Finally, unproven stem cell clinic practices might be curtailed

Finally, unproven stem cell clinic practices might be curtailed‘ is the title of an article published today in The Conversation, by Megan Munsie, Cameron Stewart and Ian Kerridge.

The authors begin:

In a welcomed move, the Therapeutic Goods Administration (TGA) has this week announced reforms will be introduced in 2018 to address long held concerns about the provision of unproven stem cell treatments to increasing numbers of Australian and international patients.

Regulation of stem cell treatments being offered outside hospitals will be increased. It will acknowledge the risks of these treatments, and advertising of certain treatments will be prohibited.

While more specific details are not yet available, it seems at last possible the most egregious practices of suburban stem cell clinics will be severely curtailed.

Neurosurgery: Information + experience

Jambrovic v Day [2017] NSWSC 1468 is a decision of particular interest as it addresses the nature of doctor’s duty to warn, including advice about surgical as opposed to conservative treatment and whether the doctor had the necessary training and experience to perform the procedure. As Justice Schmidt summarised at [12]:

…Mr Jambrovic pursued a surgical procedure which Dr Day had neither prior experience of, or training in, when the better course would have been to wait and monitor the progress of the tumour. Had Mr and Mrs Jambrovic received that advice, or even information about the risks of the surgery when compared with the risks involved in monitoring the tumour, it is quite unlikely that Mr Jambrovic would have had surgery in March 2011.

It was common ground (at [48]) that there were two available courses of treatment in Mr Jambrovic’s circumstances. First, surgical removal of the tumour. Secondly, conservative treatment, involving monitoring the tumour at regular intervals. There was also no issue (at [50]) that Dr Day recommended that the tumour be removed by endoscopic surgery which he had not previously performed, although he had performed other endoscopic procedures. He had also removed brain tumours by craniotomy. More specifically, while to that time Dr Day had performed about 50 skull-based meningioma removals and 30 transnasal removals of pituitary tumours, this was the first trans nasal endoscopic removal of a skull base meningioma which Dr Day had performed. The Hospital had to acquire the specialised endoscopic equipment required for that surgery. In his statement Dr Day did not say that he had disclosed this to Mr and Mrs Jambrovic: [72]. However in cross examination the surgeon claimed, for the first time, that he had conveyed to the patients that he did tell them that he had not performed the proposed operation before [82].

In discussing the information provided to the claimants, the court made reference to a document provided by the surgeon. However the document did not deal at all with the endoscopic procedure which the surgeon recommended. That procedure was quite different to the craniotomy described in the document, involving as it did two surgeons and the tumour being removed through the nasal passage, rather than the skull: [54].

In the concurrent evidence, while it was agreed that surgery was a reasonable option in Mr Jambrovic’s case, it was considered that it was unreasonable for Dr Day to have presented the alternative conservative option of observation and monitoring of the tumour to Mr Jambrovic, as a poor option: [124]. At [128]:

The experts further agreed that Mr Jambrovic’s tumour was not life-threatening. That is why conservative treatment is often recommended in such cases. They agreed, however, that the presence of oedema had an impact on the interval period for initial surveillance, to make sure that early or rapid growth was not present.

The surgeon accepted that it would have been improper not to have disclosed that he had not performed this surgery before (at [83]) and at [86] the court held:

The experts’ view was that Dr Day should have told Mr and Mrs Jambrovic about his lack of experience in the procedure which he recommended. What Dr Day should also undoubtedly have disclosed was that he had neither the available training nor observed the difficult procedure he recommended.

Further to the issue of whether the surgeon had the necessary skill and experience, at [113] – [117]:

On the expert evidence of Professor Harvey, Dr Santoreneos and Associate Professor Weidmann, the growth rates of a benign meningioma tumour can vary from very slow, to atypical growth consistent with malignant tumours. Their location in the brain can make their surgical removal challenging, giving rise to the risks which materialised in Mr Jambrovic’s case from the procedure which Dr Day performed on 31 March 2011. Mr Jambrovic’s complications were recognised complications of that procedure, which the experts agreed occur less frequently with experienced surgeons.

This evidence establishes that the considerable risk of injury which the surgery which Dr Day undertook inevitably poses, are reduced when such surgery is performed by a surgeon trained and experienced in the procedure.

Dr Day was, undoubtedly, an experienced surgeon who considered himself qualified to undertake the procedure he recommended to Mr Jambrovic on 2 March. There was no issue, however, that he had not undertaken the available advanced fellowship training for endoscopic surgery on such a skull based tumour.

In the joint report the experts agreed that Dr Day probably did not have the experience to perform this surgery, which involved an endoscopic nasal approach to the anterior skull base, given that he was not fellowship trained in endoscopic skull based surgery; he had not observed such surgery live; nor had he performed a number of cases of intermediate complexity, other than pituitary surgery. The experts also agreed that Dr Day ought to have disclosed his lack of experience to Mr Jambrovic and discussed it with him, before the decision to have the surgery was made.

While Dr Day undoubtedly genuinely held the belief that he was appropriately qualified to have undertaken this surgery, I am satisfied that he was not, given the views to which the experts came, when considered in light of the evidence I have already discussed.

The findings on breach of duty are summarised at [131] – [134]:

When all of this evidence is considered together with Dr Day’s lack of training and experience in the surgical procedure which he recommended and performed, I am satisfied that it must found that he breached his duty to Mr Jambrovic, not only in failing to inform Mr Jambrovic of his lack of experience and training in that procedure, but also in actually performing that surgical procedure.

Not only should the relative risks of a conservative approach have been more accurately presented to Mr and Mrs Jambrovic than they were at the 2 March consultation, an initial period of observation of the kind the experts agreed would have been more appropriate in Mr Jambrovic’s circumstances, was a course which Dr Day should have not only advised Mr Jambrovic about, but one which he should have recommended.

The result of Dr Day’s advice was that Mr Jambrovic was not given a real opportunity to choose between available treatment options for his condition. Nor was he properly advised about the low risks which initial conservative management in the first instance carried in his circumstances, by comparison to the high risks of the surgery Dr Day recommended.

In the result, it must also be concluded that the risks which materialised for Mr Jambrovic were foreseeable; that they were risks of which Dr Day knew, or ought to have known; that they were not insignificant; and that in Mr Jambrovic’s circumstances, a reasonable person in Dr Day’s position would have taken the precautions which the experts agreed should have been taken. They were advising Mr Jambrovic as to the preferable course in his circumstances, namely initial conservative treatment before any decision to pursue surgery was made. Further, given his lack of experience and training in the procedure he recommended, Dr Day should have also disclosed this to Mr Jambrovic and should not himself have undertaken that surgery: Civil Liability Act, s 5B.

In relation to causation, the court noted (at [88]) that on Dr Day’s case, the decision to proceed with surgery in order to deal with intermittent, albeit persistent headaches which the surgery might not even cure, was made despite Dr Day having advised at the consultation, about the comparable risks of the surgery and the available conservative treatment, as well as that he had never performed such surgery before.  The court found that to be ‘improbable’. Then at [90]:

On Dr Day’s own evidence, Mr Jambrovic’s tumour was a benign, slow growing tumour which might not have been causing his headaches at all and the proposed surgery might not have cured those headaches. In those circumstances, choosing surgery rather than the conservative option, which involved treating the oedema and headaches, while continuing to observe the tumour, would have been entirely irrational. On the evidence Mr Jambrovic was not an irrational man. To the contrary he had rejected Dr Day’s advice in 2009 to have other surgery, given his symptoms.

The causation analysis was further discussed at [137] – [143].

 

 

Commonwealth Redress Scheme for Institutional Child Sexual Abuse

Today saw the introduction of two bills to the House of Representatives (Federal):

The explanatory memorandum for the two bills is available online.

Drawing from that explanatory memorandum:

  • The Scheme will provide three elements of redress to eligible survivors of institutional child sexual abuse: a monetary payment of up to $150,000 may be provided as tangible recognition of the wrong survivors have suffered, survivors will receive access to counselling and psychological services and the Scheme will facilitate a direct personal response from responsible institutions at the request of a survivor.
  • The Scheme will commence on 1 July 2018 and will operate for a period of 10 years.
  • The Bill sets out the objects and principles under which the Scheme will operate,including the requirements for participating institutions (that is, Commonwealth institutions as well as Territory and non-government institutions that choose to opt into the Scheme).
  • A person will be eligible for redress under the Scheme if the person was sexually abused as a child in an institutional setting and a Commonwealth institution is primarily or equally responsible, or where it occurred in a Territory or outside Australia and a participating institution was primarily or equally responsible for the abuse.
  • The sexual abuse must also have occurred prior to the 1 July 2018, the date of the Scheme’s commencement.
  • If the Scheme establishes that a person suffered sexual abuse, any non-sexual abuse related to the child sexual abuse will also be taken into consideration for the purpose of determining the amount of the monetary payment that the person is entitled to receive.
  • The cost of providing redress for the abuse of each person for which an institution is responsible will be based on a proportionate share of the total amount of redress paid to each person.
  • Entitlement to redress is dependent on a person making a claim under the Scheme. However, applicants may only make one claim over the period of the Scheme.
  • A person who accepts an offer of redress will be required to release all the participating institutions determined by the Operator to be responsible for the sexual abuse from liability for the sexual, and related non-sexual, abuse that is within scope of the Scheme.
  • A review of the operation of the Scheme will commence as soon as possible after the eighth anniversary of the cut-off day or earlier if the rules prescribe such a review. However, the review cannot occur within the first two years of the Scheme.
  • Amendments to the Social Security Act 1991 and the Veterans’ Entitlements Act 1986 will ensure the payments are not income tested, and so will not reduce the income support payments of survivors who receive payments under the Scheme.
  • In addition amendments are made to Bankruptcy Act 1966 to ensure payments are quarantined from the divisible property of a bankrupt. These amendments have been included to ensure a survivor will receive the full benefit of their redress payment, and to ensure that a survivor is not adversely affected by the receipt of the redress payment.
  • This Bill with also exempt decisions made under the Scheme from judicial review under the Administrative Decisions (Judicial Review) Act 1977. This amendment will ensure the Scheme remains survivor focused and trauma informed by maintaining the principles that the Scheme be a low threshold and non-legalistic process for survivors who have already suffered so much. These amendments are essential to implement the Scheme’s policies and to ensure timely and appropriate decision making.

 

Autologous ‘stem cell’ treatments: Regulation

Following two cycles of public consultation on the regulation of autologous human cell and tissue products in 2015 and 2016, the Australian Government has decided that changes to regulation should be implemented. As a result of the changes, some of these products will be subject to regulation as biologicals by the TGA from early 2018, with the level of regulation being determined by the risk posed to patient safety.

The TGA announcement states that the proposed changes to the regulation of autologous cell and tissue products are to:

    1. Not permit direct advertising to consumers of autologous cell and tissue products, similar to the prohibition in Australia in the advertising of prescription medicines, but noting that services (that do not mention specific products) will still be permitted to be advertised.
    2. Exclude from regulation by the TGA only those autologous cell and tissue products that are manufactured and used in a hospital by a medical or dental practitioner, for a patient in the care of the same practitioner.
    3. Introduce regulation by the TGA, with exemptions from some requirements, for autologous cell and tissue products that are:
      • minimally manipulated, and
      • for homologous use only, and
      • manufactured and used outside a hospital by a medical or dental practitioner,
      • for a patient in the same practitioner’s care.
    4. Regulate under the Biologicals Regulatory Framework those autologous human cell and tissue products that are:
      • manufactured and used outside an accredited hospital, and
      • more than minimally manipulated, or
      • for non-homologous use.

Products would fall into the relevant class, based on risk. Inclusion in the Australian Register for Therapeutic Goods and Compliance with TGA standards is required, including manufacturing standards. Adverse event reporting to TGA is required and advertising of the products to the public would not be permitted.

Ambulance driver: Duty of care + social utility

Logar v Ambulance Service of New South Wales Sydney Region [2017] NSWCA 274 saw the NSW Court of Appeal consider an appeal in respect to a motor vehicle accident involving an ambulance driver. The ambulance driver (answering an emergency call in the second highest category) had entered an intersection against a red light and the claimant failed to  stop to allow the ambulance to finish traversing the intersection. The claim had failed at trial and the appeal from that decision was dismissed.

The majority judgment was written by Schmidt J with Emmett AJA agreeing. In relation to the duty of care and in relation to social utility (Civil Liability Act 2002 (NSW) section 5B(2)(d)), Emmett AJA said at [29]:

I also agree with her Honour that it was open to the primary judge to conclude that Mrs Logar did not establish that Ms Riches had breached the duty of care that she owed to Mrs Logar when she moved the ambulance forward into the kerb side lane. The primary judge had to take into account the social utility of the response to the emergency to which Ms Riches had been assigned. I consider that, having regard to the medical emergency to which Ms Riches was responding, her actions in proceeding slowly through the intersection against the red light, with her siren sounding and her lights flashing, having already stopped twice, justified her action in proceeding into the kerb side lane notwithstanding that she could not be completely certain that another vehicle might not be proceeding in that lane at a speed almost equal to the limit in circumstances where the vehicles in the other three lanes were stationary despite there being a green light in their favour.

 

When Lump Sum Compensation Runs Out: Personal Responsibility or Legal System Failure?

When Lump Sum Compensation Runs Out: Personal Responsibility or Legal System Failure? is the title of a paper by Prue Vines, Matthew Butt and Genevieve Grant, published in (2017) 39 Sydney Law Review 365.

The authors’ abstract explains:

In most cases where a person receives lump sum damages for personal injury,
it is assumed that the money will be enough to put them back in the position they
would have been if the injury had not occurred (indeed, that is the aim of the law
of compensation). However, in many cases people run out of compensation
earlier than expected. Where such people seek social security, they are often
thought to be ‘double dipping’, having misspent their damages, and they may be
denied payment. There is little empirical data on what has happened when people
run out of their lump sum damages, including on the extent to which they have
recklessly misspent, on what factors have contributed to the dissipation of the
funds and on whether these are factors personal to the claimant or are indeed
institutional or legal system factors. Drawing on data derived from cases where
the Welfare Rights Centre of New South Wales acted for people subject to a
social security ‘lump sum preclusion period’, this article maps out the approaches
of tort law and social security law to lump sum damages. The article seeks to
establish a picture of the circumstances associated with a person finding
themselves in this situation and concludes with some suggestions about how to
reduce its occurrence.

The authors conclude on page 397:

Our findings indicate that the dissipation of compensation is not merely a matter of a lack of financial management skills, but reflects a range of vulnerabilities that may be more prevalent among the cohort who sustain personal injuries. Further, financial management cannot make up for the fact that money is simply insufficient to restore a plaintiff to their pre-injury position. To that problem is added a complete disjuncture between the approach of social security law and the approach of personal injury law, creating a situation where there is a particularly disadvantaged group of people when it comes to approaching social security.

NDIS: Dispute over supports

Two decisions have been published in relation to an NDIS participant ‘KLMN’.

KLMN v National Disability Insurance Agency [2017] AATA 1814 saw the tribunal review a decision the Agency in respect of transport assistance, but not adjust the Agency’s decisions in respect of home security and air conditioning. At [67] – [68] the Tribunal concluded in relation to the transport:

In considering the additional transport funding sought by KLMN, the Tribunal is satisfied that the additional transport funding meets s 34(1)(a)34(1)(b) and 34(1)(d) of the Act. Howevers34(1)(c) is problematic as the Tribunal is not satisfied that the costs of the support are reasonable. In looking at Rule 5.1 the Tribunal is also not satisfied that some of the transport sought is related to KLMN’s disability support needs.

The Tribunal determines that the transport support for taxi fares to watch her grandson play sport in locations 250 kms from KLMN’s home town is not reasonable nor is her wish to take taxis to undertake biking or bush walks. To provide 10 trips of 180 kms each way to conduct events also appears to be somewhat excessive.  Furthermore the costs for the 10 trips could be ameliorated by travelling to the yet undetermined locations with persons attending the event. KLMN stated that she needed to get to the venues well ahead to prepare for them so perhaps it is reasonable to allow for three events rather than 10 events but the Tribunal believes KLMN should, in the future, test out whether others involved could take her along if they pass through or live in the same city as she.

An air conditioning unit for her rental property was refused at [78] with the tribunal commenting:

Many people who live in accommodation that is not easy to cool would like an air conditioner. However, the Tribunal accepts the NDIA’s submissions that it is not reasonable and necessary to fund the installation of such a unit into KLMN’s rental property, a property in which she has chosen to live on the basis of reasonable rent and its proximity to the university and her children and grandchildren. There is no medical evidence beyond the assertions of the allied health professionals, namely the occupational therapists and the psychologist, that the air conditioner will help her to manage her condition and lifestyle.

As for the home security claims the tribunal said at [87] – [88]:

In relation to section 34(1)(c) the Tribunal is not convinced that the additional security features represent value for money. When one looks at paragraph 3.1(b) there is no evidence beyond the treating psychologist’s comments in her report to VLA and the comments of the occupational therapist who visited KLMN at VLA’s request that the support will substantially improve the life stage outcomes for, and be of long-term benefit to KLMN. Neither is there any evidence that funding of extra security will reduce the costs of the funding of supports for KLMN in the long term.

The Tribunal is not convinced that the security upgrades sought will meet the requirements cited above under the Rules. The Tribunal finds the security additions and modifications are not reasonable and necessary supports pursuant to s 34 of the Act.

KLMN v National Disability Insurance Agency [2017] AATA 1815 was a separate consideration of a claim for six pairs of glasses with prism lenses to assist with double vision. The issues included whether the prism lenses should be funded by another support system. At [49] the Tribunal concluded:

The Tribunal is not satisfied that the VES (Victorian Eyecare Scheme) can provide the six sets of prism lenses required by KLMN, particularly the anti-glare coatings and the number of sets of frames and lenses she requires. The Tribunal believes that the four pairs that are not accessible through the VES should have been funded by the NDIA given how crucial they are to allowing KLMN some assistance with her disability. However, in light of McGarrigle, the Tribunal finds that the six pairs are all necessary and reasonable supports, and should therefore be funded as part of KLMN’s now expired plan.

 

Conclave facilitators / chairs

Coffey v Murrumbidgee Local Health District [2017] NSWSC 1441 was an interlocutory matter concerning whether a joint conference of experts should be held with a facilitator, which the defendant supported (and offered to pay for) and the plaintiff opposed. The plaintiff argued that:

  • the three liability experts were all experienced medical practitioners very familiar with the requirements of giving expert evidence including participation in a joint conference and the preparation of a joint report;
  • the parties had agreed upon the majority of the assumptions to be made and on the form of each of the questions it was unlikely that there was any complexity in the process that might require the assistance to the experts of a third person;
  • the intercession in the process of even a member of the inner bar introduced a person who was not, in a sense, objectively accountable to the parties for the conduct of the joint conference; and
  • unwittingly the presence of another person would or may stultify the free discussion of the issues amongst the experts by shutting down their discussion, by taking an unduly technical approach to the construction of the questions, the issues in the case, and the task of the experts;
  • there is no Code of Conduct for a facilitator or for a chairperson appointed by the Court by reference to which such a person may inform himself or herself as to his or her proper role;
  • under the relevant Practice Note the expression “chair” is used rather than facilitator although one of the experts can fulfil the role of chair, and that role does not have to be filled by another person.

The court held at [10] that an experienced member of the Bar, especially Senior Counsel, can be relied upon to thoroughly know the proper role of the expert witness and the purpose and function of the joint conference and preparation of a joint report. It is very unlikely that someone in that position would be tempted to put himself or herself in the shoes of the expert, or take over their deliberations, or depart from the assumptions and questions that have been agreed between the parties and submitted to the experts for their deliberation.

Accordingly it was held that the case would benefit from the involvement of senior counsel chairing the joint conference.

 

Paramedic / ambulance injury: Appeal

State of Queensland v Roane-Spray [2017] QCA 245 was an appeal from a claim arising from an injury suffered by a patient when one end of a stretcher on which she was being moved by a paramedic collapsed when it was being taken out of the ambulance.

The State argued that it was not liable because it was entitled to the benefit of the protection against civil liability afforded to certain entities performing duties to enhance public safety, in circumstances of emergency, conferred by s 27 of the Civil Liability Act 2003 (Qld). The trial judge found that the State is not a prescribed entity for the purposes of s 27 and therefore s 27 did not apply to the vicarious liability of the State for its employee, the paramedic.

The appeal was dismissed, with Bowskill J stating at [21] – [23]:

As a matter of policy, it may be accepted as being in the public interest to protect an entity such as the Queensland Ambulance Service, comprising as that does the commissioner and ambulance and medical officers, from litigation and liability where it is performing services to enhance public safety. That is the plain effect of s 27, and the inclusion of the Queensland Ambulance Service in the list of prescribed entities. There would need to be very clear language used before s 27 could appropriately be construed as removing the vicarious liability of the State, as an employer, for the negligent acts of its employees.[9]  The device of reading “Queensland Ambulance Service” in schedule 2 to the Civil Liability Regulation as a reference to the State of Queensland is not open on a proper construction of the provisions.

The State’s argument that s 27 would lack utility otherwise is unfounded. There are plainly circumstances in which an unincorporated body such as the Queensland Ambulance Service may be sued, arising from the performance of its functions articulated in s 3D of the Act. It would be a matter for the rules of court to determine how that would be styled in a formal sense. Whether the protection of s 27 would be available, in any such hypothetical scenario, would be a question of law (as to the construction of the prerequisites in s 27) and fact, as to whether the prerequisites, as construed, were met. It may be correct to say that, in the present case, there was no cause of action against the Queensland Ambulance Service itself, but that is explicable by the fact that the claim was brought against the negligent paramedic’s employer, the State, on the basis of vicarious liability. The Queensland Ambulance Service is not the employer, therefore has no vicarious liability.

For these reasons, the trial judge was correct when he said, at [45] of his Honour’s reasons:

“The defendant [the State] is not an entity listed in Schedule 2 to the Regulation. The short answer to the defence reliance on s 27 is that it does not apply to the liability of [the] State of Queensland in the form of vicarious liability for its employee, the relevant paramedic, and therefore cannot provide a defence.”