Consumer Protection Act and Medical Profession - Consent

Consent

Another major and important thing to do for a doctor is to obtain proper consent of the patient / attendant / relative.

The term ‘consent ‘ is defined thus : When two or more persons agree upon the same thing in the same sense they are said to consent as per the definition of ‘consent ‘ given in section 13 of Indian Contract Act, 1872.

Who can given consent : For the purpose of clinical examination diagnosis and treatment consent can be given by any person who is conscious, mentally sound and is of and above twelve years of age as provided under sections 88 and 90 of the Indian Penal Code, 1860.

Doctors are reminded that consent is taken under section 13 of the Indian Contract Act, 1872. This Act, however also provides under Section 11 that only those persons who are of and above 18 years of age are competent to enter into a contract.Since doctor-patient relationship amounts to entering into a contract, it is advisable that consent should be obtained,specially written consent, from parents / guardian of a patient who is below 18 years so that validity of the contract is not challengeable.

When a consent is not valid : Consent given under fear, fraud or misrepresentation of facts, or by a person who is ignorant of the implications of the consent, or who is under 12 years of age is invalid ( Sec. 90 I.P.C.).

In most of the cases filed against the doctors it is alleged that no consent was obtained. Obtaining of a consent will thus be a cornerstone of protection against litigation. Depending upon the circumstances in each case consent may be implied, express or informed.

Implied consent ( Tacit consent )

This is by far the most common variety of consent in both general practice and hospital practice. The fact that a patient comes to a doctor for an ailment implies that he is agreeable to medical examination in the general sense. This, however, does not imply consent to procedures more complex that inspection,palpation, percussion, auscultation and routine sonography.For other examinations, notably rectal and vaginal and withdrawal of blood for diagnostic purpose, express consent ( oral or written ) should be obtained. For more complicated diagnostic procedures, e.g., lumbar puncture, radiology,endoscopy, C.T. Scan, etc. express written consent should be obtained.

Express consent

Anything other than the implied consent is express consent. This may be either oral or written. Express oral consent is obtained for relatively minor examinations or therapeutic procedures,preferably in the presence of a disinterested third party. Express written consent is to be obtained for : (i) all major diagnostic procedures, (ii) general anesthesia, (iii) for surgical operations,(iv) intimate examinations, (v) examination for determining age,potency and virginity, and in medico-legal cases.

Informed Consent

The concept of informed consent has comes to the fore in recent years and many actions have been brought by patients who alleged that they did not understand the nature of the medical procedure to which they gave consent. All information must be explained in comprehensible non-medical terms preferably in local language about the (a) diagnosis, (b) nature of treatment,(c) risks involved, (d) prospects of success, ( e) prognosis if the procedure is not performed, and (f) alternative methods of treatment. The physician’s duty to disclosure is subject to the exceptions : (a) if the patient prefers not be informed and (b) if the doctor believes in the exercise of coming to a sound medical judgement, that the patient is so disturbed or anxious that the information provided would not be processed rationally or that it would probably cause significant psychological harm. This is known as Therapeutic Privilege. In such a case it is advisable that the doctor should consult the patient’s family physician.Revelation of risk is always a compromise between reasonable information and the danger of frightening off the patient from beneficial treatment. The three important components of such consent are information, voluntariness and capacity. ( See Model Form of Informed Consent at the end of this Chapter).

Proxy Consent ( Substitute consent )

All the above types of consent can take the shape of Proxy Consent. Parent for child, close relative for mentally unsound /unconscious patient, etc.Situations where consent may not be obtained

1. Medical Emergencies. - The well being of the patient is paramount and medical rather than legal considerations come first.
2. In case of person suffering from a notifiable disease. - In case of AIDS/HIV positive patients, the position in India regarding its being a notifiable disease or not is not yet clear.However, in England the Public Health ( Infectious Diseases) Regulations, 1988 extend the provisions of notifiable diseases to AIDS but not to persons who are HIV positive.
3. Immigrants.
4. Members of Armed Forces.
5. Handlers of food and dairymen.
6. New admission to Prisons.
7. In case of a person where a court may order for psychiatric examination or treatment.
8. Under Section 53 (1) of the Code of Criminal Procedure, a person can be examined at request of the police, by use of force. Section 53 (2) lays down that whenever a female is to be examined, it shall be made only by, or under the supervision of a female doctor.

Situations Requiring Extra Caution

Doctors should keep in mind certain high risk situations which are common causes for medical negligence actions, and require extra caution.

1. Failure to attend - These are particularly frequent where children are concerned,especially in relation to acute abdominal emergencies,meningitis and chest infections.

2. Retention of objects in operations sites - Swabs, packs, instruments or towels may be left behind in the field of operation. The responsibility remains with the surgeon.

3. Accident & Emergency Departments - This is the most hazardous part of the hospital and senior staff must be readily available to supervise the work.

4. Amputation of the wrong limb, digit or operation of wrong eye/tooth - This is a common mishap. Carelessness in hospital notes, errors in pre-operative skin marking and failure to check notes against the patient in the operating theater are the common reasons for the misadventure.

5. Emergency, Orthopedics and obstetrics - Surgery, Orthopedics, obstetrics, plastic-surgery, and gynaecology are ‘high-risk specialities. Missed fractures (especially the scaphoid) tight plaster casts and poor results from spinal procedures are common complaints in orthopedics.In obestetrics, damage to the newborn from anoxia or forceps procedures major damage claims. Failed sterilisation / Vesectomy is again a common cause for litigation.

6. Anesthesia - Anesthetists along with surgeons, present a common target for litigation ; the actual administration of the anesthetic is not usually the cause of complaint, but the many ancillary responsibilities such as transfusions, injections, airways, i.v.catheters, diathermy, and hot water bottle burns may form grounds for allegations of negligence. One of the serious mishaps is the production of cerebral damage from hypoxia due to failure to maintain oxygenation during the operation.Inattention rather than failure to maintain oxygenation is the more common cause,and recent surveys have shown that inexperienced junior anesthetists are a major cause of problems.

7. Therapeutic hazards - These can be avoided by :

1. Administering the right drug, the right dose, via the right route, e.g., in case of potassium chloride, insulin,antibiotics, spinal anesthesia.
2. Informing patients / attendants of the potential risks of treatment.
3. taking all possible steps to avoid undesirable consequences.

8. Failure of Communication - A doctor should inform about the patient’s medical condition in comprehensible language. IN case of reference to another doctor, it is his responsibility to communicate directly with the second doctor and not rely on the patient to carry any informal message.

What should a doctor do in the event of a medical mishap ?

When something untoward happens following a diagnostic or therapeutic procedure, or when a patient or relative makes a complaint, the doctor must take appropriate steps, some of which may be :

1. Complete the patient’s record and recheck the written notes.

2. Be frank enough and inform clearly of the mishap. Show that you were genuinely concerned about the unfortunate mishap. Answer all the queries of patient / relative and do not mind their repeated questioning, harsh attitude and at times even abusive language. Keep in mind the mental state of the close relatives / friends. Be compassionate. Try to remain on the scene as long as possible. Try to engage less excited attendants into discussion on the mishap and indirectly try to bring into focus the circumstances under which the mishap occurred. Doctors who are open-minded and communicative are much less likely to be complained against as patients / attendants are extremely forgiving of errors made by a friendly and concerned medical attendant.A high proportion of complaints are precipitated or escalated into legal action by a progressive breakdown of the doctor-patient communication.

3. After these initial responses, the doctor should contact some other doctor / protection organization to seek advice. The Medical Associations, Medical Practitioners’ Society,Hospitals and Nursing Homes’ Associations, etc. could form groups / cells to advise and assist in such situations. In future Medical defence organizations could be formed to take up cases of defence on behalf of doctors against alleged medical negligence.