- Email: [email protected]
Medico-legal problems in gynaecology
Current Obstetrics & Gynaecology (2003) 13, 294 --299
c 2003 Elsevier Science Ltd. All rights reserved. doi:10.1016/S0957-5847(03)00048 -9
Medico-legal problems in gynaecology V.P. Argent Consultant Obstetrician and Gynaecologist, East Sussex Hospitals NHS Trust, King’s Drive, Eastbourne BN20 0AG, UK
KEYWORDS medico-legal problems; litigation; risk management; clinical governance; professional misconduct
Summary Every gynaecologist should study the law applicable to their practice.This involves knowledge of civillaw, especially the tort of negligence, and criminallaw as well as the related Acts. The application of legal principles has become a part of everyday practice ranging from the signing of consent forms to risk management and incident reporting.There is considerable overlap with medical ethics. This article gives an overview of the various aspects of law in gynaecological practice ranging from the reasons for getting into trouble, statutory law and authority, new trends in consent, the provision of information, risk management, clinical incident reporting and complaints, the concept of safe practice, the legal position of guidelines, and professional and personal conduct.Forensic gynaecology also involves extensivelegal and clinical knowledge. Specif|c problem areas such as abortion, female sterilization, colposcopy, hysteroscopy, laparoscopy, hysterectomy, urogynaecology and assisted conception are discussed.The article concludes with some suggestions for training and education.
c 2003 Elsevier Science Ltd. All rights reserved.
INTRODUCTION The impact of law in the specialty of obstetrics and gynaecology far outweighs other medical f|elds. The study of law is, therefore, an integral part of the training and education of trainees and specialists who should always bear in mind the legal maxim that ignorance of the law does not excuse. Medico-legal problems in the specialty span a large range involving litigation, complaints, clinical governance and risk management, clinical incident reporting and patient safety, the implementation and importance of guidelines, professional regulation as well as ethics, statute law and criminal matters. Such is the interest and complexity of the issues involved that many colleagues in the f|eld are now specializing in medicolegal problems.Young gynaecologists may well fear their f|rst complaint investigation, clinical incident report or letter from their Trust legal department or a solicitor, but they soon realize that the handling of such problems is now an integral part of their medical practice. This article gives a snapshot of the interface between law and medical practice and will concentrate on gynaecology.
clinically sound practice. Gynaecologists’ greatest fear is of getting into trouble, although it should be realized that the thorough study of medico-legal problems does lead to improved quality of care.There are many reasons why gynaecologists may encounter medico-legal problems during their careers (Table 1). Why do patients complain and resort to legal action? There are several main themes in gynaecology (Table 2).
STATUTE LAW AND AUTHORITY
GETTING INTOTROUBLE
There are many statutes which have a direct bearing on clinical gynaecological practice such as the Abortion Act 1967, the Surrogacy Arrangements Act1985, the Prohibition of Female Circumcision Act 1985, and the Human Fertilization and Embryology Act 1990. Other statutes concern the conduct of practice, e.g. the Data Protection Act 1998, the Public Interest Disclosure Act 1998, and the various Health and NHS Service Acts. The Human Fertilization and Embryology Act set up the Human Fertilization and Embryology Authority (HFEA) which has powers of inspection and licensing. Colleagues working in the f|eld of tertiary assisted conception must be fully conversant with the HFEA regulations and code of practice.
Our primary duty is to our patients and there is increasing emphasis on the application of evidence-based
FORENSIC GYNAECOLOGY
Correspondence to:VPA.Tel.: +44(0)1323 413 706; fax: +44(0)1323 413 737; E-mail: [email protected]
Most gynaecologists have little contact with forensic problems although they should have some knowledge
MEDICO-LEGAL PROBLEMS IN GYNAECOLOGY Table 1 Getting into trouble Complaints procedures Civil claims -- litigation Trust disciplinary procedures and employment disputes Disputes with medical and management colleagues Criminal prosecutions Professional performance procedures -- National Clinical Assessment Authority and General Medical Council Professional Misconduct -- General Medical Council
Table 2
Reasons for complaints and litigation
Failure to explain the risks of proposed treatment Failure to explain limited success of proposed treatment Changing proposed treatment without adequate further counselling Departure from recommended guidelines or protocols The occurrence of complications Delayed or mistaken diagnosis Poor communication Failure to apologise Practising beyond expertise
of this discipline and the work of Forensic Medical Examiners (formerly known as Police Surgeons). Sexual assault and rape must be handled in a sensitive manner while complying with forensic procedure. Domestic violence is now recognized as a major factor in women’s health care. Sexual violence in areas of conflict has been studied by the United Nations and human rights groups.
SOME NEW TRENDS Consent Valid consent must be obtained from patients. Sometimes the consent is implied, for instance when the patient raises no objection to the request for performance of an examination. It is generally advised that written consent should be obtained for invasive procedures.The requirements for procedures such as transvaginal ultrasound scanning and colposcopy may still be unclear. In the strict legal sense, the case of Sidaway in the House of Lords conf|rmed that there is no doctrine of informed consent in English law. The correct measure of consent is the Bolam test which looks at the expected standard of the competent practitioner. This is, essentially, a peer group test but it is for the courts and their expert advisers to determine its application in an individual case. The more recent case of Bolitho, however, has moved us more towards the American standard of informed consent which depends on a patient rather than
295
a professional test of what is required. It is unfortunate that the General Medical Council (GMC) now use the term informed consent in their publication Seeking Patients’ Consent: the Ethical Considerations. It is interesting that the NHS Patient Charter considers that patients have a right to know of any risks of a proposed procedure. The new Department of Health consent forms, implemented in April 2002, contain a section Serious and Frequently Occurring Risks, but there has been no specif|c national guidance on what should be written in a specif|c case. It is now recommended that consent forms should be signed by the operating surgeon or a colleague who is capable of performing the procedure. It is essential to involve the court when contemplating an operation such as sterilization or even a hysterectomy on therapeutic grounds on adults who do not have the capacity to give consent.
Information The issue of information is being addressed by the National Collaborating Centre for Women’s Health in conjunction with the National Institute of Clinical Excellence (NICE) and the National Patient Safety Agency. These groups have a substantial lay input as well as multiprofessional input from a wide range of stakeholders. There are a few instances of recommended information for patients, e.g. prior to termination of pregnancy in the Royal College of Obstetricians and Gynaecologists’ (RCOG) Evidence Based Guideline on Induced Abortion. There is an urgent need for more thorough research into information requirements as well as increasing use of consistent patient information leaflets, information centres in gynaecological departments, and full involvement of the patient in discussion of options and management decisions.
Risk management-- clinical incident reporting--complaints This is now an integral part of gynaecological practice. Risk management includes the identif|cation of potential risk and systems design to avoid risk.Clinical incident reporting should include near-misses as well as actual adverse outcomes. Adverse outcomes must be analysed in an open, no-blame culture with full feedback to the team so that the lessons learned can be put into practice in the interests of patient safety.These procedures will be standardized by the National Patient Safety Agency. Trusts and corporate bodies are also very interested in the f|nancial limitation of claims.This may include f|nancial settlements which annoy medical staff who feel that there may have been no negligence and the adverse event was within the expected range of complications. The
296
National Health Service Litigation Authority assists Trusts with legal claims. Audit is closely linked with these processes. Standard complaints procedures are now common and the new Patient Advocacy Liaison Service and the Patient Forums will ensure that gynaecologists are involved in detailed discussions with complainants. Colleagues may be invited to appear before independent review panels and appeals to the Health Service Commissioner (the Ombudsman).
Safe practice There is an emerging concept that practitioners should conduct ‘safe practice’. This is not necessarily the same as defensive medicine, but involves a mind set which looks at what is the safest outcome for the patient, the practitioner and the corporate body. A less-effective result may be acceptable if it is achieved by safer treatment. An example would be actively promoting the use of a levonorgestrel intra-uterine contraceptive device rather than a hysterectomy for menorrhagia or a sterilization for contraception. This approach is often used in other f|elds such as chemical engineering where a lower-output, less-economic process may be used on the grounds that it is safer.
GuidelinesFthe legal position It is usually said that guidelines are not meant to dictate clinical practice. Some departments produce protocols and it has been suggested that these have more force than guidelines. NICE guidelines are particularly authoritative and practitioners will f|nd non-adherence diff|cult to defend. Recent professional conduct hearings at the GMC have shown that guidelines are increasingly used as a basis to analyse a doctor’s practice; for instance, British Society for Colposcopy and Cervical Pathology (BSCCP), RCOG guidelines and the GMC booklet Good Medical Practice have been used in presentations by GMC lawyers.
Professional and personal conduct Gynaecologists are at high risk of accusations of personal and professional misconduct. Such problems are usually closely linked to clinical practice. Never before has clinical practice been under so much scrutiny by colleagues, employers and national agencies. It is currently estimated that well over 100 gynaecologists are currently under some form of investigation. Most visits by the Commission for Health Improvement , the RCOG rapid response and review procedures as well as the National Clinical Assessment Authority (NCAA) and GMC procedures will be examining allegations of concern about clinical practice. Trust disciplinary procedures frequently deal with concerns about practice, and clinical governance is often QJ;misused. Contractual disputes require knowledge of
CURRENT OBSTETRICS & GYNAECOLOGY
employment law and access to Industrial Relations Off|cers; it is advisable to maintain membership of the British Medical Association and the Hospital Consultants and Specialists Association as well a defence society.
SPECIFIC PROBLEM AREAS Abortion There are many pitfalls involving the statutes, criminal law and civil litigation as well as some important training issues. Many issues and arguments concern ethical problems and the interpretation of the Act. Conscientious objection is covered by Section 4 of the Abortion Act 1967, and it is not commonly realized that practitioners may opt out of a particular part of the service. A practitioner may refer and counsel patients for the procedure but can opt out of the actual surgical performance of a procedure. It is clear that the Act does not allow abortion on demand. However, a patient who is refused an abortion may seek out another doctor, and the doctor who has a conscientious objection is advised by the GMC to refer the patient to a colleague. Abortion on demand is the practical effect of these situations. There is no legal def|nition of the ‘serious handicap’ clause (‘E’ on the Abortion Act form) of the grounds for termination of pregnancy as given in Section 2 of the Act, but the RCOG has suggested appropriate criteria in the1996 report onTermination of Pregnancy for Fetal Abnormality. Conf|dentiality is very important as patients may wish to remain anonymous and request that their general practitioners and even their relatives are not informed. The use of unlicensed drugs such as misoprostol for cervical ripening is covered by the Medicines Act 1968, and most Trusts have a written medicines policy which requires the specif|c consent of the patient. Litigation in this f|eld is not uncommon although some patients may be reluctant to pursue claims because of concerns about conf|dentiality. Common reasons include retained products of conception and re-admission for bleeding and infection. These are usually defensible but f|nancial settlements are frequently offered because of the low value of the claims. More serious problems such as perforation and genital tract trauma must be dealt with in a competent manner. Patients will be horrif|ed by a failed termination and ongoing pregnancy, and this is a particular risk of early surgical procedures. There have also been civil claims for failure to give an adequate warning of the psychological effects of induced abortion. Wrongful life and wrongful death actions have not found favour in English law. Criminal self-induced or illegal abortion is now a rarity in this country but the law is often invoked by pro-life groups in their objections to such procedures as postcoital contraception. Some pro-life groups encourage violence against abortion practitioners. There is a myriad of
MEDICO-LEGAL PROBLEMS IN GYNAECOLOGY
anti-abortion websites which post names on their pages and this is a huge problem in the USA. There have been prosecutions for such matters as proceeding with a hysterectomy in a patient who was found to be pregnant on entering the abdomen.
Female sterilization The application of risk management is particularly useful in this area. Sterilization is usually a social operation and patients are usually angry when the procedure fails. It is suggested that the operation should not be called ‘sterilization’ because that is the intent of the operation, and the procedures should be considered as part of the available range of contraception. Maintenance of equipment has been identif|ed as a problem leading to serial failures as well as mass action suits against manufacturers.The Medical Devices Agency have produced recommendations that clip or ring batch numbers and applicator instrument numbers should be recorded in the patients’ notes. Pre-operative information and counselling as well as a specif|c consent form are well documented in the RCOG’s Guidelines on Male and Female Sterilization. Failed sterilization occurs because the patient is pregnant at the time of the procedure (often called luteal phase failure), has an early failure following a misapplied clip or technical failure, or has a late failure related to recanalization. There is overlap between the reasons for early and late failure, although the risk of ectopic pregnancy is highest in the latter group. Risk management strategies include such matters as check information lists, pregnancy tests, proper sexual activity histories, restricting the procedure to the f|rst half of the menstrual cycle and equipment checks such as the Filshie clip gauge device. Adequate operative records must include a clear indication that the tubes and f|mbriae have been identif|ed, and many practitioners take photographic evidence of the operation. Any operative diff|culty must be fully documented together with a plan for further action if needed. It is not possible to defend the application of devices to such structures as the round ligament, and in legal terms, the facts speak for themselves. There are, however, some interesting non-negligent causes of failure such as medial f|stula formation and a patent channel. Claims from patients who have not had a follow-up operation after a failure have been successfully defended on the assumption that an experienced surgeon would be expected to have carried out the operation correctly. Failed sterilizations should be reported to the National Patient Safety Agency who are taking on the recommendations for a national register of such events.
297
Colposcopy There have been several ‘scandals’ involving mistaken diagnosis, and the area provides a common source for litigation. It is prudent to follow the recommendations of the British Society for Colposcopy and Cervical Pathology. The concept of accreditation has caused many diff|culties with clinical governance and the practice of gynaecologists. There needs to be more public education about the limitations of cervical screening and colposcopy, as well as the natural progression of diseases, if we are to reduce the incidence of litigation.
Hysteroscopy Diagnostic hysteroscopy is a reasonably safe procedure but perforations and haemorrhage can occur.There is little consensus on the information that should be provided prior to the procedure. In the case of f|rst- and secondgeneration operative hysteroscopy, recent cases have shown that patients must be routinely warned about the risks of perforation, hysterectomy and bowel damage. In the case of ensuing hysterectomy, there has been much debate about whether this can be justif|ed from the consent form which allows the surgeon to do whatever is necessary in the best interests of the patient.
Laparoscopy The main problem with laparoscopy is the need to carry out a laparotomy for unexpected organ damage. In the case of bowel damage, the preferred midline incision is far more likely to lead to a suit than a suprapubic incision. Whereas most gynaecologists discuss the possibility of laparotomy and bowel damage, few specif|cally mention a midline incision or a colostomy. There has been extensive work on risk management and medico-legal problems in diagnostic and operative laparoscopy, and the recommendations usually centre on comprehensive pre-operative counselling, minimal access surgery training and experience, correct safe technique, the prompt recognition of complications, and their correct management involving surgical colleagues where necessary. Any unexpected outcome should be explained to the patient by the actual operating surgeon, involving a consultant or clinical director where indicated.
Hysterectomy There is little public awareness of the risks of this procedure. Major complications are not infrequent and litigation is common. Current medico-legal trends include claims for unnecessary hysterectomy, removal of ovaries without consent, lack of warning about early ovarian
298 failure after a hysterectomy with ovarian conservation, and usual settlement of damaged ureter cases. In unnecessary hysterectomy claims, legal advisers will depend on such literature as the VALUE study which recommends that the levonorgestrel intra-uterine contraceptive device should be the treatment of choice for menorrhagia before endometrial ablation or hysterectomy can be justif|ed.
Urogynaecology
CURRENT OBSTETRICS & GYNAECOLOGY
PRACTICE POINTS *
*
*
* *
There is no perfect operation for stress incontinence, and patients must be fully appraised of the success rate of the technique used. There are many new ideas in this f|eld and it is becoming more diff|cult for the general gynaecologist to continue without a suff|cient caseload. The use of pre-operative dynamics now seems necessary. Repeat operations should probably be carried out in tertiary referral centres by accredited subspecialists. Failure to adhere to these changes in practice is likely to lead to litigation where a practitioner may be criticized by experts with a particular interest in urogynaecology.
RESEARCH DIRECTIONS *
* *
*
Assisted conception Assisted conception is replete with ethical and legal problems involving statutory and case law. There is increasing litigation following the adverse outcome of multiple pregnancy with criticism of poor counselling and overoptimistic forecasts, especially in the f|nancially driven private sector. The replacement of more than two embryos is not recommended by the HFEA and this is leading to various medico-legal problems ranging from litigation, threat of withdrawal of licences and GMC investigations. Court declarations have been common and have dealt with such matters as posthumous conception, producing a baby for stem cell collection, and ownership of unwanted embryos.
TRAINING AND EDUCATION Gynaecologists have a duty to acquaint themselves with the law. Some will specialize in the f|eld by conducting academic medico-legal research on litigation, clinical incidents and risk management, becoming expert witnesses, GMC performance procedure assessors or by working full time for national agencies, risk management organizations, solicitors or the defence societies. A few have crossed the floor and have become professionally qualif|ed solicitors and barristers. The further reading list gives a brief outline of some sources for further study. Some may wish to undertake formal education such as a law degree, a Masters in Law (LLM) in medico-legal studies or a Diploma in Risk Management, and even further professional qualif|cations such as the Bar examinations.
Awareness of benef|ts, risks and complications of diagnosis and treatment ^ national, local and personal statistics Knowing the civil and criminal law relating to obstetrics and gynaecology Study of relevant Acts, Statutory Bodies, Professional Authorities and Agencies Identifying the effect of the law on daily practice In-depth knowledge of relation to clinical governance, risk management, evidence-based medicine and safe practice
Database of complications and medico-legal problems and their relation to safe practice Studies of the effect of law on medical practice Relevance and authority of clinical guidelines and patient information sources National def|nitions of serious and frequently occurring risks to be discussed during counselling for valid consent
FURTHER READING, SOURCES AND STUDY Articles and Books Argent VP. Risk management in gynaecology. Curr Obstetr Gynaecol 2001; 11: 38–44. Alaily A, Sinha P. Safety Tips in Obstetrics and Gynaecology. Hastings: Roswell, 2002. Clements RV (Ed.) Risk Management and Litigation in Obstetrics and Gynaecology. London: Royal College of Obstetricians and Gynaecologists/The Royal Society of Medicine, 2001. Dalton M. Forensic Gynaecology. London: RCOG Press, 2003. Kennedy I, Grubb A. Medical Law, 3rd edn. London: Butterworths, 2000. Montgomery J. Health Care Law, 2nd edn. Oxford: Oxford University Press, 2003. Mason JK, McCall Smith R A, Laurie G T. Law and Medical Ethics, 5th edn. London: Butterworths, 1999.
Journals Casebook of the Medical Protection Society Journal of Clinical Risk Management, Royal Society of Medicine Journal of the Medical Defence Union Lloyds Medico-legal Reports
USEFUL WEBSITES Action for the Victims of Medical Accidents www.avma.org.uk CapsticksFDiploma in Risk Management www.capsticks.com Clinical Disputes Forum www.clinical-disputes-forum.org.uk
MEDICO-LEGAL PROBLEMS IN GYNAECOLOGY
Clinical Negligence Scheme for Trusts/Risk Management www.willis.com General Medical Council www.gmc-uk.org Commission for Health Improvement www.chi.nhs.uk Health Service Ombudsman www.ombudsman.uk/hsc Medical Defence Union www.the-mdu.com Medical Dental Defence Union of Scotland www.mddus.com Medical Protection Society www.mps.org.uk
299
National Care Standards Commission (Commission for Healthcare, Audit and Inspection) www.carestandards.org.uk National Clinical Assessment Authority www.ncaa.nhs.uk National Health Service Litigation Authority (also for the Clinical Negligence Scheme for Trusts and the Clinical Disputes Forum) www.nhsla.com National Institute of Clinical Excellence www.nice.org.uk National Patient Safety Agency www.npsa.org.uk
c 2003 Elsevier Science Ltd. All rights reserved. doi:10.1016/S0957-5847(03)00048 -9
Medico-legal problems in gynaecology V.P. Argent Consultant Obstetrician and Gynaecologist, East Sussex Hospitals NHS Trust, King’s Drive, Eastbourne BN20 0AG, UK
KEYWORDS medico-legal problems; litigation; risk management; clinical governance; professional misconduct
Summary Every gynaecologist should study the law applicable to their practice.This involves knowledge of civillaw, especially the tort of negligence, and criminallaw as well as the related Acts. The application of legal principles has become a part of everyday practice ranging from the signing of consent forms to risk management and incident reporting.There is considerable overlap with medical ethics. This article gives an overview of the various aspects of law in gynaecological practice ranging from the reasons for getting into trouble, statutory law and authority, new trends in consent, the provision of information, risk management, clinical incident reporting and complaints, the concept of safe practice, the legal position of guidelines, and professional and personal conduct.Forensic gynaecology also involves extensivelegal and clinical knowledge. Specif|c problem areas such as abortion, female sterilization, colposcopy, hysteroscopy, laparoscopy, hysterectomy, urogynaecology and assisted conception are discussed.The article concludes with some suggestions for training and education.
c 2003 Elsevier Science Ltd. All rights reserved.
INTRODUCTION The impact of law in the specialty of obstetrics and gynaecology far outweighs other medical f|elds. The study of law is, therefore, an integral part of the training and education of trainees and specialists who should always bear in mind the legal maxim that ignorance of the law does not excuse. Medico-legal problems in the specialty span a large range involving litigation, complaints, clinical governance and risk management, clinical incident reporting and patient safety, the implementation and importance of guidelines, professional regulation as well as ethics, statute law and criminal matters. Such is the interest and complexity of the issues involved that many colleagues in the f|eld are now specializing in medicolegal problems.Young gynaecologists may well fear their f|rst complaint investigation, clinical incident report or letter from their Trust legal department or a solicitor, but they soon realize that the handling of such problems is now an integral part of their medical practice. This article gives a snapshot of the interface between law and medical practice and will concentrate on gynaecology.
clinically sound practice. Gynaecologists’ greatest fear is of getting into trouble, although it should be realized that the thorough study of medico-legal problems does lead to improved quality of care.There are many reasons why gynaecologists may encounter medico-legal problems during their careers (Table 1). Why do patients complain and resort to legal action? There are several main themes in gynaecology (Table 2).
STATUTE LAW AND AUTHORITY
GETTING INTOTROUBLE
There are many statutes which have a direct bearing on clinical gynaecological practice such as the Abortion Act 1967, the Surrogacy Arrangements Act1985, the Prohibition of Female Circumcision Act 1985, and the Human Fertilization and Embryology Act 1990. Other statutes concern the conduct of practice, e.g. the Data Protection Act 1998, the Public Interest Disclosure Act 1998, and the various Health and NHS Service Acts. The Human Fertilization and Embryology Act set up the Human Fertilization and Embryology Authority (HFEA) which has powers of inspection and licensing. Colleagues working in the f|eld of tertiary assisted conception must be fully conversant with the HFEA regulations and code of practice.
Our primary duty is to our patients and there is increasing emphasis on the application of evidence-based
FORENSIC GYNAECOLOGY
Correspondence to:VPA.Tel.: +44(0)1323 413 706; fax: +44(0)1323 413 737; E-mail: [email protected]
Most gynaecologists have little contact with forensic problems although they should have some knowledge
MEDICO-LEGAL PROBLEMS IN GYNAECOLOGY Table 1 Getting into trouble Complaints procedures Civil claims -- litigation Trust disciplinary procedures and employment disputes Disputes with medical and management colleagues Criminal prosecutions Professional performance procedures -- National Clinical Assessment Authority and General Medical Council Professional Misconduct -- General Medical Council
Table 2
Reasons for complaints and litigation
Failure to explain the risks of proposed treatment Failure to explain limited success of proposed treatment Changing proposed treatment without adequate further counselling Departure from recommended guidelines or protocols The occurrence of complications Delayed or mistaken diagnosis Poor communication Failure to apologise Practising beyond expertise
of this discipline and the work of Forensic Medical Examiners (formerly known as Police Surgeons). Sexual assault and rape must be handled in a sensitive manner while complying with forensic procedure. Domestic violence is now recognized as a major factor in women’s health care. Sexual violence in areas of conflict has been studied by the United Nations and human rights groups.
SOME NEW TRENDS Consent Valid consent must be obtained from patients. Sometimes the consent is implied, for instance when the patient raises no objection to the request for performance of an examination. It is generally advised that written consent should be obtained for invasive procedures.The requirements for procedures such as transvaginal ultrasound scanning and colposcopy may still be unclear. In the strict legal sense, the case of Sidaway in the House of Lords conf|rmed that there is no doctrine of informed consent in English law. The correct measure of consent is the Bolam test which looks at the expected standard of the competent practitioner. This is, essentially, a peer group test but it is for the courts and their expert advisers to determine its application in an individual case. The more recent case of Bolitho, however, has moved us more towards the American standard of informed consent which depends on a patient rather than
295
a professional test of what is required. It is unfortunate that the General Medical Council (GMC) now use the term informed consent in their publication Seeking Patients’ Consent: the Ethical Considerations. It is interesting that the NHS Patient Charter considers that patients have a right to know of any risks of a proposed procedure. The new Department of Health consent forms, implemented in April 2002, contain a section Serious and Frequently Occurring Risks, but there has been no specif|c national guidance on what should be written in a specif|c case. It is now recommended that consent forms should be signed by the operating surgeon or a colleague who is capable of performing the procedure. It is essential to involve the court when contemplating an operation such as sterilization or even a hysterectomy on therapeutic grounds on adults who do not have the capacity to give consent.
Information The issue of information is being addressed by the National Collaborating Centre for Women’s Health in conjunction with the National Institute of Clinical Excellence (NICE) and the National Patient Safety Agency. These groups have a substantial lay input as well as multiprofessional input from a wide range of stakeholders. There are a few instances of recommended information for patients, e.g. prior to termination of pregnancy in the Royal College of Obstetricians and Gynaecologists’ (RCOG) Evidence Based Guideline on Induced Abortion. There is an urgent need for more thorough research into information requirements as well as increasing use of consistent patient information leaflets, information centres in gynaecological departments, and full involvement of the patient in discussion of options and management decisions.
Risk management-- clinical incident reporting--complaints This is now an integral part of gynaecological practice. Risk management includes the identif|cation of potential risk and systems design to avoid risk.Clinical incident reporting should include near-misses as well as actual adverse outcomes. Adverse outcomes must be analysed in an open, no-blame culture with full feedback to the team so that the lessons learned can be put into practice in the interests of patient safety.These procedures will be standardized by the National Patient Safety Agency. Trusts and corporate bodies are also very interested in the f|nancial limitation of claims.This may include f|nancial settlements which annoy medical staff who feel that there may have been no negligence and the adverse event was within the expected range of complications. The
296
National Health Service Litigation Authority assists Trusts with legal claims. Audit is closely linked with these processes. Standard complaints procedures are now common and the new Patient Advocacy Liaison Service and the Patient Forums will ensure that gynaecologists are involved in detailed discussions with complainants. Colleagues may be invited to appear before independent review panels and appeals to the Health Service Commissioner (the Ombudsman).
Safe practice There is an emerging concept that practitioners should conduct ‘safe practice’. This is not necessarily the same as defensive medicine, but involves a mind set which looks at what is the safest outcome for the patient, the practitioner and the corporate body. A less-effective result may be acceptable if it is achieved by safer treatment. An example would be actively promoting the use of a levonorgestrel intra-uterine contraceptive device rather than a hysterectomy for menorrhagia or a sterilization for contraception. This approach is often used in other f|elds such as chemical engineering where a lower-output, less-economic process may be used on the grounds that it is safer.
GuidelinesFthe legal position It is usually said that guidelines are not meant to dictate clinical practice. Some departments produce protocols and it has been suggested that these have more force than guidelines. NICE guidelines are particularly authoritative and practitioners will f|nd non-adherence diff|cult to defend. Recent professional conduct hearings at the GMC have shown that guidelines are increasingly used as a basis to analyse a doctor’s practice; for instance, British Society for Colposcopy and Cervical Pathology (BSCCP), RCOG guidelines and the GMC booklet Good Medical Practice have been used in presentations by GMC lawyers.
Professional and personal conduct Gynaecologists are at high risk of accusations of personal and professional misconduct. Such problems are usually closely linked to clinical practice. Never before has clinical practice been under so much scrutiny by colleagues, employers and national agencies. It is currently estimated that well over 100 gynaecologists are currently under some form of investigation. Most visits by the Commission for Health Improvement , the RCOG rapid response and review procedures as well as the National Clinical Assessment Authority (NCAA) and GMC procedures will be examining allegations of concern about clinical practice. Trust disciplinary procedures frequently deal with concerns about practice, and clinical governance is often QJ;misused. Contractual disputes require knowledge of
CURRENT OBSTETRICS & GYNAECOLOGY
employment law and access to Industrial Relations Off|cers; it is advisable to maintain membership of the British Medical Association and the Hospital Consultants and Specialists Association as well a defence society.
SPECIFIC PROBLEM AREAS Abortion There are many pitfalls involving the statutes, criminal law and civil litigation as well as some important training issues. Many issues and arguments concern ethical problems and the interpretation of the Act. Conscientious objection is covered by Section 4 of the Abortion Act 1967, and it is not commonly realized that practitioners may opt out of a particular part of the service. A practitioner may refer and counsel patients for the procedure but can opt out of the actual surgical performance of a procedure. It is clear that the Act does not allow abortion on demand. However, a patient who is refused an abortion may seek out another doctor, and the doctor who has a conscientious objection is advised by the GMC to refer the patient to a colleague. Abortion on demand is the practical effect of these situations. There is no legal def|nition of the ‘serious handicap’ clause (‘E’ on the Abortion Act form) of the grounds for termination of pregnancy as given in Section 2 of the Act, but the RCOG has suggested appropriate criteria in the1996 report onTermination of Pregnancy for Fetal Abnormality. Conf|dentiality is very important as patients may wish to remain anonymous and request that their general practitioners and even their relatives are not informed. The use of unlicensed drugs such as misoprostol for cervical ripening is covered by the Medicines Act 1968, and most Trusts have a written medicines policy which requires the specif|c consent of the patient. Litigation in this f|eld is not uncommon although some patients may be reluctant to pursue claims because of concerns about conf|dentiality. Common reasons include retained products of conception and re-admission for bleeding and infection. These are usually defensible but f|nancial settlements are frequently offered because of the low value of the claims. More serious problems such as perforation and genital tract trauma must be dealt with in a competent manner. Patients will be horrif|ed by a failed termination and ongoing pregnancy, and this is a particular risk of early surgical procedures. There have also been civil claims for failure to give an adequate warning of the psychological effects of induced abortion. Wrongful life and wrongful death actions have not found favour in English law. Criminal self-induced or illegal abortion is now a rarity in this country but the law is often invoked by pro-life groups in their objections to such procedures as postcoital contraception. Some pro-life groups encourage violence against abortion practitioners. There is a myriad of
MEDICO-LEGAL PROBLEMS IN GYNAECOLOGY
anti-abortion websites which post names on their pages and this is a huge problem in the USA. There have been prosecutions for such matters as proceeding with a hysterectomy in a patient who was found to be pregnant on entering the abdomen.
Female sterilization The application of risk management is particularly useful in this area. Sterilization is usually a social operation and patients are usually angry when the procedure fails. It is suggested that the operation should not be called ‘sterilization’ because that is the intent of the operation, and the procedures should be considered as part of the available range of contraception. Maintenance of equipment has been identif|ed as a problem leading to serial failures as well as mass action suits against manufacturers.The Medical Devices Agency have produced recommendations that clip or ring batch numbers and applicator instrument numbers should be recorded in the patients’ notes. Pre-operative information and counselling as well as a specif|c consent form are well documented in the RCOG’s Guidelines on Male and Female Sterilization. Failed sterilization occurs because the patient is pregnant at the time of the procedure (often called luteal phase failure), has an early failure following a misapplied clip or technical failure, or has a late failure related to recanalization. There is overlap between the reasons for early and late failure, although the risk of ectopic pregnancy is highest in the latter group. Risk management strategies include such matters as check information lists, pregnancy tests, proper sexual activity histories, restricting the procedure to the f|rst half of the menstrual cycle and equipment checks such as the Filshie clip gauge device. Adequate operative records must include a clear indication that the tubes and f|mbriae have been identif|ed, and many practitioners take photographic evidence of the operation. Any operative diff|culty must be fully documented together with a plan for further action if needed. It is not possible to defend the application of devices to such structures as the round ligament, and in legal terms, the facts speak for themselves. There are, however, some interesting non-negligent causes of failure such as medial f|stula formation and a patent channel. Claims from patients who have not had a follow-up operation after a failure have been successfully defended on the assumption that an experienced surgeon would be expected to have carried out the operation correctly. Failed sterilizations should be reported to the National Patient Safety Agency who are taking on the recommendations for a national register of such events.
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Colposcopy There have been several ‘scandals’ involving mistaken diagnosis, and the area provides a common source for litigation. It is prudent to follow the recommendations of the British Society for Colposcopy and Cervical Pathology. The concept of accreditation has caused many diff|culties with clinical governance and the practice of gynaecologists. There needs to be more public education about the limitations of cervical screening and colposcopy, as well as the natural progression of diseases, if we are to reduce the incidence of litigation.
Hysteroscopy Diagnostic hysteroscopy is a reasonably safe procedure but perforations and haemorrhage can occur.There is little consensus on the information that should be provided prior to the procedure. In the case of f|rst- and secondgeneration operative hysteroscopy, recent cases have shown that patients must be routinely warned about the risks of perforation, hysterectomy and bowel damage. In the case of ensuing hysterectomy, there has been much debate about whether this can be justif|ed from the consent form which allows the surgeon to do whatever is necessary in the best interests of the patient.
Laparoscopy The main problem with laparoscopy is the need to carry out a laparotomy for unexpected organ damage. In the case of bowel damage, the preferred midline incision is far more likely to lead to a suit than a suprapubic incision. Whereas most gynaecologists discuss the possibility of laparotomy and bowel damage, few specif|cally mention a midline incision or a colostomy. There has been extensive work on risk management and medico-legal problems in diagnostic and operative laparoscopy, and the recommendations usually centre on comprehensive pre-operative counselling, minimal access surgery training and experience, correct safe technique, the prompt recognition of complications, and their correct management involving surgical colleagues where necessary. Any unexpected outcome should be explained to the patient by the actual operating surgeon, involving a consultant or clinical director where indicated.
Hysterectomy There is little public awareness of the risks of this procedure. Major complications are not infrequent and litigation is common. Current medico-legal trends include claims for unnecessary hysterectomy, removal of ovaries without consent, lack of warning about early ovarian
298 failure after a hysterectomy with ovarian conservation, and usual settlement of damaged ureter cases. In unnecessary hysterectomy claims, legal advisers will depend on such literature as the VALUE study which recommends that the levonorgestrel intra-uterine contraceptive device should be the treatment of choice for menorrhagia before endometrial ablation or hysterectomy can be justif|ed.
Urogynaecology
CURRENT OBSTETRICS & GYNAECOLOGY
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There is no perfect operation for stress incontinence, and patients must be fully appraised of the success rate of the technique used. There are many new ideas in this f|eld and it is becoming more diff|cult for the general gynaecologist to continue without a suff|cient caseload. The use of pre-operative dynamics now seems necessary. Repeat operations should probably be carried out in tertiary referral centres by accredited subspecialists. Failure to adhere to these changes in practice is likely to lead to litigation where a practitioner may be criticized by experts with a particular interest in urogynaecology.
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Assisted conception Assisted conception is replete with ethical and legal problems involving statutory and case law. There is increasing litigation following the adverse outcome of multiple pregnancy with criticism of poor counselling and overoptimistic forecasts, especially in the f|nancially driven private sector. The replacement of more than two embryos is not recommended by the HFEA and this is leading to various medico-legal problems ranging from litigation, threat of withdrawal of licences and GMC investigations. Court declarations have been common and have dealt with such matters as posthumous conception, producing a baby for stem cell collection, and ownership of unwanted embryos.
TRAINING AND EDUCATION Gynaecologists have a duty to acquaint themselves with the law. Some will specialize in the f|eld by conducting academic medico-legal research on litigation, clinical incidents and risk management, becoming expert witnesses, GMC performance procedure assessors or by working full time for national agencies, risk management organizations, solicitors or the defence societies. A few have crossed the floor and have become professionally qualif|ed solicitors and barristers. The further reading list gives a brief outline of some sources for further study. Some may wish to undertake formal education such as a law degree, a Masters in Law (LLM) in medico-legal studies or a Diploma in Risk Management, and even further professional qualif|cations such as the Bar examinations.
Awareness of benef|ts, risks and complications of diagnosis and treatment ^ national, local and personal statistics Knowing the civil and criminal law relating to obstetrics and gynaecology Study of relevant Acts, Statutory Bodies, Professional Authorities and Agencies Identifying the effect of the law on daily practice In-depth knowledge of relation to clinical governance, risk management, evidence-based medicine and safe practice
Database of complications and medico-legal problems and their relation to safe practice Studies of the effect of law on medical practice Relevance and authority of clinical guidelines and patient information sources National def|nitions of serious and frequently occurring risks to be discussed during counselling for valid consent
FURTHER READING, SOURCES AND STUDY Articles and Books Argent VP. Risk management in gynaecology. Curr Obstetr Gynaecol 2001; 11: 38–44. Alaily A, Sinha P. Safety Tips in Obstetrics and Gynaecology. Hastings: Roswell, 2002. Clements RV (Ed.) Risk Management and Litigation in Obstetrics and Gynaecology. London: Royal College of Obstetricians and Gynaecologists/The Royal Society of Medicine, 2001. Dalton M. Forensic Gynaecology. London: RCOG Press, 2003. Kennedy I, Grubb A. Medical Law, 3rd edn. London: Butterworths, 2000. Montgomery J. Health Care Law, 2nd edn. Oxford: Oxford University Press, 2003. Mason JK, McCall Smith R A, Laurie G T. Law and Medical Ethics, 5th edn. London: Butterworths, 1999.
Journals Casebook of the Medical Protection Society Journal of Clinical Risk Management, Royal Society of Medicine Journal of the Medical Defence Union Lloyds Medico-legal Reports
USEFUL WEBSITES Action for the Victims of Medical Accidents www.avma.org.uk CapsticksFDiploma in Risk Management www.capsticks.com Clinical Disputes Forum www.clinical-disputes-forum.org.uk
MEDICO-LEGAL PROBLEMS IN GYNAECOLOGY
Clinical Negligence Scheme for Trusts/Risk Management www.willis.com General Medical Council www.gmc-uk.org Commission for Health Improvement www.chi.nhs.uk Health Service Ombudsman www.ombudsman.uk/hsc Medical Defence Union www.the-mdu.com Medical Dental Defence Union of Scotland www.mddus.com Medical Protection Society www.mps.org.uk
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National Care Standards Commission (Commission for Healthcare, Audit and Inspection) www.carestandards.org.uk National Clinical Assessment Authority www.ncaa.nhs.uk National Health Service Litigation Authority (also for the Clinical Negligence Scheme for Trusts and the Clinical Disputes Forum) www.nhsla.com National Institute of Clinical Excellence www.nice.org.uk National Patient Safety Agency www.npsa.org.uk