Full Judgment
IN THE HIGH COURT OF KERALA AT ERNAKULAM
PRESENT THE HONOURABLE MRS. JUSTICE C.S. SUDHA FRIDAY, THE 9TH DAY OF FEBRUARY 2024 / 20TH MAGHA, 1945 RFA NO. 20 OF 2003 AGAINST THE JUDGMENT AND DECREE DATED 21/06/2002 IN OS 609/1994 OF PRINCIPAL SUB COURT, KOTTAYAM APPELLANTS/DEFENDANTS 1, 2 & 4 IN THE O.S.: 1 STATE OF KERALA REP BY SECRETARY TO GOVT., HEALTH AND FAMILY WELFARE DEPT., SECRETARIAT, TRIVANDRUM. 2 THE SUPERINTENDENT DISTRICT HOSPITAL, KOTTAYAM. 3 THE PHARMACIST DISTRICT HOSPITAL, KOTTAYAM. BY ADV.BIMAL K.NATH, SR.GOVERNMENT PLEADER RESPONDENTS/PLAINTIFF & DEFENDANTS 3 AND 5 IN THE O.S.: 1 SALUKUTTY (NOW MAJOR), D/O SURENDRAN A.S. IKKARA PARAMBIL (H), S.H.MOUNT P.O , KOTTAYAM REP BY HER FATHER SURENDRAN A.S. 2 DR. GEETHA SHARMA DEPT. OF OPHTHALMOLOGY, DISTRICT HOSPITAL, KOTTAYAM. 3 THE DIVISIONAL MANAGER NEW INDIA ASSUARANCE CO. LTD., DIVISIONAL OFFICE, 2ND FLOOR, PADINJAREKARA CHAMBERS, K.K ROAD, KOTTAYAM. BY ADVS.SEBASTIAN VARGHESE(K/141/2000)-R3 SRI.MOHAN JACOB GEORGE-R2 THIS REGULAR FIRST APPEAL HAVING COME UP FOR FINAL HEARING ON 30.1.2024, THE COURT ON 09.02.2024, ALONG WITH RFA.45/2003, THE COURT ON THE SAME DAY DELIVERED THE FOLLOWING:
IN THE HIGH COURT OF KERALA AT ERNAKULAM
PRESENT THE HONOURABLE MRS. JUSTICE C.S. SUDHA FRIDAY, THE 9TH DAY OF FEBRUARY 2024 / 20TH MAGHA, 1945 RFA NO. 45 OF 2003 AGAINST THE JUDGMENT AND DECREE DATED 21/06/2002 IN OS APPELLANTS/3RD DEFENDANT: DR.GEETHA SHARMA,DEPARTMENT OF OPTHALMOLOGY, DISTRICT HOSPITAL KOTTAYAM (NOW WORKING AS LECTURER TRAINEE IN BIOCHEMISTRY, MEDICAL COLLEGE, TRIVANDRUM) BY ADVS.THOMAS V.JACOB V.ANOOP MOHAN JACOB GEORGE MANI KURIEN P.V.PARVATHY (P-41) REENA THOMAS RESPONDENTS/PLAINTIFF & DEFENDANTS 1, 2, 4 & 5:
1 SALUKUTTY (MINOR),D/O SURENDRAN A.S., IKKARA PARAMBIL HOUSE, S.H.MOUNT P.O., KOTTAYAM, REPRESENTED BY HER FATHER AND LEGAL GUARDIAN SRI.SURENDRAN A.S. IKKARA PARAMBIL HOUSE, S.H.MOUNT P.O., KOTTAYAM. 2 STATE OF KERALA,REPRESENTED BY SECRETARY TO GOVERNMENT, DEPARTMENT OF HEALTH, TRIVANDRUM, 3 SUPERINTENDENT, DISTRICT HOSPITAL, KOTTAYAM 4 PHARMACIST, DISTRICT HOSPITAL, KOTTAYAM. 5 DIVISIONAL MANAGER, NEW INDIA ASSURANCE COMPANY LTD., DIVISIONAL OFFICE, 2ND FLOOR, PADINJAREKKARA CHAMBERS, K.K.ROAD, KOTTAYAM. BY ADVS.SEBASTIAN VARGHESE(K/141/2000), FOR R5 V.K.SUNIL, FOR R1 B.PREMOD, FOR R1 T.R.SATHYAN, FOR R1 BIMAL K.NATH, SR.GOVERNMENT PLEADER, FOR R2 & R3
THIS REGULAR FIRST APPEAL HAVING COME UP FOR FINAL HEARING ON 30.1.2024, THE COURT ON 09.02.2024, ALONG WITH RFA.20/2003, DELIVERED THE FOLLOWING:
C.S.SUDHA, J.
------------------------------------ ---------------------------------------------------- Dated this the 9th day of February, 2024
JUDGMENT
These appeals are against the judgment and decree dated Court, Kottayam. The appellants in R.F.A.No.20/2003 are defendants 1, 2 and 4 and the respondents, the plaintiffs, and defendants 3 and 5 in the suit. The third defendant is the appellant in R.F.A.No.45/2003. The parties and the documents will be referred to as described in the plaint.
2. The suit for damages was filed by the plaintiff, a minor aged 6 years, through her next friend, father. On 18/06/1999 the plaintiff
developed slight irritation and discomfort in her eyes. Her parents suspected conjunctivitis as the said disease was widespread in their neighbourhood. The plaintiff was taken to the District Hospital, Kottayam, where the plaintiff's mother on taking a O.P. ticket was directed to the third defendant doctor, who was in-charge of the Ophthalmology Department. The third defendant on being apprised of the discomfort to the plaintiff's eyes, prescribed two medicines, namely, (i) Remiciline, one drop to be applied every five minutes and (ii) Geramycine one drop to be applied every half hour. The plaintiff's mother was advised to collect the medicine from the pharmacy of the hospital. Accordingly, the medicine was supplied in a bottle by the fourth defendant Pharmacist. As advised, the plaintiff after
returning home, applied Remicilin eye drop. The eye drop was repeated twice within a gap of five minutes as directed in the prescription. Within a few minutes of the applying the eye drops for the third time, the plaintiff developed severe pain in both her eyes and severe edema appeared on the eyelids and face. Within a short time, the edema spread over her entire body and so the eye drop was discontinued. The plaintiff's vision was getting diminished. As the plaintiff's father, a mill operator could reach home from work only after midnight, the plaintiff could be taken to the hospital only on the next day. 2.1. The next day early morning, the plaintiff was taken to the
Institute of Child Health, Gandhinagar (ICH), that is, on 19/06/1990 by which time the plaintiff completely lost vision of both eyes. There were lesions all over her body and she was in severe pain. She was admitted as an inpatient on 19/06/1990 and underwent treatment till 10/7/1990. The doctors at the hospital suspecting chickenpox, kept the plaintiff under observation and isolation in a dark room. The parents were informed that the plaintiff was in a critical condition and an opinion could be given only
after 24 hours. On 20/06/1990, the plaintiff was moved to the general ward. She was put under artificial respiration for four days, during which period, she was fighting for her life. From the second day onwards the plaintiff's skin and nails started peeling. She was unable to open her eyes due to edema. Her entire body had edema and lesions. On 10/07/1990 when she was discharged from ICH, there was no traces of skin on her body. She was surviving on drip and tube feeding, from the date of her admission till the date of discharge.
2.2. On 10/07/1990, the plaintiff was referred to the Medical College Hospital (MCH), Kottayam for further treatment under the Department of Ophthalmology where she underwent treatment till end of 1990. Inspite of prolonged treatment, the plaintiff could not regain
her lost vision. The doctors in the Department of Ophthalmology, MCH, advised the plaintiff to avail treatment at the Little Flower Hospital, Angamaly, pursuant to which she was admitted and treated in the said hospital as an inpatient twice, that is, from 14/08/1990 till 30/08/1990 and from 17/10/1990 to 29/10/1990. The plaintiff at the time of filing the suit was also undergoing treatment as an outpatient. The doctors in the Little Flower Hospital after examining the plaintiff opined that the condition was
due to reaction to the eye drops administered. During the course of her treatment in the third hospital, the plaintiff's skin, hair and nail gradually started growing. However, there was no improvement to her vision. The tenderness of the skin; facial distortion and disfiguration continues. 2.3. The third defendant doctor is responsible for the condition of the plaintiff, as she was negligent and callous in the treating and in prescribing the medicine. The loss of vision was caused solely due to the
application of Remiciline, which is not a standard medicine. Remicilin containing penicillin can cause reaction and severe complications. As an ordinary prudent doctor, the third defendant was expected to administer test dose before she prescribed the application of the eye drops. The application of the eye drops without the precautionary test dose, resulted in the loss of vision, distortion and disfiguration of the plaintiff's face. There was gross negligence on the part of the third defendant. Remicilin is not available in the open market. It was prepared in the pharmacy of the second defendant, that is, the District Hospital, Kottayam. If the medicine is not prepared in the correct proportion as well as kept in sterile bottles or containers, there is every possibility of the medicine getting contaminated resulting in severe adverse effects to the patients, as in the case of the plaintiff. Even assuming that the plaintiff lost her vision due to contaminated eye drops, it was due to the gross negligence of the fourth defendant, for which the defendants are liable to compensate the plaintiff. The first defendant State is vicariously liable for the acts of its employees, namely, defendants 2 to 4. Hence the suit, claiming damages to the tune of ₹5 lakhs.
3. The first defendant State filed a detailed written statement denying any negligence or callousness on the part of the third defendant
doctor. When the plaintiff was examined on 18/06/1990 by the third defendant, she had symptoms of conjunctivitis and hence was prescribed penicillin and gentamicin eye drops. Remicilin was never prescribed. The plaintiff was asked to come for a review the next day. She was also advised that in case she developed any problem or irritation due to the administration of the eye drops, she was to discontinue the medicine and to report immediately to the hospital. However, the plaintiff never turned up before the third defendant. As soon as the plaintiff developed irritation, immediate medical care ought to have been given to the child. There was inordinate delay on the part of the parents in taking the child to the hospital for further treatment. The allegation that the plaintiff lost her vision on
only congested when she was examined by the doctor at ICH where she was treated by an Ophthalmologist, a Paediatrician, and a Dermatologist. When the child was admitted in the ICH, she was running a temperature of 104°. The doctors at ICH suspected chickenpox, a viral infection, and so she was kept under isolation. Thereafter on 20/06/1990 when the plaintiff was provisionally diagnosed to be suffering from Stevens Johnson Syndrome (SJS), she was removed from isolation and was treated duly and sufficiently for the said ailment. However, the cause was not known to the doctors. Symptoms of SJS were not present when the plaintiff was examined by the third defendant. On 09/07/1990 the plaintiff was transferred to MCH. By
available treatment had been given. The allegation that the skin of the whole body and the nails had peeled off, is incorrect. 3.1. Erythema multiforme or SJS, a skin reaction may occur due to
several reasons. Virus is one of the most common causes of SJS. It may be caused due to organisms causing infections like herpes, infectious mononucleosis, mumps, measles, influenza etc. Other infections which can produce SJS are bacterial infections like, streptococcus, typhoid fever, proteus, dental infections, T.B., fungal infection etc. Some of the viral infections can be without symptoms also. All these infections can cause eye manifestation also. It may also occur due to immunisation or hypo sensitization. Even sunlight, food margarine can cause SJS. There are cases of SJS occurring one to three weeks after herpes infection, or one to three weeks after respiratory infection with mycoplasma and one to three weeks after drug therapy. The cause of SJS cannot be pin pointed. Conjunctivitis may be the initial manifestation of SJS, and application of penicillin drops is only incidental. Peeling of the skin of the upper eyelid and edema are symptoms of SJS. The possibility of viral infection in the plaintiff cannot be ruled out.
3.2. Drugs like sulphonamides, penicillin, tetracycline, aspirin,
cimetidine, thiabendazole etc. can also cause SJS. SJS is a late reaction to penicillin sensitivity and occur only after a few days of the application or administration of penicillin. The percentage of such reaction amounting to SJS is very limited, in fact, nil. The plaintiff is alleged to have developed reaction minutes after applying the penicillin drops. SJS in the plaintiff was not due to the application of penicillin drops. It is not possible to specify the reasonable drug or pathogenetic mechanism based on clinical appearance alone because the skin responds to a wide variety of stimuli through a limited number of morphologic reaction patterns.
3.3. Eye drops itself is a test dose and therefore it is meaningless to say that there must be a test dose for a test dose. Test dose of penicillin is
given only in the case of intradermal injections. Dose of penicillin injections usually vary from 10 lakh to 20 lakh units. Dose of penicillin drops applied in the eyes is 5000 units/ml. One drop is 1/16 of an ml. Therefore, the penicillin content in one drop is 5000/16 = 312.5 units, whereas in injections the same is between 10 lakhs to 20 lakh units. Penicillin is only one of the many drugs that can produce reaction. Allergic reaction to penicillin is of various types depending upon their clinical manifestations and postulated mechanisms of development. Allergic reaction to a particular drug is due to some inherent mechanisms in the immune system of a patient, which makes him/her sensitive to a particular drug, food, cosmetics, smell, chemical etc. It is humanly impossible to identify whether a patient is sensitive to a particular drug, chemical, smell etc. Reaction to penicillin, which may occur any time after administration of the medicine, is normally minor and around the eyes. When the plaintiff developed reaction on administering the eyedrops, she ought to have been taken immediately to the attending physician. If the eye drops were the cause, there would have been itching on the eyelids. But the plaintiff did not have any such itching, which indicates that the eye drops was not responsible for the condition of the patient.
3.4. The medicine that was prepared at the pharmacy of the second defendant hospital was applied to more than 40 patients. There were no complaints of any reaction and therefore the allegation that the medicine supplied by the Pharmacist might have been contaminated is also incorrect and false. 3.5. Had the child been given timely treatment, the problem would
never have occurred. The parents of the child were duty bound to reveal the complete history of the case to the doctors at ICH. However, they were callously negligent in doing so. Had they given the correct information, proper treatment could have been started at the earliest and the vision of the child saved. There was never any negligence, indifference, or callousness on the part of the defendants. On the other hand, it was the plaintiff's parents who were criminally negligent in not taking the child immediately to the doctor on the child developing irritation and other symptoms.
4. The third defendant, the doctor, who first treated the plaintiff
filed written statement denying the allegation of callousness and negligence on her part in treating the patient. The stand taken by the first defendant State has been taken by the third defendant also.
5. The additional fifth respondent, the New India Assurance
Company, admitted that they had issued an insurance policy in favour of the third defendant under the Doctors' Indemnity Insurance IMA Medical Protection Scheme for the period from 25/04/1990 to 24/04/1991. The fifth defendant is liable to indemnify the insured only to the extent and subject to the terms of conditions and limitations of the policy.
6. On completion of pleadings, the parties went to trial. PW1 and
PW2 were examined and Exts.A1 to A15 series were marked on the side of the plaintiff. DW1 to DW3 were examined and Ext.B1 was marked on the side of the defendants. Ext.X1 is the case records relating to the treatment of the plaintiff at the MCH, Kottayam. The trial court, on consideration of the oral and documentary evidence and after hearing both sides, decreed the suit. Aggrieved, defendants 1 to 4 have come up in appeal.
7. The points that arise for consideration in these appeals are-(i)
was the loss of the plaintiff’s vision caused due to any callous and negligent act on the part of the third defendant doctor; (ii) was there any medical protocol, which the third defendant was bound to follow before the administration of the eye drops prescribed by her as per Ext.A1; and (iii) is there is any infirmity in the findings of the trial court calling for an interference by this Court.
8. Heard both sides.
9. The fact that the plaintiff lost vision of both eyes is admitted.
The point in dispute is regarding the factors that led to the loss of vision. It was submitted by the learned counsel for the plaintiff that it was solely due to the callousness and negligence on the part of the third defendant doctor in prescribing the eye drops without first giving a test dose. The medicine/eye drop ought to have been administered under the supervision of an
expert/doctor. The eye drops ought to have been administered in the hospital and the plaintiff kept under observation to see whether there was any adverse reaction to the same. Only after ensuring that there was no reaction to the same, the third defendant doctor ought to have allowed the plaintiff to leave the hospital and permitted her to continue the eye drops in the frequency and for the duration as advised in Ext.A1 prescription. Instead of taking such care and precaution, which the third defendant doctor was duty bound to do, callously prescribed the eye drops and allowed the administration of it without proper supervision at the residence of the plaintiff. The plaintiff was a six-year-old child at the time of the incident and her parents, labourers, did not have the expertise/knowledge or ability to detect adverse reaction at the initial stage itself and take immediate medical help. This argument is disputed by the defendants who submitted that no such test dose was required to be given. There is also a dispute regarding what caused SJS. During the course of arguments several decisions and authorities were cited by both sides to substantiate their respective cases, to which I make a brief reference.
10. I shall first refer to the materials relied on by the learned
counsel for the plaintiff. An article - 'A Single Drop in the Eye - Effects on the Whole Body ?' by Arun Vaajanen, Department of Ophthalmology, Tampere University Hospital, Tampere, Finland and Heikki Vapaatalo, Medical Faculty, Pharmacology, University of Helsinki, Finland says that that local therapy as administered in dermatology, in lung, ear and nose diseases as well as in ophthalmology, is assumed to exert its effects in the organ treated, but can in fact also evoke systemic, mainly harmful effects if
the drug is absorbed into the circulation. The increase in blood pressure seen in low-birth-weight infants was found to be attributable to large
doses/high drug concentrations in the eye drops used. The mucosal epithelium in the mucous membranes of the conjunctiva and nose is readily permeable to drugs, allowing them to gain access to the systemic circulation without being subjected to first - pass metabolism in the liver. 'Systemic side effects of eye drops: a pharmacokinetic perspective' by Andre Farkouh, Peter Frigo and Martin Czejka says that when administering eye drops, even when completely correctly applied, several routes of absorption are possible and excess amounts can sometimes cause an unwanted systemic bioavailability of the drops when not completely absorbed into the eye. Furthermore, the concentration of active ingredients in such medicinal preparations is usually very high, so that despite the correct application of the recommended dose, considerable amounts may be absorbed in an unwanted manner through various routes. Children are subject to a much higher risk of systemic side effects because ocular dosing is not weight adjusted and physiological development differs from that of adults. The article also discusses about the possible adverse systemic side effects for some drug classes that are frequently prescribed. It is stated that bacterial inflammations of the eye are indeed much less common than other causes of inflammation but, when present, can often result in more serious diseases. Most ocular bacterial infections are treated with antibiotics, which may also cause systemic reactions. Yet another article- ‘Drop in the eye has widespread ripples’- Medsafe, New Zealand Medicines and Medical Devices Safety Authority, says eye drops can cause systemic adverse reactions. Only a small portion of each dose is retained in the eye. It is estimated that only 5% to 10% of the active medicine included in an eye drop remains in the eye, and up to 80% may reach the general circulation. Because of poor bio availability, the dose of the active ingredient in eye drops often needs to be comparatively high. How much remains in the eye depends on a variety of factors, such as the characteristics of the eye drop and the administration technique. Infants, pregnant and nursing women, and aged patients are particularly at risk for systemic adverse reactions from eye drops.
10.1. Referring to the aforesaid articles, the argument is that though
only three drops of penicillin eye drops had been administered to the plaintiff, it would have been absorbed in circulation causing great harm. This was cited to rebut the argument of the defendants that penicillin eye drops if at all have any adverse reaction, would only be a minor one and that too confined around the eyes.
11. Regarding the disease SJS and its causes the following
materials are relied on- ‘Sudden Onset of SJS in 14 Yr Olg girl on Taking Antibiotic Drug - A Case Report’- Lashkar Pravalika ; Heena Fathima Sirikonda Jyotsna and T.Ravi Chander, Department of Pharmacy Practice Vagdevi Pharmacy College, Telangana. SJS is a rare, serious disorder of the skin and mucous membranes. It is usually a reaction to medication that starts with flu-like symptoms, followed by a painful rash that spreads and blisters. It can occur due to an adverse hypersensitivity reaction to drugs which results in skin and mucosal eruptions that can be potentially fatal. The most commonly cited cause of SJS is an adverse allergic drug reaction. Few cases of amoxicillin induced SJS have been reported. Currently no treatment modality has been established as standard for these patients. Paracetamol is the safest drug taken in combination with amoxicillin, but few cases were reported that paracetamol can also cause cutaneous adverse drug reactions. Therefore, before prescribing the drug, dosage adjustment and duration should be done properly. Early diagnosis with prompt recognition withdrawal of all potential causative drug is essential for favorable outcome. ‘Causative Drugs and Clinical Outcome in SJS, TEN and SJS-TEN overlap in children’ by Gomathy Sethuraman, Vinod K.Sharma, Pooja Pahwa and Pooja Khetan, Dep. of Dermatology, AIIMS, New Delhi says cutaneous adverse drug reactions can be caused by a wide variety of drugs. SJS and toxic epidermal necrolysis (TEN) are considered the most severe cutaneous reactions that occur in pediatric population. The duration of illness varies from 2 to 27 days. The time period between the intake of drug and start of eruption ranges from 0.5 to 30 days.
11.1. SJS and TEN are acute, rare, and potentially fatal skin
reactions involving loss of skin and in some cases, mucosal membranes accompanied by systemic symptoms. Medications are causative in over 80% of cases. SJS and TEN are distinguished based on the extent of the detached skin surface area. Numerous medications have been reported to trigger SJS. Antibiotics like Penicillin, Cephalosporins, Quinolones, Minocycline are some among the other drugs that commonly cause SJS.
(Stevens-Johnson Syndrome - Amanda M.Oakley ; Karthik Krishnamurthy).
12. Regarding the adverse reactions that can be caused by
penicillin the following materials are relied on- 'Anaphylactic Reaction from Topical Penicillin' by L.Robert Weiss, M.D., Boston, Mass. The author discusses a case of immediate reaction following antral instillation (through nose) of penicillin. In the said case, severe immediate allergic reaction following antral instillation of penicillin was noted. The related aspects of penicillin sensitivity have been discussed. It also says that more careful attention must be paid to the patient's pre-existing sensitivities in the use of penicillin. In another article titled 'Penicillin' by Derek W.Yip and Valerie Gerriets, both from the California North State University College of Medicine, the side effects of penicillin are discussed. The drug causes adverse effects including nausea, vomiting, diarrhea, rash, abdominal pain etc.
13. Now coming to the materials relied on by the third defendant
doctor- Nelson's Textbook of Pediatrics, Book 2, 15th Edition, page 1851, discusses the potential causes of Erythema Multiforme Major or SJS. It is a serious systemic disorder in which at least two mucous membranes and the skin are involved. Purulent conjunctivitis and uveltis usually develop, and cutaneous lesions tend to rupture, leaving denuded skin that may result in significant fluid loss, anemia, and a high risk for bacterial superinfection and sepsis. Management of SJS is supportive and symptomatic. Ophthalmologic consultation is mandatory because ocular sequelae such as corneal scarring can lead to loss of vision. (page 1852). Kumar & Clark's Clinical Medicine Tenth Edition, page 697 says - SJS and TEN are severe mucocutaneous disorders. They are characterized by varying extents of blistering/epidermal detachment and mucosal ulceration. The onset SJS is usually one to two weeks after drug exposure. Initial symptoms (malaise, myalgia, fever, and cough) are nonspecific, and these are followed by tender maculopapular erythematous, lesions on the torso and inflamed mucosal surfaces.
13.1. As per Rooks Textbook of Dermatology, 4 th Volume, Ninth
Edition, page 119.14, a latent period occurs between initiation of the culprit drug and onset of SJS/TEN. This latency is typically 7-10 days, but ranges from 5 to 28 days. A history of Malaise, fever and upper respiratory tract symptoms often precedes the onset of the dermatosis by a few days. The rash of SJS/TEN commonly develops on the face and chest initially and disseminates widely over the ensuing day. Pruritus and cutaneous pain accompany the skin signs. Involvement of mucosal sites may occur before, after, or simultaneously with the dermatosis.
13.2. Harrisson's Principles of Internal Medicine, Volume 1, 14th
Edition, page 865 refers to adverse drug reactions, which are frequently classified by mechanism as either dose related (toxic) effects or unpredictable reactions. There are further categories of unpredictable reactions and dose related reactions. Many of them can be avoided by reducing dosages, limiting the duration of the therapy, or reducing the frequency or rate of administration. The various reactions to antibacterial agents are referred to. It is further stated that a small proportion, less than 2% of persons, are allergic to penicillin, hence the severe adverse reactions stated therein. In Volume-I of the 18th edition of the book at page 432 it is stated that cutaneous drug reactions are among the most frequent adverse reactions to drugs. Most are benign, but a few can be life threatening. Prompt recognition of severe reactions, drug withdrawal, and appropriate
therapeutic interventions can minimize toxicity. Several studies have established those acute cutaneous reactions to drugs affected about 3% of hospital inpatients. Reactions usually occur a few days to four weeks after initiation of therapy. In classic serum sickness, symptoms develop 6 days or more after exposure to a drug, the latent period representing the time needed to synthesize antibody (page 433). SJS and TEN are 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 target lesions, dusky or purpuric macules in which mucosal involvement is significant, and total body surface
area blistering and eventual detachment is less than 10%. Erythema multiforme (EM) major is now considered by most to be different from SJS. EM is characterized by mucosal involvement and true target lesions or atypical raised target lesions often more acrally distributed and with limited extent of skin detachment. EM is most often triggered by infection, particularly herpes simplex virus. Patients with SJS, SJS/TEN, or TEN initially present with acute symptoms, painful skin lesions, fever of 102.2°F, sore throat, and conjunctivitis resulting from mucosal membrane and ocular lesions (Page 434). 13.3. Drug Hypersensitivity is discussed in the book 'Clinical
Immunology' Principles and Practice, Fifth Edition (Robert R. Rich M.D., Thomas A.Fleisher, William T.Shearer, Harry W.Schroeder, Jr., Anthony J.Frew and Cornelia M.Weyand). Various kinds of hypersensitivity reactions, their classification into four groups and the drug-induced reactions that can be caused are discussed. SJS, TEN, and contact dermatitis are stated to be delayed hypersensitivity reactions.
13.4. Rook's textbook of Dermatology, Volume 2, page 47.3 refers to some of the triggers of EM which includes viral infections, bacterial infections, fungal infections, drug reactions etc. On page 47.4 of the Book it is stated penicillin and ampicillin have been reported to have caused EM. 13.5. Clinical features of severe cutaneous reactions often induced by drugs is discussed at page 348 in the 17th Edition of Harrison's Principles of Internal Medicine, Volume 1. In 10 - 20% of SJS cases, the cause has not been determined. 13.6. Parson's Diseases of the eye, Sixteenth Edition, by Stephen
J.H.Miller, M.D, F.R.C.S, Chapter 14, discusses the methods by which therapeutic substances can be introduced into the eye. One of the methods is local administration. Penicillin can be given in the form of drops, ointment or powder or as subconjunctival injections, the pure sodium salt being always employed. Drops should contain from 1,000 to 10,000 units per ml. and should be instilled into the eye at frequent intervals, depending on the acuteness of the infection. In the early stages of an acute infection, intervals varying from a minute to a quarter of an hour may be indicated; in less acute infections intervals of two to three hours would be sufficient.
13.7. In Kerala State Drug Formulary issued by the Health & Family Welfare Department, Government of Kerala, the strength of commonly used antibiotic eye drops for instillation into the eye for penicillin G is prescribed as 10,000 units / ml. 13.8. The learned Government Pleader referred to the 3 rd edition of
the book titled 'Ophthalmology' (Myron Yanoff & Jay S.Duker). In the chapter Conjunctivitis: Infectious and Noninfectious, it is stated that the exact cause of SJS is unknown, although the disease is seen precipitated by numerous antigens including bacteria ; viruses ; fungi and drugs. Drugs implicated in the development of SJS includes among others penicillin also. SJS often begins with symptoms of malaise, fever, headache as well as upper respiratory tract infection. Next, skin lesions develop. The extent of mucous membrane involvement usually parallels the extent of skin involvement. Any mucous membrane may be involved, but the mouth and eyes are affected most frequently and most severely. The acute phase of ocular involvement lasts 2 to 3 weeks. Patients develop acute bilateral mucopurulent conjunctivitis. A more purulent conjunctivitis may develop because of bacterial secondary infection. After the acute toxic episode subsides, major ocular problems can occur. Conjunctival scarring may occur despite all supportive measures. It can lead to severe dry eyes. Dry eye combined with other factors referred thereto can cause severe corneal problems such as ulceration, vascularization, opacification, and eventual perforation.
14. Referring to these materials, the argument advanced on behalf
of the third defendant doctor and the State is that penicillin drops could not have been the cause for SJS in the plaintiff. It could have been possibly caused due to some infection. Had it been a reaction to penicillin, the reaction would not have been immediate, but after a few days. Moreover, if the drug had caused the reaction, discontinuing the same would have brought down the symptoms. But in this case, the symptoms only became more severe despite the eye drops being discontinued. This even more probabilises the case that SJS was not caused due to penicillin drops. The use of penicillin has not been banned and the dosage given to the plaintiff as per exhibit A1 is in tune with the dosage prescribed by the Government. Penicillin eye drops was the most appropriate medicine to have been prescribed as the plaintiff showed symptoms of conjunctivitis when she was examined by the third defendant. Hence there was no callousness or negligence on the part of the third defendant, goes the argument.
15. Many of the materials cited on behalf of the plaintiff is stated to
have been accessed from the internet and in some of them the authorship is not clear. Section 59 of the Evidence Act says that all facts except contents of documents or electronic records is to be proved by oral evidence. S.60 inter alia says that oral evidence must in all cases be direct and if it refers to an opinion or to the grounds on which the opinion is held, it must be evidence of the person who holds that opinion on those grounds. However, the first proviso to Section 60 says that opinion of experts expressed in any treatise commonly offered for sale, and the grounds on which such opinions are held, may be proved by the production of such treatises if the author is dead or cannot be found, or has become incapable of giving evidence, or cannot be called as a witness without an amount of delay or expense which the court regards as unreasonable. Therefore at least one of the contingencies stated in the proviso should be attracted for the court to rely on the materials without examining the authors. Further, the authors of such treatises must be shown to be properly qualified to make statements on the subject. It would have been ideal had the materials cited before me by either side been put to the witnesses, that is, to PW2, DW2 and DW3, doctors, if not to DW1, the third defendant doctor, while they were in the box and their opinion sought. In such circumstances, it may not be proper to solely rely on the materials produced before me to arrive at a conclusion.
16. Be that as it may, the fact that eye drop was prescribed as per
Ext.A1 by the third defendant doctor is admitted. What was the medicine/eye drop that was prescribed? Ext.A1 reveals that one of the eye drops was ‘Remicillin’. It was submitted by the learned counsel for the third defendant doctor that the eye drop prescribed was not ‘Remicillin’ but Penicillin and that the first letter in Ext.A1 is ‘P’ and not 'R'. On a perusal of Ext.A1, the argument does not appear to be correct. If in fact there was such an ambiguity, the same ought to have been clarified when the 3rd defendant was examined as DW1. On the other hand, on going through the testimony of DW1 it can be seen that on many occasions there is reference to the medicine prescribed as Remicillin. During the course of arguments, it was submitted that there is no medicine named ‘Remicillin'. But neither the first defendant State who had filed quite a detailed written statement nor the third defendant doctor in their respective written statements have such a case. In the written statement of the first defendant, the specific allegation which is seen repeated several times is that 'Remicillin' had not been
prescribed. They never had a case that there exists no medicine as 'Remicillin'. But the fact that the eye drops prescribed did have the ingredient of penicillin is an admitted fact. It is also admitted that penicillin may sometimes cause adverse reactions, which, if not in many, at least in a few cases can turn out be severe or fatal. Therefore, according to the plaintiff, before the penicillin drops were administered, a test-dose ought to have been given. Per contra the defendants contend that the eye drop itself is a test dose and therefore, it is meaningless to say that a test dose will have to be administered for a test dose. Normally/usually test dose is given for injections only and not for eye drops. That is why the plaintiff's mother was advised that in case of any complaint/irritation/ reaction to the medicine, the administration of the eye drop should be discontinued, and the plaintiff brought before the third defendant doctor for examination. Despite such specific instructions, the parents failed to bring the plaintiff before the third defendant.
16.1. PW1, the father of the plaintiff admittedly was not present
when the plaintiff was examined by the third defendant. On the other hand, it was the plaintiff's mother who had taken her to the third defendant. Therefore, PW1 would only have hearsay knowledge about what transpired in the hospital on the said day. No reasons are given as to why the mother had not been examined. PW1 asserted in the box that the third defendant doctor had never advised the plaintiff or her mother to discontinue the eye drop in case of any adverse reaction or irritation and to immediately contact
the latter or seek medical help. This testimony of PW1 is not seen challenged in the cross examination. It is admitted by the plaintiff that it was only on the next day, that is, on 19/06/1990 that she had been taken to ICH. No doctors of the said hospital who had examined the plaintiff are seen examined. The plaintiff has examined only PW2, a doctor of Little Flower Hospital, who admittedly had not treated the plaintiff. In addition to PW2, there is the testimony of DW2 and DW3, who are also doctors. I will make a brief reference to the evidence of doctors examined as witnesses in this case.
17. Ext.A15, the treatment records of the plaintiff while she was in
the Little Flower Hospital was marked through PW2, an eye Specialist of the said hospital. But PW2 is not the doctor who examined or treated the plaintiff, on the other hand it was two other doctors, namely, Dr.Mohan Raj
Nair and Dr.Tomy Fernandas who had attended the plaintiff. If the examination of the said doctors was not possible for any of the reason(s) stated in Sec. 32 of the Evidence Act, the treatment records can be proved by proving their handwriting or/and signature as in the case of any document. Sections 47 and 67 are the relevant provisions to be resorted to. (Kochu v. State, 1978 KHC 321; Acharaparambath Pradeepan v. State of Kerala, 2005 KHC 937 and Kurian v. State, 2019 KHC 741). When a written or verbal statement is made by a person in the discharge of his professional duty and his attendance cannot be procured for any reason stated in Sec. 32 of the Evidence Act, such statement is relevant and admissible. (Prithi Chand v. State of H.P., AIR 1989 SC 702: 1989 KHC 1160). It is true that PW2 has deposed that he is familiar with the handwriting and signature of the aforesaid doctors who had treated the
plaintiff and made the entries in Ext.A15. But none of the contingencies/reasons in Section 32 are stated to be attracted in this case. The aforesaid doctors, who had admittedly seen and treated the plaintiff after her treatment first by the third defendant and thereafter at ICH and MCH, for reasons best known to the plaintiff have not been examined. Now even assuming that Ext.A15 stands properly proved, let me examine the testimony of PW2 to see whether it in anyway substantiates the case of the plaintiff.
17.1. In the column relating to history in the first page of Ext.A15 it
is seen recorded that allergy caused was a result of reaction to penicillin. PW2 pleaded ignorance regarding the doctor who had made the said endorsement. According to him the entry made in Ext.A15 that it was SJS, must have been made by some junior doctor on duty. Dr.Mohan Raj on page 3 of Ext.A15, that is, Ext.A15(a) has recorded that the patient had a history of using penicillin and geramycin following which the patient had developed bullous lesions all over the body. The entry in page 22 of Ext.A15 shows that the patient had been referred to a dermatologist, whose report is also seen. According to PW2, as per entry dated 25/08/1990 the dermatologist had opined that penicillin and gentamicin should not be given. This does not appear so, because on a perusal of the relevant entries, I could reads thus- Ext. A15(b) reads- “known cause Steven Johnson Syndrome
for some eye drops. P e n i c i l l i n /e y e d r o p s . On 25/08/1990 the entry seen G e nt i c yn
addressed to the dermatologist reads - “This child who is admitted ꞇ Steven Johnson Syndrome? reaction of Penicillin or Genticyn drops. Her eye swab culture growth is sensitive to Cloxacillin, Lincomycin & Erythromycin. Kindly advice if we could put any of these drops to her.” The reply of the dermatologist reads thus- “Thromycin 250 mg (Erythromycin) @ 8h - Kindly start from 26/8 Morning - See me on Monday - 27/8 - No problem please continue the same” (Emphasis supplied).
17.2. PW2 deposed that penicillin causes different types of reactions
and that anaphylaxis is a severe reaction caused by the use of penicillin. PW2 pleaded ignorance when he was asked whether anaphylaxis could develop even when a minute quantity of penicillin is administered, irrespective of the route of administration. He deposed that he does not know whether a mere handling of a tablet of penicillin or a skin test dose in hypersensitivity patients could lead to immediate severe reactions. According to him, there would be only slight/minor reaction due to penicillin eye drops, like swelling and blisters on the eyelids. To a further question whether blisters could be caused on the eyelids as well as over the body in case of severe adverse reaction, he replied that there was no such possibility. The possibility of hair-loss and peeling of nails due to penicillin reaction is remote, but it could cause swelling and contusion and
putrefaction of the tender parts of the body. According to PW2, it is not necessary to administer eye drops under the supervision of a doctor. He admitted that reaction to penicillin could result in SJS. He deposed that based on the entries in Ext.A15 case sheet, there was no possibility of SJS having been caused due to adverse reaction. PW2 denied the suggestion put to him on behalf of the plaintiff that though he was an eye specialist, he was deposing falsehood to help the case of the defendants. But no permission is seen sought under Section 154 of the Evidence Act to put questions to PW2 as put in the cross examination. In the cross examination he deposed that there are several causes for SJS. No test dose is normally/generally/usually given for eye drops as the quantity is quite minute. PW2, claiming to have 18 years of service in the field also deposed that no cases have come to his notice by which damage to the eye had been caused due to penicillin. In the cross examination by the third defendant, he deposed that the entry in Ext.A15 that penicillin had caused the reaction, was made based on the information given by the parents of the plaintiff. In Ext.A15, the disease of the child had not been confirmed. A patient who develops an adverse reaction to penicillin will not thereafter be administered the same.
18. The third defendant examined as DW1 deposed that she had
advised the plaintiff and her mother that in the event of any reaction to the eye, the administration of the eye drops should be stopped, and medical help sought. When she examined the plaintiff, the latter had all symptoms of conjunctivitis like redness of eyes, watering of eyes and ….…. [illegible] discharge. The mother did not reveal anything else. According to DW1, at the time of examination, conjunctivitis was in its severe form. Diagnosing the ailment to be conjunctivitis, she prescribed penicillin eye drops. There is no medicine named ‘Remicillin’. She directed the eye drops to be taken from the pharmacy where the fourth defendant, the Pharmacist, prepared the
medicine. DW1 admitted that there was possibility of infection being caused if the medicine had not been properly prepared or given in a bottle/container which was not sterile. The pharmacy had given the medicine in a bottle brought by the plaintiff's mother. In the hospital there was a facility for sterilisation. To a question whether bottles brought from outside could be sterilised, she answered that it was in sterile bottles, medicine are given from the hospital. The penicillin eye drop was prepared by adding water to crystalline penicillin. This is not available in the market. She does not know where crystalline penicillin was manufactured or its date of manufacture or its expiry. Eye drops required for a period of about 2
days would generally be made in one go. In the event of the bottle containing the eye drop is kept open for a long duration, there is possibility of the medicine getting contaminated. 18.1. According to DW1, there was no need for giving a test dose
before eye drops are administered. A test dose is necessary only for injections. Local reaction would be caused by topical administration of penicillin drops but the same could never cause SJS. She also deposed that only in very rare cases, adverse reaction would be caused by penicillin eye drops. The local reaction caused due to the administration of penicillin can be halted by stopping the administration of the medicine. After the eye drops were stopped, medical help was availed only after 18 hours and hence the reason why correct treatment could not be given promptly. Had that been given, the child would not have lost her vision. She did not conduct a sensitivity test before prescribing eye drops. DW1 also deposed that it is not mandatory to conduct visual acuity test on patients complaining of eye problems. She also denied the suggestion that swab test and epithelial test are to be conducted. According to her, that is not possible as it would take four to seven days to get the result of the swab test whereas treatment for conjunctivitis is to be started immediately.
18.2. DW1 said that she later came to know that at ICH the plaintiff
had been diagnosed with SJS. But the cause of the disease had not been diagnosed anywhere. According to her, Erythema multiforme (EM) and SJS are one and the same disease. Similarity in symptoms in conjunctivitis and SJS is possible. SJS can be due to infection or caused due to use of drugs. The plaintiff had developed SJS due to some viral infection. Had the eye drops caused the disease, the symptoms or adverse reaction would have developed only after seven days. It is usually between 7 to 21 days that the
symptoms appear. However, the plaintiff developed blisters within 15 minutes of administration of the drug. If the symptoms had been caused due to the eye drops, they would have subsided when the drug was discontinued. But in this case the condition of the plaintiff worsened even after the drops were discontinued. From Ext.B1, the case records of the treatment of the child at ICH shows that the child was running a temperature of 104° C. This also indicates a viral infection. Ext.B1 reveals that the child was given cephalexin, which has penicillin like structure. A patient who develops reaction to Remicillin can have reaction to cephalexin also and so such patients will never be given the latter drug. Page 17 of Ext.X1, the case sheet records relating to the treatment at MCH would also show that cephalexin had been prescribed. DW1 also pointed out that before administering cephalexin, no test dose had been given. Cephalexin and penicillin have structural similarity and so it is not correct to say that the former drug does not fall in the penicillin group. DW1 also denied the suggestion that patients with Remicillin reaction would not have any reaction to cephalexin and hence the reason why the latter drug was given to the plaintiff at MCH. According to her, a patient with penicillin reaction would never be given cephalexin.
18.3. To a question whether penicillin would cause hyper reaction,
DW1 replied that such reaction can occur only when injections are given and that it is only in very rare cases such reactions occur due to eye drops. Eye drops would only cause local reactions. Dose in eye drops is minimal and hence no test dose is required. She denied the suggestion that due to the mucus membrane in the eyes, penicillin drops would have the same effect as in the case of injections. To a further question whether SJS could be caused by penicillin, DW1 replied that it was possible in the event of injection or tablets, but not due to eye drops. She denied the suggestion that in the case of penicillin reaction, even if the drug is stopped, the adverse reaction would not stop. DW1 also denied the suggestion that plaintiff had 104° fever due to Remicillin reaction. According to her such a high fever could only be caused by an infection. She admitted that in a book shown to her it is stated that due to penicillin reaction there is possibility of high fever and that it would happen 7 to 10 days after the development of allergy. It is also stated in the book that fever would come down within 48 hours of penicillin being stopped. The book does say that SJS is associated with administration of penicillin, but it does not specifically say regarding topical application. DW1 admitted that in one of the books shown to her it is stated that topical use of penicillin has been banned. According to her, the said statement is incorrect because the Kerala State Drug Formulary issued by the State Government in the year 2000, permits its usage. She denied having been negligent or callous in prescribing the penicillin eye drops to the plaintiff.
19. DW2, a retired Professor and Head, Department of
Dermatology, Kottayam, MD, with 33 years of practice, deposed that infection is the main cause of SJS. It can also be caused by drugs. The symptoms of SJS and conjunctivitis are more or less similar. In the initial stages though they are quite similar, in the later stages there would be a
clear difference between the two. To a question whether there was possibility of diagnosing a patient having symptoms of conjunctivitis with chickenpox, he replied that in case of blisters, the same is possible. If SJS is caused due to penicillin, the temperature of the patient would not rise. Anaphylactic reaction is type I reaction which is immediate. The reaction which causes SJS is very delayed. There is no possibility of causing SJS due to administration of penicillin eye drops. This opinion according to him
is based on his experience and on knowledge derived from books. He admitted that due to SJS, transparency of the cornea could be lost. But it does not happen in all cases. It can also happen if proper treatment is not given. 19.1. According to DW2, Cephalexin is normally not given to
patients who are allergic to penicillin. Test dose is only given for intravenous and intramuscular injections, and it is not necessary for ointments or eye drops. Eye drop itself is a test dose. To a question whether swab test was to be conducted before medicines are prescribed for conjunctivitis, he again pleaded ignorance. He admitted that in one book shown to him it has been stated that cephalexin is used for patients who have reaction to penicillin. But he also deposed that there are certain other books which say otherwise. He denied that the use of penicillin has been banned. To another suggestion that penicillin is given only at the third stage of gonorrhea and not as an eye drop, again answered that he is unaware of the same.
19.2. DW2 deposed that the dosage prescribed for adults and minors
vary. Dosage for a minor is prescribed considering the height and weight. To a question as to whether the dose prescribed in Ext.A1 is the dose that is generally prescribed for adults, he replied that he does not know. To another question as to whether the dosage prescribed in Ext.A1 if applied to a minor, would result in loss of vision, replied that in his opinion there was no such possibility.
19.3. Crystalline penicillin is diluted to make penicillin eye drops.
If the eye drops are given on the same day it is prepared, its potency would be high. But the potency would go down with the passage of time. If there is any shortfall/omission in preparing the medicine in the pharmacy or in the manner in which it is given, it can result in infection. DW2 denied the suggestion that administration of penicillin eye drops, or gentamicin eye drops without giving a test dose is a negligent act on the part of the doctor.
20. DW3, a retired Professor, Department of Ophthalmology,
MCH, Kottayam, is one of the doctors who had examined the plaintiff. She deposed that she has 36 years of service in the field. DW3 admitted that in Ext.B1 O.P. ticket dated 19/06/1990, the patient was advised to be admitted due to drug reaction. On the same day after admission, in the case sheet it was recorded that the patient had SJS. On 09/07/1990 she had examined the plaintiff, afflicted with SJS. The reason for SJS had not be diagnosed. The symptoms of SJS and conjunctivitis could be similar. Redness of the eye, swelling and formation of pus are the symptoms of conjunctivitis. Due to redness and swelling of the eye, it may appear to be conjunctivitis. Fever, blisters over the body, mouth and redness in the eyes are symptoms of SJS. Conjunctivitis can be caused due to bacteria, viruses, and fungi. Allergies can cause SJS. To a question whether it would be possible to identify from the symptoms as to whether it was conjunctivitis or SJS, DW3 answered that in case there are blisters on the skin, it could be identified as SJS.
20.1. Medicines are prescribed based on the symptoms seen on the patient. For a patient showing symptoms of Conjunctivitis, the medicines prescribed in Ext.A1 are the right ones. If a patient with such symptoms
approach her, she would also prescribe the same medicine. A patient coming with such symptoms is not subjected to swab test or other tests. DW3 was unable to give the reason for the loss of vision of the child. According to her, it is very difficult to find the cause/reason for SJS. It is not possible to detect SJS at its early stage. It takes about 7 to 21 days to diagnose SJS.
20.2. Penicillin is normally used for bacterial injection. Reaction to
penicillin does not occur immediately. It can happen at a later stage also. DW3 admitted that penicillin is quite an allergic and sensitive medicine, and that test dose is usually given when penicillin injections are given. The use of penicillin has not been banned. She denied the suggestion that penicillin and gentamicin are usually given at the third stage of a disease. A patient suspected to be allergic to penicillin will not be given cephalexin which is a medicine having cross reaction with the former. Ext.X1 reveals that on
From that it is evident that the child was not allergic to penicillin. To her knowledge none has developed SJS due to the application of penicillin eye drops. In all her years of practice, she has not come across any such instance. Only local reaction would be caused by the administration of penicillin eye drops. Local reaction is easily curable and the same would not cause loss of vision. Allergy to a drug usually develops about 7 to 20
days after the administration of the drug. In such cases, the allergic symptoms would come down if the medicine is stopped. If the allergic reaction does not subside or come down, despite the medicine being stopped, it can be understood that the allergic reaction was due to some other cause. 20.3. There was no necessity of giving a test dose before the eye
drops prescribed in Ext.A1 were administered. According to her, the said eye drop itself was a test dose. There was no possibility of the vision being affected due to the application of the eye drops prescribed in Ext.A1. She also deposed that the dose prescribed in Ext.A1 is appropriate for a minor child. She denied the suggestion that the dosage prescribed in Ext.A1 was too high. The doctor who treated the plaintiff as per Ext.A1 was never negligent. All the facilities that were available in the hospital at the relevant time were used for the treatment of the child. She also denied the suggestion that she was deposing falsehood to help the third defendant.
21. Several decisions were also cited by either side in support of their
respective contentions. The decisions cited by the plaintiff are- Dr.M.K.Gourikutty v. M.K.Raghavan, AIR 2001 Ker. 398; State of Haryana v. Smt.Santra, (2000)5 SCC 182 ; Achutrao Haribhau Khodwa v. State of Maharashtra, 1996 SCC(2) 634 ; Jacob Mathew v. State of Punjab, 2005(3) KLT 965 and also a judgment rendered by me in Sinebha v. The District Collector, Thrissur, 2023 KHC 804. On behalf of the third defendant, the following decisions were relied on : Bombay Hospital and Medical Research Centre v. Asha Jaiswal, 2021 KHC 6773 ; Dr.Chanda Rani Akhouri v. Dr.M.A.Methusethupati, 2022 KHC 6438 ; Vinod Jain
v. Santokba Durlabhji Memorial Hospital, (2019)12 SCC 229 : MANU/SC/0Research ; Martin F. D'Souza v. Mohd.Ishfaq, (2009)3 SCC 1 : MANU/SC/0225/2009 ; Jacob Mathew v. State of Punjab, MANU/SC/0457/2005 ; Mohamed Tariq A.K. v. Savera Hospital Pvt. Ltd., 2019(5) KHC 88 ; Bolam v. Friern Hospital Management Committee, [1957]1 WLR 582 and Kusum Sharma v. Batra Hospital and Medical Research Centre, MANU/SC/0098/2010.
22. The law relating to medical negligence is no longer res integra.
In Sinebha (Supra) I have discussed in detail the dictums in most of the decisions cited in this case and therefore I am not referring to each one of them separately. The test of negligence laid down by the Apex court in the aforesaid decisions are not satisfied or fulfilled in this case. The testimony of the doctors does not support or substantiate the case of the plaintiff. Even PW2, the witness of the plaintiff does not support her case. Despite that as noticed earlier, no permission was sought to put questions to him as
put in cross examination. The net result is that the testimony of the plaintiff's witness also probabilises the stand taken by the defendants. The opinion of the doctors is that there was no possibility of SJS being caused to the plaintiff due to Penicillin eye drops. All of them said that eye drop need not be administered under the supervision of a doctor or an expert. They also deposed that there is no medical protocol in vogue to the effect that before eye drops are given, test dose is to be given or that the eye drops are to be administered under the supervision of a doctor or an expert and only after ensuring that there is no adverse action, should the patient be released from the hospital and advised to continue the medicine as prescribed by the doctor. The doctors at the ICH also seem to have been in the dark as to what caused the symptoms seen in the plaintiff. The plaintiff was not immediately diagnosed with SJS. On the other hand, she was suspected to be suffering from chickenpox, a virus. It was much thereafter she was diagnosed with SJS. The materials referred to herein above say that viruses can also cause SJS, and that SJS can in some cases lead to blindness. Possibility of virus infection on the plaintiff cannot also be ruled out because according to the doctors, the onset of SJS due to reaction to drugs would be delayed. However, here the plaintiff is alleged to have developed
symptoms immediately after the administration of the eye drops. The materials relied on by either side show that the intensity of adverse reaction or reaction to drugs can be brought down by discontinuing the drug or reducing the dosage or the frequency of its use. However, in this case inspite of the eyedrops being discontinued, the symptoms did not subside or stop, but the condition of the plaintiff seems to have worsened day by day. Evidence has also come on record that at the ICH and MCH, the plaintiff had been given cephalexin which is stated to have the same structure as Penicillin. Had the plaintiff been allergic to Penicillin, then it is quite unlikely for the said medicine to have been administered to her. All these aspects militate against the case of the plaintiff.
23. There is yet another allegation seen raised in the plaint that
Remicillin is not available in the market and that it was made in the pharmacy of the second defendant hospital by the fourth defendant pharmacist. It was also alleged that if the bottle/container containing the medicine was contaminated, infection could be caused. The doctors also admit this aspect. Though such an allegation is seen taken up, no evidence has come on record to substantiate the case that the eye drops given from the pharmacy of the second defendant hospital, had in fact been contaminated resulting in causing infection and subsequent loss of vision. PW1 admits that the eye drop to be administered was given to the plaintiff in the bottle brought by the mother. Was the container or bottle sterile? Was the medicine contaminated leading to infection and subsequent loss of
vision? Doubts linger in one's mind on this aspect too. In such circumstances, it would be even more unsafe to conclude regarding the negligence or callousness on the part of the third defendant doctor.
24. It was pointed out by the learned counsel that the plaintiff, then
a young child of six years, is now a young lady in her thirties. She was not born blind but lost her vision at a tender age. Such people would certainly find it quite difficult to manage things by themselves unlike people visually impaired from birth. This Court does realise the magnitude of the tragedy that befell the plaintiff. From the evidence on record it has come out that symptoms of conjunctivitis and SJS in its intial stages can be similar. Plaintiff when first examined by the third defendant showed all signs of conjunctivitis and so in such circumstances, the doctors examined have deposed that the eye drops prescribed by the former was the most appropriate one. Therefore there is no evidence to show that a wrong medicine had been prescribed or a medical protocol which the third defendant was bound to follow, had been breached. It appears that there was some delay in correctly diagonising the ailment of the plaintiff. The
third defendant diagonised it as conjunctivitis. The doctor at ICH diagonised it as chickenpox. It was only on 20/06/1990 she is stated to have been provisionally diagonised with SJS. Thus from the materials on record it cannot be stated to have been due to any negligence or callousness on the part of the third defendant because DW3, quite an experienced doctor deposed that had she been in the place of the third defendant, she would also have prescribed the same eye drops as prescribed by the former. This testimony has not been discredited in any way. It is true that the doctors examined in this case on some quite crucial questions, pleaded ignorance. The cross examiner ought to have put further probing questions if the ignorance pleaded was deliberate or with the intention to help the third defendant. But the said course is not seen followed. As soon as the child developed symptoms like irritation, it would have been better had immediate medical help been sought. But one cannot blame the parents of the plaintiff because the father is stated to have returned home from work late in the night compelling them to seek medical help only the next day. Had immediate medical attention been given, probably the vision of the plaintiff might not have been lost. But it is easy to be wiser after the incident.
25. In these circumstances, I am constrained to hold that evidence
is lacking to find negligence or callousness on the part of the third defendant doctor in holding in favour of the plaintiff. As the third defendant cannot be found to be negligent or callous, the first defendant State cannot be vicariously held liable for the acts of the third defendant. That being the position, the judgment and decree of the trial court require to be interfered with and hence I do so.
In the result, the appeals are allowed. The impugned
judgment and decree are set aside.
Interlocutory applications, if any pending, shall stand closed. Sd/- C.S.SUDHA JUDGE ami/jms