JUSTICE V.K. JAIN, PRESIDING MEMBER

         Late Smt. Chandramathi (hereinafter referred to as the ‘patient’) was taken to Tely Medical Centre Ltd., Thalassery, where on investigation, she was diagnosed to be suffering from Rheumatic Heart Disease and Mitral Stenosis.  Since her treatment in the hospital did not lead to improvement in her condition, she was taken to OP-5 Sree Chitra Tirunal Institute for Medical Sciences and Technology, for her treatment on 30.5.1997.  She was advised to undergo a procedure called Balloon Mitral Valvulu Plasty (BMV) to get rid of her ailment.  After advising medicines to her, she was asked to report at the hospital on 09.7.1997.  Later, the procedure was postponed to 16.7.1997 at 8.00 a.m. and a sum of Rs.70,000/- as advance was taken for her treatment.  Though, the procedure was scheduled to be conducted on 28.7.1997 by a team of doctors, headed by Dr. Francis, the patient was informed that the procedure would be performed during a workshop on BMV, which was being held in the hospital on that day.

2.     According to the complainants, sometime after commencement of the procedure, they noticed the patient being rushed to the Thoracic Surgery Operation Theatre, situated on the third floor, for undergoing an open heart surgery.  It came to be known that there was a complication in the BMV procedure and that was the reason the patient was being shifted to the said operation theatre, from the BMV Operation Theatre on the second floor.  According to the complainants, the patient did not regain consciousness after surgery and was in a vegetable stage, till she breathed her last on 26.7.1997.  Alleging negligence and deficiency in the service, including delay in conducting the heart surgery, a complaint was filed before the State Commission, seeking compensation amounting to Rs.10,00,000/-; besides costs of the proceedings.

3.     The complaint was resisted by the respondents inter-alia on the ground that the BMV procedure was postponed to 18.7.1997 with the consent of the relative of the patient; the possible complications which could occur during the procedure were clearly explained; since the patient did not stabilize for successful completion of the procedure, it was stopped half way and the patient was rushed to the operation theatre for the open heart surgery where another consent was obtained from her relatives.  It was further stated in the reply that though the operation was successful and the patient had stabilized, unfortunately she died after ten days of the operation, which had been done to repair the Left Ventricle Lateral Wall Rent, which had led to the Cardiac Tamponade, a known complication of BMV procedure.  It was further stated in the reply that BMV was done in the well-equipped cath lab on the second floor of the hospital building and patient was shifted to the operation theatre on the third floor without any loss of time, because said theatre was always ready to receive her for conducting such emergent operations.  It was further alleged in the reply that the lab and the operation theatre were well-equipped with highly sophisticated instruments and are managed by eminent Doctors and staff.

4.     The State Commission vide impugned order dated 19.6.2008 found no negligence in performing either the BMV procedure or the surgery that was performed upon the patient.  The Commission however, was of the view that there was deficiency in service as no specific consent for conducting BMV procedure in the workshop was obtained.  The State Commission however rejected the contention of the complainant that there was delay in shifting the patient from cath lab to the operation theatre and that delay had led to brain damage/Hypoxic Ischemic Encephalopathy.  The State Commission directed the respondents to pay compensation amounting to Rs.3,01,000/- to the complainants, comprising Rs.25,000/- towards loss of consortium, Rs.25,000/- towards pain and suffering undergone by the deceased, Rs.25,000/- towards loss of love and affection of the deceased by her family, Rs.2,16,000/- towards loss of earnings and Rs.10,000/- towards expenses for taking the body to their native place etc.  Being aggrieved form the order of the State Commission, the complainants as well as the opposite parties have filed these separate appeals.

5.     The first question which arises for consideration in these appeals is as to whether a valid consent was taken by the opposite parties before subjecting the patient, firstly to the BMV procedure and then to the open heart surgery.

6.     The requisites of a valid consent came to be considered by this Bench in First Appeal No.136/2008 “Convenient Hospitals Ltd. & Ors. Vs. Shankar Lal & Ors.”, decided on 19.8.2014 and the following view was taken:

          “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.

          However, the stringent standards laid down by the Court of Appeal in Canterbury Vs. Spence, 1972 (464) Federal Law Reporter 2d 772, have not been approved by the Hon’ble Supreme Court and it has been held that the standards laid down in Bolam Vs. Friern Hospital Management Committee (1957) 2 All ER 118, popularly known as Bolam’s Test would be appropriate in our social and economic context. The Bolam’s Test was accepted by the Hon’ble Supreme Court in Achutrao Haribhau Khodwa Vs. State of Maharashtra 1996(2) SCC 634 as well as in Samira Kohli Vs. Prabha Manchanda AIR 2008 SC 1385. Noticing that bringing American concepts and standards of treatment procedures and disclosure of risks, consequences and choices will inevitably bring in higher cost structure of American medical care, which the patients in India cannot afford and also noticing that not only people in our country have great regard for doctors, the members of the medical fraternity also have by and large shown care and concern for the patients, the Apex Court felt that to nurture the doctor-patient relationship on the basis of the trust which people in our country continue to repose in their doctors, the extent and nature of information required to be given by doctors should continue to be governed by the Bolam’s Test. The following view taken by the Apex Court in Samira Kohli (supra) is relevant in this regard.

“(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.

1. 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.
2. 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.

1. 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.”   

7.     It is an admitted case of the parties that the consent for the BMV procedure was taken from Mr. Tilak Raj, Son-in-law of the patient and not from the patient herself.  The same was the position with respect to the consent for the surgery performed on her.  The first consent is dated 16.7.1997 and the second is dated 18.07.1997.  It is an admitted case of the parties that BMV was an elective procedure and there was no urgency to perform the said procedure on the day the patient approached the hospital of the opposite parties.  Initially the patient reported at the hospital on 09.7.1997, but the procedure was postponed to 16.7.1997, thereby indicating that there was no urgency to perform the said procedure.  It is also not in dispute that at the time consent was taken from Mr. Tilak Raj on 16.7.1997, the patient was in a position to decide whether to consent to the said procedure or not.  In fact, the BMV procedure, which was initially scheduled to be conducted on 16.7.1997, was further postponed to 18.7.1997 since the opposite parties wanted the delegates attending conference to witness the said procedure.

8.     Since on 16.7.1997, the patient was in a position to understand the benefits as well as the possible complications of BMV procedure, the consent for the said procedure ought to have been taken from her and not from her son-in-law, Mr. Tilak Raj.  There is no explanation from the opposite parties as to why the said consent was not obtained directly from the patient.  It is primarily for the patient to decide whether to subject his/her body to a particular procedure or not.  The patient therefore, needs to be informed of all the common complications of the procedure so that he / she can decide whether, considering the possible benefits, complications and the risks involved, she wanted to subject her body to the said procedure or not.  Having not explained the pros and cos of the procedure to the patient and having not taken consent from her, the opposite parties were clearly deficient in rendering services to her.

9.     The State Commission has taken a view that the family members of the patient did not give an informed consent for the BMV procedure to be performed at the time the workshop was in progress in the hospital.  A perusal of para-3 of the complaint would show that according to the complainants themselves, the doctors had assured that BMV was a routine procedure and since many doctors from different parts were attending the workshop, there was absolutely nothing to worry.  It is thus evident that the family members of the patient were told, in advance, that it was proposed to perform the BMV procedure during the time the workshop would be in progress, and they did not object to the said proposal.  It is stated in the complaint that “By over simplification of the entire matter, consent was managed and manipulated to be obtained for the said operation”.   This clearly means that the patient and/or her family members had consented the procedure to be performed at the time the workshop was in progress though according to the complainants, the said consent was given on the assurance that the procedure to be performed was the routine procedure and they had nothing to worry.  Therefore, it would not be correct to say that an informed consent for performing the BMV procedure was not taken from the relatives of the patient.   Of course, there is no material on record to show that it was the patient herself who had consented to the procedure being performed at the time the workshop was in progress.

10.   There is no evidence of the procedure having been carried negligently or in a casual manner on account of its being witnessed by the doctors, who were attending the workshop.  There is no evidence on record to show that the doctors attending the workshop were physically present in the Cath Lab Operation Theatre where the procedure was actually performed.  Ordinarily, the delegates attending a conference and seeking to witness a procedure being performed on a patient would witness the procedure through a video camera, which is installed in the operation theatre and not by remaining person inside the operation theatre.  There is no evidence of the doctors performing the BMV procedure having become nervous or overawed on account of the procedure being watched by the delegates attending the conference.  In fact, the doctor performing a procedure being watched by outside delegates would give his best to the procedure since his own reputation is at stake when the procedure is being telecast live to the delegates attending the workshop.  Therefore, in my view, it cannot be said that the opposite parties were guilty of deficiency in service provided to the patient, by allowing the delegates attending the workshop to watch the procedure through a video camera.

11.   It was contended by the learned counsel for the complainants that considering the possible complications of the BMV procedure, the operation theatre meant for open heart surgery should have been kept in standby mode and skilled surgeons should have been readily available to perform an emergent surgery in the event of the patient developing some complications during the course of the BMV procedure.  When this question was put by the complainants to their own witness Dr. Murali. P. Vettath, Chief Cardiac Thoracic and Vascular Surgeon at Malabar Institute of Medical Sciences, Kozhikode, the reply given by him was that any reasonable and prudent interventional cardiologist should keep in mind the possibility of complication like rent and tamponade.  However, there is no material on record to indicate that the operation theatre meant for cardiac surgeries was not ready to receive the patient in the event of her developing a complication during the course of the BMV procedure and a qualified surgeon was not available in the said operation theatre.  In his affidavit by way of evidence Dr. S. Sivasankaran, Additional Professor of Cardiology in the hospital clearly stated that when BMV is done, cardiac surgeons are ready and they will remain in station until they are informed that procedures are having no problem.  He emphatically denied the suggestion of the complainant that cardiac surgery operation theatre was not kept ready and cardiac surgeon was not ready in time.  According to the witness, he had been working in the aforesaid hospital since 1994 and it was his duty to call the surgeon before every procedure and tell him that he was starting the procedure and would again call him at the end of the procedure.  Dr. M. Unnikrishnan, who performed surgery on the patient clearly stated in his affidavit by way of evidence that when the condition of the patient did not stabilize, she was immediately transferred to Thoracic Operation Theatre where entire team of doctors was ready to receive the patient inside and said team did the operation.  In fact, this doctor had also visited the cath lab following cardiac tamponade, which the patient developed during the BMV procedure and according to him, he found the cardiologists aspirating blood from pericardial cavity, auto transfusion and other medicines being given to the patient and she having been intubated and ventilated.  He further stated that he was informed of the BMV procedure previously and their operating room along with team was ready in case of any complication.  He further stated that noticing temponade, the cardiologists not only instituted immediate resuscitatory measures, but also passed on the information to him where upon he rushed to the cath lab.  Though the case sheets do not show that before starting the BMV procedure the Cardio Thoracic Operation Theatre was kept in a standby mode and the cardiac surgeon had been asked to remain in attendance, there is no reason to suspect that the standard protocol, which the hospital was following for such procedures was not followed in the case of this particular patient.  Once there is a standard protocol adopted by the hospital, it is followed in case of all the patients undergoing procedure in question and the hospital would not like to put the life of a patient at risk by not following the standard protocol.  The very fact that Dr. Unnikrishnan was informed and he immediately  rushed to the cath lab, clearly shows that not only the cardio thoracic operation theatre was kept ready to receive the patient in case of her developing a complication requiring surgical intervention, the surgeon was also readily available to perform the requisite surgical procedure.

12.   It was next contended by the learned counsel for the complainants that there was a delay in shifting the patient from the cath lab to the cardio thoracic operation theatre since the said shifting took 15-20 minutes on account of the operation theatre being situated on the third floor and cath lab being situated on the second floor.  In this regard it was pointed out that as stated by Dr. P. Murali Vettah, even loss of blood supply to the brain for ten minutes would result in brain death of a patient.  In my view, the opposite parties cannot be said to be negligent in rendering medical services to the patient merely because the cardiac thoracic operation theatre was not situated on the same floor on which the cath lab was situated.  The complainants have not been able to point any rule or requirement of the Medical Council of India or any other Body requiring a hospital to situate the cath lab and cardio thoracic operation theatre on the same floor so that there is no delay in shifting the patient from the cath lab to the cardio thoracic operation theatre, on account of the time taken in reaching from one floor to the other floor.  Moreover, there is absolutely no evidence to show that the blood supply to the brain of the patient stopped when she was being shifted from the cath lab to the cardio thoracic operation theatre, and it would not have stopped had the time taken in shifting the patient from the Cath Lab to the Cardio Thoracic Operation Theatre been less than ten minutes.  In fact according to the doctor, stoppage of blood supply to the brain even for two minutes could have resulted in her brain death.   Shifting the patient from the Cath Lab to the Cardio Thoracic Operation Theatre became necessary in order to try surgical intervention to save her life, and there is no evidence of any time having been wasted by the hospital in the said shifting.

13.   According to Dr. S. Sivasankaran, the procedure started at 3.15 p.m. and took about 120 minutes which is the time taken for serial manipulation of the appropriate catheters from the leg and to position them across the mitral valve, to achieve the dilation.  He further stated when the initial attempt did not prove to be successful, a second attempt was made and it was during the second attempt that recognized that the clinical status of the patient was deteriorating, which led them to start treatment such as aspiration of blood collecting and re-transfusion.  Since the patient developed serious complications during the course of the BMV procedure, it was absolutely necessary to shift her to the cardio thoracic operation theatre, in an attempt to save her life through the process of surgical intervention.  Sometime would certainly be required for shifting the patient from second floor to third floor but, the treating doctors really had no other option available to them in such a situation.

13.   It is not as if the cath lab of the opposite parties was not well equipped to perform BMV procedure or to handle the complications, which did not require surgical intervention.  The cath lab and the cardio thoracic operation theatre cannot be amalgamated since as pointed out by Dr. S. Sivasankaran, the facilities and sterility required for cardiac catheterisation under local anaesthesia are totally different from the requirements for a major thoracotomy surgery.  The witness pointed out that out of 3000 balloon mitral valvotomies and 30000 cardiac catheterisation at their centre, only 9 patients had developed cardiac temponade and out of them only four required surgery, whereas the remaining five patients remained in the cath lab itself.  Therefore, I cannot accept the contention that the opposite parties were guilty of negligence in shifting the patient from the cath lab situated on the second floor to cardio thoracic operation theatre on the third floor of the hospital.

14.   It was lastly contended by the learned counsel for the complainants that since the death took place in the hospital of the opposite parties, when the patient was under the care and treatment of their doctors, it is for them to explain how despite their claim of performing the procedure in a well-equipped cath lab by duly qualified interventional cardiologists, and having taken all necessary care and precautions, the patient turned into a vegetable stage and later died in the hospital.

15.   According to Dr. S.  Sivasankaran, who is an Additional Professor of Cardiology in the concerned hospital, if the mitral valve is narrowed, it needs to be opened in order to relieve the symptoms developed by the patient and to achieve longevity. According to him, balloon mitral valvotomy are the world-accepted procedures for management of this problem and the said procedure involves introducing balloon catheter into the heart, through the veins of the leg under local anaesthesia and X-ray monitoring.  He claimed that they had performed more than 1500 balloon mitral valvotomy by the time this patient was admitted for the procedure.  He further stated that cardiac perforation and temponade is a complication expected in balloon mitral valvotomy which can happen during the manipulation of any catheter inside the continuously beating heart.  Even according to Dr. Murali P. Vettath, who is an expert produced by the complainants, it is possible to have complication like perforation, rent and temponade during this procedure.  He made it clear that such complication can occur even at the hands of experienced interventional cardiologists.  He did not agree with the suggestion of the complainants that rent, puncture or perforation may occur only if the same has not performed properly or is done by incompetent, inexperienced or unqualified persons.  It has come in the deposition of Dr. S. Sivasankaran that the BMV procedure on this patient was performed by him and Dr. Nageshwara Rao, though initially it was planned to be performed by one Dr. Francis.  It was contended by the learned counsel for the complainants that the hospital was guilty of negligence in allowing a Junior Doctor to perform a procedure, which Dr. Francis was to perform.  Dr. S. Sivasankaran, as noted earlier, is an Additional Professor of Interventional Cardiology; whereas Dr. Nageshwara Rao is MD, DM in Cardiology, who had undergone one year fellowship training.  Since Dr. Nageshwara Rao was a super specialist in Cardiology and Dr. S. Sivasankaran was an Additional Professor of Cardiology, it cannot be said that the BMV procedure on the patient was performed by an unqualified and / or inexperienced doctors.  It is unfortunate that despite the procedure having been performed by experienced and qualified interventional cardiologist in a well-equipped cath lab of a reputed hospital, the patient developed complications which though uncommon are not unknown to the medical sciences.  But, then, a doctor or hospital cannot be said to be negligent in rendering services merely because the patient could not be saved, despite best efforts made by them.  The onus was upon the complainants to prove that the opposite parties were negligent and / or deficient in providing medical services to the patient.  They however, failed to prove any such negligence or deficiency, except to the extent that the consent was taken from the son-in-law of the patient, though it ought to have been taken personally from her.

16.   The next question which arises for my consideration is as to whether, considering that no deficiency in the treatment of the patient could be proved by the complainants and the only deficiency they have been able to establish is in the consent obtained by them, what would the just and fair compensation to be awarded to the complainants.  The State Commission, as noted earlier, has awarded a total compensation of Rs. 3,10,000/- to the complainants.  Considering all the facts and circumstances of the case and also that the amount of Rs.70,000/-, which the opposite parties had charged from the family of the patient has already been refunded to them, I am of the considered view that the opposite parties should pay a consolidated compensation amounting to Rs.1,00,000/- to the complainants along with interest on that amount @ 12% per annum from the date of the filing of the complaint, till the date aforesaid amount is paid to them.  Ordered accordingly.

17.   The Opposite Parties were directed by way of an interim order to deposit half of the awarded amount with the State Commission.  It is not known what exactly was the amount deposited by them in compliance of the said interim order.  If the amount deposited with the State Commission along with interest, which has accrued on that amount is more than the amount payable to the complainants in terms of this order, the balance amount, after making payment to the complainants in accordance with this order, shall be refunded to the opposite parties.  If however, the amount deposited by them with the State Commission and the interest, which has accrued on that amount is less than the amount which is payable to the complainants in terms of this order, the State Commission shall release the entire amount lying deposited with it, including the interest which has accrued on that amount to the complainants and the balance payment in terms of this order shall be made by the opposite parties within four weeks from today.