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TMI Blog2009 (8) TMI 1229X X X X Extracts X X X X X X X X Extracts X X X X ..... ged in research on H.I.V/ AIDS for the past 15 years. 2. They left U.S.A. for a vacation to India on 24th March, 1998. They arrived in Calcutta on 1st April, 1998. While in Calcutta, Anuradha developed fever along with skin rash on 25th April, 1998. On 26th April, Dr. Sukumar Mukherjee, Respondent No. 1 herein attended and examined Anuradha at her parental residence on a professional call. Dr. Mukherjee assured the patient and her husband of a quick recovery and advised her to take rest but did not prescribe her any specific medicine. However, two weeks thereafter, i.e., on 7th May, 1998, the skin rash reappeared more aggressively. Dr. Mukherjee was again contacted and as per his instructions, Anuradha was taken to his chamber. After examining Anuradha, Dr. Mukherjee prescribed Depomedrol injection 80 mg twice daily for the next three days. Despite administration of the said injection twice daily, Anuradha's condition deteriorated rapidly from bad to worse over the next few days. Accordingly, she was admitted at the Advanced Medicare Research Institute (AMRI) in the morning of 11th May, 1998 under Dr. Mukherjee's supervision. Anuradha was also examined by Dr. Baidyanath Ha ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... mission of an offence under Section 304A of the Indian Penal Code and sentenced them to undergo simple imprisonment for three months and to pay a fine of Rs. 3,000/- each and in default to undergo a further simple imprisonment for 15 days. Respondent No. 3, Dr. Abani Roy Chowdhury was, however, acquitted. 11. The West Bengal Medical Council dismissed the complaint filed by Dr. Kunal by its order dated 1st July, 2002. 12. On 25th May, 2003 the complainant-Kunal withdrew O.P. No. 179/2009 filed before the Commission against the doctors/Breach Candy Hospital. 13. Against the order of the learned Magistrate, Respondent No. 1 filed Criminal Appeal which was marked as Criminal Appeal No. 55 of 2002 and Respondent No. 2 filed Criminal Appeal No. 54 of 2002 before the learned Sessions Judge at Alipore, whereas the complainant, Mr. Malay Kumar Ganguly, filed a revision application being C.R.R. No. 1856 of 2002 for enhancement of the punishment imposed on Respondent Nos. 1 and 2. The complainant also filed another revision application before the High Court questioning the legality of the judgment with respect to acquittal of Respondent No. 3. The Calcutta High Court withdrew the appeals p ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... lined in the Table of the Textbook "Cutaneous Medicine and Surgery" authored by Prof. J.E. Revuz and J.C. Rojeau recommending - 5 "Primary Emergency Care" and "Symphtomatic Therapy" including specific direction for "fluid replacement', "antibacterial policy", "nutritional support' etc. The aforementioned should have been advised for treatment of Anuradha at AMRI. (v) The treatment given to Anuradha at AMRI hospital continued as Respondent Nos. 2 and 3 jointly took charge and recommended steroids, despite stopping "'Depomedrol' after 12th May, 1998 without realizing that she had already been a huge amount of a "long-acting" steroid (Depomedrol) and in that view of the matter they should have administered adopted remedial measures which was not done. (vi) Respondents Nos. 2 and 3 added more fuel to the fire in the form of a new "quick-acting" steroid, "Prednisolone" at 40 mg. three times daily, which was itself an excessive dose. Dr. Udwadia of Breach Candy Hospital noticed the same when Anuradha was examined by him; as according to him not more than 40 mg. Prednisolone daily for one day, to be reduced to 5 mg. within the next 5 to 6 days is the ideal dosage. (v ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ha to Respondent No. 3's residence as well as to his office, during Anuradha's stay at AMRI which clearly established that Respondent No. 3 was involved with Anuradha's treatment. (xix) The High Court has failed to consider the previous decisions of this Court on criminal negligence, as in the instant case gross negligence on the part of the Respondents establishes the offence committed by them under Section 304A of the Indian Penal Code. (xx) Negligence in fact in Anuradha's treatment had been admitted by the Respondents at different stages of the proceedings. A.3. SUBMISSIONS OF RESPONDENTS 17. Mr. Kailash Vasdev, learned senior counsel appearing for Respondent Nos. 1 and 2 would submit: (i) Kunal misled the doctors from time to time on the drugs/treatment to be administered to Anuradha. (ii) The Pathological Reports which were carried out on the basis of the prescription of Respondent No. 1 had never been shown to him. (iii) A panel of elected Committee of the West Bengal Medical Council being an Expert Body having come to a specific finding vis-à-vis the Respondents that there had been no deficiency or negligence on the part of the doctors and ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... fering from. The dose prescribed was also correct. He prescribed certain tests to be taken on 7th May as also on 11th May but he was not apprised of the results of those tests. On 11th May, he had also prescribed the requisite supportive treatment which was necessary for the recovery of Anuradha. (ii) Dr. Baidyanath Halder examined the patient for one day only on 12th May, 1998. He diagnosed the disease as Toxic Epidermal Necrolysis (TEN) correctly and prescribed medicines as per the treatment protocol noted in the text books. He examined the patient having been requested by a group of his students who were friends of Anuradha's husband. He did not charge any fees. He prescribed all necessary supportive therapy required for the patient of TEN. He had not been given any feedback by the husband of the deceased after 12th May, 1998. (iii) Dr. Abani Roychowdhury had never seen the patient nor treated her at AMRI at any point of time. He being attached to AMRI visited the hospital once in a week at the outdoor. On 12th May, 1998 having been requested by Dr. Kunal Saha as also Dr. Prasad, he went to the cabin only for the purpose of boosting the patient's morale. He neither t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ed to the Sub-divisional Hospital, Asansol as a Medical Officer. The President of the West Bengal Medical Council Dr. Ashoke Kumar Chowdhury was examined as PW-6. Prasenjit Bhattacharjee, a Sub-Inspector of Kolkata Police who was attached to the Lake Police Station at the relevant time was examined as PW-7. Dr. Anil Shinde, a medical practitioner and Manager of Pharmacia India Limited, Gurgaon, Haryana (the company manufacturing Depomedrol) was examined as PW-8. Dilip Kumar Ghosh who was the Registrar, West Bengal Medical Council has been examined as PW-9. Dr. Faruk E. Udwadia, a consultant physician with specialization in critical care and respiratory medicine of Breach Candy Hospital, Mumbai who treated the deceased from 12th May, 1998 to 18th May, 1998 was examined as PW-10. Dr. Salil Kumar Bhattacharjee, Professor of Pharmacology Institute of Medical Science, Benaras Hindu University was examined as an expert witness PW-11 on behalf of the prosecution. 22. The defence has also examined 3 witnesses. DW-1 Smt. Sutapa Chanda is the Nursing Superintendent of A.M.R.I. Dr. Kaushik Nandy, a Plastic Surgeon attached to AMRI, who is a Respondent in the connected civil Appeal and had tr ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... s characterized by purpuric or necrotic skin lesions, with or without systemic features. Rheumatoid Arthritis is the most common association with coetaneous leucocytoclastic vasculitis.... (ii) At least on 11th May, 1998, Anuradha was correctly diagnosed by Dr. A.K. Ghoshal as also the following day by Dr. B.N. Halder, still application of Corticosteriod Prednisolone for all these days in prohibitive quantity and dosing intervals with no supportive therapy was continued. That made her lose all her immunity to fight out bacteria and become immunosuppressed leading to `Septicemia' or `Septic shock'. (iii) PWs 5 and 11 also deposed about high dose of Depomedrol. Its adverse effects caused `Immunosuppression' and `Septicemia' which resulted in the death of Anuradha. (iv) The working Manager of Pharmacia India Ltd., Dr. Anil Shinde (PW-8) has categorically stated that the maximum recommended dose of Depomedrol for any dermatological or other clinical condition is 40 mg to 120 mg once a week or once in two weeks as per the severity of the disease and clinical need. Depomedrol cannot be given 80 mg twice daily in any clinical condition and even in the right dose it i ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... xamined on behalf of the defence were one doctor, one Nursing Superintendent and one employee of the Department of Health, Govt. of West Bengal. (xiii) It is not denied by Dr. Mukherjee in his examination under Section 313 of the Code of Criminal Procedure that immunosuppression, infection and sepsis are the serious adverse effects of Corticosteroids as also the probable effect of the overuse and excessive dose of the said steroids including Depomedrol. (xiv) Even Dr. Kaushik Nandy (DW-2) admitted that immunosuppression can be a side-effect of overuse or excessive use of Corticosteriods and may cause a chance of infection in any patient. He admitted that steroids should not be used as a standard therapy for treatment of TEN. xv) In Fitz Patrick's Dermatology for General Medicine, the text book on which both sides placed reliance, it is stated that "Glucocorticosteroids (steroids) may promote the risk of infection (Pneumonia, Septicemia)". (xvi) Steroid was used in the Breach Candy Hospital, as deposed by PW-10, to completely taper the dose as the patient had very high-circulating steroid level in her body because of her receiving 120 mg. of Prednisolone daily in Kolkata ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nstance of the patient party. (viii) The defence that the patient was removed at their own risk is not correct as Dr. Saha did not furnish any risk bond and only some other person not connected with the patient had endorsed the record for taking the patient at his own risk. In any event, such undertaking was not of much significance. (ix) The accused doctor should not be allowed to raise the question of chance of infection in transit from Kolkata to Mumbai as Anuradha was suffering from TEN which is a non-infectious disorder and she was found fit to travel from Kolkata to Mumbai. In view of her physical condition which was found at Breach Candy Hospital, the certificate issued does not properly reflect the actual physical condition of the patient, which itself amount to avoidance of responsibility on the part of the treating Physician. V. Dr. Abani Roychowdhury (i) There is nothing to show that Dr. Roychowdhury treated Anuradha except the entries which appeared in the prescription of Dr. Mukherjee dated 11th May, 1998, viz., "May I request Dr. Abani Roychowdhury to see her" and another endorsement dated 15th May, 1998 wherein PW-3 Dr. B. Prasad wrote to continue as advised b ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... t be held that the death was a natural one. The death certificate issued by the Breach Candy Hospital, Mumbai was not a conclusive proof of the cause of death but was only a tentative one. It was silent about the antecedent cause or other significant conditions contributing to the death. The death certificate could not rule out the possibility of accidental, suicidal or homicidal cause of death. The doctor who issued the death certificate was not examined. Thus immediate cause of death vis-a-vis the link thereof with the treatment at Kolkata and that too specially at the hands of Respondents 1 to 3 was not proved. (vi) Improvement to her health noticed in the Mumbai hospital after 25th May, 1998 ran contrary to the contention of complainant. Re : Dr. MUKHERJEE 26. The allegation that he was responsible for causing the death of Anuradha by his rash and negligent act not amounting to culpable homicide by advising, prescribing and treating the deceased with steroid drugs namely Depomedrol, 80 mg, IM stat twice daily and other drugs in improper dosage at improper interval without any supportive treatment was rejected for the following reasons: (i) Various tests advised by him wer ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ny point of time. Allergic vasculitis is not a dermatological disease. The treatment suggested by Dr. Mukherjee, therefore, could not be considered to be an act of rash and negligence. Re : Dr. HALDER 27. The allegation of the complainant that the prescription by Dr. Halder of Prednisolone 40 mg. thrice daily had aggravated the disease was held not tenable on the following grounds: (i) He visited the patient only on 12th May, 1998 which was supported by Dr. Balaram Prasad. He, therefore, had no role to play in the treatment of Anuradha which would be evident from the record of AMRI. (ii) There is nothing on record to show that the prescription of Prof. Halder was given effect to. (iii) Occlusive dressings were carried as a result of which infection had been increased (iv) He had suggested Benadryl Syrup as there were eruptions inside the mouth and Cortisone Kemicetin eye ointment for eye care. However, the steroid based Neomycin Antibiotic was prescribed by the Consultant Ophthalmologist Dr. S. Bhattacharya on 12th May, 1998, although Prof. Halder in his prescription advised to avoid Neomycin and Soframycin which are common causes of drug allergy. As such the treatment su ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... chowdhury but the nature of the advice had not been clarified by them. RE: CERTIFICATE 31. The allegation that the certificate was issued at the instance of Dr. Roychowdhury is not correct as the certificate issued by Prof. Halder did not indicate that Anuradha was being carried by a Chartered flight for better treatment. The words "for better treatment" were not written by Prof. Halder and only in the course of evidence it was proved that there was an interpolation in the certificate. The same was also admitted by Dr. Balaram Prasad and thus the certificate of Prof. Halder was held to be forged. The forged certificate demolishes the prosecution story that at the advice of Prof. Halder or Prof. Roychowdhury the patient was taken to Mumbai. The endorsement of Dr. Kunal Saha on the record of AMRI really proved that Anuradha was shifted from the hospital at their own risk. The evidence on record also indicates that till the evening of 18th May, 1998, the dressing of Anuradha was not changed. Thus, by removing Anuradha, her husband Kunal Saha took upon himself great risk of infection to her in course of transit being aware that infection was very common at that critical stage for the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ent only because something has gone wrong. He also cannot be held liable for mischance or misadventure or for an error of judgment in making a choice when two options are available. The mistake in diagnosis is not necessarily a negligent diagnosis. 35. Even under the law of tort a medical practitioner can only be held liable in respect of an erroneous diagnosis if his error is so palpably wrong as to prove by itself that it was negligently arrived at or it was the product of absence of reasonable skill and care on his part regard being held to the ordinary level of skill in the profession. For fastening criminal liability very high degree of such negligence is required to be proved. 36. Death is the ultimate result of all serious ailments and the doctors are there to save the victims from such ailments. Experience and expertise of a doctor are utilised for the recovery. But it is not expected that in case of all ailments the doctor can give guarantee of cure. B.3. NATIONAL COMMISSION JUDGMENT 37. The Commission in its judgment noted that doctor or a surgeon never undertakes that he would positively cure the patient nor does he undertake to use the highest degree of skill, but h ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the act, or that he was doing what was either wrong or contrary to law. The opinions of experts upon the question whether the symptoms exhibited by A commonly show unsoundness of mind, and whether such unsoundness of mind usually renders persons incapable of knowing the nature of the acts which they do, or knowing that what they do is either wrong or contrary to law, are relevant. (c) The question is, whether a certain document was written by A. Another document is produced which is proved or admitted to have been written by A. The opinion of experts on the question whether the two documents were written by the same person or by different persons are relevant. 43. A Court is not bound by the evidence of the experts which is to a large extent advisory in nature. The Court must derive its own conclusion upon considering the opinion of the experts which may be adduced by both sides, cautiously, and upon taking into consideration the authorities on the point on which he deposes. 44. Medical science is a difficult one. The court for the purpose of arriving at a decision on the basis of the opinions of experts must take into consideration the difference between an `expert witness ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... r in not placing reliance upon medical opinions i.e. Exts. 4, 5 and 6 on the premise that no objection in that behalf was raised at any point of time. 47. Kunal would argue that this Court having given him permission to examine the expert witnesses on Video Conferencing and he having deposed in terms thereof, Respondents could have asked for their cross-examination at any point of time and not having done so, it does not lie in their mouth to contend that the opinions of the said experts who are themselves authors on TEN and having done research on the disease TEN, are not admissible. FOR THE PURPOSES OF CRIMINAL PROCEEDINGS 48. Kunal, however, would contend that the aforementioned documents were exhibited without any demur whatsoever. The respondents, furthermore, did not make any prayer to cross-examine the said witnesses. 49. It is true that ordinarily if a party to an action does not object to a document being taken on record and the same is marked as an exhibit, he is estopped and precluded from questioning the admissibility thereof at a later stage. It is, however, trite that a document becomes inadmissible in evidence unless author thereof is examined; the contents there ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... on an assumption that the opposite party is not serious about the mode of proof. On the other hand, a prompt objection does not prejudice the party tendering the evidence, for two reasons: firstly, it enables the court to apply its mind and pronounce its decision on the question of admissibility then and there; and secondly, in the event of finding of the court on the mode of proof sought to be adopted going against the party tendering the evidence, the opportunity of seeking indulgence of the court for permitting a regular mode or method of proof and thereby removing the objection raised by the opposite party, is available to the party leading the evidence. Such practice and procedure is fair to both the parties. Out of the two types of objections, referred to hereinabove, in the latter case, failure to raise a prompt and timely objection amounts to waiver of the necessity for insisting on formal proof of a document, the document itself which is sought to be proved being admissible in evidence. In the first case, acquiescence would be no bar to raising the objection in a superior court. 52. Section 22 of the Consumer Protection Act, 1986 provides that Sections 12, 13 and 14 there ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... from the records. 57. This Court in J.J. Merchant (Dr) v. Shrinath Chaturvedi (2002) 6 SCC 635, held as under: 19. It is true that it is the discretion of the Commission to examine the experts if required in an appropriate matter. It is equally true that in cases where it is deemed fit to examine experts, recording of evidence before a Commission may consume time. The Act specifically empowers the Consumer Forums to follow the procedure which may not require more time or delay the proceedings. The only caution required is to follow the said procedure strictly. Under the Act, while trying a complaint, evidence could be taken on affidavits [under Section 13(4)(iii)]. It also empowers such Forums to issue any commission for examination of any witness [under Section 13(4)(v)]. It is also to be stated that Rule 4 in Order 18 CPC is substituted which inter alia provides that in every case, the examination-in-chief of a witness shall be on affidavit and copies thereof shall be supplied to the opposite party by the party who calls him for evidence. It also provides that witnesses could be examined by the court or the Commissioner appointed by it. As stated above, the Commission is also ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... earches of patients suffering from the said disease with administration of steroid as well as non-administration of them. It was found that those patients treated with steroids do not respond properly thereto. Indisputably, however, some doctors still use steroids. It is stated that the researchers found out that use of steroids was more detrimental than beneficial to the TEN patients. 62. Admittedly, Anuradha was administered steroids. The learned Counsel for the parties have brought before us a vast volume of material to contend that the experts in the field as also the doctors or medical practitioners who have specialized in TEN and other dermatological diseases are sharply divided on the administration of steroid. We for the sake of brevity refer to them as the pro-steroid group and anti-steroid group. Medical science, therefore, has a grey area in this respect. 63. At the outset, we may place on record the treatment pattern prescribed by two experts, viz., Jean Edouard Revuz and Jean Claude Roujeau who are generally accepted world over. According to them, the treatment pattern should be as under: The disease usually begins with non specific symptoms, such as fever, cough, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ever given on a BID schedule (and with some preparations no more frequently than every 4-6 weeks) because of the prolonged Depot effect related to administration by this particular route. In general, intramuscular administration of systemic corticosteroids is not employed in the treatment of dermatological diseases since this routes provides very erratic release of medication from the tissue.... 69. He also remarked, as far as the treatment in the present case is concerned: ...manner in which the treatment was instituted in your wife certainly appears to be unprecedented. 70. Dr. David Heimbach, Professor of University of Washington holds the view that the injection "DEPO" in twice daily dose was not indicated in TEN protocol and the dosing interval as advised in the prescriptions of the opposite party No. 1 is not recommended for treatment of any medical condition, leave aside for, far less an acute medical condition such as the one the patient was suffering from i.e. TEN. 71. Dr. Timothy Bradley, noted Physician wrote a famous article on TEN wherein it was stated that several patients of TEN with 95% total BSA involvement were treated without use of steroids and there ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... medical and ethical concern to relief pain in TEN. 73. Our attention has also been drawn to the resolutions adopted in the year 1985 at Creteil in France. We would label it as `Creteil Experience'. It is summarized as under: The absence of dermal inflammatory infiltration in TEN is an argument against steroid therapy. Certain authors have claimed that the extension of necrolysis is arrested by high-dose corticosteroid therapy, but the natural history of TEN is very variable both in extent and time course. In some cases nerolysis is complete within 24 hours. Clearly, steroid therapy is illogical in such patients. In other patients, necrolysis may occur in waves. The unpredictable course of the disease casts further doubt on uncontrolled claims of the efficacy of steroid therapy. The benefits of steroid therapy, if any, would be observed only at an early stage of a slowly evolving case of TEN. It cannot be overemphasised that once a large area of dermis is uncovered i.e. more than 20% of the body surface area, the supposed advantages of steroid-therapy are far outweighed by its drawbacks. The opinion that steroids should not be used as a standard therapy for TEN is shared by t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Pharmacology. - Journal of Burn Care and Rehabilitation ( A 10 year experience with TEN) - TEN - Medical Findings and Prognosis in 87 Patients, Jean Revuz, From the archives of Dermatology - J.S. Pasricha, TEN, International Journal of Dermatology. 78. Nonetheless the following principles are integral to the treatment of TEN as suggested by the Respondents: a. Treatment in burn units should be strived for in exceptional cases but is not generally necessary. b. Treatment has to be individually tailored according to cause, type, stage and presence of complications. c. Systemic glucocorticoids should not be used routinely but are justified in the early stages of drug induced TEN. They should be given in doses from 80 to 120 mg of methlypredisolone per day by mouth, for several days until disease progression has ceased. Dosages should be tapered quickly and cautiously since no further benefit can be expected thereafter and the untoward effects may then predominate. d. Treatment may focus on early detection and prevention of the most fatal complication e.g. overwhelming infection. Cultures from skin and mucosal erosions, must be regularly performed. e. Blood gases and f ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... of the difference of opinion amongst experts as noticed by us heretoabove in some detail, proceed on the assumption that steroid can be administered in the TEN patients. However, it is clear from the opinion of the pro-steroid experts that: (i) The nature of steroid which should be used is corticosteroid meaning thereby methyl prednisolone. (ii) It should be used only at the early stages for a few days and then should be stopped or tapered to avoid the effect of immunosuppression as also sepsis. (iii) Supportive treatment must be administered. (iv) It should be individually tailored according to the patients' need. 84. Supportive treatment is also advised by Dr. Pasricha and others. Two factors, however, must be noticed at this juncture: (i) The chemical composition of Depomedrol is different from other type of glucocorticosteroid inasmuch as Depomedrol is methyl prednisolone acetate and glucocorticosteroid is methyl prednisolone sodium succinate. The evidence of Kunal in this behalf is absolutely categorical and unequivocal. (ii) All the authors are one in stating that their opinion is subject to the instructions given in the package insert of the medicine. 85. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ther daily or intermittent therapy should be used. Glucocorticoids may musk some signs of infection and new infections may appear during their use. There may be decreased resistance and inability to localise infection when glucocorticoids are used. Do not use intraarticularly , intra bursally or intra tendinous administration in the presence of acute infection. IM administration can only be considered after institution of an appropriate anti microbial treatment. 86. The necessity of following the instructions given in the packet insert cannot be underestimated. Admittedly, the instructions in the said packet insert had not been followed in the instant case. EFFECT OF EXCESS DOSAGE 87. There is, thus, a near unanimity that the doses of glucocorticosteroid and in particular Depomedrol were excessive. From the prescription of Dr. Mukherjee, it is evident that he not only prescribed Depomedrol injection twice daily, but had also prescribed Wysolone which is also a steroid having the composition of Methyl Predinosolone. 88. From the AMRI records, it would appear that while admitting the patient, it had categorically been noticed that both Depomedrol injection twice daily and Wysolon ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... linical condition like Bronchial Asthama and Rheumatoid Arthritus". On being questioned whether Depomedrol can be used for TEN, the answer was "No" He furthermore stated that the recommended usage is 40 to 120 mg. at intervals of at least 1 week and a daily dose of 80 mg can never be used. On the question whether `long acting' steroids can accumulate in the body, he replied `Yes, it can accumulate.' On being questioned, whether it is discretion of the Physician to decide the mode of administration of any drug, he answered that the choice is "prerogative". However, he has to follow the pharmaco- therapeutic norms of the drug chosen. SUPPORTIVE THERAPY 92. No symptomatic therapy was administered. No emergency care was provided. Dr. Halder himself accepted that the same was necessary. This has also been stated by Roujeau and Revuz in their book in the following terms: Withdrawal of any suspect drug, avoidance of skin trauma, inserting a peripheral venous line, administration of macromolecular solution, direct the patient to burn unit or ICU. 93. AMRI records demonstrate how abysmal the nursing care was. We understand that there was no burn unit in AMRI and there was no bu ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rash, palpable penpina, enlarged neck glands were found to be present. She was diagnosed to be suffering from `Anglo-Neurotic Oedema with allergic vasculitis'. Respondent No. 1 prescribed Depomedrol stat (immediately) injection 80 mg. on a twice daily schedule(B.I.D) for 3 days to be followed by other oral steroids. One injection was given by him. 99. Despite the institution of Depomedrol, Anuradha's condition worsened from bad to worse in the next few days and Dr. Kunal Saha, contacted Respondent No. 1 from time to time for advice on telephone, who, however, insisted on continuing Depomedrol in the same dose. Anuradha was said to have also examined by two Consulting Dermatologists - Dr. A.K. Ghoshal and Dr. S. Ghosh, who diagnosed disease to be a case of Vasculitis. The injection, as suggested by Respondent No. 1, however, was continued to be given. 100. On or about 11th May, 1998 Respondent No. 1 was informed by Kunal that his wife's condition had not been improving. The skin rash was persisting alongwith the fever and palpable neck glands whereafter he was recommended that Anuradha be hospitalised immediately. On the same date Anuradha was admitted in the Advanced ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... orementioned purpose Respondent No. 2 issued a certificate. Three words in the said certificate, namely - "for better treatment" were said to be added. A Chartered Plane was arranged for taking Anuradha to Mumbai from Kolkata on 17th May, 2009. She was admitted in the said hospital at about 9.30 p.m. On her admission to the Breach Candy Hospital, it was recorded inter alia: Mrs. Anuradha Saha has been admitted to Breach Candy Hospital, on 17.5.98 at night - 9.30 PM. Her condition on admission is serious. She has been accompanied by her husband Dr. Saha, who has given the history of antibiotic injection for respiratory tract injection - Rovamycin, Routhromycin, Ampicillin and Ampiclox and Nemuslide followed by development of Toixc Epidermal Necrolysis. She has received T Prednisolone 120 mg/day for 7 days and also Inj. Depomedrol Im x 3 days. She has been hemodynamically stable till now. She is able to swallow liquids, which has been her only nourishment over the past few days. 106. She was examined by Dr. Farokh E. Udwadia at the Breach Candy Hospital in the afternoon of 18th May, 1998. His diagnosis was as under: Patient has come with a diagnosis Toxic Epidermal Necrolysis (T ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... od, it does not do harm. To allow the use of a Zinc preparation - totally unnecessary but not likely to lead to Zinc poisoning. I would not allow parental alimentation through the same central line as fluids and electrolytes as I feel that gut if viable used at IV alimentation at this point of time may add to her hazards. 109. Her condition was better during 24th May and 25th May, 1998. She, however, breathed her last on 28th May, 1998. NOSOCOMIAL INFECTIONS: 110. Nosocomial infections are infections which are a result of treatment in a hospital or a healthcare service unit, but secondary to the patient's original condition. Infections are considered nosocomial if they first appear 48 hours or more after hospital admission or within 30 days after discharge. Thus it becomes the liability of the hospital to prevent such infection specially in the cases where the patient has high risk of infection due to the nature of disease suffered. 111. AMRI as also the other respondents say that the room was made infection free. Certain restrictions on the visitors had also been taken. It is, however, not disputed that the dressing of body surface by Dr. Kaushik Nandy started only on ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the passage of time. The cause of such eruption was not ascertained. In fact what caused the onset of disease was not known. It may be from Chinese food or it may even be from use of vitamin. 115. On and from 7th May, 1998, she was prescribed injection Depomedrol twice a day and Wysolone. It was continued upto 13th May, 1998, nobody even thought of stopping the injection. Dr. Halder although stopped Depomedrol injection from 13th May, 1998, but prescribed a high dose of steroid. 116. No doctor posed unto themselves a basic question why despite use of steroid, condition of the patient was going from bad to worse. It is agreed across the board and at least during trial, that supportive treatment should have been given. The medicine was propagated which did not exist. The medical literatures were not consulted. Even for pulse therapy Depomedrol could not have been used and only Solumedrol could have been used. Kunal in his evidence explained the difference between the two. Dr. Mukherjee in his deposition indirectly accepted the same. Each of those pro-steroid group spoke of a single injection. Nobody suggested on the face of the voluminous medical literature and authoritative opinio ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... cause type and stage and presence and type of complications. c. Systemic glucocorticoids should not be used routinely but are justified in the early stages of drug induced TEN. They should be given in doses from 80 to 120 mg of methlypredisolone per day by mouth, for several days until disease progression has ceased. Dosages should be tapered quickly and cautiously since no further benefit can be expected thereafter and the untoward effects may then predominate. d. Treatment may focus on early detection and prevention of the most fatal complication e.g. overwhelming infection. Cultures from skin and mucosal erosions, must be regularly performed. e. Blood gases and fluid, electrolytes and protein balance must be monitored and adjusted appropriately. Fluid replacement regimens as used for burn patients. f. Supportive care is of great importance and particular attention must be paid to a high calorie and high - protein diet. g. Debridgement of necrotic skin should not performed before disease activity ceases. 3. Course and Prognosis: The following factors appear to be unfavourable prognostic signs: old age, extensive skin lesions, nuetropenia, impaired renal function and i ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... examined some of the including Dr. Anil Shinde P.W. 9,; Dr. Udwadia (P.W.10) and, Dr. Salil Kumar Bhattacharyya, P.W. 11. 125. Respondents did not examine any expert. They, however, relied upon some authorities to which we have referred to heretobefore. The onus of proof, therefore, on a situation of this nature shifted to the respondents. 126. While we say so we must place on record that we are not oblivious of the fact that the principle of res ipsa loquitur may not be strictly applicable in a criminal case, although certain authorities suggest application of the said principle. 127. In Spring Meadows Hospital v. Harjol Ahluwalia (1998) 4 SCC 39, this Court has held as under: 10. Gross medical mistake will always result in a finding of negligence. Use of wrong drug or wrong gas during the course of anaesthetic will frequently lead to the imposition of liability and in some situations even the principle of res ipsa loquitur can be applied. Even delegation of responsibility to another may amount to negligence in certain circumstances. A consultant could be negligent where he delegates the responsibility to his junior with the knowledge that the junior was incapable of performi ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ppeal the said principle is applicable. It has clearly been held by this Court that the onus of proof would shift on the respondents. 131. In Nizam Institute of Medical Sciences v. Prasanth S. Dhananka and Ors. 2009 (7) SCALE 407 this Court held as under: 32. We are also cognizant of the fact that in a case involving medical negligence, once the initial burden has been discharged by the complainant by making out a case of negligence on the part of the hospital or the doctor concerned, the onus then shifts on to the hospital or to the attending doctors and it is for the hospital to satisfy the Court that there was no lack of care or diligence. In Savita Garg (Smt.) v. Director, National Heart Institute it has been observed as under: Once an allegation is made that the patient was admitted in a particular hospital and evidence is produced to satisfy that he died because of lack of proper care and negligence, then the burden lies on the hospital to justify that there was no negligence on the part of the treating doctor or hospital. therefore, in any case, the hospital is in a better position to disclose what care was taken or what medicine was administered to the patient. It is t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... r. Halder in their written statements before the National Commission are not backed by any evidence on record. Even otherwise, keeping in view the specific defence raised by them individually, interference by Kunal, so far as they are concerned, would amount to hearsay evidence and not direct evidence. 136. Dr. K. Nandy in his evidence stated that he was not allowed to change the dressings on 15th May and 16th May, 1998. However, according to him, he forced his decision to do the dressing on 17th May, 1998 before she was taken away from the hospital. 137. However, it appears from the AMRI records that the name of Kunal only appears once i.e. when he got Anuradha admitted in the hospital. His name is not borne out from any other record. So far as the statement of Dr. Nandy is concerned, Kunal's explanation is that he did not follow the medical protocol in the matter of dressing. This may or may not be correct. 138. We may notice that whenever any interference in contrast to the AMRI was attempted to be made by the patient party at Breach Candy Hospital, it had scrupulously been placed on record. Wherever "Dr. Saha" appears in the record, it is evident that the same refers to ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ent. It may, however, have some role to play for the purpose of damages. C.6. NON-JOINDER OF NECESSARY PARTIES 144. Respondents contend that Dr. Kunal had been selective in prosecuting three principal doctors on the criminal side who allegedly treated Anuradha but some more before the Commission. Contending that no reason has been assigned as to why case against Dr. A.K. Ghoshal as also Breach Candy Hospital and doctors treating Anuradha at Bombay from 17th May, 1998 till 28th May, 1998 had been given up, the learned Counsel urged that these appeals should be dismissed on that ground alone. 145. We are afraid that the aforementioned submission cannot be accepted in view of the decision of this Court in Smt. Savita Garg (supra), wherein it has been held: So far as the law with regard to the non- joinder of necessary party under Code of civil Procedure, Order 1 Rule 9 and Order 1 Rule 10 of the CPC there also even no suit shall fail because of mis-joinder or non-joinder of parties. It can proceed against the persons who are parties before the Court. Even the Court has the power under Order 1 Rule 10(4) to give direction to implead a person who is a necessary party. therefore, ev ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the treatment protocol. 148. We must bear in mind that negligence is attributed when existing facilities are not availed of. Medical negligence cannot be attributed for not rendering a facility which was not available. In our opinion, if hospitals knowingly fail to provide some amenities that are fundamental for the patients, it would certainly amount to medical malpractice. As it has been held in Smt. Savita Garg (supra), that a hospital not having basic facilities like oxygen cylinders would not be excusable. Therein this Court has opined that even the so-called humanitarian approach of the hospital authorities in no way can be considered to be a factor in denying the compensation for mental agony suffered by the parents. The aforementioned principle applies to this case also in so far as it answers the contentions raised before us that the three senior doctors did not charge any professional fees. 149. In any event, keeping in view of the said decision, we are of the firm opinion that notices to a large number of persons and withdrawal of cases against some of them by itself cannot be considered to be a relevant factor for dismissal of these appeals. D. civil LIABILITY UNDER ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... s: Where you get a situation which involves the use of some special skill or competence, then the test...is the standard of ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest expert skill; it is well-established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular Article... [A doctor] is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular Article...Putting it the other way round, a [doctor] is not negligent, if he [has acted] in accordance with such a practice, merely because there is a body of opinion which [takes] a contrary view. 157. It has been laid down that an ordinary skilled professional standard of care for determining the liability of medical professional should be followed. See Maynard v. West Midland Regional Health, Authority (1985) 1 All ER 635 (HL) 158. Recently in Martin F.D' Souza v. Mohd. Ishfaq (2009) 3 SCC 1, this Court laid down the precautions which doctors/hospitals etc. should have taken, in the following terms: (a) Current ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the part of a professional is not negligence per se. (iv) Simply because a patient has not favourably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per se by applying the doctrine of res ipsa loquitor. RIGHT OF THE PATIENT TO BE INFORMED 162. The patients by and large are ignorant about the disease or side or adverse affect of a medicine. Ordinarily the patients are to be informed about the admitted risk, if any. If some medicine has some adverse affect or some reaction is anticipated, he should be informed thereabout. It was not done in the instant case. 163. In Sidaway v. Board of Governors of Bethlem Royal Hospital and the Maudsley Hospital (1985) All ER 643 , the House of Lords, inter alia held as under: 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 p ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... patient. The submission of Dr. Halder that he had issued the certificate without seeing the patient cannot be believed. If that be so, such a certificate could have been issued by Dr. Balram Prasad and/or any other doctor. Why he had taken the burden of issuing such a certificate is not explained. 166. We are of the opinion that a conclusion as to whether the words "for better treatment" have been inserted in the said certificate or not or the same was done at the instance of Kunal, is wholly unnecessary for our purpose. The only question which arises is as to whether there was any risk of Anuradha developing infection due to exposure during transportation. She was flown to Mumbai by an exclusive chartered flight (air ambulance) of East-West Rescue of Delhi. Kunal had to pay about $ 2000 for the said purpose. Respondents did not suggest that the service provided by the said airlines was of inferior character or sufficient precautions were not taken during transportation. In fact, the condition of Anuradha was so critical that there was no other option but to take her to a better hospital. Her transportation to Mumbai was necessary and was not an act borne out of desperation alone. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ices available to the patient certainly raises a legitimate expectation. We are not oblivious that the source of the said doctrine is in administrative law. A little expansion of the said doctrine having regard to an implied nature of service which is to be rendered, in our opinion, would not be quite out of place. 172. AMRI makes a representation that it is one of the best hospitals in Calcutta and provides very good medical care to its patients. In fact the learned Senior Counsel appearing on behalf of the respondents, when confronted with the question in regard to maintenance of the nurses register, urged that it is not expected that in AMRI regular daily medical check-up would not have been conducted. We thought so, but the records suggest otherwise. The deficiency in service emanates therefrom. Even in the matter of determining the deficiency in medical service, it is now well- settled that if representation is made by a doctor that he is a specialist and ultimately it turns out that he is not, deficiency in medical services would be presumed. 173. We may notice some of the decisions in this behalf. 174. In Smt. Savita Garg v. The Director, National Heart Institute 2004 (8) ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... tient suffering from any other bypass of skin disease and the maximum recommended usage by the drug manufacturer has also been exceeded by Dr. Mukherjee. On 11th May, 1998, the further prescription of Depomedrol without diagnosing the nature of the disease is a wrongful act on his part. 179. According to general practice, long acting steroids are not advisable in any clinical condition, as noticed hereinbefore. However, instead of prescribing to a quick acting steroid, the prescription of a long acting steroid without foreseeing its implications is certainly an act of negligence on his part without exercising any care or caution. As it has been already stated by the Experts who were cross examined and the authorities that have been submitted that the usage of 80-120 mg is not permissible in TEN. 180. Furthermore, after prescribing a steroid, the effect of immunosuppression caused due to it, ought to have been foreseen. The effect of immunosuppression caused due to the use of steroids has affected the immunity of the patient and Dr. Mukherjee has failed to take note of the said consequences. 181. After taking over the treatment of the patient and detecting TEN, Dr. Halder ought t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... to 16.05.1998 (Body Temperature, Respiration Rate, pulse, BP and urine input and output) (ii)I.V. Fluid not administered. (I.V. fluid administration is absolutely necessary in the first 48 hours of treating TEN) As regards, Dr. Balaram Prasad, Respondent No. 5, it may be noticed: (i) Most Doctors refrain from using steroids at the later stage of the disease - due to the fear of Sepsis, yet he added more steroids in the form of quick - acting "Prednisolone" at 40g three times a day. (ii) He stood as second fiddle to the treatment and failed to apply his own mind. (iii) No doctor has the right to use the drug beyond the maximum recommended dose. 187. So far as the judgment of the Commission is concerned, it was clearly wrong in opining that there was no negligence on the part of the hospital or the doctors. We are, however, of the opinion, keeping in view the fact that Dr. Kaushik Nandy has done whatever was possible to be done and his line of treatment meets with the treatment protocol of one of the experts, viz. Prof. Jean Claude Roujeau although there may be otherwise difference of opinion, that he cannot be held to be guilty of negligence. D.5. CONCLUSION 188. We remi ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... said principle has been applied by this Court in Gobald Motor Service Ltd., Allahabad v. R.M.K. Veluswami AIR 1962 SC 1. 193. Loss of wife to a husband may always be truly compensated by way of mandatory compensation. How one would do it has been baffling the court for a long time. For compensating a husband for loss of his wife, therefore, courts consider the loss of income to the family. It may not be difficult to do when she had been earning. Even otherwise a wife's contribution to the family in terms of money can always be worked out. Every housewife makes contribution to his family. It is capable of being measured on monetary terms although emotional aspect of it cannot be. It depends upon her educational qualification, her own upbringing, status, husband's income, etc. 194. This Court, we may notice, has laid down certain norms for grant of compensation for the death of members of family including the loss of child in some of its decisions. [See Lata Wadhwa v. State of Bihar (2001) 8 SCC 197 and R.K. Malik and Anr. v. Kiran Pal and Ors. 2009 (8) SCALE 451] 195. In R.D. Hattangadi v. Pest Control (India) (P) Ltd. AIR 1995 SC 755, this Court observed: Broadly speak ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... pondents are guilty of criminal negligence. Criminal negligence is the failure to exercise duty with reasonable and proper care and employing precautions guarding against injury to the public generally or to any individual in particular. 201. It is, however, well settled that so far as the negligence alleged to have been caused by medical practitioner is concerned, to constitute negligence, simple lack of care or an error of judgment is not sufficient. Negligence must be of a gross or a very high degree to amount to Criminal Negligence. 202. Medical science is a complex science. Before an inference of medical negligence is drawn, the court must hold not only existence of negligence but also omission or commission on his part upon going into the depth of the working of the professional as also the nature of the job. The cause of death should be direct or proximate. A distinction must be borne in mind between civil action and the criminal action. 203. The jurisprudential concept of negligence differs in civil and criminal law. What may be negligence in civil law may not necessarily be negligence in criminal law. For negligence to amount to an offence the element of mens rea must b ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nuradha's treatment (v) AMRI states that the drugs had been administered and nursing care had been given as per the directions of the doctors. (vi) Respondent Nos. 5 and 6, therefore, did not own any individual responsibility on themselves although they were independent Physicians with Post Graduate medical qualifications. 205. In `Errors, Medicine and the Law', Cambridge University Press, p.14., the authors, Alan Merry and Alexander McCall Smith, 2001 ed., stated: Many incidents involve a contribution from more than one person, and this case is an example. It illustrates the tendency to blame the last identifiable element in the claim of causation - the person holding the `smoking gun'. A more comprehensive approach would identify the relative contributions of the other failures in the system, including failures in the conduct of other individuals... 206. In R v. Yogasa Karan (1990) 1 NZLR 399, the New Zealand Court opined that the hospital is in a better position to disclose what care was taken or what medicine was administered to the patient. It is the duty of the hospital to satisfy that there was no lack of care or diligence. The hospitals are institutions, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... t. F. OBSERVATIONS OF THE CALCUTTA HIGH COURT 211. We must express our agony in placing on record that the Calcutta High Court in its judgment has made certain observations which apart from being not borne out from the records, are also otherwise highly undesirable. 212. Some of the conclusions arrived at by the High Court are not based on the findings emerging from the records. These conclusions are as produced as under: 28...On 24.5.1998, it was noted "wounds were healing well, epidermal islands have appeared over palms, soles and trunk ... no obvious Pseudomonas Colony like before". All these noting in the record of Breach Candy Hospital indicate that her skin had started healing and undoubtedly, such healing was outcome of effective treatment. This betterment of skin lesion in the instant case could have been due to timely and effective treatment, undoubtedly with steroids. This may indicate the benefit of treatment at Calcutta... It was furthermore stated: 32. In this connection it is also to be mentioned that the death certificate alone cannot rule out the possibility of accidental suicidal or homicidal cause of the death. A post-mortem examination alone could rule o ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ring from fear psychosis. 214. We must also express our great dissatisfaction when the Calcutta High Court stated: 121. But it is sufficiently clear that a man of the medical field now residing at United States with family after acquiring citizenship of that country has challenged the conduct and integrity of the three Professors. In this connection, I deem it proper to quote a remark of Lord Denning MR in White House v. Jordan (supra); ...Take heed of what has happened in the United States. 'Medical malpractice' cases there are very worrying, especially as they are tried by juries who have sympathy for the patient and none for the doctor who is insured. The damages are colossal. The doctors insure but the premiums become very high ; and these have to be passed on in fees to the patients. Experienced practitioners are none to have refused to treat patients for fear of being accused of negligence. Young men are even deterred from entering the profession because of the risks involved. In the interests of all, we must avoid such consequences in England. Not only must we avoid excessive damages. We must say and say firmly, that in a professional man, an error of judgment i ..... X X X X Extracts X X X X X X X X Extracts X X X X
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