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Litigation in gynaecology
Swati Jha MD FRCOG,a,
* Sarah Rowland MA (Oxon)
Consultant Obstetrician and Gynaecologist, a...
three years from the point a claim is made that cases will reach
a courtroom (trial). The stages of a claim leading up to ...
advice given by doctors. Doctors can proceed to advise
and treat patients provided they are satisfied by the
following crit...
intervention or operation, it is important to ensure that she
understands the nature of the condition for which it is bein...
that any bleeding will run into the abdominal cavity and
be identified.
 Use a drain when necessary.
 Patients should be gi...
negligence claim. They can arise from a simple failure to count
swabs and instruments to forgotten pessaries or removal of...
effective risk management and attention to safety issues form
the basis of good clinical practice. These will be further
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  1. 1. Litigation in gynaecology Swati Jha MD FRCOG,a, * Sarah Rowland MA (Oxon) b a Consultant Obstetrician and Gynaecologist, and Honorary Senior Clinical Lecturer, Jessop Wing, Sheffield Teaching Hospitals NHSFT, Tree Root Walk, Sheffield S10 2SF, UK b Partner, Medical Law and Patients’ Rights Team, Irwin Mitchell LLP, Riverside East, 2 Millsands, Sheffield S3 8DT, UK *Correspondence: Swati Jha. Email: Accepted on 24 September 2013 Key content Reasons for litigation and pitfalls in patient care. Knowledge of civil law and basic Acts governing clinical negligence in a medicolegal claim. Specific problem areas relating to consent, sterilisation, laparoscopy, colposcopy, hysteroscopy, urogynaecology and hysterectomy. Issues of education, training and clinical governance. Learning objectives To understand the anatomy of a claim. How to avoid litigation. What to do when things go wrong. Ethical issues Increased litigation leads to clinicians practicing defensive medicine. Are patients being exposed to unnecessary investigations and invasive procedures to prevent clinicians from being sued? Litigation has an adverse impact on healthcare professionals and affects recruitment to particular specialties. Keywords: clinical negligence / litigation / medico-legal / professional misconduct / risk management Please cite this paper as: Jha S, Rowland S. Litigation in gynaecology. The Obstetrician Gynaecologist 2014;16:51–57. Introduction Obstetrics and gynaecology has always had a reputation for being a highly litigious specialty. It is estimated in the USA that annually 11% of obstetricians and gynaecologists will face a malpractice suit of which 2.5% will result in a payout.1,2 The same study showed that over their medical careers 100% of all obstetricians and gynaecologists will face a claim for medical negligence. Within the remit of gynaecology, claims should be brought within 3 years of the injury or the date of knowledge of clinical negligence. Where the injured person is a child, the 3-year period does not begin until they reach their 18th birthday. So, in effect, a child has until their 21st birthday to bring a claim. No time limit applies to claimants who lack capacity, as is often the case in birth injury cases. If an adult dies as a result of their medical treatment, their personal representatives or dependants may bring a claim within 3 years of the date of their death. Why do doctors get sued? A study by Vincent et al.3 demonstrated that the four main reasons for litigation are: Accountability: when things go wrong someone should be held accountable for their actions. The need for an explanation: to know how the injury happened and why. Concern with standards of care: the desire to prevent similar accidents in the future. Compensation for actual losses, pain and suffering or the provision of future care for an injured person. However, Vincent et al. and several other studies have also shown that the decision to take legal action is determined not only by the original injury, but also by failure to provide information, an explanation and an apology. Insensitive handling of an injury and poor communication after the original incident increases the risk of litigation and erodes the patient–doctor relationship. Anatomy of a claim The various medical defence organisations (NHS Litigation Authority [NHSLA], Medical Defence Union [MDU], Medical Protection Society [MPS]) receive several thousand new claims per year but very few reach court (1–2%). Irrespective of outcomes, being sued is a distressing experience. It is reassuring to know that the chances of ending up in court are relatively slim and there is a 70% chance that cases are successfully defended. A claim goes through various stages before it will be dropped, settled out of court, or successfully defended or claimed. It is usually up to ª 2014 Royal College of Obstetricians and Gynaecologists 51 DOI: 10.1111/tog.12065 The Obstetrician Gynaecologist 2014;16:51–57 Review
  2. 2. three years from the point a claim is made that cases will reach a courtroom (trial). The stages of a claim leading up to and different aspects of a trial are described in Table 1. Key cases that have influenced medico-legal rulings Bolam v Friern Hospital Management Committee4 The Bolam principle formulated that a medical professional is not considered negligent if his practice reflects that of an accepted body of responsible medical opinion at that time. This is in spite of other doctors at that time adopting a different practice. This means that the standard of care is a matter of medicaljudgement,eventhoughthelawimposesthedutyofcare. Bolitho v City and Hackney Health Authority5 The Bolitho principle subjects expert evidence to close judicial scrutiny. The court is not bound to accept that a doctor escapes liability for a treatment or diagnosis purely on the grounds that other medical experts are of the opinion that the defendant’s actions were in accordance with sound medical practice. The court has to be satisfied that the exponents of the body of opinion relied upon can demonstrate that such opinion has a logical basis. The experts must question comparative risks and benefits and have reached a defensible conclusion on the matter. Roe v Minister of Health6 The Roe ruling stated that a defendant may not be liable provided he acted in accordance with medical knowledge availableatthetimeoftheincidentratherthanthetimeofthetrial. Ashcroft v Mersey RHA7 The burden of proof lies with the claimant to prove that on the balance of probabilities the defendant was negligent. Hunter v Hanley8 Departure from routine practice does not automatically constitute negligence. Crawford v Board of Governors of Charing Cross Hospital9 The standard of medical knowledge and its application will not be judged on the basis of publication in isolated medical journals. Wilsher v Essex Area Health Authority10 The standard of care is reliant on the post occupied by a doctor, not the level of training. Where multiple causes resulted in an adverse outcome it is for the claimant to prove that “But For” the defendant’s actions the damage would not have occurred. Chester v Afshar11 Patients should be told of any possible significant adverse outcomes of a proposed treatment. A patient has a prima facie right to be informed by a surgeon of a small, but well-established, risk of serious injury as a result of surgery; even if it would not have changed the claimant’s decision to proceed with the treatment. Janaway v Salford Health Authority12 Doctors who object to participating or being involved in the process of termination of pregnancies should make these opinions known to patients and give them an opportunity to see another clinician without undue delay if that is what the patient desires. The definition of ‘participating’ has been subjected to considerable scrutiny in this case. The General Medical Council (GMC), in the current edition of Good Medical Practice goes on to state ‘the doctor must ensure that arrangements are made for another suitably qualified colleague to take over this role so that the patient’s care does not suffer’. Gillick v West Norfolk Wisbeach Area Health Authority13 This ruling meant that children under 16 years of age could be deemed as competent if for a particular decision they understood the problem and its implications, risks and benefits of treatment, consequences if not treated, the alternative options and implications on the family. They need also to be able to retain (remember) the information, weigh the pros and cons and communicate a reasoned decision about their wishes. Fraser ruling14 Lord Fraser, in his ruling of the the Gillick case in the House of Lords produced guidelines with regard to contraceptive Table 1. Anatomy of a claim Pre-Trial Trials Stage 1: Letter before action Practicalities and the media Stage 2: Letter of claim Court proceedings Stage 3: The response Judgement Stage 4: Formal proceedings begin Damages and costs Stage 5: Track allocationa Appeals Stage 6: Your witness statement A security blanketb Stage 7: Exchange of expert witness reports Stage 8: Expert joint meetings a Courts allocate a claim to one of three tracks. This depends on complexity of the case and its value. This could be small claims, a fast track or a multi track. Most clinical negligence cases fall in the category of ‘multi-track’. b Defence organisations provide both financial indemnity and specialist advice and support for doctors facing a trial. 52 ª 2014 Royal College of Obstetricians and Gynaecologists Litigation in gynaecology
  3. 3. advice given by doctors. Doctors can proceed to advise and treat patients provided they are satisfied by the following criteria: 1. ‘that the girl (although under the age of 16 years of age) will understand advice; 2. that they cannot persuade her to inform her parents or to allow them to inform the parents that she is seeking contraceptive advice; 3. that she is very likely to continue having sexual intercourse with or without contraceptive treatment; 4. that unless she receives contraceptive advice or treatment her physical or mental health or both are likely to suffer; 5. that her best interests require them to give her contraceptive advice, treatment or both without the parental consent.’ Medical indemnity Gynaecologists employed by the NHS receive indemnity against claims for clinical negligence handled by the NHSLA. Whereas NHS vicarious liability covers clinical negligence claims, it would not cover coronal enquiry or GMC proceedings so all active clinicians should still have defence cover. Those working in the private sector will need insurance through defence organisations such as the MDU or MPS. The NHSLA manages clinical negligence and other claims made against the NHS in England on behalf of its member organisations. Other activities include improving safety for patients and staff, sharing learning about risks and standards in the NHS and resolving disputes fairly. The NHSLA is also responsible for handling issues relating to equal pay claims and investigating and advising the NHS on human rights case law. In 2011–12 the annual NHS bill for clinical negligence claims reached £1.28 billion. This was a 45% rise from the previous year’s total of £863 million. Though the total number of claims for clinical negligence is the highest in surgery, the value of payouts are greatest for obstetrics and gynaecology of which the large proportion is related to obstetric payouts.15 When a successful claim is made, two elements constitute a compensation award. The first is financial compensation for pain and suffering caused by the injury and is called general damages. This may include an element to represent a person’s inability to do things after the medical incident that they could do before the incident. General damages awarded are assessed using guidelines given to judges and precedents from previous cases. The second element is known as special damages and is compensation for past and future losses and expenses. In a clinical negligence claim compensation is based on outcomes had the treatment been a success. Most often, clinical negligence cases are settled out of court. Aetiology of claims in gynaecology A case of clinical negligence requires four elements are met: duty arising out of the physician–patient relationship, a breach of that duty (i.e., deviation from the accepted standard of care), a link between that breach of duty, and a specific harm that has occurred. With regard to gynaecology, common causes of claims are shown in Figure 1 and specific injuries leading to claims are shown in Figure 2. These are NHSLA data for 2012 hence exclude claims made to and defended by private insurers such as the MDU or MPS. In 2012, 504 claims were coded under gynaecology, 75 were closed with no payout and 51 were closed with payment. A total of £810,888.90 (excluding costs) was paid in damages. Common areas of litigation in gynaecology Consent With the exception of cancer patients, in gynaecology most patients are healthy with problems relating to quality of life. Most surgery is elective. The expectations of these patients are therefore high, and litigation is often related to whether these expectations have been met. Both the GMC and the Royal College of Obstetricians and Gynaecologists (RCOG) provide guidance on obtaining consent.16,17 A signature on a consent form does not equate to valid consent. The purpose is to record the patient’s decision and also the discussions that have taken place. Before seeking a woman’s consent for a test, treatment, 0 20 40 60 80 100 120 Wrong/failed/delayed diagnosis Number of claims 109 99 105 28 22 15 21 105 Intraoperative problems Inappropriate/failed/ delayed treatment Failure to obtain informed consent Failure to recognise complication Foreign body left in situ Failure to perform operation/ tests Others Figure 1. Gynaecological claims by cause between 01 January 2012 and 31 December 2012. Unpublished data provided by Mr John Mead and Ms Esther Kaikai of the NHSLA. ª 2014 Royal College of Obstetricians and Gynaecologists 53 Jha and Rowland
  4. 4. intervention or operation, it is important to ensure that she understands the nature of the condition for which it is being proposed, its prognosis, i.e. benefits and risks inherent to the procedure, likely consequences and the risks of receiving no treatment, what can realistically be expected following surgery as well as any reasonable or accepted alternative treatments.16 A discussion of the risks associated with a clinical decision is a critical element of an informed decision. Research has not yet identified best practices for communicating uncertainty about harms and benefits of treatment to patients.18 Uncertainties should be discussed. Litigation related to consent may also arise from the performance of procedures that were not discussed with the patient i.e. removal of both ovaries when consented to removal of one or none. Sterilisation The most common ground for litigation arising from a sterilisation is conception post-sterilisation. This could be a luteal phase pregnancy which was not identified at the time of surgery or an actual failure because the procedure was inappropriately or inadequately performed or recanalisation of the fallopian tubes occurred after the procedure. If pregnancy occurs within 12 months of sterilisation it is likely to be a failure of the technique whereas after 12 months it is more likely to be recanalisation. The shortest interval between operation and conception was three months and the longest 17 years.19 There are also recorded cases of litigation because of failure to perform procedures concurrently for which the patient has consented, such as removal of an IUCD. More serious was non-consented tubal sterilisation performed at caesarean section (CS), or regret related to sterilisation done at the time of CS when the patient was consented immediately before the procedure. Inadvertent injury during the procedure or injury related to the method of tubal occlusion, such as bowel injury due to cautery, are other causes of litigation during sterilisation. Medico-legal law relating to maintenance of the child born after sterilisation is controversial. In the McFarlane20 ruling it was held that parents of healthy children born after sterilisation were not entitled to the costs of bringing up the child. However, a valid claim can be made following the birth of child with disabilities, based on the additional cost of raising a child with those disabilities (Parkinson21 ). Laparoscopy Claims arising from laparoscopic procedures may be related to a variety of different issues. They may arise from an allegation of a lack of training or because a case performed laparoscopically would have been done by a more experienced body of clinicians as a laparotomy and complications arose as a result of the wrong choice of surgery. But the most common cause of litigation related to laparoscopy is internal injury or a delay in recognition of these complications. The initial laparoscopic entry into the peritoneal cavity remains the major contributor to bowel injuryand delayedrecognition wasamajor factorinassessment of liability.22 These cases can be difficult to defend, particularly if the patient’s medical records do not document that they have been closely monitored and any deterioration in their condition managed in a timely and appropriate fashion. The need to proceed to a laparotomy, particularly a midline incision as opposed to a transverse incision, also increased the risks of litigation. Unlike a laparotomy, where patients should be seen to improve on a daily basis, in laparoscopic surgery they should be improving on an hourly basis. Management of patient expectations helps ensure that they are satisfied with their care and there is early recognition of warning signs of complications post-surgery. Recommendations to avoid complications during operative laparoscopy include the following: The best possible vision should be maintained at all times. The use of sharp instruments should be avoided unless absolutely necessary. The use of diathermy, or ultrasonic devices require knowledge of their use and utmost care. The tip of the instrument may remain hot even if the power has been switched off. Rule out bowel injury after primary trocar insertion. On completion of the procedure and when removing trocars, check all areas where injury to tissue or bleeding may have occurred. All trocar sites should be inspected after withdrawal by lightly placing a finger over the skin wound at the time so 0 50 100 150 200 Bladder damage/ 94 64 80 32 14 24 19 177 Additional/unneces- sary operation(s) Unnecessary pain Bowel damage/ dysfunction Perforation Cancer Psychiatric/psy- chological damage Others Number of claims Figure 2. Gynaecological claims by injury between 01 January 2012 and 31 December 2012. Unpublished data provided by Mr John Mead and Ms Esther Kaikai of the NHSLA. 54 ª 2014 Royal College of Obstetricians and Gynaecologists Litigation in gynaecology
  5. 5. that any bleeding will run into the abdominal cavity and be identified. Use a drain when necessary. Patients should be given appropriate contact details and instructed to contact the hospital if problems occur postoperatively. Colposcopy Litigation related to colposcopy can arise from physician errors or laboratory errors. The common physician errors that lead to claims of clinical negligence include improper sampling, improper identification or failure to obtain a complete history and incomplete follow-up. Laboratory errors leading to litigation may be due to improper smear processing including identification, staining and reviewing of history of previous Pap smears as well as incorrect interpretation by a cytologist. Lack of training and supervision of a cytologist and improper recommendations by a cytologist can also be causes of litigation. Hysteroscopy Litigation in part is related to a failure of clinicians to adapt to the demands of newer technologies, lack of adequate expertise when performing complicated procedures and failure to recognise complications during relatively simple procedures. Clinicalnegligenceclaimsrelatedtohysteroscopicprocedures include complications related to uterine perforation and subsequent internal organ injury. The failure to recognise the complication is the commonest cause of litigation. When there has been internal organ damage, such as bowel, patients may remain asymptomatic for 2–10 days before the nature of the injury, often thermal, becomes apparent. Factors that increase the risk of perforation include cervical stenosis, acute anteversion or retroversion, lower-segment fibroids or intrauterine synechiae and operator inexperience.23,24 Uterine injury without the use of an electrical source can usually be managed by observation of signs of vaginal or intraperitoneal bleeding.23,25 However, where an electrical source has been used, laparoscopy is advised to rule out bowel injury. Fatal complications to which the clinician should be alert during hysteroscopy include: fluid overload causing hyponatraemia and subsequent respiratory arrest and seizures, air embolism leading to collapse and death. Though relatively rare, this has been recorded and both the surgeon and anaesthetist must be alert to the signs suggestive of this rare but fatal complication. Urogynaecology Increasingly, litigation related to urogynaecology cases are centred on the use of meshes and related complications. Following the class action against Johnson Johnson vaginal mesh kits in the US, Johnson Johnson publicly declared their decision to withdraw their vaginal meshes by the first quarter of 2013, and this was followed by a sharp decline in the use of vaginal meshes elsewhere including the UK. With the first cases now going to court in the US and already worth several million pounds, this could well be a minefield waiting to explode. Clinicians undertaking synthetic meshes for the treatment of pelvic organ prolapse should familiarise themselves with NICE guidance on the use of meshes interventional procedure guidelines (IPG) 267, 280, 281, 282, 283 and 28426–31 and those performing urinary continence procedures with IPG 138, 154, 133 and 262.32–35 Cases of vaginal or abdominal mesh and all secondary prolapse repairs should ideally be discussed at a multidisciplinary team meeting and management of all patients undergoing relatively new procedures should adhere to the principles of clinical governance and risk management. This will serve to protect clinicians against litigation related to the use of meshes. However, the primary factor is adequate training of clinicians performing these procedures. General gynaecologists must also be aware that without a sufficient workload, continuing to perform complicated urogynaecology procedures is fraught with the risk of litigation. Hysterectomy Ureteric injury is the most common cause of litigation related to hysterectomy. Though a known complication of a difficult hysterectomy, failure to detect these injuries often leads to a successful claim. Damage to the bladder and bowel are probably more common but are not generally considered to be negligent, especially if the procedure is difficult due to scarring from a previous surgery. It is important that the injury is recognised and has been appropriately repaired. In such cases, a successful claim for compensation is unlikely. However if the injury to the bladder is missed, a vesico-vaginal fistula may be formed and a missed bowel injury could result in sepsis or peritonitis. These will frequently be classed as negligent. It may be argued that some occur because of ischaemic necrosis in the bladder base, and these may be defensible. Therefore, timing of onset of the leakage is important. Early leak is probably a result of direct injury whereas later leak is a sequel of ischaemia. Litigation may also be related to unnecessary hysterectomy or an oopherectomy. Questions relating to the indication for surgery can arise particularly when a hysterectomy is associated with complications and less invasive options such as an intrauterine contraceptive or an ablation have not been offered or discussed. Foreign body Retained foreign bodies are classified as SUIs (serious untoward incidents) and inevitably result in a payment of a ª 2014 Royal College of Obstetricians and Gynaecologists 55 Jha and Rowland
  6. 6. negligence claim. They can arise from a simple failure to count swabs and instruments to forgotten pessaries or removal of one pack where two were inserted. They have been shown to be a particular problem after long and complicated procedures. Ethical issues A recent survey of MPS members demonstrated that 73% felt their practice was defensive for fear of litigation.36 As a result of increasing litigation additional and unnecessary tests are performed.37 These can be invasive and potentially harmful for the patient but also drive up healthcare costs as their need is questionable. The second aspect of litigation is the impact on the healthcare professional. A malpractice suit can have the same impact as a major illness, loss of a loved one or a severe career setback.38 It has adverse emotional consequences and often involves the stages of grief as described by K€ubler-Ross. It can cause irritability, headache, insomnia, difficulty with concentration, clinical depression and suicide.38 There has been an increasing reluctance to join specialities prone to litigation and obstetrics and gynaecology is one of these.39,40 The fear of litigation is even becoming a deterrent for doctors to assist people involved in emergency situations such as in an accidents or on a flight as the medical practitioner is open to being sued by the affected or injured person if the outcome is less than optimal. There is therefore a direct conflict of professional obligations and a reluctance to be involved in a situation that can land the clinician in a court room. Avoiding litigation The basic principles of avoiding litigation include: Good documentation The old saying ‘if it’s not in the record, it didn’t happen’ still holds true. Good record keeping includes: information provided by the patient that factored in to the diagnoses or treatment decisions, the physical findings or laboratory results that factored in to decisions, the treatment selected, and anticipated follow-up. Restraints of time sometimes make such detailed discussions difficult. Good communication Possibly more important than high standards of care is good communication with the patient and valid informed consent. Informed consent is a dialogue, not a lecture. It requires physicians to discuss: risks of the treatment, benefits of the treatment, and alternatives to the treatment including doing nothing as well as pros and cons of the individual treatment options. Any risks associated with serious long-term sequelae, must be discussed, even if the probability of the risk occurring is remote. Accurate representation It is imperative that clinicians do not misrepresent their experience. A doctor’s greatest asset is their advanced training and experience, but it is important to work within that remit. It is also important to give patients realistic expectations about their outcomes. Discharge instructions Increasingly, procedures are being performed as day cases and inpatient stay is shorter than ever before. Discharge instructions should therefore address all areas of potential concern, including pain, wound care, and signs of infection. There should also be information regarding whom to contact if there is a change in condition or if there are any further questions. Saying sorry Doctors are human and errors will sometimes happen. Taking responsibility doesn’t mean admitting negligence. It means acknowledging a complication when it occurs and hopefully minimising the consequences.41 This will sometimes involve transferring care to another physician. When things go wrong the vast majority of people just want two things: an explanation and an apology. This is also one of the recommendations of the Francis report.42 In keeping with a Duty of Candour the report states: ‘Every healthcare organisation and everyone working for them must be honest, open and truthful in all their dealings with patients and the public, and organisational and personal interests must never be allowed to outweigh the duty to be honest, open and truthful.’ Integrity Expectations of physicians to act with integrity means that higher standards of conduct are placed on the medical profession. A physician should not allow their own interests to influence a patient’s treatment. Conclusion Attention to issues such as continuing professional development, audit of outcomes and complications, supervision in theatres, preoperative safety checklists, 56 ª 2014 Royal College of Obstetricians and Gynaecologists Litigation in gynaecology
  7. 7. effective risk management and attention to safety issues form the basis of good clinical practice. These will be further reinforced through the revalidation process. MacLennan et al40 described some key strategies to reduce litigation related to cerebral palsy, however these measures are applicable to all cases of litigation related to clinical negligence. In spite of the best intentions, high standards of care, and attention to all issues discussed, litigation claims may still be made. Individual awareness and adequate support is the basis of coming through these stressful situations with one’s enthusiasm and zeal for continuing in the profession intact. Disclosure of interests None declared. Authorship SJ conceived the article, acquired and analysed data, drafted the article and revised it critically before final approval of the version to be published. SR drafted the article and revised it critically before final approval of the version to be published. Acknowledgements We would like to thank Mr John Mead and Ms Esther Kaikai of the NHSLA for providing the relevant data. References 1 Jena AB, Seabury S, Lakdawalla D, Chandra A. Malpractice risk according to physician specialty. N Engl J Med 2011;365:629–36. 2 Seabury SA, Chandra A, Lakdawalla DN, Jena AB. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. Health Aff (Millwood) 2013;32:111–9. 3 Vincent C, Young M, Phillips A. Why do people sue doctors? A study of patients and relatives taking legal action. 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Single-Incision Sub-Urethral Short Tape Insertion for Stress Urinary Incontinence in Women (IPG 262). London: NICE; 2008 [ 11858/40741/40741.pdf]. 36 Williams S. On the defensive. Africa Casebook 2011;19(8–1):1. 37 Bishop TF, Federman AD, Keyhani S. Physicians’ views on defensive medicine: a national survey. Arch Intern Med 2010;170:1081–3. 38 Kerr CD. The personal cost of medical litigation. Med J Aust 2004;181:384. 39 Barber HR. The malpractice crisis in obstetrics and gynecology: is there a solution? Bull N Y Acad Med 1991;67:162–72. 40 MacLennan A, Nelson KB, Hankins G, Speer M. Who will deliver our grandchildren? Implications of cerebral palsy litigation. JAMA 2005;294:1688–90. 41 Robbennolt JK. Apologies and medical error. Clin Orthop Relat Res 2009;467:376–82. 42 Francis R. The Mid Staffordshire NHS Foundation Trust Public Inquiry. London; The Stationery Office: 2013. ª 2014 Royal College of Obstetricians and Gynaecologists 57 Jha and Rowland