National Consumer Disputes Redressal
Suresh Chandra Mytle & Anr. vs New India Insurance Co. Ltd. & 4 Ors. on 4 July, 2016
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI REVISION PETITION NO. 2116 OF 2015 (Against the Order dated 09/04/2015 in Appeal No. 1028/2014 of the State Commission Haryana) 1. SURESH CHANDRA MYTLE & ANR. S/O LATE SH. ABINASH CHANDRA, ADVOCATE CHANDRA, ADVOCATE, HOUSE NO. 786, SECTOR 13, URBAN ESTATE, KARNAL HARYANA 2. SURESH CHANDRA MYTLE HOUSE NO.594, SECTOR-4,PANCHKULA CHANDIGARH 3. SACHIN MITTAL SON OF SHRI SURESH CHANDRA MYTLE, ADVOCATE, HOUSE NO. 594, SECTOR-4, PANCHKULA HARYANA ...........Petitioner(s) Versus 1. NEW INDIA INSURANCE CO. LTD. & 4 ORS. THROUGH AUTHORIZED SIGNATORY, HEMKUNT CHAMBERS(311800)89, NEHRU PLACE, NEW DELHI-110019 2. ALCHEMIST HOSPITALS LTD. THROUGH ITS DIRECTOR, SECTOR-21, PANCHKULA HARYANA 3. DR. I.S. VIRDI, EXECUTIVE DIRECTOR, ALCHEMIST HOSPITAL, SECTOR-21, PANCHKULA HARYANA 4. DR. PRADEEP KUMAR, M.D. MEDICINES, DNB,(GASTROLOGY) ALCHEMIST HOSPITAL, SECTOR-21, PANCHKULA HARYANA 5. UNITED INDIA INSURANCE COMPANY LTD. THROUGH ITS BRANCH MANAGER, SCO 357-358, SECTOR-35B, CHANDIGARH ...........Respondent(s)
BEFORE: HON'BLE MR. JUSTICE V.K. JAIN, PRESIDING MEMBER HON'BLE MR. ANUP K THAKUR, MEMBER For the Petitioner : Mr. Gagan Gupta, Advocate For the Respondent : For the Respondent No.1 : Mr. Navdeep Singh, Advocate For the Respondents No.2 & 3 : Mr. Ankit Swarup and Ms. Tanya Swarup, Advocates For the Respondent No.4 : NEMO For the Respondent No.5 : Mr. V.S. Chopra, Advocate Dated : 04 Jul 2016 ORDER JUSTICE V.K. JAIN, PRESIDING MEMBER Late Smt. Raj Rani Mittal, mother of the complainants and aged about 71 years, was examined by the respondent Dr. Pradeep Kumar, as an OPD patient, in Alchemist Hospital, Panchkula on 10.4.2013. She was suffering from constipation and her blood pressure at that time was 60-100. She was also a diabetic. Dr. Pradeep Kumar advised colonoscopy to the deceased. Accordingly she was admitted in the hospital on the same day for undergoing the said procedure. The colonoscopy was sought to be performed by Dr. Pradeep Kumar, without sedation. The case of the complainants is that while in the procedure room, late Smt. Raj Rani was unwilling to continue with the said procedure but despite that, doctor decided to continue with the same. When the patient experienced discomfort and palpitation, the procedure was terminated and an ECG was done which revealed increased heart rate. She was taken to the ICCU of the hospital where she expired. Alleging negligence in the treatment of the patient, the complainants approached the concerned District Forum by way of a consumer complaint impleading the hospital, its Executive Director, as well as Dr. Pradeep Kumar as the respondents. Later on, United India Insurance Co. Ltd. and New India Assurance Ltd. were also impleaded as parties to the complaint.
2. The complaint was resisted by the respondents who inter-alia stated that on being examined and advised colonoscopy by Dr. Pradeep Kumar, the patient was taken to the colonoscopy room for undergoing the procedure. It was stated in the reply that complications may occur and the pain can precipitate vasovagal attack coupled with fall in heart rate and blood pressure or may precipitate cardiac arrest / arrhythmia during the procedure. At about 7.30 p.m., the patient encountered breathing difficulties with altered sensorium during the colonoscopy and her heart rate increased to 161/min. When the condition of the patient deteriorated, she was attended by a team of doctors and was shifted to CCU. She was gasping and unconscious with no palpable pulse and was put on mechanical ventilator support. She suffered a cardiac arrest at 8.35 p.m. and eventually died at 9.15 p.m., despite best efforts made to save her life. The respondents claimed that there was absolutely no negligence in the treatment of the patient.
3. The District Forum vide its order dated 28.8.2014, allowed the complaint and directed the respondents to pay a sum of Rs.5.00 lacs to the complainants, along with interest @ 9% per annum.
4. Being aggrieved from the order passed by the District Forum, two separate appeals were preferred before the State Commission, one by United India Insurance and Dr. Pradeep Kumar and the other by New India Assurance Company Ltd., Alchemist Hospital and Dr. I.S. Virdi, Executive Director of Alchemist Hospital. Vide impugned order dated 09.4.2015, the State Commission allowed both the appeals and consequently dismissed the complaint. Being aggrieved, the complainants are before this Commission by way of these two separate revision petitions.
5. The first question which arises for our consideration is as to whether there was any negligence in conducting colonoscopy of Mrs. Raj Rani Mittal by Dr. Pradeep Kumar at Alchemist hospital, Panchkula or not.
As regards medical negligence, the Hon'ble Supreme Court in Jacob Matthew Vs. State of Punjab & Anr., III (2005) CPJ 9 (SC) inter alia held as under:
"(3) A professional may be held liable for negligence on one of the two findings; either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise with reasonable competence in the given case, the skill which he did possess. The standard to be applied for judging, whether the person charged has been negligent or not, would be that of an ordinary competent person exercising ordinary skill in that profession. It is not possible for every professional to possess the highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities, but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence".
The Hon'ble Supreme Court also held that the test for determining medical negligence as laid down in Bolam case holds good in its applicability in India. In Bolam case, the following test was laid down to determine the medical negligence.
"Where you get a situation which involves the use of some special skill or competence, then the test as to whether there has been negligence or not is not the test of the man on the top of a Clapham omnibus, because he has not got this special skill. The test is the standard of the ordinary skilled man exercising and professing to have that special skill.......A man need not possess the highest expert skill; it is well established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art". (Charlesworth & Percy, ibid, para 8.02)".
6. The onus obviously was upon the complainants to prove the negligence they had alleged in the treatment of the deceased. No medical expert was examined by the complainants to prove any negligence or deficiency on the part of the doctor or the hospital, in performing colonoscopy of Late Smt. Raj Rani Mittal. Though, she was a diabetic, there is no expert evidence or any medical literature, advising against colonoscopy of a diabetic person. Though, the blood pressure of the patient at the time she was taken to the procedure room was 60/100, no expert evidence or medical literature has been produced before us to show that 60/100 is considered to be a unsafe blood pressure for the performance of colonoscopy even of a person aged about 70 years. Therefore, it would be difficult for us to say that colonoscopy should not have been advised to late Smt. Raj Rani Mittal.
7. It was contended by the learned counsel for the complainants / petitioners 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 eventual collapse. However, no expert evidence or medical literature has been produced before us to show that the colonoscopy should not at all be performed without sedation. The medical literature, on the other hand shows that the colonoscopy is done under sedation as well as without sedation, depending primarily on the choice of the patient coupled with certain other factors. In the Article 'Colonoscopy Without Sedation' - A Viable Alternative by Peter A. Cataldo, it is recorded that though traditionally Colonoscopy has only been performed with the aid of intravenous sedation which requires intensive monitoring, the need for sedation needs to be revaluated with advances in video endoscopy and improvement in endoscopic techniques. The Article enumerates potential benefits of non-sedated colonoscopy such as:
a) decreased need for cardiopulmonary monitoring; b) no requirement for intravenous access; c) significant reduction in cost; d) minimum patient recovery time; e) availability to patients previously excluded because comorbid conditions precluded safe conscious sedation.
The Article shows that on evaluation of 258 non-sedated colonoscopy, it was found that sedation was withheld on account of patient's preference in 57% cases, medical problems in 2% cases, previous resection in 9% cases, surgeon's preference in 6.6% cases and non-intravenous access in 3%. It further shows that 133 out of these 258 patients had prior colonoscopy and in 112 cases sedation was used. 92 patients out of them preferred colonoscopy without sedation to colonoscopy with sedation, whereas 13 preferred sedation and 7 were undecided. The Article 'Sedation-risk-free colonoscopy for minimizing the burden of colorectal cancer screening' by Felix W Leung, Abdulrahman M Aljebreen, Emillo Brocchi, Eugene B Chang, Wei-Chih Liao, Takeshi Mizukami, Melvin Schapiro Knostantinos Triantafyllou, shows that un-sedated colonoscopy is available worldwide, though it is not a routine option in United States of America. The article further shows that the scheduled un-sedated colonoscopy is acceptable to patients who value communication with the colonoscopist or when they lack an escort. It further shows that sedation still continue to remain the dominant practice. Therefore, it would be difficult for us to say that performing the colonoscopy of late Smt. Raj Rani Mittal without sedation was per se an act of medical negligence.
8. The learned counsel for the complainants / petitioners has referred to an Article 'Cardio-pulmonary and Sedation-related Complications' by Professor G. Duncan Bell & Dr. Amanda Quine, where it is stated that before undertaking any GI Endoscopy procedure, the endoscopists should consider, whether formal anaesthetic help is needed or advisable. It is further stated that endoscopic procedure for certain patients are best carried out under a General Anaesthesia. The aforesaid article also enumerates the case where patients would require anaesthetists support in the procedure. However, there is no evidence of late Smt. Raj Rani, being a patient necessarily requiring sedation or anaesthesia during the colonoscopy. There is no evidence of her having severe learning difficulties or sedation having previously failed in her case. There is no evidence of her being phobic or uncooperative patient, insisting on being put to sleep. There is no evidence of her having any cardiac or pulmonary disease at the time she was taken for the colonoscopy. Therefore, it would be difficult to say that in her case, colonoscopy was advisable only under sedation.
9. The above referred articles also refers to the prevention of complications during such a procedure and the precautions include recording of the blood pressure and pulse before, during and after the endoscopic procedure. It is also advised to defer the procedure if the blood pressure is dangerously high or too low. However, there is no expert opinion to indicate that 60/100 was too low a blood pressure for performing such a procedure. The blood pressure and the pulse of the patient was recorded before the procedure. It was obviously recorded during the procedure as well, since on finding her heart rate to be 161, she was shifted to the CCU of the hospital and the procedure was stopped on finding her heart rate to be high. Since a cardiac monitoring was available in the endoscopy room where the procedure was performed, the doctor was in a position to regularly note the pulse rate as well as the blood pressure of the patient throughout the procedure. As far as ECG monitoring is concerned, the same could be advisable only if the patient had a known history of heart disease but in this case, there is no evidence of late Smt. Raj Rani having a history of heart disease at the time the procedure was undertaken, though she was a diabetic and her blood pressure at that time was 60/100. Therefore, it cannot be said that the advised precautions were not taken during the course of the procedure.
10. Undisputedly the doctor is required to obtain the consent of the patient before performing a surgery or an invasive diagnostic procedure such as colonoscopy. The consent, in the context of the treatment of a patient by a doctor means grant of permission by the patient to the doctor performing a diagnostic surgery or some other procedure, with a view to get the patient rid of his ailment. In United States of America, the Courts insist upon grant of 'informed consent' by the patient to the doctor, which requires the doctor to inform the patient about the nature and purpose of the procedure or treatment, the expected outcome and the likelihood of success, the risks, the alternatives to the procedure and supporting information regarding those alternatives. He is also expected to inform the patient about the effect of no treatment or procedure, including the effect on the prognosis and the risk associated with no treatment. In United Kingdom, the Courts insist on what is known as 'real consent', whereby the patient, having requisite capacity and competence, agrees voluntarily to a procedure, without any coercion. The patient must have minimum adequate level of information about the nature of the procedure to which he is consenting. The philosophy behind obtaining an informed consent or real consent is that it is the prerogative of the patient and not the doctor, to determine where his interest lies and which out of the available options he should choose, after evaluating the risks and benefits of all the alternatives available to him. Such a decision on the part of the patient necessarily requires his possessing at least basic understanding of various therapeutic procedures and the risks associated with them.
11. In Samira Kohli Vs. Dr. Prabha Manchanda & Anr. AIR (2008) SC 1385, the following view was taken by the Hon'ble Supreme Court with respect to consent to be obtained from the patient.
"(i) A doctor has to seek and secure the consent of the patient before commencing a 'treatment' (the term 'treatment' includes surgery also). The consent so obtained should be real and valid, which means that : the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what is consenting to.
(ii) The 'adequate information' to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment or not. This means that the Doctor should disclose (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 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. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment which may persuade a patient to undergo a fanciful or unnecessary treatment. A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment.
(iii) ..... (iv) .... (v) The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree mentioned in Canterbury but should be of the extent which is accepted as normal and proper by a body of medical men skilled and experienced in the particular field. It will depend upon the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the treatment."
12. The case of the respondents is that an informed consent from the relatives of the patient was taken by them before starting the colonoscopy of the deceased. The respondents, however, have not explained why the consent was not taken from the patient herself. Since this is not their case that the patient was unconscious or critical before the procedure was started, the consent ought to have been taken from her and not from her relatives. The consent from the relatives should have been sought only in a case where the patient was not in a position to give such a consent and the procedure was required to be performed on an emergency basis. That not being the position in this case, the consent should have been taken from her and not from her relatives. In Samira Kohli (supra) consent was taken from the mother of the patient. The Hon'ble Supreme Court held that same could not be treated as a valid or real consent because the patient was a competent adult and no medical emergency was involved. The following observation made by the Apex Court in Samira Kohli (supra) are pertinent in this case:
"The Respondent next contended that the consent given by the appellant's mother for performing hysterectomy should be considered as valid consent for performing hysterectomy and salpingo-oopherectomy. The appellant was neither a minor, nor mentally challenged, nor incapacitated. When a patient is a competent adult, there is no question of someone else giving consent on her behalf. There was no medical emergency during surgery. The appellant was only temporarily unconscious, undergoing only a diagnostic procedure by way of laparoscopy. The respondent ought to have waited till the appellant regained consciousness, discussed the result of the laparoscopic examination and then taken her consent for the removal of her uterus and ovaries. In the absence of an emergency and as the matter was still at the stage of diagnosis, the question of taking her mother's consent for radical surgery did not arise. Therefore, such consent by mother cannot be treated as valid or real consent."
13. As noted earlier, colonoscopy can be performed with or without sedation. The decision whether to undergo colonoscopy under sedation or without sedation, rests primarily with the patient. Ordinarily, the patients who want to communicate with the endoscopist during the course of the procedure prefer to undergo colonoscopy without sedation. The patients who are not accompanied by an escort may also prefer to undergo colonoscopy without sedation. Therefore, it becomes necessary for the doctor to ask the patient whether he / she would like to undergo the procedure with sedation or without sedation. The doctor needs to inform him that the procedure can be performed with as well as without sedation. The pros and cons of both the methods need to be duly explained to him in order to enable him to take an informed decision. If this is not done, the right of the patient to elect a procedure of his / her choice is seriously compromised. In the present case, there is no evidence or even allegation of the patient or her relatives having been asked as to whether they wanted the colonoscopy to be performed with or without sedation. As a result, they did not get an opportunity to take an informed decision in this regard. Late Smt. Raj Rani Mittal was not unescorted, having been accompanied by a number of family members. There is no evidence of her being keen to have a dialogue with the doctor during the course of the procedure. Therefore, it is quite likely that 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. We therefore, have no hesitation in holding that the consent taken by the respondents before undertaking the colonoscopy was not a valid consent the same having not been obtained directly from the patient and the patient having not been asked as to whether she wanted to have colonoscopy under sedation or without sedation.
14. It is an admitted position that the Alchemist hospital held Dr. Pradeep Kumar to be guilty of gross professional misconduct in the treatment of late Smt. Raj Rani Mittal. A perusal of the letter dated 19.4.2013 sent by CEO of the hospital to Dr. Pradeep Kumar shows that an enquiry was conducted and in a meeting subsequently held by the Executive Director of the hospital and attended by a number of doctors, it was found that there was a gross professional misconduct on his part. Dr. Pradeep Kumar therefore, was relieved from the services of the hospital with effect from 20.4.2013. The action taken by the hospital clearly shows that the hospital had found deficiency in the way the procedure was conducted and that was the reason Dr. Pradeep Kumar was held to be guilty of gross professional misconduct and his services were dispensed with.
15. For the reasons stated hereinabove, we hold that though Dr. Pradeep Kumar and the hospital were not negligent while performing colonoscopy on late Smt. Raj Rani Mittal, they were grossly negligent in the matter of taking consent of the patient before undertaking the said procedure. The impugned orders are therefore, set aside and considering all the facts and circumstances of the case, the respondents Dr. Pradeep Kumar and Alchemist Hospital Ltd., are directed to pay Rs.5.00 lacs as compensation to the complainants along with interest @ 9% per annum from the date of filing of the complaint till the date of the payment. The payment in terms of this order shall be made within six weeks from today. If under the policy, taken by them, they are entitled to reimbursement of the said amount from the insurers, they shall be at liberty to take such course of action, as may be open to them in law, for such reimbursement from the insurers.
The revision petitions stand disposed of accordingly.
......................J V.K. JAIN PRESIDING MEMBER ......................J ANUP K THAKUR MEMBER