State Consumer Disputes Redressal Commission
Sri Sujit Das vs Dr. Dilip Prodhan on 19 July, 2018
Cause Title/Judgement-Entry STATE CONSUMER DISPUTES REDRESSAL COMMISSION WEST BENGAL 11A, Mirza Ghalib Street, Kolkata - 700087 Complaint Case No. CC/175/2014 ( Date of Filing : 23 May 2014 ) 1. Sri Sujit Das S/o Sri Ambujaksha Das, Ujjwalnagar, Adikantanagar, Ujjwalnagar, kantanagar, Adikantanagar, Murshidabad, West Bengal -742 227. ...........Complainant(s) Versus 1. Dr. Dilip Prodhan 148/1, R.N. Tagore Road, Laldighi, Berhampore, Dist. Murshidabad, Pin-742 149. 2. Paediatric Medicine Departmentn N.R.S. Medical College & Hospital 138, A.J.C. Bose Road, Kolkata - 700 014. 3. L.V. Prasad Eye institute KAR Campus, L.V. Prasad Marg, Banjara Hills, Hyderabad, Pin -500 034, India. ............Opp.Party(s) BEFORE: HON'BLE MR. SAMARESH PRASAD CHOWDHURY PRESIDING MEMBER For the Complainant: Mr. Prabir Basu Ms. Binota Roy , Advocate For the Opp. Party: Nirendra Kr. Sarkar, Aneek Pandit,Ms. sayantani Das, Advocate Dated : 19 Jul 2018 Final Order / Judgement The instant complaint under Section 17 of the Consumer Protection Act, 1986 (for brevity, 'the Act') is at the behest of a father on behalf of his minor son Master Akash Das (hereinafter referred to as 'the Patient'), who was then four and half 41/2 years old, on the allegation of deficiency in services on the part of Opposite Party No. 1 Dr. Dilip Prodhan for medical negligence towards treatment of the Patient.
Succinctly put, complainant's case is that he and his wife, witness the sudden waking up of their son i.e. the Patient from sleep at night and complaining either of heat or fear of something which he was unable to explain. Initially the complainant and his wife did not pay any attention to them, but later on getting worried only when frequency of such occurrences increased and the complainant and his wife took the Patient to opposite party no. 1 on 04.05.2012 whereby the opposite party no. 1 had suspected 'seizure disorder' and prescribed the following medication:
FRISIUM 5 (one and half (11/2) tablet daily) for three weeks ZINCOVIT Syrup 5ml (once daily) for one month ZENTEL SYPRUP (one phial) along with an advice to do an Electroencephalogram (EEG) Test to measure the electric activity of the brain as well as CT Scan of the brain. The complainant on utmost good faith had accordingly started his son's prescribed medication as per the Doctor's advice. However, after having the said medicines continuously for fourteen (14) days the Patient had high fever and redness in the eyes. The complainant had taken him to Jangipur Sub-Divisional Hospital at Raghunathganj, Murshidabad wherein the complainant's son was admitted for treatment. However, on the same night the complainant and his wife noticed rashes of severe nature all over the body of Patient. The Patient was also complaining of pain due to such rashes. They also witnessed complete peeling off of skin from the body which seemed like removing a thick cloth from the body of the Patient. The doctors treating the Patient immediately advised the complainant to transfer him to Berhampur Sadar Hospital, Berhampur, Dist.- Murshidabad wherein the doctors further advised the complainant to take him to NRS Hospital at Kolkata since they were unable to provide the requisite treatment to the Patient. Immediately, the complainant and his wife brought the Patient at NRS Hospital, Kolkata on 22.05.2012 and admitted him to the Paediatric Medicine Ward. The Patient had been diagnosed for the first time with Stevens-Johnson Syndrome (SJS) - Toxic Epidermal Necrolysis Syndrome (TENS), which is a life threatening skin condition, in which cell death causes the epidermis to separate from the dermis layer of human skin. The syndrome is considered to be a hyper sensitivity complex that is categorized by acute skin blisters and membranes erosion. Thereafter, the Patient underwent treatment at the Paediatric Medicine Ward (Paediatric Intensive Care Unit) at NRS Hospital for nearly twenty-eight (28) days. Although the blisters and rashes of the skin of the Patient had reduced to some extent, complete cure and clearing of the same was far from reach. Moreover, the Patient continued to have problem in both his eyes with literally no vision at all. The Patient was discharged from Hospital with advice for further attendance of eye cure, skin cure and mouth cure at OPD of Pro-forma opposite party no. 2 Hospital. Thereafter, the complainant had taken the Patient to the OPD of the Hospital for further check up and treatment on several days as and when prescribed by treating doctors. Despite sincere efforts, the Patient was still unable to open both his eyes and at literally no vision and completely dependent for his basic support in his day to day activities. Thereafter, the complainant had taken the Patient to B.P. Koirala Institute Health Science at Nepal on 19.07.2012 for further treatment where it was confirmed that the Patient was suffering from SJS - TENS that had affected his skin, eyes, mouth and genitals to a great extent. Thereafter, the complainant in order to bring back normal vision in his sons eyes, took him to S.L.V. Prasad Eye Institute at Hyderabad on 24.09.2012 wherein it was revealed that the Patient had SJS along with total Limbal Stem Cell Deficiency (LSCD) in both the eyes which is a blinding decease characterised by recurrent epithelial defects, corneal vascularisation and corneal conjunctivalization. The complainant has alleged that due to gross negligence on the part of opposite party no. 1, the Patient had to suffer from SJS - TENS along with total LSCD in both the eyes which had almost taken the life of innocent child. The complainant has further alleged that opposite party no. 1 was grossly negligent in prescribing the FRISIUM 5 (CLOBAZAM drug) for 'seizure disorder' deceased that too without confirmed the same by way of EEG and CT Scan of brain. Hence, the complainant has approached this Commission with prayer for a direction upon the opposite party to pay compensation to tune of Rs. 46,60,000/- for irreparable loss and damage suffered by the complainant and his family especially the Patient.
The opposite party no. 1 by filing a written version has stated that on 04.05.2012 the Patient was brought to his chamber with some confusing symptoms like getting up from sleep at night, abnormal limb movement, abnormal look, inability to explain what happened to him. The parents of the Patient stated about sudden waking up from sleep at night and complaining of either of heat of fear of something which the Patient was unable to explain and when frequency of such occurrence increased the Patient was brought to him for treatment. After clinical examination, he suspected 'seizure disorder' and as per known treatment protocol he advised to do EEG and CT Scan of brain and as a precautionary measure prescribed Frisium - 5ml, Zincovit Syrup - 5ml once daily and Zentil Syrup one phial and also advised to report in case of emergency. According to opposite party no. 1 the symptoms suggested following probable diagnosis - (i) Parasomnia; (ii) Anxiety States and (iii) Seizure Disorder and in the case of children 'seizure disorder' is most probable. The opposite party no. 1 has stated that he requested the complainant to review early after completion of investigation and also to inform early, if any, abnormality is noticed. The opposite party no. 1 has categorically stated that he has prescribed Frisium (Clobazam) as anti-anxiety drug but later on it was found to have good anticonvulsant effect and he prescribed 7.5 mg OD is low to medium dosses for the Patient whose body weight was 16 kg. The opposite party no. 1 has categorically stated that the idea that SJS-TENS was developed to the Patient due to application of Clobazam (Frisium) is totally mistaken and misconceived. The authentic medical report and text books hold that the etiopathogenesis of SJS-TENS is not completely understood till today and no standard tests has yet been developed to predict which drug will cause this symptom. SJS-TENS is a rare disorder (1.89 case per Million). The opposite party no. 1 has also stated that the Patient underwent treatment at B.P. Koirala Institute of Health Services and in the discharge summery they advised to continue tablet VALPROTE CHRONO 200 mg, PO-BD while their EEG did not suggest any 'seizure disorder' but shows suppress brain activity. In the CT Scan report there is an observation of diffuse cerebral atrophy which has no relation with the present compliant of SJS. The opposite party no. 1 has submitted that as there was no negligence or lapse of duty on the part of him, he cannot be held responsible for anything which the Patient has alleged to have suffered and as such the complaint should be dismissed against him.
On behalf of opposite party no. 2 written version has been filed by the Professor and Head, Department of Paediatric Medicine, NRS Medical College and Hospital stating that the treatment was made available to the Patient to the best available resources available to the Department and they have been improperly pleaded as a party.
The opposite party no. 3 neither has appeared nor filed written version.
In support of his case, complainant tendered evidence through affidavit. He has also given reply against the questionnaire set forth by opposite party nos. 1 & 2. Besides complainant, no other witness was examined on behalf of the complainant. On the other hand, both opposite party no. 1 and opposite party no. 2 have tendered evidence through affidavits. They have also given reply against the questionnaire set forth by the complainant. At the time of final hearing, both the complainant and opposite party no. 1 have filed brief notes of argument in support of their respective cases.
The pleading of the parties and the evidence on record clearly indicate that on 04.05.2012 the Patient was taken by his parents to Dr. Dilip Prodhan (opposite party no. 1) as they noticed sudden waking up of his son from sleep at night and complaining of either heat or fear of something which he could not explain. The opposite party no. 1 claimed himself a qualified and experienced physician and child specialist and also a member of West Bengal Health Services having a practicing experience of more than 25 years. At the relevant time the opposite party no. 1 was carrying his medical practice in Berhampore, Dist.- Murshidabad. It reveals that the Patient was brought to the chamber of opposite party no.1 with confusing symptoms like getting up from sleep at night or complaining of either heat or fear of something which he could not explain. The opposite party no. 1 examined the Patient and after clinical examination, suspected 'seizure disorder'. The Doctor/Opposite Party No. 1 has prescribed the following medication: (i) Frisium 5 (1 and half tablet daily) for 3 weeks; (ii) Zincovit Syrup (5ml once daily) for 1 month and (iii) Zentil Syrup 1 phial along with and advice to do an EEG Test to measure and record the electric activity of the brain as well as CT Scan of the brain.
It is evident that the father of the Patient (complainant) did not take any positive step for EEG Test or CT Scan of the brain but started prescribed medication as per Doctor's advice and after having the said medicines continuously for 14 days, the Patient had attacked with high fever and redness in the eye. Immediately, the Patient was taken to Jangipur Sub-Divisional Hospital at Raghunathganj, Dist.- Murshidabad and the Patient party did not meet opposite party no. 1 i.e. the Doctor who prescribed the medicine and the tests. In any case, when the situation worsened, the Patient was transferred to Berhampur Sadar Hospital, Dist.- Murshidabad and as per advice of the doctors of the said Hospital the Patient was taken to NRS Medical College and Hospital at Kolkata where the Patient underwent treatment from 22.05.2012 to 18.06.2012 continuously for 27 days.
The report of NRS College and Hospital speaks that the provisional diagnosis has been referred as Stevens-Johnson Syndrome. The case summery of the Patient at NRS Medical College and Hospital between 22.05.2012 to 18.06.2012 speaks that the Patient was receiving some unknown medication (prescribed by some local Doctor) for 14 days and the blisters actually started to appear after consumption of five glasses of soft drinks (bought from local shop) on 17.05.2012. On 18.05.2012 at 2:00 AM the mother of the patient noticed high grade fever, appearance of blisters starting from lips, palms, soles and gradually spreading all over the body including oral cavity and eyes. The child was also in the state of delirium. Just after admission treatment of the Patient was started and on the following day the Patient was referred to Department of Dermatology for transfer the child to their child as the case was supposed to manage by Department of Dermatology. On 24.05.2012 the hospital authority transfused intravenous immunoglobulin according to literature and as per advice of Dermatology Department for better outcome in Toxic Epidermal Necrolysis. The Patient was also referred to Ophthalmology and they documented swelling of eyelids, blepharospasm (cornea could not be seen) and vision could not be documented properly. It was found that there was difficulty in eye and mouth opening during that time. The Department of Ophthalmology documented eyelids scalded, conjunctive congested and cornea dry. Ultimately the Patient was discharged on 18.06.2012 with discharge advice and after advice to attend Paediatric, Skin and Eye OPD.
The evidence on record also suggests that after treatment at NRS Medical College and Hospital at Kolkata the blisters and rashes of the skin of the Patient had reduced to some extent but the Patient continued to have problem in both his eyes with literally no vision at all. It also transpires that the Patient was taken to B.P. Koirala Institute Health Sciences in Nepal for further treatment and the Pathological tests conducted there confirmed that the Patient was suffering from SJS-TENS that had affected his skin, eyes, mouth etc. It further comes to light that the Patient was taken to L.V. Prasad Eye Institute at Hyderabad and the test report along with discharge certificate revealed that the Patient had SJS along with total LSCD in both the eyes which is a blinding disease characterized by recurrent epithelial defects, corneal vascularisation and corneal conjunctivalisation. Evidently, either NRS Hospital at Kolkata or B.P. Koirala Institute of Health Sciences at Nepal failed to give back normal vision of the Patient. These are almost admitted facts.
Ms. Binota Roy, Ld. Advocate for the complainant has submitted that the prescription of opposite party no. 1 is in itself a defective one in several ways with gross irregularities alongside discrepancies in treating the Patient as per accepted medical protocol. According to her, the complainant had taken his son with a problem as simple as disturbed sleep at night and under such circumstances, the opposite party no. 1 had no reason to suspect the same to be a 'seizure disorder'. She has further submitted that the opposite party no. 1 had no occasion to prescribe a drug like Frisium 5mg (one and half tablet daily = 7.5 mg) [trade name of Clobazam drug] continuously for three weeks to a Patient of only four and half years old child weighing only 16 kg. She has categorically asserted that due to Frisium that the Patient had to suffer from such a life threatening skin disorder like SJS along with total LSCD in both the eyes leading to irreparable damage to the cornea of the eyes.
Ld. Advocate for the complainant has referred me a decision of Hon'ble National Commission reported in 2013 (1) CPR 244 [Yashoda Super Speciality Hospital - vs. - Smt. A. Subbelakshmi & Anr.] where it was held that no patient can be treated in a casual manner and another decision reported in 2016 (3) CPR 572 [Abha Rani Srivastava - vs. - National Insurance Co. Ltd. & Anr.] where it has been held that doctor cannot act contrary to medical literature. Drawing my attention to the Prescription, Ld. Advocate for the complainant has submitted that the opposite party no. 1 did not choose to annex his Certificate of Enrolment with the West Bengal Medical Council (W.B.M.C.) wherefrom it would be evident whether the Diploma in Child Health is an approved course or WBMC or not especially when he is practicing and claiming himself as a Child Specialist. Drawing inscription to the prescription, Ld. Advocate for the complainant has also submitted that the opposite party no. 1/doctor has prescribed the drug namely, Frisium 5 mg (one and half tablet daily for three weeks) but miserably failed to specify the dosage meaning thereby the prescription does not mention as to how many times the Patient ought to have taken the said medication or any therapeutic dialogue, meaning specific instruction to the Patient about warning/caution of the possibility of adverse drug reaction of Clobazam (Frisium). Ld. Advocate for the complainant has placed before me medical journals regarding the effect of Clobazam and its effect resulting to SJS.
Mr. Nirendra Kumar Sarkar, Ld. Advocate with the assistance of Mr. Aneek Pandit, Ld. Advocate has contended that the Patient party met only once with the Doctor (opposite party no. 1) on 04.05.2012 when the Doctor after clinical examination suspected 'seizure disorder' and prescribed:- (i) Frisium 5 (1 and half tablet daily) for 3 weeks; (ii) Zincovit Syrup (5ml once daily) for 1 month and (iii) Zentil Syrup 1 phial along with and advice to do an EEG Test to measure and record the electric activity of the brain as well as CT Scan of the brain but ultimately the Patient party deserted the Doctor and go away without informing anything and only after two years after receipt of the complaint, the opposite party no. 1 came to know about the case. Ld. Advocate for the opposite party no. 1 has submitted that under medical protocol it is the general duties of a doctor - (a) to exercise a reasonable degree of skill and knowledge and a reasonable degree of care; (b) to exercise reasonable care in deciding whether to undertake the case and also in deciding what treatment to give and how to administer that treatment; (c) to extent his service with due expertise for protecting the life of the patient and to stabilize his condition in emergency situations; (d) to attend to his patient when required and not to withdraw his service without giving him sufficient notice and (e) to study the symptoms and complaints of the patient carefully and to administer standard treatment etc. and in this regard, there was no lapse on the part of his client.
Ld. Advocate for opposite party no. 1 has categorically submitted that the Patient party has asserted that the Patient was only suffering from 'a problem as simple as disturbed sleep' which stems a natural question that if he was so sure of the problem as described by him as very normal when it was ultimately found that the Patient was not experiencing simple disturbed sleep but relatively suppressed occipital brain activities and diffused cerebral atrophy. Ld. Advocate for opposite party no. 1 has submitted that the doctor (opposite party no. 1) prescribed Clobazam to extricate the immediate sufferings of the Patient from the symptoms the Patient exhibited before the doctor at clinical analysis subject to diagnostic tests i.e. EEG and CT Scan which was to be conducted by the complainant and then reviewed by the Doctor. It subsequently reveals that the apparent analysis of the Doctor comes true in another form when the ultimate report indicates - relatively suppressed occipital brain activities and diffused cerebral atrophy. He has also drawn my attention to the discharge summery of B.P. Koirala Institute of Sciences which divulges another anti-epileptic drug prescribed by the same on the observation of 'seizure disorder'.
In support of his contention, Ld. Advocate for opposite party no. 1 has placed before me several literatures regarding effects of Clobazam tablets, Drug Safety Communication etc. The crux of the present dispute is whether the doctor (opposite party no. 1), who treated the Patient clinically on 04.05.2012 was responsible for any deficiency during treatment of the Patient, which resulted in skin disorder and almost lost of vision of the Patient. It is apparent that on 14.05.2012 when the Patient was taken to opposite party no. 1, opposite party no. 1 after clinical examination prescribed the following medications:- (i) Frisium 5 (1 and half tablet daily) for 3 weeks; (ii) Zincovit Syrup (5ml once daily) for 1 month and (iii) Zentil Syrup 1 phial along with and advice to do an EEG Test to measure and record the electric activity of the brain as well as CT Scan of the brain.
On behalf of complainant, a serious question raises as to dosage of the medicine like Clobazam. At the outset, let us see what is Clobazam is. As per the Book of Essential of Medical Pharmacology by K.D. Tripathi (Publisher - Jaypee) 6th Edition (Pages 408-409) Clobazam is a 1.5 benzodiazepine (diazepam and others are 1.4 benzodiazepines) introduced first as anxiolytic and latter found to possess useful anti-epileptic efficacy in partial, secondarily generalised tonic-clonic as well as absence, myoclonic and atonic seizures, including some refractory cases. The dose start with 10-20 mg at bed times can be increased up to 60 mg/day. In this regard, it would be useful to have a look to the literature relating to use in children. Clobazam in the treatment of anxiety may have daily dosage of 5-15 mg (average dose 5mg twice daily for four weeks) reduced global assessment of anxiety in 87% of children aged between 2.5 years and 15 years and with general anxiety, School phobia, sleep disturbances, functional gastrointestinal symptoms or anxiety related to sever somatic illnesses. It the literature, it has also been mentioned that good therapeutic response rates with Clobazam (usual daily dose 0.5 mg/kg) were also observed in open studies. Be it noted here that as per Nelson's Text Book on Paediatrics (Table 593-13 relating to dosages of selected antiepileptic drugs) the Clobazam has been prescribed 10-20 mg/day and the preparations are 5mg, 10mg, 20mg tablets and 2.5mg.
The literature annexed with the brief notes of argument of complainant indicates that 0n 03.12.2013 the US Food and Drug Administration (FDA) issued a drug safety communication warning of 'rare but serious' skin reactions from the anti-seizure drug Clobazam. These included SJS and TEN. The FDA identified 20 cases of SJS and TEN associated with Clobazam from its Adverse Event Reporting System (AERS) database. Approximately, 31,000 patients received Clobazam since its approval in 2011 which suggests a rate of at least 20 cases per 31,000 users of 6 cases per 10,000 users. Two deaths occurred, one of which was "possibly" related to Clobazam. One case resulted in blindness and all required hospitalization. Many patients improved after Clobazam was stopped. The FDA advised the patients taking Clobazam should seek immediate medical treatments and talk to their health care professionals if they develop rashes, blistering or peeling of the skin, mouth sores or hives. The said warning of FDA dated 03.12.2013 see the light of the day after the date of clinical examination and therefore, opposite party no. 1 should not be blamed for the same.
Now, the question comes whether the medicine like Clobazam has resulted to Stevens-Johnson Syndrome of the Patient. In a review by Thomas Harr in Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome, it has been observed that TEN and SJS are severe adverse cutaneous drug reactions that predominantly involve the skin and mucous membranes. Both are rare, with TEN and SJS affecting approximately one or two in a Million. The complainant has failed to advance any evidence that the SJS occurred to the Patient owing to administering tablet Clobazam. Besides the affidavit of complainant and some medical literatures placed before the Commission, no other evidence is forthcoming that due to administering Clobazam, the Patient had formed the disease like SJS. On the contrary, the discharge summary of B.P. Koirala Institute of Health Sciences in respect of CT Head indicates 'diffused cerebral atrophy' has no relation with Clobazam and EEG Test speaks that there are no sharp paroxysmal activities suggestive of epileptic from discharges in the recording. However, there is relative suppressed occipital brain activity.
Regarding clinical treatment by the Doctor (opposite party no. 1), the Doctor was cross-examined at length. Some of the answers given by the Doctor appear to be very much relevant for the purpose of determining the controversy. The Doctor was asked - "May I know how did you arrive at a medical assumption that the Patient was having 'seizure disorder' and/or 'anxiety states' and/or 'parasomnia'?" to which the Doctor replied - "It was my clinical observation and primary diagnosis after taking careful history from the patient party and doing clinical examination of the patient". In another question - "Which standard treatment protocol are you referring to that prompted you to advise the necessary medication as provided by you?" to which it was replied - "On the basis of primary clinical examination, I have prescribed some medicine befitting at that juncture subject to further evaluation with investigation reports, so that standard treatment protocol could be applied." In another question - "Did you disclose to the complainant that Frisium (Clobazam) is an anti-epileptic drug?" to which it was replied - "Yes, I disclosed."
So far as qualification of the Doctor is concerned, two certificates of MBBS and DCH issued by University of Calcutta has been placed for consideration. The Doctor has explained the manner under which he has prescribed medicines and advised the patient party to undergo for tests like EEG and CT Scan.
Considering the entirety, in my view, the method adopted by opposite party no. 1 in the clinical treatment does not appear to be incorrect as per the reasonable and standard medical practice and I do not find any reason to hold that there was per se negligence on the part of the Doctor in providing medical aid to the Patient. The decision referred by the Ld. Advocate for the complainant reported in 2007 CTJ 238 [Ramdeo Prasad Singh & Ors. - vs. - Dr. Ramesh Chandra Sinha] does not appear to be applicable in our case because in the said case a child was suffering from syndactyl i.e. fingers of both the hands and toes of both the feet were fused and a surgeon through a four stage operation got separated the fingers of the hand and fingers of the left foot but could not separate the two of the fingers of the right foot due to absence of phalanx. The issue to be decided on the said case whether in such case a surgeon could be held negligent in the performance of his duties the simple answer given Hon'ble National Commission: No. In our case, it is evident that opposite party no. 1 was fit to give medical advice and treatment and he possessed of the skill and knowledge for clinical treatment keeping in view of the fact that he treated the victim only once on 04.05.2012 and never thereafter.
In a decision reported in AIR 1969 SC 128 [Dr. L. B. Joshi - vs. - Dr. Trimabak Bapu Godbole & Anr.] the Hon'ble Supreme Court has held that when a doctor is consulted by a patient the doctor owes to his patient certain duties which are (a) a duty of care in deciding whether he undertake the case; (b) a duty of care in deciding what treatment to give and (c) a duty of care in the administration of that treatment. A breach of any of the above duties may give a cause of action for negligence and the patient may on that basis recover damages from his doctor. In the case before hand, there was no deficiency or failure on duty of care from opposite party no. 1 during clinical treatment of the patient.
In AIR 2005 SCC 3180 [Jacob Mathew - vs. - State of Punjab & Anr] the Hon'ble Apex Court has held that the complainant is required to prove that the doctor did something or failed to do something which in the given facts and circumstances, no medical professional in his ordinary senses or prudence could have done or failed to do. In the instant case, the act of opposite party no. 1 was not inconsistent with the professional tone, without any lapses.
In view of the foregoing discussion and relying upon the medical literature and the authorities as referred above, I do not find any negligence on the part of opposite party no. 1. As a result, the complaint is liable to be dismissed.
Consequently, the complaint is dismissed on contest. However, there shall be no order as to costs. [HON'BLE MR. SAMARESH PRASAD CHOWDHURY] PRESIDING MEMBER