National Consumer Disputes Redressal
B. Sreekanth vs Dr. H.N. Shivakumar on 10 December, 2009
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI FIRST APPEAL NO. 368 OF 1998 (Against the order dated 30.07.1998 of the Karnataka State Consumer Disputes Redressal Commission, Bangalore in Complaint Case no.62 of 1994) B. Sreekanth Appellant versus Dr. H.N. Shivakumar Respondent BEFORE: Honble Mr. Justice R. C. Jain Presiding Member Honble Mr. Anupam Dasgupta Member For the Appellant Mr. Ajay Garg, Amicus Curiae For the Respondent Dr. Sushil Kumar Gupta, Advocate along with Dr. H.N. Shivakumar, Respondent in person Dated 10th December 2009 ORDER
Anupam Dasgupta This appeal arises from the order dated 30.07.1998 of the Karnataka State Consumer Disputes Redressal Commission, Bangalore (in short, the State Commission) in Complaint Case No. 62 of 1994.
I. The Complaint
2. The case of the complainant before the State Commission was that while riding a motorcycle on 22.06.1993, he fell down and sustained injury to his left foot. As it was a small wound that did not bleed, he ignored it. The next day, however, he developed pain in the injured foot and went for consultation to a neighbourhood doctor who administered an injection and prescribed some medicines. The same night the complainant developed severe headache and vomiting. Therefore, the following day he again went to the clinic of the same doctor who, however, was not available. Their family physician, whom the complainant and his mother then consulted, suspected that the complainant had sustained a fracture and advised him to consult Dr. Shivakumar (opposite party in the complaint and respondent before us) at Deepak Nursing Home. The complainant and his mother went to the said Nursing Home on 25.06.1993 where Dr. Shivakumar examined him and advised admission.
3. On admission, Dr. Shivakumar directed the paramedical staff to apply bandage on the complainants left leg from foot to knee and also prescribed certain medicines. The complainant remained as an indoor patient in the said Nursing Home from 25.0602.07.1993. According to the complainant, Dr. Shivakumar failed to diagnose his ailment (cellulitis) on 25.06.1993, ordered an x-ray of the injured foot rather late on that day but did not advise any pathological tests in time, caused the bandage to cover the entire lower leg too tightly as a result of which the swelling increased and the infection in the foot spread up his leg, did not carry out the necessary surgery on 26.06.1993 and delayed it to the next day, the surgery that he did perform on 27.06.1993 was incomplete and he also failed to diagnose the onset of gangrene in time. Only after Dr. Shivakumar called in a physician and two specialists to examine the complainant was it possible for him to diagnose the disease as gangrene. This was done too late, as a result of which the surgery for the gangrene was also delayed to 01.07.1993. Being thus dissatisfied with the treatment, he took discharge from the Deepak Nursing Home on 02.07.1993 and had himself admitted to Bangalore Hospital the same day, where he had to undergo further surgery and skin grafting and stay for a long period. Even thereafter, he had to undergo repeated treatment before he could recover, albeit with permanent disfigurement of his left leg. Thus, the medical negligence on the part of Dr. Shivakumar not only caused him avoidable prolonged pain and physical discomfort but also led to affecting him emotionally and career-wise because of his disfigured left leg. Later, he filed a complaint before the State Commission alleging several acts of negligence and deficiency in service against Dr. Shivakumar and holding him responsible for all the trouble and expenses he had undergo as well as the permanent disfigurement of his left foot. The allegations in the complaint have been noted in detail in the impugned order of the State Commission.
4. In his written version, Dr. Shivakumar contested each allegation. After a detailed consideration of the pleadings of the parties, evidence and the material brought on record, the State Commission dismissed the complaint holding that the complainant had not been able to establish any medical negligence on the part of the Dr. Shivakumar. Aggrieved by the said order, the complainant has come up in appeal before us.
5. We have heard Mr. Ajay Garg, learned amicus curiae (appointed by this Commission on behalf of the appellant/complainant) and Dr. Sushil Kumar Gupta, learned counsel for the respondent as well as the respondent, Dr. H. N. Shivakumar in person. We have also carefully considered the material before us, including the complete medical record of the complainant while he was at the Deepak Nursing Home as an in-patient as well as that of the subsequent treatment (to the extent made available by the complainant) and the medical literature cited by the complainant before the State Commission.
II. Arguments of Parties
6. In his arguments, Mr. Garg emphasised the following points:
(i) At the time of his first examination and even during examination after admission to the Nursing Home, Dr. Shivakumar could not diagnose that the complainant had already developed cellulitis though he had considerable swelling of his left foot, had high fever and several episodes of vomiting. On admission to the Nursing Home, even the x-ray of the left foot was delayed by several hours after admission. Pathological tests of the affected skin and the pus in the area of the wound were not carried out to identify the exact nature of the bacterial infection and its implications for the course of treatment. Instead, the left leg of the appellant/complainant was tightly dressed with a bandage soaked in a solution of magnesium sulphate and glycerine from toe to the knee.
As a result of the tight bandage, the swelling increased and in spite of the medicines administered by the opposite party Doctor, there was no remission in the symptoms of fever and vomiting.
(ii) When Dr. Shivakumar carried out the first surgery on the complainants left foot/leg to 27.06.1993, after an undue delay of one full day, it was only an attempt to drain out the pus and arrest the swelling. The gangrenous tissue was not removed. In fact, he could not diagnose the onset of gangrene at all, as he thought that the dark patch on the skin of the left foot was merely a scab on the previous wound. It was only after considerable delay and consultation with other Doctors that Dr. Shivakumar realised that the ailment, which was cellulitis to start with, had led to spreading gangrene on account of inappropriate treatment and he belatedly conducted a second surgery on 01.07.1993. Had Dr. Shivakumar been adequately vigilant and diagnosed the problem accurately on the complainants admission to the Nursing Home, the gangrene could have been arrested just up to the areas below the ankle; subsequent complications leading to extensive gangrene affective large parts of the leg, elaborate corrective surgeries therefor at the Bangalore Hospital, prolonged rehabilitative treatment thereafter, consequent expenses and the permanent disfigurement of the complainants left leg and foot could have been prevented.
(iii) Mr. Garg further argued that the proper course of action after admission to the Nursing Home, as recommended in the relevant medical texts produced before the State Commission, was to immediately make incisions in the area around the foot wound to drain out the infected fluids under the skin. Instead, going by the presumption of a fracture and consequent swelling (not cellulitis), the Doctor ordered an x-ray and applied bandage impregnated with magnesium sulphate to reduce the swelling. Had the appropriate course of treatment been administered immediately, the infection would have been contained within a small area well below the ankle and not spread over to the area up to the knee.
(iv) To prove the allegation that Dr. Shivakumar failed to promptly diagnose the onset of gangrene, Mr. Garg emphasised the contradictions between the averments of Dr. Shivakumar in his written version (paragraph 19) and his cross-examination (paragraph 3) before the State Commission.
(a) Paragraph 19 of Dr. Shivakumars written version reads as under:
The averments to the effect that 'after removing the dressing, the complainant noticed a black patch on the left foot and the opposite party tried to remove the patch by scissors and asked the complainant whether he felt any pain in that area and that the complainant replied in the negative are all correct. In fact, the gangrene which was inside had surfaced on the local skin and the symptoms of experiencing no pain even after removal of the black patch by scissors gave the indication that the body cells and tissues were dying rapidly and, therefore, the respondent advised the complainant and his mother regarding performing of surgery immediately.
(b) As against this, in paragraph 3 of his cross-examination, Dr. Shivakumar stated the following:
As the patient was vomiting intermittently with features of scepticaemia, I thought of taking the opinion of a physician. Therefore, a physician was referred in this case. A small black patch was visible around the injury after the patient had come to me. The black patch was not gangrene on the day of admission as suggested but it was a scab. I presumed the black spot as a scab. I diagnosed it as a scab. I did not undertake any chemical analysis of that scab. On examination, the patient had swelling of the left foot and ankle with abrasion covered with a scab I touched the wound scab, looked into and then arrived at the conclusion that it was a scab. It is not true to suggest that prior to operation, I came to the conclusion that there was a formation of gangrene. Within two or three days the black spot spread to the left foot and the left leg. After two or three days there was pus formation around the injured portion. It is false to suggest that there was pus formation causing swelling when the patient had come to the hospital. It is not true to say that once the diagnosis disclosed cellulitis and on symptom of swelling, the immediate step was to do surgery.
(v) He concluded his submissions with the assertion that the complainants allegations were based on the copious medical literature that he had produced before the State Commission and that the State Commission had failed completely in appreciating the significance of the said medical literature.
8. On the other hand, Dr. Gupta, learned counsel for Dr. Shivakumar emphasised that the opposite party Doctor and the Nursing Home did everything that was required in the complainants case according to the standard medical practice and level of medical/surgical knowledge generally available in the country at the relevant time. Specifically, he argued:
(i) The complainant did not bring with him any medical record of the treatment he had received from his neighbourhood doctor immediately after his injury on 22.06.1993.
The reference from the complainants family physician, as ascertained for the complainant, was regarding a suspected fracture of his left foot. However, after examination on 25.06.1993, Dr. Shivakumar diagnosed immediately that the complainant had developed cellulitis as a result of his left foot injury 3 days ago. He was accordingly put on necessary antibiotics. Noticing the complaints of fever and frequent vomiting, the Doctor also suspected a possible case of scepticaemia (sepsis), which called for immediate administration of IV fluids and antibiotics, according to standard medical protocol. Hence he was advised immediate admission to the Nursing Home. To rule out fracture of the foot, an x-ray was also done.
(ii) Magnesium sulphate being a hygroscopic chemical, application of the magsulph dressing from knee downwards was to reduce the oedema/swelling of the complainants entire left leg with which he came to the Nursing Home on 25.06.1993. This had the desired effect soon, as the swelling went down considerably.
(iii) To treat the cellulitis and thus preventing it from worsening, Dr. Shivakumar advised surgery on the very next day, i.e., 26.06.1993. However, the complainants mother insisted on drug-based treatment and withheld consent for the surgery. It was only on 27.06.1993 that she consented to the essential surgery, whereupon the surgery was carried out and fasciotomy was also done, apart from drainage of the infected fluid. IV injections were also administered to alleviate the complaint of vomiting.
(iv) Despite the fact that complainant paid only Rs. 500 at the time of admission and no more thereafter, Dr. Shivakumar arranged need-based consultations with other, specialist doctors. A Physician, Dr. Jayaprakash was consulted as the vomiting did not abate and his advice was implemented. Subsequently, two specialists, Dr. Ravi Shankar, an Orthopedic Surgeon and Dr. K. S. Shekhar, a Plastic Surgeon were brought in to examine the patient and advise the further course of treatment. A more extensive surgery was conducted on the complainant on 01.07.1993 to treat the spreading gangrene, as per the advice of Dr. Shekhar.
(v) As the complainant insisted on discharge from the Nursing Home immediately after the second surgery, he was discharged against medical advice on 02.07.1993 without, once again, insisting on settling the due payment because the complainants mother and a family friend of theirs assured that the payment would be made soon.
(vi) After his discharge, the complainant got himself admitted the same day (02.07.1993) to the Bangalore Hospital, Bangalore where he received treatment similar to what he had been given by Dr. Shivakumar. The complainant did not disclose the fact in his complaint that even there he got himself discharged against medical advice on 13.07.1993 but went back for re-admission on 16.07.1993.
(vii) Though they had promised to settle the outstanding dues, the complainant or his mother never returned to redeem the promise. They did not pay up the dues even after they were served a legal notice. Thus, the complainant ceased to be a consumer of the medical services rendered by the Doctor and the Nursing Home within the meaning of the term under section 2 (1) (d) of the Consumer Protection Act, 1986.
(viii) The State Commission considered the facts and circumstances of the case appropriately and hence returned the finding that there was no evidence against the Doctor having committed any negligence/deficiency in service.
III. Record of Treatment during 25 June 10 October 1993
9. In respect of the treatment received by the complainant, what we notice from the pleadings, evidence and documents on record before the State commission is as under:
(i) The medical record of the Deepak Nursing Home shows that the complainant came in on 25.06.1993 and was admitted as an in-patient at 9.30 a.m. On examination, the observations of fever, high pulse rate, swelling (oedema) and tenderness of the left foot and leg with the area feeling warm, etc., were clearly recorded. However, these observations did not mention the extent/spread of the swelling. More important in view of the subsequent allegations, the observations did not even allude to whether the wound on the left foot was covered with a black scab. In any case, Dr. Shivakumar clearly recorded his diagnosis that the complainant had cellulitis and his treatment advice. Accordingly, the complainant was put on intravenous (IV) drips of Ringer Lactate (RL), Dextrose Normal Saline (DNS) and Dextrose 5% along with IV injection of antibiotics, viz., Ciplox (ciprofloxacin) and Metrogyl (metronidazole). In addition, his left foot and leg were dressed with a bandage impregnated with magnesium sulphate (magsulph) solution in glycerin, which (according to the Doctor) was to reduce the swelling of his leg and foot. An x-ray of his affected foot/leg was also taken the same evening.
(ii) The subsequent medical record, though quite detailed in noting various aspects of periodical observations and treatment, does not at all show if the swelling had indeed come down when the magsulph dressing was changed in the evening of 26.06.1993 after Dr. Shivakumar had seen the patient. The record also does not show if it was at this stage that the complainant (or, Dr. Shivakumar or both) noticed for the first time a dark/black patch on the skin around his original foot injury or that this scab was excised surgically by Dr. Shivakumar with a pair of scissors and that the complainant did (or did not) feel any pain at the time of this excision. The only undisputed point is that Dr. Shivakumar excised this patch of skin or scab on the left foot/leg of the complainant sometime in the evening of 26.06.1993 and the process was painless to the complainant, indicating dead tissue.
(iii) The treatment record, however, shows that in view of his continuing vomiting, injection Perinorm (anti-emetic) was administered from time to time. Metrogyl IV injection was, however, discontinued and oral administration of syrup Perinorm started on 29.06.1993, on the advice of Dr. Jayaprakash, a Physician who examined the complainant that day on reference made by Dr. Shivakumar. Medication was changed periodically and injection Voveron was also administered to reduce pain.
(iv) The medical record also shows that at 11.30 am on 27.06.1996, Dr. Shivakumar carried out the first surgery on the complainant. The description in the medical record is: Under G.A. Multiple incisions and drainage of oedematous fluid was done with fasciotomy and decompression of the left leg was done. It is clear from the medical record that the complainant had vomited at least once in the afternoon of 26.06.1993 (at around 3.45 pm) and also around 07 am on 27.06.1993. Therefore, his allegation that Dr. Shivakumar had delayed the necessary surgery (contemplated for the evening of 26.06.1993, according to the complainant himself) merely because of his continuing vomiting and thus shown his ignorance of the consequences of such delay in treating the patients cellulitis would appear to have no basis in truth. Per contra, in our view, the assertion of Dr. Shivakumar that he was obliged to postpone the surgery to 27.06.1993 because of the insistence of the complainants mother to try out oral medication and her withholding consent for the surgery finds support.
(v) On the other hand, it stands out from the medical report that an explicit/formal diagnosis/finding of the onset of gangrene/necrosis of the cellulitis-affected tissues of the left foot/leg of the complainant was not recorded anytime by Dr. Shivakumar though he appears to have examined the complainant at least twice daily during the five days since 25.06.1993 when the complainant was admitted to the Nursing Home. It was for the first time at 6.30 pm on 29.06.1993 that Dr. D. Ravi Shankar, an Orthopaedic Surgeon to whom a reference had been made by Dr. Shivakumar, examined the complainant and recorded his observations like necrosis of skin in patches on the L leg and sloughing of skin, reflecting unmistakable symptoms of gangrene (having not only set in but also advanced to some parts of the complainants left leg). Further, at 08 pm on 30.06.1993, Dr. K. S. Shekhar, a Plastic Surgeon examined the complainant, once again on reference by Dr. Shivakumar, and noted inter alia Spreading gangrene of the skin and subcutaneous tissues around the ankle 4x4 around lateral malleolus, extending to lateral aspect of leg and over medial malleolus, spreading on to the dorsum of the foot; and segmented superficial gangrene at areas over the leg, due to Gramnegative infection and unambiguously advised, Excision of the dead skin and subcutaneous tissues and deeper tissues depending upon the vascularity. It appears that by an unsigned note, post discussion with Dr. Ravi Shankar the same evening, Dr. Shivakumar recorded, Desloughing fixed at 2 pm on 1/7/93 and altered the medication regimen to some extent.
(vi) On 01.07.1993, Dr. Shivakumar carried out the scheduled surgery with the assistance of Dr. Ravi Shankar and duly noted the essential details of the surgery:
Excision of the gangrenous skin, desloughing of the left leg and left foot done under G. A. Part scrubbed well, painted and draped. The extensive gangrenous skin and subcutaneous tissue of dorsum of left foot, left ankle and 2/3 of the left leg excised. Haemostasis maintained.
Fasciotomy incisions extended on either side, muscles were found to be healthy. Wounds cleaned with H2O2 and saline and dressed with Betadine dressings. The general condition of the complainant was recorded as satisfactory during and after the surgery.
(vii) For the surgery on 01.07.1993, a pre-printed consent form titled INFORMED CONSENT PERSONAL & PROFESSIONAL SERVICE CONTRACT is on record. This consent form, signed by the complainants mother on 01.07.1993 at 12.25 pm, reads as follows:
I the undersigned on behalf of my son (Mr. Shrikanth) hereby enter into a Personal Profession Service Contract with DEEPAK NURSING HOME, 259, 33rd Cross, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore 560 082 and Dr. H. N. Shivakumar on 1/7/93 and I unreservedly and in my full sense give my Informed Consent for any diagnostic examination, biopsy, transfusion or operation under any type of anaesthesia. I agree that no responsibility will be attached to the Consultant Surgeon, Physician, Anaesthetist, Staff and the Nursing Home. I also agree to settle the bill before discharge.
The procedures and risks involved in the course of treatment have been fully explained to me and also the rate of success with different procedures. I have understood the same to the best of my satisfaction and I abide by this contract.
However, it needs to be noticed that for the surgery carried out on 27.06.1993 under G.A. (general anaesthesia), allegedly for drainage, fasciotomy and decompression of the complainants left foot and leg, there is no consent on record, though it was claimed by Dr. Shivakumar that the complainants mother gave consent for this surgery only on 27.06.1993 after refusing it on 26.06.1993.
(viii) Another unusual feature of the medical record, otherwise in strict chronological order and, as already observed, quite detailed, is the brief record of the surgery of 27.06.1993. It is noted on the obverse side of the very first (admission) page, in between two entries of 02.07.1993, i.e., the date of discharge of the complainant from the Deepak Nursing Home.
(ix) As noticed already, the complainant, however, got himself discharged from the Nursing Home in the morning of 02.07.1993, against medical advice, on the strength of intervention of one Mr. A. N. Rao, reportedly a family friend of the complainants mother, who along with the complainants mother apparently assured early settlement of the complainants dues to the Nursing Home for his treatment during 25.06-02.07.1993.
(x) It is a documented fact, recorded in detail by the State Commission in the impugned order, that after his self-sought discharge against medical advice from Deepak Nursing Home on 02.07.1993, the complainant got himself admitted to the Bangalore Hospital, Bangalore the same day. The Discharge Record of the Bangalore Hospital, reproduced verbatim in the impugned order, shows that on 02.07.1993 itself, the complainant underwent a further surgical procedure of debridement and fasciotomy. Yet, once again, he got discharged from there, against medical advice of the Hospital, on 13.07.1993.
(xi) However, the complainant was again admitted to the Bangalore Hospital on 16.07.1993 and discharged on 02.09.1993. During this period, he underwent, according to the Discharge Certificate of the said Hospital, split skin grafting (SSG) on his left leg and foot.
(xii) The next available record of the Bangalore Hospital shows that the complainant went back to the said Hospital with complaint of non-healing ulcers on his left leg for which he received treatment as an in-patient during 07-10.10.1993. Pus culture showed presence of pseudomonas. On discharge, he was advised, No walking or weight bearing till further orders. To review on 19.10.93. It is, however, not on record if the complainant went back to the Bangalore Hospital on the said date for review.
IV. Medical Literature Produced by the Complainant
10. Before the State Commission, the complainant produced some medical literature.
(i) These consist of photocopies of (a) a pamphlet on Rabies, (b) pages from some dictionary of medical terminology, including definition of cellulitis (name of the dictionary, name of the publisher, year of publication, etc., unclear from the pages produced), (c) two pages from the Oxford Textbook of Surgery, with discussion on Acute Tropical Ulcers, (d) an article published in the New England Journal of Medicine (year of publication unclear) with the title, Gangrene Due To Hemolytic Streptococcus A Rare But Treatable Disease, (e) some pages of the chapter on Infections of Skin, Muscle and Bone from the book titled Principles and Practice of Medicine by A. McGehee Harvey and Others, (f) a page from some Colour Atlas of Medicine, including definition of cellulitis, (g) some pages again of the textbook mentioned at (c) above dealing with Infections of the Skin, mainly cellulitis/erysipelas (i.e., cutaneous cellulitis), (h) some pages of the textbook mentioned at (e) above dealing with the topic of surgery in the chapter on Clinical Management of Infectious Diseases, (i) some pages of the Textbook of Diagnostic Medicine by Bailey and Scot and (j) some pages of the Textbook of Dermatology by Moschella and Others, dealing with morphologic diagnosis of skin diseases, including smear tests and culture.
(ii) Regarding the medical literature produced by the complainant, the State Commission, however, observed as under in its impugned order:
The Xerox copies of certain passages from certain books are produced before the Commission. We are aware that it is certainly permissible for a court or a quasi-judicial authority to take aid from public history, literature, science or art, having regard to the provisions reflected in section 57(13) of the Evidence Act. However, it is necessary to remember that before the court can have recourse to the same, foundation will have to be laid by the party or parties for referring to those books. It is necessary to establish, in the first instance, that the books are such as had attained an element of authority. This can be done either by referring to some decided cases where such books are referred to as books of reference or authority or, for that matter, some experts can be examined to speak about the authenticity of the observations reflected in a particular book.
As the complainant did not examine any medical expert to prove the authenticity of these books/passages, the State Commission did not find it advisable to decide the case wholly on the basis of certain passages in certain books. In reality, the State Commission did not consider this material at all.
11. We have, however, taken a close look at the contents of the said medical literature produced by the complainant:
(a) The first pamphlet is published by Hoechst Marion Roussel, a multi-national pharmaceutical company of the relevant period to advertise their product Rabipur, a vaccine for rabies. This is clearly irrelevant in the complainants case.
(b) The second extract, from some unknown dictionary of medical terms/diseases including cellulitis, is altogether trivial, as it does not go beyond short definitions of some types of cellulitis, among several other terms in alphabetical order.
(ca) The third is an extract, from the Oxford Textbook of Surgery, which deals with Acute Tropical Ulcers.
(cb) It describes occurrence of tropical ulcers resulting from a full-thickness necrotizing bacterial infection of the skin with a minor puncture or dirty laceration providing the entry portal for the bacteria, leading to bacterial cellulitis which rapidly produces dermal gangrene. The text goes on to add, Necrotizing infection begins in a few days with the development of a painful papule and foul-smelling watery discharge or local blistering. A central area of gangrene rapidly becomes evident and the process spreads at a variable rate until it is brought to a halt, presumably by the host's defence mechanisms, and demarcation occurs.
After further description of the typical symptoms of acute tropical ulcers, the text adds, The ulcer is virtually always on the leg below the knee, common sites being the lower one-third just above the malleoli, on the shin or dorsum of the foot.
(cc) Based on our own web research (http://med-lib.ru/english/oxford/trop_ulcer.php), we find the following description from the same source, viz., Oxford Textbook of Surgery, Tropical ulcer is endemic in village communities throughout the tropics and in some subtropical regions. It is most common in the wet tropics and its incidence rises sharply in the wet season. Wherever nutrition, living conditions, and hygiene are poor, a high incidence of acute tropical ulcer will be found, especially amongst children and young adults, who suffer repeated trauma to their legs during their daily work in the field or rainforest. Medical services are often deficient in these areas and patients are rarely able to leave their work for periods of rest or treatment. Repeated trauma and infection compound the problem and lead to a high incidence of chronic ulcer. (Emphasis supplied).
(cd) We are, thus, unable to see the relevance of this medical literature to the case of the complainant. Neither the geographical nor the socio-economic background, on the one hand, nor any of the standard symptoms mentioned above, on the other corresponds with the specific background, history of complaints or physical conditions with which the complainant went to the Deepak Nursing Home, except that his condition on 25.06.1993 (i.e., three days after his injury due to a road traffic accident) was diagnosed as cellulitis. During the subsequent period of indoor treatment at the said Nursing Home, neither the descriptions in the complaint nor those in the medical record of the Nursing Home indicate any observation remotely suggestive of foul-smelling watery discharge from or blistering of his affected leg. It could not have possibly been the case of the complainant that what he suffered from was not cellulitis but in reality acute tropical ulcer.
(d) The fourth piece of literature on record is an article published in the well-known New England Journal of Medicine, dealing with a specific case of necrotizing fasciitis and going on to discuss the causes, symptoms and treatment of that disease:
In most cases, an initial lesion such as a laceration, parenteral injection, insect bite or surgical wound is present but in a significant number, no portal of entry is recognized. In the earliest stages the affected tissue becomes swollen, red, painful and warm. The inflammation progresses with alarming speed proximally and distally from the initial focus. As early as thirty-six hours after onset, the pathognomonic signs of streptococcal gangrene appear: patches of the skin take on a dusky gray-blue appearance, with or without blisters containing clear, yellow fluid. These patches progress to large regions of cutaneous gangrene that eventually slough.
Bacteremia is the rule and metastatic foci of infection may appear far from the initial site, chiefly in the subcutaneous tissues, where the process of gangrene repeats itself.
Blood cultures usually yield a pure growth of the offending organism, the hemolytic streptococcus.
The basic principles of treatment of acute streptococcal gangrene have not changed from those advocated by Meleney forty years ago. Survival depends on early and aggressive surgical intervention. The entire length of the fascial plane of the part involved is opened widely. Regions of gangrene are excised in full thickness, with the widest possible border. Wounds are then allowed to granulate and prepared for subsequent skin graft. [Emphasis supplied] [Note: From the reference to Meleney, i.e., Dr. Frank L. Meleney, MD, a pioneering US surgeon-cum-bacteriologist who first reported what has since been described as Meleneys gangrene during his stint in China in 1924, it can be inferred that this article is of the 1960s.]
(e) The complainant cited extracts of some more medical texts, as noted above.
(ea) From the portions marked important by the complainant in the extracts from A. M. Harveys Principles and Practice of Medicine, his attempt appears to be to emphasise that in treating subcutaneous skin infection, Reliance must be placed entirely on palpation of the depth of involvement and whether or not areas of fluctuation can be appreciated; and that, A true emergency exists when streptococcal gangrene occurs. The hallmark of this fulminant infection caused by beta-hemolytic streptococcus is an area of dark or purplish discoloration with diminution of the arterial pulses in the affected area. If there is any suggestion that there is a decrease in the pulse volume, the patient must be considered a surgical emergency with the same order of urgency as a person who has an uncontrolled hemorrhage. A wide drainage is necessary to relieve the vascular obstruction produced by the rapid proliferation of the organism along the fascial planes of the muscle group involved. Failure to recognise and surgically treat this form of cellulitis often leads to death of the patient despite penicillin.
(eb) Several more pages of the same book dealing with Clinical Management of Patients with Infectious Diseases have no relevance to the complainants case.
(f) A bare perusal of the Colour Atlas of Medicine as also the pages of the Oxford Textbook of Surgery and the Bailey and Scotts Textbook of Diagnostic Medicine produced on record shows that they are of little relevance to the case in hand.
(g) We also do not consider it necessary to review the 52 pages of extracts from Chapter 11 of Textbook of Dermatology by Moschella and Others because they do not aid any further, beyond the texts noticed above, in the task of adjudicating the allegations/defence in this case.
V. Standard Medical Literature
12. However, for a broad-based and yet more focussed appreciation of the medical issues involved in this case, we deem it desirable to notice what some standard medical textbooks have to say on the types, causes, symptoms and, more important, diagnosis and treatment of cellulitis and necrotizing fasciitis (emphasis supplied throughout):
(1) Cecils Medicine , Edited by Lee Goldman & Dennis Ausiello (Volume II, 23rd Edition, Publishers Saunders Elsevier) Cellulitis A non-localised staphylococcus aureus (S. aureus) skin infection is called cellulitis and may resemble the skin infections caused by Streptococcus pyogenes, the most common cause of cellulitis. S. aureus cellulitis can also lead to bacteremia, thereby proving the streptococcal origin of some of these infections (Page 2167) Necrotizing Fasciitis Necrotizing fasciitis, originally called streptococcal gangrene, is a deep-seared infection of the subcutaneous tissue that results in progressive destruction of fascia and fat but may spare the skin itself.
Subsequently, necrotizing fasciitis has become the preferred term because Clostridium perfringens, Clostridium septicum, and Staphylococcus aureus can produce a similar pathologic process. Infection may begin at the site of trivial or inapparent trauma. Within the initial 24 hours, swelling, heat, erythema and tenderness develop and rapidly spread proximally and distally from the original focus. During the next 24 - 48 hours, the erythema darkens, changing from red to purple and then to blue, and blisters and bullae form that contain clear yellow fluid. On the fourth or fifth day, the purple areas become frankly gangrenous. From the seventh to the tenth days, the line of demarcation becomes sharply defined and the dead skin begins to reveal extensive necrosis of the subcutaneous tissue. Patients become increasingly prostrated and emaciated, and they may become unresponsive, mentally cloudy, or delirious. Aggressive fasciotomy and debridement (bear claw fasciotomy) and irrigations with Dakins solution achieved mortality rates as low as 20% even before antimicrobials were available. Since 1989, the mortality rate of necrotizing fasciitis despite antimicrobials surgical debridement, and intensive care unit treatment has become higher than that reported by Meleney in 1924, probably because of the increased virulence of streptococci. (Page. 2179) (2) Harrisons Principles of Internal Medicine , Edited by S. Fauci, Eugene Braunwald, Dennis L. Kasper, Stephen L. Hauser, Dan L. Longo, J. Larry Jameson and Joseph Loscalzo (17th Edition, published by McGraw-Hill Companies, Inc.) Cellulitis Cellulitis is an acute inflammatory condition of the skin that is characterised by localised pain, erythema, swelling, and heat. Cellulitis may be caused by indigenous flora colonising the skin and appendages (e.g., S. aureus and S. pyogenes) or by a wide variety of exogenous bacteria. Because the exogenous bacteria involved in cellulitis occupy unique niches in nature, a thorough history (including epidemiologic data) provides important clues to etiology. When there is drainage, an open wound, or an obvious portal of entry, Grams stain and culture provide a definite diagnosis. In the absence of these findings, the bacterial etiology of cellulitis is difficult to establish, and in some cases staphylococcal and streptococcal cellulitis may have similar features. Even with needle aspiration of the leading edge or a punch biopsy of the cellulitis tissue itself, cultures are positive in only 20% of cases. (Page
800) Necrotizing Fasciitis Necrotizing fasciitis, formerly called streptococcal gangrene, may be associated with group A Streptococcus or mixed aerobic-anaerobic bacteria or may occur as part of gas gangrene caused by Clostridium perfringens. Strains of MRSA that produce the Panton-Valentine leukocidin have been reported to cause necrotizing fasciitis. Early diagnosis may be difficult when pain or unexplained fever is the only presenting manifestation. Swelling then develops and is followed by brawny edema and tenderness. With progression, dark-red induration of the epidermis appears, along with bullae filled with blue or purple fluid. Later the skin becomes friable and takes on a bluish, maroon, or black color. By this stage, thrombosis of blood vessels in the dermal papillae is extensive. Extension of infection to the level of the deep fascia causes this tissue to take on a brownish-gray appearance. Rapid spread occurs along fascial planes, through venous channels and lymphatics. Patients in the later stages are toxic and frequently manifest shock and multi-organ failure.
.
Necrotizing fasciitis caused by S. pyogenes has increased in frequency and severity since 1985. It often begins deep at the site of a nonpenetrating minor trauma, such as a bruise or a muscle strain. Seeding of the site via transient bacteremia is likely, although most patients deny antecedent streptococcal infection. Alternatively, S. pyogenes may reach the deep fascia from a site of cutaneous infection or penetrating trauma. Toxicity is severe, and renal impairment may precede the development of shock. In 20-40% of cases, myositis occurs concomitantly, and, as in gas gangrene, serum creatine phosphokinase levels may be markedly elevated. Necrotizing fasciitis due to mixed aerobic-anaerobic bacteria may be associated with gas in deep tissue, but gas usually is not present when the cause is S. pyogenes or MRSA. Prompt surgical exploration down to the deep fascia and muscle is essential. Necrotic tissue must be surgically removed, and Grams staining and culture of excised tissue are useful in establishing whether group A streptococci, mixed aerobic-anaerobic bacteria, MRSA, or Clostridium species are present. (Page 801) Infections of the Skin, Muscle, and Soft Tissue Early and aggressive surgical exploration is essential in patients with suspected necrotizing fasciitis, myositis, or gangrene in order to (1) visualize the deep structures, (2) remove necrotic tissue, (3) reduce compartment pressure, and (4) obtain suitable material for Grams staining and for aerobic and anaerobic cultures. Appropriate empirical antibiotic treatment for mixed aerobic-anaerobic infections could consist of ampicillin/sulbatam, cefoxitin, or the following combination .
(Page 803).
Streptococcal cellulitis tends to develop at anatomic sites in which normal lymphatic drainage has been disrupted, such as sites of prior cellulitis, the arm ipsilateral to a mastectomy and axillary lymph node dissection, a lower extremity previously involved in deep venous thrombosis or chronic lymphedema, or the leg from which a saphenous vein has been harvested for coronary artery bypass grafting. (Page885) Necrotizing fasciitis (hemolytic streptococcal gangrene) involves the superficial and/or deep fascia investing the muscles or an extremity or the trunk. The source of the infection is either the skin, with organisms introduced into tissue through trauma (sometimes trivial), or the bowel flora, with organisms released during abdominal surgery or from an occult enteric source, such as a diverticular or appendiceal abscess. The inoculation site may be inapparent and is often some distance from the site of clinical involvement; e.g., the introduction of organisms via minor trauma to the hand may be associated with clinical infection of the tissues overlying the shoulder or chest. . . Cases unrelated to contamination from bowel organisms are most commonly caused by GAS alone or in combination with other organisms (most often S. aureus). Overall, GAS is implicated in 60% of cases of necrotizing fasciitis. The onset of symptoms is usually quite acute and is marked by severe pain at the site of involvement, malaise, fever chills, and a toxic appearance. The physical findings, particularly early on, may not be striking, with only minimal erythema of the overlying skin. Pain and tenderness are only mild or moderate. As the infection progresses (often over several hours), the severity and extent of symptoms worsen, and skin changes become more evident, with the appearance of dusky or mottled erythema and edema. The marked tenderness of the involved area may evolve into anesthesia as the spreading inflammatory process produces infarction of cutaneous nerves.
Once necrotizing fasciitis is suspected, early surgical exploration is both diagnostically and therapeutically indicated. Surgery reveals necrosis and inflammatory fluid tracking along with fascial planes above and between muscle groups, without involvement of the muscles themselves. The process usually extends beyond the area of clinical involvement, and extensive debridement is required. Drainage and debridement are central to the management of necrotizing fasciitis; antibiotic treatment is a useful adjunct, but surgery is life-saving. (Pages 885-86) (3) Kelleys Textbook of Internal Medicine , Edited by H. David Humes (4th Edition, Publishers Lippincott Williams & Wilkins) Diffuse Infections Cellulitis Cellulitis is a spreading acute infection of the skin and subcutaneous tissues characterised by erythema, warmth, swelling, and tenderness. It may be primary or may secondary to a local lesion or, uncommonly, to hematogenous spread of infection from a remote area. Cellulitis may be classified as mild and uncomplicated, severe, high risk, or necrotizing.
Most cellulitis is mild and uncomplicated and is caused by group A streptococci or by S. aureus. Diffuse erythema, swelling and tenderness develop over 2 to 4 days. In an extremity, a red line along the course of the lymphatics indicates accompanying lymphangitis; enlarged, tender regional lymph nodes are common. Fever, malaise, and chills are often present. Cellulitis is potentially dangerous because of the rapidity with which infection spreads to the bloodstream.
Severe infections must be recognised, and patients must be admitted to the hospital for intravenous antibiotic therapy.
The key signs are systemic: fever, chills, toxicity, and leukocytosis. Underlying disease (e.g., diabetes) and ischemia worsen the risk and should be sought specifically. Severity may also be graded in units by the intensity of each of its four elements (fever, erythema, swelling, and tenderness). Each element is rated as absent (0), mild (1), moderate (2), or severe (3), and the total score in severity units is the sum of scores for each element.
The most serious variant of cellulitis is necrotizing cellulitis, a term used for a variety of gangrenous soft-tissue infections often associated with anaerobic bacteria, tissue toxins, and bacterial synergy (Chapter 273). (Page 1889-90) In necrotizing cellulitis, impaired host resistance, anaerobic wound conditions, bacterial synergy, and lytic enzymes and toxins produced by the microbes involved are responsible for the rapidity of onset or progression. More recently, the streptococcal toxic shock syndrome has gained notoriety as a life-threatening flesh-eating disease in young adults . (Page 1891) Investigation In all but the simplest cases of uncomplicated cellulitis, the physician should follow the ABCs of investigation of soft-tissue infection: aspiration of pus or deep tissue fluid for culture, blood tests for risk evaluation, culture of deep tissue specimens and blood, and diagnostic imaging.
Aspiration Although superficial cultures are positive for pathogenic bacteria in two-thirds of cases, they are of little value in management because most are found in open lesions that respond to blind therapy with semisynthetic penicillins. Deep tissue culture is preferable, and needle aspiration is the best method of obtaining a satisfactory specimen of tissue fluid or pus. In patients without an obvious collection of pus, a find-needle aspiration technique should be used.
Blood Tests Blood tests for risk evaluation should include a complete blood count and random blood sugar. In febrile or toxic patients, the blood urea nitrogen and serum ceatinine levels should be determined; blood tests of liver function may be performed, if indicated. Blood cultures are usually negative and should therefore be done selectively. Leukocytosis is common. Organ dysfunction may be found in TSS and in necrotizing infections.
Culture After deep tissue fine-needle aspiration, 0.5 ml thioglycolate broth is aspirated into the syringe and a few drops are inoculated onto plates of sheep blood agar, chocolate agar and MacConkey agar and into a glass tube containing a semisolid thioglycolate medium. The agar plate and tube are then incubated for 48 hours at 35oC in 5% carbon dioxide and a separate sheep blood agar plate is incubated in an anaerobic jar. Only 20% to 30% of cultures are positive in cellulitis; blood cultures are positive still less often.
Diagnostic Imaging Methods used include plain x-ray films, isotope and ultrasound imaging, and occasionally CT and MRI.
. However, plain x-rays may be normal within the first 7 to 10 days of bony infection; therefore, bone scans are often obtained. In practice, it is best to delay scanning until soft-tissue infection has been controlled by intravenous antibiotics.
Strategies for Optimal Management In managing soft-tissue infections, the first priority is to identify necrotizing infection. Figure 263.4 emphasizes the central role of risk factor analysis and clinical markers of necrotizing infection in the management scheme. A second priority is to rule out non-infectious conditions that may simulate or complicate cellulitis. A third priority is to identify complications such as bone or joint infection in extremity cellulitis and orbital and intracranial infection in facial cellulitis. These priorities are met by attention to clinical presentation and to the ABCs of investigation. Treatment itself should include antibiotic therapy, local care, and resuscitation of some patients.
Diffuse Infections Most cases of cellulitis can be managed simply on an outpatient basis. However, severe infections, high-risk infections, and complicated infections usually require aggressive inpatient antibiotic therapy and often surgery. Patients with necrotizing infections must be admitted for surgery.
In severe cellulitis, treatment should start with intravenous cloxacillin (1 g every 6 hours). Intravenous vancomycin (500 mg every 8 hours) or the related glycopeptide antibiotic teicoplanin (1 g daily) are alternatives for the penicillin-allergic patient. An aminoglycoside such as gentamicin may be added when the clinical setting suggests that a gram-negative bacillus may play a role, for instance, in patients with failed oral cloxacilin therapy, in those with cellulitis after injury and exposure to contaminated fresh water, in those with perianal cellulitis, and in those who have risk factors for gram-negative bacterial infection (neutropenia, diabetes mellitus, organ-failure, and corticosteroid treatment). (Pages 1891-92) The serious nonclostridial infections have been given many names over the years, but the most common label is necrotizing fasciitis. The fascia referred to is the superficial fascia, which consists of all tissue between the dermis and the underlying muscle. The difficulty with these infections is that the initial presentation is often misleading, resembling a simple cellulitis that would be expected to resolve with antibiotics alone. The following signs in association with an apparent cellulitis indicate that a necrotizing process is involved and that surgical exploration with probable debridement will be required: skin gangrene, ecchymoses, bullae, crepitus, edema in excess of other local signs of infection and inflammation, and failure to respond to apparently adequate antibiotic therapy. Necrotizing fasciitis can be caused by a synergistic combination of gram-negative rods, gram-positive cocci, and anaerobes, and can also be caused by B-hemolytic streptococci alone. Mixed infections tend to follow traumatic lacerations and operations on the perineum of in the abdomen involving bowel, or to complicate decubitus ulcers. Necrotizing infections that arise in trivial injuries such as varicella lesions, mosquito bites, or superficial scratches or occur with no known are almost always due to group A streptococci.
(4) Bailey & Loves Short Practice of Surgery , Edited by Norman S. Williams, Christopher J.K. Bulstrode & P. Ronan OConnell (25th Edition, Publishers Hodder Arnold) Cellulitis/Lymphangitis Cellulitis is a bacterial infection of the skin and subcutaneous tissue that is more generalized than erysipelas. It is usually associated with previous skin trauma or ulceration. Cellulitis is characterized by an expanding area of erythematous, oedematous tissue that is painful and associated with a fever, malaise and leucocytosis. Erythema tracking along lymphatics may be visible (lymphangitis). The commonest causative organism is Streptococcus. Blood and skin cultures for sensitivity should be taken before prompt administration of broad-spectrum intravenous antibiotics and elevation of the affected extremity.
Necrotizing Fasciitis Necrotising fasciitis was first described by Pare in the sixteenth century. Meleneys synergistic gangrene and Fourniers gangrene are all variants of a similar disease process. (Summary box 39.2) Summary Box 39.2 Necrotizing Fasciitis Surgical emergency Polymicrobial synergistic infection 80% have a history of previous trauma or infection Rapid progression to septic shock Urgent resuscitation, antibiotics and surgical debridement Mortality 30-50% Necrotizing fasciitis results from a polymicrobial, synergistic infection most commonly a Streptococcal species (group A beta-haemolytic) in combination with Staphylococcus, Escherichia coli, Pseudomonas, Proteus, Bacteroides or Clostridium; 80% have a history of previous trauma/infection and over 60% commence in the lower extremities. Predisposing conditions include:
diabetes;
smoking;
penetrating trauma;
pressure sores;
immunocompromised states;
intravenous drug abuse;
skin damage/infection (abrasions, bites and boils).
Classical clinical signs include: oedema stretching beyond visible skin erythema, a woody hard texture to the subcutaneous tissues, an inability to distinguish fascial planes and muscle groups on palpation, disproportionate pain in relation to the affected area with associated skin vesicles and soft-tissue crepitus. Lymphangitis tends to be absent. Early on patients may be febrile and tachycardic, with a very rapid progression to septic shock. If radiographs have been taken, they may demonstrate air in the tissues, but ideally, the diagnosis will have been made promptly on the basis of symptoms and signs without recourse to screening radiography because unnecessary delay may be lethal.
Management should commence with urgent fluid, resuscitation, monitoring of haemodynamic status and administration of high-dose broad-spectrum intravenous antibiotics. This is a surgical emergency and the diseased area should be debrided as soon as possible, until viable, healthy, bleeding tissue is reached. Early review in the operating theatre and further debridement is advisable, together with the use vacuum assisted dressings. Early skin grafting in selected cases may minimise protein and fluid losses. Mortality of between 30% and 50% can be expected even with prompt operative intervention. (Page 600)
13. We now proceed to summarise, in commonly understood terms, what the foregoing extensive review of the standard medical literature states in respect of diagnosis and treatment of the type of cellulitis affecting the complainant and, in that context, also of necrotizing fasciitis:
Cellulitis is a diffuse, bacterial infection of the soft tissues. Cellulitis may occur anywhere in the body but the leg is the most common site of the infection (particularly in the area of the tibia or shinbone and in the foot) where it involves the epidermis, dermis and subcutaneous fat. Both Group A Streptococcus (GAS) and Staphylococcus aureus varieties of bacteria can cause it, though the commonest causative organism is Streptococcus. Cellulitis may be identified as mild and uncomplicated, severe, high risk, or necrotizing.
The most serious variant of cellulitis is necrotizing cellulitis, a term used for a variety of gangrenous soft-tissue infections often associated with anaerobic bacteria, tissue toxins, and bacterial synergy.
On the other hand, necrotizing fasciitis is a serious non-Clostridial (i.e., not caused by the Clostridium bacteria) infection that involves superficial fascia, which consists of all tissue between the dermis and the underlying muscle. It is a polymicrobial synergistic infection caused most commonly by a Streptococcal species (group A beta-haemolytic) in combination with Staphylococcus.
[Note:
It is not entirely clear if necrotizing cellulitis and necrotizing fasciitis referred to in Kelleys Textbook denote the same or slightly different soft tissue conditions. However, the question is not significant for dealing with this case.] The symptoms of cellulitis include previous skin trauma or ulceration, an expanding area of erythematous (relating to or characterized by erythema; erythema meaning redness of the skin caused by dilatation and congestion of the capillaries, often a sign of inflammation or infection), oedematous (swollen with an excessive accumulation of serous fluid in body tissue spaces or cavities) tissue that is painful and associated with a fever, malaise and leucocytosis (an abnormally large increase in the number of white blood cells in the blood, often occurring during an acute infection or inflammation).
In association with an apparent cellulitis, the symptoms of necrotizing fasciitis include skin gangrene, ecchymoses (plural of ecchymosis, meaning a subcutaneous hematoma larger than 1 cm, commonly called a bruise), bullae (plural of bulla, meaning a blister more than 5 mm in diameter with thin walls that is full of fluid), crepitus (a clinical sign in medicine characterised by a peculiar crackling, crinkly, or grating feeling or sound under the skin crepitus in soft tissues is often due to gas, most often air, that has penetrated and infiltrated an area where it should not normally be), edema (swelling) in excess of other local signs of infection and inflammation (basic way in which the body reacts to infection, irritation or other injury, the key feature being redness, warmth, swelling and pain), and failure to respond to apparently adequate antibiotic therapy. The difficulty with this infection is that the initial presentation is often misleading, resembling a simple cellulitis that would be expected to resolve with antibiotics alone.
When presented with a case of suspected cellulitis, except for the simplest cases of uncomplicated cellulitis, the physician should follow the ABCs of investigation of soft-tissue infection, viz., aspiration of pus or deep tissue fluid for culture, blood tests for risk evaluation, culture of deep tissue specimens and blood, and diagnostic imaging.
To treat cellulitis, antibiotics such as derivatives of penicillin or other types of antibiotics that are effective against the responsible bacteria, are used. If the bacteria turn out to be resistant to the chosen antibiotics or in patients who are allergic to penicillin, other appropriate antibiotics can be substituted. In many cases, treatment requires the administration of intravenous antibiotics in a hospital setting, since oral antibiotics may not always provide sufficient penetration of the injury to be effective.
For necrotizing fasciitis, at the time of preliminary diagnosis, the patient needs to be hospitalized and started on intravenous antibiotics immediately. The initial choice of antibiotics can be made based upon the types of bacteria suspected of causing the infection, but many doctors believe that multiple antibiotics should be used at the same time to protect the patient from methicillin-resistant Staphylococcus aureus (MRSA), as well as infections with anaerobic bacteria, and polymicrobic infections. Antibiotic susceptibility studies, done in the laboratory after the infecting organism(s) has been isolated from the patient, can help the physician choose the best antibiotics to treat the infected individual. A surgeon needs to be consulted immediately if necrotizing fasciitis is suspected or preliminarily diagnosed. Debridement of necrotic tissue and collection of tissue samples, needed for culture to identify pathogens, are done by the surgeon. Thus, once necrotizing fasciitis is suspected, early surgical exploration is both diagnostically and therapeutically indicated, referred to as aggressive fasciotomy and debridement (bear claw fasciotomy). Surgery reveals necrosis and inflammatory fluid tracking along with fascial planes above and between muscle groups, without involvement of the muscles themselves. The process usually extends beyond the area of clinical involvement, and extensive debridement is required. Drainage and debridement are central to the management of necrotizing fasciitis; antibiotic treatment is a useful adjunct, but surgery is life-saving.
[Note: This summary is based on the medical textbooks reviewed above as well as information available on the well-known and reliable website www.medicinenet.com, providing health and medical information produced by doctors.] VI. Law on Medical Negligence
14. The law on medical negligence in India has evolved mainly through a catena of judgments of the Supreme Court, which, in turn, has taken into account the well-known judgments of the English Courts as well as those of the USA, Canada and Australia on the subject.
(i) In the context of this case, we would like to refer first to the Apex Court judgment in the leading case of Jacob Mathew v State of Punjab and Another [(2005) 6 SCC 1] in which a Constitution Bench of the Court reaffirmed, inter alia, that the test for determining medical negligence as laid down in the Bolam case [(1957) 1 WLR 583] would hold good in its applicability in India. Because this ruling has held sway so far, it would be instructive to read what the author of the judgment, viz., McNair, J had to say to the Jury trying the case of Bolam v Friern Hospital Management Committee (1957 Queens Bench Division):
I must explain what in law we mean by negligence. In the ordinary case which does not involve any skill, negligence in law means this: some failure to do some act which a reasonable man in the circumstances would do or doing some act which a reasonable man in the circumstances would not do; and if that failure or doing that act results in injury then there is a cause of action. How do you test whether this act or failure is negligent? In an ordinary case, it is generally said that you judge that by the action of the man in the street. He is the ordinary man. In one case it has been said that you judge it by the conduct of a man on the top of a Clapham* omnibus. But where you get a situation which involves the use of some special skill or competence, then the test whether there has been negligence or not is not the test of the man on the top of a Clapham omnibus, because he has not got this special skill. The test is the standard of the ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest skill at the risk of being negligent. It is well-established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art.
[*Clapham is a locality in the London Borough of Wandsworth.] I myself would prefer to put it this way: 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. I do not think there is much difference in sense. It is just a different way of expressing the same thought. Putting it the other way round, a man is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion that takes a contrary view. At the same time, that does not mean that a medical man can obstinately and pig-headedly carry on with some old technique if it has been proved to be contrary to what is really substantially the whole of informed medical opinion. Otherwise you might get men today saying: I do not believe in anaesthetics. I do not believe in antiseptics. I am going to continue to do my surgery in the way it was done in the eighteenth century. That clearly would be wrong.
Finally, bear this in mind that you are now considering whether it was negligent for certain action to be taken in August, 1954, not in February, 1957; and in one of the well-known cases on this topic it has been said you must not look through 1957 spectacles at what happened in 1954. [Emphasis supplied]
(ii) While adjudicating allegations of medical negligence on the part of a doctor on the touchstone of the Bolam test, we are thus required to answer three questions:
(a) whether the doctor in question possessed the medical skills expected of an ordinary skilled practitioner in the field at the relevant point of time, (b) whether the doctor adopted the practice (of clinical observation, diagnosis including diagnostic tests and treatment) in the case that would be adopted by such a doctor of ordinary skill in accord with (at least) one of the responsible bodies of opinion of professional practitioners in the field, i.e., whether, in the opinion of at least one such body of doctors, what he did was in order and, equally, what he omitted to do would also have been omitted by other doctors of ordinary skills, and (c) whether the standards of skills/knowledge expected of the doctor, according to the said body of medical opinion, were of the time when the events leading to the allegation of medical negligence occurred, and not of the time when the dispute was being adjudicated.
(iii) (a) To this list of criteria, we wish to add one more which, in our view, is equally important but not sufficiently highlighted and is yet in line with the observations of McNair, J: did the doctor keep himself abreast of the developments/knowledge in his chosen field at the relevant time in administering the treatment that he did to the patient, or was he one who, once again in the words of McNair, J, obstinately and pig-headedly carried on with some old technique if it had been proved to be contrary to what was really substantially the whole of informed medical opinion?
(b) This criterion was lucidly elaborated in the following passage from Eckersley v Binnie [10 (1998) 18 Con LR] which was quoted with approval in paragraph 20 of the Apex Courts judgment in the case of Jacob Mathew v State of Punjab [(2005) 6 SCC 19]:
After a review of various authorities Bingham, L.J. in his speech in Eckersley v Binnie summarised the Bolam test in the following words:
From these general statements it follows that a professional man should command the corpus of knowledge which forms part of the professional equipment of the ordinary member of his profession. He should not lag behind the other ordinary assiduous and intelligent members of his profession in the knowledge of new advances, discoveries and developments in his field. He should have such an awareness as an ordinarily competent practitioner would have of the deficiencies in his knowledge and the limitations on his skill. He should be alert to the hazards and risks in any professional task he undertakes to the extent that other ordinarily competent members of the profession would be alert. He must bring to to any professional task that he undertakes no less expertise than other ordinarily competent members of his profession would but need bring no more. The standard is that of the reasonable average. The law does not require of a professional man that he be a paragon combining the qualities of polymath and prophet. [Emphasis supplied] In other words, did the ordinarily competent doctor keep abreast of the development of knowledge in his area of special skills and apply that knowledge in treating the patient?
(c) It would also follow that in the face of allegations of improper diagnosis (including inadequate diagnostic tests, due to lack of adequate knowledge/skills) and consequent delay in appropriate treatment, the onus of proof that the doctor did not lag behind the other ordinary assiduous and intelligent members of his profession in the knowledge of new advances, discoveries and developments in his field would shift to him and not rest with the complainant, particularly when the latter cited, in support of his allegations, medical literature of the relevant (or even an earlier) period in support of his allegation that was not even attempted to be rebutted by producing at least one body of reasonably competent medical opinion/literature on the subject.
(iv) In the context of this case, the other judgment of a three-Judge Bench of the Apex Court that we need to cite is that in the case of Samira Kohli v Dr. Prabha Manchanda and Another [(2008) 2 SCC 1]. The Court held, inter alia, in that case:
49. We may now summarise the principles relating to consent as follows:
(i) A doctor has to seek and secure the consent of the patient before commencing a treatment (the term treatment includes surgery also). The consent so obtained should be real and valid, which means that the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what he is consenting to.
(ii) The adequate information to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment or not. This means that the doctor should disclose (a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any available; (c) an outline of the substantial risks; and (d) adverse consequences of refusing treatment. But there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment which may persuade a patient to undergo a fanciful or unnecessary treatment. A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment. [Emphasis supplied] In this judgment the Court also held (vide paragraph 65) that it was not enough to obtain the consent of even a close a relative when the patient was in a position to give/refuse consent.
VII. Findings and Conclusions
15. In the context of the allegations in the complaint, findings of the State Commission in the impugned order and the grounds of appeal, what emerge from the discussion above are the following:
(i) Dr. Shivakumar diagnosed the ailment of the complainant as cellulitis. He also advised immediate hopitalisation and started administration of two appropriate antibiotics along with IV drips to maintain hydration because the patient was vomiting repeatedly. While these were in line with the standard medical protocol described in section V above, there is no record that he followed, on 25.06.1993 or anytime soon thereafter, the ABCs of investigation of soft-tissue infection, viz., aspiration of pus or deep tissue fluid for culture, blood tests for risk evaluation, culture of deep tissue specimens and blood, and diagnostic imaging. At least, aspiration of deep tissue fluid and blood tests were necessary and could have been easily conducted at this stage itself.
(ii) Moreover, there appears to be no reasonable medical ground to bandage the entire left foot and leg with magnesium sulphate (magsulph) dressing for over 24 hours. The commonly available medical literature has the following to say on magsulph dressing:
Historically, abscesses as well as boils and many other collections of pus have been treated via application of magnesium sulphate paste. This works by drawing the infected pus to the surface of the skin before rupturing and leaking out; after this the body will usually repair the old infected cavity. Magnesium sulphate is, therefore, best applied at night with a sterile dressing covering it, the rupture itself is not painful but the drawing up may be uncomfortable. Magnesium sulphate paste is considered a "home remedy" and is not necessarily an effective or accepted medical treatment.
It is noteworthy that none of the medical textbooks referred to above mentions, leave alone recommending, the use of magsulph paste dressing as part of the treatment of the swelling of a lower limb affected by cellulitis.
Whether or not this was actually harmful, given the rather serious condition of the patient (signs of scepticaemia, according to Dr. Shivakumar himself) when he came for treatment to Deepak Nursing Home, is debatable and cannot be held with certainty as an act of medical negligence on the part of Dr. Shivakumar but it does raise a question whether he was abreast of the current level of medical knowledge that an average surgeon was expected to be about the efficacy of this specific treatment. This question arises because, on the one hand, of the allegation that this dressing did not help reduce either the swelling or the pain in the foot/leg of the complainant and, on the other, complete absence of any noting in the medical record of 26.06.1993 as to whether the swelling had decreased or whether the pus inside the tissues had been drawn up and absorbed by the dressing. In fact, there is no medical record at all of when the dressing was removed and the observations immediately thereafter, though the fact is mentioned in the averments and evidence.
(iii) As emphasised by Mr. Garg, learned Amicus Curiae on behalf of the complainant, there are clear contradictions in the statements (written version vis a vis cross-examination) of Dr. Shivakumar about when he diagnosed the onset of gangrene in the complainants foot/leg. During final hearing, both Dr. Gupta, learned counsel for Dr. Shivakumar and the latter himself persisted with the stand that what was noticed on 25/26.06.1993 was a scab on the abrasions/injury suffered by the complainant on 22.06.1993. However, what is undisputed is that Dr. Shivakumar excised the so-called scab (dark/black patch on the skin of the left foot) with a pair of surgical scissors but the complainant did not feel any pain. This, as we have observed, was on 26.06.1993 (evening hours) and, thus, by that time there was enough evidence of (at least, mild) necrosis of the epidermis having developed. Yet, the surgery performed by Dr. Shivakumar on the complainants leg/foot on 27.06.1993 was limited, according to the surgical notes on record, only to fasciotomy for drainage of oedematous fluid and consequent decompression (relieving of pressure in a compartment of the limb). There is no record, even at this stage, if a sample of the drained fluid or of the excised tissue/fascia was subjected to appropriate culture and sensitivity tests to ascertain the causative bacterial organisms responsible for the patients condition and the antibiotics that would have been most effective in drug-based treatment thereof. This was particularly important because between 27.06 and 01.07 (forenoon) the complainant was treated only with antibiotics in fact, Metrogyl IV injection was discontinued on 29.06.1993 at the advice of Dr. Jayaprakash, the Physician, - and the lone antibiotic Ciplox IV injection being administered clearly did nothing to arrest the fulminant growth of the bacteria. As a result, the tissue necrosis, first evident on 26.06.1993 evening, worsened very quickly and by 29.06.1993 evening, the patient had developed (++) necrosis/gangrene in patches on the left leg, as observed by Dr. Ravi Shankar on that day. In fact, the only instructions for pathological/serological tests noted in the entire medical record, advising tests like Haemoglobin, Blood urea, Serum creatinine and Blood grouping and typing are of 01.07.1993, i.e., just before the second surgery of 01.07.1993. In other words, before the first surgery of 27.06.1993, Dr. Shivakumar did not think it necessary to get even the blood grouping and typing of the complainant done.
(iv) (a) The most notable fact, which has been completely misread by the State Commission is that after his self-sought discharge, against medical advice, from the care of Dr. Shivakumar on 02.07.1993, the complainant got himself admitted to the Bangalore Hospital the same day where he underwent, under G. A., another full-scale fasciotomy and debridement surgery of his left leg. Before us too, both Dr. Shivakumar and his learned counsel sought to emphasise that the treatment accorded by the former to the complainant was almost similar to what he received at the Bangalore Hospital and thus what Dr. Shivakumar did by way of treatment of the complainant was what would have been done by any other surgeon of reasonably average competence and skill.
(b) Our reading, however, is entirely contrary: had the treatment, particularly the surgery of fasciotomy and debridement, as universally recognised to be the treatment in case of necrotising cellulitis (vide section V above) of a lower limb like foot and leg given/done by Dr. Shivakumar on 01.07.1993 been surgically adequately aggressive in the then existing condition of the patient/complainant, there was no earthly reason for the surgeon(s) at the Bangalore Hospital to carry out an identical surgery on the complainant the very next day. In other words, as explicitly alleged by the complainant, the surgery conducted by Dr. Shivakumar on 01.07.1993 was not only belated, it was also inadequate in terms of its extent and coverage.
(c) On the last-mentioned point, this then was as nearly a case of res ipsa loquitur in medical negligence as could be.
(v) Another aspect, albeit minor in comparison, may also be noticed: In the entire medical record of Deepak Nursing Home, there is not a single mention of the readings/results of any pathological/serological tests carried out on the complainant. As against that, of the 11/3 typed pages of Discharge Record of the complainant from the Bangalore Hospital for his in-patient treatment during 02
- 13.07.1993, nearly a third of a page is devoted to the results of over a dozen such tests conducted on the complainant.
(vi) On the conduct of the complainant, the State Commission has rightly observed adversely on two counts:
non-payment of the dues of the Deepak Nursing Home and, more important, the repeated self-sought discharge against medical advice.
(vii) In conclusion, therefore, we have to hold that Dr. Shivakumar (a) did not display the level of current knowledge expected of a surgeon of ordinary skills in prescribing the application of magsulph dressing to the affected leg and foot of the complainant, (b) did not follow the standard protocol (ABC) of diagnostic tests in a case of cellulitis which was certainly not of the simplest variety,
(c) was certainly unable to diagnose the onset of gangrene in the affected limb of the complainant at the point of time when there was enough clinical evidence therefor (i.e., 26.06.1993), (d) did not, as per the medical record, obtain, in the format actually used by him later (i.e., on 01.07.1993), valid consent of the complainant (or, even his mother) for the surgery of 27.06.1993, (e) did not obtain the consent of the complainant for the surgery of 01.07.1993 and instead sought and obtained the consent of the complainants mother, though the complainant was very much in a position to give valid consent on or immediately before that date, and, most important, (f) conducted a fasciotomy and debridement/desloughing surgery on the left leg/foot of the complainant on 01.07.1993 which was inadequate for the purpose, not only according to the standard protocol in this behalf as per the medical textbooks but also established by the need for an identical surgery having to be performed on the same limb of the complainant on the very next day (i.e., 02.07.1993) at the Bangalore Hospital.
(viii) As a result, the appeal has to be partly allowed and the impugned order of the State Commission deserves to be set aside. We order accordingly.
(ix) The next question that arises for determination is the reasonable amount of compensation to which the complainant would be entitled. Here the conduct of the complainant, as noticed by the State Commission, assumes significance. He left the Deepak Nursing Home without settling the dues and against medical advice. The dues owed were over Rs. 10,000/-. Even if it is assumed that the complainant was dissatisfied with the treatment that he received at the Deepak Nursing Home and accordingly sought and obtained discharge against medical advice, it cannot be overlooked that he did not settle the dues, despite promising (or, someone else promising on his behalf) to do so. On the other hand, the demand for compensation in the complaint is not only exaggerated but also largely unsubstantiated.
16. While partly allowing the appeal and setting aside the order of the State Commission, we are, therefore, of the view that in the facts and circumstances of the case, the ends of justice would be met adequately if the complainant were allowed a lumpsum compensation of Rs. 1 lakh. We accordingly direct the respondent Dr. H. N. Shivakumar to remit the sum of Rs. 1 lakh to the complainant by a demand draft in the latters favour within 4 weeks from the date of this order, failing which the amount shall carry interest @ 9% per annum from the date of this order till actual payment. There shall be no order as to costs in these or earlier proceedings.
17. Before parting with the matter, we would like to place on record the assistance rendered by Mr. Ajay Garg, Amicus Curiae in this case. We direct the Registry to disburse a sum of Rs. 10,000/- to him towards his out-of-pocket expenses.
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[R. C. JAIN, J] [ANUPAM DASGUPTA]