PER MR. JUSTICE RAM SURAT RAM (MAURYA), PRESIDING MEMBER Brief Facts : 1. The complainants stated that Surendra Kumar Maniya - the deceased - went to the Petitioner - hospital on 15.05.2014 for his treatment of ‘pain in throat’, ‘odynophagia’ and ‘change in voice’. 2. On local examination, swelling in right side tonsil was diagnosed and was admitted at 14:00 hours. Test Reports were obtained and examined at 18:00 hours, in which, everything was found normal. The doctor advised to continue same medicines. On next day i.e. on 16.05.2014 at 8:00 hours, the doctor examined him in the hospital and found his condition as improving. Some more medicines were added. On 16.05.2014, at 19:00 hours, the patient was examined. 3. On 17.05.2014, at 8:30 hours, the patient was examined by visitor Dr. R.R. Barle and found normal. The patient was sent to OPD at 10:00 hours on 17.05.2014, where he was attended by Dr. A.K. Garg at 10:15 hours. Dr. A.K. Garg, without taking any precaution, did incision in the right side tonsil to drain out pus from it. Pus started forthcoming and choked larynx and breathing tube and entered into lungs. Due to which, the patient had become unconscious. The patient was immediately taken to ICU and kept on ventilator and died. In order to conceal negligence of Dr. A.K. Garg, the other doctor of ICU fabricated papers and declared the patient as ‘dead’ at 15:45 hours. 4. It was contended that the patient - the only breadwinner for the family - was just of 36 years and he was earning Rs.15000/- per month. He was a diploma holder and was having bright career opportunities and increase of income in future. At the time of death of the patient, age of Mrs. Shradhanjali Maniya was 29 years, Ms. Tinkle Maniya was 3 years and Ms. Manashvi Maniya was 7 months. They were deprived from love and affection of their husband/father, for their whole life. Thereafter the complaint was filed on 17.12.2014. 5. The opposite parties filed written version in the complaint and contested the case. The patient was noted as ‘Afebrile’ (Without Fever) has been noted and some additional medicines were also prescribed. Dr. R.R. Barle examined the patient on 17.05.2014 at 8:30 hours and found that there was no progress in the condition of the patient and advised for examination by Senior doctor of ENT & accordingly was examined by Dr. A.K. Garg, who found that swelling was increasing due to pus in right side tonsil. 6. Dr. A.K. Garg decided to drain out the pus by incision. He explained the process and risk to the patient. E.N.T. OPD of the hospital was fully equipped with all the necessary lifesaving tools such as (i) zenon cold light source, (ii) vacuum suction, (iii) electric cautery, (iv) endoscopy attachment, (v) facility for larynx-scopy, endotracheal intubation with Ambu bag), (vi) Emergency drugs and (vii) hydraulic patient chair (with facility of angulation). 7. Incision in the tonsil is used to be done in sitting and conscious condition of the patient, so that he can split the pus through mouth and there may not be any chance of going the pus into breathing tube. The process for draining the pus from tonsil is not a major surgery. Dr. A.K. Garg was a senior doctor and specialist in ENT. He performed incision by making opening in his abscess with full care and caution as per procedure prescribed in medical books. The larynx of the patient was more sensitive and got closed due to sudden contradiction in the muscles due to which laryngospasm occurred & Interracial Tube did not go into the breathing tube. Then within 3-4 minutes, the patient was taken to ICU, where all the immediate medical treatment was started. BP was recorded as 180/100MM HG and PR as 130 per minute. At about 13:20 hours on 17.05.2014, the patient again became unconscious. The doctor diagnosed that ‘pink frothy secretion tracheotomy’ was coming from the tube. That can happen due to having laryngospasm and pulmonary edema. 8. It was contended that the relative of the patient was immediately informed about the critical condition of the patient, who gave her consent for further treatment, but in vain. It was contended that the Time recording in OPD document and ICU document of the patient was only due to different watches at these places and no tampering was done in this respect. In his answer of Interrogatory No.15, Dr. A.K.Garg had stated that as a protocol for OPD procedure, written consent was not taken but procedure/risk was explained to the patient. In the Patient Progress Note & Doctors Instruction paper, on 17.05.2014 at 10:00 am, noted as “XST done (Neg). Procedure/risk explained to the patient”. 9. State Commission, by its judgment dated 12.05.2016, found that the doctors of the hospital did not commit any negligence in treating the patient. The death of the patient occurred due to sudden contradiction in the muscles of the patient due to which laryngospasm occurred as usually “negative pressure pulmonary edema” used to be happen in such procedure of treatment. But the patient and his family members were not informed about the risk in treatment and their consent was not obtained before start of treatment. Death percentage of the patient is 11% to 40% due to laryngospasm which usually occur due to “negative pressure pulmonary edema” as such it was necessary for the doctor to inform the patient and his family member about the risk and after obtaining consent, start the process of treatment of incision by making opening in the abscess of the tonsil. The complainants have filed Income Certificate of the deceased as Rs.15000/- per month. At the time of his death, the age of the deceased was 36 years. By applying multiplier of 15 in annual income and deducting 25% towards personal expenses of the deceased, loss of Rs.1012500/- has been assessed and in total Rs.15 lakhs were awarded. . Held : 9. The entire case revolves around Informed consent and both the parties relied upon the judgment of Supreme Court in Samira Kohli Vs. Dr. Prabha Manchanda, (2008) 2 SCC 1, in which following principles have been provided for obtaining consent:- “We may now summarize principles relating to consent as follows : (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 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) Consent given only for a diagnostic procedure, cannot 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 defence in an action in tort for negligence or assault and battery. The only exception to this rule is where the additional procedure though unauthorized, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorized procedure until patient regains consciousness and takes a decision. (iv) There can be a common consent for diagnostic and operative procedures where they are contemplated. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery. (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.” 10. The commission relied upon the Evidence of Dr. A.K. Garg wherein admitted that written consent was not taken either from the patient or his family member. From medical literature it is proved that mortality rate was 11% to 40% due to laryngospasm which usually occur due to “negative pressure pulmonary edema” as such it was necessary for the doctor to inform the patient and his family member about the risk and after obtaining consent, start the process of treatment of incision by making opening in the abscess of the tonsil. 11. It was observed that Dr. A.K. Garg examined the patient on 17.05.2014 at 10:15 hours, in OPD ENT and decided to adopt the process for draining the pus. Noting in the Patient Progress Note & Doctors Instruction paper, on 17.05.2014 at 10:00 am, that “XST done (Neg). Procedure/risk explained to the patient” appears to be a subsequent endorsement as at 10:00 am, Dr. A.K. Garg, senior doctor of ENT had not decided for draining the pus. Findings of State Commission that the patient and his family members were not informed about the risk nor their consent was obtained, do not suffer from any illegality. 11. The Commission however refused to enhance the compensation as there was no cross appeal filed by the Complainants. Lack of "informed consent" has always been the main contention in most of the medico-legal cases. Had there been the proper documentation without any changes made in dates, he Appellants could have been benefited with the judgment of Samira Kohli (supra) as they would have been able to prove the consent was taken. But the Doctor himself admitted that no consent was taken. So, as I always tell in my lectures, that you may examine or operate less patients, but don't avoid taking "informed consent" or don't delegate it to your support staff. As when it comes i nthe courts, the Doctors are held liable and not the support staff. With kind regards
(Adv. ROHiT ERANDE) Pune © |
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