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.
The consequences of legally cognizable medical negligence can broadly be put into three categories:-
- Criminal liability
- monetary liability
- 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 (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 (causing hurt) and 338 (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.
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. 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; and perhaps a corollary may be extended for cases of medical negligence by medical professionals.
BASIC FEATURES OF MEDICAL NEGLIGENCE AND STANDARD 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.
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.” 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 post detection 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.
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 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.
Three-judge bench (bench strength in Dr. Suresh Gupta was two) in Jacob Mathew v. State of Punjab 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,” 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.” 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.
Errors of judgment do not necessarily imply negligence. 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. 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. 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. 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.
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. 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.
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. 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.
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. Experts only render opinions and those that are “intelligible, convincing, and tested” 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; 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 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 “In the times to come, litigation may be based on the theory of lack of informed consent.”
SANCTITY OF PROFESSIONAL JUDGEMENTS 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.”
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.
ADVISORY TO DOCTORS AND SAFEGUARDS IN CRIMINAL PROSECUTION BY SUPREME COURT
Supreme Court in one case 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: –
- 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.
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.