Anaesthesia provider's perception of law: Focus on preventive measures

Abstract

Anaesthesiology is a speciality that delivers most prompt and positive results in medical field. This naturally leads to high expectations among the general public. In the past, patients used to subject themselves to surgery after signing a simple willingness form. But in the present scenario, if any catastrophe occurs, it grabs news headlines, negligence is suspected by laymen in such cases, and these cases land up in a court of law. In the courts, decisions are left to judiciary, which can be potentially influenced by the opinon of general public. This leaves a lot of subjectivity in these decisions. There has been a rising trend in medical negligence cases registered in consumer courts after the decision of the Supreme Court, that the services provided by an anaesthesiologist come under the word “service” of Consumer Protection Act (1986). So the apprehension amongst the anaesthesiologists regarding the legal issues is rising. This article underlines the standard of care, protocols by which anaesthesiologists should abide to avoid legal consequences. Doctors should have legal awareness so that they can defend their cases in courts properly. There is a need to maintain healthy doctor-patient relationship, good record keeping, and to provide a reasonable standard of care. Doctors should keep abreast with the latest development in the medical field.

INTRODUCTION

Anaesthesiology is a high-risk speciality, and the general public is not aware of the risks involved in it. With the advent of safe drugs, good quality equipment and high standards of monitoring, the practice of anaesthesia has become safe but despite this, complications can occur. Due to commercialisation of modern medical practice and limited interactions, there is a lack of mutual trust in doctor-patient relationship. So, whenever, some catastrophe takes place, patient and attendants suspect negligence on the part of doctor and such cases are taken to courts. After the introduction of Consumer Protection Act in 1986[1] and bringing the medical professionals under this act, increased number of medical negligence cases are registered in consumer courts. Because of this, the apprehension and fear amongst anaesthesiologists is rising. For safe conduct of surgery and anaesthesia, standardised protocols formulated by World Health Organisation (WHO) should be followed like standard operative procedures (SOPs) for consent,[2] surgical safety checklist,[3] anaesthesia machine checklist etc., There should be a legal awareness among doctors, so that they can defend their cases properly in consumer courts. Institute of Medicine and Law (IML)[4] a medico legal partner of Indian Medical Association can provide information to doctors and lawyers in defending medico legal cases. For this purpose, it is very important to go through the various court judgements to understand properly: ‘What is reasonably expected from a medical professional’.

MEDICAL NEGLIGENCE

Deficiency in services is defined as ‘any fault, imperfection, shortcoming or inadequacy in the quality, nature and manner of performance, which is required to be maintained by or under any law for the time being in force or has been undertaken to be performed by a person in pursuance of a contract or otherwise in relation to any service’.[1] Deficiency in services provided by an anaesthesiologist is considered as negligence.

PRINCIPLE RELATED TO MEDICAL NEGLIGENCE

Negligence is an act of commission (should not do) or an act of omission (must do), which a responsible professional with average skill, knowledge and expertise would not do.

Principles related to act of commission

1. Requisite skill and knowledge: The Supreme Court held in a judgment that the medical professional may be held liable for negligence on the ground that he was not possessed of the requisite skill, which he professes to have and in this situation no proof is needed[5,6,7]

2. Expert advice: An expert should be consulted in case of any doubt. Whenever help is needed, it is a must to call the person expert in the subject[8]

3. Undue risks: Doctors should avoid undue experimentation on their patients

4. Medication error: In operating rooms, wrong labelling, misidentification or exchange with another drug can result in drug error that can cause serious harm to the patient. In intensive care unit (ICU), multiple drugs are given to a patient like inotropes, sedatives, narcotics and analgesics, which can result in error. Anaesthesiologist must prepare and administer the drugs himself and should not rely on others

5. Carelessness: Not checking the anaesthesia machine or anaesthesia equipment before giving anaesthesia is considered as carelessness. Properly following the operation theatre check list is mandatory.

Principles related to act of omission

• Care and precaution: In PN Rao versus G. Jayaprakasu AIR 1990 AP 207, a young boy was operated for enlarged tonsils. He did not regain consciousness for 3 days and was found that his brain suffered cerebral hypoxia due to improper conduct of anaesthesia. The court held that doctors were negligent in discharging their duties properly. Similarly, in another case, surgery was done to correct nasal deformity. During the surgery, blood seeped into the respiratory passage and patient collapsed and died. Expert view was taken, and the cause of death was stated to be, ‘not introducing cuffed endotracheal tube of proper size’. The Supreme Court held it a negligent act as there was a lack of care and precaution[9]

• Responsibility of the staff: Doctor is responsible for the paramedical staff working under him. This is vicarious liability. It is the duty of the doctor to supervise hygiene and sterility in the operating rooms. The National Consumer Commission held doctor negligent in a case, where 14 patients lost their vision after cataract surgery and enquiry revealed that two autoclaves of the hospital were not working properly, which is required for proper sterilisation of instruments used during surgery[10]

• Informed consent and record: In the case of Dr. Shyam Kumar versus Rameshbhai Harmanbhai Kachhiya, I (2006) CPJ 16 (NC), the National Commission held the doctor negligent for not taking informed consent and not producing a complete record in the court. Patient lost his vision after glaucoma surgery, and this complication was not explained to the patient before surgery.

What is not negligence?

The basic principle governing the medical negligence cases is the BOLAM'S RULE. According to it, ‘If there are two treatment practices available, doctor may use any of them and if subsequently any complication occurs with that method, then doctor cannot be held responsible for not using the second method’. In Bolam versus Friern case,[11] electroconvulsant therapy was given without using muscle relaxant and patient developed fracture during the treatment. But the doctor was not held negligent as electroconvulsant therapy can be given with or without muscle relaxant. It was held that:

‘Where you get the situation, which involves the use of some special skills or competence then the test as to whether there has been negligence or not, the test of a man on the top of a Clapham Omnibus, because he has not got this special skill. The test is the standard of the ordinary skilled man exercising and professing to have that skill’. Bolam's principle has already been approved by the Supreme Court in the matter of Jacob Mathew’ case.[12]

In the medical profession, if a competent doctor makes an error of judgement, he cannot be held negligent. Lord Denning MR held that ‘we must say and say it firmly, that in a professional man, an error of judgement is not negligence’.[13] Indian law also supports the same view that those errors, which a reasonably competent professional, acting with ordinary care might commit are not considered as negligence.[14]

When a medical negligence case goes to the court, the burden of proof falls on the complainant. But if the damage is so obvious for, e.g. pre-anaesthetic evaluation not performed,[15] unexpected cardiac arrest occurring under anaesthesia.[15] then term ‘Res Ipsa Loquitur’ - things speak for themselves is applied, and the burden of proof falls on the defendant.

Defences

Whenever a case is registered against a doctor, it creates a lot of emotional disturbance as the reputation built over the years of hard work is at stake. Always keep the lines of communication open with the patient and attendants and recognize their frustration. Keep the patient and family informed and involve them in subsequent treatment plan. In these situations, composure should be maintained, services of a good lawyer should be availed and timely filing of the reply is a must. Guidance from the IML can be sought. A well-prepared reply will send home a message that the doctor will not succumb to the pressure.

The following defences may be pleaded by the doctor:

• Doctor can deny the charges, if he is confident that nothing wrong has been done on his part, supported by written documents

• Contributory negligence by the patient can be pleaded, e.g. patient fails to follow doctor's advice

• Error of judgement in treatment can be pleaded

• The known complications of drug and procedure like anaphylaxis occurring with injection penicillin

• Treatment started after well-informed consent, explaining the side effects of the treatment, like radiation burn during radiotherapy

• Difference of opinion regarding various treatment options

• Damage occurring to a patient while life saving treatment like rib fracture during cardiopulmonary resuscitation

• There is a limitation period[16] for filing cases; in adult patients it is 3 years and for children this may extend till they become major. Beyond this period, this defence could be pleaded

• Once the case is decided between the two parties, it cannot be tried again.

FRIVOLOUS COMPLAINTS

In consumer courts, sometimes frivolous complaints are registered just to cause harassment to doctors. The Supreme Court has laid down following rules to protect doctors.

• A complaint cannot be entertained unless the complainant has produced prima facie evidence before the court in the form of credible expert opinion of a competent doctor to support the charges of negligence

• Courts must refer these complaints to a panel of competent doctors before issuing a notice

• Doctor accused of negligence cannot be arrested in a routine manner. The Supreme Court further warned the police, not to arrest or harass doctors unless the facts clearly come within the parameters laid down in Jacob Mathew's case,[12] otherwise the policemen will themselves have to face legal action.

PREVENTIVE MEASURES

As per the the various judgments and law passed by The High Courts and The Supreme Court of India, the doctors should follow the minimum standards that are expected of them by the public.[17] Following protocols should be exercised:

• Active involvement of anaesthesiologist in pre-operative optimisation and decision of subjecting for the procedure is the need of an hour. The surgeon, anaesthesiologist and hospital administrator are responsible for peri-operative well-being of the patient in every aspect

• Good rapport with patients will check the rising trend of litigation cases being registered in courts. Doctor should listen to the queries of the patient with care and sympathetic attitude during pre-operative assessment. Detailed history of any present illness as well as any past illness or trauma from which the patient is not suffering presently should also be noted as it may affect the outcome of anaesthesia. Details of pre-operative assessment should be clearly documented

• Patient education plays an important role in collaborative decision making and good doctor patient communication for a mutually respectful and trusting relationship

• Record keeping is very important because courts cannot rely on the memories of that particular incident. They should be maintained in a neat, accurate and complete form and should never be tampered.[18] As per regulation 1.3.1 of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, ‘Every doctor shall maintain the medical records pertaining to his or her indoor patients for a period of 3 years from the date of commencement of the treatment in a standard Performa laid down by Medical Council of India’. For medico-legal cases, record is to be preserved for a period of 10 years or even more; Punjab Medical Manual (1934), guidelines are for 12 years. Whenever a request for medical records is made by patient, authorised attendant or legal authorities, it is to be duly acknowledged and documents shall be issued within a period of 72 h as per Regulation of Medical Council India 1.3.2

• With growing trend in medical negligence cases, obtaining a valid informed consent has become a fundamental principle of modern anaesthesia practice. Reliance on hand written notes or consent for anaesthesia as a part of the surgical consent lacks sufficient detail to assist the anaesthesiologist in proving his or her side in medico-legal cases. Effectively, engaging patients in their own health care through anaesthesia specific informed consent may be one of the most practical steps in reducing the likelihood of litigation. Record of a complete discussion with the patient regarding agreement to a particular technique or refusal, any treatment given without consent and the reasons behind it should be made. Mostly, medical negligence cases are registered after a time lapse, written documentation will help the anaesthetist to prove his point in court. In the case of minor patients, consent is taken from parents, if parents are not available then the legal guardians appointed by parents or court act as decision makers. If parents refuse life-saving treatment of their child, then the case can be moved to court to seek intervention, but if the treatment is very urgent then it can be started without parental authorisation and even without court orders.[19] In case of critically ill patients, sometimes, difficulty arises, when they temporarily lose their capacity to make decisions, then consent is taken from proxy-decision makers appointed by the previously competent patient and if they are not available then court appointed persons can make treatment decisions. Advance directives given by the patient should be followed.[20] Emergency treatment also requires informed consent but if the patient is not competent to decide, then the reasons behind it should be noted and treatment can be started in the best interest of the patient. IML is currently working on developing a SOP on patient consent-2013.[2] This is drafted by a large number of members of the medical community and will be updated regularly with the changing medical law. This SOP can be referred in case of doubt and can also be produced in court if required

• The operation theatre equipments play a vital role in the outcome of the procedure, hence standardisation of theatre equipments and applying defined protocols for every procedure, saves patient and anaesthesiologist from disastrous results

• Minimising medication errors in operating rooms and ICU by remaining vigilant and following standardised protocols. WHO has introduced a surgical safety checklist-2008[3] under the slogan of safe surgery saves lives. It is designed for routine use in the operating room as a SOP with a goal of improving the safety of patients by reinforcing accepted safety practice and foster better communication and team work among clinical disciplines

• Expert opinion wherever necessary should be taken. Always give guarded opinion regarding prognosis, never give a guarantee for the treatment. Fellow anaesthesiologist is the best person to help in difficulty

• Well-qualified staff with good communication skills and compassionate behaviour should be appointed. Maintenance and sterilisation of the equipment should be done with care. Maintain good relation with your colleagues. Avoid undue criticism without verifying the facts

• IML,[4] provides information to doctors and lawyers regarding medical law. It has a team of advocates who continuously report on latest developments in medical laws so that these can be optimally utilised in providing medico-legal services to doctors, lawyers and patients. IML also conducts regular courses in medical law for doctors and lawyers. Guidance from IML can be taken in case of any doubt

• Anaesthesiologist should remain up to date with the newer standards of practice by taking part in continuing medical education programmes. State medical councils have made it compulsory for every medical professional to earn 30 credit hours in every 5 years by attending professional meetings for the renewal of medical registration by some states. IML, with the help of the national organisation of doctors, is formatting accreditation criteria for medical centres across country

• Registration with state medical council and medical council of India is a must. Every doctor should follow the medical ethics code which includes professional conduct, Etiquette and Ethics[21]

• Insurance: Professional indemnity cover may help to overcome financial losses and insurance companies can also help by providing legal assistance during case proceedings in courts

• To protect the doctors and hospitals from the fury of attendants, various states had framed their laws. Under this law if anybody misbehaves or damages the hospital property, then he or she will be punished monetarily or with imprisonment

• Medico-legal cells at city, district, and state level will be helpful for individual anaesthesiologists. IML runs a unique medico-legal mediation council that facilitates patients and doctors to resolve medico-legal disputes amicably in a congenial environment outside the court

• Indian Society of Anaesthesiologists shall concentrate on preparing minimum mandatory theatre conditions, protocols for SOPs, pre-operative evaluation and investigations for practising anaesthesiologist, as the working conditions in rural India differ a lot from those of western standards. Guidance from ISA is also solicited for consent forms and record keeping. Indemnity insurance from ISA will be an asset to the practicing anaesthesiologists

• Future guidelines: The present court judgements in various cases leave a lot of room for discretion. The law should be more precise and clear to understand which act is negligent and which is not. Anaesthesiologist must be taught that good practice is the best antidote to malpractice accusations. Informed consent must become part of standard curricula and patient's experience of illness must also become part of the doctor's fundamental training. Indian society of anaesthesiologists should also come up with specific protocols to be followed by the anaesthesiologist during difficult situations to avoid legal action.[22] This will go a long way in improving patient care.

SUMMARY

People are becoming more and more aware of their rights; a slight negligence on the part of a doctor can land him in civil or criminal court. If the courts impose criminal liability on doctors for every mishap or death, then the doctors would be more worried about their own safety rather than giving their best. The medical professionals expect a sympathetic approach from judiciary because even if negligence occurs, it is never with criminal intentions. Reasons for this may not be always be carelessness but may be due to overwork, burden of obtaining positive results or some preoccupied tensions in the mind of doctors. Appropriate expert opinion can only determine negligence in these cases. The judiciary should also keep in mind that the reputation of a doctor can vanish, which will be very damaging, as the practice of medicine is very much based on mutual faith. On the other hand, judiciary expects doctors to maintain healthy doctor patient-relationship, good record keeping and to provide a reasonable standard of care to their patients.