MALAY KUMAR GANGULY versus DR. SUKUMAR MUKHERJEE AND OTHERS

11. Kunal, before us, contended that the High Court committed a serious error 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. 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 c

12. Kuna!, 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. 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 thereof cannot be held to have been proved unless he is examined and subjected to cross- examination in a court of law. The document which is otherwise inadmissible cannot be taken in evidence only because no objection to the admissibility thereof was taken. In a criminal case, subject of course, to the shifting of burden depending upon the statutes and/or the decisions of the superiors courts, the right of an accused is protected in terms of Article 21 of the Constitution of India. The procedure laid in that behalf, therefore, must be strictly complied G with. Exhibits 4, 5 and 6, in our opinion, are not admissible in evidence in the criminal trial. FOR PURPOSES OF PROCEEDINGS BEFORE THE NATIONAL COMMISSION

13. The said exhibits, however. are admissible before the t consumer court. This Court in R. V.E. Venkatachala Gounder A v. Arulmigu Viswesaraswami & V.P. Temple, (2003) 8 SCC 752, at page 763 : " … Ordinarily, an objection to the admissibility of evidence should be taken when it is tendered and not subsequently. The objections as to admissibility of documents in evidence may be classified into two classes: (i) an objection that the document which is sought to be proved is itself inadmissible in evidence; and (ii) where the objection does not dispute the admissibility of the c document in evidence but is directed towards the mode of proof alleging the same to be irregular or insufficient. In the first case, merely because a document has been marked as "an exhibit", an objection as to its admissibility is not excluded and is available to be raised even at a later stage or even in appeal or revision. In the latter case, the objection should be taken when the evidence is tendered and once the document has been admitted in evidence and marked as an exhibit, the objection that it should not have been admitted in evidence or that the mode adopted for proving the document is irregular cannot be allowed to 1 E be raised at any stage subsequent to the marking of the document as an exhibit. The latter proposition is a rule of fair play. The crucial test is whether an objection, if taken at the appropriate point of time, would have enabled the party tendering the evidence to cure the defect and resort to such mode of proof as would be regular. The omission to object becomes fatal because by his failure the party entitled to object allows the party tendering the evidence to act on an assumption that the opposite party is not serious about the mode of proof. On the other hand, a G 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 t~mely objection amounts to waiver of the necessity for insisting on formal proof of a document, the document itself which is sought c to be proved being admissible in evidence. In the first case, acquiescence would be no bar to raising the objection in a superior court." Section 22 of the Consumer Protection Act, 1986 provides that Sections 12, 13 and 14 thereof and the rules y made thereunder for disposal of the complaints by the District Forum, shall with such modification as may be considered necessary by the ~Commi$sion, be applicable to the disposal of disputes by th~ National Commission.

Section 12 of the· 1986 Act provides for the rpanner in which the complaint shall be made. Section 13 prescribes the procedure on admission of the complaint. Sub-section (3) there9f reads:- "(3) No proceedings complying with the procedure laid down-in sub-sections (1) and (2) shall be called in question in any court on the ground that the principles of natural justice have not bE!!en complied with." Apart from the procedures laid down ln Section 12 and 13 as also the Rules made under the Act, the Commission is not bound by any other prescribed procedure. The provisions of the Indian Evidence Act are not applicable. The Commission is merely to comply with the principles of natural justice, save and except the ones laid down under sub.:section (4) of Se.ction 13 of the 1986 Act. The proceedings before the National Commission are ..y although judicial proceedings, but at the same time it is not a A civil court within the meaning of the provisions of the Code of Civil Procedure; It may have all the trappings of the Civil Court but yet it can not be called ca civil court. [ See Bharat Bank Ltd. v. Employees of the Bharat Bank Ltd. [1950 SCR 459] and Nahar Industries Ltd. v. Hong Kong & Shanghai Banking B Corporation etc.

(Civil Appeal arising out of SLP (C) No. 24715 of 2008 etc. decided on 29th July, 2009)] Mr. Gupta, learned counsel appearing on behalf of Dr. Bairam Prasad contended that the opinions, exhibits P-4, P-5 C and P-6 are inadmissible in evidence. The opinions of the experts as contained in the said documents are probably based on the hospital records and other relevant papers. Such opinions have been rendered on the basis. of their expertise. They were notarized. The said D opinions have been appended to the complaint petition even as documents. Respondents did not question the correctness thereof either before the court or b~fore the Commission. They did not examine any expert to show that said opinion are not correct. The concerned respondents in their depositions before the Commission also did not challenge the correctness or otherwise of the said opinions. Even otherwise the deficiencies pointed out therein are explicit from the records.

This Court in J.J. Merchant (Dr) v. Shrinath Chaturvedi, [(2002) 6 sec 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 G Commission may consume time. Th_e1 Act. specifically empowers the Consumer f arums to foll<;:>w 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 -1 examina.tion 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 copias.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 r Commissioner appointed by it. As stated above, the c Commission is also empowered to follow the said procedure. Hence, we do not think that there is any scope of delay in examination or cross-examination of the witnesses. The affidavits of the experts including the doctors can be taken as evidence. Thereafter, if cross- examination is sought for by the other side and the …,. Commission finds it proper, it can easily evolve a procedure permitting the party who intends to cross- examine by putting certain questions in writing and those questions also could be replied by such experts including doctors on affidavits. ln case where stakes are very high and still a party intends to cross-examine such doctors or experts, there can be video conferences or asking questions by arranging telephonic conference and at the initiaL stage this cost should be borne by the person who claims such video conference. Further, cross-examination f- can be taken by the Commissioner appointed by it at the working place of such experts at a fixed time." C.2. DIAGNOSIS AND TRAIL OF TREATMENT G OVERVIEW OF TOXIC EPIDERMAL NNECROLYSIS

14. Toxic Epidermal Nnecrolysis (TEN hereinafter) is also kngwn as Lyell's Syndrome, epidermolysis acuta toxica and scalded skin syndrome. TEN begins with a non- specific prodome of 1- 14 days in atleast half of the patients: It is a H severe and extensive variant of erythematobullous drug eruption. In TEN, the patient is ill with high fever occasionally suffers somnolence and lassitude. Because of the extensive area of eroded skin, large amount of body f!uid is lost with consequent disturbances of electrolyte and fluid balance. [See Dermatology in General Medicine (Fitz Patrick's) (5th Ed), and Comprehensive Dermatological Drug Therapy] NEGLIGENCE IN TREATMENT OF TEN For determining the question as to whether the respondents herein are guilty of any negligence, we may notice 'the treatment protocol. Anuradha, it is conceded, was suffering from TEN. She had been positively diagnosed to be suffering from the said disease on 12th May, 1998.

TEN is a spectrum of symptoms. _,., The treatment protocol for TEN has undergone considerable o change throughout the world. TEN was discovered in the year 1956 by Lyell. It leads to immunosuppression. For treating the patients suffering from TEN, doctors used to administer steroid. Later researches showed that they should not be used. Such a conclusion was arrived at upon undertaking researches 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. 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. 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. Ac~ording to them, the treatment pattern should be as under: "The disease usually begins with non specific symptoms, such as fever, c'bugh, sore throat, burning eyes, followed in 1 to 3 days by skin and mucous membrane lesions. A burning or painful rash starts systematically on the face and c in the upper part of the tongue and rapidly extends. Most frequently, the initial individual skin lesions form poorly defined margins with darker purpuric centre progressively emerging on the skin, chest and back. Less frequently, the initial manifestations may be extensive scarlatiniform erythema. Symptomatic therapy is a must. IV fluids must 'f be replaced mandatorily. The treatment protocol includes: * Symptomatic treatment * Monitoring. * Fluid replacement and anti-infection therapy t- *Nutrition * Warming (30-32 degree Celsius) *Skin care * Eye~ and mucous membrane care" They hold the view that the current evidence suggests that corticosteroids are more dangerous than useful in these disorders as they increase the risk of death from infections, including systemic candidiasis, a complication that had never H been observed in many patients treated without steroids.

After the death of Anuradha, Kunal consulted. a large t-· number of experts from various countries including India. The Canadian Treatment Protocol is as under: "IV fluid resuscitation- including internal feeding, use of air- fluidized beds, complete avoidance of steroids, use of narcotics for pain, use of catheters to be avoided, meticulous eye care daily, use of systemic antibiotic therapy for specific infections but not for prophylaxis, topical antibiotic therapy is not used, meticulous wound care and moist saline gauge dressing are applied once daily when most of the involved epidermal surface has sloughed off, usually 3 to 4 days after the onset of TEN the patient is given general anesthesia for washing the wounds vigorously and applying briobrane under tension to be stapled all over". Dr. George Goris, Managing Director Medical and Drug Information of Pharmacia and Upjohn expressed that "DEPO" dosage of more than the approved indication, that too 80 mg twice daily, was not correct.

Dr. David Fine, Dermatologist from University of North Carolina opined as under: " ….. conventional therapy of TEN with systemic corticosteroids involves either oral or intravenous preparation. I have personally never seen intramuscular corticosteroids administration for this condition. In addition, intramuscular corticosteroids are 11ever 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 ….. " He also remarked, as far as the treatment in the present case is concerned: II …. manner in which the treatment was instituted in your wife certaimy appears to be unprecedented." Dr. David Heimbach, Pwfessor 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 c condition, leave aside for, far less an acute medical condition such as the one the patier;it was suffering from i.e. TEN. Dr. Timothy Bradley, noted Physician wrote a famous article on TEN wherein it was stated that several patients of D TEN with 95% total BSA involvement were treated without use of steroids and there was 100% survival rate. In his view, the. 'i- ·keystone, for survival in patients with TEN is fluid resuscitation and nutritional support and vigilant surveillance for infection. Gerald Pierard in his treatise on TEN stated:- fl.' (a) Antiseptie measures are essential to treat TEN patients since septicaemia shock is the first cause of mortality. So a sterile room and antiseptic bathes have to be used. Intact blisters1can be left in place but when they burst, the narcotic skin must be eliminated otherwise it becomes an excellent medium for the proliferation of microorganisms. Repeated s.kin swabs should be done to detect excessive coetaneo~s infection and to guide prophylactic antibiotherapy. S stematic antibiotics should also be used if direct or indirect signs of septicaemia happen: positive blood cultures, pneumonia, decrease of the urinary flow, fever or rapid fall of the temperature, ·-"- impairing of the general condition, and decrease in tile white cells count with neutropenia.

The search of these signs implies a permanent patient's supervision with many blood takes. Of course, unnecessary i.v. catheters should be avoided but in practise it is impossible to totally avoid them. They have to be changed frequently and placed in culture after removal. (b) Supportive measures are also essential. Several litres of fluid per day are fleeded since fluid loss is enormous in severe cases. The absence of substitution of these fluids leads to important internal problems. The only way to bring such amount of fluid is by catheters. The oral way is absolutely inadequate, more especially as digestive c tract is also often injured. Once more, as previously said, catheters should be changed very regularly (maximum every 3 days), placed if possible in areas of intact skin and examined for bacterial contamination after removal. (c) Any definite TEN drug treatment is currently not recognised.

The case of systematic steroids is controversial. The use of high doses of quick acting corticosteroids for a short time could be defensible for patients treated at the beginning of TEN without any sign of septic contamination, to try to stop the advancement of the disease. Steroids are clearly harmful and ineffective when the disease has settled. Long-acting steroids have no place in TEN treatments. Their action is too late. (d) The slough of the skin and mucous membrane is painful and it is medical and ethical concern to relief pain in TEN." 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, c 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 the majority of authors and was unanimously agreed on at an international workshop on TEN held in Creteil, France in October 1985. More recently, Halebian et al have reported high improvement of survival in patients treated without steroids when compared with a previous series of patients treated with high dose steroid therapy in the same institution. Kunal had also consulted· several doctors and experts in India. We would notice the opinion of some of them here but we would deal with their admissibility at a later stage. Dr. S.K. Bose from ~polio Hospital, Delhi, on a query made It F by the appellant, opined that the treatment protocol should be symptomatic and corticosteroids should be avoided. The resume of the protocol which should be followed, according to him, is as under: Discontinue all drugs implicated in TEN JAAD Intravenous canali.zation for fluid replacement depending upon % of TBSA, Nasogastric tube feeding, catheter if required MALAY KUMAR GANGULY v. DR SUKUMAR MUKHERJEE AND ORS. [S.S. SINHA, J.] Topical skin care Monitoring serum electrolytes by culture Room Temperature of about 30-32 degrees Celsius, sterile environment, air fluidized bed, barrier nursing Encourage oral fluids Hyperbaric oxygen, aerosols, bronchial aspiration, physical therapy, therapies for herpes and c mycoplasma. Appellant also consulted those Indian doctors who still administered steroids. Dr. J.S. Pasricha is one of them. According to him, use of corticosteroids in TEN was very controversial; however, if they are used appropriately, the patient's life can be saved. Death due to usage of cortlcosteroids in TEN patients, he stated, occurs only when : The reaction is not controlled properly Corticosterc51tl's are not withdrawn quickly Attention has also been drawn to the protocol treatment on behalf of the responden.ts.

They have placed reliance on a number of authorities to suggest a protocol of treatment of the disease TEN in which the administration of glucocorticosteriods plays an integral role. Some of the authorities suggested by them include: Journal of Association of Physicians of India. Comprehensive Dermatological Drug Therapy. Dermatology by 0. Brian Falco. Dermatology in General Medicine (Fitz Patrick) (5th Ed) c . Goodman and Gillman:-The Pharmacological Basis of Therapuetics (9th) (Ed) Harrison's Principle of Internal Medicine Principle's of 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. Nonetheless the following principles are integral to the "1- treatment of TEN as suggested by the Respondents: a. Treatment in burn units should be strived fdr in exceptional cases but is not generally necessary. b. Treatment has to be indi¥jpually 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 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 be c performed before disease activity ceases. In the criminal case, the appellant examined Dr. Salil Kumar Bhattacharjee. For the sake of completeness it would be necessary to place on record his opinion in the matter. Dr. Bhattacharjee, as noticed hereinbefore, is a Professor of Pharmacology at the Institute of Medical Science, Benaras Hindu University. In an answer to a query, on whether he was aware of the drug Depomedrol and its usage, he answered that "it is usually used in chronic clinical condition like Bronchial Asthma and Rheumatiod Arthritis" and on being questioned, whether Depomedrol can be used for TEN, he answered in the negative. He stated that recommended usage is 40 to 120 mg at intervals of at least one week and a daily dose of 80 mg can never be used. Appellant also examined Dr. Udwadia. He is the Consultant Physician in the Breach Candy Hospital. Anuradha was a patient in the said hospital under him. He has not used Depomedrol although his personal view was that he would have used lesser doses of corticosteroid. Although he had not used Depomedrol and he had no experience with the said drug, he categorically stated that it could obviously add to steroid. In his statement, he made it clear that "all corticosteroids are double- edged weapons on the one hand, there can be a beneficial effect and on the other. they can have untoward effects and the A effect is immunosuppression leading to infection". He also testified that supportive therapy was necessary.

In the criminal case, even Dr. Prasad who was examined as PW-3 stated that he prescribed Depomedrol for a day after 8. seeing the prescription of Dr. Mukherjee. And before the National Commission he stated that Depomedrol 80 mg twice daily cannot be administered to any patient. Before the Commission Dr. Mukherjee admitted that he prescribed the injection of Depomedrol and gave it to the patient at the request C of Kunal on compassionate grounds. Dr. Halder accepted that Depomedrol is not the correct medicine for TEN and is used in acute medical condition. We would, in view of the difference of opinion amongst experts as noticed by us heretoabove in some detail, proceed D 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) (ii) (iii) The nature of steroid which should be used is corticbsteroid meaning thereby methyl prednisolone.

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 immunosuppresion as also sepsis. Supportive treatment must be administered. (iv) It should be individually tailored according to the patients' need. 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. -t (ii) All the authors are one in stating that their opinion is subject to the instructions given in the package insert of the medicine. c Kunal examined Dr. Anil Shinde as PW-8. He is the Manager, Medical Service of Pharmacia India Private Limited.

Depomedorol is manufactured by Pharmacia and Upjohn, USA The company is the distributor of the said product in India. -1 The packet insert of Depomedrol reads as under: "DOSAGE:- The usual dosage for patients with Dermatalogic Lesions benefitted by systemic corticoid therapy is 40-120 MG of Methyl Prednisolone acetate administered intramuscularly at weekly intervals for 1-4 weeks. In acute severe dermatitis due to poison IV relief may result within 8-12 hrs following intramuscular administration of a single dose of 80-120 MG In chronic Contact dermatitis, repeated injections at 5-1 O day intervals may be necessary. Following intramuscular administration of 80-120 MG to asthmatic patient's relief may result within 6-48 hrs and persist for upto 2 weeks. Intramuscular dosage will vary with the condition being treated when a prolonged effect is desired: the weekly dose may be calculated by multiplying the daily dose by 7 and given as a singular intramuscular injection. Dosage must be individualised according to the severity of the disease and the response of the patients. In general. the duration of the treatment should be kept as short as -1 possible. Medical surveillance is necessary. PROPERTIES After a single IM injection of 40-80 MG of Depomedrol, duration of HPA Axis suppression ranges from 4-8 days. An intra-articular injection of 40 MG in both knees given after 4-8 hrs methyl prednisolone peaks of approximately 21.5 micrograms/ 100 ML. After intrarticular administration, methyl prednisolone acetate defuses from the joint into c systemic circulation over approximately 7 days as demonstrated by the duration of HPA Axis suppression and by the serum Methyl Prednisolone Values. INDICATIONS For Intramuscular administration, Methyl Prednisolone acetate (Depomedrol) is not suitable for the treatment of acute life threatening conditions if a rapid hormonal effect of maximum intensity is required the IV administration of highly soluble methyl prednisolone sodium succinate (Solumedrol) is indicated. PRECAUTION Since the complications of treatment with glucocorticoids are dependant·on the size of the dose and the duration of treatment ,a risk/ benefit decision must be made in each individual case as to dose and duration of treatment and as to whether 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 intrarticulary, intra bursally or intra tendinous t- – administration in the presence of acute infection. IM administration can only be considered after institution of an appropriate anti microbial treatment." The necessity of following the instructions given in the packet insert cannot be underestimated. Admittedly, the B instructions in the said packet insert had not been followed in the instant case. —t EFFECT OF EXCESS DOSAGE

15. There is, thus, a near unanimity that the doses of c 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. From the AMRI records, it would appear that while admitting the patient, it had categorically been noticed that both Depomedrol injection twice daily and Wysolone were being administered from 7th May, 1998 following the prescription of Dr. Mukherjee. It also now stands admitted that Dr. Prasad also prescribed the same medicine. From Dr. Mukherjee's prescription dated 11.05.1998, it is furthermore evident that he _, had prescribed Wysolone 50 mg once daily for one week, 40 mg daily for next week and 30 mg daily for the third week. He had also prescribed Depomedrol injection 80 mg twice daily F for two days.

"Depomedrol", is a "long acting" steroid recommended for the treatment of "chronic" clinical conditions like "asthma" or "arthritis" for its prolonged immnumosupressive action. The maximum recommended dose of Depomedrol is 40-120 mg G )._ at 1-4 week intervals as clearly mentioned by the drug manufacturer, Pharmacia. Dr. J.S. Pasricha, Prof. and Ex – head of Dermatology at the All India Institute of Medical Sciences (Al I MS) has categorically stated, "De po .,… ·H preparations are used for chronic diseases and not for acute disease like TEN. Secondly, Depa preparations are not to be used twice a day". In his deposition, Dr. Anil Gupta deposed that, he wrote to Pharmacia Upjohn, to know from them if the drug can be used in this fashion (as was done by the Kolkata doctors) in any clinical condition. In the reply sent by Dr. S.P.S. Bindra, it was stated that "our package insert on Depomedrol does not recommend the twice daily dose of injection Depomedrol 80 c mg in any clinical condition".

Moreover he also testified to the cause of Anuradha's death was due to Septicemia, which happened as a result of profound immune – suppression, caused by overuse of steroid as prescribed by Dr. Mukherjee. Further cause of death of Anuradha was lack of supportive treatment and lack of care on the part of Dr. Abani Roycoudhuri D and Dr. Halder and other attending Physicians. In his deposition Dr. Anil Shinde stated that he was working as a Manager, Medical Service with Pharmacia India Pvt. Ltd. and elucidated the details of Depomedrol. He stated that the dosage should be between 40 to 120 mg once a week or once in two weeks. On questioned whether 80 mg of Depomedrol can be given twice daily, the answer was "No". In his deposition Dr. Salil Kumar Bhattacharya stated that he was a [Professor of Pharmacology. On being questioned whether he is aware of the Drug Depomedrol and its usage, it was answered that "it is usually used in chronic clinical 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 G 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 [S.B. SINHA, J.J administration of any drug, he answered that the choice is A "prerogative". However, he has to follow the pharmaco- therapeutic norms of the drug chosen. SUPPORTIVE THERAPY

16. No symptomatic therapy was administered. No B 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 c trauma, inserting a peripheral venous line, administration of macromolecular solution, direct the patient to burn unit or ICU." AMRI records demonstrate how abysmal the nursing care D was. We understand that there was no burn unit in AMRI and there was no burn unit at Breach Candy Hospital either. A patient of TEN is kept in ICU. All emphasis has been laid on the fact that one room was virtually made an ICU. Entry Restrictions were strictly adhered to. Hygiene was ensured. But constant nursing and supervision was required. In the name of preventing infection, it cannot be accepted that the nurses would not keep a watch on the patient.

They would also not come to see the patients or administer drugs. No nasogastric tube was given although the condition of mouth was F such that she could not have been given any solid food. She required 7 to 8 litres of water daily. It was impossible to give so much water by mouth. The doctors on the very first day found that condition of mouth was bad. The ENT specialist in his prescription noticed blisters G J….. around the lips of the patient which led her to difficulty in swallowing or eating. No blood sampie was taken. No other routine pathological examination was carried out. It is now beyond any dispute that 25-30% body surface area was affected (re. prescription of Dr. Nandy, Plastic Surgeon) The next day, he examined the patient and, he found that more and more body surface area was affected. Even Dr. Prasad found the same. Supportive therapy or symptomatic therapy, admittedly, was not administered as needle prick was prohibited. AMRI even did not maintain its records properly. The nurses reports clearly show that from 13th May onwards even the routine c check-ups were not done. LINE OF TREATMENT

17. Kuna I and Anuradha came on a vacation to Calcutta on 1st April, 1998, principally to attend a wedding in the family. Anuradha supposedly, after eating some Chinese food in some restaurant, developed fever and skin rash on or about 25.4.1998. Respondent No.1, Dr. Sukumar Mukherjee, indisputably is a very reputed Physician. He was a Professor of Medicine in Calcutta Medical College. Anuradha and Kunal were advised to consult him. Respondent No.1 examined Anuradha at her residence in the evening of 26th April, 1998. He suggested certain pathological examinations. On that date no medicine was prescribed. Two weeks thereafter i.e. on or about 7th May, 1998, Respondent No.1 was informed by Kunal Saha that Anuradha's condition had deteriorated and the skin rash and fever were back. She was taken to his chamber at 11, Shakespeare Sarani, Calcutta. Maculopropular rash, palpable G 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.l.D) for 3 days to be followed by other oral steroids. H One injection was given by him. 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 ti,ne 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. AK. 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. On or about 11th May, 1998 Respondent No.1 was c 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 Medicare Research Institute (AMRI) (Respondent No. 4). On being admitted she ~ … was examined by Dr. Balaram Prasad, Respondent No.5, who also continued with the injection of Depo-Medrol 80 mg.(2 ml.) l/M B.D. x 1 day. Anuradha was examined by Respondent No.1 at 2.15 p.m. on the same date. The prescription provided for lnj. 'Depomedrol' 80 mg IM twice daily x 2 days (then 40 mg IM twice x days) among other things. On the basis of the said advise Anuradha was examined by Consultant Dermatologist Or. A.K. Ghoshal. Anuradha was diagnosed to be suffering from TEN. The bed ticket reads as under:- "Toxic Epidermal Necrolysis. Separation of large sheets of skin from back and limbs, many small/ large bulla on limbs. Dusky red areas of vasculitis almost all over the body. Mild conjunctivitis. Erosive lesions on tongue and buccal mucosali. Adv. Maintain fluid and electrolyte balance. -1 Maintain maximum asepsis. Continue same medicines. Soframycin cream to apply on rash areas only Capsule Zevit – 1 Cap daily To be reviewed later." c Respondent No.3, Prof. Dt.

Abani Roy Chowdhury, Consultant, as recommended by Respondent No.12 was also consulted on 12th May, 1998. It is however, stated that he did not examine the patient as he had not been contacted by the hospital. Anuradha was also examined by Respondent No.2, ·~l D Dr. Baidyanath Halder, a Consultant Dermatologist of fame and t author of several Books on Skin Disorders. He also diagnosed that it could be a case of TEN. He recommended treatment with Steroids like Pedmeslan and and others and the application of ointments. Dr Halder found that Anuradha was suffering from E Erithima plus blisters. However, no abnormality in the eyes or lungs was detected. He, although opined that an electrolytic balance of the patent should be maintained and steps should be taken to prevent any secondary infection, but did not prescribe any medicine or indicated the steps to be taken F therefor. Dr. Prasad referred the patient to the following Consultants.

(i) Dr. K. Nandy – a Plastic Surgeon ; (ii) Dr. Purnima Chatterjee – a Gynecologist ; (iii) Dr. S. Ahmed – an E.N.T. Surgeon ; ,.A (iv) Dr. S. Bhattacherjee ; and (v) Dr. N. Iqbal – General Surgeon. Her condition deteriorated further. On or about 17th May, 1998 Kunal was advised to shift Anuradha to Breach Candy Hospital, Mumbai. For the aforementicned purpose Respondent No.2 issued a certificate. Three words in the said certificate, namely – "for better treatment" were said to be added. A Charte"red Plane was arranged for taking Anuradha to Mumbai from Kolkata on 17th May, 2009. She was admitted int.he 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 c 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 inject~~n – Rovamycin, -1 Routhromycin, Ampicillin and Ampiclox and Nemuslide followed by development of Toixc Epidermal Necrolysis.

She ha~ received T Prednisolone 120 mg/day for 7 days and also !nj. 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." She was examinecrby 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 (TEN). She has had a number of drugs at Calcutta form antibiotics to non-steroid and inflammatory agents. Is there any way of distinguishing this from a Stevens & Johnson Syndrome? There is no skin left. The mucus of the mouth, genitals and area is also severely ;.._ affected. And have not seen the evolution of the skin lesions to the point where there is now no skin left. So far there is no organ evolvement in particular. No pulmonary lesions nor any urinary lesions (organs commonly involved as in a Steven Johnson Syndrome).

In any case the basic management is the same. I do feel that the dose of steroids used in Calcutta is either excessive – 120 mg. Daily for a number of days, preceded by 80 mg Depomedral Injections. I would not give more than 40 mg /day Kg. body weight." On the same date Kunal's brother who is also a doctor practicing in U.S.A. flew to Mumbai. He brought with him a new antibiotic known as "Quinolone". There was some difference of .,.__ opinion between the brother-in-law of Anuradha and Dr. c Udwadia, which was noted by Dr. Udwadia. It reads as under "He was claiming of blood transfusion – insisted that his blood or the relatives or friends blood be used – no objection. But I have requested that this is done quietly. The advice was to give whole blood. My view is that 'blood' is being used to increase Hb., and it is unusually accepted that to do so one gives packed cell and not whole blood. t He was also advising the use of Erthropoitin as a marrow stimulant.

My view was that at the point of time Erythropeitin will make no difference to her condition. To increase her Hb., from the present and Requested packed RBC infusions. r He was keen on immediately giving a tonic supplement. In my experience at this point of time, Zinc SL1pplement was not of immediate importance that if gut was working and her external feed could be increased, she would receive sufficient tonic." However, some differences between Kunal and his elder brother on one hand and Dr. Udwadia persisted. He noted as under:- ,;.._ "Have had great problems with the husband and brother- in-law. It is with great difficulty that I have controlled myself. When presented with his arrogance and condescends – ,… i merely and solely for the patient's sake. To keep the peace, I have compromised on the following: To allow the use of Erythropoeitin. I reasoned that though it cannot do much good, 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 c to her hazards". Her condition was better during 24th May and 25th May, 1998. She, however, breathed her last on 28th May, 1998. NOSOCOMIAL INFECTIONS:

18. 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 . 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 13th May, 1998. What type of dressing was to be done is a matter of dispute. We may not go into the said question. But, we must notice that in Breach Candy Hospital, the dressing was done in operation theatre, firstly, on 18th May, 1998 and then on all subsequent days.

No dressing was done at AMRI in operation theatre. It is now almost accepted worldwide that the hospital is · liable to prevent such infections specially in the case where the patient has high risk thereof due to the nature of the disease suffered. It also almost stands established that use of Depomedrol and other high dose of glucocorticosteroid may B first lead to immunosuppression which may in turn lead 10 septisis. In April, 1998, when she started suffering, she had skin rash. By the time, she came to AMRI on 11th May, 1998, 25- c 30% of body surface area was infected. Admittedly, by 14th May, 1998, her entire body except the skull denuded of skin. Plastic Surgeon at Breach Candy Hospital who had been doing the dressings on 19th May, 1998 stated that green tinge had appeared on the back. Such a gree~ tinge would not occur within a day. Thus, infection was widespread. It might have been D controlled to some extent at Breach Candy Hospital.

In the said hospital, the entire body was put in bandage without leaving any part of the body open. It is only with a view to control such bacterial infec~ion, the antibiotics were administered. E C.3. FINDINGS AND ANALYSIS WITH RESPECT TO SO CALLED CLEAVAGE OF OPINION

19. FINDINGS ON SO CALLED CLEAVAGE OF OPINION Appellant, thus, has pla;ted on record the view points of F experts – both of the pro-steroid and anti-steroid group. Would it amount to cleavage of opinion so as to enable the court to arrive at a safe conclusion that no negligence is proved or there was no deficiency in service? In other words, the question is 1.- as to whether the treatment of Anuradha was in accordance G with the medical protocol. In our opinion, the answer must be rendered in the negative. Those who support use and ,.l administration of steroid do so with note of caution. They in no uncertain terms state that the same should be used at a preliminary stage. Respondents do not spell out as to what H would be the preliminary stage. The preliminary stage must have started with the onset of the disease. She had been A suffering from skin rash from 3rd week of April, 1998. It increased with 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. On and from 7th May, 1998, she was prescribed injection Depomedrol twice a day and Wysolone. It was continued upto 13th May, 1_998, nobody even thought of stopping the injection. Dr. Halder although stopped Depomedrol injection from 13th c May, 1998, but prescribed a high dose of steroid. No doctor posed unto themselves a basic question why despite use of steroid, condition of the patient was going from -f bad to worse. It is agreed across the board and at least during trial, that supportive treatment should have been given. The D 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 E 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 opinions of the experts that two injections daily could be prescribed by any prudent physician. A great deed of confusion was sought to be F created between one kind of steroid and another. Vague questions were asked from the experts to show that steroids may be used but Dr. Pasricha stated that only a quick acting steroid should be used. Depomedrol is not a quick acting steroid. Kunal in his evidence categorically stated so in the following terms: "Prednisolone can be used daily at 200 mgs for multiple sclerosis. But if instead of Prednisolone, Depomedrol H which is Methyl Prednisolone Acetate is used to this patient he or she is likely to die. Depomedrol is not Prednisolone. And majority of the dermatologists in the West do not do not use any steroid whatsoever on TEN patients." "However there is no controversy even among the "Pro-steroid" dermatologists that once more than 20% of the BSA is affected no steroid should be used as it would only enhance the chance of development of septicemia and death." c ANALYSIS The High Court as also the Commission principally proceeded on the premise that the respondents herein are not liable either for any act of criminal misconduct or negligence because of cleavage of opinion.

The cleavage of opinion, if any, as we have noticed hereinbefore, is between pro-steroid group and anti-steroid group. Accepted treatment protocol so far as the pro-steroid group is concerned has also been noticed by us. We have proceeded to determine the question of negligence on the part of the respondents herein principally on the premise that even if the opinion of the pro-steroid group is followed, the respondents have failed and/or neglected to even act strictly in terms of the treatment protocol laid down by them. The opinion of the anti-steroid group appears to be more scientific and structured but the same by itself, we are conscious of the fact, would not lead us to the conclusion that the respondents are guilty of gross negligence. We may, however, notice that Mr. Fitz Patrick in his book Dermatology in General Medicine (5th Edition), inter alia, opined as under:- "Treatment: 2. According to our view. agreement should be used on following for the treatment of TEN: 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 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 c 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 particu"lar attention must be paid\_,to a high calorie and high ~ protein diet. g. Debridgetnent df necrotic skin should not performed before, disease activity ceases. 3.

Course and ·Prognosis: The toll owing' factors appear to be unfavourable prognostic signs: old age, extensive skin lesions, nuetropenia, impaired renal function and intake of multiple drugs. Septesemia, gastrointestinal hemorrhage, pnuemoina and fluid and electrolyte imbalance leading to renalinsufficiency are major complications leading to death." As noticed hereinbefore, precautions as also the course of actions suggested by the authors have not been undertaken 8 by the respondents. It is to be noted that the learned authors' expertise in the field is neither in doubt nor in dispute, particularly when both parties have extensively relied thereupon. Even the suspected offending drug was not withdrawn at later stages. This drug is considered to be a real risk for the patient suffering from TEN. The medicine has also been administered C having regard to the physical condition of the patient. They were required to be given only as a part of the total program. We may also place on record that there has been a cleavage of opinion in regard to mortality rate. Whereas according to the one group of experts in TEN patients when properly treated and in D particular given supportive treatment, the mortality rate is 0- 10%' the respondents contend that that in fact the mortality rate is quite high being 30-70%. We would assume that the mortality rate is very high. If that E be so, we feel that the doctors should have been more careful. They should have treated the patient upon exercise of more care and caution. For the said purpose, if they had not been able to. diagnose the disease properly or identify the proper drug they would have undertaken some research. It is clear that they did F , not have any expertise in the field and therefore they ought not to have behaved as experts We are, therefore, of the opinion that the universally accepted medicated treatment protocol had also not been followed. It is also to be noted at this juncture, that there may well be a difference of opinion on the course of action to be adopted while treating a patient of TEN, but the treatment line followed by Dr. Mukherjee which entailed administration of 80 mg of H Depomedrol injection twice is not supported by any school of r thought. The treatment line, in this case, does not flow from any considered affinity to a particular school of thought, but out of sheer ignorance of basic hazards relating to use of steroids as also lack of judgment. C.4. BURDEN OF PROOF 20. Kunal had not only obtained opinion of a large number of experts, he examined some of the including Dr. Anil Shinde P.W. 9,; Dr. Udwc;idia (P.W.10) and, Dr. Salil Kumar Bhattacharyya, P.W. 11. c 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. 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. In S12ring Meadows Hos~ital v. Harjol Ahluwalia 1 [(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 performing of his duties properly." However, in Rattan Singh v. State of Punjab, [(1979) 4 SCC 719}, this Court has held :- c "3. This, however, does not excuse the accused from his rash driving of a "blind Leviathan in berserk locomotion". If we may adapt the words of Lord Greene, M.R. : "It scarcely lies in the mouth of the truck driver who plays with fire to complain of burnt fingers". Rashness and negligence are relative concepts. not absolute abstractions.

In our current conditions, the law under Section 304-A IPC and under the rubric of Negligence, must have due regard to the fatal frequency of rash driving of heavy duty vehicles and of speeding menaces. Thus viewed, it is fair to apply the rule of res ipsa loquitur, of course, with care. Conventional defences, except under compelling evidence, must break down before the pragmatic Court and must be given short shrift. Looked at from this angle, we are convinced that the present case deserves no consideration on the question of conviction." In B. Nagabhushanam v. State of Kamataka, [(2008) 5 SCC 730], this Court held as under:- "12. Reliance placed by Mr Kulkarni on Syad Akbar v. State of Kamataka1 is not apposite. It proceeded on the basis that res ipsa loquitur stricto sensu would not apply to a criminal case as its applicability in an action for injury by negligence is well known. In Syad Akbar this Court opined: (SCC p. 41, para 30): "30. Such simplified and pragmatic application of the notion of res ipsa loquitur, as a part of the general mode of inferring a fact in issue from another circumstantial fact, is subject to all the principles, the satisfaction of which is essential before an accused can be convicted on the basis of circumstantial evidence alone. These are: F:irstly, all the circumstances, including the objective circumstances constituting the accident, from which the inference of guilt is to be drawn, must be firmly established. Secondly. those circumstances must be of a determinative tendency pointing unerringly towards the guilt of the accused. Thirdly, the circumstances should make a chain so complete that they cannot reasonably raise any other hypothesis save that of the accused's guilt. That is to say, they should be incompatible with his innocence, and inferentially exclude all reasonable doubt about his guilt." There cannot, however, be any doubt whatsoever that in the civil appeal the said principle is applicable.

It has clearly been held by this Court that the onus of proof would shift on the respondents. In Nizam Institute of Medical Sciences v. Prasanth S. Dhananka and others, [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 h.e died because of lack of proper care and neglig~nce, 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 the duty of the hospital to satisfy that there was no lack of care or diligence. The hospitals are institutions, people expect better and efficient service, if the hospital fails to discharge their duties through their doctors, being employed on job basis or employed on contract basis, it is the hospital which has to justify and not impleading a particular – doctor will not absolve the hospital of its responsibilities." C.5.

CONTRIBUTORY NEGLIGENCE c 21. The High Court as also the Commission opined that the death of Anuradha took place not because of any negligence on the part of the doctors of AMRI but by reason of interference by Kunal Saha. It was on the insistence of Kuanl Saha that the patient was transferred to Bombay. It has been D submitted that it was the infection which developed during transportation which ultimately proved fatal. Interference by Kunal at AMRI was sought to be proved through Sutapa Chanda, Nursing Superintendant at AMRI, who E appeared as DW-1. However, the statement of the said Nursing Superintendent in regard to the alleged interference by Kunal Is not borne out from the record. As a matter of fact she had not been able to explain the medicines which were to be administered to her stating:- "Q.38 (Ld. complainant counsel sows the witness Exbt. 8). What do you understand by this line "Fusys 200 mg.

I weekly once"; – 3rd line from the end? Ans. Regarding this question I like to say all instructions for mediction in Exbt. 8 were carried out by Dr. Kunal Saha but not by my nurses. If I can not l:!nderstand this instruction I would have made queries and doctor would clear it. But _….. I had no such chance to make queries regarding this." It is to be noted here that Nursing Superintendent being a H professional cannot take this plea. Moreover, the same is not borne out of records at AMRI. Even if we assume this statement to be true, in a professional setting of this nature, these interferences should have been resisted by them. Interference cannot be taken to be an excuse for ab1dicating one's responsibility especially when an interference.could also have been in the nature of suggestion. Same comments were said to have been made by Dr. Halder while making his statement under Section 313 of the Code of Criminal Procedure.

They are admissible in evidence for the said purpose. Similarly the statements made by Dr. c Mukherjee and Dr. 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. 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. 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. 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 the elder brother of Kunal, who is a surgeon. However, when there is any discussion with both the brothers, like in the case of Dr. Udwadia. it had been recorded A 'both of them'. It is accepted that the elder brother of Kunal came to Mumbai on 17th May, 1998 itself. He brought with him a new antibiont;. named "Quinolone" which was not available in India. B He persuaded Dr. Udwadia to administer the said injection. This discu~sion between them has also been recorded. Some adverse remarks have also been recorded with regard to the conduct of Dr. Saha. Dr. Udwadia has noticed in the records of the Breach Candy Hospital that he tolerated the said conduct c on the part of the elder brother of Kunal solely for the patient's sake.

Though some of the suggestions of Dr. Saha did not seem particularly useful to Dr. Udwadia, but those measures which were not harmful to the patient were administered. We, however, D may also notice that where Dr. Udwadia thought that there could be some harm to the patient, he did not agree thereto. He, therefore, acted in· a professional manner. We may also place on record that despite such elaborate E and careful treatment meted out to Anuradha, her condition had been worsening; Dr. Udwadia even agreed to administer the injection "Quinolone" during her last day as he might have thought that there was no harm in trying the same at that juncture. …_ Respondents also sought to highlight on the number of antibiotics which are said to have been administered by Kunal to Anuradha while she was-in AMRI contending that the ~aid antibiotics were necessary. Kunal, however, submitted that the said antibiotics were prescribed by the doctors at AMRI and G he did not write any prescription.

We would, however; assume that the said antibiotics had been administered by Kunal on his own, but it now stands admitted that administration of such antibiotics was necessary. To conclude, it will be pertinent to note that even if we t agree that there was interference by Kunal Saha during the treatment, it in no way diminishes the primary responsibility and default in duty on part of the defendants. In si.;ite of a possibility of him playing an over-anxious role during the medical proceedings, the breach of duty to take basic standard of medical care on the part of defendants is not diluted. To that extent, contributory negligence is not pertinent. It may, however, have some role to play for the purpose of damages . …._ C.6. NON-JOINDER OF NECESSARY PARTIES 16. Respondents contend that Dr. Kunal had been c 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 -1 as to why case against Dr. AK. 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. 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 R.ule 9 and Order 1 Rule 10 of the CPC there also ev,en 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, even if after the G direction given by the Commission the concerned doctor and the nursing staff who were looking after the deceased A.K. Garg have not been impleaded as opposite parties it can not result in dismissal of the original petition as a whole." An argument has also been advanced that Anutadha was i treated by as many as 16 doctors and, thus, there was no reason as to why on_ly the respondents should have been proceeded against.

Proceeding should be initiated both under the criminal law as also the tort law only against those who are B specifically found to be guilty of criminal misconduct or medical negligence or deficiency in ser11ice and not against all. Apart from making a general submission, it has not been pointed out as to what difference would have been made if others were also impleaded as parties. The medical records were before c the court. The hospital records of both AMRI and Breach Candy were also before it. AMRI records contained 22 pages, records of Breach Candy runs into more than 400 pages. No party had relied on any evidence other than those records as also the oral evidence and documentary evidence brought on record by D them. Respondents have also not pointed out as to how treatment by any other doctor has contributed in any manner to the death of Anuradha. Submissions have also been made at the bar that Kuna! issued notices to a large number of persons but withdrew the E cases against most of them.

It was placed before us that in the first notice there were as many as 26 addresses and in the complaint filed before the National Commission. there were .1~ addresses. Withdrawal of cases against some of them. in our ,,_ opinion, is not of much significance. The Directors of AMRI w~re F impJeaded as parties. Cases against them had also been withdrawn and, in our opinion, rightly so as most of them were liable in their personal capacity. Dr. Kunal says that the proceeding against Breach Candy Hospital and doctors treating Anuradha had been withdrawn as the principal G grievance against the hospital was that they did not have any burn ward although he was already informed thereabout. Burn ward was also not there in AMRI. In fact, it was brought on record that no nursing home in Calcutta has a separate burn ward. Absence of burn ward by itself. thus. might not be a H contributory factor although existence thereof-was highly t- desirable keeping in view the treatment protocol.

We must bear in mind that negligence is attr~buted when existing facilities ar~ 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 B 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 c 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 doctors1did not charge any professional fees. 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 consJdered to be a relevant factor for dismissal of these appeals.

D. CIVIL LIABILITY UNDER TORT LAW AS ALSO UNDER CONSUMER PROTECTION ACT 23. In this case, we are concerned with the extent of negligence on the part of the doctors, if any, for the purpose of attracting rigours of Section 304A of the Indian Penal Code as also for attracting the liability to pay compensation to the appellant in terms of the provisions of the Consumer Protection Act, 1986. yve intend to deal with these questions separately. It is noteworthy that standard of proof as also culpability requirements under Section 304 -A of Indian Penal Code stands on an altogether different footing. On comparison of the provisions of Penal Code with the thresholds under the Tort Law A or the Consumer Protection Act, a foundational principle that the attributes of care and negligence are not similar under Civil and Criminal branches of Medical Negligence law is borne out. . An act which may constitute negligence or even rashness under torts may not amount to same under section 304 – A. Bearing this in mind, we further elaborate on both the questions separately. 0.1.

LAW OF NEGLIGENCE UNDER TORT LAW c Negligence is the breach of a duty caused by the omission to do something which a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs would do, or doing something which a prudent and reasonable man would not do. [See Law of Torts, Ratanlal & D Dhirajlal Twenty-fourth Edition 2002, at p.441-442] Negligence means "either subjectively a careless state of mind, or objectively careless conduct. It is not an absolute term but is a relative one; is rather a comparative term. In determining whether negligence exist in a particular case, all the attending and surrounding facts and circumstance have to be taken into account." [See Municipal Corpn. Of Greater Bombay v. Laxman Iyer, (2003) 8 SCC 731, para 6; Adavanced Law Lexicon, P Ramanatha Aiyar, 3rd ed. 2005, p. 3161] Negligence is strictly nonfeasance and not malfeasance.

It is the omission to do what the law requires, or the failure to do anything in a manner prescribed by law. It is the act which can be treated as negligence without any proof as to the G surrounding circumstances, because it is in violation of statute or ordinance or i~ contrary to the dictates of ordinary prudence. -l In Bo/am v. Friem Hospital Management Committee, [(1957) 2 All ER 118], the law was stated thus: "Where you get a situation which involves the use of some t- special skill or competence, then the test.. … is the standard A 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 art …. [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 art. … Putting it the other way round, a [doctor]- is not c negligent, if he [has acted] in accordance with such a practice, merely because there is a body of opinion which [takes] a contrary view." It has been laid down that an ordinary skilled professional i standard of care for determining the liability of medical D professional should be followed.

(See Maynard v. West Midland Regional Health, Authority, [(1985) 1 All ER 635 (HL)]) Recently in Martin F.D' Souza v. Mohd. lshfaq, [ (2009) 3 E SCC 1 ], this Court laid down the precautions which doctors/ hospitals etc. should have taken, in the following terms:- "(a) Current practices, infrastructure, paramedical and other staff, hygiene and sterility should be observed strictly …. (b) No prescription should ordinarily be given without actual examination. The tendency to give prescription over the telephone, except in an acute .emergency, should be avoided. (c) A doctor should not merely go by the version of the patient regarding his symptoms, but should also make his own analysis including tests and investigations where necessary. (d) A doctor should not experiment unless necessary and even then he should ordinarily get a written consent from the patient. (e) An expert should be consulted in case of any doubt. … " In fact, the Bolam case in common laws jurisdictions is weakened in recent years by reasons of series of decisions in Australia [Rogers v. Whitaker: (1992) 109 Aus LR 625 and Roenbreg v. Percival 2001 HCA 18]; Canada [Rib/ v. Hughes: (1980) 114 DLR 3d 1] and the United States and even in the United Kingdom.

We may refer to Bolitho v. City and Hackney Health Authority, [(1997) 4 All ER 771 (HL)], where the Court got away from yet another aspect of Bolam case. It was observed :- "The court is not bound to hold that a defendant doctor escapes liability for negligent treatment or diagnosis just because ~e leads evidence from a number of medical experts who are genuinely of opinion that the defendant's treatment or diagnosis accorded with sound medical practice. The use of these adjectives – responsible, reasonable and respectable – all show that the court has to be satisfied that the exponents of the body of opinion relied upon can demonstrate that such opinion has a logical basis. In particular in cases involving, as they so often do, the weighing. of risks against benefits, the judge before accepting a body of opinion as being responsible, reasonable and respectable, will need to be satisfied that, in forming their views, the experts have directed their minds to the question of comparative risks and benefits and have reached a defensible conclusion on the matter." In this regard it would be imperative to notice the views …\ rendered in Jacob Mathew v. State of Punjab, [(2005) 6 SCC 1, where the court came to the conclusions: (i) Mere deviation from normal professional practice is not necessarily evidence of negligence.

(ii) Mere accident is not evidence of negligence (iii) An error of judgment on 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. c RIGHT OF THE PATIENT TO BE INFORMED 24. 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. In Sidaway v. Board of Governors of BethleJ!I 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 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." The law on medical negligence also has to keep up with c the advances in the medical science as to treatment as also diagnostics.

Doctors increasingly must engage with patients during treatments espeeially 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. D In the times to come, litigation may be based on the theory of lack of informed consent. 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 E proposed therapy. [See Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972), cert. denied, 409 U.S. 1064 (19r72); see also Cobbs v. Grant, 8 Cal. 3d 229, 104 C.al. Rptr. 505, 502 P.2d 1 (1972); Hamiltorn v. Hardy, 37 Colo. App. 375, 549 P.2d 1099 (1976)]. In this respect, the only reasonable guarantee of F a patient's right of bodily integrity and self-determination is for courts to apply a stringent standard of disclosure in conjunction with a presumption of proximate cause.

At the same time, a reasonable measure of autonomy for the doctor is also pertinent to be safeguarded from unnecessary interference. G 0.2. TRANSPORTATION …._ 25. So far as transportation of Anuradha from Kolkata to Mumbai is concerned, we must place on record that a certificate in that behalf was given by Dr. Baidyanath Halder H correctness whereof, except for the words "for better treatment" is not in dispute. Dr. Halder does not contend that the contents of the same are wrong. He merely says that the same was issued at the instance of the 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. Bairam Prasad and/or any other doctor. Why he had taken the burden of issuing such a certificate is not explained. We are of the opinion that a conclusion as to whether the words "for better treatment" have been inserted in the said c 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 i was flown to Mumbai by an exclusive chartered flight (air D, 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. We may notice that even a couple of Kunal's friends, who were doctors, came to Mumbai by Jet Airways flight. It appears that East West Rescue of Delhi, which provided air ambulance, must have taken all necessary precautions.

Although lot of literature on the subject relating to the services of the said airlines showing that it is considered to be one of best in the world is available, we refrain from dealing with the same, as it is not necessary. Dr. Udwadia made a comment that transportation of Anuradha from Kolkata to Mumbai may have exposed her to infection. He, however, added a proviso thereto – unless better A care was taken. There was no reason as to why t~e proper care was not taken, particularly seeing her condition. There is no evidence on record leading to an opposite c,onclusion. Dr. Nandy, stated dressing was necessary before transportation. He must have done so keeping in view the necessity of B prevention of further infection during flight. At Bombay, Dr. Kulkarni noticed a green patch showing old infection. It must have escaped the notice of even Dr. Nandy. Dr. Kulkarni noticing the same, observed that the patient's condition was worse than he anticipated. c D.3.

LEGITIMATE EXPECTATION 26. Kunal approached the best doctors available. He admitted his wife at AMRI on the recommendation of Dr. Mukherjee, evidently, expecting the best possible treatment D from the renowned doctors and a renowned hospital. It was not too much for a patient to expect the best treatment from the doctors of the stature of Dr. Mukherjee, Dr. Halder and Dr. Abani Roy Chowdhury. Services of other experts in fields were requisitioned by the Hospital. References were made and the E Hospital on the basis of the recommendations made by the doctors themselves consulted the best doctors in their respective fields. Kunal or Anuradha or his relatives never interfered therewith. They did not call any doctor of their choice to the Hospital. In fact, after Dr. A. K. Ghoshal came to know F that Anuradha was suffering from TEN, he suggested a line of treatment which was not adhered to keeping in view the fact that Dr. Halder and hospital authorities were in charge of the case.

The standard of duty to care in medical services may also be inferred after factoring in the position and stature of the doctors concerned as also the hospital; the premium stature of services 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 H doctrine having regard to an implied nature of service which is to be rendered, in our opinion, would not be quite out of place. 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. We may notice some of the decisions in this behalf. In Smt. Savita Garg v. The Director, National Heart Institute [2004 (8) SCALE 694 : (2004) 8 SCC 56], this Court opined: "It is the common experience that when a patient goes to a private clinic, he goes by the reputation of the clinic and with the hope that proper care will be taken by the Hospital authorities. It is not possible for the patient to know that which doctor will treat him. When a patient is admitted to a private clinic/ hospital it is hospital/ clinic which engages the doctors for treatment. … They charge fee for the services rendered by them and they are supposed to bestow the best care." 0.4.

INDIVIDUAL LIABILITY OF THE DOCTORS 27. There cannot be, however, by any doubt or dispute that for establishing medical negligence or deficiency in service, the courts would determine the following: (i) No guarantee 1s given by any doctor or surgeon that c the patient would be cured. (ii) The doctor, however, must undertake a fair, reasonable and competent degree of skill, which may not be the highest skill. (iii) Adoption of one of the modes of treatment, if there are many, and treating the patient with due care and caution would not constitute any negligence. (iv) Failure to act in accordance with the standard, reasonable, competent medical means at the time would not constitute a negligence. However, a medical practitioner must exercise the reasonable degree of care and skill and knowledge which he possesses. Failure to use due skill in diagnosis with the result that wrong treatment is given would be negligence.

(v) In a complicated case, the court would be slow in contributing negligence on the part of the doctor, if he is performing his duties to be best of hjs ability. Bearing in mind the aforementioned principles, the individual liability of the doctors and hospital must be judged. We enumerate heretobelow the duty of care which OJ.Jght to have been taken and the deficiency whereof is being complained of in the criminal case and the civil case, respectively, so far as respondent Nos. 1 to 3 are concerned. When Dr. Muk~erjee examined Anuradha, she had rashes all over her body and this being the case of dermatology, he G should have referred her to a dermatologist. Instead, he prescribed "Depomedrol" for the next 3 days on his assumption that it was a case of "vasculitis". The dosage of 120 mg Depomedrol per day is certainly a higher dose in case of a TEN Patient or for that matter any patient suffering from any other t 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. 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 c 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. 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.

After taking over the treatment of the patient and detecting TEN, Dr. Halder ought to have necessarily verified the previous prescription that has been given to the patient. On 12th May, 1998 although 'depomedrol' was stopped, Dr. Halder did not take any remedial measures against the excessive amount of 'depomedrol' that was already stuck in the patient's body and added more fuel to the fire by prescribing a quick acting steroid 'Prednisolone' at 40mg three times daily, which is an excessive dose, considering the fact that a huge amount of "Depomedrol" has been already accumulated in the body. k Life saving 'supportive therapy' including IV fluids/ electrolyte replacement, dressing of skin wounds and close monitoring of infection is mandatory for proper care of TEN patients. Skin (wound) swap and blood tests also ought to be A performed regularly to detect the degree of infection. Apart from using the steroids, ~ggressive supportive therapy that is considered to be rudimentary for TEN patients was not provided by Dr. Halder.

Further 'vital-signs' of a patient such as temperature, pulse, intake-output and blood pressure were not B monitored. All these factors are considered to be the very basic necessary amenities to be provided to any patient, who is critically ill. The failure of Dr. Halder to ensure that these factors are monitored regularly is certainly an act of negligence. Occlusive dressing were carried as a result of which the C infection had been increased. Dr Halder's prescription was against the Canadian treatment protocol reference to which we have already made herein before. It is the duty of the doctors to prevent further spreading of D infections. How that is to be done is the doctors concern. Hospitals or nursing homes where a patient is taken for better treatment should not be a place for getting infection. After coming to know that the patient is suffering from TEN, E Dr. Abani Roy Chowdhury ought to have ensured that supportive therapy had been given.

He had treated the patient along with Dr. Halder and failed to provide any supportive therapy or advise for providing IV fluids or other supplements that is a necessity for the patient who was critically ill. As regards, individual liability of the respondent Nos 4, 5 and 6 is concerned, we may notice the same hereunder. As regards AMRI, it may be noticed: (i) Vital parameters of Anuradha were not examined between 11.05.1998 to 16.05.1998 (Body Temperature, Respiration Rate, pulse, BP and urine input and output) (ii) IV. Fuid not administered. (l.V. fluid administration is absolutely necessary in the first 48 hours of –t treating TEN) As regards, Dr. Balaram Prasad, Res~ondent 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. c (iii) No doctor has the right to use the drug beyond the maximum recommended dose. So far as the judgment of the Commission is concerned, it was clearly wrong in opining that there was no negligence on D 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 28. We remit the case back to the Commissioll only for F the purpose of determination of quantum of compensation. The principles of determining compensation are well- known. We may place on record a few of them. In Oriental Insurance Company Limited v. Jashuben and G Others [(2008) 4 SCC 162], this Court held: "28. We, therefore, are of the opinion that what would have been the income of the deceased on the date of retirement was not a relevant factor in the'light of peculiar facts of this H case and, thus, the approach of the Tribunal and the High Court must be held to be incorrect. It is impermissible in law to take into consideration the effect of revision in scale of pay w.e.f. 1.1.1997 or what would have been the scale of pay in 2002. 29. The loss of dependency, in our opinion, should be calculated on the basis as if the basic pay of the deceased been Rs. 3295/- X 2 = Rs. 6,590/-, thereto should be _,._ added 18.5% dearness allowance which comes to Rs. c 1219/-, child education allowance for two children @ Rs. 240/- X 2 = Rs. 480 and child bus fair Rs. 160 X 2 = Rs. 320/- should have been added which comes to Rs. 8,609/ 30. From the aforementioned figure 1/3rd should be deducted. After deduction, the amount of income comes to Rs. 5,738/- per month [Rs. 8609/- – Rs. 2871/-] and the amount of compensation should be determined by adopting the multiplier of 13, which comes to Rs. 8,95, 128/ 31. In the present case, the High Court itself has applied the multiplier of 13. We are of the opinion that no interference therewith is warranted. We furthermore do not intend to interfere with the rate of interest in the facts and circumstance of the case." Indisputably, grant of compensation involving an accident is within the realm of law of torts.

It is based on the principle of restitution in integrum. The said principle provides that a person entitled to damages should, as nearly as possible, get that sum of money which would put him in the same position as he would have been if he had not sustained the wrong. [See Livingstone v. Rawyards Coal Co. [ (1880) 5 AC 25]. When a death occurs the loss accruing to the dependent must be taken into account; the balance of loss and gain to him must be ascertained ; the position of each dependent in each case may have to be considered separately [ See Davis v. Powell Duffrya Associated Collieries Ltd. [ (1942) AC 601 ]. The said principle has been applied by this Court in Gobald Motor Service Ltd., Allahabad v. R.M.K. Ve/uswami, [AIR 1962 SC 1 ]. 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 c 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. i 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. 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 & Ors. 2009 (8) SCALE 451) In R.D. Hattangadi v. Pest Control (India) (P) Ltd. [AIR 1995 SC 755), this Court observed: "Broadly speaking while fixing an amount of compensation payable to a victim of an accident, the damages have to be assessed separately as pecuniary damages and special damages. Pecuniary damages are those which the G . ..\- victim has actually incurred and which are capable of being calculated in terms of money; whereas non-pecuniary damages are those which are incapable of being assessed by arithmetical calculations. In order to appreciate two concepts pecuniary damages may include expenses incurred by the claimant: (i) medical attendance; (ii) loss of earning of profit up to the date of trial; (iii) other material loss. So far non-pecuniary damages are concerned, they may include (i) damages for mental and physical shock, pain and suffering, already suffered or likely to be suffered in future; (ii) damages to compensate for the loss of amenities of life which may include a variety of __,_ matters i.e. on account of injury the claimant may not be abl.e to walk, run or sit; (iii) damages for the loss of c expectation of life, i.e., on account of injury the normal longevity of the person concerned is shortened; (iv) inconvenience, hardship, discomfort, disappointment, frustration and mental stress in life." The Commission must, therefore, while arriving at the adequate compensation bear in mind all these relevant facts and circumstances.

E. ASSESSING CRIMINAL CULPABILITY UNDER SECTION 304-A E.1. CRIMINAL NEGLIGENCE UNDER SECTION 304-A 29. Criminal Medical Negligence is governed by Section f 304A of the Indian Penal Code. Section 304-A of the Indian Penal Code reads as under:- "304-A. Causing death by negligence.- Whoever causes the death of any person by doing any rash or negligent act not amounting to culpable homicide, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both." _,.. Essential ingredients of Section 304-A are as under:- (i) Death of a person (ii) Death was caused by accused during any rash or negligence act. (iii) Act does not amount to culpable homicide. And to prove negligence under Criminal Law, the prosecution must prove: (i) The existence of duty. (ii) A breach of the duty causing death. (iii) The breach of the duty must be characterized as gross negligence. [See R. v. Prentice and R v. Adomako: [1993) 4 All ER 935) The question in the instant case would be whether the Respondents 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. 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. 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.

The jurisprudential concept of negligence differs in civil and A 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 be shown to exist. For an act to amount to criminal negligence, the degree of negligence should be much high degree. A negligence which B is not of such a high degree may provide a ground for action in civil law but cannot form the basis for prosecution. To prosecute a medical professional for negligence under criminal law it must be shown that the accused did something or failed + to do something which in the given facts and circumstances no c medical professional in his ordinary senses and prudence would have done or failed to do. SHIFTING OF BLAME 30. It is also of some great significance that both in the D criminal as also the civil cases, the concerned doctors took recourse to the blame game.

Some of them tried to shirk their individual responsibilities. We may in this behalf notice the following: (i) In response to the notice of Dr. Kunal, Dr. Mukherjee says that Depomedrol had not been administered at all. When confronted with his prescription, he suggested that the reply was not prepared on his instructions, but on the instruction of AMRI. (ii) Dr. Mukherjee, thus, sought to disown his prescription F at the first instance. So far as his prescription dated 11th May, 1998 is concerned, according to him, because he left Calcutta for attending an international conference, the prescription issued by him became non-operative and, thus, he sought to shift the blame on Dr. Halder. (iii) Dr. Mukherjee and Dr. Halder have shifted the blame to Dr. Prasad and other doctors. Whereas Dr. Prasad counter- -j. charged the senior doctors including the respondent No. 2 stating: "Prof. B.N. Halder (Respondent No. 2) was so much attached with the day to day treatment of patient Anuradha that he never found any deficiency in overall management at AMRI so much so that he had himself given a certificate that her condition was very much fit enough to travel to Mumbai. .. " In answer to a question as to whether Dr. Halder had given specific direction to him for control of day to day medicine to Anuradha, he stated: " … this was done under the guidance of Dr. Sukumar Mukherjee (Respondent No. 1), Dr. B.N. Halder (Respondent No. 2) and Dr. Abani Roychowdhury (Respondent No. 3)" He furthermore stated that those three senior doctors primarily decided the treatment regimen for Anuradha at AMRI.

(iv) Dr. Kaushik Nandy had also stated that three senior doctors were incharge of Anuradha'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. 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 … " In R v. Yogasa Karan [1990] 1 NZLR 399, the New B 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 ho~pitals are institutions, people expect better and efficient service, if the c hospital fails to discharge their duties through their doctors, being employed on job basis or employed on contract basis, it is the hospital which has to justify and not impleading a particular doctor will not absolve the hospital of its responsibilities. [See also Errors, Medicine and the Law, Alan Merry.and Alexander McCall Smith, 2001 ed., Cambridge University Press, p.12] It is generally expected that very senior doctors would behave' responsibly, and they were entitled to take any defence which is available to them but they should not resort to E mudslinging. This being a case where both sides being doctors, fair dealings were expected from them. CUMULATIVE EFFECT OF NEGLIGENCE 31. A patient would feel the deficiency in service having r F regard to the cumulative effect of negligence of all concerned.

Negligence on the part of each of the treating doctors as also the hospital may have been contributing factors to the ultimate death of the patient. But, then in a case of this nature, the court must deal with the consequences the patient faced keeping in G view the cumulative effect. In the instant case, negligent action has been noticed with _.,,._ respect to more than one respondent. A cumulative incidence, therefore, has led to the death of the patient. It is to be noted H that doctrine of cumulative effect is not available in criminal law. The complexities involved in the instant case as also differing nature of negligence exercised by various actors, make it very difficult to distil individual extent of negligence with respect to each of the respondent. In such a scenario finding of medical negligence under section 304-A cannot be objectively determined. E.2. CONCLUSION 32. In view of our discussions made hereinbefore, we are of the opinion that for the death of Anuradha although Dr. Mukherjee, Dr. Halder, Dr. Abani Roy Chowdhury, AMRI, Dr. c B. Prasad were negligent, the ext€nt thereof and keeping in view our observations made hereinbefore, it cannot be said that they should be held guilty for commission of an offence under Section 304-A of the Indian Penal Code.

We furthermore in a -1 case of this nature do not intend to exercise our discretionary jurisdiction under Article 136 of the Constitution of India having regard to the fact that a judgment of acquittal has been recorded by the Calcutta High Court. F. OBSERVATIONS OF THE CALCUTTA HIGH COURT 33. We must express our agony in placing on record that the Calcutta High Court in its judgment has made certain -1 observations which apart from being not borne out from the records, are also otherwise highly undesirable. 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 th~ death certificate alone cannot rule out the Rossibility of _,._ accidental suicidal or homicidal cause of the death. A post-mortem examination alone could rule out the c possibility of these three kinds of death …. On the other hand, the improvement of Anuradha as noticed before 25.5.1998 indirectly supports the argument that the treatment at Calcutta was at best not wrongly directed." "119 … But in the present case, it indicates that there was no fixed treatment, and no faith was reposed on any of the accused doctors and over-jealousness of the patient party practically brought the untimely death of a young lady. The High Court observed that Anuradha died because of interference of Kunal. Such an observation was made on the basis of some representations although his name did not appear in the records of AMRI. It was stated: "124. At the close, it is to be pointed out that Dr. Kunal Saha did not repose faith on any institution as can be ascertained from his conduct discussed hereinabove in details. He also failed to take the investigating agency of this country into confidence and in paragraph 25 of the complaint, it was noted –"that the accused persons_ are highly influential and are likely-to interfere with investigation and as such, complainant would be left with no other alternative than to institute the complaint before the highest magistracy of the Sessions Division of 24-Paraganas (South)". It is rightly contended by the learned counsel appearing on behalf of the accused doctors that such an action may lead to two conclusions:– (i) The complainant has no confidence on the police investigation of this country, or, (ii) The police investigation could unveil some untold facts or circumstances leading to the untimely death of Anuradha. Be that as it may, by filing a complaint for the purpose c of proving the rash and negligent act against the three specialized doctors, the complainant party intention?llY took upon themselves a heavy burden of proving the case which they actually failed to discharge. So it was claimed i to be an uneven battle, which was declared by the complainant party without being aware of the law on the subject and the consequences. It is needless to mention that now-a-days there is an attempt amongst the patient party to lodge complaint against the attending doctors for the purpose of their punishment. On several occasions patient party also ransacked the hospitals or chambers of the doctors and mishandled them on the plea of negligence to duty. In this way the doctors have been suffering from fear psychosis." We m_ust 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 i- involved. In the interests of all, we must avoid such c 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 is not negligent II …………… Further the statement made by the High Court that the transfer certificate was forged by the patient party is absolutely erroneous, as Dr. Anil Kumar Gupta deposed before the trial court that he saw the transfer certificate at AMRl's office and the words "for better treatment" were written by Dr.Balaram Prasad in his presence and these words were written by E Dr.Prasad, who told it would be easier for them to transport the patient.

In a case of this nature, Kunal would have expected sympathy and not a spate of irresponsible accusation from the F High Court. G. SUMMARY 34. For the reasons aforementioned, the criminal appeals are dismissed. As regards the civil appeal, the matter is G remitted to the National Commission· for determining the compensation with a request to dispose of the matter as expeditiously as possible and preferably within a period of six months from the date of receipt.of a copy of this judgment. Civil Appeal is disposed of accordingly. We, keeping in view the stand taken and conduct of AMRI and Dr. Mukherjee, direct that costs of Rs. 5,00,000/- and Rs. 1,00,000/- would payable by AMRI and Dr. Mukherjee respectively. We further direct that if any foreign experts are to be examined it shall be done only through video conferencing and at th~ cost of respondents. G.N. Appeals disposed of.