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

rogermagnusson Uncategorized , , ,

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].

What becomes of a country that cannot protect its young?

rogermagnusson Uncategorized , , ,

 

March for our lives, Washington DC, 24 March 2018

 

It’s too early to say if the grassroots social movement initiated by students who survived the gun massacre at Stoneman Douglas High School in Parkland, Florida will be successful in nudging America’s gun laws in the direction of rationality and evidence.

After killing 17 people with an AR-15 style semi-automatic weapon, and injuring 17 more, 19 year-old former student Nikolas Cruz left the school premises, blending in with the crowd and remaining free for an hour before arrested.

On March 24, students and gun control advocates took to the streets of Washington DC in a “March for Our Lives”.

They’re trying to start a movement.  You can join them.

“To the leaders, skeptics and cynics who told us to sit down and stay silent, wait your turn! Welcome to the revolution!” said student Cameron Kasky.

Barack Obama tweeted: “Michelle and I are so inspired by all the young people who made today’s marches happen. Keep at it. You’re leading us forward. Nothing can stand in the way of millions of voices calling for change.”

In the thick of it, as usual, my friend Professor Lawrence Gostin from Georgetown University Law School, who leads the O’Neill Institute for National and Global Health Law.  You can read about the march on his twitter account here.

He writes: “From a long life’s experience on health and human rights I have found that no meaningful change happens without bottom up social mobilization.”

He’s right.  This is true of gun control, tobacco control, and much else in public health.

Is there constitutional space for rational, evidence-based gun control laws in the United States?

It’s sometimes assumed that the US Second Amendment, which states that “the right of the people to keep and bear Arms, shall not be infringed”, leaves little room for rational, evidence-based gun control policies and laws.

This is not so, argues Professor Gostin in a recent paper published in the Journal of the American Medical Association.  For additional resources, click here, here, and here.

In fact, rational firearms laws are compatible with the Constitution and with recent caselaw, suggesting that the real problem is a political one.  Rational, evidence-based measures to reduce firearms deaths in the United States could include:

  • mandating a higher minimum purchasing age for firearms
  • prohibiting dangerous individuals from purchasing or owning firearms
  • requiring safe storage
  • banning weapons with especially hazardous properties such as military-style rapid-fire firearms and high capacity magazines, and
  • banning open carry of firearms (an emerging issue for college campuses, where academics receive advice about what to do in “active shooter” situations).

Young people exercising another of their constitutional rights, March for our lives, Washington DC, 24 March 2018.  (However, Rick Santorum suggests they would be better served taking CPR classes)

 

What makes bottom-up change happen?

This is a neglected but vitally important questions for public health lawyers.

Will the anger and conviction that fuels the “March for our lives” movement endure?  Will it prove capable of raising the resources that will be necessary to make a compelling case for change to the American people?

Public health advocates often focus on content: the technical content of the policies they advocate, the evidence, and the rational case for change.  And then nothing happens.

More than ever, advocates need to better understand the factors that catalyse change, the factors that make social movements successful, and enduring.

Jeremy Shiffman has written about why some global health issues attract attention while others languish: his scholarship is helpful in also analysing national public health issues.

For social constructionists like Shiffman, global health problems like HIV, polio, or non-communicable diseases do not have any inherent priority or significance.  The attention an issue receives, while not unrelated to epidemiological facts, is “always mediated by social interpretations”.

From a social constructionist perspective, the “core activity” of global health advocates is ideational: health advocates must advance truth claims about the problem and its solutions that resonate with the values and shared interpretations of political leaders and those who control resources.

On this view, global health (and the same could be said of national public health priorities) is a competitive – and brutal – process of “portraying and communicating severity, neglect, tractability and benefit in ways that appeal to political leaders’ social values and concepts of reality”.

Yet increasingly, reality itself is no longer a shared experience.  Gun control advocates and gun enthusiasts might as well live in different universes.  Their sources of information are completely unrelated; the things they find persuasive utterly different.

Speaking in Sydney on a recent visit, Barack Obama said that “social and political structures had not yet worked out how to deal with rapidly changing communications technology, a world in which people no longer watched the same TV channels or read the same newspapers. The rapid pace of change was having a flow-on effect across the globe, and was likely to get faster still. Discourse was becoming increasingly fragmented, with people becoming hermetically sealed off from each other inside very different information universes.”

The triple cocktail of extreme individualism, neoliberalism, and populism have created a social landscape in which there is less and less shared ground when it comes to values and visions for a better life.

Speaking as a non-American, it seems to me that the scale of the challenge, for gun control advocates, is reflected in the reflexive tendency of the pro-gun lobby to castigate the very mention of rational gun laws, following [America’s latest semi-automatic gunfire massacre: insert details here] as exploitative – as politicizing a tragedy.

A couple of examples.  Jesse Hughes, whose band, Eagles of Death Metal, was performing at the Bataclan theatre in Paris on 13 November 2015 when terrorists stormed in and took hostages, eventually killing 89, went on an on-line rant, calling the Stoneman High School students “disgusting vile abusers of the dead”.

Another right-wing media type tweeted the following about David Hogg, one of the Florida students advocating for stricter gun laws: “I’ve been hanging out getting ready to ram a hot poker up David Hogg’s ass tomorrow.”

All because some students who survived a mass murder at their school dared express their opinion that government ought to introduce gun control laws to help make such rampages less frequent.

Like the tragedy of the massacre at Sandy Hook Elementary School, the gun massacre at Stoneman Douglas High School reflects the failure of policy, the failure of politics and politicians, and ultimately, the potential failure of a society.

What becomes of a country that cannot – or will not – protect its young?

Authoritarian regimes, that fail the protect basic freedoms, or do so only partially, start to look a whole lot better.

That’s bad news for freedom, and bad news for America.

 

Professor Larry Gostin will be speaking at Sydney Law School on 19 July, as part of an evening event titled: ‘Public health and health leadership in the USA: what can Australia learn’.  Sydneyhealthlaw.com will advertise this event in due course.  Professor Gostin will be teaching the unit of study, Global Health Law on 17-20 July; for more information on this unit, click here.  For more information on Sydney Law School’s Master of Health Law, click here and here.

Santa, Coke and Christmas: Why we need legislative restrictions on unhealthy food marketing to children

Belinda Reeve Food, Public Health Law , , , , ,

coke bus shelter

Laws in many countries prohibit false and misleading advertising. The recent case of ACCC v Heinz (which I discussed in a blog post last week) shows how these laws can knock out false and misleading food advertisements. But what about the perfectly legal promotions for unhealthy foods and beverages that fill our TV screens, social media platforms, billboards, and bus shelters?

In some countries, governments are moving to reduce children’s exposure to unhealthy food marketing by placing legislative restrictions on when and where unhealthy food products can be marketed. For example, Chile has banned unhealthy food advertisements on TV before 10pm, along with a range of other obesity-prevention measures.

In countries like the US, Australia, and NZ, restrictions on unhealthy food marketing are found in self-regulatory codes developed by the food or advertising industries. However, these codes often contain significant loopholes and do little to reduce children’s exposure to unhealthy food marketing. This is illustrated by two complaints recently determined by New Zealand’s Advertising Standards Complaints Board.

The Complaints Board hears public complaints about breaches of the Children and Young People’s Advertising Code, developed by an advertising industry body. Following a recent review, the Code now contains a series of principles and rules on the marketing of “occasional food and beverage products” to children and young people. These products are identified using a Ministry of Health nutrient profiling system that distinguishes between “everyday”, “sometimes”, and “occasional” foods. The Code also distinguishes between children (aged under 14 years) and young people (aged 14-17 years).

Principle 1 of the Code states that “[a]dvertisements targeted at children or young people must not contain anything that is likely to result in their physical, mental or moral harm and must observe a high standard of social responsibility.” Among the rules listed under this principle are (1)(i), which states that “[a]dvertisements (including sponsorship advertisements) for occasional food or beverage products must not target children or be placed in any media where children are likely to be a significant proportion of the expected average audience.”

Under rule 1(j) advertisers must exercise a special duty of care in advertising occasional food and beverage products to young people (as opposed to children).

The Code uses three criteria to determine whether an ad targets children or young people: (1) whether the nature and intended purpose of the advertised product or service is principally or generally appealing to children/young people; (2) whether the presentation of the advertisement content (e.g., theme, images, colours, wording) is appealing to children/young people; and (3) whether the expected average audience at the time or place the advertisement appears includes a significant proportion of children/young people. Measures for determining the likely child audience of an advertisement include whether a medium’s audience comprises 25% or more children; whether the medium appears in child viewing time zones; whether a medium contains content with significant appeal to children; and whether an ad appears in locations where children gather, e.g., schools and playgrounds.

Principle 3 of the Code states that “[a] special duty of care must be exercised for Occasional Food and Beverage Product sponsorship advertising targeted to young people.” The rules under this principle include 3(a), which prevents sponsorship advertising from depicting an occasional food or beverage product, such product’s packaging, or consumption of such products.

Healthy Together Auckland has laid a series of complaints that aim to test the Code’s rules on unhealthy food marketing.

One recent complaint concerned an advertisement on a bus shelter in close proximity to a primary school and a secondary school, and to shops where a large number of children and young people stopped on their way to and from school. The advertisement (pictured above) featured Santa Clause riding in a car holding two bottles of Coke, one a no-sugar version of the product, and the other a “classic” or “full sugar” version. It included the logos for Youthline (a help line for young people) and Coca-Cola, and text encouraging donations to Youthline.

The Board upheld the complaint that the ad was a sponsorship advertisement for an occasional beverage that targeted children and young people.

In considering whether the ad targeted children and young people, the Board held that full-sugar Coke was a product that appealed to children and young people and was an occasional beverage. In relation to the content of the ad, the Board said that Youthline would not have strong appeal to children, but would with young people – Youthline’s target audience. Crucially, Santa Claus was the most prominent image in the ad, and has strong appeal with children and is closely associated with Christmas, and children asking Santa for presents, all of which would encourage children to engage with the ad. According to the Board, while Santa has less appeal for young people, his particular presentation in this ad (e.g., riding in a car) would appeal to the 14-17 year age group.

The Board held that children under the age of 14 years were unlikely to be a significant proportion of the ad’s audience (given the bus shelter’s distance from the primary school), but it would be seen by a significant proportion of young people, as it was close to the secondary school, and young people caught the bus from the stop that the ad appeared at and would gather at near-by shops.

Accordingly, the Board held that the ad breached Principle 1 and rule 1(i) of the Code by promoting an occasional beverage to children, as well as Principle 3 and rule 3(a), but note rule 1(j) (on exercising special care in unhealthy food marketing to young people) or another rule on the responsible use of characters that are popular with children (1(h)).

While this first complaint was upheld in part, a second complaint, related to Coca-Cola Christmas in the Park events held in Auckland and Christchurch, was dismissed by the Board.

The complaint concerned the events themselves, as well as event promotions that appeared on bus shelters, in newspapers and on news websites, and included fireworks, people dancing on a stage, and the messaging, “Coca-Cola Christmas in the Park. Supporting Youthline. Merry Christmas from Coca-Cola. Come share the magic.” The complainant was also concerned that hundreds of free Coke drinks were given away to children at the events, who made up a large percentage of the audience.

The Board held that it did not have the jurisdiction to consider the event itself or the product give-aways at the event. This was because the events did not constitute “advertising” for the purposes of the Code: they were a “community initiative”, of which Coke was one of many sponsors, and the event’s intended purpose was entertainment rather than influencing the choice, opinion or behaviour of consumers to purchase the product, as required by the Code’s definition of advertising.

Promotions for the events could be defined as sponsorship advertisements, meaning that they fell within the scope of the Code. However, there were no images of Coke products in the advertisement, and while the ad did include the Coke logo, the focus of the ad was on promoting the events rather than persuading views to purchase Coke. Accordingly, the ads did not promote an occasional food or beverage.

The creative content of the ads would have appeal to children and young people, as would Christmas in the Park, Youthline and the Coca-Cola Company Brand. However, the Board held that the placement of the ads was directed to parents, as children would not comprise 25% of more of the readers or viewers of the media that the ads appeared in (e.g., the New Zealand Herald), and on balance, it was unlikely that the ads would be seen by a significant proportion of children.

As the ads did not promote an occasional food or beverage product and were not targeted to children, the Board determined that the ads did not breach any of the Code’s principles and rules on food marketing to children and young people.

The New Zealand Code contains rules that are stronger in some respects than similar rules found in codes in other jurisdictions, including the two codes developed by the food industry  in Australia. For example, the New Zealand Code restricts unhealthy food marketing in settings where children gather (including around shops or bus shelters, as illustrated by the first complaint). Equivalent restrictions in the Australian codes only apply to pre-schools, primary schools and daycare centres.  However, these complaints illustrate that the New Zealand Code still contains a number of key loopholes that are common to regulation on food marketing to children in other jurisdictions.

The first of these is the need to identify advertising that is targeted to or appeals to children, as distinct from families or parents. While the Code contain a relatively strong definition of advertising that is targeted to children, it can still allows advertisers to use creative content that children find appealing. Coke asserts that it doesn’t market its products to children under 12, and claims that the association of Coke with Christmas and Santa is aimed at families rather than children. This ignores the fact that, as the Complaints Board has pointed out, Santa and Christmas have significant appeal to children, and marketing using this imagery is likely to be attractive and persuasive to children, regardless of the target audience. However, in the second complaint the Board held that Coke’s ads were not targeted to children as they appeared in media with large adult or family audiences, despite using imagery that appealed to children. In short, Coke respects the letter but ignores the spirit of its own self-imposed restriction – and in this instance, the Code permitted it to do so.

The second problem is that the NZ code (and other self-regulatory codes) continue to exclude some marketing techniques commonly used by food companies. As illustrated by the second complaint, these include brand advertising, where companies promote a particular brand, but not the products associated with that brand, which may be unhealthy. By imposing restrictions on the types of products advertised to children, the Code allows companies like Coke to circumvent restrictions by marketing only the Coca-Cola brand without featuring images of the product itself.

A third problem is that these codes are based on a single advertisement model. The Board may uphold a complaint about one advertisement, but its determination doesn’t necessarily address a sophisticated, widespread campaign that promotes a product across a number of different platforms. Further, a complaints-based system only puts a tiny dent in children and young people’s cumulative, on-going exposure to a large volume of unhealthy food marketing.

This last issue is partly due to deficiencies in the governance processes attached to self-regulatory codes, in addition to loopholes in their substantive terms and conditions. Frequently, there are no sanctions for non-compliance, nor is there any kind of systematic, independent monitoring of compliance, meaning that it’s up to advocacy groups to identify problematic ads and report them to complaint bodies.

We have legislative restrictions on false and misleading food advertising. Given the problems with self-regulatory codes on unhealthy food marketing to children, perhaps it’s time for legislation on that issue too.

 

ACCC v Heinz: A significant win for public health

Belinda Reeve Food, Public Health Law , , , ,

shredz.png

In a significant victory for public health, Australia’s Federal Court has held that Heinz engaged in misleading and deceptive conduct in the marketing of a snack food targeted to toddlers (ACCC v Heinz [2018] FCA 360). The case should be seen as a win for public health not just because of the final outcome, but also because of the Court’s discussion of the World Health Organisation guidelines on sugar consumption, as well as parents’ purchasing habits and children’s health.

The case followed a complaint laid by the Obesity Policy Coalition in 2015 about the marketing of a product called “Shredz” which formed part of Heinz’s “Little Kids” range, targeted to children aged 1-3 years. This product consisted of a chewy fruit-flavoured “stick” that was sold in an 18g packet of five sticks. Each box contained five 18g packets of the product, which came in three flavours: berry, peach, and fruit and chia.

The packaging for each of the three flavours varied slightly, but each featured a stylized representation of a tree on the front of the box, with an image of a smiling boy climbing the ladder (see picture above). At the base of the tree was a photograph of various pieces of fruit, sweetcorn kernels, and pieces of pumpkin, along with a prominent depiction of four sticks of the product. Among the text on the front of the box were the words “99% fruit and veg”, “No preservatives” and “No artificial colours or flavours.” The back of the box included the text “Made with 99% fruit and vegetable juice and purees…. Our range of snacks and meals encourages your toddler to independently discover the delicious taste of nutritious food. With our dedicated nutritionists who are also mums, we aim to inspire a love of nutritious food that lasts a life time.” A side panel on the box stated that “Our wide range of snacks and meals is packed with the tasty goodness of vegetables, fruits, grains, meat and pasta to provide nutritious options for your toddler.”

The back of the box also featured an ingredients list and a nutrition information panel required by the Australia New Zealand Food Standards Code. The ingredients list revealed that the product contained 36% apple paste and 31% apple juice concentrate, with the remainder of the product comprising berry, peach, or strawberry puree (approximately 10%), sweetcorn puree (10%) ,and pumpkin puree (10%) (with the fruit and chia version also containing chia seeds). Due to the reliance on apple paste and apple juice concentrate, over two-thirds of the product consisted of sugar.

Before Justice White in the Federal Court, the Australian Competition and Consumer Commission (ACCC) alleged that the packaging of each product contravened ss 18, 29(1)(a), 29(1)(g) and 33 of the Australian Consumer Law, which is contained in a schedule to the Competition and Consumer Act 2010 (Cth).

Section 18 was the key provision in the case. It provides that “[a] person must not, in trade or commerce, engage in conduct that is misleading or deceptive, or is likely to mislead or deceive.” Section 29 provides that “[a] person must not, in trade or commerce, in connection with the supply or possible supply of goods or services or in connection with the promotion by any means of the supply or use of goods or services (a) make a false or misleading representation that goods are of a particular standard, quality, value, grade, composition, style or model or have had a particular history or particular previous use; or… (g) make a false or misleading representation that goods or services has sponsorship, approval, performance characteristics, accessories, uses or benefits…”

Section 33 provides that “[a] person must not, in trade or commerce, engage in conduct that is liable to mislead the public as to the nature, manufacturing process, the characteristics, the suitability for their purpose or the quantity of any goods.”

The ACCC alleged that Heinz had breached these provisions because statements and images on the box impliedly conveyed representations to the effect that the product:

  • Was of an equivalent nutritional value to the natural fruit and vegetables depicted on the packaging;
  • Was a nutritious food and was beneficial to the health of children aged 1-3 years; and
  • Encouraged the development of healthy eating habits for children aged 1-3 years.

At the outset, Justice White commented that the issue for the Court to determine was whether (a) the specific representations alleged by the ACCC were made, and if so, (b) whether they were misleading and deceptive (or in the case of s 33, liable to mislead). The Court was not required to determine other issues raised during the hearing, including whether the product had an inappropriate amount of sugar per se, and whether it would be sensible for parents to give the product to their children as an alternative to fruit and vegetables. The focus of the Court was on whether the product packaging made specific representations alleged by the ACCC, and if so, whether those representations were false and misleading.

Focusing on the berry version of the product, Justice White found that representations (a) and (c) above could not be established. However, Justice White held that the packaging would convey to the ordinary and reasonable consumer – here the ordinary and reasonable parent of a toddler – that the product was nutritious and beneficial to the health of toddlers (representation (b)).

For the purposes of the case, the ACCC had obtained internal documents from Heinz, which enabled scrutiny of the processes used to manufacture the product, and the way in which it was marketed. One of these documents discussed a “brand refresh,” which indicated that Heinz intended to use the product packaging to promote Shredz as nutritious and healthy.

However, Justice White held that “[e]ven a cursory examination of the packaging indicates that Heinz was promoting the Berries Product as being healthy and nutritious and that ordinary reasonable consumers would have understood that that was so.” [99] Imagery on the packaging, including depictions of a healthy young boy climbing a tree, combined with statements that the product comprised 99% fruit and vegetables, gave the impression of nutritiousness and health. The ingredient list and nutrition information panel (which indicated that Shredz comprised 60% sugar) would not detract from this overall impression, as they were on the back of the box, in smaller print, and could be regarded as “fine print.” Particularly in the context of a busy supermarket trip, ordinary, reasonable parents were likely to pass over them, “and to respond to the dominant message conveyed by the more prominent words and imagery.” [101]

Having established that the product packaging conveyed a representation that the product was a nutritious food and beneficial for the health of toddlers, Justice White then considered whether this representation was false and misleading. In determining this issue, Justice White made extensive reference to expert witness evidence led by the ACCC and Heinz. Central to the ACCC’s case was the evidence led by Dr Rosemary Stanton, a prominent Australian nutritionist. One of Heinz’s witnesses included a consultant nutritionist who had a “continuing association” with the Australian sugar industry, which was not disclosed in his written report, raising concerns about his independence.

In establishing that representation (b) was misleading and deceptive, the ACCC placed particular reliance on the fact that the product was high in sugar. Justice White held that while the ACCC could not establish that the product was not nutritious (given that it contained some nutrients necessary for human life), the high levels of sugar in the product were not beneficial to the health of toddlers. In coming to this conclusion, Justice White referred to the World Health Organisation’s 2015 guideline for sugar intake for adults and children, which recommends that intake of free sugars be reduced to less than 10% of total energy intake, (or conditionally, to less than 5% of total energy intake), in order to maintain a healthy weight and good dental health. “Free sugars” are defined to include those present in fruit juices and concentrates.

Evidence from Dr Stanton showed that one 18g serve of the product was 19% higher in sugar than one 100g serve of fruit and vegetables. Further, a single 18g serve of Shredz contained just under three teaspoons of free sugars, more than one half of the recommended daily intake of free sugars for 1-2 year olds, and over 35% for three year olds. Justice White also referred to statistics on sugar intake in Australia, including that 2-3 year olds have an average daily intake of free sugars of 9-10 teaspoons, well in excess of the WHO guidelines, and that the majority of free sugars are consumed from energy-dense, nutrient-poor “discretionary” foods and beverages.

Of particular influence on the judge’s decision was evidence of the role of free sugars in promoting tooth decay, given by an “impressive witness” with expertise in child oral health. Dental caries is prevalent among Australian children (with 48% of five year olds having tooth decay that requires treatment such as fillings), and poor diet  (particularly foods and beverages high in sugar) is a key contributing factor to dental decay. Justice White accepted evidence that consumption of the product would increase children’s risk of developing dental caries, due to its stickiness and high sugar content.

Justice White also accepted the ACCC’s submission that an assessment of the dental and other health risks posed by the product needed to take account of other aspects of a toddler’s diet (including that toddlers are likely to consume free sugars from other sources), rather than considering the dietary impact of the product in isolation, as argued by Heinz. This position illustrates the limitations of the food industry’s argument that there are no “bad” foods. When viewed in isolation, it could be argued that a product that contributes half of a child’s recommended sugar intake is not detrimental to health. But this argument is much less persuasive when we consider what a toddler is likely to eat over an entire day – even a child with a relatively healthy diet.

Given the high level of sugar contained in a single serve of Shredz, and taking into account the totality of children’s diets (and likely free sugar consumption from other sources), Justice White concluded that it was “not easy to accept that consumption of that amount of sugar in a single snack can be regarded as beneficial to the health of 1-3 year olds.’ This was particularly so given that excess weight and obesity are a significant problem among Australian children (with more than a quarter of Australian being overweight or obese), and having regard to the role of sugars in the development of dental caries, as well significant problems in achieving good hygiene practices among Australian young children. As the high levels of sugar in the product were not beneficial to the health of toddlers, Justice White concluded that the second representation was misleading and deceptive or was likely to mislead and deceive.

Accordingly, the packaging of the berry version of the product contravened s 18(1) of the Australian Consumer Law. Justice White also reached the same conclusion in relation to the packaging of the peach and fruit and chia versions of the product. The ACCC was not able to establish a contravention of s 29(1)(a) or s 33 of the ACC, but in showing that Heinz had made a misleading and deceptive statement about the healthiness of the product, Justice White held that it had also made a misleading or deceptive statement about the “benefits” of the product for the purpose of s 29(1)(g). Although not required for the purposes of establishing a breach of the relevant provisions, the ACCC also managed to establish that Heinz knew or ought to have known that it had made a representation that the productions were nutritious and beneficial to the health of toddlers, and that this representation was false or misleading.

The outcome of ACCC v Heinz is a clear victory for public health advocates who are concerned about the way in which unhealthy food products are marketed to children and their parents. The case illustrates the valuable role that World Health Organisation guidelines can play in the courts’ consideration of public health issues, in addition to evidence of the growing problems of obesity and poor dental health among Australian children. The case also demonstrates the natural affinities between childhood obesity prevention and improving children’s dental health, which could perhaps be exploited more fully by child health advocates.

However, the case does not address one of the key concerns about the marketing of unhealthy foods and beverages, which is the cumulative impact on children and parents of exposure to a large volume of perfectly legal and truthful food marketing campaigns, appearing in many times, forms, and places. While Australia has stringent restrictions on misleading and deceptive marketing, there is little regulation of the large volume of (truthful) marketing for unhealthy foods, exposure to which makes a small but significant contribution to childhood weight gain.

This problem, and potential solutions, will be discussed in my next blogpost.

NSW Law Reform Commission recommends far-reaching reform of guardianship legislation

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In 2016, the New South Wales Law Reform Commission was asked to review the Guardianship Act 1987 (NSW), having regard to UN Convention on the Rights of Persons with Disabilities and a variety of other matters.

With the submission date for comments on the draft proposals now closed, we look forward to the final report.

The Commission’s draft proposals, available here, are wide-ranging.

The Commission would like to see a new Act called the Assisted Decision-Making Act introduced to provide a formal framework for assisted decision-making.  This Act would replace the Guardianship Act 1987, and the enduring power of attorney provisions contained in Part 4 of the Powers of Attorney Act 2003 (NSW).

This post highlights some of the most important changes the draft proposals would introduce.

New terminology, old concepts?

The Commission’s proposed legislation would introduce new terminology.  A “guardian” would be called an “enduring representative” (when previously appointed by the “represented person” in anticipation of reduced decision-making ability in future), and a “representative” if appointed by a court or tribunal.

The term “guardian” would disappear, replaced with references to persons who do not have “decision-making ability” for the purposes of a health care decision.

The proposed legislation would introduce a new definition of “decision-making ability” and would link each person’s decision-making ability to the particular decision in question, recognizing that their ability can vary, depending on the circumstances, including the time at which the decision is made (proposal 1.14).

The Commission asserts that the Guardianship Act contains no “clear or consistent definition of decision-making ability or capacity” (p 5).

However, Part V of the current Act, which governs medical decision-making, does clarify when a person is incapable of giving consent to medical treatment: ie when a person is “incapable of understanding the general nature and effect of the proposed treatment” or is incapable of communicating their consent or lack of consent: s 33(2).

Where this test is met, the common law’s presumption in favour of consent will be displaced, and the provisions governing substituted decision-making under the Act will take effect.

In cases such as Re C (adult: refusal of medical treatment) [1994] 1 All ER 819, 824, courts have identified the ability to comprehend and retain treatment information, to believe it, and to weight it in order to arrive at a choice – as the necessary capabilities a person must have in order to have the capacity to make a medical treatment decision.

In Re C, the court ruled that a patient with schizophrenia retained capacity to refuse treatment that involved amputating his right leg, which was gangrenous and ulcerated.

The case illustrates that a person’s capacity to make decisions about their medical treatment is not an “all or nothing” question, but one that arises in relation to the specific treatment under consideration.  Courts begin from a presumption of self-determination and inquire whether it is displaced on the facts.

Rather than relying on a presumption of capacity that may be displaced for the purposes of the particular medical treatment decision under consideration, the Commission’s proposals seek to introduce a definition of “decision-making ability (or capacity)” for all purposes.

Under the proposed legislation, a person would have decision-making ability if they can:

“(a) understand the relevant information;

(b) understand the nature of the decision and the consequences of making or failing to make that decision;

(c) retain the information to the extent necessary to make the decision;

(d) use the information or weight it as part of the decision-making process;

(e) communicate the decision in some way” (Recommendation 1.12).

However, for the reasons given above, this proposed definition does not appear to involve any genuine change to the pre-existing law.

 

New concepts: supported decision-making

In other areas, the Commission’s proposals clearly do involve substantive changes.

The Convention on the Rights of Persons with Disabilities, to which Australia is a party, recognizes the individual autonomy of all persons, including their right to make their own choices and their right to non-discrimination (Art. 3).

The Convention rights have contributed to a significant re-thinking of the current legislation.

The proposed legislation would introduce two new kinds of decision-making arrangements that have no counterpart in the Guardianship Act.

The first is “personal support agreements” – which formalise a situation where a supporter is appointed to assist a person to make decisions in particular areas of their life, such as health matters.

Under a personal support agreement, the supporter would be appointed by the represented person themselves, in anticipation of their future need.

The new legislation would set out the functions and responsibilities of supporters.

Those responsibilities include collecting information for the supported person, assisting them to communicate their decision, and advocating for the implementation of their decision.

The second mechanism is a “tribunal support order”.  A tribunal support order would appoint a “supporter” whose role is to assist the supported person to communicate their decisions.

It’s important to note that a supporter would not be authorised to make medical treatment decisions themselves, on behalf of the supported person, without the knowledge or consent of the supported person.

This is significant: it illustrates that a “personal support agreement” is distinct from the concept of enduring guardianship under current legislation.

Similarly, a “tribunal support order” is distinct from the concept of a guardianship order.

But what if the person in need of support is profoundly disabled in a way that means they cannot communicate their wishes or preferences?

A third kind of arrangement, an “enduring representation order” could apply here.  Here the analogy with an enduring guardian is appropriate: the enduring representative would be appointed by the represented person in anticipation that their decision-making ability might be reduced in future.

Under the proposed Act, the functions of the enduring representative, and limits on them, would be set out in the instrument of appointment.

Finally, the Commission envisages “representation orders” as a mechanism of last resort, which would replace current arrangements for guardianship and financial management under the Guardianship Act.

A “Public Representative” (who under the proposed legislation would replace the current “Public Guardian”) could be appointed as a person’s representative where no more suitable person was available.

The role of a “person responsible”, who is authorized to consent to major medical treatment in circumstances where no substituted decision-maker has been appointed (under Part V of the Guardianship Act) would continue.

Under Part V of the Guardianship Act, a person responsible cannot refuse life-supporting medical treatment, reflecting the fact that the purpose of Part V is to ensure that patients are not deprived of the treatment they need by their lack of capacity (s 32).

On the other hand, the legislation proposed by the Commission would extend to withholding or withdrawing a life-sustaining measure on behalf of the supported person (recommendation 6.14).

Furthermore, the regulation of medical decisions in Part V would be extended under the proposed legislation to cover health care decisions involving all health professionals who are regulated under the Health Practitioner Regulation National Law.

As a result, the restrictions on the provision of “special medical treatment” under the current Act would apply to “special healthcare” under the proposed Act.

While the current distinctions between “major medical treatment” (“major healthcare”) and “minor medical treatment” (“minor healthcare”) would be continued, the content of these terms would change.

For example, HIV testing and the contraceptive treatment are currently defined as “major medical treatment” in the Regulations; these would become “minor healthcare” in the proposed legislation (recommendation 6.12).

 

New concepts: prioritizing autonomy over best interests

A further example of the impact of Convention rights on the proposed legislation relates to the downgrading of “best interests” as a guiding principle for medical treatment involving persons who lack decision-making capacity.

Under the Guardianship Act, the substituted decision-making provisions found in Part V of the Act exist to ensure that patients are not denied medical treatment that they need by virtue of their lack of capacity to consent: s 32.

Caselaw has made it clear that Part V exists to provide a mechanism for lawfully administering treatment that is medically indicated and in the patient’s best interests.  It was not intended to create a mechanism for refusing treatment life-sustaining medical treatment: FI v Public Guardian [2008] NSWACT 263. (Whether this distinction can be maintained is another matter).

Under the current legislation, the patient’s best interests are balanced through provisions that authorize a “person responsible” to make treatment decisions (s 40), while allowing treatment without consent to save the patient’s life or prevent serious damage to their health (s 37). “Minor medical treatment” may also be provided where a person responsible is not available to consent and where the patient does not object (s 37). Disputes may be resolved by the Civil and Administrative Tribunal or the Supreme Court.

The views of a person who lacks the capacity to consent to proposed medical treatment are relevant, and must be taken into consideration by a “person responsible” who is given substituted decision-making power under the Act: see s 40(3).  However, the patient’s views are not determinative.

Similarly, when the decision maker is the Civil and Administrative Decisions Tribunal, the Tribunal is required to take several matters into consideration, including the views (if any) of the patient: s 44(2). However, the expressed preferences of a person who is incapable of consenting to medical treatment can’t trump the Tribunal’s assessment of that person’s best interests.

The Tribunal can only authorise medical treatment when it is satisfied that “the treatment is the most appropriate form of treatment for promoting and maintaining the patient’s health and well-being”: s 45(1).

(A person’s will and preferences are, of course, determinative in circumstances when they have made a valid advance directive in contemplation of their need for medical treatment at a time in future when they are not competent.  Courts have given effect to the previously expressed wishes of a person to refuse life-supporting treatment, contained in an advance directive, even when their effect is to shorten the patient’s life: see, e.g., Hunter and New England Area Health Service v A [2009] NSWSC 761).

The primacy of the principle of the patient’s best interests, in circumstances where a patient is not competent to decide about medical treatment would disappear in the Commission’s proposed legislation.

The proposed Act would contain general principles, the first of which is that the will and preferences of a person in need of decision-making assistance should be given effect to where possible.

Anyone exercising functions under the Act should be guided by the person’s “expressed will and preferences”. If these cannot be determined, they are to be guided by the person’s likely will and preferences, as they emerge from a person’s previously expressed will and preferences and by consulting people who have a genuine and ongoing relationship with the person and may be aware of that person’s will and preferences.

If there is no such person, then – only then – are decisions to be made to promote the person’s personal and social wellbeing. (Advance care directives, previously made when the person had decision-making ability, must also be respected) (proposal 1.11).

One issue that arises is the amount of leeway or wriggle room these proposed changes give family and associates of the patient to make hearsay allegations about the values, desires and preferences of the patient around particular kinds of medical treatment – in circumstances where the patient lacks decision-making ability and there is no advance directive.

These assertions about the patient’s values and preferences are given considerable weight in the Commission’s proposed recommendations.  The proposals are intended to honour the autonomy of a patient who cannot express it directly.

Will the proposed changes demonstrably serve the interests of those who lack decision-making ability – better than Part V currently does?

How much room is there for family and associates to act in their own self-interest – to the detriment of the person who lacks decision-making ability?

These are fair questions, especially since the proposed legislation would extend to refusals of life-supporting medical treatment, not only the provision of needed treatment to which a patient cannot consent.

Are you interested in health law?  Click here to see the units of study on offer in 2018 in Sydney Law School’s Master of Health Law and Graduate Diploma in Health Law.

A Foundation for a smoke-free world…funded by a cigarette multinational: more smoke and mirrors?

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The Swiss like butter on both sides of their toast.

Headquartered in Lausanne, half an hour’s train ride from the World Health Organisation in Geneva, you’ll find the headquarters of the world’s most profitable tobacco company, Philip Morris International (PMI).

Makers of Marlboro and other global brands.

A few years ago, at the end of a very long interview, held in the PMI Boardroom, I asked a senior PMI executive what he would most like to tell the public health community.

This gentleman, although friendly and accommodating, had smoked all over me for three solid hours.

He said:

“I would like the public health community to try to spend some time listening to what Philip Morris has to say and to see whether or not we can reach some kind of agreement… I think if we continue to fight as opposed to try to reach an accord, we’re losing an opportunity, and I think that Philip Morris has a lot to offer that can help shape and develop regulation, but the public health community has [got] to get beyond its pre-conceived notion that anything that Philip Morris or any other tobacco company proposes is immediately suspect and inappropriate.  That would be my number one concern…”

The wish of this PMI executive was the same as that of every other tobacco executive I spoke to: he wanted governments and public health advocates to listen to his company.  He wanted to partner with the public health community, he wanted a role in shaping policy and regulation.  He wanted “the war” to end.

Philip Morris International may be a step closer to this aim with the launch of a new entity called the Foundation for a smoke-free World.

 

Foundation for a Smoke-Free World

Founded by Derek Yach, the former head of the WHO’s Tobacco Free Initiative, the Foundation was launched with a promise of US$80 million funding per year for 12 years from PMI.

The aims of the Foundation are to “advance smoking cessation and harm-reduction science and technology”.  These aims appear suitably aligned with PMI’s strategy of eventually replacing cigarettes with smoke-free products, and in order to get there, lobbying governments to give preferential treatment to non-combustible recreational nicotine products.

PMI’s website states that: “we don’t agree that banning cigarettes makes sense for smokers or for society at large.”

But speaking of the success of IQOS (a heated tobacco product manufactured by PMI) in South Korea and Japan, PMI CEO André Calantzopoulos suggests that in five years, as users of heated devices outnumber smokers, “That is when we could start talking to governments about phasing out combustible cigarettes entirely.”

They’ve taken their time sharing it with us, but according to Philip Morris, there is an answer to the tobacco epidemic.  It seems you won’t find it in the World Health Organisation’s Framework Convention on Tobacco Control, nor in generations of experience with evidence-based tobacco control laws and policies.

Rather, the answer lies elsewhere:

Individual risk reduction X consumer switching = population harm reduction.

In particular, PMI wants smokers to start using IQOS, the first of four smoke-free products it is (apparently) building its future on.

Of course, PMI needs governments to play their part as well.

We are confident that the right mix of government leadership and commercial initiative will dramatically accelerate efforts to reduce the health burden of smoking.

Which is why, I suspect, substantial funding to the Foundation for a Smoke-free World makes sense at this time.

 

Independent?

The centrepiece of the Foundation’s claim to independence is the article on scientific integrity in its by-laws, which states:

“The goal of the Corporation is to promote and support significant scientific research that advances the field of tobacco harm reduction and reduces the public health burden of smoking-related diseases.  The Corporation shall not take into account the potential impact of that research on the image of the tobacco industry or any other industry or commercial entity”.

That sounds good, doesn’t it, if they can manage it?

The problem is that the funding for this Foundation would appear to depend on annual or periodic renewal by a tobacco multinational.

And that is howlingly significant.

The existence of the Foundation, certainly its size and clout, will depend on how the activities and results of the Foundation appeal to PMI’s board.

That may not be such a risk if you’re married to a vision of tobacco harm reduction that involves promoting the recreational nicotine products that PMI wants to flog around the world.

According to PMI CEO André Calantzopoulos, “The Foundation is a welcome driver of change, at a time when a smoke-free future is clearly on the horizon. We will welcome its recommendations to accelerate smoker adoption of less harmful alternatives.”

No doubt.

But if the Foundation, in all its independence, were to fail to effectively prosecute the case for harm reduction in a form that benefits PMI’s business case, surely the Board would re-consider its investment.  It would be mad not to.

 

No accident

The Foundation for a Smoke-free World has appeared at a time of unique risk for makers of e-cigarettes and heated tobacco products.

I would expect that part of the Foundation’s work, pursuant to its harm reduction agenda, would be to encourage governments to make e-cigarettes more available (in jurisdictions, like Australia, where they are banned), perhaps to tax them at a lower rate, and certainly to reverse the tendency seen in jurisdictions like California to apply smoke-free laws and minimum purchasing age restrictions equally to both cigarettes and non-combustible nicotine products. (See references to California’s legislation in a previous post).

In October, New York State became the latest U.S. state to ban use of e-cigarettes in restaurants, bars and indoor public places including workplaces.  (See here for the text of the legislation).

Addressing this dangerous tendency, and promoting a regulatory environment that allows recreational nicotine products to thrive, is best framed in terms of “saving lives”.

Australia’s Health Minister, Greg Hunt MP, has stated that he will not lift the ban on e-cigarettes: “not on my watch”.

For that, I believe, he deserves credit.

We can expect a gush of Foundation-funded research, ultimately paid for by Philip Morris, arguing that e-cigarettes and heated tobacco products save lives.

Rather than focusing on implementing the evidence-based controls in the Framework Convention on Tobacco Control, governments will be encouraged to switch strategy towards tobacco harm reduction, which translates into relaxing controls on the products that make PMI shareholders rich.

The World Health Organisation claims the Foundation has conflicts of interest and states: “WHO will not partner with the Foundation. Governments should not partner with the Foundation and the public health community should follow this lead.”

In the end, whatever the Foundation and its leaders think they are doing, given the scale of PMI’s investment, the  Foundation will perform a massively important public relations function for its economic parent.

These PR functions are important, given that in the here and now, PMI remains firmly in the cigarette business, exploiting markets around the world where tobacco control laws remain weak (see eg Kalra et al in Reuters).

 

Reaction to the Foundation for a Smoke-free World

To say that the launch of the Foundation has been taken badly by NGOs and global leaders in tobacco control is something of an under-statement.

Distinguished Professor of Tobacco Control at UC San Francisco, Stanton Glantz, writes that “Derek Yach’s journey to the dark side is now complete”, pointing out that PMI’s funding of the Foundation represents “about .1% of PMI’s revenues and 1% of its profits”.

Ruth Malone, Simon Chapman and colleagues write:

“This ‘new’ initiative is just more of the same lipstick on the industry pig, but in a way it’s far worse this time: by using a formerly high profile WHO leader as a spokesperson, PMI can also accelerate its longstanding ambition to splinter the tobacco control movement”.

WHO points out that if PMI supported a smoke-free world it would support evidence-based tobacco control policies that help people quit smoking, including tobacco taxes, graphic disease warning labels, and comprehensive bans on tobacco advertising, promotion and sponsorship.

These are building blocks of successful tobacco control.  They work.

The reality, in jurisdictions around the world, is that PMI opposes these measures.

Outside of rich western markets, where health considerations predominate, it’s business as usual for Philip Morris International and for Marlboro, their star brand.

(Marlboro advertising in Jakarta, Indonesia; the photo at the top, from the island of Lombok, is typical of advertising by Philip Morris International throughout the archipelego)

 

IVF stuff-ups and tort liability for loss of genetic affinity

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Most of us know Singapore for its excellent airport, excellent food and other diversions.  But a recent decision of Singapore’s Court of Appeal, ACB v Thomson Medical, deserves attention.

The case is noted here.

In this case, a mistake was made in the process of an in vitro-fertilisation procedure involving a Singaporean Chinese woman and her German Caucasian husband.

Mistakenly, the wife’s egg was inseminated with sperm from an unknown Indian donor.

Baby P was born healthy, but with a different skin tone.

The claimant’s affidavit states that the pain and suffering that she suffered as a result, physically, mentally and emotionally, was “beyond words” and was “agonizing” [131].

In Australia and New Zealand, in 2014, nearly 34,000 women underwent nearly 68,000 cycles of assisted reproductive technology (ART), resulting in the birth of 12,875 babies.

With so many ART procedures taking place, it’s inevitable that Australian courts will see claims for loss of genetic affinity as well.

 

Wrongful conception, wrongful birth and loss of genetic affinity claims

Loss of genetic affinity cases are a bit different to the usual claims for wrongful conception and wrongful birth.

In wrongful conception cases, such as negligent sterilisation cases, the breach of duty of care results in the claimant falling pregnant in circumstances when they were seeking professional services in order to avoid doing so.

In other kinds of wrongful birth cases, however, the opposite is the case.  The claimant may have been trying to have a child, but due to the defendant’s breach, the child is born with disabilities in circumstances where, if due care had been shown, the claimant might have had an abortion, or might have avoided having a disabled child because a different IVF embryo would have been implanted.

These are just examples, of course, rather than an exhaustive explanation of wrongful birth claims.

In ACB v Thomson Medical, the claimant claimed the expenses she would incur in raising Baby P, a baby who, by virtue of the lack of genetic affinity with the legal father, would not have been born at all if due care had been shown.

 

Cattanach in the High Court of Australia

In Australia, in the High Court case of Cattanach v Melchior, a majority of the High Court allowed a claim for the costs of bringing the child up, at least until the age of 18 years.

Cattanach was a case where the provider mistakenly failed to investigate and simply accepted the patient’s assurance that her right fallopian tube had been removed when in reality it was still there.

The woman gave birth to a healthy child as a result of the transmigration of an egg from her left ovary to her right fallopian tube.

Following Cattanach, 3 state Parliaments moved swiftly to exclude the costs of upkeep.  In NSW, following amendments to the Civil Liability Act, only the additional costs that arise in caring for a disabled child (who would not have been born at all, but for the defendant’s negligence) can be claimed.

The judgments in Cattanach reflect fundamental disagreements about the nature of the damage suffered by the plaintiffs.

In a negligence claim, proof of damage is an essential element of the claim: it’s not enough merely to show the defendant breached their duty of care.

Justice Gleeson saw the claim for costs of raising and maintaining the child as a claim for a novel form of pure economic loss arising because a parent-child relationship had come into existence [26]-[27].

He didn’t regard the claim as being for economic loss that was consequential upon personal injury (that is, a personal injury taking the form of an unwanted pregnancy), because Mr Cattanach was also a plaintiff.

Overlooking the unwanted physical burden of pregnancy on Mrs Cattanach, and framing the entire claim in terms of pure economic loss, seems remarkable to me, but the deeper point for Justice Gleeson was that he thought Mrs Cattanach’s claim implied that the creation of the parent-child relationship was itself actionable damage.

Whereas in His Honour’s view, that relationship is not primarily financial in nature and is fundamental to society, and assigning an economic value to it is not possible [38].

The majority judges saw things differently.  Justices McHugh and Gummow stated that it was not the relationship or the child that was the damage, but the “burden of the legal and moral responsibilities which arise by reason of the birth of the child” [68].

Their Honours did not accept that the values of respect for human life, the stability of the family unit and the nurture of infant children required courts in Australia to reject a claim for costs of upkeep in circumstances where the child would never have been born but for the defendant’s negligence [76].

 

ACB v Thomson Medical in the Singapore Court of Appeal

The Singaporean case of ACB v Thomson Medical was a bit different, of course, to the High Court case of Cattanach.

Unlike Cattanach, in ACB the claimant was actively trying to conceive.  She wanted a mixed Chinese-German child.  What she got was a mixed German-Indian child.

It had the wrong skin colour.

Singapore is a pretty interesting jurisdiction to run the argument that the lack of genetic affinity, and the differences in physical appearance that followed from this, should be regarded in the eyes of the law as actionable damage or “harm”.

One thing that must be said about the judgment of the Singaporean Court of Appeal is that it is extremely thoughtful and a wonderful example of the judicial craft.

The justices systematically and carefully reviewed caselaw across many jurisdictions – it’s a magnificent case for health lawyers to read in order to come up to speed with wrongful birth claims in common law jurisdictions.

The justices were also honest when it came to making the value choices that they were inevitably required to make.

Ultimately, the court rejected the claim for costs of upkeep for Baby P for the reason that “the duty to maintain one’s child is a duty which lies at the very heart of parenthood, and thus the expenses which are incurred towards the discharge of this estate are not capable of characterisation as a loss” [90].

The court regarded the creation of the parental relationship that arose from Baby P’s birth as giving rise to both financial and non-financial obligations.  The court saw no reason why the financial consequences; that is, the cost of upkeep should be compensable, when the non-pecuniary costs were not [92].  In a poignant passage, their Honours included in these non-pecuniary costs “the hours of lost sleep spent putting [Baby P] to bed; the sorrow and worry endured during a bout of illness; or the simple act of blowing on a spoonful of hot soup before feeding it to her” [91].

If the court were to award damages at all, even for the quantifiable costs of upkeep, it would necessarily mean acknowledging, as actionable damage, aspects of a relationship which is “regarded as socially foundational” [101].

While this as a principled position that a court might reasonably take, I would personally give greater weight to the consequences of such reasoning.  The consequences are to create a zone of immunity where IVF providers don’t have to be answerable for careless conduct.

Denying the costs of upkeep in wrongful birth claims may also exacerbate the economic harm the claimant suffers, especially in circumstances when the claimant was seeking to avoid pregnancy.

 

Loss of genetic affinity

In the second part of its judgment, the Singaporean Court of Appeal went on to explain that the true basis of the claimant’s complaint was the disruption, by negligence, of her desire for a shared genetic link between herself, her husband, and her child [128].

The court concluded that “damage to the [claimant’s] interest in ‘affinity’ is a cognisable injury that should sound in damages” [135].

The court ultimately decided that appropriate compensation would be to award the claimant 30% of the financial costs of raising Baby P, not as costs of upkeep, but as recognition of the interference with her interest in genetic affinity with her child.

Which leads me to say: if it is the social importance, fundamental character or moral integrity of the parental-child relationship that is the basis for denying a claim for costs of upkeep, was it not somewhat odd for the court to nevertheless accept that the absence of a genetic link between the claimant and her child qualified as actionable damage?

Personally, what I find heartening, in fact inspiring, is the way that people can – and do – create families through the sheer force of their love and commitment to each other, irrespective of skin colour or genetic affinity.

We see this with adoption and same-sex families, not to mention second marriages.

These family units are here to stay, and deserve the same measure of protection as families where the heterosexual parents share genetic links.

If awarding damages for the coming-into-existence of an unwanted parent/child relationship is offensive in terms of principle, is it not equally offensive to award damages because the (innocent) child who is the subject of the parental relationship lacks genetic affinity with one of its parents?

 

Appraisal of the decision

The Singaporean Court of Appeal acknowledged that the loss suffered by the claimant was partly the result of a complex mix of biological and social factors, including racial attitudes that might not be praise-worthy.

However, I am puzzled why – if the court was persuaded to take a principled line on the fundamental importance of the family unit by denying a claim for the costs of upkeep – why it didn’t follow that principle through and also reject the claim for damages for loss of genetic affinity.

Families are more than the shared genes between children and their parents.

The “anguish, stigma, disconcertment, and embarrassment suffered by the claimant” [150] in response to the curiosity of others about Baby P’s skin colour might actually be based upon reactions that weaken the family unit, rather than strengthen it.

In summary, I agree with the decision the court reached, but I have reservations about its reasons.

Personally I do not see a claim for costs of upkeep as signalling a disrespect for the value of the family unit, at least when the alternative is to create a zone of immunity within which IVF providers are shielded from the consequences of careless conduct.

If we value families, we need to respect the conditions under which people choose to go into parenthood, especially when they seek to avoid parenthood altogether, and also when they enter IVF arrangements in order to ensure a genetic link with their children.

In recognising an action for loss of genetic affinity, and providing a novel resolution to a claim for wrongful birth,  the Singaporean Court of Appeal was taking a pragmatic path that enabled it both to underscore the fundamental importance of the family unit, while still providing a remedy for the consequences of carelessness in the provision of IVF.

Health law at Sydney Law School

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