SEPTEMBER 2009:

• When 10% is material: breast screening case appealed
• Two Australian courts uphold the right to refuse medical treatment
• Abortion in Australia: the legal pitfalls
• Developments in E-Health
• Insurance and indemnity for human research
• Growth attenuation therapy for disabled children

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When 10% is material: breast screening case appealed

Sydney South West Area Health Service v Stamoulis

The New South Wales Court of Appeal recently delivered its decision on the liability of BreastScreen NSW, Sydney South West (BreastScreen), for a delay in diagnosing breast cancer in a patient who had been part of its screening programme for five years. The patient could not allege BreastScreen caused her breast cancer - it did not. Her case arose from a complaint that BreastScreen, by failing to recall her for further testing in February 2006, had caused a 10 month delay in the diagnosis of her cancer and an increased risk that the cancer would metastasise.

The facts of the case

Ms O’Gorman attended BreastScreen for a screening mammogram of her breasts in 2002, 2004 and February 2006. Following the 2006 mammogram, two radiologists employed by BreastScreen separately and independently reviewed the mammogram and found that it was normal.

In January 2007, Ms O’Gorman detected a lump in her left breast. A mammogram and ultrasound revealed that she had breast cancer. Ms O’Gorman underwent chemotherapy, followed by a mastectomy in August 2007 and radiation therapy. In May 2008 metastatic tumours were found in her lungs and brain.

Ms O’Gorman brought proceedings against the operators of BreastScreen, alleging that BreastScreen was negligent in failing to inform her of a suspicious mass in her breast following the 2006 mammogram, failing to recall her for further testing and failing to refer the mammogram for further opinion.

First instance decision

At first instance, Justice Hoeben found that BreastScreen was negligent in failing to recall the plaintiff for further investigation following the 2006 mammogram, and that there was a 90% chance that the cancer would have been detected if she had been recalled. His Honour also accepted the expert evidence of both parties that the delay in diagnosis increased the risk of the cancer metastasising by approximately 10% (from 38% to 42%).

Despite arguments by BreastScreen that Ms O’Gorman’s loss should be assessed on the basis of having lost the chance of a better outcome, Justice Hoeben found that the metastasis of the cancer was a separate injury, the risk of which had been increased by the delay in diagnosis, and therefore causation was established.

BreastScreen appealed the decision, challenging His Honour’s findings on negligence and causation.

Decision of the New South Wales Court of Appeal

In assessing causation - that is, did the delay in diagnosis cause or contribute to the injury (metastatic cancer) - the Court stated that a material increase in the risk of injury followed by the occurrence of that risk does not equate to a material contribution for the purpose of causation. In order to prove causation, a plaintiff must establish that it was probable that the risk in fact came home.

Justice Giles described the phrase “risk coming home” as requiring a finding that it was probable that the injury was suffered because of the increased risk. Although it could not be said that the cancer would not have metastasised anyway, it could be said that statistically the risk of the cancer metastasising was increased and the plaintiff was brought materially closer to a point where there was a substantial and real chance that tumours would develop. On this basis, His Honour found that on the balance of probabilities the increased risk had materially contributed to the metastases.

Justice Ipp, with whom the other judges concurred, subject to the additional comments of Justice Giles, cited a number of cases recognising the dangers of applying evidence which tends to quantify possibilities mathematically and in applying epidemiological or statistical evidence in a mechanical way. His Honour noted that the fact that experts cannot infer causation on the balance of probabilities does not mean that a Court cannot - a causal connection may be found even when evidence does not go beyond the possible.

On appeal, BreastScreen argued that the case was on all fours with the decision in Gett v Tabet [2009] NSWCA 76 in which the Court found that the plaintiff had failed to prove, on the balance of probabilities, that she would have had a better outcome.

In Gett v Tabet the plaintiff argued that if a CT scan had been performed on 13 January 1991, it would have detected a brain tumour, allowing for earlier treatment to relieve intracranial pressure, thereby avoiding or minimising the effects of a seizure she had the following day.

In rejecting this argument, Justice Ipp noted that in Gett v Tabet the Court found that the plaintiff’s lost chance ranged between “speculative and having some effect.” In no respect did the evidence lend itself to a degree of precision.

However, in Ms O’Gorman’s case, there was statistical evidence that if the cancer had been detected in March 2006, there was a 62% chance it would not have metastasised. Whilst this alone did not establish causation, it showed that there was a strong possibility that if the cancer had been detected in March 2006 it would not have metastasised.

His Honour went onto find that evidence that the risk of metastasis had been increased by 10% by January 2007, a risk which in itself was not negligible and was sufficient to tip the scales from a strong possibility that the cancer would not have metastasised to a finding, on the balance of probabilities, that the delay caused the metastasis.

Whilst there was some argument on appeal as to whether it should be accepted that the 10% increased risk was a risk to Ms O’Gorman individually, as opposed to a general statistical risk, the Court found that either way the 10% increase was sufficient to support a finding of causation.

Expert evidence

During the first instance proceedings, in addition to the evidence of independent experts, BreastScreen sought to rely upon written statements of the two radiologists who had examined Ms O’Gorman’s 2006 mammogram and determined that it was “normal”.

These statements covered the radiologists’ interpretation of the 2006 films and the basis for their findings that the mammogram was “normal” and did not warrant recall for further investigation. Their opinions had in large been dismissed by the trial judge because it was felt, as employees of BreastScreen, they had an interest in the proceedings.

The Court of Appeal held that such evidence constituted expert evidence and was not inadmissible merely because the expert, in this case the radiologists, had an interest in the proceedings. The Court held that such evidence was admissible and that any issues regarding the reliability of the evidence, given the expert’s material interest in the proceedings, should go to the weight given to the evidence by the Court.

Implications

The Court of Appeal made it clear that mathematical possibilities and statistical and epidemiological evidence cannot be applied mechanically. However, the Court’s finding that the respondent’s failure to diagnose the cancer, and resultant increase in the chance of metastasis from 38%-42%, was in fact causative of the metastasis, is difficult to reconcile with its own determination - it is an application of the statistics.

It is difficult to see how a small decrease in the chance that metastasis would not have occurred, from 62% to 58%, was sufficient to justify a finding on the balance of probabilities that the delay materially contributed to the metastasis.

The decision is also difficult to reconcile with the findings made in Gett v Tabet where the Court determined that the plaintiff had lost a 15% chance, but went onto find that this loss had not, on the balance of probabilities materially contributed to the plaintiff’s brain damage.

Aside from the epidemiological evidence supporting the 10% chance in the present proceedings, the only difference between the cases appears to be that in O’Gorman, in the absence of any negligence, there was a greater likelihood of the cancer not metastasising, than there was of the plaintiff having an improved outcome if her tumour had been picked up one day earlier in Gett v Tabet. Notably, Justice Ipp commented that this in itself was a further basis distinguishing Gett v Tabet.

Rather than clarify the circumstances in which it is likely that an increased risk will be found to have materially contributed to a plaintiff’s injury, the case arguably muddies the waters as to the extent to which a risk must be increased in order to be found to have materially contributed to an injury.

 

Written by Kerrie Chambers, Partner and Ashleigh Lester, Solicitor.

 

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Two Australian courts uphold the right to refuse medical treatment

In two cases, decided within days of each other, both the Supreme Court of New South Wales and the Supreme Court of Western Australia have upheld the right of a competent adult patient to refuse medical treatment, even where that refusal will lead to the patient’s death. The New South Wales decision also deals with the validity of an advance directive made by the patient, and therefore provides much needed guidance on the legal status of these documents.

In the case of Hunter & New England Area Health Service v. A [2009] NSW SC 761, decided by McDougall J of the Supreme Court of New South Wales on 6 August 2009, the Area Health Service sought a declaration from the Court as to whether it would be justified in withholding treatment from Mr A in accordance with an advance directive he had signed a year earlier. Mr A had been admitted to the Area Health Service’s Hospital on 1 July 2009, suffering from septic shock and respiratory failure. He was transferred to the Intensive Care Unit, but failed to respond to treatment. His condition deteriorated and he developed renal failure. By 14 July 2009, Mr A was being kept alive by mechanical ventilation and kidney dialysis.

Mr A was a Jehovah’s Witness. In July 2009, he had visited a solicitor in order to execute a document to appoint Mr T as his enduring guardian who would be authorised to make medical decisions on his behalf should he no longer be able to do so himself. The document signed by Mr A appointing Mr T as his enduring guardian included the following statement:

As one of Jehovah’s Witnesses I direct my guardian to refuse consent for a transfusion of whole blood, red cells, white cells, platelets or blood plasma to be given to me under any circumstances even if health care providers believe that such are necessary to preserve my life or even if any of my family, my relatives or my friends disagrees with my considered and non-negotiable decision…

At the hearing before McDougall J, Mr T also gave evidence that Mr A had completed “work sheets” in August 2008 that listed specific medical procedures and indicated whether Mr A agreed to or refused these treatment should they become necessary. One of these work sheets specifically listed haemodialysis. Mr A had completed the work sheet indicting that he refused to consent to haemodialysis.

In considering whether the Area Health Service was either permitted or obliged to give effect to Mr A’s advance directive, McDougall J noted that there may be a conflict between a competent adult patient’s right of self determination and the interest of society in the preservation of life. However, he also stated that:

…a proper understanding of society’s interest in the preservation of life cannot be considered without taking into account the constituents, or attributes, of life. In a free and democratic society those attributes include the right of autonomy or self-determination”.

He went on to conclude that as long as there is no doubt as to a person’s capacity to make his or her own decision as to medical treatment, and no factor such as misrepresentation that might vitiate that consent, the wishes of a competent adult patient must be respected. However, he emphasised that the Court must feel “a sense of actual persuasion that the individual acted freely and voluntarily, and intended his or her decision to apply to the situation at hand”.

McDougall J noted that if there is genuine and reasonable doubt as to the validity of an advance care directive, or as to whether it applies to the situation at hand, a hospital or medical practitioner should apply promptly to the Court for its aid in determining what should be done. It follows that where the advance directive is clear and unambiguous, there is no necessity to apply to the Court for a declaration prior to the withdrawal of treatment, even if this will lead to the death of the patient.

Similar principles were stated by Martin CJ of the Supreme Court of Western Australia in Brightwater Care Group (Inc) v. Rossiter [2009] WASC229, even though the factual scenario was very different. Brightwater Care Group (Brightwater) operates a residential care facility for people with disabilities in Perth. Mr Rossiter suffered from high level quadriplegia as a result of an accident in March 2008, and had been a patient at the Brightwater Facility since November 2008. According to the evidence presented to the Court, his level of physical disability was profound. He had only limited foot movement and the ability to move one finger. He was only able to talk through a tracheotomy. He was unable to eat or drink, and received nutrition and hydration through a gastrostomy tube.

Despite his physical disabilities, however, the evidence presented to the Court indicated that Mr Rossiter had undiminished mental capacity, and therefore had the capacity to make his own medical treatment decisions.

Over many months, Mr Rossiter had expressed a wish to die, and had asked that his nutrition and general hydration be withdrawn. The consequence of this would be that he would die of starvation. Mr Rossiter had requested that he be given palliative care in the form of pain relief and sedation via his gastrostomy tube following the withdrawal of nutrition.

Because of a concern that the withholding of nutrition might give rise to criminal liability on the part of Bridgewater and the treating clinicians, Bridgewater and Mr Rossiter applied jointly to the Court for declarations as to their respective rights and obligations.

Martin CJ first considered the position at common law, noting that it was well established at common law that an individual has the right to determine what should be done to his or her own body. This right gave rise to the legal requirement to obtain the informed consent of the patient before any medical treatment can be undertaken lawfully. He went on to state:

The corollary of that requirement is that an individual of full capacity is not obliged to give consent to medical treatment, nor is a medical practitioner or other service provider under any obligation to provide such treatment without consent, even if the failure to treat will result in the loss of the patient’s life.

Martin CJ then went on to consider the application of section 262 of the Criminal Code (WA) which provides that it is the duty of every person who has the charge of another person to provide for that other person “the necessaries of life”. He held that this provision did not impose a duty on a treating medical practitioner to provide nutrition and hydration to a patient in the face of the patient’s express refusal of consent. In other words, section 262 does not override the common law principle that a competent patient can choose to withhold consent to any form of medical treatment even where the refusal of treatment will result in death.

Martin CJ concluded that Brightwater would not be criminally responsible for any consequences to the life or health of Mr Rossiter caused by ceasing to administer nutrition and hydration to him, if this was done in accordance with his express and informed consent. His Honour expressed some concern as to whether Mr Rossiter had been given sufficient information to appreciate fully all the consequences of his decision to refuse nutrition and hydration, and therefore directed that he be given further advice by an appropriately qualified medical practitioner about these consequences. It was held that if Mr Rossiter then maintained his wish to refuse nutrition and hydration and this wish was complied with, no issue of liability would arise for Brightwater or the treating medical practitioners.

Because there have been only a small number of previous decisions in Australia that have considered the right to refuse medical treatment, these two decisions provide helpful and much-needed confirmation of the legal position. The fact that neither case involved a patient with an otherwise terminal illness makes it clear that the autonomy of the patient prevails over other considerations as long as the patient is fully competent and able to make a free and informed decision. The recognition of a written advance directive as a valid expression of the patient’s wishes should also reassure doctors that it is both appropriate and lawful to follow an advance directive as long as it is written in clear and unambiguous terms.

Written by Julie Hamblin, Partner

 

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Abortion in Australia: the legal pitfalls

On 11 September 2009, a 19 year old Queensland woman and her partner were committed for trial in the Cairns District Court on charges that the woman had unlawfully performed an abortion on herself using the drug Misoprostol (also known as RU486) supplied to her unlawfully by her partner. The Police allege that the young woman and her boyfriend arranged for the importation of the drugs from the Ukraine which the woman then administered at eight weeks gestation. The pair has been charged with offences under the Criminal Code of Queensland (1899); the woman with procuring her own miscarriage by unlawfully administering the drug and her boyfriend with assisting her. In both cases, substantial jail terms are at stake. The drug is available in Australia but the pair appear not to have known this.

With clinicians in Queensland refusing to perform abortions, patients are being referred to New South Wales hospitals, with some jurisdictions removing abortion from their Criminal Code. The abortion issue is very much alive for the medical profession in Australia.

The charges - apparently the first in Queensland in approximately 50 years - are a reminder of the dangers associated with performing abortions for both the medical profession and their patients. While the case concerns the prosecution of the woman and her partner, clearly the majority of abortions are now performed by doctors. The last prosecution of a doctor in Queensland was over 20 years ago, and he was acquitted. However, the recent developments in Queensland highlight just how uncertain the law is on abortion in many parts of Australia.

This article outlines the legal position in Queensland, NSW, the ACT and Victoria, the non-medical risks for medical practitioners and their staff and how they can be avoided.

Queensland and New South Wales

It may come as a shock to know that almost the same criminal sanctions for abortion exist in New South Wales as they do in Queensland, yet doctors in these two States conduct the majority of the 100,000 or so abortions that are performed each year in Australia. Under the criminal law in both Queensland and New South Wales, for more than 100 years, it has been an offence:

1. to unlawfully supply or procure a drug or other thing knowing it is to be used unlawfully to procure an abortion; or
2. for either the woman herself or any other person to unlawfully administer a drug to or use an instrument on the woman with intent to procure an abortion (or, in the case of Queensland, for a woman to permit another person to do such a thing to her).

These offences carry jail terms ranging from three years to 14 years. In Queensland (but not New South Wales) it has been a defence to perform a surgical operation upon a patient for the patient’s benefit or upon an unborn child for the preservation of the mother’s life, if it is reasonable having regard to the patient’s state and all the circumstances. In response to the public outcry over the recent charges, the Queensland government has now amended this provision of the Criminal Code to extend the defence to cover medical procedures as well as surgical procedures. This was to address the concern voiced by doctors that performing medical abortions (i.e. using RU486) would otherwise be a criminal offence.

The law in both New South Wales and Queensland relies heavily on what is “unlawful” which is not defined. Put simply, abortion is an offence if performed “unlawfully” which is for the Courts to decide.

Who can perform?

In both New South Wales and Queensland the law is silent on who can perform an abortion but Courts in both states have said that the procedure has to be performed by a medical practitioner in order to be “lawful”. A non-practitioner is almost certain to be unable to meet the requirements for establishing lawfulness (see below) and it would seem that the woman herself has no defence, even where there is no risk to herself.

In Queensland a medical practitioner has a defence to the criminal charge when performing an abortion for the preservation of the mother’s life. The Queensland defence is both unclear and limited while no comparable provision exists in New South Wales. The majority of abortions are medically induced but there is no support for this practice by medical practitioners in the statutes of either State.

When is an abortion lawful?

In both New South Wales and Queensland, the medical practitioner must honestly believe, on reasonable grounds, that:

1. the abortion is necessary to protect the woman from serious danger to her life or physical or mental health; and
2. the danger of the procedure is not out of proportion to the danger that is being avoided.

In New South Wales (but not Queensland), economic and social factors are considered to be relevant and health concerns for the woman are not limited to the pregnancy.

In Queensland, the Courts have stressed that the “law in this State has not abdicated its responsibility as guardian of the silent innocence of the unborn…There is no legal justification for abortion on demand” although in another case, the serious danger to the mother’s mental health if her severely handicapped child had been born was recognised.

The 2006 Dr Sood case illustrates the law in New South Wales. Dr Sood was convicted of performing an unlawful abortion. She had not carried out a physical examination, discussed alternatives with the woman or enquired as to her reasons for requiring a termination. The Court found that she had not honestly believed that the procedure was necessary to preserve the woman’s life or avoid serious danger and nor had she weighed the relative dangers of termination against continuing with the pregnancy. The Court held there was no requirement for the doctor to have counselled or deterred the woman.

When abortion can or should be done?

In both New South Wales and Queensland, there is no duty to perform an abortion. Accordingly, the doctor can refer a patient elsewhere. To meet his/her duty of care, the practitioner must still provide the patient with enough information to help her make an informed decision.

There are no legislative requirements in relation to late term abortions - it is a matter for practitioners, bearing in mind the other requirements.

The law is no less punitive in New South Wales than in Queensland bringing into question the recent practice of interstate referrals. Medical practitioners in Queensland have a limited defence for abortions when the woman’s life is at stake, but the principal issue in both States remains whether the abortion is “lawful”, based on the criteria laid down by the courts.

ACT and Victoria

The ACT (since 2002) and Victoria (since October 2008) have decriminalised the medical practice of abortion. However, they have handled the move in different ways. In both jurisdictions the area is regulated by health legislation rather than the criminal law. In the ACT (Health Act 1993) there are no criminal sanctions at all and in Victoria (Crimes Act 1958 and Abortion Law Reform Act 2008), very few.

Who can perform?

In the ACT only a doctor in a medical facility can perform an abortion. There are no other requirements.

In Victoria, up to 24 weeks, a doctor may perform all abortions while a nurse or pharmacist may perform a medical abortion. For abortions after 24 weeks, the doctor must consult another doctor and both must reasonably believe the abortion is appropriate in all the circumstances, including medical circumstances and the women's current and future physical, psychological and social circumstances. Provided these conditions are met a doctor may also direct, in writing, a nurse or pharmacist employed at a hospital or day procedure centre to perform a medical abortion.

When is an abortion illegal?

In the ACT abortion is never illegal as there are no criminal sanctions.

In Victoria abortion is illegal if not performed by a qualified person. A qualified person is either a doctor, a nurse or pharmacist under the circumstances described above. The maximum penalty for an unlawful abortion is 10 years imprisonment. The woman herself can never be guilty of an offence.

When abortion can or should be done?

In the ACT, the abortion can be done at any time in any circumstances but no one is under any duty (“contract, statutory or other legal requirement”) whatsoever to carry out (or assist) an abortion although there may be professional repercussions.

In Victoria, an abortion must be done if the woman’s life is at stake, otherwise, up to 24 weeks in any circumstances and, after 24 weeks, where the doctor/s considers it appropriate as set out above.

In the case of “conscientious objectors” to abortion in Victoria, the practitioner must inform the woman of the objection and refer her to a registered health practitioner in the same regulated health profession who he/she knows does not have an objection. This positive duty is unique in Australia. A doctor (and a nurse to assist) is also under a duty to perform an abortion in an emergency where it is necessary to preserve the life of the woman, even if the doctor has a conscientious objection.

What should a doctor do?

The only way for a doctor to satisfy him or herself of the requirements for legality as set out above (excluding the ACT which has none) is to take a detailed history, provide the patient with all the alternatives, conduct a thorough examination and to make a detailed record, including where appropriate, directions given to staff. This was clearly illustrated by the Sood case. The defence for abortions in Queensland by medical practitioners does not remove the necessity for such diligence.

Conclusion

Abortion law on Australia’s east coast is in a state of flux. Whereas New South Wales and Queensland retain the criminal sanctions dating back more than 100 years, the ACT and Victoria have instigated substantial reform. In those jurisdictions abortion is predominantly a health issue to be assessed by the medical profession, rather than a legal issue to be determined by lawyers and the Police.

In New South Wales, the Greens are now actively agitating for reform of abortion law. In Queensland, the current criminal matter has provoked enormous concern on the part of both the medical profession and the public. The trial of the Cairns couple will now take place next year.

 

Written by Susan Doherty, Senior Associate and Feneil Shah, Solicitor.

 

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Developments in E-Health

In 2006, the Council of Australian Governments (COAG) agreed to a national approach to developing, implementing and operating systems for individual and healthcare provider identifiers as part of accelerating work on electronic health records to improve the safety of patients and improve efficiency for healthcare providers.

The legislative framework to underpin implementation of healthcare identifiers and the establishment of appropriate national privacy arrangements for health information is currently being developed collaboratively by Commonwealth, State and Territory health departments.

The Australian Health Ministers’ Conference has asked for consultations to be held so that a broad range of perspectives can contribute to making the legislation robust and effective, protecting the privacy of personal information while achieving the healthcare benefits that can be gained through better sharing of health information.

A discussion paper has been released which describes and seeks comments on legislative proposals to support the establishment and implementation of unique identifies for healthcare purposes and the privacy of health information. The discussion paper is now available.

The scope of this paper is limited to the regulatory issues relating to the establishment of a national Healthcare Identifier Service and to the national health information privacy regulation.

While the date for submissions recently closed on 14 August 2009, the discussion paper will be of continuing interest to many.

Google and Microsoft enter the E-Health space: has the Government missed the boat?

While the Australian Government E-Health initiative wends its way forward, the lengthy period of its gestation has given rise to parallel E-Health systems. Different State and Territory Governments have generated more limited E-Health projects of their own, perhaps out of frustration at the time taken for a national Government system.

In addition to these Australian Government initiatives, last year Google and Microsoft began offering individuals their own E-Health option. It is free and enables individuals to keep all their health information in one central downloadable place. Google calls its offering Google Health, while Microsoft’s goes by the name of HealthVault. Both these E-Health systems are already operating elsewhere, with Google’s already available in Australia.

There are some enormous potential benefits to Google and Microsoft in aggregating large amounts of health information on their servers. Without disrupting the privacy of any individuals, they have the opportunity to access that health information in de-identified form. The commercial value of that information is clear. For example, it will enable them to know by postcode how many people suffer from particular conditions and target marketing to those postcodes. They can also on-sell that information to the health industry.

 

Written by Geoff Bloom, Partner

 

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Insurance and indemnity for human research

Duty to be insured

The National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2007) (National Statement) states that research sites must be satisfied, before approving a clinical trial, that arrangements exist to ensure adequate compensation to participants for any injury suffered as a result of participation in the trial.

In the case of trials involving therapeutic goods that have not been approved by the Therapeutic Goods Administration, therapeutic goods legislation usually requires the approval by the Human Research Ethics Committees (HREC) in accordance with the National Statement. Accordingly, there is an ethical duty and, in most cases involving unapproved therapeutic goods, a legal requirement, to ensure adequate compensation. This would extend to having adequate insurance cover for human research.

For many research organisations, there are additional bases for the legal duty to ensure adequate insurance cover.

Roles and responsibilities in human research

The sponsor of a clinical trial determines what is to be trialled through drafting the trial protocol, and funds the conduct of the clinical trial. Pharmaceutical companies are common commercial sponsors of clinical trials.

The investigator of a clinical trial conducts the trial. The person with primary responsibility for the conduct of the trial is called the principal investigator who will often be a medical practitioner. Other investigators may include medical practitioners, nurses and allied health professionals.

Where the investigator is also the sponsor, the trial is an investigator-initiated clinical trial. Most trials of this kind are not conducted for profit.

The principal investigator is responsible for obtaining an approval for the proposed research from an appropriately constituted HREC.

Who needs to be covered by insurance?

Any person or organisation whose involvement in human research exposes them to significant potential liabilities should be covered. Each of the persons or organisations mentioned in the previous section needs to be covered by an adequate insurance policy.

Liabilities

Potential research liabilities come from either:

• initiation or sponsorship of research including development of a research protocol; or
• conduct of research.

Initiation of research

Sponsors or investigator-initiators may be liable to research participants due to:

• professional negligence in the design of the research protocol, giving rise to professional liability;
• the harmful effect of a product under investigation, giving rise to products liability; or
• voluntarily agreeing to compensate injured participants on a no-fault basis, for example, in accordance with Medicines Australia’s guidelines for compensation.

Adequate clinical trial insurance should cover these risks.

The sponsor of a clinical trial will often have no direct relationship with research participants in the trial. Commercial sponsors of trials are required to give an indemnity to the research institution conducting the trial for any liabilities which are properly the responsibility of the sponsor. Commercial sponsors will often use the Medicines Australia standard form indemnity. Non-commercial sponsors or investigator-initiators also may be required to give an indemnity to research institutions in some circumstances.

Conduct of research

Conduct of research often includes the following activities:

• selecting potential research participants and determining whether participation in the research is appropriate and will not expose potential participants to undue risks;
• determining how the research protocol should be applied to the particular participant;
• administering the product or procedure that is being investigated; and
• monitoring the participant and ensuring that the participant’s involvement in the research is not causing the participant harm.

Liabilities may arise if any of the above activities are performed negligently and result in injury to a research participant.

Adequate clinical trial insurance should cover these risks for:

• the research institution, its directors and officers;
• the research institution’s HREC (if any);
• the investigators except for medical practitioners;
• medical practitioners, to the extent that their separate professional indemnity cover does not cover them.

Medical practitioners are required by law to be covered by approved professional indemnity insurance, generally through medical defence organisations or through an organisation’s self-insurance scheme. This insurance will generally cover potential human research liabilities for medical practitioners adequately, though some policies require the practitioner to notify their insurer of specific research involvement before the cover applies.

Treasury Managed Fund

Most research carried out by New South Wales public health system personnel, including medical practitioners, will be covered by the New South Wales Government’s self insurance scheme, the Treasury Managed Fund or TMF. The extent to which Staff Specialists Levels 2 5 and Visiting Medical Officers or VMOs will be covered by the TMF is currently under consideration by NSW Health. Any gaps in coverage must be covered by the practitioner’s professional indemnity cover.

Research in complex environments

Research often takes place in complex institutional environments involving multiple parties. This can complicate the issue of whether the proposed research is adequately insured. The following more complicated scenarios are common:

• a commercially-sponsored clinical trial might be conducted in a medical research institute by a combination of institute personnel and university personnel;
• an investigator initiator clinical academic may conduct research within a public hospital, to be carried out by a combination of university personnel and NSW Health personnel; or
• a Visiting Medical Officer may be involved in the conduct of research which is otherwise entirely carried out by NSW Health personnel.

Getting insurance right

Insurance, and sometimes indemnity, is a necessary part of conducting human research. To ensure that approvals to conduct research are not delayed, and that research organisations are adequately insured in the event of a claim by a participant, it is necessary to get insurance and indemnity issues right.

 

Written by Geoff Bloom, Partner

Geoff Bloom has been commissioned by the NSW Office for Science and Medical Research (OSMR) to write a Guide to Insurance and Indemnity for Human Research in New South Wales and a series of brochures on Insurance and Indemnity for Human Research in New South Wales.

The Guide and the brochures will soon be available on OSMR’s website at www.osmr.nsw.gov.au.

 

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Growth attenuation therapy for disabled children

Parents of disabled children often face very difficult decisions about the ongoing care of their children. Children with severe physical, neurological and cognitive impairment require 24 hour care which is most often provided by the parents. As these children grow, the physical requirements of caring for them become greater. Growth attenuation treatment with high dose oestrogen reduces the growth of these children and may therefore make it easier for them to be cared for at home as they grow older.

Growth attenuation treatment is highly controversial. In America, such treatment of a girl aged nearly seven years old gained nationwide attention in 2006 after the clinicians involved published their findings in an international medical journal. The child was severely disabled with profound developmental, neurological and cognitive impairment, and a mental age of a three-month old infant. Her growth was arrested with high dose oestrogen therapy resulting in permanent attenuation of her physical stature. The parents had requested the treatment primarily out of concern that their daughter’s continued growth would make it untenable for her to be cared for by them at home. The treatment was the subject of ethical approval by the hospital and the parents sought legal advice prior to therapy commencing.

It is not known how often clinicians in Australia are asked to prescribe growth attenuation therapy for disabled children, but there is anecdotal evidence that such requests by parents may be increasing. These requests call for a consideration of whether a parent can give valid legal consent to a procedure or course of medical treatment that is not therapeutic for the child, such as permitting the child to be a bone marrow donor. Arguably, growth attenuation therapy is a non-therapeutic intervention of this kind because its objective is to assist the carer rather than the child directly, notwithstanding possible indirect benefits to the child in being able to be more easily cared for at home.

The legal position

At common law, parents generally have the legal authority to provide consent to medical treatment for their children, where the child is not sufficiently mature to make his or her own treatment decisions. However, there are some forms of treatment that have been held by the courts to be “special cases” such that court approval is required before the treatment can lawfully be given.

The leading case which defines the limits of the types of treatments and interventions to which parents may consent on behalf of their children is Marion’s case, decided by the High Court in 1992.[1] This case involved a request for the sterilisation of a 14 year old intellectually disabled girl. The High Court noted that the treatment involved invasive, irreversible and major surgery, and therefore held that court approval was required before the procedure could be carried out. While not providing an exhaustive list of which kinds of treatment require court approval, the High Court said that two relevant considerations in this regard are:

• the significant risk of making the wrong decision, either as to a child’s present or future capacity to consent or about what are the best interests of child who cannot consent; and
• the grave consequences of a wrong decision.[2]

Apart from sterilisation, other procedures that have also been held to require court approval include surgical gender reassignment, bone marrow donation, hormonal treatment and termination of pregnancy. While Australian courts have not yet had to consider whether growth attenuation therapy would also fall into this category, there is clearly an argument that it should, since it is irreversible treatment which prevents the child from ever achieving the physical stature of an adult, and therefore has significant and permanent consequences for the child.

In Marion’s case, the High Court also considered the factors that should be taken into account by a court when deciding whether to approve medical treatment for a child. The Court held that the over-arching concern is to determine what is in the best interests of the child. Factors relevant to determining the best interests of the child in each case were held to be:

• the particular condition of the child which requires the procedure;

• the nature of the proposed procedure;

• the reasons for which it is proposed that the procedure be carried out;

• the alternative courses of treatment that are available;

• the desirability and effect of authorising the procedure proposed rather than the available alternatives;

• the physical effects on the child and the psychological and social implications for the child of:

• authorising the proposed procedure

• not authorising the proposed procedure

• the nature and degree of any risk to the child of:

• authorising the proposed procedure

• not authorising the proposed procedure

• any views expressed by:

• the guardian of the child

• a person who is responsible for the daily care and control of the child or

• the child

about the proposed procedure or any alternative procedure.[3]

Relevant legislation

Superimposed on the common law principles set out above are various statutory provisions at both Commonwealth and State levels governing consent to medical treatment for minors in “special cases” of the kind described in Marion’s Case.

Under section 67ZC of the Family Law Act 1975 (Cth), the Family Court of Australia has a general power to make orders relating to the welfare of children. This has been held to extend to making orders for the medical treatment of children in cases where the parents alone cannot give valid consent based on the principles in Marion’s Case. In exercising this power, the paramount consideration for the Family Court pursuant to section 60CC of the Act is the best interests of the child.

In New South Wales, section 175 of the Children and Young Persons (Care and Protection) Act 1998 makes it an offence for a person to carry out “special medical treatment” on a child under 16 (other than in case of emergency) without first obtaining approval from the NSW Guardianship Board. “Special medical treatment” is defined to mean:

• Any medical treatment that is intended, or is reasonably likely, to have the effect of rendering the child permanently infertile (except where the treatment is for a life-threatening condition and permanent infertility is an unwanted consequence of the treatment);

• Long-acting injectable hormonal substances for the purpose of contraception or menstrual regulation;

• Vasectomy or tubal occusion;

• The administration of an addictive drug

• Certain medical treatment involving an experimental procedure; or

• In the case of a child in residential care, the administration of a psychotropic drug to control the child’s behaviour.

The Guardianship Board is only permitted to approve special medical treatment for a child under 16 if it is satisfied that the treatment is necessary in order to save the child’s life or to prevent serious damage to the child’s psychological or physical health. This is a highly restrictive test, and certainly more restrictive than the “best interests of the child” test applied under the Family Law Act and at common law.

The fact that two different procedures exist in New South Wales for the approval of medical treatment for children that meets the definition of “special medical treatment” - an application to the Family Court under the Family Law Act and an application to the Guardianship Board under the Children and Young Persons (Care and Protection) Act - gives rise to considerable uncertainty and confusion in this area of the law. Arguably, the parents of a disabled child seeking approval for such treatment for their child could choose whichever forum they consider is most likely to lead to the desired outcome.

From the doctor’s perspective, it is to be hoped that the approval of the Family Court would be sufficient to protect the doctor from liability if special medical treatment is carried out. It could be argued that this approval prevails over the State legislative requirement as a matter of constitutional law. However, this has not been specifically tested in the courts, and the theoretical possibility remains that the doctor could still be charged under the Children and Young Persons (Care and Protection) Act if approval has not been obtained from the NSW Guardianship Board.

Ethical considerations

Apart from the requirement to obtain valid legal authorisation for medical treatment of this kind for children, there are also ethical considerations to be weighed by both parents and clinicians. A doctor is not necessarily compelled to perform the medical procedure on the child just because it is requested by the parents. Minds may differ as to what is in the best interests of the child, especially in cases where the direct therapeutic benefit for the child is questionable. A careful analysis of the ethical issues is required independently of the legal procedures for obtaining consent.

Applying these principles to growth attenuation therapy

Growth attenuation therapy does not come within the definition of “special medical treatment” under the Children and Young Persons (Care and Protection) Act 1998, so it is not mandatory to obtain the approval of the Guardianship Board for this therapy. However, there is a strong argument that it nonetheless falls outside the range of treatments for which the child’s parents alone can give valid consent, based on the principles laid down by the High Court in Marion’s Case. This is because growth attenuation therapy is permanent and irreversible, with arguable therapeutic benefit for the child, and there is a likelihood of significant adverse consequences for the child if the wrong decision is made.

If faced with a request for growth attenuation therapy from the parents of a disabled child, doctors must first weigh the ethical considerations to determine whether they consider the treatment is ethically appropriate. If the treatment is thought to be appropriate, care must then be taken to ensure that the proper legal procedures are followed to obtain valid authorisation for the treatment. In view of the legal principles summarised above, doctors would be well-advised to insist upon court authorisation before agreeing to provide growth attenuation therapy.

 

Written by Julie Hamblin, Partner and Emma Slaytor, Solicitor.