1. The Present appeal is directed against the orders dated 14.10.2011 passed by the learned District Forum-X, New Delhi. Vide impugned ordersit was held that Indraprastha Apollo Hospital, New Delhi (OP1) and Dr. Tarun Sahni(OP2) working there were not guilty of medical negligence. They were however found ‘deficient in service’ on account of not communicating clearly with the attendants of the patient. For these reasons compensation to the tune of Rs. 25,000 was awarded in favour of the complainant and against the hospital and the treating doctor.
2. Appeal has been filed by Sh. Harish Kumar Chaddha the father of the deceased seeking enhancement of compensation on account of harassment and mental agony. Complainant has sought compensation to the tune of Rs. 50 lakh.
3. Parties hereinafter shall be referred to by their status as it was in the complaint.
4. Facts in brief of the complaint are that the deceased Ms. Anupama was a college going student of 23 years of age. In July, 2004 she suffered from diarrhea and taken to family doctor named Dr. Vijay Sachdeva. She did not recover even after a treatment of four days. She was taken to Indraprastha Apollo Hospital (OP-1) on 22.7.2004 and admitted there. Dr. Tarun Sahani (OP-2) was appointed as treating doctor. After sometime senior doctors named Dr. R K Chopra, Dr. Prasad Rao and Dr. MukulVerma intervened. Dr. R K Chopra after a period of four days of the admission, diagnosed it as a case of SLE (Systemic Lupus Erythematosus). Finding haemoglobin on the lower side blood was transfused on 25/26.7.2004.Patient got a psychosis attack. Contention of the Complainant is that on 28.7.2004, Dr. Prasad Rao examined the patient and declared her fit for discharge. Complainant rushed to the chamber of Dr. Tarun Sahni to get a discharge, Dr. Tarun Sahni being the treating doctor. After discussion with Dr. Prasad Rao, complainant was informed that it was not possible to discharge the patient as the haemoglobin level was low. Complainant opposed the proposition and suggested that the haemoglobin could be improved by a healthy diet. He wanted the patientto be discharged on that very day. He also did not have a blood donor. Grievance of the complainant is that despite good condition of the patient, two units of blood were transfused by Dr. Tarun Sahani. Double dose of steroid was given. It rocked the brain of the patient. On 30.7.2004 patient was shifted to ICU. She was put on ventilator. There was no movement in her body. Grievance of the Complainant is that the OPs did so only to grab money. ICU charges were Rs. 70,000 per day. On 2.8.2004 he was asked to deposit Rs. 1 lakh. Complainant expressed his incapacity to pay the same and informed that Rs. 70,000 were deposited only one day before. Upon this ventilator, oxygen and other facilities were withdrawn. Dr. Tarun Sahni left the hospital. Death of the patient was concealed. The next day he came to know of the death of Ms. Anupama in coffee shop from Dr. Prasad Rao.
5. OPs in their separate written statements took stands which are by and large the same. They submitted that the patient was admitted to OP-1 Hospital on 22.7.2004 with complaint of vomiting 5-6 times daily for the last 10-12 days. She had loose stools, 6-8 times a day. She was having fever for the last 10 days. She disclosed the history of Reynauds Phenomenon in winter. Towards past history, it was informed that at the age of 13 years, she had developed skin rashes along with fever and ulceration.The same was resolved with treatment but no records were available. Thereafter the patient had recurring episodes of skin disorder, Bullous Lesions which were associated with generalized Lymphadenopathy. These episodes occurred 2-3 times a year and resolved with treatment. OPs further submitted that the patient was diagnosed as suffering from Systemic Lupus Erythematosus (SLE) with Coomb’s positive hemolytic anemia. Contention of the OPs is that it was a complicated disease and could not have an on spot diagnosis without referring to a stringent battery of tests. Patient had multiple Lymphnodes (cervical)of the size from 0.5 to 2 cms in neck. There was no contra indication to blood transfusion. Deceased had presented with low haemoglobin. Her condition warranted life saving measures. Steroids needed to be given. Fever was not a contraindication in such a situation. Cause of fever could be infective or non-infective due to an auto-immune disease like SLP. In non-infective fever such as in auto-immune disease, there was no contraindication to steroids. Steroids were given in a standard dose.
6. OPs submitted that after the admission, routine investigations as well as evaluation for cause of anaemia were done. LFT, blood and urine culture/ sensitivity along with PS for MP were sent. IV fluids along with Cifran, Metrogyland Pantocid were started. CBC revealed severe anaemia, normal TLC with neutrophilia and raised nucleated RBC’s. So RI, Coomb’s test, S.LDH were sent. These were suggestive of hemolytic anaemia. In view of deranged Renal Function Test, raised urea and Creatinine level s and haematuria were done to rule out renal pathology. In view of severe anaemia three units of packed red cells were transfused. ANA report was positive. Ds DNA antibody was negative. S.LDH increased. Serum Protein Electro-phoresis revealed polyclonal gammopathy and No M spikes coombs was negative. Coagulation profilewas markedly deranged with decreased platelet count. Investigations were suggestive of CTD? SLE??? TTP.Methylprednisolone was started. Platelet improved but patient developed irrelevant behaviour. Haemorrhagic spots on retina were seen, so urgent MRI of brain was done. It was found normal. Patient was continued with reduced dose of Salumedrol. Patient had an episode of GTCS (Generalized Tonic Clonic Seizures). CT Scan of brain was normal. On 31.7.2004 she had repeated GTCSs. Her neurological status further deteriorated. It did not subside in spite of phenytoin.So Theiopentone was added. Patient was shifted to ICU and supported with ventilatory support with plasma pheresis which was started and 3-4 litres of plasma was exchanged. On 1.8.2004 urine output decreased and did not improve in spite of high doses of Lasix. So hemodialysis was also started. Her blood pressure decreased. It was maintained with anorectic support.
7. Echocardiography done revealed Ejection Fraction of 35%, Cardiac output of 5.6 litre, Systematic Vascular Resistance, IVC of 1.2. Fluid challenge and otropes were continued to maintain the Blood Pressure. Urine culture sensitivity reports revealed E Coli with >1 lac count. So, antibiotic sensitive to culture i.e. Zosyn and Targocid were added. Plasmaphoresis, FFP, platelet and PRC, along with ventilator and inotropic supports were continued. But her condition continued to deteriorate. On 3.8.20104, at 3.50 p.m., she developed bradycardia (broad QRS complexes) followed by unrecordable pulse and BP. Cardio Pulmonary Resuscitatk was continued but eventually even after the best efforts she succumbed to her illness at 4.20 p.m. on 3.8.2004.
8. Learned District Forum relied upon the Experts’ opinion dated 23.5.2006 given by Medical Council of Delhi. Experts opined that the allegations of medical negligence were not proved. There was however some degree of communication gap between the family of the patients and the treating doctor. It was also opined by the experts that there was enough scope for improvement. Learned District Forum in its orders impugned, observed that the status of the patient had not been communicated clearly at relevant stages. Family had to suffer mental agony. To this limited extent, OPs were held guilty of ‘deficiency in service’. Compensation to the tune of Rs. 25,000 was awarded.
9. Before proceeding further, I find it relevant to refer to the experts’ opinion. The relevant portion of the same is reproduced below:
“The patient was admitted in Indraprastha Apollo Hospital on 22.7.2004 with a history of fever, loose motions and vomiting of ten days duration. After investigations and clinical examinations she was diagnosed to be case of hemolytic anaemia and necessary treatment was started. She was earlier treated by a private practitioners for diarrhea, with high grade fever for a period of ten days. When there was no improvement, she was brought to Indraprastha Apollo Hospital for better treatment primarily for having mediclaim coverage of the Father and his family. During the stay in the hospital, patient was seen by several consultants dealing with different specialities as the patient had multiorgan involvement of her disease conditions. The treatment provided to the patient was within the ambit of known modern scientific medical practices. However, in spite of all, treatment provided to the patient she succumbed to her illnesses. The disease from which the patient was suffering has high degree of mortality in spite of best treatment.
No medical negligence could be attributed by the Committee during the treatment of Ms. Anupama Chadha in Indraprastha Apollo Hospital. However, there appears to be some degree of communication gap between the family of the patient and the treating doctors and there is enough scope for improvement.
Complaint stands disposed.”
10. Death summary of the deceased Ms. Anupama is also reproduced below:
Ms. Anupam, 19 years old, non–diabetic, non-hypertension presented with complaint of vomiting 5-6 times daily for last 10-12 days, loose stools (watery) 6-8 times for one day 12 days back, then bowel was normal. High grade fever with chills since 10 days. For this she was shown to GP and took antimalarial along with antibiotics, but she did not get relief. She was referred to Indraprastha Apollo Hospital, New Delhi. History of Raynaud’s phenomenon in winter. No history of frequency or burning micturition.
At the age of 13 days developed skin rashes along with fever and ulceration resolved with treatment. No records regarding diagnose and treatment. Thereafter patient had recurrent episode of some skin disorder, bullous lesions with associated generalized lymphad-enopathy these episodes occur 2-3 times/year, resolved with treatment (no records available).
Conscious & oriented, restless.
Pulse Rate: 100/min
Blood Pressure: 110/80mm Hg
Respiratory Rate: 118/min
Multiple lymphnodes of size 0.5 to 2 cm in neck, mobile discrete, non-tender
Mo clubbing/cyanosis/pedal oedema/icterus/
Chest: Bilateral air entry equal crepts (+). Left infrascapular and IA region.”
CVS: S1 S2 Normal, tachycardia (+) No murmur/rub/gallo9p
P/A: Soft, non tender Liver, spleen, finger not palpable. Bowel sounds +
CNS: Clinically no abnormality detected.
Course in the Hospital:
After admission, along with routine investigations, evaluation for cause of anaemia was done. LFT, Blood and urine culture sensitivity along with PS for MP were sent. IV fluids along with Cifran, Metrogyl, Pantocid were started. CBC revealed severe anemia, normal TLC with neutrophilia and raised nucleated RBC’s. So RI, coomb’s test, S.LDH were sent, were suggestive of hemolytic anaemia. In view of reverse. A/G ratio and high protein level.S.protein electrophoresis along with urine for bence zone pretein and S.lgG, A, M levels was sent Dr. A. Mishra (Sr. Consultant, Nephrology) was consulted for deranged RFT, raised urea and creatinine levels, hematuria, to rule out renal pathology USG abdomen reflated spleenomegaly, bilateral polycyctic ovaries. Dr. P. Rao (Sr. Consultant, Internal Medicine) opinion was also taken. In view of age, history, haemalogical, renal and CNS involvement, ANA d/S DNA, PANCA, CANCA, anti SM, antibodies, FDP were sent to rule to CTD? SLF in view of severe anaemia three packed red cells were transfused. ANA report was (+) Ds DNA antibody (-) S.LDH increased, FDP (F) SPE revealed polyclonal gammopathy. No M spikes coombs negative. Coagulation profile was markedly deranged, platelet count decreased, PT and PPTT altered, C2 and C4 level severely decreased peripheral smear s/o. schistocyses with nucleated RBC, throm-bocytopenia. As per investigations which was suggestive of CTD? SLE???? TTP, methylprednisolone was started. On receipt of 2 pulse dose, patient’s ESR (+) and platelet count improved, but patient developed irrelevant behaviour. To rule out possibility of steroid induced psychosis or pathology in brain Dr. MukulVerma (Sr. Consultant, neurology) was consulted. On fundus examination haemorrhagic spots on retina were seen, so urgent MRI brain was done, which was normal. Patient was continued with reduced dose of Salumedrol. Patient had episode of GTCS. So urgent CT scan head was done to rule to possibility of haemorrhage which came out to be normal. Tab Frisom and Tegrctol were added. On 31.7.2004, she had repeated GTCS and her neurological status further deteriorated which did not subside. Inspite of phenytoin, so thiopentone was added and she was shifted to ICU and put on ventilator support with increase dose of methylprednisolone. Plasmapheresis was started along with 9-4 letre of plasma exchanged On 1.8.2004 her urine output decreased and not increased in spite of high doses of Lasix. So HD was also started. Her BP decreased which was maintained with inotropic support.
Echocardiography done revelaed EF 35%. Co 5.6 litre, SVR 571, IVC 1.2, fluid challenge and inotopes continued to maintain BP. Brine culture sensitivity reports revealed E. Coloi with > 1 lac count. So, antibiotic sensitive to culture Zosyn, Targocid were added. Plasmaphoresis, FFP, platelet and PRC, along with ventilator and inotrpic supports were continued. But her condition continued to deteriorate.
On 3.8.2004, at 3.50 p.m., she developed bradycardia (broad QURS complex) followed by pulse and BP not recordable. CPR was continued but eventually even after our best effort she succumbed to her illness at 4.20 p.m.
11. Complainant In his original complaint dated 2.3.2005 before the learned District Forum leveled allegations inter alia that the transfusion of blood to the patient on 25/26.7.2004 was a side effect of overdose of steroids. Complainant further submitted that the patient had become absolutely fit on 28.7.2004 when he made a request to the doctors to discharge her. He was assured that the patient would be discharged the next morning. It was thereafter that he was told by the treating doctor Dr. Tarun Shahni that the patient needed blood as her haemoglobin was 7.1. The same should be between 9 and 10. Contention of the Complainant is that further transfusion of the blood led to unconsciousness from which the patient never recovered.
12. Complainant alleged that there was a contradiction in the death summary and the Doctor’s report. His contention is that the death summary stated that the vomiting and diarrhoea lasted for 12 days whereas the progress sheet showed the same to have taken place for 2-3 days only. Complainant alleged that the doctor had lost his patience. Another main allegation of the Complainant is that the blood transfusion was prohibited in case of fever and chills. The patient was transfused blood despite a fever of 1020F. The steroids attacked the brain leading to death.
13. Lastly Complainant stated that the doctors had been calling him on 31.7.2004 for declaring death. The same was not declared before his wife and son.
14. Main grievance of the Complainant is that his daughter had a haemoglobin of 7.1 on 28.7.2004 when he insisted upon her discharge. Perusal of the record shows that the reading of haemoglobin of 7.1 was noted on 27.7.2004 and not on 28.7.2004. On 27.7.2004 the patient had been crying incessantly. She was not following commands. The patient was also non-verbal for 1-2 hours. She was diagnosed as having acute psychosis. There was no point in discharging her in such a condition.
15. Now coming to the patient’s condition on 28.7.2004, the patient was febrile, though she was symphomatically better. Again with fever, the patient could not have been discharged. There is no document on record suggesting that either Dr. Tarun Sahani or Dr. Prasad Rao was of the opinion that the patient was fit for discharge at any point of time during her admission. Contention of the Complainant that haemoglobin could have improved with a good diet is of no avail for other parameters remained deranged. Nature of the disease SLE is such that the body keeps on creating antibodies which attack red blood cells. Transfusion of blood would raise haemoglobin level for some temporary period. Perusal of the case sheet of the whole of the admission period (running into 135 pages) shows that the patient had haemoglobin level varying from 4.5 to 7.1. It fell drastically after reaching the climax of 7.1. Contention thus put forth by the Complainant is devoid of merits.
16. Contradiction in the death summary and the case sheet is minor in nature as episodes of vomiting and diarrhoea are noticed in case sheets on certain occasions.
17. Complainant alleged that the blood transfusion was done in case of fever/ chills. There was an advisory recorded by the doctors to avoid transfusion in case of fever/ chills which actually had been stopped. The Complainant failed to indicate the case sheet showing the transfusion having been done with fever/ chills.
18. Complainant alleged that the two doses of Methylprednisolone proved dangerous leading to the death. Case sheets show that the patient had attacks of psychosis after which reduced dose of Salumedrol was started. Psychosis was managed. Death did not take place on that day i.e. on 27.7.2004. Complainant has not placed on record any medical literature showing that the standard protocol warranted not to administer two doses of methylprednisolone. Complainant wants this Court to upset the experts’ opinion in the absence of any medical literature to the contrary.
19. Complainant has stated that even after the death of the patient, plasma therapy continued. The contention of the Complainant is against the medical records. Patient died only at 4.20 p.m. on 3.8.2004. During the period between 31.7.2004 and 3.8.2004 there are readings of blood pressure, pulse, temperature, etc. Had the patient been dead, there could not have been any pulse or blood pressure during this period.
20. In view of the reasons given above, the Complainant has failed to establish that the experts’ opinion was wrong. The Complainant and Other relatives of the deceased were disclosed the factum of death immediately.
21. All the records show that the OP-1 Hospital and the treating doctor did not obtain the consent of the patient’s attendants in giving treatment. No record shows if the patient or her attendants were disclosed information relating to the diagnosis of the disease SLE, nature of the proposed treatment, potential risk of the treatment and the consequences of the patient refusing the suggested line of treatment. All these things were fundamental requirement of law. In every field of medicine, an informed consent is mandatory. Exception to the rule is emergency medical circumstances. In the case of Malay Kumar Ganguli v. Dr. Sukumar and Others, III (2009) CPJ 17 (SC)=VI (2009) SLT 164=VI (2009) CCR 558 (SC), it was held as under:
“142. Patients by and large are ignorant about the disease or side or adverse effect of a medicine. Ordinarily the patients are to be informed about the admitted risk, if any. If some medicine has some adverse effect or some reaction is anticipated, he should be informed thereabout. It was not done in the instant case. In Sidaway v. Board of Governors of Bethlem Royal Hospital the House of Lords, inter alia held as under: (WLR pp. 504 H-505 C)
The decision what degree of disclosure of risks is best calculated to assist a particular patient to make a rational choice as to whether or not to undergo a particular treatment must primarily be a matter of clinical judgment.
An issue whether non-disclosure of a particular risk or cluster of risks in a particular case should be condemned as a breach of the doctor’s duty of care is an issue to be decided primarily on the basis of expert medical evidence. In the event of a conflict of evidence the Judge will have to decide whether a responsible body of medical opinion would have approved of non-disclosure in the case before him.
A Judge might in certain circumstances come to the conclusion that disclosure of a particular risk was so obviously necessary to an informed choice on the part of the patient that no reasonably prudent medical man would fail to make it, even in a case where no expert witness in the relevant medical field condemned the non-disclosure as being in conflict with accepted and responsible medical practice.
143. The law on medical negligence also has to keep up with the advances in the medical science as to treatment as also diagnostics. Doctors increasingly must engage with patients during treatments especially when the line of treatment is a contested one and hazards are involved. Standard of care in such cases will involve the duty to disclose to patients about the risks of serious side effects or about alternative treatments. In the times to come, litigation may be based on the theory of lack of informed consent.
144. A significant number of jurisdictions, however, determine the existence and scope of the doctor’s duty to inform based on the information a reasonable patient would find material in deciding whether or not to undergo the proposed therapy.”
22. In the case of Montgomery v. Lanarkshire Health Board, Scotland, (2015) UKSC 11, a doctors duties to advice a patient of risks involved in treatment came up for consideration before the United Kingdom Supreme Court. The relevant portion of the judgment is reproduced below:
“...To the extent that I have indicated I think that English Law must recognize a duty of the doctor to warn his patient of risk inherent in the treatment which he is proposing: and especially so, if the treatment be surgery. The critical limitation is that the duty is confined to material risk. The test of materiality is whether in the circumstances of the particular case the Court is satisfied that a reasonable person in the patient’s position would be likely to attach significance to the risk. Even if the risk be material, the doctor will not be liable if upon a reasonable assessment of his patient’s condition he takes the view that a warning would be detrimental to his patient’s health.”
23. Principles relating to consent were formulated by Supreme Court in the case of Samira Kohli v. Dr. Prabha Manchanda and Anr., I (2008) CPJ 56 (SC)=II (2008) SLT 25. The same are outlined below:
“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. 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.
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
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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. 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. 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.” 24. Coming to the case in hand the disease SLE had several risks including the risk of death. It ought have been explained to the patient or her attendants (depending upon the situation that disclosure to the patient was not advisable). 25. As discussed above there is no ‘informed consent’ or any such disclosure in black and white in the whole of the record before this Commission. There is no consent obtained while transfusing blood. Similarly there is no ‘consent’ while transfusing plasma (plasmapherosis). Experts while giving their opinion have held that the OP-1 Hospital was guilty on that count. The relevant portion of the expert opinion is reiterated below: “However, there appears to be some degree of communication gap between the family of the patient and the treating doctors and there is enough scope for improvement. Complaint stands disposed.” 26. Disclosure to the attendants could have prepared them mentally to undergo the treatment and face the risks associated with it. Attendants could have exercised their option not to undergo the treatment in question or they could have opted for some alternative treatment in other therapies. In its absence they suffered mental agony for which they are required to be compensated. Deceased was a college going student of 23 years. Compensation to the tune of Rs. 5 lacs would meet the ends of justice. Appeal is accordingly partly allowed. OP-1 Hospital and the treating doctor are directed to pay an amount of Rs. 5 lakh jointly and severally to the Complainant within a period of 30 days from today failing which it shall carry interest @12% per annum. Appeal is accordingly disposed of. File be consigned to record room. Appeal disposed of.