The tripartite relationship between laws, doctors and patients has always been a subject of study. Its awareness is continuously increasing. This can be seen from the different concepts that have evolved over a period such as “medical negligence”,“gross medical negligence”, “medical malpractice” etc. Different platforms have been created to address the grievances of the patients, handing out both civil and criminal remedies. However, it is seen that with excess regulations, the balance struck between the independence of doctors and the rights of patients gets disrupted. This issue has assumed urgency, especially with the increasingincidents of violence against the medical community.
Overtime, Medical Professionals have been made responsible for their misconduct. Although, Medical Negligenceis not defined anywhere per se, it has been derived from the offence of ‘Negligence’. Negligence is defined as a breach of duty caused by an omission to do something that a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs, would do, or doing an act which a reasonable or a prudent man would not do. 1
Therefore, ‘Medical negligence’ is a breach of a professional duty to take care in accordance with the established standards of conduct as set by a medical authority. Lack of care, inadequacy of requisite skills, and arbitrary decisions, mainly result in medical negligence. A victim of medical negligence has three ways to exercise his right. He can either approach (a) a Civil Court, (b)a Criminal Court and (c) a Consumer Dispute Redressal Forum.
To exercise civil rights, a patient can file a suit for damages under Section 9 of the Code of Civil Procedure 2 or he can file a complaint for deficiency of service under the Consumer Protection Act, 3 or he can do both. 4 To exercise criminal rights, a patient can file a complaint under section 304A, 337,338 or even 319 or 320 of the Indian Penal Code 1860. 5 However, the burden of proof shall fall on the claimant/complainant. 6
The medical profession witnesses a variety of patients in different conditions. Depending on the circumstances, each case must be treated in a manner that best suits the individual patient. This involves the application of skill and judgment by the doctor. Therefore, every decision cannot amount to Medical Negligence.
The difference between a mere error of judgment and medical negligence was decided in the case of Hucks v. Cole
The Supreme Court in the case of Jacob Mathew v. State of Punjab
For instance, under section 304A of the Indian Penal Code, the death must be caused by a rash and negligent act. A mere causal relation between the death and negligence is not enough, the act must be a proximate and effective cause that is causa causans
The most important factor for determining negligence is the threshold of ‘due care’.This was discussed at great length in the case of Bolam v. Friern Hospital Management Committee 10.
The popular Bolam test is used to determine whether a doctor has breached the expected duty of care towards the patient. This test has been accepted by the Indian Courts. 11 Essentially, the test entails that the standard of care has to be in accordance with what a reasonable body of medical professionals, in that particular field, consider adequate. The medical opinion followed should be an informed one. Alternatively, a doctor adopting a particular approach cannot be termed as negligent due to the mere existence of another body of opinion holding a different view. 12 It is more important to how the treatment was done. Therefore, negligence can either be due to lack of adequate skills which the doctor claimed to possess, or non-exercise of competence, that is the skill, which hedid in fact, possess. The Supreme Court in Spring Meadows Hospital v. Harjol Alhuwalia summarized certain scenarios that entail a breach of the duty of care. These include the use of a wrong drug, inadequate precaution, reckless manner of handling equipment, and delegation of responsibilities to incompetent juniors.
The test of due care also extends to cases where the consent of the patient is to be taken. The question which arises is, what constitutes ‘adequate information’ while taking consent. While following the Bolam test, the court in Sidaway v. Board of Governors of Bethlem Royal Hospital and the Mausely Hospital13 held that while obtaining the patient’s consent, the doctor need not disclose all the details. Therefore, relying on the importance of clinical judgment, it expressly rejected the idea of informed consent. The Bolam judgment was revisited by the UK Court in the case of Montgomery v. Lanarkshire Health Board,14 which also deals with the intricacies of informed consent. It suggests that there should be full disclosure of information to the patients to obtain their consent. The focus was changed from a ‘reasonable doctor’ to a ‘reasonable patient’. It suggested that the medical practitioners are under a duty to disclose the ‘material risks’ involved in the adopted treatment and the existence of any alternatives. The term ‘material risks’ was defined in a two-fold manner; a) the importance attached to the said risk by a reasonable person in the patient’s position or b) the ability of the doctor to ascertain the significance of a risk attached to it by the particular patient.
It was seen that the percentage of the risk is not the sole factor but other factors such as its effect, nature, availability of alternatives, and its associated risks have to be considered as well. Hence, the assessment depends on the facts and circumstances of the case and the characteristics of the patient. Some people believe that the Bolam test has been rejected, however, that is not the case. While the Bolam judgment emphasized on negligence, the Montgomery judgment relying on the test, emphasized on the full disclosure of risks. Since, for the purpose of disclosure, the opinion of a medical body was resorted to, this test was only made more stringent by imposing a general duty of full disclosure.
Some professionals, however, have a contrary opinion to what was held in Montgomery’s case. Their concerns are with respect to its effects on patient care and clinical practice.15 They believe that this will result in the development of defensive medicine rather than the promotion of clinical judgment. They also suggest that strict disclosure requirements will result in the patients being overwhelmed which will compel them to make poor decisions.16 In fact, these were the main reasons behind Sidway’s judgment
However now, it is strongly felt that an ethical stance will bar the doctor from withholding information on the apprehensions of the reluctance of patients for undergoing such treatment after disclosure.
After the Bolam and Montgomery judgment, the position of negligence and informed consent are not vague concepts. However, every coin has two sides. The fears and problems of the doctors are increasing daily. While the cases of medical negligence are important, not every one of those claimsis genuine. The doctors have become victims of frivolous litigations.17 It is not only the extent of liability imposed on them, which is problematic, but now their very safety is also under threat.
The following aspects shall throw some light on the problems faced by the doctors.
The Consumer Protection Act 1986 promotes the interest of consumers by protecting them from the defective goods and deficient services. Section 2(o) defines the term services.The term ‘but not limited to’ clarifies that its scope is not exhaustive.18
In the case of Indian Medical Association v. V.P. Shanta and others,19 the question before the apex court was whether healthcare services come within the ambit of the Act. The principle argument for excluding such services was that the Act mainly covered occupations but not professions. Medical practitioners being professionals20 should not be burdened with the liability imposed by the Act and a rational approach must be adopted to determine their liability. The exercise of professional judgment acts on a different sphere. Moreover, they are already governed by the Indian Medical Council Act 195621 and the Code of Medical Ethics22 as provided by the Medical Council of India. The damages could always be claimed from them through civil suits by tendering the necessary court fees.
The court ruled that healthcare services are within the ambit of the Act excluding those which were free of charge. In fact, in the Consumer Protection Bill 2018,23 the word ‘healthcare’ was expressly added to the list of services. The same was not adopted by the Consumer Protection Act 2019 24. However, this does not change the fact that the Act does include healthcare services.
The Act also increases the Pecuniary Jurisdiction of the District Forum to Rs. 1 Crore 25. This shall have a huge effect on the lives of the doctors. Now they can be easily embroiled in claims running into crores of rupees. Further, the Consumer Protection Rules, 2018 do not provide for a big court fee 26, so the line between speculative claims and genuine claims will vanish. The scheme of the Act is such that it cannot override any other Act. Therefore, a complaint before the forum will not bar any other court’s jurisdiction over the same matter. This has made the situation of doctors quite precarious. Third-party financing (i.e. insurance) is a thriving business just like the scenario of legal professionals. Collectively, they will become the ‘ambulance chasers’.
The problem of lack of uniformity in calculating compensation also plagues the system. Different forums might adopt different standards which leads to inconsistency.27 In some cases, courts have awarded compensation on humanitarian grounds and not on the basis of negligence, thereby sending an incorrect message.28 Even though some of these decisions have been set aside by appellate courts, the pronouncements are disproportionate and the entire process is taxing.
Slowly, the type of medical practice itself is sadly and radically changing. Sharp clinical acumen is being replaced by the “evidence based” practice of medicine. The practitioners are being compelled to perform a battery of tests to prove or disprove a diagnosis which was earlier done through the clinical judgment of an astute physician. The medical community is hence undergoing a complete state of paranoia and paralysis.
With the sword of the consumer protection law hanging over the head of the doctor as a sword of Damocles, the same astute physician who once used to rely on his sharp clinical judgment will now rather protect himself and go in for a battery of tests to rule out all the rare causes for common symptoms. This practice is not only time consuming but also involves high costs. A simple headache that would have otherwise been clinically dealt with basic initial measures would now be unnecessarily and prematurely subjected to a CT or an MRI. Such defensive medicine automatically implies that the number of tests will depend on factors such as insurance coverage and paying capacity of the patient- something which was never even considered earlier. Further, in some cases, a delay in the actual treatment will positively harm the patient. Either way the patient is put in a catch 22 situation.
The problem of safety of the doctors is not restricted to India but is spread across the world. WHO reported that during the year 2014-15 around 600 violent incidents took place across 19 countries against the medical community.29 In India, according to the Indian Medical Association, about 75% of the doctors are victims of violence at work.30 The current healthcare sector is understaffed, underpaid, and underdeveloped. Poor infrastructure, lack of proper technology, low doctor-patient ratio, and poor means of communication are just some of the problems that haunt the entire system. This triggers the causes of aggression amongst patients which is reflected on the doctors. The inability of the government to provide for good infrastructure ultimately affects both-the patients and the doctors.
Further, medical journalism can also result in wide dissemination of exaggerated claims.31 This further weakens the public faith in the healthcare system. The attitude of patients itself isthe major contributor to such violence. A mere dissatisfaction with the nursing staff, visiting violations or the manner of treatment can also trigger this behaviour. Their lack of trust coupled with commercialization and the escalating cost of treatment also results in violent behaviours. The extra regulations have also led to a belief that the medical practitioners are responsible for every such situation.
There are no specific laws for the protection of doctors. Some regulations are needed since it is essential that those who protect the health of the nation should feel safe. There have been many cases where the doctors have been brutally beaten or even killed just because the patient’s condition worsened.32 It will be counter-productive if the doctor who puts efforts to cure the patient ends up getting assaulted himself. This fear will ultimately affect the way the medical practitioners work and will also act as a disincentive for many who are yet to enter this field.
In 2019, considering the grave dangers faced by the medical practitioners, a bill titled ‘The Health Services Personnel and Clinical Establishments (Prohibition of Violence and Damage to Property) Bill, 2019’33 was introduced by the health ministry. The bill aimed at penalizing perpetrators of such violence, thereby protecting the medical practitioners. It imposed imprisonment for a period of three to ten years and fines between Rs. two to ten lakhs for grievous hurt. For damage of property, the duration of imprisonment was six months to five years and fines between Rs. fifty thousand and five lakh. In 2020, the said bill was rejected. It was felt that provisions of IPC and Cr PC provided enough protection and there was no need for a separate legislation to protect a particular profession.
In light of the current health crisis that is the COVID-19 situation, the doctors have put their lives on the line to fight the pandemic. However, with this, they have also been stigmatized, ostracised and have become victims of violence since they are now seen as potential carriers of the virus.34 This has not only posed to be an obstruction to their work but has also demoralized them to fulfil their duty. The gravity of the situation is such that the medical community has been threatening to go on a strike. In pursuance of the exorbitant increase in the number of cases of violence against the medical fraternity, the Central Government has promulgated an Ordinance titled ‘The Epidemic Diseases (Amendment) Ordinance, 202035 to amend the Epidemic Diseases Act, 189736. The ordinance seeks to protect the healthcare service personnel and their property covering their residence and work place against violence during epidemics. It makes such attacks a cognizable and non-bailable offence, where the burden of proof lies on the accused. For committing or abetting to commit violence or for causing or abetting to cause damage to property, the Ordinance prescribes punishment with imprisonment ranging from three months to five years and a penalty of a fine ranging from Rs. 50,000 to Rs. 2,00,000. For the offence of grievous hurt, the imprisonment ranges from six months to seven years along with a fine ranging from Rs. 1,00,000 to Rs. 5,00,000. Even the compensation (which is in addition to punishment) is provided. The violator is liable to compensate the victim for the hurt or grievous hurt so caused, as fixed by the court. In case of loss or damage to property, the value of compensation shall be twice the fair value of the damaged property or such loss. The ordinance also ensures that the investigation for such attacks and proceedings are timely concluded within the period of thirty days and a year respectively.
The said Ordinance has been hailed by the medical community nation-wide. The Ordinance has sufficiently catered to the protection of the medical community. Health being a priority for the nation, legislations like these are a boon for the doctors. The only issue is that the said Ordinance is only for the duration of the epidemic. It is just a temporary solution. What about the assaults that will continue in the absence of such security? A Central and uniform Act, increase in the healthcare budget and good infrastructure will provide a secure future for the doctors in the long run.
It is not as if the doctors should not be prosecuted at all. All that is required is a little care and caution which will ultimately benefit society. It is important to strike a balance between the rights of a patient and the interests of the doctors. Both should go hand in hand, otherwise, it will end up becoming counter-productive, that is, one section of the society will be overly protected at the cost of the other. Therefore, there exists a need for reforms which, while protecting the patients will also preserve the interests of the medical community- a profession which renders the most noble service to mankind.
In the case of Martin F. D’Souza v. Mohd. Ishfaq37, the apex court attempted to lay down certain guidelines for handling cases of medical negligence. It required the complaint to be scrutinized by a special committee, consisting of doctors and experts, before any notice could be issued to the medical practitioner or the concerned hospital. For instance, a private complaint is lodged against the medical officer. Neither the investigating officer nor the complainant himself will be well versed with the correct assessment of the situation at hand. That is, whether at all there exists a prima facie case coming within the ambit of the specified offence(s). The practitioner may or may not be granted bail. If in the end, it is found out that the entire case was unnecessary, the practitioner may be acquitted or discharged, but the loss of his reputation cannot be compensated. The judgment made the assistance of such committees mandatory under all circumstances. The Indian Evidence Act does recognize the importance of an expert’s opinion in matters pertaining to science or art. The same becomes essential in medical negligence cases since the officers, courts and consumer forums are not well versed with the technicalities of medical science. However, the decision was held to be bad in law since it ignored the established procedures. The said case does adopt a different approach which might not be feasible in terms of law but there is a need for the presence of an expert opinion.
The essence of D’ Souza’s case was diluted in the case of V. Kishan Rao v. Nikhil Super Specialty Hospital38. The scope of expert evidence was restricted only to complicated cases, handled by civil and criminal courts. It was held that the simple cases could be handled by the consumer forum by following the procedure laid under the Act. Otherwise, the patient could be directed to a civil court. However, this will go against the interests of the doctors. The discipline of Medicine being a science, requires an expert’s opinion to establish whether there exists a prima facie case or not. Experts can be examined by the discretion of the commission39. The same should be promoted in cases having a scientific background. It will help in disposing frivolous cases efficiently and effectively thereby reducing the burden of the courts of scrutinizing every case.
False and frivolous cases are unethical practices adopted by the people that go against the very purpose for which the laws are created. It has been observed that a good proportion of the medical negligence cases are not genuine. There is no law that seeks to punish such people. Therefore, there is a need to encourage only genuine claims, otherwise, it will be counter-productive, deterring the young aspirants to enter this field or forcing the current doctors to leave their practice. Further, separate tribunals can be created for handling cases of medical negligence and malpractices. The composition of the same can include people with a medical background who will be better equipped to adjudicate such matters. Moreover, a screening committee can be set up which could help filter out the genuine claims. This can be done by amending the Indian Medical Council Act, 1956.
There are certain grey areas which are gateways for further litigation. For instance, there is a need for proper guidelines for obtaining consent from the patients in the medical field. The manner of obtaining informed consent has been outlined in the case of Samira Kohli v. Dr. Prabha Manchanda and Anr.40. It was held that ‘adequate information’ need not include remote risks and rare complications, however, with the Montgomery Judgment throwing focus on the patients’ mindset, the meaning of ‘adequate information’ becomes vague again. Moreover, the Code of Medical Ethics41 and Professional Conduct, Etiquette and Ethics Regulations, 2002 issued by the MCI only specifies the manner of obtaining consent in rare or unique situations. In other situations, only the requirement of consent is mentioned. Most of the doctors will not be aware of the different judgments laid down. Hence, it is essential that some guidelines be brought out to remove uncertainties. The detailed guidelines issued by the General Medical Council42 in Europe can be referred to for this purpose.
The clinical judgment of the doctor needs to be promoted rather than the practice of defensive medicine. The current situation only allows the latter to operate. This is primarily because of stringent laws, arbitrary compensations, and endless litigation. If sufficient laws are protecting the medical community which will prevent them from getting dragged into frivolous lawsuits, then they will be able to rely on their judgment and years of experience. This can be achieved by the involvement of independent medical boards while deciding cases of medical negligence and malpractice. Further, efficient compensation systems will prevent arbitrariness. When the fear of unnecessary prosecution decreases, the freedom of applying clinical judgment will increase. This will not only benefit the doctors but shall reduce unnecessary costs for the patients.
Laws for the protection of doctors are extremely essential. If we look at the safety and security of professionals, the doctors are the most vulnerable and harassed at the hands of the very people they have sworn to protect. Attempts have been made to enact laws but the same have been discarded. In addition to punishing those who are the backbone of such violence, attempts can be made to increase the protection provided to hospitals. This can be in the form of an increase in security personnel in and around hospitals and emergency helplines to prevent harm and provide instant security to doctors. Victim redressal systems can be set up for proper enforcement of reforms. Regulating the supply of arms or weapons that majorly contribute to violence can help in reducing the severity of acts. Stringent security scans will also ensure that the perpetrators do not carry items such as rods, batons and sticks into the buildings and hospitals. The role of the police is of extreme significance here. The present Epidemic Diseases (Amendment) Ordinance, 2020 does protect the interests of the doctors in a good and elaborate manner. However, that is just a temporary solution to a long-stretched battle. The community can only hope and pray that such protections are extended for other times as well through new legislation.
Even though the regulations on medical professionals has been a boon for people, its constant modifications have created possibilities of over-regulations in this sector. The practitioner’s prime sense of clinical judgment has been over shadowed by the concept of defensive medicine. In order to save themselves from frivolous litigations and multiple claims, the focus has now been shifted from treatment to proof. Over regulations have also instilled the idea that the practitioner can be easily dragged into every claim. This has also threatened their very safety. Numerous cases of assaults on doctors and even deaths have been observed. This being a major deterrent for the doctors has not only discouraged them to continue their practice but has also compelled them to live with fear. Allthis has jeopardised the special doctor-patient relationship. Ultimately, the law which sought to protect the patients have made them vulnerable to costly treatments and frightened practitioners. What is left, is a double-edged sword. However, the situation can be improvedby slightly liberalising the system or by promoting those laws which safeguard the interests of the medical community as well. There must be a balance between both interests, i.e. they should go hand in hand. By positive reforms, the doctor-patient relationship can be saved and the patients can get their fair share of justice in genuine medical negligence cases.