Informed consent is the subject matter of several medico-legal litigation as invariably the consent taken from a patient or his attendant is not informed consent. Informed consent means that the patient must be made fully aware of the pros and cons of the line of treatment that he will be given by the treating Doctor and the concerned hospital staff. The very idea of informed consent is that the patient should be allowed to make a sensible decision concerning his or her treatment. In the legal parlance informed consent is always based on the basis of the treating doctors diagnosis, treatment, prognosis. A patient may gather some knowledge on his medical problem via discussions with medical/nursing staff, via the media/internet, or from friends who have undergone a similar procedure but this can not be equated to the information that the treating Doctor shares with the patient. Hence informed consent occurs only when the patient after being informed by the Doctor takes the decision to go ahead with the treatment decided by the Doctor. In informed consent the patient is fully aware of the risks and benefits of his treatment.
In a recent case, reported by Times of India, the Delhi State Consumer Disputes Redressal Commission (DSCDRC) held that merely asking patients to sign a consent form is not enough, as they ought to be informed about the consequences of a surgery. The panel clearly stated that an informed consent was when a patient was explained the consequences in layman’s language to decide on the surgery. It went as far as stating the merely writing “informed consent” on top of a form does not make it so. The clauses mentioned are very vague and signing such a form is no consent in the eyes of the Law.
The Commission observed this while awarding Rs. 8 lakh compensation to the family of a city-based journalist, Bhushan Raina, who lost vision in one of his eyes after cataract surgery in 2008. He was advised to undergo a surgery after his right eye started giving him trouble. He consulted Dr. Sudeep K Jain. He was given an option to wait for 2-3 months or in the alternative to undergo the surgery immediately. The surgery was performed and his eye checkup showed retinal detachment and thereafter he was advised to undergo another surgery, but was warned that he might not get his eyesight back. The real suffering came when he was asked to lie on his stomach for almost two months and he has to eat and sleep in same position. Due to aforementioned sufferings he lost his mental and physical strength and independence and lead a poor quality of life, which jeopardized his future. Mr. Raina died during the pendency of the case.
International guidelines state that, consent should begin with a brief explanation of the planned operation, including the anesthetic involved. It is wise to describe what the patient may expect to experience during surgery, if under a local anesthetic. Medical jargon should be avoided as it only serves to reduce understanding. Sufficient information to make a decision should also include an explanation of the risks and benefits involved; any alternative treatments; and the risks and benefits of abstaining from the treatment.
Therefore DSCDRC Member (Judicial) Mr. OP Gupta rightly found that the doctors are guilty of negligence and said, “ The life of a person is almost like death without eyesight. He cannot see properly or walk or eat with comfort. He feels secluded from society and his near and dear ones.”
This judgment not only holds importance in the life of Doctors but also for patients as they need to understand that consent is an opportunity to guide the patient to the right decision for them, and also dispel any unrealistic expectations concerning the procedure. Ultimately it is an opportunity to create a relationship of openness and trust between doctor and patient, which may help if operative complications are encountered. With high health-care expectations, a poorer than expected outcome may lead to surprise and subsequent anger: good patient education, during the informed consent process, is the surgeon’s chance to forge a relationship with the patient and make sure that the patient’s expectations are realistic.
Sourabh Kumar Mishra
Senior Legal Associate
The Indian Lawyer