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4th May 2004

PROFESSOR  SIR  LIAM  DONALDSON

CHIEF MEDICAL OFFICER

MAKING AMENDS: A CONSULTATION PAPER SETTING  OUT PROPOSALS FOR REFORMING CLINICAL NEGLIGENCE IN THE NATIONAL HEALTH SERVICE

RESPONSE

SUBMITTED ON BEHALF OF THE IATROGENIC PATIENT

BY


SUFFERERS OF IATROGENIC NEGLECT



Gillian M Bean & Margaret MacRae
Co-Directors & Founder Members SIN
© October 2003
Submitted to Department of Health  October 2003
e-mail:sinfo@boltblue.com  &  mags@sinfo.freeserve.co.uk
www.sin-medicalmistakes.org


 

SUFFERERS of IATROGENIC NEGLECT
SIN is concerned about iatrogenic suffering which relates to disorders, symptoms etc. caused inappropriately by any clinician through his/ her diagnosis, manner or treatment. © Nov. 1998

Making Amends: A consultation paper setting out proposals for reforming clinical negligence in the NHS by Chief Medical Officer, Prof. Sir Liam Donaldson

SIN’s response to consultation document:

For over four years the voluntary  organisation ‘Sufferers of Iatrogenic Neglect' has been actively campaigning for a Victim’s Compensation Fund for all those innocent patients who have suffered iatrogenic damage through no fault of their own. SIN believes that such a Fund would be a more humane way of dealing with the results of serious Adverse Medical Incidents and would lead to a reduction in the huge national medico-legal bill. SIN is delighted that a Victim’s Compensation Fund is now actively under consideration and congratulates the Chief Medical Officer for initiating discussion on this innovative project. SIN is very pleased to submit its response to the above consultation document

 Annex A : NHS Redress Scheme: Questions for Consultation 

1.    What should be the qualifying criteria: the ‘Bolam’ test currently used in assessing clinical negligence or a broader definition of sub-standard care?

1.1   The Bolam test has been criticised and found seriously wanting, having allowed, over many years, poor medical standards to go unchallenged in the courts.

1.2   It seems contradictory to suggest on the one hand that ( see part 1) : "the Tort system of medical litigation looks towards blame, retribution and deterrent as its weapons”; and to say in the next breath that ( see part 2)  : “few neutral observers would try to argue that quality and safety of health care are improving because health care professionals are behaving more conscientiously  clinically as a result of having watched their colleagues being sued”. In other words the Tort system has failed miserably to bring justice to damaged patients or to reduce medical errors. In addition, “….the majority of cases are now settled out of court” which means there is no precedent set or judgement made, and little or no accountability.

1.3   To quote from Lord Woolf’s Inaugural Lecture 17th January 2001: “the courts can no longer rely on the hospitals and the medical profession to resolve patients’ justified complaints justly".  The Tort system of medical litigation never brought in blame( accountability), retribution or acted as a deterrent.   The fact of the of the matter is that Adverse Medical Incidents have reached an all time  high, for there  never has been any (blame) accountability, a major reason for this being that  the medical profession and their legal representatives have retained  control of the medical evidence, which would vindicate many  damaged patients. The now discredited Tort system of legal litigation that has dominated the British Courts for 5 decades, should cease to operate.

1.4   The Bolam Ruling was passed by  Judge McNair  during the case of Bolam v Friem Hospital 1957  reads as follows:

 “ The test is the standard of the ordinary skilled man exercising and professing to have that special skill. A man may not possess the highest skill at the risk of being found negligent. It is well established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art”.( Ref. Health care Law ‘ Texts & Materials’ Jean McHale & Marcia Fox with John Murphy 1997.

1.5   Judge McNair supplemented this ruling with the following statement: “… he is not guilty of negligence if he has acted in accordance with a practice as accepted as proper by a responsible body of medical men skilled in that particular art.” .

1.6   With the strength of allegiance operating within the medical profession, finding such a body of medical men to support the actions of the professional under scrutiny would not have been a problem, ever since the inception of the Bolam principle.

1.7    In Canada the Bolam test has been rejected and common sense prevails. Here the Law maintains that a body of medical opinion must be logically sustainable. Coyne J’s remarks in Anderson v. Chasney in the Supreme Canadian Court explains the necessity for this approach. Otherwise, if any body of medical opinion were to be accepted without scrutiny, health professionals “….could legislate themselves out of liability for negligence to the public by adopting or continuing what was obviously a negligent practice". Furthermore, Lord Woolf points out in his Inaugural lecture on 17th January 2001, that the Canadian Courts: “have also recognised that there are questions related to medical practice which naturally fall within the comprehension of a layman”. Also Lord Browne-Wilkinson inferred that ….”in rare cases it would be negligent to act in accordance with professional opinion which is not capable of withstanding logical analysis…”

1.8   It comes as no surprise to read ( see Part 7):”... many legal commentators have argued that the Tort system is still the best framework in dealing with medical injury” , when on consideration the medico – legal fraternity will be the only guaranteed beneficiaries if the discredited and artificial adversarial Tort System continues to operate. It is all very well to claim that a victim or their family have a fundamental right of recourse to law in practise, though, extremely few, for a variety of reasons (extortionate costs; missing critical records; difficulty of finding a medical expert to speak out against colleagues), are able to exercise this so called “fundamental human right”. SIN outlined the deep seated problems of the Tort system in ites Paper 2  "The Patient’s Voice for Equity” submitted to the Bristol Inquiry in June 2000.  Lord Woolf in his Inaugural lecture on 17th January 2001 concurred with many of SIN’s comments in his examination of  the deeply flawed British medical legal process. In SIN’s Paper 3 ‘Balancing the Scales’ : A Case for  Victim’s Compensation Fund”,submitted to the Department of Health in March 2001, the problems of the present systems available to iatrogenic patients for resolving issues of iatrogenic damage were discussed. It became obvious that the NHS system as a whole was unable to cope with AMIs in an honest  (transparent ) and open manner for there was no mechanism that allows full disclosure of a serious AMI to the patient, nor can the patient be involved in the causal analysis.

1.9    We doubt that a form of no-fault compensation would usher in a scheme that would be far more expensive for the NHS than the present one. If the legal costs on both sides were drastically reduced or eliminated, and the savings allocated to where they rightly belong, i.e. to the damaged victims, surely this funding alone would reduce overall costs, and even if the costs remained the same at least it would be far more equitable for the victims? We agree whole heartedly with part 8:  "…… that tort sits uncomfortably in an NHS with an ethos of equity and a wish to bring the greatest good to the greatest numbers”. We agree that recourse to the tort system should be last option.

1.10   The seriously flawed Bolam Test has been demonstrated as capable of thwarting natural justice for victims of sub-standard health care for almost half a century and should go.

2.    What would be the preferred formulation?

2.1   A broader definition of sub-standard care should be adopted. The test should be whether a patient has suffered serious harm irrespective of the cause.

2.2   .From figures extrapolated from Prof. Charles Vincent’s examination of 1000 medical records( March 2000) it was estimated that  34,000 needless deaths occurred and approximately 46,000 patients were seriously and permanently damaged  in UK hospitals every year due to medical errors. It would appear that, Prof. Vincent had no problem in identifying that Adverse Medical Incidents had occurred from the records he studied, the logical inference to draw from this is that the AMIs were recorded by the Trusts and were witnessed by the health professionals participating in those particular care episodes. Adverse Medical Incidents (AMIs) have been recorded for many years by the Trusts’  Risk Assessment Department, and each serious incident is graded, therefore, the NHS is usually fully aware when something has gone seriously wrong with an individual patient’s care, the problem has been that the patient or their relatives have been denied this information.

2.3   We suggest that since the health professional and the Trusts were fully ware of incidents of serious medical errors causing damage, who better to write an assessment of damage, and a remedial care plan  ?

2.4   In the light of this, we suggest there should be a statutory requirement for the patient or relative to be informed should any iatrogenic damage be sustained. The details of the AMI must be admitted and full information given to the patient, for every patient has a right to the truth about their medical condition. Obviously, without this information the patient will have no grounds for claiming under NHS Redress Scheme. The patients’ perspective of the consequences must be given serious consideration with those staff operating the Redress Scheme and be part of the ‘root cause analysis’, otherwise the causal analysis will be less than thorough. Failure to provide eligible claimants with this information at the outset should incur stiff penalties for responsible parties. The withholding of critical information has clearly thwarted natural justice for victims of sub-standard health care.

2.5   The above suggestions would ensure that Truth, Logic and Equity underpin the qualifying criteria of a claim for Redress. The definition of sub-standard care should withstand logical scrutiny.

3.    Should there be a minimum qualifying level in terms of the extent of the disability e.g. in terms of days off work or in hospital or in terms of the levels of disability?

3.1   Yes.  Perhaps a minimum  qualifying level of disability could be assessed in terms of  the permanency of the disability / the impact on the day to day quality of life and the degree / length of time before the victim is able to return to his/her normal economic activity/ and the effect on prognosis.


4.    Should  there be an upper financial limit to the cases to be dealt with under the scheme? If so, is £30,000 the right starting point?

4.1   No! The Redress Scheme should have discretionary powers available to increase the financial limit providing the financial loss to the victim justifies this. If the capping remains low, then it would be obligatory for the seriously damaged and most vulnerable patients to be advised to go to mediation which would in itself  incur further unnecessary expense and time. Otherwise the only alternative would be the discredited and extortionately expensive  old system of  ‘courts and torts’..


5.    Should the financial limit for the scheme apply to the whole package of care and cash or the cash element only?
 
5.1   It should only apply to the cash payment, for any subsequent care that is needed should be given automatically, considering the iatrogenic victim finds themselves in this position through no fault of their own. However,  there should be a clearly set out remedial care plan which up to now iatrogenic patients have been unable to access, because they are perceived as being potential litigants, and many damaged patients are being left in trauma and at risk, for to give remedial care would be to acknowledge that iatrogenic damage has been sustained. To quote  from Lord Woolf’s Inaugural lecture,. January 17th 2001: “…. the Health Service was not giving sufficient priority to avoiding medical mishaps and treating patients justly when mishaps occur. They needed to recognise that because patients felt that they had been a victim of medical malpractice, this did not justify withdrawing treatment. [It meant that those who had the responsibility for treating the patient were under a particular duty to achieve the best result possible for the patient".] ([...] added after paper was submitted to D.o.H..)”

6.    Should consideration be given to including primary care from the outset?

6.1   Yes. Particularly as many very serious AMIs occur in primary care.


7 Should patients/ claimants be entitled to funding for legal advice to assess the fairness for the Redress package? If so, what limit should be set on the amount of funding
available?

7.1    If truth and equity prevails on behalf of the NHS hospital and Primary Care Trusts, then the patient would not, in theory, require such advice. The truth, apology, assurance of genuine specialist care and reasonable compensation, is much more attractive than the present system if ‘denial and cover-up’; trauma; no specialist care; and the virtual impossibility of obtaining any financial compensation. However, it might be necessary to set up an independent advisory unit.

8    Will making it easier to obtain a package of care and support plus modest financial compensation reduce or increase the number of people making applications to the Scheme? Why? Could this be mitigated?

8.1   The qualifying minimum level of disability for the Redress Scheme should control the numbers making genuine applications and added to this, if lessons are learned from the causal analysis of AMIs, the number of AMIs should decrease over time and so should the number of applications to the Redress System. Perhaps, only the very serious AMIs should be allowed to go to the Redress Scheme, (increasing the financial capping) and the smaller  degrees of harm to go  through the NHS Complaints System or the small claim courts. Bearing in mind that the Trusts will be well able to grade the harm that had been sustained.
 
9.   SIN will not be commenting on the section referring to babies who are severely neurologically impaired because of our lack of experience in this area of medical error.

10.      NHS Litigation Authority:
It is proposed that the new body established to oversee the NHS Redress Scheme should be modelled on or developed from the existing NHS Litigation Authority?

 10.1   There should be a legal requirement on the part of the Hospital and Primary care Trusts  not only to  inform the patient of the damage sustained,  but also the new NHS Litigation Authority dealing with the Redress Scheme as to the seriousness of the AMI and its consequences.  To avoid any conflict of interest there should be retraining of all NHS staff to reflect the change in the culture from one of ‘denial and cover-up’ to one of ‘openness and transparency’.  The administrators should be reminded that they are dealing with victims and not villains. The necessity of retraining  staff also applies to all the new Agencies set up recently by the government to increase patient safety.

10.2   Should this body be a Special Health Authority? or  A non-Departmental Public Body?
           No comment


Repeal of Section 2(4) of the Law reform ( Personal Injury) Act 1948
11.If an NHS cost basis is used to calculate damages for future care costs, should the NHS be required to provide guarantees for this treatment? How might it do this? Would a system of independent case managers be required?

11.1   The NHS should be required to guarantee future treatment. What is the alternative? That patients go without necessary care? They are British citizens who have paid taxes and are entitled to genuine on-going remedial care. Any health professional failing to fulfil their obligations to the patient under the terms of the care package should face stiff disciplinary action. If the NHS is unable to provide remedial care and if this care is only available in the private sector or abroad, then the NHS would have a moral obligation to fund the care package. Each iatrogenic patient should be assigned an individual case manager to whom they can refer if difficulties arise. We agree that the iatrogenic patient should not have to obtain remedial care at the Trust where the damage or denial of care had taken place.

Mediation:
12
. Are there additional ways of encouraging greater use of mediation and other alternative dispute resolution procedures?

12.1   How many people know about the option of ‘mediation’ at present? No organisation, including AVMA has actively promoted Mediation as a form of dispute resolution , as far as we are aware. In the event of an AMI the victim or their relatives should be provided with a pamphlet that outlines the advantages of Mediation and whether their particular circumstances were suitable for resolution. Details of other alternative dispute resolutions procedures could also be included in the information leaflet.

Legal Costs
12. Are there any further steps that could be taken to control legal costs in clinical cases?

12.1    If the victims get the truth about the AMI at the outset then, in the majority of cases, this will eliminate the need to resort to legal action for this purpose.

12.2    The introduction of a Victim’s Compensation Fund ( see SIN’s ‘Aims & Objectives July 1999) will greatly reduce legal fees.

12.3    All health professionals and, indeed, anyone who is aware that a medical error or near miss has taken place, will have a statutory obligation to report the matter to the Risk Management Team of the Trusts as soon as possible. It should be deemed a criminal offence to turn ‘a blind eye’ when patients are knowingly being maimed and killed. It is difficult to comprehend how this position could be challenged ethically.

12.4    It should also be a statutory requirement for the patient or relative to be informed should any iatrogenic damage be sustained. This information to be transmitted by a health professional or someone allocated and trained to impart such information. SIN’s Paper 3 ‘Balancing the Scales: case for a Victim Compensation Fund’ March 2002 page 8 para 5.1. These two tenets would greatly relieve the necessity for complex and expensive legal action, and so reduce the NHS medico-legal costs.

 12.5    At present, the claimant entitled to Legal Aid to finance a medical legal action is unable to scrutinise the bill submitted to the Legal Services Commission by their legal representatives. This, in actuality, is a blank cheque. SIN suggests that lawyers in future should be obliged to supply the claimant with a detailed breakdown of the costs for services rendered. This would enable the client to challenge any dubious claims for recompense in their name, and no bill should be submitted without the clients verifying the details with a signature. It is incredulous that this state of affairs, which is wide open to abuse, has been allowed to continue for so long. Since the Legal Aid uses public money – all the lawyers’ bills should be made available for public scrutiny.

 12.6     Patients should be made aware that they have a legal right to their medical records and they do not need to engage a solicitor to obtain them. This would reduce legal fees. Solicitors charge large amounts of money to obtain the records, and in spite of this, fail to secure  complete sets, so that critical statements or test results are missing. The experience of one member was that in spite of having obtained a complete set of medical records, the new solicitor insisted on going through the process again at a cost of several hundred pounds. He never allowed the client to check the records to verify that they were complete and accurate, or to establish whether any new ones had been added: a total waste of public money. Without the client’s knowledge he engaged an expert witness to look at a selection of medical records made by himself without any consultation with the client and unverified by his client. Based on this the medical expert witness dismissed the claim, even though he had never seen the patient who alleged to be iatrogenically damaged. The Legal Aid Certificate was dismissed.

12.7    Patients must have a statutory right to a complete set of medical records and test results, with no critical documents missing. There must be a legal obligation on the part of the Trusts to release all the medical records including evidence of the iatrogenic damage. This will again reduce legal costs.

12.8   Patients should have a right to obtain copies of medical records immediately after every consultation should they wish. These records to be checked and signed by the patient. This right should include, if the patient wishes, copies of any x-ray, scan., test result etc. A small fee may be incurred for this. This will prevent propagation of misinformation, the ‘loss’ of critical documents and will prevent any retrospective changing of documents. Again, this would reduce time spent on legal wrangling and so save money.  see SIN’s ‘Aims & Objectives’ July 1999)

12.9     A higher level of capping for financial recompense and discretionary awards under the Redress Scheme would reduce the need for seriously damaged patients to go to law and so save on legal fees. Patients to be made aware of the possibility of mediation as a positive alternative to legal action.

12.10      Reduce the extortionate costs that lawyers charge, some charge up to £300 and hour and there is often a 50% ‘uplift’ for difficult cases, and medical negligence cases are invariably classed as ‘complex & difficult’ . 

12.11   Investigation into the standards of medico-legal lawyers and their medical expert witnesses.

GM Bean & M. MacRae Co-Directors of SIN         © October 2003
Gillian M Bean B.Sc. & Margaret MacRae
 GM Bean:Tel/Fax: 0115 9431 320
M. MacRae:   Tel/Fax: 0192 4407 195
 Emails: sinfo@boltblue.com   &   mags@sinfo.freeserve.co.uk