Tuesday, 26 June 2012

Life Expectancy after Delay in Diagnosing Cancer - Part Two

In Part One I set out how the decision in Gregg-v-Scott directed litigators away from using chances of five or ten year survival as a means of assessing the impact of a negligent delay in diagnosing cancer, and towards the use of median life expectancy.

The median of a group is not the same as its mean. The mean life expectancy of a group of women with breast cancer is the average of their total expected life spans. The median life expectancy (MLE) is the age which each is likely to reach but beyond which they are not likely to live. The way I think of it is that the 50th person in the line of 100, ordered according to life expectancy, is the median.

In a case of negligent delay in diagnosing cancer we need the MLE following actual diagnosis and the MLE had earlier diagnosis been made. Each will depend on the features of the cancer at the relevant time, the treatment which would have been offered and which the claimant would have elected to undergo and, perhaps, other factors such as age. Let's disregard the impact of co-morbidities for the purposes of this blog, but factors such as smoking history, diabetes or hypertension might well be relevant. Once you have MLE for each date then you can calculate the reduction in life expectancy due to the delay (not forgetting to take into account the years that have passed during the delay).

I have been extolling the benefits of MLE for some time now. It was therefore pleasing to hear Professor Gordon Wishart, Breast Surgeon, speak at the annual AvMA conference in Brighton this month (June 2012). He said that for the purposes of litigation, life expectancy should be looked at in term of numbers of years rather than chances of survival. He has helped develop the PREDICT model which can be used to predict life expectancy following breast cancer. I have conducted many breast cancer cases where there has been a dispute about whether the Nottingham Prognostic Index or Adjuvant-on-Line gave the more accurate prognosis. PREDICT is a recent development which may become the favoured prognostic model amongst experts - time will tell. It has the advantage over AoL in being based on data of British women treated here, and certainly takes account of all modern treatment options.  It can also be used to give MLE.

With MLE the Court can quantify future claims, knowing (on the balance of probabilities) over what period such future claims should be made. Claims such as earnings in the lost years can be assessed and, if the claim is under the  Fatal Accidents Act, the Court will have evidence of how long the deceased would have been likely to live without the negligent delay in diagnosis.

However, whilst there is a huge amount of data in relation to survival following breast cancer, there maybe insufficient data to allow for calculations of MLE in relation to less common cancers. Further, it is not clear whether the data is sufficiently robust to allow calculation of MLE beyond say 15 or 20 years. In several cases which I have conducted, expert evidence from a medical statistician has been utilised to assist in calculating MLE. I would be interested to learn of others' experience in these often difficult cases.

One general difficulty with the use of statistical evidence of life expectancy is that with every day that passes, the claimant has lived a day longer. Good news for the claimant of course, but sometimes patients "buck" the statistics. You may even have a claimant who, by the date of trial, has already lived longer than expected. What is his or her life expectancy then? On the other hand there may be claimants who die earlier than expected. Is it correct to assume that with earlier diagnosis they would also have died earlier than their MLE would suggest? Or is their premature death following actual diagnosis irrelevant to the prediction of their likely age at death following timely diagnosis? To what extent does a finding of metastatic spread after actual diagnosis affect the calculation of MLE following timely diagnosis? No easy answers but I hope to have sparked a few thoughts and ideas. Please share them.

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Thursday, 21 June 2012

Life Expectancy after Delay in Diagnosing Cancer - Part One

PART ONE
Negligent delay in diagnosing cancer may well cause injury by way of prolonged or more painful symptoms, the need for more intensive or invasive treatment or psychiatric consequences. However, whether or not these other injuries result from the delay, a primary concern for the patient/claimant will be the impact on their life expectancy.

When addressing prognosis, oncologists tend to refer to the percentage chances of survival over a certain number of years. They might advise that, say, 70% of women with breast cancer of a particular stage will survive for at least 5 years. This information is of little use to litigators. We need to know how long a person is likely to live and/or how long they would have been likely to live but for the negligent delay. With that information we can draft schedules and assess damages.

The perils of relying on the oncologists' approach to prognosis were illustrated in the well known House of Lords decision in Gregg-v-Scott. The claimant had a non-Hodgkin's lymphoma wrongly thought to be a harmless lump by his GP some nine months before the proper diagnosis was made. The evidence on which the courts had to give judgment was that his chances of ten year disease free survival had fallen from 42% to 25% as a result of the delay. The HL held that a reduction in the chance of survival did not entitle the claimant to damages.

Gregg-v-Scott is not authority for the proposition that a reduction in life expectancy cannot sound in damages. Nor does it follow that to recover damages the chances of survival for a certain number of years must fall from above 50% to below 50% because of the negligent delay. If that were the requirement then the statistics could be manipulated to produce that result: for example suppose Mr Gregg's chances of five year survival were 60% without delay and 40% with the delay. Would it follow that he should have recovered damages? And if so, what level of damages?

The difficulty for Mr Gregg was that at an earlier stage in the litigation the evidence seemed to establish that without the delay he would probably have survived ten years ("a cure" to the oncologists). It was pleaded on his behalf that he would have been cured but for the delay. However by the time their Lordships considered the case the evidence had changed such that Mr Gregg would probably not have survived ten years even without the delay in diagnosis. He therefore resorted to arguing that he had a reduced chance of a cure. That was the claim that failed.

It would have been possible to put a claim for damages for the effect of the negligent delay on his prognosis in a wholly different way:
Baroness Hale held:
"There is also the distinct possibility that the delay reduced his life expectancy in the following sense. It is possible that had he been treated when he should have been treated, his median life expectancy then would have been x years, whereas given the delay in treatment his median life expectancy from then is x minus y. This argument requires that the assessment of loss of life expectancy be based on median survival rates: ie those to be expected of half the relevant population at the particular time. If half the men with Mr Gregg's condition would have survived for x years or over with prompt treatment, and half would have survived for less than x years, then x is the median life expectancy of the group. If the same calculation of life expectancy from when he should have been treated is done in the light of the delay in treatment, the median life expectancy may have fallen. There might therefore be a modest claim in respect of the 'lost years'. "

Thus the House of Lords pointed the way forward in these difficult cases. I shall address the use of Median Life Expectancy in claims for delay in diagnosing cancer in Part Two (to follow).

You can visit my profile on the Kings Chambers website

Monday, 18 June 2012

Inquests After Rabone

Coroners' Inquests - The Implications of Rabone-v-Pennine Care NHS Trust


There is litle doubt that the Supreme Court's decision in Rabone-v-Pennine Care NHS Trust will have a signficant impact on the Coronial workload. 

Previously the decisions  of the Court of Appeal in Rabone and in R(Takoushis)-v-Inner North London Coroner were relied upon to rule out Article 2 or "enhanced" inquests into the deaths by suicide of psychiatric patients who had not been detained under the Mental Health Act.

The Supreme Court ruled that an article 2 operational obligation may be owed to a patient who was not detained. So now, arguably, article 2 or "enhanced" inquests ought to be held where there are grounds to suspect that the state or state agents have failed to take reasonable steps which might have been expected to protect the lives of any psychiatric patient - detained or not detained - who was known or ought to have been known to be at a real and immediate risk of suicide.

A risk will be found to have been "real", according to Lord Dyson, where it is "substantial or signficant and not a remote or fanciful one." - paragraph 38. It is "immediate" if it is "present and continuing" at the relevant time.

It is no defence for a public authority to contend that it did not know of such a risk of suicide if it ought to have done so. As Lord Bingham said in Van Colle: "stupidity, lack of imagination and inertia do not afford an excuse to a national authority which reasonably ought, in the light of what it knew or was told, to make further enquiries or investigations: it is then to be treated as knowing what such further enquiries or investigations would have elicited."

There is no requirement to show that the steps which could and should have been taken would, on the balance of probabilities, prevented the death.

The substantive article 2 obligation to protect life has two components - the general or system obligation and the operational obligation - see the judgment of Lord Rodger in Savage. An arguable breach of either should suffice for the investigatory obligation to arise. The investigatory obligation is on the state but is most commonly met in England and Wales, through the Coronial system. To satisfy the investigatory obligation an article 2 inquest ought ordinarily to culminate in "an expression of the conclusion on the disputed factual issues at the heart of the case." - Lord Bingham in Middleton. A conclusion such as : "The deceased took his own life, in part because the risk of his doing so was not recognised and appropriate precautions were not taken to prevent him doing so" did not, thought Lord Bingham, offend rules 36(2) or 42 of the Coroners Rules.

Does the scope of the operational obligation under article 2 extend beyond psychiatric patients at risk of suicide? Lord Dyson's view was that the "the jurisprudence of the operational duty is young,. Its boundaries are still being explored by the ECtHR ... but it seems to me that the court has been tending to expand the categories of circumstances in which the operational duty will be found to exist." Thus the limits of the scope will be tested in future cases involving DOLS patients, patients in treated in the community, patients at risk of death at the hands of others or due to their mental or physical incapacity.







Thursday, 14 June 2012

Delay in Diagnosing Prostate Cancer

Having conducted several cases arising out of delay in diagnosing prostate cancer, I thought I would outline some of the key issues which have arisen.

The NICE Guidelines for referral for suspected cancer (2005) indicate that urgent referral (two weeks) should follow if the patient has a normal prostate on digital rectal examination but the age-specific PSA is raised or rising, whether or not the patient has lower urinary tract symptoms. For patients whose clinical state is compromised by other co-morbidities, a discussion may be more appropriate. The age-specific cut-off PSA measurements set out in the guidelines are:
50-59 years of age:          3.0 ng/ml or above
60 -69:                             4.0 ng/ml or above
70 and over:                     5.0 ng/ml or above (but no age-specific reference ranges for men over 80).

There are other circumstances under which urgent or non-urgent referral should follow which are set out in the Guidelines (and the predecessor Department of Health Guidelines).
In Adhsead-v-Tottle 25/10/2007 (QBD) (unreported other than on Lawtel) Mr Justice Gray held that when referral guidelines had clearly indicated urgent referral for a patient with suspected breast cancer:


"The guidelines are not prescriptive but it appears to me that in circumstnaces such as obtained here, a failure on the part of a general practitioner to follow guidelinse such as these is at least prima facie evidence of negligence on his or her part."

"In the case of a patient who presents with a potentially life-threatening symptom, I do not accept that a responsible general practitioner would delay referring her, even for a short period, in circumstances where the recommendation made unambiguously in the guidelines is to refer immediately."

The Guidelines do not have the force of law but if a GP fails to refer a man with a PSA over the age-specific cut-off then, absent a good explanation for the failure to refer urgently, a finding of negligence would, I suggest, be likely. If the decision is to repeat the test in three months, it is incumbent on the GP making that decision to ensure the repeat test is performed.

In relation to causation an expert is likely to advise that the key issue is whether the tumour would have been organ-confined at the date when referral/diagnosis ought to have been made. The grade of the cancer - measured by the Gleason score - is unlikely to change significantly or at all during the period of delay. In some cases, perhaps depending on the Gleason score, some experts will rely on tumour velocity or doubling time to assist giving a prognosis. They will rely on studies by D'Amico and others.

Issues concerning life expectancy and damages for the "dying Claimant" are for future posts.

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Tuesday, 12 June 2012

Rabone - Claiming Damages under the Human Rights Act

This is my first post on this blog so no apologies for writing about my own case: Rabone-v-Pennine Care NHS Trust [2012] UKSC 2, [2012] Med LR 212.

The judgement paves the way for certain bereaved claimants to make claims for damages under the Human Rights Act when previously they had no remedy. In his commentary on the case in the Medical Law Reports, James Watson Q.C. wrote:

"The outcome of this case was, in the eyes of many, one small step for human rights and one giant leap for the humanity of our compensatory system."

Mr and Mrs Rabone's daughter, Melanie, committed suicide having been wrongly allowed home leave from the defendant's psychiatric unit where she had been receiving care for severe depression. Melanie was over 18 and her parents had no entitlement to damages under the Fatal Accidents Act. A claim was brought and settled on behalf of her estate for her pre-death pain and suffering and for funeral expenses. The Supreme Court held that Melanie's parents were entitled to compensation in their own right under the HRA: the "operational obligation" under Article 2 of the Convention may be contravened by a public authority even though the deceased had not been detained and payment of compensation to the estate did not by itself deprive the parents of a remedy under the HRA.

Where a person has died as a result of a contravention by a public authority of article 2 of the European Convention on Human Rights, then their close relatives may be entitled to damages under the HRA. The following will have to be established for the claim to succeed:

  1. The public authority had assumed responsibility for the individual ("the deceased"), and/or the deceased was particularly vulnerable and/or the public authority had created or permitted an exceptional danger.
  2. The public authority (and those acting on its behalf) knew or ought to have known of a real and immediate risk of the deceased dying.
  3. The public authority failed to take steps which, judged reasonably, might have been expected to have protected the deceased's life.
  4. The claimants have not otherwise received effective redress and/or the public authority has not otherwise acknowledged, expressly or in substance, the contravention.

The Courts will interpret the scope of the operational obligation so as not to impose an impossible or disproportionate burden on the public authorities.The death of a patient from a physical condition after negligent treatment will not, without more, trigger article 2 (Powell-v-UK).

The Court of Appeal's assessment of damages of £5,000 for each parent was not appealled. Lord Dyson in the SC indicated that if it had been then a higher award would have been made. Lawtel has already reported one settlement where Rabone was relied upon to recover compensation where there would have been no entitlement to recovery under the FAA.