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Introduction:

Over the last few years numerous breakthroughs in medical science have resulted in increasing life expectancy and simultaneously brought about an improvement in the quality of life. The importance of the medical profession and the respect medical professionals command has increased tremendously. However, various extraneous factors have resulted in proliferation of institutions imparting medical institution with inadequate infrastructure as a result of which standards of medical education have been adversely affected to an extent. Further as a result of increasing commercialization there is a decrease in ethical values in society with “making money” becoming the prime motivator. Most professions have fallen prey to this attitude. Though insulated to a large extent the noble profession of doctors is also getting affected by these changes. Thus gone are the days when the doctor patient relationship was governed by mutual trust and instead today very often the helpless patient is treated like a commodity to be managed in a corporate environment.

Simultaneously due to simpler laws and concerted government efforts to educate its citizens about their legal rights, there has been rising awareness amongst all classes of people of their legal rights. This awareness of rights coupled with pro consumer legislation and judicial approach has emboldened citizens to approach judicial fora for redressal of their grievances. On the downside this has also resulted in citizens approaching judicial fora with a view to try their luck in litigation in facts that do not justify any such action being entertained.

In either case the result is the same, a doctor being a defendant in a medical malpractice claim. There is nothing that can perhaps be so professionally damaging and emotionally and mentally draining than being arrayed as a defendant in any such action, specially when the doctor has put in earnest efforts to alleviate the problems of the patient.

While there is not much one can do to prevent a disgruntled patient from approaching a judicial forum for redressal of grievances, there is certainly much that can be done to make sure that no such occasion arises at all. Further, an understanding of the law becomes all the more necessary for a doctor so that while performing his / her duties, the doctor is aware at every step what the law requires of him / her when attending to a patient. This article attempts to outline in brief the judicial approach to medical malpractice claims in India, some problems and solutions. This article first deals with legal avenues other than the Consumer Protection Act, 1986 (“CPA”) and then goes on to deal with the CPA itself – it being the preferred choice for litigants wanting to initiate action against medical professionals.

What is medical negligence ?

Before we begin it is important to understand what amounts to medical negligence. Ordinarily negligence can be defined as a breach of duty caused by omission to do something which a reasonable man guided by those considerations which ordinarily regulate the conduct of human affairs would do, or doing something which a prudent and reasonable man would not do.
Negligence in the context of the medical profession necessarily calls for a different definition. Being a professional a doctor may be held liable for negligence on one of the two findings: either he was not possessed of the requisite skill which he professed to have or he did not exercise, with reasonable competence in a given case, the skill which he did possess. The basic principle relating to medical negligence is known as the BOLAM Rule and has been accepted by the Supreme Court as the standard test for medical negligence (Jacob Mathew v. State of Punjab (2005) 6 SCC 1). This was laid down in the judgment in
Bolam v. Friern Hospital Management Committee (1957) 1 WLR 582 as under:

“……Where you get a situation which involves the use of some special skill or competence, then the test as to whether there has been negligence or not is not the test of the man on the top of a Clapham omnibus, because he as not got this special skill. The test is the standard of the ordinary skilled man exercising and profession to have that special skill. A man need not possess the highest expert skill…..It is well established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art…” (Emphasis supplied)

Thus to put it simply, medical negligence arises from an act or omission by a medical practitioner, which no reasonably competent and careful medical practitioner would have committed. Therefore a medical practitioner while attending to the patient is expected to adopt reasonably skilful behaviour and follow the ordinary skills and practices of the medical profession with ordinary care.

A claim for compensation based on medical negligence is primarily based on the following:
  • The doctor owed a duty of care to the patient
  • There has been a breach in the performance of the duty
  • The breach of the duty has resulted in consequential loss or harm to the patient concerned
Legal avenues other than the CPA available to aggrieved patients:

While the CPA enacted by the Parliament is the preferred choice for initiating action against erring medical professionals, prior to its enactment and even now, there are numerous legislations which can be utilized to initiate action against erring medical professionals. This section deals with these particular laws.

  1. Indian Medical Council Act, 1956 and Dentists Act, 1948The above Acts regulate the profession of allopathic medicine and dentists in India respectively. Under the above Acts the Medical Council of India (“MCI”) and the Dental Council of India (“DCI”) have been constituted along with state medical / dental councils through which the aforesaid Acts are enforced. The MCI and the DCI are the supreme bodies in the country having jurisdiction over medical and dental practitioners. The MCI and DCI are authorized to recognize the medical qualifications granted by any institution in India or other countries.To be entitled to practice all medical / dental practitioners have to register with the MCI or the DCI as the case may be. The MCI / DCI or the appropriate state council having jurisdiction in the matter is empowered to punish persons who falsely claim to be registered with them or practice without being registered with them. The MCI also prescribes standards of professional conduct and a code of ethics to be followed by all medical practitioners violation of which is actionable.Some illustrative instances under which a doctor renders himself open to charges of misconduct and negligence are:
    • Conviction in a Court of law for a crime
    • Neglect in making professional reports / maintaining professional records
    • Improper conduct towards patients
    • Performing or associating with an illegal operation
    • Contravention of any law such as the Drugs and Cosmetics Act, 1940
    • Receiving, giving commission
    • Using touts to obtain business
    • Employing unqualified persons
    • Advertising for business
    • Associating or promoting drug manufacturers products
    • Refusing to treat patients on extraneous grounds

    It may however be noted that the MCI / DCI or the state councils are not empowered to award compensation. However, they have the power to even debar permanently a person found guilty of the offence alleged.

  2. Civil CourtThis is one of the oldest remedies available to aggrieved persons. Thus an aggrieved person can initiate proceedings for compensation and award of damages against a medical practitioner for medical malpractice. The principles for initiating legal action in a civil court are based on the law of Torts. The word Tort is derived from the Latin term “Tortum”, which means to twist. It therefore includes conduct that is not straightforward of lawful. This branch of law consists of various “torts” or wrongful acts whereby the wrongdoer violates some legal rights vested in another person. A Tort is defined as a civil wrong that is redressable by an action for unliquidated damages and which is other than a mere breach of contract or breach of trust. Thus damages is the most important remedy for a tort.Under civil law claims can also be based under the provisions of the Fatal Accidents Act, 1855 and section 357 of the Code of Criminal Procedure, 1973. The Fatal Accidents Act, 1855 is based on the English Fatal Accidents Act, 1846 with certain modifications to suit the Indian framework. The said Act provides compensation to the family of the deceased for loss occasioned by the death of a person caused by an actionable wrong. The Act has a wide applicability and has been used by the Supreme Court of India to award compensation to the legal heirs of deceased patients (Dr. Laxman Balkrishna Joshi v. Dr. Trimbak Bapu Godhole AIR 1969 SC 128).
  3. Indian Penal Code, 1860Prior to and even despite enactment of the CPA actions are being initiated under the provisions of the Indian Penal Code, 1860 (“IPC”). The law of medical malpractice has developed around Sections 52, 80, 81, 88, 90, 91, 92, 304-A, 336, 337 and 338 of the IPC in the context of criminal proceedings. The Supreme Court has held that to fasten liability in criminal proceedings the degree of negligence has to be higher than the negligence which is enough to fasten liability in civil proceedings. Thus for civil liability it may be enough for the complainant to prove that the doctor did not exercise reasonable care in accordance with the accepted principles but for convicting a doctor in a criminal case, it must also be proved that this negligence was gross amounting to recklessness (Martin F. D’Souza v. Mohd. Ishfaq (2009) 3 SCC 1).
  4. Monopolies and Restrictive Trade Practices Act, 1969Prior to the enactment of the CPA, the above Act was the only recourse available to consumers against unfair and restrictive trade practices by medical practitioners. However, this Act is now in the process of being repealed and replaced with the Competition Act, 2002. With the enactment of the CPA, the aggrieved consumers have a much more effective remedy available.
  5. Writ Jurisdiction of the High Court and the Supreme Court
    Every aggrieved citizen has a constitutional right under articles 226 and 32 of the Constitution of India to approach the High Court or the Supreme Court respectively for redressal of his grievance, provided an appropriate cause of action exists on the basis of which the concerned Court has jurisdiction take up the issue. The Court can award compensatory damages against erring medical institutions and medical practitioners who have failed in their public law duties towards patients. For instance if there is a government organized medical camp for eye surgery for removal of cataract and this subsequently leads to mass blinding of patients after the surgery due to negligence during the conduct of the surgery, the Supreme Court or the High Court will have jurisdiction under article 32 and 226 respectively to adjudicate upon the issue.

Consumer Protection Act, 1986

The enactment of the CPA marks a watershed in consumer litigation in the country. The CPA was enacted in 1986 “to provide for better protection of the interest of consumers”. The CPA has created a time bound and parallel dispute redressal mechanism under which disputes raised by consumers are adjudicated. Under the CPA any person who hires or avails of any service for consideration (and includes any beneficiary of such services) qualifies as a consumer under section 2(d) of the Act. In case the services hired or availed of by a consumer suffer from deficiency in any respect, the consumer can initiate proceedings under the CPA for redressal of his grievances. Due to the simple and easy procedures available the Act has become a potent tool in the hands of consumers dissatisfied with services rendered and goods sold. One of the important and developing areas in the field of consumer law is that of medical malpractice.

With the advent of the CPA almost all cases of medical malpractice have been initiated under its provisions. The landmark judgment of the Supreme Court in the case Indian Medical Association vs. V. P. Shantha (1995) 6 SCC 651 brought the medical profession within the ambit of the CPA. The question before the Supreme Court in this case was whether a medical practitioner can be regarded as rendering a service and whether this service falls under Section 2 of the Consumer Protection Act, 1986. The Court held as under:

  • That Section 14(1)(d) of the Consumer Protection Act, 1986 indicates that the compensation to be awarded is for loss or injury suffered by the consumer due to the negligence of the opposite party and applies to medical practitioners.
  • It upheld the principles dealing with the standard of care required from medical practitioners laid down in Bolam v. Friern Hospital Management Committee [1957] 1 W.L.R. 582:
    • o The test is the standard of the ordinary skilled man exercising and professing to have that special skill. It is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular article.
  • Service rendered to a patient by a medical practitioner (except where the doctor renders service free of charge to every patient or under a contract of personal service), by way of consultation, diagnosis and treatment, both medicinal and surgical, would fall within the ambit of ‘service’ as defined in Section 2(1)(o) of the Act.
  • The fact that medical practitioners belong to the medical profession and are subject to the disciplinary control of the Medical Council of India and/or State Medical Councils constituted under the provisions of the Indian Medical Council Act would not exclude the services rendered by them from the ambit of the Act.
  • A ‘contract of personal service’ has to be distinguished from a ‘contact for personal services’. In the absence of a relationship of master and servant between the patient and medical practitioner, the service rendered by a medical practitioner to the patient cannot be regarded as service rendered under a ‘contract of persona] service’. Such service is service rendered under a ‘contract for personal services’ and is not covered by exclusionary clause of the definition of ‘service’ contained in Section 2(1)(o) of the Act.
  • The expression ‘contract of personal service’ in Section 2(1)(o) of the Act cannot be confined to contracts for employment of domestic servants only and the said expression would include the employment of a medical officer for the purpose of rendering medical service to the employer. The service rendered by a medical officer to his employer under the contract of employment would be outside the purview of ‘service’ as defined in Section 2(1)(o) of the Act.
  • Service rendered free of charge by a medical practitioner attached to a hospital/Nursing home or a medical officer employed in a hospital/Nursing home where such services are rendered free of charge to everybody, would not be “service” as defined in Section 2(1)(o) of the Act. The payment of a token amount for registration purpose only at the hospital/nursing home would not alter the position.
  • Service rendered at a non-Government hospital/Nursing home where no charge whatsoever is made from any person availing the service and all patients (rich and poor) are given free service – is outside the purview of the expression ‘service’ as defined in Section 2(1)(o) of the Act. The payment of a token amount for registration purpose only at the hospital/Nursing home would not alter the position.
  • Service rendered at a non-Government hospital/Nursing home where charges are required to be paid by the persons availing such services falls within the purview of the expression ‘service’ as defined in Section 2(1)(o) of the Act.
  • Service rendered at a non-Government hospital/Nursing home where charges are required to be paid by persons who are in a position to pay and persons who cannot afford to pay arc rendered service free of charge would fall within the ambit of the expression ‘service’ as defined in Section 2(1)(o) of the Act irrespective of the fact that the service is rendered free of charge to persons who are not in a position to pay for such services. Free service, would also be “service” and the recipient a “consumer” under the Act.
  • Service rendered at a Government hospital/health center/dispensary where no charge whatsoever is made from any person availing the services and all patients (rich and poor) are given free service – is outside the purview of the expression ‘service’ as defined in Section 2(1)(o) of the Act. The payment of a token amount for registration purpose only at the hospital/nursing home would not alter the position.
  • Service rendered at a Government hospital/health center/dispensary where services are rendered on payment of charges and also rendered free of charge to other persons availing such services would fall within the ambit of the expression ‘service’ as defined in Section 2(1)(o) of the Act irrespective of the fact that the service is rendered free of charge to persons who do not pay for such service. Free service would also be “service” and the recipient a “consumer” under the Act.
  • Service rendered by a medical practitioner or hospital/nursing home cannot be regarded as service rendered free of charge, if the person availing the service has taken an insurance policy for medical care whereunder the charges for consultation, diagnosis and medical treatment are borne by the insurance company and such service would fall within the ambit of ‘service’ as defined in Section 2(1)(o) of the Act.
  • Similarly, where, as a part of the conditions of service, the employer bears the expenses of medical treatment of an employee and his family members dependent on him, the service rendered to such an employee and his family members by a medical practitioner or a hospital/nursing home would not be free of charge and would constitute ‘service’ under Section 2(1)(o) of the Act.

Another subsequent landmark case is that of Jacob Mathew v. State of Punjab (2005) 6 SCC 1 where the proceedings arose out of a Special Leave to Appeal that was filed before the Supreme Court of India by the petitioner against the orders passed by the High Court of Punjab and Haryana dismissing the petition for quashing of the FIR and subsequent proceedings. It was contended by the complainant that his father, who was admitted in a hospital in Ludhiana, found it difficult to breathe and was attended to subsequently, however, after a substantial gap of time. On the doctor’s arrival it was found that the oxygen cylinder was empty and after some more time a full oxygen cylinder was brought however, there was no arrangement to make the second cylinder functional. Meanwhile, a doctor declared that the patient was dead. An FIR was filed by the Complainant in furtherance of which an offence was registered under Section 304A of the Indian Penal Code. A revision was filed by the Petitioner against the framing of charges against the petitioners which was dismissed. The petitioner preferred a petition for quashing the FIR and the subsequent proceedings.

The Supreme Court exhaustively dealt with the law relating to (i) negligence as a tort (ii) negligence as a tort and as a crime, (iii) negligence by professionals, (iv) medical professionals and criminal law, (v) reviewed Indian judicial precedents on criminal negligence and thereafter reached certain conclusions and framed guidelines regarding prosecuting medical professionals. The Supreme Court applied the Bolam Rule to ascertain whether section 304A IPC was applicable to the facts of the case under consideration. The relevant extracts of the judgment of the Supreme Court which deal with the aforesaid issues is reproduced for a better understanding of the approach of the Court to the above issues:

Negligence as a tort

11. The jurisprudential concept of negligence defies any precise definition. Eminent jurists and leading judgments have assigned various meanings to negligence. The concept as has been acceptable to Indian jurisprudential thought is well-stated in the Law of Torts, Ratanlal & Dhirajlal (Twenty-fourth Edition 2002, edited by Justice G.P. Singh). It is stated (at p.441-442) — “Negligence is the breach of a duty caused by the omission to do something which a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs would do, or doing something which a prudent and reasonable man would not do. Actionable negligence consists in the neglect of the use of ordinary care or skill towards a person to whom the defendant owes the duty of observing ordinary care and skill, by which neglect the plaintiff has suffered injury to his person or property…. The definition involves three constituents of negligence: (1) A legal duty to exercise due care on the part of the party complained of towards the party complaining the former’s conduct within the scope of the duty; (2) breach of the said duty; and (3) consequential damage. Cause of action for negligence arises only when damage occurs; for, damage is a necessary ingredient of this tort.”

12. According to Charles worth & Percy on Negligence (Tenth Edition, 2001), in current forensic speech, negligence has three meanings. They are: (i) a state of mind, in which it is opposed to intention; (ii) careless conduct; and (iii) the breach of duty to take care that is imposed by either common or statute law. All three meanings are applicable in different circumstances but any one of them does not necessarily exclude the other meanings. (Para 1.01) The essential components of negligence, as recognized, are three: “duty”, “breach” and “resulting damage”, that is to say:-

  1. the existence of a duty to take care, which is owed by the defendant to the complainant;
  2. the failure to attain that standard of care, prescribed by the law, thereby committing a breach of such duty; and
  3. damage, which is both causally connected with such breach and recognized by the law, has been suffered by the complainant. (Para 1.23)

If the claimant satisfies the court on the evidence that these three ingredients are made out, the defendant should be held liable in negligence. (Para 1.24)

Negligence — as a tort and as a crime

13. The term ‘negligence’ is used for the purpose of fastening the defendant with liability under the Civil Law and, at times, under the Criminal Law. It is contended on behalf of the respondents that in both the jurisdictions, negligence is negligence, and jurisprudentially no distinction can be drawn between negligence under civil law and negligence under criminal law. The submission so made cannot be countenanced inasmuch as it is based upon a total departure from the established terrain of thought running ever since the beginning of the emergence of the concept of negligence upto the modern times. Generally speaking, it is the amount of damages incurred which is determinative of the extent of liability in tort; but in criminal law it is not the amount of damages but the amount and degree of negligence that is determinative of liability. To fasten liability in Criminal Law, the degree of negligence has to be higher than that of negligence enough to fasten liability for damages in Civil Law. The essential ingredient of mens rea cannot be excluded from consideration when the charge in a criminal court consists of criminal negligence. In R. v. Lawrence, [1981] 1 All ER 974 (HL), Lord Diplock spoke in a Bench of five and the other Law Lords agreed with him. He reiterated his opinion in R. v. Caldwell 1981(1) All ER 961 (HL) and dealt with the concept of recklessness as constituting mens rea in criminal law. His Lordship warded against adopting the simplistic approach of treating all problems of criminal liability as soluble by classifying the test of liability as being “subjective” or “objective”, and said “Recklessness on the part of the doer of an act does presuppose that there is something in the circumstances that would have drawn the attention of an ordinary prudent individual to the possibility that his act was capable of causing the kind of serious harmful consequences that the section which creates the offence was intended to prevent, and that the risk of those harmful consequences occurring was not so slight that an ordinary prudent individual would feel justified in treating them as negligible. It is only when this is so that the doer of the act is acting ‘recklessly’ if, before doing the act, he either fails to give any thought to the possibility of there being any such risk or, having recognized that there was such risk, he nevertheless goes on to do it.”

14. The moral culpability of recklessness is not located in a desire to cause harm. It resides in the proximity of the reckless state of mind to the state of mind present when there is an intention to cause harm. There is, in other words, a disregard for the possible consequences. The consequences entailed in the risk may not be wanted, and indeed the actor may hope that they do not occur, but this hope nevertheless fails to inhibit the taking of the risk. Certain types of violation, called optimizing violations, may be motivated by thrill-seeking. These are clearly reckless.

15. In 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. The element of criminality is introduced by the accused having run the risk of doing such an act with recklessness and indifference to the consequences. Lord Atkin in his speech inAndrews v. Director of Public Prosecutions, [1937] A.C. 576, stated, “Simple lack of care — such as will constitute civil liability is not enough; for purposes of the criminal law there are degrees of negligence; and a very high degree of negligence is required to be proved before the felony is established.” Thus, a clear distinction exists between “simple lack of care” incurring civil liability and “very high degree of negligence” which is required in criminal cases. Lord Porter said in his speech in the same case — “A higher degree of negligence has always been demanded in order to establish a criminal offence than is sufficient to create civil liability. ( & Percy, ibid, Para 1.13)

16. The fore-quoted statement of law in Andrews has been noted with approval by this Court in Syad Akbar v. State of Karnataka MANU/SC/0275/1979. The Supreme Court has dealt with and pointed out with reasons the distinction between negligence in civil law and in criminal law. Their Lordships have opined that there is a marked difference as to the effect of evidence, viz. the proof, in civil and criminal proceedings. In civil proceedings, a mere preponderance of probability is sufficient, and the defendant is not necessarily entitled to the benefit of every reasonable doubt; but in criminal proceedings, the persuasion of guilt must amount to such a moral certainty as convinces the mind of the Court, as a reasonable man, beyond all reasonable doubt. Where negligence is an essential ingredient of the offence, the negligence to be established by the prosecution must be culpable or gross and not the negligence merely based upon an error of judgment.

17. Law laid down by Straight, J. in the case Reg v. Idu Beg (1881) 3 All. 776, has been held good in cases and noticed in Bhalchandra Waman Pathe v. State of Maharashtra 1968 Mh.L.J. 423 — a three-Judge Bench decision of this Court. It has been held that while negligence is an omission to do something which a reasonable man, guided upon those considerations which ordinarily regulate the conduct of human affairs, would do, or doing something which a prudent and reasonable man would not do; criminal negligence is the gross and culpable neglect or failure to exercise that reasonable and proper care and precaution to guard against injury either to the public generally or to an individual in particular, which having regard to all the circumstances out of which the charge has arisen, it was the imperative duty of the accused person to have adopted.

18. In our opinion, the factor of grossness or degree does assume significance while drawing distinction in negligence actionable in tort and negligence punishable as a crime. To be latter, the negligence has to be gross or of a very high degree.

Negligence by professionals

19. In the law of negligence, professionals such as lawyers, doctors, architects and others are included in the category of persons professing some special skill or skilled persons generally. Any task which is required to be performed with a special skill would generally be admitted or undertaken to be performed only if the person possesses the requisite skill for performing that task. Any reasonable man entering into a profession which requires a particular level of learning to be called a professional of that branch, impliedly assures the person dealing with him that the skill which he professes to possess shall be exercised and exercised with reasonable degree of care and caution. He does not assure his client of the result. A lawyer does not tell his client that the client shall win the case in all circumstances. A physician would not assure the patient of full recovery in every case. A surgeon cannot and does not guarantee that the result of surgery would invariably be beneficial, much less to the extent of 100% for the person operated on. The only assurance which such a professional can give or can be understood to have given by implication is that he is possessed of the requisite skill in that branch of profession which he is practising and while undertaking the performance of the task entrusted to him he would be exercising his skill with reasonable competence. This is all what the person approaching the professional can expect. Judged by this standard, a professional may be held liable for negligence on one of two findings: either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise, with reasonable competence in the given case, the skill which he did possess. The standard to be applied for judging, whether the person charged has been negligent or not, would be that of an ordinary competent person exercising ordinary skill in that profession. It is not necessary for every professional to possess the highest level of expertise in that branch which he practices. In Michael Hyde and Associates v. J.D. Williams & Co. Ltd. , [2001] P.N.L.R. 233, CA, Sedley L.J. said that where a profession embraces a range of views as to what is an acceptable standard of conduct, the competence of the defendant is to be judged by the lowest standard that would be regarded as acceptable. (Charles worth & Percy, ibid, Para 8.03)

20. Oft’ quoted passage defining negligence by professionals, generally and not necessarily confined to doctors, is to be found in the opinion of McNair J. in Bolam v. Friern Hospital Management Committee, [1957] 1 W.L.R. 582, 586 in the following words:

[quote align=”center” color=”#999999″]
“Where you get a situation which involves the use of some special skill or competence, then the test as to whether there has been negligence or not is not the test of the 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 special skill . . . A man need not possess the highest expert skill; it is well established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art.” (Charles worth & Percy, ibid, Para 8.02) .[/quote]

21. The water of Bolam test has ever since flown and passed under several bridges, having been cited and dealt with in several judicial pronouncements, one after the other and has continued to be well received by every shore it has touched as neat, clean and well-condensed one. After a review of various authorities Bingham L.J. in his speech in Eckersley v. Binnie, [1988] 18 Con.L.R. 1, 79 summarised the Bolam test in the following words:-

“From these general statements it follows that a professional man should command the corpus of knowledge which forms part of the professional equipment of the ordinary member of his profession. He should not lag behind other ordinary assiduous and intelligent members of his profession in knowledge of new advances, discoveries and developments in his field. He should have such an awareness as an ordinarily competent practitioner would have of the deficiencies in his knowledge and the limitations on his skill. He should be alert to the hazards and risks in any professional task he undertakes to the extent that other ordinarily competent members of the profession would be alert. He must bring to any professional task he undertakes no less expertise, skill and care than other ordinarily competent members of his profession would bring, but need bring no more. The standard is that of the reasonable average. The law does not require of a professional man that he be a paragon combining the qualities of polymath and prophet.” (Charles worth & Percy, ibid, Para 8.04)

22. The degree of skill and care required by a medical practitioner is so stated in Halsbury’s Laws of England (Fourth Edition, Vol.30, Para 35):-
“The practitioner must bring to his task a reasonable degree of skill and knowledge, and must exercise a reasonable degree of care. 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, and a person is not liable in negligence because someone else of greater skill and knowledge would have prescribed different treatment or operated in a different way; nor is he guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art, even though a body of adverse opinion also existed among medical men.

Deviation from normal practice is not necessarily evidence of negligence. To establish liability on that basis it must be shown (1) that there is a usual and normal practice; (2) that the defendant has not adopted it; and (3) that the course in fact adopted is one no professional man of ordinary skill would have taken had he been acting with ordinary care.”

Abovesaid three tests, have also been stated as determinative of negligence in professional practice by Charles worth & Percy in their celebrated work on Negligence (ibid, para 8.110)

23. In the opinion of Lord Denning, as expressed in Hucks v. Cole, [1968] 118 New LJ 469, a medical practitioner was not to be held liable simply because things went wrong from mischance or misadventure or through an error of judgment in choosing one reasonable course of treatment in preference of another. A medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field.

24. The decision of House of Lords in Maynard v. West Midlands Regional Health Authority, [1985] 1 All ER 635 (HL) by a Bench consisting of five Law Lords has been accepted as having settled the law on the point by holding that it is not enough to show that there is a body of competent professional opinion which considers that decision of the defendant professional was a wrong decision, if there also exists a body of professional opinion, equally competent, which supports the decision as reasonable in the circumstances. It is not enough to show that subsequent events show that the operation need never have been performed, if at the time the decision to operate was taken, it was reasonable, in the sense that a responsible body of medical opinion would have accepted it as proper. Lord Scarman who recorded the leading speech with which other four Lords agreed quoted the following words of Lord President (Clyde) in Hunter v. Hanley 1955 SLT 213 at 217, observing that the words cannot be bettered – “In the realm of diagnosis and treatment there is ample scope for genuine difference of opinion and one man clearly is not negligent merely because his conclusion differs from that of other professional men…The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of if acting with ordinary care…”. Lord Scarman added – “a doctor who professes to exercise a special skill must exercise the ordinary skill of his speciality. Differences of opinion and practice exist, and will always exist, in the medical as in other professions. There is seldom any one answer exclusive of all others to problems of professional judgment. A court may prefer one body of opinion to the other, but that is no basis for a conclusion of negligence.” His Lordship further added “that a judge’s ‘preference’ for one body of distinguished professional opinion to another also professionally distinguished is not sufficient to establish negligence in a practitioner whose actions have received the seal of approval of those whose opinions, truthfully expressed, honestly held, were not preferred.”

25. The classical statement of law in Bolam’s case has been widely accepted as decisive of the standard of care required both of professional men generally and medical practitioners in particular. It has been invariably cited with approval before Courts in India and applied to as touchstone to test the pleas of medical negligence. In tort, it is enough for the defendant to show that the standard of care and the skill attained was that of the ordinary competent medical practitioner exercising an ordinary degree of professional skill. The fact that a defendant charged with negligence acted in accord with the general and approved practice is enough to clear him of the charge. Two things are pertinent to be noted. Firstly, the standard of care, when assessing the practice as adopted, is judged in the light of knowledge available at the time (of the incident), and not at the date of trial. Secondly, when the charge of negligence arises out of failure to use some particular equipment, the charge would fail if the equipment was not generally available at that point of time on which it is suggested as should have been used.

26. A mere deviation from normal professional practice is not necessarily evidence of negligence. Let it also be noted that a mere accident is not evidence of negligence. So also an error of judgment on the part of a professional is not negligence per se. Higher the acuteness in emergency and higher the complication, more are the chances of error of judgment. At times, the professional is confronted with making a choice between the devil and the deep sea and he has to choose the lesser evil. The medical professional is often called upon to adopt a procedure which involves higher element of risk, but which he honestly believes as providing greater chances of success for the patient rather than a procedure involving lesser risk but higher chances of failure. Which course is more appropriate to follow, would depend on the facts and circumstances of a given case. The usual practice prevalent nowadays is to obtain the consent of the patient or of the person incharge of the patient if the patient is not be in a position to give consent before adopting a given procedure. So long as it can be found that the procedure which was in fact adopted was one which was acceptable to medical science as on that date, the medical practitioner cannot be held negligent merely because he chose to follow one procedure and not another and the result was a failure.

27. No sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient as the professional reputation of the person is at stake. A single failure may cost him dear in his career. Even in civil jurisdiction, the rule of res ipsa loquitur is not of universal application and has to be applied with extreme care and caution to the cases of professional negligence and in particular that of the doctors. Else it would be counter productive. Simply because a patient has not favourably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per se by applying the doctrine of res ipsa loquitur.

28. Res ipsa loquitur is a rule of evidence which in reality belongs to the law of torts. Inference as to negligence may be drawn from proved circumstances by applying the rule if the cause of the accident is unknown and no reasonable explanation as to the cause is coming forth from the defendant. In criminal proceedings, the burden of proving negligence as an essential ingredient of the offence lies on the prosecution. Such ingredient cannot be said to have been proved or made out by resorting to the said rule (See Syad Akbar v. State of Karnataka MANU/SC/0275/1979.
Incidentally, it may be noted that in Krishnan and Anr. v. State of Kerala MANU/SC/0106/1997 the Court has observed that there may be a case where the proved facts would themselves speak of sharing of common intention and while making such observation one of the learned judges constituting the Bench has in his concurring opinion merely stated ‘res ipsa loquitur’. Nowhere it has been stated that the rule has applicability in a criminal case and an inference as to an essential ingredient of an offence can be found proved by resorting to the said rule. In our opinion, a case under Section 304A IPC cannot be decided solely by applying the rule of res ipsa loquitur.

29. A medical practitioner faced with an emergency ordinarily tries his best to redeem the patient out of his suffering. He does not gain anything by acting with negligence or by omitting to do an act. Obviously, therefore, it will be for the complainant to clearly make out a case of negligence before a medical practitioner is charged with or proceeded against criminally. A surgeon with shaky hands under fear of legal action cannot perform a successful operation and a quivering physician cannot administer the end-dose of medicine to his patient.

30. If the hands be trembling with the dangling fear of facing a criminal prosecution in the event of failure for whatever reason–whether attributable to himself or not, neither a surgeon can successfully wield his life-saving scalper to perform an essential surgery, nor can a physician successfully administer the life-saving dose of medicine. Discretion being better part of valour, a medical professional would feel better advised to leave a terminal patient to his own fate in the case of emergency where the chance of success may be 10% (or so), rather than taking the risk of making a last ditch effort towards saving the subject and facing a criminal prosecution if his effort fails. Such timidity forced upon a doctor would be a disservice to the society.

31. The purpose of holding a professional liable for his act or omission, if negligent, is to make the life safer and to eliminate the possibility of recurrence of negligence in future. Human body and medical science — both are too complex to be easily understood. To hold in favour of existence of negligence, associated with the action or inaction of a medical professional, requires an in-depth understanding of the working of a professional as also the nature of the job and of errors committed by chance, which do not necessarily involve the element of culpability.

32. The subject of negligence in the context of medical profession necessarily calls for treatment with a difference. Several relevant considerations in this regard are found mentioned by Alan Merry and Alexander McCall Smith in their work “Errors, Medicine and the Law” (Cambridge University Press, 2001). There is a marked tendency to look for a human actor to blame for an untoward event – a tendency which is closely linked with the desire to punish. Things have gone wrong and, therefore, somebody must be found to answer for it. To draw a distinction between the blameworthy and the blameless, the notion of mens rea has to be elaborately understood. An empirical study would reveal that the background to a mishap is frequently far more complex than may generally be assumed. It can be demonstrated that actual blame for the outcome has to be attributed with great caution. For a medical accident or failure, the responsibility may lie with the medical practitioner and equally it may not. The inadequacies of the system, the specific circumstances of the case, the nature of human psychology itself and sheer chance may have combined to produce a result in which the doctor’s contribution is either relatively or completely blameless. Human body and its working is nothing less than a highly complex machine. Coupled with the complexities of medical science, the scope for misimpressions, misgivings and misplaced allegations against the operator i.e. the doctor, cannot be ruled out. One may have notions of best or ideal practice which are different from the reality of how medical practice is carried on or how in real life the doctor functions. The factors of pressing need and limited resources cannot be ruled out from consideration. Dealing with a case of medical negligence needs a deeper understanding of the practical side of medicine.

33. At least three weighty considerations can be pointed out which any forum trying the issue of medical negligence in any jurisdiction must keep in mind. These are: (i) that legal and disciplinary procedures should be properly founded on firm, moral and scientific grounds; (ii) that patients will be better served if the real causes of harm are properly identified and appropriately acted upon; and (iii) that many incidents involve a contribution from more than one person, and the tendency is to blame the last identifiable element in the chain of causation – the person holding the ‘smoking gun’.

34. Accident during the course of medical or surgical treatment has a wider meaning. Ordinarily, an accident means an unintended and unforeseen injurious occurrence; something that does not occur in the usual course of events or that could not be reasonably anticipated (See, Black’s Law Dictionary, 7th Edition). Care has to be taken to see that the result of an accident which is exculpatory may not persuade the human mind to confuse it with the consequence of negligence.

Medical Professionals in Criminal Law

35. The criminal law has invariably placed the medical professionals on a pedestal different from ordinary mortals. The Indian Penal Code enacted as far back as in the year 1860 sets out a few vocal examples. Section 88 in the Chapter on General Exceptions provides exemption for acts not intended to cause death, done by consent in good faith for person’s benefit. Section 92 provides for exemption for acts done in good faith for the benefit of a person without his consent though the acts cause harm to a person and that person has not consented to suffer such harm. There are four exceptions listed in the Section which is not necessary in this context to deal with. Section 93 saves from criminality certain communications made in good faith. To these provisions are appended the following illustrations:-

Section 88

A, a surgeon, knowing that a particular operation is likely to cause the death of Z, who suffers under a painful complaint, but not intending to cause Z’s death and intending in good faith, Z’s benefit, performs that operation on Z, with Z’s consent. A has committed no offence.

Section 92

Z is thrown from his horse, and is insensible. A, a surgeon, finds that Z requires to be trepanned. A, not intending Z’s death, but in good faith, for Z’s benefit, performs the trepan before Z recovers his power of judging for himself. A has committed no offence.

A, a surgeon, sees a child suffer an accident which is likely to prove fatal unless an operation be immediately performed. There is no time to apply to the child’s guardian. A performs the operation in spite of the entreaties of the child, intending, in good faith, the child’s benefit. A has committed no offence.

Section 93

A, a surgeon, in good faith, communicates to a patient his opinion that he cannot live. The patient dies in consequence of the shock. A has committed no offence, though he knew it to be likely that the communication might cause the patient’s death.

36. It is interesting to note what Lord Macaulay had himself to say about Indian Penal Code. We are inclined to quote a few excerpts from his speech to the extent relevant for our purpose from “Speeches and Poems with the Report and Notes on the Indian Penal Code” by Lord Macaulay (Houghton, Mifflin and Company, published in 1874).

“Under the provisions of our Code, this case would be very differently dealt with according to circumstances. If A. kills Z. by administering abortive to her, with the knowledge that those abortive are likely to cause her death, he is guilty of voluntary culpable homicide, which will be voluntary culpable homicide by consent, if Z. agreed to run the risk, and murder if Z. did not so agree. If A causes miscarriage to Z., not intending to cause Z’s death, nor thinking it likely that he shall cause Z’s death, but so rashly or negligently as to cause her death, A. is guilty of culpable homicide not voluntary, and will be liable to the punishment provided for the causing of miscarriage, increased by imprisonment for a term not exceeding two years. Lastly, if A took such precautions that there was no reasonable probability that Z’s death would be caused, and if the medicine were rendered deadly by some accident which no human sagacity could have foreseen, or by some peculiarity in Z’s constitution such as there was no ground whatever to expect, A. will be liable to no punishment whatever on account of her death, but will of course be liable to the punishment provided for causing miscarriage.

It may be proper for us to offer some arguments in defence of this part of the Code.

It will be admitted that when an act is in itself innocent, to punish the person who does it because bad consequences, which no human wisdom could have foreseen, have followed from it, would be in the highest degree barbarous and absurd.” (P.419)
“To punish as a murderer every man who, while committing a heinous offence, causes death by pure misadventure, is a course which evidently adds nothing to the security of human life. No man can so conduct himself as to make it absolutely certain that he shall not be so unfortunate as to cause the death of a fellow-creature. The utmost that he can do is to abstain from every thing which is at all likely to cause death. No fear of punishment can make him do more than this; and therefore, to punish a man who has done this can add nothing to the security of human life. The only good effect which such punishment can produce will be to deter people from committing any of those offences which turn into murders what are in themselves mere accidents. It is in fact an addition to the punishment of those offences, and it is an addition made in the very worst way.” (p.421)

“When a person engaged in the commission of an offence causes death by rashness or negligence, but without either intending to cause death, or thinking it likely that he shall cause death, we propose that he shall be liable to the punishment of the offence which he was engaged in committing, superadded to the ordinary punishment of involuntary culpable homicide.

The arguments and illustrations which we have employed for the purpose of showing that the involuntary causing of death, without either rashness or negligence, ought, under no circumstances, to be punished at all, will, with some modifications, which will readily suggest themselves, serve to show that the involuntary causing of death by rashness or negligence, though always punishable, ought, under no circumstances to be punished as murder.” (P.422)

37. The following statement of law on criminal negligence by reference to surgeons, doctors etc. and unskillful treatment contained in Roscoe’s Law of Evidence (Fifteenth Edition) is classic:

“Where a person, acting as a medical man, &c., whether licensed or unlicensed, is so negligent in his treatment of a patient that death results, it is manslaughter if the negligence was so great as to amount to a crime, and whether or not there was such a degree of negligence is a question in each case for the jury. “In explaining to juries the test which they should apply to determine whether the negligence in the particular case amounted or did not amount to a crime, judges have used many epithets, such as ‘culpable,’ ‘criminal’, ‘gross’, ‘wicked’, ‘clear’, ‘complete.’ But whatever epithet be used and whether an epithet be used or not, in order to establish criminal liability the facts must be such that, in the opinion of the jury, the negligence of the accused went beyond a mere matter of compensation between subjects and showed such disregard for the life and safety of others as to amount to a crime against the State and conduct deserving punishment.” (p. 848-849)

[quote align=”center” color=”#999999″]

“whether he be licensed or unlicensed, if he display gross ignorance, or gross inattention, or gross rashness, in his treatment, he is criminally responsible. Where a person who, though not educated as an accoucheur, had been in the habit of acting as a man-midwife, and had unskillfully treated a woman who died in childbirth, was indicted for the murder, L. Ellenborough said that there was no evidence of murder, but the jury might convict of man-slaughter. “To substantiate that charge the prisoner must have been guilty of criminal misconduct, arising either from the grossest ignorance or the [most?] criminal inattention. One or other of these is necessary to make him guilty of that criminal negligence and misconduct which is essential to make out a case of manslaughter.” (p.849)
[/quote]

A review of Indian decisions on criminal negligence

38. We are inclined to, and we must – as duty bound, take note of some of the relevant decisions of the Privy Council and of this Court. We would like to preface this discussion with the law laid down by the Privy Council in <John Oni Akerele v. The King AIR 1943 PC 72. A duly qualified medical practitioner gave to his patient the injection of Sobita which consisted of sodium bismuth tart rate as given in the British Pharmacopoea. However, what was administered was an overdose of Sobita. The patient died. The doctor was accused of manslaughter, reckless and negligent act. He was convicted. The matter reached in appeal before the House of Lords. Their Lordships quashed the conviction. On a review of judicial opinion and an illuminating discussion on the points which are also relevant before us, what their Lordships have held can be summed up as under:-

    • That a doctor is not criminally responsible for a patient’s death unless his negligence or incompetence went beyond a mere matter of compensation between subjects and showed such disregard for life and safety of others as to amount to a crime against the State.;
    • That the degree of negligence required is that it should be gross, and that neither a jury nor a court can transform negligence of a lesser degree into gross negligence merely by giving it that appellation…. There is a difference in kind between the negligence which gives a right to compensation and the negligence which is a crime.
    • It is impossible to define culpable or criminal negligence, and it is not possible to make the distinction between actionable negligence and criminal negligence intelligible, except by means of illustrations drawn from actual judicial opinion….The most favourable view of the conduct of an accused medical man has to be taken, for it would be most fatal to the efficiency of the medical profession if no one could administer medicine without a halter round his neck.”

(emphasis supplied)
Their Lordships refused to accept the view that criminal negligence was proved merely because a number of persons were made gravely ill after receiving an injection of Sobita from the appellant coupled with a finding that a high degree of care was not exercised. Their Lordships also refused to agree with the thought that merely because too strong a mixture was dispensed once and a number of persons were made gravely ill, a criminal degree of negligence was proved.

39. The question of degree has always been considered as relevant to a distinction between negligence in civil law and negligence in criminal law. In Kurban Hussein Mohamedalli Rangawalla v. State of Maharashtra MANU/SC/0093/1964, while dealing with Section 304A of IPC, the following statement of law by Sir Lawrence Jenkins in Emperor v. Omkar Rampratap 4 Bom LR 679, was cited with approval:-
“To impose criminal liability under Section 304A, Indian Penal Code, it is necessary that the death should have been the direct result of a rash and negligent act of the accused, and that act must be the proximate and efficient cause without the intervention of another’s negligence. It must be the causa causans; it is not enough that it may have been the causa sine qua non.”

40. K.N. Wanchoo, J. (as he then was), speaking for the Court, observed that the abovesaid view of the law has been generally followed by High Courts in India and was the correct view to take of the meaning of Section 304A. The same view has been reiterated in Kishan Chand and Anr. v. The State of Haryanav (1970) 3 SCC 904.

41. In Juggankhan v. The State of Madhya Pradesh, the accused, a registered Homoeopath, administered 24 drops of stramonium and a leaf of datur to the patient suffering from guinea worm. The accused had not studied the effect of such substances being administered to a human being. The poisonous contents of the leaf of , were not satisfactorily established by the prosecution. This Court exonerated the accused of the charge under Section 302 IPC. However, on a finding that stramonium and dhatura leaves are poisonous and in no system of medicine, except perhaps Ayurvedic system, the dhatura leaf is given as cure for guinea worm, the act of the accused who prescribed poisonous material without studying their probable effect was held to be a rash and negligent act. It would be seen that the profession of a Homoeopath which the accused claimed to profess did not permit use of the substance administered to the patient. The accused had no knowledge of the effect of such substance being administered and yet he did so. In this background, the inference of the accused being guilty of rash and negligent act was drawn against him. In our opinion, the principle which emerges is that a doctor who administers a medicine known to or used in a particular branch of medical profession impliedly declares that he has knowledge of that branch of science and if he does not, in fact, possess that knowledge, he is prima facie acting with rashness or negligence.

42. Dr. Laxman Balkrishna Joshi v. Dr. Trimbak Bapu Godbole and Anr. was a case under Fatal Accidents Act, 1855. It does not make a reference to any other decided case. The duties which a doctor owes to his patients came up for consideration. The Court held that a person who holds himself out ready to give medical advice and treatment impliedly undertakes that he is possessed of skill and knowledge for that purpose. Such a person when consulted by a patient owes him certain duties, viz., a duty of care in deciding whether to undertake the case, a duty of care in deciding what treatment to be given or a duty of care in the administration of that treatment. A breach of any of those duties gives a right of action for negligence to the patient. The practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. 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. The doctor no doubt has a discretion in choosing treatment which he proposes to give to the patient and such discretion is relatively ampler in cases of emergency. In this case, the death of patient was caused due to shock resulting from reduction of the fracture attempted by doctor without taking the elementary caution of giving anaesthetic to the patient. The doctor was held guilty of negligence and liability for damages in civil law. We hasten to add that criminal negligence or liability under criminal law was not an issue before the Court –as it did not arise and hence was not considered.

43. In the year 1996, there are 3 reported decisions available. Indian Medical Association v. V.P. Shantha and Ors. is a three-Judge Bench decision. The principal issue which arose for decision by the Court was whether a medical practitioner renders ‘service’ and can be proceeded against for ‘deficiency in service’ before a forum under the Consumer Protection Act, 1986. The Court dealt with how a ‘profession’ differs from an ‘occupation’ especially in the context of performance of duties and hence the occurrence of negligence. The Court noticed that medical professionals do not enjoy any immunity from being sued in contract or tort (i.e. in civil jurisdiction) on the ground of negligence. However, in the observation made in the context of determining professional liability as distinguished from occupational liability, the Court has referred to authorities, in particular, Jackson & Powell and have so stated the principles, partly quoted from the authorities :-

“In the matter of professional liability professions differ from occupations for the reason that professions operate in spheres where success cannot be achieved in every case and very often success or failure depends upon factors beyond the professional man’s control. In devising a rational approach to professional liability which must provide proper protection to the consumer while allowing for the factors mentioned above, the approach of the Courts is to require that professional men should possess a certain minimum degree of competence and that they should exercise reasonable care in the discharge of their duties. In general, a professional man owes to his client a duty in tort as well as in contract to exercise reasonable care in giving advice or performing services. (See : Jackson & Powell on Professional Negligence, 3rd Edn., paras 1-04, 1-05, and 1-56).”

44. In Poonam Verma v. Ashwin Patel and Ors. , a doctor registered as medical practitioner and entitled to practice in Homoeopathy only, prescribed an allopathic medicine to the patient. The patient died. The doctor was held to be negligent and liable to compensate the wife of the deceased for the death of her husband on the ground that the doctor who was entitled to practice in homoeopathy only, was under a statutory duty not to enter the field of any other system of medicine and since he trespassed into a prohibited field and prescribed the allopathic medicine to the patient causing the death, his conduct amounted to negligence per se actionable in civil law. Dr. Laxman Balkrishna Joshi’s case (supra) was followed. Vide para 16, the test for determining whether there was negligence on the part of a medical practitioner as laid down in Bolam’s case (supra) was cited and approved.

45. In Achutrao Haribhau Khodwa and Ors. v. State of Maharashtra and Ors. the Court noticed that in the very nature of medical profession, skills differs from doctor to doctor and more than one alternative course of treatment are available, all admissible. Negligence cannot be attributed to a doctor so long as he is performing his duties to the best of his ability and with due care and caution. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the medical profession. It was a case where a mop was left inside the lady patient’s abdomen during an operation. Peritonitis developed which led to a second surgery being performed on her, but she could not survive. Liability for negligence was fastened on the surgeon because no valid explanation was forthcoming for the mop having been left inside the abdomen of the lady. The doctrine of res ipsa loquitur was held applicable ‘in a case like this’.

46. Spring Meadows Hospital and Anr. v. Harjol Ahluwalia through K.S. Ahluwalia and Anr. is again a case of liability for negligence by a medical professional in civil law. It was held that an error of judgment is not necessarily negligence. The Court referred to the decision in Whitehouse & Jorden, [1981] 1 ALL ER 267, and cited with approval the following statement of law contained in the opinion of Lord Fraser determining when an error of judgment can be termed as negligence:-
“The true position is that an error of judgment may, or may not, be negligent, it depends on the nature of the error. If it is one that would not have been made by a reasonably competent professional man professing to have the standard and type of skill that the defendant holds himself out as having, and acting with ordinary care, then it is negligence. If, on the other hand, it is an error that such a man, acting with ordinary care, might have made, then it is not negligence.”

47. In State of Haryana and Ors. v. Smt. Santra also Bolam’s test has been approved. This case too refers to liability for compensation under civil law for failure of sterilisation operation performed by a surgeon. We are not dealing with that situation in the case before us and, therefore, leave it to be dealt within an appropriate case.

48. Before we embark upon summing up our conclusions on the several issues of law which we have dealt with hereinabove, we are inclined to quote some of the conclusions arrived at by the learned authors of “Errors, Medicine and the Law” (pp. 241-248), (recorded at the end of the book in the chapter titled – ‘Conclusion’) highlighting the link between moral fault, blame and justice in reference to medical profession and negligence. These are of significance and relevant to the issues before us. Hence we quote :-
(i) The social efficacy of blame and related sanctions in particular cases of deliberate wrongdoings may be a matter of dispute, but their necessity – in principle – from a moral point of view, has been accepted. Distasteful as punishment may be, the social, and possibly moral, need to punish people for wrongdoing, occasionally in a severe fashion, cannot be escaped. A society in which blame is overemphasized may become paralysed. This is not only because such a society will inevitably be backward-looking, but also because fear of blame inhibits the uncluttered exercise of judgment in relations between persons. If we are constantly concerned about whether our actions will be the subject of complaint, and that such complaint is likely to lead to legal action or disciplinary proceedings, a relationship of suspicious formality between persons is inevitable. (ibid, pp. 242-243)
(ii) Culpability may attach to the consequence of an error in circumstances where substandard antecedent conduct has been deliberate, and has contributed to the generation of the error or to its outcome. In case of errors, the only failure is a failure defined in terms of the normative standard of what should have been done. There is a tendency to confuse the reasonable person with the error-free person. While nobody can avoid errors on the basis of simply choosing not to make them, people can choose not to commit violations. A violation is culpable. (ibid, p. 245).
(iii) Before the court faced with deciding the cases of professional negligence there are two sets of interests which are at stake : the interests of the plaintiff and the interests of the defendant. A correct balance of these two sets of interests should ensure that tort liability is restricted to those cases where there is a real failure to behave as a reasonably competent practitioner would have behaved. An inappropriate raising of the standard of care threatens this balance. (ibid, p.246). A consequence of encouraging litigation for loss is to persuade the public that all loss encountered in a medical context is the result of the failure of somebody in the system to provide the level of care to which the patient is entitled. The effect of this on the doctor-patient relationship is distorting and will not be to the benefit of the patient in the long run. It is also unjustified to impose on those engaged in medical treatment an undue degree of additional stress and anxiety in the conduct of their profession. Equally, it would be wrong to impose such stress and anxiety on any other person performing a demanding function in society. (ibid, p.247). While expectations from the professionals must be realistic and the expected standards attainable, this implies recognition of the nature of ordinary human error and human limitations in the performance of complex tasks. (ibid, p. 247).
(iv) Conviction for any substantial criminal offence requires that the accused person should have acted with a morally blameworthy state of mind. Recklessness and deliberate wrongdoing, are morally blameworthy, but any conduct falling short of that should not be the subject of criminal liability. Common-law systems have traditionally only made negligence the subject of criminal sanction when the level of negligence has been high – a standard traditionally described as gross negligence. In fact, negligence at that level is likely to be indistinguishable from recklessness. (ibid, p.248).
(v) Blame is a powerful weapon. Its inappropriate use distorts tolerant and constructive relations between people. Distinguishing between (a) accidents which are life’s misfortune for which nobody is morally responsible, (b) wrongs amounting to culpable conduct and constituting grounds for compensation, and (c) those (i.e. wrongs) calling for punishment on account of being gross or of a very high degree requires and calls for careful, morally sensitive and scientifically informed analysis; else there would be injustice to the larger interest of the society, (ibid, p. 248).
Indiscriminate prosecution of medical professionals for criminal negligence is counter-productive and does no service or good to the society.

Conclusions summed up

49. We sum up our conclusions as under:-

    • Negligence is the breach of a duty caused by omission to do something which a reasonable man guided by those considerations which ordinarily regulate the conduct of human affairs would do, or doing something which a prudent and reasonable man would not do. The definition of negligence as given in Law of Torts, Ratanlal & Dhirajlal (edited by Justice G.P. Singh), referred to hereinabove, holds good. Negligence becomes actionable on account of injury resulting from the act or omission amounting to negligence attributable to the person sued. The essential components of negligence are three: ‘duty’, ‘breach’ and ‘resulting damage’.
    • Negligence in the context of medical profession necessarily calls for a treatment with a difference. To infer rashness or negligence on the part of a professional, in particular a doctor, additional considerations apply. A case of occupational negligence is different from one of professional negligence. A simple lack of care, an error of judgment or an accident, is not proof of negligence on the part of a medical professional. So long as a doctor follows a practice acceptable to the medical profession of that day, he cannot be held liable for negligence merely because a better alternative course or method of treatment was also available or simply because a more skilled doctor would not have chosen to follow or resort to that practice or procedure which the accused followed. When it comes to the failure of taking precautions what has to be seen is whether those precautions were taken which the ordinary experience of men has found to be sufficient; a failure to use special or extraordinary precautions which might have prevented the particular happening cannot be the standard for judging the alleged negligence. So also, the standard of care, while assessing the practice as adopted, is judged in the light of knowledge available at the time of the incident, and not at the date of trial. Similarly, when the charge of negligence arises out of failure to use some particular equipment, the charge would fail if the equipment was not generally available at that particular time (that is, the time of the incident) at which it is suggested it should have been used.
    • A professional may be held liable for negligence on one of the two findings: either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise, with reasonable competence in the given case, the skill which he did possess. The standard to be applied for judging, whether the person charged has been negligent or not, would be that of an ordinary competent person exercising ordinary skill in that profession. It is not possible for every professional to possess the highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities, but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence.
    • The test for determining medical negligence as laid down in Bolam’s case [1957] 1 W.L.R. 582, 586 holds good in its applicability in India.
    • The jurisprudential concept of negligence differs in civil and criminal law. What may be negligence in civil law may not necessarily be negligence in criminal law. For negligence to amount to an offence, the element of mens rea must be shown to exist. For an act to amount to criminal negligence, the degree of negligence should be much higher i.e. gross or of a very high degree. Negligence which is neither gross nor of a higher degree may provide a ground for action in civil law but cannot form the basis for prosecution.
    • The word ‘gross’ has not been used in Section 304A of IPC, yet it is settled that in criminal law negligence or recklessness, to be so held, must be of such a high degree as to be ‘gross’. The expression ‘rash or negligent act’ as occurring in Section 304A of the IPC has to be read as qualified by the word ‘grossly’.
    • To prosecute a medical professional for negligence under criminal law it must be shown that the accused did something or failed to do something which in the given facts and circumstances no medical professional in his ordinary senses and prudence would have done or failed to do. The hazard taken by the accused doctor should be of such a nature that the injury which resulted was most likely imminent.
    • Res ipsa loquitur is only a rule of evidence and operates in the domain of civil law specially in cases of torts and helps in determining the onus of proof in actions relating to negligence. It cannot be pressed in service for determining per se the liability for negligence within the domain of criminal law. Res ipsa loquitur has, if at all, a limited application in trial on a charge of criminal negligence.
    • 50. In view of the principles laid down hereinabove and the preceding discussion, we agree with the principles of law laid down in Dr. Suresh Gupta’s case and re-affirm the same. Ex abundanti cautela, we clarify that what we are affirming are the legal principles laid down and the law as stated in Dr. Suresh Gupta’s case. We may not be understood as having expressed any opinion on the question whether on the facts of that case the accused could or could not have been held guilty of criminal negligence as that question is not before us. We also approve of the passage from Errors, Medicine and the Law by Alan Merry and Alexander McCall Smith which has been cited with approval in Dr. Suresh Gupta’s case (noted vide para 27 of the report).

      Guidelines – re: prosecuting medical professionals

      51. As we have noticed hereinabove that the cases of doctors (surgeons and physicians) being subjected to criminal prosecution are on an increase. Sometimes such prosecutions are filed by private complainants and sometimes by police on an FIR being lodged and cognizance taken. The investigating officer and the private complainant cannot always be supposed to have knowledge of medical science so as to determine whether the act of the accused medical professional amounts to rash or negligent act within the domain of criminal law under Section 304A of IPC. The criminal process once initiated subjects the medical professional to serious embarrassment and sometimes harassment. He has to seek bail to escape arrest, which may or may not be granted to him. At the end he may be exonerated by acquittal or discharge but the loss which he has suffered in his reputation cannot be compensated by any standards.

      52. We may not be understood as holding that doctors can never be prosecuted for an offence of which rashness or negligence is an essential ingredient. All that we are doing is to emphasize the need for care and caution in the interest of society; for, the service which the medical profession renders to human beings is probably the noblest of all, and hence there is a need for protecting doctors from frivolous or unjust prosecutions. Many a complainant prefers recourse to criminal process as a tool for pressurizing the medical professional for extracting uncalled for or unjust compensation. Such malicious proceedings have to be guarded against.

      53. Statutory Rules or Executive Instructions incorporating certain guidelines need to be framed and issued by the Government of India and/or the State Governments in consultation with the Medical Council of India. So long as it is not done, we propose to lay down certain guidelines for the future which should govern the prosecution of doctors for offences of which criminal rashness or criminal negligence is an ingredient. A private complaint may not be entertained unless the complainant has produced prima facie evidence before the Court in the form of a credible opinion given by another competent doctor to support the charge of rashness or negligence on the part of the accused doctor. The investigating officer should, before proceeding against the doctor accused of rash or negligent act or omission, 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’s test to the facts collected in the investigation. A doctor accused of rashness or negligence, may not be arrested in a routine manner (simply because a charge has been leveled against him). Unless his arrest is necessary for furthering the investigation or for collecting evidence or unless the investigation officer feels satisfied that the doctor proceeded against would not make himself available to face the prosecution unless arrested, the arrest may be withheld.

      Case at hand

      54. Reverting back to the facts of the case before us, we are satisfied that all the averments made in the complaint, even if held to be proved, do not make out a case of criminal rashness or negligence on the part of the accused appellant. It is not the case of the complainant that the accused-appellant was not a doctor qualified to treat the patient whom he agreed to treat. It is a case of non-availability of oxygen cylinder either because of the hospital having failed to keep available a gas cylinder or because of the gas cylinder being found empty. Then, probably the hospital may be liable in civil law (or may not be — we express no opinion thereon) but the accused appellant cannot be proceeded against under Section 304A IPC on the parameters of Bolam’s test………….”
      This landmark case crystallized the law relating to criminal consequences of medical negligence to a large extent. A subsequent case where the Supreme Court referred to Jacob Matthew’s case (supra) and gently reminded the medical community about its primary duties is that of State of Punjab v. Shiv Ram & Ors. (2005) 7 SCC 1. This case is important because the Court was trying to convey a message to the medical community and the government, which though given way back in August 2005 is relevant even today as the Court’s appeal seems to have fallen on deaf years. Some of the important observations of the Supreme Court are as under:

      “…….23. We have decided the question of law and held that the decree awarding the damages was totally uncalled for and had no foundation in law, and therefore, has to be set aside. The present case is an occasion, which we would like to utilize for the purpose of making certain observations on three related topics noted hereunder.

      (1) Jacob Mathew’s case: a post script

      24. In Jacob Mathew this Court dealt with the liability of a medical practitioner in criminal law. Of course, the decision also discussed in detail the law of medical negligence in general and indicated the parameters of fixing liability. The distinction between the concept of negligence in civil law and negligence in criminal law was highlighted. The present case deals with the law of negligence in tort. The basis of liability of a professional in tort is negligence. Unless that negligence is established, the primary liability cannot be fastened on the medical practitioner. Unless the primary liability is established, vicarious liability on the State cannot be imposed. Both in criminal jurisprudence and in civil jurisprudence, doctors are liable for consequences of negligence. In Jacob Mathew even while dealing with criminal negligence, this Court has indicated the caution needed in approaching a case of medical negligence having regard to the complexity of the human body which is subjected to treatment and the uncertainty involved in medical procedures. A doctor, in essence, needs to be inventive and has to take snap decisions especially in the course of performing surgery when some unexpected problems crop up or complication sets in. If the medical profession, as a whole, is hemmed in by threat of action, criminal and civil, the consequence will be loss to the patients. No doctor would take a risk, a justifiable risk in the circumstances of a given case, and try to save his patient from a complicated disease or in the face of an unexpected problem that confronts him during the treatment or the surgery. It is in this background that this Court has cautioned that the setting in motion of the criminal law against the medical profession should be done cautiously and on the basis of reasonably sure grounds. In criminal prosecutions or claims in tort, the burden always rests with the prosecution or the claimant. No doubt, in a given case, a doctor may be obliged to explain his conduct depending on the evidence adduced by the prosecution or by the claimant. That position does not change merely because of the caution advocated in Jacob Mathew in fixing liability for negligence, on doctors.

      (2) How the medical profession ought to respond

      25. Medical profession is one of the oldest professions of the world and is the most humanitarian one. There is no better service than to serve the suffering, wounded and the sick. Inherent in the concept of any profession is a code of conduct, containing the basic ethics that underline the moral values that govern professional practice and is aimed at upholding its dignity. Medical Ethics underpins the values at the heart of the practitioner-client relationship. In the recent times, professionals are developing a tendency to forget that the self-regulation which is at the heart of their profession is a privilege and not a right and a profession obtains this privilege in return for an implicit contract with society to provide good, competent and accountable service to the public. It must always be kept in mind that doctor’s is a noble profession and the aim must be to serve humanity, otherwise this dignified profession will lose its true worth.

      26. Medical profession has long subscribed to a body of ethical statements developed primarily for the benefit of the patient. The oldest expression of this basic principle comes from Hippocrates, an early Greek Physician, born in 460 B.C. who came to be known as the “Father of Medicine” and had devoted his entire life to the advancement of medical science. He formulated a code of conduct in the form of the Hippocratic Oath, as he realized that knowledge and skill were not enough for a physician without a code of standards and ideals. He coined an oath of integrity for physicians, a code of standards and ideals to which they must swear to adhere in the practice of their profession. This continues till date to be the oath administered to doctors when they join the profession:

      [quote align=”center” color=”#999999″]
      “I swear by Apollo the physician, by Fsculapius, Hygeia, and Panacea, and I take to witness all the gods, all the goddesses, to keep according to my ability and my judgement, the following Oath.
      To consider dear to me as my parents him who taught me this art; to live in common with him and if necessary to share my goods with him; to look upon his children as my own brothers, to teach them this art if they so desire without fee or written promise; to impart to my sons and the sons of the master who taught me and the disciples who have enrolled themselves and have agreed to the rules of the profession, but to these alone the precepts and the instruction. I will prescribe regimens for the good of my patients according to my ability and my judgement and never do harm to anyone. To please no one will I prescribe a deadly drug nor give advice which may cause his death. Nor will I give a woman a peccary to procure abortion. But I will preserve the purity of my life and my art. I will not cut for stone, even for patients in whom the disease is manifest; I will leave this operation to be performed by practitioners, specialists in this art. In every house where I come I will enter only for the good of my patients, keeping myself far from all intentional ill-doing and all seduction and especially from the pleasures of love with women or with men, be they free or slaves. All that may come to my knowledge in the exercise of my profession or in daily commerce with men, which ought not to be spread abroad, I will keep secret and will never reveal. If I keep this oath faithfully, may I enjoy my life and practice my art, respected by all men and in all times; but if I swerve from it or violate it, may the reverse be my lot.”
      .[/quote]

      27. Many versions of Hippocratic Oath are prevalent. “Light From Many Lamps” a book edited by Lilian Eichler Watson contains a little different phraseology of that oath but certainly a beautiful commentary on the significance of the Hippocratic Oath. We would like to reproduce the oath and the commentary hereunder: (pages 181-182);

      “I do solemnly swear by that which I hold most sacred:

      That I will be loyal to the profession of medicine and just and generous to its members;

      That I will lead my life and practice my art in uprightness and honor;

      That into whatsoever house I shall enter, it shall be for the good of the sick to the utmost of my power, I holding myself aloof from wrong, from corruption, and from the temptation of others to vice;

      That I will exercise my art solely for the cure of my patients, and will give no drug, perform no operation for a criminal purpose, even if solicited, far less suggest it;

      That whatsoever I shall see or hear of the lives of men which is not fitting to be spoken, I will keep inviolably secret.

      These things I do promise, and in proportion as I am faithful to this my oath may happiness and good repute be ever mine – the opposite if I shall be forsworn.”

      [F.N.: The Hippocratic Collection, containing the best of the ancient Greek medical writings, was put together by Aristotle and has survived through the centuries. The “Hippocratic Oath” is one of the last and most inspiring passages in this Collection. There are a number of versions of the famous Oath; but the form given here is the one commonly used today; and is an adaptation of a translation from the original Greek.]

      “The medical profession is and always has been one of the most ethical of all professions; and this is due at least in part to the centuries-old influence of the Hippocratic Oath. This famous Oath has kept alive the high standards and ideals set by Hippocrates, and forms the basis of modern medical ethics.

      Written more than twenty centuries ago, the Hippocratic Oath has inspired generations of doctors … and continues to do so even now. The Oath is still administered by medical schools to graduating classes; and thousands of physicians have framed copies on their walls along with their diplomas. Conscientious practitioners continue to live up to the principles and ideals set down for their profession so long ago by the “Father of Medicine.”

      Though it was written specifically for physicians, the Hippocratic Oath sets an enduring pattern of honor, integrity, and devotion to duty for all people, in all professions.” And certainly to surgeons.”

      28. Many people argue that the original Hippocratic Oath is inappropriate in a society that has seen drastic socio-economic, political and moral changes, since the time of Hippocrates. Certain parts of the original oath such as teaching the master’s sons the secrets of medicine without fees and the promise not to bring a knife to another’s body but to leave it to ‘practitioners of the craft’ have been rendered obsolete as the modernisation of education has led to the teaching of medical science in institutions of higher learning, and specialisation in medicine has led to physicians who specialize in a variety of fields including surgery. Similarly, the legalisation on abortion and physician- assisted suicide in certain parts of the world, has made it awkward for some medical practitioners there to carry on in the tradition of the original oath.

      29. This has led to the modification of the oath to something better suited for our times. One of the most widely used versions is The Declaration of Geneva which was adopted by the General Assembly of the World Medical Association at Geneva in 1948. Written with the medical crimes committed in Nazi Germany in view, it is a ‘declaration of physicians’ dedication to the humanitarian goals of medicine.’ It is also perhaps the only one to mention treating people equally, without regard as to race, religion, social standing and political affiliations:

      [quote align=”center” color=”#999999″]
      “I solemnly pledge myself to the service of humanity. I will give to my teachers the respect and gratitude which is their due. I will practice my profession with conscience and dignity. The health of my patient will be my first consideration. I will respect the secrets which are confided in me. I will maintain by all means in my power the honour and noble traditions of the medical profession. My colleagues will be my brothers and sisters. I will not permit consideration of religion, nationality, race or social standing to intervene between my duty and my patient. I will maintain the utmost respect for human life even under threat. I will not use my medical knowledge contrary to the laws of humanity. I make these promises solemnly, freely and upon my honour.”

      [/quote]

      30. In recent times the self regulatory standards in the profession have shown a decline and this can be attributed to the overwhelming impact of commercialization of the sector. There are reports against doctors of exploitative medical practices, misuse of diagnostic procedures, brokering deals for sale of human organs, etc. It cannot be denied that black sheep have entered the profession and that the profession has been unable to isolate them effectively. The need for external regulation to supplement professional self-regulation is constantly growing. The high costs and investments involved in the delivery of medical care have made it an entrepreneurial activity wherein the professionals look to reaping maximum returns on such investment. Medical practice has always had a place of honour in society; currently the balance between service and business is shifting disturbingly towards business and this calls for improved and effective regulation, whether internal or external. There is need for introspection by doctors – individually and collectively. They must rise to the occasion and enforce discipline and high standards in the profession by assuming an active role.

      (3) Need for devising a welfare fund or insurance scheme

      31. Failure of many a sterilization operation, though successfully performed, is attributable to causes other than medical negligence as we have already discussed hereinabove. And, yet the doctors are being faced with claim for damages. Some of the claims have been decreed by the courts without arriving at any finding providing a foundation in law for upholding such a claim. The state is also being called upon to honour such decrees on the principle of vicarious liability when the surgeon has performed a surgery in discharge of his duty. Mostly such surgeries are performed on a large scale and as a part of family welfare programmes of the Government. Obviously, such programmes are in public interest. Such like decrees act as a disincentive and have deterrent effect on the surgeons performing sterilization operations. The State, flooded with such decrees is also inclined not to pursue family planning camps on large scale though in public interest.

      32. In Javed and Ors. v. State of Haryana and Ors., popularly known as ‘Two-Child Norm’ case, this Court had an occasion to deal with the problem of increasing population, the danger which it poses for the progress of the nation and equitable distribution of its resources and upheld the validity of the Haryana legislation imposing a disqualification on persons having more than two children from contesting for an elective office. The fact cannot be lost sight of that while educated persons in the society belonging to the middle-class and the upper class do voluntarily opt for family planning and are careful enough to take precautions or remedial steps to guard against the consequences of failure of sterilization, the illiterate and the ignorant and those belonging to the lower economic strata of society face the real problem. To popularize family planning programmes in such sections of society, the State Government should provide some solace to them if they, on account of their illiteracy, ignorance or carelessness, are unable to avoid the consequences of a failed sterilization operation. Towards this end, the State Governments should think of devising and making provisions for a welfare fund or taking up with the insurance companies, a proposal for devising an appropriate insurance policy or an insurance scheme, which would provide coverage for such claims where a child is born to woman who has undergone a successful sterilization operation, as in the present case…….”

      Though the above observations were given in a case arising out of a failed tubectomy operation, the observations with the passage of time seem to have taken on a wider meaning. The problems and issues alluded to by the Supreme Court as have been culled out aforesaid have with the passage of time become relevant to the medical profession as a whole. The message of the Court of self regulation, adhering to high ethical standards, providing competent and accountable service to society, checking commercialization and exploitative medical practices and keeping cost of services reasonable is most important today.

      Very often the issue of consent arises in medical malpractice claims. The case of Samira Kohli v. Dr. Prabha Manchanda & Anr. (2008) 2 SCC 1 decided by the Supreme Court is exhaustive on this issue. The Supreme Court in the above case held as under:

      “…….14. Consent in the context of a doctor-patient relationship, means the grant of permission by the patient for an act to be carried out by the doctor, such as a diagnostic, surgical or therapeutic procedure. Consent can be implied in some circumstances from the action of the patient. For example, when a patient enters a Dentist’s clinic and sits in the Dental chair, his consent is implied for examination, diagnosis and consultation. Except where consent can be clearly and obviously implied, there should be express consent. There is, however, a significant difference in the nature of express consent of the patient, known as ‘real consent’ in UK and as ‘informed consent’ in America. In UK, the elements of consent are defined with reference to the patient and a consent is considered to be valid and ‘real’ when (i) the patient gives it voluntarily without any coercion; (ii) the patient has the capacity and competence to give consent; and (iii) the patient has the minimum of adequate level of information about the nature of the procedure to which he is consenting to. On the other hand, the concept of ‘informed consent’ developed by American courts, while retaining the basic requirements consent, shifts the emphasis to the doctor’s duty to disclose the necessary information to the patient to secure his consent. ‘Informed consent’ is defined in Taber’s Cyclopedic Medical Dictionary thus:

      Consent that is given by a person after receipt of the following information : the nature and purpose of the proposed procedure or treatment; the expected outcome and the likelihood of success; the risks; the alternatives to the procedure and supporting information regarding those alternatives; and the effect of no treatment or procedure, including the effect on the prognosis and the material risks associated with no treatment. Also included are instructions concerning what should be done if the procedure turns out to be harmful or unsuccessful.

      In Canterbury v. Spence 1972 [464] Federal Reporter 2d. 772, the United States Courts of appeals, District of Columbia Circuit, emphasized the element of Doctor’s duty in ‘informed consent’ thus:

      It is well established that the physician must seek and secure his patient’s consent before commencing an operation or other course of treatment. It is also clear that the consent, to be efficacious, must be free from imposition upon the patient. It is the settled rule that therapy not authorized by the patient may amount to a tort – a common law battery – by the physician. And it is evident that it is normally impossible to obtain a consent worthy of the name unless the physician first elucidates the options and the perils for the patient’s edification. Thus the physician has long borne a duty, on pain of liability for unauthorized treatment, to make adequate disclosure to the patient.

      [Emphasis supplied]

      15. The basic principle in regard to patient’s consent may be traced to the following classic statement by Justice Cardozo in Schoendorff v. Society of New York Hospital (1914) 211 NY 125:

      Every human being of adult years and sound mind has a right to determine what should be done with his body; and a surgeon who Page 0441 performs the operation without his patient’s consent, commits an assault for which he is liable in damages.

      This principle has been accepted by English court also. In Re : F. 1989(2) All ER 545, the House of Lords while dealing with a case of sterilization of a mental patient reiterated the fundamental principle that every person’s body is inviolate and performance of a medical operation on a person without his or her consent is unlawful. The English law on this aspect is summarised thus in Principles of Medical Law (published by Oxford University Press — Second Edition, edited by Andrew Grubb, Para 3.04, Page 133):

      Any intentional touching of a person is unlawful and amounts to the tort of battery unless it is justified by consent or other lawful authority. In medical law, this means that a doctor may only carry out a medical treatment or procedure which involves contact with a patient if there exists a valid consent by the patient (or another person authorized by law to consent on his behalf) or if the touching is permitted notwithstanding the absence of consent.

      26. In India, majority of citizens requiring medical care and treatment fall below the poverty line. Most of them are illiterate or semi-literate. They cannot comprehend medical terms, concepts, and treatment procedures. They cannot Page 0449 understand the functions of various organs or the effect of removal of such organs. They do not have access to effective but costly diagnostic procedures. Poor patients lying in the corridors of hospitals after admission for want of beds or patients waiting for days on the roadside for an admission or a mere examination, is a common sight. For them, any treatment with reference to rough and ready diagnosis based on their outward symptoms and doctor’s experience or intuition is acceptable and welcome so long as it is free or cheap; and whatever the doctor decides as being in their interest, is usually unquestioningly accepted. They are a passive, ignorant and uninvolved in treatment procedures. The poor and needy face a hostile medical environment – inadequacy in the number of hospitals and beds, non-availability of adequate treatment facilities, utter lack of qualitative treatment, corruption, callousness and apathy. Many poor patients with serious ailments (eg. heart patients and cancer patients) have to wait for months for their turn even for diagnosis, and due to limited treatment facilities, many die even before their turn comes for treatment. What choice do these poor patients have? Any treatment of whatever degree, is a boon or a favour, for them. The stark reality is that for a vast majority in the country, the concepts of informed consent or any form of consent, and choice in treatment, have no meaning or relevance.

      The position of doctors in Government and charitable hospitals, who treat them, is also unenviable. They are overworked, understaffed, with little or no diagnostic or surgical facilities and limited choice of medicines and treatment procedures. They have to improvise with virtual non-existent facilities and limited dubious medicines. They are required to be committed, service oriented and non-commercial in outlook. What choice of treatment can these doctors give to the poor patients? What informed consent they can take from them?

      27. On the other hand, we have the Doctors, hospitals, nursing homes and clinics in the private commercial sector. There is a general perception among the middle class public that these private hospitals and doctors prescribe avoidable costly diagnostic procedures and medicines, and subject them to unwanted surgical procedures, for financial gain. The public feel that many doctors who have spent a crore or more for becoming a specialist, or nursing homes which have invested several crores on diagnostic and infrastructure facilities, would necessarily operate with a purely commercial and not service motive; that such doctors and hospitals would advise extensive costly treatment procedures and surgeries, where conservative or simple treatment may meet the need; and that what used to be a noble service oriented profession is slowly but steadily converting into a purely business.

      28. But unfortunately not all doctors in government hospitals are paragons of service, nor fortunately, all private hospitals/doctors are commercial minded. There are many a doctor in government hospitals who do not care about patients and unscrupulously insist upon ‘unofficial’ payment for free treatment or insist upon private consultations. On the other hand, many private hospitals and Doctors give the best of treatment without exploitation, at a reasonable cost, charging a fee, which is resonable recompense for the service rendered. Of course, some doctors, both in private practice or in government service, look at patients not as persons who should be relieved Page 0450 from pain and suffering by prompt and proper treatment at an affordable cost, but as potential income-providers/ customers who can be exploited by prolonged or radical diagnostic and treatment procedures. It is this minority who bring a bad name to the entire profession.

      29. Health care (like education) can thrive in the hands of charitable institutions. It also requires more serious attention from the State. In a developing country like ours where teeming millions of poor, downtrodden and illiterate cry out for health-care, there is a desperate need for making health-care easily accessible and affordable. Remarkable developments in the field of medicine might have revolutionalized health care. But they cannot be afforded by the common man. The woes of non-affording patients have in no way decreased. Gone are the days when any patient could go to a neighbourhood general practitioner or a family doctor and get affordable treatment at a very reasonable cost, with affection, care and concern. Their noble tribe is dwindling. Every Doctor wants to be a specialist. The proliferation of specialists and super specialists, have exhausted many a patient both financially and physically, by having to move from doctor to doctor, in search of the appropriate specialist who can identify the problem and provide treatment. What used to be competent treatment by one General Practitioner has now become multi-pronged treatment by several specialists. Law stepping in to provide remedy for negligence or deficiency in service by medical practioners, has its own twin adverse effects. More and more private doctors and hospitals have, of necessity, started playing it safe, by subjecting or requiring the patients to undergo various costly diagnostic procedures and tests to avoid any allegations of negligence, even though they might have already identified the ailment with reference to the symptoms and medical history with 90% certainly, by their knowledge and experience. Secondly more and more doctors particularly surgeons in private practice are forced to cover themselves by taking out insurance, the cost of which is also ultimately passed on to the patient, by way of a higher fee. As a consequence, it is now common that a comparatively simple ailment, which earlier used to be treated at the cost of a few rupees by consulting a single doctor, requires an expense of several hundred or thousands on account of four factors : (i) commercialization of medical treatment; (ii) increase in specialists as contrasted from general practitioners and the need for consulting more than one doctor; (iii) varied diagnostic and treatment procedures at high cost; and (iv) need for doctors to have insurance cover. The obvious, may be naove, answer to unwarranted diagnostic procedures and treatment and prohibitive cost of treatment, is an increase in the participation of health care by the state and charitable institutions. An enlightened and committed medical profession can also provide a better alternative. Be that as it may. We are not trying to intrude on matters of policy, nor are we against proper diagnosis or specialisation. We are only worried about the enormous hardship and expense to which the common man is subjected, and are merely voicing the concern of those who are not able to fend for themselves. We will be too happy if what we have observed is an overstatement, but our intuition tells us that it is an understatement.

      30. What we are considering in this case, is not the duties or obligations of doctors in government charitable hospitals where treatment is free or on Page 0451 actual cost basis. We are concerned with doctors in private practice and hospitals and nursing homes run commercially, where the relationship of doctors and patients are contractual in origin, the service is in consideration of a fee paid by the patient, where the contract implies that the professional men possessing a minimum degree of competence would exercise reasonable care in the discharge of their duties while giving advice or treatment.

      31. There is a need to keep the cost of treatment within affordable limits. Bringing in the American concepts and standards of treatment procedures and disclosure of risks, consequences and choices will inevitably bring in higher cost-structure of American medical care. Patients in India cannot afford them. People in India still have great regard and respect for Doctors. The Members of medical profession have also, by and large, shown care and concern for the patients. There is an atmosphere of trust and implicit faith in the advice given by the Doctor. The India psyche rarely questions or challenges the medical advice. Having regard to the conditions obtaining in India, as also the settled and recognized practices of medical fraternity in India, we are of the view that to nurture the doctor-patient relationship on the basis of trust, the extent and nature of information required to be given by doctors should continue to be governed by the Bolam test rather than the ‘reasonably prudential patient’ test evolved in Canterbury. It is for the doctor to decide, with reference to the condition of the patient, nature of illness, and the prevailing established practices, how much information regarding risks and consequences should be given to the patients, and how they should be couched, having the best interests of the patient. A doctor cannot be held negligent either in regard to diagnosis or treatment or in disclosing the risks involved in a particular surgical procedure or treatment, if the doctor has acted with normal care, in accordance with a recognised practices accepted as proper by a responsible body of medical men skilled in that particular field, even though there may be a body of opinion that takes a contrary view. Where there are more than one recognized school of established medical practice, it is not negligence for a doctor to follow any one of those practices, in preference to the others.

      32. We may now summarize principles relating to consent as follows:

      • A doctor has to seek and secure the consent of the patient before commencing a ‘treatment’ (the term ‘treatment’ includes surgery also). The consent so obtained should be real and valid, which means that : the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what is consenting to.
      • The ‘adequate information’ to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment as to whether he should submit himself to the particular treatment or not. This means that the Doctor should disclose (a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any available; (c) an outline of the substantial Page 0452 risks; and (d) adverse consequences of refusing treatment. But there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment which may persuade a patient to undergo a fanciful or unnecessary treatment. A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment.
      • Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. The fact that the unauthorized additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defence in an action in tort for negligence or assault and battery. The only exception to this rule is where the additional procedure though unauthorized, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorized procedure until patient regains consciousness and takes a decision.
      • There can be a common consent for diagnostic and operative procedures where they are contemplated. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery.
      • The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree mentioned in Canterbury but should be of the extent which is accepted as normal and proper by a body of medical men skilled and experienced in the particular field. It will depend upon the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the treatment.

      33. We may note here that courts in Canada and Australia have moved towards Canterbury standard of disclosure and informed consent – vide Reibl v. Hughes (1980) 114 DLR (3d.) 1 decided by the Canadian Supreme Court and Rogers v. Whittaker 1992 (109) ALR 625 decided by the High Court of Australia. Even in England there is a tendency to make the doctor’s duty to inform more stringent than Bolam’s test adopted in Sidaway. Lord Scarman’s minority view in Sidaway favouring Canterbury, in course of time, may ultimately become the law in England. A beginning has been made in Bolitho v. City and Hackney HA 1998 1 AC 232 and Pearce v. United Bristol Healthcare NHS Trust 1998 (48) BMLR 118. We have however, consciously preferred the ‘real consent’ concept evolved in Bolam and Sidaway in preference to the ‘reasonably prudent patient test’ in Canterbury, having regard to the ground realities in medical and health-care in India. But if medical practitioners and private hospitals become more and more commercialized, and if there is a corresponding increase in the awareness of patient’s rights among the Page 0453 public, inevitably, a day may come when we may have to move towards Canterbury. But not for the present……..”

      Thus while exhaustively dealing with the issue of consent, the Supreme Court in this case has once again cautioned the medical community regarding the ill effects of commercialization and decline in ethical standards as well declining medical standards. In fact the Supreme Court has indicated that in case private medical practitioners and hospitals become more commercialized the standard of obtaining consent could be made more rigorous with the patient’s right to information becoming paramount. It may be kept in mind that Regulation 7.16 of the Indian Medical Council (professional conduct, etiquette and ethics) Regulations 2002 requires that:

      “7.16 Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of minor or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed……”

      In the recent decision of Martin F. D’Souza v. Mohd. Ishfaq (2009) 3 SCC 1 the Supreme Court had an opportunity to further clarify and crystallize the law regarding medical malpractice and the criminal law. The Supreme Court has laid down important guidelines regarding (i) medical negligence, (ii) protection to doctors in criminal cases, (iii) precautions which doctors / hospitals / nursing homes should take, (iv) undertaken a review of Indian judicial precedents and (iv) framed guidelines to be followed by adjudicatory fora when dealing with medical malpractice claims. The important observations of the Supreme Court have been culled out as under:

      “…….34. The law, like medicine, is an inexact science. One cannot predict with certainty an outcome of many cases. It depends on the particular facts and circumstances of the case, and also the personal notions of the Judge concerned who is hearing the case. However, the broad and general legal principles relating to medical negligence need to be understood.

      35. Before dealing with these principles two things have to be kept in mind :

      (1) Judges are not experts in medical science, rather they are lay men. This itself often makes it somewhat difficult for them to decide cases relating to medical negligence. Moreover, Judges have usually to rely on testimonies of other doctors which may not necessarily in all cases be objective, since like in all professions and services, doctors too sometimes have a tendency to support their own colleagues who are charged with medical negligence. The testimony may also be difficult to understand, particularly in complicated medical matters, for a layman in medical matters like a Judge; and (2) A balance has to be struck in such cases. While doctors who cause death or agony due to medical negligence should certainly be penalized, it must also be remembered that like all professionals doctors too can make errors of judgment but if they are punished for this no doctor can practice his vocation with equanimity. Indiscriminate proceedings and decisions against doctors are counter productive and serve society no good. They inhibit the free exercise of judgment by a professional in a particular situation.

      36. Keeping the above two notions in mind we may discuss the broad general principles relating to medical negligence.

      General Principles Relating to Medical Negligence

      37. As already stated above, the broad general principles of medical negligence have been laid down in the Supreme Court Judgment in Jacob Mathew v. State of Punjab and Anr. (supra). However, these principles can be indicated briefly here:

      38. The basic principle relating to medical negligence is known as the BOLAM Rule. This was laid down in the judgment of Justice McNair in Bolam v. Friern Hospital Management Committee (1957) 1 WLR 582 as follows :

      Where you get a situation which involves the use of some special skill or competence, then the test as to whether there has been negligence or not is not the test of the 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 special skill. A man need not possess the highest expert skill….. It is well-established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular Article

      Bolam’s test has been approved by the Supreme Court in Jacob Mathew’s case.

      39. In Halsbury’s Laws of England the degree of skill and care required by a medical practitioner is stated as follows:

      The practitioner must bring to his task a reasonable degree of skill and knowledge, and must exercise a reasonable degree of care. 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, and a person is not liable in negligence because someone else of greater skill and knowledge would have prescribed different treatment or operated in a different way; nor is he guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art, even though a body of adverse opinion also existed among medical men.

      Deviation from normal practice is not necessarily evidence of negligence. To establish liability on that basis it must be shown (1) that there is a usual and normal practice; (2) that the defendant has not adopted it; and (3) that the course in fact adopted is one no professional man of ordinary skill would have taken had he been acting with ordinary care.

      (emphasis supplied)
      40. Eckersley v. Binnie (1988) 18 CLR 1 summarized the Bolam test in the following words:

      From these general statements it follows that a professional man should command the corpus of knowledge which forms part of the professional equipment of the ordinary member of his profession. He should not lag behind other ordinary assiduous and intelligent members of his profession in the knowledge of new advances, discoveries and developments in his field. He should have such an awareness as an ordinarily competent would have of the deficiencies in his knowledge and the limitations on his skill. He should be alert to the hazards and risks in any professional task he undertakes to the extent that other ordinarily competent members of the profession would be alert. He must bring to any professional task he undertakes no less expertise, skill and care than other ordinarily competent members of his profession would bring, but need bring no more. The standard is that of the reasonable average. The law does not require of a professional man that he be a paragon combining the qualities of a polymath and prophet.

      41. A medical practitioner is not liable to be held negligent simply because things went wrong from mischance or misadventure or through an error of judgment in choosing one reasonable course of treatment in preference to another. He would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field. For instance, he would be liable if he leaves a surgical gauze inside the patient after an operation vide Achutrao Haribhau Khodwa and Ors. v. State of Maharashtra and Ors. or operates on the wrong part of the body, and he would be also criminally liable if he operates on someone for removing an organ for illegitimate trade.

      42. There is a tendency to confuse a reasonable person with an error free person. An error of judgment may or may not be negligent. It depends on the nature of the error.

      43. It is not enough to show that there is a body of competent professional opinion which considers that the decision of the accused professional was a wrong decision, provided there also exists a body of professional opinion, equally competent, which supports the decision as reasonable in the circumstances. As Lord Clyde stated in Hunter v. Hanley 1955 SLT 213 :

      In the realm of diagnosis and treatment there is ample scope for genuine difference of opinion and one man clearly is not negligent merely because his conclusion differs from that of other professional men…. The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of if acting with ordinary care.

      44. The standard of care has to be judged in the light of knowledge available at the time of the incident and not at the date of the trial. Also, where the charge of negligence is of failure to use some particular equipment, the charge would fail if the equipment was not generally available at that point of time.

      45. The higher the acuteness in an emergency and the higher the complication, the more are the chances of error of judgment. At times, the professional is confronted with making a choice between the devil and the deep sea and has to choose the lesser evil. The doctor is often called upon to adopt a procedure which involves higher element of risk, but which he honestly believes as providing greater chances of success for the patient rather than a procedure involving lesser risk but higher chances of failure. Which course is more appropriate to follow, would depend on the facts and circumstances of a given case but a doctor cannot be penalized if he adopts the former procedure, even if it results in a failure. The usual practice prevalent nowadays is to obtain the consent of the patient or of the person in-charge of the patient if the patient is not in a position to give consent before adopting a given procedure.

      46. There may be a few cases where an exceptionally brilliant doctor performs an operation or prescribes a treatment which has never been tried before to save the life of a patient when no known method of treatment is available. If the patient dies or suffers some serious harm, should the doctor be held liable? In our opinion he should not. Science advances by experimentation, but experiments sometime end in failure e.g. the operation on the Iranian twin sisters who were joined at the head since birth, or the first heart transplant by Dr. Barnard in South Africa. However, in such cases it is advisable for the doctor to explain the situation to the patient and take his written consent.

      47. Simply because a patient has not favourably responded to a treatment given by a doctor or a surgery has failed, the doctor cannot be held straightway liable for medical negligence by applying the doctrine of res ipsa loquitur. No sensible professional would intentionally commit an act or omission which would result in harm or injury to the patient since the professional reputation of the professional would be at stake. A single failure may cost him dear in his lapse.

      48. As observed by the Supreme Court in >strong>Jacob Mathew’s case :

      A medical practitioner faced with an emergency ordinarily tries his best to redeem the patient out of his suffering. He does not gain anything by acting with negligence or by omitting to do an act. Obviously, therefore, it will be for the complainant to clearly make out a case of negligence before a medical practitioner is charged with or proceeded against criminally. A surgeon with shaky hands under fear of legal action cannot perform a successful operation and a quivering physician cannot administer the end-dose of medicine to his patient.

      If the hands be trembling with the dangling fear of facing a criminal prosecution in the event of failure for whatever reason – whether attributable to himself or not, neither can a surgeon successfully wield his life-saving scalpel to perform an essential surgery, nor can a physician successfully administer the life-saving dose of medicine. Discretion being the better part of valour, a medical professional would feel better advised to leave a terminal patient to his own fate in the case of emergency where the chance of success may be 10% (or so), rather than taking the risk of making a last ditch effort towards saving the subject and facing a criminal prosecution if his effort fails. Such timidity forced upon a doctor would be a disservice to society.

      49. When a patient dies or suffers some mishap, there is a tendency to blame the doctor for this. Things have gone wrong and, therefore, somebody must be punished for it. However, it is well known that even the best professionals, what to say of the average professional, sometimes have failures. A lawyer cannot win every case in his professional career but surely he cannot be penalized for losing a case provided he appeared in it and made his submissions.

      50. To fasten liability in criminal proceedings e.g. under Section 304A IPC the degree of negligence has to be higher than the negligence which is enough to fasten liability in civil proceedings. Thus for civil liability it may be enough for the complainant to prove that the doctor did not exercise reasonable care in accordance with the principles mentioned above, but for convicting a doctor in a criminal case, it must also be proved that this negligence was gross amounting to recklessness.

      51. The difference between simple negligence and gross negligence has broadly been explained in paragraphs 12 to 16 of Jacob Mathew’s case, though difficulties may arise in the application of the principle in particular cases. For instance, if a mop is left behind in the stomach of a patient while doing an operation, would it be simple negligence or gross negligence? If a scissors or sharp edged medical instrument is left in the patient’s body while doing the operation would that make a difference from merely leaving a mop?

      52. The professional is one who professes to have some special skill. A professional impliedly assures the person dealing with him (i) that he has the skill which he professes to possess, (ii) that skill shall be exercised with reasonable care and caution.

      53. Judged by this standard, the professional may be held liable for negligence on the ground that he was not possessed of the requisite skill which he professes to have. Thus a doctor who has a qualification in Ayurvedic or Homeopathic medicine will be liable if he prescribes Allopathic treatment which causes some harm vide Poonam Verma v. Ashwin Patel and Ors.. In Dr. Shiv Kumar Gautam v. Alima, Revision Petition No. 586 of 1999 decided on 10.10.2006, the National Consumer Commission held a homeopath liable for negligence for prescribing allopathic medicines and administering glucose drip and giving injections.

      Protection to Doctors in Criminal Cases

      54. In para 52 of Jacob Mathew’s case the Supreme Court realizing that doctors have to be protected from frivolous complaints of medical negligence, has laid down certain rules in this connection:

      • A private complaint should not be entertained unless the complainant has produced prima facie evidence before the court in the form of a credible opinion given by another competent doctor to support the charge of rashness or negligence on the part of the accused doctor.
      • The investigating officer should, before proceeding against the doctor accused of rash or negligent act or omission, 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 opinion applying the Bolam test.
      • A doctor accused of negligence should not be arrested in a routine manner simply because a charge has been leveled against him. Unless his arrest is necessary for furthering the investigation or for collecting evidence or unless the investigating officer feels satisfied that the doctor proceeded against would not make himself available to face the prosecution unless arrested, the arrest should be withheld.

      Precautions which Doctor/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 and Ors. Original Petition No. 181 of 1997, decided on 18.7.2007 by the National Consumer Commission, the facts were that out of 52 cataract operations performed between 26th and 28th September, 1995 in an eye hospital 14 persons lost their vision in the operated eye. An enquiry revealed that in the Operation Theatre 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 Smt. Indrani Bhattacharjee, Original Petition No. 233 of 1996 decided by the National Consumer Commission on 9.8.2007, the patient was diagnosed as having `Mild Lateral Wall Eschemia’. The doctor prescribed medicine for gastro-entiritis, 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.

      Application of the above mentioned general principles to particular cases:

      Decisions of the Court

      55. In Pt. Parmanand Katara v. Union of India and Ors., the petitioner referred to a report published in the newspaper “The Hindustan Times” in which it was mentioned that a scooterist was knocked down by a speeding car. Seeing the profusely bleeding scooterist, a person who was on the road, picked up the injured and took him to the nearest hospital. The doctors refused to attend and told the man that he should take the patient to another hospital located 20 kilometers away authorized to handle medico-legal cases. The injured was then taken to that hospital but by the time he could reach, the victim succumbed to his injuries.

      56. The Supreme Court referred to the Code of Medical Ethics drawn up with the approval of the Central Government under Section 33 of the Indian Council Medical Act and observed “Every doctor whether at a Government Hospital or otherwise has the professional obligation to extend his services for protecting life. The obligation being total, absolute and paramount, laws of procedure whether in statutes or otherwise cannot be sustained and, therefore, must give way.”

      57. The Supreme Court held that it is the duty of the doctor in an emergency to begin treatment of the patient and he should not await the arrival of the police or to complete the legal formalities. The life of a person is far more important than legal formalities. This view is in accordance with the Hippocratic oath of doctors.

      58. Although this decision has laid down that it is the duty of a doctor to attend to a patient who is brought to him in an emergency, it does not state what penalty will be imposed on a doctor who refuses to attend the said patient. Consequently it will depend on the fact and circumstances of the case. However, this case is important because nowadays health care has often become a business, as is mentioned in George Bernard Shaw’s play “The Doctor’s Dilemma”. The medical profession is a noble profession and it should not be brought down to the level of a simple business or commerce. The truth of the matter, sadly, is that today in India many doctors (though not all) have become totally money-minded, and have forgotten their Hippocratic oath. Since most people in India are poor the consequence is that for them proper medical treatment is next to impossible, and hence they have to rely on quacks. This is a disgrace to a noble profession.

      59. In Paschim Banga Khet Mazdoor Samity and Ors. v. State of West Bengal and Anr., the Supreme Court held that the denial of emergency aid to the petitioner due to the non availability of bed in the Government Hospital amounts to the violation of the right to life under Article 21 of the Constitution. The Court went on to say that the Constitutional obligation imposed on the State by Article 21 cannot be abdicated on the ground of financial constraint.

      60. In Md. Suleman Ansari (D.M.S.) v. Shankar Bhandari (2005) 12 SCC 430 the respondent suffered a fracture of his hand. He went to the appellant who held himself out to be a qualified medical practitioner. The appellant bandaged the respondent’s hand and prescribed certain medicines. He was ultimately taken to another doctor but by this time the damage to his hand was permanent. It was found that the appellant was not a qualified doctor to give treatment to the respondent. The Supreme Court had directed him to pay Rs. 80,000 as compensation to the respondent.

      61. In Surendra Chauhan v. State of M.P., the appellant was having a degree of Bachelor of Medicine in Electrohomoeopathy from the Board of Electrohomoeopathy Systems of Medicines, Jabalpur (M.P.). He did not possess any recognized medical qualification as defined in the Indian Medical Council Act, 1956. Yet he performed an operation to terminate the three month pregnancy in a woman, who died in the clinic due to shock due to non application of anesthesia. The Supreme Court confirmed his sentence but reduced it to one and a half years rigorous imprisonment under Section 314/34 IPC and a fine of Rs. 25000 payable to the mother of the deceased.

      62. In State of Haryana and Ors. v. Raj Rani it was held that if a child is born to a woman even after she had undergone a sterilization operation by a surgeon, the doctor was not liable because there cannot be a 100% certainty that no child will be born after a sterilization operation. The Court followed the earlier view of another three Judge Bench in State of Punjab v. Shiv Ram and Ors.. These decisions will be deemed to have overruled the two Judge Bench decision in State of Haryana and Ors. v. Smt. Santra in which it was held that if a child is born after the sterilization operation the surgeon will be liable for negligence.

      63. In P.N. Rao v. G. Jayaprakasu, the plaintiff was a brilliant young boy who had passed the pre-University course securing 100% marks in Mathematics and 93.5% in physical sciences. He was also getting a monthly scholarship. He was offered a seat in B.E. Degree course in four Engineering Colleges. He had a minor ailment – chronic nasal discharge – for which his mother took him to a doctor for consultation who diagnosed the disease as Nasal Allergy and suggested operation for removal of tonsils. He was admitted in the Government General Hospital, Guntur and the operation was performed. He did not regain consciousness even after three days and thereafter for another 15 days he was not able to speak coherently. When he was discharged from hospital, he could only utter a few words and could not read or write and lost all his knowledge and learning. His father took him to Vellore where he was examined by a Professor of Neuro Surgery and it was found that his brain had suffered due to cerebral anoxia, which was a result of improper induction of anaesthetics and failure to take immediate steps to reduce anaesthesia. The court after examining the witnesses including the Professor of Anaesthesiology held that defendants were clearly negligent in discharging their duties and the State Government was vicariously liable.

      64. In Dr. Laxman Balkrishna Joshi v. Dr. Trimbak Bapu Godbole and Anr., a patient had suffered from fracture of the femur. The accused doctor while putting the leg in plaster used manual traction and used excessive force for this purpose, with the help of three men, although such traction is never done under morphia alone but done under proper general anaesthesia. This gave a tremendous shock causing the death of the boy. On these facts the Supreme Court held that the doctor was liable to pay damages to the parents of the boy.

      65. In Dr. Suresh Gupta v. Government of N.C.T. of Delhi and Anr., the appellant was a doctor accused under Section 304A IPC for causing death of his patient. The operation performed by him was for removing his nasal deformity. The Magistrate who charged the appellant stated in his judgment that the appellant while conducting the operation for removal of the nasal deformity gave incision in a wrong part and due to that blood seeped into the respiratory passage and because of that the patient collapsed and died. The High Court upheld the order of the Magistrate observing that adequate care was not taken to prevent seepage of blood resulting in asphyxia. The Supreme Court held that from the medical opinions adduced by the prosecution the cause of death was stated to be `not introducing a cuffed endotracheal tube of proper size as to prevent aspiration of blood from the wound in the respiratory passage.’ The Supreme Court held that this act attributed to the doctor, even if accepted to be true, can be described as a negligent act as there was a lack of care and precaution. For this act of negligence he was held liable in a civil case but it cannot be described to be so reckless or grossly negligent as to make him liable in a criminal case. For conviction in a criminal case the negligence and rashness should be of such a high degree which can be described as totally apathetic towards the patient.

      66. In Dr. Sr. Louie and Anr. v. Smt. Kannolil Pathumma and Anr. the National Consumer Commission held that Dr. Louie showed herself as an M.D. although she was only M.D. Freiburg, a German Degree which is equivalent to an M.B.B.S. degree in India. She was guilty of negligence in treating a woman and her baby which died. There was vacuum slip, and the baby was delivered in an asphyxiated condition.

      67. In Nihal Kaur v. Director, P.G.I.M.S.R. (1996) CPJ 112 a patient died a day after surgery and the relatives found a pair of scissors utilized by the surgeon while collecting the last remains. The doctor was held liable and a compensation of Rs. 1.20 lakhs was awarded by the State Consumer Forum, Chandigarh.

      68. In Spring Medows Hospital and Anr. v. Harjol Ahluwalia thr’ K.S. Ahluwalia and Anr., a minor child was admitted by his parents to a nursing home as he was suffering fever. The patient was admitted and the doctor diagnosed typhoid and gave medicines for typhoid fever. A nurse asked the father of the patient to get an injection Lariago which was administered by the nurse to the patient who immediately collapsed. The doctor was examined and testified that the child suffered a cardiac arrest on account of the medicine having being injected which led to brain damage. The National Commission held that the cause of cardiac arrest was intravenous injection of Lariago of such a high dose. The doctor was negligent in performing his duty because instead of administering the injection himself he permitted the nurse to give the injection. There was clear dereliction of duty on the part of the nurse who was not even a qualified nurse and was not registered with any nursing council of any State. Both the doctor and nurse and the hospital were found liable and Rs. 12.5 lakhs was awarded as compensation to the parents.

      69. In Consumer Protection Council and Ors. v. Dr. M. Sundaram and Anr. (1998) CPJ 3, the facts were that one Mrs. Rajalaxmi was admitted to a nursing home which diagnosed the ailment as Hodgkin’s Lymphoma. She was administered Endoxan injection five doses in five days. She was referred to another doctor who was an ENT specialist, who after examination opined that no lymph glands were seen. A sample of her bone marrow was sent to an Oncologist who opined that the picture does not fit with Hodgkin’s disease but the patient had megaloblastic anemia in the bone marrow. Subsequently she was discharged from the nursing home and was advised to visit CMC Vellore for treatment. The patient consulted another doctor who diagnosed the same as renal failure. The complainant alleged that the first doctor failed and neglected to refer the matter to a Cancer Specialist but wrongly diagnosed the ailment of the patient as Hodgkin’s Lymphoma and had unnecessarily administered injection of Endoxan and because of the toxicity of that drug the kidney cells of the patient got destroyed resulting in renal failure for which she had to undergo kidney transplantation which led to her death. The National Commission, upholding the State Commission decision, held that there was no negligence on the part of the doctor who had consulted a pathologist, and in the light of discussion with him and on inspection of some more slides of bone marrow specimens which also revealed the same finding, namely, existence of deposits of Hodgkin’s Lymphoma, proceeded to administer the patient injections of Endoxan. It was held on the basis of medical opinion that any prudent consultant physician would not delay the commencement of chemotherapy where repeated examination of the bone marrow slides had yielded the report that the Hodgkin’s deposits were present. Endoxan is a drug of choice in the treatment of Hodgkin’s Lymphoma and there was no negligence on the part of the doctor.

      70. In Sethuraman Subramaniam Iyer v. Triveni Nursing Home and Anr. (1998) CPJ 110, the complainant’s wife suffered from Sinusitis and was advised surgery by the doctor. She had suffered a massive heart attack while in the operation theatre. The State Commission found that necessary precautions and effective measures were taken to save the deceased and dismissed the complaint. The State Commission relied on the affidavits of four doctors who opined that there was no negligence. The complainant had not given any expert evidence to support his allegation and in these circumstances it was held that no case was made out against the doctor.

      71. In A.S. Mittal and Anr. v. State of U.P. and Ors. a free eye camp was organized for ophthalmic surgical treatment to patients. However, the eyes of several patients after operation were irreversibly damaged, owing to post-operative infection of the intra ocular cavities of the eyes, caused by normal saline used at the time of surgery. The Supreme Court directed the State Government to pay Rs. 12,500/- as compensation to each victim as there was a clear negligence.

      72. In Indian Medical Association v. V.P. Shantha it has been held that the following acts are clearly due to negligence :

      • Removal of the wrong limb;
      • Performance of an operation on the wrong patient;
      • Giving injection of a drug to which the patient is allergic without looking into the out-patient card containing the warning;
      • Use of wrong gas during the course of an anaesthetic, etc.

      73. From the aforementioned principles and decisions relating to medical negligence, with which we agree, it is evident that doctors and nursing homes/hospitals need not be unduly worried about the performance of their functions. The law is a watchdog, and not a bloodhound, and as long as doctors do their duty with reasonable care they will not be held liable even if their treatment was unsuccessful.

      74. However, every doctor should, for his own interest, carefully read the Code of Medical Ethics which is part of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 issued by the Medical Council of India under Section 20A read with Section 3(m) of the Indian Medical Council Act. 1956……

      117. We, therefore direct that whenever a complaint is received against a doctor or hospital by the Consumer Fora (whether District, State or National) or by the Criminal Court then before issuing notice to the doctor or hospital against whom the complaint was made the Consumer Forum or Criminal Court should first refer the matter to a competent doctor or committee of doctors, specialized in the field relating to which the medical negligence is attributed, and only after the doctor or committee reports that there is a prima facie case of medical negligence should notice be then issued to the concerned doctor / hospital. This is necessary to avoid harassment to doctors who may not be ultimately found to be negligent. We further warn the police officials not to arrest or harass doctors unless the facts clearly come within the parameters laid down in Jacob Matthew’s case (supra), otherwise the policemen will themselves have to face legal action…….”

      Thus the Apex Court recognizing the inherent limitations faced by judges while dealing with cases of medical malpractice due to the specialized nature of the medical profession and the extremely technical nature of the evidence that has to be led in these kind of cases has tried to bring in an impartial mechanism involving the members of the medical profession at the outset with a view to ensure that only genuine cases reach the Courts.

      While this is a step in the right direction it remains to be seen how the procedure advocated by the Supreme Court in the above decision will be implemented. Being judge made law, it is equally prone to being overruled or modified by subsequent judicial precedents.

      In a recent case (Nizam Institute of Medical Sciences v. Prashanth S. Dhananka- Civil Appeal Nos. 4119 of 1999 and 3126 of 2000, decided on 14 May 2009), the Supreme Court while dealing with a medical malpractice case arising out of an operation for removal of a tumor held that the institute and the doctors concerned were guilty of negligence and awarded a compensation of Rs. 1,00,00,000/- with interest @ 6 % from 1 March 1999 to the date of payment to the complainant. An examination of the judgment reveals serious lapses on the part of the institution and the attending doctors in inter alia not obtaining written consent of the patient for performing the surgery, maintenance of the requisite record of the patient and its timely production in Court, erroneous diagnosis, non involvement of the required specialist surgeon during the operation, lack of necessary pre-operative investigations and negligence at the time of the operation. These factors were taken into consideration by the Supreme Court while adjudicating upon the issues raised. The complainant in the said matter before the Supreme Court of India was an engineering student, who underwent an excision biopsy for the removal of a tumor. On completion of the biopsy it was found that the complainant developed acute paraplegia with a complete loss of control over his lower limbs.

      A complaint was filed before the National Consumer Redressal Commission by the complainant alleging utter and complete negligence on the part of the doctor and the State of Andhra Pradesh was alleged to be statutorily liable for the negligence of the concerned doctors.

      The complainant alleged negligence of the concerned doctors in the three stages of the surgery, that is, pre-operative tests, during the operation and post-operative treatment. It was held by the Commission that there was negligence and deficiency of service on the part of the doctor in the different stages of the case. Two appeals were preferred by the parties before the Supreme Court against the order of the Commission. The complainant preferred an appeal claiming that the amount of compensation was not enough and an appeal was preferred by the defendants against the order disowning any liability that has been accrued to them.

      The Supreme Court considered the question of negligence by the doctors in the three stages of the case, pre-operative tests, the operation and post-operative treatment. The Court relied on Samira Kohli v. Dr. Prabha Manchanda (supra) and held that with regard to the first stage of the treatment, consent given by the complainant for the biopsy cannot be considered to be an implied consent for a surgery. The Apex Court relied on the principles of medical negligence as laid down in Jacob Mathew v. State of Punjab (supra) and reiterated in State of Punjab v. Shiv Ram (supra). The Court maintained that the service rendered by medical practitioners falls under the definition of service under Section 2(1)(o) of the Consumer Protection Act, 1986 as per the judgment in Indian Medical Association v. V.P. Shantha (supra).The Court upheld the findings of the commission with respect to the negligence of the doctors and held that it was on account of the conduct of the operation that the paraplegia set in. Though the Court held that the enhanced amount of compensation claimed by the complainant is unjustified, hypothetical and therefore declined the same, it nevertheless enhanced the compensation awarded to the complainant by the National Consumer Disputes Redressal Forum.

      The Lessons:

      From a perusal of various proceedings initiated against medical professionals in consumer for a, one can say that the most common complaints received against medical practitioners centre around the following factors-

      • refusal to admit patients / delay in involving specialists in the case.
      • refusal to process reimbursement of expenditure in civil / private hospitals.
      • failure to settle medical malpractice cases prior to the matter reaching Court.
      • failure to redress the grievances of patients and their attendants prior to the matter reaching Court.
      • inadequate trained staff to handle patients.
      • inadequate / outdated equipment and sample collection facilities.
      • failure to keep the patient and attendants informed at all stages about the patients condition.
      • refusal of permission to attendants for being near a terminally ill patient.
      • providing incomplete information regarding diagnostic and medical procedures to patients and their attendants.
      • treating the patient as a commodity and showing insensitivity to the patient.
      • negligence in keeping up to date records of the patient and all communication with the patient and attendants.
      • making patients undergo expensive and sometimes unnecessary medical tests.
      • rude behaviour at various times with patient and their attendants.
      • delayed / incorrect treatment and failure to inform patient about the same.
      • refusal / delay in transferring patient or discharging patient.
      • incomplete medication / giving incorrect medication.
      • using expired medication.
      • having no policy for enforcing accountability amongst staff and medical practitioners in eventuality of patient complaints / court cases.
      • failure to obtain a proper and valid written consent of the patient and attendant / guardian for a particular medical treatment thereby showing that the patient was probably not informed of the medical treatment being administered.

      Thus the above should be redressed at the earliest. Certain precautions that medical practitioners must take are enumerated herein-below-

      (i) Current practices, infrastructure, paramedical and other staff, hygiene and sterility should be observed strictly.

      (ii) 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.

      (iii) 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.

      (iv) A doctor should not experiment unless necessary and even then he should ordinarily get a written consent from the patient.

      (v) An expert should be consulted preferably in writing in case of any doubt.

      (vi) Full record of the diagnosis, treatment, communications with patient, etc. should be maintained throughout and up to 4 years after discharge of patient.

      (vii) Staff should be trained and polite, courteous and motivated with an attitude to help the patient.

      (viii) Doctor should spend time with patients and their attendants to establish a human bond with them and should have a caring attitude and not make them feel that they are like commodities.

      (ix) Patient should be made aware in writing at all stages and his consent obtained for the treatment being prescribed.

      (x) Debriefing the attendant in case of death of the patient and insistence on post mortem report or in case the attendant is not cooperative to take unwillingness certificate from the attendant.

      (xii) Regular meetings with the patient and attendant to ensure that they do not have any grievances regarding the treatment or attending staff and doctors.

      (xiii) Ensure presence of female attendant while examining lady patients.

      (xiv) Framing in house procedure for fixing accountability in case of death both on staff and doctors.

      (xv) Handling of Court cases with care and deputing responsible officers to oversee the same. Closely liasing with lawyer and engaging good lawyers to represent the defendant in the case.

      (xvi) Making honest sincere attempt at out of Court settlement prior to any action being initiated against by the patient / attendant.

      (xvii) Regular rating of doctors and staff by the patient and attendants and maintenance of these records.

      (xviii) Familiarizing themselves with the Indian Medical Council (professional conduct, etiquette and ethics) Regulations 2002

      While the above examples are by no means exhaustive and only illustrative, following them would minimize the chances of any medical malpractice claims being made. In case the same are made, it would be easier to defend such cases if the above guidelines are scrupulously adhered to. While the above may lead to more paperwork and increase administrative time, in the long term, the benefits of having comprehensive treatment record, etc would eliminate frivolous litigation at the threshold.