legislation, should be construed liberally in favour of employees.  There is no argument with that principle but the Act still requires the Tribunal to determine what is reasonable medical treatment in the circumstances of the case.
8.	In Comcare v Rope (2004) 80 ALD 99, the Federal Court observed that there is “a surprising dearth of judicial authority” on the interpretation of s 16(1).  Justice Stone noted that the question of reasonability is “often subsumed in consideration of whether the treatment in issue is “medical treatment””, and the numerous Tribunal decisions on point turned so much on the circumstances of the particular claimant as to be of little assistance.  He cited the decision of Gray J in Re Jorgensen and Commonwealth (1991) 23 ALD 321 where His Honour stated:
The idea of reasonableness involves objectivity. A reference to the circumstances raises subjective factors, but they are intended to be subjective factors related to the nature of the injury, and not to details of the personal life of the applicant for compensation.
9.	Justice Stone was satisfied that “the predominant medical opinion before the Tribunal” was that the proposed treatment had therapeutic value for Mrs Rope.  He also observed that:
… the reference in s 16(1) of the SRC Act to treatment being “reasonable in the circumstances” is a clear indication that, in this case, the tribunal was required to engage in a costs/benefit analysis in relation to [the proposed] treatment, which means that it needed, to weigh the benefit of [the treatment] against the costs of obtaining it….
10.	That observation had particular relevance in the circumstances of the treatment sought by Mrs Rope but the costs of proposed treatment as against the likely or probable benefit will be a factor for consideration in many cases.  
11.	Dr Sorrenti does not dispute that the proposed bilateral knee stem cell assisted arthroscopy is a relatively new treatment.  In Re King and Comcare (1998) 53 ALD 791, the treatment recommended by the applicant’s doctor was outside that accepted by the mainstream medical profession.  The Tribunal said (at 24):
In determining whether a particular form of treatment is objectively reasonable, applying the test enunciated by Gray J in Re Jorgensen, we think allowances should be made in appropriate cases for different schools of thought within the medical profession.  If a particular form of treatment is advocated by a significant minority of the medical profession, and is regarded by the majority as controversial, we do not think obtaining that form of treatment would ordinarily be regarded as unreasonable.  If, on the other hand, a patient undertakes treatment on the advice of a doctor whose views are at odds with the rest of the medical profession, one would have to conclude that it was not reasonable to obtain such treatment in the circumstances.  Whether a particular form of treatment in particular circumstances enjoys sufficient support within the medical profession to be regarded as reasonable is a question of degree.
12.	It is necessarily a matter for judgment in the circumstances of the case whether new or emerging forms of treatment are reasonable in the circumstances.  
13.	In King (above), the Tribunal found that the doctor’s views as to the therapeutic value of vitamin and mineral supplements for allergic conditions (the proposed treatment) “had so little support in the medical profession”, it was not reasonable for the applicant to obtain in the circumstances.  A factor that the Tribunal took into consideration was that the doctor’s diagnostic techniques were unreliable. 
14.	In Re Kentish and Telstra Corporation Limited [1999] AATA 661, the Tribunal was satisfied there was sufficient evidence, supported by a minority of the medical profession, of the benefits of nutritional supplements in the treatment of back pain.  It was satisfied that the applicant's position was supported by “an apparently growing number of medical practitioners” and there was no evidence to suggest the doctor’s position was “completely ‘at odds with the rest of the medical profession’".  While it lacked sufficient evidence to conclude that the treatment was advanced by a “significant minority”, nor was the doctor “in an entirely isolated position within the medical profession”. There was evidence of benefit to the applicant from the treatment and the Tribunal concluded it reasonable treatment for the applicant to obtain in the circumstances of the case.   
15.	In Stroud and Comcare [2002] AATA 350, the Tribunal decided that faecal infusion and dietary supplements were reasonable treatment for a chronic bowel infection.  The respondent contended it was a "controversial experimental therapy" not widely accepted by the medical community.  There was evidence that the applicant had made “slow but steady improvement” after two courses of faecal infusions.  The Tribunal was satisfied it was reasonable treatment for the applicant to obtain. It accepted by “all the medical practitioners” that she no longer had the particular condition and was left with minor symptoms only.  The Tribunal found the faecal infusion treatment had “done what it was intended to do” and that its success was one indicator of its reasonableness.  The Tribunal also found that, while the doctor proposing the treatment was in a minority, it could not find that his views “were at odds with the rest of the medical profession”.   It was also satisfied that dietary supplements were reasonable medical treatment in the circumstances.
16.	In Doan and Australian Postal Corporation [2014] AATA 66, there was some improvement in the applicant’s elbow condition after autologous blood injections.  The doctor gave evidence that it would be appropriate that the applicant have additional injections to determine whether there was further improvement.  The doctor acknowledged that opinions varied as to the benefits of such treatment but, in her view autologous blood injections represent a recognised medical practice which in appropriate cases may be considered an alternative to cortisone injections.  After hearing from several doctors, the Tribunal acknowledged the varying opinions about the efficacy of the proposed treatment for conditions such as the applicant’s epicondylitis but did not regard it as “experimental”.  The Tribunal was satisfied it was a recognised treatment among a range of treatment options recommended and performed by licensed and registered medical practitioners. 
The history of Mr Caplikas’ injuries and treatment
17.	Mr Caplikas was working at Mascot airport in August 2000 when he slipped into a hole, injuring his knee.  His general practitioner referred him to Dr Sorrenti who performed a left knee arthroscopic patella chondroplasty and partial medial meniscetomy on 23 August 2000.  Dr Sorrenti recommended physiotherapy, strengthening and stretching exercises, and anti-inflammatory medication.
18.	In 2000, Dr Sorrenti administered a course of three Synvisc injections with good results.  Mr Caplikas continued working and continued his exercise rehabilitation program, and his knee was “quite good” until 2006 when he developed symptoms again.  Dr Sorrenti administered a further course of Synvisc.  
19.	In May 2008, Dr Sorrenti performed a further arthroscopy and osteoarthritis was found in Mr Caplikas’ knee.  He had further courses of Synvisc in November 2008 and May 2009.  He continued exercising and physiotherapy throughout.
20.	In December 2010, Mr Caplikas injured his right knee while working at Kingsford Smith airport.  He went back to see Dr Sorrenti who performed an arthroscopy in March 2011.  Between August 2010 and August 2013 he had a series of bilateral Synvisc injections and continued physiotherapy and painkillers. 
21.	In May 2012, Dr Sorrenti noted that Mr Caplikas’ knees were again deteriorating.  He considered further Synvisc injections but wondered “whether we can change course”.  In his view, Mr Caplikas was “a very good candidate for stem cell assisted arthroscopic surgery”.  In June 2012, Dr Sorrenti asked the respondent to meet the cost of bilateral knee stem cell assisted arthroscopic surgery.  He referred to literature demonstrating regenerative and therapeutic effects of mesenchymal stem cells in induced disease models of osteoarthritis and said this treatment has been very successful in patients that have been treated to this point.  He referred in particular to a double-blind placebo-controlled trial performed at Royal North Shore Hospital for which the treatment phase was completed in March 2012.
22.	Around late 2012 or early 2013, Dr Sorrenti retired and Dr Greggory Burrow, orthopaedic surgeon, took over Mr Caplikas’ treatment.  He was the last person to administer Synvisc injections.  In May 2013, Dr Burrow reported that he agreed with Dr Sorrenti that Mr Caplikas would not benefit from further injections of Synvisc in either knee.
23.	Mr Caplikas is employed by a government department whose employees are likely to have to pass strenuous physical exercises to maintain their employment.  He is worried that, without the treatment recommended by Dr Sorrenti, he may not pass the tests.
24.	Mr Caplikas suffers from genetic high blood pressure.  His father died at a young age and Mr Caplikas works hard to maintain his weight and reduce his blood pressure.  He has participated in triathlons for many years.  He scaled back his activities after his injuries but has continued swimming and bike riding.  He wishes to continue his physical exercise and does not wish to undergo knee replacements earlier than absolutely necessary.  He is plainly highly motivated to maintain his health.
25.	We accept Mr Caplikas’ evidence that he experiences pain on household tasks such as mowing the lawn or anything that involves climbing a ladder. When the pain is bad he takes Voltaren twice daily for about two weeks then weans himself off them; he takes Panadol Osteo as needed and Nurofen three of four times each fortnight.  He is not currently under the care of a treating specialist.
Dr Sorrenti’s evidence
26.	Dr Sorrenti has provided written reports and gave oral evidence before the Tribunal.  He retired from general orthopaedic practice in 2013.
27.	Dr Sorrenti gave evidence that he had long been fascinated with stem cell therapy and became more interested after his retirement.  When he wrote to Comcare in August 2012 on behalf of Mr Caplikas, he had had encouraging results with patients who had been told they should have knee replacements.  Of approximately 75 patients he has treated since he retired, treatment failed in only one case.  Treatment involves liposuction of 200 grams of fat from the patient’s stomach, a method which Dr Sorrenti says has the benefit of being able to store cells for future treatment if needed.
28.	Given Mr Caplikas’ age, Dr Sorrenti said, he would not do a knee replacement; at best, they last 15 years, meaning he would likely need two further bilateral replacements.  He said knee replacements are intended for older people who are less concerned with physical activity, and it leaves no further options.  In contrast, stem cell therapy leaves options including knee replacement if necessary.  Further, he said, a knee replacement leaves a person unable to run. 
29.	Dr Sorrenti gave evidence that he is satisfied with the efficacy of his treatment and he would be deregistered if it were not beneficial to patients.  To his knowledge, about three orthopaedic surgeons in Sydney and some in Victoria are using the therapy, and a larger number of sports physicians are using it.  He referred to papers published worldwide on the success of stem cell therapy and, to his knowledge, there have been no adverse effects.  However, he could not say for how long the treatment was likely to be effective.  He agreed that stem cell therapy is “an evolving, learning process”.
30.	Giving evidence, Dr Sorrenti said he had no idea of the cost of each treatment he administered.  A letter dated 28 September 2012 from his practice to Comcare sets out a cost of $13,464.00 for arthroscopy, stem cell harvesting and injection, HiQCell procedure, anaesthetist’s fee and assistant surgeon.  
Other medical evidence
31.	Dr Burrow provided a written report to Comcare on 19 May 2013 in which he agreed with Dr Sorrenti that Mr Caplikas required no further Synvisc injections for his “continuing bilateral knee arthritis”.  He stated:
It is my opinion that arthroscopy is only helpful for mechanical catching type symptoms and then it is not always a guaranteed result.  Arthroscopy however will do nothing for background knee pain.  This seems to be the complaint of Mr Caplikas.  Further, stem cell therapy, as tested in the Royal North Shore Hospital study, has been found to be no different from placebo arthroscopy.  I do not recommend Mr Caplikas proceed to stem cell assisted arthroscopy.  In the long term, his arthritis will become more and more severe and he will eventually require total knee replacements.
32.	Dr Neil McGill, rheumatologist, provided an opinion to Comcare based on documentation provided to him.  He did not see Mr Caplikas.  He has provided written reports and gave oral evidence.  He undertook a detailed literature review including studies referred to on Mr Caplikas’ behalf.  He stated there was sufficiently encouraging information from the animal models to make a controlled trial of this type of therapy in humans appropriate, but the proposed therapy had not been shown to be effective for knee injuries, and in particular, for osteoarthritis.  Further, as the treatment is new, there remains the possibility that risks may be found in the future.
33.	Dr McGill gave evidence that available studies and other relevant information are reviewed at regular meetings between rheumatologists and orthopaedic surgeons and their current position does not support the use of stem cell therapies except as part of a research study. The Australian Rheumatology Association position statement on stem cell therapies as of 9 December 2014 with respect to osteoarthritis is that "at this point there is no high-quality evidence base to be confident of the safety and efficacy of this treatment".  
34.	Dr Frank Machart, orthopaedic surgeon, saw Mr Caplikas for assessment in February 2014.  He provided a written report and gave oral evidence.  In his view, the proposed treatment is not uniformly accepted as effective or appropriate in the short or long term, and is subject to investigations and clinical research.  He does not recommend it until it is sufficiently investigated.  In the meantime “it is not part of evidence-based medicine”.  He agreed that knee replacement is “radical” but said it is also effective.  He would expect it to last about 20 years.  He agreed that high-impact activities such as jogging and bicycle riding are not recommended after knee replacement.
35.	On behalf of Mr Caplikas, we were provided with an extract from the Regeneus HiQCell website which lists under “Find a Medical Practitioner” four orthopaedic surgeons in NSW and one in Victoria, and four sports physicians in NSW and two in Victoria.  Dr Machart gave evidence that there are currently three to four hundred orthopaedic surgeons in NSW.  It is reasonable to conclude from this that the procedure is practised by very few in the medical profession.
Is the proposed treatment reasonable in the circumstances?
36.	The doctors agree that no issue arises as to the safety of the proposed treatment, and nor is Dr Sorrenti’s professional standing in question.  The debate concerns the efficacy of stem cell therapy for knee osteoarthritis.
37.	The doctors all agreed on the importance of evidence based medicine, such as derived from research studies published in peer review journals, in assessing the safety and efficacy of a treatment.  Dr McGill explained, and it seemed to be common ground, that the "gold standard" research methods providing the strongest evidence are randomised double blind studies with control groups. Other research methods such as observational studies and anecdotal case reports are of less value but can often make a case for further higher quality studies to be carried out. He explained that the strength of double blind studies is the control group which is unaware of which treatment modality they have been given. The size of the study group is also a relevant factor. 
38.	A number of research papers concerning stem cell therapy for the knee joint were put in evidence. Only a few employed control groups and are discussed in detail as they are considered to provide the most important evidence. 
39.	The results of the OSCARS study have not been published but an interim report was delivered on 1 October 2013.  The study involved a randomised double blind, placebo controlled trial to evaluate the safety and efficacy of stem cell therapy for the treatment of osteoarthritis.  It is yet to be peer reviewed.  It was sponsored by Regeneus, a company that promotes, and has a commercial interest in, stem cell therapy. 
40.	The OSCARS study was conducted at Royal North Shore Hospital in Sydney and involved injecting adipose tissue derived from stem cells into the knees of one group, and saline into the knees of another group of 20 subjects who became the control group. None of the 40 subjects were aware of which treatment they were given. It was pointed out that the procedures (knee injections only) employed in this study were different to Dr Sorrenti's proposal which was an arthroscopy plus delivery of stem cells. 
41.	Pain scores were assessed at baseline and at six months and showed no significant difference between the two groups.  Dr McGill’s view was that success should be primarily measured by reduced pain and improved function, and the pain score results went against the efficacy of the therapy.  Dr Sorrenti had not seen the interim report but had heard about it and agreed that it was disappointing from efficacy point of view.
42.	The OSCARS researchers also assessed outcomes such as MRI studies and urine metabolites, which they considered more objective markers of cartilage damage, and found significant improvements in the treatment group.  They reported that the results indicated that “HiQCell may slow the progression of [osteoarthritis] and produce improved outcomes in the longer term".  Dr McGill dismissed these findings on the ground that they were not valid markers of osteoarthritis.  Dr Sorrenti was not able to comment as he had not seen the interim report. 
43.	A high quality study by Vangsness et al, “Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy”, J Bone Joint Sug Am (2014) 96 90-8, was discussed at some length.  Fifty-six patients who were undergoing arthroscopic medial menisectomy were divided into three groups; two were given a low and a high dose of stem cells, and a control group was given hyaluronic acid.  The patients were followed up sequentially for a two year period. There were significant decreases in pain and increases in meniscal volumes in the treatment groups when compared to the controls. 
44.	Dr McGill gave evidence that, because this study involved patients who underwent menisectomy, the results were not relevant to Mr Caplikas.  As well, the stem cells used in this study were derived from bone marrow of other donors as opposed to autologous adipose tissue cells that Dr Sorrenti proposes using. Even then, despite the seemingly positive results, the authors remained cautious, stating that the results “support the study of human mesenchymal stem cells for the apparent knee-tissue regeneration and protective effects" (emphasis added).
45.	Excerpts from a study in April 2013 by Saw et al, “Articular cartilage regeneration with autologous peripheral blood stem cells versus hyaluronic acid: a randomized controlled trial” (2013) 29(4) Arthroscopy: The Journal of Arthroscopic and Related Surgery 684 – 694, show that it researched a different technique from that proposed, in which chondral lesions were treated by subchondral drilling followed by intra articular injections of autologous peripheral blood stem cells.  Results were measured by MRI evaluation of the articular cartilage.  Some improvements in the quality of articular cartilage repair were noted in the treatment group but Dr McGill pointed out that there were no significant differences recorded in clinical scores at 24 months.
46.	A South Korean study conducted between March 2009 and September 2011 by Hyunchul et al, “Intra-Articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: proof of concept clinical trial” Stem Cells (2014) 32 1254 – 1266, showed promising results in decreased pain, increased function and increased cartilage volume as well as decreases in the size of the cartilage defects.  The authors concluded that the results were “promising to encourage large randomised clinical trials, and we are cautiously optimistic about this new step for the treatment of osteoarthritis of the knee".
47.	Interim reports in March 2014, August 2014 and October 2014 from the "HiQCell Joint Registry" maintained by Regeneus were submitted on behalf of Mr Caplikas.  The register is of people in Australia and New Zealand who have undergone stem cell treatments carried out using their product in a range of joints, the majority of them knees. There are no controls in these "observational studies" which reported large decreases in pain and improved function in significant proportions of participants. Dr McGill and Dr Machart agreed that such studies play an important part in medical research and are useful in identifying promising treatment as suitable for further research, but the interim reports must be approached with some caution because they are not peer reviewed and Regeneus has an interest in HiQCell.  
48.	Extracts from several other studies were referred to on Mr Caplikas’ behalf.  All reported improvements in subjects treated with a range of stem cell treatments.  However, most were small case reports with no control groups. 

Conclusion
49.	In Kentish, Stroud and Doan (above) the Tribunal accepted that the particular treatment was reasonable despite it being new or somewhat experimental.  We would distinguish those decisions because in each case the applicant had undergone some treatment, with positive results.  That is not to say that a person must undergo treatment before it can be considered reasonable but there may be insufficient evidence otherwise of the value of the treatment to make it reasonable in the circumstances.  
50.	While there is evidence of encouraging results in stem cell therapy for osteoarthritis of the knees, the few high value, peer reviewed studies that are available do not report on quite the same technique as proposed by Dr Sorrenti, and their authors did not recommend adoption of the treatment but rather support further study.  Nor is there evidence of support by a significant minority of the medical profession for the proposed treatment.
51.	We are not satisfied, on the information before us, that the proposed bilateral knee stem cell assisted arthroscopy is treatment that is reasonable in the circumstances for Mr Caplikas to obtain.
52.	We affirm the decision under review.  
53.	I certify that the preceding 52 (fifty-two) paragraphs are a true copy of the reasons for the decision herein of Senior Member J F Toohey and Dr Isles, Member.  	

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Associate

Dated 25 March 2015
Date(s) of hearing	16 – 17 February 2015	

Representatives for the Applicant	
Mr Adrian Coombs, Counsel
Mr Abraham Ghaleb, Slater & Gordon Lawyers	

Representatives for the Respondent	
Ms Rhonda Henderson, Counsel
Mr Peter Lehmann, Lehmann, Snell Lawyers