medicolegal issue in gynaecology by Kyaw Si Thu

REVIEW

Medico-legal issues in gynaecology

test); however, the court must be satisfied that exponents of that practice could demonstrate that their opinion had a logical basis (the Bolitho test). The duty of care may be breached by a failure or delay in diagnosis or treatment, failure to advise or to provide adequate information, administering a wrong treatment (including performing the wrong surgery), or performing an inappropriate operation. The breach of duty, whilst regrettable and unacceptable, will not in itself be enough to establish a case of clinical negligence. The claimant has to show that the breach caused an injury; in other words, it must be shown that but for the breach of duty the injury would not have occurred (or would not have been as severe). This is known as ‘causation’. If causation is established, the court will grant compensation for losses that the claimant has suffered as a result of the injury, provided that such losses are recognized by the court as deserving of compensation. The compensation comprises a sum for the ‘pain, suffering and loss of amenity’ caused by the injury and another sum covering the financial losses and extra expenses caused by the injury. For most cases in gynaecology, the claim has to be brought within 3 years of the injury, or within 3 years of the time when the patient realized or could reasonably have known that she had suffered an injury attributable to her treatment. This rule of limitation does not apply if the patient is a child (the 3-year period starts on her 18th birthday) or if the patient has a recognized mental illness.

Leroy C Edozien

Abstract Gynaecologists, like other healthcare professionals, have a legal obligation to adhere to a reasonable standard of care while acting in their professional capacity (the ‘duty of care’). A breach of this duty, whether due to proximate causes such as poor decision-making or to remote causes such as destitute safety culture in the organization, could lead to litigation. This review discusses the burden and causes of litigation in gynaecology and outlines the process taken by a medico-legal claim. Failure to diagnose, intra-operative complications, unnecessary surgery, consent issues, poor supervision and retention of foreign bodies are common causes. An illustrative case study is presented and some ways of reducing the risk of litigation are recommended.

Keywords clinical negligence; medico-legal; patient safety; risk management; safe practice

Introduction

NHS indemnity

Sometimes patients suffer harm, physical or psychological, from care that was intended to heal them. In some cases, this is due to human error or to defects in the organization and delivery of care. In other cases, the harm is attributable to sub-standard care associated with technical incompetence, poor decision-making or departure from accepted clinical practice. Whatever the underlying cause, litigation may follow. In this article, the burden and causes of litigation in gynaecology are discussed and the process taken by a medico-legal claim is outlined. Recommendations are made to reduce the risk of litigation.

Gynaecologists working under a contract of employment with the National Health Service (NHS) e unlike those working in the private sector or colleagues in countries like the USA e do not have to worry about being sued in their personal capacity. This is because they are indemnified by their employer for any alleged negligence in the course of their employment. NHS indemnity also covers locums and academic medical staff holding an honorary contract who have a duty of care to the NHS patient. This indemnity has implications for pattern of care because clinicians working under the fear of litigation are often accused of practicing ‘defensive medicine’ e that is, practicing an interventionist style of medicine in a bid to avert litigation. Claims against NHS Trusts are handled by the NHS Litigation Authority (NHSLA). Apart from handling claims, the NHSLA has a statutory duty to help improve the quality of patient care by assisting NHS bodies with risk management. It does this largely through the Clinical Negligence Scheme for Trusts (CNST).

Clinical negligence Gynaecologists, like other healthcare professionals, owe a ‘duty of care’ to their patients. The duty of care is a legal obligation to adhere to a reasonable standard of care while acting in a professional capacity. When a case goes to litigation, the question arises whether this duty of care has been breached. To determine this, the court relies on the evidence of expert witnesses. In turn, expert witnesses will take account of national and local evidence-based guidelines and conventional practice when advising on the standard of care provided. The courts will apply the principle that states that a doctor is not negligent if he/she acts in accordance with accepted medical practice at the time, even though there may be doctors who hold a contrary opinion (the Bolam

CNST This scheme, funded by member trusts, provides an indemnity to members and their employees in respect of clinical negligence claims arising from events that occurred on or after 1st April 1995. The CNST provides incentives for trusts to reduce patient safety incidents and litigation through attainment of risk management standards. Some of these standards, such as those relating to patient identification, consent, infection control, record keeping and transfer of care between professionals, cover areas that feature regularly in gynaecological cases proceeding to litigation.

Leroy C Edozien LLB FRCOG is a Consultant Obstetrician and Gynaecologist at St Mary’s Hospital, Manchester, UK. Conflicts of interest: none declared.

OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 22:10

273

REVIEW

Litigation: life-cycle of a claim

Open gynaecology claims by cause as at 31/01/2012 (NHSLA)

Most gynaecologists would at some point in their career have to address a complaint filed by a patient about their care. Sometimes it is anticipated that this complaint would be followed by litigation. At other times, the complaints route is not followed and the first indication of imminent litigation is a letter from a solicitor requesting for the patient’s medical records. The solicitor passes the records to an expert witness for a report on breach of duty and causation (see above). If the report suggests that there is a claim, the solicitor writes a Letter of Claim setting out the facts of the case, the alleged sub-standard care and the resultant injury. The NHSLA obtain reports from the clinicians who looked after the patient and solicitors commissioned by the NHSLA instruct an expert witness to write a report on the case. On the basis of these reports a Letter of Response is drafted, which sets out which aspects of the claim are agreed and which ones are repudiated. Negotiations and mediation usually follow. In the cases where contentious issues remain unresolved, formal legal proceedings start. The claimant files Particulars of Claim and the NHSLA files a Defence. Statements of witnesses of fact and reports of expert witnesses are exchanged between both parties, as are a schedule of the financial losses sustained as a result of the injury and the defendant’s counterschedule. In the small number of cases that remain unresolved at this stage, trial begins. Only about 4% of cases reach the courts.

No. of claims

Wrong diagnosis Intra-operative problems Inappropriate treatment Failure/delayed treatment Failure/delayed diagnosis Failure to obtain valid consent Failure to recognize complication Operator error Failed sterilization Failure to perform operation

146 119 98 65 58 39 31 22 14 11

20 17 14 9 8 5 4 3 2 2

NHSLA, National Health Service Litigation Authority.

Table 1

Open gynaecology claims by injury as at 31/3/07 (NHSLA)

Burden of claims in gynaecology Obstetrics steals the limelight from its twin sister when it comes to litigation statistics but gynaecology has its own fair share of medico-legal claims. Between 2001 and 2011, the NHSLA received 3757 claims relating to gynaecology, and paid out a total of £189 million on gynaecology claims. During the same period, there were 9035 new obstetric claims and the total amount paid out on obstetric claims was £2824.6 million. In the NHSLA’s books, gynaecology accounted for 4% of open claims by specialty as of 31 March 2011 (obstetrics 20%; orthopaedics 13%; accidents and emergencies 12%; general medicine 6%; general surgery 8%; and paediatrics 5%). These figures, however, do not tell the whole story. Firstly, most patients in other adult specialties are older persons with major health problems, higher levels of morbidity and lower expectations. Gynaecology patients, bar those with cancer, are mostly healthy younger women seeking better quality of life through fertility treatment or fertility control, regulation of the menstrual cycle, treatment of non-life-threatening infection or treatment of pelvic floor dysfunction. Their expectations of a good outcome are relatively high. Secondly, the litigation statistics are the tip of the iceberg e many victims of patient safety incidents do not proceed to litigation. Thirdly, no matter how small the fraction of payments for gynaecological claim, this is money that should have gone into patient care.

Injury

No. of claims

Bladder damage Additional/unnecessary operation(s) Unnecessary pain Bowel damage/dysfunction Infertility Psychiatric/psychological damage Cancer Advanced stage cancer Perforation of viscus Incontinence Fatality Unwanted pregnancy

215 126 78 34 24 24 21 13 18 16 16 15

30 17 11 5 3 3 3 2 2 2 2 2

NHSLA, National Health Service Litigation Authority.

Table 2

operating theatre. These include injuries to viscera e bladder, bowel, ureter, major blood vessels e and the problems that flow from an allegedly unnecessary operation. Some of these incidents are the result of human error on the part of the gynaecological surgeon; others have their roots in systemic deficiencies e such as poor safety culture, inadequate staffing, absence of supervision and poor team work. Although only 4.5% of cases have been classified as failure to obtain consent, it is likely that many of the cases of unnecessary surgery were consent cases e the patient arguing that had she been given adequate information about the benefits and risks, she would not have agreed to undergo the operation. In the next few paragraphs some of the common causes of claims are discussed further.

Causes of claims The common causes of claims in gynaecology are shown in Table 1 and are essentially the same as previously reported. The distribution of claims by type of injury is shown in Table 2. More specific examples of incidents that lead to claims are given in Table 3. Many claims arise from patient safety incidents occurring in the

OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 22:10

Cause

Consent All patients undergoing treatment should be given appropriate information on the nature and purpose of the treatment, benefits,

274

REVIEW

Failure to diagnose Many of the claims under this heading relate to cancers of the ovary, endometrium, cervix and vagina. With arrangements now in place to meet the deadlines set under HSC205 for the treatment of cancers (62 days from the referral of a suspected cancer to treatment) and the centralization of cancer services, this will probably become a less frequent claim. A common source of claims for ‘failure to diagnose’ is missed ectopic pregnancy. In some of these cases, the claimant has alleged that but for the failure to diagnose this condition earlier, she would have had fertility sparing treatment; that late diagnosis had led to the avoidable loss of a fallopian tube. In other cases, a missed diagnosis has led to emotional distress and longer hospitalization as a result of a ruptured ectopic gestation.

alternatives and risks, and the consent process must comply with the hospital’s consent policy. The emphasis here is on consent as a process, not merely obtaining the patient’s signature on a consent form. Consent should be seen not as an end in itself but a means to responsible participation by patients in their own care and a means to a mutually rewarding relationship between clinician and patient. All too often clinicians equate consent with the signing of a form or consider consent primarily as protection against litigation. The signatures on a form are not a substitute for a proper discussion of the proposed intervention and engaging the patient in decision-making about her own care. Guidance in this regard has been provided by the Royal College of Obstetricians and Gynaecologists. The decision of the House of Lords in Chester vs Afshar emphasizes the need for gynaecologists and other surgeons to pay attention to consent and document consent discussions adequately. Miss Chester underwent surgery in the hands of the neurosurgeon Mr Afshar to remove three protruding intervertebral discs that were causing back pain and had not responded to conservative management. The operation carried a 1e2% risk of cauda equina syndrome developing. Unfortunately, this risk materialized. Miss Chester alleged e and this was contested by the defence but accepted by the trial judge e that Mr Afshar did not warn her of the risk of paralysis. Expert witnesses testified to the effect that there had been no negligence in performance of the surgery. The defence argued that even if the surgeon had failed to warn the patient of the risk of cauda equina syndrome, there was no evidence that, had she been given this warning, Miss Chester would never have had the operation. This argument followed the traditional principle of causation described above e that unless a claimant can prove, on the balance of probabilities, that the defendant’s sub-standard care caused her injuries, the claim fails. The House of Lords, by a majority of 3:2, modified this principle and decided in favour of the claimant. The majority held that not informing Miss Chester of the risk of cauda equina syndrome denied her the chance to make a fully informed decision e and this fundamental right to make an informed decision deserved protection. This means that gynaecologists must pay particular attention to consent and remember that the usual principle of causation may not apply in these cases. The case also draws attention to the importance of fully documenting consent discussions.

Failed or incomplete operation Gynaecologists have paid particular attention to good practice in consent in the past 10e15 years, so failed sterilization claims based on lack of consent are disappearing. Most claims now are based on negligent performance of the operation, where the clip (on one or both sides) has been applied to a structure other than the fallopian tube, or where a clip has been applied to a tube insecurely such that it drops off within minutes of application, unknown to the hapless surgeon. It is important that trainees performing tubal ligation are supervised until certified competent for independent practice. It is conceivable that sterilization claims based on consent may reemerge with rising awareness that the Mirena coil offers an equally effective, reversible and non-surgical alternative to laparoscopic tubal ligation. A woman who suffers injury to a viscus at laparoscopy could reasonably claim that had she been made aware of the Mirena coil she would not have opted for surgical contraception. The author offers this form of long-term contraception to all women presenting with a request for sterilization and documents that information leaflets on both options have been provided. Other examples of failed operation include failure of surgical termination of pregnancy, the patient presenting afterwards with advanced pregnancy, and incomplete evacuation of products of conception, resulting in sepsis and uterine perforation at a subsequent attempt to evacuate the septic uterus. In cases of incomplete evacuation, it sometimes happens that the surgeon had his or her own suspicions that the products of conception had not been completely evacuated but failed to act on that suspicion.

Unnecessary surgery Examples of claims of unnecessary surgery include removal of one or both ovaries when the woman was scheduled for hysterectomy with conservation of the ovaries, and removal of both ovaries when consent was given for removal of one ovary only. These are usually due to the surgical team’s inattention at the critical moments; however, systemic defences (such as the ‘time-out’ and checklist, see below) could be put in place to reduce the risk of this type of incident. Claims have also arisen from unnecessary removal of a fallopian tube, which is usually associated with an operation on the wrong side for tubal pregnancy. A claim that unnecessary surgery has been performed may arise when complications have followed the operation. The patient looks back and questions the indication for surgery; she may also feel that she was not given adequate information about the risks and benefits of the operation.

OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 22:10

Retained foreign bodies Retention of foreign bodies in the abdomen or vagina remains a problem despite longstanding guidelines for the counting of swabs and instruments. The incident may be due to a failure to follow protocols for counting swabs and instruments, or due to inattention in counting. Double witnessing does not guarantee that one person’s inattention will be compensated for by an alert seconder. Vaginal packs are sometimes forgotten, or one gauze roll is removed when two have been put in. In an unusual case, a ring pessary was left in place forgotten for years because the elderly patient missed an appointment.

Reducing the number of incidents As seen from Tables 1 and 2, most medico-legal claims in gynaecology relate to events in the operating theatre.

275

REVIEW

Checklist and ‘time-out’ Following an international multicentre study which showed its effectiveness in patient safety, a Surgical Safety Checklist is now in wide use. The checklist includes consent, equipment checks and antibiotic prophylaxis. It requires that a pre-incision ‘timeout’ be observed for the purpose of double-checking the patient’s identity and the procedure to be undertaken.

Examples of patient safety incidents Failure in diagnosis/treatment C Failure to diagnose C Cancer: ovarian, endometrial, cervical, vaginal C Ectopic pregnancy C Failure to exclude pelvic infection before hysterosalpingogram C Failure to perform pregnancy test prior to sterilization C Latex allergy not addressed C Failure to administer antibiotic or antithrombotic prophylaxis C Failure to ensure biopsy specimen delivered to histopathology laboratory

Delayed treatment Delayed treatment resulting from alleged failure to action a change of address

Unnecessary pain Alleged negligent attempt to remove cervical polyp in clinic Failure to ensure appropriate disposal of fetal tissue

C C

C C C C

C C C C C

Supervision A large fraction of claims where the patient has been injured in theatre concern trainees performing surgery under less than satisfactory supervision. In a case that went to court (see Box 1), the judge held that the supervising surgeon was under a duty to satisfy himself/herself by appropriate inquiry that the trainee had sufficient recent experience of the procedure. The judge found that the supervisor failed in that duty and was, therefore, medically negligent to that extent. This case makes it clear that a supervisor has a legal duty to satisfy himself/herself about the extent of a trainee’s appropriate recent experience before allowing them to undertake the procedure.

Surgery without valid consent Hysterectomy without consent Removal of both ovaries when only listed for removal of one or none

Risk management Issues such as supervision and surgical safety checklists cannot be effectively addressed in isolation. They are best addressed within a holistic clinical governance framework that incorporates risk assessment and control, audit, education and user involvement. The RADICAL (Raise Awareness, Design for safety, Involve users, Collect and Analyze safety data, Learn from patient safety incidents) framework serves this purpose. The risk management agenda has in the past often been regarded by many clinicians as essentially a matter for managers to deal with. Revalidation will shift risk management towards centre-ground, and individual clinicians will have to take responsibility for managing risks in their practice.

Intra-operative problems Damage to viscus during open or minimal access surgery Bladder, ureter, bowel, major blood vessel, uterine perforation Diathermy burns in peritoneal cavity, vagina or externally Wrong fallopian tube removed Incomplete/failed operation Failure to remove both ovaries as planned during hysterectomy Unsuccessful surgical termination of pregnancy Incomplete evacuation of a miscarriage During sterilization operation, contraceptive coil not removed Wrong cyst/mole/skin tag removed from vulva

When things go wrong

Foreign bodies retained in vagina or abdomen Wound drain, vaginal pack, swabs, surgical instruments, rubber tip of Spackmann’s cannula

Despite our best efforts, accidents will sometimes happen. Often, the manner in which this situation is handled determines whether it proceeds to litigation. Not always, but frequently enough, an explanation and an apology will stave off a claim. Clinicians fear that this could leave them vulnerable to a claim but the opposite is generally the case. The NHSLA encourages clinicians to render an apology where required. In a circular, its Chief Executive has said:

The above list has been extracted with permission from the database of the National Health Service Litigation Authority.

Table 3

Interventions to reduce the number of claims should address peri-operative care as a priority (Edozien, 2005). A range of such interventions is discussed elsewhere. Issues to be addressed include management of the theatre list, supervision, introduction of new techniques, surgical safety checklist and human factors (including team work).

‘It is both natural and desirable for clinicians who have provided treatment which produces an adverse result, for whatever reason, to sympathize with the patient or the patient’s relatives; to express sorrow or regret at the outcome; and to apologize for shortcomings in treatment. It is most important to patients that they or their relatives receive a meaningful apology. We encourage this, and stress that apologies do not constitute an admission of liability. In addition, it is not our policy to dispute any payment, under any scheme, solely on the grounds of such an apology.’ He also encouraged staff to give explanations:

The operating theatre list In a sense, the patient’s journey to the operating theatre starts when the theatre list is prepared. This list shows who is to be operated on, what operations are to be performed and in what order. It is remarkable how often things go wrong because of errors in compiling and publishing a list. Good practice in this regard could reduce the number of incidents of misidentification, wrong-site surgery and surgery exceeding what was consented to.

OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 22:10

‘Explanations should not contain admissions of liability. For the avoidance of doubt, the NHSLA will not take a point

276

REVIEW

Case study: Greenhorn vs South Glasgow University Hospitals NHS Trust (2008) CSOH 128

For the purposes of this review, the focus is not on the actual facts of the incident but on lessons that can be learned from the judgement.

Summary of the case The patient was a 33-year-old woman. Para 3. Five years after hysterectomy she had urodynamic assessment that showed genuine stress incontinence and detrusor instability. She did not respond to physiotherapy and was thus offered colposuspension. The operation was performed by a senior registrar, assisted and supervised by a senior surgeon. In the course of the operation she suffered massive blood loss. An emergency angiography was performed after abortive attempts in theatre to stop the bleeding. This revealed bleeding from a branch of the right iliac artery and embolization stopped the bleeding. The blood loss resulted in a neurological injury. The claimant averred not only that the surgeon was negligent in carrying out the operation but also that this surgeon lacked the necessary experience to carry it out and that the senior surgeon failed to supervise the trainee properly during the operation. Justice Uist found that the supervising surgeon ‘did not go far enough’ to determine the extent of the trainee’s recent experience and ‘had no clear idea’ about the nature of the trainee’s experience in doing this type of operation and how recent the experience was. The senior surgeon had expected that as a senior registrar, the trainee would be a skilled surgeon but the judge described this as ‘an unfounded assumption’ about the trainee’s experience and surgical ability. It was established that arterial bleeding was not an accepted or recognized risk of colposuspension. If an occurrence was not a known complication of a medical procedure or was so rare, that itself could support an inference of negligence. Once the claimant proved that there was arterial damage (radiological evidence confirmed it), this raised a prima facie inference of negligence and the onus was on the defendants to prove that this injury occurred without negligence on their part. The judge quoted Lord Denning’s statement in an earlier case that a claimant is entitled to say: ‘I went into hospital to be cured of two stiff fingers. I have come out with four stiff fingers, and my hand is useless. That should not have happened if due care had been used. Explain it, if you can.’

Box 1

against any NHS body or any clinician seeking NHS indemnity, on the basis of a factual explanation offered in good faith before litigation is in train. We consider that the provision of such information constitutes good clinical and managerial practice.’

Conclusion Most women attending gynaecological consultations are young and fit and expect to have safe care. The swift transition from a low-risk to a high-risk situation that is a common scenario in obstetrics does not apply here. For this group of women, medicolegal claims can and should be reduced below current levels. Individual clinicians’ attention to safety issues and effective risk management systems should help to achieve this. Revalidation will be a strong driver in this direction. A

FURTHER READING Bolam vs Friern Hospital Management Committee [1957] 1 WLR 582. Bolitho vs City & Hackney health authority. Lloyd’s Rep Med 1998; 1: 26. Clements RV. Litigation in gynaecology. Rev Gynaecol Pract 2003; 3: 70e4. Edozien LC. Patient safety in the operating theatre: an overview. Clin Risk 2005; 11: 177e84. Edozien LC. Risk management in gynaecology: principles and practice. Best Pract Res Clin Obstet Gynaecol 2007; 21: 713e25. Greenhorn vs South Glasgow University Hospitals NHS Trust [2008] CSOH 128. Haynes AB, Weiser TG, Berry WR, et al. Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009; 360: 491e9. NHS Litigation Authority (NHSLA) website. (http://www.nhsla.com). NHS Litigation Authority (NHSLA). Circular from the chief executive, endorsed by the Medical Protection Society, Medical Defence Union Medical and Dental Defence Union of Scotland. Royal College of

Lessons from the case C

A supervisor should be fully aware of a trainee’s recent appropriate experience before allowing him/her to be first surgeon The supervisor will be held liable if a complication occurs as a result of the trainee applying a wrong manoeuvre, so must be fully attentive throughout the procedure and intervene immediately if a risk is anticipated Risk assessment should be undertaken and factors such as previous hysterectomy and obesity should inform decisions about who operates, when and under what circumstances. Use of the surgical safety checklist (see text) will

OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 22:10

help focus attention on risk factors and anticipated problems at the start of surgery The surgeon’s operation notes were closely scrutinized during trial. In all cases, but particularly where there has been a safety incident, there should be meticulous documentation Although the patient was recognized to be obese (the anaesthetist noted ‘obese þþ’) her body mass index was not recorded. The theatre records had the supervising surgeon as the first surgeon and the second assistant (a junior registrar) as the first assistant. Such lapses do not reflect a good safety culture. Record keeping standards should be seen as part of operating theatre safety The surgeon estimated the blood loss to be 6e7 litres blood but there was a suggestion that this may have been an overestimate. In cases of massive haemorrhage, the swabs should be weighed and an attempt made to obtain an objective assessment of peri-operative blood loss

277

REVIEW

Nursing, British Medical Association, National Patient Safety Agency and General Medical Council, May 2009. NHS Litigation Authority. NHSLA Risk Management Standards for Acute Trusts, Primary Care Trusts and independent sector providers of NHS care 2009/10. London: NHSLA, February 2009. Reed MW, Phillips WS. Operating theatre lists e accidents waiting to happen? Ann R Coll Surg Engl 1994; 76(6 suppl): 279e80. Royal College of Obstetricians and Gynaecologists. Improving patient safety: risk management in maternity and gynaecology. Clinical Governance Advice No. 2. London: RCOG, 2009.

OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 22:10

Royal College of Obstetricians and Gynaecologists. Obtaining valid consent. Clinical Governance Advice No. 6. London: RCOG, 2009.

Acknowledgement The author is grateful to Mr John Mead (Technical Claims Director) and Catherine Anderson (statistician), NHS Litigation Authority for kindly providing the data used in this paper.

278