Can a doctor remove a patient’s organs without informed consent, in the course of surgery, even if he thinks it’s in the patient’s best interest? In a recent judgment, the Supreme Court decreed that correctness or appropriateness of the treatment procedure does not make the treatment legal in the absence of consent
There have been no authoritative pronouncements by the Indian courts on the issue of the nature of consent required for medical procedures and operations. Even regulatory bodies like the Indian Council for Medical Research and institutions like the All-India Institute of Medical Sciences are guilty of a negligent attitude towards the issue of patient consent. In the late-’90s, joint research by these two institutions revealed that 1,100 women patients were not informed about the existence of pre-cancerous lesions. In addition to the issue of consent of the women with respect to the research, the act of allowing the progression of a life-threatening disease clearly amounts to a criminal offence. The controversy came to light when the findings of the research were sought to be published in The Lancet.
As patients know, doctors in India do not follow the practice of informing individuals of various dimensions of their illness, alternatives available, side-effects and related matters. Rare exceptions apart, the courts have acquiesced in the ‘benevolent paternalism’ of the profession. In fact, the apex court’s judgment in the Dr Jacob Mathew case in 2005 carved out an extraordinary exception with regard to registration of a case with regard to criminally negligent acts of doctors.
It is this backdrop that makes judgment in the Samira Kohli case a landmark one in the history of medical jurisprudence. The judgment was delivered on January 11, 2008, and is reported as Samira Kohli versus Dr Prabha Manchanda, 2008(1) SCALE 442.
The patient Samira, an unmarried woman aged 44 years, consulted Dr Manchanda on May 9, 1995, complaining of prolonged menstrual bleeding. An ultrasound test was conducted and the doctor advised her to return the next day for a laparoscopy test. Samira and her mother returned to the clinic the following day. Samira was admitted and her signature taken on the 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 May 10, 1995”. The consent form for surgery described the procedure to be carried out on Samira as “diagnostic and operative laparoscopy. Laparotomy may be needed”. The patient was put under general anaesthesia and subjected to a laparoscopic examination. While Samira was still unconscious, Dr Lata Rangan came out of the operation theatre and took the consent of the patient’s mother for a hysterectomy. Thereafter, Dr Manchanda removed the patient’s uterus (abdominal hysterectomy) and, in addition, removed the ovaries and fallopian tubes (bilateral salpingo-oopherectomy). The patient left the clinic on May 15, 1995, without settling the bill.
On May 23, 1995, Dr Manchanda lodged a complaint with the police that the patient’s friend Commander Zutshi threatened the doctor and got Samira discharged against medical advice and without clearing the bill. The patient too lodged a complaint against the doctor alleging negligence and unauthorised removal of her reproductive organs. The doctor issued a legal notice demanding Rs 39,325 as fees. On January 19, 1996, Samira Kohli filed a complaint before the National Consumer Disputes Redressal Commission claiming compensation of Rs 25 lakh from Dr Manchanda.
The patient submitted that the doctor had been negligent and that the radical surgery by which her uterus, ovaries and fallopian tubes had been removed had taken place without her consent. That the removal of her reproductive organs was unauthorised and unwarranted. The compensation claimed was for loss of reproductive organs, loss of opportunity to become a mother, diminished matrimonial prospects, loss of vital body organs, irreversible body damage as well as for pain and emotional trauma.
The National Commission dismissed the complaint holding that the patient had voluntarily gone to the clinic for treatment and that the hysterectomy had been done with adequate care and caution. An appeal was filed and the matter reached the apex court.
The submission before the Supreme Court was that Samira had visited the clinic only for diagnostic laparoscopy. Her signature was taken on some blank printed forms without giving her an opportunity to read the contents. As only a diagnostic procedure was to be carried out there was no discussion about any proposed treatment. That when the patient was under general anaesthesia, the doctor rushed out of the operation theatre and told Samira’s mother that the patient was bleeding profusely, giving her the impression that the only way to save her life was to perform extensive surgery. That the mother’s consent for a hysterectomy had been obtained by misrepresentation and that there had been no valid consent for radical surgery. The failure to exhaust conservative treatment before resorting to a drastic procedure like removal of the reproductive organs amounted to a second count of negligence.
According to Dr Manchanda, the patient had given real and informed consent for the removal of the reproductive organs. The radical surgery performed had been the proper course of action and there had been no negligence or illegality on the part of the doctor. Removal of the uterus and ovaries not only cured the patient but also saved her intestines, bladder and ureter from possible damage. The patient was on the wrong side of 40, was not ovulating regularly, did not have a regular menstrual cycle and endometriosis prevented fertilisation. Therefore, there was no possibility of her conceiving. Removal of the uterus and ovaries was proper and necessary and there had been no negligence on the part of the doctor. It was argued that a doctor who had acted in accordance with a practice accepted as proper by the medical fraternity could not be said to have acted negligently, even if other doctors may have taken a different course of action.
The Supreme Court held that ‘consent’ in the context of a doctor-patient relationship meant granting of permission by the patient for an act to be carried out by the doctor. Consent, in some circumstances, could be implied from the patient’s actions — for example, when a patient enters a dentist’s clinic and sits in the dental chair, consent for examination, diagnosis and consultation is implied. The court declared that except where consent can be clearly and obviously implied, there should be express consent.
It observed that it was possible that if the patient had been conscious she would have agreed to the additional procedure. That it may well be that removal of the affected organ during the initial diagnostic or exploratory surgery would save the patient the pain and cost of a second operation. But the judgment categorically lays downs that however practical or convenient the reasons may be, they are not relevant. The relevant factor is “the inviolable nature of the patient’s right in regard to his body and his right to decide whether he should undergo the particular treatment or surgery or not”.
That unless the unauthorised additional or further procedure was necessary in order to save the life or preserve the health of the patient, and it would be unreasonable (not merely inconvenient) to delay the procedure, the doctor could not perform the procedure without the patient’s consent. That the proper course of action was to wait for the patient to regain consciousness and take a decision regarding the additional procedure suggested by the doctor. The principle to be followed in medical law has been laid down as: “Where a surgeon is consulted by a patient, and consent of the patient is taken for a diagnostic procedure/surgery, such consent cannot be considered as authorisation or permission to perform therapeutic surgery either conservative or radical (except in life-threatening 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 it is beneficial to the patient or is likely to prevent some danger developing in the future, where there is no imminent danger to the life or health of the patient.”
The judgment declares that the nature and extent of information to be furnished by the doctor to the patient to secure consent should be that which is accepted as normal by a body of medical men skilled in the particular field. It would also depend on the physical and mental condition of the patient, the nature of treatment, and the risks and consequences attached to the treatment. The consent must be real — that is, the patient must be given sufficient information about the operation and effects in order to reach a proper decision. It is for the doctor to decide how much information should be given to the patient. A surgeon need not warn the patient of remote risks. However, if the patient asks a direct question, then it is the duty of the doctor to give a truthful answer.
Applying the law declared to the facts of the case, the court held that consent for diagnostic and operative laparoscopy and “laparotomy if needed” did not amount to consent for removal of the uterus, ovaries and fallopian tubes. Laparotomy was a first step in the procedure to be followed by the actual specific operation. If Samira had consented to the removal of her uterus, ovaries and fallopian tubes then the consent form would have recorded consent for “diagnostic and operative laparoscopy. Laparotomy, hysterectomy and bilateral salpingo-oopherectomy, if needed”. It was observed that a catch-all clause giving the surgeon permission to do anything necessary does not give roving authority to remove whatever he fancies may be good for the patient. The court held that the evidence clearly showed that Samira had not given consent for a hysterectomy and bilateral salpingo-oopherectomy.
The court rejected the submission that Samira’s mother’s consent should be considered valid consent for removal of the uterus, ovaries and fallopian tubes. The judgment declares that when a patient is a competent adult, there is no question of someone else giving consent on his/her behalf. Samira was neither a minor nor mentally challenged or incapacitated. There was no medical emergency during surgery. Samira was only temporarily unconscious, undergoing laparoscopy. Dr Manchanda ought to have waited until the patient regained consciousness, discussed the results of the laparoscopic examination and then taken her consent for removal of the uterus and ovaries. In the absence of an emergency, the question of taking the mother’s consent for radical surgery did not arise. Therefore, the mother’s consent could not be treated as valid consent.
The judgment held that Samira had been admitted only for diagnostic laparoscopy and, at best, for limited surgical treatment that could be done by laparoscopy. She had not been admitted for a hysterectomy and bilateral salpingo-oopherectomy. The words “laparotomy may be needed” in the consent form can only refer to therapeutic procedures that are conservative in nature, such as removal of chocolate cysts and fulguration of the endometric areas. There was no consent for a hysterectomy and bilateral salpingo-oopherectomy.
Adverting to the submission that Dr Manchanda had been negligent in removing the uterus and ovaries, the court observed that there was more than one way to treat endometriosis. One view favours conservative treatment with hysterectomy as a last resort, the other favours hysterectomy as a complete and immediate cure. Therefore, Dr Manchanda could not be held negligent merely because she chose to perform radical surgery in preference to conservative treatment. However, the judgment declared that correctness or appropriateness of the treatment procedure did not make the treatment legal in the absence of consent.
In view of absence of consent by Samira, the performance of hysterectomy and bilateral salpingo-oopherectomy was held to be an unauthorised invasion and interference with the patient’s body amounting to a torturous act of assault and battery and therefore a deficiency in service. The court observed that the patient was 44 years old, had serious menstrual problems and the doctor thought that surgical removal of her uterus and ovaries would provide permanent relief. Holding that it was a case of the doctor acting in excess of consent but in good faith and for the benefit of the patient, the judgment denied the fee charged by Dr Manchanda and awarded Samira the rather low sum of Rs 25,000 as compensation.
