SITARAM BHARTIA INSTITUTE OF SCIENCE AND RESEARCH v. VIDYA BHUSHAN JAIN & 3 ORS.

This appeal arises out of order of State Commission Delhi dated 29.03.2016 in CC No. 322 of 1997.

2. Briefly stated, the facts relevant for the disposal of the appeal are that respondent no.1 filed a consumer complaint in State Commission Delhi alleging that on 27.09.1996, he approached OP No.2 Dr. D K Bhargawa, Senior Consultant, Department of Gastroenterology at OP No.1 hospital. The complainant was diagnosed by OP No.2 as Acute Pancreatitis. On the advice of OP No.2, the complainant got himself admitted in OP No.1 hospital. Various investigations / tests were conducted and treatment for ailment of pancreatitis was started. On 03.10.96, the complainant found considerable improvement and he was advised to consume oral food like soup etc. On 04.10.96 on the advise of OP No.2, CT scan of abdomen of the complainant was done by Dr. J S Khurana. On the same day at about 3.00 p.m., a team of anaesthesiologists / technicians / junior doctors accompanied by a nurse arrived in the room of the complainant. Family members of the complainant were asked to go out. On the queries from the family members of the complainant, the said team told that as per the instructions of OP No.2 Doctor, some procedure had to be performed on the complainant. It is alleged that neither consent of the complainant nor consent of his family members were taken for performing the procedure. On repeated questioning, team of doctors got irritated and behaved rudely with family members of the complainant and told them to leave the room. Having no option left, complainants family members left the room. Thereafter, the aforesaid team started to perform unexplained procedure without there being consent of the complainant. While performing the procedure, some injection was given and intubation was done by pushing some tubes down the throat of the complainant. After some time, complainant suffered severe pain and on hearing his cries, his family members rushed into the room but they were ordered to stand outside. The procedure continued for half an hour. The complainant suffered severe pain and became unconscious. When the complainant gained consciousness almost after four days, he learnt that he was shifted to Apollo Hospital. Father of the complainant told him that due to negligence on the part of team of aforesaid doctors, some complications had occurred due to which the complainant was first taken to ICU of OP No.1 where he was put on respirator. It is alleged that six units blood was also given to the complainant and he was ultimately shifted to OP No.3 Hospital.

3. According to the hospital, team of doctors had attempted invasive procedure called Central Venous Line / Triple Lumen CVP and due to their negligence, jugular artery was ruptured resulting in profused bleeding leading to collection of blood in the chest resultantly the lungs of the complainant collapsed and he had to be put on artificial respiration. It is also alleged that due to pressure of blood, the complainant suffered Leftward Shift of Mediastinum.

4. It is further case of the complainant that due to negligence of the team of doctors / technicians, the complainant suffered Haemothorax/Haemotoma-right side of chest and had to undergo a major surgical procedure on 07.10.96 called Thoractomy at Apollo Hospital ( OP No.3). The complainant was discharged from Apollo Hospital on 04.11.96 and he had to pay sum of Rs.3,09,507/- for his stay / treatment in the said hospital. It is alleged that due to negligence on the part of Op No.1 & 2, complainant is unable to lead normal life and is unable to breathe freely and laugh freely. He is also unable to enjoy normal sexual relations with his wife.

5. It is alleged that due to aforesaid negligent act on the part of OP No.1 & 2 and the team of doctors and technicians of OP No.1, the complainant suffered monetary as well as physical pain and trauma. Hence, the consumer complaint seeking compensation to the tune of Rs.19,60,507/-. The break-up of compensation under various heads is detailed as follows: a. Money paid to opposite party no.1 Rs.60,000/- b. Money paid to doctor J S Khurana for C T Abdomen on 04.10.96 Rs.3,000/- c. Money paid to opposite party no.3 Rs.3,09,507/- d. Money paid to nurse for one month Rs.18,000/- Towards Medicines/Treatment after discharge from Apollo Hospital till date of filing complaint Rs.1,00,000/- Future Medicines/Treatment expenses at an approximate @ Rs.40,000 p.a. for the next three years Rs.1,20,000/- Direct loss of income / investment / business opportunities during 6 months from 04.11.96 onwards Rs.3,50,000/- h. Loss in future due to complainants reduced efficiency and physical handicap Rs.5,00,000/-

i. Mental tension/agony/torture due to complainantsprecarious condition Rs.5,00,000/- Total Rs.19,60,507/-

6. Op No.3 despite of service of notice of complaint, failed to file written statement and was proceeded ex parte on 27.09.1999.

7. Op No.1 & 2 filed separate written statement wherein the allegations of medical negligence on merits were denied. It was pleaded that complainant was diagnosed as acute case of pancreatitis on the basis of clinical, biochemical and imaging techniques ( ultrasound and CT scan). He was given proper requisite treatment. The complainant was given intravenous fluids. On 29.9.96 the complainant was allowed to take few sips of water to keep his throat wet. On 30.9.96, the complainant could tolerate about 12 tea spoons of water. On 02.10.96, the complainant started taking small amount of fluids in the form of water and clear vegetable soup. Again on 3.10.96, it was not possible for the complainant to consume fluids by mouth due to abdominal pain, nausea and fear of vomiting. After few days of treatment, it was getting difficult to provide intravenous fluids to the complainant because of inability to locate peripheral veins on hands and arms of complainant. Because of the aforesaid reason, it was decided to provide food through central venous line. The prognosis was explained to the father of the complainant after taking the decision to insert Central Venous Catheter. Its pros and cons were discussed with the complainant, his wife and son. They were explained about the possible complications which may result. The father of the complainant was also explained the procedure and possible implications in the lobby. It was explained that complication does occur in 5-10% cases. After understanding the entire procedure, relatives of the patient gave a go ahead to proceed with the procedure. It is further the case of the opposite party that procedure for inserting Central Venous Line was done by the experienced doctors with utmost care. If accidentally, the artery got punctured, for that the opposite parties cannot be held liable.

8. The State Commission on consideration of pleadings and analysis of evidence did not find the treating doctors negligent so far as treatment of the patient is concerned but State Commission was of the view that a proper informed consent for the invasive procedure i.e. inserting central venous line was not obtained by the concerned doctors of the opposite party hospital. Therefore, the State Commission holding that to be deficiency on the part of the opposite parties, allowed the complaint and directed the opposite partyno.1 hospital as under;

The evidence on record establishes that complication had taken place due to unconsented procedure of Central Venous Line upon complainant when internal Jugular artery was cut and the complainant had suffered Haemathorax and was taken to OP-3 i.e. Apollo Hospital on 7.10.1996 where surgical procedure called Thoractomy was performed. It is also admitted position that complainant had remained admitted at OP-3 from 7.10.1996 to 4.11.1996 and had paid a bill of Rs.3,09, 507/- which was an unnecessary expense. The complainant had also paid a bill of Rs.60,000/- to the OP-1. The complainant has claimed compensation under various heads, the details of which has been given above, for a sum of Rs.19,60,507/-. The complainant has also suffered mental agony and harassment. He had also to undergo monetary loss and was forced to remain on bed for few months due to unconsented procedure. The complainant has also suffered mentally as well as physically and has also undergone medical treatment even after discharged from Apollo hospital. The complainant has made allegation that he is still permanently disabled. However, there is nothing on record to substantiate the same. Considering the suffering, mental agony and paid of complainant, we find it appropriate to award Rs.7 lakhs in all to him as we find the same as just and reasonable. The payment shall be made to the complainant by OP-1 within six weeks of receipt of this order.

9. We have heard learned counsel for the appellant as also counsel for contesting respondent nos. 1 and 3. Opposite party no. 2 & 4 failed to put in appearance. As such, they were proceeded ex parte.

10. The first contention of learned counsel for the appellant is that order of the State Commission is erroneous for the reason that State Commission has proceeded on entirely wrong premise that the procedure of insertion of Central Venous Line Catheter in the patients neck was a surgical / invasive procedure. It is argued that State Commission has failed to appreciate that aforesaid procedure is a routine procedure like giving injection or intravenous drip to the patient.

11. We do not find merit in the above contention. A Central Venous Catheter (CVC) also known as central venous line or central venous access catheter, is a procedure in which catheter is placed into a large vein. A catheter can be placed in veins in the neck ( internal jugular vein), chest (subclavian vein or axillary vein), groin ( femoral vein) or through veins in the arm. It is used to administer medication or fluids that are unable to be taken by the mouth. From the record it transpires that in the instant case, the Central Venous Catheter was tried to be placed by the team of doctors of opposite party no.1 in the internal jugular vein, which went wrong resulting in injury to the vein and excessive bleeding. The aforesaid procedure obviously is an invasive procedure which admittedly carries the risk. Therefore, in our considered view, the placement of Central Venous Line in the body of a patient cannot be equated with ordinary procedure like giving injection or intravenous drip to the patient.

12. Now, the question arises whether before undergoing the procedure of Central Venous Line, the doctors of the opposite party hospital were under obligation to obtain consent from the respondent complainant or his family members? In the matter of Samira Kohli Vs. Dr. Prabha , Honble Supreme Court has extensively dealtManchanda & Another 1 (2008) CPJ 56 (SC) with the concept of consent to be taken from the patient or his family members. In the said case, it has been held that patient has an inviolable right in regard to his body and he has a right to decide whether or not he should undergo the particular treatment or surgery. It was further held by the Honble Supreme Court that unless the procedure is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay the further procedure until the patient regains consciousness and takes a decision, a doctor cannot perform such procedure without the consent of the patient. In the instant case, as discussed above the insertion of catheter by Central Venous Line procedure being an invasive procedure carrying certain risk of complication including the injury to the jugular vein or bursting of the blood cells, the concerned team of doctor was legally required to obtain the consent of the patient.

13. Counsel for the appellant has contended that State Commission has erred in holding that the above noted procedure was undertaken by the team of doctors of opposite party no.1 without taking informed consent of the patient and his family members. It is contended that State Commission has failed to appreciate that at the time of admission of the respondent, a consent form was signed, which authorized the appellant opposite party to undertake the procedure which was necessary for ensuring that body of the respondent gets necessary nutrients particularly when the patient was not in a position to take oral food. It is further contended that otherwise also, before undergoing the aforesaid procedure, oral consent of the family members of the patient was taken and they were explained the nature of the procedure and the risk of complication involved. Even the nature of procedure and the risk involved were explained to the father of the respondent who was sitting in the lobby, who also gave oral consent to proceed with the procedure. In support of the above contention, counsel for the appellant has referred to the affidavit evidence of the appellant particularly Dr. Ravi Bhaskar.

14. Before considering the submissions made on behalf of the appellant, it would be useful to have a clear view of the term Informed Consent. The definition of is defined in Tabers Cyclopedic Medical Dictionary and is Informed consent also quoted in Samira Kohlis Case is as under : Informed consent is defined in Tabers Cyclopedic Medical Dictionary thus: Consent that is given by a person after receipt of the following information : the nature and the purpose of the proposed procedure or treatment ; the expected outcome and the likelihood of success ; the risks ; the alternatives to the procedure and supporting information regarding those alternatives; and the effect of no treatment or procedure, including the effect on the prognosis and the material risks associated with no treatment. Also included are instructions concerning what should be done if the procedure turns out to be harmful or unsuccessful. In (supra), reference is also made to the code of Medical Ethics laid down by Samira Kohlis case the Medical Council of India. The relevant portion of the same is reproduced as under :

18. We may also refer to the code of medical ethics laid down by the Medical council of India (approved by the Central Government under Section 33 of Indian Medical Council Act, 1956). It contains a chapter relating to disciplinary action which enumerates a list of responsibilities, violation of which will be professional misconduct. Clause 13 of the said chapter places the following responsibility on a doctor :

13. Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of a minor, or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed.

15. In light of the above noted position in law, in order to succeed in this appeal, the appellant is required to establish that informed consent for undertaking the procedure of Central Venous Line Catheter was obtained by the concerned team of doctors. Ex. RW2/1 is the general consent signed by the son of the complainant at the time of his admission. The consent form reads as under:

Consent is hereby given for the performance of any diagnostic Examination biopsy, transfusion or operation under anaesthesia, local or general that may be deemed necessary in the proper medical/surgical care of while the patient is in SBISR. Signature of patient/ Relative : Abhishek (son) Name (Capital letters) : Jain House With address : B-11, Maharani Bagh, New Delhi-65 Relationship : Son Witness Signature _________________________________ Name (Capital letters) _________________________________ With address _________________________________

16. On bare reading of the above, it is clear that this consent form cannot be a substitute of informed consent because it neither explains the procedure of placement of Central Venous Line nor mentions about the risk of complications involved in the procedure. It is not the case of the appellant that there was an emergency threatening the life of the complainant which could justify the emergency procedure to save the life without seeking the consent. On the contrary, appellant has tried to justify its act by taking a plea that procedure was undertaken after explaining the nature of the procedure and the risk of complications involved to the family members of the patient and receiving oral go ahead from them. If the version of appellant opposite party is to be believed, then before undergoing the procedure, the relatives of respondent complainant were explained about the procedure of Central Venous Line and risk or complications involved. If that was true, we fail to appreciate as to what prevented the concerned doctors, namely Dr. G C Saxena and Dr. Ravi Bhaskar to obtain the consent of the respondent or his family members in writing. Therefore, in our view, the defence of the opposite party that consent before the procedure was taken orally is not acceptable and has been rightly rejected by the State Commission.

17. In view of the discussion above, we do not find any fault with the order of the State Commission. We concur with finding of the State Commission and set aside the appeal. At the time of admission of appeal, the appellant was directed to deposit 50% of the decretal amount with the State Commission within four weeks. The amount, if it has been deposited be released to the respondent. The appellant to pay the balance amount in terms of order of the State Commission within 30 days. ......................J AJIT BHARIHOKE PRESIDING MEMBER ...................... ANUP K THAKUR MEMBER