Personal Practice

Indian Pediatrics 2001; 38: 488-495  

Medical Negligence

Satish Kamtaprasad Tiwari
Mahesh Baldwa*

From the Department of Pediatrics, Dr. Panjabrao Deshmukh M. Medical College, Shivaji Nagar, Amravati 444 603, Maharashtra, India and *Department of Law, (Visiting Professor), Mumbai University, Mumbai 400 032, India.

Correspondece to: Dr. Satish Tiwari, Yashodanagar No. 2, Amravati 444 606, Maharashtra, India.

E-mail: [email protected]

The last few decades have seen many ups and downs in medical sciences. Some of these are positive changes like scientific and technical advances, increasing longevity, decreasing mortality, morbidity and overall improvement in quality of life. At the same time there are some negative changes such as decreasing standard of medical education, decreasing values and morality and commercialization and corporate culture in management of patients(1). These changes have an important impact on doctor-patient relationship. This relationship is usually of fiduciary (that of mutual trust) nature. A doctor should treat the patient to the best of his knowledge, skill, care and judgement. In today’s situation this relationship is strained resulting in increasing number of legal problems. Bringing the doctors under the ambit of Consumer Protection Act (CPA) has further marginalized this relationship. The legal cases of medical negligence are rising because of the ease with which cases can be launched in consumer court.

Medical negligence is an act of commission or an act of omission which a prudent doctor of average skill, knowledge and experience would not do. The essentials of negligence(2) are, four "D"s: (i) there is duty towards patients; (ii) there is deficiency in duty towards patients; (iii) this directly results in; and (iv) damage which may be physical, mental or financial loss to patient or relatives.

As soon as a doctor accepts to treat the patient (except in emergency situation), the duty starts. There is no duty if the patient is turned away by the doctor. For example, a doctor is called to attend a patient (who is not under his care) but the doctor refuses to go. In this case there is no negligence as there is no acceptance. The idea of negligence and duty are strictly correlative.

The duty starts irrespective of financial considerations. The concept of fee is more important in CPA. If the patient is not charged fee then a litigation may not be possible under CPA for example, in government hospitals. This may not be an absolute prerequisite for medical negligence since a civil/criminal negligence can occur even if a patient is treated without any fees. The relationship starts even if the doctor has not directly communicated with the patient, for example, Pathologist, Biochemist, Anesthetist, etc. The factors which decide the relationship are willingness to examine, to diagnose and to treat the case irrespective of the payment for such service. However, a doctor-patient relationship does not establish automatically in the following situations: (A) Medico-legal cases: (i) For assessment of injuries; (ii) For assessment of drunkenness; (iii) Cases of sexual offence; and (iv) Evaluation of disability for compensation; and (B) Examination for insurance purposes.

Once the doctor starts caring for the patient, the standard of care must be of average skill, knowledge and experience equal to what a prudent doctor should have, which is neither too high nor too low but only average. According to Justice Denning, it would be a great disservice to community at large; if we impose liabilities on doctors, for each and every thing that happens to go wrong(3). Standard of care is not a subject of law but a subject of medical judgement. There should be foresee-ability of averting complications in a given situation.

The standard of care is also proportional to duty undertaken, i.e., a pediatrician is expected to provide a better care as compared to a general practitioner while managing a child. If the doctor commits any deficiency in his duty, he may be liable for his act.

The deficiency in duty must be "Causa causans", i.e., direct and proximate cause for injury or damage. The cause must be foreseeable and not too remote. For example, if a child of acute gastroenteritis is under treatment and he develops encephalitis, this is not negligence. But if this child develops severe dehydration then it may be a negligence.

The damage can be measured in terms of: (a) additional financial expenses for treat- ment of complication resulting as a consequence of negligence; (b) loss due to absence from work; (c) decreased life expectancy; (d) loss of organ or limb; and (e) death of the patient who could be a wage earner for the family.

Rashness is undertaking any act which is beyond one’s competence. No prudent man in similar circumstances would have done this act. Rashness is part of negligence. For example, a pediatrician managing a case of myocardial infarction or doing surgeries or dressing a punctured wound without assessing how much internal damage is present.

The doctrine of res ipsa loguitur means "things speak for themselves". The doctor is personally or vicariously liable for the negligent act. In such cases, damage is so obvious that there is no need for any proof of negligence. For example, operating on wrong eye, limb or patient; retained sponges or forceps after surgery; and doing exchange transfusion on wrong baby. In one Canadian study(4), it was observed that res ipsa loquitur was pleaded in only 37 out of 142 cases, it was applied in only 14 cases and defendants were found liable in only 10 of these cases.

Sometimes if the act of commission or omission is so rash that it results in death or serious injury to the patient then it may amount to criminal negligence. In such cases the situation is much more difficult to tackle as compared to civil negligence.

Negligence can result either due to an act of commission (which a prudent man shouldn’t do) or an act of omission (which a prudent man must do). According to objective theory of negligence(5) there is carelessness in approach towards the patient and the act of commission results in injury to the patient. Following are the some of the example of acts of commission(6):

(a) Undertaking care beyond one’s skill and experience: If a doctor with homeopathy degree practices allopathic medicine, in which he doesn’t have basic knowledge, he is guilty of negligence per se and no further proof is needed. This was the verdict of the Supreme Court in the case of Poonam Verma vs Ashwin Patel and others(7); (b) Giving harmful drugs un-necessarily to a patient; (c) Injuries due to faulty techniques for example, gangrene or necrosis due to leakage of intravenous fluids or drugs in subcutaneous tissue; (d) Overdoses of drugs, giving wrong drugs, etc.; and (e) Iatrogenic problems.

According to subjective theory, negligence is a mental attitude of undue indifference. The doctor is indifferent to the consequences of his act of omission thus causing damage to the patient. The acts of omission can be as follows: (i) Failure to attend to patient; (ii) Failure to examine and investigate carefully (iii) Failure to obtain proper consent for any procedure or intervention; (iv) Failure to give standard treat-ment; (v) Failure to take proper precautions while giving injections; (vi) Failure to advise hospitalization; and (viii) Abandoning treat-ment without making alternative arrange-ments. A doctor should handle only those cases which are within the limit of his knowledge, skill and experience. It is better to refer the case to a proper consultant or a hospital after giving primary treatment. If a doctor has to abandon the treatment under unavoidable circum-stances, he must make alternative arrangement of a qualified consultant or shift the patient to a properly equipped center.

Sometimes the unexpected results may not be only due to negligence of the doctor but also due to negligence of patients or relatives. This is known as contributory negligence. Examples include: (a) Not coming for follow-up as per the advice of doctor; (b) Failure to follow the instructions given by the treating doctor; (c) Investigations advised by the doctor are not done by the patient; (d) Patient fails to take advice of a specialist (for example, in case of acute abdomen or head injury, the Pediatrician has referred to a surgeon but the patient fails to take such a consultation); and (e) patient leaves the hospital against medical advice. The liability for the damage in such cases is suitably divided between the doctor, patients and relatives. The burden of proof of contributory negligence on the part of patient is on doctors.

Negligence is difficult to prove. Burden of proof is on patients or relatives (according to law, compailnant should prove that the proximate cause of injury is negligence by doctor). But in following cases the onus of proof may be on doctors (Jagdish Singh, personal communication): (i) If the patient is in operation theatre or intensive care where relatives or attendants have no access; (ii) If the doctor has raised a plea, i.e., suppose a patient of hydro-pneumothorax is admitted. The patient is not taken for surgery and dies of respiratory failure. The doctor pleads that surgery was not done as patient or relatives didn’t given consent. In this case doctor has to prove that consent was refused (hence it should always be in writing whether the consent is given or refused); and (iii) In cases of res ipsa loquitur.

In the following situations it is not negligence and hence the doctor may not be held liable:

(i) Difference of opinion: If there are two accepted schools of thought, any particular method may be adopted by the doctor in the patient.

Bolam’s Test: In a case (Bolam vs. Friern) Hospital Management Committee in UK, the following principles were derived: If there are two accepted schools of thoughts, for any treatment, doctor may use any one of them. If some complications occur due to particular method (accepted school of thought) the doctor can’t be held responsible only on the ground that why he didn’t use the other method(8). This is known as Bolam’s principle. In this particular case, electroconvulsive therapy was given without muscle relaxant and the patient developed a fracture of jaw. In those days two schools of thought were accepted; that electroconvulsive therapy can be given with or even without muscle relaxant. Hence, negligence was not held.

(ii) Wrong diagnosis in spite of diligence: Sometimes it is very difficult to differentiate between some of the common and similar presentations of diseases like partially treated pyogenic meningitis, tubercular meningitis and encephalitis. In such cases, if the doctor has taken all the care but still complications occur due to improper diagnosis, then this is not negligence.

(iii) Accidents: Sometimes some accident may occur during hospital stay like breaking of needle or instruments not working. It is not negligence if such accidents are detected, attended and managed within reasonable time.

(iv) Unexpected results: According to Sir Williams Osler (a USA Physician), medicine is a "science of uncertainty and art of probability"(6). All persons in community do not acquire all diseases. There is always a probability of acquiring a disease. Some acquire the disease while others do not, inspite of being exposed in an equal amount. Every individual has different body response not only to disease but also to treatment. Hence there is uncertainty in every case. Hence we talk of "most probable diagnosis" and "most probable outcome" of a disease. A doctor can’t be held negligent only because there was unexpected outcome.

Whenever there is allegation of negligence, the following defenses may be pleaded by the doctor:

(a) Actual Denial: If a doctor is very confident that there is no negligence on his part, the best way is to deny that the injury is due to negligence.

(b) Contributory negligence on part of patient, relatives shall be helpful in minimizing the severity of the doctor’s negligence. For example, if the patient was instructed to come for regular follow-up but did not comply, or the patient was instructed to remain nil orally but the patient was given orally.

(c) Delegation of duties to a qualified assistant, partner, laboratory attendant or nursing staff may be one of the defenses. In such cases the responsibility is of the person to whom duty was delegated. But if a consultant delegates his responsibility to his junior with the knowledge that junior was incapable of performing his duties properly, this is negligence on part of consultant. This was held by Supreme court in the landmark decision in the case of Spring Meadows Hospital vs. Harjot Ahluwalia through K.S. Ahluwalia(7). The doctor shall be liable for the act of his staff if they are unqualified. This is vicarious liability. But if the qualified staff makes the mistake then the doctor may not be held directly responsible.

(d) Inherent Risk: There is "assumption of risk" whenever treatment is started. This is based on principle of "Volenti non fit injuria" i.e., no person can ask for any action if he has voluntarily consented for it. For example, radiation burns may result even during proper radiation therapy. This is not negligence. But the patient has a right to sue if burns result from over exposure.

(e) Emergency Situation: Cardio-respiratory arrest is an emergency situation. Some-times fracture of ribs can occur during cardio-pulmonary resuscitation. A doctor can’t be held negligent for causing fracture of rib in such a situation.

(f ) Known Complication: Some drugs or procedures have known complications. For example, anaphylaxis after Penicillin injections is a known complication. A doctor cannot be held responsible if proper sensitivity test was done and all measures for management of anaphylaxis were readily available in the hospital.

(g) Unexpected Results: Some unexpected results occur inspite of proper diagnosis and adequate treatment. A doctor cannot be held negligent in such cases. For example, a pre-term or small for date baby may develop cerebral palsy or mental retarda-tion inspite of adequate and proper care. A doctor shouldn’t be held negligent for this outcome.

(h) Difference of Opinion: There may be a difference of opinion amongst doctors while treating a case. This is not negli-gence. This principle was derived in "Balam’s Test"

(i) Limitation Period: If a particular case is filed beyond the period of limitation (according to Civil Law 3 years), this defense could be forwarded by the defendant. While managing a child the limitation period may extend till he becomes major (Section 6 of Limitations Act 1963) and is able to take his own decisions. So in the case of a neonate, the limitation period may extend as long as 21 years of his age (age of majority 18 years plus period of limitation 3 years).

(j) Counter Suits: Counter suits by doctors against the patients may be helpful in minimizing cases of negligence.

(k) "Res Judicata" means "the thing has been decided". This means that once the case is completed between two parties, it cannot be tried again between the same parties. For example, if a doctor sues a patient for non payment of bill and the patient doesn’t plead negligence on part of the doctor, the patient cannot subsequently sue the doctor for negligence after the completion of the case.

The cases of negligence against doctors are rising. In an analysis of 202 cases done by Dr. Jagdish Singh (Personal communication), 6 cases (about 3%) were against Pediatricians. Out of the 183 decided cases in this study, negligence was held in 52 (28.4%) cases. In an analysis of about 4054 cases of liability claims between 1991-1996 in Puerto Rico, 3506 cases were closed against physicians or institutions and payment was issued in 1272 (36.3%) cases(9). In another study conducted in California, 375 physicians were disciplined for 465 offences: the most frequent(34%) cause was negligence or incompetence(10). Members of medical profession are constantly under the spotlight of media scrutiny though they enjoy a significant degree of cultural and social authority in the press(11).

It is said that "An ounce of prevention is better than a pound of cure". So it is better that we take precautions to prevent the cases of negligence rather than fighting them out in the court of law. The following steps may be helpful in avoiding cases of negligence:

(a) Attend and treat patients with reasonable care and skill. A second opinion may be taken whenever required (especially in complicated and critical patients). Advise proper investigations related to the case. If vaccines are available, the patient must be informed accordingly. While managing a case, give guarded prognosis. "Guarantee for care and not cure" while treating a case. Keep the hospital instruments and equip-ments in proper and working condition. Instruments must be properly sterilized. Most malpractice suits claim negligence. The claims usually include failure or delay in diagnosis, negligent treatment, failure to obtain expert opinion, failure to obtain informed consent and negligence during the procedure(12).

(b) Record Keeping: Proper record must be maintained including history, examination and investigation reports. Treatment adopted, consent for various procedures (including refusals) and any expert opinion (if advised) shall be recorded in writing. A well maintained record can be a friend of the doctor in an hour of crisis. Don’t try to manipulate the records(13).

(c) Staff and Partners including assistants, subordinates, locum, etc. should be selected carefully. They shouldn’t only be qualified but their behavior towards the patient should also be good and compassionate. The communication skill with patient and relatives should be good. If a doctor is employed in some hospital (e.g., Corporate hospital), the hospital management will also be responsible for the outcome of negligence. It is the responsibility of the hospital management to provide proper equipment, qualified, competent, trained paramedical and nursing staff. If proper and adequate facilities are not available, a timely referral to well equipped center is a desirable alternative.

(d) Don’t Criticize Colleagues: Criticizing our own colleagues is one of the major cause of increasing litigation against doctors. Before making any comment we must verify the actual facts and situation in the particular case. It has been observed that majority of cases in CPA are because of the instigation and criticism by some of our own disgruntled colleagues.

Whenever there is a case in CPA and a doctor is going as an expert, he may have some "ethical dilemma" while giving evidence against his own professional colleague. But one should remember that the concept of truth and "natural justice" must prevail under all circumstances.

(e) Update Your Knowledge: A doctor should try to keep abreast with latest developments as far as possible in his field. Law doesn’t expect one to know each and every detailed advance but one must know the things expected of an average prudent man.

(f ) Inform Regarding Hazards: The patient and relatives should always be informed regarding complications or adverse reac-tions of drugs and procedures. The blanket consent or getting a thumb impression may not be a valid defense. As far as possible the consent should be an informed consent (preferably in presence of witnesses). Informed consent may be helpful in cases of negligence, but it does not give absolute immunity. While giving drugs like Peni-cillin, Xylocaine, etc. a proper sensitivity test must be done. If complications occur, measures for emergency treatment must be readily available. Injection vials should be preserved for about 24 hours. In spite of all the precautions, if reaction occurs, it is an accident and not negligence.

(g) Insurance: Professional indemnity cover may be helpful whenever there is a litigation in the court. It may not be helpful in minimizing the damage to the reputation of the practitioners, but it may help as far as financial liabilities are concerned. The insurance companies may also help by providing services of advocates and legal experts as the companies are themselves parties to such litigations. It is preferable to know someone in the insurance company so that the dealing and processing of the matter becomes easy. The disadvantage of insurance is that: (i) if the patients or relatives know that the doctor is insured then they may be encouraged to go in for the litigation; and (ii) many times even the insurance companies are willing for the out of the court settlement which is cheaper and of "least resistance" to them rather than fighting out the case.

(h) Counter Compensation Suits: The time is not far away when doctors will need to file counter suits against patients. Such trends have started in western countries and it has been observed that this has resulted in decreased incidences of negligence suits against doctors.

The Medical Council of India is concerned with standard of medical education, while the state Medical Councils deal with the complaints of negligence against doctors. It was expected that the councils will be effective in providing cheap and quick justice. The councils have power to punish the doctors by giving warnings, suspending their registrations (temporarily or permanently) but they can’t order compensation to the patient. It is desirable that Medical Council Act be updated so as to give more powers to decide patient’s complaints.

Now-a-days the doctor-patient relationship is under constant strain. The doctors must be aware of the pros and cons of day-to-day medical practice. We must communicate and behave properly with the patient and their relatives. Records must be properly main-tained. The best way is to avoid legal cases by having grievance redressal forum and medico-legal cells, preferably in the hospital premises itself.

We are grateful to Professors P. Chaturvedi and K.Y. Vilhekar for the constant constructive criticism provided in drafting this article. We are also thankful to Dr. Janki N. Borkar for help in drafting this manuscript.

Key Messages

Technical, scientific advances and corporate hospital culture has resulted in soaring expectations in patient’s mind. Patients and relatives can be easily encouraged to sue the doctor in a court of law. To establish negligence, damage must be causa causans of negligent act or deficiency in care. Good, compassionate behavior, proper record maintaining and a valid consent may be of great help whenever there is a case of negligence. Ethical committees, medico-legal cells and consumer organizations may help in minimizing unwanted litigations.

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