Thursday, January 17, 2008

SC Judgment on Patient's Informed Consent

Today’s Hindu carried a news item about a SC decision delivered by a three-judge bench on the need for a patient’s informed consent before the doctor embarks on a surgical procedure. The report, quoting from the opinion, said that not only is it imperative but the consent so obtained is limited to the procedure planned:

““the doctor should disclose the nature and procedure of the treatment and its purpose, benefits and effect; alternatives if any available; an outline of the substantial risks; and adverse consequences of refusing treatment. But there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment.” The Bench made it clear that consent given only for a diagnostic procedure could not be considered as consent for therapeutic treatment. “Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. The fact that the unauthorized additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defense in an action in tort for negligence or assault and battery.”

This view is unexceptionable. In this case, the doctor began by conducting a diagnostic laparoscopy but followed it up immediately thereafter, having obtained additional consent only from the patient’s mother (as the patient was still unconscious), with a second and more elaborate treatment procedure (‘laparotomy’) that resulted in removal of the patient’s uterus and ovaries (hysterectomy and bilateral salpingo-oophorectomy). [The patient, upset over this fact, refused to pay upon discharge. The doctor sued for recovery of charges and got a favorable ruling from the National Consumers' Commission. The patient appealed in the SC]. The consent form signed by the patient at the very beginning stated that the patient had been informed that the treatment to be undertaken is ‘diagnostic and therapeutic laparoscopy. Laparotomy may be needed’. The outcome of the case turned on the definition of ‘laparotomy’ – the word simply refers to opening the abdomen; so, in this instance, did it also imply consent to remove organs from the patient’s abdomen after it had been opened (as the doctor argued)? The court’s answer was in the negative and it emphasized that if that was indeed the case, the consent form ought to have read “"diagnostic and operative laparoscopy. Laparotomy, hysterectomy and bilateral salpingo-oopherectomy, if needed."

The analysis ought to have ended at this point. Strangely, the court added soon after: “The words "Laparotomy may be needed" in the consent form dated 10.5.1995 can only refer to therapeutic procedures which are conservative in nature (as for example removal of chocolate cyst and fulguration of endometric areas, as stated by respondent herself as a choice of treatment), and not radical surgery involving removal of important organs.” This only raises more issues than it solves. One may well ask how ‘laparotomy’ can also mean ‘laparotomy, cystectomy (removal of cyst) and fulguration’ but not ‘laparotomy, hysterectomy and bilateral salpingo-oophorectomy’. Even if one answers that this is a matter of degree (a limited or ‘conservative’ procedure being acceptable without a separate heading), it may only serve to ignite more controversy over what constitutes a ‘conservative’ as opposed to a ‘radical’ procedure, questions that are not easily settled. Furthermore, even in the specific context of this patient’s diagnosis, a ‘conservative’ surgical option did not really exist (as the expert witness testified), so the more ‘liberal’ reading of ‘laparotomy’ as the court suggests does not make much sense.

This is however a relatively minor point. The importance of the decision lies really in the court’s recognition of obtaining a proper and informed consent and reasonably limiting the scope of intervention to what is permissible therein. Future cases may well arise on the scope of information that ought to be revealed, the distinction between a substantial and an insubstantial risk, and exceptional instances where the benefits of revelation may be outweighed by the potential harm to the patient.

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