Tej Pal Rustogi vs Century Rayon Hospital

THE case of the complainant is that his wife-Sushila Devi (deceased) started feeling giddy in the morning of 23.1.2001 and after rest her giddiness gradually subsided. She was taken to a hospital and at that time she was in fully conscious state of mind and was intelligent in her speech. Patient was taken to a nursing home where an ECG was done and nothing abnormal was detected and as a precautionary measure she was taken to Century Rayon Hospital - OP No. 1. She was admitted at about 10.30 a.m. under the charge and treatment of OP No. 2 - Dr. S.V. Khadikar and she was perfectly alright till 3.30 p m. At about 3.30 p.m. OP No. 2 told the complainant that an injection costing about Rs. 10,000 had to be administered to the patient. Immediately after injection was administered, the patient fell unconscious and extremely restless. OP No. 2 asked the relative of the patient to go out of the room. Afterwards it was found that the skin of the patient was covered with bluish patches and she had not regained consciousness. The condition of the patient did not improve and at about 11.00 a.m. on 24.1.2001 the complainant asked the OP No. 2 to discharge the patient and refer her to Jaslok Hospital. The OPs took seven long hours to discharge the patient even though formal request had been made at 10.30 a.m. Discharge card, letter referring the patient to Jaslok Hospital and investigation reports have been annexed with the complaint. Patient was shifted to Jaslok Hospital in an Ambulance equipped with sophisticated instrument and gadgets and a cardiologist was also present in the van. The ambulance bill was for Rs. 3000. On 25.1.2001 the patient was declared dead at Jaslok Hospital. She died due to massive intra cerebral bleed as a result of Urokinase injection. The complainant sent legal notice calling upon the respondent to compensate him for Rs. 25 lakh failing which to furnish the medical record of the deceased so as to file the case against them. True copies of the replies received after filing the original petition have been annexed. According to the complainant, OPs have been negligent in diagnosing and treating the patient, as a result of which the patient died. The complainant has also annexed the treatment papers from the Jaslok Hospital. The complainant claims compensation of Rs. 25 lakh with 24% interest and also further compensation for pain and mental agony, etc.

OPPOSITE party-hospital in its written statement has stated that patient had been admitted to the hospital on 23.1.2001 with complaint of chest pain, giddiness with history of hypertension and was attended by the doctor''s on duty and routine medical tests were done. Blood Pressure was 150/100 and history of Ischemic Heart Disease was narrated by the patient and her relatives. Considering the history and clinical findings, treatment was started to control the blood pressure so as to avoid heart attack. The doctor as a precautionary measure prescribed life saving drug, namely injection Urokinase (15 lakh units) and a note was made in the case paper against the said injection as SOS, which means that as and when required it should be given. At about 3.00 p.m. the condition of the patient deteriorated and blood pressure was 180/100 and there was a complaint of severe chest pain and the cardiac profile result was shown positive. Therefore, injection, Urokinase was administered to the patient to control the condition which would have lead to heart-attack. It is submitted that injection Urokinase was a life saving drug and its side effects are never fatal or dangerous/injurious to the health of the patient. The patient was given other medicines and after administering medicines, the condition of the patient was brought under control. It has been denied that after administering injection Urokinase the patient fell unconscious and became extremely restless and presence of blue patches on the skin was also denied. On the next day at about 11.00 a.m. the patient was discharged on the request of her relatives. It is denied that the OP took inordinate long time in preparing the bill and discharge papers. It is also denied that massive intra cerebral bleed was as a result of Urokinase injection. Injection Urokinose is commonly given to patients having history and symptoms of IHD and hypertension which may lead to heart attack. It is further submitted that the condition of the patient was not at all bad when she was taken to Jaslok Hospital and the OP is not responsible for the death of the patient in Jaslok Hospital. It is also submitted that the cause of death i.e. massive cerebral bleeding is not due to any side effect of the injection Urokinase.

OP No. 2 Dr. S.V. Khadikar has filed a separate written statement in which basically the same stand taken by OP Hospital has been put forth. It has been emphasized that while administering injection Urokinase there was no such contra indications during the course of administering the drug immediately thereafter till discharge of the patient. There was no side effect till discharge.

THE complainant has filed a rejoinder in which the stand taken in the complainant has been reiterated and the stand taken by the OPs has been denied.

THE complainant has filed affidavit evidence along with the medical records of the OP Hospital. On behalf of OPs, affidavit evidence was filed by Holaram Uttamchandani, Chairman of OP Hospital and Dr. Shashikant Khadikar - OP 2. Interrogatories were served by the OPs on the complainant which were answered. Likewise interrogatories were served by the complainant on the OPs which were answered by the Chairman of the OP Hospital and Dr. Khadikar OP 2.

THE opposite party was permitted to file affidavit of Dr. Santosh Kaushik. On behalf of the complainant affidavit of Dr. Rajendra S. Bangal was filed challenging the affidavit of Dr. Kaushik. Dr. S.V. Khadikar filed an affidavit in rebuttal to the affidavit filed by Dr. R.S. Bangal. Subsequently, the complainant filed an additional affidavit of Dr. R.S. Bangal on behalf of the complainant in terms of the order dated 28.4.2008 of this Commission.

WRITTEN arguments have been filed on behalf of the complainant as also OPs. Advocates for parties were also orally heard. Advocates for parties have filed medical literature as also rulings of the Apex Court.

WE have gone through the records. The case of the complainant is that Doctors of OP - Hospital had not properly diagnosed the ailment and had administered injection Urokinase without conducting the basic and essential tests. According to learned Counsel for the complainant, history of hypertension and IHD has been fabricated. The learned Counsel for the complainant submits that the symptoms pointed out that it was a case of stroke/cerebral bleeding, but injection Urokinase was administered which worsened the bleeding as a result of which the patient died due to massive intera cerebral bleeding. However, on the other hand, according to the OPs, it was a case of myocardial infarction. The treatment was given to bring down the blood pressure and as a precautionary measure in order to prevent heart attack life saving drug namely injection Urokinase was administered to the patient, as the complainant suffered severe chest pain and the cardiac result profile was positive. According to the OPs, the condition of the patient was brought under control and neither she fell unconscious nor there has been bleeding as contended by the complainant.

INDOOR case papers of OP Hospital and investigation record which are at pages 136 to 147 of the record show that the diagnosis of the patient according to the doctors at OP Hospital was IHDc Hypertension. Typed true copies have been filed. Symptoms recorded at the time of admission are chest pain, weakness and history of IHD with hypertension. On examination of the patient, anxious Pallor ++ BP 180/100, pulse 88, clinically normal. Patient was advised CMC, Cardiac Profile, Trop T Urgent, RBS Urgent and was prescribed medicines in addition to injection Urokinase (15 lakh units), if Trop T is positive, and I/V NTG Drip SOS was advised. Learned Counsel for the complainant submits that Trop T test was advised and was to be done urgently but was never done at the OP Hospital and the said injection was administered without conducting the said test in spite of the fact that doctors had advised administration of injection, if Trop T test was positive. According to the learned Counsel for the OP, the result of Trop T test takes 72 hours and the condition of the complainant was such that the report could not be awaited. Trop T test was ultimately done at Jaslok Hospital and the report of the Trop T test was negative. Patient was admitted in the Jaslok Hospital after 4.30 p.m. on 24.1.2001 and the patient died on 25.1.2001.

THE question which arises for consideration is whether it is a case of improper diagnosis and whether in the absence of Trop T test, there was sufficient justification for administering the said injection Urokinase. According to Dr. Khadikar, patient had chest pain with history of IHD with hypertension and when the patient complained of chest pain, she was already put on cardiac monitor which had shown changes of myocardial infarction (ST-T changes) with severe chest pain and hence injection Urokinase was administered to protect her from further damage to her myocardium. He has further stated that symptoms narrated by the patient were clearly indicative of IHD and hence CT Scan of brain was not mandatory. The ST-T changes in ECG are indicative of IHD and not CVA or diabetes. It is further stated by him that though the Trop T test was ordered and written in the case paper, the doctor on duty noted changes in the Cardiac monitor and decided to give injection Urokinase to avoid any complications of myocardial infarction and did not wait for the result of the Trop T test. OP in fact have not produced the result of the Trop T test, if at all it was done and the Trop T test done at Jaslok Hospital shows it was negative.

THE case records of the patient from the OP Hospital do not show as to whether any further inquiries were made by the doctor in relation to the history of IHD or hypertension. The records do not disclose any inquiries having been made nor the doctor asked for any previous cases papers which would suggest that the patient was suffering from Ischemic Heart Disease. Hospital record also does not show as to what was the condition of the patient when injection Urokinase was given. There is nothing in the case record maintained by OPs to suggest that the patient was suffering from severe chest pain at 3.30 p.m. and injection was given to avoid heart attack.

IN the Text Book Pathology by Harsh Mohan upon which reliance has been placed by the Counsel for the complainant, diagnosis of acute MI is made on the observations of three types of features-clinical features, ECG Changes and serum enzyme determinations. It would be appropriate to quote the details in extenso: "Diagnosis-The diagnosis is acute MI is made the observations of three types of features-clinical features, ECG changes, and serum enzyme determinations. 1. Clinical features-Typically AMI has a sudden onset. The following clinical features usually characterize a case of AMI- (i) Pain-Usually sudden, severe, crushing and prolonged, substernal or precordial in location, unrelieved by rest or nitroglycerin, often radiating to one or both the arms, neck and back. (ii) Indigestion-Pain is often accompanied by epigastric or substernal discomfort interpreted as ''heartburn'' with nausea and vomiting. (iii) Apprehension-The patient is often terrified, restless and apprehensive due to great fear of death. (iv) Shock-Systolic blood pressure is below 80 mm Hg lethargy, cold clammy limbs, peripheral cyanosis, weak pulse, tachyardia or bradycardia are often present. (v) Oliguria-Urine flow is usually less than 20 ml per hour. (vi) Low grade fever-Mild rise in temperature occurs within 24 hours and lasts upto one week, accompanied by leucocytosis and elevated ESR. (vii) Acute pulmonary oedema- Some cases develop severe pulmonary congestion due to left ventricular failure and develop suffocation, dyspnoea, orthopnoea and bubbling respiration. 2. ECG Changes-The ECG changes are one of the most important parameters. Characteristic ECG changes include ST segment elevation, T wave inversion and appearance of wide deep Q waves. 3. Serum cardiac markers: Certain proteins and enzymes are released into the blood from necrotic heart muscle after MI. Measurement of their levels in serum is helpful in making a diagnosis and plan management. Rapid assay of some more specific cardiac proteins is now available rendering the estimation of non-specific estimation of SGOT of historical importance only in current practice. Important myocardial markers his use nowadays are as under: (i) Creatine phosphokinase (CK) and CK-MB, CK has three forms: . CK-MM derived from skeletal muscle. . CK-BB derived from brain and lungs; and . CK-MB mainly for cardiac muscles and insignificant amount from extracardiac tissue. Thus total CK estimation lacks specificity while elevation of CK-MB isoenzyme is considerably specific for myocardial damages. CK - MB has further 2 forms-Ck-MB2 is the myocardial form while CK-MB1 is extracardiac form. A ratio of CK - MB2, CK-MB 1 above 1.5 is highly sensitive for the diagnosis of acute MI after 4-6 hours of onset of myocardial ischaemia. CK-MB disappears from blood by 48 hours. (ii) Lactic dehydrogenase (LDB)-Total LDH estimation also lacks specificity since this enzyme is present in various tissues besides myocardium such as in skeletal muscle kidneys, liver, lungs and red blood cells. However, like CK, LDH too has two isoforms of which LDH - 1 is myocardial specific. Estimation of ration of LDH-1, LDH-2 above 1 is reasonably helpful in making a diagnosis. LDH levels begin to rise after 24 hours, reach peal in 3 to 6 days and return to normal in 14 days. (iii) Cardiac specific troponins (cTn)-Immunoassay of cTn recently as a new cardiac serum marker has rendered L-estimation obsolete. Troponins are contractile muscle proteins present in human cardiac and skeletal muscle but cardiac troponins are specific for myocardium. There are two types of cTn: . cardiac troponin T (cTnT); and . cardiac troponin I (cTnl). Both cTnT and cTnl are not found in the blood normally, but after myocardial injury their levels rise very high around the same time when CK-MB is elevated (i.e. after 4-6 hours). Both troponin levels remain high for much longer duration; cTnl for 7-10 days and cTnT for 10-14 days. (iv) Myoglobin-Though myoglo bin is the first cardiac marker to become elevated after myocardial infarction, it lacks cardiac specificity and is excreted in the urine rapidly. Its levels, thus, return to normal within 24 hours of attack of acute MI".

THE condition of the patient at 3.30 p.m. when injection Urokinase was administered has not been recorded so as to justify the administration of said injection without Trop T test. Such justification should have been recorded in the case papers especially when the said injection was advised only when Trop T test was positive. No record was maintained by OPs regarding examination of the patient before injection Urokinase was administered or that the patient had suffered severe pain in chest which could be clinical feature of myocardial infarction. The patient was admittedly in ICU, but no ECG recordings have been produced by the OPs. In the light of the condition of the patient reported by OPs, CT Scan was absolutely necessary at least immediately after the condition of patient had deteriorated. It may be mentioned here that there are contra-indications of said injection Urokinase. Dr. S.V. Khadikar has admitted that intra cerebral bleed is contra indication for Urokinose.

LITERATURE filed along with the reply to interrogatories by Dr. S.V. Khadikar shows contra indications, i.e. because thrombolytic therapy increases the risk of bleeding. Urokinase is contra indicated in the following situations: "Active internal bleeding".

THE case of the complainant is that the patient had suffered from stroke/ intra cerebral bleeding and it was not a case of IHD. On administration of Urokinase injection it worsened the bleeding. Counsel for the complainant placed reliance on Harrison''s Principles of Internal Medicine dealing with strokes under the heading ''Cerebrovascular Diseases and the approach to the patient is as under: "Patients with acute stroke often do no seek medical assistance their own, both because they are rarely in pain, as well as they may lose the appreciation that something is wrong. It is often a family member or a by-stander who calls help. The rapid evaluation of patients is essential for use of sensitive treatments such as thrombolysis. Patients at risk for should be counselled to call emergency medical services immediately if they experience the sudden onset of any of the following loss of sensory and/ or motor function on one side of the body (nearly 85% of ischemic stroke patients have hemiparesis) in vision, gait or ability to speak or understand; or if they experience a sudden, severe headache."

IN this connection, the learned Counsel for the complainant has also pointed out the history recorded by the Jaslok Hospital after the patient was received from the OP Hospital. The said history was given by the doctor who transferred the patient from Century Rayon Hospital. The history as narrated by the OP Hospital as also diagnosis on examination by the Jaslok Hospital is as under: "Hypertensive- Admitted with H/o Instability of gait, speech heaviness. Since 23rd morning. Admitted at Century Rayon Hospital diagnosed to have myocardical infarction thrombolyed with Urokinase. Patient had allergic reaction with H O. Following Urokinase, patient''s sensor deteriorated. Patient was restless an irritable. She was sedated with seranace, phenargan and norphine. Put on LMWH/Disprin. Since 24th afternoon general condition deteriorated and patient was unresponsive to stimuli. Transferred to Jaslok Hospital and Research Centre (JHRC). (As informed by doctor who transferred the patient from the Century Rayon Hospital, patients pupils were dilated and fixed before transfer and hand shallow resp.) P : 68/ min NSR B P : 80 Systolic R R: N spontaneous resp. efforts. Pale : No oedema CNS : Camatose Pupils dilated and fixed. Corneals. No response to pain (deep) Plantars -No neck rigidity NAD Imp: Cerebrovascular accident (Intracerebral bleed) ? IWMl"

ON examination at Jaslok Hospital, the diagnosis was clinical evidence of brain stem failure? Intra cerebral haemorrhage. It also indicated possibility of intra cerebral bleed following Urokinase leading to brain stem dysfunction. It is important to note that the patient was brought to Jaslok Hospital with pupils dilated and fixed and no response to pain. This means that the condition of the patient was critical at the time of clinical examination at Jaslok Hospital. The OP hospital had treated the patient for myocardial infarction and had administered injection Urokinase. Jaslok Hospital record shows clinical evidence of brain failure? Intra cerebral haemorrhage and the cause of death has been stated to be IHD c massive intracerebral bleeding.

AT this stage reference be made to Death Summary issued by Jaslok Hospital which reads as under: "This elderly lady was admitted in an unconscious state. She has an history of acute onset CVA. Admitted outside on 23.1.2001. She was treated C IV Urokinase for suspected in Infer Wall M I. Subsequently, the condition deteriorated, and was shifted to Jaslok for further management. On admission patient was gasping immediately put on ventilator and inotropic support. Subsequent evaluating revealed less of all brain stem refill she was seen by Dr. Mehta (Honorary Carbolic) and Dr. J. Desai, (Hon. Neurologist) CT Plain of head should large-left Thalmic Bleed with Intraventrical extension into both lateral and IV Ventricle. Her condition continued to deteriorate and on 20.1.2001 at 3.40 p.m. She had ........... of failure of cardiac function also. All. the efforts to resuscitate yielded no result. Patient was declared dead on 25.1.2001 at 4.15 p.m. Cause of death : IHD I Inferior Wall infarct with large intra cerebral bleed."

FROM the above discussion it is clear that no proper examination of the patient was done by the doctors at OP Hospital and injection Urokinase was administered with great haste which lead to intra cerebral bleed resulting into the death of the patient. After administering injection Urokinase and the patient was shifted to Jaslok Hospital, no details of condition of patient have been recorded by OP in the records. There is no record for 24.1.2001 except for reference to Special Visit of Dr. S.V. Khadikar, but the condition of patient is not recorded. Thus it is clear that no treatment whatsoever was given, even though the patient was in a serious condition when discharged. Admittedly, when the patient was examined, she was deeply unconscious and there was no reference to deep painful stimuli and pupils were widely dilated and fixed. There has been thus medical negligence on the part of Dr. S.V. Khadikar and other doctors of OP Hospital.

AT this stage we would like to point out that proper records have not been maintained by the hospital as also proper records of ICU. In this connection, reliance has been placed by the complainant on an article on Intensive Care by Dr. Khusrav Bajan (page 105 - volume II) and an article on Indoor Papers by Dr. Lalit Kapoor. The hand written records of the OP Hospital placed before the Commission are not clearly legible and readable. There is nothing on record to show that the risk factor in the case of administering Urokinase injection were explained to the patient or to her relatives.

AFFIDAVIT of Dr. Satish Kaushik is only based upon the case papers of the patient maintained by OP Hospital. It does not take into consideration the condition of the patient as disclosed by the records of Jaslok Hospital, when the patient was received nor it has taken into consideration the opinion of Jaslok Hospital on the issue of diagnosis of the ailment of the patient. The opinion given by Dr. Rajendra S. Bangal who is otherwise an MD in Forensic Medicine took into consideration not only the record of the OP Hospital but also the record of the Jaslok Hospital. However, he has exceed much beyond giving his opinion in the matter and has gone to the extent of pleading the case of the complainant as authorized representative on behalf of the complainant which is clear from the additional affidavit filed by him. Therefore, not much value can be attached to his affidavit.

BALANCING the pros and cons of the material on record, we are of the opinion that the patient was not thoroughly examined for the purpose of diagnosis of ailment and we hold that there has been medical negligence on the part of the OPs in proper diagnosis and treatment of the patient as result of which the patient lost her life.

COMING now to the compensation sought by the complainant, the deceased was 67 years old at the time of her death. Taking into consideration the longevity of the life as 75 years, the deceased though was not earning, but taking into account her own contribution in looking after the complainant in his old age, the contribution of the deceased towards the complainant can be taken @ Rs. 75,000 per year and for eight years it comes to Rs. 6.00 lakh. Besides that compensation of Rs. 1.00 lakh is awarded for pain and mental agony due to the sudden and unexpected death of the deceased. Medical expenses are taken at Rs. 50,000 and cost of litigation at Rs. 50,000. Accordingly, we award total compensation of Rs. 8.00 lakh Complainant shall be entitled to 9% interest on the said amount from the date of death of the deceased i.e. 25.1.2001. The complaint is allowed against OPs in the aforesaid terms who shall be severally and jointly liable to pay the same. Complaint allowed.