Informed Consent taken from relatives and not from the patient herself, who was otherwise in a position to give consent, cost Drs. Rs.5 lakhs.
The National Commission in its recent judgment dated 4th July, has given the important verdict in the case of SURESH CHANDRA MYTLE & ANR V/s. NEW INDIA INSURANCE CO. LTD. & 4 ORS. Please see the following link
The Facts in short :
1. Late Smt. Raj Rani Mittal – 71 years, mother of the complainants was advised to undergo colonoscopy for her complaints of constipation etc.
2. It was alleged that the colonoscopy of Mrs Raj Rani Mittal should have been performed under sedation whereas it was performed without sedation, which resulted in her developing acute pain and that, in turn, led to complications resulting in increased heart rate which led to her death.
3. Smt. Raj Rani was unwilling to continue with the said procedure but despite that, the doctor decided to continue with the same.
Drs. stand :
1. Drs. denied the charges of negligence. the patient was diabetic and having High B.P. All the due care was taken and when the condition of the patient deteriorated, she was attended by a team of doctors and was shifted to CCU.
2.Informed consent from the relatives of the patient was taken by them before starting the colonoscopy of the deceased.
1. The National Commission released the Drs. from the charges of Medical Negligence.
2. On the crucial point of colonoscopy with or without Sedation, after going through the medical record and literature, it observed that the colonoscopy may be done under sedation as well as without sedation, depending primarily on the choice of the patient coupled with certain other factors and no expert evidence or medical literature has been produced before us to show that the colonoscopy should not at all be performed without sedation.
3.The decision whether to undergo colonoscopy under sedation or without sedation rests primarily with the patient.
4. However, the national commission held Drs responsible for not taking proper informed consent for the patient, relying upon the landmark judgment of Hon. Apex court in the case of Samira Kohli Vs. Dr Prabha Manchanda & Anr. AIR (2008) SC 1385,
5. The Drs. failed to explain as to why the consent was taken from relatives of Patient and not by patient herself because the patient was a competent adult and no medical emergency was involved (As observed in Samira Kohli’s Case)
6.In the present case, the patient or her relatives were not explained pros and cons of the colonoscopy to be performed with or without sedation and as a result, they did not get an opportunity to take an informed decision in this regard.
7. Had a choice been given to her or even to her family members they would have opted for colonoscopy under sedation, so as to avoid pain which the patient necessarily has to suffer in a case of colonoscopy without sedation.
In my previous Articles also I have tried to explain the importance of Informed consent and that it’s not an empty formality. The Apex Court has clearly held that the Doctor should disclose to the patient before every treatment/ surgery (a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any available; (c) an outline of the substantial risks; and (d) adverse consequences of refusing treatment, but not no need to explain remote or theoretical risks involved.
As the common adage goes, A stitch in time saves nine, proper informed consent was taken by spending time initially, can save Drs from a great amount of mental, physical, monetary pain and agony.
Thanks and Regards
Adv. Rohit Erande