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Malpractice issues in modern anaesthesiology

Mavroforou, A.*‡; Stamatiou, G.; Koutsias, S.; Michalodimitrakis, E.; Vretzakis, G.; Giannoukas, A. D.

European Journal of Anaesthesiology (EJA): November 2007 - Volume 24 - Issue 11 - p 903–911
doi: 10.1017/S0265021507000919

Medical malpractice has been raised as an important problem in daily practice, while the media and public remain unforgiving to those perceived to have harmed the patients' life. This article highlights important legal issues related to medical malpractice and summarizes the sources and the nature of potential errors in anaesthesiology practice.

University of Thessaly Medical School, Department of Medical Law and Ethics, Larissa, Greece

University of Thessaly Medical School, Department of Anaesthesiology, Larissa, Greece

University of Thessaly Medical School, Department of Vascular Surgery, Larissa, Greece

University of Crete Medical School, Forensic Sciences Department, Heraklion, Crete, Greece

Correspondence to: Anna Mavroforou, 13 Ath. Agorogianni Street, 41335 Larissa, Greece. E-mail:; Tel: +30 2410 627600; Fax: +30 2410 627645

Accepted for publication 10 May 2007

First published online 21 June 2007

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Over the last two decades, there has been a serious increase in claims for medical negligence. It has been estimated that the rate of new claims against hospital doctors in the UK is as high as 10.5% [1]. The threat of malpractice lawsuits changes the practice style of many physicians, leading to defensive medicine, and the rising tide of medical negligence actions is destroying good patient-doctor relationships and driving promising junior doctors away from specialties that have become high-risk for negligence claims [2,3].

In a survey conducted by the Australian and New Zealand College of Anaesthetists to assess the influence of the current medico-legal climate on their anaesthetic practice, it was found that 23.6% of the respondents had personal experience of litigation and 73.6% expected to have a claim made against them during their career. Additionally, respondents spent an average of 8.3% of their gross annual income on medical insurance premiums and 47.2% were concerned about the viability of their practice given the rising costs of medical insurance [2]. In the same survey, it was shown that obstetric anaesthesia was the most common area of practice have ceased due to medico-legal concerns. It was reported that in the next two years, 20.2% of obstetric anaesthetists who responded intended to cease practice. Also, 3.1% of respondents retired due to their litigation concerns, while 12.8% (average age 56.7 yr) were intending to retire in the next two years for the same reasons [2]. It appears that anaesthetists worldwide are concerned about the current medico-legal climate and as a result, some are retiring earlier and giving up high-risk areas of practice [2,4,5].

There is no doubt that there is increasing consumer awareness of the possibility of bringing legal actions following media coverage of cases involving consumer rights and better consumer education. Patients now expect diagnostic tests and procedures as well as operations to be carried out with a high level of competence and accuracy. The public seems to be unforgiving of those perceived to have harmed patients as a result of medical negligence. Also, it is the public's belief that suspending doctors who have committed clinical errors is an effective prevention strategy [6].

The field of anaesthesia is an unfinished symphony, which continues to be written by newer technological developments and innovative clinical applications. Although equipment operation has become easier and the knowledge of clinical pharmacology better, the wide spectrum of operations and diagnostic invasive procedures carried out currently is considerable. The use of monitored anaesthesia care (MAC) as the technique of choice for a variety of invasive or non-invasive procedures as well as the use of regional anaesthesia for major surgical operations is increasing [7]. Also, more complex operations are carried out with general anaesthesia.

The aim of this article was to highlight important issues related to medical malpractice as well as to identify the sources and the nature of potential errors in anaesthesiology practice.

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Principles of medical litigation

The legal basis for professional liability is not well appreciated by many and therefore confusion abounds concerning the definitions of negligence and malpractice. Not every medical mishap gives the patient the right to sue for damages as the success of a claim depends on the ability of the injured party to prove negligence.

In law, negligence is defined as a breach of duty to practice to the standard of care expected and which causes substantial injury to a patient [8]. The following elements should be established in order to document a negligence action:

  1. the defendant was duty bound to take care,
  2. the defendant was in breach of that duty or was careless in that duty,
  3. the patient was injured as a direct result. The damage, which was suffered, must not be too remote and
  4. the result of which (the victim claims) was directly caused by that carelessness. There was a causal relationship between injury and breach of care.

Therefore, duty refers to practitioners responsibility to treat a patient according to the standard of care, negligence is defined by law as a deviation from the accepted standard of care and, therefore, a breach of duty, while causation requires that the patient's damage is the result of negligence, and damage infers harm, detriment or loss sustained by reason of an injury.

In general, legislators seek to establish how the average physician would act under similar circumstances. All doctors are not expected to have levels of awareness equal to those of a professor and certainly all hospitals are not expected to have the same level of equipment sophistication as a tertiary hospital. A doctor must be judged on what is to be expected of a doctor in regular everyday practice [8]. An unsuccessful result is not necessarily related to malpractice as long as the physician can prove that he or she acted as a reasonably prudent person and used a method or technique that is acceptable within medical practice and validated in clinical practice as derived from published reports. Whether the majority does not use this method or technique is of no importance [8]. Should a well-respected professional body agree that the defendant did what a reasonably prudent person would do in similar circumstances, this would constitute a strong defence.

Any physician is liable for all aspects of his/her own practice including everything from indications for a diagnostic or therapeutic procedure, making comprehensive explanations to patients, taking decisions and proceeding to actions, to up-to-date instrumentation and maintenance of the highest level of competence through continuous education and training.

In the UK, the vast majority of medical negligence claims used to be settled out of Court, and 83% of those that reached trial stage were unsuccessful [9]. With minor variations, this represented the situation in most western European countries. However, an important point is that judicial attitudes are changing in parallel to the atmosphere over current medical practice. To this end, the growing media attention to negligent treatment and changing public opinion of the medical profession play an important role, as do patients' unrealistic expectations of care and the increase in procedures with a greater risk. It therefore follows that in the forthcoming years more malpractice suits and insurance claims involving physicians and healthcare professionals will come to Court.

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The importance of adequate communication and the role of informed consent

Communication between doctors and patients is of paramount importance [10-12]. Most medical malpractice suits are the result of inadequate communication between doctors and patients, and litigation has very little to do with errors [10]. Failure to provide adequate, comprehensible information to a patient could expose a medical practitioner to action for negligence or assault [10].

Informed consent is one of the most important doctrines governing professional conduct grounded as it is in a basic human right freedom from institutional coercion. Additionally, informed consent remains an integral part of the communication process between physicians and patients and offers vital professional protection [13,14]. In medicine, a patient, or the patient's surrogate, is informed of the procedures which the doctor proposes to undertake in the attempt to treat the individual and then, based on this information, the patient is asked to provide consent. An important aspect in the consent form completion remains the comprehensiveness of the information that the healthcare specialist should give to the patient. In the current context of medical practice, the amount of detailed information that should be given to the patient appears to be increasing and reversal of this trend in the future is unlikely.

Consent must be obtained in a proper way and the patient should be allowed enough time to decide or even refuse. This process includes the following elements: the doctor has adequately explained the procedures (and possible alternatives) and their risks; the patient indicates that these procedures and risks have been understood; and, finally, the patient agrees to undergo them. The physician or healthcare specialist should spend enough time providing sufficient information on the possible complications and the expected benefit to the patient from any diagnostic test or procedure [12-14].

For the communication to be effective, it must consist of two essential elements, namely, the conveying of information by a person and the comprehension of the content of such information by another. Yet, when looked at critically, effective communication may occur less often than is surmised. For example, a study showed that of 100 patients interviewed between 2 and 5 days after surgery, 27 had no idea on which organ had undergone the operation and 44 did not know the exact nature of their surgical procedure [15].

In England and Wales, a minor who has attained the age of 16 yr is eligible to consent to any surgical, medical or dental treatment without the need to obtain any consent for it from his parent or guardian [16]. Additionally, even a minor under the age of 16 yr may have the capacity to consent to treatment [17].

Proxy consent occurs when an individual is provided with the legal right to make decisions on behalf of another who is unable to do so for himself or herself. Thus, a parent providing, or refusing, consent for a minor is doing so in the capacity of a proxy. In these instances when parents are called on to provide consent on behalf of their children, the parents must meet the same requirements of competency that would be needed if they were granting consent on behalf of themselves.

There is a universal view that parental right to consent derives from the belief that they are best placed to judge the welfare of their child and it should be presumed that their refusal is because they believe it to be in the child's best interest to do so [18]. It has also been reported that parents feel better about the decisions made on behalf of their children when they (the parents) perceive themselves to be part of the decision-making team and not merely individuals who sign consent forms granting permission for things to be done. Thus, it was recommended basing informed consent on a two-way exchange of information, rather than on parents being simply informed by doctors. Moreover, in this manner, doctors can also learn from families [19].

Written consent should be obtained in all cases where the treatment or procedure is complex, involves significant risks and/or side effects, or there might be significant consequences for the patient's employment, social or personal life and when the investigation or the treatment is part of a research programme. In all other cases, oral consent may be accepted provided that the key elements of the discussion with the patient, specific requests by the patient and the details of the scope of the consent have been written to the patient's case notes. An informed consent, obtained either in writing or orally, does not necessarily bar a patient from raising a claim against a negligent physician or healthcare specialist, but it is certainly an important document in the hands of the defendant's lawyer [20,21].

In cases where complications arise, if litigation is raised by the patient on the basis that they were given inadequate information before treatment and thus were unaware of the potential complications, it may result in the punishment of the physician by the Court, even if he was not guilty of committing an error [22]. An important issue remains the fact that in most of the cases the nature and risks of anaesthesia are usually discussed as part of the general information given from surgeons about the planned operation. Anaesthesia is, however, associated with its own particular set of risks and consequences, which are quite separate from those associated with surgery. It is, therefore, important that anaesthetists should obtain separate consent from patients besides that taken by surgeons [22,23].

It has been reported that patients were not happy with the information they had received concerning their pathology and treatment, and although they had signed the consent documents, the patients did not feel they had really understood the risks involved in the surgery they had undergone [24,25]. This underpins the fact that consent is a process rather than just simply the signing of a form, which should provide the patient with the information and understanding needed to authorize a procedure.

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Errors in anaesthesiology practice

While the large epidemiological trials seemed to have ignored anaesthesia, anaesthetists had been studying error all along while Cooper was the first to apply the concept of critical incident reporting, developed by military aviators [26], to improving safety in anaesthesia [27] Nevertheless, there is no universally agreed classification of human error and several investigators have developed their own taxonomy. Reason's classification [28], which draws widely from the aviation industry, nuclear industry and medicine, has been adopted by many investigators. According to this classification, errors can be distinguished into slips, lapses and mistakes. Slips result from a failure in the execution of an action, irrespective of whether or not the plan behind it was adequate to reach its objective. Writing the year incorrectly in the date shortly after New Year is a slip. Lapses involve memory failure and may only be apparent to the persons who experience them [28]. For instance, forgetting to administer antibiotic prophylaxis prior to arterial cross-clamping. Mistakes happen when a plan proves inadequate, the operator is aware of the problem and begins to use rules or knowledge to solve it. A rule-based mistake is due to failure to apply or the misapplication of normally good rules, or the application of bad rules. Knowledge-based mistakes are those resulting from an individual's lack of judgement or knowledge, while violation is when rules of correct behaviour are consciously ignored [29].

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Medication errors

Medication errors are among the potential anaesthetic mishaps [20-33,27]. A medication error is an error in the prescription, dispensing or administration of a medication with the result that the patient fails to receive the correct drug or the indicated proper drug dosage. It does not necessarily result in injury.

An ‘adverse drug event’ (ADE) is any injury related to the use of a drug [34], hence it includes adverse drug reactions such as anaphylactic and other allergic reactions. Therefore, a medication error only becomes an ADE when a patient is harmed, and not all ADEs are caused by a medication error. The American Society of Health-System Pharmacists refined the definition of an ADE to include [injury caused by] the lack of an intended medication [35].

In an analysis of 2000, incidents of all anaesthetic errors showed that 7.2% of all incidents accounted for medication error but none was fatal [36,37]. In another study for which data were collected from 8000 anaesthetics, the drug administration error rate was 0.75%, with a ‘near-miss’ rate of 0.37% [38]. The most frequent errors were dose errors (20%) and drug substitutions (20%). Most (63%) errors involved intravenous boluses, 20% involved infusions and 15% involved inhalational agents.

Incorrectly written prescriptions are a common cause of medication errors [39] and they are the most common type of avoidable medication errors and are most likely to cause an ADE [40,41]. Anaesthetists record rather than prescribe the drugs they administer in the theatre, but do prescribe pre- and postoperatively, and in critical care. Only 35 (2%) cases involved preoperative events, and only two of these appear to have been prescribing errors among the first 2000 incident reports recorded in the AIMS database [42]. There are no published data concerning postoperative prescription errors. In paediatric critical care, incident reporting systems have yielded prescription error rates from 3.1% to as high as 56.2 per 1000 patient days [43-46]. Drug chart review of prescriptions written in a UK teaching hospital found an error rate of 1.5%, but the ICU was among the places where errors were most likely [47].

Transcribing drug [48] or numerical [49] data is prone to error; rewriting drug charts or transcribing prescriptions is associated with an error rate of 1%, a third of which are serious [47]. In critical care, anaesthetists often need to rewrite or transcribe many drugs on to new drug charts, or from ICU charts to ward charts. While computerised note-keeping and drug-ordering systems reduce such errors [50], most anaesthetists still work with paper-based records. The frequency or consequences of anaesthetists' transcription errors is not known, but on paediatric ICUs, transcription errors are the most common prescribing errors [51].

Interestingly, more than half (57%) were skill-based slips or lapses, 39% were rule-based mistakes and only 4% were violations among 88 potentially serious prescribing errors evaluated in a UK teaching hospital [52]. None of the prescribers could explain why these arose; however, doctors often mentioned that they were busy, tired, had been interrupted, had poor knowledge of a particular drug or were confused by looking after other teams' patients.

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Monitored anaesthesia care

The use of MAC is increasing as the technique of choice for a variety of invasive and non-invasive procedures [8]. Although there is lack of large prospective studies looking at the safety of MAC, serious complications such as cardiorespiratory depression and death after sedation for diagnostic or therapeutic procedures have been reported in both adults and children [53-55]. Polypharmacy of sedative-analgesic drugs [56], medication errors [56], inadequate monitoring of physiologic parameters [57] and delayed or inadequate resuscitation [57] contribute to serious injury during sedation.

It has been reported that of 1952 claims for surgical anaesthesia, only 121 claims (6%) were associated with MAC, but MAC claims involved a higher proportion of patients aged more than 70 yr as compared with general anaesthesia claims, and a higher proportion of ASA physical status III-V as compared with general or regional anaesthesia claims. One-fifth of MAC claims occurred during eye surgery, and one-fifth occurred during reconstructive or plastic surgical procedures in the head and neck areas, in contrast to general or regional anaesthesia for head and neck procedures. The severity of injury for MAC claims was similar to that for general anaesthesia claims, with a similar proportion of death and permanent brain damage. Death and permanent brain damage were more common and temporary injuries were less common in MAC claims compared with regional anaesthesia claims [58]. It is of note that nearly half of the injuries related to sedation in this report were judged as preventable by the use of additional or better monitoring.

Most MAC cases are for simple or superficial operations that are regularly performed in a routine fashion in relatively healthy patients (ASA physical status Class I or II). As such, they are considered to require simple, low-risk anaesthesia care. In some cases, the least-qualified anaesthetist is assigned to the case. Drugs used in MAC are routinely used in the post-anaesthesia care unit and in other sites where patients are more or less awake and breathing on their own. With familiar drugs and routine operations, diligence is often less by both the anaesthetist and the surgeons. In many situations, there has been a lengthy history of ‘safety’, which makes everyone quite comfortable. The pre-anaesthetic evaluation may be limited, and relevant data about the patient's medical history, drug regimen, physical examination, laboratory results and medical consultations may be missing [59].

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Other causes of anaesthetic mishaps

The severity of injury in malpractice claims is decreasing, as indicated by the incidence of claims for death and brain damage because of the clinical use of pulse oximetry and capnography. In the 1970s, 56% of claims were for death and brain damage compared with only 31% in the 1990s [60]. The occurrence of respiratory system events has decreased primarily in claims for injuries due to inadequate ventilation and, to a lesser extent, oesophageal intubation. Inadequate ventilation and oesophageal intubation were two of the three most common respiratory system events before the use of pulse oximetry and capnography. Whether this reduction in claims for injuries caused by inadequate ventilation and oesophageal intubation is actually a result of better monitoring cannot be determined by retrospective analysis afforded by the Closed Claims Project. However, the occurrence of difficult tracheal intubation, the third most common respiratory-related event that would not be expected to be affected by improved monitoring, has remained relatively constant.

With the decrease in respiratory events leading to death and brain damage, an increase in cardiovascular events has appeared. In the 1970s, cardiovascular events accounted for 13% of death and brain damage claims, and in the 1990s, they accounted for 25% (P ≤ 0.01) [60]. This trend may reflect more accuracy in diagnosis of the damaging event afforded by monitoring with pulse oximetry and capnography, changing legal strategies, patient characteristics or other factors. Adverse outcomes associated with respiratory events was found as the single largest class injury (37%) in the American Society of Anaesthesiologists Closed Claims Project [61,62].

There were also 16% of claims for anaesthesia-related nerve injury among 4183 claims [63]. The most frequent sites of injury were the ulnar nerve (28%), brachial plexus (20%), lumbosacral nerve root (16%) and spinal cord (13%). Ulnar nerve injuries were more likely to have occurred in association with general anaesthesia whereas the others were more likely to have occurred with regional techniques [63]. Nevertheless, the incidence of claims for nerve injury, a far less-serious complication, has remained relatively constant over the years. Unfortunately, it cannot be determined from claims whether the actual incidence of severe injuries is decreasing or is simply offset by an increase in claims for minor injuries. Nerve injury may well assume the position as a leading cause of anaesthesia-related injury for which a malpractice claim is made. The finding that most injuries to the ulnar nerve and brachial plexus seem to occur in the presence of adequate positioning and padding suggests that the mechanisms of such injuries are not well known [64]. Because preventive strategies for these nerve injuries are not apparent, no reduction in claims for these injuries may be expected.

It is surprising that among claims for nerve damage in which the injury occurred in the 1990s, injury to the spinal cord was the most frequent [64]. This seems to be related to injuries from neuraxial block in anticoagulated patients and blocks for chronic pain management.

From the same source it was reported that the most common complications in the obstetric claims were maternal death (22%), newborn brain damage (20%) and headache (12%). In contrast, the most common complications in non-obstetric claims were death (39%), nerve damage (16%) and brain damage (13%) [65].

Claims for central catheter injuries accounted for 1.7% among 6449 claims and they had a higher severity of injury with an increased proportion of death [66].

Death, quadriplegia, brain damage and lifelong care injury were reported as the more common malpractice causes in anaesthesia in the USA [67]. In Canada, the commonest error involved the administration of muscle relaxants instead of a reversal agent, while ‘syringe swaps’ and the misidentification of the label were the common contributing factors [68]. In Germany, the most common errors were reported to be involved with airway and ventilation management, followed by errors in fluid and cardiovascular management. The main causes were distraction, lack of experience, lack of specific training and communication deficits [69].

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Final remarks and conclusions

Current data suggest that anaesthesiologists are at risk for litigation even in the absence of deviations from the standard of care. A series of seemingly minor events that combine by chance and result in an accident form a system error [70]. In a report it was shown that of the total 734 adverse outcomes, the peer review process determined that system error contributed to 644 (88%) and human error, or deviations from the standard of care, contributed to only 90 (12%) [71]. In another study it was found that the standard of care was met in 59% of the MAC closed claims, 64% of general anaesthesia closed claims and 74% of regional anaesthesia closed claims [72].

Physician competence and technical skill are essential for good outcomes. Most patients and members of juries recognize that physicians are human beings and perfection is not always possible. If mistakes are acknowledged forthrightly and plans for dealing with the consequences are explained, patients and their families are usually forgiving. But when patients become frustrated with the lack of communication, perceive that they are being deceived by a cover-up, or otherwise are being ignored and avoided, they become angry. Anger and deception are strong incentives to make a claim and file a suit. Some patients and families file suits when there is, in fact, no malpractice [73]. Additionally, the public's perception of doctor's ‘deep pockets’ may be a motivation for the patients and their lawyers to raise claims for compensation in cases of undesirable results. Nevertheless, it is not clear whether the lack of health insurance from the patients is a contributing factor for raising such claims.

Inexperienced clinicians and unsupervised trainees are more likely to make clinical errors [74,75]. In an observational study in two UK hospitals it was shown that more than half of drug administration episodes were associated with an error, and most of these were deliberate violations of the guidelines that boluses should be injected over 3-5 min. Nursing staff felt that guidelines inappropriately increased the length of the drug round [76].

Nevertheless, it is the easiest thing after an error to blame an individual for carelessness, inattention, recklessness or lack of education, which is the ‘person approach’ according to Reason's ‘Swiss cheese model’ [70]. Interestingly, cognitive psychologists believe that slips, lapses and mistakes are the price we pay for advanced higher cerebral function, and these are inevitable. As Ernest Mach said, ‘Knowledge and error flow from the same mental sources, only success can tell one from the other’ [77]. The physicians and nurses are only part of a system that includes a chain of actions such as ordering and prescribing drugs, their storage and presentation, layout of drug charts, communication, management and bureaucratic issues and equipment used. According to the ‘system approach’, the system fails when several of these factors interact by chance to cause an error [70].

Anaesthetists in Western countries have been relying increasingly on sophisticated equipment, which have been implicated in as high as 40% of incidents [78-81]. Equipment failure includes not only failure of the equipment itself but also several other errors occurring when staff are confronted with new, unfamiliar or non-standard equipment [81-84]. There are several reports of fatal errors with opioid infusions that confirm the fact that the consequences of equipment error in anaesthesia may be grave [83,85].

The use of more sophisticated technology to prevent the error may cause the next error as the skills and expertise that it requires may go beyond those of the final user. Strategies that reduce complexity are most likely to improve safety. Simple but effective improvements to drug charts and paperwork may reduce medication error. Education of clinicians and nursing staff may also help along these lines.

Over the last decade, the growing recognition that medication errors usually result from a system failure rather than from an individual have made many institutions adopt a policy of full disclosure of mistakes and untoward events. Early offers of payment of the actual financial losses to the patient are made in an attempt to minimize the risk of unrealistic judgments for pain and suffering, which are often based on unhappiness with the outcome and distrust of the healthcare providers and institutional administrators.

A considerable amount of anaesthesia malpractice litigation appears groundless, while practitioners are placed at risk for litigation, and plaintiffs can receive awards in the absence of negligence. Likewise, patients who are victims of deviations from the standard of care resulting in disabling injuries are often not compensated. Therefore, the establishment of peer review could aid the legal system as a means of detecting deviations from the standard of care, which would offer the advantages of being more applicable to judging clinical competence and more justifiable in compensating injured patients. Furthermore, deviations from the standard of care, as determined by peer review, represent a stable process and, therefore, these occurrences would be predictable in terms of frequency and cost.

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