Personal Practice

Indian Pediatrics 2000;37: 961-966

Legal Aspects in Medical Practice

Satish Tiwari

In ancient days, medical profession was considered to be a noble field. The patient’s faith and trust in doctors was so much that a doctor was equated to an "Angel or Semigod". Gradually, this relationship is turning into a love and hate phenomenon. In this era of specialisa-tion and super specialisation, the focus of medical profession is progressing from a noble one to a commercial one. The increasing cost of medical education, equipments, construction of clinics and hospitals are to some extent responsible for the commercial approach on part of doctors. Patients now are also more interested in facilities and good looking hospital rather then quality of care and competency of doctors. In this scenario, litigations related to medical practice are on the rise. The intent of this article is to sensitise the readers to the basics of legal aspects in medical practice in India. Usually, legal problems start if there is a controversy regarding the duties and rights of doctors.

Every doctor has some basic things to do as he approaches a patient(1). He must listen to the patient (take proper history) and examine him carefully. A doctor has to attend to the patient and give diligent care, once he decides to treat the patient. He must explain the relevant facts related to the illness and give proper medicines. The doctors must have average, recent knowledge and equipments in possession, as per their speciality. The practitioners must be able to foresee the complications and refer the patient at proper time. Doctors must also maintain a proper record of their patients.

Doctors don’t just have duties, they also have some rights. A doctor has a right to turn away a patient before starting treatment but he should provide minimal basic care especially in an emergency situation. He has a right to select the drugs from wide range of options available, supported by standard medical practice. A doctor can also select the investigations and method of treatment depending upon various factors. He/she should obtain a written refusal in case the patient does not want to do as advised. He/she can delegate the powers to properly trained personnels or colleagues, usually with the willingness of patient. However, a better alternative for the practitioners is to start group practice so that one of the regular consultant is always available. A doctor can decide regarding visits, fees to be charged and to maintain the patient's record including its secrecy in certain specific situations.

Every individual has a private right and in order to protect the right there is a legal remedy. According to Law of Torts, a doctor shall be responsible for his negligent act. According to Sec. 70 of Indian Contract Act, there is a contract (oral, written or implied) between a doctor and a patient, and both parties are bound by it. If a doctor doesn’t give complete or proper treatment then he/she may be held liable. Similarly, if a patient doesn’t pay the fees, doctors can file a civil suit. Doctors can take advances or deposits (this is legal) before starting treatment but they can’t keep the patient in confinement (this is against law) on the ground of nonpayment of fees.

Civil suits most of the times are expensive, time-consuming and cumbersome.

There are some public wrongs. In order to protect the community, the state/government has the right to punish the wrong doer, through various agencies. Criminal laws and police are usually not involved in doctor-patient relation-ship unless there is gross rashness or negligence resulting either in death or serious injury. Some of the common sections of Indian Penal Code (IPC) which are applicable to doctors include: (i) Sec. 52 which defines what is good faith; (ii) Sec. 87-91 which are related to consent, (iii) Sec. 304-A which is related to death of patient due to negligent act; (iv) Sec. 312-316 are related to causing abortions or miscarriage without proper consent; (v) Sec. 319-322 deals with causing grievous hurt, or disfigurement endangering the life; (vi) Sec. 340-342 which are related to wrongful confinement of patient; and (vii) Sec. 499 which is related to defamation.

There are many possibilities of misuse of the act also which is discussed in greater detail later.

These include the MTP Act, IT Act, Drug Act, Labour Laws and Medical Council’s Act. These are intended to have a watch on medical practitioners.

Once the doctor decides to take care of the patient, the liability starts.

Every individual is liable for his wrongful acts under various laws. The wrongful act can be an act of commission or an act of omission. "Mens rea" guilty mind with intention, knowledge and awareness of doing wrong is more punishable than the acts done without willful intent. Negligence, incompetence, mal-practice, etc. constitute the liability of medical persons. Vicarious liability involves the acts of staff members, partners and locums in different situations(2). The doctors shall be liable for the act of their staff if they are unqualified. But if the staff is qualified and makes a mistake then the doctor may not be held directly responsible. For example, doctor has prescribed some medicines or injections correctly and the nurse (qualified) makes a mistake; in such cases, the doctor is not responsible for her act. However, if the nurse is unqualified, then the doctor shall be held responsible. Thus depending upon the situation, the doctor or his staff shall be liable for their act of negligence.

Negligence is an act of commission (positive act) or an act of omission (failure to act) which a prudent man of average skill and objective standards should not perform(3).

According to objective theory of negli-gence, there is carelessness in approach towards the patient and the act of commission results in injury to the patient. According to subjective theory, the doctor is indifferent to the conse-quences of his act of omission and thus causing damage to the patient.

In a case Donoghue vs Stevenson the following were the facts; Stevenson, the defendant was manufacturer of ginger beer. Plaintiff Donoghue consumed the ginger beer which contained decomposed snail. Plaintiff suffered from shock and gastroenteritis. It was decided that defendant was negligent as he failed to take sufficient care in preventing the contamination of beer. In the judgement the Judge said that you owe a duty to your neighbour (neighbour means the person who is so closely and directly affected by my act, that outght reasonably to have then in contempla-tion). Similarly, a doctor owes duty to his patient and relatives of patient. Whenever a duty is undertaken it shall be with full foresightness about competence, care, knowledge and skill which a prudent man acquires. If a man has not acquired skill he is imprudent, how so ever much careful he may be.

If there is a breach in duty undertaken, resulting in damage or injury–this is negligence. Greater the risk voluntarily undertaken, greater care and skill must be exercised. According to law a pediatrician will be responsible to a greater extent as compared to general practitioner if there is negligence while managing a child (because a pediatrician is more skilled and competant for treating a child) If a doctor has not acquired special skill and competancy (i.e., he/she is not a specialist) then of course average skill and care are sufficient to avoid the charge of negligence.

The degree of care is usually proportional to the duty undetaken. Negligence is many times difficult to prove. The burden of proof is on the patient or relatives except in cases where relatives have no access (e.g., operation theater, intensive care unit, nursery, etc. Res ipsa loquitur is a situation of gross negligence where things speak for themselves and hence there is no need to prove. Contributory negligence, known complications, unexpected results, differ-ence of opinion and emergency care are the usual defenses in case of negligence.

Some common situations with impor- tant medico-legal implication are illustrated below:

If there is any mishap while giving any drug or vaccine, then known complications are usual defenses. However, the doctors should have taken all the precautions to manage such complications. Anaphylaxis after Penicillins, Xylocaine and Measles vaccine are known complications. A doctor must do skin sensitivity before giving penicillin, xylocaine, etc. Oxygen, Adrenaline, IV fluids and Steroids must be available in case reaction occurs. It is always better to explain to the relatives that such complications can occur. A written consent is preferable before administering injectable drugs. History of drug allergy shall be recorded before prescribing any drugs which are known to cause allergic reactions.

In case of vaccine related encephalopathy, shock, etc. relatives should be informed of possible complications (written consent is preferred). Proper history of any previous com-plications must be recorded in writing. For example, before giving triple vaccine take history of any neurological complications, exist-ing neurological deficits, excessive irritability with previous dose, etc.

Sometimes if IV fluid goes at an undersirable fast speed, various complications may occur. The doctor shall not be held responsible if he/she had written proper orders and the nurse is qualified. If the para-medical staff is not qualified, then the doctor shall be responsible. It is better to use pediatric bottles, micro-drip sets or chambers. If these are not available extra fluid from the bottle may be discarded at the time of starting IV line.

A doctor or qualified nurse must check name and age of donor and recipient along with their respective blood group before starting the transfusion. Pediatrician shall not be held responsible for wrong cross-matching or tests for HIV, hepatitis B infection etc. (pathologist shall be responsible). However, it is the pediatricians’ responsibility to see the blood is transfused in proper volume and at proper rate. Proper orders for monitoring pulse, respiratory rate, temperature and early signs of mismatched blood transfusion must be given. A valid consent is a necessity before starting any procedure or some specific treatment.

According to Sec. 90 IPC, a person who consents can’t complain. Giving a consent is a an act of reasoning and deliberations after balancing the good and evil. The various types of consents can be: (a) Implied consent; (b) Blanket consent; (c) Written consent; and (d) Informed consent. A valid consent is that which is given voluntarily (without pressure), by an adult of sound mind who is not under any intoxication. The consent is obtained after explanation and reasonable understanding of facts and not by hiding facts or mis-representation of facts. Consent should be informed and preferably in writing. The consent should preferably be taken in presence of witness (two from patient side and two from hospital side).

Sometimes a child is brought to pediat-ricians by neighbors (parents of child are immediately not available for consent). In such situations if it is a genuine and real emergency, the child can be managed even without con- sent. The neighbors consent doesn’t have legal validity.

In the following situations it may not be necessary to take the consent: (i) if you are managing a patient in an Emergency situation; (ii) While working in situations of public interest like during floods, cyclones, earthquakes, etc.; (iii) Treating patients in places like mental asylums, orphanages, etc.; and (iv) Working under Court order, e.g., in case of smuggling, operations are done for detecting narcotics or gold kept in intestine or other parts of body.

Documents can be friend as well as foe of medical personnel. Documents are property of hospitals and should be produced on written requests only. Documents carry confidential information of patients and should be released with consent. Well maintained documents may be helpful in most of the cases of negligence. Care should be exercised to ensure that documents are clean, complete, chronological, comprehensive, correct and without manipulations. Docu- ments can be asked for: (a) Outdoor patients, indoor admissions; (b) Medical termination of pregnancy, medicolegal cases, operations, (c) death certificates; and (d) other certificates.

COPRA was enacted in 1986. As far the medical services were concerned, different courts had different rulings till the Supreme Court in November 1995 by its ruling included medical services in COPRA. A consumer can approach District Forum, State Commission, National Commission and finally the Supreme Court according to jurisdiction or amount of damage claimed(4,5). The limitation period is two years but can be extended if the judge thinks so in a particular case (after recording the reasons).

A complainant can be consumer himself, any beneficiary, voluntary consumer organization or Government. The complaint can be filed for the consideration which may be paid/promised, part paid/part promised or even deferred payment. The complaint can be for any fault, deficiency, shortcomings in quantity, quality or standard of work performance.

Goodfaith as per Sec. 52 of IPC means any work done/believed to be done with due care and attention.

According to analysis of compiled cases under CPA by Dr. Jagdish Singh (Personal communication) the maximum number of cases are from Obstetrics and Gynecology and Surgery branches. The hospital covered under CPA include all private hospitals, ESIS, SAIL, Corporate hospitals and even Government hospitals where some facilities are on payment. Government and charitable hospitals where all the services are totally free, at present are not covered by CPA. The outcome of about 202 cases was as follows: (i) Negligence held 28.4%; (ii) Negligence not held 62.3%; and (iii) No negligence compensation granted to Doctors/Hospitals 9.3%.

Though the act has been amended in 1993, still there are many shortcomings. Some of the important shortcomings in CPA include (i) Litigation is easy and convenient; (ii) There is no stamp fee or court fee; (iii) Medical experts are not there to judge the negligence; and (iv) "Justice may be hurried". This may result in a large number of false or frivolous complaints.

If there is a case in consumer court, take due cognizance of the case and give a reply in time. Try to explain misunderstandings and mis-representation in written statement. Attend personally with or without your lawyer. The answers should be brief, clear and compre-hensive. Produce affidavits of colleagues and ask for expert witness whenever necessary. Give reference relevant to the case and demand cross examination. As far as possible always ask for counter compensation (Behre S. personal communication).

Whenever there is a case in CPA, don't ignore or disrespect court. Don’t give unnces-sary details and don’t volunteer to hand over documents unless specifically asked for. Never get panicky or frightened simply because there is case in CPA.

In this era of deteriorating doctor patient relationship, the legal cases are going to increase. If you wish to avoid such situation, attend all patients personally and carefully. Behave humanely, avoid rough, rude or inhuman behavior with the patients or their relatives. Communicate with the patient and take proper consent after explaining the condition. Documents related to a particular case should be maintained properly. Be efficient and have proper expert opinion especially in serious illnesses. Finances and bills should be properly explained and informed at the time of admission or even before admission. Always give guarded prognosis especially in diseases known to have high mortality or morbidity. Your hospital staff should be properly trained and adequately experienced. Insurance and indemnity schemes should be availed whenever possible and available. Junior staff and locums should be qualified and starting of group practice is a better option in this era. Keep your knowledge updated and latest instruments should be available, if possible. Creation of medicolegal cells and Medical organizations may be helpful in setting the grievances before going for legal action. No manipulations should be done in patients records. A second opinion should be taken in serious and complicated cases.

1. Joshi MK. Doctor and Medical Law, 2nd edn. Ahmedabad, 1995; pp 15-39.

2. Jhabvala NH. The Law of Torts, 24th edn. Mumbai, C Jamnadas and Co, 1997, pp 56.

3. Jhabavala NH. The Indian Panel Code, 13th edn. Mumbai, C Jamnadas and Co, 1997, pp 25-27..

4. Potdar RD. Consumer protection law and pediatrician. Indian Pediatr 1997; 34: 283-286.

5. Bal A. Consumer protection act and medical profession. Indian Pediatr 1997; 34: 319-327.