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Medico-Legal Update

Consent – Medico Legal Aspects

Author(s): Murkey P.N., Khandekar I.L., Tirpude B.H., Ninave S.V.

Vol. 6, No. 4 (2006-10 - 2006-12)

(1)Murkey P.N., (2)Khandekar I.L., (3)Tirpude B.H., (4)Ninave S.V.
(1)Reader, (2)PG Student, (3)Prof and Head, (4)Lecturer Dept. of Forensic Medicine and Toxicology, M.G.I.M.S., Sewagram, Wardha (M.S.)

Abstract

Consent of the patient has an immense practical importance to the clinicians. Doctors may do nothing to or for a patient without valid consent. This principle is applicable not only to surgical operations but also to all forms of medical treatment and to diagnostic procedures that involve intentional interference with the person. Given the volume of papers, treatises, and books on the subject of informed consent, it will only be possible to broad brush most elements of the concept. We have put most of comments, examples and cases as to how it affects medical practitioners and patients.

Key Words: Informed consent, medical practice, patients.

Introduction

The legal precedent for informed consent in the United States arises from a court case in 1914 in New York State in which a patient with a tumor underwent an operation to which he had not agreed. Then New York Justice Benjamin Cardoza wrote in his opinion “Every human being of adult years and sound mind has a right to determine what shall be done with his own body and the surgeon who performs operation without his (patient’s) consent commits assault for which he is liable in damages.”1 This landmark opinion established the concept of consent as an integral part of the most fundamental precept for respect of a person’s bodily integrity.2

The actual phrase “informed consent “entered American jurisprudence in 1957 in a California medical malpractice case. In Salgo V Stanford University, patient’s legs were paralyzed when his physician performed aortography to locate an obstruction in his abdominal aorta3. Apparently, the treating physician had not counseled the patient at the risk inherent in the procedure. In its decision, the court held that “a physician violates his duty to his patient and subjects himself to liability if he holds any facts which are necessary to from the basis of an intelligent consent by the patient to the proposed treatment.”

Consent is fundamental and established principle in the Indian law. Every person has the right to determine what shall be done to his body. Self-defense of body (IPC sections 96 to 102, 104, 106) provides right to the protection of bodily integrity against invasion by other. All medical procedures, including examinations, diagnostic procedures and medical research on patients potentially acts of bodily trespass or assault (IPC 351), in the absence of consent or statutory sanction.3 Treatment and diagnosis cannot be forced upon anyone who does not wish to receive them except in statutory sanction.

In India at present legal cases concerning absence of consent are rare. Such cases will increase in the coming years as medical techniques become more advanced, complicated, medical care becomes more widespread and level of awareness and education of population increases.

What consent means

Consent means free, voluntary agreement or compliance. Sec.13 of Indian contract act lays down that two or more persons are said to be in consent with each other when they agree upon the same thing in same manner. In consent there are three separate but correlated elements that are voluntary ness, capacity and knowledge. Voluntary ness suggests willingness of patient to undergo treatment. Capacity means a degree of ability of the patient to understand the nature and consequences of treatment offered.

Knowledge means that sufficient amount of information about the nature and consequence of treatment has been disclosed to patient. These three elements must be present in the consent, only then it is legally valid.

Section 90 of IPC defines consent in negative terms. As per this section, any consent given under the following five circumstances will not be true consent. Analysis of this section shows that consent is not true consent if it is given —

  1. By a person under fear of injury or,
  2. 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 in consequence of such fear / misconception.
  3. By intoxicated person or,
  4. By a person who is of unsound mind or, unable to understand the nature and consequences of that to which he gives consent.
  5. By a person who is below the age of 12 yrs.

Who can give consent

Adulthood is achieved at the age of 18 yrs in India but person above the age of 12 yrs can give consent for medical treatment. In Western countries like UK a person below the age of 16 yrs cannot give consent for medical treatment with out the prior permission of parent or guardian unless the child is sufficiently mature of understanding. Thus in UK a girl below the age of 16 yrs can not give consent to take contraceptive pills. The Indian penal code and other law reforms are silent on this aspect. For a person under 12 years of age, or of unsound mind, his/ her guardians / person in whose lawful custody he / she is, can give consent (89 IPC)4. Locoparentis- in a emergency involving children, when their parent or guardian are not available consent is taken from the person in charge of the child for example school teacher can give consent for treating child, who become sick during picnic away from the home town or the consent of the principal of a residential school.

The age for consent for medical treatment is not officially laid down. There are obscure provisions made in Indian penal code section (IPC87 and 88), which refers to the validity of consent, which may occur from any act done in good faith and for individual benefit. Perhaps, these provisions are not specifically directed at medical treatment. When both the IPC (Sections 87 & 88) are combined, one can conclude that there is an implication that parental consent is necessary for medical treatment or surgical procedures on the minor. No one can give consent for any treatment on behalf of adult, but it is advisable to be on the safer side that the doctor should take the consent of the next of kin of the patient. Local guardian can give consent on behalf of a person only if the treatment is an emergency one. Unconscious / Unknown patient when admitted in hospital, the medical superintendent / In charge of hospital can give consent for treatment. Pathological autopsy should not be carried out without the consent of next of kin of the deceased. In case of consent for donation of organ after death the will of the deceased is enough. Not taking consent is considered as deficiency in medical services under the section 2(1) of the Consumer Protection Act. Consent of ones spouse is not necessary for the treatment of other. Husband or wife has no right to refuse consent to any operation, which is required to safeguard the health of the partner.

Provisions for consent under law

Sections 87 to 91 of Indian penal code deals with consent. Section 88 of IPC lays down that an act is not offence if it is not intended or not known to be likely to cause death, which causes any harm to a person from whose benefit it is done in good faith with his consent to suffer it. Thus after a valid consent if surgeon operates on patient and patient dies on the operation table, then the surgeon can not be held guilty of murder. Persons who are non-qualified in medical profession are not allowed to take the plea of this section, as they are not said to do the act in good faith. IPC 52 says that an act is only done in good faith if it is done with due care and attention. Section 91 of IPC serves as a corollary to sections 87 to 89. It states that the exceptions contained in sect 87 to 89 do not extend to acts, which are offences independently of any harm, which they may cause to the person, giving consent. Thus causing miscarriage (unless caused in good faith for the purpose of saving the life of the women) is an offence independently of any harm which it may cause or be intended to cause to the women and the consent of the women or of her guardian for causing such miscarriage does not justify the act ( 91 IPC )4 . Barring physical examination, any medical procedure requires written consent. Written consent should refer to one specific procedure and not blanket permission on admission to hospital. It is on the safest side to take the consent of a spouse if the operation destroys or limits sexual function. While not legally necessary it is good medical practice to consult with relatives of patient in patient’s best interest and ones this has been established then doctor can continue to give treatment in good faith. Consultation, consent and clinical confidence will never put the doctor in any tort fessors cases.

Prisoners and persons released on bail can be treated without their consent in the interest of justice of society. A registered medical practitioner can examine an accused by using reasonable force if the examination is requested by the investigating police officer not below the rank of police sub inspector (CrPC 53).(Force should be applied by police.) Under subsection 2 of CrPC 53 which lays down that, whenever the person to be examined is female the examination shall be made only by or under the supervision of female registered medical practitioner. The obtaining of such evidence, it has been held, is not violative of article 20(3) of constitution, which grants protection against self-incrimination, it was held so by high court in Bombay vs. Kathi Kalu case5.

Consent of the patient cannot be defense to medical practitioner in negligence. Whole law of negligence assumes the principle of consent6. Not to be applicable when the act is not done with reasonable care and competence. If found under the influence of alcohol, then consent of such person will not be valid, so it is always better to obtain consent from guardian / parents.(Exception- Section 53 CrPc and Bombay prohibition act.)

Types of consents

Medical profession in India practices following types of consents.

Implied consent is one, which is not written but legally effective. When patient comes to doctor’s consulting room or hospital and waits for the doctor, implied consent is presumed. Such implied consent only goes to history taking and ordinary medical examination like inspection, palpation and auscultation; it does not cover the consent for examination of private parts of the patient or matters such as vein punctures or injections or any major intervention. If any material risk is involved the specific or expressed consent must be obtained. The above discussion, thus, shows that in certain circumstances an implied consent may not be considered as sufficient. In the case of Male v. Hopkins7 it was observed that it was not negligence of a doctor, who had the patients consent for general treatment, to prescribe a particular drug known to have side effects, without first obtaining specific consent. The observation was that it was a proper exercise of his discretion to prescribe the drug even with the risk involved. However, negligence did not arise in his failure to carry out recommended tests for the presence of other side effects, once the prescription of the drug had commenced. A good case of implied consent came up before the National Commission8 where one of the witnesses had stated that once the consent for excision biopsy through thoracotomy was given, the consent for removal of the mass was implied. The Commission observed (Para 19) that the surgeon need not limit the operation to diagnostic purpose but can proceed with the same for curative purposes also.

The express or specific consent may be oral or written. An oral consent is legally valid, but it is preferred to obtain written consent for major procedures because there is risk involved that the patient, in the case of oral consent, may at later stage deny that any oral consent was given by him. If, for whatever reason, only oral consent is possible, it is appropriate to make an entry in the patient’s clinical record which may be of use in future if any action is brought on this count and this entry in the clinical record may afford corroborative evidence to support the defense taken by the medical practitioner concerned. In a Tamil Nadu case9 it was observed that in all cases where a treatment consists of certain dangerous instruments, it is the duty of medical authority to take the consent of patient, preferably in writing. However, in that case an oral consent was taken and the Commission regarded this consent as proper. This shows that written consent is not an absolute necessity to defend an action for assault or battery, but a written consent would afford documentary evidence that the consent was actually obtained. The cases are not rare where the action has been brought after several years prefer the evidence of the patient if a documentary evidence of express consent is not provided.

Informed consent is an ongoing process that includes the exchange of information and development of choices. This does not say that the same should be in writing. Emphasis on informed consent has been laid in Dr. Janki S. Kumar v. Mrs. Sarafunnisa10 where the sterilization was done without consent. It was observed that when one speaks of consent, that should be informed consent. The person who should give consent must be aware of the risks involved and on that awareness the patient should give consent. When, as indicated, the patient was in general anesthesia neither could she understand the risks involved nor could she give consent. It may be understood that it is only in emergency that the consent may be done away. Otherwise, the consent is necessary and that to in writing. In a case Aplarain Jayanand Rathod v. Dr. Shailesh Shah11 the operation of appendicitis was performed without written consent under the guise of removal of stitches and no explanation was given for the second operation. The State commission found that the Doctor was deficient in service and was liable for compensation. In patients who are more prone for anxiety / full disclosure in presence of malignancy or unavoidable total results the doctor should use therapeutic privilege in the interest of patient, disclose the fact to the kin rather than to the patient.

Presently in India, doctrine of informed consent is not in routine practice. This type of consent may take routes in the Indian medical practice soon, since advancement in technology and information is taking place very fast and increase consumer awareness.

How consent should be obtained

The elements that a physician must discuss with his / her patient to fully obtain informed consent are the following:

  • The diagnosis and the nature of the condition or illness calling for medical intervention.
  • The nature and purpose of the treatment or procedure recommended.
  • The material risks and potential complications associated with the recommended Treatment / procedure.
  • All feasible alternative treatments or procedures, including the option of taking no action, with description of material risks and potential complications associated with the alternatives.
  • The relative probability of success for the treatment or procedure in understandable terms.

A recent case12,13 came up before the Pondicherry State Commission where the question of obtaining consent was involved. In this case consent was on printed form except the following portion: -

“I Vasanthakumari Hosp. No. —— in my full senses hereby give my complete consent for flap cover and SSG or any other procedure deemed fit, which is a diagnostic procedure / biopsy / transfusion/operation to be performed on me / my son / my daughter / my ward —— age — — under any anesthesia deemed fit. The nature and the risks involved in the procedures have been explained to me to my satisfaction.’

“The expected chances of success and failure, the risk and benefit of procedure, the hazards and complications of the particular surgery, should be explained to the patient before obtaining his written consent for the operation. To avoid future allegations of negligence the surgeon may record in the case history the points of discussion as far as possible.”

Therefore, the legal formalities regarding consent shall be fulfilled only if the discussion is recorded in the case history and simply obtaining the form may not be sufficient. The commission also observed that ‘the dialogue between the patient and a surgeon is an utmost necessity and at each stage the patient or his relatives should be informed of all the possibilities and pros and cons of the various possibilities and the patient is allowed to decide freely without any amount of influence by the surgeon who may have his own ideas and his own preferences. The commission also observed that there is no record whatsoever in the case sheet or any explanations or information passed on to the patient.

It should also be borne in mind that merely singing the consent form does not exclude doctor’s responsibility if he is negligent in carrying on his duties14. In this case a consent form was obtained from the patient by virtue of whom she had consented to be responsible for the consequences of anesthesia being administered. Thus, the argument was the complainant was stopped from claiming damages. In these circumstances the Maharastra State Commission observed that the signing of the consent from doesn’t exclude doctor’s responsibility if he is negligent in carrying his duties.14

Right to refuse consent

A competent adult has a right to refuse treatment even if others, including the medical practitioners, believe that the refusal is neither in his / her best interest nor reasonable. In a Canadian case13 the lady patient / plaintiff who was seriously injured in a road accident was taken to the hospital where the defendant treated her. As her condition worsened and she lapsed into unconsciousness, the need to treat her as an emergency arose. It became necessary to give her blood transfusion. A Jehovah’s Witness card was found among her belongings. The card when translated read as under:

As one of the Jehovah’s Witness with firm religious convictions, I request that no blood products be administered to me under any circumstances. I fully realize the implications of the position but have absolutely decided to obey the Bible command —”

The defendant doctor was made aware of both the card and its contents but, as the patient’s condition deteriorated, he decided to administer blood. The patient’s daughter on arrival at the hospital confirmed her mother’s wish not to be given a blood transfusion and actually signed a consent to treatment and release of liability for’. Despite this the defendant continued to administer the blood. The Ontario Court of Appeal held that the defendant was liable in trespass. As Robin JA said, the instructions imposed a valid restriction on emergency treatment that could be provided— and precluded blood transfusion.”

This case precisely and accurately represent the position in English law that may unauthorized touching is technically a battery and a civil claim can be maintainable even if there is no evidence of damage to the plaintiff. It may seem harsh to conclude that a defendant is legally liable in damages when the only thing that he is ‘guilty of’ is trying, must be respected if autonomy is to have any meaning.

Advance directives

Also known as living wills. Some patients (especially in Western countries) elect to express their wishes concerning their future treatment of a condition that has not yet arisen, or of a current condition that may deteriorate in future. These are made by the competent patients with the intention that they will remain effective if the patient becomes incompetent. There is no direct law regarding such advance directives. The advance directives made when the patient had the capacity to consent or refuse, the treatment in question may be binding on the medical practioners. When it expresses a refusal to treatment in circumstances that the patient had anticipate. In our country, there is no law regarding advance directives. A refusal to treat the patient can only be acceptable if this possesses no additional risk to the patient and a colleague was available to take over the patient’s case. The medical practitioner should also make a note of refusal placed upon him by the patient.

A refusal to accept a specific aspect of treatment doesn’t remove a patient’s entitlement to reasonable and proper care, nor it confers upon the patient a right to an alternative form of treatement.15

Can Consent be done away

The consent can be done away if there is emergency and there is no advance directive or refusal to take treatment. The most sacred duty of the medical practitioner is to save the life of his patient. If the patient needs emergent and immediate surgery and the waiting for the consent may prove fatal for the patient, the surgeon may go ahead with the operation without waiting for the consent of the patient because it is an attempt to save the life of the patient. This view has been taken by our Indian courts also. It was observed in the case of T.T.Thomas (Dr.) v. Smt. Elisa that a16 surgeon who failed to perform an emergency operation must prove with satisfactory and convincing evidence that the person had refused to undergo the operation, not only at the initial stage but even after the patient was informed about the dangerous consequences of not undergoing the operation.

One case came up before Gujarat State Commission117 where the complainant, a lady, having the son and the daughter, both minors, contacted the doctor while she was carrying 13 weeks pregnancy. She was advised Medical Termination of Pregnancy (MTP) and consent in writing was taken. After the operation the husband of the complainant was informed that the uterus was removed. The complainant filed a case alleging that no consent for the removal of uterus was obtained either from the patient or from her husband. It was found the eminent gynecologist had participated in order to save life of the patient and they all were unanimous for removal of the uterus, as there was continuous bleeding and the condition of the patient was deteriorating. Thus, no negligence regarding removal of uterus was found on the part of doctors.

Consent of maternity patients

Consent to obstetric procedure should be discussed during the antenatal period. If the medical practitioner finds that the wishes of the pregnant woman are unusual, these should be noted carefully in the antenatal record. It is necessary because the practitioner who discussed the matter with the lady may not be on duty when that lady is admitted in labor. If the pregnant woman insists on restrictions that were unsafe in view of the doctor attending her, or the woman places such restrictions which make the doctor reluctant to accept the responsibility, he (the doctor) should frankly say so to the patient and, if possible, refer her to a colleague for further advice.

If no immediate necessity for operation, consent should be obtained

In the case of Devi v. West Midland Area Health Authority18.

The plaintiff, aged 29, had 4 children and longed for more. Her religious belief precluded sterilization and contraception. She was admitted to the hospital for a minor operation on her womb. Without her consent and knowledge the surgeons decided to sterilize her because they feared that if she becomes pregnant again her womb would rupture. Although acting in the patient’s interest, there was no immediate urgency to perform the operation without permission. The defendants admitted the liability, and damages to the tune of 4000 pounds were awarded.

In a Canadian case19 the doctor tied the patient’s fallopian tubes during a caesarian operation, as he was concerned about the consequences of a second pregnancy. No consent for it had been obtained. It was held that there was no immediate danger and therefore, the liability existed. But in another Canadian case20 the patient’s diseased testicle was removed in the course of an operation of hernia. It was observed that there was no liability, as it was an emergency.

Discussion

Consent is necessary for every medical examination, which should be obtained in or in the presence of disinterested party. Barring physical examination, any medical procedure requires written consent. Written consent should refer to one specific procedure and not blanket permission on admission to hospital. It is on the safer side to take the consent of spouse if the operation destroys or limits sexual functions. While it is not legally necessary it is good medical practice to consult with relatives of patient in patient’s best interest and ones this has been established then doctor can continue to give treatment in good faith. Consultation, consent and clinical confidence will never put the doctor in tort fessors cases. In the era of advancement of knowledge and technique the belief that as long as the patient signs everything will be, well misguided, if the doctor is not having reasonable care and skill.

Conclusion

Free, voluntary, informed consent is most essential in medical practice. The consent of women concerned is useless in cases of criminal abortion since the act itself is crime. During emergency, a doctor can treat a patient without the consent of the patient to preserve his health, well being or life of the patient (IPC 92)

References

  1. The law of torts by Ramaswami Iyer (Ed 8th page 561) Tripathi publications.
  2. Story of equity (Ed 3rd section 222 page 90) Law publication, Allah bad.
  3. Indian contract act 1872 (act number 9 of 1872).
  4. The law of torts by Ratanlal (Ed 25th, page 75) Vadhwa and Co., Nagpur.
  5. Gillick V West Norfolk and Wisbeck, Area health authority 1985.3, AIIER 402 (HL).
  6. Sukhrao, O. Khobiraj, V. state 1887, 14, Calcutta 566.
  7. Practice, legally and ethically. The patient has right to full information in one professional term with advancement of medical technology and increasing sect. 3(22).
  8. Criminal procedure code 1973 (act number 2 of 1974) Govt. of India, New Delhi.
  9. M Hidayat Ullah and SP Sathe. The code of criminal procedure 13th ed. 1987, Vadhava & Co. Private Ltd. Page 43-44.
  10. Transplantation of human organs acts 1994.
  11. K. Grackutty v. Dr. Annama 1992(1) CPR 25 Ip- 260 (Kerala SCDRC).
  12. Sideway V Benthlem, Royal Hospital Governer, 1 All ER 543- Doctrine of informed consent first considered.
  13. V. Vassanda Caumary v. T. Ramachandrudu (Dr), 1998 (3) CPR 227.
  14. Raja ram S. Parab v. Kalpana Desai (Dr) 1998 (3) CPR 398, Para 13, Maharashtra state Commission.
  15. (1994) 4 All ER 649.
  16. AIR 1987 Kerala 52.
  17. Mrs. Manjulaben Vinodbhai Patel v. Dr. Harshida K.Patel and another, 1997 (3) CPR 264 – Gujarat State Commission.
  18. (1981) Kemp & Kemp, Vol 2, F5—108 and F5— O17.
  19. Murray v. McMurchy, (1949) 2 DLR 442.
  20. Marshall v. Curry, (1933) 3 DLR 260.

Reprint requests: Dr. P.N. Murkey
Qtr. No. 07, MLK Colony, M.G.I.M.S., Sewagram Wardha (M.S.)

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