research paper on medical negligence

Medical errors, medical negligence and defensive medicine: A narrative review

Affiliations.

• 1 Department of Legal Medicine, Ethics and Occupational Health, Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil. Electronic address: [email protected].
• 2 Discipline of Legal Medicine and Bioethics, Faculdade de Medicina do ABC, Santo André, SP, Brazil.
• PMID: 35640458
• PMCID: PMC9160317
• DOI: 10.1016/j.clinsp.2022.100053

Error in medicine and medical liability has a long history dating back to Antiquity. During the 19th Century, most lawsuits related to errors in treating surgical problems were settled. However, in the first half of the 20th Century, lawsuits claimed that mistakes were related to the doctor's action: the doctor made something wrong (errors of commission). In Brazil, medical error is defined as inappropriate conduct, including negligence and recklessness, that causes harm to the patient. The physician's fear of being suited is the reason for some practice named defensive Medicine (D.M.), defined as ordering unnecessary tests and procedures or avoiding treatments for patients considered at high-risk. Thus, this narrative review aims to analyze and describe the relationship between medical errors, medical negligence, and the practice of D.M. So, the authors propose procedures and attitudes to avoid medical errors and the approach of D.M.: a national focus to create leadership and research tools to enhance the knowledge base about patient safety; a reporting system that would help to identify and learn from errors; the use of a computer-based protocol reminder; some technological devices to help the medical practice (electronic prescribing and information technology systems); creating risk management programs in hospitals. Therefore, the authors conclude that the most critical attitude to avoid medical liability is a good and ethical medical practice with the proper use of technology, based on knowledge of scientific evidence and ethical principles of medicine - for the benefit of patients.

Keywords: Defensive medicine; Medical errors; Medical liability; Negligence.

Copyright © 2022 HCFMUSP. Published by Elsevier España, S.L.U. All rights reserved.

Publication types

• Defensive Medicine*
• Malpractice*
• Medical Errors
• Patient Safety
• Risk Management

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Article Contents

Criminal negligence, liability for negligence, conclusions, conflict of interest.

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Duty of care and medical negligence

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Daniele Bryden, Ian Storey, Duty of care and medical negligence, Continuing Education in Anaesthesia Critical Care & Pain , Volume 11, Issue 4, August 2011, Pages 124–127, https://doi.org/10.1093/bjaceaccp/mkr016

Negligence arising from medical acts may result in a civil action by the injured party (claimant) or a criminal prosecution by the state.

Medical negligence is proved if all components of the three-part test are established on the balance of probabilities (civil suit) or beyond reasonable doubt (criminal prosecution).

The three-part test establishes that the doctor owed a duty of care to the patient, the duty of care was breached, and as a direct result of the breach the patient suffered harm.

Successful civil actions result in monetary compensation to the injured party or dependents which may be paid by the employing trust or the doctor's defence organization.

Successful criminal prosecutions may result in a custodial sentence for the doctor and an additional GMC fitness to practice hearing.

Good record keeping and adherence to established practice guidelines are important as negligence cases may take many years to be resolved.

The Department of Health estimates that 10% of hospital inpatient admissions result in an adverse event, 1 but <2% of claims for medical negligence handled by the NHS Litigation Authority result in court action. 2 However, both the number of claims for negligence and the sums involved in settlement are increasing and so it is important that anaesthetists understand the factors leading to a possible civil claim for negligence and the potentially considerably more serious charge of criminal negligence, both of which can arise from failures to uphold a suitable standard of care. This article does not consider claims of negligence in relation to consent which has been considered in a separate article in the journal.

The principle of ‘duty of care’ was established by Donoghue v Stevenson in 1932 wherein Lord Atkin identified that there was a general duty to take reasonable care to avoid forseeable injury to a ‘neighbour’. 3 In this case, a woman in Paisley drank ginger beer from a bottle until she found a decomposing snail at the bottom. As a result the woman became ill and a case was brought against the ginger beer manufacturers for compensation. Lord Atkin determined that the company producing the ginger beer had been negligent in failing to ensure the woman's safety during the production process, even though the ginger beer was not bought by the woman but by her friend. It was established that a general duty of care was owed to a neighbour; a neighbour was defined as ‘someone who may be reasonably contemplated as closely and directly affected by an act’. In this case, it did not matter who had bought the ginger beer, since it was reasonable to consider that anyone who drank the beer would have suffered the same consequences and could therefore be considered under the ‘neighbour’ principle.

Where a duty of care is breached, liability for negligence may arise. Medical negligence is part of a branch of law called tort (delict in Scotland) derived from the Latin verb ‘tortere’=to hurt. The idea of hurt is an important consideration in establishing negligence, as the majority of tortious claims for medical negligence that do not succeed fail because they cannot establish that harm has occurred as a direct result of an act or a failure to act.

The negligence test

To determine negligence, a three-stage test must be satisfied. The procedure therefore relies on establishing fault on the part of the doctor, hospital, etc. The person making the claim (the claimant) must establish on the balance of probabilities that negligence has occurred by the hospital or doctor (the defendant). Compensation is paid in order to return the claimant to the position they would theoretically have been if the harm had not occurred. A monetary value will attach not just to actual expenses incurred (to include a loss of earnings) but additionally to the loss of amenity experienced and the pain and suffering endured in consequence of the injury. There are also more philosophical objectives of promoting accountability and ensuring that those at fault are deterred from future acts of carelessness by the need to pay compensation. This deterrent effect is somewhat reduced by a standard fee for professional indemnity for NHS-employed doctors unless the doctor is engaged in independent practice. The Clinical Negligence Scheme for Trusts (CNST) does include such a deterrent element, since the premiums payable by a Trust to indemnify its activities can be reduced by having appropriate measures in place to reduce the likelihood of claims using a three-level rating system that takes account of the robustness of safety and governance processes in operation. 4

A person is owed a duty of care.

A breach if that duty of care is established.

As a direct result of that breach, legally recognized harm has been caused.

Medical duty of care

The relationship between a doctor and a patient is a special one. Most anaesthetists work in a hospital environment and do not usually have patients directly admitted under their care. When a patient is admitted to hospital, a duty of care relationship is created, which can be applied to any doctor coming into contact with the patient not just the admitting team. Hence, it has been argued by medical law academics that any patient we come across in our professional environment is owed a duty of care, not only by the doctors the patient comes into contact with, but also by those who are employed by the Trust to deliver patient care. For example, a patient who has a cardiac arrest on a hospital corridor is owed a duty of care by any doctor who happens to be passing, and provision of assistance in such circumstances would probably be expected and would not be classed as a ‘good Samaritan’ act, however this academic view has not currently been tested in a British court environment to our knowledge.

Breach of duty

This is established where a doctor's practice has failed to meet an appropriate standard. The standard of the ‘reasonable man’ or the famous ‘man on the Clapham omnibus’ who is said to be an ordinary person placed in the same circumstances is usually applied for most tort cases. However, where there has been a potential breach of professional duty, this is reinterpreted as that of the standard of comparable professional practice. Bolam v Friern Hospital Trust is the most well-known case in relation to this professional standard. 5 It concerned a patient who sustained fractures during ECT treatment and who alleged that care under anaesthesia had been negligent in part because he had not been given muscle relaxation for the procedure, and had not been restrained or warned of the risks of fracture. It was concluded, however, that negligence could not be established, as evidence was provided that at the time it was not universal practice to administer muscle relaxation, as contrasting opinions existed as to the benefits of muscle relaxation balanced against the increased risks of the relaxant. It was argued that if a doctor acted in accordance with a practice that was considered acceptable by a responsible body of doctors that was sufficient and the claimant must show that no reasonable doctor acting in the same circumstances would have acted in that way. The ‘Bolam standard’ (by which the alleged negligent practice is compared with that of a doctor's peers) is subject to criticism and heavily dependent on expert evidence for either side which may be in conflict; however, this is the same test as for other professional groups where negligence is under consideration (e.g. engineers). It has been argued that the presence of a body of opinion that supports a doctor's actions is in favour of the medical profession, handing responsibility for determining negligence back on to those same professionals. Support from eminent professionals for a course of action arguably makes it easier to defend claims of a breach of duty. The Bolam test is still frequently considered in cases of medical negligence, but it is not definitive, as subsequent cases have called in to doubt the idea that an acceptable standard of care is judged by doctors commenting on practice standards and that it may be part of the role of the court. ‘The court must be vigilant to see whether the reasons given for putting a patient at risk are valid … or whether they stem from a residual adherence to out of date ideas’. 6 Since the case of Bolitho, where a child with intermittent croup was not intubated by a paediatric registrar and subsequently suffered hypoxic brain injury from a respiratory arrest, it is possible for the court to decide that negligence has been proved even if a body of medical opinion suggests otherwise. 7 In Bolitho, it was accepted that failure by the paediatric registrar to attend to the child during an earlier episode of croup was negligent. However, it was argued that even if the registrar had attended, it would not have been appropriate to intubate the child at that point, and that therefore the final subsequent respiratory arrest and hypoxic brain injury sustained by the child could not have been prevented by earlier action. The judge reasoned that the argument that a failure to attend the child would not have made any difference to the eventual outcome was inconclusive and asserted that on some occasions, differing bodies of medical opinion could be legitimately distinguished by the court. ‘It is not enough for a defendant to call a number of doctors to say that what he had done or not done was in accord with accepted clinical practice. It is necessary for the judge to consider that evidence and [to] decide whether that clinical practice puts that patient unnecessarily at risk’. Bolitho, however, is not universally applied and many judgements of negligence still rely on the principles of peer review outlined in Bolam, although the greater use of evidence-based medicine, and the extensive practice guidelines produced by bodies like NICE, now allows judges to have objective benchmarks of practice for comparison. It is less easy for doctors to rely on providing a supporting body of opinion as a defence for an alleged breach of duty for practice that is contrary to recommendations and guidelines from external agencies.

There is, however, an understanding that progress in medical knowledge takes some time to be disseminated and not every new change can be immediately put in to practice. In Crawford v Board of Governors of Charing Cross Hospital , a patient sustained a brachial plexus injury from being in one position for too long a time period. 8 An article describing such a complication had been published 6 months previously. However, the anaesthetist had not read this article and was not aware of its implications and so was found not to have breached their duty of care to the patient.

Moreover, errors of judgement do not automatically amount to breaches of duty. They only do so in circumstances where the doctor has not acted with a level of care that would be expected from a reasonably competent professional. For doctors in training, this is of particular relevance, as the standard is that expected of the doctor in the same grade of that specialty or in that unit. There is an assumption, established in Nettleship v Weston where a learner driver lost control of a car, that there should be a public expectation of safety, and that doctors in training should be acting to the standard of the grade they are operating in. 9 There are therefore no concessions for a lack of relevant experience, and a doctor in the first day of a new post is expected to work to the same standard of public safety as one who is on the last day of the post. The difference in performance of the two relates to the degree by which the new doctor may be expected to consult and seek assistance to compensate for their relative lack of knowledge or skill and the degree to which they should expect to be supervised. We would argue that there is an expectation that supervisors allow trainees to do work only that they believe them to be capable of doing. The onus therefore is as much on the supervising department/consultant to reassure themselves of the trainee's abilities to do the case or procedure as it does for the trainee to consult (e.g. by departmental/consultant reviews of log books on rotation changes, etc.).

Harm and causation

Establishing causation can be difficult, as it must be demonstrated that ‘but for’ the doctor's action/inaction harm would not have occurred. Anaesthetists rarely work alone and it can sometimes be difficult to establish where the harm occurred in relation to an episode of medical care (e.g. paralysis after aortic aneurysm repair may be caused by the surgery or the provision of epidural analgesia). Unsurprisingly, claims for medical negligence most frequently fail due to an inability to establish causation as there are often a variety of possible explanations for the outcome. However, if it can be shown that the breach materially contributed to the damage or it is more likely that the damage was due to negligence than another cause that is usually sufficient.

Sometimes, in the absence of any other reasonable explanation for a phenomenon, the principle of ‘res ipsa loquitur’ (literally ‘the thing speaks for itself’) applies (e.g. the finding of a retained swab in the abdomen at laparotomy can only be assumed to be due to its negligent loss during a previous laparotomy). Such a situation would apply to procedures performed on the wrong limb/side (e.g. brachial plexus block and if damage occurs from that, then causation is assumed to be established unless the defendant can show that there is another reasonable explanation).

If negligence occurs as a result of carelessness, then where the carelessness has been so severe that it is judged to be ‘gross’, the doctor may be subject to a charge of criminal negligence. Although the requirement to prove criminal negligence is a much higher one (i.e. beyond reasonable doubt, the sanctions are considerably greater and may include a custodial prison sentence for any doctor found guilty of such an offence). A doctor found guilty of criminal negligence is also likely to be subject to fitness to practice procedures by the General Medical Council.

Prosecutions for criminal negligence are rare, but the number of occasions when doctors are investigated by the police for a potential linkage to a charge of manslaughter after a serious untoward event are increasing. Conduct which goes beyond the level of civil negligence almost invariably involves the death of the patient but there are difficulties in establishing what actions constitute this. Extreme subjective recklessness such as indifference to an obvious risk to the patient or objective evidence of incompetence or ignorance may all satisfy the requirement. It is also of concern that recent prosecutions have generally been of doctors in training, where it is perhaps easier to establish a sufficient degree of incompetence. Ultimately, the decision rests with a jury as to whether a doctor's action/inaction was so bad that it amounted to a crime. R v Adomako concerned an anaesthetist who had failed to notice his patient was disconnected from the ventilator whilst the patient was undergoing an eye operation. The patient suffered a fatal cardiac arrest and the anaesthetist was convicted of manslaughter. It is not clear whether Dr Adomako was not in the theatre and had failed to make adequate arrangements to monitor the patient in his absence or had been present and grossly incompetent in delivering the anaesthetic and failing to notice the disconnection as the cause of the patient's deterioration. However, the House of Lords considered that either action was sufficient to uphold a conviction as consistent with a consideration that ‘the extent to which the defendant's conduct departed from the proper standard of care incumbent upon him, involving as it must have done a risk of death to the patient, was such that it should be judged criminal’. 10 It is sobering to consider that anaesthesia—a specialty associated with a significant risk of death from inadequate actions—could meet such considerations of negligence in the way that other specialties may not.

The civil procedure rules in England and Wales allow for claims for medical negligence to be started within 3 years of the alleged negligence occurring or within 3 years of the victim becoming aware of possible negligence. This is of relevance to minors where the 3 years starts when the minor reaches the age of maturity (i.e. 18 years of age). Anaesthetists employed by the NHS and acting within the scope of their employment will be indemnified by the CNST. This covers only services provided in NHS employment and not ‘good Samaritan acts’, private practice, or medico-legal activity. Medical defence organizations will provide cover for these activities and also where appropriate for other independent practice activties (e.g. medical report writing). It is recognized that the deterrent effect on individual doctors of civil negligence claims is weak, although the process is stressful for the individuals involved and time consuming. In 2001, the National Audit Office identified that the average clinical negligence case took 5½ years from inception to conclusion and that 22% of outstanding cases related to events over 10 years previously. 11 Unsurprisingly the importance of comprehensive, contemporaneous anaesthetic records is paramount in being able to defend any claim. It is also noteworthy that in the Chief Medical Officer's 2003 consultation paper, ‘Making Amends’, many victims of iatrogenic injury desire explanation, apology, and evidence of learning from any mistakes as major outcomes and they are not content with mere financial compensation.

Medical negligence is a three-part test whereby a duty of professional care is owed to a patient and as a consequence of a breach of that duty, the patient suffers harm. All parts of the test must be satisfied.

Civil considerations of negligence require doctors to act to an appropriate standard usually but not exclusively judged by the standard of their peers, whereas for criminal negligence the standard of practice has to result in serious harm from actions that could be considered to be incompetent or grossly negligent. Due to the greater availability of practice guidelines to guide the courts, doctors should always consider the implications and justification for deviations from accepted practices should the patient suffer harm, and doctors in training should be aware that they are expected to seek advice and assistance where they lack experience in order to preserve public safety. Adequacy of note keeping to help defend any claims is vital.

None declared.

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• Research article
• Open access
• Published: 25 April 2018

The struggle against perceived negligence. A qualitative study of patients’ experiences of adverse events in Norwegian hospitals

• Gunn Hågensen   ORCID: orcid.org/0000-0002-8332-5083 1 ,
• Gudrun Nilsen 1 ,
• Grete Mehus 1 &
• Nils Henriksen 2  

BMC Health Services Research volume  18 , Article number:  302 ( 2018 ) Cite this article

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A Correction to this article was published on 14 March 2019

This article has been updated

Every year, 14 % of patients in Norwegian hospitals experience adverse events, which often have health-damaging consequences. The government, hospital management and health personnel attempt to minimize such events. Limited research on the first-hand experience of the patients affected is available. The aim of this study is to present patients’ perspectives of the occurrence of, disclosure of, and healthcare organizations’ responses to adverse events. Findings are discussed within a social constructivist framework and with reference to principles of open disclosure policy.

This qualitative study with an explorative descriptive design included fifteen in-depth interviews with former patients recruited by the Health and Social Services ombudsmen in the two northernmost counties of Norway. Inclusion criteria were as follows: 1) experience of adverse events in connection with surgical, orthopedic or medical treatment in general hospitals; 2) men and women; 3) aged 20–70; and 4) a minimum of one year since the event occurred. Transcribed audio-recorded interviews were analyzed through qualitative content analysis.

The analysis revealed three main topics regarding patients’ experiences of adverse events: 1) ignored concerns or signs of complications; 2) lack of responsibility and error correction; and 3) lack of support, loyalty and learning opportunities. Patients had to struggle to demonstrate the error that had occurred and to receive the necessary treatment and monitoring in the aftermath of the events.

Conclusions

Patient narratives reveal a lack of openness, care and responsibility in connection with adverse events. Conflicting power structures, attitudes and established procedures may inhibit prevention, learning and patient safety work in spite of major efforts and good intentions. Attitudes in day-to-day patient care and organizational procedures should be challenged to invite patients into open disclosure processes and include them in health and safety work to a greater extent. The study’s small sample of self-selected participants limits the generalizability of the findings, and future studies should include a larger number of patients as well as professional perspectives.

Peer Review reports

Illness and health problems shock people out of their natural rhythm by placing their life and health at risk [ 1 ]. People utilize health services to regain their health and welfare to the greatest extent possible and expect that their care will be performed in a safe and beneficial manner. Norway’s health service is considered high quality. However, calculations show that 13–14% of patients experience adverse events (AEs) from hospital treatments [ 2 ], and this value corresponds to international figures found in recent decades [ 3 ]. The World Health Organization (WHO) has defined an AE as “An injury related to medical management, in contrast to complications of disease. Medical management includes all aspects of care, including diagnosis and treatment, failure to diagnose or treat, and the systems and equipment used to deliver care” [ 4 ]. Patients are affected by AEs in two different ways: partly by the injury itself and partly by the hospital’s responses before, during and after the incident [ 5 , 6 ].

In line with increasing international focus on the issue of AEs, Norwegian public investigations and consultations have indicated the need to develop a culture guided by principles of open disclosure in the health service. Key elements of such a culture include care for patients and their families after an injury, documentation of organizational responsibility, registration and reporting systems, investigations of undesirable incidents, systems for measuring patient safety and risk, and the involvement of patients and their families [ 7 , 8 ]. Legislation has included internationally recognized principles of open disclosure [ 9 ] to ensure that injured patients receive information and help with follow-up care after incidents have occurred [ 10 ]. The Norwegian Ministry of Health and Care Services emphasizes the increasing need to account for patient perspectives in the planning and implementation of patient treatment as well as in systematic quality and safety activities [ 11 ].

Thus far, hospital responses to AEs have been deficient. An Australian study based on “100 patient stories” found a lack of open disclosure and follow-up after the occurrence of AEs [ 12 ]. These findings corroborate an American study of cancer patients’ views on apologies and open disclosure when an error occurs [ 13 ] and studies of injured patients from the UK [ 14 , 15 ]. All of these results suggest a lack of recognition of patients’ need for an explanation of the event that has occurred, acceptance of responsibility, corrective apologies and initiation of measures to prevent the occurrence of similar incidents in the future. This issue is identified as the “disclosure gap” [ 16 ] or the “disclosure dilemma” [ 17 ]. Research has suggested that clinicians often avoid openness to protect their professional integrity and prevent personal consequences of an emotional, career or legal nature [ 17 , 18 ]. A publication from the Harvard Medical Practice Study III concluded that “Medical-malpractice litigations infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care” [ 19 ].

To date, patient safety activities and research on AEs have largely followed a system-based and biomedical perspective [ 20 ], which has been subject to critique as a top-down approach that often excludes patient voices from patient safety research and programs [ 21 ]. Within the sociotechnical systems tradition, the Systems Engineering Initiative for Patient Safety represents a person-centered model that incorporates human factors and stands out as an alternative to more limited traditional approaches [ 22 ]. However, the authorities and health personnel appear to have prioritized clinical, efficiency-related, financial and legal perspectives [ 23 , 24 ].

Scholars have critiqued these perspectives for potentially obscuring a range of social processes that affect AEs [ 14 , 20 ], and have argued for closer investigation of the multiple perspectives and different versions of events that may exist [ 25 , 26 ]. Ocloo states that it is time to re-identify the challenges and recognize the experiences of harmed patients as essential to patient safety efforts [ 14 ].

Clinical practice evolve through developments in medical research and interactions and negotiations between people who act within specific organizational frames that shape through professional, scientific and political discourses and the enactment of power [ 27 , 28 , 29 , 30 ]. These discourses and processes define the context, content of and responses to AEs and patient injuries. Extended patient safety discourses should include how professional power and control affect the articulation of patient experiences [ 15 ].

Patients possess power in the form of knowledge of their own body and health issues. However, the balance of strength and power remain askew. From a social constructivist [ 31 ] and interactionist [ 32 ] perspective, the rules of situations and settings in which social practices unfold are frames that influence actors’ behaviors. How patients perceive and interpret these frames may contribute to a broader understanding of how encounters are constructed and how power is exercised in hospitals when AEs occur.

Patient perspectives have largely been investigated using survey questionnaires with predefined questions and limited opportunities for patients to provide detailed accounts of their experiences [ 33 ], while in-depth interviews, which provide more detailed knowledge, have rarely been used [ 12 , 13 , 14 ]. First-hand accounts can provide authentic perspectives that illustrate patients’ experiences. The aim of this article is to illuminate conditions surrounding AEs from the patient perspective. Key aspects include how patients perceive the occurrence of events and the responses from health personnel and the health service.

Study design and setting

This qualitative study with an explorative descriptive design is part of an independent Ph.D. project entitled Experiencing an Adverse Event and Life Afterwards . The researchers have a background in nurse education, nursing and healthcare research and sociology and are affiliated with the UiT, The Arctic University of Norway. Individual open-ended interviews were considered an appropriate method for collecting data to capture complementary thick descriptions from patients about their experiences of AEs. Explorative designs allow participants an opportunity to emphasize important issues narrated from their own perspectives [ 34 ]. An in–depth interview is a professional conversation that seeks deep information and understanding of lived experiences from the interviewee’s perspective [ 35 , 36 ].

Recruitment and the sample

In Norway, The Health and Social Services ombudsman in each county can support patients and clients who experience AEs or insufficient help for their needs. The ombudsmen in the two northernmost counties Troms and Finnmark receive approximately 430 complaints related to hospital care each year [ 37 ], and were asked to assist in recruitment of study participants. As a statistical generalization was not an issue, we instructed the ombudsmen to obtain a varied sample. They performed a non-random search in their archives using the following inclusion criteria: adults between 20 and 70 years; both male and female; experience of AEs attached to surgical, orthopedic or medical treatment at general hospitals; and at least one year had passed since the event, allowing sufficient time for participants to reflect on and process the event. For qualitative in-depth studies, 10–25 interviews are considered sufficient to provide adequate data related to the research question [ 34 ].

The ombudsmen posted sixty invitation letters that included information sheets and informed consent forms that were all prearranged by the first author. The researcher did not participate in the recruitment process until the informed consent forms arrived by mail. Participants were contacted via telephone, and interviews were arranged based on their preferences.

A total of 19 former patients responded to the invitation. Two of these patients chose not to participate because they had enough trouble caused by the event, one had moved to a different geographical area, and one was unable to focus on the event during the interview. Thus, the study included fifteen participants, nine females and six males, ranging from 43 to 70 years old (median = 61 years). The incidents had occurred across three local hospitals and one university clinic in Northern Norway and one national hospital and one private clinic in Southern Norway. The interviews were conducted one to ten years after the AE, with an average of four years (median = 4 years). A maximum time limit was not set, as such a limit was viewed as a potential obstacle to recruiting a satisfactory number of participants. At the time of the interview, some of the informants were still undergoing treatment. All participants had experienced an injury as patients and approached the Health and Social Services ombudsman but had not necessarily claimed compensation from the Norwegian System of Patient Injury Compensation (NPE) (Table  1 ).

Data collection

The first author conducted individual interviews during the period from September 2013 to January 2014. Based on her experience with interview research and to position herself, she informed the participants that she had a background in nursing, that the study was independent and that she had no obligation toward the hospitals or to the Health and Social Services ombudsmen.

The conversations took place in the informants’ homes or in a desired meeting place. The first language of all participants was Norwegian, and the conversations were held in Norwegian. Each interview began with the open question: Please tell me what happened to you ..., and the participants were given an opportunity to speak as freely as possible to emphasize their own reflections and understandings. The researcher took a listening role and asked follow-up questions to increase the richness and depth of the stories [ 34 ]. A thematic interview guide formulated from findings of previous research [ 5 , 6 , 12 , 13 , 14 ] was used as a supporting document (see Additional file  1 ). ZxXThis guide served to ensure coverage of main themes across patient stories and to obtain more details about statements or topics if necessary [ 34 ]. Examples of follow-up questions include: What do you mean by that? Can you explain more about that? Side notes were written during the interviews. As no substantial new information appeared during the last interviews, the sample size was considered adequate for research purposes. The interviews lasted 45–150 min, were recorded as sound files and were transcribed to text by the first author. Expressions such as silences, sighs, laughter, crying, etc. were noted because they may influence the underlying meaning [ 38 ]. Eight of the participants released their discharge reports as supporting material.

Ethical considerations

Ethical considerations corresponding with the Helsinki declaration and national research regulations were made throughout the entire project [ 39 , 40 ]. After receiving oral and written information about the design and goals of the study, all participants provided their voluntary approval for participation and publication by signing an informed consent form. The participants were informed about their right to withdraw at any time, without stating a reason, and were guaranteed confidentiality and the anonymous presentation of findings. Fictitious names are used in the presentation of the results.

Data analysis

In qualitative research, analysis involves hermeneutic processes in which a pre-understanding derived from personal experience, former research and theoretical perspectives meets data and produces a deeper understanding and new concepts [ 38 , 41 ]. All text from the interviews (approximately 141,600 words) was subjected to the analysis, which was inspired by Graneheim and Lundman’s inductive model of qualitative content analysis [ 38 ] and supported by Malterud’s approach [ 34 ]. Our analysis addressed the manifest content aspects and describes the visible, obvious components in the texts as well as the latent underlying meaning based on interpretation. The texts were reread a number of times (GH and GN all interviews; NH 5 interviews) to gain an overall understanding and to generate preliminary categories.

Next, we made thematic categories and categorized the material in the texts that addressed the experiences related to the event itself. We then analyzed this material closely for the current paper. Statements related to the same central meaning were converted into condensed meaning units, which were coded and further interpreted and categorized as sub-topics and finally collected into main topics without use of qualitative software. The manifest content addressed the event that occurred, where and when it occurred, who was involved, how it was handled, and the patients’ perception of the event. Additionally, latent content, e.g. cover up , arose ‘unexpectedly’ or inductively from interview statements and was subject to interpretation. Coding and interpretations were checked against original transcripts. An example of this analysis is provided in Table  2 .

Trustworthiness of the data was achieved through reading the manuscripts multiple times and discussing themes in a series of meetings, and the three researchers’ independent generation of topics and themes. Discrepancies were resolved through several discussions until consensus was reached. The authors had different levels of experience with AEs from their professional and personal backgrounds. Reflexivity, practiced by noting biases and prior expectations, was an important piece of the analysis process to elicit the new understandings. The discharge reports were analyzed in light of whether the events were described and how they were presented. All the authors discussed the topics in light of relevant theory and achieved overall agreement. The following main topics emerged from the data (Table  3 ): ignored concerns or signs of complication; lack of responsibility and error correction; and lack of support, loyalty and learning. All study participants ( n  = 15) reported experiences that related to each of the three themes.

Descriptions of events

The findings concern AEs in various stages of the treatment chain and cover a wide range of basic illnesses and degrees of severity at the time of the event. A common feature among the fifteen study participants was that they experienced that something or someone had failed. The accounts represent many common denominators with regard to the overall sequence of events; reaction patterns; and patients’ perceptions of health personnel, the system, the care provided, and follow-up afterwards. Failures and defects are found in medical treatment but also in communication, information and documentation. Six of the events were related to failures and defects before treatment began. In these cases, the patients received a delayed or incorrect cancer diagnosis, which postponed the start of cancer treatment.

Various forms of cancer were represented: breast, prostate, kidney and stomach/colon. The informants assessed the causes of the events as follows: incorrect medical assessment of clinical signs and symptoms, failure of diagnostic tests, notices of appointments that were sent incorrectly or were missing or test results/referrals that were put aside for later examination but were not assessed. According to the informants, the delays resulted in an increased spread of cancer; more severe complications, resulting in more complicated treatment regimens; and mental stress. The informants mentioned the stress involved in getting cancer but stated that the most difficult aspect was the perceived incorrect or deficient treatment, which they viewed as a sign that their lives and health were not sufficiently valued.

The other nine events represent experiences related to orthopedic conditions, such as hip or knee interventions; surgery on the cheek/neck; incorrect anesthesia; incorrect medication; radiation injury; and deficient stroke treatment.

The events include errors/failures that were discovered while the patient was in hospital as well as errors/serious complications that became evident after discharge. Several of the informants believed that medical assessments, test analyses or organizational/administrative systems did not function properly. According to the interviewee’s, the events resulted in functional impairment requiring further surgery or treatment, difficult rehabilitation, organs that failed, pain and a more complicated sequence of treatment.

Ignored concerns or signs of complications

All the informants understood that hospital treatment involves a certain degree of risk. They stated that information about operations, other treatments and delayed diagnosis was presented in a standardized and everyday manner. When an undesirable event occurred, the health personnel did not appear to relate to the event or come to grips with the problem that the patient experienced Health personnel were perceived as trivializing, rejecting, skeptical or doubtful.

Most of the respondents described a powerful inner concern that something was wrong but felt as though they were ignored or overlooked when they mentioned their concern. In the case of diagnostic errors, the concern was related to bodily symptoms or a long wait for or absence of further tests and treatment. A woman with a delayed diagnosis of breast cancer explained:

Eva: “ I didn’t like that lump, and I felt strongly that something wasn’t right ... The lump was visible and painful. I went to the doctor several times and tried to speak up ..., but mammography and tissue samples had been taken, and the specialist at the hospital had signed them as normal.”

It was later proven that an error had been committed with the samples and that the cancer had been discovered many months earlier. The test results had rested in a pile at the hospital for new assessment, but a review was not performed. Positive test results were found coincidentally.

The events that became evident during the hospital stay or after returning home concerned symptoms of errors or of complications assessed as normal issues or symptoms that would disappear over time.

Peter: “I asked how the operation had gone, and the doctor said that it had been a little more complicated than first envisioned, but everything had gone well. I had pains when discharged, but I could still manage to move my arm. At home, I suddenly could not hold my arm out. I contacted the doctor at the hospital; he said it was completely normal and I could relax. It would get better again. But it certainly did not: it got worse and worse. I spoke to the hospital again but got the same answer ...”

After a long struggle, neurological examinations found nerve damage that resulted in permanent pain, paralysis and loss of function.

When errors became visible, health personnel appeared unwilling to talk about the errors, support the patients during a difficult situation, or help with further follow-up and treatment.

Lack of responsibility and error correction

The informants reported their experiences of being in the middle of situations that were decisive for life and health. They had expectations that any damages and errors would be rapidly limited and corrected, but they were disappointed. Few of the informants received an apology or detailed explanation of the event that had occurred, and none of them had a meeting with those involved to clarify the situation afterwards. The two informants who received an apology and explanation viewed them as noncommittal because they were not invited to share their experiences with the staff in general. Most informants perceived that hospital staff denied responsibility by avoiding dialogue and not providing suggestions for correction and damage limitation. The informants clearly expressed their disappointment.

Kari: “The doctor held his head up and walked straight past me; I know he saw me - that was a really unpleasant feeling.” Tone: “I had gotten much worse, but the doctor just turned around and walked out. And that was that. It was this denial of responsibility; that you were not allowed to talk about it like ... it would have meant a lot to me to have a good discussion with someone...”

The accounts show that it was essentially the patients’ responsibility to prove the AE. They encountered a hospital culture that normalized and trivialized AEs by referring to the fact that current procedures and rules had been followed and/or that tests and examinations showed normal findings.

Bjørn: “Not very much I can do when the doctor says it looks fine. You have to be quite active and more or less healthy to be able to keep up with all this. I don’t know ... you feel almost like a scoundrel. Feel that you are being met with doubt the whole time.”

This was experienced as a challenge in that patients can refer to only unexpected symptoms and feelings. Patients experiencing pain, discomfort and vulnerability must struggle to ensure that their condition is re-assessed. In Camilla’s case, after a hip operation, the prosthesis came out of joint. She heard a click , which was followed by serious pains and mobility problems. The staff thought that the pains were normal postoperative pains, and the patient had to make a fuss to get a new X-ray, which confirmed the luxation. She then had to wait four painful days for reoperation, which revealed a splinter of bone that had remained in the hip joint. Other informants experienced similar difficulties with circumstantiation and clinicians who they perceived as rejecting and arrogant:

Nina: “I could see for myself that the muscle was just hanging, but they said it would get better.” “He (the doctor) said that everything was perfect without touching me. I couldn’t understand how ... he had just done perfect work.”

These deficiencies reinforced the informants’ feelings of discouragement, vulnerability, pain and bitterness. The interviewees perceived that those who were responsible did not wish to accept the consequences of their decisions and actions, while the patients had to struggle to receive further help and treatment. The informants felt that they were not prioritized and that the time between the discovery of the error and the start of treatment could be long.

Peter: “Everyone can be unlucky, but can’t they just be nice enough to say so. Say ‘we’ll help you’ -why can’t they do that?”

Responsibilities regarding follow-up appeared to be unclear, and the informants stated that they were placed on new waiting lists where they received little or no information about what was to be done and when.

Eva: “That was when the struggle began, and that was the worst. I was naive enough to think that once an error had been discovered then things would move quickly. Nothing could be done about what had happened, but they could come to grips with things quickly, but that didn’t happen ... I had to fight my way to treatment, pure and simple. I had to stay on the phone and ring, and ring, and ring ...”

Lack of support, loyalty and learning

All the informants felt alone with their problems. Admitted patients found that hospital personnel rarely noticed their need for physical or mental support.

Kari: “There has been no real follow-up with me as a person, and I don’t feel that I have had any support ...”

Nurses and other carers showed understanding related to the performance of concrete tasks such as pain relief, showering or toilet visits but were otherwise perceived to be silent and absent. However, there were references to nurses who expressed understanding and recommended that the patient seek help from the patient and services ombudsman or report the incident as a patient injury. Informants described physiotherapists as one professional group that was supportive and asked questions about the patients’ progress and if they could help in any way.

The informants described how errors and defects in case notes made the course of further treatment difficult. Hospital doctors, other health personnel and GPs did not have knowledge about earlier events or complications due to a lack of written documentation in patient records. Some of these professionals notice problems and support the patient, while others are more concerned about documentation in the medical records before they refer patients to new examinations, check-ups and rehabilitation. The released discharge reports confirm the lack of descriptions of events and complications. When new health professionals must refer to incomplete written records, it is difficult for the patient to gain acceptance of his or her version and participate in decision making that could correct the error or prevent a new error from occurring. Thus, reoperations or corrective treatments are viewed as new treatments without considering the situation as a whole. Informants perceived this view as problematic and expressed that clinicians and administrative systems should be aware of the event, facilitate better follow-up, and be more attentive to patient needs in the situation.

Several of the informants spoke of specialist assessments and second opinions that finally supported their assertion that an error had occurred. The feeling of being seen and cared for as a person was of great significance. Kari explained this when describing the surgeon who performed the reoperation.

Kari: “He has followed up, telephoned me and given me very good information. This is reassuring, and it is directed at me as a person, not just two knees.”

However, informants also found that verbal feedback did not necessarily correspond with written statements in the medical records.

Bjørn: “He actually saw what was wrong with me straight away. It was good to have it confirmed ... but he did not want to stab a colleague in his back, which is why the report is as it was. However, he would follow my case, and he was one hundred per cent behind me. Therefore, I imagine he has something of a bad conscience. This hierarchy is like nothing else in society. They can’t just sit and cover each other.” Mari: “The doctor I spoke to said that the first doctor had made an incorrect assessment but that the system then got involved. A cover-up begins, and there are rules about what they can say and what they can do. Anyway, I am glad he was honest enough to say that. It helps a little.”

The informants appeared to be strongly affected by the events and their impact on their lives. At the same time, they believed that health personnel and the health service at both the individual and system levels should learn from the events and prevent similar events in the future. They interpreted the experience of a lack of recognition, disclosure and understanding to imply that learning is hindered when events are trivialized to such an extent.

The struggle against perceived negligence

The purpose of this study was to illuminate patients’ experiences of AEs as bottom-up inputs in patient safety work. Our sample represents a variety of diagnoses and conditions. The fact that all the “before treatment” cases in our study involved cancer, in contrast to only one of the during/after treatment cases, was somewhat surprising. This may be due to the sample composition. However, we are unable to evaluate this issue further at this time. One major finding concerns patients’ struggle against perceived negligence by clinicians and hospitals when they present their anxiety and concerns or point out errors and deficiencies. In summary, these reports describe the clinicians’ and health service’s avoidance or lack of response, signs of denial of responsibility and use of loyalty systems to largely support and protect each other. In these cases, patients are shocked by illness [ 1 ], and this shock may double due to injury or even triple due to the lack of adequate follow-up and treatment. The descriptions reveal potential barriers to openness and indicate that these patients were not invited into processes of open disclosure. This finding is in line with results reported by Iedema et al. [ 12 ], Ocloo [ 14 ] and Mazor et al. [ 13 ], who found that patients clearly expressed that a patient-centered and respectful dialogue to promote healing, learning and safety should follow the disclosure of an AE. In our study, informants’ descriptions also revealed a practice that was not in line with Norwegian governmental policy statements regarding the promotion of trust and openness in patient safety work [ 7 ].

However, some informants reported positive experiences of health personnel who acknowledged their experiences, offered help related to their condition and supported them in reporting the incident.

On the other hand, health personnel have been described as the second victims and also experience great stress from AEs; these factors must be taken into consideration [ 42 ]. Furthermore, individual clinicians may lack communication skills and may generally find it easier to avoid difficult conversations [ 18 ]. Several informants referred to their perceptions of doctors’ reluctance to criticize colleagues openly. This reluctance could connect to the Medical Associations’ ethical rules [ 43 ] of the handling of such events between colleagues but could also indicate that professional codes of collegiality and loyalty exist within the medical profession and potentially hamper an open disclosure process [ 17 , 18 ].

At a more general level, the breaches may represent more or less latent and unrecognized driving forces against defining errors and serious complications in hospitals. Hospitals work hard to avoid negative figures in reports and/or to maintain their reputation and income; paradoxically, such efforts may tend to counteract openness about undesirable circumstances [ 17 ]. However, we have no data to evaluate the extent to which hospitals used the errors narrated by study participants in learning processes to improve patient safety. Nevertheless, our findings may be interpreted as signs of professional and organizational cultures that do little to communicate errors to patients and to include them in learning processes at any organizational level, which potentially impedes open disclosure and even hampers learning from AEs as outlined in high-quality guidelines, e.g. guidelines from Harvard hospitals [ 9 ]. This could contribute to the understanding of why patients struggle to obtain evidence that recognizes the event and promotes further support.

The discursive power

The participants’ perception of being ignored and that the definition of events was not in line with the personal consequences that they experienced, was problematic. Our findings indicate that practitioners and hospitals have discursive power in the form of expert knowledge , which determines and limits the prevailing definition of the truth in the situation [ 27 ]. In general, professional knowledge and the hospital environment give health personnel an authority to assess the best course of action in any patient situation. Participants reported lack of acknowledgement of their condition in the encounter with the experts. This finding corroborate results from Eriksson and Svedlund who studied patients’ dissatisfaction with hospital care [ 44 ]. The results further shows that patients did not experience to be part of assessment processes or in the social construction of categories that defined what was considered normal in the patient’s situation. Sharpe and Faden argue that the definition of medical injury is overly one-sided and tends to reflect a narrow clinical understanding that excludes non-clinical perspectives and outcomes that the patients experience as damaging [ 45 ]. In this sense, the understanding of AEs may be selective and contribute to disciplinary actions and stigmatization [ 30 ]. Events described as foreseeable complications, misunderstandings, organizational failure etc. place the responsibility outside the potential control of the health personnel and attribute the events to chance, natural surgical risk or patient factors.

Some informants reported feeling uneasy when asking questions. Patients who speak up and ask questions may thus be perceived as extra concerned, having a negative attitude, being bothersome, difficult to treat etc. When problem descriptions take little account of patient perspectives, there is a risk that general intentions about increased patient involvement, empowerment, openness and AE reduction are not spread downwards through the organization and do not make contact with the prevailing values of the professional and organizational cultures. In practice, this may imply that a number of patients do not receive the treatment and follow-up that they need and begin a difficult process to ensure that their condition is acknowledged. The patients in our study were not involved in designing measures to avoid incidents, and to their knowledge, their experiences were not pursued for subsequent learning. Thus, intentions regarding patient-centered care and patient participation in the development of safety efforts appeared to be practiced to a limited extent in the reported cases.

Patient safety within fixed frames

Patterns of action that replicate many times in organizations like hospitals, become typified and institutionalized as permanent attitudes, actions and methods that tend to be taken as a given [ 31 , 32 ]. Within these frames, social practice unfolds. In this way, awareness in the everyday understanding of patient treatment has become routine. This issue not only applies to individual errors or deficiencies related to everyday performance, but may also represent practice cultures in which the exclusion of patients and events becomes routine and maintained by the prevailing knowledge regimes and professional hierarchies. Changing these regimes requires increased awareness, not only in terms of the authorities’ intentions to increase patient safety but also in terms of the inclusion of both personnel and patients at all levels of professional and organizational cultures [ 31 ].

Learning processes can be inhibited if the goal, in this case, the reduction of AEs and improved follow-up with patients, does not coincide with other goals, such as maintaining professional autonomy, promoting the individual clinician’s career opportunities or earning the status of the professional center or hospital with the fewest reported errors. Argyris and Schӧn [ 46 ] refer to this dilemma as the differences between espoused theory and theory-in-use , where ideals and reality do not concur. Changing fixed attitudes and patterns requires obtaining information that includes all relevant perspectives, weighing alternative knowledge-based actions, continuously assessing the consequences of the action taken and questioning whether the action is congruent with governing values [ 46 ].

The study results show that patient experiences may serve to identify barriers to patient safety work that are necessary to overcome to prevent future AEs.

Strengths and limitations

The data are from interviews with a small, selected group of patients who had the energy and resources to contact the Health and Social Services ombudsman for assistance. Thus, the findings cannot be generalized to the entire population of patients who experience AEs in Norwegian hospitals. Personal stories might also be selective, exposed to recall bias and affected by a wish to narrate only aspects that favor the quest for some kind of compensation following an AE. In addition, the relatively long time span between the incidents and the interview may have provided informants with new contexts of interpretation due to their personal biography and the increased public attention toward patient safety issues. On the other hand, an expanded time frame may contribute to greater richness in terms of reflections on the event. Overall, the patient stories bear significant similarities and appear to be consistent across all subject areas and diagnoses, across a wide range of institutional settings, and regardless of whether the persons had applied for or received compensation. This consistency should contribute to the trustworthiness of results and indicates that the stories reveal important aspects of a widespread deep structure within hospitals that inhibits the realization of principles of open disclosure. Another important limitation is that the study does not include clinicians or health service providers’ perspectives of the events. Some of the events may expose grey areas between complications and AEs. Nevertheless, experiences of a struggle against perceived negligence are present across all stories.

Implications

Patients are in need of emphatic and professional acceptance of responsibility when an error occurs. Health personnel must listen to the patient and bear in mind that communication and open dialogue have great implications for the person’s evaluation of the event and future life and health. This qualitative study may promote reflection among care providers irrespective of professional area, hospital management and government. Acknowledging that patients are co-producers with important knowledge about their health situation is essential to the development of safer treatment. Future research should include a larger number of patients as well as organizational and professional perspectives. The impact of AEs on the daily lives of patients and their families should also be studied.

This small-scale, qualitative study shows that some patients experience a lack of care, openness and acceptance of responsibility when AEs occur. They perceived that their perspective was largely ignored. We have no data to evaluate whether their cases are used as input for learning and development in patient safety work. However, open disclosure guidelines advocate for the inclusion of patients at early stages and throughout the process. Our results indicate that the full potential of such learning and development is not realized in hospital units. Considerable cultural and attitudinal changes in day-to-day patient care are necessary. Patients exposed to AEs should be invited into open disclosure processes and included as fellow architects of their own health and safety.

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Acknowledgements

We are grateful to all the participants who shared their accounts with us. We also thank the Health and Social Services ombudsmen for their recruitment efforts.

This study was funded by UiT, The Arctic University of Norway.

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The dataset supporting the conclusions of this article is not made available to secure participant confidentiality and because of the consistency of a large amount of qualitative interview transcripts in Norwegian.

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Gunn Hågensen, Gudrun Nilsen & Grete Mehus

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GH was responsible for the conception and design of the study, the acquisition of data, the analysis and interpretation of data and the drafting of the manuscript. GN was involved with the design of the study, the analysis and interpretation of data, and the revision of the article. GM contributed to the refinement of the data analysis and the preparation of the manuscript. GM provided critical comments and suggestions for revisions. NH contributed to the conception and design of the study, the analysis of data, the incorporation of sociological theory, and the writing and critical revision of the manuscript. All authors read and approved the final version of the manuscript.

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Correspondence to Gunn Hågensen .

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The Norwegian Social Science Data Services (NSD) gave their approval (Reference number 34221), while the Regional Committee for Medical Research Ethics judged that the project did not require approval (REK North Reference number 2013/131), corresponding to the Norwegian regulations for ethical research practice and ethical principles stated in the Helsinki declaration. After receiving oral and written information about the design and goals of the study, all participants gave their voluntary approval for participation by signing an informed consent form.

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Hågensen, G., Nilsen, G., Mehus, G. et al. The struggle against perceived negligence. A qualitative study of patients’ experiences of adverse events in Norwegian hospitals. BMC Health Serv Res 18 , 302 (2018). https://doi.org/10.1186/s12913-018-3101-2

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Received : 06 May 2016

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DOI : https://doi.org/10.1186/s12913-018-3101-2

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It is unsettling, and dismaying, to read Dr. Carl Elliott’s account of moral lapses continuing to exist, if not thrive, in medical education. As a neurology resident in the early 1970s, I was assigned a patient who was scheduled to have psychosurgery.

He was a prisoner who had murdered a nurse in a hospital basement, and the surgery to remove part of his brain was considered by the department to be a therapeutic and even forward-looking procedure. This was despite its being widely discredited, and involving a prisoner who could not provide truly informed consent.

A fellow resident and I knew that refusing would almost certainly result in suspension or dismissal from the residency, so we anonymously contacted our local newspapers, whose reporting resulted in an overflow protest meeting, cancellation of the psychosurgery and legislative action placing conditions on the acceptance of informed consent by prisoners.

It is lamentable that even though bioethics programs are widely incorporated into medical education, moral and ethical transgressions remain a stubborn problem as part of medical structures’ groupthink.

As Richard Feynman has emphasized , doubt, uncertainty and continued questioning are the hallmarks of scientific endeavor. They need to be an integral element of medical education to better prepare young doctors for the inevitable moral challenges that lie ahead.

Robert Hausner Mill Valley, Calif.

I would like to thank Carl Elliott for exposing the “Moral Dilemmas in Medical Care.” There is a medical school culture that favors doctors as privileged persons over patients.

I can remember multiple patient interactions in medical school in which I thanked a patient for allowing me to examine them and apologized for hurting them during my exam of their painful conditions.

I was then criticized by attending physicians for apologizing to the patients. I was told, on multiple occasions, that the patient should be thanking me for the privilege of assisting in my education.

Medical training, in a medical school culture that favors the privilege of the medical staff over the rights and feelings of patients, needs to be exposed and changed.

Doug Pasto-Crosby Nashville The writer is a retired emergency room physician.

As a psychiatrist and medical ethicist, I commend Dr. Carl Elliott for calling attention to several egregious violations of medical ethics, including failure to obtain the patient’s informed consent. Dr. Elliott could have included a discussion of physician-assisted suicide and the slippery slope of eligibility for this procedure, as my colleagues and I recently discussed in Psychiatric Times .

For example, as reported in The Journal of Eating Disorders , three patients with the eating disorder anorexia nervosa were prescribed lethal medication under Colorado’s End-of-Life Options Act. Because of the near-delusional cognitive distortions present in severe anorexia nervosa, it is extremely doubtful that afflicted patients can give truly informed consent to physician-assisted suicide. Worse still, under Colorado law, such patients are not required to avail themselves of accepted treatments for anorexia nervosa before prescription of the lethal drugs.

Tragically, what Dr. Elliott calls “the culture of medicine” has become increasingly desensitized to physician-assisted suicide, nowadays touted as just another form of medical care. In the anorexia cases cited, informed consent may have been one casualty of this cultural shift.

Ronald W. Pies Lexington, Mass. The writer is on the faculty of SUNY Upstate Medical University and Tufts University School of Medicine, but the views expressed are his own.

Carl Elliot’s article on medical ethics was excellent. But it is not just in the medical profession that there exists the “subtle danger” that assimilation into an organization will teach you to no longer recognize what is horrible.

Businesses too have a culture that can “transform your sensibility.” In many industries executives check their consciences at the office door each morning. For example, they promote cigarettes; they forget they too breathe the air as they lobby against clean-air policies; they forget they too have children or grandchildren as they fight climate-friendly policies or resist gun-control measures. The list could go on.

In every organization, we need individuals to say no to policies and actions that may benefit the organization but are harmful, even destructive, to broader society.

Colin Day Ann Arbor, Mich.

Re “ Columbia’s Protests Also Bring Pressure From a Private Donor ” (front page, May 11):

Universities are meant to be institutions of higher learning, research and service to the community. They are not items on an auction block to be sold to the highest bidder.

Universities that sell off their policy platform to spoiled one-issue donors who threaten to throw a tantrum no longer deserve our respect. Grant-making foundations should not be grandstanding online. Give money, or don’t, but don’t call a news conference about it.

If Columbia caves, why should prospective students trust it as a place where they can go to become freethinkers and explore their own political conscience as they begin to contemplate the wider world and issues of social justice?

This is a real test of Columbia and its leadership. I do not envy its president, Nemat Shafik, who has few good choices and no way to make everyone happy. What she should not sell is her integrity, or the university’s. She should stand up to these selfish donors. Learn to say, “Thanks, but no thanks.”

Carl Henn Marathon, Texas

Re “ Book Bans? So Open a Bookstore ” (Arts, May 13):

Deep respect for the American novelist Lauren Groff and her husband, Clay Kallman, for opening the Lynx, their new bookstore in Gainesville, Fla. The store focuses on offering titles among the more than 5,100 books that were banned in Florida schools from July 2021 through December 2023.

To all the book clubbers and haters of bans: Order straight from the Lynx.

Fight evil. Read books.

Ted Gallagher New York

Re “ Keep a Firm Grip on Those Mickey Mouse Balloons. It’s the Law ” (front page, May 9):

Balloons are some of the deadliest ocean trash for wildlife, as mentioned in your article about Florida’s expected balloon release ban.

Plastic balloon debris poses a significant threat to marine life, often mistaken for food or becoming entangled in marine habitats, leading to devastating consequences for our fragile ocean ecosystems.

As the founder of Clean Miami Beach, an environmental conservation organization, I’m concerned about the impact of plastic pollution on Florida’s wildlife and coastal areas. Florida’s stunning beaches and diverse marine life are not only treasures to us locals but also draw millions of tourists each year.

Because of the dangers, intentional balloon releases have been banned in many cities and counties across the state. A poll released by Oceana showed that 87 percent of Florida voters support local, state and national policies that reduce single-use plastic. Gov. Ron DeSantis must waste no time in signing this important piece of legislation into law.

Our elected officials should continue to work together to address environmental issues so Floridians and tourists can enjoy our beautiful state without its being marred by plastic pollution.

Sophie Ringel Miami Beach

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MEDICAL NEGLIGENCE IN INDIA: A CRITICAL STUDY MEDICAL NEGLIGENCE IN INDIA: A CRITICAL STUDY

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RCOG responds to APPG Birth Trauma inquiry report and the Saving Babies Lives’ progress report

This week, the All Party Parliamentary Group (APPG) for Birth Trauma launched a new inquiry report and the second ‘Saving Babies Lives’ progress report was published by the Sands and Tommy’s Joint Policy Unit.

The Royal College of Obstetricians and Gynaecologists (RCOG) welcomes the APPG Birth Trauma Report, which highlights some of the key challenges and instrumental areas in which progress can be made. The RCOG submitted both written and oral evidence to help support the report's development.

Overall the report highlights several key themes. Including failure to listen to women, lack of informed consent, poor communication, lack of pain relief, lack of kindness, breastfeeding problems, postnatal care, the impact of COVID and medical negligence. The report includes many first-hand birth trauma experiences from women and highlights many of the challenges that currently face maternity services and perinatal care in the NHS.

The College supports the call to recruit, train and crucially retain more midwives, obstetricians and anaesthetists in the report. The workforce across the health system also needs to be able to meet the needs of perinatal women and their families this includes general practice support for postnatal checks and appropriately trained interpreters.

One key focus of the report was obstetric anal sphincter injury (OASI), also known as a severe perineal tear, which can occur during vaginal birth. To combat this the RCOG, with the Royal College of Midwives (RCM), has developed the OASI Care Bundle- a comprehensive set of interventions aimed at reducing the incidences of severe tears and improving outcomes for women. The success of the OASI Care Bundle is evident, with piloting taking place in 16 maternity units and a decrease in OASI rates by 20%. The RCOG fully supports the report’s recommendation that the OASI Care Bundle be rolled out nationally and implemented, with adequate staff training across all hospital trusts. This would be a significant step towards reducing the risk of injuries in childbirth.

The RCOG also echoes the report’s calls for the implementation of NHS England’s Perinatal Pelvic Health service specification in maternity units and would support further exploratory work around linking pelvic floor health clinics with maternal mental health services, as suggested in the report.

Dr Ranee Thakar, President of the Royal College of Obstetricians and Gynaecologists, said: “The College welcomes this important report from the APPG, which highlights the very moving stories of women who have been affected by birth trauma. Birth trauma is often overlooked, despite its life-changing impact so we sincerely thank the APPG for its work to shine a light on this difficult yet important topic, and commend the bravery of the women who shared their stories. “As the stories of women affected starkly show, physical birth trauma can also have a significant effect on a woman’s mental health and well-being. Providing services in a joined-up way would potentially make it easier for women to get the holistic support they need.”

Also published this week, the ‘Saving Babies Lives’ report found that progress in reducing rates of stillbirth and neonatal death is stalling and there has been little progress in reducing preterm births. The RCOG fully supports the call by Sands and Tommy’s for meaningful action to end the persistent and widening inequalities in rates of pregnancy and baby loss by ethnicity and deprivation, driven by a Government ambition.  

Dr Ranee Thakar, said: “The RCOG is committed to supporting progress in these critical areas, working alongside partners including Tommy’s and Sands. The College’s clinical guidelines and professional development courses and events also support maternity teams offer safe, personalised and compassionate clinical care. However, the inescapable reality is maternity services are under incredible strain. Sufficient, dedicated government funding for maternity services, and a cross-government department focus on tackling inequalities in maternity outcomes, is urgently needed.”

• Read the APPG on Birth Trauma report here.
• To read the full Saving Babies Lives progress report click here. 
• Find out about the OASI Care Bundle
• OASI resources: eLearning
• Read about the RCOG’s maternity safety programme here.
• Policy and governance
• Pregnancy and birth

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Medical negligence: Indian legal perspective

Amit agrawal.

Advocate, New Delhi, India

A basic knowledge of how judicial forums deal with the cases relating to medical negligence is of absolute necessity for doctors. The need for such knowledge is more now than before in light of higher premium being placed by the Indian forums on the value of human life and suffering, and perhaps rightly so. Judicial forums, while seeking to identify delinquents and delinquency in the cases of medical negligence, actually aim at striking a careful balance between the autonomy of a doctor to make judgments and the rights of a patient to be dealt with fairly. In the process of adjudication, the judicial forums tend to give sufficient leeway to doctors and expressly recognize the complexity of the human body, inexactness of medical science, the inherent subjectivity of the process, genuine scope for error of judgment, and the importance of the autonomy of the doctors. The law does not prescribe the limits of high standards that can be adopted but only the minimum standard below which the patients cannot be dealt with. Judicial forums have also signaled an increased need of the doctors to engage with the patients during treatment, especially when the line of treatment is contested, has serious side effects and alternative treatments exist.

Introduction

The term “medical negligence” is an omnibus one, which has come in vogue to refer to wrongful actions or omissions of professionals in the field of medicine, in pursuit of their profession, while dealing with patients. It is not a term defined or referred to anywhere in any of the enacted Indian laws.

This article seeks to outline the basic features of “medical negligence” with minimal usage of legal phraseology. Furthermore, rather than exploring the thorny issues surrounding the subject matter, this piece is intended to be informative. The methodology adopted is descriptive; it is based on judicial opinions of the higher courts of India and is limited to select judicial opinions rather than being an encyclopedia of authorities.

The consequences of medical negligence under broad heads are outlined at the outset in this article, which are followed by an outline of the basic constituents of medical negligence and the duties of doctors together with certain illustrations and the minimum standards of care required under law. Thereafter, the article deals with the nature of information required to be imparted to the patient for the purposes of consultation and treatment and concludes after a reference to the general advisory issued by the Supreme Court for doctors to be taken as precautionary measures and the guidelines issued by the Supreme Court for protection of doctors from harassment if criminally prosecuted.

Overview of Consequences

The consequences of legally cognizable medical negligence can broadly be put into three categories: 2 (i) Criminal liability, (ii) monetary liability, and (iii) disciplinary action.

Criminal liability can be fastened pursuant to the provisions of the Indian Penal Code, 1860 (“IPC”), which are general in nature and do not provide specifically for “medical negligence.” For instance, Section 304A of IPC 3 (which deals with the death of a person by any rash or negligent act and leads to imprisonment up to 2 years) is used to deal with both cases of accidents caused due to rash and negligent motor vehicle driving and also medical negligence leading to the death of a patient. Similarly, other general provisions of IPC, such as Section 337 4 (causing hurt) and 338 5 (causing grievous hurt), are also often deployed in relation to medical negligence cases.

Civil liability, i.e., monetary compensation can be fastened under the general law by pursuing a remedy before appropriate civil court or consumer forums. An action seeking imposition of the civil liability on the erring medical professional is initiated by dependents of the deceased patient or by the patient himself (if alive) to seek compensation. Doors of permanent lok adalats , constituted pursuant to the Legal Services Authority Act, 1987, can also be knocked at by a complainant seeking relief in the relation to services “in a hospital or dispensary” which are considered to be “public utility services” within the meaning thereof, wherein first a conciliation is attempted and thereafter determination on merits of the matter is made. Permanent lok adalats are conferred powers akin to that of a civil court in specified matters (such as summoning and enforcing the attendance of witnesses) and have jurisdiction in the matters up to Rs. 1 Crore. 6

Another consequence of medical negligence could be in the form of imposition of penalties pursuant to disciplinary action. Professional misconduct by medical practitioners is governed by the Indian Medical Council (IMC) (Professional Conduct, Etiquette, and Ethics) Regulations, 2002, made under IMC Act, 1956. 7 Medical Council of India (MCI) and the appropriate State Medical Councils are empowered to take disciplinary action whereby the name of the practitioner could be removed forever or be suspended. Professional misconduct is, however, a broad term which may or may not include medical negligence within its fold. For instance, in the context of lawyers, it is not only a professional misconduct but other misconduct also which may lead to imposition of disciplinary penalties, for example, violation of prohibition on liquor under Bombay Prohibition Act, 1949, by the advocate; 8 and perhaps a corollary may be extended for cases of medical negligence by medical professionals.

Basic Features of Medical Negligence and Standard of Care

To comprehend the scope of negligence, it is important to understand the scope of the duty imposed on a doctor or medical practitioner. A doctor or other medical practitioner, among others, has a duty of care in deciding whether to undertake the case or not, duty in deciding what treatment to give, duty of care in administration of that treatment, duty not to undertake any procedure beyond his or her control, and it is expected that the practitioner will bring a reasonable degree of skill and knowledge and will exercise a reasonable degree of care. 9

Negligence, simply put, is a breach of duty of care resulting in injury or damage.

The causal relationship between breach and injury is a must for fastening the liability of negligence, and such cause must be “direct” or “proximate.” 10 It is important to note that the test is an “or” one, and therefore the casual link can be either direct causation or proximate causation, and in both cases, negligence can be ascribed. For instance, where a patient with about 50% burns died 40 days after the date of a wrong blood type transfusion in spite of receiving substantial care thereafter postdetection of error; the finding of medical negligence could not be escaped as the causal relation between the transfusion of wrong blood type and death was proximate. 11

The line between civil liability and criminal liability is thin, and no sufficiently good criteria have yet been devised by the Supreme Court providing any clear and lucid guidance. The Supreme Court in Dr. Suresh Gupta v. Govt. of NCT Delhi 12 put the standard for fastening criminal liability on a high pedestal and required the medical negligence to be “gross” or “reckless.” Mere lack of necessary care, attention, or skill was observed to be insufficient to hold one criminally liable for negligence. It was observed in Dr. Suresh Gupta that mere inadvertence or simply a want of a certain degree of care might create civil liability but will not be sufficient to attract criminal liability. In this case, a young man was stated to have died during the simple procedure for nasal deformity for “not introducing a cuffed endotracheal tube of proper size as to prevent aspiration of blood from the wound in the respiratory passage,” and the prosecution under Section 304A IPC was quashed by the Supreme Court setting aside the order of the High Court which had declined to quash the prosecution. The soundness of the view of the Supreme Court was subsequently doubted considering that word “gross” is absent in Section 304A IPC and that different standards cannot be applied for actions of the negligence of doctors and others. Consequently, the matter was placed for reconsideration before a bench of higher strength. 13

Three-judge bench (bench strength in Dr. Suresh Gupta was two) in Jacob Mathew v. State of Punjab 14 on a reconsideration endorsed the approach of high degree of negligence being the prerequisite for fastening criminal liability as adopted in Dr. Suresh Gupta, and it was observed that”[i] n order to hold the existence of criminal rashness or criminal negligence, it shall have to be found out that the rashness was of such a degree as to amount to taking a hazard knowing that the hazard was of such a degree that injury was most likely imminent.” Supreme Court in Jacob Mathew observed that the subject of negligence in the context of medical profession necessarily calls for a treatment with a difference. In this case, an aged patient in an advanced stage of terminal cancer was experiencing breathing difficulties and the oxygen cylinder connected to the mouth of the patient was found to be empty. By the time replacement could be made, the patient had died. Supreme Court set aside the judgment of the High Court and held that the doctors could not be criminally prosecuted.

It would not be surprising if different benches of the Supreme Court in the above facts were to arrive at different conclusions. High Courts in both of the above cases, i.e., Dr. Suresh Gupta and Jacob Mathew surely held views different from that of the Supreme Court. The abstract principles sometimes do pose difficulty in their application to facts, much like in the practice of medicine.

The criminal liability and civil liability are not exclusive remedies and for the same negligence, both actions may be available.

“Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law requires,” 15 as the standard of care from a doctor. It has been held by the courts that in the cases of medical negligence, Bolam test is to be applied, i.e., “standard of the ordinary skilled man exercising and professing to have that special skill,” and not of “the highest expert skill.” 16 This is applicable to both “diagnosis” and “treatment.” It is noted that the Supreme Court has now observed the need to reconsider the parameters set down in Bolam test. 17

Errors of judgment do not necessarily imply negligence. 18 Gross mistakes would, however, invite the finding of negligence such as use of wrong drug or wrong gas during the course of anesthetic process, delegation of the responsibility to a junior with the knowledge that the junior is incapable of performing the duties properly, removal of the wrong limb, performing an operation on the wrong patient or injecting a drug which the patient is allergic to without looking at the outpatient card containing the warning, and leaving swabs or other items inside the patients. 19 Persons not qualified in general or a certain branch of medicine yet embarking upon a treatment course in that field has been held to be negligent. 20 Not taking care of a premature baby who is given supplemental oxygen and blood transfusion for prevention of a disease called retinopathy of prematurity (which such premature children are highly prone to and which makes them blind progressively), and not seeking views of pediatric ophthalmologist, has been held to be an incidence of negligence. 21 Instances of senior doctor deciding to do a surgery but actually taking up another surgery at the same time and leaving the patient to the care of a junior doctor, who is not incompetent but has no experience as such (even if such junior doctor performs the surgery without mistakes) has also led to the finding of medical negligence. 22

In the cases involving medical negligence, at the beginning, the person alleging the negligence has the initial onus to make out a case of negligence, and thereafter the onus shifts on to the doctor or the hospital to satisfy that there was no lack of care or diligence. 23 It may also be noted that for imposition of civil liability on the hospital, it is not necessary that treating doctors or the nursing staff be made a party (the hospital alone can be the party to the proceeding), and it is immaterial if the medical professionals are the permanent staff or come on a visiting basis. 24

The standard of care is to be judged keeping in view the body of knowledge and equipment available at the time of the incident. For example, if the allegation is that a doctor was negligent on account of his failure to use a particular equipment which should have been used, the court would consider whether such equipment was “generally available at that point of time” and therefore available for use. 25 Every hospital cannot be expected to have state-of-the-art facilities and be fully equipped with the latest inventions and techniques. Sometimes, it becomes difficult to prove that certain equipment was generally available or not considering that there is no central or regional record of equipment used by medical professionals or hospitals. For instance, in a case where post a hernia operation in Hospital A, the arterial saturation of a diabetic patient could not be maintained due to unknown reasons, the patient had to be shifted to Hospital B which was equipped with a mechanical ventilator considering that Hospital A did not have it. The patient became comatose by the time he reached Hospital B and ultimately passed away. In this case, the State Commission fastened civil liability on Hospital A holding it guilty of medical negligence, among others, on the assumption (without any actual finding) that mechanical ventilators were generally available in Jaipur, Rajasthan, in September 2002 and Hospital A should have also had the same. 26

While dealing with medical negligence cases, the opinions of the medical experts are often called for from both sides. Section 45 of the Indian Evidence Act, 1872, provides that when a court has to form an opinion on a point of science, the opinion of a person especially skilled in such science is considered “relevant.” It is to be noted that a “relevant” opinion is not synonymous to the opinion being “conclusive” and law reports are replete with illustrations of expert opinions being discarded for one reason or another. The real function of the expert is to put before the court all the material together with reasons which induce him to come to a certain conclusion so that the court, even though not an expert, may form its own judgment using its own observation of those materials. 27 Experts only render opinions and those that are “intelligible, convincing, and tested” 28 become important factors in the determination of the matter together with other evidence. Therefore, while the courts do not substitute their views for the view of the experts but if they determine that the course adopted by the medical professional concerned was inconceivable or highly unreasonable, it would be open to the court to return a finding of medical negligence.

Treatment without informed consent may also amount to negligence

The existence of doctor–patient relationship is a prerequisite to fasten liability on the doctor. The relationship is fiduciary in nature, and the obligation on the medical practitioner is greater when the patient ordinarily has an imprecise understanding of the ailment, diagnostic process, treatment, and all its attendant consequences. Duty to act in the best interest, however, cannot be stretched to a level where actions are taken against the will of the patient or without the consent of the patient if the patient is capable of understanding. Every patient has a right of self-determination and to reject the treatment even if such rejection were to be considered foolish by most rationale standards, and the medical professional cannot impose his will. Medical practitioners can, however, act on the substituted consent, if the primary consent is not available for a variety of reasons such as patient being a minor, mentally unsound, and unconscious.

In Samira Kohli v. Dr. Prabha Manchanda, 29 a 44-year-old patient complaining of menstrual bleeding for 9 days, underwent an ultrasound test and was advised laparoscopy test under general anesthesia for making an affirmative diagnosis. The patient, while under general anesthesia, was subjected to a laparoscopic examination and simultaneously with the consent of the mother waiting outside the operation theater, abdominal hysterectomy (removal of uterus) and bilateral salpingo-oophorectomy (removal of ovaries and fallopian tubes) were conducted. It was held by the Supreme Court that consent taken for diagnostic procedure/surgery is not valid for performing therapeutic surgery either conservative or radical except in life-threatening or emergent situations. It was also held that where the consent by the patient is for a particular operative surgery; it cannot be treated as consent for an unauthorized additional procedure involving removal of an organ on the ground that such removal is beneficial to the patient or is likely to prevent some danger developing in future, if there is no imminent danger to the life or health of the patient. Supreme Court in the process of arriving at its judicial opinion examined the concept of “real consent” in the UK and “informed consent” in the US and finding the US standards to be too high and unsuitable for Indian conditions expressly rejected the same. It was further held that a doctor must secure the consent of the patient, and such consent should be “real and valid,” “adequate information” is to be furnished to the patient to enable him or her to make a balanced judgment, remote possibilities need not be disclosed, and the nature and extent of information to be furnished will be such as is considered “normal and proper by a body of medical men skilled and experienced in the particular field.” Subsequently, Supreme Court in Malay Kumar Ganguly v. Sukumar Mukherjee 30 without reference to its previous judicial opinion in Samira Kohli emphasized on the need of doctors to engage with the patients during treatment, especially when the line of treatment is contested, has serious side effects and alternative treatments exist, and observed that “[i] n the times to come, litigation may be based on the theory of lack of informed consent.”

Sanctity of professional judgments and other limitations

The legal system has to strike a careful balance between the autonomy of a doctor to make judgments and the rights of a patient to be dealt with fairly. Indian courts tend to give sufficient leeway to doctors and expressly recognize the complexity of the human body, inexactness of medical science, the inherent subjectivity of the process, genuine scope for error of judgment, and the importance of the autonomy of the medical professional. Few observations of Supreme Court in this context are worthy of reproduction:

“101. The Commission should have realized that different doctors have different approaches, for instance, some have more radical while some have more conservative approaches. All doctors cannot be fitted into a straitjacketed formula and cannot be penalized for departing from that formula….102. While this court has no sympathy for doctors who are negligent; it must also be said that frivolous complaints against doctors have increased by leaps and bounds in our country, particularly after the medical profession was placed within the purview of the Consumer Protection Act. To give an example, earlier when a patient who had a symptom of having a heart attack would come to a doctor, the doctor would immediately inject him with morphia or pethidine injection before sending him to the Cardiac Care Unit because in cases of heart attack time is the essence of the matter. However, in some cases, the patient died before he reached the hospital. After the medical profession was brought under the Consumer Protection Act vide Indian Medical Assn. v. V. P. Shantha ((1995) 6 SCC 651), doctors who administer morphia or pethidine injection are often blamed and cases of medical negligence are filed against them. The result is that many doctors have stopped giving (even as family physicians) morphia or pethidine injection even in emergencies despite the fact that from the symptoms the doctor honestly thought that the patient was having a heart attack. This was out of fear that if the patient died the doctor would have to face legal proceedings….111. The courts and the Consumer Fora are not experts in medical science, and must not substitute their own views over that of specialists. …112. It must be remembered that sometimes despite their best efforts the treatment of a doctor fails. For instance, sometimes despite the best effort of a surgeon, the patient dies. That does not mean that the doctor or the surgeon must be held to be guilty of medical negligence unless there is some strong evidence to suggest that he/she is.” 31

Courts endeavor to protect the medical professionals from harassment but do not give in to misplaced sympathies. In fact, the courts do not substitute their own judgment with that of the medical professionals. For instance, adoption of a procedure involving higher risk with the bona fide expectation of better chances of success in preference to a procedure involving lesser risk but greater chances of failure, even if it invites divergent views among doctors, would not lead to a finding of negligence. 32

Advisory to Doctors and Safeguards in Criminal Prosecution by Supreme Court

Supreme Court in one case 33 noted broadly the precautions which ought to be taken, and the same are reproduced herein below:

“Precautions which doctors/hospitals/nursing homes should take:

• Current practices, infrastructure, paramedical and other staff, hygiene, and sterility should be observed strictly. Thus, in Sarwat Ali Khan v. Prof. R. Gogi (OP No. 181 of 1997 decided on July 18, 2007 [NC]) the facts were that out of 52 cataract operations performed between September 26, 1995, and September 28, 1995, in an eye hospital, 14 persons lost their vision in the operated eye. An enquiry revealed that in the operation theater, two autoclaves were not working properly. This equipment is absolutely necessary to carry out sterilization of instruments, cotton, pads, linen, etc., and the damage occurred because of its absence in working condition. The doctors were held liable
• No prescription should ordinarily be given without actual examination. The tendency to give prescription over the telephone, except in an acute emergency, should be avoided
• A doctor should not merely go by the version of the patient regarding his symptoms but should also make his own analysis including tests and investigations where necessary
• A doctor should not experiment unless necessary and even then he should ordinarily get a written consent from the patient
• An expert should be consulted in case of any doubt. Thus, in Indrani Bhattacharjee (OP No. 233 of 1996 decided on 9-8-2007 [NC]), the patient was diagnosed as having 'mild lateral wall ischemia.’ The doctor prescribed medicine for gastroenteritis but he expired. It was held that the doctor was negligent as he should have advised consulting a cardiologist in writing
• Full record of the diagnosis, treatment, etc., should be maintained.”

The above are in the nature of broad advisory.

Keeping in the view the rise in criminal prosecution of doctors, which is both embarrassing and harassing for them, and to protect them from frivolous and unjust prosecutions Supreme Court laid certain binding guidelines till statutory rules or instructions by the government in consultation with MCI are issued, which are as follows: 34

• Private complaint may not be entertained unless the complainant has produced prima facie evidence in the court in the form of a credible opinion given by another competent doctor
• Investigation officer should obtain an independent and competent medical opinion preferably from a doctor in government service qualified in that branch of medical practice who can normally be expected to give an impartial and unbiased opinion applying Bolam test to the facts collected in the investigation
• Doctor may not be arrested in a routine manner unless the arrest is necessary for furthering the investigation or for collecting the evidence or if the investigation officer is satisfied that doctor may flee.

The necessity for obtaining independent medical opinion was insisted upon considering that the knowledge of medical science to determine whether the acts of medical professional amounts to negligent act within the domain of criminal law could not be presumed. This requirement was subsequently sought to be made a necessity by the Supreme Court even for initiating the action seeking imposition of civil penalties but was done away with thereafter for civil actions. 35

Few would disagree that delinquency, like in every other profession, needs to also be dealt with sternly in the field of medicine. The reasons are not difficult to discern. The question only is of defining the contours of “delinquency” which may give rise to adverse legal consequences. The outcome of treatment is of minimal significance for the imponderables are many in the practice of medicine. Two competing interests, and each being equally important as the other, need to be balanced in the process of fixing the parameters of liability: One relates to freedom of a professional in arriving at the judgment and the other of the victims in which the existence of discretion of the medical professional is not sought to be foreclosed but only its abuse and recklessness with which it may be made. Indian courts in the process of arriving at a balance lean, perhaps not unjustifiably, heavily in favor of the doctors.

The law does not seek to make any unnecessary intrusion into the territory which rightfully belongs only to medical professionals, and judges do not seek to impose their own wisdom on to them. The legal system does not adopt complete hands off approach either and does scrutinize the actions of medical professional and seeks to punish those who fall below the minimum standard, and the test for judging the minimum standard is also heavily influenced by the prevalent medical practices and opinions, and the body of knowledge available as on the relevant date. The standards are not too high and by fastening the liability in certain cases accountability is reinforced for no one can remain immune to scrutiny. In this regard, law zealously safeguards the autonomy of medical professionals and fully realizes that prescribing unreasonably high standards may have a kind of chilling effect which is not desirable, however, the law also seeks to protect and safeguard the interests of a patient to expect a minimum standard of care.

Financial support and sponsorship

Conflicts of interest.

There are no conflicts of interest.

1 Author is an advocate practicing at New Delhi including before National Consumer Disputes Redressal Commission. Interactions held by the author at 23 rd Conference of Indian Academy of Neurology in 2015 at Agra with medical professionals, subsequent to which the author was invited to contribute this article, have influenced the structuring of this article. He can be reached at [email protected] .

2 Consequences of violating specific statutory provisions providing impermissible acts more precisely such as those under Pre-Conception and Pre-Natal Diagnostic Techniques Act, 1994, are not included in this category.

3 Section 304A, IPC reads as, “304A. Causing death by negligence.—Whoever causes the death of any person by doing any rash or negligent act not amounting to culpable homicide shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.”

4 Section 337, IPC reads as, “337. Causing hurt by act endangering life or personal safety of others.—Whoever causes hurt to any person by doing any act so rashly or negligently as to endanger human life, or the personal safety of others, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five hundred rupees, or with both.”

5 Section 338, IPC reads as, “338. Causing grievous hurt by act endangering life or personal safety of others.—Whoever causes grievous hurt to any person by doing any act so rashly or negligently as to endanger human life, or the personal safety of others, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine which may extend to one thousand rupees, or with both.”

6 Chapter VI A dealing constitution of the permanent lok adalats was inserted by way of Legal Services Authorities (Amendment) Act, 2002 w.e.f. 11.06.2002. Section 22C (1) of Legal Services Authorities Act, 1987 (as amended) read with notification number S.O. 803(E) dated 20.03.2015 issued by Ministry of Law and Justice provides the jurisdiction of permanent lok adalats up to Rs. 1 Crore. The challenge to the constitutionality of the permanent lok adalats and their powers to adjudicate on merits were declined by the Supreme Court in 2012 in Bar Council of India v. Union of India (2012) 8 SCC 243.

7 Section 20A of the Indian Medical Council Act, 1956, reads as follows: “20A. Professional Conduct. 1. The Council may prescribe standards of professional conduct and etiquette and a code of ethics for medical practitioners. 2. Regulations made by the Council under subsection (1) may specify which violations thereof shall constitute infamous conduct in any professional respect, that is to say, professional misconduct and such provisions shall have effect notwithstanding anything contained in any law for the time being in force.”

8 In Mr. D, An Advocate of the Supreme Court, AIR 1956 SC 102.

9 Laxman Balkrishna Joshi (Dr) v. Dr. Trimbak Bapu Godbole AIR 1969 SC 128.

10 In the context of criminal liability, classic statement of law by Sir Lawrence Jenkins in Emperor v. Omkar Rampratap (1902) 4 Bom LR 679 made in reference to Section 304A IPC approved by the Supreme Court subsequently and followed by the High Courts in general may also be quoted: “To impose criminal liability under Section 304-A, Indian Penal Code, it is necessary that the death should have been the direct result of a rash and negligent act of the accused and that act must be the proximate and efficient cause without the intervention of another's negligence. It must be the causa causans; it is not enough that it may have been the causa sine qua non.”

11 Postgraduate Institute of Medical Education and Research v. Jaspal Singh (2009) 7 SCC 330.

12 (2004) 6 SCC 422.

13 Jacob Matthew v. State of Punjab, Supreme Court Order dated 09.09.2004.

14 (2005) 6 SCC 1.

15 Laxman Balkrishna Joshi (Dr) v. Dr. Trimbak Bapu Godbole AIR 1969 SC 128.

16 This is known as Bolam test propounded by McNair J in Bolam v. Friern Hospital Management Committee (1957) 2 All ER 118 in the UK. It has been approved and followed by the courts in India. However, in the UK Bolam test has been slightly departed from wherein it has been held that course propounded by the medical professional to be reasonable practice it must also be logical.

17 V Kishan Rao v. Nikhil Super Speciality Hospital (2010) 5 SCC 513.

18 Spring Meadows Hospital v. Harjol Ahluwalia (1998) 4 SCC 39.

19 Illustrations taken from Supreme Court's judgments in Spring Meadows Hospital v. Harjol Ahluwalia (1998) 4 SCC 39 and Indian Medical Association v. V P Shantha (1995) 6 SCC 651.

20 Surendra Chauhan v. State of MP (2000) 4 SCC 110. See also, Martin F. D'Souza v. Mohd. Ishfaq (2009) 3 SCC 1.

21 V. Krishnakumar v. State of Tamil Nadu and Ors. (2015) 9 SCC 388.

22 P B Desai v. State of Maharashtra (2013) 15 SCC 481.

23 Nizam's Institute of Medical Science v. Prasanth S Dhananka (2009) 6 SCC 1.

24 Savita Garg v. Director, National Heart Institute (2004) 8 SCC 56.

25 Martin F. D'Souza v. Mohd. Ishfaq (2009) 3 SCC 1.

26 Vimal Kumar Mundra and Others v. Pardaya Memorial Hospital and Others IV (2013) CPJ 9A (CN) (Raj). In the appeal arising there from before the National Consumer Disputes Redressal Commission, the allegations of medical negligence were withdrawn, and the hospital agreed to make ex-gratia payment purely on humanitarian grounds, see Pardaya Memorial Hospital and Others v. Vimal Kumar Mundra and Others, First Appeal 604/2013, decided on 09.07.2014.

27 Titli v. Alfred Robert Jones AIR 1934 All 273.

28 Ramesh Chandra v. Regency Hospital Limited (2009) 9 SCC 709.

29 (2008) 2 SCC 1. Even though it was held that the doctors acted in excess of the consent, doctors were let off very leniently by the Supreme Court as they had acted in good faith and for the benefit of the patient in the given facts.

30 (2009) 9 SCC 21.

31 Martin F. D'Souza v. Mohd. Ishfaq (2009) 3 SCC 1. This judgment was observed to be per incuriam to a limited extent it required independent medical opinion even for civil action. In Kusum Sharma v. Batra Hospital (2010) 3 SCC 480 Supreme Court observed that “78. It is a matter of common knowledge that after happening of some unfortunate event, there is a marked tendency to look for a human factor to blame for an untoward event, a tendency which is closely linked with the desire to punish. Things have gone wrong and, therefore, somebody must be found to answer for it. A professional deserves total protection.”

32 Kusum Sharma and Ors. v. Batra Hospital and Medical Research Centre and Ors. (2010) 3 SCC 480. Here, removal of malignant abdominal tumor by surgical operation adopting an anterior approach in preference to posterior approach, though failed to save the life of the patient, was not held to be negligent.

33 Martin F. D'Souza v. Mohd. Ishfaq (2009) 3 SCC 1.

34 Jacob Mathew v. State of Punjab (2005) 6 SCC 1. The Supreme Court in this case had observed that “28. A medical practitioner faced with an emergency ordinarily tries his best to redeem the patient out of his suffering. He does not gain anything by acting with negligence or by omitting to do an act. Obviously, therefore, it will be for the complainant to clearly make out a case of negligence before a medical practitioner is charged with or proceeded against criminally. A surgeon with shaky hands under fear of legal action cannot perform a successful operation, and a quivering physician cannot administer the end-dose of medicine to his patient 29. If the hands are trembling with the dangling fear of facing a criminal prosecution in the event of failure for whatever reason—whether attributable to himself or not, neither can a surgeon successfully wield his life-saving scalpel to perform an essential surgery nor can a physician successfully administer the life-saving dose of medicine. Discretion being the better part of valor, a medical professional would feel better advised to leave a terminal patient to his own fate in the case of emergency where the chance of success may be 10% (or so), rather than taking the risk of making a last ditch effort toward saving the subject and facing a criminal prosecution if his effort fails. Such timidity forced upon a doctor would be a disservice to society.”

35 In Martin F. D'Souza v. Mohd. Ishfaq (2009) 3 SCC 1 necessity of medical opinion was observed to be mandatory even for civil cases which requirement was subsequently observed to be per incuriam in V Kishan Rao v. Nikhil Super Speciality Hospital (2010) 5 SCC 513.

Key References References

Canterbury v. Spence: The Case Study Research Paper

The case of Canterbury v. Spence revolved around the plaintiff, a 19-year-old clerk typist working with the FBI. He was experiencing back pain and sought medical intervention from the defendant, a Washington Neurosurgeon, Dr. William T. Spence. The defendant performed a myelogram to determine the cause of the illness. Dr. Spence then performed a laminectomy on the plaintiff. The surgery was successful, but unfortunately, the claimant reportedly fell off the bed, causing him to suffer significant paralysis.

Due to his condition, the plaintiff sued the doctor for negligence, claiming he didn’t get his informed consent before performing the surgery. The doctor didn’t warn him that the procedure carried a 1% paralysis risk (“464 F2d 772 Canterbury v. Spence,” n.d.). The court held that the healthcare provider is legally required to provide any information a patient would wish to know concerning a particular medical intervention before performing surgery or procedure. Additionally, the doctor must obtain a patient’s informed consent before performing surgery or procedure.

Elements of Informed Consent

Patients must be able to make their own medical and health decisions. Before a patient agrees to treatment, the doctor must explain the risks, benefits, and alternatives (Shah et al., 2022). The patient must agree to the therapy after understanding the risks and advantages. Documenting informed consent should comprise five components: the procedure’s nature, risks and advantages, feasible alternatives, risks and benefits, and patient understanding.

For informed consent to be legitimate, certain conditions must be met. First, the consenting party must be capable of making independent judgments. Secondly, the subject must grasp the risks and benefits of the proposed treatment. Thirdly, the patient must be given ample time to weigh the risks and benefits of the proposed treatment. People shouldn’t be rushed or coerced into making a decision; they should be given time to ask questions and consider their options (Shah et al., 2022). The patient must agree they understand the risks and advantages of the recommended treatment.

Reasonable Person Standard

One of the acceptable legal approaches to adequate informed consent is the reasonable person standard, a legal standard used to determine whether a person can be held liable for negligence or a tort. It focuses on the information a typical patient needs to comprehend the decision (Shah et al., 2022). The criterion is founded on the idea that a reasonable person would take the same care to prevent injury to himself or another person.

Importance of Informed Consent in Medical Care

In medical care, informed consent is essential because it enables patients to choose treatments they want or do not want based on all available facts. Additionally, it allows the patient to collaborate with their healthcare professional in making decisions (Cohen, 2020). Furthermore, it shields healthcare professionals from liability by demonstrating that the patient was aware of the risks and advantages of a particular treatment and voluntarily consented to it.

Relationship between Informed Consent and Ethics and Relevant Ethical Principles

Informed consent is a vital ethical and legal concept in modern healthcare. The informed consent process is critical to ethical healthcare because it ensures that patients can make healthcare decisions. Informed consent is subject to several ethical considerations. To begin, informed consent is based on autonomy, emphasizing that individuals can make their own life choices. Additionally, informed consent is founded on beneficence, which holds that healthcare professionals should act in the best interests of their patients. Finally, informed consent is founded on the nonmaleficence principle, which states that medical personnel should not cause harm to patients (Varkey, 2020). Consent with awareness ensures that proposed healthcare measures will not harm patients.

Hospital’s Responsibility in Insuring Informed Consent

A hospital is accountable for a few essential factors to provide informed consent. First, the hospital must disclose all information needed for a reasonable person to decide whether to have surgery or treatment. Additionally, the hospital must ensure that the patient understands this information. The healthcare personnel must therefore take the time to explain the content to the patient and answer any questions they may have. In conclusion, the hospital must ensure that the patient’s consent is freely and voluntarily given.

464 F2d 772 Canterbury v. Spence . (n.d.). Legal Resources | OpenJurist. Web.

Cohen, I. G. (2020). Informed consent and medical artificial intelligence: What to tell the patient? SSRN Electronic Journal . Web.

Shah, P., Thornton, I., Turrin, D., & Hipskind, J. E. (2022). Informed consent – StatPearls – NCBI bookshelf . National Center for Biotechnology Information. Web.

Varkey, B. (2020). Principles of clinical ethics and their application to practice . Medical Principles and Practice , 30 (1), 17-28. Web.

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IvyPanda. (2024, May 19). Canterbury v. Spence: The Case Study. https://ivypanda.com/essays/canterbury-v-spence-the-case-study/

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Bibliography

IvyPanda . "Canterbury v. Spence: The Case Study." May 19, 2024. https://ivypanda.com/essays/canterbury-v-spence-the-case-study/.

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