MEDICAL CONSENT FORMS: A LEGAL ANALYSIS UNDER THE CONSUMER PROTECTION ACT, 1986

I. Introduction

The term “consent” has always been an area of attraction in the legal field. Legal jurisprudence usually requires the consent of capable persons (people who have attained the age of majority) in order to validate various kinds of transactions, else the transactions would be void or voidable in the eyes of law. The word “consent” finds place in various legislations such as the Indian Contract Act, the Indian Penal Code, etc. However, consent in medical situations is a very complex deal. But before delving into this aspect, one needs to understand the relationship between doctor and patient.

II. The Relationship Between Patient Under The Consumer Protection Act, 1986

The Supreme Court in Indian Medical Association v. V.P. Shantha & Ors.[i] expressly observed that patient is a “consumer” and the medical assistance provided by him/her was a “service”. The Court held that, “Service rendered to a patient by a medical practitioner (except where the doctor renders service free of charge to every patient or under a contract of personal service), by way of consultation, diagnosis and treatment, both medicinal and surgical, would fall within the ambit of 'service' as defined in Section 2(1) (o) of the Act.” Thus, the services rendered by medical practitioners shall fall within the ambit of the Consumer Protection Act, and the patients aggrieved by any deficiency in treatment, from both private clinics and Govt. Hospitals, are entitled to seek damages under the Consumer Protection Act, 1986

With this background, since the consumer has a right to be informed about the treatment to be undertaken and the associated risks and benefits, it becomes necessary for the medical fraternity to obtain “informed consent” from the patients, which is usually obtained in the form of “medical consent forms”. However, these forms usually enumerates the patient’s consent to any form of treatment which is a blanket consent whose legal validity can obviously be questioned. This consent form needs to be signed before the treatment is started, which is generally used by the doctors as defence in cases of medical negligence.

III. What Is Consent?

The Consumer Protection Act, 1986 does not define the term “consent”. However, the term has been defined under section 13 of the Indian Contracts Act which provides that, “Two or more persons are said to consent when they agree upon the same thing in the same manner.” Consent is of various forms: Implied, Express, Blanket, Informed, etc. In the case of medical consent forms, there is a requirement of informed consent on the part of the patient. The concept of informed consent requires that the patient should be explained all information in comprehensible and non-medical terms preferably in local terms about (a) diagnosis (b) nature of treatment (c) risks involved (d) prospects of success (e) prognosis if the procedure is not informed, and (f) alternative methods of treatments.[ii]

The informed consent doctrine was evolved in the case of Canterbury v. Spence wherein the court emphasised on patient’s right to know all material risks and conferred an obligation on the doctors to disclose all the associated risks with treatment and a failure to do so on the part of the doctors would amount to medical negligence.[iii] The first Indian case which emphasized on the importance of informed consent was Ram Bihari Lal v. Dr JN Srivastava.[iv] In this case, the patient was suspected to have appendicitis. However, when operated her appendix was found to be normal. Despite this, the doctor removed her gall bladder in the interest of the patient but in doing so, the doctor exceeded the limits of the consent obtained by the patient. Thus, the doctor acted as per traditional paternalistic notion which was unacceptable in the legal regime and hence, the doctor was held liable for operating sans valid consent.

IV. Who Can Give Consent Under A Medical Consent Form?

Any person who is conscious, mentally sound and is of and above twelve years of age can provide consent for the purpose of clinical examinations, diagnosis and treatment.[v] If one examines the medical consent form, one can deduce that the consent to carry out the medical surgery or operation can not only be given by the patient himself/herself but also by any related person to the patient, such as mother, father, husband, wife, etc. However, the Supreme Court in the case of Samira Kohli v. Prabha Manchanda and Ors.[vi] explicitly held that when the patient is an adult and is competent to give consent, then there is no point of obtaining consent from someone else in his/her behalf. In the present case, the doctor obtained the consent of the mother of the patient in order to perform a hysterectomy and as a consequence, removed her reproductive organs due to which she suffered premature menopause. The Court held that “since consent was not obtained from the patient, the act constituted an unauthorised invasion and interference with appellant’s body. Hence, the act amounted to a tortious act of assault and battery. As a consequence, the doctor was held liable under the Consumer Protection Act, 1986 for deficiency in services.” Thus, one can infer that the consent of the patient cannot be justified by a general consent obtained from the relatives of the patient unless there is a situation of emergency. Hence, the judgment upheld the concept of patient autonomy, which is an accepted principle in medical ethics.

V. Medical Consent Forms: An Unfair Trade Practice

Recently, the Hon’ble National Consumer Disputes Redressal Commission in the case of Vinod Khanna v. R.G. Stone Urology Hospital and Ors. held that, “The use of pre-printed and fixed “informed consent cum undertaking “ forms by the hospitals to record consent from the patients amounts to “unfair trade practice” within the meaning of section 2(1)(r) of the Consumer Protection Act, 1986.”[vii] The Hon’ble NCDRC observed that, “However, we cannot ignore the peculiarity of the ‘informed consent’ in the instant case which needs prompt and proper rectification. It is pertinent to note that it is a pre-printed form- ‘informed consent cum undertaking’ having blank spaces for limited selective handwritten entries and for the signatures. The main body of the form is fixed pre-printed. Such consent form fits into any procedure, any doctor, and any patient. Thus, it will take shape of informed consent if someone after filling up the blank spaces in handwriting and affixing the signatures of the patient and his sister as a witness. This to be administrative arbitrariness and one-sided high handedness, and to be unfair and deceptive, on the part of the OP-1 (hospital); though the complainant has not been prejudiced in this particular case.” What is interesting to note is that though no medical negligence per se was found in the present case, the Hon’ble NCDRC imposed a penalty of Rs. 10 lacs on the account that “pre-printed consent form with blank spaces for handwritten entries” amounts to unfair trade practice.[viii]

VI. Conclusion

The interesting fact to be noted here is that the term “healthcare” has not been included in the definition of “service” under section 2(42) of the present Consumer Protection Act, 2019 which implies that the medical profession has been excluded from the purview of the 2019 Act. However, the mention of the phrase “means and is not limited to” in the definition of service makes it clear that the services rendered by the medical fraternity can be considered as services and hence, fall within the scope of Consumer Protection Act. Since medical consent forms have not proved to be a sufficient defence to protect the medical fraternity, that is why the above-mentioned amendment had been included in the 2019 Act.

[Keywords]: Medical Consent Forms, Patient, Doctor, Informed, service, unfair trade practice.

[Profile of the author]: Shubhangi Komal is a 5th year Law student in National University of Study and Research in Law, Ranchi and holds keen interest in constitutional, criminal, environmental, labour and human rights laws.

[FAQs]: What is a Blanket Consent?

Ans: It refers to consent taken to cover everything done to patient without specific mentioning the procedure. Blanket consent is legally inadequate for any procedure that has risks or alternatives.

[i] AIR 1996 SC 550.

[ii] Consumer Protection Act and Medical Profession-Consent, MedIndia https://www.medindia.net/indian_health_act/consumer_protection_act_and_medical_profession_consent.htm

[iii] Canterbury v. Spence, 464 F.2d 772, 782 (C.A.D.C. 1972).

[iv] Ram Bihari Lal v Dr. J. N. Srivastava. AIR 1985 MP 150.

[v] Indian Penal Code, §§ 88 and 90 (1860).

[vi] Samera Kohli v Dr. Prabha Manchanda and Another. 2008 (1) SCALE 442.

[vii] “Informed Consent Cum Undertaking” Form Used by the Hospitals, is amount to Unfair Trade Practice: NCDRC, India Legal (July 9, 2020) https://www.indialegallive.com/constitutional-law-news/courts-news/informed-consent-cum-undertaking-form-used-by-hospitals-is-amount-to-unfair-trade-practice-ncdrc/

[viii] Vinod Khanna v. R.G. Stone Urology Hospital and Ors., Consumer Case No. 428 of 2018.