The UK has recently altered its position in relation to the important question of a doctor’s obligations to warn their patients concerning risks of treatment.

Preceding the decision in Montgomery v. Lanarkshire Health Board [2015] UKSC 11, delivered on 11 March 2015, the UK had long maintained its acceptance of the so-called Bolam principle, reiterated in the mid 1980s by its House of Lords decision in Sidaway, that the question of what information a doctor was obliged to disclose to their patient, concerning risks involved in proposed treatment was essentially a matter determined by the medical profession. It was a defence to any claim that a relevant risk had not been disclosed, to demonstrate that other reasonable doctors would not have informed their patients of such risk.

The Supreme Court in Montgomery reversed this position and adopted the position that has existed in Australia since 1992 and our landmark decision in Rogers v. Whittaker.

The position in the UK, as in Australia, is now that a doctor’s obligation to disclose information relating to proposed treatment, including as to its risks, is determined by the question of whether the patient would be likely to attach significance to it in deciding whether or not to proceed with such treatment. If the patient would be likely to attach such significance, the doctor is obliged to disclose such information including as to the risk.

The test is “patient driven” as it depends on whether they would consider the relevant risk or other information significant in making their decision, rather than being ‘doctor driven‘ by whether the doctor thinks that they ought to attach significance.

There is some irony in the UK altering its position, given Australia has moved away from such ‘patient driven’ position in relation to other non-advice aspects of medical care, by the Civil Liability Acts.

The UK case is also interesting for obstetric care more generally.

The risk about which it was found warning ought to have been given, was the risk shoulder dystocia may occur if Mrs Montgomery delivered her child by a ‘natural’ or vaginal birth. It was found that Mrs Montgomery would have attached significance to this risk if warned of it. This had not occurred and so such lack of advice was found to have been negligent.

Mrs Montgomery was relatively small and a diabetic. While neither of these factors were particularly rare, they did modestly increase the risks of difficulty if such a dystocia occurred.  Mrs. Montgomery’s evidence was accepted that if warned of the risk of shoulder dystocia, even though this was unlikely and unpredictable, she would have elected to give birth via an elective cesarean section rather than a vaginal delivery.  Interestingly, the Supreme Court reversed the trial judge’s conclusion on this, which had been that a warning as to the risk of shoulder dystocia would not have led to the mother electing to proceed via a cesarean delivery.

This is a very common scenario in day-to-day obstetric care. There are very many patients of small stature and diabetic [whether gestational or otherwise]. The case appears to establish that in the UK at least, such patients need to be warned of a risk of shoulder dystocia because it ought to be accepted that such risk may be of significance to the mother in deciding whether to proceed via a natural delivery or ‘elect’ to have a cesarean.

The facts are an excellent example of the difference between the Rogers test and the Bolam approach.

It is also an illustration of why the Rogers test has been so unpopular amongst some medical practitioners who, rightly or wrongly, say the emphasis on patient autonomy potentially leads to patients making ‘wrong’ or poor decisions based on a flawed assessment (or in truth weighting) of the risks relating to their treatment options.

The High Court recently dismissed the special leave application brought in this case by Ms Paul, seeking to overturn the New South Wales Court of Appeal’s decision rejecting her claim.

As may be known, the case concerned a delay in diagnosis of an intracranial aneurysm suffered by Ms Paul. She underwent a head CT Scan in 2003 and Dr Cooke, the radiologist, negligently failed to identify and therefore diagnose the aneurysm.  In 2006, following a further scan, the aneurysm was diagnosed. Sadly during surgery to remove the aneurysm it ruptured causing Ms Paul a stroke and serious injury.

For the purposes of the special leave application it was accepted that the risk of rupture/stroke associated with the operation Ms Paul underwent in 2006 was no different to the risk had she undergone surgery in 2003, as would have occurred had Dr Cooke not negligently failed to diagnose the aneurysm.

The New South Wales Court of Appeal had concluded that Dr Cooke’s negligence was not the cause of Ms Paul’s surgical complication. His negligence changed the timing of surgery but did not alter the risk associated with it. It did not matter that it could be fairly said that had Ms Paul undergone surgery in 2003, it was very unlikely that she would have suffered the rupture and stroke she did in 2006.  Dr Cooke had breached his duty of care, but was not responsible for the stroke.

The High Court rejected the application for permission to appeal from such decision (the special leave application), because its members, in essence, agreed with the Court of Appeal. There was not sufficient doubt to warrant granting permission to appeal.

There is now a clear distinction between diagnosis and treatment cases on one hand and failure to warn cases on the other in this important context.  In the latter, it is well recognised (and recently reaffirmed by the High Court in Wallace v Kam, [2013] HCA, 19) that a patient can succeed in a claim if able to show that had they been properly warned of the risks associated with treatment they would have delayed proceeding, even if ultimately such surgery or treatment was likely to occur and would involve the same risks as eventuated at the time of their operation. More must be shown in diagnosis/treatment cases. A negligently caused delay in surgery carrying the same risk is not sufficient for liability.

Paul v Cooke failed, apart from on general causation principle, by reason of the terms of section 5I of the NSW Civil Liability Act which provides that:

“a person is not liable in negligence for harm suffered by another person as a result of the materialization of an inherent risk.”

The New South Wales Court of Appeal rejected argument on Ms Paul’s behalf that this section was limited to materialisation of a risk associated with treatment provided by the negligent defendant. This section was interpreted as broad enough to exclude liability when the inherent risk that materialised, as occurred in the surgery performed by the team caring for Ms Paul in 2006, well after the negligent failure to diagnose by Dr Cooke.  Interestingly the WA equivalent provision, section 5P is differently worded from the New South Wales legislation and does seem to be limited to inherent risk associated with the defendant’s treatment.

The Victorian Court of Appeal delivered its decision in relation to the Appeal in this case on 18 February 2014.  The Court of Appeal unanimously agreed to dismiss Ms Odisho’s appeal against the Trial Judge’s dismissal of her claim.

The case concerned an alleged failure to warn Ms Odisho of a very rare risk of thrombo-embolism associated with recommended gynaecological treatment for her heavy menstrual bleeding via tranexamic acid medication.  The Court of Appeal upheld the Trial Judge’s conclusions that in fact Ms Odishi’s thrombo-embolism was not caused by her use of this medication and in any event, although she was not warned of such risk, she had not established that had she been warned, she would have declined such recommended treatment.

The case was interesting to me in the following respects.

  1. The Court of Appeal left open the question of whether they would have overturned the Trial Judge’s conclusions that no duty to warn of the relevant risk arose, had they reached a different conclusion in relation to causation.  It is therefore a good example of the relatively low probability of a risk that may nonetheless be required to be disclosed.  Interestingly the fact that thrombo-embolic event was included as a rare side effect (in less than 1/1000) in MIMS was important in supporting a conclusion that a duty to inform the patient of this risk arose.  MIMS should now be on every Plaintiff lawyer’s desk, for reference in medication cases.
  2. The case is an example of the combined objective, then subjective aspects of enquiry to determine whether a duty to warn arose.  As established, the enquiry is initially whether a reasonable patient would attach significance to the relevant risk.  The disclosure obligation can then be increased if there are particular features of the patient in question, which suggest significance would attach to the relevant risk.  Members of the Court recognised that Ms Odisho was stated to have been anxious and concerned about treatment for her condition, though not that this proved she would have attached significance to the risk in question.
  3. Although already well established, the Court confirmed that whether or not provision of a warning was usual practice was not the issue in deciding whether duty to warn arose (see at [27]).
  4. The case is a good example of the limited utility of a Plaintiff’s bald assertion that if warned they would not have proceeded with given treatment.  As members’ of the Court stated “the exaggerated nature of the Appellant’s answers to the questions put to her on the issue of what she would have done had she received a warning well justified the Trial Judge’s rejection of this evidence.  When one looks at the whole of the evidence, including the evidence of treatment to which the Appellant was prepared to consent, like the Trial Judge, we are unpersuaded that an appropriate warning of the risk of pulmonary emboli would have made any material change to the events that occurred.”

The case is yet another example of the difficulty of proving causation in failure to warn cases where the risk is very small indeed.  Whilst breach of duty may be established, it is another thing to have confidence that a patient will establish causation unless there is good reason to argue that, despite the low probability of such risk, it would have been decisive in altering the patient’s decision to undertake the relevant treatment.

 

After what I have felt has been a slow start to year, in terms of important medical negligence case law, 2 important decisions in 2 days…

On Monday, as reported, the NSW Supreme Court delivered the long awaited (it seems 15 months from trial to decision) decision in Waller v James, the equally unfortunate, as it transpires, case spin-off from Harriton v Stephens, the wrongful life case in which the High Court held no damages could be recovered by the child who would not have been born (because his parents would have terminated the pregnancy), had there not been negligent in the antenatal advice. In Waller, Justice Hislop dismissed the allegations of negligence against IVF doctor Dr James. He made a number of important findings relevant to the assessment of damages in such cases, on topics which have to this point been undecided. I will post a more detailed summary of this case shortly. It will be interesting to see whether the case is appealed. The stakes seem high enough to make this likely.

Then today, the High Court delivered a unanimous decision in the appeal in Wallace v Kam, the NSW case I have written about previously, concerning an action for failure to warn of significant risks of complication. Once again, I will write a summary of such case, when the reasons of the Court are published. In the meantime, by the Court’s published case summary, their decision hinged on their conclusion that:

"Mr Wallace was not to be compensated for the occurrence of physical injury, the risk of which he was willing to accept."

Of course the converse argument, not accepted by the Court, was that Mr Wallace suffered a serious complication from an operation he would not have agreed to undergo, had Dr Kam properly warned him of the risks of it. It will be interesting to see how the Court reached its conclusion. 

The NSW Court of Appeal, on 13 April 2012 handed down its decision in relation to Mr Wallace’s claim against neurosurgeon Dr Kam. The case sought to challenge the accepted position in relation to failure to warn cases. Following the High Court’s decision in Rosenberg v Percival, it has generally been accepted that to succeed in a case alleging a failure to warn on the part of their surgeon etc, it was necessary to show:

  • the risk of the type of complication the patient suffered was such (by a combination of its seriousness if it eventuated, it’s probability and the patient’s realistic options other than proceeding with the treatment) likely to be considered of significance by the patient in deciding whether or not to undergo the proposed treatment;
     
  • no warning of such complication was provided;
     
  • if the warning had been provided, the patient would not have proceeded with the treatment, at least not at the time and place they did.
     
  • the risk that ought to have been warned about (but was not), then occurred.

In Wallace, the 4th of these requirements was sought to be challenged.  It was claimed to be sufficient if a warning of a risk of complication had not been given, that would have convinced Mr Wallace not to proceed with the surgery, even though it was not this risk that occurred, but rather another risk, that whilst also not disclosed when it ought to have been, was not such as would have convinced Mr Wallace not to proceed with his surgery (because it was so unlikely) – yes, even I had to read this several times before understanding it…

It was argued that Mr Wallace should be compensated for serious complications caused by surgery he would not have undergone, had Dr Kam appropriately warned him of the risks (plural) it involved. When put that way, it is easy to see the appeal of Mr Wallace’s claim ( see particularly the convincing reasoning accepted in Moylen’s case [117] per Lord Caplan).

Unfortunately for him, the Court of Appeal, it has to say with some hesitancy, obviously considerable careful thought and analysis, with 1 of the 3 Judges dissenting, affirmed the conventional position and concluded Mr Wallace’s claim should fail.. Nonetheless, on my reading, the Court made clear that, in part due to the Civil Liability Act’s introduction, the position is not as clear cut as perhaps previously believed. That this is the case is obvious from the divergence of opinion among the 3 members of the Court.

An intriguing question that occurred to me is: what would have happened if the case had been run focusing not on the scientific question of the risks of the operation, but more practically, upon the warning the surgeon ought to have given?  Whether such warning would embrace the risk that eventuated. It occurs to me that in practice, it may well be that a surgeon would be likely to discharge their duty to warn of the risk of various types of nerve injuries by such a single warning, embracing both the form of injury Mr Wallace suffered and the more serious risk.  If it was the same warning that ought to have been given, that was not, which would cover both forms of nerve injury, conventional theory would suggest Mr Wallace ought to have succeeded.

 

I note with interest the Court of Appeal’s decision in Nigam v Harm [2011] WASCA 211.

Whilst a case concerning a negligence action against a firm of solicitors, the important aspects of the case predominantly related to medical negligence claims.  

It was alleged the relevant firm of solicitors had been negligent in failing to:

  • take action to protect a potential medical negligence claim by Mrs Harm against surgeon, Dr Hastwell.
  • pursue various lines of investigation concerning possible lack of care on the part of the relevant surgeon, Dr Hastwell.

Mrs Harm had succeeded in her case against such solicitors at trial, but on appeal, such claim was overturned. The court majority concluded that the solicitors had not been negligent.

For a lawyer working in this area, it was interesting to read the degree of initiative/imagination considered required on the part of solicitors investigating quality of medical care issues.. My impression was that the ‘bar’ was set lower than I would expect.

This was particularly so, in relation to the issue of reminding Ms Harm about the impending expiry of the ‘holding’ writ that had been lodged (which would end any claim if it expired without action).  Given it seems she was still eager to pursue claim, I am surprised her solicitor was not considered obliged to remind her of this deadline so a decision could be made, whether the writ was served (or an application made to extend), given the consequences if it was not (which it was not clear to me, from reading the decision, she knew).

Justice Newnes made interesting comments in relation to the one area he did consider the solicitors ought to have considered some prospects of a legitimate claim, a claim that the surgeon had failed to appropriately warn Mrs Harm of the risk that the surgery may cause significant post-operative nerve pain in the area of scarring at her surgical incision (see for example @ [116] – [121]).

His Honour concluded, that any claim by Mrs Harms would not have prevailed, because she would not have proved that if warned she would not have gone ahead with such surgery.

With respect, I am not sure the evidence really supported such a conclusion (as distinct from a conclusion that ‘no conclusion’ could be drawn, because too many important things were unknown relevant to such decision (for example: the true scale of such risk, the alternatives open to her, other than such surgery {including the risk if it was performed laparoscopically, if this was possible}).

Justice Newnes view was shared by McLure P and so prevailed.   Interestingly, Justice Murphy disagreed and considered the solicitor had been negligent in relation to this failure to warn aspect of the potential claim.

 

Maintaining the sobering record of Plaintiff claims based on informed consent, is a recent South Australian case, Coombes v Katsaros [2011] SADC 93.

The claim concerned alleged complex regional pain syndrome ("CRPS") said to have arisen following hand surgery.

The key to the Plaintiff’s claim was his assertion that he ought to have been warned of the risk that such hand surgery, which was indicated, but not essential, could cause CRPS and so further suffering.

Evidence at trial was given suggesting some hand surgeons would provide such a warning, whilst others would not. The evidence as to the incidence of such complication was not clear, but accepted by the trial judge as occurring in a severe form in perhaps 1 in 2,500 cases.

In the circumstances, Judge Millstead was not convinced the Defendant had a duty to warn of such risk (see @ [267]). Interestingly, Judge Millstead appeared to place significant weight in his conclusion, upon the absence of any specific questioning by Mr Coombes concerning risks with the surgery.

The implication is that perhaps had he appeared more cautious about proceeding, questioning the doctor as to what may go wrong, a duty may then have arisen to warn of the complication that occurred.

Mr Coombes case therefore fell at the first hurdle. Given Judge Millstead’s conclusion, it would have failed at the second (and more onerous) stage, assuming a duty to warn of the relevant risk arose, of showing that such a warning would have lead to the patient refusing to proceed.

 

 Judge Davis of the District Court rejected Ms Lentzner’s medical negligence claim against general surgeon, Max Baumwol, delivering her decision on 6 November 2009.

Ms Lentzner’s claim alleged that Mr Baumwol was negligent in the manner in which he sought to perform repair of bilateral inguinal hernias in 2003.  For an explanation of surgery (albeit laparoscopic so different from in Ms Lentzner’s case) to repair inguinal hernias, see here.

The primary allegation was that such repair ought to have utilised mesh to repair the relevant hernias and not, consisted only of surgical suturing of the relevant hernias.  It was said that if this had occurred, the relevant hernias would not have recurred.

Judge Davis [55] concluded that Ms Lentzner’s account of events was in some respects unreliable, though she accepted Ms Lentzner believed the truth of what she said.  This was based on Judge Davis conclusion that Ms Lentzner’s claims as to very severe pain immediately following her surgery were unreliable, because the observations recorded in the hospital records did not suggest anything out of the ordinary.  Judge Davis emphasised hospital staff’s appreciation of the importance of the accuracy of records, as reason she could confidently conclude that if Ms Lentzner’s claimed symptoms had been present, they would have been reported.

Despite clear inconsistencies between his claims as to the method of repair of 1 hernia and the contemporaneous records, Judge Davis accepted Dr Baumwol’s claims as to the manner in which he performed such repair, based only on his claims as to his usual practice [111].  

This, with respect, was generous to him.  If inconsistency with the records was enough to reject Ms Lentzner’s claims (as set out above), why was such reason not reason to reject Dr Baumwol’s claims, which were not even asserted to be based on recollection, but of ‘usual practice.’

In accordance with the majority of expert evidence before her, Judge Davis accepted that Dr Baumwol’s decision to repair the hernias using sutures and not mesh, was reasonable.  The experts agreed that there was no hard evidence available at the time (or now) suggesting a benefit to one technique over the other (though interestingly, and this matches my uninformed understanding, they accepted that since 2003 there had been a move towards greater use of mesh, particularly as problems relating to infection with mesh at that time had been reduced).  Judge Davis concluded:

 

I find that the evidence from the experts establishes that whether to use mesh in these repairs involves a matter of clinical judgment on which reasonable minds might differ

 Consequently this basis of alleged negligence failed.

Based on the same medical evidence, Judge Davis dismissed the claim that there was an obligation to warn Ms Lentzner that if mesh were used to repair her hernias, this would reduce the risk of recurrence.  The evidence before Judge Davis did not support this conclusion that such a reduced risk would apply.

Of significance, Dr Archer, a surgeon relied upon by Ms Lentzner who had operated upon her following Dr Baumwol’s care, gave clear evidence at trial that the problems he identified were not, as Ms Lentzner’s case alleged, a recurrence of the hernias that had been treated by Dr Baumwol [R80].  This was really the end of Ms Lentzner’s case, because if her hernia did not recur, she had little claimed consequence of any of the alleged shortcomings in her care.

All in all an unhappy experience no doubt for Ms Lentzner.

From a legal principle perspective, the case included 2 further interesting issues:

1) The case included an interesting examination of the capacity for a psychologist to provide expert evidence concerning diagnosis.  Traditionally this has been an area in which psychologists (I have thought unfairly) have been held unable to give expert evidence.  This issue was identified but not decided by Judge Davis in relation to evidence of diagnosis based on knowledge of DSM IV on the part of a well known local psychologist, Bill Douglas.

2) the case confirmed the traditional 30% discount for early receipt of past lost superannuation benefits is now too great.  Judge Davis, in accordance with submissions from both Counsel accepted that a rate of 15% was now reasonable (in her provisional assessment of damages).

 

 

Reading the recent West Australian Court of Appeal decision in Gingin -v- Coomb [2009] WASCA 92, handed down last month.  This was a case concerning a catastrophically injured young man who suffered injury when he lost control of his trail-bike when riding it in a designated off-road recreational area, near Lancelin, a beach side town an hour or so North of Perth.

Unfortunately for Mr Coomb, the Court of Appeal (2:1) reversed the trial judge’s finding that the Shire were in breach of the duty they owed him, in failing to more adequately warn him of the potential for such injury when riding in the dune area.

I have to say I am very surprised at the evidence at trial (which it does not seem was contradicted) that because the dunes in the designated area were "ever changing, depending on wind strength and direction" (Martin CJ @ R26), it was not feasible for the Shire to inspect the area and cordon off obviously dangerous areas, despite it being found the Shire encouraged use of such area (R20) and that a designated area was set aside for this activity (and was very popular).

It surprises me that it seems the dune face Mr Coombs fell down, which was 10 – 15m high at an angle of 80 degrees, with a hard rock bottom, would not have been an obvious hazard, had it been inspected even a month or 2 before the accident.  In fact very shortly prior to Mr Coombs’ accident (on the same day) another rider was fatally injured at the precise same location. This suggests the area was commonly crossed and again, in my view, indicates that inspection/identification of the particular and unusual hazard of the particular location ought to have been possible. The danger (or near inevitability of injuries) for someone riding at anything other than very low speed, over such a dune, and confronting such a face, seems absolutely clear as a matter of common sense.

The case is another example of the difficulty of demonstrating claims, based on an alleged failure to warn. See the contrasting factual conclusions by Martin CJ (in the majority) -v- McLure JA on this.

Once again, the case faced a fundamental evidentiary gap, because Mr Coombs was not asked (as he should have been) and so did not say, how a better sign warning of the particular risk of this sort of dune, would have changed the way he approached the relevant dune on his trail bike (appreciating the difficulty of this, because he had no recollection of the accident).

Although this is not a medical negligence case, it is relevant, given a ‘failure to warn‘ is a very common type of medical negligence or malpractice case investigated.  The key question of whether the person making claim can show that if warned, they would have acted differently (in a medical context, would not have had the surgery etc), remains the most substantial hurdle for claims.

image: GrahamKing 

I noticed via a recent news release, that 2 Queensland women are pursuing medical negligence claims via Maurice Blackburn, Lawyers, against BreastScreen Queensland.

This follows the O’Gorman case in Sydney in late 2008. In that case Ms O’Gorman was successful against the New South Wales equivalent, BreastScreen NSW, which was found negligent in relation to a screening mammogram. Ms O’Gorman had breast cancer that should have been identified. By the time it was, her cancer had progressed. At the time of trial, she was given only a very short period to live.

As with O’Gorman, these new cases appear to arise from routine breast screening mammograms being read as normal, when it is alleged they were abnormal. In 1 of the 2 women’s cases, the delay in identification and treatment is alleged to have resulted in spread of her cancer such that she has been given 2 years to live.

 

Continue Reading BreastScreen – Litigation about Screening Mammograms