Some recent cases on s 5O of the Civil Liability Act 2002 (NSW)

Belinda Reeve Healthcare Law , ,
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Image: Matt Madd, Flickr

Section 5O of the Civil Liability Act 2002 (NSW) (CLA) introduced a modified version of the Bolam principle into the law of civil liability in NSW, extended to professionals other than medical professionals (the original subject of the principle). The effect of s 5O(1) is that a court is prevented from making a finding of negligence against a defendant professional where it can be shown that he or she acted in accordance with a practice widely accepted as being competent by peer professional opinion, unless that opinion is irrational (s 5O(2)) (s 5P excludes the application of s 5O to risk warnings in certain circumstances). Three recent cases involving s 5O provide some guidance on how the provision should be interpreted.

“A practice”

In Sparks v Hobson [2018] NSWCA 29 (recently covered on this blog by Professor Roger Magnusson) the plaintiff, Mr Hobson, required corrective surgery to straighten his spine, which took place in two stages. The first stage proceeded without incident, but the second stage had to be brought ahead of schedule and done urgently. The surgery was terminated after the anesthetist, Dr Sparks, became concerned that Mr Hobson’s blood pressure and oxygen levels were dangerously low as a result him being positioned face down for the surgery. While a later surgery successfully addressed the spinal condition, Mr Hobson was rendered paraplegic as a result of the second urgent surgery. He brought an action in negligence against the hospital and members of his treating team, including Dr Sparks and the principal surgeon Dr Grey. The trial judge found that both doctors had been negligent in not terminating the surgery 13 minutes sooner than they did, and that s 5O could not be made out. The defendants appealed to the NSW Court of Appeal.

Dr Grey was successful in establishing that he had not been negligent, but a majority of the Court of Appeal found that Dr Sparks had been negligent in failing to terminate the surgery sooner. Justice McFarlan and Justice Simpson accepted that they were bound by the Court of Appeal’s reasoning in McKenna v Hunter & New England Local Health District [2013] NSWCA 476. Here, the court held that in order for s 5O to be established, a medical practitioner must demonstrate that what he or she did conformed with a practice that was in existence at the time the medical service was provided. Then, he or she must establish that that practice was widely (although not necessarily universally) accepted by peer professional opinion as competent professional practice.

Justice Basten rejected the requirement that there be “a practice” (described as a “regular course of conduct adopted in particular circumstances”), on the basis that the Court of Appeal’s decision in McKenna was overturned on appeal to the High Court and its reasoning was no longer binding. However, His Honour agreed with Justice McFarlan (but on different grounds) that Dr Grey’s evidence was insufficient to establish s 5O.

The majority’s judgment in Sparks v Hobson narrows the scope of the operation of s 5O, meaning that it will not be available in circumstances where the defendant cannot show that he or she followed a discrete, established “practice”. This includes in unusual factual situations or potentially, situations involving new medical techniques or procedures. The High Court recently denied an application for leave to appeal from the Court of Appeal’s decision.

“Irrational”

Under s 5O(2) peer professional opinion cannot be relied upon for the purposes of s 5O(1) if the court considers that the opinion is “irrational”. The NSW Court of Appeal considered the meaning of this term in South Western Sydney Local Health District v Gould [2018] NSWCA 69. The plaintiff, a young boy, slipped and fell on wet concrete and injured his thumb. He was administered antibiotics at Campbelltown Hospital and a different antibiotic at Liverpool Hospital, which he was transferred to in the evening on the day of the incident. However, gangrene developed in his thumb after he was discharged and it was amputated. The plaintiff successfully brought a claim in negligence against the health district responsible for Liverpool Hospital. The trial judge found that the treating team at Liverpool Hospital had been negligent in failing to give the plaintiff an additional course of a different antibiotic, and that the opinion of the defendant’s two expert witnesses (that the additional course of antibiotics was not required) was irrational under s 5O(2).

On appeal to the NSW Court of Appeal, Justice Leeming (with whom Meaghar J agreed) made a series of comments on s 5O after considering the history, objective and statutory context of the provision. Justice Leeming concluded that ([96]):

Text, context and purpose [of s 5O] all support the conclusion that it is a seriously pejorative and exceptional thing to find that a professional person has expressed an opinion that is ‘irrational’ and even more exceptional if the opinion be widely held. To consider a body of opinion to be ‘irrational’ is a stronger conclusion than merely disagreeing with it, or preferring a competing body of peer professional opinion.

Justice Leeming held that the trial judge had erred by conflating the process of resolving a conflict between competing expert opinions “with the entirely different process required by s 5O(2) of determining whether an opinion is ‘irrational’” ([65]). It was also procedurally unfair for the trial judge to find the evidence of the defendant’s witnesses irrational when this point had not been argued at trial or raised with either party. Further, the evidence of the defendant’s witnesses was sufficient to establish s 5O(1) and the appeal was allowed.

Does s 5O operate as a defence?

Based on the decision in Dobler v Halveson (2007) 70 NSWLR 151, s 5O has commonly been interpreted as a defence, meaning that the plaintiff must establish a breach of the duty of care for the purposes of s 5B of the CLA (as well as the other elements of negligence), following which the defendant must raise evidence that his or her conduct accorded with competent professional practice for the purposes of s 5O.

In Gould, Justice Leeming commented that the proper interpretation of Dobler was that if the defendant could establish the preconditions in s 5O, then it would act to set the standard of care. If the preconditions in s 5O could not be established then ss 5B and 5C of the CLA would apply. However, “[t]here is no occasion to compare the s 5O standard with that which would be considered in the application of s 5B in a case where the preconditions of s 5O have been made out” ([129]). Justice Leeming noted that this interpretation of s 5O was also suggested by Justice Basten and Justice Simpson in Sparks v Hobson. In that case, Justice Basten commented that ([18]):

…once s 5O is invoked, arguably the general exercise required by s 5B becomes otiose. There can only be one standard against which to judge the conduct of a professional defendant, although that standard may depend upon the resolution of conflicting evidence called by the plaintiff and the defendant. It is only if one takes the plaintiff’s evidence in isolation that a two-stage process, involving the assessment of the plaintiff’s claim followed by assessment of an affirmative defence, will arise. However, in a practical sense, that is not how the dispute should be determined. Rather, a judgment will be given based on all of the evidence. Nor is the exercise helpfully clarified by speaking of shifting burdens of proof. The question for the trial judge is ultimately whether the plaintiff has established that the conduct of the defendant failed to comply with the relevant standard of care.

According to Justice Basten, s 5O will be engaged where there is evidence of a widely accepted professional practice supporting the defendant’s conduct, but that evidence, when available, will set the relevant standard: “there cannot be two legally supportable standards operating in the one case” ([24]). So while the defendant may need to establish the elements of s 5O, it is the starting point for determining the standard of care owed by the defendant and whether the defendant fell below the standard of care – not a defence that is considered after breach has been established for the purposes of s 5B of the CLA.

“Professional”

The word “professional” is not defined in s 5O. It clearly extends to medical professions, but it is unclear which other professions it might include. The meaning of the word “profession” was considered in Zhang v Hardas (No 2) [2018] NSWSC 432. In this case, Ms Zhang sued Mr Hardas, a chiropractor, alleging that he had been negligent in treating her over 12 consultations between February and September 2007, causing her to develop a depressive disorder. The case concerned Mr Hardas use of an “activator” device on Ms Zhang’s spine, which delivered a significant force to the spine for the purpose of moving bones in the spine. Ms Zhang alleged that the device had been applied hundreds of times to her cervical spine during each of the consultations with Mr Hardas.

Justice Leeming in the NSW Supreme Court rejected this argument, with the evidence supporting Mr Hardas’ position that the device had been used no more than a dozen times during each session with Ms Zhang. Further, it was not reasonably foreseeable that a person of normal fortitude might suffer a recognized psychiatric injury as a result of undergoing treatment with the activator device when it was used no more than a dozen times on each occasion. However, Justice Leeming considered whether s 5O would apply, if His Honour was incorrect on the point of whether the plaintiff owed the defendant a duty of care, as argued by the defendant.

Justice Leeming considered whether Mr Hardas, as a chiropractor, could be said to be “practicing a profession”. After reviewing the history of professionalization, Justice Leeming stated that he preferred the view “that the essential nature of practising a profession is closely linked to a partial monopoly, justified by education and public benefit, and involving a measure of altruism distinct from the drive for profit” ([144]). However, Justice Leeming did not express a conclusive view of the meaning of the word “profession” for the purposes of s 5O, but instead confined his decision to the narrower question of whether chiropractors practiced a profession.

Justice Leeming noted that at the time the incident occurred, chiropractors were regulated under a series of acts, including the Chiropractors Act 2001 (NSW), the Health Care Complaints Act 1993 (NSW) and the Public Health Act 1991 (NSW). The Chiropractors Act established a Registration Board that developed a code of professional conduct for chiropractors and also included definitions of “professional misconduct” and “unsatisfactory professional conduct.” Public complaints could be made to the board, and the Act also established a Chiropractors Tribunal that dealt with complaints that could involve suspending or cancelling a chiropractor’s registration. The Public Health Act provided that a person could not engage in spinal manipulation unless they were a registered chiropractor.

Justice Leeming concluded that s 5O “was enacted in a context in which (a) it was plain that the conventional medical profession was squarely within the mischief to which it was directed and (b) legislation treated chiropractors in ways which were similar to medical practitioners”, including through the creation of a tribunal dealing with instances of professional misconduct, combined with statutory concepts of professional misconduct and unsatisfactory professional conduct ([169]).

The Chiropractors Act 2001 also consistently treated chiropractors as professionals and “there is every reason for the defined term “professional” in s 5O to extend to occupations regarded by the same Legislature as professional” ([169]). Accordingly, chiropractors could be regarded as practising a profession for the purposes of the provision. Further, “the notion of a licensed monopoly of people who practice spinal manipulation, with educational qualifications and mechanisms for admitting and excluding those who meet or fail to meet those standards, also appears to apply” ([170]).

Mr Hardas could establish that he had acted in a manner that was widely accepted in Australia as competent professional practice as he had established that the “activator technique” was widely accepted in Australia, and the fact that other chiropractors used different methods did not prevent him from establishing that he had followed competent professional practice (s 5O(3)). Justice Leeming left to one side the issue of whether s 5O required the defendant to establish that he or she had followed “a practice” but noted that Mr Hardas’ conduct would have met this requirement if necessary.

 

Accessing assisted dying in Victoria: how will it happen, exactly?

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Last November, Victoria passed the Voluntary Assisted Dying Act, becoming the first Australian State to legalise assisted dying.

The Act comes into force on 19 June 2019.

How will a person lawfully use the Act?  This post provides a brief walk through the procedure established by the Act.

This is not the first time Victoria has been at the vanguard of law reform on a hotly contested bioethical issue.  In 1988, Victoria introduced Australia’s first advance directives legislation, the Medical Treatment Act (it was repealed on 12 March 2018, replaced by the Medical Treatment Planning and Decisions Act 2016).  Earlier, in 1984, Victoria passed the Infertility (Medical Procedures) Act 1984, the world’s first legislation regulating IVF and human embryo research,  now replaced by the Assisted Reproductive Treatment Act 2008.

Can’t talk about it

Prior to the Parliamentary vote, former Prime Minister Paul Keating argued passionately against the Act, writing that “The experience of overseas jurisdictions suggests that pressures for further liberalisation are irresistible”.

The Act is said to contain 68 safeguards to guard against abuse.

One of the most interesting safeguards is section 8(1), which states that a medical practitioner must not initiate a discussion with a patient that is “in substance about voluntary assisted dying”.

A doctor who does so engages in unprofessional conduct under (Victoria’s version of) the Health Practitioner Regulation National Law.

Section 75 of the Act also imposes mandatory notification requirements [to the Australian Health Practitioner Regulation Agency] on a medical practitioner who reasonably believes that another registered health practitioner has initiated a discussion about voluntary assisted dying, or offered to provide voluntary assisted dying in a manner that is not in accordance with the Act.

Mandatory notification requirements are imposed on an employer in the same circumstances (s 76).

Before assisted dying was legalized in Victoria, there was nothing unlawful about talking to a terminally ill person about assisted dying.  The topic was not “off the table”, so long as no action was taken.

But now, drawing a person’s attention to a lawful course of action under an Act of Parliament apparently amounts to reportable misconduct, in order to ensure that zealous health care workers do not nudge sick and distressed, aging or disabled people towards “euthanasia”.

Right to opt-out

There is no obligation on a medical practitioner to assist a patient to die under the Act.

Under section 7, a medical practitioner who has a conscientious objection to voluntary assisted dying has the right to refuse to provide information about assisted dying, to participate in the process the Act establishes, and to supply drugs or be present at the time an assisted dying substance is administered.

A complex process

With 143 sections, the Voluntary Assisted Dying Act is a complex piece of legislation.

This is intentional: the legislative requirements that must be satisfied before assistance in dying can lawfully be given are intended to act as safeguards against misuse.

Eligibility

Victoria’s assisted dying regime is only open to adults who have been resident in Victoria for at least 12 months – this is clear from section 9 [s 9(1)(b)].

This is intended to prevent Swiss-style euthanasia tourism – the kind of tourism illustrated in the film “Me before You” starring Emilia Clarke and Sam Claflin.

A person doesn’t meet the eligibility criteria for assistance unless they are suffering from an incurable disease that has reached such an advanced state that death is expected within 6 months, and the disease is causing suffering that is intolerable to the person [s 9(1)(d)].

One exception to this is in s 9(4), which allows a person to access assistance if they have a neurodegenerative disease that will cause death within 12 months.

Coordinating medical practitioner

The process of assisted dying under the Act begins when a person makes a “first request” for access to voluntary assisted dying to a registered medical practitioner (s 11).

This request may be verbal.  The medical practitioner may accept or refuse the request, but if they accept they must record the request, and become the patient’s coordinating medical practitioner (ss 13-15).

A coordinating medical practitioner must be either a medical specialist, or a vocationally registered general practitioner.

[A vocationally registered GP attracts higher Medicare rebates and special Medicare item numbers.  There are a variety of pathways to accessing these higher rebates, including through membership of the Royal Australasian College of GPs, or by meeting requirements for vocational registration by the General Practice Recognition Eligibility Committee.]

The coordinating medical practitioner must carry out approved assessment training and then assess whether the patient meets the eligibility criteria set out in s 9. (Approved assessment training must be approved by the Secretary of the Department of Health and Human Services [see s 114]).

In order to be eligible for voluntary assisted dying, a person must have “decision-making capacity” in relation to voluntary assisted dying: s 9(1)(c).

The term “decision-making capacity” is defined in s 4, and it requires a person to be able to understand information, retain it, and use it or weight it in order to reach a decision.  The person must also be able to communicate their decision to a medical practitioner.

The coordinating medical practitioner must be satisfied that the patient is acting voluntarily and without coercion, and that their request for assistance to die is enduring (s 20).

If they are assessed as eligible, the coordinating medical practitioner must report to the Voluntary Assisted Dying Review Board (established under s 92 – see s 21) and refer the patient for a consulting assessment (s 22).

Consulting assessment

The consulting medical practitioner who carries out the this assessment must have  completed “assessment training” (s 26) and must be a specialist or vocationally registered GP with at least 5 years’ experience and have “relevant expertise and experience in the disease, illness or medical condition expected to cause the [patient’s] death” (ss 23-24).

If the consulting medical practitioner concludes that all the eligibility criteria are met, they must notify the person and also notify the Board (s 30).

Formal written request

At that point, the patient may make a written declaration requesting access to voluntary assisted dying which meets the requirements set out in s 34.

This request must be signed by the patient in the presence of 2 witnesses and the coordinating medical practitioner.

Witnesses need to meet requirements set out in s 35 and must also sign a certificate dealing with matters set out in s 36.

Final request

The patient may then make a final request under s 37.  This final request must be at least 9 days after their first request (made under s 11), and at least one day after they were assessed by the consulting medical practitioner as eligible (s 38).  However, the requirement for at least 9 days of reflection following the first request may be shortened if the person’s death is imminent and they are likely to die within that 9 day period.

Following the final request, the patient must then appoint a contact person who, amongst other things, must return unused assisted dying drugs to pharmacists (ss 39-40).

The coordinating medical practitioner must then review all the documentation and certify that the request and assessment process complies with the Act.  They must give the completed final review form to the Board (s 41).

Voluntary assisted dying permits

This enables the coordinating medical practitioner to apply for a “voluntary assisted dying permit” for the patient (s 43).

There are 2 kinds of voluntary assisted dying permit.

The coordinating medical practitioner can apply for a “self-administration permit” under s 47 if the patient is physically capable of self-administering the drug or poison.  The drug in question must be specified in the permit.

Under s 45, a “self-administration permit” authorises the coordinating medical practitioner to prescribe and supply a quantity of drug for self-administration by the patient in sufficient quantity to cause death.  It also authorises possession of the drug by the permit holder, and possession by the contact person of unused drug – for the purposes of returning it to a pharmacist.

Alternatively, the coordinating medical practitioner can apply for a practitioner administration permit where the patient is physical incapable of self-administering or ingesting the poison or drug (s 48).

As you might expect, a practitioner administration permit authorises the coordinating medical practitioner to administer the drug in the presence of a witness only if the patient is physically incapable of doing so and the patient has decision-making capacity at the time the request for administration of the drug is made (s 46(c)).

This means that a patient cannot make an advance directive for assisted dying.

The decision to issue a permit is made by the “Secretary” ie the Head of the Department of Health and Human Services, doubtless under delegation (s 49).

Section 57 sets out the information that the coordinating medical practitioner must give the patient before prescribing a drug under a self-administration permit.  This includes information about how to self-administer the “voluntary assisted dying substance”, and the fact that the person is under no obligation to fill the prescription or to use it.  The drug itself must be stored in a locked box that satisfies prescribed specifications.

The Act also contains labelling and storage requirements, and requirements imposed on pharmacists.

Administration requests

Section 64 states that the patient may make an administration request to the coordinating medical practitioner, in the presence of a witness, to administer the drug specified in a practitioner administration permit.

The person making the request must be the subject of the permit, they must have decision-making capacity in relation to voluntary assisted dying, and they must understand that the drug is to be administered immediately after the request is made.

The coordinating medical practitioner will only have a practitioner administration permit if the person is physically incapable of self-administering the drug to themselves (s 46).

The drug can then be administered.

The witness and the coordinating medical practitioner must jointly fill out a form called the “coordinating medical practitioner administration form”, which must be sent to the Board (ss 65-66).

After the death

The death must be reported as voluntary assisted dying under the Births, Deaths and Marriages Registration Act 1966 (s 67).  The Coroner must also be routinely informed of such deaths (s 67(2)).

Section 80 protects a medical practitioner who acts in accordance with the Act from any kind of liability, including liability for unprofessional conduct or professional misconduct.

Part 8 of the Act includes a range of offences for people who take actions otherwise than in accordance with the Act.

Will doctors choose to participate in the process?

It remains to be seen whether Victorian medical practitioners regard the procedures established by the Act as so complex or cumbersome that they prefer to provide assistance informally, rather than triggering the Act’s processes and subjecting themselves to scrutiny.

I’d be surprised if there were not at least a few doctors who adopt this course of action.

The legislation is complex.  Doctors may also – again, for reasons of self-protection – confine themselves to traditional forms of palliative care.  Those who take a conservative view on the legalization of assisted dying may urge doctors to do this.

For example, if a coordinating medical practitioner administers a drug to a person who is the subject of a practitioner administration permit otherwise than as authorised by that permit, they are liable to life imprisonment (life or such other term as fixed by the Court) (s 83).

It is an offence to fail to give copies of forms to the Board (s 90) and for a contact person to fail to return the unused portion of a euthanatic drug to the pharmacist who dispensed it (s 89).

Using this new legislation is not for the faint-hearted.  Doctors who choose to do so will need to know what they are doing.

Are you interested in health law?  Sydney Law School offers a Master of Health Law that is open to lawyers, health professionals and other qualified applicants.  Click here and here for more information, or click here for information on the units of study on offer in 2018 and 2019.

First, protect the child, then worry about the penitent sinner: South Australia’s new mandatory reporting legislation

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South Australia is on a collision course with the Catholic Church hierarchy following passage of the Children and Young People (Safety) Act 2017.

Chapter 5, Part 1 (ss 30-31), deals with reporting of suspicion that a child or young person may be at risk.  These sections come into effect on 22 October 2018, and impose a duty on ministers of religion, including priests, to report suspicions of child abuse, irrespective of whether that information was obtained during a confession.

Under the Children’s Protection Act 1993 (SA), which currently applies, ministers of religion and employees and volunteers in religious organisations owe a duty to notify suspicions of abuse or neglect: s 11(2).

However, a priest or minister of religion is given a specific exemption from divulging “information communicated in the course of a confession made in accordance with the rules and usages of the relevant religion”: s 11(4).

That changes in October.

Section 31 of the new Act requires health and welfare professionals and ministers of religion to report the suspicion that a child or young person is “at risk”.  There are no exemptions for information disclosed during a confession.

Priests are not singled out in the new legislation.  Section 30 applies to ministers of religion and employees or volunteers of organisations formed for religious or spiritual purposes.  The obligation also applies to medical practitioners, dentists, nurses, psychologists, pharmacists, police officers, community correction officers, social workers, teachers, and employees or volunteers for organisations that provide health, welfare, education, sporting, recreational child care or residential services for children.

Concept of “at risk”

Section 31 requires health and welfare professionals and ministers of religion to report the suspicion that a child or young person is “at risk”.

The concept “of risk” is defined in section 18: it includes circumstances where a child has suffered harm or is likely to suffer harm of a kind from which a child or young person is ordinarily protected.  This includes sexual assaults and related criminal offences.

The concept of “at risk” also includes a suspicion that a child is to be removed from the state for the purposes of undergoing female genital mutilation.

Section 31(3) states that a health or welfare professional may – but is not required – to report when they suspect on reasonable grounds the physical or psychological development of an unborn child is at risk, whether because of the pregnant woman’s behaviour or otherwise.

“Course of employment”

The obligation to report under s 31 arises when a health or welfare professional has a suspicion on reasonable grounds that arises in the course of their employment.

The concept of “employment” is defined broadly to include an employee, independent contractor, volunteer, as well as someone who “carries out work as a minister of religion or as part of the duties of a religious or spiritual vocation”.

Priests to defy new law

Debate about South Australia’s new mandatory reporting requirements takes place against the background of the conviction of Adelaide’s Archbishop Philip Wilson for concealing a serious indictable offence by failing to report credible allegations of sexual abuse of two altar boys by a paedophile priest.

This information did not come to Archbishop Wilson in the confessional and Catholic doctrine did not preclude him acting on it.

The Royal Commission into Institutional Responses to Child Sexual Abuse recommended that any minister of religion convicted of a crime relating to child sexual abuse should “in the case of Catholic priests and religious [orders], be dismissed from the priesthood and/or dispensed from his or her vows” (16.56.a).

Archbishop Wilson was sentenced to 12 months imprisonment, but has said he will appeal the conviction.  In the meantime, he has refused to resign, indicating, however, that he would resign if the conviction was upheld.

Meanwhile, Acting Archbishop Greg O’Kelly has confirmed that priests are bound by church doctrines and that the new law “doesn’t affect us”.

Appraisal

The fact that a minority of priests have committed sexual offences against children, and that other senior Catholic clergy have failed to act on knowledge of such offences does not mean that sexual predators regularly or even occasionally confess to sexual offences during confession.  The two issues are distinct.

However, even if information about the abuse of a child reaches a priest during a confession only rarely, what does the Catholic church’s rule about absolute secrecy say about its sense of right and wrong?

The very position that such information should remain absolutely confidential if conveyed during the Sacrament of Reconciliation suggests that it is more important to encourage the penitent sinner to seek absolution than to protect the child.

You’d have to be a priest, as distinct from a parent, to follow the logic or the morality of that.

I’m a parent, and I’ll tell you what every other parent will tell you: the over-riding moral priority is to protect your child.

Protect the child.  That’s more important than swearing secrecy to someone who reveals that they are a sexual predator.  What’s not to understand?

In fact, how does someone – acutely sensitised to the rightness and wrongness of things – get to a place where they don’t understand this?

Do penitent sexual offenders never re-offend?

If the person who confesses is truly penitent, surely they would not want the child they harmed to be isolated from services to help them recover from their trauma?

The confessional should not enable further wrong-doing.

It this case it’s secular morality, and the South Australian Parliament, that is leading the way.

Public health law in the USA: What can Australia learn?

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SEMINAR ANNOUNCEMENT: 

Public Health Law and Health Leadership in the United States: What can Australia learn?

Thursday 19 July, 6.00-7.30pm, Sydney Law School

In 2016, life expectancy at birth in the United States fell for the second year in a row.  Since his inauguration in 2017, President Trump and his administration have taken a number of actions that arguably weaken America’s public health infrastructure.

At the same time, the Unites States remains one of the world’s great innovators. With 52 States and more than 89,000 local and city governments, the United States frequently functions as a social laboratory for social policies, and public health laws and practices. While constrained in some areas by its constitutional design, the United States remains a leader: its influence and innovations in public health law cannot be ignored.

What can Australia learn from recent American experience with public health law and regulation?  What are the good ideas?  What should be avoided?  How can Australian jurisdictions adapt the best American innovations and create an enabling legal and political environment for public health and wellbeing?

This seminar features presentations reviewing public health law and leadership in the United States, with particular reference to: communicable diseases and pandemic preparedness, non-communicable diseases, health care, injuries and global health leadership.

This seminar is co-hosted by the United States Studies Centre at the University of Sydney, and Sydney Law School.

This event features a keynote presentation by Professor Lawrence Gostin, who is the Linda and Timothy O’Neill Professor of Global Health Law, Georgetown University Law School, Washington DC, and Faculty Director of the O’Neill Institute for National and Global Health Law. Prof. Gostin is also the Director of the WHO Collaborating Center on National and Global Health Law.

For further information on this event, further speaker details, and to register for this event, click here.

Trump: the war on breastfeeding

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The New York Times reports that US officials threatened to unleash trade sanctions and withdraw military aid from Ecuador unless it withdraw a resolution at May’s World Health Assembly calling on governments to “protect, promote and support breast-feeding”.

The article is worth reading in its entirety.

As the father of a currently breastfeeding infant, I find this kind of behaviour utterly repellent.

There are echoes of Right to Health language (respect, protect, fulfil) in the resolution which might have displeased the Americans, but the real motivator was American support for large corporate manufacturers of breast-milk substitutes.

(Like Chicago-based Abbott Laboratories.)

Ecuador backed off from the offending resolution, as did “at least a dozen other countries, most of them poor nations in Africa and Latin America”.

Then Russia stepped in, and the intimidation apparently stopped.

“We’re not trying to be a hero here”, said a Russian delegate to the World Health Assembly, “but we feel that it is wrong when a big country tries to push around some very small countries, especially on an issue that is really important for the rest of the world.”

Plenty of ironies here.  But they have a point.

According to the New York Times report, a Department of Health and Human Services spokesperson said: “The resolution as originally drafted placed unnecessary hurdles for mothers seeking to provide nutrition to their children.  We recognize not all women are able to breast-feed for a variety of reasons. These women should have the choice and access to alternatives for the health of their babies, and not be stigmatized for the ways in which they are able to do so.”

Well gosh, that ought to sort out the doubters.

The Lancet reports that scaling up breast-feeding to near universal levels could avoid 823,000 deaths of children under 5 each year, and 20,000 maternal deaths from breast cancer.

Breastfeeding protects both mother and child, and it’s free, which is important if you’re poor.

Yet for billion dollar formula companies, the temptation to monetise the act of feeding by targeting young mothers, is just irresistible.

Read the Guardian’s investigation into Nestle’s marketing practices flogging formula to poor women in central Manila here.  Then weep.

Here is the resolution that eventually passed in the World Health Assembly, with American support.

Amongst other things, it requests the WHO Director-General to provide, upon request, “technical support to Member States to establish, review and implement national laws, policies and programmes to support infant and young child feeding”.

However, US hostility scuttled language that would have called on WHO to provide “technical support to member states seeking to halt “inappropriate promotion of foods for infants and young children.”

“Inappropriate” in this context would refer to the promotion of foods in contravention of the International Code of Conduct of Breast-milk Substitutes.

The Code prohibits the advertising of infant formula and other breast-milk substitutes to the general public, to pregnant women and mothers, and to health workers who are concerned with infant and maternal nutrition.  It also prohibits the giving of samples and other incentives for purchase. Governments are urged to implement the Code through national legislation, regulations or other suitable measures.

In addition, the Code states that infant formula should contain a clear statement of the superiority of breastfeeding, and a statement that the product should only be used following advice from a health worker. The container and labels should not contain pictures of infants, or include pictures or text that “may idealize the use of infant formula”.

Appropriately, the resolution does urge Member States (of the World Health Organisation) to strengthen national initiatives to implement the Code.

However, when you put it all together, it appears the Trump administration does not want sovereign countries receiving technical support from WHO about how best to frame their laws and policies to prevent predatory marketing practices that breach the Code.

It’s the Trump administration’s war on breastfeeding women.

Click here for information about the Australian Breastfeeding Association.

ANNOUNCEMENT: Sydney Law School and the United States Studies Centre at the University of Sydney are co-hosting an evening seminar entitled “Public health law and health leadership in the United States: What can Australia learn?” on 19 July 2018, 6.00-7.30pm.  Click here for the brochure and further details.  A separate post will follow about this event.

If you’re interested to learn more about law and non-communicable diseases, Sydney Law School is offering a Masters unit, “Law, Business & Healthy Lifestyles” in the coming semester.  Click here for more information.

Cracking the Codex: the new frontier for nutrition labelling

Alexandra Jones Food, Global Health, Health Policy , , ,

Alexandra Jones, Global health lawyer and PhD Candidate at The George Institute for Global Health and the University of Sydney
Dr Anne Marie Thow, Senior Lecturer in Health Policy at the University of Sydney
Dr Carmen Huckel Schneider, Senior Lecturer, Health Policy at the University of Sydney and co-lead of the Health Governance and Financing Group and the Menzies Centre for Health Policy

Food labels hit the New York Times recently when leaks from North American Free Trade Agreement negotiations suggested the US was being urged by big American food and soft-drink companies to limit the ability of the pact’s three members – Mexico, Canada and the US – to implement warning labels on unhealthy foods.

There is no escaping the health imperative here. Obesity has nearly tripled since 1975 worldwide: 41 million children under 5 are now overweight, while 1.9 billion adults are overweight or obese. Spiralling health and economic costs mean governments are turning to evidence-based policies to prevent and control diet-related diseases like obesity, heart disease, stroke, diabetes and dental caries.

Better nutrition labelling – including front-of-pack labels that interpret nutrition information through symbols, colours or words – are part of the comprehensive package recommended by the World Health Organization. Over 20 countries already have policies in place – they include the UK’s traffic lights, France’s Nutriscore, Chile’s ‘stop sign’ warnings (which Peru appears set to follow), and Australasia’s Health Star Rating.

This proliferation and diversity poses trade and commercial challenges, and calls for some degree of consistency in global approach have been made.

Cracking the Codex (Alimentarius Commission)

This is where the international food standards body – the Codex Alimentarius Commission – comes in.

A UN body created by the WHO and UN Food and Agriculture Organization, Codex has a dual mandate: to protect consumer health, and promote fair trade practices.

Codex standards and guidance are voluntary, but in practice frequently act as a touchstone for countries looking to develop national policies. As Codex enjoys recognition as an international standards setting body by the WTO, guidance it develops also has potential to show up in trade discussions around food.

In short: what happens at Codex matters for public health nutrition.

Done well, Codex could bolster countries to take action. Left unchecked, there’s a risk outcomes could deter countries’ from implementing policies desperately needed to stem the rising global tide of non-communicable diseases.

As Codex is also notoriously slow – there’ll be a general meeting 2-6 July in Rome, and a further discussion paper for feedback later this year – it’s critical that the process itself not be used as a ‘brake’ on growing global momentum to implement strong front-of-pack labels.

Time for public health to assume a seat at the Codex table

Industry Observers have been quick to jump on opportunities to provide input into new Codex work on front-of-pack labelling. The first working group included representation from 13 international organizations representing the food industry, particularly the sugar and beverages sectors. Only two consumer groups were there.

It’s now critical we ensure public health bring their perspective to the table.

What you can do:

Read our briefing note for more information, and

  • Get involved – contact your national Codex Contact Point or join an Observer organization
  • Speak up about the public health priorities, like:
    • the importance of a definition of ‘front-of-pack nutrition labelling’ that supports schemes most likely to be effective in achieving public health objectives – and not, for example, industry preferred options such as the Guideline Daily Amount that aren’t backed by evidence
    • preserving policy space for strong and innovative measures – evidence is rapidly evolving but currently suggests for informing consumers and improving diets, this may include mandatory labels that use interpretive elements like colours, symbols or words, underpinned by robust and transparent criteria for scoring foods
  • Encourage continued action at a national level – remember, nothing in the current process prevents interested countries from pursuing front-of-pack labelling

Want to read more?

 

This piece was originally posted on the PLOS Global Health Blog on 25/06/2018, and has been re-posted with author consent.

 

Sparks v Hobson must go to the High Court: here’s why

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In NSW, Section 5O of the Civil Liability Act provides a defence to a doctor or health professional who is defending a negligence claim.

Under s 5O, a person will not be liable “if it is established that the professional acted in a manner that (at the time the service was provided) was widely accepted in Australia by peer professional opinion as competent professional practice”.

S 5O is often regarded as re-introducing a version of the Bolam test, since the standard of care required of a professional person is ultimately determined by the practices of his or her peers.

In Dobler v Halverson, the NSW Court of appeal clarified how s 5O operates.  It pointed out that in a medical negligence case, both parties will call expert evidence to attempt to demonstrate that what the defendant did fell short of – or did not fall short of – acceptable professional practice [59].

According to the Court, the effect of s 5O is that if the court finds the doctor’s conduct was in accordance with “professional practice regarded as acceptable by some” in the profession, then (subject to the court considering professional opinion to be irrational), that professional practice will set the standard of care and the plaintiff patient will therefore fail: [59].

 

Sparks v Hobson; Gray v Hobson

Understanding about the scope of s 5O has been thrown into disarray by the NSW Court of Appeal in Sparks v Hobson; Gray v Hobson [2018] NSWCA 29 (1 March 2018).

The facts are complex.  Mr Hobson suffered from Noonan Syndrome, a genetic disorder that resulted in serious curvature of his spine and a reduced chest cavity that prevented his left lung from filling with air.  This caused breathlessness and restrictive airways disease.  He underwent surgery that was intended to strength his spine and relieve pressure on the chest cavity.

The first stage of the operation was uneventful; however, the second stage was brought forward because Mr Hobson was in intensive care due to pneumonia in his left lung and the obstruction of his left airway.  The second stage of the operation required Mr Hobson to lie face down on the operating table, while screws were placed in his spine.

The position of Mr Hobson during the operation, and the placing of the screws, created further pressure on the chest wall, further restricting his breathing.

Mr Hobson was regarded by the expert witnesses as presenting a “very unusual and difficult anaesthetic challenge due to the significant compression of his left main bronchus by his spine and due to the requirement for prone positioning during surgery” [296]

The operation began at 7pm on 17 November 2009.  The level of carbon dioxide in Mr Hobson’s blood rose during the surgery, and at 9.30pm, Dr Sparks administered a drug called vecuronium to try to improve ventilation.  It led to no improvement; also, vecuronium was a muscle relaxant, and it meant that spinal cord monitoring was thereafter ineffective.  From that point onwards, Dr Sparks could only be guided by the oxygen and blood pressure readings “as his criteria for stopping the operation” [177].

Dr Sparks described Mr Hobson’s high blood carbon dioxide level, at 8.30 to 8.35pm as “very serious”.  He had what the clinicians called “profound respiratory and metabolic acidosis”.  At 8.50, Dr Sparks made two telephone calls to two colleagues (Dr Barratt, an anaesthetist, and Dr Marshman, a cardiothoracic surgeon), but they were unable to make any further suggestions about how to reduce the risk of cardiovascular failure.

At around 9.25pm, Mr Hobson’s blood pressure and oxygen levels dropped dramatically, and at Dr Spark’s request, the wound was closed rapidly and the operation terminated.

One of the issues in dispute was whether Dr Sparks should have terminated the operation at a time earlier than he did.  There was evidence that due to respiratory collapse around 9.30pm, precipitated by obstruction of circulation (causing lack of oxygen), irreparable damage was done to Mr Hobson’s spinal cord, leaving him a paraplegic.

Although the surgery was later completed successfully, Mr Hobson’s paraplegia remained.

The trial judge found against both Dr Sparks, and the principal surgeon, Dr Gray.

On appeal, the Court of Appeal unanimously allowed Dr Gray’s appeal.  However, Dr Sparks’ liability was upheld by a majority of 2:1.

The Court of Appeal’s decision in Sparks v Hobson raises a number of issues relating to the interpretation of provisions in the Civil Liability Act.

These include the relationship between s 5O and s 5B, and the meaning of s5I.

This post focuses specifically on the court’s interpretation of the defence in s 5O.

The uncertainty introduced by the irreconcilable judgments of the Court of Appeal in Sparks v Hobson is so significant that it will be a great shame if leave to appeal to the High Court is not granted.

 

Irreconcilable judgments

In McKenna v Hunter & New England Local Health District [2013] NSWCA 476, Macfarlan JA pointed out that the defence in s 5O is premised on the defendant doctor demonstrating that they conformed with “a practice that was in existence at the time the medical service was provided” and secondly, that the “practice was widely although not necessarily universally accepted by peer professional opinion as competent professional practice”: [160].

This emphasis on the existence of a “practice” – in the sense of a pattern of response by medical practitioners to a clinical scenario, is in contradistinction to there simply being a widespread view among peers that what the defendant did in the circumstances of the case constituted “competent professional practice”.

The significance of the need for a “practice”, as suggested by Macfarlan JA, is that in an unusual case, there may be no relevant practice in existence that the defendant doctor can identify and appeal to for the purposes of a defence.

 

Basten JA

In Sparks v Hobson, Basten JA rejected the suggestion in McKenna that the defence in s 5O only applies where the defendant can identify “a regular course of conduct adopted in particular circumstances” [31].

McKenna was overturned by the High Court, so Basten JA thought that the reasoning of the majority of the Court of Appeal, on the interpretation of s 5O, was no longer binding: [35]

He said: “there is no grammatical or semantic difficulty in describing an argument run by counsel in a novel case as demonstrating competent or incompetent professional practice” [31].

In a novel case, Basten JA thought that a defendant may invoke the defence in s 5O “by reference to how an assessment of the circumstances (which may be unique) would be undertaken by a knowledgeable and experienced practitioner” [31].

Although Basten JA did not think a defendant needed to establish they acted in accordance with a “practice” (understood in the sense of an established course of conduct followed in the circumstances of the case), he nevertheless concluded that Dr sparks had failed to establish a standard, widely accepted in Australia, of competent professional practice, for the purposes of availing himself of the s 5O defence.

 

Macfarlan JA

In Sparks v Hobson, Macfarlan JA reiterated his approach in McKenna.  He said: “It is not enough that experts called to give evidence consider that the conduct was reasonable and that it would have been so regarded by other professionals if they had been asked about it at the time of the conduct” [211].

In this case, the surgery was highly unusual.  Although the expert witnesses all agreed Dr Sparks acted reasonably in the actions he took during the operation, and although they considered professional peers would likely have taken the same view, the experts and the defendant did not point to an established practice that was followed by Dr Sparks in the circumstances of the case [221].

In Macfarlan JA’s analysis, this was fatal to Dr Sparks’ defence: see [223].

 

Simpson JA

The third justice in the NSW Court of Appeal was Simpson JA, who considered that she was bound to accept the construction of s 5O adopted in the McKenna case.

But for the constraint of precedent, Simpson JA would not have adopted the approach of Macfarlan JA.

She said: “As construed in McKenna, s 5O can apply only in limited circumstances, where the defendant can, or seeks to, identify a discrete practice to which he or she conformed.  It necessarily excludes unusual factual circumstances, such as occurred in McKenna, and such as occurred in the present case.  It does not appear to me that s 5O was intended to have such limited application.  However, as I have said, I consider myself constrained to follow and apply that decision” [336].

In Justice Simpson’s view, Dr Sparks failed to establish a defence based on s 5O because he could not identify a “practice” to which he conformed in the highly challenging and unusual circumstances of the case.  This, “notwithstanding that the overwhelming medical evidence was that his conduct was in accordance with what was widely accepted in Australia as competent professional practice’” [346].

Despite this, Simpson JA found in favour of Dr Sparks because she thought that in the circumstances of the case, s 5I applied.

S 5I provides that a person is not liable for the materialisation of an inherent risk that cannot be avoided by the exercise of reasonable care and skill.

In her Honour’s view, once it was found that Mr Hobson’s deteriorating condition warranted the surgery “as emergency surgery”, and that the surgery carried the risk of paraplegia, s 5I applied to excuse Dr Hobson from liability.

In addition, Simpson JA concluded that the evidence did not establish that the failure by Dr Sparks to terminate the operation before 9.30pm amounted to a departure from the standard of reasonable care and skill required of a specialist anaesthetist [350], given that Mr Hobson “needed urgent surgery to ensure his survival”: [352].

 

The future of the s 5O defence

As things stand, the judgments of Justices Macfarlan and Simpson in Sparks v Hobson give majority support to an interpretation of s 5O that limits its scope as a defence for doctors in medical negligence proceedings.

The issue at stake goes to the heart of what the defence requires courts to do.

In the view of Justice Simpson, the task of the court when considering the defence in s 5O is not to choose between competing views but to determine whether as a factual matter, the acts and/or omissions of the defendant that give rise to allegations of breach of duty of care “had the acceptance of peer opinion, even if other peer opinion was different”: [345].

This view is consistent with the assumption that s 5O was intended to introduce a version of the Bolam principle into New South Wales law, thereby ensuring that medical practices, rather than a court, ultimately define the standard of care by which a doctor’s conduct will be judged.

If the view of Justice Macfarlan is followed, by contrast, the role of the court would focus on determining whether a relevant “practice” exists on which a defence might be founded.

In cases where no such practice exists, s 5O can have no application.

The question of standard of care and breach would then fall to be determined by the court, applying common law principles, “guided by the evidence of medical practitioners skilled in the area of medical practice in question” [321], and altered (to the extent that it is altered) by the principles set out in 5B [see [338] per Simpson JA].

 

So, on what basis did the  majority Justices consider that Dr Sparks had breached his duty of care?

Justices Basten and Macfarlan held against Dr Sparks.

According to Justice Macfarlan, Dr Sparks’ failure to terminate the operation was not limited to a short period of time, but extended for at least 20 minutes after the two telephone calls to Dr Barratt and Dr Marshmann until 9.25pm, when Mr Hobson’s blood pressure and oxygen level dropped.  By then the damage had been done.

Essentially, Justice Macfarlan thought the breach of duty was made out because Dr Sparks unreasonably ignored a “serious and imminent intra-operative danger” (the high carbon dioxide levels) when the other countervailing risk (the risk to Mr Hobson if the operation was terminated) did not have the same immediacy: [188].

Also, “Dr Sparks had to assess and respond to the immediate danger to Mr Hobson (rather than the more remote risks that could eventuate if the operation was not completed) because Dr Sparks’ duty as principal anaesthetist was to protect the patient’s well-being whilst the operation was in progress” [182].

Justice Basten agreed that the decision to allow the operation to continue for so long, after he had sought help from experienced colleagues, without success, was more than just an “erroneous clinical judgment” but was a breach of his duty of care to Mr Sparks [93].