In Law

Medico-Legal Warning

Neither RAGE as an entity, nor the Members’ of RAGE, are medically or legally qualified to offer advice.All of the information and opinions appearing on this website are entirely a reflection of our own experiences of radiation induced injuries.Patients with similar radiation induced injuries should not engage in any of the prospective medical or legal interventions, described in this website, without the complete prior knowledge and support of their clinicians or lawyers.

English Law concerning the use of Radiotherapy

Too much radiation is still too much radiation, if you are not mindful of the basic laws of physics.The use of radiation therapy is a serious business.

No matter how safe the use of radiation has been made by various regulations and legal requirements, clinicians can still deliver an excessive dose of radiation to a patient if they do not pay attention to the basic concept of the time-and-dose relationship.

doi:10.1053/clon.2001.9221

Statute and Case Law

As with many other legal jurisdictions the English Legal System is governed by Statute and practiced in accordance with precedents established in Case Law.


English Statutes - on Radiotherapy

The English Statutes which have governed Radiotherapy in the United Kingdom are:

            1. Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988 (POPUMET)

            2. The Ionising Radiation (Medical Exposure) Regulations 2000, (IR(ME)R 2000)

Department of Health

Medical Exposures – The Regulatory Background

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/329842/Medical_exposures.pdf

The Ionising Radiation (Medical Exposure) Regulations 2000, (IR(ME)R 2000), came into force on 13 May 2000 POPUMET

These regulations replaced the Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988 (POPUMET) which have been repealed.

These two statutes, while establishing protection for the operators of radiation diagnostic and treatment machines, offer very limited protection for the patient.

These two statutes established the “ALARA Principle” - the use of a dose of diagnostic or therapeutic radiation which is “as low as reasonably acceptable”.

The Statutes do not stipulate the size of that “acceptable” fraction - or by whom it would be considered to be acceptable.

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English Case Law - on Radiotherapy

The case law which tentatively established the parameters for radiotherapy treatment of breast cancer within the UK was initiated by RAGE as a result of encouragement and guidance from the Department of Health

The Breast Radiation Injury Litigation*

*Robb v. East London and City Health Authority and Unitt v. Bristol and District Health Authority.

In 1998 RAGE, after discussions with the Department of Health, entered into litigation to establish claims for injury as a result of radiotherapy treatment for Breast Cancer.

This became known as: The Breast Radiation Injury Litigation

Otherwise known as: Robb v. East London and City Health Authority and Unitt v. Bristol and District Health Authority.


From Hansard Reports:

Breast Cancer: Actions for Damages - Hansard Reports

http://www.publications.parliament.uk/pa/ld199899/ldhansrd/vo990524/text/90524w01.htm

Lord Ironside asked Her Majesty's Government: Whether all the High Court proceedings involving plaintiffs in the Legal Board's multi-party action seeking compensation for injuries caused by radiotherapy treatment for breast cancer have now been completed; and

(a) Which cases were withdrawn;
(b) Which cases were settled either in court or out of it and what sums were settled; and
(c) What judgments were handed down.[HL2423]

The Lord Chancellor: On 17 November 1997, the group plaintiffs (then 109 in number) submitted to judgment against them on the principal issues.

Two cases (Robb v. East London and City Health Authority and Unitt v. Bristol and District Health Authority) were tried as separate actions.

Judgment was given for the defendants on 8 May 1998.

Eighty of the underlying cases were then discontinued as a result of the judge's findings.

Ten cases were settled. These were:

  1. Smallwood v. East London and City Health Authority,

  2. Eels v. Barking, Havering and Brentwood Health Authority;

  3. Wainman v. Barking, Havering and Brentwood Health Authority;

  4. Ford v. Barking, Havering and Brentwood Health Authority;

  5. Virdi v. Barking, Havering and Brentwood Health Authority;

  6. McClure v. East Kent HA;

  7. Crawford v. Dalley;

  8. Bushby v. Cambridge HA;

  9. Elliott v. Dr. Xaavier;

  10. Haxton v. North East Essex HA.

The sums awarded were confidential between the parties and were, for that reason, not disclosed in open court.

Further medical examinations and negotiations took place in the remaining cases: this resulted in discontinuance or withdrawal of the remaining cases.

Four cases are currently outstanding for trial. It is anticipated that they will be tried in the Autumn term of 1999.

Lord Ironside asked Her Majesty's Government: What are the total costs incurred to date by the firm of solicitors acting for the plaintiffs, under contract to the Legal Aid Board, seeking compensation for injuries caused by radiotherapy treatment for breast cancer; and whether these are the final costs.[HL2424]

24 May 1999 : Column WA67

The Lord Chancellor: The total paid on account to date, to all solicitors including the firm acting for the claimants under a contract to the Legal Aid Board, is £2.9 million.

I am not in a position at present to give details of the costs paid specifically to the firm of solicitors acting under contract with the Legal Aid Board as their claims have yet to be assessed by the court. A final detailed assessment was adjourned by the court until June 1999, in order to allow the costs of private clients to be assessed at the same time.

http://www.publications.parliament.uk/pa/ld199899/ldhansrd/vo990524/text/90524w01.htm


The outcome was unsatisfactory for a number of reasons;

  1. Mrs Robb and Mrs Unitt Lost

  2. RAGE lost

  3. The claims of 320 patients were not permitted to be examined on a case by case basis.

  4. The judgement was a Bolam Judgement [reasonable, respectable, responsible bodies of medical opinion].

  5. The judgement was not a Bolitho Judgement [whether such opinion is susceptible to logical analysis].

  6. Very limited case law was established.

Millington, Jan (09/1999) : Breast Cancer Radiation Claims

Rhodes-Kemp, Rosamund: solicitor, Russell Jones and Walker : Breast Radiation Injury Claims


The breast radiation injury litigation and the clinical oncologist.

http://www.ncbi.nlm.nih.gov/m/pubmed/9890537/?i=2&from=/10645205/related

Authors
Dische S, Joslin CA, Miller S, Bell NL, Holmes JC.

Author information
Journal Clin Oncol (R Coll Radiol). 1998;10(6):367-71.

Affiliation

Comment in

Abstract

A number of women with breast cancer believed they were suffering injury because radiotherapy had been given negligently.

In March 1995, their solicitors were permitted by the High Court, to select 10 cases in order to further a group action. In the legal exchanges which followed, the principal issues put forward by the plaintiffs went through a number of modifications until finally, in December 1997, they were abandoned.

Two cases came to trial and after a hearing of 21 days, the Judge found no negligence. Clinical oncologists should be aware of the course of the litigation and consider the lessons to be learned.

PMID9890537 [PubMed - indexed for MEDLINE]

Related citations

The RAGE litigation. Radiation Action Group Exposure.

Dische S, et al. Lancet. 1998


An acceptable risk or negligence? The dilemma of the modern clinical oncologists in the UK in the era of clinical governance.

Clin Oncol (R Coll Radiol). 1998.


Breast radiation injury litigation and RAGE. Radiotherapy Action Group Exposure.

Clin Oncol (R Coll Radiol). 1999.


Breast cancer radiotherapy litigation and the clinical oncologist.

Clin Oncol (R Coll Radiol). 1999.


A systematic overview of radiation therapy effects in breast cancer.

Acta Oncol. 2003. Review article


Adjuvant therapy for breast cancer.

NIH Consens Statement. 2000. Review article


Lessons from the Breast Radiation Litigation

Søren M. Bentzen and Stanley Dische

In England, in 1991, a group of women who had experienced problems after radiotherapy given in the management of breast cancer, formed an organization called RAGE (Radiation Action Group Exposure) (65).

Consequently, in December 1994, a law firm reported that they had heard from 1600 women who claimed to have suffered severe injury as a result of radiotherapy and that there were 131 documented cases (66).

In the Royal Court of Justice in March 1995, permission was granted for 10 cases to be considered so that they might demonstrate what was being put forward as the generic (common) issues.

A moratorium was placed on the processing of the remaining 121 cases. If generic issues were established, then the remaining cases would be resolved by a process which would then be fairly swift.

Nine principal issues, including overall dose and dose per fraction, were brought forward and many experts were involved on both sides.

Legal exchanges took place and the generic issues went through several amendments.

Finally, the generic case collapsed and in November 1997, Mrs Justice Ebsworth passed judgement in favour of the Defence, and awarded costs.

The defence, however, did acknowledge failures in 3 of the 10 cases and settlements were made in each case.

Two of the cases did in fact go to a trial, which lasted nearly four weeks.

A very detailed examination of radiotherapy, radiobiology and morbidity was completed by the Court.

The Judge found that the treatment, given to both (in 1980), had not been negligent.

Subsequently, all the remaining 121 cases have been reviewed out of court.

There was considerable variation in the way in which the patients had been treated, the date of their care and type of radiation damage.

So far, in 13 of all the 131 cases, the Defence has agreed that there had been a failure in care and settlements ranging from £30000 to £465000 have been made. The dominant causes were considered to have been:

  • For the year of treatment, inadequate technique leading to a higher than acceptable risk of injury (3 cases).

  • Re-irradiation without satisfactory evidence of recurrence (2 cases).

  • An unacceptable dose fractionation regime for the year of treatment (1 case).

  • Re-treatment with an unacceptable dose fractionation regimen (1 case).

  • Deviation from the planned dose fractionation regimen originally prescribed (1 case).

  • Radiotherapy to a fully dissected axilla without any indication (in 1990) (1 case).

  • Radiotherapy given without proof of malignancy (1 case).

Seven cases remain under negotiation and a further 104 have been abandoned. It is likely that when all the proceedings are completed, the legal costs will have amounted to over 5 million pounds, while the total settlement is unlikely to exceed 2 million pounds.

In the treatment of patients with early breast cancer, the risk of severe morbidity must be kept to a very low level, perhaps less than 0.1%.

In the past, in some centres in the UK, risk levels may have reached or exceeded 1%. It should be noted, however, that during the 30-year period in question, more than 100000 patients will have undergone radiotherapy for early breast cancer and the numbers of cases must be seen in this perspective.

Furthermore, in a number of cases, investigation showed no evidence of serious radiation damage.

It was extremely difficult in many cases to determine the exact cause of severe radiation damage, but three factors probably contributed to the incidence of damage:

  1. 1 A dose per fraction exceeding 2 Gy was often employed and commonly 3 and 4 Gy fractions were used. This was considerably influenced by a great shortage of radiotherapy equipment and the need to manage an ever-increasing number of cases. Although the total doses were reduced, with our current knowledge, we now recognize that the total dose reduction may not have been adequate. Although the threshold for serious injury may not have been reached, there was a lower margin of safety.

  2. When supervoltage replaced orthovoltage, many of the existing techniques were adapted. Some, particularly those involving movement of the patient between the giving of individual treatment fields, proved less safe with supervoltage apparatus.

  3. The use of unequally loaded anterior and posterior fields to the axilla, particularly if the posterior field was not employed on each treatment day, led to greater biological effects in the anterior axilla at the site of the brachial plexus.

What is most important is that a combination of these factors most probably contributed to an incidence of radiation damage.

It is important that the lessons be learned and that all patients, especially those women with early breast cancer and a good prognosis, should receive the very highest standard of treatment so that they will have the greatest chance of benefit with the minimum risk of post-radiation injury.

Reference:

1. Acta Oncologica Vol. 39, No. 3, pp. 337–347, 2000

Morbidity Related to Axillary Irradiation in the Treatment of Breast Cancer

Søren M. Bentzen and Stanley Dische

Correspondence to: Professor Søren M. Bentzen, Gray Laboratory Cancer Research Trust and The Cancer Centre, PO Box 100, Mount Vernon Hospital, Northwood, Middlesex HA6 2JR, UK. Tel: _44 (0)1923 82 86 11

Subsequent to the completion of this Trial the Royal College of Radiologists (RCR) has published:

Royal College of Radiologists (RCR) – Dose Fractionation Survey

http://www.rcr.ac.uk/docs/oncology/pdf/Dose-Fractionation_Final.pdf

See:-

  • Fractionation in Radiotherapy a Brief History – SS. 3.1 - Pg. 10

  • Breast Cancer – SS. 4.3 - Pg.26

So how has the RCR responded to the comments of Sorensen and Dische?

“What is most important is that a combination of these factors most probably contributed to an incidence of radiation damage.

It is important that the lessons be learned and that all patients, especially those women with early breast cancer and a good prognosis, should receive the very highest standard of treatment so that they will have the greatest chance of benefit with the minimum risk of post-radiation injury”.

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The World’s First Radiation Litigation

Almost immediately after the announcement in 1895 of Wilhelm Roentgen’s discovery of the X-ray beam, a number of manufacturers began producing X-ray apparatuses designed to diagnose medical conditions.

Radiation-Induced Skin Injuries and Fluoroscopy

http://www.ajronline.org/content/177/1/21.full

Because the potential dangers of X-radiation were not well understood at that time and equipment used low-energy X-ray tubes without shielding, beam filtration, and coning, many patients sustained skin injuries as a result of undergoing diagnostic radiography.

Where there was medically induced injury, there was malpractice litigation.

In 1896, in what was apparently the first malpractice lawsuit in the United States to be brought for damages sustained by exposure to X rays, a Chicago labourer sued a physician who specialized in using this new diagnostic modality, claiming that an ulcerating burn of the skin on his ankle had developed as a result of radiologic studies.

The patient had fractured his ankle, and the radiographs that were obtained had necessitated exposure times of 35-40 min each. The skin injury eventually led to amputation, and the jury awarded the patient $10,000 in damages [$10,000,000 in the modern day]

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English Tort Law - Medical Negligence Cases

Among those who do bring cases, the chances of success are sometimes slim.

This is particularly the case in medical negligence, where the Bolam ruling has essentially meant that if doctors stick together, it is extremely difficult to prove them negligent.

How far this will eventually change in the light of Bolitho (see below) still remains to be seen; certainly the judgment in Bolitho leaves plenty of room to keep the old standard in all but exceptional cases.

There seems no compelling reason why medical negligence should be treated so differently from other areas of negligence, and English law is alone among the major common law juris¬dictions in giving doctors this privileged status.

In practice the vast majority of negligence cases are settled without going to court - sometimes early on, but often almost literally at the door of the court. This saves a lot of money for the side which would have lost the case, since a trial can drastically raise the costs, and the loser must pay those of the winner as well as dieir own. From the point of view of adequately compensating those injured though, out of court settlements can be problematic.

Hazel Genn's 1984 study, Hard Bargaining, showed that in cases where the defendant is an insurance company (which is the case in the vast majority of accident and professional negligence claims, for example) and the claimant an ordinary member of the public, the insurance companies, with their vast experience of these cases, are able to manipulate the pre-trial process in order to achieve not a fair settle¬ment but the lowest offer they can get away with.

What seems to happen is that small claims are over-compensated because it is not cost-effective for insurance companies to fight them, while very big claims (such as, for example, those brought by parents of children damaged by negligence at birth, who will need care throughout their lives) are often under-compensated because the claimants need compensation quickly, and so can effectively be forced to accept a lower settlement than they might get if they went to court.

Because the law on negligence is complicated, cases can be long and involved. Specialist legal representation is usually required, and the expert witnesses often needed to prove fault add to the cost. The result in practice is that only a fraction of the money spent on negligence cases actually goes to the victims of harm.


From Bolam to Bolitho: unravelling medical protectionism.

Christopher Stone. January 2011.

http://www.medicalandlegal.co.uk/wp-content/uploads/2012/05/From-Bolam-to-Bolitho-unravelling-medical-protectionism.pdf

The Bolitho test

http://medical-dictionary.thefreedictionary.com/Bolitho+test

A legal test that modified the 1957 Bolam test, which the English courts had been using to determine medical negligence by a doctor or nurse.

In Bolitho v City and Hackney Health Authority, 1997, Lord Browne-Wilkinson restricted the boundaries of Bolam, stating:

(1) "The court should not accept a defence argument as being ‘reasonable’, ‘respectable’ or ‘responsible’ without first assessing whether such opinion is susceptible to logical analysis”,

and

(2) "However, where there is a body of medical opinion which represents itself as ‘reasonable’, ‘respectable’ or ‘responsible’ it will be rare for the court to be able to hold such opinion to be other than represented”.

Bolitho turned Bolam on its axis, in that the court, and not the medical profession, became the final arbiter of medical breach.


Bolitho v City and Hackney HA

http://en.wikipedia.org/wiki/Bolitho_v_City_and_Hackney_HA

The House of Lords held that there would have to be a logical basis for the opinion not to intubate.

This would involve a weighing of risks against benefit in order to achieve a defensible conclusion.

This means that a judge will be entitled to choose between two bodies of expert opinion and to reject an opinion which is 'logically indefensible'.

This has been interpreted as being a situation where the Court sets the law not the profession.

However, Lord Browne-Wilkinson held that the court would hold a practice that was in conformity with a sound body of expert opinion to be negligent only in "a rare case".[2]

On the facts, it was decided that not intubating the child in the particular circumstances at hand was not a negligent way to take, even though the expert opinion on the matter was divided.


The Role of Biologically Effective Dose (BED) in Clinical Oncology

B. Jonesa, R.G. Dalea, C. Deehanb, K.I. Hopkinsc, D.A.L. Morgand


a Imperial College School of Medicine, Hammersmith Hospitals NHS Trust, London

b The Royal Marsden Hospital, London

c Bristol Oncology Centre, Bristol

d Nottingham City Hospital, Nottingham, UK

Received for publication April 2000, Accepted July 2000. Available online 24 May 2002.

Abstract

  • There are many clinical situations in which radiobiological considerations can be usefully applied and all clinicians should be aware of the potential benefits of developing a quantitative radiobiological approach to their practice.

  • The concept of biologically effective dose (BED) in particular is useful for quantifying treatment expectations, but clinical oncologists should recognize that careful interpretation of modelling results is required before clinical decisions can be made and that there is a lack of reliable human parameters for application in some situations.

  • Correct use of the BED concept will, in more complex treatment situations, sometimes involve the use of multiple parameters and BED calculations.

Examples include:

  • Where the dose per fraction is being altered and it is possible that normal tissue tolerance may be compromised, calculations should include two or more ratio values, some being less than 3 Gy, in order to estimate the ‘worst case scenario’.

  • A single one-point BED calculation will not be representative of the biological effect throughout a large planning target volume where there are significant ‘hot spots’. Multiple BED evaluations are then indicated.

  • Where there are combinations of radiotherapy treatments or phases of treatments, these can be quantitatively assessed by the addition of BEDs, although the volume of tissue is not inherently included in the BED calculation and any high- dose region needs to be separately assessed as in point 2.

  • Allowance for tumour clonogen repopulation during therapy is required for some tumour types.

  • Different histological classes of cancers require the use of different ratios. Where there is reasonable doubt regarding this parameter, a suitable range should be used.

The principles involved are illustrated by worked examples. Attention to detail and the examination of ranges of possible results should offer a safer guide to alternative dose fractionation schedules, although the ultimate choice will be tempered by clinical circumstances.

Keywords: Fractionation; Linear quadratic model; Mathematical models; Radiobiology; Radiotherapy

Copyright © 2001 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

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The Law and the Foundation of RAGE

English Statutes - on Radiotherapy

The English Statutes which have governed Radiotherapy in the United Kingdom are:

3. Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988 (POPUMET)

4. The Ionising Radiation (Medical Exposure) Regulations 2000, (IR(ME)R 2000)

Department of Health

Medical Exposures – The Regulatory Background

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/329842/Medical_exposures.pdf

The Ionising Radiation (Medical Exposure) Regulations 2000, (IR(ME)R 2000), came into force on 13 May 2000 POPUMET

These regulations replaced the Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988 (POPUMET) which have been repealed.

These two statutes, while establishing protection for the operators of radiation diagnostic and treatment machines, offer very limited protection for the patient.

These two statutes established the “ALARA Principle” - the use of a dose of diagnostic or therapeutic radiation which is “as low as reasonably acceptable”.

The Statutes do not stipulate the size of that “acceptable” fraction - or by whom it would be considered to be acceptable.

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English Case Law - on Radiotherapy

Some background to the foundation of RAGE and how the “Breast Radiation Litigation” became inevitable.

At the outset RAGE consisted of two groups of patients. One group treated with radiotherapy for breast cancer, the other for pelvic malignancies.

These injuries that they sustained were so severe that they were the subject of debates in the Houses of Parliament.


Radiotherapy and RAGE

HC Deb 17 June 1994 vol 244 c689W
http://hansard.millbanksystems.com/written_answers/1994/jun/17/radiotherapy#S6CV0244P0_19940617_CWA_197


Mr. Barry Jones

To ask the Secretary of State for Health

(1) if she will set up specialist centres to look at all aspects of radiotherapy injuries; and if she will make a statement;
(2) if she will meet members of the Radiotherapy Action Group Exposure; and if she will make a statement;
(3) what action she has taken to ensure that radiotherapy in the NHS is properly supervised; and if she will make a statement.


§Mr. Sackville

I am very concerned that patients receiving radiotherapy should have confidence in their treatment. My noble Friend the Parliamentary Under-Secretary of State for Health, Baroness Cumberlege, has met recently representatives from Radiotherapy Action Group Exposure, together with Government's Chief Medical Officer, to discuss how best to consider their concerns. We are also working closely with the Royal College of Radiologists.

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Radiotherapy Overdoses (Compensation)

HC Deb 24 June 1997 vol 296 cc507-8W
http://hansard.millbanksystems.com/written_answers/1997/jun/24/radiotherapy-overdoses-compensation#S6CV0296P0_19970624_CWA_432


Mr. Corbyn

To ask the Secretary of State for Health what proposals he has for a compensation plan for those suffering as a result of receiving the wrong dosage of radiotherapy; and if he will make a statement. [4764]

§Ms Jowell

The Government have every sympathy with women who have suffered adverse side-effects as a consequence of radiotherapy treatment. Where people have been harmed by clinical treatment and negligence can be shown to have caused this, compensation may be sought through the courts. However, it is a longstanding principle that compensation should only be paid by the NHS when there is evidence that negligence has been involved.

The following action has been taken to help women with damage as a result of radiotherapy for breast cancer: In May 1994 the Department issued guidance entitled "Quality Assurance in Radiotherapy—A Quality Management System for Radiotherapy".508WThe Royal College of Radiologists at the Department's request, convened a small group of professionals and lay people in Autumn 1994 to consider guidelines for care of women who have suffered tissue damage following radiotherapy for breast cancer. This report was issued to the NHS by the Department in October 1995.The Royal College of Radiologists carried out a confidential clinical review of 126 women who had suffered injury following radiotherapy treatment for breast cancer at 15 centres in the period 1980–93. The report makes recommendations on the management of breast cancer, particularly on radiotherapy, and for further research.

With regard to those suffering adverse effects following pelvic radiotherapy for gynaecological cancers, in 1996, a Working Group, which includes representatives from a number of Royal Colleges, voluntary organisations and the Department, was set up to consider the preparation of patient information leaflets concerning possible adverse effects following pelvic radiotherapy and to raise awareness generally. A sub-group is also considering issuing guidelines for health professionals on the care of women suffering adverse effects as a result of pelvic radiotherapy.

§Mr. Corbyn

To ask the Secretary of State for Health what discussions he has had with representatives of those suffering as a result of radiotherapy overdoses; and if he will make a statement. [4763]

§Ms Jowell

Representatives of those suffering as a result of radiotherapy treatment-both RAGE BREAST and RAGE NATIONAL have asked to meet Ministers to outline their aims and concerns. I am glad to report that my Noble Friend the Minister of State, Baroness Jay has agreed to see a joint representation from both these organisations.

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Plans to investigate totals and percentages of the instances of harmful effects from radiography treatment.

Radiography - Mr Paul Boateng - Written Answers — June 5, 1997

http://hansard.millbanksystems.com/written_answers/1997/jun/05/radiography#S6CV0295P0_19970605_CWA_174

Mr. Flynn

To ask the Secretary of State for Health what plans he has to investigate the totals and percentages of the instances of harmful effects from radiography treatment. [1958]

§Mr. Boateng

We have no plans currently to collect centrally, information on those who have suffered adverse effects following radiotherapy treatment, although we are keeping these issues under review. It is more appropriate for monitoring to be undertaken at a local level where local problems can be identified. Cancer centres are expected to audit their results, including adverse effects.

The following action has been taken to help women with damage as a result of radiotherapy for breast cancer. In May 1994 the Department issued guidance entitled "Quality Assurance in Radiotherapy—A Quality Management System for Radiotherapy".The Royal College of Radiologists at the Department's request, convened a small group of professionals and lay people in Autumn 1994 to consider guidelines for care of women who have suffered tissue damage following radiotherapy for breast cancer. This report was issued to the NHS by the Department in October 1995.The Royal College of Radiologists carried out a confidential clinical review of 126 women who had suffered injury following radiotherapy treatment for breast cancer at 15 centres in the period 1980–1993. The report makes recommendations on the management of breast cancer, particularly on radiotherapy, and for further research.

243W

With regard to those suffering adverse effects following pelvic radiotherapy for gynaecological cancers, in 1996, a Working Group, which includes representatives from a number of Royal Colleges, voluntary organisations and the Department, was set up to consider the preparation of patient information leaflets concerning possible adverse effects following pelvic radiotherapy and to raise awareness generally. A sub-group is also considering issuing guidelines for health professionals on the care of women suffering adverse effects as a result of pelvic radiotherapy.

Radiotherapy - Mr Paul Boateng - Written Answers — June 16, 1997
http://hansard.millbanksystems.com/written_answers/1997/jun/16/radiotherapy#S6CV0296P0_19970616_CWA_150


Mr. Laurence Robertson

To ask the Secretary of State for Health if he will make a statement regarding his Department's policy towards compensation payments to women who claim to have been injured through receiving radiotherapy treatment; and what steps his Department is taking to investigate the causes of this problem. [3394]

§Mr. Boateng

The Government have every sympathy with women who have suffered adverse side-effects as a consequence of radiotherapy treatment. However, it is a longstanding principle that compensation should be paid by the National Health Service only when there is evidence that negligence has been involved.

The following action has been taken to help women with damage as a result of radiotherapy for breast cancer: In May 1994 the Department issued guidance entitled "Quality Assurance in Radiotherapy—A Quality Management System for Radiotherapy".The Royal College of Radiologists at the Department's request, convened a small group of professionals and lay people in Autumn 1994 to consider guidelines for care of women who have suffered tissue damage following radiotherapy for breast cancer. This report was issued to the NHS by the Department in October 1995.The Royal College of Radiologists carried out a confidential clinical review of 126 women who had suffered injury following radiotherapy treatment for breast cancer at 15 centres in the period 1980–1993. The report makes recommendations on the management of breast cancer, particularly on radiotherapy, and for further research.

With regard to those suffering adverse effects following pelvic radiotherapy for gynaecological cancers, in 1996, a Working Group, which includes representatives from a number of Royal Colleges, voluntary organisations and the Department, was set up to consider the preparation of patient information leaflets concerning possible adverse effects following pelvic radiotherapy and to raise awareness generally. A sub-group is also considering issuing guidelines for health professionals on the care of women suffering adverse effects as a result of pelvic radiotherapy.

Proposals to compensate female patients who have suffered serious physical damage following post-operative radiotherapy to treat breast cancer;

Radiotherapy- Ms Tessa Jowell - Written Answers — June 24, 1997

http://hansard.millbanksystems.com/written_answers/1997/jun/24/radiotherapy#S6CV0296P0_19970624_CWA_412

Mr. Willis

To ask the Secretary of State for Health what proposals he has to compensate female patients who have suffered serious physical damage following post-operative radiotherapy to treat breast cancer; and if he will make a statement. [4836]

§Ms Jowell

The Government have every sympathy with women who have suffered adverse side-effects as a consequence of radiotherapy treatment. However, it is a longstanding principle that compensation should be paid by the National Health Service only when there is evidence that negligence has been involved.

The following action has been taken to help women with damage as a result of radiotherapy for breast cancer: In May 1994 the Department issued guidance entitled "Quality Assurance in Radiotherapy—A Quality Management System for Radiotherapy".The Royal College of Radiologists at the Department's request, convened a small group of professionals and lay people in autumn 1994 to consider guidelines for care of women who have suffered tissue damage following radiotherapy for breast cancer. This report was issued to the NHS by the Department in October 1995.The Royal College of Radiologists carried out a confidential clinical review of 126 women who had suffered injury following radiotherapy treatment for breast cancer at 15 centres in the period 1980–1993. The report makes recommendations on the management of breast cancer, particularly on radiotherapy, and for further research.

With regard to those suffering adverse effects following pelvic radiotherapy for gynaecological cancers, in 1996, a Working Group, which includes representatives from a number of Royal Colleges, voluntary organisations and the Department, was set up to consider the preparation of patient information leaflets concerning possible adverse effects following pelvic radiotherapy and to raise awareness generally. A sub-group is also considering issuing guidelines for health professionals on the care of women suffering adverse effects as a result of pelvic radiotherapy.


House of Commons Debate - Cervical Cancer (Radiation Injuries)

http://hansard.millbanksystems.com/commons/1995/nov/21/cervical-cancer-radiation-injuries#S6CV0267P0_19951121_HOC_428

House of Commons Debate - 21 November 1995 vol 267 cc562-70562

10.18 pm

§Ms Janet Anderson(Rossendale and Darwen)

I am grateful for the opportunity this evening to highlight the plight of a number of women who have suffered the most severe injuries resulting from radiation treatment for cervical cancer. Approximately one year ago, I was invited to meet a group of women in the Manchester area who had, during a period from the late 1970s to the early 1980s, received radiation treatment for cervical cancer at the Christie hospital in Manchester.

It transpired, as revealed by a BBC Radio 4 "File on Four" programme in 1991, that hundreds of patients had been damaged by the experimental selectron treatment. It was shortly after that that Vicky and others founded the action group RAGE—Radiotherapy Action Group Exposure…..

File on 4 - Trial and Error, Christie Hospitals & RAGE Bowel Patients – 15/10/1991

https://www.youtube.com/watch?v=IKzYhHRSNKk&list=UUtKTLppkEtx6OP77ioF6H8Q

It is hard to believe that in this country, and in this day and age, cancer patients were completely unaware that they were part of a clinical trial in which they had absolutely no say.

In October 1991, 20 RAGE victims started individual legal actions against the Christie hospital. The cases are so complicated, dealing not only with legal aspects but medical rules and ethical questions, that they are still going on. However, nothing could ever compensate the victims and their families for what has happened.

RAGE now has 3,000 members. Not all its members have had injuries through a pelvic or abdominal cancer: some have been victims of radiotherapy for breast 564 cancer, and they have their own group, RAGE Breast. It is now apparent that it is not only women who have been abused in this way. RAGE now has a small number of men among its members who have radiotherapy injuries from treatment for prostate, bladder, testes and colon cancers.

The women are now seeking an independent investigation into radiotherapy damage and compensation. The Government have decided to audit injuries on two breast cancer cases. Surely the Minister must now agree to a simultaneous audit for all radiotherapy injuries.

Mr. Andrew Miller(Ellesmere Port and Neston)

……….. Does my hon. Friend agree that the issue of consent, a form for which appears to have been introduced by the Christie hospital only in 1991, is critical? Many of the women were clearly experimental guinea pigs prior to that time. It was only after the damage had been identified that people were asked to sign that form.

Ms Anderson

………. He [AM] is quite right. The whole case turns around whether the women knew they were part of an experiment. As he pointed out, the Christie did not introduce the consent form until 1991. The women that I am talking about received treatment in the late 1970s and early 1980s. I thank my hon. Friend for that well-timed intervention.

Surely the Minister must agree to a simultaneous audit for all radiotherapy injuries, and most particularly those sustained during the period of experimental treatment for cervical cancer on the selectron machine.

Finally, will the Minister tonight give us an assurance that he will agree to that, and that he will now take steps to set up a national register of victims? There are hundreds of women such as Vicky Parker and her colleagues who deserve to have their voices heard and their condition recognised. It is the responsibility of the Government to assess the scale of the problem, to give recognition to those women, and to make sure that nothing like this ever happens again.

The Parliamentary Under-Secretary of State for Health (Mr. Tom Sackville)

I am grateful to the hon. Member for Rossendale and Darwen (Ms Anderson) for bringing this matter to the attention of the House. I start by expressing my deepest sympathy for the women who have suffered severe adverse effects as a result of radiotherapy treatment for cervical cancer, many of whom were treated using the selectron, as the hon. Lady said, at the Christie hospital in Manchester in the 1980s.

Let me first say something about the selectron treatment. Internal radiotherapy has been available for decades. The difference with the selectron is that, in old-style therapy, the radiation sources were inserted manually. The selectron is a way of inserting the source and removing it automatically by remote control. Such a system has the advantage of reducing staff exposure to radiation, because the radioactive sources could be withdrawn along pipes into a lead-lined safe at the foot of the bed.

565 In 1978, the low dose rate selectron system devised by the Christie hospital was introduced. It is now in use at other United Kingdom centres, including Edinburgh, Glasgow, Leeds, Liverpool and the Marsden.

In its early days, the correct dose on the selectron had to be calculated because stronger sources were used than in the former manual—that is, non-retractable—treatment system. It must be remembered that, although it was a higher dose of radiation than before, it was still a relatively low dose.

The treatment of women using the selectron during the 1980s was part of a randomised, controlled trial, designed to try to establish the optimum dose for patients with an early stage cancer. As I said, the selectron is still used in the treatment of cervical cancer, and the system developed at Manchester is used worldwide.

§Mr. Miller

Can the Minister advise the House how the calculations were undertaken in those early clinical trials and what the dose rates were? Furthermore, does he agree that it is unacceptable that the letter from the Christie to my hon. Friend dated 26 July stated that those patients had experienced difficulties and distress? It is far more than that. Those women have had their lives destroyed; the Christie ought to admit it, and so should the Department of Health.

§Mr. Sackville

The hon. Gentleman will perhaps not be surprised to learn that I do not have the information on his first, technical question. I will try to supply him with it in writing. On his second question, that was a highly regrettable series of events. As I said, we all have the deepest sympathy. Later, I will explain how I very much hope that ways will be found to avoid that situation recurring.

The selectron is still in use, and we now have the benefit of experience of doses that have been found to have acceptable levels of adverse effect. I am aware that the women who received significant adverse effects, which they believed were caused by their treatment with the selectron, are taking legal action against the Christie hospital, on the grounds that they were given insufficient information as to the nature of the treatment.

It is now clear Government policy that all patients have a right to consent to or reject treatment, and are entitled to a clear explanation of any treatment proposed, including any risks and alternatives. All treatments carry some level of risk, and patients must be allowed to decide whether they wish to continue with the treatment proposed. That is a principle that has been highlighted in the patients charter.

Some of those suing the Christie are part of a support group, RAGE National, which, with its sister group RAGE Breast, is pressing central Government for recognition and compensation for radiotherapy-related injuries. Representatives from RAGE met my noble Friend Lady Cumberlege and the chief medical officer last year to discuss its members' concerns. Following that meeting, and at the Department's behest, the Royal College of Radiologists agreed to undertake a confidential clinical review of 126 RAGE Breast members to discover what —


Full Hansard Report:
http://hansard.millbanksystems.com/commons/1995/nov/21/cervical-cancer-radiation-injuries#S6CV0267P0_19951121_HOC_428

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Radiotherapy Damage

To ask Secretary of State for Health if he will award ex gratia payments to women suffering permanent, progressive, disabling injuries after radiotherapy treatment for breast cancer;

HC Deb 17 February 1998 vol 306 c553W553W
http://hansard.millbanksystems.com/written_answers/1998/feb/17/radiotherapy-damage#S6CV0306P0_19980217_CWA_198


§Mr. Sanders

To ask the Secretary of State for Health if he will award ex gratia payments to women suffering permanent, progressive, disabling injuries after radiotherapy treatment for breast cancer; and if he will make a statement. [29867]

§Mr. Boateng

We are aware of the often severe problems experienced by women who have been injured following radiotherapy treatment for breast cancer. Unfortunately, there are risks associated with most medical interventions and radiotherapy treatment for breast cancer is not the only area where patients may suffer health and other problems as a result of treatment they have received.

Following careful consideration of the issues we have no plans to introduce a general scheme of ex gratia payments for specific groups such as those who have suffered injury as a result of radiotherapy treatment for breast cancer.

National Health Service bodies already have the authority exceptionally to make ex gratia payments in individual cases. Decisions to do so for those suffering adverse side effects from medical treatment are a matter for the individual NHS trust, after careful appraisal of the facts.

Lord Edmund Ironside

http://www.publications.parliament.uk/pa/ld199596/ldhansrd/vo960425/index/60425-x.htm
Radiotherapy Quality Assurance [25 Apr 1996]
Lord Ironside -- Radiotherapy Quality Assurance [25 Apr 1996]
Baroness Cumberlege
Lord Ironside -- Radiotherapy Quality Assurance [25 Apr 1996] Baroness...
Location: Parliamentary Business


http://www.publications.parliament.uk/pa/ld199798/ldhansrd/vo981027/index/81027-x.htm
Ironside -- Breast Cancer Radiotherapy: Legal Aid Board Action [27 Oct 1998]
The Lord Chancellor (Lord Irvine of Lairg)
Lord Ironside -- Breast Cancer Radiotherapy: Legal Aid Board Action [27 Oct 1998...
Location: Parliamentary Business


http://www.publications.parliament.uk/pa/ld199798/ldhansrd/vo971112/index/71112-x.htm
The Minister of State, Department of Health (Baroness Jay of Paddington)
X-Ray Mammography [12 Nov 1997]
Lord Ironside -- X-Ray Mammography [12 Nov 1997]
Baroness Jay of Paddington Lord...
Location: Parliamentary Business

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Effects of radiation on normal tissue: consequences and mechanisms - Lancet

http://www.researchgate.net/publication/10575447_Effects_of_radiation_on_normal_tissue_consequences_and_mechanisms

The use of radiation therapy to treat cancer inevitably involves exposure of normal tissues.

As a result, patients may experience symptoms associated with damage to normal tissue during the course of radiotherapy for a few weeks after radiotherapy or months or years later.

Symptoms may be due to cell death (in normal healthy tissues) or wound healing initiated within irradiated tissue………

  1. Acute (early) effects are those that are observed during the course of treatment or within a few weeks after treatment.

  2. Consequential effects (sometimes called consequential late effects) appear later, and are caused by persistent acute damage.

  3. Late effects emerge months to years after radiation exposure.


Other Sources of Information..........

And Finally……

The Judgement – May 8 1998 - Mrs Justice Ebsworth

Full text here:- Robb and Unitt - The Breast Radiation Litigation.doc

[1999] Medical Litigation Cases 0102
Queens Bench Division
Before Mrs Justice Ebsworth
The Breast Radiation Litigation

Robb (1)

Unitt (2)

v

East London and City Health Authority (1)

Bristol and District Health Authority (2)


Date of judgment: May 8, 1998

Medical negligence: Clinical radiotherapy - Breast radiation - Whether price of destroying original disease paid as result of negligent prescription or treatment - Claims for damages for alleged medical negligence arising out of prophylactic post-surgery radiotherapy treatment for early breast cancer - Treatment on Cobalt 60 machines - Patients suffering brachial plexus neuropathy.

Claims for damages for alleged medical negligence arising out of prophylactic post-surgery radiotherapy treatment on Cobalt 60 machines for early breast cancer where patients suffered brachial plexus neuropathy were dismissed where hospitals and consultants had no reason, arising from their own treatment, to expect such a devastating result from their treatment regimes.

These were two actions claiming damages for alleged medical negligence arising out of prophylactic post-surgery radiotherapy treatment for early breast cancer - suspected residual microscopic carcinoma - in 1980.

The cases involved cancers characterised by small primary tumours, no fixed nodes and no distant metastasis. Both patients were treated on Cobalt 60 machines. Both suffered brachial plexus neuropathy…………..

It is understandable that those who have suffered serious and unexpected injury should wish to know why and how; I regard it as unfortunate that litigation in terms of medical negligence was felt to be the only mechanism available to obtain the answers.

Because medicine is constantly developing there are obvious problems inherent in allegations of negligence directed to the choice of a method of treatment used many years ago. Dr Halnan, in his report of May 1997, wrote:
“Over the last 40 or 50 years there has been a gradual change in the treatment of cancer. Maximal surgery, even at the expense of mutilation, maximal tolerable radiotherapy with more side effects that should be tolerated today, and possibly indiscriminate chemotherapy all directed towards cure and survival have been given up. Nowadays surgery is more conservative, radiotherapy uses megavoltage radiation with less toxicity and greater precision and chemotherapy is considerably more specific. There is true collaboration and integration and subsequent quality of life has become a major objective. This generalisation certainly applies to all breast cancer.”

That view is not, as a generalisation, in dispute although even today there is no agreed single pattern of treatment. In the USA in June 1990 the National Cancer Institute sponsored a consensus development conference on the treatment of early breast cancer. That conference concluded:
“Breast conservation is an appropriate method of primary therapy for the majority of women with Stage 1 and 2 breast cancer, and is preferable, because it provides survival equivalence equivalent to mastectomy and axillary dissection while preserving the breast.”

They were commending excision of the primary tumour and adjacent breast tissue followed by radiotherapy. Clearly views as to techniques, all designed to assist women with breast cancer, have continued to vary.

The appropriate level of radiotherapy has been equally contentious. It was not until 1997 that a draft protocol was arrived at to embark upon a randomised comparison of fractionation regimens after mastectomy for early breast cancer in an endeavour to standardise breast radiotherapy.

The whole purpose of that trial is to test the effects of radiotherapy schedules using fraction sizes of more than 2 Gy in terms of normal tissue response and tumour control as well as the consequences in terms of quality of life and economics.

The background material for that trial points out that historically there has been a difference in the practice of fractionation in the United Kingdom and elsewhere in the world. There was a prevailing idea that increases in fraction size may cause relatively more damage to tumours than to normal tissues in the breast.

The cost/benefit assessment was made on that basis; Dr Hope Stone and Dr Fenner both fell into that category of clinical belief and to this day there has been no formal comparison of the advantages of one approach as opposed to another.

These two cases have been concerned with patterns of treatment seventeen to eighteen years ago and it is by the then prevailing United Kingdom standards they have fallen to be judged.

To have found negligence, either at the London or at Bristol would in my view have involved assessing the treatment, given with the best of motives and carried out with care, either by the standards and with the knowledge of a different era of oncology or ignoring the fact that there was more than one sustainable view as to the best method of treatment.

In each case, over so many years, the primary purpose of destroying the original disease and holding back its recurrence has, fortunately, been achieved.

The price, it can now be seen, has been in all probability higher than would be paid today but it was not paid as the result of negligence prescription or treatment. In each case the claims must fail and there must be judgment for the defendants.

Costs will follow the event with, where appropriate orders for Legal Aid taxation.

Medical Negligence – MEDNEG © Medical Negligence Online 2015


[These references and the embedded links in this section are still being developed]…..

http://www.medneg.com/Default.aspx

A Year in the life of Funding Clinical Negligence Claims

Rhodes-Kemp, Rosamund: solicitor, Russell Jones and Walker : Breast Radiation Injury Claims

Millington, Jan (09/1999) : Breast Cancer Radiation Claims

Allen, Tony (11/1999) : Mediating Clinical Negligence Claims After Woolf


[These references and the embedded links in this section are still being developed]…..

Hall, Geoffrey : MMR/MR Vaccine Litigation Funding: So who got what, then?

Hall, Geoffrey : Clinical Negligence Law for Patients and their Relatives 3rd Edition Hall, Geoffrey (10/1998) : Multiparty Legal Aid Actions

Hall, Geoffrey (10/1998) : MEDICAL NEGLIGENCE Analysis of Reported Cases

Hall, Geoffrey (April 2004) : The National Patient Safety Agency: 7 Steps to Patient Safety

Hall, Geoffrey (August 2007) : NHS DEFENCE COSTS: A matter of public concern?

Hall, Geoffrey (December 2002) : Legal Aid Success Rates in Clinical Negligence

Hall, Geoffrey (February 2004) : Multiparty Medical Litigation: Legal Aid Winners - and Losers

Hall, Geoffrey (July 2003) : MAKING AMENDS

Hall, Geoffrey (June 2004) : MEDIATE DON’T LITIGATE

Hall, Geoffrey (October 2006) : NHS REDRESS BILL: Commons amendments rejected by Lords

Hall, Geoffrey: barrister : Whither multi-party product liability? Sheep Farmers and Organophosphates - The end of the road?

Hall, Geoffrey: Editor, Medical Litigation Online : Freedom of Information


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