Health Law Final Draft

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SUBJECT: HEALTH LAW PROJECT TOPIC:

MEDICAL NEGLIGENCE IN INDIA WITH REFERENCE TO SAMIRA KOHLI VS PRABHA MANCHANDA

SUBMITTED BY

NAYAN SINGH ROLL NO. 1417 5TH YEAR, 10TH SEMESTER, B.B.A.LL.B (HONS.)

SUBMITTED TO:

MR. KUMAR GAURAV (FACULTY OF HEALTH LAW)

CHANAKYA NATIONAL LAW UNIVERSITY, PATNA,

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ACKNOWLEDGEMENT We take this opportunity to express our profound gratitude and deep regard to our guide Mr. Kumar Gauravfor his exemplary guidance, monitoring and constant encouragement throughout the course of this project. The blessing, help and guidance given by him time to time shall carry us a long way in the journey of life on which we are about to embark. We are obliged to staff members of Chanakya National Law University, for the valuable information provided by them in their perspective fields. We are grateful to this cooperation during the period of my assignment. Last but not the least, we thank almighty, our parents and our friends for their constant support and encouragement without which this project would not be possible.

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CONTENTS Contents

ACKNOWLEDGEMENT....................................................................2 CONTENTS.........................................................................................3 OBJECTIVES.......................................................................................4 LIMITATION.......................................................................................4 HYPOTHESIS......................................................................................4 RESEARCH METHODOLOGY........................................................5 RESEARCH GAP...............................................................................5 RESEARCH QUESTIONS.................................................................5 CH-1.....................................................................................................6 INTRODUCTION................................................................................6 CH-2...................................................................................................11 LAWS RELATING TO MEDICAL NEGLIGENCE........................11 CH-3...................................................................................................17 Basic Features of Medical Negligence and Standard of Care............17 CH-4...................................................................................................20 Role of Informed Consent..................................................................20 Criteria of Valid Informed Consent.................................................22 Ethical Elements of Informed Consent............................................25 Exceptions for Obtaining Consent...................................................25 CH-5...................................................................................................27 Judicial Deliberations on Informed Consent......................................27 Samira Kohli vs Prabha Manchanda................................................28 CH-6...................................................................................................37 3

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ENFORCEMENT MACHINERIES..................................................37 CH-7...................................................................................................41 EVOLUTION OF MEDICAL JURISPRUDENCE THROUGH LAWS AND DECISIONS.................................................................41 CONCLUSION AND SUGGESTIONS............................................45 BIBLIOGRAPHY..............................................................................46

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OBJECTIVES The objectives of the research paper are the following: 1. To present a detailed study as to what is meant by medical negligence. 2. To know about the deficiency in medical services and medical malpractices. 3. To understand the remedies availableto the victims of medical negligence under various law of India. 4. To know about the recent trends of the judiciary in the matters pertaining to medical negligence.

LIMITATION The researcher has relied only on doctrinal study for medical negligence. The study is limited to medical negligence in India only. The research does not make a comparative analysis of the topic with other countries.

HYPOTHESIS The researcher has used the arguendo that cases of medical negligence have to be dealt with a difference. They are not the same as occupational negligence. Simple lack of proof or error of judgment shall not amount to professional negligence.

RESEARCH METHODOLOGY The researcher has adopted doctrinal method of research. Various books, articles, law journals, Acts etc. will be referred for the preparation of this project work. The sources used for the collection of materials regarding this topic will be primary as well as secondary sources. A uniform method of citation shall be followed in this whole project work.

RESEARCH GAP There is no specific legislation in India dealing with medical negligence. It is covered under civil liability, criminal liability and Consumer Protection Act. The researcher discusses the latest developments in cases of medical negligence in India and what is required to prove such negligence. 5

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REVIEW OF LITERARTURE Speaking for Indian context, academic and research endeavors revolving literature. In addition to the influential impact of English Common Law Jurisprudence, the literature under review quite explicitly reflects analysis of judicial decisions rendered by various Courts and Consumer Forums, Research Articles, Text Books and Commentaries. By and large, the literature under review depicts the following, though not in a segmental and coherent manner:

I. Premise of medical negligence liability. The extent and amplitude of the liability is explored. II. Evolution of medical negligence liability. The role of informed consent has only become prominent due to the rising ethical concerns evolving in the practice. III. Paradigm shift in Judicial Interpretation with the Bolan Test and the case of Saminra Kohli vs Prabh Manchanda, and related afterthoughts; The Bolan Test has drawn a line of objective skill and care required for operating patients while Supreme court through Samira Kohli case has provided guidelines that in all cases must be adhered to safeguard the bodily integrity of the patient. IV. Criminal liability for medical negligence understanding on the part of Judiciary; The imposition of criminal liability is just to ensure that doctors become answerable and more responsible while dealing with patients. It ensures they don’t flout the norms and get away with it.

RESEARCH QUESTIONS The research questions are the following: 1. What is the standard of duty and care to be taken by the medical practioners so that they cannot be held liable for medical negligence. 2. Whether persons other than the doctor like nurses etc. can be held liable for medical negligence. 3. Whether the principle of vicarious liability is applicable on doctors or not. 4. Whether commission of medical negligence attracts civil liability or criminal liability. 5. What are the defence available for the medical practioner when he or she has been accused of medical negligence. 6. Which principle i.e. bolem principle or Bolitho principle is applicable for the determination of medical negligence in India.

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CH-1 INTRODUCTION In everyday usage, the word negligence denotes mere carelessness. Meaning of Negligence: Negligence has two meanings in law of torts: (1) Negligence as a mode of committing certain torts, e.g., negligently or carelessly committing trespass, nuisance or defamation. In this context, it denotes the mental element.(2) Negligence is considered as a separate tort. It means a conduct which creates a risk of causing damage, rather than a state of mind. The House of Lords in Donoghue v. Stevenson,1“treats negligence, where there is a duty to take care, as specific tort in itself, and not simply as an element is some more complex relationship or in some specialized breach of duty. Medical malpractice can be defined as a professional negligence by act or omission by a health care provider in which the treatment to be provided falls below the accepted standards of practice in the medical community and in turn causes injury or death to the patient, with most cases involving medical error. Therefore any negligence by an act or omission of a medical practitioner in performing his/her duty is referred as medical negligence.The standard of skill and care required of every health care provider in rendering professional services or health care to a patient shall be that degree of skill and care which is ordinarily being employed in the same or similar field of medicine as defendant, and with use of reasonable care and diligence.2 “In medical profession, skills may differ from one doctor to another and there is always more than one alternative course of treatment is available, which are all admissible. Negligence can’t 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, he wouldn’t be liable if the course of action chosen by him was acceptable to the medical profession.” With an idea of protecting the consumers The Consumer Protection Act, 1986 was enacted by the legislature to arm each and every consumer and consumer associations with rights to seek speedy, cheap and efficient remedies which are proving to be very popular and effective as well, leaving behind a trail of rulings and findings under which so many people have been benefited. Consumer complaints are growing at a fast rate of 20%. But at the same time patients who belong to the lower income groups or those who are illiterate, do not get the benefit of the Act. Doctors often get away with their act of negligence, because the patients neither have the medical knowledge nor sufficient evidence to fight their case. Therefore these situations are favourable to the doctors and corporate medical firms.

Donoghue v. Stevenson, (1932) UKHL 100. Market and Regulatory Approaches to Medical Malpractice, https://www.ncbi.nlm.nih.gov/books/NBK218654/, last seen on April 01, 2019. 1 2

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According to present legal position, 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 3. He would be liable only where his conduct falls below that of the standards of a reasonably competent practitioner in his field. For instance, the surgeon is liable, if he leaves surgical gauze inside the patient after an operation.4 The word health is changing in its contents radically after the World Health Organisation defined the term positively as a state of complete physical, mental and social wellbeing, and not just the absence of diseases and wellness5. As per the Constitution of the World Health Organisation, everyone has a right to have the highest standard of Health. 6 Such a fundamental right shall be available to all without distinction of race, religion and political belief, economic or social condition that health of all people is fundamental to the attainment of peace and security.7 After the establishment of the World Health Organization, the right to health care was recognized internationally, and various international conventions recognized the importance of the right to health care. The objective of the organization is declared as the attainment by people, of the highest possible level of health.8 Medical negligence or medical malpractice is often considered as one and the same. It actually means medical care that is hampered due to negligence by the healthcare provider. It may include doctors and all other related staff who are responsible for providing health care. Those patients or their family members have all the right to initiate legal actions against such practices, and the people involved can be sued in court. It is, however, very difficult to prove that the injury occurred as a result of medical negligence. In most of the jurisdictions in the United States, people are qualified to get a certain standard and level of medical care. When such standards are brought down due to any reasons, the entire staff responsible for providing medical care is subjected to the lawsuit. The reasons of low standards are when the staff do not adhere to the guidelines and are either too busy or tend to get distracted. Sometimes, erroneous actions or faulty machines can also result in unwanted negligence. Insufficient skill, care, pace or attention can lead to negligence. Professionals providing psychological care to patients are equally responsible for providing due care to their patients. In case of any negligence on their part, they may be charged for medical malpractice. Patients are authorized to receive good medical facilities during their course of treatment. Hence, any negligence in that can also be charged. The medical professionals who have been charged under medical negligence are often compared to other medical professionals of their group for professionalism and competency before trying them in the court. Meaning of Breach of Duty & Care Jacob Mathew vs State Of Punjab & Anr, Appeal (crl.) 144-145 of 2004. A Comparative Analysis of Various Indian Legal Systems Regarding Medical Negligence, available at: http://www.legalserviceindia.com/medicolegal/mlegal.htm, last seen on April 01, 2019. 5 Preamble to the Constitution of the World Health Organisation. 6 Ibid. 7 Article 22 and 25(1) of the Universal Declaration of Human Right. 8 Article 1 of the Constitution of the World Health Organisation. 3 4

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The question of professional duty to take care of health has immense significance in the present day world. The WHO is committed to provide health for all. The Directive Principles of State Policy under the Constitution of India demands the State to make effective provision for public health, and for just and humane conditions of work.9 It is the primary duty of the State to raise the level of nutrition, the standard of living of its people and the improvement of public health. 10 The Supreme Court has declared that right to medical aid as an integral part of the right to life. It is an obligation on the State to preserve life by extending required medical assistance. 11 In fact the Apex Court has held that right to health and medical care is a fundamental right under the Constitution of India. 12 On jurisprudential analysis of this issue, it is clear that it has become a socio-legal problem. A person, who holds himself out as ready to give medical advice or treatment, impliedly undertakes that he is possessed of skill and knowledge for the purpose. Such a person whether he is a registered medical practitioner or not, if he is consulted by a patient he owes the patient certain duties namely a duty of care in administration of the treatment. 13 A breach of any of these duties will support an action for negligence by the patient. This principle has also been followed by the Hon'ble Supreme Court in Phillips India Lev. Kunjupunnuand others14, relying on English decisions. Similar is the view of Madhya Pradesh High court15 in Shrivastava v Rarnbiliarilal and others. It would appear from the above line of decisions that our courts have mostly relied on English decisions. Therefore the essential ingredients of actionable negligence in medical profession are: a) Existence of duty to take care whether it is so or not depends on the question of proximity16 b) Breach of duty to take care c) The breach of duty must cause the injury or loss to the defendant For the analysis of these three components, comprehensive information regarding duty of care, Breach of Injury and duty of care arising out of breach of duty of care is needed. Diagnosis of the patient is the yew basis upon which whole of the treatment has to be carried out; mistaken diagnosis may result in wrong prescription, and wrong treatment causing harm or injury to the patient. Hence, failure to diagnose the patient properly amounts to negligence.But medical practitioners are not infallible. Even a very highly qualified and experienced person may commit mistake in diagnosis, hence for every mistake in diagnosis

Article 41 and 42 of the Constitution of India. Article 47 of the Constitution of India. 11 State of Punjab v. Mahinder Singh Chawla, AIR 1997 SC 1225. 12 Paramanand Katara v. Union of India, AIR 1989 SC 2039 13 Consumer Education and Research Center v. Union of India, AIR 1995 SC 1922. 14 Phillips India Lev. Kunjupunnu, AIR 1975 Bom.306. 15 Shrivastava v Rarnbiliarilal, AIR (1982) M.P.132. 16 Supra N 1. 9

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he is not to be held liable. He can be liable, where he fails to do according to the reasonable standard of care.17 Mistaken diagnosis is not necessarily negligent diagnosis, unless the symptoms are so apparent that any reasonably competent and skilful physician could say that 'this is disease'. Diagnosis must also be judged in relation to development in science of medicine at that time. If he fails to observe the later developments and adheres to original mistaken diagnosis, he may be held to have been negligent18. The justification in pleading that some other doctor could have done better doesn’t form ground for litigation. The standard of care is adaptable and flexible to circumstance as the same standard of skill or competence is not expected of every medical man. Therefore standard of responsible care cannot be defined with mathematical precision. Reasonableness of care depends on numerous factors like advancement of science of medicine, time, place and experience etc. It must be the standard of care and skill, which any medical man exercising the professional skill ought to observe. Medical practitioner is not 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 act, merely because there was a body of opinion that would take a contrary view.19 Thus the judicial decisions affirm that the standard of care required of medical man is that of the average practitioner of the category (e.g.: Allopathic, Homoeopathic, Ayurvedic, etc.) to which the negligent practitioner belongs. As already noted, fair and reasonable standard of skill and competence is variable because some people may be more skilled and some may have only the lowest standard of skill and competence.20 In Jaiprakash Saini v. Director Rajiv Gandhi Cancer Institute & Research Center21, it has been held that in order to decide whether negligence is established in any particular case, the alleged act or omission or course of conduct, complained must be judged not by ideal standard nor in the abstract but against the background of circumstances in which the treatment in question was given and the true test for establishing negligence on the part of a doctor is that whether a doctor of ordinary skill would be guilty if acting with reasonable care. Merely because a medical procedure fails it cannot be stated that the medical practitioner is guilty of negligence unless it is proved that the medical practitioner did not act with sufficient care and skill and the burden of proving the same, rests upon the person who assists it. So the duty of a medical practitioner arises from the fact that he does something to a human being, which is likely to cause physical damage unless it is done with proper care and skill. Supra N 2. Maynard v. West Midlands Regional Health Authority,(1985) 1 All ER 635. 19 Historical Evolution, available at: http://shodhganga.inflibnet.ac.in/bitstream/10603/26000/8/08_chapter %202.pdf 20 Bolam v. Friern Hosp. Management Committee,(1957) 1 WLR 582. 21 Jaiprakash Saini v. Director Rajiv Gandhi Cancer Institute & Research Center, 2003 (2) CPR.205. 17 18

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CH-2 LAWS RELATING TO MEDICAL NEGLIGENCE With the Consumer Protection Act, 1986 coming into effect, a number of patients have filed cases against doctors. Public awareness of medical negligence in India is rapidly growing. Hospital’s managements are increasingly facing complaints regarding the facilities, standards of professional competence, and the appropriateness of their therapeutic and diagnostic methods. After the Consumer Protection Act, 1986 has come into force patients filing legal cases against doctors, have established that the doctors were negligent in their medical service, and have also claimed and received compensation. Therefore, a number of legal decisions have been made on what constitutes negligence and what is required to prove it.22 Persons who offer medical advice and treatment implicitly state that they have the required skill and knowledge to do so, that they have the skill to decide whether to take a case, to decide the treatment, and to administer that treatment. This is referred as an “implied undertaking” on the part of a medical professional.In the case of the State of Haryana v SmtSantra, the Supreme Court held that every doctor “has a duty to act with a reasonable degree of care and skill”23 Doctors in India may be held liable for their services individually or vicariously unless they come within the exceptions specified in the case of Indian Medical Association v V P Santha24. “Doctors are not liable for their services individually or vicariously if they do not charge fees. Thus free treatment at a nongovernment hospital, governmental hospital, health centre, dispensary or nursing home would not be considered a “service” as defined in Section 2 (1) (o) of the Consumer Protection Act, 1986.” Having said that, no human being is perfect and even the most renowned specialist can make a mistake in detecting or diagnosing the true nature of a disease. A doctor can be held liable for negligence only if one can prove that he is guilty of a failure, which no doctor with ordinary skills would be guilty of he had acted with reasonable care. 25 An error of judgement constitutes negligence only if a reasonably competent professional with the standard skills that the defendant professes to have, and acting with ordinary care, would not have made the same error26. In a key decision on this matter in the case of DrLaxman Balkrishna Joshi v Dr TrimbakBapuGodbole, the Supreme Court held that “if a doctor has adopted a practice that is

K K S R Murthy, Medical negligence and the law, available at: https://ijme.in/articles/medical-negligenceand-the-law/?galley=html, last seen on April 04, 2019. 23 State of Haryana vs. Smt. Santra , AIR 2000 SC 3335. 24 Indian Medical Association vs V P Santha, AIR 1996 SC 550 25 Hunter vs Hanley (1955) SLT 213. 26 Whitehouse vs.Jordan (1981) 1 All ER 267. 22

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considered “proper” by a reasonable body of medical professionals who are skilled in that particular field, he or she will not be held negligent only because something went wrong.” Doctors have an obligation to exercise an ordinary degree of skill. But, they cannot give a warranty of the perfection of their skill or a guarantee of cure. If the doctor has adopted the right course of treatment, if the doctor is skilled and has worked with a method and manner best suited to the patient, he cannot be blamed for negligence if the patient is not fully cured.Certain set of conditions must be satisfied before liability can be considered. The person who is accused must have committed an act of omission or commission; the said act must have been in breach of the person’s duty; and which must have caused harm to the injured person. The complainant should prove the allegation against the doctor by citing the best evidence available in medical science and presentation by way of expert opinion.27 The complainant in some situations can invoke the principle of res ispa loquitur or “the thing speaks for itself”. In certain circumstances no proof of negligence is required beyond the accident itself. The National Consumer Disputes Redressal Commission applied this principle in Dr JanakKantimathi Nathan vs MurlidharEknathMasane.28The principle of res ipsa loquitur comes into operation only when there is proof that the occurrence was unexpected, that the accident could not have happened without negligence and lapses on the part of the doctor, and that the circumstances conclusively show that the doctor and not any other person was negligent.29 Section 304A of the Indian Penal Code of 1860, Causing death by negligence.— Whoever causes the death of any person by doing any rash or negligent act not amounting to culpable homicide, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both. In Poonam Verma vs Ashwin Patel the Supreme Court distinguished between negligence, rashness, and recklessness30. A negligent person is one who inadvertently commits an act of omission and violates a positive duty. A person who is rash knows the consequences but foolishly thinks that they will not occur as a result of her/ his act. A reckless person knows the consequences but does not care whether or not they result from her/ his act. Any conduct falling short of recklessness and deliberate wrongdoing should not be the subject of criminal liability. Thus a doctor cannot be held criminally responsible for a patient’s death unless it is shown that she/ he was negligent or incompetent, with such disregard for the life and safety of his patient that it amounted to a crime against the State.31 Sections 80 and 88 of the Indian Penal Code contain defences for doctors accused of criminal liability. According to section 80nothing is an offence which is done by accident or Dr Laxman Balkrishna Joshi vs Dr Trimbak Bapu Godbole, AIR 1969 (SC)128. Dr Janak Kantimathi Nathan vs Murlidhar Eknath Masane, 2002 (2) CPR 138. 29 Supra N 35. 30 Poonam Verma vs Ashwin Patel, 1996 4 SCC 332. 31 House of Lords decision in R vs Adomako, 1994 3 All ER 79. 27 28

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misfortune and without any criminal intention or knowledge in the doing of a lawful act in a lawful manner by lawful means and with proper care and caution.According to Section 88, nothing which is not intended to cause death, is an offence by reason of any harm which it may cause, or be intended by the doer to cause, or be known by the doer to be likely to cause, to any person for whose benefit it is done in good faith, and who has given a consent, whether express or implied, to suffer that harm, or to take the risk of that harm. Burden of Proof and Chances of Error The burden of proof of negligence, carelessness, or insufficiency generally lies with the complainant. The law requires a higher standard of evidence than otherwise, to support an allegation of negligence against a doctor. In cases of medical negligence the patient must establish her/ his claim against the doctor. In Calcutta Medical Research Institute vs Bimalesh Chatterjee it was held that the onus of proving negligence and the resultant deficiency in service was clearly on the complainant 32. In Kanhaiya Kumar Singh vs Park Medicare & Research Centre, it was held that negligence has to be established and cannot be presumed.33 Even after adopting all medical procedures as prescribed, a qualified doctor may commit an error. The National Consumer Disputes Redressal Commission and the Supreme Court have held, in several decisions, that a doctor is not liable for negligence or medical deficiency if some wrong is caused in his treatment or in his diagnosis if she/ he has acted in accordance with the practice accepted as proper by a reasonable body of medical professionals skilled in that particular art, though the result may be wrong. In various kinds of medical and surgical treatment, the likelihood of an accident leading to death cannot be ruled out. It is implied that a patient willingly takes such a risk as part of the doctor-patient relationship and the attendant mutual trust.34 Concept of Gross Negligence & Recklessness Before the case of Jacob Matthew’s case, the Supreme Court of India delivered two different opinions on doctors’ liability. In Mohanan vs Prabha G Nair and another 35, it ruled that a doctor’s negligence could be ascertained only by scanning the material and expert evidence that might be presented during a trial. In Suresh Gupta’s case in August 2004 the standard of negligence that had to be proved to fix a doctor’s or surgeon’s criminal liability was set at “gross negligence” or “recklessness.” 36 The Supreme Court distinguished between an error of judgement and culpable negligence. It held that criminal prosecution of doctors without adequate medical opinion pointing to their

Calcutta Medical Research Institute vs Bimalesh Chatterjee, (1999) CPJ 13 (NC). Kanhaiya Kumar Singh vs Park Medicare & Research Centre, III (1999) CPJ 9 (NC). 34 Paschim Banghakhet Mazdoor Samity and others v. State of West Bengal and another, (1996) 4 SCC 37. 35 Mohanan vs Prabha G Nair and another, (2004) CPJ 21(SC). 36 Dr. Suresh Gupta vs Govt. Of N.C.T. Of Delhi & Anr, Appeal (crl.) 778 of 2004. 32 33

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guilt would be a great disservice to the community. A doctor cannot be tried for culpable or criminal negligence in all cases of medical mishaps or misfortunes.37 A doctor may be liable in a civil case for negligence but mere carelessness or want of due attention and skill cannot be described as so reckless or grossly negligent as to make her/ him criminally liable. The courts held that this distinction was necessary so that the hazards of medical professionals being exposed to civil liability may not unreasonably extend to criminal liability and expose them to the risk of imprisonment for alleged criminal negligence. Hence the complaint against the doctor must show negligence or rashness of such a degree as to indicate a mental state that can be described as totally apathetic towards the patient. Such gross negligence alone is punishable. On September 9, 2004, J. ArijitPasayat and J. CK Thakker referred the question of medical negligence to a larger Bench of the Supreme Court. They observed that words such as “gross”, “reckless”, “competence”, and “indifference” did not occur anywhere in the definition of “negligence” under Section 304A of the Indian Penal Code and hence they could not agree with the judgement delivered in the case of Dr Suresh Gupta. The issue was decided in the Supreme Court in the case of Jacob Mathew vs State of Punjab38. The court directed the central government to frame guidelines to save doctors from unnecessary harassment and undue pressure in performing their duties. It ruled that until the government framed such guidelines, the following guidelines should prevail: A private complaint of rashness or negligence against a doctor may not be entertained without prima facie evidence in the form of a credible opinion of another competent doctor supporting the charge. In addition, the investigating officer should give an independent opinion, preferably of a government doctor. Finally, a doctor may be arrested only if the investigating officer believes that he wouldn’t be available for prosecution unless arrested. IPC & Medical Negligence Indian Penal Code, 1860 sections 52, 80, 81, 83, 88, 90, 91, 92 304-A, 337 and338 contain the law of medical malpractice in India. Nothing is an offence which is done by accident or misfortune, and without any criminal intention or knowledge in the doing of a lawful act in a lawful manner by lawful means and with proper care and caution.39 Nothing is an offence merely by reason of its being done with the knowledge that it is likely to cause harm, if it be done without any criminal intention to cause harm, and in good faith for the purpose of preventing or avoiding other harm to person or property. 40 Dr. T.K.K. Naidu, Doctor and Law, http://medind.nic.in/jal/t07/i4/jalt07i4p71.pdf Jacob Mathew vs State of Punjab, Criminal Appeal Nos 144-145 of 2004. 39 Section 80, The Indian Penal code,1860. 40 Section 81, The Indian Penal code,1860. 37 38

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Nothing which is not intended to cause death, is an offence by reason of any harm which it may cause, or be intended by the doer to cause, or be known by the doer to be likely to cause, to any person for whose benefit it is done in good faith, and who has given a consent, whether express or implied, to suffer that harm, or to take the risk of that harm.41 A consent is not such a consent as it intended by any section of this Code, if the consent is given by a person under fear of injury, or under a misconception of fact, and if the person doing the act knows, or has reason to believe, that the consent was given in consequence of such fear or misconception; or Consent of insane person.—if the consent is given by a person who, from unsoundness of mind, or intoxication, is unable to understand the nature and consequence of that to which he gives his consent; or Consent of child.—unless the contrary appears from the context, if the consent is given by a person who is under twelve years of age.42 Nothing is an offence by reason of any harm which it may cause to a person for whose benefit it is done in good faith, even without that person’s consent, if the circumstances are such that it is impossible for that person to signify consent, or if that person is incapable of giving consent, and has no guardian or other person in lawful charge of him from whom it is possible to obtain consent in time for the thing to be done with benefit:43 Whoever causes the death of any person by doing any rash or negligent act not amounting to culpable homicide, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.44 Whoever causes hurt to any person by doing any act so rashly or negligently as to endanger human life, or the personal safety of others, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five hundred rupees, or with both.45 A physician can be charged with criminal negligence when a patient dies from the effects of anaesthesia during an operation or other kind of treatment, if it can be proved that the death was the result if malicious intention, or gross negligence. Before the administration of anaesthesia or performance of an operation, the medical man is expected to follow the accepted precautions. In such cases, the physician should be able to prove that he used reasonable and ordinary care in the treatment of his patient to the best of his judgment. He is, however, not liable for an error judgment. The law expects a duly qualified physician to use that degree of skill and care which an average man of his qualifications ought to have, and does not expect him to bring the highest possible degree of skill in the treatment of his patients, or to be able to guarantee cures.

Section 58, The Indian Penal code,1860. Section 90, The Indian Penal code,1860. 43 Section 92, The Indian Penal code,1860. 44 Section 304A, The Indian Penal code,1860. 45 Section 337, The Indian Penal code,1860. 41 42

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It has long been recognized that criminal liability of a physician may result from a high degree of negligent conduct. What the law calls criminal negligence is largely a matter of degree; it is incapable of a precise definition. To prove whether or not it exists is like chasing a mirage. It requires that any of the following to be established in a case of criminal medical negligence. When a FIR is filed against a doctor for the death of a patient who was under his treatment, under this Indian Penal Code Section 304-A the doctor can be arrested. A doctor charged under this section can obtain bail and if proved guilty, the doctor can be punished with a maximum of two years imprisonment or fine or both. But, if the patient is alive, the doctor is charged under the Indian Penal Code Section 337 and 338.46

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Medical Malpractice & Indian Penal Law, available at: www.legalpulse.in/mmip.php/policy.php

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CH-3 BASIC FEATURES OF MEDICAL NEGLIGENCE AND   STANDARD OF CARE To comprehend the scope of negligence, it is important to understand the scope of the duty imposed on a doctor or medical practitioner. A doctor or other medical practitioner, among others, has a duty of care in deciding whether to undertake the case or not, duty in deciding what treatment to give, duty of care in administration of that treatment, duty not to undertake any procedure beyond his or her control, and it is expected that the practitioner will bring a reasonable degree of skill and knowledge and will exercise a reasonable degree of care. 9 Negligence, simply put, is a breach of duty of care resulting in injury or damage. The causal relationship between breach and injury is a must for fastening the liability of negligence, and such cause must be “direct” or “proximate.” 10 It is important to note that the test is an “or” one, and therefore the casual link can be either direct causation or proximate causation, and in both cases, negligence can be ascribed. For instance, where a patient with about 50% burns died 40 days after the date of a wrong blood type transfusion in spite of receiving substantial care thereafter postdetection of error; the finding of medical negligence could not be escaped as the causal relation between the transfusion of wrong blood type and death was proximate.47 The line between civil liability and criminal liability is thin, and no sufficiently good criteria have yet been devised by the Supreme Court providing any clear and lucid guidance. The Supreme Court in Dr. Suresh Gupta v. Govt. of NCT Delhi  put the standard for fastening criminal liability on a high pedestal and required the medical negligence to be “gross” or “reckless.” Mere lack of necessary care, attention, or skill was observed to be insufficient to hold one criminally liable for negligence. It was observed in Dr. Suresh Gupta that mere inadvertence or simply a want of a certain degree of care might create civil liability but will not be sufficient to attract criminal liability. In this case, a young man was stated to have died during the simple procedure for nasal deformity for “not introducing a cuffed endotracheal tube of proper size as to prevent aspiration of blood from the wound in the respiratory passage,” and the prosecution under Section 304A IPC was quashed by the Supreme Court setting aside the order of the High Court which had declined to quash the prosecution.

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Postgraduate Institute of Medical Education and Research v. Jaspal Singh (2009) 7 SCC 330.

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The soundness of the view of the Supreme Court was subsequently doubted considering that word “gross” is absent in Section 304A IPC and that different standards cannot be applied for actions of the negligence of doctors and others. Consequently, the matter was placed for reconsideration before a bench of higher strength.13 Three-judge bench (bench strength in Dr. Suresh Gupta was two) in Jacob Mathew v. State of Punjab on a reconsideration endorsed the approach of high degree of negligence being the prerequisite for fastening criminal liability as adopted in Dr. Suresh Gupta, and it was observed that”[i] n order to hold the existence of criminal rashness or criminal negligence, it shall have to be found out that the rashness was of such a degree as to amount to taking a hazard knowing that the hazard was of such a degree that injury was most likely imminent.” Supreme Court in Jacob Mathew observed that the subject of negligence in the context of medical profession necessarily calls for a treatment with a difference. In this case, an aged patient in an advanced stage of terminal cancer was experiencing breathing difficulties and the oxygen cylinder connected to the mouth of the patient was found to be empty. By the time replacement could be made, the patient had died. Supreme Court set aside the judgment of the High Court and held that the doctors could not be criminally prosecuted. It would not be surprising if different benches of the Supreme Court in the above facts were to arrive at different conclusions. High Courts in both of the above cases, i.e., Dr. Suresh Gupta and Jacob Mathew surely held views different from that of the Supreme Court. The abstract principles sometimes do pose difficulty in their application to facts, much like in the practice of medicine. The criminal liability and civil liability are not exclusive remedies and for the same negligence, both actions may be available. ”Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law requires,”15 as the standard of care from a doctor. It has been held by the courts that in the cases of medical negligence, Bolam test is to be applied, i.e., ”standard of the ordinary skilled man exercising and professing to have that special skill,” and not of “the highest expert skill.”16 This is applicable to both “diagnosis” and “treatment.” It is noted that the Supreme Court has now observed the need to reconsider the parameters set down in the Bolam test. Errors of judgment do not necessarily imply negligence. 18 Gross mistakes would, however, invite the finding of negligence such as use of wrong drug or wrong gas during the course of anesthetic process, delegation of the responsibility to a junior with the knowledge that the junior is incapable of performing the duties properly, removal of the wrong limb, performing an operation on the wrong patient or injecting a drug which the patient is allergic to without looking at the outpatient card containing the warning, and leaving swabs or other items inside the patients.19 Persons not qualified in general or a certain branch of medicine yet embarking upon a treatment course in that field has been held to be negligent.  Not taking care of a premature baby who is given supplemental oxygen and blood transfusion for prevention of a disease called retinopathy of prematurity (which such premature children 18

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are highly prone to and which makes them blind progressively), and not seeking views of pediatric ophthalmologist, has been held to be an incidence of negligence. 21 Instances of senior doctor deciding to do a surgery but actually taking up another surgery at the same time and leaving the patient to the care of a junior doctor, who is not incompetent but has no experience as such (even if such junior doctor performs the surgery without mistakes) has also led to the findings of medical negligence.48 In the cases involving medical negligence, at the beginning, the person alleging the negligence has the initial onus to make out a case of negligence, and thereafter the onus shifts on to the doctor or the hospital to satisfy that there was no lack of care or diligence. 23 It may also be noted that for imposition of civil liability on the hospital, it is not necessary that treating doctors or the nursing staff be made a party (the hospital alone can be the party to the proceeding), and it is immaterial if the medical professionals are the permanent staff or come on a visiting basis.49 The standard of care is to be judged keeping in view the body of knowledge and equipment available at the time of the incident. For example, if the allegation is that a doctor was negligent on account of his failure to use a particular equipment which should have been used, the court would consider whether such equipment was “generally available at that point of time” and therefore available for use. Every hospital cannot be expected to have state-of-the-art facilities and be fully equipped with the latest inventions and techniques. Sometimes, it becomes difficult to prove that certain equipment was generally available or not considering that there is no central or regional record of equipment used by medical professionals or hospitals. For instance, in a case where post a hernia operation in Hospital A, the arterial saturation of a diabetic patient could not be maintained due to unknown reasons, the patient had to be shifted to Hospital B which was equipped with a mechanical ventilator considering that Hospital A did not have it. The patient became comatose by the time he reached Hospital B and ultimately passed away. In this case, the State Commission fastened civil liability on Hospital A holding it guilty of medical negligence, among others, on the assumption (without any actual finding) that mechanical ventilators were generally available in Jaipur, Rajasthan, in September 2002 and Hospital A should have also had the same. While dealing with medical negligence cases, the opinions of the medical experts are often called for from both sides. Section 45 of the Indian Evidence Act, 1872, provides that when a court has to form an opinion on a point of science, the opinion of a person especially skilled in such science is considered “relevant.” It is to be noted that a “relevant” opinion is not synonymous to the opinion being “conclusive” and law reports are replete with illustrations of expert opinions being discarded for one reason or another. The real function of the expert is to put before the court all the material together with reasons which induce him to come to a certain conclusion so that the court, even though not an expert, may form its own judgment using its own observation of those materials. 27 Experts 48 49

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only render opinions and those that are “intelligible, convincing, and tested” 28 become important factors in the determination of the matter together with other evidence. Therefore, while the courts do not substitute their views for the view of the experts but if they determine that the course adopted by the medical professional concerned was inconceivable or highly unreasonable, it would be open to the court to return a finding of medical negligence.

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CH-4 ROLE OF INFORMED CONSENT Informed consent is a process for obtaining permission before conducting a healthcare intervention on a person. A health care provider may ask a patient to provide a prior consent for the purpose of medical treatment, or a clinical researcher may ask a research participant before enrolling that person into a clinical trial. Informed consent is being collected by the medical practitioners according to guidelines of medical ethics and research ethics. An informed consent can be said to have been given based upon a clear appreciation and understanding of the facts, implications, and consequences of an action. To give informed consent, the individual concerned must have adequate reasoning faculties and be in possession of all relevant facts. Impairments to reasoning and judgment that may prevent informed consent include basic intellectual or emotional immaturity, high levels of stress such as Post Traumatic Stress Disorder (PTSD) or a severe intellectual disability, severe mental illness, intoxication, severe sleep deprivation, Alzheimer’s disease, or being in a coma. “Informed consent” is a technical term first used in a medical malpractice US court case in 1957. Whereas various cultures in various places practiced informed consent, the modern concept of informed consent was developed by people who drew influence from Western tradition. Historians cite a series of medical guidelines to trace the history of informed consent in medical practice. The Hippocratic Oath, a 500 BC Greek text, was the first set of Western writings giving guidelines for the 2 conduct of medical professionals. It advises that physicians conceal most information from patients to give the patients the best care. The rationale is a beneficence model for care—the medical practitioner knows better than the patient, and therefore should direct the patient’s care, because the patient is not likely to have better ideas than the doctor.50 In cases where an individual is considered unable to give informed consent, another person is generally authorized to give consent on his behalf, e.g., parents or legal guardians of a child though in some circumstances the child may be required to provide informed assent and conservators for the mentally ill. The practice of informed consent has historical roots in various disciplines and plays a critical role in medicine as we are entering the era of patient as a consumer and medical practitioner as a service provider. In India, there has been an increase in the number of malpractice suits that have arisen because of lack of informed consent or inadequate consent from the patients for various procedures. Based on ethical and legal principles of respect for individual autonomy the legal doctrine of informed consent states that “every human being of adult years has the right to determine what shall be done with his own body.” 50

Ruth R Faden et al, A history and theory of Informed Consent,, New York: Oxford University Press 1986.

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All the procedures involving medical treatment, surgical operations, assisting reproductive technologies, treatment of mentally disabled persons and treatment of children should have proper consent in terms of age, mental capacity, free will, and full disclosure. If the patient is not medically or legally competent to give consent, the consent of the parents or guardians or any person present at the time with the patient can be taken. Any researches on a potential subject, removal of organs for transplantation, publication of information obtained during medical examination also require consent of the concerned person. Consent of the patient is not required in situations like medical emergency. Ignorance of law is not a defense in legal cases, so all medical practitioners should be aware of their duties with regard to consent in clinical setting. Any examination by medical practitioner without prior consent amounts to an assault on the patient and liable under the tort and criminal laws. Medical Council of India (MCI) laid down the rules according to which surgical treatment without consent is considered as misconduct and is punishable. Informed consent means an agreement, compliance or permission given voluntarily without any compulsion.51 It can be defined as “the voluntary and revocable agreement of a competent individual to participate in a therapeutic or research procedure, based on an adequate understanding of its nature, purpose and implications”. It is also fundamental and established principle in the Indian law. Self-defense of body52 provides right to the protection of bodily integrity against invasion by other. The fundamental principles of autonomy were first expressed in Nuremberg Code of 1947.53 Informed Consent is now accepted as the cornerstone of medical practice. 54 Informed consent of patient or his relative/attendant is necessary to ensure patient's interest. Ordinarily patients are to be informed about admitted risk, if any. If some medicine has some adverse effect or some reaction is anticipated, he should be informed thereabout. It was not done in the instant case.55 Law on medical negligence also has to keep up with advances in medical science as to treatment as also diagnostics. Medical practitioners increasingly must engage with patients during treatments especially when line of treatment is a contested one, and hazards are involved. Standard of care in such cases will involve duty to disclose to patients about risks of serious side effects or about alternative treatments.56 Informed consent is the continuous process of providing the patient or, in the case of a minor or incompetent adult, the custodial parent or legal guardian with relevant information by medical practitioner regarding diagnosis and treatment needs so that an educated decision Pillay VV: Handbook of Forensic Medicine and Toxicology. 13th edition, Hyderabad: Paras Publication; 2003:24-25. 52 Sections 96 to 102, 104, 106 of Indian Penal Code, 1860. 53 Nuremberg Code 1947. 54 Berg JW, et al: Informed Consent: Legal Theory and Clinical Practice. 2nd Edition, Oxford: Oxford University Press, 2001: 1-340. 55 Malay Kumar Ganguly v. Sukumar Mukherjee (2009) 9 SCC 221 : (2010) 2 SCC (Cr') 299 : (2009) 3 CPJ 17 (SC) : (2009) 3 SCC (Civ) 663 : AIR 2010 SC 1162. 56 Id. 51

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regarding consent for treatment can be made by the patient or custodial parent/legal guardian. Treatment and diagnosis cannot be forced upon anyone who does not wish to receive them except in statutory sanction. In the United Kingdom and India informed consent in medical procedures requires proof as to the standard of care to meet the recognised standard of acceptable professional practice (the Bolam’s Test). That what risks would a medical professional usually disclose in the circumstances. The present medical practitioner has to disclose the same. This is known as sufficient consent rather than informed consent. However, Medicine Laws in the US, Australia, and Canada take a more patient-centeric approach to “informed consent.” Informed consent in these jurisdictions requires medical practitioners to disclose significant risks, as well as risks of particular importance to that patient. This approach combines an objective and subjective approach. The objective approach is the reasonable patient approach and subjective approach is the particular patient approach. The doctrine of informed consent should be contrasted with the general doctrine of medical consent. The Consent Standard in Medical consent is that the person understands, in general terms, the nature and purpose of the intended intervention. It applies to the battery cases. However informed consent has the higher standard which applies to cases of negligence not to the battery. Significantly, causation must be shown to make the medical practitioner liable in cases of negligence. Where there is an informed consent there will be no causation.

Criteria of Valid Informed Consent Generally speaking the informed consent requires discussion of the following:57 i. The patients diagnosis ii. The nature and purpose of a proposed treatment or procedure iii. The risks and benefits of a proposed treatment or procedure iv. Alternatives and associated risks and benefits v. The risks and benefits of not receiving or undergoing a treatment or procedure vi. The special precautions required postoperatively vii. What the medical practitioner recommends For an individual to give valid informed consent, legally three components must be present: disclosure, capacity and voluntariness. i. Disclosure requires the researcher to supply the subject with the information necessary to make an autonomous decision; the investigators must ensure that subjects have adequate comprehension of the information provided. This latter requirement implies that the consent form be written in lay language suited for the comprehension skills of subject, as well as assessing the level of understanding. 14 Appelbaum PS et al :Informed Consent: Legal theory and clinical practice. Oxford University Press, New York, 1987 Catherine SweeKian TAY: Recent developments in informed consent: The basis of modern medical ethics, APLAR Journal of Rheumatology,2005; 8: 165–170. 57

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ii. Capacity pertains to the ability of the subject to both understand the information provided and form a reasonable judgment based on the potential consequences of his/her decision. iii. Voluntariness refers to the subject’s right to freely exercise his/her decision making without being subjected to external pressure such as coercion, manipulation, or undue influence. It is essential that this information be discussed in simple terminology that can be readily understood by the patient. It is also essential that the patient be given an opportunity to ask questions about his or her condition and the proposed treatment or surgery.

Finally, a medical practitioner should thoroughly document the communications process in the patient’s chart. A timely and thorough documentation in the patient’s record can be a strong piece of evidence in a court as the communications process in fact took place and that the physician made an adequate disclosure to the patient. Omission of any of the above information may invalidate the consent of the patient.

It is the responsibility of the treating medical practitioner to ensure that the patient fully understands all of the information that has been provided. It is also the responsibility of the treating medical practitioner to provide further information requested by the patient and to answer all questions asked by the patient in a manner that the patient considers satisfactory and in understandable terms.58

Consent from a patient is generally considered to be valid if (and only if) the following criteria are satisfied:59 i. The patient has decision-making capacity. (The ability to take decisions regarding consent and degree of ability of the patient to understand the nature and consequences of the treatment offered)

ii. The patient has been adequately informed. (Means that sufficient amount of information about the nature and consequence of the treatment has been disclosed to the patient). There are three “standards of disclosure for adequate informing. Wear S: Informed consent: Patient autonomy and clinician beneficence within healthcare. 2 nd Edition. Georgetown University Press, Washinton DC, 1998. 59 Singhal SK; The Doctor and Law. 1st Edition, MESH Publishing House, Mumbai,1999:166-169. 58

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a. Professional Practice Standard. The amount of information disclosed is determined by the traditional practice of a professional community, such as a community of physicians or clinical psychologists.

b. Reasonable Person Standard-The pertinence of a piece of information is measured by the significance a hypothetical reasonable person would attach to it in deciding whether to undergo a procedure. The physician must disclose all information the reasonable person would judge relevant.

c. Subjective Standard. Adequacy of information is judged by reference to the specific beliefs, desires and fears of the individual patient. Typically, it is expected that a physician will meet (ii) and, where she has (or should have) information about a particular patient that would shed light on the desirability for that patient of additional information, (iii) as well. iii. The patient has not been coerced. The patient must consent to treatment voluntarily. If she is forced to agree or threatened with grave consequences if she refuses, her consent is not valid. Informed Consent is a continuous process, which includes the exchange of information and development of choices. If after due information the patient gives contradictory or doubtful signals in a particular procedure, then he also has the right to withhold consent at any point of time of the ongoing procedure. The Indian law provides protection to the medical practitioners against legal actions in any misadventure that had happened during a procedure which is done in good faith after taking well-informed consent of the patient or his/her relatives or legal guardian in case of minor or an insane in its Criminal Law. 60 Moreover, if any consent given under the following circumstances it will not be true consent.61 i. By a person under fear of injury or, ii. By a person who is under misconception of the facts and person who obtain consent knows or has reason to believe that or consent was given inconsequence of such fear / misconception. iii. By intoxicated person or, iv. By a person who is of unsound mind or, unable to understand the nature and consequences of that to which he gives consent. v. By a person who is below the age of 12 yrs. 60 61

Section 87, 88 and 89 of Indian Penal Code, 1860. Section 90 of Indian Penal Code, 1860

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Ethical Elements of Informed Consent There are two ethical justifications for the claim that medical practitioners should get consent from patients for tests or treatments. The first is based on the moral (and ethical) principle of autonomy, according to which a person has a right to determine the course of her own life and to be free (within limits that must themselves be justified) from interference by others. A central aspect of this right is a person’s right to bodily integrity. It is impermissible for any person (including a medical practitioner) to invade or manipulate the body of another without permission. The second is based on the ethical principle of beneficence, according to which medical practitioners should act out of compassion or concern for their patients and aim at doing what will be best for them.

Exceptions for Obtaining Consent There are two exceptions to the common law rule where less information may be justifiable: i. Therapeutic privilege: It that a medical practitioner can withhold information if he/she feels that it would be psychologically damaging or harm the patient (e.g. if the patient is suicidal or mentally ill) if disclosed. Even in this case, however, a medical practitioner may not be justified in withholding information if a patient asks a specific question.62 Therapeutic privilege does not extend to giving medical practitioners the right to lie to their patients. Medical practitioners have an ethical duty to share information with their patients for their interest. However a result in any misadventure is not punishable by law.63 ii. Emergency life-threatening situation: The most sacred duty of the medical practitioner is to save the life of his patient. Treatment may be given without any information or consent if it is necessary to protect the patient's life or health. Where a patient is unconscious, intoxicated, and disoriented unable to consent or appreciate what is required, the medical practitioner may administer the necessary medical treatment in good faith or for the benefit of the patient. 64 Failure on the part to provide timely medical treatment to a person in need of such treatment results in the violation of his right to life guaranteed under Article 21 of Indian Constitution.

Krishnan VIJ; Textbook of Forensic Medicine and Toxicology: Principles and Practice. 4th Edition,Elsevier India, 2008: 482-490. 63 Section 93, Indian Penal Code , 1860. 64 Section 92, Indian Penal Code , 1860. 62

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CH-5 JUDICIAL DELIBERATIONS ON INFORMED CONSENT Barring physical examination, informed consent is necessary for every medical examination and surgical procedures, which should be obtained in or in the presence of disinterested party. Informed consent is also required in anesthesia (local, regional, or general) with explanations regarding the procedure of anesthesia, its complications during the procedures, and it‟s after effects. If during the ongoing procedure any extension of the procedure is required which is not covered, fresh consent should be insisted. Similarly, treatment by chemotherapy and radiotherapy should involve consent for treatment after proper disclosure of side effects and further disabilities. Research studies or clinical trials should be conducted and have informed consent as per the guidelines laid by Indian Council of Medical Research.65 Separate care should be taken in case of blood transfusion during the procedure and patient should have proper information about the amount of blood to be transfused. It is on the safer side to take the consent of spouse if the operation destroys or limits sexual functions. All the transplants involving human tissue or organ should have consent based upon the guidelines of Transplantation of the Human Organ Act 1994. If prior consent for organ donation before death is given in the presence of two or more witnesses, then transplantation of the organ should be presumed and is permissible without seeking further consent.66 While it is not legally necessary it is good medical practice to consult with relatives of patient in patients best interest and ones this has been established then medical practitioner can continue to give treatment in good faith Patients nowadays no longer want to be treated as passive recipients of medical care. Medical litigation and demands for medical accountability is the trend of the day. To avoid negligence and breaching, the medical practitioner should exercise his skill with competence in accordance with accepted practice. He should discuss his diagnosis and treatment plan with the patient. If the patient inquires about the risks of proposed medical treatment, the medical practitioner must disclose the material risks to the patient. It is good practice to document contemporaneously his advice to which the patient has consented. In doubt, it is prudent for the medical practitioner to seek a second opinion from his colleagues professing a similar skill. It can therefore be concluded that Informed Consent should be taken seriously by all clinicians and medical researchers in the broader interest of patient-doctor relationship and there should be no compromise in providing 65

55 Ethical guidelines for biomedical research on human participants (New Delhi, Indian Council of Medical Research: 2006) Chapter III. 66

56 Ethical guidelines for biomedical research on human participants, (New Delhi: Indian Council of Medical Research, 2006) Guidelines on Cadaver Donor Transplants P.88.

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information that is not “reasonable” in the eyes of the court. In the event of an adverse medical outcome written records of such discussions can be medical practitioner’s best defense as the court can demand relevant documents/ X-ray films of the patient.67

Samira Kohli vs Prabha Manchanda In India, the extent and nature of information required to be given by medical practitioners to the patient in order to obtain a valid consent is governed by the Bolam test 68 and not by the "reasonably prudential patient" test evolved in Canterbury. 69 It is for the medical practitioner to decide, with reference to the condition of patient, nature of illness and the prevailing established practices as to how much information regarding the risks and consequences should be given and how they should be couched in the best interest of the patient. A medical practitioner acting accordingly with normal care and in accordance with a recognised medical practice cannot be said to be negligent merely because a body of opinion takes a contrary view. In Samira Kohli vs Prabha Manchanda,70 on evidence the patient had given consent for laparoscopy and not for hysterectomy (removal of uterus) and bilateral salpingooopherectomy (removal of ovaries and fallopian tubes). In the absence of any medical emergency, consent given by the patient's mother when the patient was a competent adult, was not a valid consent. Moreover, the consent given by the mother for hysterectomy did not amount to consent for bilateral salpingooopherectomy.71 The appellant,72 an unmarried woman, aged 44 years, visited the clinic of the respondent complaining of prolonged menstrual bleeding for nine days. The respondent examined and advised her to undergo an ultrasound test. After examining the report, the respondent had a discussion with the appellant and advised her to undergo a laparoscopy test under general anesthesia, for making an affirmative diagnosis. Accordingly, on the next day, the appellant went to the respondent's clinic with her mother. On admission, the appellant's signatures were taken on Admission and discharge card; Consent form for hospital admission and medical treatment; and Consent form for surgery. The admission card showed that admission was "for diagnostic and operative laparoscopy" on the date specified. The consent form for surgery filled by the respondent's assistant described the procedure to be undergone by the appellant as "diagnostic and operative laparoscopy" and added that laparotomy might be needed. Thereafter, the appellant was put under general anaesthesia and subjected to a laparoscopic examination. When the appellant was still 57 Rathor MY,et al; Informed Consent: A Socio-Legal Study, Med J Malaysia, 2011; 66(5):423- 428; Levinson W,et al: Physician-patient communication: The relationship with malpractice claims among primary care physicians and surgeons. Journal of the American Medical Association, 1997; 277(7) S: 553-559. 68 (1957) 1 WLR 582 69 Canterbury v. Spence, 464 F 2d 772: 150 US App DC 263 (1972) 30. 67

70 71 72

60 Samira Kohli: v. Dr. Prabha Manchanda (2008) 2 SCC 1 Id.

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unconscious, respondent's assistant came out of the operation theatre and took the consent of the appellant's mother, who was waiting outside, for performing hysterectomy under general anaesthesia. Thereafter, the respondent performed an abdominal hysterectomy (removal of uterus) and bilateral salpingo-oopherectomy (removal of ovaries and fallopian tubes). The appellant left the respondent's clinic five days later without settling the bill. A few days later, the respondent lodged a complaint with the police alleging that the appellant's friend had abused and threatened the respondent and had got the appellant discharged without clearing the bill and against medical advice. Subsequently, the appellant also lodged a complaint against the respondent alleging negligence and unauthorised removal of her reproductive organs. The respondent then issued a legal notice demanding Rs 39,325 for professional services. Thereafter some correspondence in that regard took place between them. At last, the appellant filed a complaint before the National Consumer Disputes Redressal Commission claiming a compensation of Rs 25 lakhs from the respondent on the grounds that the respondent was negligent in treating her; that the radical surgery by which her uterus, ovaries and fallopian tubes were removed without her consent, when she was under general anaesthesia for a laparoscopic test, was unlawful, unauthorised and unwarranted; that the removal of her reproductive organs had led to premature menopause necessitating a prolonged medical treatment and a hormone replacement therapy (HRT) course, besides other possible side- 32 effects. The compensation claimed was for the loss of reproductive organs and consequential loss of opportunity to become a mother, for diminished matrimonial prospects, for physical injury resulting in the loss of vital body organs and irreversible permanent damage, for pain, suffering emotional stress and trauma, and for decline in the health and increasing vulnerability to health hazards. The Court held that i. the appellant voluntarily visited the respondent's clinic for treatment and consented for diagnostic procedures and operative surgery; ii. the hysterectomy and other surgical procedures were done with adequate care and caution; and iii. the surgical removal of uterus, ovaries, eft. was necessitated as the appellant was found to be suffering from endometriosis (Grade IV), which might culminate in damage to the intestines and bladder, the Commission dismissed the complaint. The appellant then filed the appeal before the Supreme Court, the appellant contended that since only a diagnostic procedure by way of a laparoscopic test was to be conducted, there was no discussion with regard to any proposed treatment. 

That when the appellant was under general anaesthesia, the respondent rushed out of the operation theatre and obtained the signature of the appellant's mother on some paper on the pretext that in order to save the appellant's life an extensive surgery had become necessary. 29

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

That since the appellant had given consent only for a laparoscopic test and as her mother's consent for conducting hysterectomy had been obtained by misrepresentation, there was no valid consent for the radical surgery much less an informed consent therefore.



That moreover the respondent failed to exhaust conservative treatment before resorting to radical surgery.



That the respondent did not inform the appellant, of the possible risks, side-effects and complications associated with such surgery, before undertaking the surgical procedure. Such surgery without her consent was also in violation of medical rules and ethics.

On the other hand, the respondent contended 

That she had informed the appellant that if on the laparoscopic examination, if the lesion was found to be extensive, then hysterectomy would have to be performed.



That the appellant had agreed to that.



That the appellant's mother also, when informed in that regard stated that the respondent might do whatever was best for her daughter.



That the appellant had signed the consent forms only after she read the duly filled up forms and understood their contents.



That the consent given by the appellant's mother for performing hysterectomy should be considered as valid consent for performing hysterectomy and salpingooopherectomy.



That the term "laparotorny" used in the consent form was equal to or same as hysterectomy.



That on laparoscopic examination, it was found that conservative surgery would not be sufficient and removal of uterus and ovaries was necessary. After such surgery had been done, there was no protest from the appellant or her mother.



That in view of the advanced age of the appellant the said organs were not vital ones.



That however, later the appellant's fiancé created a scene, got her discharged and went away without paying the bill.

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

That the respondent had performed the proper surgical procedure in pursuance of the consent given by the appellant and there was no negligence, illegality, impropriety or professional misconduct.



That in the realm of diagnosis and treatment there was ample scope for genuine differences of opinion and no medical practitioner could be said to have acted negligently merely because his or 34 her opinion differed from that of other medical practitioners or because he or she has displayed lesser skill or knowledge when compared to others.

On the basis of the pleadings of the parties, the Supreme Court formulated the following questions: i. Whether informed consent of a patient is necessary for surgical procedure involving removal of reproductive organs? If so, what is the nature of such consent? ii. When a patient consults a medical practitioner, whether consent given for diagnostic surgery can be construed as consent for performing additional or further surgical procedure-either as conservative treatment or as radical treatment-without the specific consent for such additional or further surgery? iii. Whether there was consent by the appellant, for the abdominal hysterectomy and bilateral salpingooopherectomy (for short AH-BSO) performed by the respondent? iv. Whether the respondent had falsely invented a case that the appellant was suffering from endometriosis to explain the unauthorised and unwarranted removal of uterus and ovaries, and whether such radical surgery was either to cover-up negligence in conducting diagnostic laparoscopy or to claim a higher fee? v. Even if the appellant was suffering from endometriosis, the respondent ought to have resorted to conservative treatment/surgery instead of performing radical surgery? vi. Whether the respondent is guilty of the tortious act of negligence/battery amounting to deficiency in service, and consequently liable to pay damages to the appellant?"

Allowing the appeal and allowing the claim in part. The Court held that regarding questions (i) and (ii) 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 medical practitioner, 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. 31

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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 of consent, shifts the emphasis on the medical practitioner's duty to disclose the necessary information to the patient to secure his consent. The element of medical practitioner's duty in "informed consent" was emphasised in Canterbury 36 case.73 That principle was accepted by an English court also. The principle of necessity by which the medical practitioner is permitted to perform further or additional unauthorized procedure purportedly pursuant to the consent given for a particular operative procedure, is restricted to cases where the patient is temporarily incompetent for being unconscious, to permit the procedure delaying of which would be unreasonable because of the imminent danger to the life or health of the patient. Unless the unauthorised additional or further procedure is necessary in order to save the life or preserve the health of the patient and it would be unreasonable as contrasted from being merely inconvenient) to delay the further procedure until the patient regains consciousness and takes a decision, a medical practitioner cannot perform such procedure without the consent of the patient. Moreover, in view of the provisions contained in Clause 13 of the chapter relating to disciplinary action, of the Code of Medical Ethics laid down by the Medical Council of India as approved by the Central Government under Section 33 of the Indian Medical Council Act, 1956 and the guidelines to medical practitioners issued by the General Medical Council of UK says that in seeking consent of the patient for investigation and treatment, and the stipulations contained in the consent form for hospital admission used in the present case, which can safely be presumed to constitute the contract between the parties, it is held in medical law, where a surgeon is consulted by a patient, and consent of the patient is taken for diagnostic procedure/surgery, such consent cannot be considered as authorisation or permission to perform therapeutic surgery either conservative or radical except in lifethreatening or emergent situations. Similarly where the consent by the patient is for a particular operative surgery, it cannot be treated as consent for an unauthorised additional procedure involving removal of an organ, only on the ground that such removal is beneficial to the patient or is likely to prevent some danger developing in future, where there is no imminent danger to the life or health of the

73

Canterbury v. Spence, 464 F 2d 772: 150 US App DC 263 (1972).

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patient. The stringent standards regarding disclosure laid down in Canterbury, as necessary to secure an informed consent of the patient, were not accepted in the English courts. In England, standard applicable is popularly known as the Bolam test, first laid down in Bolam case.74 The present case is not concerned with the duties or obligations of medical practitioners in government charitable hospitals where treatment is free or on actual cost basis but with medical practitioners in private practice and hospitals and nursing homes run commercially, where the relationship of medical practitioners 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. Having regard to the conditions obtaining in India, as also the settled and recognised practices of medical fraternity in India, it is held that to nurture the doctor-patient relationship on the basis of trust, the extent and nature of information required to be given by medical practitioners should continue to be governed by the Bolam test rather than the "reasonably prudential patient" test evolved in Canterbury case. The principles relating to consent can be summarised as follows: i. A medical practitioner 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 he is consenting to. ii. The "adequate information" to be furnished by the medical practitioner (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 or not. This means that the medical practitioner 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 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 avoiding the possibility of 74

(1957) 1 WLR 582.

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the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment. iii. 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 unauthorised 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 unauthorised, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorised procedure until patient regains consciousness and takes a decision. iv. 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. v. The nature and extent of information to be furnished by the medical practitioner 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. The "real consent" concept has, herein, been preferred over the "reasonably prudent patient test" having regard to the ground realities in medical and health care in India. But if 'medical practitioners and private hospitals become more and more commercialised, and if there is a corresponding increase in the awareness of patient's rights among the public, inevitably, a day may come when the Court may have to move towards Canterbury but not in the present scenario. The Court observed that regarding question no. (iii) According to the respondent, the abdominal hysterectomy and bilateral salpingooopherectomy (AH-BSO) was not necessitated on account of any emergency or life-threatening situation developing or being discovered when laparoscopic test was conducted, but according to an agreed plan, consented by the appellant and her mother, reiterated in writing the next day. Therefore the defence of the respondent is one based on specific consent. However, besides other documents, the admission card makes it clear that the appellant was admitted only for diagnostic and operative laparoscopy. It does not refer to laparotomy. The consent form shows that the appellant gave consent only for diagnostic operative laparoscopy, and laparotomy if needed. Laparotomy is a surgical procedure to open up the abdomen or an abdominal operation. It refers to the operation performed to examine the abdominal organs and aid diagnosis.

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Hysteroscopy is inspection of uterus by special endoscope and laparoscopy is abdominal exploration by special endoscope. When a specific operation say hysterectomy or salpingooopherectomy is planned, laparotomy is merely the first step of the procedure, followed by the actual specific operation, namely, hysterectomy or salpingo-oopherectomy. Therefore, when the consent form refers to diagnostic and operative laparoscopy and "laparotomy if needed", it refers to a consent for a definite laparoscopy with a contingent laparotomy, if needed. It does not amount to consent for the abdominal hysterectomy and bilateral salpingooopherectomy (AHBSO) surgery removing the uterus and ovaries/fallopian tubes. The respondent's contention that "laparotomy" refers to and includes hysterectomy and bilateral salpingo-oopherectomy cannot be accepted. Medical texts and authorities clearly spell out that laparotomy is at best the initial step that is necessary for performing hysterectomy or salpingooopherectomy. Laparotomy by itself is not hysterectomy or salpingooopherectomy. Nor does "hysterectomy" include salpingooopherectomy, in the case of woman who has not attained menopause. Laparotomy does not refer to surgical removal of any vital or reproductive organs. When the oral and documentary evidence is considered in the light of the legal position discussed while answering questions no. (i) and (ii), it is clear that there was no consent by the appellant for conducting hysterectomy and bilateral salpingo-oopherectomy. As regards the respondent's contention that the consent given by the appellant's mother for performing hysterectomy should be considered as valid consent for performing hysterectomy and salpingo-oopherectomy, it is held that when a patient is a competent adult, there is no question of someone else giving consent on her behalf. In the absence of an emergency and as the matter was still at the stage of diagnosis, the question of taking her mother's consent for radical surgery did not arise. Therefore, such consent by mother cannot be treated as valid or real consent. Further a consent for hysterectomy, is not a consent for bilateral salpingo-oopherectomy. It was, therefore, held that there was no consent by the appellant for hysterectomy or bilateral salpingo-oopherectomy. The words "Laparotomy may be needed" in the consent form can only refer to therapeutic procedures which are conservative in nature (as for example removal of chocolate cyst and fulguration of endometric areas, as stated by the respondent herself as a choice of treatment), and not radical surgery involving removal of important organs. As regards the respondent's contention that what were removed were not "vital" organs and having regard to the advanced age of the appellant, suffice it to say that for a woman who has not married and not yet reached menopause, the reproductive organs are certainly important organs. After going through all these deliberations it was concluded that process of obtaining informed consent can be improved by following ways: i. Work on your rapport-The importance of good rapport between the patient and medical practitioner cannot be overemphasized. The level of rapport is a better predictor of the risk of litigation than the actual content of any particular discussion. ii. Discuss all treatment options with regardless of insurance coverage-Determining what should be disclosed as a material risk in the consent process can be challenging. 35

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iii. For guiding and documenting your discussion with the patient ensure following things: a. Alternative therapies available. b. Benefits of the therapy proposed. c. Common but not devastating risks. d. Devastating but not common risks. e. Extra considerations specific to this patient. f. Facial expressions, body language, and questions iv. Decide how much medication information the patient needs v. Discuss how test results will be communicated -Laboratory or radiology investigations and their results introduce a unique set of issues. Particularly for nonroutine lab work, it is prudent to discuss the advantages, disadvantages, and limitations of the test being ordered or recommended. vi. Keep a record of referrals-A patient generally has the right to refuse specialty treatment or referral to a specialist, once informed of the risks of delay or lack of treatment after making such a decision. If a patient still refuses referral, document the decision in case it results in a delayed diagnosis or an adverse outcome. vii. Avoid making guarantees about procedure -All procedures, including associated anesthesia, require a discussion of risks and benefits. If appropriate, also discuss available alternative procedures and your reasons for not recommending them. viii. Document, document, document -Documentation is a necessary, final step. It records the process that is vital to good patient care and it may be the only proof that a discussion took place. Legal case opinions shed little light on what represents adequate documentation.

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CH-6 ENFORCEMENT MACHINERIES The civil liability is enforced through the civil court system and consumer liability is enforced through the consumer court. The common law enforcement under Tort law is being discussed below. Enforceability under tort law The damages are awarded by the Civil Court, and each and every suit shall be instituted in the Court of the lowest grade competent to try it. A suit for compensation may be instituted at the option of the plaintiff either in the court within the local limits of whose jurisdiction the wrong is done, the cause of action arises or in the court within the local limits of whose jurisdiction the defendant resides, or carries on business, or personally works for gain. A huge amount of court fee is required to be paid in any suit for compensation on the allegation of medical negligence. Moreover a much quicker and cheaper remedy is available to the consumer of medical service under different Consumer Disputes Redressal Agencies established by the Consumer Protection Act 1986.Another common law enforcement system is through the Criminal Court.75 Enforcement of Criminal Liability Criminal Liability is mainly enforced though the criminal court with respect to the provisions of Indian Penal Code and Criminal Procedure code. The extent of liability in tort depends on the extent of damages, but the extent of liability in criminal law depends on the amount and degree of negligence. Now unliquidated damages are awarded in criminal liability. This distinction between tort and crime has been reduced in England by giving power to the criminal courts to award compensation to the victims while passing judgment of conviction. By way of interpretation of section 357 of the Code of Criminal Procedure 1973, the Supreme Court has observed that the Criminal Court may order the accused to pay some amount by way of compensation to victim who has suffered by action of the accused. It may be noted that this power of criminal courts to award compensation is not ancillary to other sentence, but it is in addition thereto. In Harikrishnan's case76 the Supreme Court has directed all criminal courts to exercise the power of awarding compensation to victims of offences in such a liberal way, that the victims or their legal heirs may not have to rush to the civil court for compensation. By authorizing the Criminal Courts to award compensation on consideration of the nature of the crime, justness of claim of the victim, and ability of the accused to pay, the distinction between tort and crime has been reduced to a large extent, that the degree of negligence in 75 76

Supra N 35. Hari Kishan & Anr vs Sukhbir Singh & Ors, AIR 1988 SC 2127.

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Criminal liability is higher than that of negligence in tortious liability. But negligence in the context of criminal liability, the expression Mens Rea becomes relevant. Mens Rea in Negligence: The expression Mens Rea is used to mean the mental state expressly or impliedly mentioned in the definition of crime charged. An act done doesn’t make a person guilty unless the mind is guilty. The Mens Rea in criminal negligence was defined by Lord Diplock77 in the following way “without having given any thought to the possibility of there being such risk or having recognised that there was some risk involved, had nevertheless gone on to take it.” In order for the act to amount to criminal rashness or criminal negligence one must find out whether that rashness has been of such a degree that injury must most likely to be occasioned thereby. The criminality lies in running the risk or doing such an act with recklessness and indifference to the consequences.78 Enforcement Mechanism under Indian Consumer Protection Act The agencies which have been constituted under the Act for redressal of consumer grievances are to adjudicate disputes at the district, State and National level. The District Consumer Disputes Redressal Forum in each district of the State established by the State Government is also known as District Forum. It is the first court in the hierarchy. Then, there is State Consumer Disputes Redressal Commission known as the State Commission, also established by the State Government. In both the cases, the approval of the Central Government is required. Finally, there is the National Consumer Dispute Redressal Commission established by the Central Government. Establishment of all the aforesaid various agencies have to be done by notification. Interestingly, all the States in the country did not achieve the distinction of having a Forum in each and every district, thus time and again public spirited bodies agitated the issue and appropriate directions were issued to the government concerned. It is pertinent to mention that the consumer agencies as constituted under the Act are to comprise of one judicial member and others having adequate knowledge or experiences of, or having shown capacity in dealing with problems relating to economics, law, commerce, accountancy, industry, public affairs or administration, one of whom shall be a woman. To deal with cases of medical negligence, expert knowledge of science is also required. It is advisable that the agencies should also have at least one medical man to adjudicate such disputes.79 In the alternative, Forums can also try cases of medical negligence with a panel of medical expert as a jury on special days in a week or month so fixed. Appeal and Revision As earlier stated, subject to the pecuniary limits, the District Forum is the first court in the hierarchy of agencies under the Act.80 The State Commission has jurisdiction to entertain R v. Lawrence (1981) , 1 All ER 974, (1982) AC 510, (1981)2WLR 5249(HC). Dr. Krishnaprasad vs State of Karnataka, II (1988) ACC 423, ILR 1988 KAR 923. 79 Section 10 of the Consumer Protection Act of 1986. 80 Section 17 (a) (ii) of the Consumer Protection Act of 1986. 77 78

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appeals against the orders of any District Forum within the state. Any person aggrieved by an order of the District Forum may prefer an appeal to the State Commission within thirty days from date of the order81. However, delay in filing an appeal may be condoned if sufficient cause is shown. Similarly, the National Commission has jurisdiction to entertain appeals against the orders made by a State Commission.82 The person aggrieved by an order made by the State Commission may prefer an appeal to the National Commission within a period of thirty days from the date of the order. Delay in filing maybe condoned, provided sufficient cause is shown for not filing an appeal within the time. Furthermore, any person aggrieved by an order made by the National Commission in exercise of its powers to entertain complaints may prefer an appeal against such order within thirty days to the Supreme Court. Revisionary power is also allowed by this law. Apart from appellate jurisdiction, the State Commission and the National Commission have been vested with powers of revision.83 There is no limitation period for filling a revision petition. These powers are analogous to those conferred on civil court of competent jurisdiction under section 115 of the code of Civil Procedure, 1908. In the Consumer Protection Act 1986, all the provisions are enshrined which regulate the adjudication of consumer disputes in accordance with established principles of law and statutory codes obviating any scope for arbitrariness, bias or non-application of judicial mind. There are checks over the judgments of trial agencies by the superior Commission, wherever the question of jurisdiction has to be decided, so even under an Act which postulates summary trial, provisions have been incorporated to settle the law through a systematic hierarchy of courts. Although, a final judgment pronounced after hearing and evidence of the parties can be assailed by availing the remedy of appeal, sometimes even the final order may be affected by apparent jurisdictional questions, making way for a revision to be filed. Where no sufficient cause was established for condonation of delay, the appeal was dismissed in Oriental Insurance Co. v. Bahadar Ram84. A compliant was dismissed in default because of absence of complainant and his counsel. An application was filed for restoration. There is no appeal against an interlocutory order. It can be treated and disposed of as revision petition. An appeal can be filed beyond limitation period with a plea for condonation on the ground that review petition was pursued, and dismissed as the Act has no provision for any review85. Delay occasioned while the appeal papers are examined by various officers of the appellant cannot be condoned. Even though such speedy system is provided in the statute practically the court could not implement it in proper way. The court has power to issue stay order.

Section 15 of the Consumer Protection Act of 1986. Section 21(a) (ii) of the Consumer Protection Act of 1986. 83 Section 17 (b) and Section 21 (b) of the Consumer Protection Act of 1986. 84 Oriental Insurance Co. v. Bahadar Ram, 1992 CPJ 526. 85 Union of India v. Nadhu Shah Kapoor , II (1993) CPJ 1044. 81 82

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CH-7 EVOLUTION OF MEDICAL JURISPRUDENCE THROUGH LAWS AND DECISIONS The Apex in the recent years has based its decisions on a balanced note. Wherein though the rights of the patients has been given the upper hand the apex in its view has kept an eye to maintain the interest and safeguard the interest of the practitioners; the following which can be better understood with the landmark judicial precedents which have paved a way for the evolution of medical negligence. Landmark Judgements and Judicial Precedents The main source of evolution of law is through judicial decisions. The following are the discussions relating to judicial law making in India. Court rendered some landmark decisions like in Indian Medical Association v. VP. Shantawherein the medical profession was included within the meaning of deficiency in services under Consumer Law. This decision contributed speedy, inexpensive, accessible and expeditious remedy to the complainant. Supreme Court at the same time criticised the competency of consumer court to appreciate medical evidence. This was a revolutionary outcome of the judicial decision. In Vineetha Ashok v. Lekshmi Hospital86 the court declared that if there is any mistake in the process of diagnosis, it cannot be considered as a case for medical negligence. Thus the court made a valuable contribution in upholding the professional freedom of doctors. In Spring Medow 's Hospital case87, court declared that “the parents can act as potential consumers on behalf of minor child. They can bring the compensation suit before court. This was the positive stand of court to provide maximum access to justice.” Summarization Of The Principles Laid Down For Determining Medical Negligence The Supreme Court decided a number of cases in this area, and doing so they largely referred to English cases. They adopted the principles of English law to decide the case. The following are the outcome of this study in brief relating to law of medical negligence that developed through judicial decisions i. Negligence is the breach of a duty caused by omission to do something which a reasonable man guided by those consideration which ordinarily regulate the conduct of human affairs would do, or for something which a prudent and reasonable man wouldn’t do. Negligence becomes actionable on account of injury which resulted from the act or omission amounting 86 87

Vineetha Ashok v. Lekshmi Hospital, Appeal (civil) 2977 of 1992. Spring Meadows Hospital v. Harjol Ahluwalia, AIR 1998 SC 1801.

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to negligence attributable to the being person sued. The essential components of negligence are three, duty, breach of duty and damage ii. 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, herein particular a doctor, additional consideration applies. A case of occupational negligence is different from that of professional negligence. An error of judgement or a simple lack of care also an accident, is not proof of negligence on the part of a medical professional. So long as 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 wouldn’t have chosen to follow or resort to that practice or procedure which the accused followed.88 iii. When it comes to the failure of taking precautions it can be checked whether those precautions were taken without the standard of an ordinary medical practitioner, which has found to be sufficient in this situation. 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 purview 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 will 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. iv. 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, that he did not exercise, with reasonable competence in the said case, the skill which he did possess. The standard to be applied for judging , whether the person charged has been negligent or not, will 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 skill 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. v. The test for determining medical negligence as laid down in Bolam's Case 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. An act to be amounting to criminal negligence, the degree of negligence should be much higher ie, 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 of prosecution.89 vi. The word 'gross' has not been used in section 304 A 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'. Supra N 4. MEDICAL NEGLIGENCE &COMPENSATION, available at: http://shodhganga.inflibnet.ac.in/bitstream/10603/130522/13/13_chapter%206.pdf, last seen on April 01, 2019. 88 89

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The expression rash or negligent act 'as occurring in section 304A of the IPC has to be read as 'grossly' vii. 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 resulted in the cause of action. viii. Res Ipsa Loquitur is only a rule of evidence and operates in the domain of civil law especially in cases of torts and helps in determining the onus of proof in actions relating to negligence. It can’t 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.90 ix. A doctor has to seek and secure the consent of the patient before commencing a “treatment” (the “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 and 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 he is consenting to. x. The “adequate information” to be furnished by the doctor (or a member of his team) who is treating the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment or not. This means that the doctor should disclose a) b) c) d)

nature and procedure of the treatment and its purpose, benefits and effect alternatives if any available an outline of the substantial risks; and adverse consequences of refusing treatment.

Also there is no required need to explain remote or theoretical risks involved which may frighten or confuse a patient and result in refusal of consent for a necessary treatment. Similarly, there isn’t 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 avoiding the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment. xi. Consent given only for a diagnosis procedure cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure isn’t valid for conducting some other treatment procedure. The sole fact that the unauthorized additional surgery is beneficial to the patient., or that it will save considerable time and expense to the patient., or would be able to 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 exception to this rule is where the additional procedure through unauthorized, is necessary in order to save 90

State of Haryana vs. Smt. Santr, AIR 2000 SC 3335.

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the life or preserve the health of the patient and it would be termed unreasonable to delay such unauthorized procedure until patient regains consciousness and takes a decision.91 xii. There can be a common consent for diagnostic and operative procedure where they are contemplated. There can also be a common consent or a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery. Thus, several landmark judgements have made a strong impact on the medical jurisprudence in India; keeping in view the interest of the medical practitioners and also the rights of the patients.

Liberalizing consent - Supreme Court's preference for real consent over informed consent , available athttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC2747446/, last seen on April 01, 2019. 91

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CONCLUSION AND SUGGESTIONS Noting an increasing number of medical negligence cases coming before the consumer forums, the court said it hopes this verdict “acts as a deterrent and a reminder to those doctors, hospitals, the nursing homes and other connected establishments who do not take their responsibility seriously.” Some plausible and effective measures to check malpractices so that propriety and professional dignity is not put at stake; To start with, the Consumer Protection Act and also other related laws can be modified and reformed by integrating crucial provision in it. i. There should be mandated a scrutiny of all cases before the same is put into trial. The scrutiny should be done by medical experts and only such cases which are prima facie act of negligence, should be subjected to the summary jurisdiction of Consumer Forum. It should be also foreseen that while trying such disputes the Forum should comprise an additional member from the medical field so that the evidence is cited and judged in a proper perspective. ii. Fixing one or two days in a month wherein the Forum would hear only cases of medical negligence. The cases should be heard before a panel of medical experts who may act like a jury. And in turn pronounce judgment on any issue of medico-legal importance. iii. It must be made obligatory on the part of medical men to maintain records of their indoor patients for a period of three years. And furnish the same within 72 hours of being demanded. The misunderstandings and misconceptions based on mistrust would be resolved if medical records are provided to the patients or their descendants timely.92 iv. The above modifications in the substantive and procedural part of the statute would, inter alia, ensure two things: Those false and malicious cases would not see the light of day and secondly genuine claims will not fail for want of proper testimony. These two things put together would pave the way for more confidence and trust between the doctors and patients on the one hand and between doctor patient and the administration of consumer justice on the other.

92

Supra N 35.

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BIBLIOGRAPHY A) BOOKS:      

Anoop K. Kaushal, Medical Negligence and Legal Remedies,Universal Law Publishing Company Pvt. Limited. B. Sandeepa Bhat, Reflections on Medical Law and Ethics in India, Eastern Law House Private Limited. Dr. Jagdish Singh, Vishwa Bhushan,Medical Negligence and Compensation, Bharat Law Publications. Krishan Pal Singh Mahalwar, Medical negligence and the Law, Deep & Deep Publications. R. K. Bag, Law of Medical Negligence and Compensation, Eastern Law House. Tapas Kumar Koley, Medical Negligence and the Law in India: Duties, Responsibilities, Rights, Oxford University Press.

B) JOURNALS: 

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Aditya Singhal, The Veracity of Laws relating to Medical Malpractice in India, International Journal of Scientific and Research Publications (ISSN: 2250-3153), available at: http://www.ijsrp.org/monograph/Veracity_of_laws_relating_to_medical_malpractice_ in_India.pdf Daya Tiwari, Medical Negligence In India: A Critical Study, available at:https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2354282 Dr. Sonia Shali, MedicalNegligence in India: Current Issues and Ethics, International Journal of Advance Research, Ideas and Innovations in Technology, ISSN: 2454132X, available at: https://www.ijariit.com/manuscripts/v3i6/V3I6-1360.pdf K K S R Murthy, Medical negligence and the Law, Indian Journal of Medical Ethics Vol IV No 3 July-September 2007, available at: https://ijme.in/articles/medicalnegligence-and-the-law/?galley=html Lavlesh Kumar, Medical negligence- Meaning and Scope in India, journal of the Nepal Medical Association 51(181):49-52 · March 2011, available at: https://www.researchgate.net/publication/221833087_Medical_negligence_Meaning_and_Scope_in_India Mukesh Yadav, Pooja Rastogi, A Study of Medical Negligence Cases decided By the District Consumer Courts of Delhi, J Indian Acad Forensic Med. Jan-March 2015, Vol. 37, No. 1 (ISSN 0971-0973), available at: https://www.academia.edu/10258995/A_Study_of_Medical_Negligence_Cases_decid ed_by_the_District_Consumer_Courts_of_Delhi

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B) WEBSITES:             

http://medind.nic.in/jal/t15/i1/jalt15i1p50.pdf. http://shodhganga.inflibnet.ac.in/bitstream/10603/124067/16/16_conclusion.pdf. http://www.ijsrp.org/monograph/Veracity_of_laws_relating_to_medical_malpractice_ in_India.pdf. http://www.legalservicesindia.com/article/1685/Test-of-Medical-Negligence.html. https://ijme.in/articles/medical-negligence-and-the-law/?galley=html. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2354282. https://www.academia.edu/7576947/MEDICAL_NEGLIGENCE_IN_INDIA_A_CRI TICAL_STUDY_MEDICAL_NEGLIGENCE_IN_INDIA_A_CRITICAL_STUDY. https://www.ijariit.com/manuscripts/v3i6/V3I6-1360.pdf. https://www.indiatimes.com/news/india/5-recent-incidents-of-medical-negligenceshow-that-doctors-need-to-wake-up-from-slumber-344053.html. https://www.lawctopus.com/academike/medical-negligence/. https://www.lawteacher.net/cases/bolitho-v-hackney.php. https://www.ncbi.nlm.nih.gov/pubmed/28784730. https://www.researchgate.net/publication/221833087_Medical_negligence_Meaning_and_Scope_in_India.

C) CASE LAWS: 1. Achutrao Haribhau Khodwa and Other vs State of Maharastra and Others; 1996 SCC (2) 634, JT 1996 (2) 624. 2. Bolam v. Friern Hosp. Management Committee,(1957) 1 WLR 582. 3. Calcutta Medical Research Institute vs Bimalesh Chatterjee (1999)CPJ 13 (NC). 4. Chameli Singh v. State of U.P., AIR 1996 SC 1051. 5. Consumer Education and Research Center v. Union of India, AIR1995 SC 1922. 6. Delhi Development Authority v. J.N. Luthra 1993 II CPJ 934. 7. Donoghue v. Stevenson, (1932) A.C. 31.H.L. 8. Dr LaxmanBalkrishna Joshi vs Dr TrimbakBapuGodbole AIR1969 (SC)128. 9. Dynavox Electronic v. BJS Rampura Jain College 1991(1)CPJ 440. 10. Francis Coralie Mullin v. The Administration Union Territory of Delhi AIR 1981 SC 746. 11. House of Lords decision in R vs Adomako (1994) 3 All ER 79. 12. Housing Board vs Dr. S.L. Chaudhary 1991 (1) CPR 515. 13. Indian Medical Association v. V.P.Shantha 111 (1995) CPJ 1 (SC). 14. Jaipur Stock Exchange v C P.Mehta 1991 (1) CPR 26. 15. Oriental Insurance Co. v. Bahadar Ram 1992 CPJ 526. 16. ParamanandKatara v. Union of India, AIR 1989 SC 2039. 17. Paschim Banghakhet Mazdoor Samity and others v. State of West Bengal and another (1996) 4 SCC. 18. Phillips India Lev. Kunjupunnu, AIR 1975 Bom.306. 47

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19. Poonam Verma vs Ashwin Patel (1996) 1996 4 SCC 332. 20. Shrivastava v Rarnbiliarilal AIR (1982) M.P.132. 21. Spring Meadows Hospital v. Harjol Ahluwalia, AIR 1998 SC 1801. 22. State of Punjab v. Mahinder Singh Chawla, AIR 1997 SC 1225. 23. Union of India v. Nadhu Shah Kapoor II (1993) CPJ 1044. 24. Vincent Panikulangara v. Union of India AIR 1987 SC. 994. 25. Wheel World v. Dr. Snit. Janak -Narendra 1991 (11) CPR 632 37.

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