National Consumer Disputes Redressal
Jayendra Maganlal Padia vs Dr Lalit P Trivedi And Ors on 6 July, 2011
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI FIRST APPEAL No. 396 OF 1996 (From the Order dated 01.07.1996 of the Gujarat State Consumer Disputes Redressal Commission, Ahmedabad in Complaint Case No. 84 of 1993) Jayendra Maganlal Padia Appellant versus 1. Dr. Lalit P. Trivedi 2. Dr. Ashok Nathwani 3. Dr. Kishor J. Doshi Respondents 4. Navalben Maniram Virani Hospital 5. The New India Assurance Co. Ltd. BEFORE: HONBLE MR. JUSTICE R. C. JAIN PRESIDING MEMBER HONBLE MR. ANUPAM DASGUPTA MEMBER For the Appellants Mr. Harshawardhan Jha, Advocate (Amicus Curiae) and Appellant in person For Respondents no. 1 and 3 Mr. Jos Chiramel, Advocate For Respondent no. 4 Mr. Chirag M. Shroff and Mr. Dattatraya V. Vyas, Advocates For Respondent no. 5 NEMO Dated 6th July 2011 ORDER
ANUPAM DASGUPTA The appellant was the complainant before the Gujarat State Consumer Disputes Redressal Commission, Ahmedabad (in short, the State Commission) in consumer complaint no. 84 of 1993. By the impugned order, the State Commission dismissed the complaint against all the Opposite Parties (OPs) except Dr. Ashok Nathwani, consulting paediatrician (OP 2) at the Navalben Maniram Virani General Hospital, Rajkot (hereafter, the OP 4 or, the Hospital). The State Commission found Dr. Nathwani, OP 2 in the complaint, guilty of medical negligence to a limited extent in treating the complainants young son Hiren and directed him to pay the complainant a compensation of Rs. 10,000/- with cost of Rs. 2,000/-. Aggrieved, the complainant is in appeal before us. For convenience, we continue to refer to the parties according to their status before the State Commission.
It was brought to the notice of this Commission during the appeal proceedings that Dr. Nathwani had expired in the intervening period. By order dated 25.05.2007, this Commission directed that the proceedings would, therefore, abate against OP 2 but the liability of the OP 4 for the omissions, etc., if any, of OP 2 would continue to be subject to examination, for which the learned counsel for OP 4 would get an opportunity to be heard.
Complainants Case
2. The case of the complainant before the State Commission needs recapitulation in some detail for proper appreciation of the disputes:
(i) The complainants version before the State Commission was that son, Hiren, a boy of about 8 years at that time, had fever on 26.02.1990 and, therefore, the complainant consulted OP 1, a general practitioner and his family physician. OP 1 examined Hiren and prescribed some medicines for three days. In spite of this treatment, Hirens fever did not subside; in fact, his weakness increased and he developed swelling of his lips.
The complainant, therefore, again consulted OP 1 who after examining Hiren gave medicine for application on lips and some tablets. Still, there was no improvement in Hirens condition and he developed small blisters both inside and outside his mouth. OP 1, on examining Hiren again, diagnosed that he was suffering from measles and started treatment accordingly. The complainant pointed out to OP 1 that Hiren had been vaccinated against measles and, therefore, he was unlikely to suffer therefrom. OP 1, however, told the complainant that failure of measles vaccine was not uncommon and that he had no doubt that Hiren was suffering from measles. Though the medical treatment advised by OP 1 was continued, the small blisters in the mouth spread inside and also to other parts of Hirens body. As a result, he was unable to take medicines orally and became so weak that he could not get up from the bed. On 02.03.1999, therefore, the complainant requested OP 1 to examine Hiren at the complainants house. When OP 1 visited the complainants house on that date, he still insisted that Hiren was suffering from measles but suggested consulting OP 2 who was a paediatrician. OP 2 also visited the complainants house and after examining Hiren and discussing his case with OP 1, confirmed the diagnosis that Hiren was suffering from measles. He, however, advised to move Hiren to the OP 4 Hospital (to which OP 2 was attached as a consulting paediatrician) and wrote a note to the Hospital. Hiren was admitted to the Hospital at about 11.30 a.m. on 02.03.1990.
(ii) At to the Hospital, Hiren was treated for measles under the instructions of OP 2 for over 36 hours. However, the blisters, which had spread all over his body during this period, became more severe and his condition deteriorated further. The complainant, therefore, requested the Hospital management as well as OP 2 to either give proper treatment or consult some other specialist/expert. It was only at about 3 p.m. of 03.03.1990 that OP 2 referred Hiren to Dr. Vinod Pandya, an E.N.T. surgeon attached to the Hospital.
(iii) Dr Pandya, after examining Hiren and considering the history of his ailment, diagnosed the disease as Stevens-Johnsons Syndrome (SJS) and started treatment accordingly. At about 10 p.m. the same night, Dr. B.C. Kamdar, a Dermatologist attached to the Hospital was called in to examine Hiren. The complainant alleged that like Dr. Pandya, Dr. Kamdar too expressed surprise as to how Hirens case was diagnosed as that of measles. According to the complainant, Dr. Kamdar observed that there was no symptom of measles and the treatment given so far was wrong. By the time the treatment for SJS was started, Hirens whole body was covered with large blisters.
(iv) The complainant further stated that on 05.03.1990, OP 3, a consulting ophthalmologist at OP 4, was called in to treat Hirens eyes for the adverse effects of SJS. OP 3 told the complainant that Hirens eyes were normal but as a matter of precaution, he had prescribed some medicines. The complainants grievance was that OP 3 did not prescribe steroid eye drops, which were necessary to prevent permanent damage to the eyes. Hirens tear glands were also affected during the time he was under the treatment of OP 3. According to the complainant, it was because of negligence on the part of OP 3 that there was permanent damage to Hirens eyes leading to severe impairment of his vision and inability to even keep his eyes open. However, all the time OP 3 told the complainant that there was nothing to worry about, Hirens eyes were normal and he was suffering only from photophobia. Hiren was discharged from the hospital on 10.04.1990.
(v) Thereafter, the complainant consulted Dr. Vijay Maheshwari, ophthalmic surgeon attached to the Civil Hospital, Rajkot and Dr. Mathur attached to the Civil Hospital, Ahmedabad. According to the complainant, their opinion was that Hirens tear glands had been permanently damaged and only artificial teardrops and eye ointment could be of some help. The suggested/prescribed medicines were not available in India at that time.
(vi) On the above allegations, the complainant submitted that because of negligence on the part of OPs 1 to 4, Hirens vision was permanently impaired and he had to lead a disabled life. Hiren was not even in a position to attend to his daily chores without help. Had Hirens ailment not been wrongly diagnosed as measles and instead treatment for SJS been given in time and while at the Hospital had OP 3 treated Hirens eyes properly; Hiren would have recovered completely and not suffered such a permanent disablement. It was thus on account of the negligence of the OPs that Hiren finds himself in a helpless condition. The complainant, therefore, prayed for compensation of Rs. 9.995 lakh on various counts.
Versions of Opposite Parties
3. All OPs (except OP 2) contested the allegations in the complaint before the State Commission.
(i) In his written version, OP 1 raised the question of maintainability of the complaint under the Consumer Protection Act, 1986 (hereafter, the Act) but admitted that Hiren was brought to him on 26.02.1990 and on examination he found that he had history of fever, cold and cough. He, therefore, prescribed Bactrim tablets, which contain long-acting sulfa (sulfonamide - known for curing fever and infection) and dispensed paracetamol and C.P. Maleate tablets (an antihistaminic drug). According to OP 1, he had administered sulfa drugs to Hiren in the past and he never had any reaction. He prescribed these medicines for three days and again examined Hiren on 28.02.1990. At that time, he noticed Kopliks spots, few rashes on the face, red eyes and congestion in the chest. According to OP 1, all three symptoms were suggestive of measles coupled with broncho pneumonia. The months of February and March were known season for measles epidemic in the area. He denied the allegation that Hirens fever was not controlled or that his lips were swollen when he was brought to him on 28.02.1990. When he was told that Hiren had been vaccinated for measles, OP 1 told the family members of Hiren that failure of measles vaccination was not uncommon. Measles, according to OP 1, was a viral disease and there was no specific treatment for it: only symptomatic treatment and treatment to prevent bacterial infection could be administered. OP 1 also stated that he advised the complainant to consult a paediatrician and gave a reference note to OP 2 who, as stated above, was a paediatrician attached to the Hospital. Local application for soothing was also prescribed. When the complainant again approached him on 01.03.1990, OP 1 found that the paediatrician had not been consulted. He, therefore, again advised to consult the paediatrician. According to OP 1, Hirens grandmother insisted that measles could not be cured by medicine and that Hiren should not be taken out of the house. OP 1 claimed to have warned the members of Hirens family that carelessness might result in major problems. It was only on 02.03.1990 that the complainant and the members of his family agreed to consult OP 2. OP 2, called in for a visit to the complainants house, examined Hiren and confirmed the diagnosis of measles with broncho pneumonia, and advised that Hiren be hospitalised immediately. Therefore, Hiren was moved to the Hospital. It is the case of OP 1 that he did not treat Hiren after 02.03.1990. OP 1 further denied that SJS was the reaction of the sulfa drug, Bactrim, since Hiren had been administered sulfa drugs in the past without any reaction/complication. Hirens SJS could have been due to a number of factors, including measles. In short, OP 1 claimed that there was no negligence on his part in treating Hiren and he was not liable to pay any compensation to either the complainant or Hiren.
(ii) OP 2, a paediatrician attached to the Hospital (OP 4) did not appear to contest the complaint despite notice. The State Commission, therefore, proceeded with hearing the complaint ex parte against him.
(iii) In his written version, OP 3 also denied that there was any medical negligence or deficiency in service on his part in treating Hirens eyes. According to him, he had followed the standard and recognised medical protocol in treating Hirens eyes. He was called in to examine Hiren at the Hospital on 05.03.1990. On examination, he did not find any damage to Hirens eyes, besides redness. He, therefore, started treatment by administering necessary eye drops and ointments. He further stated that by then OP 2 and other doctors had already started treating Hiren for SJS by prescribing, inter alia, steroid injection, steroid tablets and steroid ointment for application on the skin. He added that under these circumstances, it was not necessary to prescribe topical steroid drops for Hirens eyes. Further, according to OP 3, there was no damage to the cornea of Hirens eyes nor was there any impairment of vision. Therefore, to treat Hirens eyes, it was not necessary for him to prescribe any medicine other than what he had actually done. He further stated that steroid eye drops were likely to cause harm to Hiren having regard to their condition and that Dr. Maheshwari, who examined Hiren later, also did not prescribe steroid eye drops for him. Thus, the treatment, which OP 3 gave Hiren, was proper. OP 3 also claimed that after consulting Dr. Nagpal on 18.06.1990, the complainant did not consult him again as alleged by him. The complainant, however, continued to put steroid eye drops in Hirens eyes without consulting any doctor and that was how he alone was responsible for causing severe damage to Hirens eyes. OP 3 thus denied the allegation and any liability to pay compensation to the complainant.
(iv) In its written version, OP 4, the Hospital, also denied the complainants allegations of negligence. It claimed that it engaged the services of specialists in various branches of medicine and provided treatment to the patients according to the advice of these specialists/experts. Accordingly, Hiren was treated as advised by the Paediatrician, Dermatologist, ENT Specialist and Ophthalmologist who attended on him. Hiren was given proper treatment and there was no negligence on the part of OP 4, as alleged by the complainant. Therefore, OP 4 also prayed for dismissal of the complaint.
Evidence Affidavits
4. All parties (except OP 2) filed their affidavits by way of evidence.
(i) In his rejoinder affidavit in reply to the written version of OP 1, the complainant stated that through a typographical mistake he had mentioned 26.02.1990 as the date since which OP 1 treated Hiren. According to his recollection, OP 1, in fact, started treating Hiren on 23.02.1990.
(ii) In support of the above-mentioned claim, the complainant also filed affidavits of Jitendra Rasiklal Kamdar and Jayantilal D. Sampat. J. R. Kamdar stated that Hiren had fever since abut 25.02.1990 and, for the next 4/5 days, he went to the complainants house to enquire about Hirens health. Hirens lips were swollen and a blue ointment had been applied to his lips. J. D. Sampat stated that Hiren had fever and swelling of lips on or about 23.02.1990, four or five days before his admission to the Hospital. The complainant also filed a copy of an affidavit purported to have been made by one Mahendrabhai Laljibhai Ashra. According to this affidavit, OP 1 had told the complainant in his presence that Dr. Vinod Pandya had telephoned him to say that Hirens case was not of measles but of SJS. He also stated that Dr. Kamdar had asked OP 1 as to how he could not distinguish between rashes/lesions of measles and those due to SJS.
(iii) The complainant examined one Dr. M. K. Joshi, a general surgeon as an expert in support of his allegations. Dr. Joshi was also cross-examined.
(iv) The parties examined/cross-examined each other and filed medical literature before the State Commission in support of their respective contentions.
Impugned Order
5. The State Commission declined to take cognisance of the complainants averments (in his rejoinder affidavit to the written version of OP 1) to correct the date when OP 1 first examined Hiren, stated as 26.02.1990 in the complaint, to (on or about) 23.02.1990. For, the State Commission held it to be a belated attempt of the complainant to improve his case, after obtaining medical advice or consulting medical literature (during the period between OP 1 filing his version and the complainant filing his counter affidavit). This, the State Commission held, was to derive advantage by showing that Hirens rashes and swelling of lips had appeared in about five days since the start of the treatment by OP 1, in which case there would be little possibility of diagnosing Hirens case as measles on 28.02.1990. The State Commission also did not attach any importance to the affidavits of J. R. Kamdar and J. D. Sampat, whom the complainant examined as his witnesses in support of the date when OP 1 started treating Hiren. We shall presently address the findings of the State Commission but this particular aspect is important enough to be noticed at the outset.
6. Assessment of the case alleged against OP 1 is constrained by the absence, on record, of any of his medical notes/prescriptions in respect of Hiren. When asked during the hearing of this appeal, OP 1, present in person, stated that Hiren being an out patient, he did not keep any record at his clinic and handed over the prescriptions to the complainant. The complainant, also present in person, pleaded inability to produce them because of the lapse of time. Thus, in the absence of any direct documentary evidence regarding Hirens symptoms observed on examination and consequent diagnosis of his ailment by OP 1, only the averments and secondary documents would have to suffice.
7. As implied by the State Commission, the date of OP 1 starting Hirens treatment has significance in adjudicating the dispute because of medical reasons. Hence, a discussion of the medical literature on the subject is necessary at this stage.
Medical Literature
8. The relevant medical literature informs us as under:
(i) Measles (or, red measles) is a viral disease, caused by the rubeola virus.
(a) The well-known textbook Harrisons Principles of Internal Medicine (17th Edition, Volume I;
pp 1214-1217) has the following to say on measles:
CLINICAL MANIFESTATIONS Measles begins with a 2-to-4 day respiratory prodrome (a symptom or group of symptoms that appears shortly before an acute attack of illness) of malaise, cough, coryza (nasal discharge often accompanying the common cold and other conditions), conjunctivitis (an inflammation or redness of the lining of the white part of the eye and the underside of the eyelid (conjunctiva) that can be caused by infection, allergic reaction, or physical agents like infrared or ultraviolet light) with lacrimation (secretion of tears, especially in excess), nasal discharge and increasing fever [with temperatures as high as 40.60C (1050F), probably reflecting secondary viremia]. At this stage of the illness, in which the rash has not yet developed, influenza may be suspected. Just before rash onset, Kopliks spots appear as 1-to-2 mm blue-white spots on a bright red background.
Without adequate illumination for examination, they may be overlooked. Kopliks spots (irregular, bright red spots on the buccal and lingual mucosa, with tiny bluish-white specks in the centre of each; seen in the prodromal stage of measles) are typically located on the buccal mucosa (the mucous membranes lining the inside of the mouth), alongside the second molars, and may be extensive; they are not associated with any other infectious disease. The spots wane after the onset of rash and soon disappear. The entire buccal and inner labial mucosa may be inflamed, and the lips may be reddened.
The characteristic erythematous (characterised by redness of the skin due to congestion of the capillaries), nonpruritic (non-itching), maculopapular (both macular and papular; macular being the adjective of macule which is defined as an area (5 to 10 mm at its widest diameter) of the skin distinguishable from its surroundings by surface colour without elevation or depression and papular being the adjective of papule which means a small, circumscribed, solid, elevated lesion of the skin small being from the size of a pinhead to about 5-10 mm in diameter at its widest point) rash of measles begins at the hairline and behind the ears, spreads down the trunk and limbs to include the palms and soles, and often becomes confluent. By the fourth day, the rash begins to fade in the order in which it appeared. Fever usually resolves by the fourth or fifth day after the onset of rash; prolonged fever suggests a complication of measles. The entire illness, which usually lasts ~ 10 days, tends to be more severe in adults than in children [Notes: 1. Emphasis supplied. 2. The quotations within parenthesis are common language meanings of medical terms drawn from the websites http://medical-dictionary.thefreedictionary.com and http://en.wikipedia.org/wiki/Cutaneous_conditions, which in turn draw from various well-known medical dictionaries mentioned as the source in each case]
(b) Another well-known medical textbook, Kelleys Textbook of Internal Medicine (4th Edition; pp 2147-48) has the following, inter alia, on measles:
CLINICAL FEATURES The typical pattern of measles symptoms is a 2-to-4 day prodrome of fever, malaise, cough, coryza, conjunctivitis and photophobia. Kopliks spots, which are faint, white, 1-2 mm elevated lesions on an erythematous base, may be present for 1 or 2 days before and after the onset of rash and are pathognomonic of measles. The prodrome is followed by the appearance of a characteristic rash beginning on the head, neck and trunk and spreading centrifugally over the course of 2 or 3 days. The rash lasts 5 to 7 days and may be followed by a period of desquamation lasting upto 1 week. [Emphasis supplied]
(ii) On the other hand, the above-mentioned textbooks say the following on SJS.
(a) According to Harrisons Principles of Internal Medicine (17th Edition, Chapter 56, p. 346):
SJS and Toxic epidermal necrolysis (TEN) are terms that, most believe, describe the same usually drug-induced disorder, which is characterized by blisters and epidermal detachment resulting from epidermal necrosis in the absence of substantial dermal inflammation. The term SJS is now used to describe cases with blisters developing on dusky or purpuric macules in which total body surface area blistering and eventual detachment is <10%. The term SJS / TEN is used to describe cases with 10 30 % detachment, and TEN is used to describe cases with >30% detachment. Erythema multiforme major is now considered by most to be different from SJS, characterized by typical target lesions and resulting from a reaction to infection, most commonly from herpes simplex virus.
Patients with SJS, SJS/TEN initially present with acute symptoms, painful skin lesions, fever >39OC (102.2OF), sore throat, and visual impairment resulting from mucous membrane and ocular lesions. Intestinal and pulmonary involvements are associated with a poor prognosis, as are a greater extent of epidermal detachment and older age. About 10% and 30% of SJS and TEN-affected persons die from their disease, respectively. Drugs that most commonly cause SJS or TEN are anti-infectious sulphonamides, nevirapine, allopurinol, lamotrigine, aromatic anticonvulsants, and oxicam NSAIDs. At this time SJS or TEN have no treatment of proven efficacy. The best results come from early diagnosis, immediate discontinuation of any suspected drug, and supportive therapy, paying close attention to ocular complications, often in burn units or intensive care units.
TABLE 56-3: CLINICAL FEATURES OF SELECTED SEVERE CUTANEOUS REACTIONS OFTEN INDUCED BY DRUGS Diagnosis Mucosal Lesions Typical Skin Lesions Frequent Signs and Symp-toms Alternative Causes Not Related to Drugs Stevens-Johnson syndrome Erosions usually at >two sites Small blisters on dusky purpuric macules or atypical targets; rare areas of confluence; detachment < >10% of body surface area Most cases involve fever 10 20% cause not determined Toxic epidermal necrolysis Erosions usually at >two sites Individual lesions like those seen in Stevens-Johnson syndrome; confluent erythema;
outer layer of epidermis separates readily from basal layer with lateral pressure; large sheet of necrotic epidermis; total detachment of >30% of body surface area Nearly all cases involve fever, acute skin failure, leukopenia 10 20% cause not determined Induction of SJS is most often due to drugs, especially sulphonamides, phenytoin, barbiturates, penicillins, and carbamazepine. Widespread dusky macules and significant mucosal involvement are characteristic of SJS, and the cutaneous lesions may or may not develop epidermal detachment. If the latter occurs, by definition, it is limited to <10% of the body surface area (BSA). Greater involvement leads to the diagnosis of SJS/TEN overlap (10-30% BSA) or TEN (>30% BSA). (p. 328) However, in the Table below from Chapter 32 on Oral Manifestations of Disease, the same textbook has a somewhat different description of SJS:
TABLE 32-1:
VESICULAR, BULLOUS OR ULCERATIVE LESIONS OF THE ORAL MUCOSA Dermatologic Diseases Condition Usual Location Clinical Features Course Erythema multiforme minor and major (Stevens-Johnson syndrome) Primarily the oral mucosa and the skin of hands and feet Intra-oral ruptured bullae surrounded by inflammatory area; lips may show hemorrhagic crusts; the Iris, or target lesion on the skin is pathognomonic; patient may have severe signs of toxicity Onset very rapid; usually idiopathic, but may be associated with trigger such as drug reaction; condition may last 36 weeks; mortality with EM major 515% if untreated
(b) On the other hand, Kelleys Textbook of Internal Medicine (4th Edition, Chapter 197, pp.
1497-98) has the following on these diseases:
Erythema multiforme is a spectrum of acute, self-limited, cutaneous and mucosal inflammatory syndromes, the hallmark of which is a persistent erythematous, annular, target lesion.
Etiology and Pathogenesis A wide variety of agents have been implicated in the cause of Erythema multiforme. The most common of these are infections and drugs. Drugs commonly associated with Erythema multiforme major and minor include sulfonamides (and sulfonamide derivatives), phenylbutazone, phenytoin, and the penicillin derivatives. Two infectious agents, recurrent herpes simplex and Mycoplasma, cause most cases of infection-associated erythema multiforme. Physical agents (e.g., x-radiation), immunizations and hyposensitizations, malignancies (e.g., carcinoma, lymphoma), contact allergies (e.g., as part of a vigorous response to poison ivy or poison oak), and various autoimmune diseases also have been associated with erythema multiforme, but not as frequently.
Clinical Features and Laboratory Findings Erythema multiforme has been divided into major (involving skin and mucous membranes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis) and minor (involving only one surface) forms. In reality, a continuum of disease exists. Often, lesions become acute after a prodrome of fever, malaise, and sore throat. Diagnostic lesions are typical erythematous, annular, target lesions with concentric rings of colour and a symmetric distribution. Bullae often develop in the centre target lesions and evolve into erosions that eventually crust. Mucosal involvement, particularly of the mouth or conjunctiva, occurs in upto 50% of patients. Widespread bulla formation, often on a background of large erythematous plaques, can result in the loss of substantial amounts of the epidermis.
Stevens-Johnson syndrome, or erythema multiforme major, represents the intermediate form of the disease and is more likely to be triggered by drug than by infectious agents. At least two mucosal surfaces (e.g., oral labial, conjunctival, anogenital) must be involved in addition to the usual cutaneous findings of erythematous targetlike or bullous lesions to make the diagnosis of Stevens-Johnson syndrome. The mucosal lesions may precede the cutaneous erythema or bullae and can be painful in contrast to the skin lesions, which usually are nontender.
Course, Therapy, and Prognosis Both minor and major erythema multiforme are self-limited, the former resolving in 1 to 2 weeks and the latter in 3 to 6 weeks. If the oral involvement is severe, food and fluid intake may be compromised. Ophthalmologic (keratitis and perforation) and respiratory (obstruction or pneumonia) problems and progression to toxic epidermal necrolysis with associated fluid and protein loss, internal organ involvement, and predisposition to septicaemia are major complications. Death may occur in upto 20% of patients with severe erythema multiforme major and in upto 50% of patients with toxic epidermal necrolysis.
The mainstay of therapy is nutritional and fluid support and local care (compress or whirlpool baths) to provide gentle debridement and prevent infection. Erythema multiforme major with widespread bullae formation and toxic epidermal necrolysis probably can be treated most effectively in a burn unit, where requirements for aggressive fluid and nutritional support are recognised and local care is routine.
Systemic corticosteroid therapy for erythema multiforme is controversial. If prednisone is given early in the course of the illness, mortality may be diminished. The use of high doses of corticosteroids (e.g., prednisone, 1 to 2 mg per kilogram per day) in toxic epidermal necrolysis can decrease morbidity and may halt progression of cutaneous inflammation, but may not alter the high mortality rate seen in severely affected patients. For patients with recurrent erythema multiforme secondary to recurrent herpes simplex infection, chronic oral administration of acyclovir in suppressive doses has been helpful.
(c) On the ophthalmological implications of SJS, we notice the following from the Oxford Textbook of Ophthalmology (Volume 2, page 1042):
Children are also affected by Stevens-Johnson syndrome (erythema multiforme major), a severe form of ocular cutaneous reaction following drug therapy. This is a major illness in which the patient is systemically ill and there are typical target lesions on the skin with mucus membrane involvement including a non-specific conjunctivitis. The conjunctivitis may be associated with a mucopurulent discharge and membrane formation. There may also be an anterior uveitis and sometimes acute corneal ulceration. As serious as this acute phase may be, the chronic ocular disease, which follows can be particularly troublesome. There is submucosal scarring, which can result in gross structural changes in the eyelid resulting in trichiasis and subsequent corneal damage. In addition there is ocular surface metaplasia, which may be severe and keratinizing.
The precise cause is unknown, and there is no pathognomonic pathological picture the diagnosis is clinical, but there is a general acceptance that circulating immune complexes which have been found during the acute phase of the disease in the subepithelial microvasculature, are relevant.
In the acute phase of the disease treatment of a generally supportive nature is all that can be offered. Treatment of the chronic sequelae may include dealing with trichiasis, treating keratinization of the ocular surface with topical vitamin A, and the use of surgical procedures to reorganize the ocular surface and tear film supplementation.
(d) Parsons Diseases of the Eye (20th Edition, Section IV, pp 174) has the following:
Stevens Johnson syndrome (Erythema multiforme major). This is a type II hypersensitivity reaction usually due to an immunological reaction to drugs (sulphonamides, non-steroidal anti-inflammatory drugs, antibiotics, antimalarials, antiepileptics (such as barbiturates and phenytoin) or systemic infections (caused by Mycoplasma pneumoniae, herpes simplex virus and some fungi). It is a serious disease, fatal in some patients, characterized by skin rash, erythematous lesions followed by bullae and epidermal necrosis, fever, malaise and ulcerative lesions of the mucous membranes, particularly the mouth and the eyes. Late ocular sequelae include severe dry eye, symblepharon, lid deformity (cicatricial entropion), corneal vascularization and scarring. Ocular treatment in the acute stage includes supportive therapy with topical lubricants, antibiotics to prevent secondary bacterial infection, and lysis of adhesions forming between the bulbar and palpebral conjunctiva by passing a glass rod coated with antibiotic or plain paraffin ointment in the fornices. The late cicatricial stage can be treated medically to control the manifestations of a dry eye and lid deformities can be surgically corrected.
Additional measures such as punctal occlusion, transplantation of conjunctival or buccal mucous membrane and transplantation of limbal stem cells with amniotic membrane to promote healing may be needed to restore the integrity of the damaged ocular surface. [Emphasis supplied]
(e) Similarly, the Textbook Essentials of Ophthalmology by Neil J. Friedman and Peter K. Kaiser (First Edition, Chapter 9, pp 158-59) has the following, much clearer statements:
Stevens Johnson Syndrome (Erythema Multiforme Major) Definition Stevens-Johnson syndrome is a cutaneous, bullous disease with mucosal involvement resulting in acute bilateral, membranous conjunctivitis.
Etiology This systemic disorder is usually caused by a drug reaction (i.e., sulfonamide, penicillin, aspirin, barbiturates, isoniazid, or phenytoin) or infection (HSV, adenovirus, Mycoplasma and Streptococcus species).
Symptoms Patients present with constitutional symptoms of fever, upper respiratory infection, headache, arthralgias, and malaise. They complain of skin eruptions and eye involvement causing decreased vision, pain, redness and swelling.
Signs Inspection of the skin reveals of rash consisting of characteristic target lesions. Patients have elevated temperature, and the mucous membranes show ulceration and strictures. The conjunctivitis is characterized by decreased visual acuity, conjunctival injection, discharge, membranes, symblepharon (adhesion between the palpebral and bulbar conjunctiva), trichiasis and corneal ulceration scarring, vascularization, and keratinization.
Differential diagnosis Other diseases that can produce similar eye findings include ocular cicatricial pemphigoid, chemical burn, radiation, squamous cell carcinoma, scleroderma, infectious or allergic conjunctivitis, trachoma, sarcoidosis and ocular rosacea.
Evaluation A main goal of the history is to identify the causative agent if possible.
The eye exam should focus on the lids (trichiasis), conjunctiva (injection, symblepharon, ulceration), and cornea (staining, ulceration, scarring). If the patient presents during the acute phase of the disease, it is also important to inspect the skin and oral mucosa for characteristic lesions.
Medical consultation.
Management Treatment of Steven-Johnson syndrome is supportive, consisting of:
Topical lubrication using non-preserved artificial tears (up to q1h) and ointment (qhs).
Topical antibiotic (polymyxin B sulfatetrimethoprim (Polytrim) qid or erythromycin ointment tid) for corneal epithelial defects.
Topical steroid (prednisolone acetate 1% upto q2h) depending on the degree of inflammation. Systemic steroids (prednisone 60-100 mg PO qd) may be necessary in very severe cases.
Consider punctual occlusion and possible tarsorrhaphy to control dry eye.
Some cases may require lysis of symblepharon, and surgery for trichiasis or corneal scarring.
Prognosis The prognosis is fair because, even though Stevens Johnson syndrome is usually self-limited (<6 weeks) and recurrences are rare, the mucous membrane damage is permanent and can be difficult to treat. Furthermore, these patients are susceptible to secondary infection, with a mortality rate up to 30%.
[Emphasis supplied]
(f) Finally, we may also notice the simplified literature on the ophthalmological implications of SJS on the website of the National Eye Institute of the USA (http://www.nei.nih.gov/health/cornealdisease/):
Stevens-Johnson syndrome: Stevens-Johnson syndrome (SJS), also called erythema multiforme major, is a disorder of the skin that can also affect the eyes. SJS is characterised by painful, blistery lesions on the skin and the mucous membranes (the thin, moist tissues that line body cavities) of the mouth, throat, genital region, and eyelids. SJS can cause serious eye problems, such as severe conjunctivitis, iritis, an inflammation inside the eye, corneal blisters and erosions, and corneal holes. In some cases, the ocular complications from SJS can be disabling and lead to severe vision loss.
Scientists are not certain why SJS develops. The most commonly cited cause of SJS is an adverse allergic drug reaction. Almost any drug--but most particularly sulfa drugs--can cause SJS. The allergic reaction to the drug may not occur until 7-14 days after first using it. SJS can also be preceded by a viral infection, such as herpes or the mumps, and its accompanying fever, sore throat, and sluggishness. Treatment for the eye may include artificial tears, antibiotics, or corticosteroids. About one-third of all patients diagnosed with SJS have recurrences of the disease.
SJS occurs twice as often in men as women, and most cases appear in children and young adults under 30, although it can develop in people at any age. [Emphasis supplied]
9. A reading of the medical literature in these medical textbooks brings out that there is some confusion in the use of the term erythema multiforme major to signify SJS. From our own web-based research, we have, however, been able to locate an (August 2009) article by Dr. Don R Revis Jr., MD of the Division of Plastic and Reconstructive Surgery, University of Florida College of Medicine (vide website: eMedicine Specialties > Infectious Diseases > Skin and Soft-Tissue Infections) which lucidly clarifies this confusion:
Background Erythema multiforme (also known as Stevens-Johnson syndrome [SJS]) and toxic epidermal necrolysis (TEN) are often confused in the medical literature.
In 1860, Ferdinand von Hebra initially described erythema multiforme as an acute, self-limited condition with characteristic red papular skin lesions. The papules evolve into pathognomonic target lesions or iris lesions that appear within a 72-hour period and begin on the extremities. Lesions remain in a fixed location for at least 7 days and then begin to heal. Precipitating factors include herpes simplex virus (HSV), Epstein-Barr virus, and histoplasmosis. Because this condition may be related to a persistent antigenic stimulus, recurrence is the rule rather than the exception, with most affected individuals experiencing 1-2 recurrences per year. Erythema multiforme is typically a benign, self-limited disorder.
SJS is a mucocutaneous disorder. It was first described by Stevens and Johnson in 1922 as febrile erosive stomatitis (note: inflammation of the mucous lining of any of the structures of the mouth), severe conjunctivitis, and disseminated cutaneous eruption. Lesions typically begin on the face and trunk. They are flat, atypical lesions, described as irregular purpuric macules with occasional blistering. Most patients also have extensive mucosal involvement. More than 50% of all cases are attributed to medications. This is a more serious illness and is potentially life threatening.
The confusion between these two separate clinical entities began in 1950, when Thomas coined the terms erythema multiforme minor and erythema multiforme major to describe conditions he encountered.
Erythema multiforme minor was applied to patients with the illness originally described by von Hebra as erythema multiforme.
Erythema multiforme major was applied to patients who also displayed oral mucosal involvement, similar to that described by Stevens and Johnson.
Up to 50% of patients with HSV (herpes simplex virus)-associated erythema multiforme have been found to have oral ulcers.
However, this is now recognized as a variant of erythema multiforme, rather than SJS. Because SJS and erythema multiforme have different precipitating factors and different clinical patterns, the terms erythema multiforme major and erythema multiforme minor should no longer be used.
Erythema multiforme with mucosal involvement is now termed bullous erythema multiforme.
SJS is recognized as a separate clinical entity.
Lyell first described TEN in 1956. His original description made no reference to the work of Stevens and Johnson. The distinction between SJS and TEN is not clear. In fact, these conditions probably represent differing severities of the same disease process.
SJS and TEN have similar precipitating factors, identical histopathologic lesions, and similar clinical patterns.
By current convention, the following terminology is used:
The term SJS is used when the disease involves less than 10% of the total body surface area.
TEN is used when the disease involves more than 30% of the body surface area.
Patients whose disease involves 10-30% of their body surface area are said to have SJS/TEN overlap. Mortality increases as the percentage of involved body surface increases, making TEN the more severe of the skin reactions. [Emphasis supplied]
10. On the basis of the foregoing medical literature, we may now summarise the differences between measles and SJS, on the one hand and between SJS and erythema multiforme major, on the other:
MEASLES
(i) Measles is caused by rubeola virus.
(ii) The disease is preceded by a 2-4 day period of symptoms (prodrome) of malaise, cough, nasal discharge, and conjunctivitis with excessive secretion of tears, and increasing fever of up to 105oF. At this stage, when the rash has not yet developed, influenza may be suspected.
(iii) Before the onset of rash, Kopliks spots appear.
These look like 1-2 mm faint blue-white spots on the bright red background of the mucous membrane lining of the mouth in the area of the second molars, and may be extensive. They wane after the onset of rash and soon disappear. The period for which they last is thus about 1-2 days before and after the appearance of rash, i.e., in all for 2-4 days - overlapping the end of the prodrome and the onset of the rash. They may be overlooked altogether unless the inside of the patients mouth is examined in sufficient illumination. The entire mucous membrane lining inside the mouth may be inflamed and the lips may be reddened.
(iv) The characteristic rash of measles - small, circumscribed, solid, elevated lesions of the skin appear, after the prodrome, at the hairline and behind the ears, spread down the trunk and limbs to include the palms and soles, and often become confluent.
(v) By the fourth day (of its appearance), the rash begins to fade in the order in which they appeared. Fever usually resolves by the fourth or fifth day after the onset of rash. The entire illness usually lasts ~ 10 days.
SJS
(i) SJS is usually (in more than 50% cases) a drug-induced, immunological, mucocutaneous (mucocutaneous zone in humans are at the lips, nostrils, conjunctivae, urethra, vagina and anus) disorder (there is no evidence so far that SJS is caused by any virus, leave alone the rubeola virus which causes measles). Drugs that most commonly cause SJS (and/or, toxic epidermal necrosis/necrolysis TEN) are sulfonamides (sulfa-related group of antibiotics, used to treat bacterial and some fungal infections), nevirapine (oral medication for HIV AIDS), allopurinol (oral drug for treatment of gout), lamotrigine (oral drug for treating seizures), aromatic anticonvulsants, and oxicam NSAIDs (non-steroidal anti inflammatory drugs). Patients with SJS or SJS/TEN initially present with acute symptoms, painful skin lesions, fever above 102.2OF, sore throat, and visual impairment resulting from mucous membrane and ocular lesions.
(ii) SJS was first described by Stevens and Johnson in 1922 as febrile erosive stomatitis (note: stomatitis is an inflammation of the mucous lining of any of the structures in the mouth, which may involve the cheeks, gums, tongue, lips, throat, and roof or floor of the mouth), severe conjunctivitis, and disseminated cutaneous eruption. Lesions typically begin on the face and trunk (as against the rash of measles, which begins at the hairline and behind the ears, spreads down the trunk and limbs to include the palms and soles, and often becomes confluent). The SJS lesions are flat, atypical lesions, described as irregular purpuric macules with occasional blistering (as against the rash of measles which consists of small, circumscribed, solid, elevated lesion of the skin). Most patients of SJS also have extensive mucosal involvement in at least two mucocutaneous areas (as against measles in which the mucous membrane lining inside the mouth may be inflamed and the lips may be reddened). SJS is a more serious illness and is potentially life threatening.
(iii) The confusion between the two separate clinical entities, viz., SJS and erythema multiforme major began in 1950, when Thomas coined the terms erythema multiforme minor and erythema multiforme major to describe conditions he encountered.
Erythema multiforme minor was applied to patients with the illness originally described by von Hebra as erythema multiforme.
Erythema multiforme major was applied to patients who also displayed oral mucosal involvement, similar to that described by Stevens and Johnson.
(iv) Up to 50% of patients with HSV (herpes simplex virus)-associated erythema multiforme have been found to have oral ulcers. However, this is now recognised as a variant of erythema multiforme, rather than SJS. Because SJS and erythema multiforme have different precipitating factors and different clinical patterns, the terms erythema multiforme major and erythema multiforme minor should no longer be used.
Erythema multiforme with mucosal involvement is now termed bullous erythema multiforme.
SJS is recognized as a separate clinical entity.
(v) Erythema multiforme major is characterised by typical target or iris lesions resulting from a reaction to infection, most commonly from herpes simplex virus (HSV).
(vi) SJS is characterised by blisters and epidermal detachment, the latter resulting from epidermal necrosis. In more than 50% cases, this is a drug-induced disorder. Among the drugs implicated, sulfonamides (sulfa-related group of antibiotics, used to treat bacterial and some fungal infections) are prominent.
Arguments of Parties 11 (i) We have heard Mr. Harshawardhan Jha, Advocate who was appointed amicus curiae to assist us with the case of the complainant (who too appeared in person); Mr. Jose Chiramel, learned counsel on behalf of OP 1 and OP 3; and Mr. Chirag M. Shroff and Mr. Dattatraya Vyas, Advocates on behalf of OP 4.
(ii) (a) Mr. Jha submitted that OP 1 wrongly diagnosed Hirens ailment as measles with broncho-pneumonia and, even worse, continued with his treatment for measles with the sulfa drug Bactrim even after Hiren had developed unmistakable signs of severe adverse reaction to the latter. The diagnosis of measles by OP 1 was further belied by the referral note dated 02.03.1990 of OP 2 to OP 4 for Hirens admission, in which OP 2 had written the following: Apical consolidation in a case of measles with severe thrush and stomatitis. Admission in Virani Hospital. Severe thrush (thrush being a disease of the mucous membrane of the mouth characterised by white patches and caused by a parasitic/fungal organism known as Candida albicans, vide Blacks Medical Dictionary) and stomatitis are not at all the symptoms of (or, related to) measles. Moreover, if the thrush and stomatitis were severe on 02.03.1990, they could not have been as mild on 28.02.1990 as to confuse them with the typical rash of measles at the time of its onset. This should have alerted both OP 1 and OP 2 to look for the real cause of Hirens condition.
(b) As regards OP 2, Mr. Jha further submitted that despite being a paediatrician, he failed to correctly diagnose Hirens condition and continued his treatment for measles for one-and-a-half days after his admission to the OP 4 Hospital. It was only in the late afternoon of 03.03.1990 that OP 2 thought it fit to seek the opinion of an E.N.T. surgeon, viz., Dr. Pandya.
(c) As regards OP 3, Mr. Jha argued that it was the formers negligence that was solely responsible for the permanent damage to Hirens eyes. OP 3 first saw Hiren on 05.03.1990, and despite his severe conjunctival inflammation, failed to prescribe topical steroid eye drops to control the said inflammation. Administration of topical steroid drops, in addition to antibiotics to control secondary infection, is the most preferred course of treatment for a patient of SJS showing signs of involvement of the eyes. For this, Mr. Jha sought to rely on the extracts of medical literature produced before the State Commission, viz., Clinical Ophthalmology Stevens Johnson Syndrome; Erythema Multiforme Exudativum Stevens Johnson Syndrome by George M. Howard, MD; Essentials of Ophthalmology by Samar K. Basak; and Parsons Diseases of the Eye.
(iii) (a) On behalf of OP 1, Mr. Chiramel argued that the former treated Hiren on 26.02.1990 and prescribed Bactrim for three days, as admitted in the complaint (para. 3 (1)). However, the complainant failed to produce the prescription given by OP 1 before the State Commission. It was on 28.02.1990 that OP 1 diagnosed Hirens ailment as measles based on his examination during which he noticed Kopliks spots inside Hirens mouth. These spots being pathognomonic of measles, diagnosis of OP 1 was correct. Further, as per the complaint itself, the only allegation against OP 1 was that he administered the sulfa drug, Bactrim to Hiren. However, Hiren had been treated with sulfa drug even on earlier occasions without any adverse reaction. Therefore, there was no valid ground for the complainant to allege medical negligence on the part of the OP 1 only because he prescribed Bactrim for Hiren this time too. If the complainant wished to allege wrong diagnosis, it was incumbent on him to specify in the complaint the date of such allegedly wrong diagnosis and also what according to him would have been the correct diagnosis. The complaint did not do so. The complainant also failed to produce the prescriptions given by OP 1, which would have normally been in the possession of the complainant because Hiren was treated as an outpatient. During the cross-examination of OP 1, the complainant made no suggestion that the former had maintained an independent case diary or that he had noticed that the alleged lesions and rashes had spread over all over Hirens body. The allegation of Hiren having developed swollen lips when OP 1 referred him to a Paediatrician was not borne out by the record of Hirens admission to the Hospital. Moreover, it was the complainant or his family who/which delayed showing Hiren to a Paediatrician (OP 2) whom OP 1 had recommended. It was at the insistence of OP 1 that OP 2 visited the house of the complainant and examined Hiren. OP 2 also concurred with the diagnosis of OP 1. Moreover, it was because of the stern caution given by OP 1 that the complainant finally agreed to shift Hiren to OP 4 Hospital for further treatment. Thus, OP 1 had acted with due care in treating Hiren according to standard medical protocol based on his specific observations of Hirens condition, advised the complainant from time to time to seek a Paediatricians opinion and, finally, recommended Hirens admission to a hospital for better treatment. There was, thus, no ground to differ with the finding of the State Commission that OP 1 did not commit any medical negligence or deficiency in service in treating Hiren.
(b) As regards OP 3, Mr. Chiramel stated that the only allegation in the complaint was that the former did not prescribe topical steroid eye drops during his treatment of Hirens problems with his eyes because of which his eyes were permanently damaged. However, this allegation was not supported by record of treatment of Hiren at OP 4. Hirens treatment for SJS had started on 03.03.1990 with steroid injection, antibiotic drops and ointments. In addition, treatment of the eyes with normal saline wash had also been started on 03.03.1990. Based on his observation of Hirens condition on 05.03.1990, OP 3 concluded that application of topical steroid eye drops was not advisable, as that would have damaged Hirens eyes. Topical steroid eye drops have a role only in the acute inflammatory stage of the eyes. OP 3 noticed symptoms of dry eyes and photophobia when he examined Hiren on 05.03.1990 but not acute inflammation or acute conjunctivitis and in such a situation; administration of steroid eye drops locally was contra-indicated. In view of these reasons OP 3 did not deem it fit to advise administration of topical steroid eye drops. The validity of the approach of OP 3 was also borne out by the fact that Hiren developed Herpetic Keratitis on 24.07.1991 and had to be referred to a cornea specialist at the Civil Hospital for treatment because, after his discharge he was administered steroid eye drop as late as on 05.07.1991.
(c) On behalf of OP 4, Mr. Shroff stated that the doctors at the Hospital, mainly consultants/specialists had diagnosed Hirens ailment correctly within 36 hours of Hirens admission and promptly administered the requisite treatment. The Hospital, a charitable organisation at that, could do no better than providing the medical services of qualified and experienced doctors and supporting nursing service. Though Hirens skin condition showed marked improvement by the time he was discharged it was unfortunate that despite proper treatment, Hirens eyesight worsened. No Hospital could, however, guarantee complete cure in each case all that was expected of a Hospital in providing treatment to a patient was to do so according to the standard medical protocol relevant to the ailment. Thus, there was no ground to hold that OP 4 Hospital was in any way negligent in providing treatment to Hiren.
Discussion The Law on Medical Negligence
12. The law on medical negligence that has evolved in India over time is essentially derived from the doctrine on professional (not necessarily medical) negligence enunciated in the case of Bolam v Friern Hospital Management Committee [(1957) 1 WLR 582; (1957) 2 All ER 118 (QBD)] by McNair, J:
Where you get a situation which involves the use of some special skill or competence, then the test as to 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 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.
13. As quoted with approval by the Supreme Court in Jacob Mathew v State of Punjab [(2005) 6 SCC 1], the Bolam Test was summarised by Bingham, L.J. in Eckersley v Binnie [(1988) 18 Con LR] 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 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 that he undertakes to the extent that other ordinarily competent members of the profession would be alert. He must bring to any professional task he undertakes no less expertise, skill and care than other ordinarily competent members of his profession would bring, but need bring no more. The standard is that of the reasonable average. The law does not require a professional man that he be a paragon combining the qualities of polymath and prophet.
14. In the Jacob Mathew case (supra), a Constitution Bench of the Apex Court, after a comprehensive review of its own decisions as well as those of Courts in the U. K. summarised the criteria for medical negligence in paragraph 48 of its judgment as under:
48.(1)xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx (2) Negligence in the context of the medical profession necessarily calls for treatment with a difference. To infer rashness or negligence on the part of a professional, in particular a doctor, additional considerations apply. A case of occupational negligence is different from one of professional negligence. A simple lack of care, an error of judgment or an accident is not proof of negligence on the part of a medical professional. So long as a doctor follows a practice acceptable to the medical profession of that day, he cannot be held liable for negligence merely because a better alternative course of treatment was also available or simply because a more skilled doctor would not have chosen to follow or resort to that practice or procedure which the accused followed. When it comes to the failure of taking precautions, what has to be seen is whether those precautions were taken which the ordinary experience of men has found to be sufficient; a failure to special or extraordinary precautions which might have prevented the particular happening cannot be the standard fro judging the alleged negligence. So also, the standard of care, while assessing the practice as adopted, is judged in the light of knowledge available at the time of the incident, and not at the date of the trail.
Similarly, when the charge of negligence arises out of failure to use some particular equipment, the charge would fail if the equipment was not generally available at that particular time (that is, the time of the incident) at which it is suggested it should have been used.
(3) A professional may be held liable for negligence on one of the two findings: either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise, with reasonable competence in the given case, the skill which he did possess. The standard to be applied for judging whether the person charged has been negligent or not would be that of an ordinary competent person exercising ordinary skill in that profession. It is not possible for every professional to possess the highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence.
(4) The test for determining medical negligence as laid down in Bolam case, WLR at p. 586 holds good in India.
(5)xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
15. For effective adjudication of the issues involved in this case, it is also necessary to notice the Apex Courts observations on another dimension of negligence, viz., what is described as negligence per se. In the case of Poonam Verma v Ashwin Patel and Others [(1996) 4 SCC 332], the Court observed:
42. Negligence has many manifestations it may be active negligence, collateral negligence, comparative negligence, concurrent negligence, continued negligence, criminal negligence, gross negligence, hazardous negligence, wilful or reckless negligence, or negligence per se, which is defined in Blacks Law Dictionary as under:
Negligence per se Conduct, whether of action or omission, which may be declared or treated as negligence without any argument or proof as to the particular surrounding circumstances, either because it is in violation of a statute or valid municipal ordinance, or because it is so palpably opposed to the dictates of common prudence that it can be said without hesitation or doubt that no careful person would have been guilty of it. As a general rule, the violation of a public duty, enjoined by law for the protection of person or property so constitutes.
Case of Respondent/OP 1
16. The State Commission discussed the case of the complainant against OP 1 in the following words:
13. In support of his allegations, the complainant relies on his own evidence and the evidence of above-mentioned witnesses. He has not examined Dr. Pandya and Dr. Kamdar. It may be recalled that it was Dr. Pandya who first diagnosed SJS and it was Dr. Kamdar who treated Hiren for SJS. Both these doctors are alleged to have expressed shock of surprise as to how mistake was committed in diagnosing the reaction or disease from which Hiren was suffering. However, neither of the two doctors is examined. The complainant also relies on the medical literature which he has produced. Opponent nos. 1 and 3 are also examined as witnesses. So far as opponent no.4 is concerned, Dr. K.H. Chhaya, Medical Director of the hospital is examined. Opponents have also produced medical literature in support of their contentions.
14. The complainants story about his consulting opponent no.1 on or before February 23, 1990 is clearly an afterthought. His specific case in the complaint was that he had first consulted opponent no.1 for Hirens fever on February 26, 1990. It appears that after obtaining medical advice or perusing medical literature he thought that perhaps it was more advantageous to allege that opponent no.1 was consulted on or before February 23, 1990. If the treatment of opponent no.1 was started on or before February 23, 1990, it would appear that symptoms of rash, swelling of lips manifested about five days after the treatment was started and, therefore, there was no possibility of diagnosing Hirens case as that of measles. We are inclined to accept opponent no.1s statement that he was consulted for the first time for Hirens ailment on February 26, 1990. We are therefore, not inclined to believe the complainant and his two witnesses Kamdar and Sampat when they say that Hiren was under treatment of opponent no.1 from February 23 or February 25, 1990. This improvement in the story to suit what the complainant thought was his purpose of object case raises doubt about the veracity of the statement of the complainant and his aforesaid witnesses.
[Emphasis supplied] 17 (i) Thus, the main reason why the State Commission rejected the complainants contention regarding the date of commencement of treatment of Hiren by OP 1 was its suspicion that he sought to improve upon his initial version in the complaint in this regard, after obtaining medical advice or reading up medical literature, to better suit his aim of proving medical negligence against OP 1.
(ii) However, we notice from Hirens medical record at the OP 4 Hospital that the following was mentioned in the very first notes of the physician examining Hiren at the time of his admission on 02.03.1990:
Fever since 10 days Vomiting off and on Skin rashes 4-5 days Now c/o coughing weakness not able to take anything orally xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx O/E Skin rashes +++ xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx [Emphasis supplied]
(iii) Though the foregoing history of Hirens ailment was obviously given to the examining physician by the complainant, there is no reason to suspect anything untrue about his statement regarding the period for which Hiren had had fever. Counting back 10 days, as noted in the aforesaid medical record, the start date of Hirens fever would come to 20.02.1990. It is no ones case that the complainant had obtained any medical advice or read up any medical literature on measles and SJS at this stage or had any reason to foresee that his son was suffering from a disease like SJS that would cause permanent damage to his eyes, which would eventually impel him to allege medical negligence in his treatment and seek redressal before a Consumer Forum.
Therefore, based on this contemporaneous record of the OP 4 Hospital, it is clear that the complainants assertion in his rejoinder affidavit regarding the dates of start of Hirens fever (on or about 20.02.1990) and his treatment by OP 1 (23.02.1990, or, even earlier) was indeed correct as also his clarification that in mentioning the start date of Hirens treatment by OP 1 (as 26.02.1990) in his complaint memorandum, he made an inadvertent error because the month of February in 1990 had only 28 days.
(iv) If the above-mentioned conclusion that Hirens fever started on 20.02.1990 and the version of OP 1 about the date of start of Hirens treatment (as 26.02.1990) are held to be correct, it would imply that Hiren was taken to OP 1 for the first time on the sixth day of his developing fever when OP 1 prescribed Bactrim, a sulphonamide. OP 1 also claimed that he next saw Hiren on 28.02.1990 when, for the first time, he noticed Kopliks spots inside Hirens mouth and some rashes. This would mean that OP 1 noticed Kopliks spots on the 9th day of the onset of Hirens fever, which together with the rash, led OP 1 to diagnose it as measles. The same Hospital record, however, also noted that Hiren had rashes for 4-5 days as on 02.03.1990. In other words, Hirens rashes had appeared by 25/26.02.1990.
(v) It is instructive at this stage to notice what the American Paediatrician Henry Koplik himself had to say on the spots of measles that bear his name:
The onset of measles as described by Koplik in 1896 The first twenty-four to forty-eight hours of the invasion of measles is marked by a suffusion, slight or marked, of the eyes, and the conjunctiva at the nasal canthus is not only reddened but also slightly redundant. There is, at this stage, a slight febrile movement; there may be a cough or some little sneezing; the mother has noticed nothing except that the infant or child has a slight fever. At this period the eruption on the skin has not made its appearance. In the majority of cases there is no suspicion of any exanthema. In a few cases there is an indistinct spotting around the lips and alae nasi, but no eruption.
The mouth If we look in the mouth at this period we see a redness of the fauces; perhaps, not in all cases, a few spots on the soft palate. On the buccal mucous membrane and the inside of the lips, we invariably see a distinct eruption. It consists of small, irregular spots, of a bright red colour. In the centre of each spot, there is noted, in strong daylight, a minute bluish white speck. These red spots, with accompanying specks of a bluish colour, are absolutely pathognomonic of beginning measles, and when seen can be relied upon as the forerunner of the skin eruption. [Emphasis supplied] [Source: Canadian Medical Association Journal:
http://www.cmaj.ca/cgi/content/full/180/5/583]
(vi)(a) The unanimous view in the medical literature discussed above is that the measles prodrome begins with fever (and some other symptoms like cough, runny nose and red eyes) and lasts for a maximum of about 4 days during which the symptoms would resemble those of influenza. The pathognomonic Kopliks spots appear towards the end of the prodrome, when the rash has not yet appeared, and last for a maximum of 4 days, i.e., about two days towards the end of the prodrome and about two days after the rash have appeared. The entire disease lasts for about 10 days. As we have seen from the Hospital record, if Hiren had measles, the prodrome started, with the fever developing, on 20.02.1990 and would thus extend at the most upto 24.02.1990. The Kopliks spots would then have appeared by 22.02.1990 (even according to Koplik within 24-48 hours of the fever developing) and have disappeared latest by 26.02.1990. The Hospital record also shows that Hirens rashes had appeared by 25/26.02.1990. This sequence of dates and appearance of symptoms, read with the medical literature on measles and the start date of Hirens fever as 20.02.1990, would completely falsify the claim of OP 1 that he diagnosed the case of Hiren as measles after noticing the pathognomonic Kopliks spots, for the first time, as late as on 28.02.1990. Thus, if anyone has tried to base his case after reading up/referring to the medical literature, it would appear to be OP 1 and not the complainant.
(b) With regard to the claim of diagnosing Hiren with measles on the basis of the pathognomonic Kopliks spots, it is also interesting to notice what the State Commission noted in its impugned order summarising the medical view in Nelsons Textbook on Paediatrics (14th Edition):
.
Chapter 12.64 deals with Measles (Rubeola). . It is stated that the prodromal phase, which follows, lasts 3-5 days and is characterised by low-grade to moderate fever, a hacking cough, coryza and conjunctivitis. These nearly always precede Koplik spots, the pathognomonic sign of measles, by 2-3 days. An enanthem or red mottling is usually present on the hard and soft palates. Koplik spots are greyish white dots, usually as small as grains of sand, with slight reddish areolae; occasionally they are hemorrhagic. They appear and disappear rapidly, usually within 12-18 hours. [Emphasis supplied] Even from the sequence, usual timelines and duration of the symptoms given in this Textbook, it would be clear how absurd it was for OP 1 to claim that he diagnosed the disease of Hirens as measles mainly on the basis of Kopliks spots as late as on 28.02.1999, given the fact that the Hospital record independently noted the date of onset of fever as 20.02.1999 and of rashes as 25/26.02.1999. For, according to this Textbook, the Kopliks spots would have appeared 2-3 days after the onset of the prodrome, i.e., 20.02.1999 and would be very difficult indeed to notice, being as small as grains of sand and tending to disappear within 12-18 hours of their appearance unless the patient happened to be presented to the physician within the very narrow time window. In any case, these spots would have disappeared latest by 26.02.1999 if the prodrome started, as it did, on 20.02.1999.
(vii) Based on the start date of Hirens fever as 20.02.1990 (established independently from the Hospital record), it also follows that it would be natural for the complainant to take Hiren for medical advice to OP 1 on 23.02.1990 because that would be the period of the prodrome (even if his was a case of measles) and it would be also quite natural for an ordinary general physician like OP 1 to prescribe Bactrim, suspecting some infection leading to fever.
(viii) However, the claims of OP 1 that he first saw Hiren on 26.02.1999 and prescribed Bactrim for three days at that time and that on 28.02.1999 he noticed Kopliks spots inside Hirens mouth to conclude he had measles are both concocted. This is because with his fever setting in on 20.02.1999, had Hiren been suffering from measles, he would have developed the measles rash by 26.02.1999 and the Kopliks spots would have certainly disappeared by 28.02.1999, in view of the general sequence of the appearance of the rash and Kopliks spots discussed above. This defence version of OP 1, being wholly untenable in the face of the independently recorded fact of Hirens fever setting in on 20.02.1999 and rashes appearing on 25/26.02.1999, thus leads us to only one set of conclusions, viz., that OP 1 misdiagnosed Hirens ailment in spite of examining him twice at his clinic and once at Hirens house; failed to recognise that the sulphonamide (Bactrim) prescribed by him had caused adverse reaction (leading to SJS); failed to initiate timely and appropriate measures for treating Hiren for the said reaction (if not SJS); and, worst of all, took undue and unprofessional advantage in his written version of an inadvertent error of the complainants in mentioning in his complaint the date of start of Hirens treatment by OP 1.
(ix) OP 1 has also sought to support his case by citing that according to one medical textbook, measles can lead to SJS. This contention deserves to be rejected on two counts. First, the discussion above would demonstrate that it is highly doubtful if Hiren had measles at all.
Secondly, and more important, measles is caused by the rubeola virus whereas apart from reaction to specific drugs, SJS is the result of immunological disorder and some specific types of infection, as we have seen from the authoritative medical textbooks discussed above. In fact, SJS is a syndrome which is a medical term used to describe a disorder the aetiological basis of which is not properly understood, another medical fact noted in the all the medical textbooks we have noticed in extenso.
Case of Respondent/OP 2
18. As regards OP 2, the State Commission has held him guilty of medical negligence a finding with which we cannot but agree though in our view the amount of compensation awarded by the State Commission is grossly inadequate, given the consequences of the negligence. However, OP 2 expired while the complaint was under adjudication. Hence no liability can continue to be fastened on the legal representatives of OP 2, in view of the settled legal position in this behalf. Yet, in view of the ruling of the Apex Court in the case of Savita Garg v Director, National Heart Institute [(2004) 8 SCC 56], it would be in order to hold OP 4 Hospital, to which OP 2 was attached as a consulting paediatrician at the relevant time, liable for the said negligence on the part of OP 2 after the latters demise.
Case of Respondent/OP 3
19. OP 3, the ophthalmologist, has produced photocopy (handwritten along with corresponding typed copy) of the original medical record of treatment of Hiren during his stay in the OP 4 Hospital. The (handwritten) entries on each page of this compilation are recorded under three columns titled, Date and Time, Daily Clinical Notes and Treatment Advised. In the absence of any separate Nursing Notes, it has to be held that the treatment actually administered to Hiren was according to the directions/entries recorded under the heading Treatment Advised. The handwritten entries of Clinical Notes and Treatment Advised relating to OP 3 from 05.03.1990 (date of his first examination of Hiren) are discussed below in some detail.
(i) OP 3 examined Hiren for the first time in the evening of 5th March 1990, because of a reference made on that date sometime before 1.45 p.m. and recorded the following, unsigned observations:
Seen by Dr. Doshi Cornea clear Conjunctival congestion + + No discharge No Chemosis Gentycin drops Neosporin eye ointment
(ii) The Treatment Advised entries of 06.03.1990 were Gentycin eye drops and Neosporin eye ointment three hourly. Eyewash with normal saline and then put eye drops and eye ointment.
These entries were in accordance with the directions dated 05.03.1990 of OP 3.
(iii) OP 3 next saw Hiren on 7th March 1990, again on reference and recorded as under:
Seen by Dr. Doshi Cornea clear Ocular movements are normal No adhesions seen Adv.
ct drops Yet, under the Treatment column, the relevant entries of 07.03.1990 (made before OP 3 saw Hiren) were changed to, Gentycin eye drops, eyewash with normal saline and then put eye drops and eye ointment. Neosporin eye ointment was specifically struck off without any apparent authorisation. Advice of OP 3 on 07.03.1990 was to continue only eye drops and there was no mention of any eye ointment. However, the corresponding Treatment entries under the heading Fresh orders were, Eye wash with normal saline and put Gentycin eye drops / Neosporin eye ointment. The same entries continued on 08.03.1990. On 09.03.1990, while Eyewash with normal saline and Gentycin eye drops were continued, there was no entry of any eye ointment. On 10.03.1990 the relevant entries were changed to Eyewash with normal saline then put Neosporin eye ointment, thus stopping Gentycin eye drops altogether and re-introducing Neosporin eye ointment without any physicians authorisation. There was no mention of Gentycin eye drops in the treatment advised on 11.03.1990, 12.03.1990 and 13.03.1990, though Neosporin eye ointment (6 hourly) was continued. Yet, on 14.03.1990, Neosporin eye ointment was replaced by Neosporin eye drops and the latter was continued on 15.03.1990, 16.03.1990 and 17.03.1990. Once again, these changes were without any prior orders of a physician/ophthalmologist who had seen Hiren.
(iv) The next visit of OP 3, also on reference, was on 17th March 1990, when Hirens complaint of photophobia was first noticed and recorded by the attending Hospital staff/Resident. The observations of OP 3 on that date, however, were recorded as under:
Seen by Dr. Doshi Left eye adhesion at lower fornix cleaning done and ointment applied To show on Monday for glass rod separation of lids Ointment to be applied two times Gentycin drops three times Vit C Cleaning of eyes 3 times Thus OP 3 took no notice of the complaint of photophobia in the clinical notes reproduced above. His advice also did not mention either the name of the eye ointment or the frequency of administration of Vitamin C and the form in which it was to be administered. However, under Treatment Advised, the entries recorded were, Eyewash with normal saline, put Neosporin eye drops, TDS thus the specific advice of OP 3 was not at all noticed. The same treatment regime of Eyewash with normal saline and Neosporin eye ointment TDS was continued on 18.03.1990.
(v) On 19th March 1990 OP 2 saw Hiren again and recorded the following observations:
Seen by Dr. Doshi Adhesions to remove by sweeping plain forceps Cornea clear Chloro ointment Gentycin drops Once again, OP 3 did not mention the frequency of application of either the ointment or the drops. On the other hand, what was recorded under Fresh Orders was, Eyewash with normal saline, put Gentacyn ointment, Chloromycetin eye application BD, Gentamycin eye drops BD. Gentacyn eye ointment was thus without any authorisation. Yet, the same treatment was continued for full five days, during
20 - 24.03.1990.
(vi) On reference, OP 3 again saw Hiren on 24th March 1990 and recorded the following observations:
Seen by Dr. Doshi RE Keratitis (? Herpetic) To stain with Fluorescein on Monday Adv. Toxyl eye drops As in the past, OP 3 did not refer at all to what he had prescribed earlier and whether any of those medications ought to be discontinued/continued or prescribe what the frequency of application of the new eye drop Toxyl should be.
This treatment continued on 25.03.1990.
(vii) Entries of 26th March 1990 (i.e., Monday next) show that ophthalmic advice on eye staining for Keratitis was followed and the following observations were recorded:
Seen by Dr Doshi Both eyes Herpes Simplex Keratitis stain + Adv.
Ocivir ointment (3 to 4 times) Ridinox drops (one hourly) Once again without any instructions about the continuance or otherwise of the medications already in use, OP 3 prescribed Ocivir ointment and Ridinox eye drops. In the column of Treatment Advised, the frequency of application of each new drug was also noted. Entries of 27.03.1990 show continuation of eyewash with normal saline, Gentacyn eye drops BD, Droxyl eye drops TDS, Acivir eye ointment 3 to 4 times a day and Ridinox eye drops 1 hourly.
Thus, both Gentacyn and Toxyl (not Droxyl) eye drops were not according to prescription of OP 3.
(viii) We may add here that Ocuvir (which has been variously written in the medical record produced by OP 3 as Acivir, Ocivir, etc.) is the brand name of Acyclovir, an over-the-counter antiviral medication (tablets or ointment) used for treatment of HSV infection of the eye and some other organs (vide http://www.no-prescription-needed.us/ocuvir.htm) while Ridinox is the Indian brand name of Idoxuridine, an ophthalmic antiviral eye drop also used for treatment of HSV infection of the eyes (vide http://www.orgyn.com/resources/genrx/D001523.asp). However, we have not been able to ascertain from the list of drugs available on the Internet as to what the indications of Toxyl eye drops are.
(ix) A quick reference to the medical literature on Herpetic Keratitis (particularly, that caused by Herpes Simplex Virus HSV) would be useful at this stage.
(a) The following are the extracts on the subject from the Textbook Essentials of Ophthalmology, already referred to above (pp 182, 186 87):
Viral keratitis is caused by both herpes simplex and herpes zoster.
HSV: Recurrent HSV is the most common cause of central infectious keratitis and is cause of reactivation of latent virus in the Gasserian ganglion. Triggers include sun exposure, fever, stress, menses, trauma, illness, and immunosuppression. HSV can produce different types of corneal infection:
Epithelial keratitis is the most common manifestation of HSV, but does not always appear as a classic dendrite with ulceration and terminal bulbs. It can also present as a superficial punctate keratitis or geographic ulcer. Epithelial involvement is associated with scarring and decreased corneal sensation.
Disciform keratitis xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Necrotizing interstitial keratitis xxxxxxxxxxxxxxxxxxxx Endotheliitis xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx MANAGEMENT Viral:
HSV epithelial keratitis: this active viral infection requires a topical antiviral (trifluridine (Viroptic) 9 times a day or vidarabine monohydrate (Vira-A) 5 times a day for 10-14 days).
Debridement of the dendrite reduces the viral load.
Consider an oral antiviral (acyclovir 400 mg PO [by mouth, orally] tid [three times daily] for 10-21 days, then prophylaxis with 400 mg bid [twice a day] for up to 1 year to prevent recurrence (or longer after penetrating Keratoplasty). The Herpetic Eye Disease Study (HEDS) showed that chronic suppressive therapy with acyclovir (400 mg PO bid for 1 year) reduces the incidence of recurrent keratitis by almost 50%.
HSV disciform or endotheliitis: this immunemediated keratitis is treated with a topical steroid (prednisolone phosphate 0.12-1.0% qd [every day] to qid [four times a day] depending on the severity of inflammation; adjust and then taper slowly over months depending on the response).
Consider a topical cycloplegic (scopolamine 0.25% bid to qid).
Topical antiviral (trifluridine (Viroptic) qid) for concomitant epithelial keratitis or prophylactically when using steroid doses greater than prednisolone phosphate 0.12% bid. Alternatively, oral acyclovir (400 mg PO bid) can be used.
HSV metaherpetic/trophic ulcer: this non-healing epithelial defect is managed with topical lubrication with non-preserved artificial tears (up to q1h [every hour]) and ointment (qhs) [every hour of sleep] a broad-spectrum topical antibiotic (polymyxin B sulfate-trimethporim (Polytrim), tobramycin (Tobrex), moxifloxacin (Vigamox), or gatifloxacin (Zymar) qid), and a bandage contact lens.
Topical mild steroid (fluorometholone qd to bid) for stromal inflammation.
HSV complications include uveitis, glaucoma, episcleritis, scleritis, secondary bacterial keratitis, corneal scarring, corneal perforation, and punctal stenosis (due to topical antiviral therapy).
Note: Explanations in [] supplied
(b) Likewise, Parsons Diseases of the Eye (pp 193-195) has the following on Keratitis caused by the HSV:
The treatment of herpes simplex eye disease depends on the nature of ocular involvement and requires the judicious use of topical and systemic antivirals, topical steroids and supportive therapy with lubricants (artificial tears) and cycloplegics.
Commercially available antiviral agents include 5% idoxuridine (5-iodo-2-deoxyuridine, IDU), 1% trifluridine (trifluorothymidine, F3T) eye drops, 3% acyclovir eye ointment, 3% vidarabine eye ointment and oral acyclovir (400 mg and 800 mg tablets).
Epithelial keratitis responds well to topical antivirals which are prescribed along with topical antibiotics to prevent secondary bacterial infection, lubricants to relieve discomfort and cycloplegics if required. Debridement of the edges of the dendritic ulcer with a moistened, fine cotton-tipped applicator is also useful in reducing the load of active virus-infected cells. Eighty five per cent of initial dendritic ulcers treated with IDU drops 5 times a day are cured within 2 weeks. Trifluridine 1% drops 4 times a day or acyclovir 3% ointment 5 times a day or 3% vidarabine ointment 5 times a day produce resolution of herpes simplex viral keratitis in approximately 95% of patients. It is uniformly accepted that topical steroids are contraindicated in the presence of active viral replication as occurs in herpes simplex epithelial keratitis.
(x) What becomes amply clear from scrutiny of the record of treatment in the light of the medical texts cited above is that the treatment prescribed by OP 3 for HSV Keratitis of both eyes that Hiren developed (without any apparent reason for he was under intensive care in OP 4 Hospital and had no history of any HSV infection) was not in accord with the standard treatment regime for this purpose: both Ridinox and Ocuvir are not prescribed simultaneously nor is the standard frequency of Ridinox eye drops 1 hourly. Secondly, the treatment actually administered after this prescription perhaps also included Gentacyn and Toxyl eye drops, according to the entries in the Treatment Advised record and whether Toxyl was at all indicated/necessary is doubtful.
(xi) OP 3 saw the patient again on 28th March 1990, this time on his own, and the following observations were recorded:
Seen by Dr. Doshi No stain Adv. To ct drops and ointment Application of Gentacyn eye drops BD, Acivir eye ointment 3 to 4 times a day and Ridinox eye drops 1 hourly seems to have continued on 28.03 and 29.03.1990, there being no mention of Droxyl eye drops.
(xii) OP 3 seems to have seen Hiren again on 30th March 1990. The following observations were recorded on his behalf:
Seen by Dr. Doshi Stain + Adv.
To ct. Ridinox eye drops Acivir ointment To see on next Wednesday This treatment with Acivir eye ointment and Ridinox eye drops was continued till 03.04.1990.
(xiii) On his next visit on 4th April 1990 [i.e., next Wednesday], based on referral, the following observations of OP 3 were recorded:
No stain To omit Ridinox and Acivir Adv. Gentamycin drops Nothing was, however, noted in the Treatment Advised column of the records for the eyes on 05.04 and 06.04.1990.
(xiv) Gentamycin eye drops (2/3 drops?) appear to have been administered on 07.04 and 08.04.1990. On 09.04.1990, there is no mention of any medication for the eyes in the (typed copies of the) records.
(xv) Hiren was seen by Dr. B. C. Kamdar, Dermatologist sometime in the forenoon of 9th April 1990 who again noted Photophobia and advised reference to OP 3. Accordingly, OP 3 saw Hiren for the last time in the afternoon of 9th April 1990 and his observations were recorded as under:
Seen by Dr. Doshi Superficial Punctate Keratitis + To see under slit lamp for details Adv. Vit A, Vit C, B complex To ct Gentamycin TDS (xvi) It may be further noticed that the same day, i.e., 9th April 1990 Dr. Kamdar also noted To discharge tomorrow after having a look and, finally, in the discharge directions dated 10th April 1990 he advised, inter alia, To carry out Dr. K. J. Doshis prescription.
(xvii) Despite this specific reference, the Advice on Discharge contained in the Discharge Certificate actually issued by the Hospital on 10th April 1990 did not mention either continuation of the medications suggested by OP 3 on 9th April or that Hiren ought to be brought back soon for examination of his eyes under slit lamp microscope the only direction, apart from medications and ointments prescribed was to visit for a follow-up after 7 days (and to contact immediately in case of any complaint developing). Further, the in-charge doctors mentioned in the Discharge Certificate were Dr. Ashok Nathwani (OP 2) and Dr. B. C. Kamdar and there was no reference to Dr. K. J. Doshi, OP 3 at all in these directions.
(xviii) (a) We may also compare the recording of clinical observations followed by consulting Doctors other than OP 3 who examined and treated Hiren at the OP 4 Hospital. For example, the very first reference to see Hiren was made to Dr. Vinod Pandya, an ENT Surgeon on 3rd March 1990.
(b) We have already seen the unsigned notes recorded on behalf of OP 3 on his first examination of Hiren (sub-para. (i) above), which we again reproduce:
Seen by Dr. Doshi Cornea clear Conjunctival congestion + + No discharge No Chemosis Gentycin drops Neosporin eye ointment
(c) Per contra, Dr. Pandya recorded the following and signed it:
S/B Dr. V. Pandya Thanks for the reference.
Pt has got muco-cutaneous lesions all over body, conjunctiva, throat, nose, mouth, pharynx, all over palates, both lips.
Rx ..
..
Eye wash with normal saline & put Neosporin ointment + Gentycin eye drops 3 hourly.
Review after 48 hours Sd/-. YYY 3/3/90 3.00 PM (ixx) We may now summarise various aspects of the treatment given by OP 3 for the ophthalmic problems of Hiren who was suffering from SJS.
(a) The first point that stands out in respect of recording of the clinical observations of OP 3 and the treatment administered by him to Hiren is its completely passive nature. Each time OP 3 visited Hiren, someone on his behalf recorded his observations and prescriptions none of these appear to have been signed by OP 3 to see if the observations and prescriptions had been correctly recorded. As against this, every other Doctor who visited, examined and prescribed for Hiren mostly wrote, in his own hand, not only the clinical observations but also the advice.
(b) Secondly, on no occasion did OP 3 make any specific observation on either the status (improvement/worsening) of the symptoms last noticed by him or the (fresh) complaint for which he was called in.
(c) Further, the advice recorded by Dr. Pandya on 3rd March 1990 shows that on his first visit on 5th March 1990 OP 3 did not prescribe anything other than what was already being administered - in fact, unlike Dr. Pandyas, the advice of OP 3, as recorded, did not even mention the frequency of application of the eye drops or the ointment that OP 3 merely reiterated and he did not say anything about continuance of eye wash with normal saline.
(d) Next, there was no mention in the recorded clinical observations of OP 3 on 7th March 1990 (or ever thereafter) if the conjunctival congestion noticed on the first visit had improved or otherwise on account of the medications advised. The advice was also silent on whether the Neosporin eye ointment, reiterated by OP 3 on 5th March 1990 ought to have been continued.
(e) The observations recorded on 17th March 1990 did not even mention the complaint of photophobia (for which the reference was specifically made) leave alone the corrective action, if any, directed by OP 3 regarding this new development. Equally important, the clinical observations did not state anything about the status of the cornea or any other part of the eyes, unlike on the last two occasions. Likewise, though application of ointment was advised two times, surprisingly the name of the ointment was not mentioned, unlike that of the eye drops (Gentycin). Even on 19th March 1990, there was no mention in the recorded advice of the frequency and duration of application of either the ointment or the eye drops.
(f) (1) On 24th March 1990, OP 3 diagnosed Hiren with (suspected?) Herpetic Keratitis which, after staining, he confirmed on 26th March to be Keratitis caused by the Herpes Simplex Virus - HSV. It is thus amply clear that while Hirens skin-related condition improved/stabilised over the past three weeks, his eye problems worsened during the same period despite administration of the medications prescribed by OP 3.
(2) We have already noticed at length the standard treatment prescribed for HSV-related Keratitis and the treatment actually administered by OP 3: it is obvious that the treatment advised by OP 3 was not in accord with the standard protocol.
(g) The observations of OP 3 regarding the dates of appearance and disappearance of the HSV Keratitis stains in Hirens eyes make a strange reading: Stains + in the cornea of Hirens both eyes were first seen by OP 3 on 26th March, 1990 while, according to him, there was No stain on 28th March 1990; however, on 30th March there was again Stain + but on 4th April 1990, the observation was No stain. If anything, this hide and seek sequence of fluoresceine staining ought to have alerted any Ophthalmologist of average skills of the need to look more closely at the patients eyes. However, OP 3 had the following to say in the counter reply to the memorandum of appeal:
I examined the patient on 28.3.1990 of my own without getting reference from the hospital, for observing any additional complications of Cornea in the eyes of the patient. When I examined the patient on 28.3.1990 I found that there was no stain in the Cornea, thereby meaning the Cornea got healed by the treatment and I advised the patient to continue with the drops and ointment. Even on 30.3.1990 without any reference I examined the patient and found complications of Cornea as stain was present in Cornea. Therefore, drops and ointments were continued. [Emphasis supplied] Thus all that OP 3, who claimed to be a specialist eye surgeon with over 25 years of experience, had to say was that the cornea stain disappeared on 28th March 1990 showing that the ulcers caused by the HSV Keratitis in Hirens cornea had healed and yet on 30th March 1990 complications of the cornea reappeared though the same treatment which had led to the healing had been continued! In this context, it is useful to see a short but highly relevant write-up on the well-known medical website of Merck Manuals (www.merckmanuals.com - the Merck Manuals Online Medical Library):
The more often the infection recurs, the more likely is further damage to the surface of the cornea. Several recurrences may result in the formation of deep ulcers, permanent scarring, and a loss of feeling when the eye is touched. The herpes simplex virus can also cause blood vessels to grow onto the cornea and, occasionally, can lead to significant visual impairment. To diagnose a herpes simplex infection, a doctor examines the eye with a slit lamp.
The doctor may prescribe an antiviral eye drop, such as trifluridine. Acyclovir, another antiviral drug, can be taken by mouth. Treatment should be started as soon as possible. Deep infections that cause a lot of inflammation may require use of corticosteroid drops and drops that dilate the eye, such as atropine or scopolamine. Occasionally, to help speed healing, after numbing the eye, an ophthalmologist may have to gently swab the cornea with a soft cotton-tipped applicator to remove infected and damaged cells. [Emphasis supplied]
(h) On 9th April 1990, OP 3 found that Hirens eyes had developed superficial punctate keratitis. In this context, we may notice what OP 3 had to say:
The patient was thereafter referred to me on
4.4.1990 for reviewing the case. I saw the patient on 4.4.1990 when there was no stain on Cornea and treatment of viral ulcer was omitted and anti-biotic drops and ointment were advised to be continued. On 8.4.1990 there was advice of ophthalmic reference by the treating doctor and therefore I was called on 9.4.1990 when I found Superficial Punctate Keratitis i.e. complication of dry eye in Cornea. The patient was advised sophisticated microscopic slit lamp examination for details. [Emphasis supplied] To see if superficial punctate keratitis (described in simple terms as death of small groups of cells on the surface of the cornea, vide www.merckmanuals.com) is indeed complication of dry eye in Cornea, we may again go back to the Textbook, Essentials of Ophthalmology and notice, Epithelial keratitis is the most common manifestation of HSV, but does not always appear as a classic dendrite with ulceration and terminal bulbs. It can also present as a superficial punctate keratitis or geographic ulcer. Epithelial involvement is associated with scarring and decreased corneal sensation. While one of the factors leading to superficial punctate keratitis can be dry eyes, a viral infection is the leading cause of this condition, followed by a bacterial infection. The fact that this condition appeared in Hirens eyes after he was treated for HSV-induced Keratitis leads us to the only conclusion that this happened because the viral infection was not treated adequately, soon enough and for long enough. It is also to be noted that all that OP 3 mentioned in his clinical observations on Hirens eyes from 24th March 1990 onwards was in terms of stain in the cornea not once did he describe the type of corneal ulcers that the stains reflected, i.e., whether they were dendritic ulcers or geographical ulcers or some other variety, to start with. To diagnose the kind of corneal impact of the HSV infection of Hirens eyes, slit lamp microscopic examination should have been undertaken straight away when the fluoresceine test first showed stains on the cornea. This elementary diagnostic process was deferred for full two weeks. Incidentally, the slit lamp microscope has been in use by ophthalmologists all over India for decades since the 1950s along with the ophthalmoscope, it is a basic investigative instrument of an ophthalmologist and not such a sophisticated instrument as our highly experienced OP 3 would have us believe.
(k) As we have noticed about the ophthalmic treatment recommended on the previous occasions, though Gentamycin eye drops were re-introduced on 04.04.1990 by OP 3, neither the frequency of application nor the period of continuation was indicated. Moreover, the detailed chart of daily treatment advice showed no mention of Gentamycin eye drops on 5th and 6th April 1990 though there was mention of these eye drops (2-3 drops) from 7 to 9th April 1990. It is very obvious that not only were his directions regarding treatment of Hirens eyes imprecise and incomplete on many occasions but also that at no stage of his examination and advising treatment did OP 3 care to check if his previous directions on medication were being followed by the nursing staff.
(l) The consistent defence of OP 3 (against the specific allegation of the complainant in this regard) is that he did not prescribe topical steroid eye drops for Hiren because he was being administered steroid injections for his cutaneous problems and had dry eyes right from the beginning and that topical/local administration of steroid eye drops was contraindicated particularly because of Hirens dry eye problem.
(m) We have already noticed the first set of clinical observations of OP 3 on 05.03.1990. It is noteworthy that neither on that date nor any time later did OP 3 make any observation regarding Hirens dry eye symptoms. In fact, we were unable to find the words dry eye anywhere in the entire medical record produced by OP 3 himself. In the course of hearing, when queried specifically on this issue, OP 3 pointed to his observation, No discharge on 05.03.1990 itself to claim that he had noticed dry eye on the very first day. In his counter-reply to the memorandum of appeal, OP 3 stated, the cornea was clear, conjunctival congestion was present, there was no watery discharge from the eye meaning thereby the eye was dry. [Emphasis supplied] It is noteworthy that the word watery was not mentioned in the clinical observation of OP3 recorded on 5th March 1990. The medical literature on the ophthalmological implications of SJS that we have noticed above in extenso refer unambiguously to SJS causing mucopurulent discharge in/from the eyes and No discharge has thus to be read to mean no mucopurulent discharge, i.e., secretion of fluid containing both mucus and pus from the eyes that gets caught in the eyelashes and is generally the sign of an eye infection or inflammation. In our view, therefore, this attempt to show that OP 3 had noticed Hirens dry eye syndrome on the very first day of his examination (05.03.1990) is not only an afterthought but actually a deliberate attempt to mislead. More important, if OP 3 had adopted the standard of medical care expected of even an ophthalmologist of ordinary skills, he would have at least undertaken a few simple routine tests (like tear film break-up time (BUT), Schirmer I-test and Rose Bengal staining) to see if his suspicion of Hiren having developed dry eye as a result of the SJS was true when any two of these tests are positive, diagnosis of dry eye syndrome is confirmed (vide Comprehensive Ophthalmology, Fourth Edition by Dr. A. K. Khurana (pp 365-366)).
(o) The medical records also show that Hirens complaint of photophobia was first noticed on 17.03.1990 whereupon a reference was made to OP 3. However, neither in his clinical observations of that date nor anytime later did OP 3 make a single mention of this complaint, leave alone advising any treatment therefor. In fact, it was one of the allegations of the complainant that though Hiren developed dry eye and also photophobia resulting from SJS, OP 3 did not provide any treatment at all for Hirens dry eyes and this continued neglect led to several complications. The medical record that we have noticed above in detail amply bears out the truth of this allegation. This conclusion is further strengthened by the indirect admission of OP 3 in his counter reply to the memorandum of appeal: The above treatment continued till 17.3.1990 when I was again referred the case of the patient for complaints of photophobia. Photophobia is a sign of dry eye, developed as corneal complication of SJS. I examined the patient on 17.3.1990 and found adhesions at lower fornix i.e. space between lid and the eye ball. Cleaning of the eye was done on 17.3.1990 and ointment was applied. Vitamin C tablets were also advised in addition for corneal complication. I advised the patient on 17.3.1990 to get separation of adhesions done with the help of instruments on 19.3.1990. On 19.3.1990 I removed the adhesions by sweeping the fornix with the help of plain forceps. We may notice that OP 3 did not utter a word, even in this reply as to what specifically he did to deal with Hirens dry eye problem which according to OP 3 had caused the photophobia. Moreover, rather strangely, OP 3 advised the patient on 17.3.1990 to get separation of adhesions done with the help of instruments on 19.3.1990. This reads as if the patient should have gone out and got the separation of eye lid adhesion done somewhere else. Incidentally, OP 3 did the separation himself on 19.03.1990, as he was expected to and the instrument involved in this process was no more than a pair of plain forceps! We wonder what prevented OP 3 from actually doing this separation of adhesion on 17.03.1990. Was this the conduct of a physician of average skills owing a duty of average care to his patient? The answer has to be a firm no.
(p) As regards the topical application of steroid eye drops, the medical literature discussed above does not state anything categorical enough to support the complainants allegation. The contention of OP 3 that topical corticosteroid eye drops need not have been used when systemic steroid injections were being administered to deal with skin lesions/blisters caused by SJS may be medically questionable but that too does not help the complainant establish his specific allegation in this regard.
(q) However, the repeated/frequent failures of OP 3 to note in his clinical observations the specific complaints of the patient he was asked on reference to look into, to specify the dosages of the medicines prescribed by him and/or the duration for which they were so prescribed and to see if his directions regarding prescriptions were being followed by the nursing and other staff amount to what has to be termed negligence per se for, no doctor of ordinary prudence will ever commit any of the acts mentioned above. The failure to state clearly the period and frequency of each medication was particularly significant because OP 3 was not attending on Hiren regularly, like Dr. Kamdar, the Dermatologist. Hence, if OP 3 did not specify the period of application of each medication, the nursing staff would be perfectly justified in continuing the treatment irrespective of the standard protocol in this behalf unless the patient developed some other complaint. These failures on the aprt of OP 3 become even more glaring when we compare the actions of all other doctors attending on Hiren and their written directions or clinical conduct as reflected by the treatment records produced by OP 3 himself. Further, it cannot be lost sight of that though claiming that the root cause of all troubles, as it were, in Hirens case was his dry eye syndrome, OP 3 completely failed to do anything for that problem in fact, there was no claim at all that he either prescribed any of the standard tests to determine the extent and nature of the dry eye syndrome in Hirens case or provided any treatment, even palliative, therefor Thus, we have no manner of doubt that the level of professional skill and degree of care that OP 3 brought to bear in treating the SJS affected eyes of Hiren were not those expected of even the very average ophthalmologist, leave alone those of one who claimed to have been a practitioner for 25 years.
Case of Respondent/OP 4 20 (i) As already discussed above, the case of negligence/deficiency in service on the part of the Hospital OP 4 consists, first, of the major omission to mention in the discharge summary that Hiren was expected to go to OP 3 for immediate ophthalmic follow-up (examination of his eyes under slit lamp microscope). Not only did the failure to mention this in the discharge summary misdirected the complainant and clearly led to further complications in Hirens eyes, it also constituted a basic violation of the medical code, namely, non-compliance of a written direction of Dr. B. C. Kamdar who, as the main treating physician, had specifically written to carry out the prescription of OP 3.
(ii) The second instance of medical negligence/deficiency in service on the part of OP 4 relates to the divergence, on several occasions, between the instructions of OP 3 and the recording of the corresponding Treatment Advice, as we have noticed in the extensive discussion above. Part of this lapse is of course attributable to OP 3 himself who never checked during his visits if his directions on each previous occasion had been correctly followed. However, the assisting medical staff of the Hospital, like the Residents, staff nurse(s), etc., cannot escape the principal blame. This too is, in fact, a variety of negligence per se, as it also amounts to a violation of the basic code of medical practice, and need not be specifically proved.
(iii) The third instance of medical negligence/deficiency in service for which OP 4 is liable that attributable to OP 2 for the reasons already discussed in paragraph 14 supra.
21. In conclusion, the appeal succeeds and is partly allowed by setting aside the order of the State Commission, which is erroneous on facts as well as in appreciation of medical aspects.
22. We may notice here that the total claim for compensation in the complaint was Rs. 9, 79,500/- in 1993. The facts of the case (including the treatment record after the date of his discharge from OP 4 Hospital and the opinions of expert Medical Institutions to which Hiren was referred by this Commission to see if his condition was curable) would show that the debility from which Hiren continues to suffer even now as a young man can be largely but not entirely attributed to the treatment he received from OP
3. Moreover, even according to the complaint, the negligence on the part of OP 1 and OP 2 was rather limited to the counts already discussed above and OP 2 having expired in the course of the proceedings, the liability on account of negligence of the latter would devolve on OP 4.
23. Therefore, considering all things together we are of the view that a compensation of Rs. 5 lakh (Rupees five lakh) only, payable at the relevant time would have met the ends of justice in this case. This amount would naturally carry interest at a suitable rate. Further, in keeping with our assessment of the relative deficiencies/negligence, the amount needs to be suitably apportioned among the OPs. We accordingly direct OP 1 (General Physician) to pay Rs. 0.5 lakh, OP 3 (Ophthalmologist) to pay Rs. 2 lakh and OP 4 (Hospital) to pay Rs. 2.5 lakh to the appellant/complainant along with interest @ 9 per cent per annum payable since the month and year of the complaint till payment. The amounts shall be paid by each of the above-mentioned OPs within 4 weeks from the date of this order, failing which the rate of interest shall be enhanced to 12 per cent per annum from the same date. In addition, each of the OPs 1, 3 and 4 shall pay Rs. 10,000/- to the appellant by way of costs in these and the preceding proceedings. It shall of course be open to the OPs 1, 3 and 4 to realise insurance claims from OP 5, if they are insured and their claims are found admissible under the respective policies. We also direct the appellant/complainant to invest the entire amount received from the OPs suitably in the name of Hiren (who is now an adult) so as to provide the latter a steady monthly annuity.
24. Before parting with the matter, we would like to place on record our appreciation of the assistance rendered by Mr. Dhruv Mehta and Mr. Harshawardhan Jha, Advocates who dealt with the case as amicus curiae; Mr. Mehta in particular worked very hard though the final submissions before this Bench were made by Mr. Jha. We direct the Registry to disburse Rs. 10,000/- to Mr. Mehta and Rs. 5,000/- to Mr. Jha towards their out-of-pocket expenses.
sd/-
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[R. C. Jain, J] sd/-
[Anupam Dasgupta]