Monday, 31 March 2014

Re-writing the Bolam Test

The consultation on Lord Saatchi's Medical Innovation Bill is open until the end of April. I have previously posted on the Bill. Against my better judgement I am returning to the issue here. The reason why is that there have been, as yet,  few public comments from representative bodies of  doctors and patients (other than the MDU which is not supportive of the Bill)  and, to my surprise, little noise from clinical negligence lawyers. Meanwhile the public is busy responding to the Bill having been told that it will lead to a cure for cancer (see my previous posts). It will be unsurprising therefore if the response is largely positive!

The government's view can be predicted from the way it has introduced the consultation:

"We want to make sure doctors are not held back if they want to use pioneering treatments to offer a lifeline to dying patients..."

What kind of evil person would want to hold back pioneering treatment and deprive dying patients of a lifeline?

Well, sorry, but I do oppose this Bill. In my opinion the existing law of clinical negligence does not hinder innovation. The claims made for the Bill are far-fetched. The Bill is unnecessary but, more worryingly, it will remove reasonable and proportionate patient safeguards.

The present law

A doctor who provides treatment or management of a patient which a responsible body of fellow practitioners would support is not negligent, even if most other practitioners would not support it. A doctor is only negligent if no responsible body of fellow practitioners would support their treatment or management. If that negligent treatment or management harms the patient then the patient will be entitled to compensation for their injuries.

The current law does not mandate adherence to a standard treatment as Lord Saatchi has claimed. It allows innovative treatment provided a responsible body of medical opinion would support it.


The Bill
Clauses 1(1) and (2) of the Bill seek to change the law on clinical negligence by providing that a doctor is not negligent if he treats or manages a patient in a manner which no responsible body of medical opinion would support, provided the decision so to treat or manage the patient is "taken responsibly".

A decision is taken responsibly under the Bill if the doctor bases it on certain considerations and makes it by an open process. By clause 1(7) factors which "may be taken into account" in determining whether the process of decision making was open include:

(a) whether the doctor has discussed the proposed treatment with the patient and given the patient the explanation that the doctor would in the circumstances be expected to give of the doctor’s reasons for carrying out the treatment,
(b) whether the decision has been made within a multi-disciplinary team, and
(c) whether the doctor has given notification in advance to the doctor’s responsible officer (if any).

Proponents of the Bill have claimed that it requires that a "panel of senior doctors" will have to approve the proposed treatment. As can be seen, that is not so. Clause 1(7) sets out factors which may, not must, be taken into account and 1(7)(b) does not require the approval of a panel of senior doctors. The MDT might not include any other doctors at all. Clause 1(7)(c) requires only notification to not approval of a responsible officer.

Patient Protection
Over emphasis on patient protection might in principle thwart other desirable goals but I do not believe that depriving patients of compensation when they are harmed by doctors who act in a way which no responsible body of practitioners would support is the right way to promote innovation.

Take the hypothetical case of a maverick doctor who genuinely believes that vitamin x capsules can cure bowel cancer. He sets up a clinic with a  nurse and a nutritionist with whom he consults before giving treatment. In fact his capsules are ineffective but do cause severe liver problems in some patients. Those patients sue for negligence. No other doctors would support the treatment. Under the current law those patients would have a remedy. If this Bill is enacted the doctor would have a defence. And if he has a defence in law, how could the GMC seek to intervene to prevent such conduct?

You can respond to the consultation here 

Monday, 10 March 2014

What A Pain

When an initially minor physical injury leads to large claim because of a psychiatric disorder, scepticism can cloud assessment of the issues which fall to be determined. The recent first instance decision in Malvicini--Ealing Primary Care Trust is a useful reminder of the sorts of issues which arise and a demonstration of how the courts might deal them.

The Claimant, a nurse, suffered an accident at work. Judgment had been entered for damages to be assessed and the trial of damages came before Robert Francis QC sitting as a Deputy High Court Judge. He noted that  the Claimant "sustained a soft tissue injury to the left upper arm and scapular region from which she has developed a seriously disabling condition largely mediated by psychological factors. She accepts that the physical effects of the injury have largely, if not entirely, dissipated, but the remaining psychological effects remain with her and are seriously disabling. She claims that her disability is permanent. The gravity of this is shown by her claim for lifetime loss of earnings and a substantial claim for future care. "

In 2013 one expert "observed her walk with a "tottering", spastic-like gait, and an ability to walk five steps without crutches before leaning against a wall. He noted a variety of other movements which led him to suggest that there was evidence of a degree of calculation and conscious exaggeration. This included sudden jerking of limb, groaning, a claim of difficulty in rotating her neck whereas later she succeeded in doing so to 65 degrees, and a demonstration of foot drop which was contradicted by the way she walked ".

The orthopaedic experts agreed to describe her condition as "bizarre".

The psychiatric experts agreed that "she fulfilled the diagnostic criteria for persistent somatoform disorder according to ICD-10".

The Defendant's case was noted to raise the following issues:

"i) That there are indications of malingering and exaggeration, which are entirely or partially conscious. In other words the defendant suggests that the claimant has been dishonest in respect of the extent of her condition;
ii) That if the disability is genuine and psychological then it demonstrates such vulnerability to an abnormal reaction to a minor incident that it was bound to occur in any event. Such an event occurred in June 2010.

In any event there is a good prospect of the claimant's condition improving significantly, following the end of the litigation."

Malingering
The Defendant accepted that malingering involved dishonesty. Its expert had said there were elements of malingering. The Judge held:

  1. "As was accepted by Miss Ayling to accuse a person of malingering is to accuse them of dishonesty. While there is only one standard of proof in a claim such as this, the balance of probabilities, clear evidence is required to support an allegation of that nature. The principle was put clearly by Lord Nicholls of Birkenhead in Re H and others (Minors) (Sexual Abuse: Standard of Proof) [1996] AC 563, 586

  2. "The balance of probability standard means that a court is satisfied an event occurred if the court considers that, on the evidence, the occurrence of the event was more likely than not. When assessing the probabilities the court will have in mind as a factor, to whatever extent is appropriate in the particular case, that the more serious the allegation the less likely it is that the event occurred and, hence, the stronger should be the evidence before the court concludes that the allegation is established on the balance of probability. … Built into the preponderance of probability standard is a generous degree of flexibility in respect of the seriousness of the allegation.
    Although the result is much the same, this does not mean that where a serious allegation is in issue the standard of proof required is higher. It means only that the inherent probability or improbability of an event is itself a matter to be taken into account when weighing the probabilities and deciding whether, on balance, the event occurred. The more improbable the event, the stronger must be the evidence that it did occur before, on the balance of probability, its occurrence will be established."
  3. I have no hesitation in concluding on the evidence I have heard and have summarised above that the claimant has not at any material time been malingering in the sense of deliberately pretending to be more disabled than she believes she is, or in the sense of deliberately exaggerating her symptoms, beyond an occasional tendency to over-state symptoms a little through anxiety to persuade experts of the truth of her very real suffering. She is genuinely suffering from a condition with a diagnosis as variously described in the evidence I considered in the preceding section of this judgment. There is no direct evidence which demonstrates malingering, and a number of factors satisfy me that she is not a malingerer." 
This is a familiar finding in such cases. I had a very similar case last year (which the Defendant is appealing and which, therefore I will not comment upon). 

Defendants need to be aware that good evidence is required to establish malingering and deliberate exaggeration for the purpose of gain which will undermine the whole or a very substantial part of the claim.

Vulnerability
The Defendant contended that the extreme response to a minor initial injury showed that the Claimant was "exquisitely vulnerable"to a pain disorder and had an "all encompassing need to be dependent and unwell".  She would have suffered a similar response to any one of a number of minor injuries which she might have befallen even in the absence of the index accident, for example a minor injury she did in fact suffer after the accident. The Judge held that 
  1. "I find that the claimant would not, on the balance of probability, have sustained an injury from an event for which the defendant was not tortiously liable. Indeed I find that the particular circumstances that surrounded the index accident, including the immediate perception of the claimant that it should not have happened, were likely to have been significant. We know that the claimant had sustained relatively routine injuries and illnesses in the past, unrelated to her work, and had not suffered this sort of psychological reaction."
However, he did find that the Claimant was vulnerable to some extent and taking into account all the circumstances her damages should be reduced by 10% to reflect that vulnerability.

Defendants might wish to consider the particular circumstances of the accident and why it gave rise to the extreme reaction. How did they compare with previous or subsequent incidents.

Prognosis
The Judge was influenced by the expert evidence of the pain management experts who were gloomy as to the prospects of recovery. As such he did not accept the more optimistic view of the Defendant's psychiatrist.
In my experience of such cases there are often difficulties in presenting a coherent and consistent set of expert reports. Orthopaedic surgeons, for example, may be sceptical about continuing symptoms, psychiatrists may differ about diagnosis and pain management experts might take a third view!

This initially minor physical injury resulted in an award of about £690,000 (after the 10% reduction).

Thanks to Lee Jenkins for alerting me to this case