Master Nitish Sethi And Ors. vs Dr. Naresh Trehan And Ors.

THIS complaint has been filed by Master Nitish Sethi, 4 years of age, Complainant No. 1; Baby Niti Sethi, 2 years old, complainant No. 2; Ms. Indu Sethi, aged 37 years, wife of the deceased, Shri Raman Sethi complainant No. 3; Mrs. Shakuntla Sethi, 78 years of age, mother of the deceased, complainant No. 4 and Dr. M.D. Sethi aged 81 years old, father of the deceased, complainant No. 5, against Dr. Naresh Trehan, Executive Director, Escorts Heart Institute, New Delhi, opposite party No. 1; Dr. A.K. Omar, Consultant Cardiologist, Escorts Heart Institute, New Delhi, opposite party No. 2 and Escorts Heart Institute, New Delhi, opposite party No. 3 alleging medical negligence on the part of the opposite parties in treatment of Mr. Raman Sethi.

INITIALLY , Dr. M.D. Sethi was authorised to proceed in this case on behalf of the complainants. Subsequently, since Dr. Sethi and his wife Mrs. Sethi expired, thus, by Order dated 7.2.2003, the Commission appointed Miss Astha Tyagi, Advocate as amicus curiae to present the case on behalf of Ms. Indu Sethi and Mr. Krishnamani, Senior Advocate, argued on her behalf.

MS . Indu Sethi, complainant No. 3, Dr. Naresh Trehan, opposite party No. 1 and Dr. A.K. Omar, opposite party No. 2, were cross -examined by the Commission. Brief facts of the case are:

ON 13.5.1995, 37 years old Shri Raman Sethi was brought to Escorts Heart Institute and Research Centre, opposite party No. 3, for expert advice and management of an Aortic Valve, which had a narrow aperture. A Cardiac Cath Coronary Angiography was performed on 17.5.1995 as advised by Dr. Naresh Trehan, opposite party No. 1, without examining the patient. It is submitted that at the time of admission in the hospital, the patient had normal kidney and liver functions and his lungs were clear. Mr. Sethi was performing normal activities without any inconvenience and continued to do his office work. It is submitted that Dr. Trehan, after seeing the report, said that there is no urgency of operation and that he was going to US and he will do the operation after his return. He asked the patient to take admission on 18.6.1995 in Escorts Hospital, opposite party No. 3. Complainants paid Rs. 2,23,800 to Escorts Hospital and accordingly he was admitted for operation on 18.6.1995. He was operated on 22.6.1995 and he was in the operation theatre from 1.00 p.m. to 8.00 p.m. Complainants were annoyed with opposite party No. 3 for not giving any information regarding the condition of the patient and only after 8.00 p.m. they were allowed to see Mr. Sethi for few minutes from distance and at that time he was still unconscious.

ON 23.6.1995, at 9.00 a.m., Mrs. Indu Sethi was informed that the patient had gained consciousness but she was not permitted to see him. When she met her husband later in the ICU, he said to her, "These doctors are talking together that my reports are wrong". Indu Sethi conveyed this to her father -in -law, Dr. Sethi. Indu Sethi''s sister -in -law saw the patient in the evening around 6.00 p.m. and, according to her, the patient said, "I had high fever that has been lowered by putting ice -pack on my head." "My tests are not coming properly." "Call the doctor." Dr. Sethi was not allowed to see his son in the night of 23.6.1995 on the pretext that two persons were already allowed to see the patient.

ON 23.6.1995, at 8.00 p.m., Mr. Sethi''s condition was reported as critical as he had a cardiac arrest. Heart massage was given immediately in the absence of Dr. Trehan by inexperts, which caused further damage. It is Dr. Sethi, who informed Dr. Trehan about the critical condition of the patient around 8.30 p.m. and only then Dr. Trehan came in at 10.30 p.m.

IT is submitted by the learned Counsel for the complainants that in the process of performing the heart massage, which was performed by the hospital staff, blood oozed out from the freshly operated area when the patient was in a very critical condition, which made the patient''s condition worse.

IN their prayer, complainants prayed for a claim of Rs. 45,99,000 considering the salary and the pay -scale of Mr. Sethi who died at the age of 37 years and on the ground that he would have earned till the age of retirement of 60 years.

LEARNED Counsel for the complainants alleged medical negligence on the part of the opposite parties on the following grounds:

FIRSTLY , that the deceased was asymptomatic as per the report dated 18.6.1995 and did not require any surgery because the report indicated; (a) Medication -Nil (b) Pulse -74/min. (c) Blood Pressure -120/90 mm Hg (d) No clubbing. The advice given by the opposite parties was wrong and that there was no indication of any block of larger or medium size coronaries.

SECONDLY , the opposite parties did not obtain consent to operate upon second time as the consent was only for normal surgery. The second operation is being called re -exploration to cover up a major surgery of cutting open again. Learned Counsel for the complainants has relied on the judgment passed by the Hon''ble Supreme Court in Samira Kohli v. Prabha Manchanda (Dr.) and Anr., I (2008) CPJ 56 (SC)=II (2008) SLT 25=(2008) 2 SCC 1, which is extracted as hereunder: (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 he 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.

THIRDLY , he was taken to the operation theatre for re -operation/re -exploration in the early morning hours at 4.00 a.m., on 24.6.1995. Complainants were informed that the patient was shifted to "Isolated room" in ICU due to his critical condition. Dr. Sethi went in to see his son and saw his pupils with a torch and found that they were widely dilated; that they were not .responding to light; that corneal reflex was absent and the patient''s feet were icy cold. It was also brought to their notice that the patient was given dialysis, which was only a cover up action by the opposite parties because the patient had expired long before Dr. Sethi saw him.

FOURTHLY , there was a cut mark around the kidney of the deceased and there was good possibility that the kidney or any other organ could have been removed.

FIFTHLY , dialysis was being given to the patient in the absence of a Nephrologist, which is evident from the hospital record that Dr. Ashwini Goel, Nephrologist, came only on the next day and it is averred that there was no evidence to show that the patient required dialysis.

SIXTHLY , the hospital record has many inconsistencies as recorded by the opposite parties such as; on page 20 of the hospital record vol -ll wherein the opposite parties have mentioned that re -operation of the patient was done on 23.6.1995 whereas in the reply they stated the same as re -exploratipn. Critical Chart record, which has been produced by the opposite parties, is fabricated because the same handwriting has been used for the entire treatment given to the patient whereas after every 8 hours the staff is changed in the hospital as a matter of practice.

SEVENTHLY , the team of doctors, which was present for re -operation, does not show the name of Dr. Trehan in the record; whereas the opposite parties in their reply submitted that Dr. Trehan did re -exploration on 23.6.1995. Learned Counsel contended that at that time Dr. Trehan did not come to do the needful and it is deficiency in service on the part of Dr. Trehan.

EIGHTHLY , the opposite parties did not give the surgery notes of the re -exploration on 23.6.1995 and this act only proves the crucial point that the hospital authorities managed the crucial record to suit their contentions.

NINTHLY , Mr. Sethi died at about 8 p.m. on 23.6.1995 but the opposite parties did not declare him dead till 4.00 p.m. on 24.6.1995. The body of the deceased was decomposed and the same is evident from the photographs of the patient as the body was swollen which indicates that the death occurred much earlier then what is being stated.

TENTHLY , Dr. M.D. Sethi was never allowed to see the patient on 23.6.1995 after the operation on the pretext that his daughter has seen the patient earlier and therefore he could only see the patient at 4.00 a.m. on 24.6.1995. He, being a doctor, found out on his own with the help of a torch by examining the deceased that the pupils of the deceased were widely dilated and were not responding to light, feet of the patient were ice cold and indicating that, he was already dead. This in itself shows that the hospital has not been transparent about the correct facts.

ELEVENTHLY , the record of treatment on 23.6.1995 of re -exploration has not been maintained and it is incomplete and this goes against the opposite parties as nothing is disclosed to the complainants as to what went wrong on the crucial night.

TWELFTHLY , the patient was subjected to dialysis on 23.6.2009; whereas the deceased never had diabetes or any trouble with kidneys or renal. Although the patient had died, the opposite parties continued to tell the story that they were trying their best to revive the patient. EEG record could have shown a recording of viability of the patient''s brain, patient''s revival, which has not been shown to the complainants on the grounds that it was monitored but the record is not kept.

LASTLY , the opposite party No. 1 refunded Rs. 1,15,000 because he is guilty of negligence in operation and he was afraid of being exposed for mismanagement in treating the patient which shows admission of negligence on his part.

ARGUMENTS of the opposite party No. 1: 1. Learned Counsel for opposite party No. 1, Dr. Naresh Trehan submitted that the patient received treatment in accordance with the highest standards of medical practice and that there is no negligence whatsoever. It is submitted that the medical history of the patient clearly reveals that he is high -risk case of Aortic stenosis, dyspnea on exertion, palpitation, fatigue and dizziness, history of chest pain and fainting episode with fall of BP. He had a congenital anomaly of bi -cuspid aortic valve. The patient was hypertensive and his ECG revealed a Left Bundle Branch Block, which clearly indicated that the disease was at an advanced stage, and he was therefore a High Risk Patient. The patient was diagnosed in 1993 as a case of Aortic Stenosis. He, however, came to Escorts for the first time in May 1995.

The patient and his attendants were regularly apprised of the risk factors involved in the surgery and also "High Risk" consent was personally signed by both the patient and his wife on 21.6.1995 with full understanding of the high risk factors of the patient''s case.

The patient was symptomatic since 1993 and he had previously consulted in King George''s Medical College, Lucknow; Sanjay Gandhi Postgraduate Institute, Lucknow and All India Institute of Medical Sciences, New Delhi. These reports were not produced by the complainants for obvious reasons. The Aortic Valve aperture is normal between 1.5 and 2.6 centimetres whereas the patient had 1.1 centimetres. The Echo concucted on the patient on 24.3.1997 showed (a) Aortic Stenosis (b) Bi -cuspid AV (c) Pressure gradient 19.3 mm HG. The patient has been suffering from congenital anomaly of Bicuspid Valve and hence it is a known case with the history of heart problem which complainants were completely aware of.

The relatives of the patient brought the medical record on 13.5.1995 for consultation with the doctors and did not bring the patient. They reported that the patient was suffering from: 1. Moderately Severe Aortic Stenosis.

History of Chest pain with Dyspnea on Exertion.

History of Fainting episode with fall of BP.

At Escorts, Echo test was done which revealed as under: 1. Aortic Valve Leaflet thickened and heavily calcified.

Max PG = 107 mm Hg

Concentric LVH (Left Ventricular Hypertrophy)

The patient was admitted in Escorts for undergoing CART (Coronory Angiography) with Aortic Valve Replacement and the discharge summary showed that the patient was hypertensive and had a positive family history of Ischaemic Heart Disease. The patient was a known case of Aortic Stenosis. The ECHO done on 25.4.1993 revealed that he had Bi -cuspid Aortic Valve with Pressure Gradient of 19.3 mm Hg. The patient complained of having fatigue, dizziness for the past one month, history of DOE Class II and palpitation. On examination, it was found that he was having ESM (Ejection Systolic Murmur) Grade 4/6 in Aortic area radiating to Carotids (an artery in the neck). It was also found that he was having complete LBBB (Complete Left Bundle Branch Block). On 18.6.1995, the patient got admitted for Aortic Valve Replacement. The clinical summary recorded the history as given by the patient as follows - (i) Hypertensive

(ii) Known case of Aortic Stenosis since 3 years (Bicuspid AV).

(iii) Gradient 19.3 mmHg on ECHO in 1993.

(iv) History of DOE Class II.

(v) Palpitation, fatigue and dizziness.

(vi) Moderate AS.

(vii) CART: AV calcified, gradient 74 mmHg.

(viii) Breathlessness - positive

(ix) Harsh ESM (Ejection Systolic Murmur) 4/6 radiating to carotids.

The patient was operated for aortic valve replacement surgery by Dr. Trehan assisted by Dr. Mahendra Mairal and Dr. Pankaj Maheswari and the Trans Esophogical Echo (TEE) was done post operatively which revealed normal functioning of the prosthetic heart valve (PHV) and the patient was shifted to the recovery room on very small amount of inotropic support and his condition was haemodynamically stable. Smt. Indu Malhotra, Senior Advocate submitted that the surgery by itself was successful and that there is no negligence/deficiency in service on the part of the opposite party No. 1.

Post operative record shows; on 23.6.1995, which is the first post -operative day, he was extubated in the morning and was haemodynamically stable till 8.00 p.m.. The patient maintained normal temperature till 28 hours after the surgery. At 8.00 p.m., on 23.6.1995, the patient suddenly developed supraventricular tachycardia (fast heart beat) followed by bradycardia (slow heart beat), [collectively called "arrhythmia" (abnormal heart beat)], hypotension (low blood pressure of 40/20n), followed by cardiac arrest. That immediately injection Soda bicarb, Injection Isoptin were given to decrease the heart rate. Injection Epinepohrin Bolus, Injection Calcium was given to increase the low Blood Pressure. The treatment that has been given is not in question now, as there is no complaint against the same by the complainant.

It is submitted that Dr. Pankaj Maheshwari and Dr. Mahender Mairal, as cardiac surgeons, are having MS, MCH qualifications and they conducted heart massage at 8.30 p.m. Learned Counsel for the opposite party No. 1, vehemently, objected to the averments made by the complainant that these doctors were not qualified.

At 9.00 p.m. the blood pressure became normal i.e., 120/80 and thereafter Echo test was done and again at 10.00 p.m. his blood pressure started falling i.e. 83/40. The patient''s haemoglobin count which was previously maintaining at 11 suddenly dropped to 8.3 at 10.00 p.m.

Dr. Naresh Trehan took a considered decision to conduct a re -exploration surgery and the patient was shifted to the operation theatre for reviving his cardiac function at 10.25 p.m.. Dr. Trehan and his team of doctors re -explored and maintained his blood pressure. The patient was put on heavy inotropic support and Intra Aortic Ballon Pump (AIBP). Thereafter, the patient was shifted to recovery room on heavy inotropic support, which supports the heart and increases the blood pressure. The patient was put on respirator machine since the time he was brought to the recovery room after the operation.

After re -exploration when it was seen that the patient had no urine output, injection lasix was administered. Thereafter, as the patient post operatively showed symptoms of acute renal shut down, it necessitated peritoneal dialysis, which was started immediately. The Consultant Nephrologist, Dr. Ashwini Goel, reviewed the patient''s condition and advised further treatment for patient''s renal problem.

The Critical Flow Sheet on 24.6.1995 showed clearly that the patient was maintaining vital parameters while on the support system that is the heart rate, blood pressure, blood gases, cardiac out put according to the Critical Care Flow Sheet, Nurses Chart and other clinical records.

At 4.30 p.m., on 24.6.1995, despite the best efforts of the opposite party the patient could not be further resuscitated and declared dead. The allegation that Dr. Sethi, father of the patient, found that the patient was dead when he went to see him is incorrect on the basis of the record maintained by the hospital.

It is stated by the learned Counsel that Dr. M.D. Sethi, father of the patient, requested for a subsidy on the ground of financial hardship and also on the ground of he being a doctor and accordingly a subsidy of Rs. 42,900 on bill No. 000146 dated 24.6.1995 was given.

It is stated that Dr. Trehan had a telephonic conversation with late Dr. M.D. Sethi and Mrs. Indu Sethi on 3.8.1995 when he explained the facts and circumstances pertaining to the treatment of the patient to them.

Thereafter, on 30.8.1995, Mrs. Indu Sethi met Dr. Trehan in his office with some relatives and addressed a letter to him requesting financial help on humanitarian grounds and the contents of the letter are given below -

"Sir, My husband Raman Sethi was admitted in your Institute on June 18, 1995 for Aortic Valve Replacement hut unfortunately despite of your best efforts and medical care he could not survive and expired on 24.6.1995. Since I am left with a lot of responsibilities on my shoulder I humbly request to your good honour to please assist me and my family with maximum financial help. I am sure you will show good gesture in accepting my request for which I shall be grateful to you. Thanking you, Sincerely Yours Indu Sethi."

Considering this request and keeping in mind the financial hardship as requested by Indu Sethi, an amount of Rs. 1,15,000 was refunded to her by cheque No. 282990 dated 18.9.1995. It is contended that there was no allegation with respect to the course of treatment being incorrect nor was there any allegation about the actual procedure of Aortic Valve Replacement surgery. It is vehemently argued that the complainants made misconceived and vague allegations against the opposite parties after taking the initial subsidy asked by Dr. Sethi and after receiving a large amount of Rs. 1,15,000.

Learned Counsel has relied upon the medical text, which is reproduced as hereunder: "Most importantly the condition of the patient having Bi -cuspid Aortic Valve, Aortic Stenosis, and Left Bundle Branch Block (LBBB) and increased pressure gradient, the patient has more chances of Ventricular Arrhythmia, tachycardia and sudden cardiac arrest. Bi -cuspid Aortic Valve -complications and the need for immediate surgery -The aortic valve is the outflow valve of the left side of the heart, meaning that it opens during systole (when the ventricle squeezes blood out into the aorta and the rest of the body). When the aortic valve is too narrow or stenotic, the ventricle has to work harder to pump the blood out to the body. Aortic stenosis is often progressive, growing worse with time. As the valve gets tighter, the heart has to continue to work harder and harder to keep pumping blood out of the heart. At some point the heart can no longer compensate, fluid will build up in the lungs creating congestion. When the aortic valve leaks, the heart has to work harder and similar problem occurs. The ventricle must pump more blood with each contraction to produce the same forward output, creating a condition called volume overload. The heart can compensate for this volume overload for many months or years provided the leakage develops slowly. Eventually, the heart begins to fail producing shortness of breath and fatigue. The abnormal structure of the bi -cuspid aortic valve induces turbulent flow, which injures the leaflets and leads to fibroids, increased rigidity, leaflet calcification, and narrowing of the aortic valve orifice. Bi -cuspid valves are often associated with dilatation of the ascending aorta related to accelerated degeneration of the aortic medium that in some cases may progress to aneurysm formation.

It is stated that in a normal aortic valve there are three leaflets i.e. Tricuspid Aortic Valve, and the aortic systolic and LV systolic pressure are equal and there is no pressure gradient. However, in the present case, the patient had Bi -cuspid aortic valve along with aortic stenosis with pressure gradient of 107 mm Hg (as revealed in the ECHO test dated 15.5.1995) and the Cardiac Catherization and Angiography Report dated 17.5.1995 revealed moderately severe aortic stenosis and Grade 2/4 aortic regurgitation which in the present case necessitated surgical intervention and in any event there is no conventional method of treatment.

It is submitted that the blood flow across bi -cuspid aortic valve is more turbulent, causing increased wear and tear on the valve leaflets. Overtime, excessive wear and tear leads to calcification, scarring and reduced mobility of the valve leaflets. About 10% of Bi -cuspid valves become significantly narrowed resulting in symptoms and heart problems of aortic stenosis. For a person suffering from severe aortic stenosis, there is no conservative treatment for the above mentioned condition and it can be corrected through surgical intervention.

Arguments of opposite party No. 2 Dr. Omar, opposite party No. 2, on his affidavit stated that the deceased, Mr. Sethi, consulted him on 13.5.1995 and has been diagnosed as a moderately severe aortic stenosis in 1993; that the patient had history of chest pain and dyspnea on exertion; that there was history of fainting episode with fall of blood pressure; that he was advised coronial angiography; that the patient underwent cardiac cath and coronary angiography on 17.5.1995 which confirmed that he was suffering from moderately severe aortic stenosis with gradient across bi -cuspid calcified aortic valve - 65 mm Hg., LVEF 65% and that he was advised aortic valve replacement in view of his symptoms and cardiac cath findings. It is further submitted by the learned Senior Counsel, Ms. Indu Malhotra that Dr. Omar did not see or treat the patient after the first diagnosis and that deficiency in service or negligence cannot be attributed to him and that he is only made a proforma party to the complaint. Arguments of opposite party No. 3

LEARNED Counsel for the opposite party No. 3 submitted that the medical record clearly shows all the details regarding the heart ailment of Mr. Sethi. Necessary investigations were done based on his earlier record and the patient underwent angiography on 17.5.1995 and there is no whisper of deficiency in service/medical negligence in the treatment given till then. The case revolves regarding the post -operative treatment; and it is an admitted fact that on 23.6.1995 the patient suffered a cardiac arrest at 8.00 p.m. when his condition became critical. The patient was resuscitated at that time without any delay and subsequently shifted to operation -theatre for re -exploration and this has been done as per best medical practice and there is no deficiency in service or negligence by them. That, thereafter, the patient did not pass urine and hence dialysis was necessary which was started immediately without any delay to ensure that the kidneys do not fail. The doctors and the hospital staff had given complete care to the patient to revive him and administered resuscitating measures till Dr. Trehan came in.

IT is further submitted that the two doctors who gave heart massage were qualified and trained doctors with qualifications of MS/MCH in cardiac surgery. The allegation made against Dr. Trehan and the other doctors in the hospital is that there was blood collected around the heart of the patient due to heart massage ineffectively or wrongly given by the other two doctors on duty who are not qualified and that it necessitated re -exploration is not true. It is not true because the blood does not get collected because of heart massage that was given and that too by highly qualified doctors and there is no evidence of the blood being collected and that this allegation should be rejected.

THE two doctors were always present round the clock and the Critical Care Flow Sheet regarding all the vital parameters of the patient shows that the patient died only at 4.30 p.m. on 26.4.1995. Dr. Sethi''s allegation that the patient was dead much earlier and that the hospital authorities have been showing false pretext of dialysis on the patient whereas the kidney of the patient was being removed when the patient actually died is a false allegation and that the hospital would never do such criminal activities as alleged.

IT is further stated that, although a statement has been made that some organs of the body must have been removed like kidney, etc., in a cross -examination, Ms. Indu Sethi herself admitted that she is not aware if kidney has been removed.

MS . Indu Sethi also, in her cross -examination, admitted that the record of treatment of her husband at King George''s Medical College, Lucknow; Sanjay Gandhi Postgraduate Institute, Lucknow and All India Institute of Medical Sciences, New Delhi were not filed along with the complaint since they were with her late father -in -law. Learned Counsel stated that such an admission could not absolve her of the responsibility to produce the medical record of various hospitals regarding her husband''s treatment. The learned Counsel has placed reliance on the judgment of this Commission reported as III (2006) CPJ 293 (NC), Sukumari Sahu and Anr. v. Tata Memorial Hospital and Ors. In Para 6 of the judgment, it has been stated that: "The complainats have not produced extracts from any standard medical text to prove the contention that the patient was given wrong treatment which is not authorised by medical science."

"The complainants have also alleged deficiency in service and negligence by the doctors of the hospital. They have not produced any evidence from any expert in Oncology to support their contention that their son died on account of sheer negligence, carelessness and casual treatment, etc., as alleged by them."

FURTHER , she has filed complaints in other Fora i.e. UP Medical Council, Medical Council of India, Metropolitan Magistrate, etc., and none of these complaints have been proved and nowhere any negligence has been clearly elaborated by the hospital and also the doctors. Further, after taking a subsidy of Rs. 42,900 on the ground of financial hardship and subsequently once again pleading for further amount and took a refund of Rs. 1,15,000, complainants cannot continue to litigate in the same fashion in filing complaints after complaints against the opposite parties with the main motive to extract money.

WE heard both the parties at length, perused the record, the affidavits, cross -examination and interrogatories exchanged between the parties.

FIRSTLY , there is no evidence that kidney or any other organ has been removed during the operation by the opposite parties. This allegation is completely baseless and is an uncalled for accusation. A mere small cut on the body cannot be made into allegation of organ removal without any basis. Relatives of the patient could have got the post -mortem of Mr. Sethi done after his death, if they had this doubt at the relevant time. But post -mortem was not done. Mrs. Sethi in her cross -examination answered that she is unsure if kidney has been removed. For making such serious, false and criminal allegation against doctors and Hospital authorities, which have serious consequences without any substance the complainants should be made to pay cost which we are not inclined to order in view of the death of her husband.

SECONDLY , the patient and his wife Indu Sethi had given consent along with the witness on 21.6.1995. The following excerpts are taken from the consent form: Informed Consent 1. I hereby authorize Dr. Trehan and those whom he may designate as associates or assistants to perform upon me the following Medical treatment, Surgical operation and/or diagnostic/therapeutic procedures: AVR.

It has been explained to me that, during the course of the operation/procedure unfore -seen conditions may be revealed or encountered which necessitate surgical or other procedures in addition to or different from those contem -plated. I therefore further request and authorize the above named physician/surgeon or his designates to perform such additional surgical or other procedures as he or they deem necessary or desirable. 2. ***

I further consent to the administration of such drugs, infusions, plasma or blood transfusions or any other treatment or procedure deemed necessary in the judgment of the medical staff.

The nature and the purpose of the operation and/or procedures, the necessity therefore, the possible alternative methods of treatment, the risks involved and the possibility of complication in the treatment of my condition have been fully explained to me and I understand the same.

It has been explained to me that the risk of the operation in my case is high ( -%) because of the following factors.

Hypertension 2. LBBB (Left Bundle Branch Block)

THE condition of the patient was serious and since High Risk consent form was taken signed by the patient and his wife keeping in mind in case emergency arises where a procedure needs to be done in critical condition and circumstances necessitate such procedure is a must for the survival of the patient, then it cannot be termed as negligence/deficiency in service. We relied on the decision passed by the Hon''ble Supreme Court in Samira Kohli v. Dr. Prabha Manchanda and Anr. (supra), wherein it is clearly held that: "(ii) 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 unreasonable to delay such unauthorized procedure until patient regains consciousness and takes a decision. (iii) 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."

WHEN the patient''s condition became critical as haemoglobin count which was maintaining at 11 at 9.00 p.m. dropped to 8.3 at 10.00 p.m., a considered decision was taken to conduct re -exploration surgery by opposite party No. 1 along with his team of doctors to revive cardiac function of the patient at 10.25 p.m. on 23.6.1995 and this action cannot be considered as deficiency in service/negligence.

THIRDLY , in our view, in a High Risk patient when the patient showed symptoms of acute renal shutdown, which necessitated dialysis to be done, it is being done in the best interest of the patient in emergency.

FOURTHLY , It is an admitted fact that the patient in a Cardiac Evaluation Form dated18.6.1995 has admitted diagnosis that the patient inter alia had a history of syncope (loss of consciousness/fainting) and in the clinical summary it has been noted that the patient was hyper -tensive, non -diabetic, non -smoker with positive history of Ischaemic Heart Disease. In the complaint itself it is admitted that: "My son, Raman Sethi, has Aortic Valve aperture 1.1 cm (i.e. it was not less than 1 cm. normally being 2 cm and Aortic Root diameter=2.6 cm which was normal. Secondly his heart (left ventricle) had adapted itself, to normalize its systolic function (vide angiography report stating left ventricle function, normal), coronaries normal with normal LVEF indicating that patient was asymptomatic -Annexure No. 8 and 9 and his left ventricular systolic volume was increased by the vigour of the hypertropnied and dilated left atrium. To make up the deficiency casued by the L.V.diastolic dysfunction and thereby to normalize its output (vide Echo -report left AtriaI Dimension) L.V. Dimension."

FIFTHLY , Dr. R.R. Kasliwal, a well known Senior Consultant, Incharge, Heart Station, Escorts has given a report of final diagnosis based on the Echo report. It is only after one month the earlier reports the CART was done and it showed complete LBBB (Complete Left Bundle Branch Block) and it is also noted that the patient had breathlessness, palpitation, hypertension, aortic murmurs, Harsh ESM. It cannot be said when the patient has a positive family history of Ischaemic Heart Disease, the advice to go for AVR is incorrect. We do not find any deficiency/negligence on this count.

SIXTHLY , regarding non -physical examination of the patient as alleged, Dr. Trehan has answered the Question -8 in the interrogatories that the patient has been examined by him on 17.6.1995 and that he recommended for aortive valve replacement surgery on the basis of his physical examination prior the angiography and based on the medical report and other investigations including the investigations conducted at Escorts Heart Institute.

SEVENTHLY , regarding the congenital abnormality, Dr. Trehan has answered Question -10, i.e., "According to you, for how long was the patient suffering from moderately severe aortic stenosis - Dr. Trehan answered, "The patient was diagnosed to have a Bi -cuspid Aortic Valve, which is a congenital abnormality. The patient had complained of fatigue, shortness of breath, and fainting episodes."

EIGHTHLY , Dr. Trehan categorically stated to the question being put to him "if there is any other form of treatment other then operation" it has been answered as, "No, there is no other form of treatment for moderately severe aortic stenosis with gradient Bicuspid Calcified Aortic Valve except AVR surgery. If the gradient across the aortic valve is more than 50 mm -60 mm Hg and the patient is symptomatic such as chest pain, difficulty in breathing, fainting episodes, etc., we advise the patients to undergo Aortic Valve Replacement." The complainant has not rebutted this with any counter from any medical expert to disbelieve the answer given by Dr. Trehan.

NINTHLY , a question was put to Dr. Trehan in Question -20, i.e. "what made you ignore the contraindications to open heart surgery'' such as Left Ventricular Hypertrophy with coronary insufficiency conduction block (complete LBBB with LAD), Aortic Aperture not less than 1 Cm2 asymptomatic" He answered, "these are not contraindications to open heart surgery''. On the contrary, these are indications that the disease is severe, and requires surgical intervention. The LVH, Coronary insufficiency and Aortic Aperture less than 1 cm indicate necessity of Aortic Valve Replacement." No medical text evidence has been produced to counter this explanation by Dr. Trehan.

TENTHLY , complainants alleged that the heart massage was done by untrained and unqualified doctors in the recovery room and that too in the absence of opposite party No. 1, which must have caused blood accumulation in the body of the patient necessitating re -operation/re -exploration. In our view, this allegation is unsubstantiated, because the doctors who have done the heart massage are well qualified doctors having qualification of MS/MCH in cardiology who gave the heart massage around 8.30 p.m. and the doctors were available round -the -clock in recovery room of the hospital. Further, opposite party No. 1 has specifically answered in his interrogatories that the blood was not collected after the heart massage and that he had done the re -exploration because of the deteriorating condition of the patient. We do not agree with the submission that the two doctors in question were not competent to do the heart massage and that blood got collected.

ELEVENTHLY , as far as the allegation of record being tampered with and that only one person has written the entire record is concerned it is not a justified allegation because the entire record has been shown to us which has given hourly treatment that has been given to the patient and justified effort has been done by the team of doctors headed by Dr. Trehan during that fateful night. The entire Critical Care Flow Sheet has been produced and the vital parameters of the patient were shown till 4.30 p.m. on 24.6.1995 till the time of death of the patient. As for details of re -exploration, the submission that it was uneventful except that the patient''s condition continued to be critical is acceptable considering it was an emergency case and every effort was made to save the patient in critical condition. There is no evidence of tampering the record or non -disclosure of any important details by the opposite party is being seen, and we discard this as baseless allegation.

TWELFTHLY , we are surprised that the complainants have not filed the history of previous treatment received by the patient before coming to the opposite parties. Indu Sethi herself has admitted in the cross -examination that record of her husband''s treatment at King George''s Medical College, Lucknow; Sanjay Gandhi Postgraduate Institute, Lucknow and All India Institute of Medical Sciences, New Delhi have not been filed since they were with her late father -in -law and that she could not get them. We are unable to believe that she could not get the record of her husband''s treatment to produce before this Commission and we hold that the best evidence to prove her allegations has been withheld for reasons best known to her.

THIRTEENTH LY , the allegation that the patient died in the night and the body was decomposed by 4.30 p.m. and the hospital authorities have hid this fact from the complainants is not substantiated because the Critical Care Flow chart shows the treatment that has been given from 8.00 p.m. onwards on 23.6.1995 which has not been rebutted by the complainants. Further, there is no evidence to prove this allegation as no post -mortem report has been obtained by the complainant.

FOURTEENTH LY , regarding the contention made by the learned Counsel for the complainant that Dr. Trehan was not in the operation theatre when the patient was taken for reoperation/re -exploration, in para 16 of the complaint itself it is admitted by the complainant No. 1 himself that they were told that Dr. Trehan had come at 10.30 p.m. and he was there in the night of 23.6.1995. Even the hospital record shows his presence as his name has been there on the record as NT. The allegations made by the complainants in this regard are not tenable on the basis of the facts of the case. It is evident that Dr. Trehan and his team had been with the patient. In a letter dated 12.4.1996 written by Dr. Sethi to this Commission it has been mentioned that - "the treatment details'' (factuals supported by documentary evidence of my son''s treatment of that period from 18.6.1995 to 23.6.1995 which ended with the death of my son and then keeping the death of my son concealed for 20 hours from 8 p.m. on 23.6.1995 to 4.30 p.m. on 24.6.1995) during which time Trehan'' is said to have committed his nefarious act".

IT is crystal clear that father of the patient, Dr. Sethi had made contradictory statements at various places regarding Dr. Trehan''s absence on the fateful night of 23/24.6.1995 which are not substantiated. We discard this baseless allegation because Dr. Trehan was very much present at that night.

IN the present case we find that the opposite parties have rendered treatment based on known medical text procedures. The allegations made by the complainant are not substantiated by any evidence. Mere allegations, apprehensions, conjectures and surmises cannot be relied upon unless they are corroborated with evidential value to conclude that there is deficiency in service or negligence on the part of the opposite parties. It is unfortunate that a young person died at an early age and hence one can understand the anguish the complainants must be feeling.

IN view of the foregoing discussion, we do not find any merit in this complaint. There is no deficiency in service/negligence on the part of the opposite parties. The complaint is, therefore, dismissed. Complaint dismissed.